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  药店国别: 德国药房
产地国家: 德国
所属类别: 肝脏、胆囊性疾病->乙肝
处方药:处方药
包装规格: 33毫克/克 60毫克
计价单位:
   
生产厂家英文名:
Gilead
该药品相关信息网址1:
http://www.viread.com/en/
原产地英文商品名:
Viread Granules 33mg/g 60mg
原产地英文药品名:
TENOFOVIR DISOPROXIL
中文参考商品译名:
替诺福韦酯 33毫克/克 60毫克
中文参考药品译名:
替诺福韦酯
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
hepatitis B
临床试验期:
完成
中文适应病症参考翻译1:
B 型肝炎
药品信息:
药品名称 中文通用名: 替诺福韦酯 别 名: 替诺福韦,替诺福韦酯富马酸盐 英文名: Tenofovir Disoproxil, Viread 药理毒理 本品是一种新型核苷酸类逆转录酶抑制剂。以与核苷类逆转录酶抑制剂类似的方法抑制逆转录酶,从而具有潜在的抗HIV-1活性。替诺福韦的活性成分替诺福韦双磷酸盐可通过直接竞争性地与天然脱氧核糖底物相结合而抑制病毒聚合酶,及通过插人DNA中终止链。 药代动力学 替诺福韦几乎不经胃肠道吸收,因此进行酯化、成盐,成为替诺福韦酯富马酸盐。替诺福韦酯具有水溶性,可被迅速吸收并降解成活性物质替诺福韦,然后替诺福韦再转变为活性代谢产物替诺福韦双磷酸盐。给药后1~2h内替诺福韦达血药峰值。替诺福韦与食物服时生物利用度可增大约40%。替诺福韦双磷酸盐的胞内半衰期约为10h,可1天给药1次。由于该药不经CYP450酶系代谢,因此,由该酶引起的与其他药物间相互作用的可能性很小。该药主要经肾小球过滤和主动小管转运系统排泄,约70%~80%以原形经尿液排出体外。 适应症 用于治疗HIV、HBV感染。本品和逆转录酶抑制剂合用于HIV-1感染、乙肝的治疗。 用法用量 口服每日1次,每次300mg, 与食物同服。 谨遵医嘱! 不良反应 1.全身无力。 2.胃肠道反应: 轻至中度的胃肠道不适,常见的有腹泻、腹痛、食欲减退、恶心、呕吐和胃肠胀气、胰腺炎。 3.代谢系统: 低磷酸盐血症(1%发生率);脂肪蓄积和重新分布,包括向心性肥胖、水牛背、末梢消瘦、乳房增大、库兴综合征。 4.可能引起乳酸中毒、与脂肪变性相关的肝肿大等。 5.神经系统: 头晕、头痛。 6.呼吸系统: 呼吸困难。 7.皮肤: 药疹。 其它信息 *替诺福韦(Viread)是HIV/HBV复合感染的治疗选择 在美国第12届逆转录病毒和机会感染会议上,美国学者报告,他们进行的一项有关替诺福韦(tenofovir)与阿德福韦(adefovir)安全性临床对照研究显示,替诺福韦可安全有效地降低HIV感染病人的乙型肝炎病毒(HBV)水平。 该研究的领导者Peters医师解释说,这是替诺福韦对HIV/HBV复合感染病人治疗有效的首次随机对照研究。他说,在HIV感染者中,有20%的人合并乙型肝炎。 无论在美国还是在全世界,复合感染都是一个重要问题。 Peters和AIDS临床试验组A5127的研究人员,对52例应用稳定联合抗逆转录病毒治疗的合并HBV感染的病人进行了研究。基线时,有75%的病人HIVRNA低于50拷贝/mL,98%有代偿性肝病。 这些病人随机进入替诺福韦300 mg/d+安慰剂组,或阿德福韦10mg/d+安慰剂组,疗程96周。每周进行实验室评估。有80%的病人服用过拉米夫定。 结果显示,替诺福韦对野生型和拉米夫定抗药型HBV均有治疗活性。Peters说,替诺福韦曾被批准用于治疗HIV感染,但非HBV感染。阿德福韦最近被允许用于HBV感染。 分析表明,替诺福韦的疗效不亚于阿德福韦。替诺福韦降低HBVDNA的效果实际上优于阿德福韦。48周后,替诺福韦组病人的HBV DNA平均log10倍加权平均值较基线时降低4.4,阿德福韦组降低3.21。 两组均有18例病人的实验室指标异常;均无不良事件发生。虽然两组均有2例死亡,但与治疗用药无关;未发现有肾毒性。 Peters总结认为,替诺福韦是HIV/HBV复合感染病人的治疗选择。虽然曾有非对照试验资料,但这是证明疗效的首次随机对照研究,它为HIV/HBV感染病人增加了新的治疗选择。 *美国抗HIV药Viread将申报抗肝炎适应症 美国生物制药公司 Gilead Sciences(Nasdaq: GILD)于2007年6月25日对外公布说,新的III期临床研究再次证实其抗HIV药Viread 对丙型肝炎病毒有疗效。Viread是非核酸类反转录酶抑制剂,2006年获批在美国和欧洲上市。Gilead在今年6月完成了2个III期临床研究,分别针对两种不同亚型的乙型肝炎病毒,都得到了阳性结果。 Gilead将于今年第四季度完成在美国和欧洲以乙型肝炎为扩大适应症的上市申请。 Gilead公司3月8日宣布,美国FDA已授予其抗逆转录病毒药物Viread(替诺福韦)和Truvada(恩曲他滨/替诺福韦)传统批准地位。Truvada含有该公司两种抗逆转录药Emtriva(恩曲他滨)和Viread。 *替诺福韦VIREAD 的使用 VIREAD (tenofovir disoproxil fumarate) 是一种称为核苷酸类似物逆转录酶和乙型肝炎病毒 (HBV) 聚合酶抑制剂 (NRTI) 的药物。VIREAD 被用来治疗 18 岁以上的慢性乙型肝炎(感染 HBV)成人患者。VIREAD 的作用机理是干扰乙型肝炎病毒自身复制所必需的一种酶(HBV DNA 聚合酶)的正常运作。VIREAD可以通过降低病毒繁殖和感染新的肝细胞的能力,来帮助减少患者体内乙型肝炎病毒的数量。 VIREAD 也被用来治疗 18 岁以上感染艾滋病病毒 1 (HIV-1) 的成人患者。VIREAD 一直与其他抗 HIV-1 药物配合使用,治疗感染 HIV-1 的患者。 VIREAD 无法治愈 HIV-1 感染或艾滋病,或降低将 HIV-1 或 HBV 传染给他人的风险。 VIREAD 的长期效果目前尚不得而知。 如果您对 VIREAD 或其中任何一种成分过敏,请勿服用 VIREAD。VIREAD 不应同 TRUVADA®(emtricitabine 200 毫克/tenofovir disoproxil fumarate 300 毫克)或 ATRIPLA®(efavirenz 600 毫克/emtricitabine 200 毫克/tenofovir disoproxil fumarate 300 毫克)一起使用,因为 VIREAD 是 TRUVADA 和 ATRIPLA 中的一种有效成分。