《英文药品说明书》PPT课件

英文药品说明书PackageInsert,美国FDA规定其应包括十项：1.Drugnames（药物名称）2.Description（性状）3.Clinicalpharmacology（临床药理学）4.Indicationsandusage（适应症和用法）5.Contraindications（禁忌症）,FDA英文药品说明书规定项目,药品说明书旧称description,instruction,direction.今称packageinsert，insert,6.Precautions（注意事项）7.Warnings（警告）8.Adversereactions（不良反应）9.Overdosage（用药过量）10.Dosageandadministration（剂量和用法）,Druginteractions（药物相互作用）Storageanddurationofefficacy（贮藏与失效期）Package（包装）References（参考文献）Manufacturer（生产者）,其他项目：,1.通常每种药物有三个名字(1)proprietaryname（商品名称）(2)popularname（通用名）(3)chemicalname（化学名）,一、drugnames(药物名称),2.说明书标题多用商品名其右上角标有R者，表示registeredtrademark（注册商标）,例如：舒喘灵SalbutamolVentolin2-t-butylamino-l-(-4-hydroxy-3-hydroxymethyl)-phenylethanol,1音译：药品英文名称音节较少，而化学结构复杂的尽量使用音译。如：Atropine;coffeine;cortisone;quinine;amicacin,英语药名汉译常用译法,2意译：1）英文名中显示了化学基团，对应译名又比较简短通顺的，采用化学基团简缩命名。如：Imidazate;cholicacid;tetracycline;tribromidi;,2)药品英文名称中含某种物质，用意译能比较简短明确而含义对应的就采用意译。如：Ketoconazole;,3音、意合译：药品英文名称中只有一部分显示化学基团者采用音意合译。如：medemycin;Indobufen;coumadin(coumarrin香豆素);codeinphosphas;,4中文译名的转化现象：vitamin;penicillin;hormone;atropine,1）药物与酸形成的盐中文名是酸在前药名在后，英文相反。,翻译药名名称注意：,2）药物与碱金属形成的盐中文药名在前而碱金属在后，英文相同,3）考虑化学名称重点字头，又考虑同类药名的名称的系列化（即相同的词头、词干或词尾）如：CeforanideceforxadinecefotazidimeCefotetanPefloxacinNorfloxacinOfloxacin,4）记住一些药品英文名称的常用词首和词尾,常用description,introduction,composition包括药品的：chemicalstructure（化学结构）chemicalcomposition（化学成分）physicalandchemicalproperties（物理和化学性质）,二、description（性状）,颜色(Color);味道(Taste);气味(Smell);溶解度(Solubility);成分(Composition);主要成分(ChiefComposition);分子式(Formula);分子量(MolecularWeight)性质(Property)等。,1.物理和化学性质,1）表示组成、制备的词及短语：bederivedfrom由衍生consistof由组成beobtained制得contain含有bepreparedfrom由制备have(possess)有（具有）,2.本项中常用的词语,colo(u)r颜色;colo(u)rless无色的；odo(u)rless无臭的；odo(u)r气味；taste味道；tasteless无味的；,2）表示性质的一些词类：,molecularformular分子式molecularweight分子量structure结构；derivative衍生物；,crystalline结晶的；powder粉末；liquid液体；solid固体；soluble可溶的;insoluble不溶的;solubility溶解度stable稳定的；,solution溶液;tablets片剂;injection注射剂sterile无菌的；,例2Intralipids10%isawhiteopaquefatemulsionforintravenousinjection,containing10W/V%ofpurifiedsoybeanoil.脂肪乳剂（10%）是白色，不透明，供静脉注射用的脂肪乳剂，含有10%（W/V）的精制大豆油。,例1Folicacidisayellowishtoorange,crystallinepowder;odourlessoralmostodourless.叶酸是淡黄色至橙色结晶粉末，无臭或几乎无臭。,例3UrsosanTablet50mgisawhiteplaintabletwhichcontains50mgofursodesoxycholicacid.熊去氧胆酸片为白色素片，每片含50mg熊去氧胆酸。,例4Sterilepyrogen-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阿霉素盐酸盐与乳糖。,例5Itoccursasawhitetooff-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。,例6Pamine,chemicallyknownasepoxytropinetropatemethylbromide,hastheempiricalformulaC18H24NO4Brandthemolecularweight398.3.