PackageInsert

药品说明书 (package insert),英文药品说明书包含的项目，也是从简到繁，昔日药品说明书不过三四项内容（药名，成分，适应症，剂量用法），现在美国FDA规定为十项，但实际项目已经远远超过十项。,比如：1. Animal Pharmacology and Animal Toxicology 动物药理学与动物毒理学2. Absorption and Excretion 吸收与排泄3. Tolerance 耐受性4. Drug Interactions 药物相互作用5. Treatment of Overdosage 过量治疗,6. Storage and Duration of Efficacy 贮存与有效期7. Advantage 优点8. Reference 参考文献9. Further Information 补充说明10. Manufacturer 生产者,一. 英文药品说明书的翻译,记住各个项目中一些常见的词汇与句型，对于准确翻译说明书是极为有用的。1.项目名称药品说明书旧称Description, Instruction或Direction ,现称Insert或Package Insert,一篇药品说明书大致应包括下列内容：1.药品名称 （Drug Name)2.性状（Description)3.作用（Action)或药理作用(Pharmacological Action)4.适应症（Indication )5.禁忌症（Contraindications)6.注意事项（Precaution)7.副作用（Side Effects)或不良反应（Adverse Reaction)8.剂量与用法（Dosage and Administration)9.包装（Packing)10.失效期（Expiry Date)11.出厂日期（Manufacturing Date)12.参考文献（Reference ),2.药品名称英文药品说明书中常见的是商品名（Trade Name或Proprietary Name), 通用名（Generic Name)和化学名（Chemical Name）。以商品名最常用，右上角表示注册商标（Registered Trademark），表示此药已获该国工商管理部门注册核准专用，享有专用商标权（Trademark Right）。其它厂不能再用.,日本田边有限公司:熊去氧胆酸片商品名:Ursosan (Tablets)通用名:Ursodesoxycholic Acid化学名: 3,7-dihydroxy-5-cholanoic acid 3,7-二羟基-5-胆烷酸,药名的翻译可采用音译、意译、音意合译及谐音意译等方法。1）音译，按英文药名的读音译成相同或相近的汉语，音译较为方便，但是不能表意：Atropine 阿托品Caffeine 咖啡因Cortisone 可的松Quinine 奎宁,2）意译，（1）按药品名称所表达的含意译成相应的汉语： Cholic Acid 胆酸 Tetracycline 四环素,3）谐音译 Reserpine 利血平4）音、意合译 Neostigmine bromide 溴化新斯的明 Morphinic Hydrochloride 盐酸吗啡 Codeine Phosphate 磷酸可待因,5）.中文译名的转化： Vitamin 维他命 维生素 Penicillin 盘尼西林 青霉素 Hormone 荷尔蒙 激素 Atropine 阿托品 颠茄碱,3.药品的性状英文药品说明书中第一项是Description (性状），或称Introduction, Composition, Physical and Chemical Properties, Chemical Structure.,a.本项中常见句型：1. Folic 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。,2. This 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。此血浆经检验，并且证明对肝炎澳大利亚抗原无反应。,b.本项中常用词语：1.表示组成、制备的词及短语be derived from 由.衍生be obtained 由.制得be prepared from 由.制备consist of 由组成contain 含有,2.表示性质的一些词类,4.药理作用（Pharmacological Actions)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,其他的表示方法还有： Actions 作用 Actions and Properties 作用与性质 Clinical Effect 临床效果,Mechanism of Action 作用机理 Mode of Action 作用方式 Biological Activity 生物活性,a.本项中常见句型：Mean peak serum concentrations of tobramycin(妥布霉素) occur between 30 and about 60 minutes after intramuscular administration. 肌肉注射后30-60分钟之间妥布霉素的平均血药浓度达到峰值。,2. 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，三磷酸腺苷注射液显示了非常好的效果，特别是活化神经的功能及代谢，以及舒张冠脉与外周血管以增加血流方面更是如此。vasoconstriction,adenosine triphosphate三磷酸腺苷cytidine triphosphate胞苷三磷酸guanosine triphosphate鸟苷三磷酸inosine triphosphate次黄苷三磷酸deoxyinosine triphosphate脱氧次黄苷三磷酸nucleoside triphosphate三磷酸核苷uridine triphosphate尿苷三磷酸,b.本项中常用词语：,5.适应症 常用标题 Indication 适应症 Major ( Principle ) Indication 主要适应症,Action and Use 作用与用途 Clinical Indication 临床适应症 Treatment 主治,a.本项中常见句型：In the treatment of all forms of pulmonary tuberculosis in association with other antitubercular drugs. 与其他抗结核药配伍，治疗各种类型的肺结核。,2. Benemid(丙磺舒) is recommended for the treatment of gout and gouty arthritis, and to increase and prolong the plasma concentration of penicillins and cephalosporins(头孢) 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及头孢菌素类的血浆浓度。,b.本项中常用词语： be active against 对.