英文药品说明指导书结构简介

英文药品说明书结构介绍一、英文说明书介绍“药品说明书”英文表示方法：InstructionsDirectionsDescriptionLeafletDataSheetsPackageInsert现多用PackageInsert，或简称Insert。Insert原意为“插入物，插页”。药品说明书即为附在每种药品包装盒中用药说明。经过注册进口药品通常是国家认可有效药品，其说明书是指导医生和患者合理用药关键依据，含有一定法律效力。说明书繁简难易不一样。短者仅百余词，长者可达上万词。较简单说明书仅介绍成份、适应症、禁忌症、使用方法和用量等内容；较详尽说明书中除上述内容外还包含：药品性状、药理作用、临床药理、临床前动物试验、临床经验、药代动力学、庄意事项、不良反应或副作用、用药过量、药品相互作用、警告、使用期、包装、贮存条件、患者须知及参考文件等很多项目。大多数英文说明书全部包含以下内容：药品名称DrugName性状Description药理作用PharmacologicalActions适应症Indications禁忌症Contraindications用量和使用方法DosageandAdministration不良反应AdverseReactions注意事项Precautions包装Package贮藏Storage其它项目Others完整FDA说明书通常包含：【尤其警示】Warning【临床应用】IndicationsandUsage【使用方法和用量】DosageandAdministration【制剂和规格】DosageformsandStrengths【禁忌症】Contraindications【注意事项】WarningsandPrecautions【不良反应】AdverseReactions【药品相互作用】DrugInteractions【特殊人群】UseinSpecificPopulations药品滥用依靠性DrugabuseandDependence【药品过量】Overdosage性状Description临床药理学ClinicalPharmacology非临床毒理学NonclinicalToxicology临床研究ClinicalStudies【贮藏】Howsupplied/storageandHandlingPatientCounselingInformationMedicationGuide二、药品名称-DrugName常见药品名称有商品名、通用名和化学名，其中最常见是商品名。有时同一个药品，不一样厂家使用不一样商品名称。商品名-TradeName，ProprietaryName通用名-GenericName化学名-ChemicalName药品说明书中标题药名用其商品名。有时在其右上角(或在上角)有一(R)标识，比如ADRIBLASTNA(R)(阿霉素)。“R”是Register(注册)缩写，表示表示该产品已经本国相关部门核准，取得了此项专用注册商标(RegisteredTradeMark)。药品名称翻译可采取音译、意译、音意合译及谐音译意等方法：1、音译：按英文药品名读音译成相同或相近汉语。如Tamoxitn它莫西芬，Ritalin利她林。音译较为方便，但不能表意。2、意译：按药品名称所表示含意译成对应汉语。如cholicAcid胆酸，Tetracyline四环素。也可按其药理作用翻译，如Minidiab灭糖尿(诊疗糖尿病药品)，Natulan疗治癌(细胞生长抑制剂)。3、音意合译：药品名称中一部分采取音译，另一部分采取意译，如Coumadin香豆定(coumarin香豆素)，Neo-Octin新握克丁(neo-新)；Medemycin麦迪霉素(－mycin霉素)，Cathinone卡西酮(－one酮)。4、谐音译意：以音译为标准，选择谐音汉字，既表音，又表意，音意结合。比如：Antrenyl安胄灵，Doriden多睡丹，Legalon利肝隆，Webilin胃必灵商品名称能够这么翻洋，而法定名称则要求不能够这么翻译。药品化学名称反应出该药品化学结构组成成份，可借助英汉化学化工词典进行翻译。假如名称很长，能够分解开来，分别查出各个组成部分名称，组合而成。比如：Catalin(卡她林)化学名称是1－Hvdroxy-5－oxo-5H－pyrido(3，2－a)－Phenoxazine－3-carboxylicacid,译成汉语是1-羟基－5－氧－5H－吡啶开(3，2－a)吩嗪－3－羧酸。为了统一药品名称译名，卫生部药典委员会已确定出原料药和辅料命名标准，并刊行了《药名词汇》一书，可供翻译英文药品名称时参考。常见酸、碱、盐、基因、化合物英文名称，和常见前缀、后缀以下：chloride氯化物sulfate(sulphate)硫酸盐hydrochloric盐酸acetyl乙酰基amino氨基di－二neo-新－mycin霉素dihydro-二氢nitro-硝基－ester酯－lactone内酯－one酮－oxide氧化物－urea脲三、性状-Description很多药品说明书第一项是Description(性状)，其原意是“叙述”、“描写”，在药品说明书及药典中通常全部译为“性状”，其内容关键是介绍外观、理化性质、组成成份、结构、特征等。这一项最常见标题是Description，另外还可能有其它表示法如：化学结构ChemicalStructure成份Composition理化性质PhysicalandChemicalProperties3.1本项中常见句型【例1】Folicacidisayellowishtoorange,crystallinepowder;odourlessoralmostodourless叶酸是淡黄色至橙色结晶粉沫，无臭或几乎无臭。【例2】Intralipos10%isawhiteopaquefatemulsionforintravenousinjection,containing10W/V%ofpurifiedsoybeanoil脂肪乳剂(10%)是白色，不透明，供静脉注射用脂肪乳剂，含有10%(W/V)精制大豆油。【例3】UrsosanTablet50mgisawhiteplaintabletwhichcontains50mgofursodesoxycholicacid熊去氧胆酸片为白色素片，每片含50mg熊去氧胆酸。【例4】Sterilepyrogen-free,orangered,freeze-driedpowderinvialscontaining10mgand50mgofdoxorubicinhydrochloridewithlactose(本品)为小瓶装，灭菌无热原，桔红色冻干粉沫，每小瓶含有10mg或50mg阿霉素盐酸盐和乳糖。【例5】Itoccursasawhitetooff-white,crystallinesolid,poorlysolubleinwater,diluteacidandmostorganicsolvents本品(炎痛息康)为白色至类白色结晶固体，难溶于水、稀酸及大多数有机溶剂中。