Title 21 CFR reference

Specifications.(a)(1) Each package contains 2 vials. One vial contains dry, powdered, porcine pituitary gland equivalent to 75 units (NIH-FSH-S1) of follicle stimulating hormone. The other vial contains 10 milliliters of aqueous diluent. Sponsor.(2) See No. 052923 in § 510.600(c) of this chapter. Conditions of useDosage.(3) —(i) 12.5 units of follicle stimulating hormone twice a day for 3 days (a total of 75 units). To effect regression of the corpus luteum, prostaglandin should be given with the 5th dose. Indications for use.(ii) For induction of superovulation in cows for procedures requiring the production of multiple ova at a single estrus. Limitations.(iii) For intramuscular use in cows that are not pregnant and have a normal corpus luteum. Federal law restricts this drug to use by or on the order of a licensed veterinarian. SpecificationsSingle pack.(b)(1) —(i) Each package contains 2 vials. One vial contains 700 international units (IU) porcine-pituitary-derived follicle stimulating hormone (FSH) equivalent to 400 milligrams NIH-FSH-P1, as a dry powder. The other vial contains 20 milliliters (mL) of bacteriostatic sodium chloride injection. When constituted, each…

Specifications.(a) Each milliliter (mL) of solution contains 7 milligrams (mg) frunevetmab. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useCatsAmount.(c) —(1) —(i) Administer once a month by subcutaneous injection the full contents of one or two 1-mL vials to achieve a minimum dosage of 0.45 mg/lb (1 mg/kg) body weight. Indications for use.(ii) For the control of pain associated with osteoarthritis in cats. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [87 FR 58962, Sept. 29, 2022]

Specifications.(a) (1) Each milliliter (mL) of solution contains 50 milligrams (mg) furosemide monoethanolamine. (2) Each mL of solution contains 50 mg furosemide diethanolamine. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use of products described in paragraph (a) of this section for use as in paragraph (d) of this section. (1) No. 000010 as described in paragraph (a)(1) of this section for use as in paragraphs (d)(1) and (d)(2)(ii) of this section. (2) No. 061133 as described in paragraph (a)(2) of this section for use as in paragraph (d)(2)(ii) of this section. (3) No. 058198 as described in paragraph (a)(2) of this section for use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section. (4) No. 000061 as described in paragraph (a)(2) for use as in paragraphs (d)(1), (d)(2)(iii), and (d)(3) of this section. Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditions of useDogs and catsAmount.(d) —(1) —(i) 1.25 to 2.5 mg per pound (/lb) body weight once or twice daily, intramuscularly or intravenously. Indications for use.(ii) For the treatment of edema (pulmonary congestion,…

Specifications.(a) Each milliliter (mL) of solution contains 150 milligrams (mg) gamithromycin. Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.292 of this chapter. Conditions of useCattleAmount.(d) —(1) —(i) Administer 6 mg/kilogram of body weight (2 mL per 110 pounds) one time by subcutaneous injection in the neck. Indications for use.Mannheimia haemolytica, Pasteurella multocida,Histophilus somni,Mycoplasma bovisM. haemolyticaP. multocida.(ii) For the treatment of bovine respiratory disease (BRD) associated with and in beef and non-lactating dairy cattle; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with and Limitations.(iii) Cattle intended for human consumption must not be slaughtered within 35 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [76 FR 57906, Sept. 19, 2011, as…

Specifications.(a) Each 100 milliliters contains 8 grams of gelatin in a 0.85 percent sodium chloride solution. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) The exact dosage to be administered must be determined after evaluating the animal's condition and will vary according to the size of the animal and the degree of shock. A suggested dosage range for small animals such as dogs is 4 to 8 cubic centimeters per pound body weight. The suggested dosage range for large animals such as sheep, calves, cows, or horses is 2 to 4 cubic centimeters per pound of body weight. Indications for use.(2) For use to restore circulatory volume and maintain blood pressure in animals being treated for shock. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16189, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains gentamicin sulfate equivalent to 5, 50, or 100 milligrams (mg) gentamicin. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 000061 for use of 5 mg per milliliter (/mL) solution in swine as in paragraph (d)(4), 50 mg/mL solution in dogs and cats as in paragraph (d)(1), 50 mg/mL and 100 mg/mL solution in chickens and turkeys as in paragraphs (d)(2) and (d)(3) of this section. (2) No. 058005 for use of 5 mg/mL solution in swine as in paragraph (d)(4) of this section. (3) No. 069043 for use of 50 mg/mL solution in dogs as in paragraph (d)(5) of this section. (4) Nos. 016592 and 061133 for use of 100 mg/mL solution in turkeys as in paragraph (d)(2) and in chickens as in paragraph (d)(3) of this section. Related tolerances.(c) See § 556.300 of this chapter. Conditions of useDogs and catsAmount.(d) —(1) —(i) Two milligrams of gentamicin per pound of body weight, twice daily on the first day, once daily thereafter, using a 50 milligram-per-milliliter solution. Indications for useaDogs.(ii) —() For the treatment of infections of urinary tract (cystitis, nephritis),…

Specifications.(a) Each milliliter (mL) contains the equivalent of 200 milligrams of elemental iron as gleptoferron, a complex of ferric hydroxide and dextran glucoheptonic acid. Sponsors.(b) See No. 013744 in § 510.600(c) of this chapter. Conditions of use in swineIndications for use and amounts.(c) —(1) (i) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection on or before 3 days of age. (ii) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of deficiency appear. (2) [Reserved] [81 FR 59134, Aug. 29, 2016, as amended at 82 FR 11508, Feb. 24, 2017; 82 FR 21690, May 10, 2017]

Specifications.(a) Each milliliter of solution contains 0.2 milligram glycopyrrolate. Sponsors.(b) See Nos. 054771 and 069043 in § 510.600(c) of this chapter. Conditions of use in dogs and catsAmount.(c) —(1) 5 micrograms per pound of body weight (0.25 milliliter per 10 pounds of body weight) by intravenous, intramuscular, or subcutaneous injection in dogs or by intramuscular injection in cats. Indications for use.(2) As a preanesthetic agent. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 64451, Nov. 2, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016]

Specifications.(a) Each milliliter (mL) of solution contains: (1) 43 micrograms (µg) of gonadorelin as gonadorelin acetate; (2) 100 µg of gonadorelin as gonadorelin acetate; (3) 50 µg of gonadorelin as gonadorelin diacetate tetrahydrate (equivalent to 43 µg gonadorelin); or (4) 50 µg of gonadorelin as gonadorelin hydrochloride. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter. (1) No. 000061 for use of the 43-µg/mL product described in paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section. (2) No. 068504 for use of the 100-µg/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section. (3) Nos. 000010 and 061133 for use of the 50-µg/mL product described in paragraph (a)(3) of this section as in paragraphs (e)(1)(i) and (v) of this section. (4) No. 054771 for use of the 50-µg/mL product described in paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section. Related tolerances.(c) See § 556.304 of this chapter. Special considerations.(d) (1) Concurrent luteolytic drug use is approved as follows: (i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of this section as provided by No.…

Specifications.(a) Each dose consists of 400 international units (I.U.) serum gonadotropin and 200 I.U. chorionic gonadotropin as a freeze-dried powder to be reconstituted with 5 milliliters of sterile aqueous diluent. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.304 of this chapter. Conditions of use in swineAmount.(d) —(1) 400 I.U. serum gonadotropin with 200 I.U. chorionic gonadotropin per 5 milliliters dose per animal. Indications for useGilts.(2) —(i) For induction of fertile estrus (heat) in healthy prepuberal (noncycling) gilts. Sows.(ii) For induction of estrus in healthy weaned sows experiencing delayed return to estrus. Limitations.(3) For subcutaneous use only. Gilts.1/2(i) For use only in gilts over 5 months of age and weighing at least 85 kilograms (187 pounds). Sows.(ii) Delayed return to estrus is most prevalent after the first litter. The effectiveness has not been established after later litters. Delayed return to estrus often occurs during periods of adverse environmental conditions, and sows mated under such conditions may farrow smaller than normal litters. [55 FR 1405, Jan. 16, 1990, as amended at 58 FR…

Specifications.(a) Each vial contains 5,000, 10,000 or 20,000 USP units of lyophilized powder for constitution with accompanying diluent to a 10-milliliter solution. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B) and (d)(1)(i)(C) of this section. (2) [Reserved] (3) No. 000061 for use as in paragraphs (d)(1)(i)(A) and (d)(2) of this section. Related tolerances.(c) See § 556.304 of this chapter. Conditions of useCattleAmount.per rectum(d) —(1) —(i) As a single dose. Dosage may be repeated in 14 days if the animal's behavior or examination of the ovaries indicates retreatment. (A) 10,000 USP units by intramuscular injection. (B) 500 to 2,500 USP units by intrafollicular injection. (C) 2,500 to 5,000 USP units by intravenous injection. Indications for use.(ii) For parenteral use in cows for treatment of nymphomania (frequent or constant heat) due to cystic ovaries. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. FinfishAmount.(2) —(i) 50 to 510 IU per pound of body weight for males, 67 to 1,816 IU…

Specifications.(a) Each milliliter (mL) of solution contains 0.2 milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid conjugate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in swineAmount.(c) —(1) Each intact male pig or gilt should receive two 2-mL (0.4 mg) doses by subcutaneous injection. Administer the first dose no earlier than 9 weeks of age. Administer the second dose at least 4 weeks after the first dose. Indications for useIntact male pigs intended for slaughter:(2) —(i) For the temporary immunological castration (suppression of testicular function) and reduction of boar taint. Gilts intended for slaughter:(ii) For the temporary suppression of estrus. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. For reduction of boar taint, intact male pigs should be slaughtered no earlier than 3 weeks and no later than 10 weeks after the second dose. [76 FR 27889, May 13, 2011, as amended at 77 FR 4227, Jan. 27, 2012; 79 FR 16189, Mar. 25, 2014; 85 FR 45308, July 28, 2020]

Specifications.(a) The product is a sterile powder containing guaifenesin. A solution is prepared by dissolving the drug in sterile water for injection to make a solution containing 50 milligrams of guaifenesin per milliliter of solution. Sponsors.(b) See Nos. 037990 and 054771 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 1 milliliter of prepared solution per pound of body weight by rapid intravenous infusion. Indications for use.(2) For use as a muscle relaxant. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16189, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) of guaifenesin and 50 mg of dextrose. Sponsors.(b) See Nos. 037990 and 058198 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 1 milliliter per pound of body weight by rapid intravenous infusion. Indications for use.(2) For use as a skeletal muscle relaxant. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16189, Mar. 25, 2014, as amended at 86 FR 14820, Mar. 19, 2021]

Specifications.(a) Each 125 milliliter bag contains 13 grams per deciliter of polymerized hemoglobin of bovine origin in modified Lactated Ringer's Solution. It is a sterile, clear, dark purple solution. Sponsor.(b) See No. 063075 in § 510.600(c) of this chapter. (c) [Reserved] Conditions of useAmount.(d) —(1) One-time dose of 10 to 30 milliliters per kilogram of body weight administered intravenously at a rate of up to 10 milliliters per kilogram per hour. Indications for use.(2) For the treatment of anemia in dogs by increasing systemic oxygen content (plasma hemoglobin concentration) and improving the clinical signs associated with anemia, regardless of the cause of anemia (hemolysis, blood loss, or ineffective erythropoiesis). Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [63 FR 11598, Mar. 10, 1998, as amended at 65 FR 20732, Apr. 18, 2000; 79 FR 16189, Mar. 25, 2014]

Specifications.(a)(1) Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium. Sponsor.(2) See 054771 in § 510.600(c). Conditions of useAmount.(3) —(i) Small and medium-size joints (carpal, fetlock): 20 mg; larger joint (hock): 40 mg. Treatment may be repeated at weekly intervals for a total of three treatments. Indications for use.(ii) Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. Limitations.(iii) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Specifications.(b)(1) Each milliliter of sterile aqueous solution contains 5 milligrams of hyaluronate sodium. Sponsor.(2) See 054771 in § 510.600(c) of this chapter. Conditions of useAmount.(3) —(i) Small and medium-size joints (carpal, fetlock): 10 mg; larger joint (hock): 20 mg. Treatment may be repeated at weekly intervals for a total of four treatments. Indications for use.(ii) Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. Limitations.(iii) Do not use in horses intended for…

Specifications.(a) The product is a sterile powder containing imidocarb dipropionate. Each milliliter of constituted solution contains 100 milligrams (mg) of imidocarb base. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Special considerations.(c) Imidocarb dipropionate is sold only under permit issued by the Director of the National Program Planning Staff, Veterinary Services, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, to licensed or full-time State, Federal, or military veterinarians. Conditions of use in horses and zebrasAmount.Babesia caballiBabesia equi(d) —(1) For infections, administer 2 mg of imidocarb base per kilogram of body weight by intramuscular injection in the neck region, repeating dosage once after 24 hours. For infections, administer 4 mg of imidocarb base per kilogram of body weight by intramuscular injection in the neck region, repeating dosage four times at 72-hour intervals. Indications for use.Babesia caballiBabesia equi.(2) For the treatment of babesiosis (piroplasmosis) caused by and Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the…

