GONABREED- gonadorelin acetate injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

GONADORELIN ACETATE (UNII: 2RG1XQ1NYJ) (GONADORELIN - UNII:9O7312W37G)

제공처:

Parnell Technologies Pty Ltd

INN (국제 이름):

GONADORELIN ACETATE

구성:

GONADORELIN 100 ug in 1 mL

관리 경로:

INTRAMUSCULAR

처방전 유형:

PRESCRIPTION

치료 징후:

INDICATIONS AND DOSAGE: Cystic Ovaries GONAbreed 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 luteinizing hormone (LH) such as human chorionic gonadotrophin. GONAbreed initiates release of endogenous LH to cause ovulation and luteinization. The recommended intravenous or intramuscular dosage of GONAbreed is 100 mcg (1 mL) per cow. Reproductive Synchrony GONAbreed is indicated for use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows. The recommended intramuscular dosage of GONAbreed is 100 mcg (1 mL) per cow, used in reproductive synchrony programs similar to the following: Administer the first GONAbreed injection (1 mL) at Time 0. Administer 500 mcg cloprostenol (as cloprostenol sodium) by intra

제품 요약:

HOW SUPPLIED: GONAbreed is available in a concentration of 100 mcg gonadorelin/mL as gonadorelin acetate. GONAbreed is supplied in multidose vials containing 20 mL and 100 mL of sterile solution.

승인 상태:

Abbreviated New Animal Drug Application

제품 특성 요약

GONABREED- GONADORELIN ACETATE INJECTION, SOLUTION
PARNELL TECHNOLOGIES PTY LTD
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GONABREED
Approved by FDA under ANADA # 200-541
GONABREED®
(gonadorelin acetate)
Equivalent to 100 mcg gonadorelin/mL
Sterile solution
FOR THE TREATMENT OF CYSTIC OVARIES IN DAIRY 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:
GONAbreed is a sterile solution containing 100 micrograms of
gonadorelin (GnRH) as gonadorelin
acetate per milliliter 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 . The acetate salt has a molecular
weight of 60.05 and an empirical formula C
H N O . C H O .
Gonadorelin is the hypothalamic releasing factor responsible for the
release of gonadotropins (e.g.,
LH, FSH) from the anterior pituitary. Synthetic gonadorelin is
physiologically and chemically identical
to the endogenous bovine hypothalamic releasing factor.
PHARMACOLOGY AND TOXICOLOGY:
Endogenous gonadorelin is synthesized and/or released from the
hypothalamus during various stages of
the bovine estrous cycle following appropriate neurogenic stimuli. It
passes via the hypophyseal portal
vessels, to the anterior pituitary to effect the release of
gonadotrophins (e.g. LH, FSH). Synthetic
gonadorelin administered intravenously or intramuscularly also causes
the release of endogenous LH
or FSH from the anterior pituitary.
Gonadorelin acetate has been shown to be safe. The LD for mice and
rats is greater than 60 mg/kg,
and for dogs, greater than 600 mcg/kg, respectively. No untoward
effects were noted among rats or
dogs administered 120 mcg/kg/day or 72 mcg/kg/day intravenously for 15
days.
It has n