国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
FOLLITROPIN ALFA(r-hFSH)
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)
G03GA05
凍晶乾燥注射劑
FOLLITROPIN ALFA(r-hFSH) (6818000500) I.U.
小瓶;;針筒裝附溶劑
菌 疫
限由醫師使用
MERCK SERONO S.P.A. VIA DELLE MAGNOLIE 15, ZONA INDUSTRIALE DI MODUGNO, 70026 MODUGNO, ITALY IT
follitropin alfa
(1)婦女經CLOMIPHENE CITRATE治療,仍無法排卵者(含多囊性卵巢症,PCOD)。(2)對於實施人工生殖協助技術(ART),如體外受精(IVF),配子輸卵管植入(GIFT),合子輸卵管植入(ZIFT)的病人,可刺激其多濾泡發育。(3)Gonal-F®併用人類絨毛膜性腺刺激素(hCG),用於治療患有先天或後天性腺刺激素不足之性腺功能低下症之男性患者,以刺激精子生成。
有效日期: 2028/06/03; 英文品名: GONAL-F 75IU(5.5MCG)
2003-04-08
PAGE 1 N1973801G • Unexplained vaginal bleeding (gynaecological haemorrhages of unknown aetiology) • Cancer in the ovaries, uterus or breasts Gonal-f must not be used when an effective response cannot be obtained, such as: • Primary ovarian failure • Malformations of sexual organs incompatible with pregnancy • Fibroid tumours of the uterus incompatible with pregnancy • Primary testicular insufficiency Do not use GONAL-f if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine. SPECIAL WARNINGS AND PRECAUTIONS GONAL-F is a potent ganadotrophic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of GONAL-f calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients and exaggerated response in others. The lowest effective dose in relation to the treatment objective should be used in both men and women. PORPHYRIA Tell your doctor before you start treatment, if you or any member of your family have porphyria (an inability to break down porphyrins that may be passed on from parents to children) as GONAL-f may increase the risk of an acute attack. Patients with porphyria or a family history of porphyria should be closely monitored during treatment with GONAL-f. Deterioration or a first appearance of this condition may require cessation of treatment. Tell your doctor straight away if: • your skin becomes fragile and easily blistered, especially skin that has been frequently in the sun, and/or • yo 阅读完整的文件