ProstaMate™ Sterile Solution

522.690 Dinoprost tromethamine sterile solution.

Specifications: Each milliliter of sterile solution contains the equivalent of 5 milligrams of dinoprost.

Conditions of use:

Horses (mares)

Amount: Equivalent of 1 milligram of dinoprost per 100 pounds of body weight. For use once as a single intramuscular injection.

Indications: For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum.

Limitations: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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 bronchospasms. 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 intravenously; this may potentiate adverse reactions.

Cattle (beef, nonlactating dairy heifers)

Amount: 5 milliliters (equivalent to 25 milligrams of dinoprost). Inject a dose of 5 milliliters intramuscularly either once or twice at a 10- to 12-day interval.

Indications: For its luteolytic effect to control timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum.

Limitations: 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. 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 bronchospasms. 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.

Amount: 5 milliliters (equivalent to 25 milligrams of dinoprost). For intramuscular use as a single injection.

Indications: For treatment of pyometra (chronic endometritis).

Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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 bronchospasms. 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.

Cattle (nonlactating)

Amount: Five milliliters intramuscularly as a single injection. For intramuscular use only, during first 100 days of gestation.

Indications: For its abortifacient effect.

Limitations: 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. 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 bronchospasms. 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.

Cattle (lactating dairy)

Amount: Five milliliters intramuscularly as a single injection.

Indications: For treatment of unobserved (silent) estrus in lactating dairy cattle that have a corpus luteum.

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. 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 bronchospasms. 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.

Swine

Amount: 2 milliliters (equivalent to 10 milligrams of dinoprost). Inject a dose of 2 milliliters intramuscularly within 3 days of predicted farrowing.

Indications: For parturition induction in swine when injected within 3 days of normal predicted farrowing.

Limitations: 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. 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 bronchospasms. 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.