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21 CFR Ch. I (4–1–02 Edition)

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21 CFR Ch. I (4–1–02 Edition) § 522.1885 21 CFR Ch. I (4–1–02 Edition) (d) Conditions of use. (1) The drug is (2) It is administered to horses intended for the treatment of horses, intramuscularly at a dosage level of 100 dogs, and cats.1 to 300 milligrams and intrasynovially (2)(i) The dosage for horses is 50 to at a dosage level of 50 to 100 milli- 100 milligrams as an initial dose given grams. It is administered intravenously over a period of one-half intramuscularly to dogs and cats at a to 1 minute, or intramuscularly, and dosage level of 1 milligram per 5 may be repeated in inflammatory, al- pounds of body weight and lergic, or other stress conditions at in- intrasynovially at a dosage level of 10 tervals of 12, 24, or 48 hours, depending to 20 milligrams. Intramuscular re- upon the size of the animal, the sever- treatment of horses in 24 to 48 hours ity of the condition and the response to may be necessary, depending on the treatment. 1 general condition of the animal and the (ii) In dogs, the drug is administered severity and duration of the disease.1 intravenously at a range of 2.5 to 5 mil- (3) Clinical and experimental data ligrams per pound of body weight as an have demonstrated that corticosteroids initial dose followed by maintenance administered orally or parenterally to doses at 1, 3, 6, or 10 hour intervals, as animals may induce the first stage of determined by the condition of the ani- parturition when administered late in mal, for treatment of shock. pregnancy and may precipitate pre- (iii) In dogs and cats, the drug may mature parturition followed by be given intramuscularly for treatment dystocia, fetal death, retained pla- of inflammatory, allergic and less se- centa, and metritis.1 vere stress conditions, where imme- (4) Federal law restricts this drug to diate effect is not required, at 1 to 5 use by or on the order of a licensed vet- milligrams ranging upward to 30 to 50 erinarian.1 milligrams in large breeds of dogs. Dos- age may be repeated in 12 to 24 hours [40 FR 13858, Mar. 27, 1975, as amended at 62 and continued for 3 to 5 days if nec- FR 63271, Nov. 28, 1997] essary. If permanent corticosteroid ef- § 522.1890 Sterile prednisone suspen- fect is required oral therapy with pred- sion. nisolone tablets may be substituted. (3) Federal law restricts this drug to (a) [Reserved] use by or on the order of a licensed vet- (b)(1) Specifications. Each milliliter of erinarian. 1 sterile aqueous suspension contains 10 to 40 milligrams of prednisone. [40 FR 13858, Mar. 27, 1975, as amended at 46 (2) Sponsor. See 000061 in § 510.600(c) of FR 13215, Feb. 20, 1981; 46 FR 33513, June 30, this chapter. 1981; 52 FR 25212, July 6, 1987; 66 FR 23588, (3) Conditions of use—(i) Amount. Ad- May 9, 2001] minister intramuscularly as follows: § 522.1885 Prednisolone tertiary (a) Horses. 100 to 400 milligrams, re- butylacetate suspension. peating if necessary. If no response is observed after 3 to 4 days of therapy, (a) Specifications. Prednisolone ter- 1 tiary butylacetate (Pregna-1,4-diene-3, reevaluate diagnosis. 20-dione-11B, 17α 21-triol 21-(3,3, di- (b) Dogs and cats. 0.25 to 1.0 milligram methyl butyrate) suspension contains per pound of body weight for 3 to 5 days 20 milligrams of prednisolone tertiary or until a response is noted. Treatment butylacetate per milliliter. It is sterile. may be continued with an orally ad- 1 (b) Sponsor. See No. 050604 in ministered dose. § 510.600(c) of this chapter. (ii) Indications for use. It is used for (c) Conditions of use. (1) It is used as conditions requiring an anti-inflam- 1 an anti-inflammatory agent in horses, matory agent. 