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英文药品说明书的写法

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英文药品说明书的写法蓝宙工作室收集英文药品说明书的写法yanzezao整理-1-目录
第一节进口药英文说明书的结构简介
第二节药品名称
第三节性状
第四节药理作用
第五节适应症
第六节禁忌症
第七节用法用量
第八节不良反应
第九节注意事项
第十节包装
第十一节贮存
第十二节其它项目-2-
一、进口药英文说明书的结构简介药品说明书的英文表达方式有现在多用Package Insert或简称Insert,也有用Leaflet或Data Sheets.Insert原意为插入物,插页.药品说明书即为附在每种药品包装盒中的一份用药说明.经过注册的进口药品一般是国家承认的有效药物,其说明书是指导医生与患者合理用药的重要依据,具有一定的法律效力.进口药的英文说明书随药品来源的不同、有以英语为母语的国家,也有以英语为外语的国家.说明书繁简难易不同.短者仅百余词、长者可达上万词.较简单的说明书仅介绍成分,适应症,禁忌症,用法与用量等内容;较详尽的说明书中除上述内容外还包括:药品性状,药理作用,临床药理,临床前动物试验、临床试验、药代动力学,注意事项、不良反应或副作用,用药过量,药物的相互作用,警告,有效期,包装、贮存条件,患者须知及参考文献等诸多项目.为了顺利阅读和正确翻译进口药英文说明书,读者除应具备较好的英语基础、掌握一定的专业知识(如医学,化学,药剂学,药理学,药物代谢动力学等)外,还应熟悉英文药品说明书的结构及语言待点等.
大多数英文说明书都包括以下内容:⑴药品名称(Drug Names),⑵性状(Description),⑶药理作用 Actions),⑷适应症(Indications),⑸禁忌证⑹用量与用法(Dosage ⑺不良反应(Adverse Reactions),⑻注意事项(Precautions),⑼包装(Package),⑽贮存(Storage),⑾其他项目(Others).现将各项专题的表述方法与翻译,结构特点、常用词语及阅读技巧等分述如下.
二、药品名称-3-英文药品说明书中常见的药品名称有商品名(Trade Name或Proprietary Name),通用名(Generic Name)和化学名(Chemical Name),其中最常见的是商品名.例如日本田边有限公司生产的熊去氧胆酸片,其商品名为通用名为 Acid(熊去氧胆酸);化学名为3α,7β-dihydroxy-5β-cholanoic acid(3α,7β-二羟基-5β-胆烷酸).有时同一种药品、不同的厂家使用不同的商品名称.药品说明书中的标题药名用其商品名.有时在其右上角(或在上角)有一R标记,例如ADRIBLASTNAR(阿霉素),TEGRETOL(痛痉宁).R是Register(注册)的缩写,表示该产品已经本国的有关部门核准.取得了此项专用的注册商标(Registered Trade Mark).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)之下列有罗红霉素);Minipress(脉宁平)之后列有盐酸哌唑嗪); Nitro-Dur(护心贴片)之下又列有甘油).药品名称的翻译可采用音译,意译,音意合译及谐音译意等方法.
(1)音译按英文药品名歌的读音译成相同或相近的汉语.如:Tamoxifen 它莫西芬,Ritalin 利他林,Amikacin 阿米卡星.音译较为方便,但不能表意.
(2)意译按药品名称所表达的含意译成相应的汉语.例如:Cholic Acid 胆酸、Tetracyline 四环素;也可按其药理作用翻译,如:Minidiab 灭糖尿(治疗糖尿病药物),Natulan 疗治癌(烷化剂抗肿瘤药),Uraly 消石素(治疗尿路结石药物)等.
(3)音意合译药品名称中的一部分采用音译,另一部分采用意译.例如:Coumadin-4-香豆定(coumarin香豆素),Neo-Octin 新握克丁(neo-新),Medemycin麦迪霉素(-mycin 霉素),Cathinone 卡西酮(-one酮).
(4)谐音译意以音译为原则,选用谐音的汉字,既表音,又表意,音意结合.例
如:Antrenyl 安胃灵,Doriden 多睡丹、Legalon 利肝隆,Webilin 胃必灵.商品名称可以这样翻译,而法定名称则规定不可以这样翻译.药品的化学名称反映出该药品的化学结构组成成分,可借助英汉化学化工词典进行翻译.如果名称很长,可以分解开来,分别查出各个组成部分的名称,组合而成.例如Catalin(卡他林)的化学名称是[3,2-α acid,译成汉语是1-羟基-5-氧-5H-吡啶并[3,2-α-吩恶嗪-3-羧酸.如能掌握一些常用的酸、碱,盐,基团,化合物的英文名称,以及常用的前缀、后缀等、翻译时会顺利得多.例如,chloride 氯化物盐,acetyl- 乙酰基、amino- 氨基、di- 二、dihydro- 二氢,nitro- 硝基-ester酯-lactone 内酯-one 酮-oxide氧化物-urea 脲等等.
为了统一药品名称的译名、卫生部药典委员会已拟定出原料药和辅料命名原则,并刊行了《药名词汇》一书,可供翻译英文药品名称时参考.
三、性状许多药品说明书的第一项是Description(性状),其原意是叙述,描写,在药品说明书及药典中一般都译为性状,其内容主要是介绍外观,理化性质,组成成分,结构,特征等.这一项最常用的标题是Description,此外还可能有其他的表示法,如:Chemical Structure 化学结构Composition 成分Physical and Chemical Properties 理化性质-5-这一项中的英语词汇除一部分化学专业词汇外,多为常用词、借助英汉化学化工词典及英汉词典即可通读.
(1)本项中常见的句型例1. Folic acid isayellowish to orange, crystalline powder, odorless oralmost odorless.叶酸是淡黄色至橙色结晶、无臭或几乎无臭.例2.Intralipos 10% isawhite opaque fat emulsion for containing 10 WV % 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%(WV)的精制大豆油.例3.Ursosan Tablet 50mg isawhite plain tablet, which contains 50mgof acid.熊去氧胆酸片为白色素片,每片含50mg熊去氧胆酸.例4.Sterile pyrogen-free, orange red, freeze-dried powder in 10mg and 50mg of doxorubicin hydrochloride with lactose.
