复方索非布韦/维帕他韦薄膜片(Epclusa film coated tablets)说明书

产地国家:英国

处方药:是

所属类别: 400毫克/100毫克/片 28片/瓶

包装规格: 400毫克/100毫克/片 28片/瓶

计价单位:瓶

生产厂家英文名:Gilead Sciences, Inc

原产地英文商品名:Epclusa filmcoated tablets(400mg/100mg)/tabs 28tabs/bottle

原产地英文药品名:sofosbuvir/velpatasvir

中文参考商品译名:Epclusa复方薄膜片(400毫克/100毫克)/片 28片/瓶

中文参考药品译名:索非布韦/velpatasvir

简介

部份中文索非布韦/维帕他韦处方资料(仅供参考)

英文名:sofosbuvir/velpatasvir

商标名:Epclusa Filmtabletten

中文名:复方索非布韦/维帕他韦薄膜片

生产商:Gilead Sciences GmbH

药品介绍

近日,欧洲药品管理局(EMA)人用医药产品委员会(CHMP)支持批准Epclusa(sofosbuvir/velpatasvir,sof/vel,400mg/100mg),用于治疗全部6种基因型丙肝。作用机制EPCLUSA是sofosbuvir和velpatasvir的固定剂量组合,其是针对丙型肝炎病毒的直接作用抗病毒剂[参见MICROBIOLOGY]。

适用范围及用途

EPCLUSA是sofosbuvir,丙型肝炎病毒(HCV)核苷酸类似物NS5B聚合酶抑制剂和velpatasvir,HCV NS5A抑制剂的固定剂量组合,用于治疗慢性HCV基因型1,2,3,4,5或6感染:没有肝硬化或补偿性肝硬化与代偿失调性肝硬化联合利巴韦林

剂量和管理

开始治疗之前的测试:通过测量HBsAg和抗HBc测试所有患者的HBV感染。

推荐用量

每日一次口服一片(400毫克沙夫布韦和100mg维拉帕斯维司),每日口服一次,不论有无食物参见下表中基因型1,2,3,4,5或6型HCV患者推荐的治疗方案和持续时间:患者人口方案和持续时间*在临床试验中,方案包含有或没有HCV NS3/4A蛋白酶抑制剂(波普瑞韦,辛伐他韦或特拉匹韦)的聚乙二醇干扰素α/利巴韦林。治疗无效和治疗经验*无肝硬化和补偿性肝硬化(Child-Pugh A)EPCLUSA 12周治疗无效和治疗经验*代偿失代偿性肝硬化(Child-Pugh B和C)EPCLUSA +利巴韦林12周HCV/HIV-1共同感染​​:对于HCV / HIV-1共感染患者,按照上表中的剂量建议不能对严重肾损伤或终末期肾病患者进行剂量推荐剂量

形式和强度

片剂:400毫克和100mg

禁忌症

对于利巴韦林禁忌的患者,EPCLUSA和利巴韦林组合方案禁忌。

警告和注意事项

乙型肝炎病毒反应的风险:在开始HCV治疗之前,测试所有患者的HBV或HBV感染现象。在HCV治疗和治疗后随访期间监测HCV/HBV合并感染患者HBV再激活和肝炎闪光。针对HBV感染启动适当的患者管理。胺碘酮联合给药的心动过缓:严重的症状性心动过缓可能发生在服用胺碘酮的患者中,特别是在接受β受体阻滞剂或具有潜在的心脏并发症和/或晚期肝病的患者中。不建议将胺碘酮与EPCLUSA联合使用。在没有替代可行治疗方案的患者中,建议进行心脏监测。

不良反应

用EPCLUSA治疗12周观察到的最常见的不良反应(发生率大于或等于10%,所有等级)是头痛和疲劳。在失代偿性肝硬化患者中用EPCLUSA和利巴韦林治疗12周时观察到的最常见的不良反应(发生率大于或等于10%,所有等级)是疲劳,贫血,恶心,头痛,失眠和腹泻。

药物相互作用

P-gp诱导剂和/或中等至强的CYP诱导剂(例如利福平,圣约翰麦芽汁,卡马西平):可以降低sofosbuvir和/或velpatasvir的浓度。不推荐使用EPCLUSA与P-gp诱导剂和/或中等至强CYP诱导剂在使用潜在的药物相互作用之前,请咨询完整的处方信息

