21 C.F.R. § 522.313c Ceftiofur sodium.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents. (b) Sponsor. See No. 000009 in §510.600(c) of this chapter. (c) Related tolerances. See §556.113 of this chapter. (d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e) Conditions of use—(1) Swine—(i) Amount. 3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days. (ii) Indications for use. For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis. (iii) Limitations. Treated pigs must not be slaughtered for 4 days following the last treatment. (2) Cattle—(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response. (ii) Indications for use. For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni in beef and dairy cattle; and for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. (iii) Limitations. Treated cattle must not be slaughtered for 4 days following the last treatment. (3) Sheep—(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response. (ii) Indications for use. For treatment of sheep respiratory disease (pneumonia) associated with M. haemolytica and P. multocida. (4) Goats—(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response. (ii) Indications for use. For treatment of caprine respiratory disease (goat pneumonia) associated with M. haemolytica and P. multocida. (5) Chickens—(i) Amount. 0.08 to 0.20 mg as a single subcutaneous injection in the neck. (ii) Indications for use. For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur in day-old chicks. (6) Turkeys—(i) Amount. 0.17 to 0.5 mg as a single subcutaneous injection in the neck. (ii) Indications for use. For control of early mortality associated with E. coli organisms susceptible to ceftiofur in day-old poults. (7) Horses—(i) Amount. 2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. 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 mL should be administered per injection site. (ii) Indications for use. For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus. (iii) Limitations. Do not use in horses intended for human consumption. (8) Dogs—(i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared, for 5 to 14 days. (ii) Indications for use. For treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis. [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; 69 FR 47362, Aug. 5, 2004. Redesignated and amended at 71 FR 39544, July 13, 2006]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.313c Ceftiofur sodium.