3.2本项中常见词语1、表示组成、制备词及短语，如：bederivedfrom由……衍生consistof由……组成beobtained制得contain含有bepreparedfrom由……制备have(possess)有(含有)2、表示性质部分词类，如：colo(u)r颜色stable稳定taste味道molecularformular分子式odo(u)rless无臭molecularweight分子量crystalline结晶structure结构solubility溶解度injection注射剂insoluble不溶solution溶液odo(u)r气味tablets片剂colo(u)rless无色derivative衍生物tasteless无味liquid液体sterile无菌powder粉沫soluble可溶solid固体四、药理作用-PharmacologicalActions有些说明书较具体地介绍药品药理作用(PharmacologicalActions)。其内容关键包含药理作用、临床药理(ClinicalParmacology)、体外试验(invitroexperiments)、药品代谢(Metabolism)、药效(Potency)及毒性(Toxicity)等。这一项常见标题是：药理作用PharmacologicalAction药理性质PharmacologicalProperties药理学Pharmacology临床药理ClinicalPharmacology其它表示方法还有：作用Actions作用和性质ActionsandProperties临床效果(用途)ClinicalEffect(Use)作用机理MechanismofAction作用方法ModeofAction假如药品一个抗生素，可能出现：生物活性BiologicalAction微生物学Microbiology这一项目中包含词汇范围包含药理学、生理学、化学、毒理学、微生物学及医学等学科，专业词汇多，是较难阅读一部分内容，阅读时可参阅《英汉医学词汇》、《英汉微生物学词汇》及《英汉化学化工词汇》等工具书。另外，还会碰到很多缩写词，如：CNS(中枢神经系统)、EEG(脑电图)、LD50(半数致死剂量)、ECG(心电图)等，这些缩写词可在英汉医学缩略语词典中查到。CNS-中枢神经系统-centralnervoussystemEEG-脑电图描记器-electroencephalo-graphECG-心电图-ElectrocardiographLD50半数致死剂量-LethalDose50test4.1常见句型举例【例1】Meanpeekserumconcentrationsoftobramycinoccurbetween30andabout60minutesafterintramuscularadministration肌注后约30~50分钟之间妥布毒素平均血药浓度达成高峰。【例2】NembutalSodiumexertsadepressantactionontheCNSandsharesthesedative-hypnoticactionstypicalofthebarbiturates戊巴比妥钠对中枢神经系统产生抑制作用，并显示戊巴比妥类特有镇静催眠作用。【例3】Inclinicaltrialsthedrugwasshowntobehighlyeffectinveinimprovingandnormalizingthealteratedcerebralcirculationandthosedisordersrelatedtoinsufficientarterialflowinthelimbs临床试验证实，本品疗效高，可改善已改变了脑循环，使之恢复正常，诊疗和四肢动脉血流不畅相关疾病。【例4】Orbeninisstabletostaphylococcalpenicillinase,andhighlyeffectiveagainstresistantstaphylococciItisbactericidal,acid-stableandwellabsorbedbyeithertheoralortheintramuscularroute全霉林对葡萄球菌青霉素酶稳定，对耐药葡萄球菌十分有效。本品具杀菌、耐酸作用，且口服或肌注吸收良好。【例5】Nystainhasbeenfoundtoinhibitthegrowthofyeastlikefloraintheintestinaltract已查明制霉菌素在肠道内可抑制菌丛类酵母菌生长。4.2常见词及短语举例1、动词absorb吸收act作用cause(becauseby)引发(由……引发)demonstrate显示exert(actionon)起……作用exhibit显示inhibit抑制accumulate积蓄administrate投药excrete排泄resultin造成indicate表明maintain维持produce产生protect(from)保护(不变)reach达成show显示，表明treat诊疗metabolize代谢promote促进prevent阻止，预防tolerate耐受2、形容词(be)active(effective)against对…有效(be)relatedto和……相关(be)sensitiveto对……敏感resistantto……有耐药性average平均minimum最低(小)maximum最高(大)normal正常3、名词ability能力activity活性distribution分布excretion排泄action作用clearance廓清率effecton对…作用function功效，作用halflife半衰期invitro体外kidney肾mechanism机理serumconcentration血清浓度tolerance耐受性infection感染invivo体内level水平，浓度plasmlever血浆浓度(水平)toxicity毒性五、适应症-Indications“适应症”最常见有以下多个表示方法：适应症Indications适应症和用途IndicationsandUsage关键适应症Major(Principal)Indications用途Uses作用和用途ActionandUse本项中出现频率最高是疾病名称和微生物(尤其是致病菌)名称，如：anginapectoris心绞痛cancer癌diabetes(mellitus)糖尿病hypertension高血压virus病毒Ecoli大肠杆菌gram-positivemicroorganisms(bacteria)革兰氏阳性菌gram－negativemcroorgansms(bacteria)革兰氏阴性菌5.1常见句型本项是说明书关键，从句子结构来分析，大致有以下多个类型。1、不完全句结构．仅列出疾病或微生物名称如：【例1】Anginapectoris,Prinzmetal'sangina,hypertension心绞痛，变异性心绞痛，高血压。【例2】Thefollowingdiseasescausedbybacteriaincludinggram－positiveandgram－negativebacteriasuchasStaphylococcus，Streptcoccus,Escherichiacoli,Klebsiellapneumoniae……用于诊疗由革兰氏阳性和革兰氏阴性细菌，如葡萄球菌、链球菌。