产地国家：日本 处方药：是 所属类别： 150毫克/胶囊 28胶囊/盒 包装规格： 150毫克/胶囊 28胶囊/盒 计价单位：盒 生产厂家英文名：MSD 原产地英文商品名：VANIHEP Capsules(バニヘップカプセル)150mg/cap 28caps/box 原产地英文药品名：Vaniprevir 中文参考商品译名：VANIHEP(バニヘップカプセル)150毫克/胶囊 28胶囊/盒 中文参考药品译名：Vaniprevir

简介

新一代丙肝新药VANIHEP Capsules(Vaniprevir バニヘップカプセル150mg)获日本批准上市Vaniprevir/Vanihep®是2014年9月26日由日本厚生劳动省(MHLW)批准上市的抗丙肝药物。该药由默沙东(MSD)开发、生产和销售。Vanihep®被批准用于治疗基因型1慢性丙肝感染和病毒血症。Vanihep®是口服胶囊，每粒含150mg Vaniprevir，与干扰素和利巴韦林联用，推荐给药剂量为每天300mg Vaniprevir，分1次或2次服用。治疗类别名称抗病毒药物批准上市日期：2014年9月商標名VANIHEP Capsules 150mg 一般名：バニプレビル(Vaniprevir) 化学名 (5R, 7S, 10S)-10-(1, 1-Dimethylethyl)-N-{(1R, 2R)-1-[N-(cyclopropanesulfonyl)carbamoyl]-2-ethylcyclopropyl｝-15, 15-dimethyl-3, 9, 12-trioxo-2, 3, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19-hexadecahydro-2, 23：5, 8-dimethano-1H-benzo[n][1, 10, 3, 6, 12]dioxatriazacyclohenicosine-7-carboxamide 分子式：C38H55N5O9S 分子量：757.94 性状：白色粉末。它是易溶于甲醇，乙醇(99.5)，以易微溶，极微溶于水。操作注意事项不冷藏(因为有一种可能性，即在胶囊变脆)。 药效药理 1. 作用机序Banipurebiru是可逆地结合到HCV NS3 / 4A丝氨酸蛋白酶的大环肽结构的抑制剂为HCV复制所必需的。Banipurebiru具有相比于人丝氨酸蛋白酶和其它蛋白酶为HCV NS3 / 4A丝氨酸蛋白酶的高选择性。 2.抗病毒活性(体外)对酶Banipurebiru是，HCV基因型1a，1b中，图4a的抑制作用，在5A和6A强烈(IC50<0.20纳米)，基因型2a和2b相当弱，在基因型3a弱。Banipurebiru显示，HCV基因型1a和1b复制子细胞显著的抑制活性，所述EC90值分别为4.0和3.9纳米。在40%正常人血清存在下的活性变化小于7倍。Banipurebiru没有显示出细胞毒性(在Hela细胞和Huh-7细胞CC50值：分别>25微摩尔和>50微摩尔)。在复制子细胞Banipurebiru和干扰素α-2b或利巴韦林的组合的影响是一般添加剂或添加剂/协同性的。 3.抗病毒活性(体内)7天Banipurebiru HCV感染黑猩猩(HCV基因型1a)(5毫克/千克，1，每天两次)口服给药，迅速减小低于1/105是在2-5天给药血浆HCV RNA量并且，这种减少在给药期间保持。 4.药物抗耐性在与HCV基因型1a和1b复制子细胞面板，R155，A156和在由D168的氨基酸突变，以Banipurebiru灵敏度变化Banipurebiru的抗病毒活性变化进行了观察。的EC 90值是100倍以上，所述HCV基因型1a R155K / T和D168A，同样在HCV基因型1b R155G / K / Q / W，A156T / V和D168A / G / K / T /他们是V / Y的每个突变在另一方面，V36，T54，对于包含Y56和Q80在其他氨基酸序列的突变Banipurebiru的EC90值的变化是HCV基因型1b F43S(14.8倍)为约小于5倍的除外。治疗无应答者通过Banipurebiru在日本III期临床试验已经表明，一个大规模参与的突变一)D168的。此外，Y56是什么往往被视为突变治疗开始前已经存在，Q80和V170是突变的)，这些都是显著影响三重组合疗法包括Banipurebiru的结果有没有。a)使用的(直接测序法ABI 3730XL DNA分析仪) 适应症 改善下列病毒血症(慢性丙型肝炎)(1)未经治疗的患者血液中HCV RNA的量高(2)患者禁用或复发与干扰素治疗。 用法与用量 聚乙二醇干扰素α-2b(重组体)和与利巴韦林组合使用。如果要用于谁已成为治疗方法复发，包括未经治疗的患者或干扰素，高位患者血液HCV RNA量成人每日一次，两次300毫克的Banipurebiru，12周口服。在被禁用的用干扰素治疗的患者使用时每天两次一次300毫克作为Banipurebiru于成年人，口服24周。 包装规格 150毫克*28粒(吸塑4粒×7)

