FOLLTROPIN (follicle stimulating hormone- porcine injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Follicle Stimulating Hormone (Porcine) (UNII: 8FYM5179QJ) (Follitropin - UNII:076WHW89TW)

Available from:

Vetoquinol USA, Inc.

INN (International Name):

Follicle Stimulating Hormone

Composition:

Follicle Stimulating Hormone (Porcine) 700 [iU]

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

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. 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.

Product summary:

FOLLTROPIN® DUAL PACK contains two 20 mL vials each containing 700 IU1 FSH as a lyophilized powder.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

FOLLTROPIN- FOLLICLE STIMULATING HORMONE (PORCINE) INJECTION, POWDER,
FOR SOLUTION
VETOQUINOL USA, INC.
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FOLLTROPIN DUAL PACK
[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.
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 each vial of FOLLTROPIN with 20 mL bacteriostatic sodium
chloride injection, using
strict aseptic technique. Do not use if clumps or particles are
visible after gentle mixing. Once
reconstituted, FOLLTROPIN should be stored refrigerated at 2-8°C
(36-46°F) for no longer than 4
days.
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 indicated.
Collection of