碘化油注射液Miripla suspension vehicle 4ml 1X10Ampul

药店国别： 产地国家：日本 处方药：是 所属类别： 4毫升 1X10安醅 包装规格： 4毫升 1X10安醅 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：Dainihon Sumitomo 原产地英文商品名：Miripla4ml 1X10Ampul 原产地英文药品名：Iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil 中文参考商品译名：Miripla混悬液 4毫升 1盒X10安醅 中文参考药品译名：碘化油

简介

部份中文碘化油处方资料(仅供参考) 英文名：Iodine addition products 商品名：MIRIPLA 中文名：碘化油水合物 持证商：日本住友製薬株式会社。于2010年在日本批准上市注射剂 药品简介 Miripla suspension vehicle 4ml是溶于专用碘化罂粟子油脂肪酸乙酯、肝动脉内给药的抗癌药物，其与碘化罂粟子油脂肪酸乙酯的亲和性高，且肝动脉内给药后滞留于肿瘤部位，混悬液中的铂成分可长时间缓慢释放进入血液或组织中，铂二价化合物与DNA结合，通过阻止DNA合成抑制癌细胞增殖，提高了抗癌效果。 批准日期：2009年12月 商標名：MIRIPLA suspension vehicle 一般名：碘化罂粟油脂肪酸乙酯Iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil本质上是将碘结合在罂粟油脂肪酸乙酯上，定量时含有碘（I：126.90）36.0-40%。 性状 它是淡黄色至褐色的粘性油溶液。 乙醇(95),与二乙醚或氯仿混合。 它不溶于水。 空气或光线逐渐呈深棕色。粘 度27~54mm2/s (20°)比重d2020 1.270-1.292处理注意事项有一些不同的颜色取决于很多,但并不特别,只要它是在浅黄色到褐色的范围。 药用药理学 对于大鼠肝癌菌株AH109A和人肝癌菌株Li-7移植到大鼠肝脏中,液体悬浮毫铂通过单次给药在肝动脉中显示出剂量依赖性抗肿瘤作用。 适应症：悬浮量为70mg：治疗肝细胞癌。 用法与用量 到毫铂70mg,用于添加悬浮液3.5mL。 临床表现 临床试验结果摘要如下。 另外，该剂的延长寿命效果尚未得到验证。2対象疾患名TE V注)の割合肝細胞癌26.5%(22/83)注:TE V(100%坏死效应或肿瘤切除率100%)为肝癌治疗直接影响标准包装4mL:10

英文版说明书

Therapeutic Agent for Hepatocellular Carcinoma “MIRIPLA®” Obtained Manufacturing and Marketing ApprovalOctober 16, 2009-Dainippon Sumitomo Pharma Co.Ltd. (Head Office: Osaka, Japan; President: Masayo Tada) announces that the Company has obtained a manufacturing and marketing approval for “MIRIPLA® for intra-arterial injection 70 mg” (generic name: miriplatin hydrate), a therapeutic agent for hepatocellular carcinoma in Japan as of October 16, 2009 from Ministry of Health, Labor and Welfare.“MIRIPLA®” is first suspended in an oily lymphographic agent and then administered through hepatic artery into hepatocellular carcinoma. As such an oily lymphographic agent, the Company has “MIRIPLA® suspension vehicle 4 mL” (generic name: iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil), which is approved for suspending MIRIPLA®. The manufacturing and marketing approval for this suspension vehicle was obtained on August 20, 2009 from the competent Ministry.“Lipiodolization” or “Chemo-lipiodlization” is one of the standard methods for treating hepatocellular carcinoma , where an anticancer drug is suspended in an oily lymphographic agent (iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil, Lipiodol) and then administered into hepatic artery.The Company has carried out a research program to discover an anticancer drug suitable for this treatment and succeeded in development of a lipophilic platinum complex, miriplatin which has high affinity to Lipiodol.MIRIPLA®has a high suspensibility in “MIRIPLA® suspension vehicle 4 mL “. Some of the characteristics of MIRIPLA®are: it accumulates and stays in a tumor after the administration into hepatic artery, platinum component is released gradually over a long duration and yet exposure to entire body is minor. In clinical tests on hepatocellular carcinoma, satisfactory anti-tumor effects were confirmed not only on patients of initial treatment but also on patients who relapsed after treatment such as hepatic resection. Some side effects were observed, but they were regarded as those generally observed under chemo-lipiodolization therapy, and they were thought to be tolerable at medical institutions familiarized with this treatment.There was no adverse event on vessel disorder in hepatic artery related to this drug.The Company has an intention to launch both “MIRIPLA® for intra-arterial injection 70 mg” and “MIRIPLA® suspension vehicle 4 mL” after they are listed on the national health insurance drug price standard.