(本品)为小瓶装、灭菌无热原,桔红色冻干、每小瓶含有10mg或50mg阿霉素盐酸盐与乳糖.例5.It occurs asawhite to off-white, crystalline solid, poorly solublein 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6.Pamine, chemically known as epoxytropine tropate the empirical formula C18H24NO4Br and the molecular weight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7.Kanendomycin isavery stable antibiotic, and its activity does notdecrease when the powder is placed in an airtight container and kept at for more than2years.
卡内多霉素是一种很稳定的抗生素,其置于密封容器中、在室温下保存二年以上,活性不减.例8.This product is prepared from units of human plasma, which havebeen tested and found non-reactive for hepatitis associated 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)本项中常用的词语
Ⅰ表示组成,制备的词及短语、如: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)
Ⅱ表示性质的一些词类,如:colo(u)r 颜色stable 稳定的taste 味道molecular formular 分子式odo(u)rless 无臭的molecular weight 分子量crystalline 结晶的structure 结构solubility 溶解度injection 注射剂-7-insoluble 不溶的solution 溶液odo(u)r 气味tablets 片剂colo(u)rless 无色的derivative 衍生物tasteless 无味的liquid 液体sterile 无菌的powder soluble 可溶的solid 固体还有许多其他词汇,不能一一列举.记住这些常用词对阅读本项内容大有益处.
四、药理作用有些说明书较详细地介绍药品的药理作用其内容主要包括药理作用,临床药理(Clinical Pharmacology),体外试验(in vitro experiments),药物代谢(Metabolism),药效(Potency)
及毒性(Toxicity)等.这一项常用的标题是 Action 药理作用 Properties 药理性质Pharmacology 药理学Clinical Pharmacology 临床药理
其他的表示方法还有:Actions 作用Actions and Properties 作用与性质-8-Clinical Effect (Use) 临床效果(用途)Mechanism of Action 作用机理Mode of Action 作用方式
如果药品的一种抗生素,可能出现:Biological Action 生物活性Microbiology 微生物学此外,还有一此其他的表示方法,这里不一一列举.这一项目中涉及的词汇范围包括药理学,生理学,化学,毒理学,微生物学及医学等学科,专业词汇多,是较难阅读的一部分内容、阅读时可参阅《英汉医学词汇》,《英汉微生物学词汇》及《英汉化学化工词汇》等工具书.另外,还会遇到许多缩写词、如:CNS(中枢神经系统),EEG(脑电图),LD50(半数致死剂量),ECG(心电图)等、这些缩写词可在英汉医学缩略语词典中查到.
(1)常见句型举例例1. Mean peek serum concentrations of tobramycin occur between 30and about 60 minutes after intramuscular
肌注后约30~50分钟之间妥布毒素的平均血药浓度达到高峰.例2. Nembutal Sodium action on the CNS andshares the 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 effective inimproving and normalizing the alternated cerebral circulation and thosedisorders 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. Orbenin is stable to staphylococcal penicillinase, and against resistant staphylococci. It is bactericidal, acid-stable andwell absorbed by either the oral or the intramuscular route.
全霉林对葡萄球菌的青霉素酶稳定,对耐药葡萄球菌十分有效.本品具杀菌、耐酸作用,且口服或肌注吸收良好.例5. Nystain has been found to inhibit the growth of yeast like flora inthe intestinal tract.已查明制霉菌素在肠道内可抑制菌丛类酵母菌的生长.例6. Fenarol has proved to be effective asastriated muscle relaxant.
已证明芬那露是疗效很好的横纹肌松驰药.例7. Halcion isapotent short-acting hypnotic agent, which producesits hypnotic activity from the first night of
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8. ATP injection exhibits effects, especially such asactivation of the function and metabolism of the nerve, and also coronaryand 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. (2)常用词及短语举例Ⅰ动词absorb 吸收act 作用cause (be cause by) 引起(由.引起)demonstrate 显示exert (action on) 起.作用exhibit 显示inhibit 抑制accumulate 积蓄administrate 投药excrete 排泄result in 导致indicate 表明maintain 维持produce 产生protect (from) 保护(不变)reach 达到show 显示、表明treat 治疗metabolize 代谢promote 促进prevent 阻止,预防tolerate 耐受Ⅱ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Ⅲ名词ability 能力activity 活性distribution 分布excretion 排泄action 作用clearance 清除率effect on 对的作用function 功能,作用half life 半衰期in vitro 体外kidney 肾mechanism 机理serum concentration 血清浓度tolerance 耐受性infection 感染in vivo 体内level 水平,浓度plasm lever 血浆浓度(水平)toxicity 毒性以上仅举部分例词、此外还有许多专业词汇和基础词汇请参阅有关资料.
五、适应症适应症最常用的有以下几种表示方法Indications适应症Indications and Usage 适应症与用途主要适应症Uses用途Action and Use作用与用途偶尔也会见到其他的表示方法.本项中出现频率最高的是疾病名称
以及微生物(尤其是致病菌)的名称,如:angina pectoris 心绞痛cancer癌糖尿病hypertension 高血压gram-positive 革兰氏阳性菌virus 病毒gram-negative 革兰氏阴性菌E.coli 大肠杆菌这些词汇可借助英汉医学词典进行阅读和翻译,只要掌握了这些词意,即可了解本项基本内容.
(1) 常见句型本项是说明书的重点、从句子结构来分析,大致有以下几种类型.Ⅰ不完全句结构,仅列出疾病或微生物的名称.例如:
例1. Angina pectoris, Prinzmetals angina, hypertension心绞痛、变异性心绞痛、高血压.例2. The following diseases caused by bacteria including gram-negative bacteria such as coli, Klebsiella pneumoniae.
