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.
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 6th 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 indicated.
Collection of embryos is normally started on day 7 following insemination.
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.
WARNINGS AND PRECAUTIONS:
Neither a withdrawal period nor a milk
discard time is required when this product
is used according to label directions.