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医药说明书翻译指导,INSTRUCTONS,第一节药品说明书基本结构,药品说明书英文表达方式有:Instructions,Directions,Description现在多用PackageInsert,或简称Insert,也有用Leaflet或DataSheets,包括下列内容:药品名称(Drugname)性状(Description)药理作用(PharmacologicalActions)适应症(Indication)禁忌症(Contraindication)注意事项(Precaution)副作用(Sideeffects)剂量和用法(Dosageandadministration)包装(Packing)有效期(Expirydate)出厂日期(Manufacturingdate)参考文献(References),药品名称有商品名(Tradename)、通用名(GenericName)化学名(ChemicalName)药品说明书上最常用的名称是商品名。有时在商品名之下(或后)又列有通用名或化学名.例如:Rulide(罗力得)之后列有(Roxithromycin,罗红霉素);Minipress(脉宁平)之后列有(PraxosinHCl,盐酸哌唑嗪),一药品名称(DrugName),1.商品名(Tradename)商品名是由生产厂家命名并向该国政府有关部门(国家食品药品管理局)注册的药品名.商品名右上角往往有一符号,意思是注册商标,是Register的缩写。商品名因厂而异,因国而异,一种药物可以有几个,几十个商品名,因此仅根据商品名很难确定该药为何种药物,需要查阅其化学结构.药物说明书一开头,除了商品名外,还有时标有“Issuedto/forthemedicalprofessiononly”意思为“仅供医学界专业参考”,2.商品名译法药品名称的中文翻译方法有多种,包括音译、意译、音意合译、谐音译以及按药理作用或药物成分翻译。a.音译Penicilin盘尼西林,Cediland(西地兰),Persantin(潘生丁),aspirin(阿司匹林)b.意译Chlorimycin氯霉素;Tetracyclin四环素;CholicAcid胆酸c.音意合译Medemycin麦迪霉素(mycin霉素)d.谐音Legalon利肝隆,Webilin胃必灵e.按药理作用或药物成分翻译,二药品性状(Description),药品性状:包括药品的外观、理化性质、成分、结构、特征等。除了用Description外,还常用Property/Properties;Physicalandchemicalproperties;Characteristics(性状);有些说明书介绍很简单,仅给出化学结构或成分,标题为:Chemicalstructure(化学结构);Composition(成分)Activeingredients(有效成分)等,此部分结构差异较大,长短不一。介绍药物多用被动语态。除了普通性和描述性词汇外,还常涉及到化学化工词汇。由于是对药物性质的一般描述,故多用一般式。,1结构特点:,Example1,DescriptionBuflomedilHydrochloride(丁咯地尔盐酸盐脑功能改善药),theactiveingredientofIkelan(麦道可兰(含buflomedilhydrochloride),isavasoactive(血管活性的)andnerveprotectivedrug.Theempiricalformular(实验组成)isC17H25NO4.HCl,representingamolecularweightof343.8.Eachampoule(一次用量的针剂,安瓿)ofIkelaninjectioncontains50mgBuflomedilHydrochloride.Itisaclear,colorlessorlightyellowsolution(溶液).Eachfilmcoatedtablet(薄膜衣片剂)fororaladministrationcontains150mgor300mgofBuflomedilHydrochloride.Eachmloftheoralsolutiondropscontains150mgBuflomedilHydrochloride.,Example2PropertiesThisdrugisanangiotensinconvertingenzymeinhibitor(ACEI,血管紧张素转换酶抑制剂).,Example3DescriptionKirinSterilePowdercontainsspectinomycinhydrochloride(盐酸奇放线菌素)whichisanaminocyclitolantibiotics(卡那霉素B)producedbyaspeciesofsoilmicroorganismdesignatedasStreptomycesspectabilis(紫色团孢链霉菌).,例1Folicacidisayellowishtoorange,crystallinepowder;odourlessoralmostodourless.叶酸是淡黄色至橙色结晶粉沫,无臭或几乎无臭。例2Intralipos10%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3UrsosanTablet50mgisawhiteplaintabletwhichcontains50mgofursodeoxycholicacid.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盐酸阿霉素和50mg的乳糖。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,实验式为C18H24NO4Br,分子量为398.3。例7Kanendomycinisaverystableantibiotic,anditsactivitydoesnotdecreasewhenthepowderisplacedinanairtightcontainerandkeptatroomtemperaturesformorethan2years.