用于治疗由革兰氏阳性和革兰氏阴性细菌、如葡萄球菌、链球菌、大肠杆菌、肺炎杆菌引起的下列疾病.
Ⅱ由For(或In等)引出的短语、例如:例2. For prevention of the advance of cataract用于预防白内障进展.例4. In the treatment of all forms of pulmonary tuberculosis inassociation with other antitubercular drugs与其他抗结核药配伍、治疗各种类型肺结核.
ⅢTo动词原形构成的短语、如:
例5. To prevent the formation of urinary in caseswhere they tend to recur用于预防尿路,特别是易发部位的结石的形成.例6. To protect the liver cell during administration of drugs hazardousto the liver在服用对肝脏有危害的药物期间,用以保护肝细胞.Ⅳ完整的句子结构或段落,有时结构很复杂.如:
例7. Amikacin is useful in the treatment of infections sensitive species,which include the Pseudomonas species, itmay also be useful to treat infections caused by sensitive staphylococci.
阿米卡星可用于治疗革兰氏阳性敏感菌(其中包括假单孢菌)引起的感染,也可用于治疗敏感葡萄球菌引起的感染.例8. Nebcin is indicated for the treatment of the following by susceptible
乃柏欣适用于治疗下列由敏感细菌引起的感染:
例9. Octinum-D has proved effective in the prophylaxis and therapy ofdisorders arising from spasm of the smooth musculature.
新握克丁已证实对平滑肌痉挛引起的病症有预防和治疗作用.例10. Fungizone intravenous is especially intended to 注射用凡疾送特别适用于治疗隐球菌病.例11. Kanamycin is active both in vitro and vivo against gram-negative bacteria as well as acid-fast bacteria.
卡那霉素在体外及体内对革兰氏阳性和革兰氏阴性菌以及耐酸菌都有效.例12. Benemid is recommended for the treatment of gout and and to increase and prolong the plasma concentration of penicillinsand cephalosporins during anti-infective therapy.
丙磺舒被推荐用于治疗痛风及痛风关节炎,及在强化抗感染治疗时增加并延长青霉素类及头孢菌素类的血浆浓度.例13. Information available at present suggests that Oncovin may beuseful either alone or in conjunction with other oncolytic drugs for thetreatment of acute leukaemias.据现有资料表明,长春新碱可单独使用,亦可与其他溶瘤细胞药物合用,以治疗急性白血病例14. Adriamycin is frequently used in combination with other cytotoxic drugs.
阿霉素常与其他细胞毒药物合用于化疗方案.例15. Concomitant therapy with other calcium and alcohol may potentiate the hypotensive action of thedrug.与其他的钙拮抗剂,抗高血压药物及酒精饮料同时使用,会增强本品的降低血压的作用.
(2) 本项中的常用词及短语举例许多常用词及疾病名、微生物名词等与药理作用项类同、此外还有以下词组与短语(例句参见前文).be active against 对.有效be intended to 适用于.be administered in 适用于be of value of 适用于.be effective in (for, against) 对.有效be recommended for 推荐用于.be employed to 用于be used to (for, as) 用于.be helpful in 用于.be useful in 用于.be indicated in (for) 适用于.for (in) the treatment (management) of 用于治疗(控制)
表示与其他药物合用的结构有:be associated within association withbe combined within combination withbe compatible within conjunction withtogether with
六、禁忌症本项中最常用的英语表示法是也有用Restrictionson Use(用药限制)的.
(1)本项中涉及到禁用(或慎用)某些药物的患者或某种特殊情
况,例如:Ⅰ孕妇,妊娠期或哺乳期,幼童等pregnant woman 孕妇lactation 哺乳期in pregnancy 妊娠期children under.years of age .岁以下儿童the first trimester (3 months) of pregnancy 妊娠期的最初三个月
Ⅱ患有某些疾病或过敏的患者、如:allergic to.对.过敏的allergic (anaphylactic) reaction 过敏反应allergy to.对.过敏patients with.(who.) 患有.的患者(2)本项中常出现一些疾病名称,例如:cardiac failure 心力衰竭cardiac (renal) insufficiency 心(肾)功能不全severe hypotension 严重低血压impairment of kidney (renal function) 肾功能损伤diabetes 糖尿病liver (hepatic) damage 肝损伤severe anemia 严重贫血(3)常见句型Ⅰ省略句型,只列出禁忌对象或疾病名称等.例1. Pregnancy, allergy to methotrexate, functional disorders of liverand kidneys, diseases of the haematopoietic system (bone leucopenia, anaemia), infectious of the oral cavity and the tract, recent 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.例2. to quinolones, severe renal insufficiency对喹喏酮类过敏,严重肾功能不全.
Ⅱ完整的句子或段落.其中常用的结构有 are.禁忌症是.be 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
还可能有一些其他的结构,如:
例3. Cefazolin sodium is in patients with 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 cyclopropane orhalothane anesthesia, unless clinical circumstances demand such use.
如果不是临床需要、建议本品(阿拉明)不要与环丙烷或氟烷麻醉剂合用.例5. Do not take Benemid if prior administration resulted Benemid is not recommended for persons with knowndisorders of the blood or uric acid kidney stones. Do not give Benemid tochildren under two years of age.
若以前使用丙磺舒曾引起过敏反应、则应禁用.已知有血液疾患及尿酸性肾结石的患者建议不要使用本品、二岁以下儿童不得服用.例6. Phenothiazine compounds should not be used in patients receivinglarge doses of hypnotics, and should be used, with caution in patients withahistory of convulsive disorders, since grand mal convulsions have beenknown to occur.接受大剂量的患者不应使用吩噻嗪化合物,对有惊厥病史的患者应慎用,因为已知有发生过癫痫大发作.例7. Ursosan should not be given to patients suffering from and bile duct obstruction.
暴发性肝炎及胆管阻塞患者禁用熊去氧胆酸.例8. This product is in those patients who have to it unless, in the opinion of the physician, the treatment is life threatening and amenable only to 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9. Children under5years of age should not be treated 岁以下儿童禁用敌胺.例10. The use of Alexan in nursing mothers is not recommended.
