[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: 21CFR522.690]

[Page 228-229]
 
                        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. 522.690  Dinoprost tromethamine sterile solution.

    (a) Specifications. Each milliliter of sterile solution contains the 
equivalent of 5 milligrams of dinoprost.
    (b) Sponsor. See Nos. 000009 and 059130 in Sec. 510.600(c) of this 
chapter.
    (c) Special considerations. Women of child-bearing age, asthmatics, 
and persons with bronchial and other respiratory problems should 
exercise extreme caution when handling this product. Dinoprost 
tromethamine is readily absorbed through the skin and can cause abortion 
and bronchiospasms. Accidental spillage on the skin should be washed off 
immediately with soap and water. Use of this product in excess of the 
approved dose may result in drug residues. Do not administer to pregnant 
cattle unless abortion is desired. Do not administer intravenously; this 
may potentiate adverse reactions.
    (d) Conditions of use--(1) Mares--(i) Amount. Equivalent of 1 
milligram of dinoprost per 100 pounds of body weight.
    (ii) Indications. For its luteolytic effect to control timing of 
estrus in estrus cycling mares and in clinically anestrous mares that 
have a corpus luteum.
    (iii) Limitations. For use once as a single intramuscular injection. 
Not for

[[Page 229]]

use in horses intended for food. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) Cattle--(i) Amount. 5 milliliters (equivalent to 25 milligrams 
of dinoprost).
    (ii)(a) Indications. For its luteolytic effect to control timing of 
estrus and ovulation in estrous cycling cattle that have a corpus 
luteum.
    (b) Limitations. For use in beef cattle and nonlactating dairy 
heifers, as follows: Inject a dose of 5 milliliters intramuscularly 
either once or twice at a 10- to 12-day interval. With a single 
injection, cattle should be bred at the usual time relative to estrus. 
With the two injections, cattle can be bred after the second injection 
either at the usual time relative to detected estrus or at about 80 
hours after the second injection. Estrus is expected to occur 1 to 5 
days after injection if a corpus luteum was present. Cattle that do not 
become pregnant to breeding at estrus on days 1 to 5 after injection 
will be expected to return to estrus in about 18 to 24 days. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (iii)(a) Indications. For treatment of pyometra (chronic 
endometritis).
    (b) Limitations. For intramuscular use as a single injection. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Nonlactating cattle--(i) Amount. Five milliliters 
intramuscularly as a single injection.
    (ii) Indications. For its abortifacient effect in nonlactating 
cattle.
    (iii) Limitations. For intramuscular use only, during first 100 days 
of gestation. Cattle that abort will abort within 35 days after 
injection. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (4) Lactating dairy cattle--(i) Amount. Five milliliters 
intramuscularly as a single injection.
    (ii) Indications. For treatment of unobserved (silent) estrus in 
lactating dairy cattle that have a corpus luteum.
    (iii) Limitations. Breed cattle as they are detected in estrus. If 
estrus has not been observed by 80 hours after injection, breed at 80 
hours. If cattle return to estrus breed at the usual time relative to 
estrus. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (5) Swine--(i) Amount. 2 milliliters (equivalent to 10 milligrams of 
dinoprost).
    (ii) Indications. For parturition induction in swine when injected 
within 3 days of normal predicted farrowing.
    (iii) Limitations. For use in swine as follows: Inject a dose of 2 
milliliters intramuscularly within 3 days of predicted farrowing. The 
response to treatment varies by individual animals with a mean interval 
from administration to parturition of approximately 30 hours. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[41 FR 4818, Feb. 2, 1976, as amended at 46 FR 13214, Feb. 20, 1981; 46 
FR 39127, July 31, 1981; 48 FR 6331, Feb. 11, 1983; 48 FR 46023, Oct. 
11, 1983; 49 FR 4373, Feb. 6, 1984; 64 FR 15685, Apr. 1, 1999]