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522.46—Alfaprostol.

(a) Specifications. Each milliliter of sterile solution contains 1 milligram of alfaprostol.

(b) Sponsor. No. 055882 in § 510.600(c) of this chapter.

(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.

Code of Federal Regulations

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

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