英文藥品說明書ppt課件

.,英文藥品說明書PackageInsert,.,.,美國FDA規(guī)定其應包括十項：1.Drugnames（藥物名稱）2.Description（性狀）3.Clinicalpharmacology（臨床藥理學）4.Indicationsandusage（適應癥和用法）5.Contraindications（禁忌癥）,FDA英文藥品說明書規(guī)定項目,藥品說明書舊稱description,instruction,direction.今稱packageinsert，insert,.,6.Precautions（注意事項）7.Warnings（警告）8.Adversereactions（不良反應）9.Overdosage（用藥過量）10.Dosageandadministration（劑量和用法）,.,Druginteractions（藥物相互作用）Storageanddurationofefficacy（貯藏與失效期）Package（包裝）References（參考文獻）Manufacturer（生產者）,其他項目：,.,1.通常每種藥物有三個名字(1)proprietaryname（商品名稱）(2)popularname（通用名）(3)chemicalname（化學名）,一、drugnames(藥物名稱),.,2.說明書標題多用商品名其右上角標有R者，表示registeredtrademark（注冊商標）,例如：舒喘靈SalbutamolVentolin2-t-butylamino-l-(-4-hydroxy-3-hydroxymethyl)-phenylethanol,.,1音譯：藥品英文名稱音節(jié)較少，而化學結構復雜的盡量使用音譯。如：Atropine;coffeine;cortisone;quinine;amicacin,英語藥名漢譯常用譯法,2意譯：1）英文名中顯示了化學基團，對應譯名又比較簡短通順的，采用化學基團簡縮命名。如：Imidazate;cholicacid;tetracycline;tribromidi;,2)藥品英文名稱中含某種物質，用意譯能比較簡短明確而含義對應的就采用意譯。如：Ketoconazole;,.,3音、意合譯：藥品英文名稱中只有一部分顯示化學基團者采用音意合譯。如：medemycin;Indobufen;coumadin(coumarrin香豆素);codeinphosphas;,4中文譯名的轉化現(xiàn)象：vitamin;penicillin;hormone;atropine,.,1）藥物與酸形成的鹽中文名是酸在前藥名在后，英文相反。,翻譯藥名名稱注意：,2）藥物與堿金屬形成的鹽中文藥名在前而堿金屬在后，英文相同,3）考慮化學名稱重點字頭，又考慮同類藥名的名稱的系列化（即相同的詞頭、詞干或詞尾）如：CeforanideceforxadinecefotazidimeCefotetanPefloxacinNorfloxacinOfloxacin,4）記住一些藥品英文名稱的常用詞首和詞尾,.,常用description,introduction,composition包括藥品的：chemicalstructure（化學結構）chemicalcomposition（化學成分）physicalandchemicalproperties（物理和化學性質）,二、description（性狀）,.,顏色(Color);味道(Taste);氣味(Smell);溶解度(Solubility);成分(Composition);主要成分(ChiefComposition);分子式(Formula);分子量(MolecularWeight)性質(Property)等。,1.物理和化學性質,.,1）表示組成、制備的詞及短語：bederivedfrom由衍生consistof由組成beobtained制得contain含有bepreparedfrom由制備have(possess)有（具有）,2.本項中常用的詞語,.,colo(u)r顏色;colo(u)rless無色的；odo(u)rless無臭的；odo(u)r氣味；taste味道；tasteless無味的；,2）表示性質的一些詞類：,molecularformular分子式molecularweight分子量structure結構；derivative衍生物；,crystalline結晶的；powder粉末；liquid液體；solid固體；soluble可溶的;insoluble不溶的;solubility溶解度stable穩(wěn)定的；,solution溶液;tablets片劑;injection注射劑sterile無菌的；,.,例2Intralipids10%isawhiteopaquefatemulsionforintravenousinjection,containing10W/V%ofpurifiedsoybeanoil.脂肪乳劑（10%）是白色，不透明，供靜脈注射用的脂肪乳劑，含有10%（W/V）的精制大豆油。,例1Folicacidisayellowishtoorange,crystallinepowder;odourlessoralmostodourless.