[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: 21CFR522.313] [Page 223-224] 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. 522.313 Ceftiofur sodium powder for injection. (a) Specifications. Ceftiofur sodium sterile powder for injection is reconstituted to form an aqueous solution containing the equivalent of 50 milligrams ceftiofur per milliliter. (b) Sponsor. See 000009 in Sec. 510.600 of this chapter. (c) Related tolerances. See Sec. 556.113 of this chapter. (d) Conditions of use--(1) Cattle--(i) Amount. 0.5 to 1.0 milligram of ceftiofur per pound of body weight intramuscularly or subcutaneously. (ii) Indications for use. Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Pasteurella hemolytica, P. multocida, and Haemophilus somnus in beef and dairy cattle. Also, for the treatment of acute bovine interdigitial necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. (iii) Limitations. Treatment should be repeated once every 24 hours for 3 days. Treat for an additional 2 days if animals do not show a satisfactory response. Do not use in animals previously found to be hypersensitive to the drug. Use of doses in excess of those indicated may result in illegal residues in tissues. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) 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, [[Page 224]] Pasteurella 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. (3) Day-old chickens--(i) Amount. 0.08 to 0.20 milligram per chick. (ii) Indications for use. For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur. (iii) Limitations. For subcutaneous use in the neck of day-old chicks only. As a single dose only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (4) Day-old turkey poults--(i) Amount. 0.17 to 0.5 milligram per poult. (ii) Indications for use. For control of early mortality associated with E. coli organisms susceptible to ceftiofur. (iii) Limitations. For subcutaneous use in the neck of day-old poults only. As a single dose only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (5) Horses--(i) Amount. 2.2 to 4.4 milligrams per kilogram (1.0 to 2.0 milligrams per pound) of body weight. (ii) Indications for use. For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus. (iii) Limitations. For intramuscular use only. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 milliliters should be administered per injection site. Not for use in horses intended for food. Do not use in animals previously found to be hypersensitive to the drug. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (6) Dogs--(i) Amount. 1.0 milligrams per pound (2.2 milligrams per kilogram) of body weight. (ii) Indications for use. Treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis. (iii) Limitations. For subcutaneous use only. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared, for 5 to 14 days. Do not use in animals found to be hypersensitive to the drug. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (7) Sheep--(i) Amount. 0.5 to 1.0 milligram per pound (1.1 to 2.2 milligrams per kilogram) of body weight. (ii) Indications for use. For treatment of sheep respiratory disease (pneumonia) associated with Pasteurella haemolytica and/or P. multocida. (iii) Limitations. For intramuscular use only. Treatment should be repeated at 24 hour intervals for a total of 3 consecutive days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response. Use of dosages in excess of those indicated or by unapproved routes of administration may result in illegal residues in tissues. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (8) Goats--(i) Amount. 0.5 to 1.0 milligram per pound of body weight by intramuscular injection at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days 4 and 5 for animals that do not show satisfactory response. (ii) Indications for use. For treatment of caprine respiratory disease (goat pneumonia) associated with Pasteurella haemolytica and P. multocida. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [53 5369, Feb. 24, 1988, as amended at 55 FR 13768, Apr. 12, 1990; 56 FR 12119, Mar. 22, 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666, Aug. 15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR 51719, Oct. 3, 1995; 61 FR 35130, July 5, 1996; 61 FR 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30, 2001; 66 FR 32540, June 15, 2001]