(a) Specifications. Each milliliter (mL) of solution contains:
(1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin.
(2) 300 mg florfenicol in the inactive vehicle n-methyl-2-pyrrolidone.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (d)(1)(i) and for use of product described in paragraph (a)(2) as in paragraph (d)(1)(ii).
(c) Related tolerances. See Sec. Sec. 500.1410 and 556.283 of this chapter.
(d) Conditions of use--(1) Cattle--(i) 300 mg/mL florfenicol in 2-pyrrolidone and triacetin (inactive vehicles).
(1) Cattle--(i) 300 mg/mL florfenicol in 2-pyrrolidone and triacetin (inactive vehicles).
(i) 300 mg/mL florfenicol in 2-pyrrolidone and triacetin (inactive vehicles).
(A) Amount. 40 mg/kilogram (kg) body weight as a single subcutaneous injection.
(B) Indications for use. For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.
(C) Limitations. Do not slaughter within 44 days of treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. 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.
(ii) 300 mg/mL florfenicol in n-methyl-2-pyrrolidone (inactive vehicle).
(A)(1) Amount. 20 mg/kg of body weight as an intramuscular injection. A second dose should be administered 48 hours later. Alternatively, 40 mg/kg of body weight as a single subcutaneous injection may be used.
(2) Indications for use. For treatment of BRD associated with Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus somnus. For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
(B)(1) Amount. 40 mg/kg of body weight as a single subcutaneous injection.
(2) Indications for use. For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus somnus.
(C) Limitations. Do not slaughter within 28 days of last intramuscular treatment or within 38 days of subcutaneous treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. 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.
(2) [Reserved] [73 FR 21041, Apr. 18, 2008, as amended at 74 FR 66574, Dec. 16, 2009; 79 FR 18158, Apr. 1, 2014; 79 FR 53136, Sept. 8, 2014]