大肠杆菌、肺炎杆菌引发下列疾病。2、由For(或In等)引出短语，比如：【例3】Forpreventionoftheadvanceofcataract用于预防白内障进展。【例4】Inthetreatmentofallformsofpulmonarytubercuosisinassociationwithotherantituberculardrugs和其它抗结核药配伍，诊疗多种类型肺结核。3、To+动词原形组成短语，如：【例5】Topreventtheformationofurinarycalculi，especiallyincaseswheretheytendtorecur用于预防尿路，尤其是易发部位结石形成。【例6】Toprotectthelivercellduringadministrationofdrugshazardoustotheliver．在服用对肝脏有危害药品期间，用以保护肝细胞。4、完整句子结构或段落，有时结构很复杂；【例7】AmikacinisusefulinthetreatmentofinfectionsfromGram－negativesensitivespecies，thereincludedthePseudomonasspecies；itmayalsobeusefultotreatinfectionscausedbysensitivestaphylococci,阿米卡星可用于诊疗革兰氏阳性敏感菌(其中包含假单孢菌)引发感染，也可用于诊疗敏感葡萄球菌引发感染。医学全在线提供【例8】Nebcinisindicatedforthetreatmentofthefollowinginfectionscausedbysusceptiblemicroorganisms：乃柏欣适适用于诊疗下列由敏感细菌引发感染【例9】OctinumDhasprovedeffectiveintheprophylaxisandtherapyofdisordersarisingfromspasmofthesmoothmusculature新握克了已证实对平滑肌痉挛引发病症有预防和诊疗作用。【例10】Concomitanttherapywithothercalciumantagonists,antihypertensivesandalcoholmaypotentiatethehypotensiveactionofthedrug和其它钙桔抗剂、抗高血压药品及酒精饮料同时使用，会增强本品降低血压作用。5.2本项中常见词及短语举例很多常见词及疾病名、微生物名词等和“药理作用”项类同，另外还有以下词组和短语(例句参见前文)。beactiveagainst对……有效beintendedto…适适用于……beadministaredin…适适用于…beofvalueof…适适用于……beeffectivein(for，against)…对…有效berecommendedfor推荐用于……beemployedto…用于……beusedto(for，as)…用于……behelpfulin…用于……beusefulin…用于……beindicatedin(for)…适适用于…for(in)thetreatment(management)of…用于诊疗(控制)表示和“其它药品适用”结构有：beassociatedwithinassociationwithbecombinedwithincombinationwithbecompatiblewithinconnjunctionwithconcomitantwithtogetherwith六、禁忌症-Contraindications本项中最常见英语表示法是Contraindications，也有用RestrictionsonUse(用药限制)。6.1本项中包含到禁用(或慎用)一些药品患者或某种特殊情况，比如：1、孕妇、妊娠期或哺乳期，幼童等：pregnantwoman孕妇lactation哺乳期inpregnancy妊娠期childrenunder…yearsofage…岁以下儿童thefirsttrimesterofpregnancy妊娠早期2、患有一些疾病或过敏患者，如：allergic(hypersensitive)to…对…过敏allergic(anaphylactic)reaction过敏反应allegy(hypersensitivity)to…对…过敏patientswith…(who…)患有…患者6.2本项中常出现部分疾病名称，比如：cardiacfailure心力衰竭hypertension高血压cardiacinsufficiency心功效不全renalinsufficiency肾功效不全severehypotension严重低血压impairmentofkidney肾功效损伤diabetes糖尿病liver(hepatic)damage肝损伤severeanemia严重贫血6.3常见句型1、省略句型，只列出禁忌对象或疾病名称等。【例1】Pregnacy,allergytomethotrexate,functionaldisordersofliverandkidneys,diseasesofthehaematopoieticsystem(bonemarrowhypoplasia,leucopenia,thrombocy-topenia,anaemia),intectiousdiseases,ulcersoftheoralcavityandthegastrointestinaltract,recentoperationwounds孕期，对氨甲叶酸过敏，肝、肾功效障碍，血液系统疾病(骨髓机能减退、白细胞及血小板降低、贫血)，传染病，口腔及胃溃疡，近期术后伤口等忌用。【例2】Hypersensitivitytoquinoiones,severerenalinsufficiency对喹喏酮类过敏，严重肾功效不全。2、完整句子或段落。其中常见结构有：contraindicationsare…禁忌症是…becontraindicatedin(for)…对…禁忌shouldnotbeused(employed)in…不得用于…Itisadvisabletoavoidtheuseof…提议不用于…mustnotbeadministered(given)to…对…不得用药shouldbeusedwithcaution慎用benotrecommendedfor…最好不用于…nonereported未见报道notknown不清楚【例3】Cetazolinsodiumiscontraindicatedinpatientswithknownhypersensitivitytocephalosporingroupofantibiotics先锋5号禁用于已知对头孢菌素类抗生素过敏患者。【例4】ItisadvisabletoavoidtheuseofAraminewithcyclo-propaneorhalothaneanesthesia,unlessclinicalcircumstancesdemandsuchuse假如不是临床需要，提议本品不要和环丙烷或氟溴氯乙烷麻醉剂适用。