盐酸曲美他嗪片说明书_中英文对照说明书.doc

盐酸曲美他嗪片说明书请仔细阅读说明书并在医师指导下使用。药品名称通用名称：盐酸曲美他嗪片商品名称：万爽力英文名称：TrimetazidineDihydrochlorideTablets(VASOREL）汉语拼音：YansuanQumeitaqinPian成份化学名称：盐酸曲美他嗪，1-(2,3,4-三甲氧基苯甲基)哌嗪二盐酸盐分子式：C14H22N2O32HCl分子量：339.3性状本品为薄膜衣片，除去薄膜衣后呈白色。适应症心绞痛发作的预防性治疗。眩晕和耳鸣的辅助性对症治疗。规格20mg用法用量每24小时60mg：每日3次，每次1片，三餐时服用。不良反应罕见胃肠道不适（恶心，呕吐）。由于辅料中有日落黄FCFS（E110）及胭脂红A（E124）成份，可能会发生过敏反应。禁忌对药品任一组份过敏者禁用。哺乳期通常不推荐使用（参见孕妇及哺乳期妇女用药）。注意事项此药不作为心绞痛发作时的对症治疗用药，也不适用于对不稳定心绞痛或心肌梗死的初始治疗。此药不应用于入院前或入院后最初几天的治疗。心绞痛发作时，对冠状动脉病况应重新评估，并考虑治疗的调整（药物治疗和可能的血运重建）。孕妇及哺乳期妇女用药妊娠动物实验没有提示致畸作用；但是由于缺乏临床资料，致畸的危险不能排除。因此，从安全的角度考虑，最好避免在妊娠期间服用该药物。哺乳由于缺乏通过乳汁分泌的资料，建议治疗期间不要哺乳。儿童用药儿童用药的安全性和有效性尚未确定。老年用药参见其他项下内容或遵医嘱。核准日期：2006-12-26236300002贮藏30以下贮藏包装铝铝泡罩包装，15片，30片，60片/盒有效期36个月执行标准YBHI13562005批准文号国药准字H20055465生产企业Insert of TrimetazidineDihydrochlorideTabletsCarefully read insert and conform to the physicians prescription.DrugnamesGenericname:TrimetazidinedihydrochloridetabletsTradename:VASORELEnglishname:TrimetazidineDihydrochlorideTablets(VASOREL)ChinesePinyin:YansuanQumeitaqinPianIngredientsChemicalname:Trimetazidinedihydrochloride,1-(2,3,4-trimethoxybenzyl)piperazinedihydrochlorideMolecularformula:C14H22N2O32HClMolecularweight:339.3DescriptionFilm-coatedtabletwithwhitecoreIndicationsProphylactictreatmentofepisodesofanginapectoris.Adjuvantsymptomatictreatmentofvertigoandtinnitus.Strength20mgDosageandadministration60mgper24hours:1tablettobetaken3timesadayatmealtimes.AdversereactionsRarecasesofgastrointestinaldisorders(nauseaandvomiting).BecauseofthepresenceofsunsetyellowFCFS(E110)andcochinealredA(E124),riskofallergicreactions.ContraindicationsThisdrugshouldneverbeusedincaseofhypersensitivitytoanyoneoftheproductsconstituents.Thisdrugisgenerallynotrecommendedduringbreastfeeding(Cf.Pregnancyandlactation).PrecautionsThisdrugisnotacurativetreatmentforanginaattacks,norisitindicatedasinitialtreatmentforunstableangina,ormyocardialinfarction.Itshouldnotbeusedinthepre-hospitalphasenorduringthefirstdaysofhospitalization;Intheeventofananginaattack,thecoronaropathyshouldbereevaluatedandanadaptationofthetreatmentconsidered(drugtreatmentandpossiblyrevascularisation).PregnancyandlactationPregnancyStudiesinanimalshavenotdemonstratedateratogeniceffecthowever,intheabsenceofclinicaldata,theriskofmal-formationcannotbeexcluded.Therefore,forsafetyreasons,itispreferabletoavoidprescriptionduringpregnancy.BreastfeedingIntheabsenceofdataonexcretioninbreastmilk,breastfeedingisnotrecommendedduringtreatment.UseinChildrenSafetyandeffectivenessinpediatricpatientshavenotbeenestablished.UseinElderlySeeinformationinotheritemsorfollowphysiciansinstructions.S