[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: 21CFR522.46]

[Page 217]
 
                        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.  522.46  Alfaprostol.

    (a) Specifications. Each milliliter of sterile solution contains 1 
milligram of alfaprostol.
    (b) Sponsor. No. 055882 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is used in horses as follows:
    (1) Amount. For average mature mares, 6.0 micrograms per kilogram of 
body weight.
    (2) Indications for use. To cause luteolysis in mares with active 
corpora lutea.
    (3) Limitations. For intramuscular or subcutaneous use as a single 
injection. Not for horses intended for food. Alfaprostol is readily 
absorbed through the skin and can cause abortion and/or bronchial 
spasms. Women of childbearing age, asthmatics, and persons with 
bronchial and other respiratory problems should exercise extreme caution 
when handling this product. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[48 FR 43300, Sept. 23, 1983, as amended at 53 FR 40057, Oct. 13, 1988]