有效 be administered in 适用于 be effective in 对有效 be employed to 用于 be indicated in 适用于 be intended to 适用于 be of value of 适用于 be recommended for 推荐用于,表示“与其他药物合用”的结构 be associated with be combined with be compatible with concomitant with in association with in combination with in conjunction with,6. 药品的剂量与用法（一）常用标题Dosage and Administration 用（剂）量与用法 Administrations 用法 Method of (for ) Administration 用法 Mode of Application 用法 Posology 剂量学 Application and Dosage 用法与剂量 Clinical Application 临床应用,（二）常用给药途径,（三）常用剂量单位g = gram 克g = microgram 微克mg = milligram 毫克kg = kilogram 千克I = liter 升ml = milliliter 毫升cc = cubic centimeter 立方厘米IU = International Unit 国际单位,（四）给药对象 adult; male; female; pregnancy 成人，男性，女性，孕妇children; infants; newborns 儿童，幼儿，新生儿adolescents 青少年debilitated patients 体弱患者elderly patients 老年患者pediatric 儿科的senile patients 老年患者(gerontal patient),（五）服药时间和次数 every hour; an hour; per hour; hourly 每小时 every day; a day; per day; daily 每天 every week; a week; per week; weekly 每星期 every month; a month; per month; monthly 每月 every other hour; two-hourly 每2小时（每隔1小时） every other day; two-daily 每2天（每隔1天） every other week; two-weekly每2星期（每隔1星期）,once a day 每日1次 twice a day 每天2次 three times a day 每天3次 four times a day 每天4次,（六）句型 1) Unless otherwise prescribed by the physician, the average daily dose is 1 capsule 3 times daily. 如医生不另开处方，平均日剂量为每日3次，每次一个胶囊。,2) For adults give intramuscular injection of 400 to 600 mg per day in 2-3 divided doses. For infants give intramuscular injection of 10-20 mg/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，分两次注射。,7. 不良反应与停药（一）常用标题1.不良反应 Adverse Reaction Unwanted ( Untoward ) Reaction (s),2. 副作用 Side Effects Side Reaction (s) Unwanted ( Undesirable ) Effects By-effects,（二）常用表达1. 停药 Abandon Withdrawn Terminate Discontinue Suspend Cessation,2. 毒性、耐受性 Toxicity 毒性 Tolerate (toleration) 耐受性 Tolerance (tolerability) 耐受性,3. 常见的毒副反应的症状及体征 allergic reactions 过敏反应local reaction 局部反应,skin reactions 皮肤反应 symptom (s) 症状 systematic 全身的 blood count 血细胞计数,anorexia 食欲减退,厌食症 coma 昏迷 nausea 恶心 vomiting 呕吐,dizziness 眩晕 fever 发热 flushing 潮红diarrhea 腹泻,pruritus 瘙痒 rash 皮疹 spasm 痉挛tiredness 疲倦,4. 常见的基本词汇及短语 acute 急性的 chronic 慢性的 common 常见的 irreversible 不可逆的,mild 轻微的 normal 正常的 rarely 罕见的,reversible 可逆的 severe 严重的 temporary 暂时的 transient 一过性的，短暂的,control( be controlled) 控制 diminish ( reduce, reduction) 减少 disappear 消失 encounter 遇到,give rise to 产生 include 包括 lead to 导致 manifest 表明,observe 观察 produce 产生 react to 对反应 result from 由.引起 result in 导致,treat (treatment) 治疗 appear 产生、出现 cause (be cause by) （由）引起 special care (caution) should be exercised 特别小心 include 包括,（三）常用句型Ciprofloxacin(环丙沙星) is generally well tolerated. The most frequently reported adverse reaction are: nausea, diarrhea, vomiting, dyspepsia, abdominal 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、不安、皮疹、头晕及瘙痒(itch)。,2. With high dosage continuous infusion (more than 200 mg/m2/day) over 5-7 days, the gastrointestinal complications are more pronounced and can on occasion lead to ileus. All side effects are reversible after cessation of therapy. 大剂量连续输注超过5-7日（超过200mg/m2/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。,8. 