哺乳期妇女最好不用爱力生.
例11. Pregnancy: Coumadin is in women who are ormay become pregnant because the drug basses through the placental barrierand may cause fatal hemorrhage to the fetus in utero.
妊娠期禁用:香豆定禁用于孕妇,或可能已怀孕的妇女,因为本品可能穿过胎盘屏障,引起子宫内胚胎致命的出血.
(3)在Restrictions on use 的项目中有时还有小标题禁忌症Precautions (Notes) 注意事项Warning 警告Pregnancy and Lactation 妊娠与哺乳
七、用量与用法
本项最常用的英语表示法有:Dosage and Administration 用(剂)量与用法Route of Administration 给药途径(用法用法Direction for Use 用法Method of (for) Administration 用法Application and Dosage 用法与用(剂)量Mode of Application 用法Dosage 用(剂)量How to Use 用法Posology 剂量学还可能有其他的表示方法.本项也是阅读的重点、读者必须正确理解本项内容中的给药对象,给药方式,剂量及剂量单位、给药时间等.
(1) 常用表示剂量的术语:average dose 平均剂量minimal (minimum) dose 最小有效量daily dose 日剂量(一日量)multiple dose 多剂量divided dose 分次剂量overdose (overdose) 过量fatal (lethal) dose 致死量single dose 一次剂量indicated dose 有效剂量standard dose 标准(合适)剂量initial (beginning, starting) dose 首次量suggested (recommended) dose 推荐剂量maintenance dose 维持量therapeutic dose 治疗剂量maximum dose 最大剂量(极量)usual (normal) dose 常用剂量(2) 常用的剂量单位表示法g = gram 克l = liter (litre) 升mg = milligram 毫克ml = milliliter 毫升kg=kilogram 千克c.c. 毫升mcg = microgram 微克I.U. = International Unit 国际单位μg 微克body weight 体重per square meter of body surface 每平方米体表面积(3) 每次给药次数的表示方法daily (per day,aday, 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 timesaday (daily) 每日三次three timesaweek 每周三次once (twice)aweek (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)
例1. Unless other wise prescribed by the physician, the average dailydose 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 body weight daily in3-4 divided doses orally, taken with meals.
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 12 tablet of Madopa 250 threetimes 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 mgkgday total, given infour equally divided and spaced doses.
儿童:常用总剂量为每日50~100mgkg体重、均分为四等份,等间隔给药.例5 The recommended starting dose is 20mg given asasingle dailydose.推荐的首剂量为每20mg,一次服用.
(4) 给药对象最常见的用词有:adolescents 青少年infant(s) 幼儿adult(s) 成年人male 男性baby (babies) 婴儿newborn baby (babies) 新生儿children (child) 儿童patient(s) 患者、病人debilitated patients 体弱患者pediatric 儿科的elderly patient(s) 老年患者pregnant women 孕妇female 女性senile patient(s) 老年患者(病人)
(5)给药方式的表示法多用副词成或介词短语表示、例如静脉内给药by mouth (O.S.) 口服intragluteally 臀肌内给药by phleboclysis 静脉输液肌内给药by intramuscular (I.M.) injection 肌肉注射腹(膜)腔内给药by intravenous (I.V.) injection 静脉注射intrapleurally 胸(膜)腔内给药by the intraarticatar administration 关节内给药intrathecally 鞘内给药by the intramuscular administration (route) 肌内给药intravenously 静脉内给药by the intranasal route 鼻内给药locally 局部给药orally 口服给药parenterally 肠道外给药by the administration 腹(膜)腔内给药结膜下给药by the intravenous infusion (perfusion) 静脉输注subcutaneously 皮下给药sublingually 舌下给药submucously 粘膜下给药by the intrathecal administration 鞘内给药by aerosol 喷雾给药by the sublingual administration 舌下给药by drip phleboclysis 点滴静脉输液per rectum 直肠给药by enema 灌肠per vagina 给药by lumbar 腰椎给药pro recto 直肠给药此外还有许多其他的表示法,不一一列举.
(6)表示投药的常用动词:
administer (或be indicated)给药,投药use (或be used ,employ,be employed) 用药recommend (be suggested) 推荐给药(7)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 is1ampoule, or intravenously.
建议一次剂量为1安瓿,皮下,肌肉或静脉注射给药.例7. I.M. injections should be administered in the amount of 25-50mgdaily per kilo of body weight, subdivided into injections everyhours.
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 dayin 2-3 divided doses. For infants give intramuscular injection of 10-20mgkgper 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10~20mgkg体重、分2次注射.例9. The tablets (or the syrup) are to be taken during or liquid.片剂(或糖浆)应于食间或饭后用少量液体送服.例10. Apply the Nitro-Dur system firmly to the skin surface. TheNitro-Dur system may be applied to any convenient skin area;arecommended side of application is the arm or chest.
把护心贴片紧贴在皮肤表面,护心贴片可贴在任何方便的皮肤区域,最好是贴在手臂或胸部.例11. In doses should be inhaled or sprayedonto or under the tongue at the every onset of anginal pain.
一般应在心绞痛开始发作时就吸入,或向舌上或舌下喷入1~3个规定的剂量.
(8)其它的短语或句型,例如: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 from.to.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 ) 建议例子很多,不一一列举.例12. Dosage should be adapted to patients individually, on the basisof 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 is advisable to initiate therapy with massive doses: 3×2 tabletsdaily after meals over 2-4 days.
建议开始治疗时采用大剂量,每日剂量为3×2片,饭后服用,持续2~4日.例14. In severs chronic cases, treatment is started with of Bilocid and continued 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安瓿缓慢静脉注射.例15. The number of injections required may vary from patient topatient.所需注射次数因患者而异.例16. The dosage of Glutril must be adjusted by the doctor accordingto the individual metabolic state.
