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1、第五章英文药品说明书,英文药品说明书,InstructionsDirectionsDescription Package Insert 或简称 Insert，LeafletData Sheets,主要内容,Drug Names Description Pharmacological Actions Indications Contraindications Dosage and Administration Adverse Reactions Precautions Package Storage,第一节 药品名称,商品名（Trade Name 或 Proprietary Name）通用名（G
2、eneric Name）化学名（Chemical Name）,例：日本田边有限公司生产的熊去氧胆酸片Trade Name：Ursosan(tablets)Generic Name：Ursodeoxycholic Acid（熊去氧胆酸）；Chemical Name：3,7dihydroxy-5-Cholanoic acid(3,7二羟基5胆烷酸）,药品名称的翻译,音译：按英文药品名称的读音译成相同或相近的汉语。如：Tamoxitn它莫西芬音译较为方便，但不能表意。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；也可按其药理作用翻译如：Minidiab灭糖尿（治疗糖
3、尿病药物）等。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香豆定（coumarin香豆素）。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：Doriden多睡丹，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。,第二节 性状,DescriptionChemical Structure Composition Physical and Chemical Properties,常用的词语,表示组成、制备的词及短语，如：contain 含有；be prepared from 由制备；have（possess）由（具有）表示性质的一些词类
4、，如：crystalline 结晶的 structure 结构 solubility 溶解度 injection 注射剂 insoluble 不溶的 odo(u)r 气味 solution 溶液 tablets 片剂 derivative 衍生物colo(u)rless 无色的 tasteless 无味的 liquid 液体 sterile 无菌的 powder 粉末 solid 固体 soluble 可溶的 molecular weight 分子量,常见的句型,例1Folic acid is a yellowish to orange,crystalline powder;odourless
5、 or almost odourless.叶酸是淡黄色至橙色结晶粉末，无臭或几乎无臭。例2Intralipos is a white opaque fat emulsion for intravenous injection,containing 10 W/V%of purified soybean oil.脂肪乳剂是白色，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。,常见的句型,例3熊去氧胆酸片为白色素片，每片含50mg熊去氧胆酸。Ursosan Tablet is a white plain tablet which contains 50mg of ursodeso
6、xycholic acid.例4.本品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。It occurs as a white to off-white,crystalline solid,poorly soluble in water,dilute acid and most organic solvents,第三节 药理作用,常用标题：Pharmacological Action 药理作用 Pharmacological Properties 药理性质 Pharmacology 药理学 Clinical Pharmacology 临床药理 Actions 作用 Actions a
7、nd Properties 作用与性质 Clinical Effect(Use)临床效果（用途）Mechanism of Action 作用机理 Mode of Action 作用方式,主要内容,药理作用(Pharmacological Action)临床药理(Clinical Parmacology)体外试验(in vitro experiments)药物代谢(Metabolism)药效(Potency)毒性(Toxicity),常用词及短语举例,动词 administrate 投药 excrete 排泄 maintain 维持 result in 导致 produce 产生 tolerat
8、e 耐受metabolize 代谢 promote 促进 protect(from)保护（不变）形容词,常用词及短语举例,名词 serum concentration 血清浓度 tolerance 耐受性 in vivo 体内 infection 感染 level 水平，浓度 mechanism 机理 kidney 肾,常见句型举例,例1.Peak 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
9、的血药浓度达到高峰。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。,常见句型举例,例3.已发现制霉菌素（Nystain）在肠道内可抑制酵母菌（yeast）的生长。Nystain has been found to inhibit the growth of yeast in the intestinal tract.例
10、4.熊去氧胆酸的生物半衰期时3.5-5.8天 the biological half-life of ursodeoxycholic acid is 3.5-5.8 days,第四节 适应症,Indications适应症 Indications and Usage 适应症与用途 Major(Principal)Indications 主要适应症 Uses用途 Action and Use作用与用途,表示与“其他药物合用”的结构有：,be associated with in association with be combined with in combination with be com
11、patible with in conjunction with concomitant with together with,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1 Angina pectoris,hypertension.心绞痛，高血压。2.由For（或In等）引出的短语，例如：例2 In the treatment of all forms of pulmonary tuberculosis in association with other antitubercular drugs.与其他抗结核药配伍，治疗各种类型肺结核。,常见句型,3.To+动词原形构成的短语，
12、如：例 3 To protect the liver cell during administration of drugs hazardous to the liver 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 4 Nebcin is indicated for the treatment of the following infections caused by susceptible microorganisms.乃柏欣适用于治疗下列由敏感细菌引起的感染：,课后作业,丙磺舒（Benemid）被推荐用于治疗痛风及在抗感染治疗时增加并延长青霉
13、素类（penicillins）的血浆浓度;阿霉素（Adriamycin）常与其他细胞毒(cytotoxic)药物合用于化疗方案;阿米卡星(Amikacin)可用于治疗革兰氏阳性敏感菌引起的感染，也可用于治疗敏感葡萄球菌（staphylococci）引起的感染。,第五节 禁忌症,ContraindicationsRestrictions on Use Contraindications 禁忌症 Precautions(Note)注意事项 Warning 警告 Pregnancy and Lactation 妊娠与哺乳,常用的结构有：,contraindications are 禁忌症是 be c
14、ontraindicated 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,常见句型,1)省略句型，只列出禁忌对象或疾病名称等。例1.Hypersensitivity to quinoiones,sever
15、e renal insufficiency.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.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。,课后作业：,5岁以下儿童禁用敌胺（Antistine）。对本品过敏的患者禁用本品。胆管阻塞（bile duct obstruction）患者禁用熊去氧胆酸。如果不是临床需要，建议本品（Aramine）不要与环丙烷（cy