药品的注意事项（一）常用标题,（二）常见检查项目blood count 血细胞计数blood level 血浓度clotting time 凝血时间creatinine clearance 肌酐清除率kidney (renal) function 肾功能liver (hepatic) function 肝功serum concentration 血清浓度serum creatinine test 血清肌酐检查urine routine ( examination) 尿常规,（三）“遵医嘱”常用表示法under the supervision of 在.监督下under medical control 在医生监护下to the instruction of the physician 遵照医嘱consult their physician 找医生诊视require physicians permission 需有医生同意observe doctors orders 遵照医嘱not fail to observe doctors orders 必须遵医嘱,（四）常见句型1. Warning and precautionsCiprofloxacin(环丙沙星) should be used with caution in epileptics(癫痫患者) and patients with a history of CNS disorders and only if the benefits of treatment are considered to outweigh the risk of 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。,2. The most serious risk associated with anticoagulant(凝结剂) therapy with sodium warfarin(华法林钠) are hemorrhage in any tissue or organ and less frequently, necrosis(坏死) and/or gangrene(坏疽) of skin and other tissues. The risk of hemorrhage is related to the 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。,9. 禁忌症（一）常用标题 Contraindication 禁忌症 Restriction on use 限制使用 Contraindication and risks 禁忌症,（二）禁忌对象1. 孕妇pregnant women 孕妇during pregnancy and puerperium 在妊娠和产褥期the first 3 months of pregnancy 妊娠头三个月women of child bearing age 育龄妇女lactation 哺乳期early infancy 哺乳期,2. 过敏者allergic reaction 有过敏（变态）反应（者）hypersensitive to 对某药物过敏manifestation of allergy 过敏反应表现anaphylactic reaction 过敏反应3. 青光眼glaucoma 青光眼,4. 心、肾、肝病患者等cardiac failure 心力衰竭cardiac (renal ) insufficiency 心（肾）功能不全impairment of kidney (renal function) 肾功能损伤liver ( hepatic ) damage 肝损伤liver parenchyma damage 肝实质损伤hypertension 高血压severe hypotension 严重低血压diabetes 糖尿病severe anemia 严重贫血,（三）常用句型（省略句，只列出禁忌对象）1. Pregnancy, allergy to methotrexate(氨甲叶酸), functional disorders of liver and kidneys, diseases of the haematopoietic(造血) system ( bone marrow hypoplasia(发育不全，机能减退), leucopenia, thrombocytopenia, anaemia), infectious 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。,2. Do not take Benemid(丙磺舒) if prior administration resulted in hypersensitivity. Benemid is not recommended for persons with known disorders of the blood or uric acid kidney stones. Do not give Bebemid to children under two years of age.若以前使用丙磺舒曾引起过敏反应，则应禁用。已知有血液病患者及尿酸性肾结石的患者建议不要使用本品。二岁以下儿童不得使用。,10. 包装（一）常用标题Pack(s) (Packing(s) 包装Package(s) 包装Supply (Supplied) 包装Packing for Hospital 医院用包装Hospital (size) Packs 医院用包装Trade Packs (Packings) 商用包装Mode ( Form) of Issue 包装Supply for export 出口包装Commercially available packs 市场包装,（二）包装单位ampoule (s) 安瓿bottle 瓶box 盒canister 罐carton 纸盒pack 包sheet 张strip 条 tube 管 vial 玻璃小瓶blister pack 铝塑包装（水泡眼包装）,in tin 听装in form of strip 成张包装packed in sheets 成板片包装press-through-packed tablets 压片包装sterile powder blend in vials 无菌混合粉状瓶式包装in packs of 20 tablets 20片组合包装chemists pack 药店零售包装retail pack 零售包装,（三）剂型,（四）常见句型Mode of issueCeporan(先锋霉素) is issued in vials containing 250 mg, 500 mg, and 1 gram of cephaloridine(头孢噻定).包装方式：本品小瓶包装，内装250 mg，500 mg及1 g头孢菌素II (头孢噻啶) 。,2. Packing Bottle of 12 capsules 250 mg and 500 mg.Box of 12 capsules 250 mg in blister.Bottle for pediatri use (granulated): 20 g granulated contain 1 g ampicillin(氨苄青霉素). The content of the s