英文版说明书

Epclusa 400 mg/100 mg film coated tablets.The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/16/1116/001.Epclusa 400 mg/100 mg film-coated tabletsPackage leaflet: Information for the userEpclusa 400 mg/100 mg film-coated tabletssofosbuvir/velpatasvir1. What Epclusa is and what it is used for2. What you need to know before you take Epclusa3. How to take Epclusa4. Possible side effects5. How to store Epclusa6. Contents of the pack and other information1. What Epclusa is and what it is used forEpclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet. It is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 years and older.The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.Epclusa is sometimes taken with another medicine, ribavirin.It is very important that you also read the leaflets for the other medicines that you will be taking with Epclusa. If you have any questions about your medicines, please ask your doctor or pharmacist.2. What you need to know before you take EpclusaDo not take EpclusaIf you are allergic to sofosbuvir, velpatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).If this applies to you, do not take Epclusa and tell your doctor immediately.If you are currently taking any of the following medicines:rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);St. John’s wort (Hypericum perforatum – herbal medicine used to treat depression);carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);Warnings and precautionsTalk to your doctor if you:have liver problems other than from hepatitis C, for instanceif you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;if you have had a liver transplanthave kidney problems, since Epclusa has not been fully tested in patients with some severe kidney problems;are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.Talk to your doctor or pharmacist before taking Epclusa if:you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine).you have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Epclusa. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Epclusa.Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:shortness of breathlight-headednesspalpitationsfaintingBlood testsYour doctor will test your blood before, during and after your treatment with Epclusa. This is so that:Your doctor can decide if you should take Epclusa and for how long;Your doctor can confirm that your treatment has worked and you are free of the hepatitis C virus.Children and adolescentsDo not give this medicine to children and adolescents under 18 years of age. The use of Epclusa in children and adolescents has not yet been studied.Other medicines and EpclusaTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Warfarin and other similar medicines called vitamin K antagonists used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.If you are not sure talk to your doctor or pharmacist.Some medicines should not be taken with Epclusa.Do not take any other medicine that contains sofosbuvir, one of the active substances in Epclusa.Tell your doctor or pharmacist if you are taking any of the medicines below:amiodarone used to treat irregular heartbeats;rifapentine (antibiotic used to treat infections, including tuberculosis);oxcarbazepine(medicine used to treat epilepsy and prevent seizures)tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;efavirenz used to treat HIV infection;digoxin used to treat heart conditions;dabigatran used to thin the blood;modafinil used to treat sleep disorders;rosuvastatin or other statins used to treat high cholesterol.Taking Epclusa with any of these may stop your medicines from working properly, or make any side effects worse. Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking. This change could be to Epclusa or another medicine you are taking.Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers, heartburn or acid reflux as they can decrease the amount of velpatasvir in your blood. These medicines include:antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These should be taken at least 4 hours before or 4 hours after Epclusa;proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole). Epclusa should be taken with food 4 hours before using a proton pump inhibitor.H2-receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine). If you need high doses of these medicines your doctor may give you a different medicine instead or adjust the dose of the medicine you are taking.These medicines can decrease the amount of velpatasvir in your blood. If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.Pregnancy and contraceptionThe effects of Epclusa during pregnancy are not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.Epclusa is sometimes used together with ribavirin. Ribavirin can harm your unborn baby. It is therefore very important that you (or your partner) do not become pregnant during this treatment or for a period of time after completing treatment. You must read the “Pregnancy” section in the ribavirin package leaflet very carefully. Ask your doctor for effective contraception method suitable for you and your partner.Breast-feedingDo not breast-feed during treatment with Epclusa. It is not known whether sofosbuvir or velpatasvir, the two active substances of Epclusa, pass into human breast milk.Driving and using machinesEpclusa should not affect your ability to drive or use any tools or machinery.3. How to take EpclusaAlways take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.Recommended doseThe recommended dose is one tablet once a day for 12 weeks.Swallow the tablet whole with or without food. Do not chew, crush or split the tablet as it has a very bitter taste.If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Epclusa.If you are taking a proton pump inhibitor, take Epclusa with food 4 hours before using a proton pump inhibitor.If you are sick (vomit) after taking Epclusa it may affect the amount of Epclusa in your blood. This may make Epclusa work less well.If you are sick (vomit) less than 3 hours after taking Epclusa, take another tablet.If you are sick (vomit) more than 3 hours after taking Epclusa, you do not need to take another tablet until your next scheduled tablet.If you take more Epclusa than you shouldIf you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.If you forget to take EpclusaIt is important not to miss a dose of this medicine.If you do miss a dose, work out how long it is since you last took your Epclusa:If you notice within 18 hours of the time you usually take Epclusa, you must take the tablet as soon as possible. Then take the next dose at your usual time.If it’s 18 hours or more after the time you usually take Epclusa, wait and take the next dose at your usual time. Do not take a double dose (two doses close together).Do not stop taking EpclusaDo not stop taking this medicine unless your doctor tells you to. It is very important that you complete the full course of treatment to give the medicine the best chance to treat your hepatitis C virus infection.If you have any further questions on the use of this medicine, ask your doctor or pharmacist.4. Possible side effectsLike all medicines, this medicine may cause side effects, although not everybody gets them.Other effects that may be seen during treatment with sofosbuvir:The frequency of the following side effects is not known (frequency cannot be estimated from the available data).a wide spread severe rash with peeling skin which may be accompanied by fever, flu like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens Johnson syndrome).If you get any side effects tell your doctor.Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:5. How to store EpclusaKeep this medicine out of the sight and reach of children.Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”. The expiry date refers to the last day of that month.This medicine does not require any special storage conditions.Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.6. Contents of the pack and other informationWhat Epclusa containsThe active substances are sofosbuvir and velpatasvir. Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.The other ingredients areTablet core:Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearateFilm-coating:Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide redWhat Epclusa looks like and contents of the packThe film-coated tablets are pink, diamond-shaped tablets debossed with “GSI” on one side and “7916” on the other side. The tablet is 20 mm long and 10 mm wide.The following pack sizes are available:outer cartons containing 1 bottle of 28 film-coated tabletsMarketing Authorisation HolderGilead Sciences Ireland UCCarrigtohillCounty CorkT45 DP77IrelandManufacturerGilead Sciences Ireland UChttps://www.medicines.org.uk/emc/product/7294/smpc

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