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21 C.F.R. § 522.1890   Sterile prednisone suspension.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.1890   Sterile prednisone suspension.

(a) [Reserved]

(b)(1) Specifications. Each milliliter of sterile aqueous suspension contains 10 to 40 milligrams of prednisone.

(2) Sponsor. See 000061 in §510.600(c) of this chapter.

(3) Conditions of use—(i) Amount. Administer intramuscularly as follows:

(a) Horses. 100 to 400 milligrams, repeating if necessary. If no response is observed after 3 to 4 days of therapy, reevaluate diagnosis.¹

(b) Dogs and cats. 0.25 to 1.0 milligram per pound of body weight for 3 to 5 days or until a response is noted. Treatment may be continued with an orally administered dose.¹

(ii) Indications for use. It is used for conditions requiring an anti-inflammatory agent.¹

(iii) Limitations. ¹ Do not use in viral infections. Except in emergency therapy, do not use in animals with tuberculosis, chronic nephritis, or Cushings's disease. With infections, use appropriate antibacterial therapy with and for at least 3 days after discontinuance of use and disappearance of all signs of infection. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

¹ These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

[45 FR 13446, Feb. 29, 1980, as amended at 50 FR 6160, Feb. 14, 1985; 52 FR 7832, Mar. 13, 1987]

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