【例5】DonottakeBenemidifprioradministrationresultedinhypersensitivityBenemidisnotrecommendedforpersonswithknowndisordersofthebloodoruricacidkidneystonesDonotgiveBenemidtochildrenundertwoyearsofage若以前使用丙磺舒曾引发过敏反应，则应禁用。已知有血液疾患及尿酸性肾结石患者提议不要使用本品，二岁以下儿童不得服用。【例6】Phenothiazinecompoundsshouldnotbeusedinpatientsreceivinglargedosesofhypnotics,andshouldbeused,withcautioninpatientswithahistoryofconvulssivedisorders,sincegrandmalconvulsionshavebeenknowntooccur接收大剂量安眠药患者不应使用吩噻嗪化合物，对有惊厥病史患者应慎用，因为已知有发生过癫痫大发作。【例7】Ursosanshouldnotbegiventopatientssufferingfromfulminanthepatitisandbileductobstruction暴发性肝炎及胆管阻塞患者禁用熊去氧胆酸。【例8】Thisproductiscontraindicatedinthosepatientswhohaveshownhypersensitivitytoitunless,intheopinionofthephysician,theconditionrequiringtreatmentislifethreateningandamenableonlytoamphotencinBtherapy除非依据医生意见，认为需要诊疗患者病情危及生命，而且只有两性霉素诊疗才可能使其有所改善之外，对本品过敏患者禁用本品。【例9】Childrenunder5yearsofageshouldnotbetreatedwithAntistine5岁以下儿童禁用敌胺。【例10】TheuseofAlexaninnursingmothersisnotrecommended哺乳期妇女最好不用爱力生。6.4在Restrictionsonuse项目中有时还有小标题Contraindications禁忌症Precautions(Note)注意事项Warning警告PregnancyandLactation妊娠和哺乳七、使用方法和用量-DosageandAdministration本项最常见英语表示法有：DosageandAdministration使用方法和用量RouteofAdministration给药路径(使用方法)Administration使用方法DirectionforUse使用方法Methodof(for)Administration使用方法ApplicationandDosage使用方法和用(剂)量ModeofApplication使用方法Dosage用(剂)量HowtoUse使用方法Posology剂量学1、常见表示剂量术语averagedose平均剂量minimal(minimum)dose最小有效量dailydose日剂量(一日量)multipledose多剂量divideddose分次剂量overdosage(overdose)过量fatal(lethal)dose致死量singledose一次剂量indicateddose有效剂量standarddose标准(适宜)剂量initial(beginning,starting)dose首次量suggested(recommended)dose推荐剂量maintenancedose维持量therapeuticdose诊疗剂量maximumdose最大剂量(极量)usual(normal)dose常见剂量2、常见剂量单位表示法g=gram克l=liter(litre)升mg=milligram毫克ml=milliliter毫升kg=kilogram千克cc毫升mcg=microgram微克IU=internationalunit国际单位ug微克bodyweight体重persquaremeterofbodysurface每平方米体表面积3、每次给药次数表示方法daily(perday,aday,everyday)每日every…hours每隔…小时intervatsof…每隔…once(twice)daily(aday)每日一(二)次everyotherday每隔一日threetimesaday(daily)每日三次threetimesaweek每七天三次once(twice)aweek(weekly)每七天一(二)次Dividedinto…doses分…次intwoorthreedivideddoses分为二或三次(个剂量)【例1】Unlessotherwiseprescribedbythephysician,theaveragedailydoseis1capsule3timesdaily假如医生不另开处方，平均日剂量为每日3次、每次1个胶襄。【例2】Thesuggesteddoseis10to15mgperkgdodyweightdailyin3-4divideddosesorally,takenwithmeets日剂量最好每千克体重10-15mg，分3-4次口服，和食物共服。【例3】Theinitialdosagerecommendedis1/2tabletofMadopa250threetimesdaily开始剂量最好为每日3次，每次半片美多巴250。【例4】Children:Theusualdoseis50to100mg/kg/daytotal,giveninfourequallydividedandspaceddoses儿童：常见总剂量为每日50-100mg/kg体重，均分为四等份，等间隔给药。【例5】Therecommendedstartingdoseis20mggivenasasingledailydose推荐首剂量为每20mg，一次服用。