VIREAD 不应同 HEPSERA® (adefovir dipivoxil) 一起使用。 VIREAD 的常用剂量为每天一次,每次一片300 毫克的片剂。如果您有肾脏问题,您的医护人员可能会建议您减少服用 VIREAD 的频率。服用 VIREAD 期间必须接受医护人员的照料。 *重要安全信息 如果在服用 VIREAD 期间出现下列任何一种副作用或情况,请立即与医护人员联系: - 恶心、呕吐、不寻常或意想不到的胃部不适和虚弱。这些可能是血液中乳酸浓度升高的迹象(乳酸性酸中毒),这是一种严重的医学症状 - 大便颜色淡、尿液颜色深和/或者如果皮肤或眼白变黄。这些可能是严重肝脏疾病(肝脏毒性),以及肝脏变大(肝肿大)和脂肪肝(脂肪变性)的迹象 - 如果您有乙型肝炎病毒感染或是同时有 HIV 和 HBV 感染情况,在停止服用 VIREAD 后,您可能会出现乙型肝炎「再度突然发作」的现象,并且您的肝脏疾病可能会突然恶化。非经由医护人员的建议,请勿停止服用 VIREAD。在您停止服用 VIREAD 后的几个月内,医护人员仍然需要检查您的身体并且进行血液检验,以观察您的肝脏状况。 - 有一些接受 VIREAD 治疗的患者曾有肾脏问题。如果您过去曾有肾脏问题或是服用其它可能造成肾脏问题的药物,医护人员可能需要对您进行其他的血液检验。 - 化验室检验结果显示接受 VIREAD 治疗的患者骨骼会发生变化。如果您过去曾有骨骼方面的问题,医护人员可能需要对您进行其他检验,或者建议您服用其他药物。肾脏疾病也可能导致出现骨痛和骨质松软(可能导致骨折)。 已经发现某些服用抗 VIREAD 和其它抗 HIV-1 药物的患者体内脂肪发生改变的现象。 如果您在开始 HIV-1 治疗后不久发现任何感染症状,请立即告诉医护人员。 针对慢性乙型肝炎患者所进行的研究显示:VIREAD最常见的副作用为恶心。较不常见的副作用包括腹痛、腹泻、头痛、眩晕、疲惫、鼻咽炎、背痛以及皮疹。 针对 HIV-1 患者所进行的研究显示:VIREAD 最常见的副作用为:皮疹、头痛、疼痛、腹泻、抑郁、虚弱以及恶心。较不常见的副作用包括呕吐、眩晕以及肠胃胀气。 与医护人员讨论您服用的所有药物并注意: 如果您与 VIREAD 一起服用 Videx 或 Videx EC (didanosine)、Reyataz(atazanavir sulfate) 或 Kaletra(lopinavir/ritonavir),医护人员可能需要更密切地关注您的情况或者调整治疗。 IMPORTANT SAFETY INFORMATION What is the most important information I should know about VIREAD? VIREAD can cause serious side effects, including: 1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take VIREAD. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get the following symptoms which could be signs of lactic acidosis: feeling very weak or tired have unusual (not normal) muscle pain have trouble breathing have stomach pain with nausea (feel sick to your stomach) vomiting feel cold, especially in your arms and legs feel dizzy or lightheaded have a fast or irregular heartbeat 2. Severe liver problems. Severe liver problems can happen in people who take VIREAD or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take VIREAD. Call your healthcare provider right away if you have any of the following symptoms of liver problems: your skin or the white part of your eyes turns yellow (jaundice). dark “tea-colored” urine light-colored bowel movements (stools) loss of appetite for several days or longer nausea stomach pain You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking VIREAD for a long time. 3. Worsening of your Hepatitis B infection. Your hepatitis B Virus (HBV) infection may become worse (flare-up) if you take VIREAD and then stop it. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Do not let your VIREAD run out. Refill your prescription or talk to your healthcare provider before your VIREAD is all gone. Do not stop taking VIREAD without first talking to your healthcare provider. If you stop taking VIREAD, your healthcare provider will need to check your health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking VIREAD. 