21 C.F.R. § 522.812 Enrofloxacin solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile solution contains either 22.7 milligrams of enrofloxacin when intended for use in dogs or 100 milligrams of enrofloxacin when intended for use in cattle. (b) Sponsor. See No. 000859 in §510.600(c) of this chapter. (c) Related tolerance. See §556.228 of this chapter. (d) Conditions of use—(1) Dogs—(i) Amount. 2.5 milligrams per kilogram (1.13 milligrams per pound) of body weight as an initial dose only. (ii) Indications for use. Dogs for management of diseases associated with bacteria susceptible to enrofloxacin. (iii) Limitations. As a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 10 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cattle—(i) Amount. Single-dose therapy: 7.5 to 12.5 milligrams enrofloxacin per kilogram of body weight (3.4 to 5.7 milliliters per 100 pounds). Multiple-day therapy: 2.5 to 5.0 milligrams per kilogram of body weight (1.1 to 2.3 milliliters per 100 pounds) administered once daily for 3 to 5 days. (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus. (iii) Limitations. For subcutaneous use in cattle only. Do not inject more than 20 milliliters at each site. Do not slaughter within 28 days of last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. The effect of enrofloxacin on bovine reproductive performance, pregnancy, and lactation have not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals. [55 FR 26683, June 29, 1990, as amended at 62 FR 38907, July 21, 1997; 63 FR 49003, Sept. 14, 1998]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.812 Enrofloxacin solution.
