英文药品说明书.ppt

英文药品说明书Package Insert,美国FDA规定其应包括十项：1.Drug names（药物名称）2.Description（性状）3.Clinical pharmacology（临床药理学）4.Indications and usage（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package insert，insert,6.Precautions（注意事项）7.Warnings（警告）8.Adverse reactions（不良反应）9.Overdosage（用药过量）10.Dosage and administration（剂量和用法）,Drug interactions（药物相互作用）Storage and duration of efficacy（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)proprietary name（商品名称）(2)popular name（通用名）(3)chemical name（化学名）,一、drug names(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registered trademark（注册商标）,例如：舒喘灵 Salbutamol Ventolin 2-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;cholic acid;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);codein phosphas;,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：Ceforanide ceforxadine cefotazidime Cefotetan Pefloxacin Norfloxacin Ofloxacin,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：chemical structure（化学结构）chemical composition（化学成分）physical and chemical properties（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(Chief Composition);分子式(Formula);分子量(Molecular Weight)性质(Property)等。,1.物理和化学性质,1）表示组成、制备的词及短语：be derived from 由衍生 consist of 由组成 be obtained 制得 contain 含有 be prepared from 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：,molecular formular 分子式 molecular weight 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2Intralipids 10%is a white opaque fat emulsion for intravenous injection,containing 10 W/V%of purified soybean oil.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1Folic acid is a yellowish to orange,crystalline powder;odourless or almost odourless.叶酸是淡黄色至橙色结晶粉末，无臭或几乎无臭。,例3Ursosan Tablet 50mg is a white plain tablet which contains 50mg of ursodesoxycholic acid.熊去氧胆酸片为白色素片，每片含50mg熊去氧胆酸。,例4Sterile pyrogen-free,orange red,freeze-dried powder in vials containing 10mg and 50mg of doxorubicin hydrochloride with lactose.（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5It occurs as a white to off-white,crystalline solid,poorly soluble in water,dilute acid and most organic solvents.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,chemically known as epoxytropine tropate methylbromide,has the empirical formula C18H24NO4Br and the molecular weight 398.3.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7Kanendomycin is a very stable antibiotic,and its activity does not decrease when the powder is placed in an airlight container and kept at room temperatures for more than 2 years.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8This product is prepared from units of human plasma which have been tested and found nonreactive for hepatitis associated(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：clinical data（临床数据）;clinical experience（临床经验）;clinical use（临床应用）;clinical observation（临床观察）,三、clinical pharmacology（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。,clinical effect（临床疗效）;clinical discussion（临床讨论）;mode of mechanism of action（临床机理及途径）;pharmacological actions（药理作用）;therapeutical actions（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(be cause by)引起（由引起）demonstrate 显示；exhibit 显示；excrete 排泄；exert(action on)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；result in 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)related to 与有关的(be)sensitive to 对敏感的resistant to 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；effect on 对的作用；distribution 分布；excretion 排泄；clearance 廓清率；function 功能，作用；half life 半衰期；kidney 肾；mechanism 机理；tolerance 耐受性；infection 感染in vitro 体外；in vivo 体内；level 水平，浓度；plasm lever 血浆浓度（水平）；serum concentration 血清浓度toxicity 毒性；,例1.Mean peek serum concentrations of tobramycin occur between 30 and about 60 minutes after intramuscular administration.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.Nembutal Sodium exerts a depressant action on the CNS and shares the sedative-hypnotic actions typical of the barbiturates.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.In clinical trials the drug was shown to be highly effectinve in improving and normalizing the alterated cerebral circulation and those disorders related to insufficient arterial flow in the limbs.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.Fenarol has proved to be effective as a striated muscle relaxant.已证明芬那露是疗效很好的横纹肌松施药。,例5.Halcion is a potent short-acting hypnotic agent,which produces its hypnotic activity from the first night of administration.