4. Talk to your doctor about taking an HIV test before starting treatment with VIREAD for chronic hepatitis B. What should I tell my healthcare provider before taking VIREAD? Before you take VIREAD, tell your healthcare provider if you: have liver problems, including hepatitis B (HBV) infection. have kidney problems. have bone problems. have any other medical conditions, including HIV infection. are pregnant or plan to become pregnant. It is not known if VIREAD will harm your unborn baby. are breastfeeding or plan to breastfeed. Do not breastfeed if you are taking VIREAD. Tenofovir passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. VIREAD may affect the way other medicines work, and other medicines may affect how VIREAD works. Do not take VIREAD if you also take: other medicines that contain tenofovir (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®) adefovir (HEPSERA®) Especially tell your healthcare provider if you take the following medications: didanosine (VIDEX, VIDEX EC) atazanavir (REYATAZ) darunavir (PREZISTA) lopinavir with ritonavir (KALETRA) Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take VIREAD? See “What is the most important information I should know about VIREAD?” Take VIREAD exactly as your healthcare provider tells you to take it. Take VIREAD at the same time every day. For adults and children 12 years of age and older, the usual dose of VIREAD is one 300 mg tablet each day. If you are an adult with kidney problems, your healthcare provider may tell you to take VIREAD less often. Take VIREAD tablets by mouth, with or without food. Do not miss a dose of VIREAD. If you miss a dose of VIREAD, take the missed dose as soon as you remember. If it is almost time for your next dose of VIREAD, do not take the missed dose. Take the next dose of VIREAD at your regular time. If you take too much VIREAD, call your local poison control center or go right away to the nearest hospital emergency room. What are the possible side effects of VIREAD? VIREAD may cause serious side effects, including: See “What is the most important information I should know about VIREAD?” New or worse kidney problems, including kidney failure, can happen in some people who take VIREAD. Your healthcare provider should do blood tests to check your kidneys before you start treatment with VIREAD. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with VIREAD. Bone problems can happen in some people who take VIREAD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones. The most common side effects in all people who take VIREAD are: nausea rash diarrhea headache pain depression weakness In some people with advanced HBV-infection, other common side effects may include: sleeping problems itching vomiting dizziness fever Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VIREAD. For more information, ask your healthcare provider or pharmacist.
更新日期: 2019-3-7
附件:
20145620341637.pdf    

 
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