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: 21CFR522.311]

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. 522.311 Cefovecin.

(a) Specifications. Each milliliter of constituted solution contains 80 milligrams (mg) cefovecin as the sodium salt.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use - (1) Dogs - (i) Amount. 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.

(ii) Indications for use. For the treatment of skin infections (secondary superficial pyoderma, abscesses, and wounds) in dogs caused by susceptible strains of Staphylococcus intermedius and Streptococcus canis (Group G).

(2) Cats - (i) Amount. Administer 3.6 mg/lb (8 mg/kg) body weight as a single, one-time subcutaneous injection.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida.

[73 FR 29685, May 22, 2008, as amended at 79 FR 16185, Mar. 25, 2014]