克糖利的剂量需由医生根据每个患者的代谢状况调整.例17. In such instance, it is recommended that the dose be reduced.
在这种情况下,建议减少剂量.例18. The maintenance dosage is determined by response of the维持剂量视患者对药物的反应而定.从上述例句可见、本项中英语的普通词汇较多,只要有一定的英语基础均可读懂,专业词汇多为医学词汇,可从英汉医学词典中查出.
八、不良反应不良反应这一项中包括药物的副作用,症状及体征、毒性作用及耐受力、过敏反应、停药等、现分述如下.
(1)不良反应的常用的英语表示法有:adverse reaction(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unwanted (undesirable) effects 副作用side reaction(s) 副作用by-effects 副作用(3)常见的毒副反应的症状及体征的词语很多,但记住下列词语
很有必要:
allergic anaphylactic) reaction(s) 过敏反应allergy 过敏dizziness 眩晕 tract 胃肠道fever 发热local reaction(s) 局部反应flush 潮红skin reaction(s) 皮肤反应headache 头痛symptom(s) 症状nausea systematic 全身的pruritus 瘙痒anorexia 厌食rash 皮疹blood count 白细胞计数spasm 痉挛blood pressure 血压thirst 口渴coma 昏迷tiredness 疲倦diarrhea 腹泻vomiting 呕吐(4)毒性,耐受性的英语表示法:tolerance (tolerability) 耐受力、耐药性tolerate (toleration) 耐受(5)停药的英语表示法举例:abandon 停药discontinue 停药,中断(治疗)cease (cessation, stop) 停药(停止治疗)dont use 勿使用(停药)suspend 停药terminate 停止,结束withdraw (be 停药(6)其他一些常见的基本词汇及短语:acute 急性的control (be controlled) 控制chronic 慢性的diminish (reduce, reduction) 减少common 常见的disappear 消失irreversible 不可逆的encounter 遇到,见到mild 轻微的give rise to 产生include 包括rare(ly) 罕见的(地)lead to 导致reversible 可逆的manifest 表明,显示severe 严重的observe (be observed) (被)观察到temporary 暂时的transient 一过性的,短暂的react to 对反应appear (develop, happen, occur) 出现(产生)result from.由.引起be reported (被)报道cause (be caused by.) 由引起treat (treatment) 治疗special care (caution) should be exercised 特别小心(注意)
例1. Ciprofloxacin is generally well tolerated. The most adverse reactions are: nausea, diarrhaea, vomiting, 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:、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 israpidly 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 irritation reactions (cutaneous and mucous reactions) are onlyobserved 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 anddisappear 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 oftenenough during 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.例6. These unwanted effects usually disappear spontaneously after7-14 days or reduction in the dosage.
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.例7. With high dosage continuous infusion (more than 200mgm2day)
over5to7days, the complications are more pronounced andcan on occasion lead to ileus. All side effects are reversible after cessation of大剂量连续输注超过5~7日(超过200mgm2日),胃肠道并发症更为明显,偶尔可导致肠梗阻.停药后副作用皆可逆转.例8. In some patients nausea, dizziness, and vomiting may occur in thefirst days of treatment but the treatment need not be discontinued for that. Inrare casesadecrease of blood pressure may appear for check-up is recommended in outpatients before the treatment isinitiated. If side effects persist, lower doses should be administered.
服用本品的头几天,有些病人可能会出现、头晕和呕吐,但不必停药.偶有血压下降的病例,为此,在治疗开始前建议对门诊患者检测血压.若副作用持续不消失,应减少服用剂量.例9. Major adverse reactions (much less common than the minoradverse reactions) include inhibition of myelopoiesis, drug fever andhepatitis.较重的不良反应(远不及轻度不良反应常见)包括抑制骨髓细胞生成,药物热及肝炎.
例10. Side effects: loss of appetite and nausea occur in most with vomiting. These symptoms are usually confined to the firstfew days of treatment and then tend to disappear.
副作用:多数病例出现食欲减退、、有时呕吐.这些症状通常发生在治疗的最初几天,以后逐渐消失.
九、注意事项注意事项也是药品说明书中的重要内容之一.为了安全用药,厂商在本项中特别强调应注意的事项、其中主要包括:正确的剂量和用法,超过剂量时的应急措施,用药对象,可能出现的较严重的副作用及治疗方案,药物的配伍、药液的配制,使用及保管等、方面的注意事项.
现就本项内容详细介绍如下.
(1) 本项常用的英语表示法:precaution(s) 注意事项special note (caution, precaution) 特别注意caution(s) 注意事项N.B. 注意note 注意warning(s) 警告
有时也用:important 重要事项important for the patients 患者须知(2)本项中常见的检查项目:blood count 血细胞计数kidney (renal) function 肾功能blood picture (hemogram) 血像liver (hepatic) function 肝功能blood level 血浓度serum creatinine test 血清肌酸酐检验clotting time 凝血时间urine routine (examination) 尿常规creatinine clearance 肌酸酐清除率(3)本项的特点是内容长短不一、有难有易,词汇量大,涉及面广,既有普通词汇,也有大量的专业词汇及编写词.许多词汇,结构和句型可在药理作用,适应症,禁忌症,剂量和用法,副作用,贮藏等项中见到.从英语结构上分析,句型变化较多,长句,难句也屡屡出现,是比较难读的一个项目.例1. Warnings and precautions: Ciprofloxacin should be used withcaution in epileptics and patients withahistory of CNS disorders and only ifthe benefits of treatment are considered to overweight the risk of possibleCNS 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 todrive or operate machinery, 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 physician experienced in the use of cancer
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.例4. The most serious risk associated with anticoagulant therapy withsodium Warfarin are hemorrhage in any tissue or organ and less and or gangrene of skin and other tissues. The risk of hemorrhageis related to level of intensity and the duration of anticoagulant therapy.
