药品说明书翻译指南10
药品说明书英文翻译
Drug Instructions Manual English Translation IntroductionThe purpose of this document is to provide a comprehensive English translation of the drug instructions manual. This manual is intended to guide patients on the safe and effective use of the medication. It contains important information about the drug, including dosage, administration, possible side effects, and precautions. It is important for patients to carefully read and understand these instructions before taking the medication.Drug DescriptionThe drug is a medication that is used to treat a specific medical condition. It is available in the form of tablets and should be taken orally. The tablets are white in color and round in shape. Each tablet contains an active ingredient, which helps alleviate the symptoms associated with the condition.Dosage and AdministrationThe dosage of the drug may vary depending on the severity of the condition and the individual’s response to the treatment. It is important to follow the prescribed dosage as instructed by the healthcare professional. The tablets should be taken with a full glass of water and can be taken with or without food.It is important to not crush or chew the tablets, as they are formulated to be swallowed whole. If you have difficulty swallowing the tablets, consult your healthcare professional for alternative options.Possible Side EffectsLike any medication, the drug may cause certain side effects. It is important to be aware of these side effects to ensure prompt medical attention if necessary. Common side effects of the drug include nausea, headache, and dizziness. These side effects are usually mild and subside on their own.However, if you experience any severe or persistent side effects such as difficulty breathing, chest pain, or swelling of the face, it is important to seek immediate medical attention.PrecautionsBefore taking the medication, it is important to inform your healthcare professional about any existing medical conditions or allergies. Certain medicalconditions or allergies may interact with the drug and affect its effectiveness or cause adverse reactions.It is also important to inform your healthcare professional about any other medications or supplements you are currently taking. Some medications may interact with the drug and cause potential harm.StorageThe drug should be stored in a cool and dry place, away from direct sunlight and moisture. It should be kept out of reach of children and pets. Do not use the medication after the expiration date printed on the packaging.ConclusionThis is a summary of the drug instructions manual in English. It provides important information about the medication, including dosage, administration, possible side effects, and precautions. It is essential for patients to carefully read and understand these instructions before taking the medication to ensure the safe and effective use of the drug. If you have any questions or concerns, consult your healthcare professional for further guidance.。