Specifications.(a) Each milliliter of solution contains 120 milligrams (mg) of imidocarb dipropionate. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer 6.6 mg per kilogram (3 mg per pound) of body weight by intramuscular or subcutaneous injection. Repeat the dose after 2 weeks for a total of two treatments. Indications for use.Babesia(2) For the treatment of clinical signs of babesiosis and/or demonstrated organisms in the blood. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16190, Mar. 25, 2014, as amended at 87 FR 10969, Feb. 28, 2022]

Specifications.(a) (1) Each milliliter (mL) of porcine insulin zinc suspension contains 40 international units (IU) of insulin. (2) Each mL of protamine zinc recombinant human insulin suspension contains 40 IU of insulin. Sponsors.(b) See sponsors in § 510.600 of this chapter for use as in paragraph (c) of this section. (1) No. 000061 for use of product described in paragraph (a)(1) as in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section. (2) No. 000010 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of this section. Conditions of useDogsAmountPorcine zinc insulin zinc.(c) —(1) —(i) —(A) Administer an initial once-daily dose of 0.5 IU per kilogram of body weight by subcutaneous injection concurrently with or right after a meal. Adjust this once-daily dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained. Twice-daily therapy should be initiated if the duration of insulin action is determined to be inadequate. If twice-daily…

Specifications.(a) See § 510.440 of this chapter. Each milliliter (mL) of solution contains the equivalent of: (1) 100 milligrams (mg) of elemental iron derived from: (i) Ferric hydroxide; (ii) Ferric oxide; or (iii) Elemental iron. (2) 200 mg of elemental iron derived from ferric hydroxide. Sponsors and conditions of us(b) e. It is used in young piglets by sponsors in § 510.600(c) of this chapter as follows: (1) Nos. 016592 and 042552 for use of product described in paragraph (a)(1)(i) of this section as follows: (i) For prevention of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection at 2 to 4 days of age. (ii) For treatment of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection. Dosage may be repeated in approximately 10 days. (2) No. 054771 for use of product described in paragraph (a)(1)(i) of this section as follows: (i) For the prevention of anemia due to iron deficiency, administer an initial intramuscular injection of 100 mg at 2 to 4 days of age. Dosage may be repeated in 14 to 21 days. (ii) For the treatment of anemia due to iron deficiency, administer an intramuscular injection of 200 mg. (3) Nos. 000061 and 013744…

Specifications.(a) Each milliliter of suspension contains 2 milligrams (mg) of isoflupredone acetate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useCattleAmount.(c) —(1) —(i) Administer 10 to 20 mg by intramuscular injection. Indications for use.(ii) For use in the treatment of bovine ketosis. For alleviation of pain associated with generalized and acute localized arthritic conditions; for treating acute hypersensitivity reactions; and as an aid in correcting circulatory defects associated with severe toxicity and shock. Limitations.(iii) Animals intended for human consumption should not be slaughtered within 7 days of last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Horses and swineAmountHorses.(2) —(i) —(A) Administer 5 to 20 mg by intramuscular injection for systemic effect or by intrasynovial injection into a joint cavity, tendon sheath, or bursa for local effect. Swine.(B) The usual dose for a 300-pound animal is 5 mg by intramuscular injection.…

Specifications.(a) (1) [Reserved] (2) Each mL of solution contains 10 mg ivermectin. (3) Each mL of solution contains 2.7 mg ivermectin. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section. (1) Nos. 000010, 016592, 055529, 058005, and 061133 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2) through (e)(5) of this section; and (2) No. 000010 for use of the product described in paragraph (a)(3) of this section as in paragraphs (e)(3) and (e)(6) of this section. Related tolerances.(c) See § 556.344 of this chapter. Special considerations.(d) (1) See § 500.25 of this chapter. (2) Labeling shall bear the following precaution: “This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.” Conditions of use(e) —(1) [Reserved] CattleAmount.(2) —(i) 200 micrograms per kilogram (µg/kg) of body weight by subcutaneous injection. Indications for use.Haemonchus placeiOstertagia ostertagiO. lyrataTrichostrongylus axeiT. colubriformisCooperia oncophoraC. punctataC. pectinataOesophagostomum radiatumNematodirus helvetianusN.…

Specifications.(a) Each milliliter (mL) of solution contains 10 milligrams (mg) (1 percent) ivermectin and 100 mg (10 percent) clorsulon. Sponsors.(b) See Nos. 000010, 055529, 058005, 061133, and 061651 in § 510.600(c) of this chapter. Related tolerances.(c) See §§ 556.163 and 556.344 of this chapter. Special considerations.(d) See § 500.25 of this chapter. Conditions of use in cattleAmount.(e) —(1) Administer 1 mL (10 mg ivermectin and 100 mg clorsulon) per 50 kilograms (110 pounds) by subcutaneous injection. Indications for use.Haemonchus placei, Ostertagia ostertagiO. lyrata, Trichostrongylus axei,T. colubriformis, Cooperia oncophora,C. punctata, C. pectinata,Oesophagostomum radiatum, Nematodirus helvetianusN. spathigerBunostomum phlebotomum;Dictyocaulus viviparusFasciola hepaticaHypoderma bovis, H. lineatumLinognathus vituli, Haematopinus eurysternus, Solenopotes capillatusPsoroptes ovisP. communisbovisSarcoptes scabieibovisD. viviparusO. radiatumO. ostertagi, T. axei,C. punctataH. placeiC. oncophora(2) For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) ( (including inhibited larvae), (adults only), (adults only), lungworms…

Specifications.(a) Each milliliter of solution contains 50 or 200 milligrams (mg) of kanamycin as kanamycin sulfate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in dogs and catsAmount.(c) —(1) Administer by subcutaneous or intramuscular injection 5 mg per pound of body weight per day in equally divided doses at 12-hour intervals. Indications for use.(2) For the treatment of bacterial infections due to kanamycin sensitive organisms in dogs and cats. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16190, Mar. 25, 2014]

Specifications.(a) Each milliliter contains ketamine hydrochloride equivalent to 100 milligrams (mg) ketamine base activity. Sponsors.(b) See Nos. 00010, 017033, 054771, 058198, 059399, 063286, and 069043 in § 510.600(c) of this chapter. Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditions of useCatsAmount.(d) —(1) —(i) 5 to 15 mg/pound body weight intramuscularly, depending on the effect desired. Indications for use.(ii) For restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. Subhuman primatesAmount.(2) —(i) 3 to 15 mg/kilogram body weight intramuscularly, depending upon the species, general condition, and age of the subject. Indications for use.(ii) For restraint. [67 FR 17283, Apr. 10, 2002, as amended at 73 FR 8192, Feb. 13, 2008. Redesignated at 79 FR 16191, Mar. 25, 2014, as amended at 80 FR 13229, Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018; 86 FR 14820, Mar. 19, 2021; 88 FR 27699, May 3, 2023]

Specifications.(a) Each milliliter of solution contains ketamine hydrochloride equivalent to 100 milligrams (mg) ketamine base activity, 7.5 (mg) of promazine hydrochloride, and 0.0625 mg of aminopentamide hydrogen sulfate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in catsAmount.(c) —(1) Administer by intramuscular injection 15 to 20 mg ketamine base per pound of body weight, depending on the effect desired. Indications for use.(2) It is used in cats as the sole anesthetic agent for ovariohysterectomy and general surgery. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16191, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 100 milligrams (mg) ketoprofen. Sponsors.(b) See sponsors in § 510.600(c) of this chapter. (1) No. 054771 for use as in paragraphs (d)(1) and (d)(2) of this section. (2) No. 061133 for use as in paragraph (d)(1) of this section. Related tolerances.(c) See § 556.345 of this chapter. Conditions of useHorsesAmount.(d) —(1) —(i) Administer by intravenous injection 1.0 mg per pound (/lb) of body weight once daily for up to 5 days. Indications for use.(ii) For alleviation of inflammation and pain associated with musculoskeletal disorders in horses. Limitations.(iii) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. CattleAmount.(2) —(i) Administer by subcutaneous injection 3 mg per kilogram (1.36 mg/lb) of body weight once daily for up to 3 days. Indications for use.(ii) For the control of pyrexia associated with bovine respiratory disease (BRD) in beef heifers, beef steers, beef calves 2 months of age and older, beef bulls, replacement dairy heifers, and dairy bulls. Limitations.(iii) Not for use in reproducing animals over 1 year of…

Specifications.(a) Each milliliter of solution contains levamisole phosphate equivalent to 136.5 or 182 milligrams of levamisole hydrochloride (13.65 or 18.2 percent). Sponsor.(b) See Nos. 000061 and 016592 in § 510.600 of this chapter for use of 13.65 percent injection, and see No. 054771 for use of 13.65 and 18.2 percent injection. Related tolerances.(c) See § 556.350 of this chapter. Conditions of useAmount.(d) —(1) 2 milliliters per 100 pounds of body weight, subcutaneously in the neck. Indications for use.Haemonchus, Trichostrongylus, OstertagiaTrichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, ChabertiaDictyocaulus(2) (i) The 13.65 percent injection is used as an anthelmintic in cattle for treatment of the following parasites: stomach worms (), intestinal worms (), and lungworms (). Haemonchus, Trichostrongylus, OstertagiaTrichostrongylus, Cooperia, Nematodirus, Bunostomum, OesophagostomumDictyocaulus(ii) The 18.2 percent injection is used as an anthelmintic in cattle for treatment of the following parasites: stomach worms (), intestinal worms () and lungworms (). Limitations.(3) Do not administer more than 10 milliliters per site. Cattle that are…

Specifications.(a) Each milliliter of solution contains lincomycin hydrochloride monohydrate equivalent to: (1) 25, 50, 100, or 300 milligrams (mg) lincomycin. (2) 25, 100, or 300 mg lincomycin. (3) 300 mg lincomycin. (4) 100 or 300 mg lincomycin. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for uses as in paragraph (e) of this section. (1) No. 054771 for use of concentrations in paragraph (a)(1) of this section as in paragraph (e) of this section. (2) Nos. 016592 and 058005 for use of concentrations in paragraph (a)(2) of this section as in paragraph (e)(2) of this section. (3) No. 054771 for use of concentration in paragraph (a)(3) of this section as in paragraph (e)(2) of this section. (4) No. 061133 for use of concentrations in paragraph (a)(4) of this section as in paragraph (e)(2) of this section. Special considerations.(c) When common labeling for use of the drug in dogs, cats, and swine is included with the drug, all such uses are subject to the labeling requirements of § 201.105 of this chapter. Related tolerances.(d) See § 556.360 of this chapter. Conditions of use.(e) It is used for animals as follows: Dogs and catsAmount.(1) —(i) 5 mg per…

Specifications.(a) Each milliliter of suspension contains 100 milligrams (mg) of lufenuron. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of use in catsAmount.(c) —(1) 10 mg per kilogram (4.5 mg per pound) of body weight every 6 months, by subcutaneous injection. Indications for use.(2) For control of flea populations in cats 6 weeks of age and older. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16191, Mar. 25, 2014, as amended at 80 FR 61297, Oct. 13, 2015]

Specifications.(a) Each milliliter of solution contains 7.5 milligrams (mg) luprostiol. Sponsor.(b) See No. 051311 in § 510.600(c) of this chapter. Special considerations.Warning:(c) Labeling shall bear the following statements: Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Luprostiol is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water. Conditions of use in horsesAmount.(d) —(1) 7.5 mg by intramuscular injection. (2) Indications for use. For estrus control and termination of pregnancy in mares. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. [55 FR 1185, Jan. 12, 1990, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 61 FR 66582, Dec. 18, 1996; 74 FR 25146, May 27, 2009]

Specifications.(a) Each milliliter of solution contains 10 milligrams (mg) maropitant as maropitant citrate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useDogsAmount.(c) —(1) —(i) Administer 1.0 mg per kilogram (mg/kg) of body weight by subcutaneous or intravenous injection once daily for up to 5 consecutive days. Indications for use.(ii) For the prevention and treatment of acute vomiting. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. CatsAmount.(2) —(i) Administer 1.0 mg/kg of body weight by subcutaneous or intravenous injection once daily for up to 5 consecutive days. Indications for use.(ii) For the treatment of vomiting. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 9243, Mar. 1, 2007, as amended at 77 FR 39391, July 3, 2012; 79 FR 16191, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016]

Specifications.(a) Each milliliter of solution contains 1.0 milligrams of medetomidine hydrochloride. Sponsor.(b) See Nos. 015914 and 052483 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) 750 micrograms intravenously (IV) or 1,000 micrograms intramuscularly per square meter of body surface. The IV route is more efficacious for dental care. Indications for use.(2) As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [61 FR 21075, May 9, 1996, as amended at 79 FR 16191, Mar. 25, 2014; 82 FR 58556, Dec. 13, 2017]

Specifications.(a) Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride. Sponsor.(b) See No. 043264 in § 510.600(c) of this chapter. Conditions of useAmount.2(c) —(1) Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m ) BSA or use the dosing table provided in labeling. Indications for use.(2) For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022]

Specifications.(a) The drug is a silicone rubber elastomer implant containing 2.7 milligrams of melatonin. Sponsor.(b) See No. 053923 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) One implant per mink. Indications for use.Mustela vison(2) For use in healthy male and female kit and adult female mink () to accelerate the fur priming cycle. Limitations.(3) For subcutaneous implantation in mink only. Do not implant potential breeding stock. Do not use in food-producing animals. [59 FR 37422, July 22, 1994]

