FACTREL- gonadorelin hydrochloride injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
08-12-2022

유효 성분:

GONADORELIN HYDROCHLORIDE (UNII: 3PFC574ITA) (GONADORELIN - UNII:9O7312W37G)

제공처:

Zoetis Inc.

INN (국제 이름):

GONADORELIN HYDROCHLORIDE

구성:

GONADORELIN 50 ug in 1 mL

관리 경로:

INTRAMUSCULAR

처방전 유형:

PRESCRIPTION

치료 징후:

For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers. The treatment effect of FACTREL Injection when used in lactating dairy cows, beef cows, and replacement dairy and beef heifers is a reduction in the number of days to first estrus. For use with LUTALYSE® (dinoprost tromethamine injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

제품 요약:

FACTREL Injection (gonadorelin injection), 50 mcg/mL is available in 20 mL and 50 mL multi-dose vials (box of one).

승인 상태:

New Animal Drug Application

제품 특성 요약

                                FACTREL- GONADORELIN HYDROCHLORIDE INJECTION
ZOETIS INC.
----------
FACTREL INJECTION
Approved by FDA under NADA # 139-237
FACTREL® INJECTION
(GONADORELIN INJECTION)
50 mcg gonadorelin per mL (as gonadorelin hydrochloride) Solution for
Intramuscular
Injection.
For use in cattle only
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
FACTREL Injection is a sterile solution containing 50 micrograms of
synthetic gonadorelin
(as hydrochloride) per mL in aqueous formulation containing 0.6%
sodium chloride and
2% benzyl alcohol (as a preservative).
Gonadorelin is the gonadotropin releasing hormone (GnRH) which is
produced by the
hypothalamus and causes the release of the gonadotropin luteinizing
hormone (LH) and
follicle-stimulating hormone (FSH) from the anterior pituitary.
FACTREL Injection has the identical amino acid sequence as endogenous
gonadorelin; 5-
oxo Pro-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH with identical
physiological activities.
The molecular weight of gonadorelin is 1182 with a molecular formula
of C
H
N
O
.
The corresponding values for gonadorelin hydrochloride are 1219 (1
HCl) expressed as
C
H
N
O
HCl, or 1255 (2 HCl) expressed as C
H
N
O
2HCl.
INDICATIONS FOR USE
For the treatment of ovarian follicular cysts in lactating dairy cows,
beef cows, and
replacement dairy and beef heifers. The treatment effect of FACTREL
Injection when
used in lactating dairy cows, beef cows, and replacement dairy and
beef heifers is a
reduction in the number of days to first estrus.
For use with LUTALYSE® (dinoprost tromethamine injection) Injection
to synchronize
estrous cycles to allow fixed-time artificial insemination (FTAI) in
lactating dairy cows.
DOSAGE
®
2
55
75
17
13
55
75
17
13
55
75
17
13
For the treatment of ovarian follicular cysts in lactating dairy cows,
beef cows, and
replacement dairy and beef heifers: Administer 2 mL of FACTREL
Injection as a single
intramuscular injection.
For use with LUTALYSE (dinoprost tromethamine injection) Injection to
syn
                                
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