(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]