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替诺福韦富马酸二酯片(テノゼット錠Tenozet Tablets 300mg)说明书

产地国家:日本

处方药:是

所属类别: 300毫克/片 30片/瓶

包装规格: 300毫克/片 30片/瓶

计价单位:瓶

生产厂家英文名:GLAXOSMITHKLINE

原产地英文商品名:Tenozet Tablets(テノゼット錠)300mg/Tablets 30Tablets/bottle

原产地英文药品名:Tenofovir Disoproxil Fumarate

中文参考商品译名:Tenozet片(テノゼット錠)300毫克/片 30片/瓶

中文参考药品译名:替诺福韦酯富马酸盐

简介

部份中文替诺福韦富马酸二酯处方资料(仅供参考)

英文名:Tenofovir Disoproxil Fumarate

商品名:Tenozet Tablets

中文名:替诺福韦富马酸二酯片

生产商:葛兰素史克制药テノゼット錠300mg

药用类别名称:抗病毒化疗药物

批准日期:2014年5月

商標名:Tenozet Tablets

一般名:テノホビル ジソプロキシルフマル酸塩(Tenofovir Disoproxil Fumarate)

化学名:Bis(isopropoxycarbonyloxymethyl){[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl}phosphonate monofumarate

分子式;C19H30N5O10P・C4H4O4

分子量:635.51

構造式性状

是一种白带淡黄色白色结晶性粉末,甲醇,微溶于乙醇、丙酮, 几乎不溶于水, 不溶于乙醚。熔点112至119°c分布系数1.25 (1-octanol/6.5-6 的磷酸盐缓冲液)

药用药理学

1. 作用机制这种药物通过体内二酯水解代谢为替诺福韦, 在体内进一步代谢为细胞中的替诺福韦二磷酸替诺福韦)。替诺福韦二磷酸抑制HBV-DNA聚合酶与脱氧腺苷5 ‘-三磷酸酯具有竞争力, 是一种天然底物, 在被纳入 DNA后, 抑制HBV-DNA复制作为链式终止剂。二磷酸替诺福韦对哺乳动物DNA聚合酶α、β和线粒体DNA聚合酶γ的抑制作用较弱。

2. 抗病毒活性替诺福韦与HBV HepG2 2.2.15细胞表达, 在0.14 ~ 1.5μm 的 ic 50下表现出抗乙肝病毒活性。另一方面, CC50对人体细胞的细胞毒性作用超过100微米。此外, HBV-DNA聚合酶抑制剂的恩替卡韦体外, 层压素和替比夫定 (国产未释放), 以及抗HIV-1逆转录酶抑制剂三西他滨抗乙肝病毒活性, 观察到显示加性效应的拮抗作用。

3. 阻力在海外临床试验(gs-us-174-0102、0103、0106、0108和0121检测)中, 每年最后检查 (或在治疗停止时)病毒血液疾病(hbv-dna*400 c:400 copese/ ML)检查结果检测患者 HBV 的替诺福韦敏感性最多240周, 表明没有观察到对该制剂的耐药性的特定基因突变。

