[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.48]

[Page 92]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.48  Altrenogest solution.

    (a) Specifications. Each milliliter of altrenogest solution contains 
2.2 milligrams of altrenogest.
    (b) Sponsor. See No. 012799 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally at the rate of 
1 milliliter per 110 pounds body weight (0.044 milligram per kilogram 
body weight). Give one dose daily for 15 consecutive days.
    (2) Indications for use. For suppression of estrus in mares.
    (3) Limitations. For oral use in horses only; avoid contact with the 
skin. Do not administer to horses intended for use as food. The drug is 
contraindicated for use in mares having a previous or current history of 
uterine inflammation (i.e., acute, subacute, or chronic endometritis). 
Natural or synthetic gestagen therapy may exacerbate existing low-grade 
or smoldering uterine inflammation into a fulminating uterine infection 
in some instances. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[48 FR 40887, Sept. 12, 1983, as amended at 55 FR 26431, June 28, 1990; 
64 FR 42597, Aug. 5, 1999]