葉酸是淡黃色至橙色結晶粉末，無臭或幾乎無臭。,.,例3UrsosanTablet50mgisawhiteplaintabletwhichcontains50mgofursodesoxycholicacid.熊去氧膽酸片為白色素片，每片含50mg熊去氧膽酸。,例4Sterilepyrogen-free,orangered,freeze-driedpowderinvialscontaining10mgand50mgofdoxorubicinhydrochloridewithlactose.（本品）為小瓶裝，滅菌無熱原，桔紅色凍干粉沫，每小瓶含有10mg或50mg阿霉素鹽酸鹽與乳糖。,.,例5Itoccursasawhitetooff-white,crystallinesolid,poorlysolubleinwater,diluteacidandmostorganicsolvents.本品（炎痛息康）為白色至類白色結晶固體，難溶于水、稀酸及大多數(shù)有機溶劑中。,例6Pamine,chemicallyknownasepoxytropinetropatemethylbromide,hastheempiricalformulaC18H24NO4Brandthemolecularweight398.3.哌明的化學名稱為環(huán)氧莨菪堿托品酸酯溴代甲烷，分子式為C18H24NO4Br，分子量為398.3。,.,例7Kanendomycinisaverystableantibiotic,anditsactivitydoesnotdecreasewhenthepowderisplacedinanairlightcontainerandkeptatroomtemperaturesformorethan2years.卡內多霉素是一種很穩(wěn)定的抗生素，其粉末置于密封容器中，在室溫下保存二年以上，活性不減。,例8Thisproductispreparedfromunitsofhumanplasmawhichhavebeentestedandfoundnonreactiveforhepatitisassociated(Australia)antigen.本品由人血漿制備，此血漿業(yè)經檢驗，并且證明對肝炎（澳大利亞）抗原無反應。,.,常用的名稱還有：clinicaldata（臨床數(shù)據(jù)）;clinicalexperience（臨床經驗）;clinicaluse（臨床應用）;clinicalobservation（臨床觀察）,三、clinicalpharmacology（臨床藥理學）,.,主要記載藥物的藥理作用和臨床療效等。本項涉及微生物學、生物化學、生理學、藥理學、毒理學等專業(yè)詞匯多。閱讀時可參閱英漢醫(yī)學詞匯及英漢化學化工詞匯等工具書。,.,clinicaleffect（臨床療效）;clinicaldiscussion（臨床討論）;modeofmechanismofaction（臨床機理及途徑）;pharmacologicalactions（藥理作用）;therapeuticalactions（治療作用）;bacteriology（細菌學）;microbiology（微生物學）、physiology（生理學）;toxicology（毒理學）,.,1.動詞absorb吸收；act作用；accumulate積蓄；administrate投藥；cause(becauseby)引起（由引起）demonstrate顯示；exhibit顯示；excrete排泄；exert(actionon)起作用indicate表明；inhibit抑制；maintain維持；metabolize代謝；produce產生；protect(from)保護（不變）；promote促進；prevent阻止，預防；reach達到；resultin導致；show顯示，表明；treat治療；tolerate耐受,常用詞及短語舉例,.,2.形容詞(be)active(effective)against對有效的(be)relatedto與有關的(be)sensitiveto對敏感的resistantto有耐藥性的average平均的minimum最低（?。┑膍aximum最高（大）的normal正常的,.,3、名詞ability能力；activity活性；action作用；effecton對的作用；distribution分布；excretion排泄；clearance廓清率；function功能，作用；halflife半衰期；kidney腎；mechanism機理；tolerance耐受性；infection感染invitro體外；invivo體內；level水平，濃度；plasmlever血漿濃度（水平）；serumconcentration血清濃度toxicity毒性；,.,例1.Meanpeekserumconcentrationsoftobramycinoccurbetween30andabout60minutesafterintramuscularadministration.肌注后約3050分鐘之間妥布毒素的平均血藥濃度達到高峰。