用华法林钠进行抗凝治疗产生的最严重的危险就是组织或器官出血、以及不大常出现的皮肤和其他组织的坏死和(或)坏疽.出血的危险与抗凝治疗的药物浓度(水平)及疗程长短有关.例5. The occurrence ofaplatelet count below 50,000mm3 or anabsolute neutrophil count below 500mm3 is an indication to therapy until the blood counts have sufficiently recovered.
血小板数低于50,000mm3或绝对中性白细胞数低于500mm3,表明不能继续使用本品治疗,待白细胞计数充分恢复后才能继续用药.
例6. Warfarin therapy should be discontinued when Warfarin issuspected to be the cause of developing necrosis and heparin therapy may beconsidered for
当怀疑华法林治疗引起坏死时,则须停止治疗,并且考虑使用肝素治疗.例7. Dosage should be controlled by periodic determinations ofprothrombin time (PT) or other suitable coagulation tests.
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.
例8. Please note: Cerebral convulsive disease is regarded for examinations in the subarachnoid space. If after these examinations are nevertheless performed, all equipmentand medicines necessary to counter any convulsions may occur must beprepared ready for use beforehand.
请注意:脑惊厥被认为相对禁止进行蛛网膜下腔检查,如经谨慎考虑后,仍要进行这些检查时.必须事先备妥应付可能发生惊厥所需的所有设备与药品.例9. Caution must be exercised in the case of toiodinated contrast media, latent and bland nodular goitre.
对碘造影剂过敏,隐匿性甲状腺亢进和轻微甲状腺肿的病例,应慎重.
例10. Caution: Alcohol intake may enhance nitrate effects induce hypotension with subsequent impairment of reactivity.
During the first three months of pregnancy drugs should only be used on theexpress direction of the attendant physician. Isket spray should not be storedeven for short periods! Do not force canister open, even when empty!
注意:饮酒可增强盐的作用,偶尔引起低血压,继而损害反应力.妊娠三个月时,只有在监护医生明确指导下才可使用本品.异舒吉喷雾剂的贮存温度不应超过25℃!避免超过40℃.即使短时间也不可!
不要用力开罐,即使空罐时也不可用力开!例11. As with all new drugs, patients should be followed carefully sothat any side effects or unusual manifestations of drug idiosyncrasy may bedetected. If any allergic reaction to Keflex occurs, the drug should bediscontinued and the patient treated with the usual agents.
像使用所有新药一样,应细心地随访患者、以便观察任何副作用或药物特异反应.如果出现对头孢菌素IV的过敏反应、应停药,并用常规药物治疗患者.例12. In patients with normal renal function, chronic be associated with an increase in serum creatinine. While this is it is important in such patients to pay careful attention to thosefactors, which may lead to hypercalcemia.
对于肾功能正常的患者、慢性高钙血症可能与血清肌酸酐增多有关.这通常虽然是可逆的,然而对这样的病人、密切注意可能导致血钙过多的各种因素是很重要的.
例13. the concomitant use, in the absence of laboratory of parameters, of anticoagulants or aspirin. Inform theattending physician in the event of bleeding or of the occurrence ofahematoma.
注意事项:在无化验室参考指标的专门监测情况下,避免与抗凝剂或阿司匹林合用.如发生出血或出现血肿,应通知主治医生.例14. Periodical examination of hepatic or renal function and bloodpicture is desirable since Kedacillin may increase SGOT, SGPT and BUN,and decrease erythrocyte and leucocyte.
磺苄青霉素钠可使血清谷草转氨酶,血清谷丙转氨酶和血液尿素氮增高,使红细胞和白细胞减少.所以最好要定期检查肝、肾功能和血象.
例15. from insulin to Glutril may be attempted incase of maturity-onset diabetes with obesity; dosage is based upon the resultof the necessarily frequent metabolic tests.
注意:伴有肥胖症的成年型糖尿病患者、可试从胰岛素改用格路特利治疗,剂量应以必须经常进行的代谢试验为依据.
十、包装(1)包装在英文药品说明书中的表示法有许多,最常用的是pack(package) 和supply,例如:pack(s), packing(s) 包装supply (supplies) 包装package(s) 包装how supplied 包装方式packing for hospital 医院用包装method of supply 包装方式package quantity (quantities) 包装量
此外还有:presentation 包装hospital (size) packs 医院用包装availability 包装trade packs (packing) 商品包装mode (form) of issue 包装(2)常见的包装单位(工具)的英语表示法:ampoule(s) 安瓿carton 纸盒blister pack (package) 铝塑包装(水泡眼包装)pack 包blister strip 铝塑条状包装(水泡眼条包装)sheet 张bottle 瓶strip 条box 盒tube 管canister 罐vial 玻璃小瓶(3)药物的常见剂型的英语表示法:aerosol (spray, inhaler) 气雾剂ampoule 针剂capsules 胶囊oral solution 口服液coated-tablets 包衣片pill 丸剂cream 乳膏powder 粉剂TTS 透皮吸收剂retard capsules (tablets) 缓释胶囊(片)sugar-coated pill 糖衣丸scored-tablets 刻(划)痕片drops 滴剂solution 溶液剂emulsion 乳剂栓剂sugar-coated tablets 糖衣片film-coated tablets 薄膜片.膜衣片suppositories 栓剂granule 颗粒suspension 悬浮剂,混悬剂injection 注射剂,针剂sustained release tablets 恒(缓)释片liniment 搽剂syrup 糖浆liquid 液剂ointment 软膏(4)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、词汇容易阅读.
例1. 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 mg.Box of 12capsules 250 mg in blister. Bottle for pediatric use (granulated): 20 gmgranulated contain1gm ampicillin. The content of the spoon included in thepacking corresponds to 100 mg ampicillin.
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:20g颗粒剂每瓶含有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4. Mode of issue: The product is issued in vials containing 250 mg,
500 mg and1gram of cephaloridine.
包装方式本品小瓶包装、内装250mg,500mg及1g头孢菌素II.
例5. Trade packs: Trade packs containing 50 and 100 sugar coatedtablets.
商品包装:50及100糖衣片包装.
例6. Packs: Madopar250, cross-scored tablets, each contains 200mglevodopa and 50 mg benserazide.