Specifications.(a) The drug consists of a vial of lyophilized powder containing 50 milligrams of melarsomine dihydrochloride which is reconstituted with the provided 2 milliliters of sterile water for injection. Sponsor.(b) See Nos. 000010 and 086073 in § 510.600(c) of this chapter. Conditions of useAmount.352552(c) —(1) Administer only by deep intramuscular injection in the lumbar muscles (L-L). Indications.Dirofilaria immitis552(2) Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L) to mature adult infections of in dogs. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [60 FR 49340, Sept. 25, 1995, as amended at 79 FR 16191, Mar. 25, 2014; 82 FR 21690, May 10, 2017; 84 FR 39184, Aug. 9, 2019]

Specifications.(a) Each milliliter of solution contains 5.0 milligrams (mg) meloxicam. Sponsors.(b) See Nos. 000010, 016729, 017033, 055529, and 086101 in § 510.600(c) of this chapter. Conditions of useDogsAmount.(c) —(1) —(i) Administer 0.09 mg per pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) by intravenous or subcutaneous injection on the first day of treatment. For treatment after day 1, administer meloxicam suspension orally at 0.045 mg/lb (0.1 mg/kg) body weight once daily as in § 520.1367(c) of this chapter. Indications for use.(ii) For the control of pain and inflammation associated with osteoarthritis. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. CatsAmount.(2) —(i) Administer 0.14 mg/lb (0.3 mg/kg) body weight as a single, one-time subcutaneous injection. Indications for use.(ii) For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration when administered prior to surgery. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 68724, Dec. 10, 2003, as amended at 69 FR 69523,…

Specifications.(a) Each milliliter (mL) of solution contains 20 milligrams mepivacaine hydrochloride. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) For nerve block, 3 to 15 mL; for epidural anesthesia, 5 to 20 mL; for intra-articular anesthesia, 10 to 15 mL; for infiltration, as required; for anesthesia of the laryngeal mucosa prior to ventriculectomy, by topical spray, 25 to 40 mL, by infiltration, 20 to 50 mL. Indications for use.(2) For use as a local anesthetic for infiltration, nerve block, intra-articular and epidural anesthesia, and topical and/or infiltration anesthesia of the laryngeal mucosa prior to ventriculectomy. Limitations.(3) Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 39547, July 13, 2006, as amended at 79 FR 16191, Mar. 25, 2014; 88 FR 14898, Mar. 10, 2023]

Specifications.(a) Each milliliter of solution contains 100 milligrams (mg) of methocarbamol. Sponsor.(b) See No. 051031 in § 510.600(c) of this chapter. Conditions of useAmountDogs and cats.(c) —(1) —(i) Administer by intravenous injection 20 mg per pound of body weight for moderate conditions or 25 to 100 mg per pound of body weight for severe conditions (tetanus and strychnine poisoning). The total cumulative dose should not to exceed 150 mg per pound of body weight. Horses.(ii) Administer by intravenous injection 2 to 10 mg per pound of body weight for moderate conditions or 10 to 25 mg per pound of body weight for severe conditions (tetanus). Additional amounts may be needed to relieve residual effects and to prevent recurrence of symptoms. Indications for use.(2) As an adjunct for treating acute inflammatory and traumatic conditions of the skeletal muscles and to reduce muscular spasms. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16191, Mar. 25, 2014, as amended at 82 FR 11508, Feb. 24, 2017]

Specifications.(a) Each milliliter of suspension contains 20 or 40 milligrams (mg) of methylprednisolone acetate. Sponsors.(b) See Nos. 054771 and 069043 in § 510.600(c) of this chapter. (c) [Reserved] Conditions of useDogsAmount.(d) —(1) —(i) Administer 2 to 40 mg (up to 120 mg in extremely large breeds or dogs with severe involvement) by intramuscular injection or up to 20 mg by intrasynovial injection. Indications for use.(ii) For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. CatsAmount.(2) —(i) Administer 10 to 20 mg by intramuscular injection. Indications for use.(ii) For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. HorsesAmount.(3) —(i) Administer 200 mg by intramuscular injection or 40 to 240 mg by…

Specifications.(a) Each milliliter of solution contains 10.0 milligrams arsenamide sodium. Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer 0.1 milliliter (mL) per pound of body weight (1.0 mL for every 10 pounds) by intravenous injection twice a day for 2 days. Indications for use.Dirofilaria immitis.(2) For the treatment and prevention of canine heartworm disease caused by Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16184, Mar. 25, 2014, as amended at 84 FR 39183, Aug. 9, 2019]

Specifications.(a) Each milliliter (mL) of solution contains 10 milligrams (mg) moxidectin. Sponsors.(b) See Nos. 055529 and 058198 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.426 of this chapter. Special considerations.(d) See § 500.25 of this chapter. Conditions of use in cattle—(1) Amount.(e) Administer by subcutaneous injection 1 mL for each 110 pounds (lb) (50 kilograms (kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. Indications for use.Ostertagia ostertagiHaemonchus placeiTrichostrongylus axeiTrichostrongylus colubriformisCooperia oncophoraCooperia pectinataCooperia punctataCooperia spatulataCooperia surnabadaNematodirus helvetianusOesophagostomum radiatumTrichurisDictyocaulus viviparusHypoderma bovisHypoderma lineatum;Psoroptes ovisPsoroptes communisbovisLinognathus vituliSolenopotes capillatus.Dictyocaulus viviparusOesophagostomum radiatumHaemonchus placeiOstertagia ostertagiTrichostrongylus axei(2) Beef and nonlactating dairy cattle: For treatment and control of Gastrointestinal roundworms: (adults, fourth-stage larvae, and inhibited larvae), (adults), (adults and fourth-stage larvae), (adults and fourth-stage…

Specifications.(a) The drug product consists of two separate vials. One vial contains 10 percent moxidectin microspheres and the second vial contains a vehicle for constitution of the moxidectin microspheres. (1) Each milliliter (mL) of constituted suspension contains 3.4 milligrams (mg) moxidectin. (2) Each mL of constituted suspension contains 10 mg moxidectin. Sponsor.(b) See No. 54771 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) (i) Using the suspension described in paragraph (a)(1) of this section, administer 0.05 mL of the constituted suspension per kilogram (kg) of body weight (0.023 mL per pound (lb)) as a single subcutaneous injection to provide 0.17 mg/kg body weight (0.0773 mg/lb). (ii) Using the suspension described in paragraph (a)(2) of this section, administer 0.05 mL of the constituted suspension/kg of body weight (0.023 mL/lb) as a single subcutaneous injection to provide 0.5 mg/kg body weight (0.23 mg/lb). Indications for useSuspension described in paragraph (a)(1) of this section.Dirofilaria immitisAncylostoma caninumUncinaria stenocephala(2) —(i) For prevention of heartworm disease caused by in dogs 6 months of age and older;…

Specifications.(a) Each milliliter of solution contains 5 milligrams of nalorphine hydrochloride. Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) One milligram per 5 pounds; intravenously, intramuscularly, or subcutaneously. Indications for use.(2) Respiratory and circulatory depression in dogs resulting from overdosage of, or unusual sensitivity to, morphine and certain other narcotics. Not for depression due to any other cause. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 6707, Feb. 2, 1979, as amended at 47 FR 36418, Aug. 20, 1982; 62 FR 63271, Nov. 28, 1997; 79 FR 16191, Mar. 25, 2014; 84 FR 39184, Aug. 9, 2019]

Specifications.(a) Each milliliter of solution contains 50 milligrams of naltrexone hydrochloride. Sponsor.(b) See 053923 in § 510.600(c) of this chapter. Conditions of use in elk and mooseAmount.(c) —(1) 100 milligrams of naltrexone hydrochloride for each milligram of carfentanil citrate administered. One-quarter of the dose should be administered intravenously and three-quarters of the dose should be administered subcutaneously. Indications for use.Cervidae(2) As an antagonist to carfentanil citrate immobilization in free-ranging or confined elk and moose (). Limitations.(3) Do not use in domestic food-producing animals. Do not use in free-ranging animals for 45 days before or during hunting season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [62 FR 5320, Feb. 5, 1997, as amended at 79 FR 16191, Mar. 25, 2014]

Specifications.(a) The drug is a lyophilized powder which is reconstituted with sterile water for injection to form a 10 percent sterile aqueous solution (100 milligrams per milliliter). Sponsor.(b) See 054771 in § 510.600(c) of this chapter. Conditions of use in horsesDosage.(c) —(1) Five milligrams per kilogram of body weight intravenously followed by maintenance oral therapy of 10 milligrams per kilogram of body weight twice daily for up to 14 consecutive days. Indications for use.(2) For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system of the horse. Limitations.(3) Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [46 FR 26763, May 15, 1981. Redesignated and amended at 51 FR 24525, July 7, 1986; 61 FR 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride. Sponsor.(b) See Nos. 015914 and 052483 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Inject intramuscularly the same volume as that of dexmedetomidine or medetomidine used. Indications for use.(2) For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007; 84 FR 8973, Mar. 13, 2019]

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) of neomycin sulfate (equivalent to 35 mg of neomycin base). Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in dogs and catsAmount.(c) —(1) Administer 5 mg per pound of body weight daily by intramuscular or intravenous injection, divided into portions administered every 6 to 8 hours for 3 to 5 days. Indications for use.(2) For the treatment of acute and chronic bacterial infections due to organisms susceptible to neomycin. Limitations.(3) Not for parenteral use in food-producing animals because of prolonged residues in edible tissues. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16192, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 40 milligrams (mg) azaperone. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.68 of this chapter. Conditions of useIndications for use.(d) —(1) For control of aggressiveness when mixing or regrouping weanling or feeder pigs weighing up to 80 pounds. Dosage.(2) 2.2 mg per kilogram (1 mg per pound) by deep intramuscular injection. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [74 FR 65689, Dec. 11, 2009, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48702, July 26, 2016; 84 FR 32992, July 11, 2019]

Specifications.(a) Each milliliter of solution contains 2 milligrams (mg) neostigmine methylsulfate. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useAmount.1/2(c) —(1) Administer to cattle and horses at a dosage level of 1 mg per (/) 100 pounds (lbs) of body weight subcutaneously. Administer to sheep at a dosage level of 1 to 1 mg/100 lbs body weight subcutaneously. Administer to swine at a dosage level of 2 to 3 mg/100 lbs body weight intramuscularly. These doses may be repeated as indicated. Indications for use.(2) For treating rumen atony; initiating peristalsis which causes evacuation of the bowel; emptying the urinary bladder; and stimulating skeletal muscle contractions. Limitations.(3) Not for use in animals producing milk, since this use will result in contamination of the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 62 FR 61625, Nov. 19, 1997; 79 FR 16192, Mar. 25, 2014]

Specifications.(a) Each milliliter of suspension contains: (1) Betamethasone acetate equivalent to 10.8 milligrams (mg) betamethasone and betamethasone disodium phosphate equivalent to 3 mg of betamethasone. (2) Betamethasone dipropionate equivalent to 5 mg betamethasone and betamethasone sodium phosphate equivalent to 2 mg of betamethasone. Sponsor.(b) See sponsor numbers in § 510.600(c) of this chapter: (1) No. 000061 for product described in paragraph (a)(1) of this section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section. (2) No. 000061 for product described in paragraph (a)(2) of this section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(B), and (c)(2)(iii) of this section. Conditions of useDogsAmount.(c) —(1) —(i) Administer by intramuscular injection 0.25 to 0.5 milliliter (mL) per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of four injections. Indications for use.(ii) As an aid in the control of pruritus associated with dermatoses.…

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) of sodium oleate. Sponsor.(b) See No. 037990 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer by parenteral injection depending on the area of response desired. An injection of 1 milliliter (mL) will produce a response of approximately 15 square centimeters. Do not inject more than 2 mL per injection site. Regardless of the number of injection sites, the total volume used should not exceed 10 mL. Indications for use.(2) It is used in horses to stimulate infiltration of cellular blood components that subsequently differentiate into fibrous and/or fibrocartilagenous tissue. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [41 FR 27034, July 1, 1976, as amended at 50 FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25, 2014]

Specifications.(a) Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension is a sterile aqueous suspension. Each milliliter of the suspension contains the equivalent of 5 milligrams of betamethasone as betamethasone dipropionate and 2 milligrams of betamethasone as betamethasone sodium phosphate. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useDogs.(c) —(1) (i) It is used as an aid in the control of pruritus associated with dermatoses. (ii) It is administered by intramuscular injection at a dosage of 0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of 4 injections. Horses.(2) (i) It is used as an aid in the control of inflammation associated with various arthropathies. (ii) It is administered aseptically by intraarticular injection at a dosage of 2.5 to 5 milliliters per joint, depending on the severity of the condition and the joint size. Dosage may be repeated upon recurrence of clinical signs. Injection into the joint cavity…

