CFR

522.812—Enrofloxacin.

(a) Specifications. Each milliliter (mL) of solution contains:

(1) 22.7 milligrams (mg) enrofloxacin or

(2) 100 mg enrofloxacin.

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

(d) Special considerations. 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.

(e) Conditions of use— (1) Dogs. Use the product described in paragraph (a)(1) of this section as follows:

(i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per pound) 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.

(ii) Indications for use. For the management of diseases associated with bacteria susceptible to enrofloxacin.

(2) Cattle. Use the product described in paragraph (a)(2) of this section as follows:

(i) Amount. Single-dose therapy: 7.5 to 12.5 mg/kg of body weight by subcutaneous injection. Multiple-day therapy: 2.5 to 5.0 mg/kg of body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals for 3 days. Additional treatments may be given on days 4 and 5 to animals that have shown clinical improvement but not total recovery.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni (previously Haemophilus somnus) in beef and non-lactating dairy cattle.

(iii) Limitations. Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. Use of enrofloxacin in this class of cattle may cause milk residues. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

(3) Swine. Use the product described in paragraph (a)(2) of this section as follows:

(i) Amount. Administer 7.5 mg/kg of body weight once, by subcutaneous injection behind the ear.

(ii) Indications for use. For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.

(iii) Limitations. Animals intended for human consumption must not be slaughtered within 5 days of receiving a single-injection dose.

Code of Federal Regulations

[72 FR 10597, Mar. 9, 2007, as amended by 73 FR 17890, Apr. 2, 2008; 73 FR 21819, Apr. 23, 2008]

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