[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.314]

[Page 224-225]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 522.314  Ceftiofur hydrochloride sterile suspension.

    (a) Specifications. Each milliliter contains ceftiofur hydrochloride 
equivalent to 50 milligrams of ceftiofur.

[[Page 225]]

    (b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.113 of this chapter.
    (d) Conditions of use. (1) Swine--(i) Amount. 3 to 5 milligrams per 
kilogram (1.36 to 2.27 milligrams per pound) of body weight.
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus (Haemophilus) pleuropneumoniae, Pastureurella 
multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
    (iii) Limitations. For intramuscular use only. Treatment should be 
repeated at 24-hour intervals for a total of 3 consecutive days. Do not 
use in animals previously found to be hypersensitive to the drug. Use of 
dosages in excess of those indicated or route of administration other 
than that recommended may result in illegal residues in tissues. Safety 
of ceftiofur has not been determined in breeding swine. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Cattle--(i) Dosage. 1.1 to 2.2 milligrams per kilogram (0.5 to 
1.0 milligrams per pound) of body weight, at 24-hour intervals for 3 to 
5 consecutive days. In addition, for bovine respiratory disease, 
administer 2.2 milligrams per kilogram (1.0 milligram per pound) of body 
weight every other day on days 1 and 3 (48-hour interval).
    (ii) Indications for use. For treatment of bovine respiratory 
disease (BRD, shipping fever, pneumonia) associated with Pasteurella 
haemolytica, P. multocida, and Haemophilus somnus and acute bovine 
interdigital necrobacillosis (foot rot, pododermatitis) associated with 
Fusobacterium necrophorum and Bacteroides melaninogenicus.
    (iii) Limitations. For intramuscular or subcutaneous use only. Do 
not inject more than 15 milliliters at each intramuscular injection 
site. Do not slaughter treated cattle for 48 hours (2 days) after last 
treatment. A withdrawal period has not been established 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.

[61 FR 29479, June 11, 1996, as amended at 63 FR 53578, Oct. 6, 1998]