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출처: NLM (National Library of Medicine)
GONADORELIN HYDROCHLORIDE (UNII: 3PFC574ITA) (GONADORELIN - UNII:9O7312W37G)
Zoetis Inc.
GONADORELIN HYDROCHLORIDE
GONADORELIN 50 ug in 1 mL
INTRAMUSCULAR
PRESCRIPTION
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.
FACTREL Injection (gonadorelin injection), 50 mcg/mL is available in 20 mL and 50 mL multi-dose vials (box of one).
New Animal Drug Application
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 전체 문서 읽기