卡内多霉素是一种很稳定的抗生素,其粉沫置于密封容器中,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。,2.常用词语,(1)性状部分常用词语表达color颜色taste味道tasteless无味colorless无色crystalline结晶的solubility溶解度yellowish淡黄色bitter苦味whitish微白色的odour气味greenish淡绿色的odourless无嗅sterile灭菌,无菌的orangered桔红色的pyrogen-free无热原的soluble可容的insoluble,brown棕色brownish浅棕色的transparent透明的opaque不透明的off-white类白色或黄白色的stable稳定的molecularformularinjectionliquidmolecularweightsolutionpowderchemicalstructuretabletsolid,(2)表示组成、来源、制备方法的常用表达,constituents组成;prepare制备,bederivedfrom由衍生;beobtainedfrom由制的;bepreparedfrom由制备;obtainedby由获得;consistof由组成;becomposedof由组成;contain;have;possess有(具有),三.药理作用(PharmacologicalActions),较详细的药品说明书一般要介绍药品的临床药理、体外实验、药效、药物代谢、毒性和毒理作用等。该部分常用的标题为:PharmacologicalActions药理作用Pharmacology药理学PharmacologicalProperties药理性质Actionsandproperties作用与性质MechanismofAction作用机理ModeofAction作用方式ClinicalExperiments临床实验Pharmacologyandtoxicology药理学与毒理学BiologicalActivity生物活性(若为抗生素类药品,常用之),有时还列出小标题,例如:ClinicalPharmacology临床药理学;Clinicaleffect/use临床效果/用途;Pharmacodynamics药效学;Pharmacokinetics药物代谢动力学。,1结构特点该部分涉及到多学科的词汇,如药理学(药效学,药物代谢动力学)、生理学、毒理学、化学与微生物学等专业的词汇,有时较难理解。此外,在本部分还经常遇到一些医学缩略词,如:CNS(中枢神经系统)、EEG(脑电图)、LD50(半数致死量)、ED50(半数有效量)、t1/2(半衰期)等。该项一般用陈述句,句子结构有时比较复杂。,2常用词语,(1)动词:Indicate表明,提示;Maintain维持;Demonstrate显示;exert(actionon)起一作用Exhibit显示;,Inhibit抑制;Accumulate积蓄(积累);metabolize代谢;Administer给药;Excrete排泄;Tolerate耐受,(2)形容词:averagemean平均的;beeffectiveagainst对有效;berelatedto与有关;(be)sensitiveto对敏感;(be)resistantto对有耐药,(3)名词,Activity活性;Mechanism机理;Absorption吸收;Distribution分布;Elimination清除;Excretion排泄,Serumconcentration血清浓度;Tolerance耐受性;,Clearancerate廓清率;Toxicity毒性;Plasmalevel血浆浓度(水平);Halflife半衰期;Effecton对的作用;Invitro体外;invivo体内。,常见句型举例,例1.Peakserumconcentrationsoftobramycinoccurbetween30andabout60minutesafterintramuscularadministration.肌注后约3060分钟之间妥布毒素的血药浓度达到高峰。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的镇静催眠作用。,例3.已发现制霉菌素(Nystain)在肠道内可抑制酵母菌(yeast)的生长。Nystainhasbeenfoundtoinhibitthegrowthofyeastintheintestinaltract.例4.熊去氧胆酸的生物半衰期时3.5-5.8天thebiologicalhalf-lifeofursodeoxycholicacidis3.5-5.8days,四适应症Indications,该项是药品说明书的重点,常用标题:Indications适应症;IndicationsandUsage适应症与用途;MajorPrincipalIndications主要适应症;Uses用途;ActionandUse作用与用途。,1结构特点一般来说,该项仅列出疾病名称,或用短语表示该药能治疗的疾病。较详细的说明书亦用完整的句子表述该药能治疗什么病,及对哪些细菌和微生物有效或无效。由于疾病和细菌、病毒名称太多,请查阅英汉医学词汇等工具书。,2常用词语,疾病名称是适应症部分最常见的词汇还涉及到微生物(尤其是各种致病菌)方面的词汇。例如:(1)名词和名词短语:bacteria细菌;germs病菌;microbes,microorganisms微生物;aerobes需氧菌;anaerobes厌氧菌;Gram-Positivebacteria革兰阳性菌;gram-negativebacteria革兰阴性菌;staphylococcus葡萄球菌:staph.Aureus金黄色葡萄球菌;,streptococcus链球菌;faecalis粪链球菌;Escherichiacoil大肠杆菌Pseudomonasaeruginosa绿脓杆菌;Klebsiellapneumoniae肺炎杆菌;Diplococcuspneumoniae肺炎双球菌;Cryptococcus隐球菌;virus病毒。