16、clo-propane）合用。,第六节 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 Administration 用法Route of Administration 给药途径（用法）Direction for Use 用法Method of(for)Administration 用法 Mode of Application 用法Application and Dosage 用法与用（剂）量 Dosage 用（剂）量How to Use 用法 Dosology 剂量学,常用句型：,例1 Unless other wise presc
17、ribed 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 body weight daily in 3-4 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。,常用句型：,例3 In severs chronic cases,treatment is started with
18、daily 1 to 2 ampoules 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安瓶缓慢静脉注射。例4 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。,课后作业,片剂（
19、或糖浆）应于食间或饭后用少量液体送服。开始剂量推荐为每日3次，每次半片美多巴(Madopa)。推荐的首剂量为每20mg，一次服用。成年人肌肉注射，每日400-600mg，分2-3次注射,第七节 不良反应,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 Side Reaction(s)副作用 Unwanted（Undesirable）Effects 副作用 By-effects 副作用,常用句型：,例1 Ciproflo
20、xactin is generally well tolerated.The most frequently reported adverse reactions are:nausea,diarrhea,vomiting,abdominal pain,headache,restlessness,rash and dizziness.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2 When adverse reactions occur,they are usually reversible and disappear when the hormo
21、ne 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。,常用句型：,例3 The most serious side-effect is damage to the bone marrow.Because of this,the white blood cell count should be controlled often enough 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4 These unwanted effects usually disappear spontaneo
22、usly after 7-14 days or following a temporary 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。,第八节 注意事项,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 Noto 注意 Warning(s)警告 Important 重要事项 Important for the patients 患者须知,常用句型：,例1 Ciprofloxacin could result
23、in impairment of the patients ability to drive 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2 Dosage should be controlled by periodic determinations of prothrombin 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。,Ursofalk
24、 capsules must be used under medical supervision.Ursofalk 胶囊必须在医生指导下用药 OsyContain Tablets are NOT intended for use as a prn analgesic.OxyContain片不用于短暂的（临时的）疼痛,常用句型：,注：prn=pro re nata=临时的,第九节 包 装,常用的英语表示法 Pack(s)（Packing（s）包装 Supplies(Supplied)包装 Package(s)包装 How Supplied 包装方式 Packing for Hospital 医院
25、用包装 Method of Supply 包装方式 Package Quantities（Quantity）包装量 Presentation 包装 Hospital(Size)Packs 医院用包装 Availability 包装 Trade Packs（Packings）商品包装 Mode（Form）of Issue 包装,常用句型：,例1 Packing Bottle of 12 capsules 250 mg and 500 mgBox of 12 capsules 250 mg in blister.Bottle for pediatric use(granulated):20 gra
26、m granulated contain 1 gram ampicillin,The content of the spoon included in the packing 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：每瓶20克颗粒剂含有 1 g 氨苄青霉素。附在包装内的一匙的量，相当于100 mg 氨苄青霉素。,常用句型：,例2 Packages：Box containing one 100 mg bottle 包装：盒装，每盒1瓶，每瓶100 mg。例
27、3 Temaril 250：white,film-coated tablets marked on one side with 250,each tablet containing 291.5mg ciprofloxacin hydrochloride monohydrate(equivalent 250mg ciprofloxacin).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）。,常用句型：,包装 美多巴（Madopa）刻痕片，每片含200mg左旋多巴和50mg苄丝肼。商品包装 包括50 及 100 片
28、糖衣片。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。也提供医院用的单位剂量（Unit-Dose）的铝塑包装，（每包）100片装,第十节 贮存（Storage）,常用的一些短语有：store(keep)in a cool and dry place 存于于阴凉干燥处 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,常用句型：,例1 store medici
29、nes 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 Store at controlled room temperature（15一30）.Dispense in airtight,light-resistant container 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。,常用句型：,例4 Ampoules and unopened nasal spray
30、 bottles should be stored in a refrigerator(2-8).Once opened the nasal spray bottle must be kept at room temperature;it should be kept in the upright position and used for a maximum of 4 weeks.Like all drugs，Miacalcic should be kept out of reach of 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
31、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。,课后作业：,本栓剂不得存于25以上的温度。有效期（Validity）及贮法：溶液放置于20以下可保存5年。药液应在配制后立即使用，但在4下可贮存一周。,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
32、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）Asverin is an entirely new and patented cough medicine.2）Asverin being a non-narcotic,can be used as a common medicine.3）Antitussive effect of Asverin is equal to or more powerful than that of codeine.4）Asverin is provided with an expectorant
