CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.1883]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1883 Prednisolone sodium phosphate.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) prednisolone sodium phosphate (equivalent to 14.88 mg of prednisolone).

(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer intravenously in a dosage of 2 1/2 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.

(2) Indications for use. Administer when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is necessary.

(3) Limitations. 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]