英文药名: Antagon(ganirelix acetate prefilled syringe )
中文药名: 醋酸加尼瑞克预充式注射器
生产厂家: 欧加农制药美国公司 药品简介 中文药名:醋酸加尼瑞克 英文药名:ganirelix acetate 商品名称:ANTAGON 上市公司:ORGANON INC 适应症:用于对卵巢过度兴奋妇女过早黄体生成素来潮的抑制。 包装规格 注射器 剂量:0.25mg/0.5ml 5支一盒
Antagon Ganirelix DESCRIPTION Antagon (ganirelix acetate) Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-napthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N 9 ,N 10 -diethyl- D-homoarginyl-L-leucyl-N 9 ,N 10 -diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for ganirelix acetate is 1570.4 as an anhydrous free base. Antagon is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each sterile, prefilled syringe contains 250 g/0.5 mL of ganirelix acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF. INDICATIONS AND USES Antagon (ganirelix acetate) Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. DOSAGE AND ADMINISTRATION After initiating FSH therapy on Day 2 or 3 of the cycle, Antagon (ganirelix acetate) Injection 250 g may be administered subcutaneously once daily during the early to mid follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced. Treatment with Antagon should be continued daily until the day of hCG administration. When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS. Directions for Using Antagon (ganirelix acetate) Injection 1.Antagon is supplied in a sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only. 2.Wash hands thoroughly with soap and water. 3.The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh. 4.The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and let the disinfectant dry for at least one minute before proceeding. 5.Remove needle cover. 6.Pinch up a large area of skin between the finger and thumb. Vary the injection site a little with each injection. 7.The needle should be inserted at the base of the pinched-up skin at an angle of 45-90 to the skin surface. 8.When the needle is correctly positioned, it will be difficult to draw back on the plunger. If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery. If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin. Alternatively, remove the needle and use a new, sterile, prefilled syringe. Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within one or two minutes. 9.Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged. 10.Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant. 11.Use the sterile, prefilled syringe only once and dispose of it properly. HOW SUPPLIED Antagon (ganirelix acetate) Injection is supplied in: Disposable, sterile, prefilled 1 mL glass syringes containing 250 g/0.5 mL of ganirelix acetate. Each Antagon sterile, prefilled syringe is affixed with a 27 gauge inch needle and is blister-packed. Single syringe NDC 0052-0301-51 Box of 5 NDC 0052-0301-61 Box of 50 NDC 0052-0301-71 Storage Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature]. Protect from light. Rx only Manufactured for Organon Inc. http://www.kiessig.com/drugs/druginfo.aspx?id=714 醋酸加尼瑞克注射液由默沙东公司(在美国和加拿大被称为默克)研发、生产。 醋酸加尼瑞克注射液是一种促性腺激素释放激素(GnRH)的拮抗剂,可竞争性阻断垂体促性腺细胞上的GnRH 受体,以及其后的转导通路,从而产生一种快速、可逆的促性腺激素分泌抑制作用。在辅助生殖医学控制性促排卵治疗中,用于拮抗剂方案。 Cochrance一项荟萃分析显示拮抗剂方案能够减轻接受辅助生殖技术女性的治疗负担,也能减少严重不良事件如卵巢过度刺激综合症(OHSS)等的发生.
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