药品英文说明书药品英文说明书
药品英文说明书药品英文说明书药品英文说明书药品英文说明书篇一:药品说明书英文翻译英语药品说明书的翻译英语药品说明书由以下12项内容组成，大多数英语药品说明书结构基本相同。
1. pakage insert (insert)说明书2. drug name (medicine) 药品名称3. description 性状4.action 作用 5. indication适应症6. contraindications 禁忌症 7. precaution注意事项 8. side effects副作用 9. dosage and administration 剂量和用法 10. dacking 包装 11.expiry 失效期 12. manufactring date (manu.date)出厂日期 13.reference 参考文献药品名称一、英语药品说明书一般用商品名，由生产厂家向该国政府有关部门申请注册正式名称，受该国政府法律保护，在药品名称的右上角有个?r的符号，意思是已经申请注册的法定名称，不可随意改变名称。
?r=recive 在药品之后有时issued to(for) the medical profession only短语，意:仅供医界参考。
r例:mobic ? issued to(for) the medical prfession.二、译法:分四种译法1. 音译:按英语读音用相应的汉字译出例:mobic莫比可 rifampicin利福平 2. 意译:按药品名称各组成部份的英语意义译成汉语例:streptomycine是由strepto和mycine组成，其中strepto(链球状)，mycine(霉素)，则按英语意思，译成:链霉素。
因此必须掌握大量前、后缀，才以准确翻译，此种译法多数是抗生素类药物。
nitroglycerine 由nitro(硝基)+glycerin(甘油)组成，则意为硝酸甘油aminophylline由amino+phylline译:氨茶碱 3. 音意并译:按英语药名组成，前面部份按音译，后面部份按意译。
英语药品说明书的翻译
英语药品说明书的翻译英语药品说明书由以下12项内容组成，大多数英语药品说明书结构基本相同。
1. Pakage Insert (Insert) 说明书2. Drug Name (Medicine) 药品名称3. Description 性状4. Action 作用5. Indication 适应症6. Contraindications 禁忌症7. Precaution 注意事项 8. Side Effects 副作用9. Dosage and Administration 剂量和用法 10. Dacking 包装失效期 12. Manufactring Date 出厂日期参考文献药品名称一、英语药品说明书一般用商品名，由生产厂家向该国政府有关部门申请注册正式名称，受该国政府法律保护，在药品名称的右上角有个○R的符号，意思是已经申请注册的法定名称，不可随意改变名称。
○R=Recive 在药品之后有时Issued to(for) the Medical profession only短语，意：仅供医界参考。
例：Mobic ○R Issued to(for) the medical prfession.二、译法：分四种译法1. 音译：按英语读音用相应的汉字译出例： Mobic 莫比可 Rifampicin 利福平2. 意译：按药品名称各组成部份的英语意义译成汉语例： Streptomycine 是由Strepto和mycine组成，其中Strepto(链球状)，mycine(霉素)，则按英语意思，译成：链霉素。
因此必须掌握大量前、后缀，才以准确翻译，此种译法多数是抗生素类药物。
Nitroglycerine 由Nitro(硝基)+glycerin(甘油)组成，则意为硝酸甘油Aminophylline由Amino+phylline 译:氨茶碱3. 音意并译：按英语药名组成，前面部份按音译，后面部份按意译。
药品说明书翻译指南
药品说明书翻译指南1:药品名称Drug Name“药品说明书”的英文表达方式有Inｓｔructｉｏns,Ｄiｒecｔionｓ，Ｄeｓcrｉｐtion。
现在多用Package Insert，或简称Iｎseｒt,也有用Leeflｅt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。
本系列具体讲述了进口药品说明书的语言特点及翻译方法。
虽然药品和食品不同,但通用的时候还是用得着的。
ﻫﻫ“药品说明书”的英文表达方式有Instruｃtions,Dｉrｅｃｔｉｏns,Ｄescｒiption。
现在多用Packａge Inｓerｔ,或简称Insert,也有用Ｌeeflｅt或Data S ｈeets。
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。
ﻫ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。
较简单的悦明书仅介绍成分、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、临床经验、药代动力学、庄意事项、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。
ﻫﻫ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；①药品名称(ＤruｇNamｅＳ)，②性状（Desｃｒiptioｎ），③药理作用（Ｐｈarmａcological Ａctiｏns)，④适应症(Indiｃatｉｏnｓ）,⑤禁忌证(Coｎｔrａiｎdicaｔiｏns)，⑥用量与用法（DO ｓagｅandＡdministratioｎ）.⑦不良反应(Ａdveｒse Reａcｔionｓ)。
药品英文说明书药品英文说明书
药品英文说明书药品英文说明书篇一：药品说明书英文翻译英语药品说明书的翻译英语药品说明书由以下12项内容组成，大多数英语药品说明书结构基本相同。