,(2)形容词及词组:acid-fast耐酸的;resistantto耐受;susceptibleto对敏感的;beactiveagainst,beeffectiveinforagainst对有效;have(has)actionagainst对有作用;beusedto,beusedin/for,beemployedto用于;beofvalueof,beintendedto,beindicatedinfor适用于;forinthetreatmentof.用于治疗;forinthemanagementof.用于控制.,表示与“其他药物合用”的结构有:,beassociatedwithinassociationwithbecombinedwithincombinationwithbecompatiblewithinconjunctionwithconcomitantwithtogetherwith,常见句型,1.不完全句结构仅列出疾病或微生物的名称例如:例1Anginapectoris,hypertension.心绞痛,高血压。2.由For(或In等)引出的短语,例如:例2Inthetreatmentofallformsofpulmonarytuberculosisinassociationwithotherantituberculardrugs.与其他抗结核药配伍,治疗各种类型肺结核。,3.To+动词原形构成的短语,如:例3Toprotectthelivercellduringadministrationofdrugshazardoustotheliver在服用对肝脏有危害的药物期间,用以保护肝细胞。4.完整的句子结构或段落,有时结构很复杂;例4Nebcinisindicatedforthetreatmentofthefollowinginfectionscausedbysusceptiblemicroorganisms.乃柏欣适用于治疗下列由敏感细菌引起的感染:,Example(1)Cedilanidisusedforthetreatmentofallformsofheartfailureandcardiacarrythmia.西地兰可用于治疗各类心力衰竭和心率不齐(2)Hyminalisalsousedforthetreatmentofinsomniaduetoorganicdisorder.海米那也可用于由器质性疾病引起的失眠症。(3)Thetabletsareeffectiveforthepreventionofanginalattack.本片剂对预防心绞痛发作有疗效(4)ClinicallyPersantinhasprovedeffectiveinthetreatmentofcoronarydiseaseandheartcondition临床证明“潘生丁”治疗冠心病和心脏病有效。(5)Thedrugiseffectiveagainstvariouskindsofbacteriaresistanttootherdrugs.本药对于抗其他药物的各种细菌有效。,(6)Kanamyciniseffectivebothinvitroandinvivoagainstgram-positiveandgram-negativebacteriaaswellasacid-fastbacteria.卡那霉素在体内外对革兰氏阳性和革兰氏阴性菌以及耐酸菌均有效。(7)Thisantibioticshasstrongantibacterialactionagainstgram-positiveandgram-negativebacteria.本抗菌素对革兰氏阳性和革兰氏阴性菌有强的抗菌作用。(8)Vionactanehasaspecifictuberculostaticactionagainsttuberclebacilli.“紫霉素”对结核杆菌具有特殊的抑菌作用。(9)Possess;manifests;showactionagainstdisplays;exerts.,五禁忌症Contraindications,本部分最常用的标题是Contraindications,也可用RestrictionsonUse(用药限制)在RestrictionsonUse下面常列小标题,如:Contraindications(禁忌症);PrecautionsNote(注意事项);Warnings(警告)等。,1结构特点本部分段落较短,句子结构一般不复杂,常用省略句和祈使句。Example1:Contraindications禁忌症TheuseofKirinSterilePowderiscontraindicatedinpatientspreviouslyfoundhypersensitivetoit(对本品过敏者禁用),常用的结构有:,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.常用词语及句式:,(1)禁用或慎用药物的疾病。例如:Cardiacfailure心力衰竭;Cardiacinsufficiency心功能不全;renalinsufficiency肾功能不全;impairmentofthekidney,impairmentofrenalfuncion肾功能损伤;insufficiencyoftheliver肝功能不全;liverhepaticdamage肝损伤;functionaldisorderofliver肝功能(异常)障碍;hypertension高血压;severehypotension重度低血压;severeanemia重度贫血;Diabetes糖尿病.,(2)禁用或慎用药物的人群、病人和情况,例如:pregnantwomen孕妇;Pregnancy孕期,妊娠期;thefirst/lasttrimester/3monthsofpregnancy妊娠期的最初后3个月;Lactation哺乳期;childrenunderyearsofage,岁以下儿童;patientwith/who患者;breastfeeding哺乳(的);Hypersensitivity过敏(性);Allergic过敏的;Anaphylactic过敏的.,(3)常用句式,allergic/hypertensive/anaphylacticto对过敏hypersensitivitytest过敏实验;Contraindicationsare禁忌症是becontraindicatedin/for对禁忌,禁用于shouldnotbeused/employedin不得用于Itisadvisabletoavoidtheuseof建议不用于mustnotbeadministered/givento不得用于shouldbeusedwithcaution应慎用benotrecommendedfor最好不用于,常见句型,1)省略句型,只列出禁忌对象或疾病名称等。