包装:美多巴250,刻痕片,每片含200mg左旋多巴和50mg羟苄丝肼.例7. Method of supply: Tablets in tubes, each containing 30 tablets.
Paint in glass bottles of 24 ml. Meladinine is supplied only on prescription.
包装方式:管装片剂,每管30片.玻璃瓶装搽剂,每瓶24ml.敏白灵只按处方供药.
例8. Orbenin syrup is available in powder for preparing an aqueous solution. Whendispensed each5ml teaspoonful contains 125mg cloxacillin as the sodiumsalt.
包装:糖浆.全霉林糖浆为瓶装、内含可供再配制水溶液的.配制后的每茶匙5ml药液中含125mg邻氯青霉素钠盐.
例9. How supplied: Tablets. Coumadin (crystalline Warfarin sodium),for oral use, single scored, imprinted numerically and packaged in bottleswith potencies and colors as follows:
包装:片剂.香豆定(结晶华法林钠),供口服、药片上有一条划
痕,印有数字,瓶装、效价及颜色如下:
例10. Also available in hospital unit-dose blister package of 100也提供医院用的单位剂量的铝塑包装、每包100片装.
例11. Temaril 250:White, film-coated tablets marked on one side with250mg, each tablet containing 291.5mg ciprofloxacin (equivalent 250mg
特美力250:白色,有刻痕标记的薄膜片,一面刻有250mg字样,每片含291.5mg盐酸环丙沙星一水合物(相当于250mg环丙沙星).
例12. Packs:Standard packs of 20 sugarcoated pills. Hospital packs ofand 1000 sugarcoated pills.
包装:标准包装为20粒糖衣九.医院用包装为100,500及1000粒糖衣丸.例13. Package Nasal Spray withaspecially designed nasal applicator. Each canister provides
包装:必可酮喷雾剂是一种气雾剂,配有专门设计可供鼻用的喷雾器,每罐可喷雾200次.
十一、贮存贮存的英语常用表示法是Storage.本项中常用的一些短语有:store (keep) inacool and dry place 存于阴凉干燥处away from light 避光away from children 勿让儿童接触protect from light (heat) 避光(热)out of (the) reach of children 勿让儿童触及prevent moisture 防潮本项的句子较简单多为一简单句,其中多为祈使句,用词也不多.例1. Store medicines carefully. Keep away from children.
注意保存,勿让儿童接触.例2. Store below 25℃protecting from freezing and light.
存于25℃以下,防冻,避光.例3. Validity and storage: The solution will keep for five years if stored
有效期及贮法:放置于20℃以下可保存5年.例4. Storage instructions: Protect from heat and light.
贮存方法;避光及防热贮存.例5. To be stored inadry place atatemperature not above 25℃存于不高于25℃的干燥之处.例6. Do not store the suppositories over 25℃.
本栓剂不得存于25℃以上的温度.例7. store at below 25℃and protect from moisture.
存于25℃以下,防潮.例8. The solution should be prepared immediately prior to use, but can药液应在配制后立即使用,但在4℃下可贮存一周.
有时也有较复杂的结构,或较多的内容、如:
例9. Ampoules and unopened nasal spray bottles should be stored inaroom temperature; it should be kept in the upright position and used foramaximum of4weeks. Like all should be kept out of reachof children.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.例10. Protect from light. Store in carton until contents have been used.
tight, container as defined in the U.S.P.
避光保存.药片在使用前于纸盒中保存.在恒温室温(59~86F,15~30℃)下保存.调剂时,使用美国药典规定的密闭、避光容器.
例11. Fungizone intravenous in powder form should be stored in protected against exposure to light. The concentrate may bestored in the dark, at room temperature for 24 hours, or at for one week with minimal loss of potency and clarity. Anyunused material should then be discarded.
两性霉素B粉剂应避光存于冰箱中.浓缩液可存于暗处,室温下可保存24小时,或可在冰箱温度下保存一周,其效价及澄明度变化极小.
那以后一切尚未用的药物就应弃之.
十二、其他项目上述10项是绝大多数英文药品说明书中必备项目,但是许多说明
书中还常常出现其他一些项目.例如:
(1) 特点
(2) 性质(Properties)
(3) 药代动力学
(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(Others)
现将各项简要分述如下:
特点)或Features(特点)的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1.
1)Asverin is an entirely new and patented cough medicine developedby Tanabes can be used asacommon medicine.
3)Antitussive effect of Asverin is equal to or more powerful than thatof is provided with an expectoranting action which has beennever found in any conventional antitussitive agents so far available in can be administered safely foralong duration without anyside effects.
特点:1)安嗽灵是一种全新的,获有专利的用塔那勃氏方法研制的镇咳药.2)安嗽灵属非麻醉药,可作为常用药使用.3)安嗽灵的镇咳作用相当于或强于可待因.4)安嗽灵的祛痰作用是迄今市场上可买到的常用镇咳药中前所未有的.5)安嗽灵可长期服用,既安全又无副作用.
(2)Properties(性质).本项内容与基本相同.
例2. Methotrexate (MTX) is an antimetabolite of folic acid that hasbeen used foralong time in the chemotherapy of tumors.
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.例3. Unlike it is not rapidly inactivated in the liver anda reliable clinical effect can be expected. Toxicity is low-effects are minimalwith Motazomin.玛多明与甘油不同、在肝脏不能迅速失活,因而可望具有可靠的临床效果,本品毒性小,副作用极为轻微.例4. Urgenin acts as an reducing the swelling in theprostatic bladder region caused by general obstruction. It also stimulates theblood circulation in this area and the bodys natural defense mechanism.
护前列腺素具有抗炎作用,能减轻前列腺膀胱区因一般性梗阻引起的肿胀、本品能刺激上述部位的血液循环,并增加机体的自然防御机制.