,常見句型舉例,例2.NembutalSodiumexertsadepressantactionontheCNSandsharesthesedative-hypnoticactionstypicalofthebarbiturates.戊巴比妥鈉對中樞神經系統(tǒng)產生抑制作用，并顯示戊巴比妥類特有的鎮(zhèn)靜催眠作用。,.,例3.Inclinicaltrialsthedrugwasshowntobehighlyeffectinveinimprovingandnormalizingthealteratedcerebralcirculationandthosedisordersrelatedtoinsufficientarterialflowinthelimbs.臨床試驗證實，本品療效高，可改善已改變了的腦循環(huán)，使之恢復正常，治療與四肢動脈血流不暢有關的疾病,例4.Fenarolhasprovedtobeeffectiveasastriatedmusclerelaxant.已證明芬那露是療效很好的橫紋肌松施藥。,.,例5.Halcionisapotentshort-actinghypnoticagent,whichproducesitshypnoticactivityfromthefirstnightofadministration.好而睡是一種強力速效催眠藥，它從服藥后的第一個夜晚開始產生催眠作用。,例6.Therapeutically,ATPinjectionexhibitseffects,especiallysuchasactivationofthefunctionandmetabolismofthenerve,andalsocoronaryandperipheralvasodilationtoincreasethebloodstream.從治療上看，三磷酸腺苷注射劑顯示了非常好的效果，特別是在活化神經的功能及代謝，以及舒張冠狀與外周血管以增加血流方面更是如此。,.,常用標題：indications,majorindications,clinicalindications,principalindications,condications,uses,treatment,四、Indicationsandusage（適應癥和用法）,.,Arthro-關節(jié)Broncho-支氣管Cardio-心臟Gastro-胃Nephro腎臟Pheumono-肺Hepato-肝-algia痛-rrhagia出血-itis炎癥-osis病態(tài)-oma腫瘤,積累和熟記一些病名的構詞法，在沒有工具書時，可解決不少問題。,1病名的構成法及有關問題,常見病名構詞：病名=器官名+癥候名,.,Infra-上部Infra-axillarySub-下方sub-cutaneousPeri-周圍Periarticularcricum-經過circumorbitalDia-DiarrheaPer-percolate-Supra-super-SuprarenalsupercerebralAnti-抗、逆Antibioticcontra-contraindicationMulti-MulticellularPoly多數(shù)polyuriaMacro-巨大Macrocytosismegalo-megaloscope,英文同義詞,詞義例詞,.,英文反義詞詞義例詞Pre-post-前；后anesthetic(麻醉)Brady-tachy-緩慢；迅速pnea（呼吸）Endo-exo-內部；外部crine（分泌）Eu-dys-正常；異常kinesis（運動）Hyper-hypo-高；低tenson（緊張）Infra-supra-下部；上部sterna（胸骨）Macro-micro-巨大；微小cyte（紅細胞）Hemi-holo-半；全hemicrania偏頭痛holotonia全身肌肉緊張,英文詞頭反義詞比較,.,五、contraindications（禁忌證）,1.常用標題contraindications,restrictiononuse(限制使用),.,pregnantwomen孕婦womenofchildbeatingage育齡婦女lactation,earlyinfancy乳期behypersensitiveto對.過敏者allergicreaction變態(tài)反應heart,cardiac,myocardial心臟，心臟的，心肌的kidney,renal腎，腎臟的liver,hepatic肝，肝臟的insufficiency,impairment機能不全damage,danger,failure損傷，危險，-衰,2.常用詞（組）,.,例1.Pregnacy,allergytomethotrexate,functionaldisordersofliverandkidneys,diseasesofthehaematopoieticsystem(bonemarrowhypoplasia,leucopenia,thrombocy-topenia,anaemia),intectiousdiseases,ulcersoftheoralcavityandthegastrointestinaltract,recentoperationwounds.