4、给药对象：最常见用词有adolescents青少年intant(s)幼儿adult(s)成年人male男性baby(babies)婴儿newbornbaby(babies)新生儿children(child)儿童patient(s)患者，病人debilitatedpatients体弱患者pediatric儿科elderlypatient(s)老年患者pregnantwomen孕妇female女性senilepatient(s)老年患者(病人)5、给药方法表示法：多用副词成或介词短语表示，比如：intra-arterially静脉内给药bymouth(OS)口服intragluteally臀肌内给药byphleboclysis静脉输液intramuscularly肌内给药byintramuscular(IM)injection肌肉注射intraperitoneally腹(膜)腔内给药byintravenous(IV)injection静脉注射intrapleurally胸(膜)腔内给药bytheintra-articataradministration关节内给药intrathecally鞘内给药bytheintramuscularadministration(route)肌内给药intravenously静脉内给药bytheintranasalroute鼻内给药locally局部给药orally口服给药parenterally肠道外给药bytheintraperitonealadministration腹(膜)腔内给药subconjuntivally结膜下给药bytheintravenousinfusion(perfusion)静脉输注subcutaneously皮下给药sublingually舌下给药submucously粘膜下给药bytheintrathecaladministration鞘内给药byaerosol喷雾给药bythesubligualadministration舌下给药bydripphleboclysis点滴静脉输液perrectum直肠给药byenema灌肠pervaginum阴道给药bylumbar腰椎给药prorecto直肠给药另外还有很多其它表示法，不一一列举。6、表示“投药”常见动词administer(beadministered、give、begiven、indicate、beindicated)给药、投药use(beused、employ、beemployed)用药recommend(berecommended、suggest、besuggested)推荐给药7、表示不一样用药方法动词：take服用inhale吸入applyto用于、涂于、敷于spray喷雾inject注射swallow吞服【例6】therecommendedsingledoseis1ampoule,givensubcutaneously,intramuscularlyorintravenously提议一次剂量为1安瓶，皮下肌肉或静脉注射给药。【例7】IMinjectionsshouldbeadministeredintheamountof25-50mgdailyperkiloofbodyweight,subdividedintoinjectionsevery6-8-12hours肌肉注射：每日每千克体重给药25-50mg，每6-8-12小时一次。【例8】Foradultsgiveintramuscularinjectionof400to600mgperdayin2-3divideddosesForintantsgiveintramuscularinjectionof10-20mg/kgperdayintwodivideddoses成年人：肌肉注射，每日400-600mg，分2-3次注射；婴儿：肌肉注射，每日10-20mg/kg体重，分2次注射。【例9】Thetablets(orthesyrup)aretobetakenduringorafteramealwithalittleliquid片剂(或糖浆)应于食间或饭后用少许液体送服。【例10】ApplytheNitro-DursystemfirmlytotheskinsurfaceTheNitro-Dursystemmaybeappliedtoanyconvenientskinarea,arecommendedsideofapplicationisthearmorchest把护心贴片紧贴在皮肤表面，护心贴片可贴在任何方便皮肤区域，最好是贴在手臂或胸部。8、其它短语或句型，比如：accordingto依据beadjusted调整dependon依据adaptto适合，修改onthebasisof在…基础上varyfromto改变范围由…至…，因…而异rangefrom…to…改变范围由…至…itisadvisableto(itisrecommendedto、itissuggestedto)提议【例12】Dosageshouldbeadaptedtopatientsindividually,onthebasisofperiodictestsofglycosuriaandbloodsugar在周期性检验尿糖和血糖基础上，调整剂量，使之适适用于不一样患者。【例13】Itsiadvisabletoinitiatetherapywithmassivedoses:3x2tabletsdailyaftermealsover2-4days提议开始诊疗时采取大剂量，每日剂量为3x2片，饭后服用，连续2-4日。【例14】Inseverschroniccases,treatmentisstartedwithdaily1to2ampoulesofBilocidandcontinusedwithoneampouleeveryotherday,injectedslowlybytheintravenousroute诊疗严重慢性疾病时，诊疗从每日1-2支利胆素注射剂开始，继续诊疗时每隔一日1安瓶缓慢静脉注射。【例15】Thenumberofinjectionsrequiredmayvaryfromfrompatienttopatient所需注射次数因患者而异。八、不良反应-AdverseReactions不良反应这一项中包含药品副作用、症状及体征、毒性作用及耐受力、过敏反应、停药等。1、不良反应”常见英语表示法有：AdverseReaction(s)Unwanted(Untoward)Reaction(s)2、副作用”常见英语表示法有：Side-effect(s)Unwanted(Undesirable)EffectsSideReaction(s)By-effects3、常见症状及体征表述词语：allergy(hypersensitivity)过敏gastrointestinaltract胃肠道localreaction(s)局部反应skinreaction(s)皮肤反应symptom(s)症状systematic全身pruritus瘙痒bloodcount白细胞计数spasm痉挛bloodpressure血压thirst口渴coma昏迷tiredness疲惫whitepatchesinmouth口腔白斑fever发烧chills寒战nausea恶心hives荨麻疹dizziness头晕fainting晕厥drowsiness嗜睡flushing面部潮红headache头痛bruising瘀斑weakness虚弱/乏力vomiting呕吐diarrhea腹泻anorexia厌食oedema水肿fatigue疲惫palpitations心悸sweats发汗insomnia失眠rash皮疹drymouth口干skinrash皮疹nightsweats盗汗acutepain急性疼痛severepain激痛dullpain钝痛pressingpain压痛sharppain刺痛piercingpain戳痛tearingpain裂痛flankpain胁腹痛chestpain