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,ATP injection exhibits effects,especially such as activation of the function and metabolism of the nerve,and also coronary and peripheral vasodilation to increase the blood stream.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,major indications,clinical indications,principal indications,condications,uses,treatment,四、Indications and usage（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-axillary Sub-下 方 sub-cutaneousPeri-周 围 Periarticular cricum-经 过 circumorbitalDia-Diarrhea Per-percolate-Supra-super-Suprarenal supercerebralAnti-抗、逆 Antibiotic contra-contraindicationMulti-MulticellularPoly 多数 polyuriaMacro-巨大 Macrocytosis megalo-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,restriction on use(限制使用),pregnant women孕妇women of childbeating age育龄妇女lactation,early infancy 乳期be hypersensitive to 对.过敏者 allergic reaction 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,allergy to methotrexate,functional disorders of liver and kidneys,diseases of the haematopoietic system(bone marrow hypoplasia,leucopenia,thrombocy-to penia,anaemia),intectious diseases,ulcers of the oral cavity and the gastrointestinal tract,recent operation wounds.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.Hypersensitivity to quinoiones,severerenal insufficiency.对喹喏酮类过敏，严重肾功能不全。,contraindications are 禁忌症是be contraindicated in(for)对禁忌should not be used(employed)in 不得用于It is advisable to avoid the use of 建议不用于must not be administered(given)to 对不得用药should be used with caution 慎用be not recommended for 最好不用于none reported 未见报道not known 不清楚,2)完整的句子或段落 其中常用的结构有：,例3.Cetazolin sodium is contraindicated in patients with known hypersensitivity to cephalosporin group of antibiotics.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.It is advisable to avoid the use of Aramine with cyclo-propane or halothane anesthesia,unless clinical circumstances demand such use.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.This product is contraindicated in those patients who have shown hypersensitivity to it unless,in the opinion of the physician,the condition requiring treatment is life threatening and amenable only to amphotencin B therapy.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.Children under 5 years of age should not be treated with Antistine.5岁以下儿童禁用敌胺。例7.The use of Alexan in nursing mothers is not recommended.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：additional warnings(告戒事项),例1 Warnings and precautions:Ciprofloxacin should be used with caution in epileptics and patients with a history of CNS disordersand only if the benefits of treatment are considered to outweight the risk of possible CNS side-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2 Ciprofloxacin could result in impairment of the patients ability to drive or operate machinary,particularly in conjunction with alcohol.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:Vepeside should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.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：side reaction（副反应）、untoward reaction（不良反应）、toxicity reaction（毒性反应）、anaphylactic reaction（过敏反应）、side effects,by-effects,after effects,undesirable effects（副作用）、double infection（双重感染）,八、adverse reactions（不良反应）,Allergic(Hypersensitive anaphylactic）reactionGastrointestinal tract reaction胃肠道 Local reaction,Skin reaction,2.常见的毒副作用的症状及体征词语,Symptom:Anorexia 厌食 Blood count Blood pressure Coma Diarrhea Dizziness 眩晕 fever flush headache nausea恶心 pruritus 瘙痒 rash 皮疹 spasm Systematic 全身的 tiredness thirst vomiting,Dont use 勿使用 Shouldnt be in use 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,Acute Chronic control diminish reduce reduction Irreversible Mild Normal Rarely Reversible Severetemporary Transient Appear Develop Happen Occur,4.其他一些常见基本词汇及短语,例1 Ciprofloxactin is generally well tolerated.The most frequently reported adverse reactions are:nausea,diarrhaea,vomiting,dyspepsia,abdomina pain,headache,restlessness,rash,dizziness and pruritus.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2 Side-effects are rare with slow-K,as any excess potassium is rapidly excreted in the urine.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3 At the recommended dosage side-effects e.g.venous irritatiion or hypersensitivity reactions(cutaneous and mucous reactions)are only observed in isolated cases.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4 When adverse reactions occur,they are usually reversible and disappear when the hormone is discontinued.