孕期，對氨甲葉酸過敏，肝、腎功能障礙，血液系統(tǒng)疾病（骨髓機能減退、白細胞及血小板減少、貧血），傳染病，口腔及胃潰瘍，近期術后傷口等忌用。,1)省略句型，只列出禁忌對象或疾病名稱等。,例2.Hypersensitivitytoquinoiones,severerenalinsufficiency.對喹喏酮類過敏，嚴重腎功能不全。,.,contraindicationsare禁忌癥是becontraindicatedin(for)對禁忌shouldnotbeused(employed)in不得用于Itisadvisabletoavoidtheuseof建議不用于mustnotbeadministered(given)to對不得用藥shouldbeusedwithcaution慎用benotrecommendedfor最好不用于nonereported未見報道notknown不清楚,2)完整的句子或段落其中常用的結構有：,.,例3.Cetazolinsodiumiscontraindicatedinpatientswithknownhypersensitivitytocephalosporingroupofantibiotics.先鋒5號禁用于已知對頭孢菌素類抗生素過敏的患者。,例4.ItisadvisabletoavoidtheuseofAraminewithcyclo-propaneorhalothaneanesthesia,unlessclinicalcircumstancesdemandsuchuse.如果不是臨床需要，建議本品不要與環(huán)丙烷或氟溴氯乙烷麻醉劑合用,.,例5.Thisproductiscontraindicatedinthosepatientswhohaveshownhypersensitivitytoitunless,intheopinionofthephysician,theconditionrequiringtreatmentislifethreateningandamenableonlytoamphotencinBtherapy.除非根據(jù)醫(yī)生的意見，認為需要治療的患者的病情危及生命，并且只有兩性霉素治療才可能使其有所改善之外，對本品過敏的患者禁用本品。,例6.Childrenunder5yearsofageshouldnotbetreatedwithAntistine.5歲以下兒童禁用敵胺。例7.TheuseofAlexaninnursingmothersisnotrecommended.哺乳期婦女最好不用愛力生。,.,六、precautions（注意事項）常用標題:cautions,remark,note,notice,attention,awakening,N.B.,七、warnings（警告）常用標題：additionalwarnings(告戒事項),.,例1Warningsandprecautions:CiprofloxacinshouldbeusedwithcautioninepilepticsandpatientswithahistoryofCNSdisordersandonlyifthebenefitsoftreatmentareconsideredtooutweighttheriskofpossibleCNSside-effects.警告和注意事項：癲癇病人及有中樞神經系統(tǒng)病史的患者慎用環(huán)丙沙星，僅當認為療效超過可能產生的中樞神經系統(tǒng)副作用的危險時才可使用。,例2Ciprofloxacincouldresultinimpairmentofthepatientsabilitytodriveoroperatemachinary,particularlyinconjunctionwithalcohol.環(huán)丙沙星能損害人們駕駛汽車或操縱機器的能力，尤其是在飲酒之后。,.,例3.Warnings:Vepesideshouldbeadministeredunderthesupervisionofaqualifiedphysicianexperiencedintheuseofcancerchemotherapeuticagents.警告：泛必治應該在使用治療癌癥的化療制劑方面有經驗、有資格的醫(yī)生的監(jiān)護下使用。,.,1.常用標題：sidereaction（副反應）、untowardreaction（不良反應）、toxicityreaction（毒性反應）、anaphylacticreaction（過敏反應）、sideeffects,by-effects,aftereffects,undesirableeffects（副作用）、doubleinfection（雙重感染）,八、adversereactions（不良反應）,.,Allergic(Hypersensitiveanaphylactic）reactionGastrointestinaltractreaction胃腸道Localreaction,Skinreaction,2.