4. 交叉阻力(1) 体外检测替诺福韦的体外敏感性、灯剂和替比布丁耐药突变 (rtV173L、RtV173L 和 rtm204iv) 降低了HBV中野生型的0.7至3.4倍, 其中乙肝病毒 (Rt180m+rtm204iv)降低3.4倍。 HBV 中的Entecavir抗突变(rtL180M、Rt184g、rtL180M i、RtL180M & rtM250V) 已减少到06倍至6.9倍于野型, 乙肝病毒耐阿登霍韦突变(rtA181V 和 RtA181V)在乙肝病毒中减少到2.9至10倍。另外, 在治疗制剂时, rtA181T突变乙肝病毒表达的替诺福韦敏感性是野生类型的0.9倍至1.5倍。(2) 活体试验(临床试验结果)在国内临床试验 (LOC115912 试验) 中, 29例b型慢性肝病患者在给药开始时承认已知的与耐药性相关的HBV突变到核酸模拟制剂[adenhovir耐药相关突变(Rta181t v、rtN236T 或rta181t2/V+rtN236T): 1例, lambuzine n耐药相关突变 (Rtm204i±Rtl180m): 5例, lambuzine ine和adenhovir 耐药相关突变: 1例, 恩替卡韦耐药相关突变 (rtN236T-f2, rtN236T/G或rtm250vl):20例, 兰布定, 安登韦韦和恩替卡韦耐药相关突变: 2例], 接受了兰布辛或恩替卡韦和制剂的联合给药, 最长48周。因此, 在48周内获得了持续 HBV-DNA 的病毒效应(小于2.1 log10 copisl) 的患者, 5例患者中有4例承认与乙肝病毒耐药相关的卡玛拉嗪耐药突变, 20例中12例承认恩替卡韦耐药相关突变HBV和l初丁, 2例承认adenhovir和entecavir 耐药相关突变HBV。此外, 一个例子承认adenhovir耐药相关突变HBV, 在一个案例中, 承认Lambu季和adenhovir耐药相关突变 HBV, 负HBV-DNA被观察到48周。在海外临床试验(GS-US-174-0102、0103、0106、0108和0121测试)中, 已知的耐药相关突变HBV在给药152例b型慢性肝病患者开始[adenhovir耐药相关突变(Rta181ss/tw, RtN236T或Rta181s/+rtN236T):14例, 灯剂耐药相关突变 (rtm204isv): 135例, adenhovir和lambuzine耐药相关突变: 3例]给予本剂。在治疗该制剂长达240周, 11例在14例患者中承认adenhovir耐药相关突变HBV, 124例在135例患者中确认了丙胺耐药相关突变HBV, 并在2例中确认HBV的2例患者中确认了腺苷和单丁胺耐药相关突变, 以持续HBV-DNA阴性(小于400copiesml)为指标的病毒效应。在5例确认Rta181st和rtN236T的HBV突变的3例患者中, 观察到HBV-DNA阴性。

 

用法与用量

通常情况下, 成人一次口服一次300毫克, 每天一次。

包装

片300mg:30 片

葛兰素史克制药注

以上中文处方资料不够完整,使用者以原处方资料为准。

英文版说明书

Tenozet Tablets(Tenofovir disoproxil fumarate)Tenozet Tablets 300mg(テノゼット錠300mg)Brand name : Tenozet Tablets 300mg Active ingredient: Tenofovir disoproxil fumarate Dosage form: white or light blue tablet, major axis: 17.0 mm, minor axis: 10.5 mm, thickness: 5.0 mm Print on wrapping:Effects of this medicineThis medicine decreases the amount of virus by suppressing the growth of the hepatitis B virus and improves liver function.It is usually used to treatchronic hepatitis B virus infection.Before using this medicine, be sure to tell your doctor and pharmacist•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.•If you are pregnant or breastfeeding.•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)Dosing schedule (How to take this medicine)•Your dosing schedule prescribed by your doctor is <>•In general, for adults, take one tablet (300 mg of the active ingredient) at a time once a day. Strictly follow the instructions.•If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.•Do not stop taking the medicine unless your doctor instructs you do so.Precautions while taking this medicine•It is important that you receive medical examination on a regular basis because symptoms of chronic hepatitis B and hepatic cirrhosis B are extremely difficult to detect on your own.Possible adverse reactions to this medicineThe most commonly reported adverse reactions include nausea and abdominal pain. If any of these symptoms occur, consult with your doctor or pharmacist.The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.•edema, decreased urine output, thirst [renal failure, severe renal dysfunction]•hyperpnea, disturbed consciousness, shivering limbs [lactic acidosis]•fatty deposition in hypodermal tissues or internal organs, enlargement of the liver (pressured feeling in the right hypochondrium) [severe liver enlargement due to fatty deposition (hepatic steatosis)]•nausea, severe abdominal pain, back pain [pancreatitis]The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.Storage conditions and other information•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.•Discard the remainder. Do not store them. Consult with your dispensing pharmacy or medical institution on how to discard the medicine.GlaxoSmithKline K.K.InternalRevised: 1/2016The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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