胸痛cloudyurine尿混浊bloodyurine血尿inabilitytourinate无尿highfever高热、高烧lowbackpain腰痛light-headedness眩晕irregularpulse不规则脉搏shortnessofbreath气促difficultyinbreathing呼吸困难sorethroat咽喉痛racingthoughts思维奔逸skippingbeats心脏漏搏lossofvision、visualloss视力丧失purplespotsundertheskin皮下瘀斑palestools大便颜色变浅lossofappetite食欲缺乏(或减退)orthostatichypotension直立性低血压painbehindbreastbone胸骨后疼痛lossofvision、diminutionofvision视力减退darkeningofurine、darkurine尿色变深signsofsuperinfection二重感染症状black"furry"tongue黑毛舌loose，foul-smellingstools稀便或恶臭便yellowingofskinoreyes皮肤和巩膜黄染vaginalitchingordischarge阴道瘙痒或分泌物异常beatingveryfastorveryslowly心动过速或过缓providerpoundinginthechest、heartpounding心跳加速pain,redness,orswellingatinjectionsite注射部位疼痛、发红或肿胀4、“霉性”、“耐受性”英语表示法：toxicity毒性tolerance(tolerability)耐受力，耐药性tolerate(toleration)耐受5、“停药”英语表示法举例：abandon停药discontinue停药discontinuance,discontinuation中止(诊疗)cease(cessation)(stop)停药(停止诊疗)don'tuse勿使用(停药)suspend停药terminate停止，结束withdraw(bewithdrawn，withdrawal)停药6、其它部分常见基础词汇及短语：acute急性control(becontrolled)控制chronic慢性diminish(reduce，reduction)降低common常见disappear消失irreversible不可逆encounter碰到，见到mild轻微giveriseto产生normal正常include包含rare(ly)罕见(地)leadto造成reverside可逆manifest表明，显示severe严重observe(beobserved)(被)观察到temporary临时produce产生transient一过性，短暂reactto对……反应appear(develop，happen，occur)出现(产生)resultfrom由……引发bereported(被)报道resultin造成cause(becausedby)(由……)引发treat(treatment)诊疗specialcare(caution)shouldbeexercised尤其小心(注意)【例1】CiprofloxactinisgenerallywelltoleratedThemostfrequentlyreportedadversereactionsare:nausea,diarrhaea,vomiting,dyspepsia,abdominapain,headache,restlessness,rash,dizzinessandpruritus环丙沙星通常耐受良好。最常报道副作用有：恶心、腹泻、呕吐、消化不良、腹痛、头痛、不安、皮疹、头晕及瘙痒。【例2】Side-effectsarerarewithslow-K,asanyexcesspotassiumisrapidlyexcretedintheurine施乐凯副作用根罕见，因为任何过量钾全部快速由尿排出。【例3】Attherecommendeddosageside-effectsegvenousirritatiionorhypersensitivityreactions(cutaneousandmucousreactions)areonlyobservedinisolatedcases用推荐剂量诊疗时，仅见部分静脉刺激或过敏反应(皮肤及粘膜反应)病例。【例4】Whenadversereactionsoccur,theyareusuallyreversibleanddisappearwhenthehormoneisdiscontinued当不良反应发生时，它们往往是可逆，停用激素后副作用即消失。【例5】Themostseriousside-effectisdamagetothebonemarrowBecauseofthis,thewhitebloodcellcountshouldbecontrolledoftenenoughdruingthetreatment最严重副作用是骨髓损害，所以在诊疗期间，要常常监测白细胞计数。【例6】Theseunwantedeffectsusuallydisappearspontaneouslyafter7-14daysorfollowingatemporaryreductioninthedosage这些副作用通常在7-14日以后，或临时降低剂量便自行消失。【例7】Withhighdosagecontinuousinfusion(morethan200mg/m2/day)over5to7days,thegastrointestinalcomplicationsaremorepronouncedandcanonoccasionleadtoileusAllsideeffectsarereversibleaftercessationoftherapy大剂量连续输注超出5～7日(超出200mg／m2／日)，胃肠道并发症更为显著，偶然可造成肠梗阻。停药后副作用皆可逆转。【例8】Insomepatientsnausea，dizziness，andvomitingmayoccurinthefirstdaysoftreatmentbutthetreatmentneednotbediscontinuedforthatInrarecasesadecreaseofbloodpressuremayappearforwhichabloodpressurecheck-upisrecommendedinout-patientsbeforethetreatmentisinitiatedIfside-effectspersist,lowerdosesshouldbeadministered服用本品头几天，有些病人可能会出现恶心、头晕和呕吐，但无须停药。偶有血压下降病例，为此，在诊疗开始前提议对门诊患者检测血压。若副作用连续不消失，应降低服用剂量。