盐酸纳呋拉啡_Remitch_盐酸纳呋拉啡软胶囊Nalfurafin中英对照说明书

[caption id="attachment_34780" align="alignleft" width="300"] Remitch Capsules 2.5mcg（Nalfurafine 盐酸纳呋拉啡软胶囊）[/caption] 药店国别： 产地国家：日本 处 方 药：是 所属类别：2.5微克 140软胶囊/盒 包装规格：2.5微克 140软胶囊/盒 计价单位：盒 生产厂家中文参考译名:Torii 生产厂家英文名:Torii 原产地英文商品名:REMITCH Soft Capsules2.5mcg 140Caps 原产地英文药品名:Nalfurafine hydrochloride 中文参考商品译名:REMITCH软胶囊2.5微克 140软胶囊/盒 中文参考药品译名:盐酸纳呋拉啡 简介： 部份中文盐酸纳呋拉啡处方资料(仅供参考) 商品名：REMITCH CAPSULES 英文名：Nalfurafine Hydrochloride 中文名：盐酸纳呋拉啡 剂 型：软胶囊 研发单位：鳥居薬品 药物类名称：口腔瘙痒症的改善剤 批准日期：2009年3月 商标名：REMITCH CAPSULES 2.5μg 一般名：Nalfurafine Hydrochloride 化学名：(2E)-N-[(5R,6R)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-yl]-3-(furan-3-yl)-N-methylprop-2-enamide monohydrochloride 分子式：C28H32N2O5・HCl 分子量：513.03 性状：白色至极浅黄色粉末。 它具有高度吸湿性，对光线有些不稳定。 溶解性可溶于水和甲醇，难溶于乙醇(95)，几乎不溶于乙酸乙酯和乙醚。 分配因子 0.95[1-辛醇/pH 6.8缓冲液的分配系数(Log D)] 批准条件：制定并适当实施药物风险管理计划。 药用药理学 药效药理： 1.针对瘙痒症的行动 抗组胺药是一种抗瘙痒药，可抑制有效的组胺皮内给药诱导的小鼠搔抓行为和P物质皮内给药诱导的小鼠搔抓行为，其中抗组胺药无效。此外，抗组胺药物抑制吗啡脑池注射诱导的小鼠搔抓诱导的中央划痕瘙痒模型。 2.行动机制 使用人类阿片受体表达细胞的体外受体结合和受体激动试验的结果表明它们是选择性阿片样物质κ受体激动剂。此外，在体外试验中，它们不与除阿片受体(包括组胺受体，转运蛋白和离子通道)之外的各种受体结合，并且对肥大细胞的脱粒没有任何抑制作用。此外，通过脑室内给予阿片样物质κ受体拮抗剂降二酰胺(nor-BNI)，完全拮抗P物质皮内给药诱导的小鼠搔抓行为抑制作用。 3.依赖性 因为在大鼠戒断症状观察期间观察到很少的吗啡观察到的戒断症状，​​所以药物的物理依赖性较弱，并且在猴子自我给药试验中没有观察到强化效果，因此它在精神上依赖。人们认为没有性行为。 适应症： 改善以下患者的瘙痒症(仅在现有治疗无效的情况下) *血液透析患者，慢性肝病患者 用法与用量：通常，对于成人，在晚餐后或睡觉前每天一次口服2.5μg。另外，虽然根据症状可以增加，但是每天一次限制5微克。 包装：胶囊 2.5μg：PTP 14粒(14粒×1)，PTP 140粒(14粒×10) 制造商和分销商：Toray Industries，Inc   Launch of REMITCH® CAPSULES 2.5 µg , new oral antipruritus drug Toray Industries, Inc. (Head Office: Chuo-ku, Tokyo; President: Sadayuki Sakakibara; “Toray”); Japan Tobacco Inc. (Head Office: Minato-ku, Tokyo; President: Hiroshi Kimura); and Torii Pharmaceutical Co., Ltd. (Head Office: Chuo-ku, Tokyo; President: Norihiko Matsuo; “Torii”) hereby announced that Torii would launch REMITCH® CAPSULES 2.5 µg (generic name: nalfurafine hydrochloride), an oral antipruritus drug for hemodialysis patients , starting March 24. It was jointly developed by the three companies and its manufacturing and marketing approval was obtained in Japan by Toray on January 21, 2009. Hemodialysis-related uremic pruritus is a condition that causes systemic and severe itching without inflammation on the skin and its cause has yet been clearly elucidated. It is known that this type of itching is not relieved by conventional antipruritus drugs (such as antihistamines) and the development of effective medicines has long been awaited. REMITCH® CAPSULES 2.5 µg is a selective κ(kappa)-opioid receptor agonist, originated from Toray, Japan for the first time as an oral drug to treat itching in hemodialysis patients that is resistant to existing treatments. This drug is expected to make further contribution to the treatment of pruritus in hemodialysis patients. Following is the outlines of REMITCH® CAPSULES 2.5µg. Brand name : REMITCH® CAPSULES 2.5 µg Generic name : Nalfurafine hydrochloride Indication : Improvement of pruritus in hemodialysis patients (only for cases resistant to conventional treatments) Dosage and administration : The usual oral dosage for adults is 2.5µg of nalfurafine hydrochloride, once a day, after supper or before sleep. The dosage may be adjusted according to symptoms provided that it does not exceed 5µg once a day. Packaging : REMITCH® CAPSULES 2.5µg: 140 capsules in press-through package (PTP) (14 capsules x10) Date of manufacturing and marketing approval : January 21, 2009 Date of NHI price listing : March 13, 2009 Date of launch : March 24, 2009 Marketing Authorization Holder : Toray Industries, Inc. Distributed by : Torii Pharmaceutical Co., Ltd. Co-developed by : Japan Tobacco Inc.