利巴韦林胶囊Ribavirin(REBETOL Capsules 200mg)说明书

产地国家:日本

处方药:是

所属类别: 200毫克/胶囊 28胶囊/盒

包装规格: 200毫克/胶囊 28胶囊/盒

计价单位:盒

生产厂家英文名:MSD K.K

原产地英文商品名:REBETOL(レベトールカプセル)200mg/Capsules 28Capsules/box

原产地英文药品名:Ribavirin

中文参考商品译名:REBETOL(レベトールカプセル)200毫克/胶囊 28胶囊/盒

中文参考药品译名:利巴韦林

简介

部份中文利巴韦林处方资料(仅供参考)

商品名:利巴韦林

英文名:Ribavirin

中文名:利巴韦林

研发单位:MSD K.Kレベトールカプセル200mg

类别名称:抗病毒药物

商標名:REBETOL Capsules

一般名:リバビリン(JAN)、Ribavirin(JAN)

化学名:1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide

構造式分子式:C8H12N4O5

分子量:244.20

性状

白色结晶粉末,水,甲酸或N,易溶于N-二甲基甲,甲醇,乙醇(95)或乙酸(100)微溶,在丙酮,乙腈,乙醚或己烷极微溶于几乎不熔融。融点167-171℃分配係数(1辛醇 – 水体系)pH2:3.76×10-3 pH8:1.38×10-3pH4:3.85×10-3 pH10:1.70×10-4pH6:3.44×10-3 pH12:1.78×10-4

适应症

1.干扰素α-2b(基因重组),干扰素α-2b(基因重组)或者在任一慢性丙型肝炎中的下一个病毒血症的组合的改进是由于β干扰素。(1) 患者血液HCV RNA量高(2) 患者残疾病人或干扰素制剂单用干扰素单一治疗配方后复发2. 聚乙二醇干扰素α-2b的(基因重组)的组合,代偿性肝硬化C型病毒血症的改进。3. 在慢性丙型肝炎或C病毒血症的改善通过组合使用2(基因型2)的补偿Sohosububiru血清群的肝硬化类型

用法用量

口服给药:1. 干扰素α-2b(基因重组)或病毒血症在慢性丙型肝炎的聚乙二醇化的干扰素α-2b的与干扰素β的改善的组合的情况下通常情况下,成人,以下口服给药的利巴韦林剂量和给药。在此药物的给药,考虑到患者的病情,体重下降,适当的措施,如停止2. 干扰素α-2b的改善的代偿性肝硬化C型病毒血症的情况下,与(基因重组)的组合通常情况下,成人,以下口服给药的利巴韦林剂量和给药。在此药物的给药,考虑到患者的病情,体重下降,适当的措施,如停止。(1) 患者的血红蛋白浓度低于14克/升以上的管理开始前(2) 给药开始前病人血红蛋白浓度低于14克/升3. 组合通过在慢性丙型肝炎或C病毒血症(基因型2)改进Sohosububiru壳体的血清群2补偿肝硬化类型通常情况下,成人,以下口服给药的利巴韦林剂量和给药。在此药物的给药,考虑到患者的病情,体重下降,适当的措施,如停止。

药效药理

通过用利巴韦林和干扰素α-2b或PEG-IFNα-2b的组合,抗病毒效果增强。虽然没有详细利巴韦林的作用机理显然,同时抑制由鸟苷三磷酸的RNA的HCV衍生的RNA依赖性RNA聚合酶的摄取,通过被掺入丙型肝炎病毒RNA,指标和抗HCV活性的可以想象的。(1) 抗HCV效果(抗HCV密切相关的病毒的抗病毒活性)病毒性腹泻病毒密切相关的HCV病毒,利巴韦林显示出抗病毒效果,通过与IFN.alpha-2b或PEG-IFNα-2b被增强的组合作用(体外)。(2) 抗病毒机制作用利巴韦林是磷酸在细胞中由三磷酸鸟苷的RNA(体外)抑制HCV衍生的RNA依赖性RNA聚合酶的摄取。此外,利巴韦林三磷酸酯是由丙型肝炎病毒衍生的RNA依赖性RNA聚合酶掺入RNA的RNA的生产过程中,这被认为是破坏病毒基因组(体外)。

包装规格

胶囊200毫克140粒(PTP14胶囊×10),28胶囊(胶囊PTP14×2)

制造厂商MSD有限公司注:以上中文资料仅供参考,以原处方为准

英文版说明书

REBETOL capsules(Ribavirin)REBETOL capsules 200mg(レベトールカプセル200mg)Brand name : REBETOL capsules 200mg Active ingredient: Ribavirin Dosage form: white opaque hard gelatin capsule (length: 19.2mm) Print on wrapping: (Face) 921 (Back)レベトール, 200mg, 921Effects of this medicineThis medicine is used with interferon preparations (interferon alpha-2b, peginterferon alpha-2b or interferon beta) and other antiviral agents to inhibit the growth of hepatitis C virus. It also helps eliminating the virus from your body so that to improve the liver functioning.It is usually used to treat chronic hepatitis C.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 have heart disease (myocardial infarction, heart failure, arrhythmia), abnormal hemoglobin disease (thalassemia, drepanocytic anemia), kidney/liver disorder, autoimmune hepatitis, mental illness or with history of it.•If you are pregnant, possibly 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 this medicine according to your body weight after meals. If your weight is 60kg and below, take 3 capsules (600 mg) a day [1capsule (200 mg) after breakfast and 2 capsules (400 mg) after dinner]. If your weight ranges over 60kg to 80kg, take 4 capsules (800 mg) a day [2 capsules (400 mg) after breakfast and 2 capsules (400 mg) after dinner]. If your weight is over 80kg, take 5 capsules (1,000 mg) a day [2 capsules (400 mg) after breakfast and 3 capsules (600 mg) after dinner]. The dosage should be reduced or this medicine should be discontinued according to your age and symptoms. Strictly follow the instructions.•If you miss a dose, consult with your doctor or pharmacist. 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.Precautions while taking this medicine•Female patient who may possibly become pregnant must have a pregnancy test each month during the medication and for 6 months afterward in order to make sure you are not pregnant. And if you/your partner can possibly become pregnant, you/your partner should avoid pregnancy and should use a reliable contraceptive method while you are taking the medicine and for 6 months after the treatment.•Male patients: If your partner is pregnant or possibly become pregnant, wear condoms during the medication and for 6 months afterward in order to prevent transporting semen into the uterus.•Follow your doctor’s instructions and take periodical blood tests.Possible adverse reactions to this medicineThe most commonly reported adverse reactions include fever, lassitude, headache, top-heavy feeling, chills, sleeplessness, loss of appetite, vomiting, nausea, joint pain, muscle pain, abdominal pain, anaemia, eye floater (view of flying mosquito), visual degradation and itch. 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.•palpitation when going upstairs or uphill, shortness of breath, dizziness [anemia]•sore throat, muscle pain, high fever with chills or shivering [blood disorders such as agranulocytosis and leukopenia]•sleeplessness, anxiety, irritation [depression, suicide attempt, manic state, aggressive behavior]•facial pallor, cold sweat, dizziness on standing up [shock]•dry cough, breathing difficulty, general malaise, fever [interstitial pneumonia, pulmonary fibrosis, pulmonary edema]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 at room temperature (1 to 30℃), away from direct sunlight and moisture.•Discard the remainder. Do not store them. Ask the pharmacy or medical institution how to discard.MSD K.K.InternalRevised: 7/2015The 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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