哌明的化学名称为环氧莨菪碱托品酸酯溴代甲烷，分子式为C18H24NO4Br，分子量为398.3。,例7Kanendomycinisaverystableantibiotic,anditsactivitydoesnotdecreasewhenthepowderisplacedinanairlightcontainerandkeptatroomtemperaturesformorethan2years.卡内多霉素是一种很稳定的抗生素，其粉末置于密封容器中，在室温下保存二年以上，活性不减。,例8Thisproductispreparedfromunitsofhumanplasmawhichhavebeentestedandfoundnonreactiveforhepatitisassociated(Australia)antigen.本品由人血浆制备，此血浆业经检验，并且证明对肝炎（澳大利亚）抗原无反应。,常用的名称还有：clinicaldata（临床数据）;clinicalexperience（临床经验）;clinicaluse（临床应用）;clinicalobservation（临床观察）,三、clinicalpharmacology（临床药理学）,主要记载药物的药理作用和临床疗效等。本项涉及微生物学、生物化学、生理学、药理学、毒理学等专业词汇多。阅读时可参阅英汉医学词汇及英汉化学化工词汇等工具书。,clinicaleffect（临床疗效）;clinicaldiscussion（临床讨论）;modeofmechanismofaction（临床机理及途径）;pharmacologicalactions（药理作用）;therapeuticalactions（治疗作用）;bacteriology（细菌学）;microbiology（微生物学）、physiology（生理学）;toxicology（毒理学）,1.动词absorb吸收；act作用；accumulate积蓄；administrate投药；cause(becauseby)引起（由引起）demonstrate显示；exhibit显示；excrete排泄；exert(actionon)起作用indicate表明；inhibit抑制；maintain维持；metabolize代谢；produce产生；protect(from)保护（不变）；promote促进；prevent阻止，预防；reach达到；resultin导致；show显示，表明；treat治疗；tolerate耐受,常用词及短语举例,2.形容词(be)active(effective)against对有效的(be)relatedto与有关的(be)sensitiveto对敏感的resistantto有耐药性的average平均的minimum最低（小）的maximum最高（大）的normal正常的,3、名词ability能力；activity活性；action作用；effecton对的作用；distribution分布；excretion排泄；clearance廓清率；function功能，作用；halflife半衰期；kidney肾；mechanism机理；tolerance耐受性；infection感染invitro体外；invivo体内；level水平，浓度；plasmlever血浆浓度（水平）；serumconcentration血清浓度toxicity毒性；,例1.Meanpeekserumconcentrationsoftobramycinoccurbetween30andabout60minutesafterintramuscularadministration.肌注后约3050分钟之间妥布毒素的平均血药浓度达到高峰。,常见句型举例,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的镇静催眠作用。,例3.Inclinicaltrialsthedrugwasshowntobehighlyeffectinveinimprovingandnormalizingthealteratedcerebralcirculationandthosedisordersrelatedtoinsufficientarterialflowinthelimbs.临床试验证实，本品疗效高，可改善已改变了的脑循环，使之恢复正常，治疗与四肢动脉血流不畅有关的疾病,例4.Fenarolhasprovedtobeeffectiveasastriatedmusclerelaxant.已证明芬那露是疗效很好的横纹肌松施药。,例5.Halcionisapotentshort-actinghypnoticagent,whichproducesitshypnoticactivityfromthefirstnightofadministration.好而睡是一种强力速效催眠药，它从服药后的第一个夜晚开始产生催眠作用。,例6.Therapeutically,ATPinjectionexhibitseffects,especiallysuchasactivationofthefunctionandmetabolismofthenerve,andalsocoronaryandperipheralvasodilationtoincreasethebloodstream.从治疗上看，三磷酸腺苷注射剂显示了非常好的效果，特别是在活化神经的功能及代谢，以及舒张冠状与外周血管以增加血流方面更是如此。,常用标题：indications,majorindications,clinicalindications,principalindications,condications,uses,treatment,四、Indicationsandusage（适应症和用法）,Arthro-关节Broncho-支气管Cardio-心脏Gastro-胃Nephro肾脏Pheumono-肺Hepato-肝-algia痛-rrhagia出血-itis炎症-osis病态-oma肿瘤,积累和熟记一些病名的构词法，在没有工具书时，可解决不少问题。