FERTAGYL- gonadorelin injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

GONADORELIN (UNII: 9O7312W37G) (GONADORELIN - UNII:9O7312W37G)

제공처:

Merck Sharp & Dohme Corp.

INN (국제 이름):

GONADORELIN

구성:

GONADORELIN 43 ug in 1 mL

관리 경로:

INTRAMUSCULAR

처방전 유형:

PRESCRIPTION

치료 징후:

INDICATIONS FOR USE: Cystic Ovaries Fertagyl is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are nonovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus. Historically, cystic ovaries have responded to an exogenous source of LH such as human chorionic gonadotropin. Fertagyl initiates release of endogenous LH to cause ovulation and luteinization. Reproductive Synchrony Fertagyl is indicated for use with Estrumate (cloprostenol injection) to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows. Fertagyl is indicated for use with cloprostenol sodium to synchronize estrous cycles to allow for FTAI in beef cows.

제품 요약:

HOW SUPPLIED : Fertagyl is available in a concentration of 43 mcg/mL gonadorelin (as gonadorelin acetate) pH adjusted with sodium phosphate (monobasic and dibasic). Fertagyl is supplied in multi-dose vials containing 20 mL and 100 mL of sterile solution. STORAGE, HANDLING, AND DISPOSAL: Keep refrigerated: 2°-8°C (36°-46°F). 20 mL vial: Use within 28 days of first puncture. 100 mL vial: Use within 28 days of first puncture and puncture a maximum of 10 times when using an 18 gauge needle. When using a draw-off spike or needle with bore diameter larger than 18 gauge, discard any product remaining in the vial immediately after use.

승인 상태:

Abbreviated New Animal Drug Application

제품 특성 요약

FERTAGYL- GONADORELIN INJECTION
MERCK SHARP & DOHME CORP.
----------
FERTAGYL
(GONADORELIN)
43 MCG/ML GONADORELIN INJECTABLE SOLUTION
189979 R9
FOR TREATMENT OF CYSTIC OVARIES IN DAIRY CATTLE
FOR USE WITH ESTRUMATE (CLOPROSTENOL INJECTION) TO SYNCHRONIZE ESTROUS
CYCLES TO ALLOW FOR FIXED
TIME ARTIFICIAL INSEMINATION (FTAI) IN LACTATING DAIRY COWS
FOR USE WITH CLOPROSTENOL SODIUM TO SYNCHRONIZE ESTROUS CYCLES TO
ALLOW FOR FTAI IN BEEF COWS
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
Fertagyl is a sterile solution containing 43 mcg/mL of gonadorelin
(GnRH: as gonadorelin acetate)
suitable for intramuscular or intravenous administration according to
the indication.
Gonadorelin is a decapeptide composed of the sequence of amino acids
–
5-oxoPro-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH
a molecular weight of 1182.32 and empirical formula C
H N O .
Each mL of Fertagyl contains:
Gonadorelin (as gonadorelin
acetate)
43 mcg
Benzyl Alcohol
9 mg
Sodium Chloride
7.47 mg
Water for Injection, USP
q.s.
pH adjusted with sodium phosphate (monobasic and dibasic).
Gonadorelin is the hypothalamic releasing factor responsible for the
release of gonadotropins (e.g.,
luteinizing hormone [LH], follicle stimulating hormone [FSH]) from the
anterior pituitary.
Synthetic gonadorelin is physiologically and chemically identical to
the endogenous bovine
hypothalamic releasing factor.
INDICATIONS FOR USE:
CYSTIC OVARIES
Fertagyl is indicated for the treatment of ovarian follicular cysts in
dairy cattle. Ovarian cysts are
nonovulated follicles with incomplete luteinization which result in
nymphomania or irregular estrus.
Historically, cystic ovaries have responded to an exogenous source of
LH such as human chorionic
gonadotropin.
Fertagyl initiates release of endogenous LH to cause ovulation and
luteinization.
REPRODUCTIVE SYNCHRONY
Fertagyl is indicated for use with Estrumate (cloprostenol injection)
to synchronize estrous cycles to
®
2
55
75
17
13
allow for fixed time artificial i