例1.Hypersensitivitytoquinoiones,severerenalinsufficiency.对喹喏酮类过敏,严重肾功能不全。2)完整的句子或段落例2.Cetazolinsodiumiscontraindicatedinpatientswithknownhypersensitivitytocephalosporingroupofantibiotics.先锋5号禁用于已知对头孢菌素类抗生素过敏的患者。,六用法与剂量,应特别注意该部分中各种剂量单位的表示法、成人、儿童和孕妇的剂量差别、服药时间以及剂量用法。常用的标题有:DosageandAdministration剂量与用法;ApplicationandDosage用法与用量;Administration用法;DirectionforUse用法;methodofAdministration用法;Howtouse用法;RouteofAdministration给药途径;Dosage剂量,用量;Dosology剂量学。,1结构特点,用法与剂量是药品说明书不可缺少的内容,但祥略不一。应特别注意本项中关于给药对象、给药方式、剂量、剂量单位、给药时间等用词的准确性,尤其是剂量单位,稍不小心,则差之千里。本部分常用祈使句和省略句,句中谓语动词多用被动语态。,Example1.DosageAdults(includingelderlypatients):Theusualdosageis1.63.2gTimentin68hourlyaccordingtobodyweight.Themaximumrecommendeddosageis3.2gevery4hours.,Dosageinrenalimpairment:Mildimpairment(Creatinineclearance30ml/minute):3.2gevery8hours.Moderateimpairment(Creatinineclearancel030ml/minute):l.6gevery8hours.Severeimpairment(Creatinineclearance10ml/minute):l.6gevery12hours,Children:TheusualdosageofTimentinforchildrenis80mg/kgbodyweightgivenevery6-8hours.Forprematureinfantsandfullterminfantsduringtheperinatalperiod,thedosageis80mg/kgbodyweightevery12hours,increasingtoevery8hoursthereafter.Childrenwithrenalimpairment:Aswiththeadultdosage,similarreductionshouldbemadeforchildren.,Example2:DosageandAdministration,Intramuscularadministration:3ampoules(150mg)daily,i.m.in3divideddosesforaperiodupto14days.Intravenousadministration:50to400mgdaily(1to8ampoules)individeddosesforaperiodupto10days,atregulartimeintervals.Incaseofslowintravenousinfusion,Ikelaninjectablesolutionshouldbedissolvedin500mlisotonicsolutionofdextroseorSodiumChloride.Afterdilution,itmustbeadministeredwithin4hours.,Oraladministration:Themeandailydoseis300to600mgdailyintwodivideddoses.Dosageadjustmentisnotrequiredinpatientswithrenalfailureorillpatientsunderhemodialysis.Ikelandropsdonotcontainsugar,thusitcanbeadministeredtodiabeticpatients.,2.常用词语,(1)表示剂量averagemaintenancedose平均维持剂量minimalminimumdose最小剂量;dailydosage日剂量;multipledoses多剂量;divideddoses分次剂量;overaldose/overdosage过量;fatal/lethaldose致死量;singledose一次剂量;,individualdose单次剂量;indicateddose有效剂量;standarddose标准剂量initialstarting/beginningdose首次剂量;suggested/recommendeddose推荐剂量;therapeuticdose治疗剂量;maximumdosage最大剂量;usualnormaldose常用普通剂量;totaldose总剂量,(2)表示剂量单位g=gram克;mg=milligram毫克;kg=kilogram千克;mcg=microgram微克;g微克;L=literlitre升;ml=milliliter毫升;IU=internationalunit国际单位,(3)表示给药次数,dailyperdayadayeveryday每日;atintervalsof每隔;every.hours每隔小时;once(twice)aday每日一(二)次;threetimesaday每日三次;everyotherday隔日;everytwo(three)days每隔2(3)日;once(twice)aweek每周1(2)次;threetimesaweek每周三次;dividedintodose分次(服用给药);intwoorthreedivideddoses分二或三次服用.,(4)表示给药对象newbornbabies新生儿;Baby婴儿;Infants幼儿;Adolescents青少年;Children儿童;debilitatedpatients体弱患者;elderlypatients老年患者;senilepatients老年病人,(5)表示给药方式副词:intra-arterially动脉内给药;intravenously静注;Intragluteally臀肌内给药;intrasmuscularly肌注;intraperitoneally腹(膜)腔内给药;intrapleurally胸(膜)腔内给药;Intrathecally鞘内给药;,Locally局部给药;Topically局部外敷;orally口服;parenterally肠道外给药;subconjunctivally结膜下给药;Subcutaneously皮下给药;Sublingually舌下给药;Submucously粘膜下给药,介词短语:byaerosol喷雾给药;bydripphleboclysis点滴静脉输液;byenema灌肠;bylumbar腰椎给药;byphleboclysis静脉输液;byintramuscularinjection(i.m.)肌肉注射;byintravenousinjection(i.v.)静脉注射;byintra-articularadministration关节内给药;bytheintramuscularadministration(route)肌内给药;,bytheintranasalroute鼻内给药;bytheIntraperitonealadministration腹(膜)腔内给药;bytheintravenousinfusion(perfusion)静脉输液;bytheintrathecaladministration鞘内给药;bythesublingualadministration舌下给药;peros(bymouth)经口;perrectum直肠给药;perrecto直肠给药;perviginum阴道给药,动词:Take服用,inhale(beinhaled)吸人;applyto涂于,敷于;spray喷雾;Swallow吞服;Administer给药,投药;give给药;use用药;employ用药;recommendsuggest推荐给药;Suggest推荐给药,常用句型:,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2Thesuggesteddoseis10to15mgperkgbodyweightdailyin3-4divideddosesorally,takenwithmeals.日剂量最好每公斤体重10-15mg,分3-4次口服,与食物共服。,例3Inseverechroniccases,treatmentisstartedwithdaily1to2ampoulesofBilocidandcontinuedwithoneampouleeveryotherday,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。例4therecommendedsingledoseis1ampoule,givensubcutaneously,intramuscularlyorintravenously.建议一次剂量为1安瓶,皮下、肌肉或静脉注射给药。,七不良反应与副作用,本项主要指明药品的副作用、毒性作用、耐受、过敏反应及停药等。常用的标题有:AdverseReaction(s),UnwantedUntowardReaction(s)不良反应;Sideeffect(s),UnwantedUndesirableeffects,SideReaction(s),By-Effects;After-Effects,1.结构特点,句子结构一般不复杂,常用短语或省略句,有时也用陈述句。Example1AdversereactionsFLUIDANDELECTROLYTEDISTURBANCESodiumretention,congestiveheartfailureinsusceptiblepatients,hypertension,fluidretention;potassiumlossandhypokalemicalkalosis(低钾血症性碱中毒),MUSCULOSKELETALSodiummyopathy,muscleweakness,osteoporosis,pathologicfracture,vertebralcompressionfracturesandasepticnecrosis,GASTROINTESTINALPepticulcerationwithpossibleperforationandhemorrhage,gastrichemorrhage,pancreatitis,esophagitisandperforationofthebowel.,Example2SideeffectsSide-effectsareuncommonandtypicalofotherinjectablepenicillins副作用:该药副作用不常见,与其它注射青霉素类有相似的副作用,2.常用词语,(1)不良反应、副作用所导致的症状和体征allergichypersensitiveanaphylacticreaction(s)过敏反应;allergy/hypersensitivity过敏;dizziness眩晕;localreaction(s)局部反应;systematicreaction全身反应;toxicityreaction毒性反应;doubleinfections双重感染;flush潮红;nausea恶心;vomiting呕吐;anorexia厌食skinreaction皮肤反应;pruritus瘙痒;rash皮疹;lethargy嗜睡;spasm痉挛;coma昏迷;tiredness疲倦;diarrhea腹泻;lossofappetite食欲减退;thirst口渴;restlessness不安;dyspepsia消化不良;,1.