1 dogs, and cats.1 (iii) Limitations. Do not use in viral infections. Except in emergency ther- apy, do not use in animals with tuber- 1 These conditions are NAS/NRC reviewed and found effective. Applications for these culosis, chronic nephritis, or uses need not include effectiveness data as specified by § 514.111 of this chapter, but may 1 These conditions are NAS/NRC reviewed require bioequivalency and safety informa- and deemed effective. Applications for these tion. uses need not include effectiveness data as 272 VerDate May<13>2002 09:47 May 15, 2002 Jkt 197067 PO 00000 Frm 00272 Fmt 8010 Sfmt 8010 Y:\SGML\197067T.XXX pfrm17 PsN: 197067T Food and Drug Administration, HHS § 522.1940 Cushings’s disease. With infections, use (3) For use only by or on the order of appropriate antibacterial therapy with a licensed veterinarian. and for at least 3 days after discontinu- [40 FR 13858, Mar. 27, 1975, as amended at 56 ance of use and disappearance of all FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, signs of infection. Clinical and experi- 1995] mental data have demonstrated that corticosteroids administered orally or § 522.1940 Progesterone and estradiol parenterally to animals may induce benzoate in combination. the first stage of parturition when ad- (a) [Reserved] ministered during the last trimester of (b) Sponsors. See 000856 in § 510.600(c) pregnancy and may precipitate pre- of this chapter for use as in paragraphs mature parturition followed by (d)(1)(i)(A), (d)(1)(ii), (d)(1)(iii), dystocia, fetal death, retained pla- (d)(2)(i)(A), (d)(2)(ii), (d)(2)(iii), and centa, and metritis. Not for use in (d)(3) of this section. See 021641 in horses intended for food. Federal law § 510.600(c) of this chapter for use as in restricts this drug to use by or on the paragraphs (d)(1) and (d)(2)(i) through order of a licensed veterinarian. (d)(2)(iii)(A) of this section. [45 FR 13446, Feb. 29, 1980, as amended at 50 (c) Related tolerances. See §§ 556.240 FR 6160, Feb. 14, 1985; 52 FR 7832, Mar. 13, and 556.540 of this chapter. 1987] (d) Conditions of use. It is used for im- plantation in animals as follows: § 522.1920 Prochlorperazine, (1) Suckling beef calves—(i) Amount. isopropamide for injection. (A) 100 milligrams of progesterone and (a) Specifications. Prochlorperazine, 10 milligrams of estradiol benzoate in isopropamide for injection, veterinary, four pellets per implant dose. contains in each milliliter, 6 milli- (B) 100 milligrams of progesterone grams of prochlorperazine edisylate and 10 milligrams of estradiol benzoate (equivalent to 4 milligrams in four pellets with 29 milligrams of prochlorperazine), and 0.38 milligrams tylosin tartrate as a local antibacterial of isopropamide iodide (equivalent to in one pellet per implant dose. 0.28 milligrams of isopropamide) in (ii) Indications for use. Increased rate buffered aqueous solution. of weight gain. (b) Sponsor. See No. 000069 in (iii) Limitations. For use in suckling § 510.600(c) of this chapter. beef calves (at least 45 days of age) up (c) Conditions of use. (1) The drug is to 400 pounds of body weight. For sub- used in dogs and cats in which gastro- cutaneous ear implantation, one dose intestinal disturbances are associated per animal. Do not use in bull calves with emotional stress. intended for reproduction. (2) Dosage is administered by sub- (2) Steers—(i) Amount. (A) 200 milli- cutaneous injection twice daily as fol- grams of progesterone and 20 milli- lows: grams estradiol benzoate in eight pel- lets per implant dose. Dosage in Weight of animal in pounds Milliliters (B) 200 milligrams progesterone and 20 milligrams estradiol benzoate in Up to 4 ................................................................. 0.25 eight pellets with 29 milligrams tylosin 5 to 14 ................................................................. 0.5–1 15 to 30 ............................................................... 2–3 tartrate as a local antibacterial in one 30 to 45 ............................................................... 3–4 pellet per implant dose. 45 to 60 ............................................................... 4–5 (ii) Indications for use. For increased Over 60 ................................................................ 6 rate of weight gain and improved feed efficiency. Following the last injection, admin- (iii) Limitations. (A) For animals ister prochlorperazine and weighing 400 pounds or more; for sub- isopropamide sustained release cap- cutaneous ear implantation, one dose sules as indicated. per animal. (B) For additional improvement in specified by § 514.111 of this chapter, but may rate of weight gain in steers fed in con- require bioequivalency and safety informa- finement for slaughter, reimplant at tion. approximately day 70. 273 VerDate May<13>2002 09:47 May 15, 2002 Jkt 197067 PO 00000 Frm 00273 Fmt 8010 Sfmt 8010 Y:\SGML\197067T.XXX pfrm17 PsN: 197067T.
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