部分中文Visanne处方资料(仅供参考)
Visanne(Dienogest)-治疗子宫内膜异位新药获准上市
拜耳先灵制药公司已完成了治疗子宫内膜异位症的新药Visanne在欧洲的审批程序。
Visanne是每日一次的口服片剂,含地诺孕素2毫克用于治疗子宫内膜异位症。
该公司称,一项研究计划表明,Visanne减轻子宫内膜异位症疼痛,减少子宫内膜异位症病灶并有良好的安全性和耐受性。计划于2010年第二季度开始将产品的推向市场。
此外,Visanne已被证明是有效的GnRH类似物减少子宫内膜异位症疼痛优于安慰剂。缓解疼痛持续时间长(临床研究显示持续15个月),包括痛经,疼痛,经前痛,弥漫性盆腔疼痛和性交疼痛。
What is Visanne®?
Visanne contains 2 mg dienogest and is indicated for the treatment of endometriosis Dienogest is a progestin that combines the properties of both 19-nortestosterone derivatives and progesterone derivatives
What makes Visanne® an excellent treatment option for endometriosis? Visanne® effectively reduces both the painful symptoms of endometriosis and also underlying endometriotic lesions. It offers equivalent efficacy to gonadotropin-releasing hormone (GnRH) agonists but has a more favorable side-effect profile. Visanne® is not associated with clinically relevant androgenic or hypoestrogenic effects associated with other agents such as danazol and GnRH agonists, respectively. Dienogest is associated with moderate inhibition of gonadotropin secretion, which, when given continuously, leads to a hypoestrogenic environment and initial decidualisation of endometrial tissue, followed by atrophy of endometriotic lesions. In addition to its effects on gonadotropin secretion, dienogest also directly inhibits proliferation of endometrium-like tissue.
How does Visanne® work? Visanne reduces endometrial lesions through both local and systemic biological mechanisms. The active ingredient in Visanne, dienogest, is associated with moderate inhibition of gonadotropin-releasing hormone secretion. Disruption of this hormonal pathway leads to a decrease in the level of estradio Dienogest also demonstrates a direct inhibitory effect on the proliferation of endometrium-like tissue. Additionally, preclinical evidence indicates that dienogest also shows anti-angiogenic properties.
How should Visanne ® be administered? Visanne® is administered orally as a once-daily tablet. Visanne® treatment can start on any day of the menstrual cycle, and must be continuous regardless of vaginal bleeding. Hormonal contraception should be stopped before initiation of Visanne®. ---------------------------------------------------------- 原产地英文商品名: VISANNE 2mg/tab 28tabs/box 原产地英文药品名: DIENOGEST 中文参考商品译名: VISANNE 2毫克/片 28片/盒 中文参考药品译名: 地诺孕素 生产厂家中文参考译名: 拜耳 生产厂家英文名: Bayer Vital GmbH Geschäftsbereich Pharma
该药品相关信息网址1: http://eurekasalud.es/prospecto-visanne+comp.+recub.+1%2F2+mg-65746
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