FOLLTROPIN (follicle stimulating hormone- porcine kit

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Vetoquinol USA, Inc.

INN (Међународно име):

Follicle Stimulating Hormone

Састав:

Follicle Stimulating Hormone (Porcine) 700 [iU]

Тип рецептора:

PRESCRIPTION

Терапеутске индикације:

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.

Резиме производа:

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.

Статус ауторизације:

New Animal Drug Application

Карактеристике производа

FOLLTROPIN- FOLLICLE STIMULATING HORMONE (PORCINE)
VETOQUINOL USA, INC.
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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