[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.812]

[Page 236]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.812  Enrofloxacin solution.

    (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 Sec.  510.600(c) of this chapter.
    (c) Related tolerance. See Sec.  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]