例5. Medomin induces restorative sleep lasting 6-8 hours. Because itis rapidly and completely broken down in the body, it is unlikely to producemorning hangover and does not cumulate. It retains its full activity evenwhen used repeatedly.美多眠可使消除疲劳的睡眠持续6~8小时;由于本品在体内能迅速和完全分解,因而不会产生清晨的残留作用,也没有积蓄作用.即使经常服用,本品仍能保持充分的活性.
药物代谢动力学)的内容王要是代谢(metabolism),吸收(absorption),分布与排泄(distribution 等.例6 Ampicillin is stable in the presence of gastic acid and is wellabsorbed from the tract (30-60% ofadose being absorbedby this route). Its absorption, however, is diminished when it is takentogether with food.氨苄青霉素在胃酸中稳定,而且易被胃肠道吸收(30~60%的一次剂量经此途径吸收).然而与食物共服、其吸收减少.例7. The absolute of Miacalic following subcutaneous injection is approximately 70. Its peak is attained within one hour and it has half-life of drug. The apparent volume of distribution iskg and肌注或者下注射后,密钙息的绝对生物利用率约为70.1小时内其血药浓度可达高峰,其半衰期为70~90分钟.高达95%的剂量经由肾脏排出、2%以其不变的药物原型排出.表观分布容积为0.15~
0.31kg,蛋白质结合率为30~4C. 例8. Midazolam is completely metabolized in the body. The after its formation, this active metabolite is conjugated withglucuronic then eliminated by the kidneys.
速眠安在体内代谢完全,主要的代谢产物为α-羟基速眠安、可在血浆中查出.代谢产物形成后,此活性代谢物便立即与葡萄糖醛酸结合(失活),然后由肾脏排出.
(4)Overdosage(超剂量,药物过量).主要介绍用药过量所产生的后果(effect),症状(signs and symptoms)及处理(treatment)方法.
其英语词汇和结构等与剂量与用法,副作用,注意事项等项目中的词汇和结构相似.例9. Overdosage may give rise to the following signs and symptoms:
tremor, excitation, convulsions, changes in blood pressure impairment and coma. EEG and ECG changes may also occur. Treatment:
Measures to monitor and safeguard vital functions and when necessary.
超剂量可能引起下列体征和症状:震颤,兴奋,痉挛、血压改变,意识损害及昏迷.心电图和脑电图也可能发生改变.
治疗:采取措施监护重要器官的功能,必要时给予安定.例10. Manifestations of Halcion overdosage include extensions of activity, namely somnolence and hypnosis. As in all casesof drug overdosage, respiration, pulse, and blood pressure should bemonitored and supported by general measures when necessary. lavage should be performed. Intravenous fluids should beadministered and an adequate airway maintained.
海乐神服用过量的表现是其药理活性的扩展,即嗜睡和催眠.像处理所有药物过量的病例一样,必须对呼吸、脉搏和血压进行监测,必要时采用通用措施,应立即洗胃、静脉输液,并保持呼吸道畅通.
或drug Interactions(相互作用或药物的交互作用).
本项内容主要是介绍药物合用时的注意事项.例11. Temaril tablets should not be administered with4hours ofmedications containing or iron salts as absorption may occur.在使用了含镁、铝或铁盐的药物之后的4小时内不应使用环丙沙星片剂,因为可能影响吸收.例12. Simultaneous consumption of alcohol can impair reaction timee.g. in traffic or during operation of machines. At higher dosage of Elantanwith simultaneous administration of medicamentsthe effect of the latter can be potentiated.
同时饮酒可能损害反应时间,例如驾驶车辆或操纵机器期间.大量服用单异山梨醇的同时服用降血压药物,可能会增强后者的药效.
例13. Dormicum can enhance the central sedative effect of sleep-inducing drugs, analgesics 速眠安能增强神经抑制剂,安定剂,抗抑郁剂,催眠,镇静剂和麻醉剂的中枢神经镇静作用.例14. Concomitant treatment with other vasodilators, β-blockers, diuretics, major tranquilizers, and as well as theconsumption of alcohol, may potentiate the blood pressure lowering effectof Nitroderm TTS.
与其他药物,例如:血管扩张药,钙桔抗剂,β-受体阻断剂,利尿剂,抗高血压药,三环抗抑郁药,强镇静剂及二氢麦角胺合用,以及饮酒等、可加强甘油护心贴膏的降血压作用.
(6)Validity(有效期).药品的有效期或失效期有以下几种表示方
法:validity 有效期storage life 贮存期expiry (Exp.) date 失效(日)期shelf life 贮存期(贮藏期限)expiring 失效期stability 稳定性expiration date 失效(日)期
例15. Expiry: 18 months (Expiry date is printed on the vial label.)
有效期:18个月(失效日期印在瓶签上).例16. Validity and storage: The solution will keep for five years ifstored atatemperature below 20℃
有效期及贮存法:于20℃以下可保存5年.
例17 Stability: Cefoperazone is stable at least 24 hours in aqueousform is really effective till the expiry date indicated on packings.
稳定性:头孢哌酮存于5~25℃温度下的稳定性至少可达24小时.
木品粉剂的药效实际上可保持到包装上规定的失效日期.
例18. Stability: See expiry date on the outside of the pack.
稳定性;见外包装上的失效日期.
例19. Shelf life: The drug should not be used after the expiry date(Exp.) printed on pack.本品超过包装上印刷的有效期后不得使用.
(7) 其他可能出现的项目1) References (Literature) 参考文献参考文献2) Clinical data 临床数据3) Formula (Formulation) 分子式4) 建议5) Remarks (Attention) 注意注意6) Tolerance 耐受性7) Information for the patients 患者须知8) Further information 补充资料9) Batch No. 批号10)Made in.(Produced by, Manufactured by.) 由.制造;由生产;由.制造 Precautions 药品的注意事项还可能有其他项目.这里不再列举.以上是英文药品说明书中的主要项目的英文标题,不同的表示方法,结构特点、常用词、短语及句型等.掌握这些内容有助于了解英文说明书的脉络,但要完全理解说明书的全部内容还需要经过一番努力.

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