常見的毒副作用的癥狀及體征詞語,Symptom:Anorexia厭食BloodcountBloodpressureComaDiarrheaDizziness眩暈feverflushheadachenausea惡心pruritus瘙癢rash皮疹spasmSystematic全身的tirednessthirstvomiting,.,Dontuse勿使用Shouldntbeinuse不應使用Withdraw停藥Terminate停藥Discontinue中斷用藥Abandon停藥Suspend停藥Stop停止用藥Cessation停藥,3.停藥的表示法,.,AcuteChroniccontroldiminishreducereductionIrreversibleMildNormalRarelyReversibleSeveretemporaryTransientAppearDevelopHappenOccur,4.其他一些常見基本詞匯及短語,.,例1Ciprofloxactinisgenerallywelltolerated.Themostfrequentlyreportedadversereactionsare:nausea,diarrhaea,vomiting,dyspepsia,abdominapain,headache,restlessness,rash,dizzinessandpruritus.環(huán)丙沙星一般耐受良好。最常報道的副作用有：惡心、腹瀉、嘔吐、消化不良、腹痛、頭痛、不安、皮疹、頭暈及瘙癢。,例2Side-effectsarerarewithslow-K,asanyexcesspotassiumisrapidlyexcretedintheurine.施樂凱的副作用根罕見，因為任何過量的鉀都迅速由尿排出。,.,例3Attherecommendeddosageside-effectse.g.venousirritatiionorhypersensitivityreactions(cutaneousandmucousreactions)areonlyobservedinisolatedcases.用推薦劑量治療時，僅見個別的靜脈刺激或過敏反應（皮膚及粘膜反應）病例。,例4Whenadversereactionsoccur,theyareusuallyreversibleanddisappearwhenthehormoneisdiscontinued.當不良反應發(fā)生時，它們往往是可逆的，停用激素后副作用即消失。,例5Themostseriousside-effectisdamagetothebonemarrow.Becauseofthis,thewhitebloodcellcountshouldbecontrolledoftenenoughdruingthetreatment.最嚴重的副作用是骨髓損害，因此在治療期間，要經常監(jiān)測白細胞計數(shù)。,.,常用標題：administrationprocedure,methodforadministration,methodofuse,directionforuse,howtouse,recommendation,reconstitution（用法）posology,dosage（劑量）applicationanddosage,usageanddosage（用法與劑量）clinicalapplication（臨床應用）,九、overdosage（用藥過量）,常用標題：treatmentofoverdosage(用藥過量的治療),十、dosageandadministration（劑量用法）,.,Intramuscularly肌肉注射Intragluteally臀肌注射Intraarterially動脈注射Intravenously靜脈注射Intrathecally鞘內注射Intracerebeospinally腦脊髓腔注射Orally口服Parentarally腸道外給藥Locally局部給藥Subconjunctivally結膜下給藥Sublingually舌下給藥Submucously黏膜下給藥,modeofadministration(給藥方式),.,1給藥對象infants幼兒babies嬰兒senilepatient老年病人pregnantwomen孕婦,2給藥劑量單位I.U.=internationalunitKg,g,mg=milligraml=litreml=milllitreMcg=microgramc.c.=ml,3給藥途徑byos口服orally口服Bytheintramuscularroute肌內給藥Byintramuscularinjection肌注法Byphleboclysis靜脈輸液Perrectum直腸給藥,.,5給藥常用劑量術語Singledose一次劑量Initialdose開始劑量MaximumdailydoseMinimumeffectivedoseAveragemaintenancedose平均維持劑量Intermittentdose間歇劑量Test-dose試驗劑量Overdose過量劑量,4給藥時間表示法Daily;perday;everyday;every8hours;eight-hourly;oncedaily;twicedaily;,.,daily(perday,aday,everyday)每日everyhours每隔小時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分為二或三次（個劑量）,6.