Specifications.(a) Each milliliter of sterile solution contains 200 milligrams of oxytetracycline base. Sponsors.(b) See Nos. 000010, 016592, 054771, 055529, 061133, and 069254 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.500 of this chapter. Special considerations.(d) When labeled for the treatment of anaplasmosis or anthrax, labeling shall also bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” Conditions of useBeef cattle, dairy cattle, and calves including prerumenative (veal) calvesAmounts and indications for use.PasteurellaHaemophilusFusobacterium necrophorum,Escherichia coli,Actinobacillus lignieresii,Leptospira pomona,StaphylococcusStreptococcusBacillus anthracis.(e) —(1) —(i) (A) 3 to 5 mg per pound of body weight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of pneumonia and shipping fever complex associated with spp. and spp., foot-rot and diphtheria caused by bacterial enteritis (scours) caused by wooden tongue caused by leptospirosis caused by wound infections and acute metritis caused by spp. and spp., and anthrax caused by Anaplasma…

Specifications.(a) Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base. Sponsor.(b) See No. 055529 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.500 of this chapter. Special considerations.(d) When labeled for use as in paragraph (e)(1)(i)(D) or (e)(1)(i)(E) of this section, labeling shall also bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”. Conditions of useBeef cattle, nonlactating dairy cattle, and calves including preruminating (veal) calvesAmounts and indications for use.PasteurellaHistophilusFusobacterium necrophorum,Escherichia coli,Actinobacillus lignieresii,Leptospira pomona,StaphylococcusStreptococcus(e) —(1) —(i) (A) 3 to 5 mg per pound of bodyweight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of pneumonia and shipping fever complex associated with spp. and spp., foot-rot and diphtheria caused by bacterial enteritis (scours) caused by wooden tongue caused by leptospirosis caused by wound infections and acute metritis caused by spp. and spp. (B) 5 mg/lb BW/day intramuscularly, subcutaneously, or intravenously…

(a) For related tolerances see § 556.500 of this chapter. Specifications.(b)(1) The drug contains 50 milligrams of oxytetracycline hydrochloride in each milliliter of sterile solution. Sponsor.(2) See No. 069043 in § 510.600(c) of this chapter. Conditions of useAmount.Pasteurella spp.; Hemophilis spp.; Klebsiella spp.E. coliSpherophorus necrophorusSpherophorus necrophorusActinobacillus lignieresiLeptospira pomona(3) —(i) The drug is intended for use in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves for treatment of disease conditions caused by one or more of the following oxytetracycline sensitive pathogens listed as follows: pneumonia and shipping fever complex ( ), bacterial enteritis (scours) (), foot-rot (), diphtheria (), wooden tongue (), leptospirosis (), and wound infections; acute metritis; traumatic injury (caused by a variety of bacterial organisms (such as streptococcal and staphylococcal organisms).) Indications for use.(ii) It is administered by intramuscular injection of 3 to 5 milligrams of oxytetracycline hydrochloride per pound of body weight per day. Leptospirosis, severe foot-rot and severe forms of the indicated diseases should be…

Specifications.(a) The drug contains 50 or 100 milligrams of oxytetracycline hydrochloride and 2 percent lidocaine in each milliliter of sterile aqueous solution. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use.Hemolytic staphylococcus, Streptococcus spp.,Brucella bronchiseptica, Streptococcus pyogenes, Staphylococcus aureus,Micrococcus pyogenes var. albus, Brucella bronchiseptica, Streptococcus spp.(c) (1) The drug is indicated for use in the treatment of diseases of dogs caused by pathogens sensitive to oxytetracycline hydrochloride including treatment for the following conditions in dogs caused by susceptible microorganisms: Bacterial infections of the urinary tract caused by Bacterial pulmonary infections caused by secondary bacterial infections caused by (2) The drug is administered intramuscularly at a recommended daily dosage to dogs at 5 milligrams per pound of body weight administered in divided doses at 6 to 12 hour intervals. Therapy should be continued for at least 24 hours after all symptoms have subsided. (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended…

Specifications.(a) Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base as amphoteric oxytetracycline and 20 mg flunixin base as flunixin meglumine. Sponsor.(b) See No. 055529 in § 510.600(c) of this chapter. Related tolerances.(c) See §§ 556.286 and 556.500 of this chapter. Conditions of use cattleAmount.(d) —(1) Administer once as an intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW) where retreatment of calves and yearlings for bacterial pneumonia is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable. Indications for use.Pasteurella(2) For the treatment of bacterial pneumonia associated with spp. and for the control of associated pyrexia in beef and nonlactating dairy cattle. Limitations.(3) Discontinue treatment at least 21 days prior to slaughter of cattle. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not…

Specifications.(a) Each milliliter (mL) of suspension contains 6 milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate). Sponsor.(b) See No. 010797 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 1.5 mL (9 mg total betamethasone) per joint by intra-articular injection. May be administered concurrently in up to two joints per horse. Indications for use.(2) For the control of pain and inflammation associated with osteoarthritis in horses. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [80 FR 18776, Apr. 8, 2015]

Specifications.(a) Each milliliter (mL) of solution contains 20 USP units oxytocin. Sponsors.(b) See Nos. 054771 and 061133 in § 510.600(c) of this chapter. Conditions of useAmountObstetrical.(c) —(1) —(i) Administer drug intravenously, intramuscularly, or subcutaneously under aseptic conditions as indicated. The following dosages are recommended and may be repeated as conditions require: Milk letdown.(ii) Intravenous administration is desirable. The following dosage is recommended and may be repeated as conditions require: Indications for use.(2) Oxytocin may be used as a uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris. In surgery it may be used postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood. It will contract smooth muscle cells of the mammary gland for milk letdown if the udder is in proper physiological state. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Table | mL | U.S.P. units | | --- | --- | | Cats | 0.25 to 0.5 | 5 to 10. | | Dogs | 0.25 to 1.5 | 5 to 30. | | Ewes, Sows | 1.5 to 2.5 |…

Specifications.(a) Each pre-filled, single-dose syringe contains 15 milligrams of pegbovigrastim. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of use in cattleAmount.(c) —(1) Administer the first dose (syringe) by subcutaneous injection 7 days prior to the cow's or heifer's anticipated calving date. If necessary, the first dose may be administered within a range of 4 to 10 days prior to the anticipated calving date to accommodate management schedules. Administer the second dose (syringe) by subcutaneous injection within 24 hours after calving. Indications for use.(2) For the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows and periparturient replacement dairy heifers. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [81 FR 36789, June 8, 2016, as amended at 81 FR 48702, July 26, 2016]

Specifications.(a) Each milliliter of aqueous suspension contains penicillin G benzathine and penicillin G procaine, each equivalent to 150,000 units of penicillin G. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for the conditions of use in paragraph (d) of this section as follows: (1) Nos. 054771 and 061133 for use as in paragraph (d)(1) of this section. (2) Nos. 016592 and 061133 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(2)(iii) of this section. (3) No. 054771 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of this section. Related tolerances.(c) See § 556.510 of this chapter. Conditions of useHorses, dogs, and beef cattleAmountBeef cattle.(d) —(1) —(i) —(A) 2 milliliters per 150 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours. Horses.(B) 2 milliliters per 150 pounds of body weight intramuscularly. Repeat dosage in 48 hours. Dogs.(C) 1 milliliter per 10 to 25 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours. Indications for use.(ii) Treatment of bacterial infections susceptible to penicillin G. Limitations.(iii) Not for use in beef cattle within 30 days…

Specifications.(a) Each milliliter contains penicillin G procaine equivalent to 300,000 units of penicillin G. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter as follows: (1) Nos. 016592 and 054771 for use as in paragraph (d) of this section. (2) Nos. 055529 and 061133 for use as in paragraph (d)(2) of this section. Related tolerances.(c) See § 556.510 of this chapter. Conditions of useDogs and catsAmount.(d) —(1) —(i) 10,000 units per pound body weight daily by intramuscular injection. Indications for use.(ii) Treatment of infections caused by penicillin-sensitive organisms. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cattle, sheep, swine, and horsesAmount.(2) —(i) 3,000 units per pound body weight (1 milliliter per 100 pounds body weight) daily by intramuscular injection. Indications for use.Pasteurella multocidaErysipelothrix rhusiopathiaeStreptococcus equi.(ii) Treatment of cattle and sheep for bacterial pneumonia (shipping fever) caused by ; swine for erysipelas caused by ; and horses for strangles caused by Limitations.(iii) Not for use in horses intended for food. Milk that has been taken…

Specifications.(a) Each milliliter contains penicillin G procaine equivalent to 300,000 units of penicillin G. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) Dogs and cats—10,000 units per pound of body weight once daily. Horses—3,000 units per pound of body weight once daily. Indications for use.(2) Treatment of infections of dogs, cats, and horses caused by penicillin-susceptible organisms such as Streptococci, Staphylococci, and Corynebacteria. Limitations.(3) Not for use in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37333, Aug. 18, 1992, as amended at 79 FR 16193, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains pentazocine lactate equivalent to 30 milligrams (mg) of pentazocine base. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useHorsesAmount.(c) —(1) —(i) Administer 0.15 mg pentazocine base per pound of body weight daily by intravenous or intramuscular injection. In cases of severe pain, a second dose is recommended by intramuscular injection 10 to 15 minutes after the initial dose at the same level. Indications for use.(ii) For symptomatic relief of pain due to colic. Limitations.(iii) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. DogsAmount.(2) —(i) Administer 0.75 to 1.50 mg of pentazocine base per pound of body weight by intramuscular injection. Indications for use.(ii) For amelioration of pain accompanying postoperative recovery, fracture, trauma, and spinal disorders. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [42 FR 31450, June 21, 1977, as amended at 42 FR 36995, July 19, 1977; 47 FR 5409, Feb. 5, 1982; 55 FR 23076, June 6, 1990; 79 FR…

Specifications.(a) Each milliliter (mL) of solution contains 390 milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium. Sponsors.(b) See Nos. 000061, 051311, 054925, and 059399 in § 510.600(c) of this chapter. Special considerations.(c) Product labeling shall bear the following warning statements: “ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.” Conditions of use in dogsAmount.(d) —(1) Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous or intracardiac injection. Indications for use.(2) For humane, painless, and rapid euthanasia. Limitations.(3) Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [85 FR 18120, Apr. 1, 2020, as amended at 85 FR 45308, July 28, 2020. Redesiganted at 86 FR 61685, Nov. 8, 2021]

Specifications.(a) Each milliliter of solution contains 64.8 milligrams (mg) of sodium pentobarbital. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) The drug is administered intravenously “to effect”. For general surgical anesthesia, the usual dose is 11 to 13 mg per pound of body weight. For sedation, the usual dose is approximately 2 mg per pound of body weight. For relieving convulsive seizures caused by strychnine in dogs, the injection should be administered intravenously “to effect”. The drug may be administered intraperitoneally. When given intraperitoneally, it is administered at the same dosage level as for intravenous administration. Indications for use.(2) The drug is indicated for use as a general anesthetic in dogs and cats. Although it may be used as a general surgical anesthetic for horses, it is usually given at a lower dose to cause sedation and hypnosis and may be supplemented with a local anesthetic. It may also be used in dogs for the symptomatic treatment of strychnine poisoning. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a…

Specifications.(a) Each milliliter of solution contains 250 milligrams (mg) of pentosan polysulfate sodium. Sponsor.(b) See No. 086073 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) Administer 3 mg per kilogram of body weight (1.4 mg per pound) by intramuscular injection once weekly for 4 weeks for a total of four doses. Indications for use.(2) For the control of clinical signs associated with osteoarthritis in horses. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [88 FR 16548, Mar. 20, 2023]

Specifications.(a) (1) Each milliliter of solution contains 100 milligrams (mg) of phenylbutazone. (2) Each milliliter of solution contains 200 mg of phenylbutazone. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (c) of this section. (2) Nos. 000061, 054771, 058198, and 061133 for use of product described in paragraph (a)(2) of this section as in paragraph (c) of this section. (3) Nos. 058005 and 069043 for use of product described in paragraph (a)(2) as in paragraph (c)(2) of this section. Conditions of useDogsAmount.(c) —(1) —(i) Administer by intravenous injection 10 mg per pound of body weight daily in three divided doses, not to exceed 800 mg daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow. Indications for use.(ii) It is used for the relief of inflammatory conditions associated with the musculoskeletal system. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. HorsesAmount.(2) —(i) Administer by intravenous…

Specifications.(a) The drug is a lyophilized pituitary extract. Each 6-milliliter vial contains an amount equivalent to 25 milligrams of standard pituitary luteinizing hormone and is reconstituted for use by addition of 5 milliliters of 0.9 percent aqueous sodium chloride solution. Sponsor.(b) No. 000061 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) Cattle and horses: 25 milligrams; swine: 5 milligrams; sheep: 2.5 milligrams; and dogs: 1.0 milligram. Preferably given by intravenous injection, it may be administered subcutaneously. Treatment may be repeated in 1 to 4 weeks, or as indicated. Indications for use.(2) As an aid in the treatment of breeding disorders related to pituitary hypofunction in cattle, horses, swine, sheep, and dogs. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 16193, Mar. 25, 2014]

Specifications.(a) (1) Each 1-milliliter (mL) ampule of solution contains 250 milligrams (mg) polysulfated glycosaminoglycan. (2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan. Sponsor.(b) See No. 010797 in § 510.600(c) of this chapter. Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditions of useHorsesIndications for use.(d) —(1) —(i) For the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. AmountIntra-articular use (carpal)(ii) —(A) : 250 mg once a week for 5 weeks. Intramuscular use (carpal and hock)(B) : 500 mg every 4 days for 28 days. Limitations.(iii) Do not use in horses intended for human consumption. DogsIndications for use.(2) —(i) For control of signs associated with noninfectious degenerative and/or traumatic arthritis of canine synovial joints. Amount.(ii) 2 mg per pound of body weight by intramuscular injection twice weekly for up to 4 weeks (maximum of 8 injections). [72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec.…

