Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
Follicle Stimulating Hormone (Porcine) (UNII: 8FYM5179QJ) (Follitropin - UNII:076WHW89TW)
Vetoquinol USA, Inc.
Follicle Stimulating Hormone
Follicle Stimulating Hormone (Porcine) 700 [iU]
PRESCRIPTION
INDICATIONS FOR USE: For the induction of superovulation in beef and dairy heifers and cows. Not for use in male cattle or reproductively immature heifers because safety and effectiveness have not been tested. CONTRAINDICATIONS: Do not use in pregnant cattle. Laboratory studies with FSH in rats and rabbits have shown evidence of embryotoxicity/fetotoxicity and the safety of the product has not been assessed in pregnant cows. Do not use FOLLTROPIN® in cows that are known to be hypersensitive to the active ingredient, porcine pituitary-derived follicle stimulating hormone.
HOW SUPPLIED: FOLLTROPIN® contains one 20 mL vial containing 700 IU1 FSH as a lyophilized powder and one 20 mL diluent vial containing Bacteriostatic Sodium Chloride.
New Animal Drug Application
FOLLTROPIN- FOLLICLE STIMULATING HORMONE (PORCINE) VETOQUINOL USA, INC. ---------- FOLLTROPIN [PORCINE PITUITARY-DERIVED FOLLICLE STIMULATING HORMONE FOR INJECTION] NADA 141-431, APPROVED BY FDA CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: FOLLTROPIN (porcine pituitary-derived follicle stimulating hormone for injection) is a powder for solution containing 700 IU (equivalent to 400 mg NIH-FSH-P1) of follicle stimulating hormone (FSH) per vial. FOLLTROPIN contains a low amount of luteinizing hormone (less than 1000 µg NIH-LH- S19 per vial). When reconstituted according to label directions the final solution contains 35 IU FSH per mL for intramuscular injection. There are no inactive ingredients in the FSH vial. A 20 mL vial of sterile diluent for FOLLTROPIN is supplied containing 9 mg/mL sodium chloride, 18 mg/mL benzyl alcohol, sodium hydroxide in sufficient quantity to adjust pH, and water for injection q.s. INDICATIONS FOR USE: For the induction of superovulation in beef and dairy heifers and cows. Not for use in male cattle or reproductively immature heifers because safety and effectiveness have not been tested. DOSAGE AND ADMINISTRATION: For intramuscular injection only. Reconstitute FOLLTROPIN with 20 mL of the diluent provided using strict aseptic technique. Do not use if clumps or particles are visible after gentle mixing. Regimen: Start injections on day 8 to 10 following observed or induced estrus. Administer 2.5 mL (87.5 IU ) of FOLLTROPIN intramuscularly, twice daily at 12 hour intervals, for 4 consecutive days. In conjunction with the 6 dose of FOLLTROPIN , administer an FDA-approved prostaglandin product (cloprostenol sodium or dinoprost tromethamine) for cattle, using the labeled dosage and administration instructions to cause luteolysis and induce estrus. Inseminate animals at 12 and 24 hours after the onset of estrus or 60 and 72 hours after prostaglandin treatment. Additional inseminations may be conducted at 12 hour intervals, if ind Lue koko asiakirja