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醋酸地加瑞克粉剂|Gonax(Degarelix Acetate for Subcutaneous Injection)

2014-05-22 19:31:39  作者:新特药房  来源:互联网  浏览次数:498  文字大小:【】【】【
简介: 英文药名:Gonax(Degarelix Acetate for Subcutaneous Injection) 中文药名:醋酸地加瑞克注射剂 生产厂家:安斯泰来制药商標名 Gonax for Subcutaneous Injection 通用名:醋酸地加瑞克 适应症: ...

英文药名:Gonax(Degarelix Acetate for Subcutaneous Injection)

中文药名:醋酸地加瑞克注射剂

生产厂家:安斯泰来制药
商標名
Gonax for Subcutaneous Injection
通用名:醋酸地加瑞克
适应症:前列腺癌
给药方案:
地加瑞克的一般起始剂量为成人240毫克是给出120毫克两种皮下注射。 4周的初始剂量后,地加瑞克的维持剂量是80毫克给定为1皮下注射,每4周。
起始剂量:每一个注射点,重建含120毫克加瑞克日本药典无菌注射用水3毫升小瓶和重建后,立即注入皮下(在40mg/mL的浓度)
维持剂量:
重组含有80毫克加瑞克日本药典无菌注射用水的4.2毫升小瓶和重建后,立即注入皮下(在20mg/ml的浓度)


包装
皮下注用80mg[維持用量(每4周)包装]:1瓶


皮下注用120mg[初回用量包装]:2瓶


生产厂家:
完整处方资料附件:http://www.info.pmda.go.jp/go/pack/2499412D1024_1_03/
Gonax is a gonadtrophin-releasing hormone (GnRH) blocker with a subcutaneously injectable formulation. GnRH is a hormone produced in the hypothalamus in the brain and is involved in the production of the male hormone testosterone thorough binding to the GnRH receptors in the pituitary gland. Although testosterone is an important hormone that plays a central role in the maintenance of male function, it also stimulates prostate cancer to grow and to spread out and in result, often aggravates symptoms in prostate cancer patients. Gonax competitively inhibits the binding of GnRH to the GnRH receptors and controls the growth of prostate cancer by suppressing the testosterone production. Based on the results of Phase I and Phase II studies in Japan, Astellas decided to submit the market authorization application by using abroad Phase-III data.
In Phase II studies in Japan and the abroad Phase III studies, Gonax suppressed and maintained the blood testosterone below castration at Day 3, without a testosterone surge which frequently occurs with GnRH agonist treatment. Also, based on the safety results, Gonax appears to be safe and well tolerated.
Gonax has been approved in 59 countries.
In January 2006, Astellas and Ferring Pharmaceuticals (“Ferring”; headquarters: Saint-Prex, Switzerland; Chairman: Frederik Paulsen) entered into a license agreement that gives Astellas exclusive rights to develop and market degarelix for the treatment of prostate cancer in Japan. Since then, Astellas has conducted the development of Gonax in Japan from Phase II. Upon this marketing approval in Japan, Astellas will pay to Ferring the milestone payment of

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