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Zefix Tablets 70×100mg(Lamivudine,ゼフィックス錠,拉米夫定片)
药店国别  
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 
生产厂家中文参考译名:
葛兰素史克公司
生产厂家英文名:
GlaxoSmithKline K.K
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/6250020F1023_1_11/
该药品相关信息网址2:
该药品相关信息网址3:
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
曾用名:
简介:

 

部份中文拉米夫定处方资料(仅供参考)
商品名:Zefix Tablets
英文名:Lamivudine
中文名:拉米夫定片
生产商:葛兰素史克公司
药品简介
Zefix(Lamivudine)是第一代口服抗病毒药物,可抑制乙型肝炎病毒的复制,由日本葛兰素史克生产。用于治疗16岁或以上的患者,以下患有慢性乙型肝炎和乙型肝炎病毒复制迹象的患者、慢性乙型肝炎急性发作患者(由乙型肝炎病毒引起)。
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
作用机制
拉米夫定在细胞内磷酸化,转化为活性体拉米夫定5′-三磷酸。
在HBV的DNA复制过程中,拉米夫定5′-三磷酸竞争性地抑制脱氧胞嘧啶5′-三磷酸(dCTP)通过DNA聚合酶进入DNA链。另外,拉米夫定5’-三磷酸作为DNA聚合酶的底物被导入病毒DNA链,但拉米夫定5’-三磷酸由于没有与下一个核苷酸结合所需的3’位的OH基,所以DNA链伸长停止(链终止)。
综上所述,认为拉米夫定抗HBV活性的作用机制有两种:病毒对DNA聚合酶的竞争性拮抗作用和DNA伸长停止作用。
抗病毒活性
In vitro试验
当转染HBV DNA的HepG2.2.15细胞与拉米夫定一起孵育7天或12天时,从HepG2.2.15细胞释放的HBV-DNA量呈浓度依赖性降低。将HBV-DNA游离量抑制50%的拉米夫定的培养液中浓度(IC50)为0.032μ或0.018μ是M。
In vivo试验
对慢性HBV感染的黑猩猩,每天2次口服0.1 mg/kg拉米夫定14天,血清中HBV-DNA浓度减少到给药前值的10%以下。并且,每天2次给药0.3mg/kg的拉米夫定,结果血清中HBV-DNA浓度在检出限以下。
耐药性
已知通过长期给药本制剂,YMDD变异病毒(DNA聚合酶活性中心的氨基酸序列从YMDD变异为YIDD或YVDD的病毒)出现,对本制剂的敏感性降低。在国内临床试验中,给药第1年为20.0%,第2年为35.4%,第3年为47.1%,第4年为47.1%,第5年为59.7%。实验表明,YMDD变异病毒的增殖能力较弱7.2参照]
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。
完整说明附件:
https://www.info.pmda.go.jp/go/pack/6250020F1023_1_17/?view=frame&style=XML&lang=ja
---------------------------------------------------
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 mg
Effects of this medicine
This 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 <<to be written by a healthcare professional>>
•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 medicine
The 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.Internal
Revised: 9/2014
The 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. 

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