【例9】Majoradversereactions(muchlesscommonthantheminoradversereactions)includeinhibitionofmyelopoiesis,drugfeverandhepatitis较重不良反应(远不及轻度不良反应常见)包含抑制骨髓细胞生成，药品热及肝炎。【例10】Side-effects:Lossofappetiteandnauseaoccurinmostcases,sometimeswithvomitingThesesymptomsareusuallyconfinedtothefirstfewdaysoftreatmentandthentendtodisappear副作用：多数病例出现食欲减退、恶心，有时呕吐。这些症状通常发生在诊疗最初几天，以后逐步消失。九、注意事项-Precautions“注意事项”也是药品说明书中关键内容之一。为了安全用药，厂商在本项中尤其强调应注意事项，其中关键包含：正确剂量和使用方法，超出剂量时应急方法，用药对象，可能出现较严重副作用及诊疗方案，药品配伍，药液配制、使用及保管等、方面注意事项。现就本项内容具体介绍以下：1本项常见英语表示法：Precaution(s)注意事项Specialnote(caution,precaution)尤其注意Caution(s)注意事项NB注意Noto注意Warning(s)警告有时也用：Important关键事项Importantforthepatients患者须知2本项中常见检验项目：bloodcount血细胞计数Kidney(renal)function肾功效bloodpicture(hemogram)血象Liver(hepatic)function肝功bloodlevel血浓度serumconcentration血清浓度bloodpressure血压serumcreatininetest血清肌酸酐检验clottingtime凝血时间urineroutine(examination)尿常规creatinineclearance肌酸酐清除率3、本项特点是内容长短不一，有难有易；词汇量大，包含面广，现有一般词汇，也有大量专业词汇及编写词。很多词汇、结构和句型可在药理作用、适应症、禁忌症、剂量和使用方法、副作用，贮藏等项中见到。从英语结构上分析，句型改变较多，长句、难句也频频出现，是比较难读一个项目。【例1】Warningsandprecautions:CiprofloxacinshouldbeusedwithcautioninepilepticsandpatientswithahistoryofCNSdisordersandonlyifthebenefitsoftreatmentareconsideredtooutweighttheriskofpossibleCNSside-effects警告和注意事项：癫痫病人及有中枢神经系统病史患者慎用环丙沙星，仅当认为疗效超出可能产生中枢神经系统副作用危险时才可使用。【例2】Ciprofloxacincouldresultinimpainnentofthepatientsabilitytodriveoroperatemachinary,particularlyinconjunctionwithalcohol环丙沙星能损害大家驾驶汽车或操纵机器能力，尤其是在饮酒以后。【例3】Warnings:Vepesideshouldbeadministeredunderthesupervisionofaqualifiedphysicainexperiencedintheuseofcancerchemotherapeuticagents警告：泛必治应该在使用诊疗癌症化疗制剂方面有经验、有资格医生监护下使用。【例4】Themostseriousriskassociatedwithanticoagulanttherapywithsodiumwarfarinarehemorrhageinanytissueororganandlessfrequently,necrosisand/organgreneofskinandothertissuesTheriskofhermorrhageisrelatedtolevelofintensityandthedurationofanticoagulanttherapy用华注林钠进行抗凝诊疗产生最严重危险就是组织或器官出血，和不大常出现皮肤和其它组织坏死和(或)坏疽。出血危险和抗凝诊疗药品浓度(水平)及疗程长短相关。【例5】Theoccurrenceofaplateletcountbelow50,000/mm3oranabsoluteneutrophilcountbelow500/mm3isanindicationtowithholdfurthertherapyuntilthebloodcountshavesufficientlyrecovered血小板数低于s0，000／mm3或绝对中性白细胞数低于500／mm3，表明不能继续使用本品诊疗，待白细胞计教充足恢复后才能继续用药。医学全在线提供【例6】Warfarintherapyshouldbediscontinuedwhenwarfarinissuspectedtobethecauseofdevelopingnecrosisandheparintherapymaybeconsideredforanticoagulation当怀疑华法林诊疗引发坏死时，则须停止诊疗，而且考虑使用肝素诊疗。【例7】Dosageshouldbecontrolledbyperiodicdeterminationsofprothrombintime(PT)orothersuitablecoagulationtests必需定时检验凝血酶原时间(PT)，或做其它对应凝血试验来控制剂量。【例8】PleasenoteCerebralconvulsivediseaseisregardedasarelativecontraindicationforexaminationsinthesubarachnoidspaceIfaftercarefulconsideration,theseexaminationsareneverthelessperformed,allequipmentandmedicinesnecessarytocounteranyconvulsionsmayoccurmustbepreparedreadyforusebeforehand请注意：脑惊厥被认为相对严禁进行蛛网膜下腔检验，如经谨慎考虑后、仍要进行这些检验时．必需事先备妥应付可能发生惊厥所需全部设备和药品。【例9】Cautionmustbeexercisedinthecaseofhypersensitivitytoiodinatedcontrastmedia,latenthyperthyroidismandblandnodulargoitre对碘造影剂过敏、隐匿性甲状腺亢进和轻微甲状腺肿病例，应慎重。【例10】CautionAlcoholintakemayenhancenitrateeffectsandoccasionallyinducehypotensionwithsubsequentimpairmentofreactivityDuringthefirstthreemonthsofpregnancydrugsshouldonlybeusedontheexpressdirectionoftheattendantphysicianIsketsprayshouldnotbestoredattemperaturesabove25。