CFR

522.995—Fluprostenol sodium injection.

(a) Specifications. Each milliliter of sterile aqueous solution contains fluprostenol sodium equivalent to 50 micrograms of fluprostenol.

(b) Sponsor. See 000859 in § 510.600(c) of this chapter.

(2) Indications for use. The drug is used in mares for its luteolytic effect to control the timing of estrus in estrous cycling and in clinically anestrous mares that have a corpus luteum.

(3) Limitations. Administer by intramuscular injection only. Warning: Not for use in horses intended for food. For veterinary use only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Fluprostenol is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.

Code of Federal Regulations

[44 FR 52191, Sept. 7, 1979, as amended at 47 FR 22092, May 21, 1982]

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