,1病名的构成法及有关问题,常见病名构词：病名=器官名+症候名,Infra-上部Infra-axillarySub-下方sub-cutaneousPeri-周围Periarticularcricum-经过circumorbitalDia-DiarrheaPer-percolate-Supra-super-SuprarenalsupercerebralAnti-抗、逆Antibioticcontra-contraindicationMulti-MulticellularPoly多数polyuriaMacro-巨大Macrocytosismegalo-megaloscope,英文同义词,词义例词,英文反义词词义例词Pre-post-前；后anesthetic(麻醉)Brady-tachy-缓慢；迅速pnea（呼吸）Endo-exo-内部；外部crine（分泌）Eu-dys-正常；异常kinesis（运动）Hyper-hypo-高；低tenson（紧张）Infra-supra-下部；上部sterna（胸骨）Macro-micro-巨大；微小cyte（红细胞）Hemi-holo-半；全hemicrania偏头痛holotonia全身肌肉紧张,英文词头反义词比较,五、contraindications（禁忌证）,1.常用标题contraindications,restrictiononuse(限制使用),pregnantwomen孕妇womenofchildbeatingage育龄妇女lactation,earlyinfancy乳期behypersensitiveto对.过敏者allergicreaction变态反应heart,cardiac,myocardial心脏，心脏的，心肌的kidney,renal肾，肾脏的liver,hepatic肝，肝脏的insufficiency,impairment机能不全damage,danger,failure损伤，危险，-衰,2.常用词（组）,例1.Pregnacy,allergytomethotrexate,functionaldisordersofliverandkidneys,diseasesofthehaematopoieticsystem(bonemarrowhypoplasia,leucopenia,thrombocy-topenia,anaemia),intectiousdiseases,ulcersoftheoralcavityandthegastrointestinaltract,recentoperationwounds.孕期，对氨甲叶酸过敏，肝、肾功能障碍，血液系统疾病（骨髓机能减退、白细胞及血小板减少、贫血），传染病，口腔及胃溃疡，近期术后伤口等忌用。,1)省略句型，只列出禁忌对象或疾病名称等。,例2.Hypersensitivitytoquinoiones,severerenalinsufficiency.对喹喏酮类过敏，严重肾功能不全。,contraindicationsare禁忌症是becontraindicatedin(for)对禁忌shouldnotbeused(employed)in不得用于Itisadvisabletoavoidtheuseof建议不用于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,2)完整的句子或段落其中常用的结构有：,例3.Cetazolinsodiumiscontraindicatedinpatientswithknownhypersensitivitytocephalosporingroupofantibiotics.先锋5号禁用于已知对头孢菌素类抗生素过敏的患者。,例4.ItisadvisabletoavoidtheuseofAraminewithcyclo-propaneorhalothaneanesthesia,unlessclinicalcircumstancesdemandsuchuse.如果不是临床需要，建议本品不要与环丙烷或氟溴氯乙烷麻醉剂合用,例5.Thisproductiscontraindicatedinthosepatientswhohaveshownhypersensitivitytoitunless,intheopinionofthephysician,theconditionrequiringtreatmentislifethreateningandamenableonlytoamphotencinBtherapy.除非根据医生的意见，认为需要治疗的患者的病情危及生命，并且只有两性霉素治疗才可能使其有所改善之外，对本品过敏的患者禁用本品。,例6.Childrenunder5yearsofageshouldnotbetreatedwithAntistine.5岁以下儿童禁用敌胺。例7.TheuseofAlexaninnursingmothersisnotrecommended.哺乳期妇女最好不用爱力生。,六、precautions（注意事项）常用标题:cautions,remark,note,notice,attention,awakening,N.B.,七、warnings（警告）常用标题：additionalwarnings(告戒事项),例1Warningsandprecautions:CiprofloxacinshouldbeusedwithcautioninepilepticsandpatientswithahistoryofCNSdisordersandonlyifthebenefitsoftreatmentareconsideredtooutweighttheriskofpossibleCNSside-effects.警告和注意事项：癫痫病人及有中枢神经系统病史的患者慎用环丙沙星，仅当认为疗效超过可能产生的中枢神经系统副作用的危险时才可使用。