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(a) Specifications. Each milliliter of suspension contains:
(1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of ceftiofur equivalents in the inactive vehicles phospholipan 90H, sorbitan monooleate, and cottonseed oil;
(2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles polyoxyethylene sorbitan monooleate (polysorbate 80) in a caprylic/capric triglyceride suspension; or
(3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles aluminum monostearate, sorbitan monooleate, and medium chain triglycerides.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 054771 for products described in paragraphs (a)(1) and (2) of this section; and
(2) No. 055529 for the product described in paragraph (a)(3) of this section.
(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. 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.
(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. For products described in paragraphs (a)(1) and (3) of this section: Treated swine must not be slaughtered for 4 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated swine must not be slaughtered for 6 days following the last treatment when injection site volumes are greater than 5 mL up to the maximum injection site volume of 15 mL. Treated swine must not be slaughtered for 4 days when injection site volumes are less than or equal to 5 mL.
(2) Cattle - (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. (A) For products described in paragraphs (a)(2) and (3) of this section: Treated cattle must not be slaughtered for 3 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated cattle must not be slaughtered for 4 days following the last treatment.
(B) 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; 84 FR 39183, Aug. 9, 2019; 84 FR 53311, Oct. 7, 2019]
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