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拉米夫定片,ゼフィックス錠Lamivudine(Zefix Tablets 100mg)说明书

产地国家:日本

处方药:是

所属类别: 100毫克/片 70片/盒

包装规格: 100毫克/片 70片/盒

计价单位:盒

生产厂家英文名:GlaxoSmithKline K.K

原产地英文商品名:Zefix(ゼフィックス錠)100mg/Tablets 70Tablets/box

原产地英文药品名:Lamivudine

中文参考商品译名:Zefix(ゼフィックス錠)100毫克/片 70片/盒

中文参考药品译名:拉米夫定

简介

部份中文拉米夫定处方资料(仅供参考)

商品名:Zefix

英文名:Lamivudine

中文名:拉米夫定片

生产商:葛兰素史克公司ゼフィックス錠100

治疗类别名称:抗病毒化疗药物

商標名:Zefix Tablets

一般名:ラミブジン(Lamivudine)

化学名:(-)-1-[(2R,5S)-2-hydroxymethyl-1,3-oxathiolan-5-yl]cytosine

分子式:C8H11N3O3S

分子量:229.26

構造式性状:白色至浅黄色结晶性粉末。易溶于二甲基亚砜,微溶于水,微溶于甲醇或乙醇(99.5),并在乙醚中几乎不溶。熔点关于176℃分配系数-0.9(1-辛醇/水系统)

药效药理

1. 抗病毒作用其中慢性HBV感染的黑猩猩为拉米夫定为0.1mg/ kg的每日两次持续14天口服给药,血清HBV-DNA的浓度降低至先前值给药的不到10%。当除了施用拉米夫定为0.3mg/ kg的每日2次,14天,血清HBV-DNA的浓度低于检测极限。

2. HBV-DNA産生阻害作用HepG22.2.15细胞中的HBV-DNA转染孵育7天拉米夫定或12天,HBV-DNA量从HepG2细胞释放2.2.15细胞减少浓度依赖性。培养拉米夫定和HBV-DNA的游离量(IC 50)的50%抑制的浓度为0.032μM或0.018μM。

3. 转化为通过磷酸化活性形式与HBV转染的DNA的HepG22.2.15细胞培养[3H]标记的拉米夫定和24小时,其中,细胞内的[3H]标记的拉米夫定和磷酸化体通过HPLC法测定,细胞内拉米夫定23.56%到35.65%被转换成5′-三磷酸物的活性形式。

4. 作用机序拉米夫定在细胞中磷酸化,它被转换为活性物质的拉米夫定5′-三磷酸。在乙型肝炎病毒DNA复制,拉米夫定-5′-三磷酸抑制脱氧胞苷5′-三磷酸(的dCTP)的DNA链通过DNA聚合酶竞争的摄取。此外,由于尽管拉米夫定5′-三磷酸掺入病毒DNA链作为DNA聚合酶的底物,拉米夫定-5′-三磷酸具有用于下一个核苷酸的DNA结合所需无OH基团的3’位置的链延伸被停止(链终止)。

抗拉米夫定

适应症:病毒的肝功能的乙型肝炎病毒的乙型肝炎增殖生长抑制伴随着异常已经证实B型慢性肝病

用法与用量

成人每天一次,每次100毫克。

包装规格

100mg:70片(PTP)

生产商葛兰素史克日本公司注:以上中文不够完整,使用者以原处方资料为准。

英文版说明书

Zefix Tablets(Lamivudine ゼフィックス錠)Zefix Tablets 100(ゼフィックス錠100)Brand name : Zefix Tablets 100 Active ingredient: Lamivudine Dosage form: pale orange brown tablet, major axis: 11.5 mm, minor axis: 5.5 mm, thickness: 3.6 mm Print on wrapping: (Face) Zefix 100 mg, GX CG5, (Back) ゼフィックス100 mgEffects 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 treat chronic 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 (100 mg of the active ingredient) at a time once a day. Strictly follow the instructions.•If you miss a dose, take the missed 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 to do so. In general, it is necessary to take this medicine for a long period of time. Discontinuation of this medicine without permission may lead to disease progression.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 headache and malaise. 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.•nasal bleeding, gum bleeding, subcutaneous bleeding [thrombocytopenia]•muscle pain of limbs, feeling of weakness, reddish brown urine [rhabdomyolysis]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: 9/2014The 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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