1. pa kageinser t (in sert)说明书2. drug name (med icine) 药品名称 3.descr iptio n 性状4. ac tion作用 5. indi catio n适应症6. con train dicat ions禁忌症7. pre cauti on注意事项 8.sideeffec ts副作用 9. d osage andadmin istra tion剂量和用法 10.dacki ng 包装 11.e xpiry 失效期12. m anufa ctrin g dat e (ma nu.da te)出厂日期 13.refe rence参考文献药品名称一、英语药品说明书一般用商品名，由生产厂家向该国政府有关部门申请注册正式名称，受该国政府法律保护，在药品名称的右上角有个○r的符号，意思是已经申请注册的法定名称，不可随意改变名称。
○r=re cive在药品之后有时iss ued t o(for) the medi cal p rofes siononly短语，意：仅供医界参考。
r例： mob ic ○issue d to(for)the m edica l prf essio n.二、译法：分四种译法1. 音译：按英语读音用相应的汉字译出例：mobic莫比可r ifamp icin利福平 2.意译：按药品名称各组成部份的英语意义译成汉语例：strep tomyc ine是由strep to和my cine组成，其中s trept o(链球状)，myc ine(霉素)，则按英语意思，译成：链霉素。
药品说明书翻译指南
药品说明书翻译指南药品说明书翻译指南1：药品名称Drug Name“药品说明书”的英文表达方式有Instructions，Directions，Description。
现在多用Package Insert，或简称Insert，也有用Leeflet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。
本系列具体讲述了进口药品说明书的语言特点及翻译方法。
虽然药品和食品不同，但通用的时候还是用得着的。
“药品说明书”的英文表达方式有Instructions，Directions，Description。
现在多用Package Insert，或简称Insert，也有用Leeflet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。
较简单的悦明书仅介绍成分、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、临床经验、药代动力学、庄意事项、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；①药品名称（Drug NameS），②性状（Description），③药理作用（Pharmacological Actions），④适应症（Indications），⑤禁忌证（Contraindications），⑥用量与用法（DOsage and Administration）．⑦不良反应（Adverse Reactions）。
药品英文说明书翻译
药品英文说明书翻译篇一：英语药品说明书的翻译英语药品说明书的翻译英语药品说明书由以下12项内容组成，大多数英语药品说明书结构基本相同。
1. Pakage Insert (Insert)说明书2. Drug Name (Medicine) 药品名称3. Description 性状4. Action 作用5. Indication适应症6. Contraindications 禁忌症7. Precaution注意事项 8. Side Effects副作用9. Dosage and Administration 剂量和用法10. Dacking 包装11.Expiry 失效期 12. Manufactring Date (Manu.date)出厂日期13.Reference 参考文献药品名称一、英语药品说明书一般用商品名，由生产厂家向该国政府有关部门申请注册正式名称，受该国政府法律保护，在药品名称的右上角有个○R的符号，意思是已经申请注册的法定名称，不可随意改变名称。
○R=Recive在药品之后有时Issued to(for) the Medical profession only短语，意：仅供医界参考。
R例：Mobic ○Issued to(for) the medical prfession.二、译法：分四种译法1. 音译：按英语读音用相应的汉字译出例： Mobic莫比可 Rifampicin利福平2. 意译：按药品名称各组成部份的英语意义译成汉语例： Streptomycine是由Strepto和mycine组成，其中Strepto(链球状)，mycine(霉素)，则按英语意思，译成：链霉素。
因此必须掌握大量前、后缀，才以准确翻译，此种译法多数是抗生素类药物。
Nitroglycerine 由Nitro(硝基)+glycer(本文来自： 小草范文网:药品英文说明书翻译)in(甘油)组成，则意为硝酸甘油 Aminophylline由Amino+phylline译:氨茶碱3. 音意并译：按英语药名组成，前面部份按音译，后面部份按意译。
药品说明书翻译指南
药品说明书翻译指南1. 介绍1.1 目的和范围此文档旨在提供一份详尽的药品说明书翻译指南，以帮助专业人士准确、清晰地将原始语言中的医学术语和信息转化为目标语言。
1.2 定义与缩写解释- 药物：用于预防、治疗或者改善健康状态的任何物质。
- 翻译：将源语言（原始文本）转换成目标语言（要求被传达给另一个群体/读者）。
2. 准备工作在开始进行药品说明书翻译之前，请务必完成以下步骤：2.1 收集资料a) 原始文件: 获取需要进行翻译处理的完整且最新版本电子格式文件；b) 参考材料: 包括相关法规、行业惯例及其他可参考资源；c) 典型用户画像: 针对产品使用对象所需特定背景知识。
3.注意事项在进行药品说明书翻译时，请遵循以下建议：3.１保持准确性a）理解原文：确保对源语言的理解准确，特别是医学术语和药物相关信息；b）遵循规范：按照国际、地区或行业标准进行翻译，并尽量使用已确认的专业术语。
3.２注意清晰度a) 使用简明易懂的句子结构和表达方式；b) 避免歧义性及模棱两可的描述；4. 翻译流程在开始正式翻译之前，请根据以下步骤制定一个合适且高效率工作计划：4.1 分析与策略a）仔细阅读并分析原始文件内容以确定其整体结构、主题等重要元素。
b）了解目标用户群体需求, 并针对不同类型用户调整相应风格与用字选择。
4.2 确认关键术语核实所有涉及到药品名称、剂型、成份等核心信息是否正确无误。
４.３开展初稿按章节顺序将每个段落从源文字转换为目标文字，并在此过程中记录任何需要进一步讨论或验证事项。
5.质量控制完成初稿后，请进行以下质量控制步骤以确保最终翻译的准确性和一致性：5.1 校对将初稿与原始文件逐行核对，纠正任何错误、遗漏或不符合要求之处。
５.２审校邀请专业人士（如医生、药剂师等）参与审查并提供反馈意见。
