[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: 21CFR529.50]

[Page 325]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  529.50  Amikacin sulfate intrauterine solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 250 milligrams of amikacin (as the sulfate).
    (b) Sponsor. See No. 000856 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. Two grams (8 milliliters) diluted 
with 200 milliliters of sterile physiological saline per day for 3 
consecutive days.
    (2) Indications for use. For treating genital tract infections 
(endometritis, metritis, and pyometra) in mares when caused by 
susceptible organisms including E. coli, Pseudomonas spp., and 
Klebsiella spp.
    (3) Limitations. For intrauterine infusion in the horse only. Not 
for use in horses intended for food. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[48 FR 9640, Mar. 8, 1983, as amended at 53 FR 27852, July 25, 1988; 62 
FR 15110, Mar. 31, 1997; 62 FR 23358, Apr. 30, 1997]