,例2Ciprofloxacincouldresultinimpairmentofthepatientsabilitytodriveoroperatemachinary,particularlyinconjunctionwithalcohol.环丙沙星能损害人们驾驶汽车或操纵机器的能力，尤其是在饮酒之后。,例3.Warnings:Vepesideshouldbeadministeredunderthesupervisionofaqualifiedphysicianexperiencedintheuseofcancerchemotherapeuticagents.警告：泛必治应该在使用治疗癌症的化疗制剂方面有经验、有资格的医生的监护下使用。,1.常用标题：sidereaction（副反应）、untowardreaction（不良反应）、toxicityreaction（毒性反应）、anaphylacticreaction（过敏反应）、sideeffects,by-effects,aftereffects,undesirableeffects（副作用）、doubleinfection（双重感染）,八、adversereactions（不良反应）,Allergic(Hypersensitiveanaphylactic）reactionGastrointestinaltractreaction胃肠道Localreaction,Skinreaction,2.常见的毒副作用的症状及体征词语,Symptom:Anorexia厌食BloodcountBloodpressureComaDiarrheaDizziness眩晕feverflushheadachenausea恶心pruritus瘙痒rash皮疹spasmSystematic全身的tirednessthirstvomiting,Dontuse勿使用Shouldntbeinuse不应使用Withdraw停药Terminate停药Discontinue中断用药Abandon停药Suspend停药Stop停止用药Cessation停药,3.停药的表示法,AcuteChroniccontroldiminishreducereductionIrreversibleMildNormalRarelyReversibleSeveretemporaryTransientAppearDevelopHappenOccur,4.其他一些常见基本词汇及短语,例1Ciprofloxactinisgenerallywelltolerated.Themostfrequentlyreportedadversereactionsare:nausea,diarrhaea,vomiting,dyspepsia,abdominapain,headache,restlessness,rash,dizzinessandpruritus.环丙沙星一般耐受良好。最常报道的副作用有：恶心、腹泻、呕吐、消化不良、腹痛、头痛、不安、皮疹、头晕及瘙痒。,例2Side-effectsarerarewithslow-K,asanyexcesspotassiumisrapidlyexcretedintheurine.施乐凯的副作用根罕见，因为任何过量的钾都迅速由尿排出。,例3Attherecommendeddosageside-effectse.g.venousirritatiionorhypersensitivityreactions(cutaneousandmucousreactions)areonlyobservedinisolatedcases.用推荐剂量治疗时，仅见个别的静脉刺激或过敏反应（皮肤及粘膜反应）病例。,例4Whenadversereactionsoccur,theyareusuallyreversibleanddisappearwhenthehormoneisdiscontinued.当不良反应发生时，它们往往是可逆的，停用激素后副作用即消失。,例5Themostseriousside-effectisdamagetothebonemarrow.Becauseofthis,thewhitebloodcellcountshouldbecontrolledoftenenoughdruingthetreatment.最严重的副作用是骨髓损害，因此在治疗期间，要经常监测白细胞计数。,常用标题：administrationprocedure,methodforadministration,methodofuse,directionforuse,howtouse,recommendation,reconstitution（用法）posology,dosage（剂量）applicationanddosage,usageanddosage（用法与剂量）clinicalapplication（临床应用）,九、overdosage（用药过量）,常用标题：treatmentofoverdosage(用药过量的治疗),十、dosageandadministration（剂量用法）,Intramuscularly肌肉注射Intragluteally臀肌注射Intraarterially动脉注射Intravenously静脉注射Intrathecally鞘内注射Intracerebeospinally脑脊髓腔注射Orally口服Parentarally肠道外给药Locally局部给药Subconjunctivally结膜下给药Sublingually舌下给药Submucously黏膜下给药,modeofadministration(给药方式),1给药对象infants幼儿babies婴儿senilepatient老年病人pregnantwomen孕妇,2给药剂量单位I.U.=internationalunitKg,g,mg=milligraml=litreml=milllitreMcg=microgramc.c.