Specifications.(a) Each vial contains 1 gram (g) of pralidoxime chloride powder for mixing with 20 cubic centimeters of sterile water for injection. Each milliliter of constituted solution contains 50 milligrams (mg) pralidoxime chloride. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) Administer as soon as possible after exposure to the poison. Before administration of the sterile pralidoxime chloride, atropine is administered intravenously at a dosage rate of 0.05 mg per pound of body weight, followed by administration of an additional 0.15 mg of atropine per pound of body weight administered intramuscularly. Then the appropriate dosage of sterile pralidoxime chloride is administered slowly intravenously. The dosage rate for sterile pralidoxime chloride when administered to horses is 2 g per horse. When administered to dogs and cats, it is 25 mg per pound of body weight. For small dogs and cats, sterile pralidoxime chloride may be administered either intraperitoneally or intramuscularly. A mild degree of atropinization should be maintained for at least 48 hours. Following severe poisoning, a second dose of sterile pralidoxime…

Specifications.(a) Each milliliter (mL) of solution contains 56.8 milligrams of praziquantel. Sponsors.(b) See Nos. 058198 and 061133 in § 510.600(c) of this chapter. Conditions of useDogsAmount.(c) —(1) —(i) Administer by subcutaneous or intramuscular injection for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight to a maximum of 3 mL. Indications for use.Dipylidium caninum, Taenia pisiformis,Echinococcus granulosus,Echinococcus multilocularis.(ii) For removal of canine cestodes and and removal and control of canine cestode Limitations.(iii) Federal law restricts the drug to use by or on the order of a licensed veterinarian. CatsAmount.(2) —(i) Administer by subcutaneous or intramuscular injection for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and over, 0.6 mL maximum. Indications for use.Dipylidium caninumTaenia taeniaeformis.(ii) For removal of feline cestodes and Limitations.(iii) Federal law restricts the drug to use by or on the order of a licensed veterinarian. [46 FR 10464, Feb. 3, 1981, as amended at 47 FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12, 1993; 67…

Specifications.(a) Each milliliter of suspension contains 25 milligrams (mg) of prednisolone acetate. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) The drug is administered to horses intra-articularly at a dosage level of 50 to 100 mg. The dose may be repeated when necessary. The drug is administered to dogs and cats intramuscularly at a dosage level of 10 to 50 mg. The dosage may be repeated when necessary. If the condition is of a chronic nature, an oral corticosteroid may be given as a maintenance dosage. The drug may be given intra-articularly to dogs and cats at a dosage level of 5 to 25 mg. The dose may be repeated when necessary after 7 days for two or three doses. Indications for use.(2) The drug is indicated in the treatment of dogs, cats, and horses for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and postoperatively and for various stress…

Specifications.(a) Each milliliter of solution contains 20 milligrams (mg) prednisolone sodium phosphate (equivalent to 14.88 mg of prednisolone). Sponsor.(b) See No. 061133 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.1/2(c) —(1) Administer intravenously in a dosage of 2 to 5 mg per pound of body weight, initially for shock and shock-like states, followed by equal maintenance doses at 1-, 3-, 6-, or 10-hour intervals as determined by the condition of the animal. Indications for use.(2) Administer when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is necessary. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 59881, Oct. 20, 2003, as amended at 84 FR 8974, Mar. 13, 2019]

Specifications.(a) Each milliliter of prednisolone sodium succinate injection contains: Prednisolone sodium succinate equivalent in activity to 10, 20, or 50 milligrams (mg) of prednisolone. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter for products containing 10, 20, and 50 mg equivalent prednisolone activity per milliliter for use in horses, dogs, and cats as provided in paragraphs (c)(1)(i), (ii), and (iii) of this section. Conditions of useAmount and indications for useHorses.(c) —(1) —(i) Administer 50 to 100 mg as an initial dose by intravenous injection over a period of one-half to 1 minute, or by intramuscular injection, and may be repeated in inflammatory, allergic, or other stress conditions at intervals of 12, 24, or 48 hours, depending upon the size of the animal, the severity of the condition and the response to treatment. Dogs.(ii) Administer by intravenous injection at a range of 2.5 to 5 mg per pound of body weight as an initial dose followed by maintenance doses at 1, 3, 6, or 10 hour intervals, as determined by the condition of the animal, for treatment of shock. Dogs and cats.(iii) Administer by intramuscular injection for treatment of…

Specifications.(a) Each milliliter of suspension contains 10 to 40 milligrams (mg) of prednisone. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useAmountHorses.(c) —(1) —(i) Administer 100 to 400 mg by intramuscular injection, repeating if necessary. Dogs and cats.(ii) Administer 0.25 to 1.0 mg per pound of body weight by intramuscular injection for 3 to 5 days or until a response is noted. Treatment may be continued with an orally administered dose. Indications for use.(2) It is used for conditions requiring an anti-inflammatory agent. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16194, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains prochlorperazine edisylate equivalent to 4 milligrams (mg) prochlorperazine and isopropamide iodide equivalent to 0.28 mg of isopropamide. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) (i) Dosage is administered by subcutaneous injection twice daily as follows: (ii) Following the last injection, administer prochlorperazine and isopropamide sustained release capsules as indicated. Indications for use.(2) For use in dogs and cats in which gastrointestinal disturbances are associated with emotional stress. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Table | Weight of animal in pounds | Dosage inmilliliters | | --- | --- | | Up to 4 | 0.25 | | 5 to 14 | 0.5-1 | | 15 to 30 | 2-3 | | 30 to 45 | 3-4 | | 45 to 60 | 4-5 | | Over 60 | 6 | [79 FR 16194, Mar. 25, 2014]

Sponsors.(a) See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and (c)(3) of this section. (2) No. 058198 for use as in paragraphs (c)(1) and (c)(2) of this section. Related tolerances.(b) See §§ 556.240 and 556.540 of this chapter. Conditions of use in cattle.(c) It is used for implantation as follows: Suckling beef calves at least 45 days old and up to 400 lb of body weightAmount.(1) —(i) (A) 100 milligrams (mg) progesterone and 10 mg estradiol benzoate (one implant consisting of 4 pellets, each pellet containing 25 mg progesterone and 2.5 mg estradiol benzoate) per implant dose. (B) 100 mg progesterone and 10 mg estradiol benzoate (one implant consisting of 5 pellets, each of 4 pellets containing 25 mg progesterone and 2.5 mg estradiol benzoate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose. Indications for use.(ii) For increased rate of weight gain. Limitations.(iii) For subcutaneous ear implantation, one dose per animal. Do not use in beef calves less than 45 days of age, dairy calves, and veal…

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section. (2) No. 061133 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of this section. Conditions of useHorsesAmount.(c) —(1) —(i) (A) 0.2 to 0.5 milligrams per pounds (mg/lb) body weight intramuscularly or intravenously every 4 to 6 hours. (B) 0.2 to 0.5 mg/lb body weight intravenously as required. Indications for use.(ii) (A) For use as a tranquilizer, preanesthetic, or for minor operative procedures in conjunction with local anesthesia; and as adjunctive therapy for tetanus. (B) For use as a tranquilizer and preanesthetic. Limitations.(iii) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dogs and catsAmount.(2) —(i) 1 to 2 mg/lb body weight intramuscularly or intravenously every 4 to 6 hours. Indications for use.(ii) For use as a tranquilizer,…

Specifications.(a) Each milliliter of solution contains 5 or 10 milligrams (mg) propiopromazine hydrochloride. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in dogs and catsAmounts and indications for use.(c) —(1) Administer 0.05 to 0.5 mg per pound of body weight by intravenous or intramuscular injection for tranquilization. Administer 0.25 mg per pound of body weight by intravenous injection as a preanesthetic. Limitations.(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16195, Mar. 25, 2014]

Specifications.(a) Each milliliter of emulsion contains 10 milligrams (mg) propofol. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter. (1) No. 086064 for use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section. (2) No. 054771 for use as in paragraph (c) of this section. Conditions of use in dogs and catsAmount.(c) —(1) Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements. Indications for use.(2) (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (ii) For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 20269, Apr. 19, 2010, as amended at 75 FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, 2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, Apr. 8, 2015; 81 FR 36789, June 8, 2016]

Specifications.(a) Each milliliter of solution contains 1 milligram of prostalene. Sponsor.(b) No. 054771 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 5 micrograms per kilogram of body weight as a single subcutaneous injection. Indications for use.(2) For the control of estrus in mares. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16195, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 25 or 50 milligrams (mg) boldenone undecylenate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) 0.5 mg per pound body weight by intramuscular injection. Treatment may be repeated at 3-week intervals. Indications for use.(2) As an aid for treating debilitated horses when an improvement in weight, hair coat, or general physical condition is desired. Limitations.(3) Do not administer to horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [70 FR 70998, Nov. 25, 2005, as amended at 79 FR 16184, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 20 milligrams (mg) of pyrilamine maleate. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter for uses in paragraph (c) of this section. (1) No. 000061 for use as in paragraph (c)(1)(i), (2), and (3) of this section. (2) No. 061133 for use as in paragraph (c)(1)(ii), (2), and (3) of this section. Conditions of useAmount.(c) —(1) (i) Horses, 40 to 60 mg per 100 pounds (lbs) body weight; foals, 20 mg/100 lbs body weight. Administer by intramuscular, subcutaneous, or intravenous injection. Dosage may be repeated every 6 to 12 hours whenever necessary. (ii) Horses, 40 to 60 mg/100 lbs body weight; foals, 20 mg/100 lbs body weight. Administer by slow intravenous injection. Dosage may be repeated every 6 to 12 hours if necessary. Indications for use.(2) It is intended for treating horses in conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16195, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13,…

Specifications.(a) Each vial of powder contains 16.4 milligrams (mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 mg rabacfosadine. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer rabacfosadine at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once every 3 weeks, for up to 5 doses. Indications for use.(2) For the treatment of lymphoma in dogs. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [87 FR 10969, Feb. 28, 2022]

Specifications.(a) Each milliliter of solution contains 20 milligrams (mg) robenacoxib. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of useDogsAmount.(c) —(1) —(i) Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day. See § 520.2075(c)(1) of this chapter. Indications for use.(ii) For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs at least 4 months of age for a maximum of 3 days. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. CatsAmount.(2) —(i) Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days. Indications for use.(ii) For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats at least 4 months of age…

Specifications.(a) Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of useDogsAmount.(c) —(1) —(i) Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure. Indications for use.(ii) For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery. CatsAmount.(2) —(i) Administer 5.3 mg/kg per forelimb (0.4 mL/kg per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve block prior to onychectomy. Indications for use.(ii) For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy. [81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24, 2020]

Specifications.(a) Each milliliter of solution contains 10 milligrams (mg) acepromazine maleate. Sponsors.(b) See Nos. 000010 and 058198 in § 510.600(c) of this chapter. Conditions of use in dogs, cats, and horsesAmount.(c) —(1) Dogs: 0.25 to 0.5 mg per pound (/lb) of body weight; Cats: 0.5 to 1.0 mg/lb of body weight; Horses: 2.0 to 4.0 mg per 100 lbs of body weight. Indications for use.(2) For use as a tranquilizer and as a preanesthetic agent. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR 16182, Mar. 25, 2014; 86 FR 14819, Mar. 19, 2021]

Specifications.(a) Each milliliter of solution contains 1.8 milligrams (mg) buprenorphine. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in catsAmount.(c) —(1) Administer 0.24 mg per kilogram (0.11 mg per pound) by subcutaneous injection once daily, for up to 3 days. Administer the first dose approximately 1 hour prior to surgery. Indications for use.(2) For the control of postoperative pain associated with surgical procedures in cats. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 53136, Sept. 8, 2014, as amended at 80 FR 18776, Apr. 8, 2015]

Specifications.(a) Each milliliter of solution contains 11 milligrams (mg) butamisole hydrochloride. Sponsors.(b) See Nos. 054771 and 058198 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer 0.1 mg per pound of body weight by subcutaneous injection. In problem cases, retreatment for whipworms may be necessary in approximately 3 months. For hookworms, a second injection should be given 21 days after the initial treatment. Indications for use.Trichuris vulpisAncylostoma caninum(2) For the treatment of infections with whipworms (), and the hookworm (). Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16184, Mar. 25, 2014, as amended at 86 FR 14819, Mar. 19, 2021]

Specifications.(a) Each milliliter of solution contains butorphanol (as butorphanol tartrate) in the following amounts: (1) 0.5 milligrams (mg); (2) 2 mg; or (3) 10 mg Sponsors.(b) See sponsors in § 510.600(c) of this chapter as follows: (1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section; for use of the product described in paragraph (a)(2) as in paragraph (d)(2) of this section; and for use of the product described in paragraph (a)(3) as in paragraph (d)(3) of this section. (2) No. 043264 for use of the product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section. (3) Nos. 000061, 017033, 043264, and 059399 for use of the product described in paragraph (a)(3) of this section as in paragraph (d)(3) of this section. Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditions of useDogsAmount.(d) —(1) —(i) Administer 0.025 mg per pound of body weight by subcutaneous injection at intervals of 6 to 12 hours, as required. If necessary, increase dose to a maximum of 0.05 mg per pound of body weight. Treatment should not normally…

