CYSTORELIN- gonadorelin diacetate tetrahydrate injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

GONADORELIN DIACETATE TETRAHYDRATE (UNII: L8CRY8PWF2) (GONADORELIN - UNII:9O7312W37G)

제공처:

Merial, Inc.

INN (국제 이름):

gonadorelin diacetate tetrahydrate

구성:

gonadorelin diacetate tetrahydrate 50 ug in 1 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION

치료 징후:

Cystic Ovaries CYSTORELIN is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated 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 gonadotrophin. CYSTORELIN initiates release of endogenous LH to cause ovulation and luteinization. Reproductive Synchrony CYSTORELIN is indicated for use with cloprostenol sodium to synchronize estrous cycle to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.

제품 요약:

CYSTORELIN is available in a concentration of 50 mcg/mL gonadorelin diacetate tetrahydrate (43 mcg/mL gonadorelin) pH adjusted with potassium phosphate (monobasic and dibasic). CYSTORELIN is supplied in multi-dose vials containing 10 mL and 30 mL of sterile solution.

승인 상태:

New Animal Drug Application

제품 특성 요약

CYSTORELIN- GONADORELIN DIACETATE TETRAHYDRATE INJECTION, SOLUTION
MERIAL, INC.
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CYSTORELIN
(GONADORELIN)
50 MCG/ML GONADORELIN DIACETATE TETRAHYDRATE INJECTABLE SOLUTION
FOR THE TREATMENT OF CYSTIC OVARIES IN CATTLE
FOR USE WITH CLOPROSTENOL SODIUM TO SYNCHRONIZE ESTROUS CYCLES TO
ALLOW FOR FIXED TIME ARTIFICIAL
INSEMINATION (FTAI) IN LACTATING DAIRY COWS AND BEEF COWS.
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the
order of a licensed veterinarian.
DESCRIPTION:
CYSTORELIN is a sterile solution containing 43 mcg/mL of gonadorelin
(GnRH) as 50 mcg/mL
gonadorelin diacetate tetrahydrate suitable for intramuscular or
intravenous administration according to
the indication. Gonadorelin is a decapeptide composed of the sequence
of amino acids—
a molecular weight of 1182.32 and empirical formula C
H N O . The diacetate tetrahydrate ester
has a molecular weight of 1374.48 and empirical formula C
H N O .
Each mL CYSTORELIN contains:
pH adjusted with potassium 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 AND USAGE:
CYSTIC OVARIES
CYSTORELIN is indicated for the treatment of ovarian follicular cysts
in dairy cattle. Ovarian cysts are
non-ovulated 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
gonadotrophin. CYSTORELIN initiates release of endogenous LH to cause
ovulation and luteinization.
REPRODUCTIVE SYNCHRONY
CYSTORELIN is indicated for use with cloprostenol sodium to
synchronize estrous cycle to allow for
fixed time artificial insemination (FTAI) in lactating dairy cows and
beef cows.
DOSAGE AND ADMINISTRATION:
®
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