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5 The most serious side-effect is damage to the bone marrow.Because of this,the white blood cell count should be controlled often enough druing the treatment.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：administration procedure,method for administration,method of use,direction for use,how to use,recommendation,reconstitution（用法）posology,dosage（剂量）application and dosage,usage and dosage（用法与剂量）clinical application（临床应用）,九、overdosage（用药过量）,常用标题：treatment of overdosage(用药过量的治疗),十、dosage and administration（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,mode of administration(给药方式),1给药对象 infants 幼儿 babies 婴儿 senile patient 老年病人 pregnant women 孕妇,2给药剂量单位 I.U.=international unit Kg,g,mg=milligram l=litre ml=mill litre Mcg=microgram c.c.=ml,3给药途径by os 口服 orally 口服By the intramuscular route 肌内给药 By intramuscular injection 肌注法By phleboclysis 静脉输液 Per rectum 直肠给药,5给药常用剂量术语Single dose 一次剂量 Initial dose 开始剂量Maximum daily dose Minimum effective doseAverage maintenance dose 平均维持剂量 Intermittent dose 间歇剂量Test-dose 试验剂量Overdose过量剂量,4给药时间表示法 Daily;per day;every day;every 8 hours;eight-hourly;once daily;twice daily;,daily(per day,a day,every day)每日every hours 每隔小时intervals of 每隔once(twice)daily(a day)每日一（二）次every other day 每隔一日three times a day(daily)每日三次three times a week 每周三次once(twice)a week(weekly)每周一（二）次divided into doses 分次in two or three divided doses 分为二或三次（个剂量）,6.每次给药次数的表示方法,例1 Unless other wise prescribed by the physician,the average daily dose is 1 capsule 3 times daily.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2 The suggested dose is 10 to 15 mg per kg dody weight daily in 3-4 divided doses orally,taken with meets.日剂量最好每公斤体重10-15mg，分3-4次口服，与食物共服。,例3 The initial dosage recommended is 1/2 tablet of Madopa 250 three times daily.开始剂量最好为每日3次，每次半片美多巴250。,例4 Children:The usual dose is 50 to 100 mg/kg/day total,given in four equally divided and spaced doses.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5 The recommended starting dose is 20mg given as a single daily dose.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be administered、give、be given、indicate、be indicated)给药、投药use(或be used、employ、be employed)用药recommend(be recommended、suggest、be suggested)推荐给药,8.表示不同的用药方式的动词：take 服用;inhale 吸入;apply to 用于、涂于、敷于;spray 喷雾;inject 注射;swallow 吞服,例6.the recommended single dose is 1 ampoule,given subcutaneously,intramuscularly or intravenously.建议一次剂量为1安瓶，皮下、肌肉或静脉注射给药。,例7.I.M injections should be administered in the amount of 25-50mg daily per kilo of body weight,subdivided into injections every 6-8-12 hours.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.For adults give intramuscular injection of 400 to 600 mg per day in 2-3 divided doses.For intants give intramuscular injection of 10-20mg/kg per day in two divided doses.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。,according to 根据 be adjusted 调整 depend on 依据 adapt to 适合，修改 on the basis of 在基础上 vary fromto 变化范围由至，因而异 range from to 变化范围由至 it is advisable to(it is recommended to、it is suggested to)建议,9.其它的短语或句型,例12.Dosage should be adapted to patients individually,on the basis of periodic tests of glycosuria and blood sugar.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.It si advisable to initiate therapy with massive doses:3x2 tablets daily after meals over 2-4 days.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.In severs chronic cases,treatment is started with daily 1 to 2 ampoules of Bilocid and continused with one ampoule every other day,injected slowly by the intravenous route.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,Packs packing Package Packing for hospital,Packing quantities,Hospital pack,Supply,supplied,Method of supply,how supplyAvailability,Mode of issue,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。,AmpouleBlister pack 铝塑包装 Blister strip 铝塑条状包装 Bottle Box Canist 罐 Carton 纸盒 Pack Sheet 张 strip 条 Tube Vial 玻璃小瓶,2.常见的包装单位,Aerosol（spray,inhaler）Ampoule Capsules Cream Dregees糖衣丸 Drops Granule Liniment搽剂 Ointment Oral solution Powder Pill Liquid syrup Solution SuspensionTabletsRetard capsules(tablets)Sustained-release tablets Coated-tablets Sugar-coated tablets Scored-tablets Suppositories derm TTS皮肤贴膏,药物的常见剂型,例1 Presentation 30 capsules.包装：30粒胶囊装。例2 Packages：Box containing one 100 mg bottle包装：盒装，每盒1瓶，每瓶100 mg。,例3 Packing Bottle of 12 capsules 250 mg and 500 mgBox of 12 capsules 250 mg in blister.Bottle for pediatri use(g