Specifications.(a) Each milliliter of solution contains 20 milligrams (mg) N-butylscopolammonium bromide. Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) 0.3 mg per kilogram of body weight (0.14 mg per pound) slowly intravenously. Indications for use.(2) For the control of abdominal pain (colic) associated with spasmodic colic, flatulent colic, and simple impactions. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [69 FR 35512, June 25, 2004]

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) carprofen. Sponsors.(b) See Nos. 016729, 017033, 054771, and 055529 in § 510.600(c) of this chapter. (c) [Reserved] Conditions of use in dogsAmount.(d) —(1) 2 mg/lb (4.4 mg/kg) body weight once daily or 1 mg/lb (2.2 mg/kg) twice daily, by subcutaneous injection. For the control of postoperative pain, administer approximately 2 hours before the procedure. Conditions of use.(2) For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 26205, May 15, 2003, as amended at 68 FR 34796, June 11, 2003; 68 FR 49351, Aug. 18, 2003. Redesignated at 73 FR 29685, May 22, 2008, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 43484, Sept. 18, 2017; 88 FR 16547, Mar. 20, 2023]

Specifications.(a) Each milliliter of constituted solution contains 80 milligrams (mg) cefovecin as the sodium salt. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditions of useDogsAmount.(d) —(1) —(i) Administer 3.6 mg/pound (lb) (8 mg/kilograms (kg)) body weight as a single subcutaneous injection. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be administered if response to therapy is not complete. Indications for use.Staphylococcus intermediusStreptococcus canis(ii) For the treatment of skin infections (secondary superficial pyoderma, abscesses, and wounds) in dogs caused by susceptible strains of and (Group G). CatsAmount.(2) —(i) Administer 3.6 mg/lb (8 mg/kg) body weight as a single, one-time subcutaneous injection. Indications for use.Pasteurella multocida.(ii) For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of [73 FR 29685, May 22, 2008, as amended at 79 FR 16185, Mar. 25, 2014]

Specifications.(a) The product is a suspension of ceftiofur crystalline free acid. (1) Each milliliter (mL) contains 100 milligrams (mg) ceftiofur equivalents. (2) Each mL contains 200 mg ceftiofur equivalents. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.113 of this chapter. Conditions of useSwine.(d) —(1) The formulation described in paragraph (a)(1) of this section is used as follows: Amount.(i) 5.0 mg CE per kilogram (kg) of body weight by intramuscular injection in the postauricular region of the neck. Indications for use.Actinobacillus pleuropneumoniaePasteurella multocidaHaemophilus parasuisStreptococcus suis.A. pleuropneumoniae, P. multocida,H. parasuis,S. suis(ii) For the treatment of swine respiratory disease (SRD) associated with , , , and For the control of SRD associated with and in groups of pigs where SRD has been diagnosed. Limitations.(iii) Following label use as a single treatment, a 14-day pre-slaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in swine for disease prevention…

Specifications.(a) Each milliliter of suspension contains: (1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of ceftiofur equivalents in the inactive vehicles phospholipan 90H, sorbitan monooleate, and cottonseed oil; (2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles polyoxyethylene sorbitan monooleate (polysorbate 80) in a caprylic/capric triglyceride suspension; or (3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles aluminum monostearate, sorbitan monooleate, and medium chain triglycerides. Sponsors.(b) See sponsors in § 510.600(c) of this chapter as follows: (1) No. 054771 for products described in paragraphs (a)(1) and (2) of this section; and (2) No. 055529 for the product described in paragraph (a)(3) of this section. Related tolerances.(c) See § 556.113 of this chapter. Special considerations.(d) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle and swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in…

Specifications.(a) Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents. Sponsors.(b) See Nos. 054771 and 068330 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.113 of this chapter. Special considerations.(d) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle, swine, chickens, and turkeys for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes. Conditions of useSwineAmount.(e) —(1) —(i) 3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days. Indications for use.Actinobacillus pleuropneumoniaePasteurella multocidaSalmonella choleraesuisStreptococcus suis.(ii) For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with , , , and Limitations.(iii) Treated pigs must not be slaughtered for 4 days following the last treatment. CattleAmount.(2) —(i) 0.5 to 1.0 mg/lb body weight by intramuscular or…

Specifications.(a) Each milliliter of solution contains 42.5 milligrams (mg) of chloral hydrate, 8.86 mg of pentobarbital, and 21.2 mg of magnesium sulfate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) For general anesthesia: Administer 20 to 50 milliliters per 100 pounds of body weight by intravenous injection until the desired effect is produced. Cattle usually require a lower dosage on the basis of body weight. As a sedative-relaxant: Administer at a level of one-fourth to one-half of the anesthetic dosage level. Indications for use.(2) For general anesthesia and as a sedative-relaxant in cattle and horses. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16185, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 100 milligrams of chloramphenicol. Sponsor.(b) See Nos. 054771 and 069043 in § 510.600(c) of this chapter. Conditions of use.DogsAmount.(c) —(1) 5 to 15 milligrams per pound of body weight, intramuscularly or intravenously, every 6 hours. In severe infections, use 4 to 6 hour treatment intervals the first day. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis. Indications for use.(2) Treatment of infections of the respiratory tract, the urinary tract, and enteritis and tonsillitis caused by organisms susceptible to chloramphenicol. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals. [57 FR 37331, Aug. 18, 1992, as amended at 65 FR 45877, July 26, 2000; 78 FR 17597, Mar. 22, 2013; 79 FR 16185, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016]

Specifications.(a) Each milliliter of solution contains 60 milligrams (mg) clodronate disodium. Sponsor.(b) See No. 043264 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 1.8 mg per kilogram of body weight by intramuscular injection up to a maximum dose of 900 mg per horse. Indications for use.(2) For the control of clinical signs associated with navicular syndrome. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 37620, July 2, 2014]

Specifications.(a) Each milliliter of solution contains cloprostenol sodium equivalent to: (1) 125 micrograms (µg) of cloprostenol; or (2) 250 µg of cloprostenol. Sponsors.(b) See sponsors in § 510.600(c) of this chapter. (1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) of this section. (2) Nos. 000061 and 068504 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii), (c)(1)(iii), and (c)(2) of this section. (3) No. 000061 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(iv) and (c)(2) of this section. Conditions of use in cattleAmount and indications for use.1/2(c) —(1) (i) Administer 375 µg by intramuscular injection to induce abortion in pregnant feedlot heifers from 1 week after mating until 4 months of gestation. (ii) Administer 500 µg by intramuscular injection for abortion of unwanted pregnancies from mismatings from 1 week after mating until 5 months after conception; for unobserved (non-detected) estrus; for treatment of mummified fetus, luteal cysts, and pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and…

Specifications.(a) Each vial contains colistimethate sodium equivalent to 10 grams colistin activity and mannitol to be reconstituted with 62.5 milliliters sterile saline or sterile water for injection. The resulting solution contains colistimethate sodium equivalent to 133 milligrams per milliliter colistin activity. Sponsor.(b) See 054771 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.167 of this chapter. Conditions of use.(d) (1) 1- to 3-day-old chickens. Dosage.(i) 0.2 milligram colistin activity per chicken. Indications for use.Escherichia coli(ii) Control of early mortality associated with organisms susceptible to colistin. Limitations.(iii) For subcutaneous injection in the neck of 1- to 3-day-old chickens. Not for use in laying hens producing eggs for human consumption. Do not use in turkeys. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [63 FR 13123, Mar. 18, 1998, as amended at 79 FR 16185, Mar. 25, 2014; 84 FR 32992, July 11, 2019]

Specifications.(a) Each milliliter of aqueous solution contains 40 or 80 U.S.P. (I.U.) units of repository corticotropin. Sponsor.(b) See sponsors in § 510.600(c) of this chapter. (1) No. 061133 for use as in paragraphs (c)(1) and (2) of this section. (2) No. 043264 for use as in paragraph (c)(2) and (3) of this section. Conditions of useDogsAmount.(c) —(1) —(i) Administer one unit per pound of body weight by intramuscular injection. Indications for use.(ii) As a diagnostic aid to test for adrenal dysfunction. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dogs and catsAmount.(2) —(i) Administer one unit per pound of body weight by intramuscular or subcutaneous injection, to be repeated as indicated. Indications for use.(ii) For stimulation of the adrenal cortex where there is a general deficiency of corticotropin (ACTH). Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. CattleAmount.(3) —(i) Administer 200 to 600 units by intramuscular or subcutaneous injection as an initial dose, followed by a dose daily or every other day of 200 to 300 units. Indications for…

Specifications.(a) Each milliliter contains 10 milligrams (mg) alfaxalone. Sponsor.(b) See No. 049480 in § 510.600(c) of this chapter. Conditions of use in cats and dogsAmountCatsInduction of general anesthesia.(c) —(1) —(i) —(A) Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a preanesthetic or 1.0 to 10.8 mg/kg for cats that received a preanesthetic. Maintenance of general anesthesia following induction.(B) Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes anesthesia in unpreanesthetized cats. DogsInduction of general anesthesia.(ii) —(A) Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received a preanesthetic. Maintenance of general anesthesia following induction.(B) Administer an intravenous bolus containing 1.2 to 1.4…

Specifications.(a) Each milliliter of solution contains 180 milligrams (mg) danofloxacin as the mesylate salt. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.169 of this chapter. Conditions of use in cattleAmount and indications for use.(d) —(1) Administer by subcutaneous injection either: Mannheimia haemolyticaPasteurella multocida;(i) 6 mg per kilogram (/kg) of body weight, repeated in 48 hours, for the treatment of bovine respiratory disease (BRD) associated with and or M. haemolyticaP. multocidaM. haemolyticaP. multocida.(ii) 8 mg/kg of body weight as a single dose for the treatment of BRD associated with and and for the control of BRD in beef cattle at high risk of developing BRD associated with and Limitations.(2) Animals intended for human consumption should not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label…

Specifications.(a) (1) Each implant contains 2.1 milligrams (mg) deslorelin acetate. (2) Each milliliter (mL) of suspension contains 1.8 mg deslorelin acetate. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter as follows: (1) No. 051311 for use of product described in paragraph (a)(1) as in paragraph (c)(1) of this section. (2) No. 043264 for use of product described in paragraph (a)(2) as in paragraph (c)(2) of this section. Conditions of useHorses and poniesAmount.(c) —(1) —(i) One implant per mare subcutaneously in the neck. Indications for use.(ii) For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 millimeters (mm) in diameter. Limitations.(iii) Do not use in horses or ponies intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. HorsesAmount.(2) —(i) Administer 1.8 mg (1 mL) by intramuscular injection in the neck. Indications for use.(ii) For inducing ovulation within 48 hours in cyclic estrous mares with an ovarian follicle between 30 and 40 mm in diameter. Limitations.(iii) Do not use in horses intended for human consumption. Federal law…

Specifications.(a) Each milliliter of suspension contains 25 milligrams (mg) of desoxycorticosterone pivalate. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter. (1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and (c)(3) of this section. (2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and (c)(3) of this section. Conditions of useAmount.(c) —(1) (i) Administer an initial dose of 2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection. Subsequent dosages should be individualized according to label instructions based on patient response to therapy. (ii) Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Initial dose of 1 milligram per pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days. Indications for use(2) —(i) For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's Disease). (ii) For use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.…

Specification.(a) Each milliliter of solution contains 10 milligrams of detomidine hydrochloride. Sponsor.(b) See Nos. 015914, 052483, and 059399 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) For sedation, analgesia, or sedation and analgesia: 20 or 40 micrograms per kilogram (0.2 or 0.4 milliliter per 100 kilogram or 220 pounds) by body weight, depending on depth and duration required. For sedation, administer by intraveneous (IV) or intramuscular (IM) injection; for analgesia, administer by IV injection; for both sedation and analgesia, administer by IV injection. Indication for use.(2) As a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16186, Mar. 25, 2014, as amended at 86 FR 13184, Mar. 8, 2021; 88 FR 27699, May 3, 2023]

Specifications.(a)(1) Each milliliter of solution contains 2 milligrams (mg) dexamethasone. Sponsors.(2) See sponsors in § 510.600(c) of this chapter: (i) Nos. 000061, 016592, and 061133 for use as in paragraph (a)(3) of this section. Sponsors.(ii) See Nos. 054925 and 058005 for use as in paragraphs (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this section. Conditions of useAmount.(3) —(i) The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary, as follows: Dogs.(A) 0.25 to 1 mg. Cats.(B) 0.125 to 0.5 mg. Horses.(C) 2.5 to 5 mg. Cattle.(D) 5 to 20 mg, depending on the severity of the condition. Indications for use.(ii) The drug is indicated: (A) For the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses; (B) As an anti-inflammatory agent in dogs and cats. Limitations.(iii) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Specifications.(b)(1) Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).…