每次給藥次數(shù)的表示方法,.,例1Unlessotherwiseprescribedbythephysician,theaveragedailydoseis1capsule3timesdaily.如果醫(yī)生不另開處方，平均日劑量為每日3次、每次1個膠囊。,例2Thesuggesteddoseis10to15mgperkgdodyweightdailyin3-4divideddosesorally,takenwithmeets.日劑量最好每公斤體重10-15mg，分3-4次口服，與食物共服。,例3Theinitialdosagerecommendedis1/2tabletofMadopa250threetimesdaily.開始劑量最好為每日3次，每次半片美多巴250。,.,例4Children:Theusualdoseis50to100mg/kg/daytotal,giveninfourequallydividedandspaceddoses.兒童：常用總劑量為每日50-100mg/kg體重，均分為四等份，等間隔給藥。,例5Therecommendedstartingdoseis20mggivenasasingledailydose.推薦的首劑量為每20mg，一次服用。,.,7.表示“投藥”的常用動詞administer(或beadministered、give、begiven、indicate、beindicated)給藥、投藥use(或beused、employ、beemployed)用藥recommend(berecommended、suggest、besuggested)推薦給藥,8.表示不同的用藥方式的動詞：take服用;inhale吸入;applyto用于、涂于、敷于;spray噴霧;inject注射;swallow吞服,.,例6.therecommendedsingledoseis1ampoule,givensubcutaneously,intramuscularlyorintravenously.建議一次劑量為1安瓶，皮下、肌肉或靜脈注射給藥。,例7.I.Minjectionsshouldbeadministeredintheamountof25-50mgdailyperkiloofbodyweight,subdividedintoinjectionsevery6-8-12hours.肌肉注射：每日每公斤體重給藥25-50mg，每6-8-12小時一次。,例8.Foradultsgiveintramuscularinjectionof400to600mgperdayin2-3divideddoses.Forintantsgiveintramuscularinjectionof10-20mg/kgperdayintwodivideddoses.成年人：肌肉注射，每日400-600mg，分2-3次注射；嬰兒：肌肉注射，每日10-20mg/kg體重，分2次注射。,.,accordingto根據(jù)beadjusted調整dependon依據(jù)adaptto適合，修改onthebasisof在基礎上varyfromto變化范圍由至，因而異rangefromto變化范圍由至itisadvisableto(itisrecommendedto、itissuggestedto)建議,9.其它的短語或句型,.,例12.Dosageshouldbeadaptedtopatientsindividually,onthebasisofperiodictestsofglycosuriaandbloodsugar.在周期性檢驗尿糖和血糖的基礎上，調整劑量，使之適用于不同的患者。,例13.Itsiadvisabletoinitiatetherapywithmassivedoses:3x2tabletsdailyaftermealsover2-4days.建議開始治療時采用大劑量，每日劑量為3x2片，飯后服用，持續(xù)2-4日。,例14.Inseverschroniccases,treatmentisstartedwithdaily1to2ampoulesofBilocidandcontinusedwithoneampouleeveryotherday,injectedslowlybytheintravenousroute.治療嚴重的慢性疾病時，治療從每日1-2支利膽素注射劑開始，繼續(xù)治療時每隔一日1安瓶緩慢靜脈注射。,.,十一、包裝及儲存,PackspackingPackagePackingforhospital,Packingquantities,Hospitalpack,Supply,supplied,Methodofsupply,howsupplyAvailability,Modeofissue,1.包裝在英文說明書中的表示法,本項的結構特點；內容結構簡單，多為不完全句，或僅僅列出包裝工具、劑型、裝量等，詞匯量容易閱讀。,.,AmpouleBlisterpack鋁塑包裝Blisterstrip鋁塑條狀包裝BottleBoxCanist罐Carton紙盒PackSheet張strip條TubeVial玻璃小瓶,2.常見的包裝單位,.,Ae