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Electronic Code of Federal Regulations

e-CFR data is current as of December 10, 2019

Title 21Chapter ISubchapter EPart 522 → §522.812


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.812   Enrofloxacin.

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

(1) 22.7 milligrams (mg) enrofloxacin or

(2) 100 mg enrofloxacin.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter:

(1) Nos. 000859, 026637, and 055529 for use of product described in paragraph (a)(1) as in paragraph (e)(1); and

(2) Nos. 000859, 055529, and 061133 for use of product described in paragraph (a)(2) as in paragraphs (e)(2) and (3) of this section.

(c) Related tolerance. See §556.226 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—(A) Single-dose therapy: For treatment of bovine respiratory disease (BRD), administer 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL per 100 pounds (/100 lb)) once by subcutaneous injection. For control of BRD, administer 7.5 mg/kg of body weight (3.4 mL/100 lb) once by subcutaneous injection.

(B) Multiple-day therapy: For treatment of BRD, administer 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) 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—(A) Single-dose therapy: For the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle; for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

(B) Multiple-day therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni 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. This product is not approved for 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 preruminating 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) Amounts and indications for use. (A) Administer 7.5 mg/kg of body weight once, by intramuscular or subcutaneous injection behind the ear, for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma hyopneumoniae.

(B) Administer 7.5 mg/kg of body weight once, by intramuscular or subcutaneous injection behind the ear, for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

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

[72 FR 10597, Mar. 9, 2007, as amended at 73 FR 17890, Apr. 2, 2008; 73 FR 21819, Apr. 23, 2008; 76 FR 22611, Apr. 22, 2011; 77 FR 55415, Sept. 10, 2012; 77 FR 76863, Dec. 31, 2012; 78 FR 19987, Apr. 3, 2013; 79 FR 37620, July 2, 2014; 80 FR 13229, Mar. 13, 2015; 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13, 2015; 84 FR 8973, Mar. 13, 2019; 84 FR 53311, Oct. 7, 2019]

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