Specifications.(a) Each milliliter of solution contains: (1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or (2) 0.5 mg dexmedetomidine hydrochloride. Sponsors.(b) See sponsors in in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (1) Nos. 017033, 059399, and 086117 for use of product described in paragraph (a)(2) of this section. (2) No. 052483 for use of products described in paragraph (a) of this section. Conditions of useDogsIndications for use and amount.22(c) —(1) —(i) (A) For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m ) of body surface area by intravenous injection or 500 µg/m of body surface area by intramuscular injection. 22(B) For use as a preanesthetic to general anesthesia, administer 125 µg/m of body surface area or 375 µg/m of body surface area by intramuscular injection. Limitations.(ii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. CatsAmount.(2) —(i) 40 µg/killogram by intramuscular injection. Indications for use.(ii) For use as a…

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) of amikacin as amikacin sulfate. Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) 5 mg/pound (lb) of body weight twice daily by intramuscular or subcutaneous injection. Indications for use.Escherichia coliProteusPseudomonasE. coli.(2) For treatment of genitourinary tract infections (cystitis) caused by susceptible strains of and spp. and skin and soft tissue infections caused by susceptible strains of spp. and Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [76 FR 17338, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016]

Specifications.(a) Each milliliter of solution contains 34.3 percent diatrizoate meglumine and 35 percent diatrizoate sodium, or 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in dogs and catsAmount.(c) —(1) For excretion urography, administer 0.5 to 1.0 milliliter (mL) per pound of body weight to a maximum of 30 mL intravenously. For cystography, remove urine, administer 5 to 25 mL directly into the bladder via catheter. For urethrography, administer 1.0 to 5 mL via catheter into the urethra to provide desired contrasts delineation. For angiocardiography (including aortography) rapidly inject 5 to 10 mL directly into the heart via catheter or intraventricular puncture. For cerebral angiography, rapid injection of 3 to 10 mL via carotid artery. For peripheral arteriography and/or venography and selective coronary arteriography, rapidly inject 3 to 10 mL intravascularly into the vascular bed to be delineated. For lymphography, slowly inject 1.0 to 10 mL directly into the lymph vessel to be delineated. For arthrography, slowly inject 1.0 to 5 mL directly into the joint to be…

Specifications.(a) Each milliliter of solution contains 0.5 milligram (mg) aminopentamide hydrogen sulfate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in dogs and catsAmount.(c) —(1) Administer by subcutaneous or intramuscular injection every 8 to 12 hours as follows: For animals weighing up to 10 pounds (lbs): 0.1 mg; For animals weighing 11 to 20 lbs: 0.2 mg; For animals weighing 21 to 50 lbs: 0.3 mg; For animals weighing 51 to 100 lbs: 0.4 mg; For animals weighing over 100 lbs: 0.5 mg. Dosage may be gradually increased up to a maximum of five times the suggested dosage. Following parenteral use, dosage may be continued by oral administration of tablets. Indications for use.(2) For the treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16183, Mar. 25, 2014]

Specifications.(a) Each milliliter contains dihydrostreptomycin sulfate equivalent to 500 milligrams of dihydrostreptomycin. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Related tolerance.(c) See § 556.200 of this chapter. Conditions of useAmount.(d) —(1) Administer 5 milligrams per pound of body weight by deep intramuscular injection every 12 hours, for 3 to 5 days or until the urine is free of leptospira for at least 72 hours as measured by darkfield microscopic examination. Indications for use.Leptospira canicola, L. icterohemorrhagiae,L. pomona;L. pomona;L. pomona;L. grippotyphosa.(2) Treatment of leptospirosis in dogs and horses due to and in cattle due to and in swine due to and Limitations.(3) Discontinue use 30 days before slaughter for food. Not for use in animals producing milk because use of the drug will contaminate the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 16187, Mar. 25, 2014; 85 FR 18119, Apr. 1, 2020]

Specifications.(a) Each milliliter (mL) of solution contains dinoprost tromethamine equivalent to: (1) 5 milligrams (mg) dinoprost; or (2) 12.5 mg dinoprost. Sponsors.(b) See sponsors in § 510.600(c) of this chapter as follows: (1) Nos. 054771 and 061133 for use of product described in paragraph (a)(1) as in paragraph (d) of this section. (2) No. 054771 for use of product described in paragraph (a)(2) as in paragraph (d)(1) of this section. Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditions of useCattle.(d) —(1) Administer products described in paragraph (a) of this section as follows: Amount.(i) 25 mg as an intramuscular injection of the 5 mg/mL product or as an intramuscular or subcutaneous injection of the 12.5 mg/mL product. Indications for use.i.e.,(ii) As a luteolytic agent; effective only in those cattle having a corpus luteum, those which ovulated at least 5 days prior to treatment. (A) For estrus synchronization in beef cows, beef heifers and replacement dairy heifers. (B) For unobserved (silent) estrus in lactating dairy cows with a corpus luteum. (C) For treatment of pyometra (chronic…

Specifications.(a) Each milliliter of solution contains 2 milligrams of diprenorphine hydrochloride. Sponsors.(b) See No. 053923 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) It is administered intramuscularly or intravenously at a suitable dosage level depending upon the species. Indications for use.(2) The drug is used for reversing the effects of etorphine hydrochloride injection, veterinary, the use of which is provided for in § 522.883, in wild and exotic animals. Limitations.(3) For use in wild or exotic animals only. Do not use in domestic food-producing animals. Do not use 30 days before, or during, the hunting season in free-ranging wild animals that might be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Distribution is restricted to veterinarians engaged in zoo and exotic animal practice, wildlife management programs, and researchers. [79 FR 16187, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 500 milligrams (mg) dipyrone. Sponsor.(b) See No. 043264 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 30 mg per kilogram of body weight (13.6 mg per pound) by intravenous injection, once or twice daily at a 12-hour interval for up to 3 days. Indications for use.(2) For control of pyrexia in horses. Limitations.(3) Do not use in horses intended for human consumption. Do not use in any food-producing animals, including lactating dairy animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [85 FR 18119, Apr. 1, 2020, as amended at 88 FR 14898, Mar. 10, 2023]

Specifications.(a) Each milliliter of solution contains 10 milligrams of doramectin. Sponsor.(b) See No. 054771 in § 510.600 (c) of this chapter. Related tolerances.(c) See § 556.222 of this chapter. Conditions of useCattleAmount.(d) —(1) —(i) 200 micrograms per kilogram (10 milligrams per 110 pounds). Indications for use.Cooperia oncophoraHaemonchus placeiOstertagia ostertagiC. punctata, Oesophagostomum radiatum,Dictyocaulus viviparus(ii) For treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites. To control infections and to protect from reinfection with and for 14 days, for 21 days, and and for 28 days after treatment. Limitations.(iii) Administer as a single subcutaneous or intramuscular injection. Do not slaughter cattle within 35 days of treatment. Not for use in female dairy cattle 20 months of age or older. Do not use in calves to be processed for veal. SwineAmount.(2) —(i) 300 micrograms per kilogram (10 milligrams per 75 pounds). Indications for use.(ii) For treatment and control of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites. Limitations.(iii) Administer as a single…

Specifications.(a) Each milliliter of solution contains 5 milligrams (mg) of doramectin and 150 mg levamisole hydrochloride. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Related tolerances.(c) See §§ 556.222 and 556.350 of this chapter. Conditions of useCattleAmount.(d) —(1) —(i) Inject subcutaneously in the neck as a single dose at a dosage of 0.2 mg doramectin (0.91 mg/lb) and 6 mg of levamisole hydrochloride per kg (2.72 mg/lb) of body weight. Indications for use.Ostertagia ostertagiO. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, T. longispicularis, Cooperia oncophora, C. pectinata, C. punctata, C. surnabada, Bunostomum phlebotomumStrongyloides papillosusOesophagostomum radiatum, Trichuris spp.Nematodirus helvetianusDictyocaulus viviparus;ThelaziaHypoderma bovisH. lineatum;Haematopinus eurysternus, Linognathus vituli,Solenopotes capillatus;Psoroptes bovisSarcoptes scabiei(ii) For treatment and control of gastrointestinal roundworms (adults and fourth stage larvae): (including inhibited larvae), (adults only), (adults only), (adults only) and (adults only); lungworms (adults and fourth stage larvae): eyeworms (adults): spp.; grubs…

Specifications.(a) Each milliliter contains 11.36 milligrams (mg) of doxylamine succinate. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useAmountHorses:(c) —(1) —(i) Administer 25 mg per hundred pounds of body weight by intramuscular, subcutaneous, or slow intravenous injection. Dogs and cats:(ii) Administer 0.5 to 1 mg per pound of body weight by intramuscular or subcutaneous injection. Doses may be repeated at 8 to 12 hours, if necessary, to produce desired effect. Indications for use.(2) For use in conditions in which antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16187, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 20 milligrams (mg) of droperidol and 0.4 mg of fentanyl citrate. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) (i) For analgesia and tranquilization, administer as follows: (A) 1 milliliter (mL) per 15 to 20 pounds (lbs) of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight; or (B) 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight. (ii) For general anesthesia, administer as follows: (A) Administer 1 mL per 40 lbs of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed in 10 minutes by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight; or (B) Administer 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed within 15…

Specifications.(a) Each milliliter (mL) of solution contains 135 milligrams (mg) embutramide; 45 mg chloroquine phosphate, U.S.P.; and 1.9 mg lidocaine, U.S.P. Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) One mL per 5 pounds of body weight. Indications for use.(2) For euthanasia. Limitations.(3) Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [70 FR 36337, June 23, 2005, as amended at 78 FR 17597, Mar. 22, 2013; 81 FR 17608, Mar. 30, 2016]

Specifications.(a) Each milliliter (mL) of solution contains: (1) 22.7 milligrams (mg) enrofloxacin or (2) 100 mg enrofloxacin. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter: (1) Nos. 016729, 017033, 055529, 058198, and 086101 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section; and (2) Nos. 051311, 055529, 058005, 058198, and 061133 for use of product described in paragraph (a)(2) of this section as in paragraphs (e)(2) and (3) of this section. Related tolerance.(c) See § 556.226 of this chapter. Special considerations.(d) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals. Conditions of useDogs.(e) —(1) Use the product described in paragraph (a)(1) of this section as follows: Amount.(i) 2.5 mg per kilogram (/kg) of body weight (1.13 mg per pound) as a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days. Indications for use.(ii) For the management of diseases associated with bacteria susceptible to…

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) eprinomectin. Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter. Related tolerances.(c) See §§ 500.1410 and 556.227 of this chapter. Conditions of use in cattle on pastureAmount.(d) —(1) Administer 1 mg/kilogram of body weight by subcutaneous injection. Indications for use.Bunostomum phlebotomum, Cooperia oncophora,C. punctata, C. surnabada,Trichostrongylus axei, Ostertagia ostertagiHaemonchus placei, Oesophagostomum radiatum,O. lyrata, T. colubriformis;Dictyocaulus viviparus;Hypoderma bovis;Sarcoptes scabieibovis.C. oncophora, C. punctata,T. axeiH. placei, O. radiatum,O. lyrata,O. ostertagiB. phlebotomumD. viviparus(2) For the treatment and control of the following internal and external parasites: Gastrointestinal roundworms (adults and fourth-stage larvae) (including inhibited stage); (adults) lungworms (adults) cattle grubs mites var. Prevents reinfection with and for 100 days following treatment; and for 120 days following treatment; and and for 150 days following treatment. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Animals…

Specifications.(a) Each milliliter of solution contains aminopropazine fumarate equivalent to 25 milligrams (mg) aminopropazine base. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useDogs and catsAmount.(c) —(1) —(i) 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated, by intramuscular or intravenous injection. Indications for use.(ii) For reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. HorsesAmount.(2) —(i) Administer 0.25 mg per pound of body weight, repeated every 12 hours as indicated, by intramuscular or intravenous injection. Indications for use.(ii) For reducing excessive smooth muscle contractions, such as occur in colic spasms. Limitations.(iii) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16183, Mar. 25, 2014]

Specifications(a) —(1) Each milliliter (mL) of solution contains 100 milligrams (mg) erythromycin base. (2) Each mL of solution contains 200 mg erythromycin base. Sponsor.(b) See No. 061133 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.230 of this chapter. Conditions of useDog.(d) —(1) Administer product described in paragraph (a)(1) of this section as follows: Amount.(i) 3 to 5 mg per pound (/lb) body weight, intramuscularly, two to three times daily, for up to 5 days. Indications for use.StaphylococcusStreptococcusCorynebacterium(ii) For the treatment of bacterial pneumonia, upper respiratory infections (tonsillitis, bronchitis, tracheitis, pharyngitis, pleurisy), endometritis and metritis, and bacterial wound infections caused by spp., spp., and spp., sensitive to erythromycin. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cats.(2) Administer product described in paragraph (a)(1) of this section as follows: Amount.(i) 3 to 5 mg/lb body weight, intramuscularly, two to three times daily, for up to 5 days. Indications for use.StaphylococcusStreptococcus(ii) For the treatment of bacterial…