=ml,3给药途径byos口服orally口服Bytheintramuscularroute肌内给药Byintramuscularinjection肌注法Byphleboclysis静脉输液Perrectum直肠给药,5给药常用剂量术语Singledose一次剂量Initialdose开始剂量MaximumdailydoseMinimumeffectivedoseAveragemaintenancedose平均维持剂量Intermittentdose间歇剂量Test-dose试验剂量Overdose过量剂量,4给药时间表示法Daily;perday;everyday;every8hours;eight-hourly;oncedaily;twicedaily;,daily(perday,aday,everyday)每日everyhours每隔小时intervalsof每隔once(twice)daily(aday)每日一（二）次everyotherday每隔一日threetimesaday(daily)每日三次threetimesaweek每周三次once(twice)aweek(weekly)每周一（二）次dividedintodoses分次intwoorthreedivideddoses分为二或三次（个剂量）,6.每次给药次数的表示方法,例1Unlessotherwiseprescribedbythephysician,theaveragedailydoseis1capsule3timesdaily.如果医生不另开处方，平均日剂量为每日3次、每次1个胶囊。,例2Thesuggesteddoseis10to15mgperkgdodyweightdailyin3-4divideddosesorally,takenwithmeets.日剂量最好每公斤体重10-15mg，分3-4次口服，与食物共服。,例3Theinitialdosagerecommendedis1/2tabletofMadopa250threetimesdaily.开始剂量最好为每日3次，每次半片美多巴250。,例4Children:Theusualdoseis50to100mg/kg/daytotal,giveninfourequallydividedandspaceddoses.儿童：常用总剂量为每日50-100mg/kg体重，均分为四等份，等间隔给药。,例5Therecommendedstartingdoseis20mggivenasasingledailydose.推荐的首剂量为每20mg，一次服用。,7.表示“投药”的常用动词administer(或beadministered、give、begiven、indicate、beindicated)给药、投药use(或beused、employ、beemployed)用药recommend(berecommended、suggest、besuggested)推荐给药,8.表示不同的用药方式的动词：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.建议一次剂量为1安瓶，皮下、肌肉或静脉注射给药。,例7.I.Minjectionsshouldbeadministeredintheamountof25-50mgdailyperkiloofbodyweight,subdividedintoinjectionsevery6-8-12hours.肌肉注射：每日每公斤体重给药25-50mg，每6-8-12小时一次。,例8.Foradultsgiveintramuscularinjectionof400to600mgperdayin2-3divideddoses.Forintantsgiveintramuscularinjectionof10-20mg/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。,accordingto根据beadjusted调整dependon依据adaptto适合，修改onthebasisof在基础上varyfromto变化范围由至，因而异rangefromto变化范围由至itisadvisableto(itisrecommendedto、itissuggestedto)建议,9.其它的短语或句型,例12.Dosageshouldbeadaptedtopatientsindividually,onthebasisofperiodictestsofglycosuriaandbloodsugar.在周期性检验尿糖和血糖的基础上，调整剂量，使之适用于不同的患者。,例13.Itsiadvisabletoinitiatetherapywithmassivedoses:3x2tabletsdailyaftermealsover2-4days.建议开始治疗时采用大剂量，每日剂量为3x2片，饭后服用，持续2-4日。,例14.Inseverschroniccases,treatmentisstartedwithdaily1to2ampoulesofBilocidandcontinusedwithoneampouleeveryotherday,injectedslowlybytheintravenousroute.治疗严重的慢性疾病时，治疗从每日1-2支利胆素注射剂开始，继续治疗时每隔一日1安瓶缓慢静脉注射。,十一、包装及储存,PackspackingPackagePackingforhospital,Packingquantities,Hospitalpack,Supply,supplied,Methodofsupply,howsupplyAvailability,Modeofissue,1.包装在英文说明书中的表示法,本项的结构特点；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，词汇量容易阅读。,AmpouleBlisterpack铝塑包装Blisterstrip铝塑条状包装BottleBoxCanist罐Carton纸盒PackSheet张strip条TubeVial玻璃小瓶,2.常见的包装单位,Aerosol