“不良反应”的常用的英语表示法有:AdverseReaction(s)不良反应Unwanted(Untoward)Reaction(s)不良反应2.“副作用”的常用的英语表示法有:Side-effect(s)副作用SideReaction(s)副作用Unwanted(Undesirable)Effects副作用By-effects副作用,(2)表示停药的词语abandon停(药);cessationstop停药,停止治疗;discontinuediscontinuance,discontinuation停药,中断治疗;suspend暂停(用药);withdraw停药,撤药;terminate停(药),(3)其它常见词汇tolerance耐受;tolerability耐受性;(ir)reversible(不)可逆的;temporary暂时性的;transient一过性的,短暂的;spontaneously自行(性)地。,常用句型:,例1Ciprofloxactinisgenerallywelltolerated.Themostfrequentlyreportedadversereactionsare:nausea,diarrhea,vomiting,abdominalpain,headache,restlessness,rashanddizziness.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、腹痛、头痛、不安、皮疹、头晕。例2Whenadversereactionsoccur,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3Themostseriousside-effectisdamagetothebonemarrow.Becauseofthis,thewhitebloodcellcountshouldbecontrolledoftenenoughduringthetreatment.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。例4Theseunwantedeffectsusuallydisappearspontaneouslyafter7-14daysorfollowingatemporaryreductioninthedosage.这些副作用通常在7-14日之后,或者暂时降低剂量便自行消失。,八注意事项,该部分也是说明书的重要内容之一,主要强调用药应注意的事项,以免引起副作用。如:药物单独和合并使用的注意事项及其主要缺点;药物配伍、给药及保存的注意事项等。常见标题有:Precautions注意事项;Caution注意事项;Specialnotes/CautionPrecaution特别注意;Note注意;Warnings警告;重要事项Importantforthepatient(s)患者须知。,1.结构特点该项内容常涉及许多专业词汇及缩写词,其中一些词汇、结构和句型也用于药理作用、适应症、禁忌症、剂量和用法、副作用等项,句型变化多,多用长句和难句,结构比较复杂,常用句型:,例1Ciprofloxacincouldresultinimpairmentofthepatientsabilitytodriveoroperatemachinery,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2Dosageshouldbecontrolledbyperiodicdeterminationsofprothrombintime(PT)orothersuitablecoagulationtests.必须定期检查凝血酶原时间(PT),或做其他相应的凝血试验来控制剂量。,常用句型:,Ursofalkcapsulesmustbeusedundermedicalsupervision.Ursofalk胶囊必须在医生指导下用药OsyContainTabletsareNOTintendedforuseasaprnanalgesic.OxyContain片不用于短暂的(临时的)疼痛,2.常用句式shouldbeusedwithcautionin应慎用.couldresultin.可能导致.shouldbeadministeredunderthesupervisionofthedoctor/physician.应遵医嘱用药Themostseriousriskassociatedwith.is.使用最严重的危险是.therapyshouldbediscontinuedwhen.当时,应终止治疗Dosageshouldbecontrolledby.应通过来控制剂量Cautionmustbeexercisedinthecaseofhypersensitivityto.对过敏时须慎用Cautionshouldbeexercisedintheadministrationof.用应谨慎,.shou1dbekeptoutofthereachofchildren.勿使儿童接近Aclosewatchiskepton.要密切注意Caremustbetakenof(ortodo.).对(或做)须谨慎Attentionshouldbepaidto.应注意Cautioniscalledfor.对须谨慎Itissuggested/recommendedthat.最好Itisimportant/essential/imperativethat.重要(必要)的是,九包装,该部分的常用标题为Pack,Package和Supply。下列标题亦经常使用:Packing(s)包装;HowSupplied包装方式;MethodofSupply包装方式;Packingforhospital医院用包装;Hospitalpacks医院用包装;Packaging包装;presentation包装;availability包装;Mode/FormofIssue包装;packagequality包装量;tradepackspackagings商品包装;Dispensing包装,1.