Specifications.(a) Each silicone rubber implant contains 25.7 or 43.9 milligrams (mg) estradiol and is coated with not less than 0.5 mg oxytetracycline powder. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.240 of this chapter. Conditions of use.(d) For implantation in steers and heifers as follows: Amounts and indications for use25.7-mg extended-release implant.(1) —(i) Insert one implant for increased rate of weight gain for up to 200 days in beef steer calves 2 months of age and older; for increased rate of weight gain for up to 200 days in growing beef steers and heifers on pasture (stocker, feeder, and slaughter); and for increased rate of weight gain and improved feed efficiency for up to 200 days in growing beef steers and heifers fed in confinement for slaughter. 43.9-mg extended-release implant.(ii) Insert one implant for increased rate of weight gain for up to 400 days in beef steer calves 2 months of age and older; for increased rate of weight gain for up to 400 days in growing beef steers and heifers on pasture (stocker, feeder, and slaughter); and for increased rate of weight gain and improved feed efficiency for up…

Specifications.(a) The product is a two-component drug consisting of the following: (1) An implant containing 6.0 milligrams of norgestomet. (2) An injectable solution (sesame oil) containing 3.0 milligrams of norgestomet and 5.0 milligrams of estradiol valerate per 2 milliliters. Sponsor.(b) See 000010 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.240 of this chapter. Conditions of useAmount.(d) —(1) One implant and 2 milliliters of injection at time of implantation. Indications for use.(2) For synchronization of estrus/ovulation in cycling beef cattle and non-lactating dairy heifers. Limitations.(3) Insert implant subcutaneously in the ear only; then immediately inject solution intramuscularly only. Counting the day of implantation as day 1, remove the implant on day 10. Collect all implants as they are removed and burn them. While animals are restrained for artificial insemination, avoid other treatments such as vaccinations, dipping, pour-on grub and louse prevention, spraying, etc. When inseminating without estrus detection, the entire treated group should be started at 48 hours after the last implant has been removed and should be completed within…

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) of ethylisobutrazine hydrochloride. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer 2 to 5 mg per pound of body weight by intramuscular injection for profound tranquilization. Administer 1 to 2 mg per pound of body weight by intravenous injection to effect. Indications for use.(2) For use as a tranquilizer. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16187, Mar. 25, 2014]

Specifications.(a) Each milliliter contains 100 milligrams (mg) etodolac. Sponsor.(b) See No. 000010 in § 510.600 of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer 4.5 to 6.8 mg/pound (10 to 15 mg/kilogram) body weight as a single, dorsoscapular subcutaneous injection. If needed, the daily dose of etodolac tablets as in § 520.870 of this chapter may be given 24 hours after the injection. Indications for use.(2) For the control of pain and inflammation associated with osteoarthritis. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 51365, Sept. 7, 2007, as amended at 75 FR 10167, Mar. 5, 2010]

Specifications.(a) (1) Each vial contains 3 grams (g) of amoxicillin trihydrate. Each milliliter of constituted suspension contains 100 or 250 milligrams (mg) amoxicillin trihydrate for use as in paragraph (d)(1) of this section. (2) Each vial contains 25 g of amoxicillin trihydrate. Each milliliter of constituted suspension contains 250 mg amoxicillin trihydrate for use as in paragraph (d)(2) of this section. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Related tolerance.(c) See § 556.38 of this chapter. Conditions of useDogs and catsAmount.(d) —(1) —(i) Administer 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection. Indications for useDogs.Staphylococcus aureus, StreptococcusEscherichia coli,Proteus mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis;S. aureus, StreptococcusP. mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis.(ii) —(A) For treatment of infections caused by susceptible strains of organisms as follows: Respiratory infections (tonsillitis, tracheobronchitis) due to spp., and genitourinary infections (cystitis) due to spp., and gastrointestinal…

Specifications.(a) Each milliliter of solution contains 1 milligram of etorphine hydrochloride. Sponsor.(b) See No. 053923 in § 510.600(c) of this chapter. Special considerations.(c) Distribution is restricted to veterinarians engaged in zoo and exotic animal practice, wildlife management programs, and researchers. Conditions of useAmount.(d) —(1) Administered intramuscularly by hand syringe or syringe dart at a suitable dosage level depending upon the species. Indications for use.(2) For the immobilization of wild and exotic animals. Limitations.(3) Do not use in domestic food-producing animals. Do not use 30 days before, or during, the hunting season in free-ranging wild animals that might be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16188, Mar. 25, 2014]

[79 FR 16183, Mar. 25, 2014]

Specifications.(a) (1) Each milliliter contains ampicillin trihydrate equivalent to 200 milligrams (mg) of ampicillin. (2) Each milliliter contains ampicillin trihydrate equivalent to 150 mg of ampicillin. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter. (1) No. 054771 for use of product described in paragraph (a)(1) as in paragraphs (d)(1), (d)(2), (d)(3)(i)(A), (d)(3)(ii)(A), (d)(3)(iii), and (d)(4) of this section. (2) No. 054771 for use of product described in paragraph (a)(2) as in paragraphs (d)(3)(i)(B), (d)(3)(ii)(B), and (d)(3)(iii) of this section. Related tolerances.(c) See § 556.40 of this chapter. Conditions of useCattleAmount.(d) —(1) —(i) For enteritis: 3 mg per pound of body weight, intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3 mg per pound of body weight, intramuscularly, twice daily, for up to 3 days. Indications for use.Escherichia coliPasteurella(ii) For treatment of bacterial enteritis in calves caused by and bacterial pneumonia caused by spp. susceptible to ampicillin. Limitations.(iii) Treated animals must not be slaughtered for food use during treatment or for 9 days after the last treatment. Federal law…

Specifications.(a) Each milliliter of aqueous suspension constituted from ampicillin trihydrate powder contains 200, 250, or 400 milligrams (mg) ampicillin equivalents. Sponsors.(b) See Nos. 000010 and 042791 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.40 of this chapter. Conditions of useDogs and catsAmount.(d) —(1) —(i) 3 mg/pound (lb) of body weight twice daily by subcutaneous or intramuscular injection. Indications for use.(ii) For treatment of strains of organisms susceptible to ampicillin and associated with respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections. Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. CattleAmount.(2) —(i) 2 to 5 mg/lb of body weight once daily by intramuscular injection. Indications for use.AerobacterKlebsiellaStaphylococcusStreptococcusPasteurella multocida,Escherichia coli.(ii) For treatment of respiratory tract infections caused by organisms susceptible to ampicillin, bacterial pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused by spp., spp.,…

Specifications.(a) Each milliliter of aqueous solution constituted from ampicillin sodium powder contains 300 milligrams (mg) ampicillin equivalents. (b) See Nos. 042791 and 054771 in § 510.600(c) of this chapter. Conditions of use in horsesAmount(c) —(1) : 3 mg per pound of body weight twice daily by intravenous or intramuscular injection. Indications for use.StaphylococcusStreptococcusS. equiEscherichia coliProteus mirabilisStaphylococcusStreptococcusE. coliP. mirabilis(2) For the treatment of respiratory tract infections (pneumonia and strangles) due to spp., spp. (including ), , and , and skin and soft tissue infections (abscesses and wounds) due to spp., spp., , and , when caused by susceptible organisms. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 45158, Aug. 13, 2007, as amended at 79 FR 16184, Mar. 25, 2014; 86 FR 57997, Oct. 20, 2021]

Specifications.(a) (1) Each milliliter of solution contains 0.5 milligram (mg) fenprostalene. (2) Each milliliter of solution contains 0.25 mg fenprostalene. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section; and for use of product described in paragraph (a)(2) as in paragraph (e)(2) of this section. Related tolerances.(c) See § 556.277 of this chapter. Special considerations.(d) Labeling shall bear the following statements: Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. It is readily absorbed through the skin and may cause abortion and/or bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Conditions of useCattleIndications for use and amount.(e) —(1) —(i) (A) For feedlot heifers to induce abortion when pregnant 150 days or less, administer 1 mg (2 milliliter (mL)) subcutaneously. (B) For beef or nonlactating dairy cattle for estrus synchronization, administer a single or two 1-mg (2-mL) doses subcutaneously, 11 to 13…

Specifications.(a) Each milliliter of solution contains 20 milligrams (mg) firocoxib. Sponsors.(b) See No. 000010 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 0.04 mg/pound (lb) (0.09 mg/kilogram (kg)) of body weight (BW) intravenously, once daily, for up to 5 days. If further treatment is needed, firocoxib oral paste can be administered at a dosage of 0.045 mg/lb (0.1 mg/kg) of BW for up to an additional 9 days of treatment. Indications for use.(2) For the control of pain and inflammation associated with osteoarthritis. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 59611, Sept. 28, 2010, as amended at 84 FR 39184, Aug. 9, 2019]

Specifications.(a) Each milliliter of solution contains: (1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin. (2) 300 mg florfenicol in the inactive vehicles n-methyl-2-pyrrolidone, propylene glycol, and polyethylene glycol. (3) 300 mg florfenicol in the inactive vehicles 2-pyrrolidone and glycerol formal. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter: (1) No. 000061 for use of product described in paragraph (a)(1) as in paragraph (d)(1)(i); and (2) No. 000061 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii) and (d)(2) of this section. (3) Nos. 058005 and 058198 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this section. (4) No. 055529 for use of product described in paragraph (a)(3) as in paragraph (d)(1)(ii). Related tolerances.(c) See §§ 500.1410 and 556.283 of this chapter. Conditions of useBeef and non-lactating dairy cattle.(d) —(1) (i) 300 mg per milliliter (mL) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin: Amount.(A) 40 mg/kilogram (kg) body weight as a single subcutaneous injection. Indications…

Specifications.(a) Each milliliter (mL) of solution contains 300 milligrams (mg) florfenicol and 16.5 mg flunixin (27.37 mg flunixin meglumine). Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter for use as in paragraph (d) of this section. Tolerances.(c) See §§ 556.283 and 556.286 of this chapter. Conditions for use in cattleAmount.(d) —(1) 40 mg florfenicol/kg body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW or 6 mL/100 lbs) once, by subcutaneous injection. Indications for use.Mannheimia haemolyticaPasteurella multocidaHistophilus somniMycoplasma bovis(2) For treatment of bovine respiratory disease (BRD) associated with , , , and , and control of BRD-associated pyrexia in beef and non-lactating dairy cattle. Limitations.(3) Animals intended for human consumption must not be slaughtered within 38 days of treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law…

Specifications.(a) Each milliliter of suspension contains 2 milligrams (mg) of flumethasone. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 6 to 10 mg by intra-articular injection. Dosage is limited to a single injection per week in any one synovial structure. Indications for use.(2) For use in the various disease states involving synovial structures (joints) of horses where excessive synovial fluid of inflammatory origin is present and where permanent structural changes do not exist. Such conditions include arthritis, carpitis, and osselets. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16188, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 2 milligrams (mg) of flumethasone acetate. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer by intramuscular injection as follows: Dogs weighing up to 10 pounds (lbs): 2 mg; dogs weighing 10 to 25 lbs: 4 mg; dogs weighing over 25 lbs: 8 mg. Dosage should be adjusted according to the weight of the animal, the severity of the symptoms, and the response noted. Dosage by injection should not exceed 3 days of therapy. With chronic conditions intramuscular therapy may be followed by oral administration of flumethasone tablets at a daily dose of from 0.0625 to 0.25 mg per animal. Indications for use.(2) For use in certain acute and chronic canine dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16188, Mar. 25, 2014]

Specifications.(a) Each milliliter of solution contains 0.5 milligrams (mg) of flumethasone. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use.(c) It is used as follows: HorsesAmount.(1) —(i) Administer 1.25 to 2.5 milligrams (mg) daily by intravenous, intramuscular, or intra-articular injection. Indications for use.(ii) For use in the treatment of musculoskeletal conditions due to inflammation, where permanent structural changes do not exist, e.g., bursitis, carpitis, osselets, and myositis; and allergic states, e.g., hives, urticaria, and insect bites. Limitations.(iii) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. DogsAmount.(2) —(i) Administer 0.0625 to 0.25 mg daily by intravenous, intramuscular, or subcutaneous injection; 0.125 to 1.0 mg daily by intra-lesional injection, depending on the size and location of the lesion; or 0.166 to 1.0 mg daily by intra-articular injection, depending on the severity of the condition and the size of the involved joint. Indications for use.(ii) For use in the treatment of musculoskeletal conditions due to…

Specifications.(a) Each milliliter of solution contains flunixin meglumine equivalent to 50 milligrams (mg) flunixin. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section. (1) See Nos. 000061, 055529, 058198, and 061133 for use as in paragraph (e) of this section. (2) See No. 054771 for use as in paragraph (e)(1) of this section. (3) See No. 016592 for use as in paragraphs (e)(1) and (e)(2) of this section. Related tolerances.(c) See § 556.286 of this chapter. Special considerations.(d) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditions of useHorsesAmount.(e) —(1) —(i) 0.5 mg per pound (/lb) of body weight per day, intravenously or intramuscularly, for up to 5 days. Indications for use.(ii) For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic. Limitations.(iii) Do not use in horses intended for human consumption. CattleAmounts and indications for use(2) —(i) —(A) Administer 1.1 to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day intravenously, as a single dose or divided into two…

Specifications.(a) Each milliliter of solution contains fluprostenol sodium equivalent to 50 micrograms (µg) of fluprostenol. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 0.55 µg fluprostenol per kilogram of body weight by intramuscular injection. Indications for use.(2) For use in mares for its luteolytic effect to control the timing of estrus in estrous cycling and in clinically anestrous mares that have a corpus luteum. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16189, Mar. 25, 2014, as amended at 86 FR 14820, Mar. 19, 2021]