(a) Specifications. The product is a suspension of ceftiofur crystalline free acid.
(1) Each milliliter (mL) contains 100 milligrams (mg) ceftiofur equivalents.
(2) Each mL contains 200 mg ceftiofur equivalents.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.113 of this chapter.
(d) Conditions of use--(1) Swine. The formulation described in paragraph (a)(1) of this section is used as follows:
(1) Swine. The formulation described in paragraph (a)(1) of this section is used as follows:
(i) Amount. 5.0 mg CE per kilogram (kg) of body weight by intramuscular injection in the postauricular region of the neck.
(ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. For the control of SRD associated with A. pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of pigs where SRD has been diagnosed.
(iii) Limitations. Following label use as a single treatment, a 14-day pre-slaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved, major food-producing species/production classes.
(2) Cattle. The formulation described in paragraph (a)(2) of this section is used as follows:
(i) Amount. For subcutaneous (SC) injection in the posterior aspect of the ear where it attaches to the head (base of the ear) in lactating dairy cattle. For SC injection in the middle third of the posterior aspect of the ear or in the base of the ear in beef and non-lactating dairy cattle.
(A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight as a single injection.
(B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight given as two injections in the base of the ear approximately 72 hours apart.
(ii) Indications for use--(A) Single-dose regimen: For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle. For the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.
(A) Single-dose regimen: For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle. For the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.
(B) Two-dose regimen: For the treatment of acute metritis (0-to 10-days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.
(iii) Limitations. Following label use as either a single-dose or 2-dose regimen, a 13-day pre-slaughter withdrawal period is required after the 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. Federal law prohibits extra-label use of this drug in cattle for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved, major food-producing species/production classes.
(3) Horses. The formulation described in paragraph (a)(2) of this section is used as follows:
(i) Amount. Two intramuscular injections, 4 days apart, at a dose of 3.0 mg/lb (6.6 mg/kg) body weight.
(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 60296, Oct. 22, 2003, as amended at 69 FR 43892, July 23, 2004. Redesignated and amended at 71 FR 39546, July 13, 2006; 73 FR 58872, Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75 FR 62468, Oct. 12, 2010; 77 FR 26162, May 3, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 37620, July 2, 2014] Sec. 522.313b Ceftiofur hydrochloride.
(a) Specifications. Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) ceftiofur equivalents.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.113 of this chapter.
(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle and swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.
(e) Conditions of use. (1) Swine--(i) Amount. 3 to 5 mg per kilogram (/kg) of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
(1) Swine--(i) Amount. 3 to 5 mg per kilogram (/kg) of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
(i) Amount. 3 to 5 mg per kilogram (/kg) of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 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 swine must not be slaughtered for 4 days following the last treatment.
(2) Cattle--(i) Amount. Administer by subcutaneous or intramuscular injection as follows:
(i) Amount. Administer by subcutaneous or intramuscular injection as follows:
(A) For bovine respiratory disease and acute bovine interdigital necrobacillosis: 1.1 to 2.2 mg/kg of body weight at 24-hour intervals for 3 to 5 consecutive days.
(B) For bovine respiratory disease: 2.2 mg/kg of body weight administered twice at a 48 hour interval.
(C) For acute metritis: 2.2 mg/kg of body weight at 24-hour intervals for 5 consecutive days.
(ii) Indications for use. For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.
(iii) Limitations. Treated cattle must not be slaughtered for 4 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. [61 FR 29479, June 11, 1996, as amended at 63 FR 53578, Oct. 6, 1998; 67 FR 45901, July 11, 2002; 69 FR 47362, Aug. 5, 2004. Redesignated and amended at 71 FR 39544, July 13, 2006; 73 FR 45612, Aug. 6, 2008; 76 FR 17338, Mar. 29, 2011; 78 FR 66264, Nov. 5, 2013] Sec. 522.313c Ceftiofur sodium.
(a) Specifications. Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.
(b) Sponsors. See Nos. 000409, 054771, and 068330 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.113 of this chapter.
(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle, swine, chickens, and turkeys for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.
(e) Conditions of use--(1) Swine--(i) Amount. 3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.
(1) Swine--(i) Amount. 3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.
(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.
(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, Pasteurella multocida, and Histophilus somni. Also, for the 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.
(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 (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella 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.
(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 Mannheimia haemolytica and Pasteurella multocida.
(5) Chickens--(i) Amount. 0.08 to 0.20 mg as a single subcutaneous injection in the neck.
(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.
(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.
(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 for 5 to 14 days.
(i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals for 5 to 14 days.
(ii) Indications for use. For treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis. [53 FR 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; 74 FR 34236, July 15, 2009; 77 FR 29218, May 17, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 21127, Apr. 15, 2014]