药品说明书旧称description,instruction,direction今…药品说明书旧称description,instruction,direction.今称insert,package insert美国FDA规定其应包括十项。
一.drug names(药物名称)1.通常每种药物有三个名字(1)proprietary name(商品名称)(2)popular name(俗名)(3)chemical name(化学名)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)二.description(性状)(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)三.clinical pharmacology(临床药理学)常用的还有:clinical data(临床数据)、clinical experience(临床经验)、clinical use(临床应用)、clinical observation(临床观察)、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)四.indications and usage(适应症和用法)常用标题:indications,major indications,clinical indications,principal indications,condications,uses,treatment五.contraindications(禁忌症)1.常用标题contraindications,restriction on use(限制使用)2.常用词(组)pregnant women孕妇women of childbeating age育龄妇女be hypersensitive to 对......过敏者allergic reaction变态反应lactation,early infancy乳期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,衰弱六.precautions(注意事项)常用标题:causions,remark,note,notice,attention,awakening, N.B.七.warnings(警告)常用标题:additional warnings(告戒事项)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)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)1.常用标题:administration procedure,method foradministration,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)2.mode of administration(给药方式)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黏膜下给药现各大药厂的说明书,项目远远超过十项,如:1.animal pharmacology and animal toxicology(动物药理学和动物毒理学)2.absorption and excretion(吸收和排泄)3.tolerance(耐受性)4.drug interactions(药物相互作用)5.storage and duration of efficacy(贮藏与失效期)6.packages(包装)7.advantages(优点)8.references(参考文献)9.further information(补充说明)10.manufacturer(生产者)英文药品说明书的翻译(1)人吃五谷杂粮没有不生病的。
现在的医生都喜欢开进口药。
进口药好些都是简短的中文说明之后便是大段的英文说明。
准确翻译英文药品说明书的关键词和关键句是性命攸关的大事情,它可以帮助患者更好地了解进口药的性能、用法和注意事项。
以下简要介绍英文药品说明书中的一些关键点。
1 药物名称常见的名称有下列几种情况:(1)给出药物商品名,并在括号内给出正名,下附包装形式。
如:Benemicin 利福平(Rifampicin) (利福霉素)Capsules 胶囊(2)给出药名,在右上方用小字标明“药用”,如:For the Medical Profession 药用Dihydrostreptomycin Sulphate B.P 硫酸双氧氢链霉素英国药典(3)不仅给出药物商品名,在右上方标明“药用”,还给出正名:For the Medical Profession 药用Aerosporin Brand 嗜气芽胞菌素商标Polymyxin B sulphate 硫酸多粘菌素(4)给出药名,说明类别及用法,有时并附另名:Kanendomycin 卡南多霉素A new broad-spectrum antibiotic 新广谱抗生素For injection 注射用Fungizone Intravenous 丰吉中静脉内用Amphotericin B For Injection U.S.P 二性霉素B注射用美国药典2 药物成分介绍此项常用标题为Composition(成份),Introduction(介绍)或Description(说明)。
有的开门见山就介绍药物的potency(疗效)或Pharmacology(药理学),有的则详细介绍Physical and chemical properties(物理和化学性质),有的标题则仅列出properties(性能)。
本项常用句型有:It is active against... 本品对......有效It is relatively insensitive to... 本品对......不太敏感It is (an antifungal antibiotic) derived from...本品系衍生于......的(抗真菌抗菌素)3 适应症此项常用标题为Indication(适应症),或者Indications and Posology(适应症和剂量)。
常用句型是:It is (a radiopaque) used chiefly in (bronchography). 本品(不透X线)主要用于(支气管造影)。
It is used in the treatment of... 本品适用于治疗......In therapeutic doses (hydergine) exerts an effect on...使用治疗剂量时,(氢化麦角碱)对治疗......有效(Pseudomonas organisms) are resistant to...(假单胞菌)对......有抗药性4 用法指示此项常见的标题有:Administration(用法),Dosage(剂量),Application and Dosage(用法和剂量),General dosage and administration(一般剂量和用法)。
有的则用Administration and Dosage(用法和剂量)或Administration under medical advice (按医嘱用药)。
在此项下,有的说明书更进一步细分为Standard dosage(标准剂量)和High dosage(大剂量)。
本项常用句型有:For intramuscular use, (Pyopen) should be given every 6 hours. 肌肉内注射用药,(羧苄青霉素)应六小时用药一次。
病)时,成人剂量为每日每公斤体重0.05毫克-0.10毫克。
2 to 4 gm for adults and 40-80 mg/1kg body weight for children in 2 to 4 divided doeses by intramuscular, intravenous injection or intravenous drip infusion.成人每日2-4克,儿童每日每公斤体重40至80毫克,分2-4次用,肌肉或静脉注射或静脉点滴。
Up to twice a day 1,000 mcg, depending on acuteness of the disease.根据病情的急性程度,剂量可达1,000微克,每日两次。
As a rule, oral medication is sufficient, 1 or 2 tablets beinggiven 3 times daily preferably after meals. In severe cases, Regitine should be administered parenterally, i.e. 10 mg. i.m., possibly i.v., once or twice daily. 通常口服即可,每日三次,一次一至两片,最好饭后服用。