§ 516.812 - Enrofloxacin.

§ 516.812 Enrofloxacin.

(a) Specifications. Each milliliter (mL) of solution contains 100 milligrams (mg) enrofloxacin.

(b) Sponsor. See No. 000859 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in cattle -

(1) Amount. Administer, by subcutaneous injection, a single dose of 12.5 mg/kilogram of body weight (5.7 mL/100 pounds of body weight). Administered dose volume should not exceed 20 mL per injection site.

(2) Indications for use. For the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves.

(3) Limitations. 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. Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment. This 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 for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

[86 FR 13184, Mar. 8, 2021, as amended at 87 FR 58960, Sept. 29, 2022]