Страна: Тайвань
Язык: китайский
Источник: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
CETRORELIX ACETATE
台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)
H01CC02
凍晶注射劑
CETRORELIX ACETATE (9200042810) (3.12-3.24 MG)MG
小瓶;;注射針筒
製 劑
須由醫師處方使用
ABBOTT BIOLOGICALS B.V. VEERWEG 12,8121 AA OLST,THE NETHERLAND NL
cetrorelix
預防接受卵巢強效刺激排卵治療的患者,早發性的排出不成熟的卵。
註銷日期: 2017/04/14; 註銷理由: 許可證已逾有效期; 有效日期: 2016/08/01; 英文品名: CETROTIDE 3MG
已註銷
2001-08-01
3 mg powder and solvent for solution for injection Active substance: Cetrorelix acetate Composition One vial with 167.7 mg powder containing as active substance 3.12 - 3.24 mg cetrorelix acetate equivalent to 3 mg cetrorelix. Additionally, the powder contains mannitol as excipient. One pre-filled syringe containing 3 ml water for injections. 1028702 5662-0130 Pharmaceutical form Cetrotide ® 3 mg is a powder for solution for injection. Pharmacotherapeutic group Cetrotide ® 3 mg inhibits the effects of a natural hormone, called luteinising hormone releasing hormone (LHRH). LHRH regulates the secret ion of another hormone, called luteinising hormone (LH), which induces ovulation during the menstrual cycle. Cetrotide ® 3 mg inhibits premature ovulation which is undesirable during hormone treatment for ovarian stimulation as only mature egg cells are suitable for fertilisation. Indications Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. In clinical trials Cetrotide ® 3 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant FSH suggested similar efficacy. Contra-indications • Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol. • Pregnancy and lactation. • Postmenopausal women. • Patients with moderate and severe renal and hepatic impairment. Pregnancy and lactation Cetrotide ® 3 mg is not intended to be used during pregnancy and lactation (see section ”Contra-indications”). Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy. No teratogenic effects occurred when the drug was administered during the sensitive phase of gestation. Special warnings and special precautions for use During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur. This event must be considered as an intrinsic risk of the stimulation procedure wit Прочитать полный документ