C!Temperaturesabove40℃aretobebeavoided,evenforbriedperiods!Donotforcecanisteropen,evenwhenempty!注意：饮酒可增强硝酸盐作用、偶然引发低血压，继而损害反应力。妊娠三个月时，只有在监护医生明确指导下才可使用本品。异舒吉喷雾剂贮存温度不应超出25℃！避免超出40℃。即使短时间也不可！不要用力开罐，即使空罐时也不可用力开！勿使儿童接触本品十、包装-Package1、“包装”在英文药品说明书中表示法有很多，最常见是Pack(Package)和Supply，比如：Pack(s)(Packing(s))包装Supplys(Supplied)包装Package(s)包装HowSupplied包装方法PackingforHospital医院用包装MethodofSupply包装方法PackageQuantitiess(Quantity)包装量另外还有，Presentation包装Hospital(Size)Packs医院用包装Availability包装TradePacks(Packings)商品包装Mode(Form)ofIssue包装2、常见包装单位(工具)英语表示法：ampoule(s)安瓿carton纸盒blisterpack(package)铝塑包装(水泡眼包装)pack包blisterstrip铝塑条状包装sheet张bottle瓶strip条box盒tube管canist罐vial玻璃小瓶3、药品常见剂型英语表示法：片剂Tablets胶囊剂Capsules注射剂Injections颗粒剂Granules溶液剂Solution气雾剂Aerosol喷雾剂Spray软膏剂Ointment乳膏剂Cream糖浆剂Syrup粉雾剂PowderforInhalation吸入剂Inhalation滴丸剂PillsDrops滴眼剂EyeDrops滴耳剂EarDrops滴鼻剂NasalDrops眼膏剂Eyeointments口服液OralSolution口服乳剂OralEmulsion口服混悬剂OralSuspension口服溶液剂OralSolutions洗剂、冲洗剂 Lotion涂剂、搽剂 Liniment，Paints散剂 Powders丸剂 Pills栓剂 Suppositories乳剂 Emulsion合剂 Mixture糊剂 Paste贴剂 Patch酏剂 Elixir醑剂 Spirit汤剂 Decoction酊剂 Tincture膜剂 Membrane胶剂 Colloid茶剂 MedicinalTeas酒剂 MedicinalWine膏药 Plaster露剂 AromaticSolution植入剂 Subdermal含潄剂 Garles浸膏剂 Extract凝胶剂 Gelatin煎膏剂 ConcentractedDecoctions软胶囊剂 SoftCapsules巴布膏剂 Cataplasmata橡胶膏剂 AdhesivePlaster透皮贴剂 Transdermal干混悬剂 DrySuspension芳香水剂 Aromaticwaters流浸膏剂 FluidExtractLiquidExtract贴剂、贴膏剂 Transdermal粉针剂 PowderforInjection冻干粉针剂LyophilizedPowderforInjection小容量注射剂SmallVolumeParenteralSolution大容量注射剂LargeVolumeParenteralSolution造影剂（注射液）ContrastMedia（Injection）原料药BulkDrug无菌原料药SterileBulk中药饮片PreparedSlicesofChineseCrudeDrugs放射性药品Radiopharmaceutical血液制品BloodProducts体外诊疗试剂ExtrinsicDiagnosticTests医用氧MedicalOxygen眼科用药OphthalmicMedications4、本项结构特点；内容结构简单，多为不完全句，或仅仅列出包装工具、剂型、装量等。【例1】Presentation30capsules包装：30粒胶囊装。【例2】Packages：Boxcontainingone100mgbottle包装：盒装，每盒1瓶，每瓶100mg。【例3】PackingBottleof12capsules250mgand500mg．Bxoof12capsules250mginblisterBottleforpediatriuse(granulated):20gmgranulatedcontain1gmampicillin,Thecontentofthespoonincludedinthepackingcorrespondsto100mgampicillin包装瓶装12粒胶囊，每粒含量250或500mg。盒装12粒胶囊(水泡眼包装)，每粒含量250mg。瓶装儿童用颗粒剂：20克颗粒剂每瓶含有1g氨苄青霉素。附在包装内一匙量，相当于1O0mg氨苄青霉素。【例4】ModeofissueCeopranIsissuedinvialscontaining250mg,500mgand1gramofcephaloridine包装方法本品小瓶包装，内装250mg、500mg及1g头抱菌素II。【例5】TradepacksTradepackscontaining50and100sugarcoatedtablets商品包装50及100糖衣片包装。【例6】Packs(Madopar)250:Cross-scroredtabletseachcontaining200mglevodopa+50mgbenserazide包装美多巴”250”刻痕片，每片含200mg左族多巴50mg羟苄丝肼。【例7】MethodofsupplyTabletsintubes,eachcontaining30tabletsPaintinglassbottlesof24mlMeladinineissuppliedonlyonprescription包装方法管装片剂．每管30片。玻璃瓶装搽剂，每瓶24ml。敏白灵只按处方供药。【例8】AvailabilitySyrup:OrbeninsyrupisavailableinbottlescontainingreconstitutablepowderforpreparinganaqueoussolutionWhendispensedeach5mlteaspoonfulcontains125mgcloxacillinasthesodiumsalt包装糖浆：全霉林糖浆为瓶装，内含可供再配制水溶液粉末。配制后每茶匙5ml药液中含125ml邻氯青霉素钠盐，【例9】HowsuppliedTablets:Coumadin(crystallineWartarinSodiumUSP),