结构特点该部分内容比较简单,常用祈使句和省略句,有时仅列出包装方式、容器及包装量。2.Example:Packaging500mglyophilisatevials:5via1s+5solventampoules(forintramuscularandintravenoususe).500mgentericcoatedtablets:10tablets.,常用句型:,例1PackingBottleof12capsules250mgand500mgBoxof12capsules250mginblister.Bottleforpediatricuse(granulated):20gramgranulatedcontain1gramampicillin,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:每瓶20克颗粒剂含有1g氨苄青霉素。附在包装内的一匙的量,相当于100mg氨苄青霉素。,例2Packages:Boxcontainingone100mgbottle包装:盒装,每盒1瓶,每瓶100mg。例3Temaril250:white,film-coatedtabletsmarkedononesidewith250,eachtabletcontaining291.5mgciprofloxacinhydrochloridemonohydrate(equivalent250mgciprofloxacin).替马利尔250:白色的薄膜片,一面刻有“250mg”字样、每片含291.5mg盐酸环丙沙星-水合物(相当于250mg环丙沙星)。,贮存(Storage),常用的一些短语有:store(keep)inacoolanddryplace存于于阴凉干燥处awayfromlight避光awayfromchildren勿让儿童接触protectfromlight(heat)避光(热)outof(the)reachofchildren勿让儿童触及preventmoisture防潮,常用句型:,例1storemedicinescarefully.Keepawayfromchildren.注意保存勿让儿童接触。例2Storebelow25protectingfromfreezingandlight.存于25以下,防冻,避光。例3Storeatcontrolledroomtemperature(15一30).Dispenseinairtight,light-resistantcontainer避光保存。药片在使用前于纸盒中保存。在恒温室温(15一30)下保存。调剂时,使用密闭,避光容器。,例4Ampoulesandunopenednasalspraybottlesshouldbestoredinarefrigerator(2-8).Onceopenedthenasalspraybottlemustbekeptatroomtemperature;itshouldbekeptintheuprightpositionandusedforamaximumof4weeks.Likealldrugs,Miacalcicshouldbekeptoutofreachofchildren.安瓿或未开启的喷雾剂瓶应存于冰箱(2-8)中。喷雾剂瓶一旦开启。就应于室温下保存、药瓶应直立存放,使用时间最多为4周。与其他药物一样,密钙息应妥善保存,勿让儿童接触。,第十一节其他项目,1、特点(Characteristics)2、性质(Properties)3、药代动力学(Phamacokinetics)4、用药过量(Overdosage)5、相互作用(Interactions)6、有效期(Validity)7、其他可能出现的项目。,1、特点(Characteristics),主要内容是药物的药理作用特点、疗效、剂量及药物代谢等。所以本项内的英语词汇及结构特点与“药理学”、“剂量”等项内容相似。例句:Characteristics:1)Asverinisanentirelynewandpatentedcoughmedicine.2)Asverinbeinganon-narcotic,canbeusedasacommonmedicine.3)AntitussiveeffectofAsverinisequaltoormorepowerfulthanthatofcodeine.4)Asverinisprovidedwithanexpectorantingactionwhichhasbeenneverfoundinanyconventionalantitussitiveagentssofaravailableinthemarket.5)Asverincanbeadministeredsafelyforalongdurationwithoutanyside-effect.,2、性质(Properties),本项内容与Characteristics基本相同。例Methotrexate(MTX)isanantimetaboliteoffolicacidwhichhasbeenusedforalongtimeinthechemotherapyoftumours.氨甲叶酸(简称MTX)为甲酰四氢叶酸的抗代谢物,长期以来一直用作治疗肿瘤的化疗药物。,3、药代动力学(Phamacokinetics),内容主要是代谢(metabolism),吸收(absorption),分布与排泄(distributionandelimination)等例Ampicillinisstableinthepresenceofgastricacidandiswellabsorbedfromthegastrointestinaltract.Itsabsorption,however,isdiminishedwhenitistakentogetherwithfood氨苄青霉素在胃酸中稳定而且易被胃肠道吸收然而与食物共服,其吸收减少。,例TheabsolutebioavailabilityofMiacalicfollowingintramuscularorsubcutaneousinjectionisapproximate
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