英文版说明书

Product Name: Bani Hepp capsule 150mgActive ingredient: Banipurebiru (Vaniprevir)Dosage form: yellow-red capsules, long diameter 24.5mm / short diameter 8.5mmSheet described: (Table) Baniheppu 150mg, MSD 700 (back) VANIHEP 150mg Baniheppu 150mgEffects of this medicineInhibit the essential is protease for the replication of the hepatitis C virus, shows the effect of suppressing the growth of hepatitis C virus (anti-virus effect). Pegylated interferon alpha -2b (gene recombination), and I use with ribavirin.Normally, I will be used in the treatment of chronic hepatitis C.Please tell your doctor and pharmacist before certainly responsible for the following people to use.• Before using this medicine, itch, sometimes had any unusual or allergic reaction such as rash. There is a liver dysfunction.• If you are pregnant or breastfeeding.• other you are using, such as medicine (You can strengthen the effect on each other, so there is also likely to weaken, please note, including OTC drugs and food in use to others).• Normally, a back two adult wa ka pu Daicel (main ingredient To shi te 300mg) 1st wo back 12 weeks between 2 mo shi ku wa taken between 24 weeks shi ma si. Connecticut will re ta zu indication of taking ~ te ku da ni Cong I Connecticut.• There Pharmaceutical wa ko pe gu center have イ nn nn ア Hikaru ro fu fu Epolight ASTON -2b (left vale subgroups exchange E), O yo び Bldg ba ri ri nn To use a thread ni ma si sa me cry. Drugs made me cry ra ko ni tsu There I te mo ke explained by te wo ku da sa I.• Drink Mi forget where wa re ta, ta wa ma doctor Ji Pharmaceutical division ni shi te ku da talk I Connecticut. Two back points must Dui ni ni wo once I drink san で wa ma ke se san.• misuse ~ te ku drink more occasions san da ma ta wa wa physicians Pharmaceutical division Ji talk ni shi te ku da sa I.• There are instructions physician na shi ni, from the sub-judge で There are only drink Mu There wo ku da Circular で I na sa I.Notes on life• There are reports of teratogenic effects in animal experiments to ribavirin to be used in conjunction with this medicine (can cause malformations in the fetus). People people and partners are likely to pregnancy is likely to pregnancy, six months after you stop and between taking are taking ribavirin, please contraception. Also, please go once a month pregnancy test to confirm that you are not pregnant.• St. John's Wort (Hypericum perforatum) lowers the blood levels of the drug, the effect is likely to be attenuated, please avoid St. John's wort-containing foods.• grapefruit juice can increase the blood levels of drugs, because there is a possibility that the side effects may occur, please avoid grapefruit juice.That where I am with the after care you use this medicine (side effects)The main side effects, fever, headache, nausea, languid, hair loss, itching, rash, etc. have been reported. If you notice these symptoms, please consult your doctor or pharmacist.In rare cases symptoms appear, such as the following, there is likely to be early symptoms of side effects indicated in brackets [].In such cases, stop the use, please immediately seek medical care.• fever, sore throat, hands and feet of bruising, nosebleeds [blood disorders]• palpitations when you climb the stairs or hill, shortness of breath, dizziness [anemia, hemoglobin decrease]• insomnia, anxiety, irritability, state that motivation is reduced [depression]Other side effects does not describe all. If you notice any symptoms of concern other than the above came out, please consult your doctor or pharmacist.Storage and other• infants, where it is not out of reach of children, direct sunlight, high temperature, please keep away the moisture.• If the drug remained, please discard it. Please consult your pharmacy and medical institutions that received for disposal.• Do not refrigerated. (There is a possibility that the capsule becomes brittle)