- (a) Specifications. Each milliliter (mL) of solution contains 200 milligrams (mg) pradofloxacin.
- (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
- (c) Related tolerances. See § 556.530 of this chapter.
- (d) Conditions of use—(1) Cattle—(i) Amount. Administer a single dose of 10 mg/kg (2.3 mL/100 lb) body weight by subcutaneous injection.
- (ii) Indications for use. Cattle intended for slaughter (beef calves 2 months of age and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age): for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
- (iii) Limitations. Cattle intended for human consumption must not be slaughtered within 4 days of treatment. Not for use in female dairy cattle 1 year of age and older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
- (2) Swine—(i) Amount. Administer a single dose of 7.5 mg/kg (1.7 mL/100 lb) body weight by intramuscular injection.
- (ii) Indications for use. Weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter): for the treatment of swine respiratory disease associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae.
- (iii) Limitations. Swine intended for human consumption must not be slaughtered within 2 days of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
[89 FR 85427, Oct. 28, 2024]