33、ing action which has been never found in any conventional antitussitive agents so far available in the market.5）Asverin can be administered safely for a long duration without any side-effect.,2、性质（Properties）,本项内容与Characteristics 基本相同。例 Methotrexate(MTX)is an antimetabolite of folic acid which has b
34、een used for a long time in the chemotherapy of tumours.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（distribution and elimination）等例 Ampicillin is stable in the presence of gastric acid and is well absorbed from the gastrointestinal tra
35、ct.Its absorption,however,is diminished when it is taken together with food 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 The absolute bioavailability of Miacalic following intramuscular or subcutaneous injection is approximately 70.Its peak plasma concentration is attained within one hour and it has half-li
36、fe of elimination of 7090 minutes.Up to 95%of the dose is excreted via the kidneys,2%as unchanged drug.The apparent volume of distribution is 0.150.31kg and protein binding 3040.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 7090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0.150.31/kg、蛋白质结合率为 3040。,4、用药过量（Over
37、dosage）,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。,5、相互作用（Interactions）,本项内容主要是介绍药物合用时的注意事项。例 Temaril tablets should not be administered with 4 hours of medications containing magnesium，aluminum or iron salts as interference with absorpt
38、ion 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。,6、有效期（Validity）,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1 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2
39、Validity and storage:The solution will keep for five years if stored at a temperature below+20 有效期及贮存法：于20以下可保存5年。,常用句型：,7、其他可能出现的项目。,1）References 参考文献 Literature 参考文献2）Clinical data 临床数据3）Formula(Formulation)分子式 4）Recommendations 建议 5）Remark(s)注意 Attention 注意 6）Tolerance 耐受性 7）Information for the p
40、atients 患者须知 8）Further information 补充资料 9）Batch No 批号10）Made in 由制造 Produced by 由生产 Manufactured（Manfd）by 由制造11）Pharmaceutical Precautions 药品的注意事项,附录：,例 丙磺舒（Benemid）被推荐用于治疗痛风及在抗感染治疗时增加并延长青霉素类（penicillins）的血浆浓度。Benemid is recommended for the treatment of gout,and to increase and prolong the plasma co
41、ncentration of penicillins during anti-infective therapy.,附录：,Adriamycin is frequenly used in combination chemotherapy regiments with other cytotoxic drugs.阿霉素（Adriamycin）常与其他细胞毒(cytotoxic)药物合用于化疗方案。,附录：,Amikacin is useful in the treatment of infections from Gram-negative sensitive species；it may al
42、so 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。,5岁以下儿童禁用敌胺（Antistine）。children under 5 years of age should not be treated with Antistine 对本品过敏的患者禁用本品。this product is contraindicated in those patients who have shown hypersensitivi
43、ty to it胆管阻塞（bile duct obstruction）患者禁用熊去氧胆酸。Ursosan should not be given to patients suffering from bile duct obstruction如果不是临床需要，建议本品（Aramine）不要与环丙烷（cyclo-propane）合用。it is advisable to avoid the use of Aramine with cyclo-propane,unless clinical circumstances demand such use,片剂（或糖浆）应于食间或饭后用少量液体送服。th
44、e tablets(or the syrup)are to be taken during or after a meal with a little liquid.开始剂量推荐为每日3次，每次半片美多巴(Madopa)。the initial dosage recommended is tablet of Madopa three times daily.推荐的首剂量为每20mg，一次服用。the recommended starting dose is 20 mg given as a single daily dose.成年人肌肉注射，每日400-600mg，分2-3次注射 for ad
45、ults given intramuscular injection of 400 to 600 mg per day in 2-3 divided doses.,包装 美多巴（Madopa）刻痕片，每片含200mg左旋多巴和50mg苄丝肼。packs(Madopa):cross-scored tablets each containing 200mg levodopa and 50mg benserazide.商品包装 包括50 及 100 片糖衣片。trade packs containing 50 and 100 sugar coated tablets 包装 标准包装为20粒糖衣九。医
46、院用包装为100，500及1000粒糖衣丸。Packs Standard packs of 20 dregees;Hospital packs of 100,500 and 1000dregees.也提供医院用的单位剂量（Unit-Dose）的铝塑包装，（每包）100片装 Also available in Hospital Unit-Dose blister package of 100,本栓剂不得存于25以上的温度。do not store the suppositories over 25 有效期（Validity）及贮法：溶液放置于20以下可保存5年。validity and storage:the solution will keep for five years if stored at a temperature below 20药液应在配制后立即使用，但在4下可贮存一周。the solution should be prepared immediately prior to use,but can be stored at 4 up to one week,