6.附件- 原文档：[在此插入]7. 法律名词及注释在本文中使用到的法律名词及其解释：a) 药品监管机构: 指国家级或地区级部门，负责管理和监督药物相关事务；b) GMP (Good Manufacturing Practice): 是指为了获得高度稳定且可靠产品而执行的规范化操作标准；8. 结束语此次药品说明书翻译指南旨在协助从事该领域工作人员更好地理解并完成相应任务。
英语药品说明书的翻译
英语药品说明书的翻译英语药品说明书由以下12项内容组成，大多数英语药品说明书结构基本相同。
1. Pakage Insert (Insert) 说明书2. Drug Name (Medicine) 药品名称3. Description 性状4. Action 作用5. Indication 适应症6. Contraindications 禁忌症7. Precaution 注意事项8. Side Effects 副作用9. Dosage and Administration 剂量和用法10. Dacking 包装11.Expiry 失效期12. Manufactring Date (Manu.date)出厂日期13.Reference 参考文献药品名称一、英语药品说明书一般用商品名，由生产厂家向该国政府有关部门申请注册正式名称，受该国政府法律保护，在药品名称的右上角有个○R的符号，意思是已经申请注册的法定名称，不可随意改变名称。
○R=Recive在药品之后有时Issued to(for) the Medical profession only短语，意：仅供医界参考。
例：Mobic ○R Issued to(for) the medical prfession.二、译法：分四种译法1. 音译：按英语读音用相应的汉字译出例：Mobic 莫比可Rifampicin 利福平2. 意译：按药品名称各组成部份的英语意义译成汉语例：Streptomycine 是由Strepto和mycine组成，其中Strepto(链球状)，mycine(霉素)，则按英语意思，译成：链霉素。
因此必须掌握大量前、后缀，才以准确翻译，此种译法多数是抗生素类药物。
Nitroglycerine 由Nitro(硝基)+glycerin(甘油)组成，则意为硝酸甘油Aminophylline由Amino+phylline 译:氨茶碱3. 音意并译：按英语药名组成，前面部份按音译，后面部份按意译。
药品说明书、标签管理规定的英文翻译
Administrative Regulation for Insert and packaging Labels of drug(SFDA Order No.24)State Food and Drug Administration OrderNo.24“Administrative Regulation for Insert and packaging Labels of Drug” had been evaluated & agreed by the management meeting of SFDA by Mar.10, 2006, and publish here, the same to be implemented since June 1st, 2006.SFDA Director: Shao Ming LiMar. 15, 2006 Administrative Regulation for the Insert and Packaging Labels of DrugSection I General rulesNo.1 For standardizing the administration for the insert and packaging labels of drug on the basis of “Drug Administration law of the P. R. of China” and “Regulations for Implementation of the Drug Administration Law of the P. R. of China”.No.2 Relevant inserts and packaging labels for all the drugs which are sold in china to be in line with the requirements from present regulation.No.3 The Inserts and packaging labels of drugs should be approved by SFDA.The packaging labels of drugs to be drafted as per the insert, their text should not exceed the range of insert, and should not contain the character and mark which suggests the efficacy, mislead uses and unsuitable publicity the product.No.4 The label should be printed or stickled on the package for drug as per relevant regulations, and can’t carry any other character, audiovisual, or material for introduction or publication propaganda for product and / or manufacturer.The smallest pack sold in market from the pharmaceutical manufacturer should contain insert.No.5 The text expression for drug’s insert and labels should be scientific, standard and accurate.The text expression for the insert for OTC drug should be easy for understanding for the patients whom could be able to self judges, selects and uses.No.6 The text of drug’s insert and labels should be clear and easy to be differentiated, the mark should be clear and striking, the appearance with dropping words or unstick etc. should not appear, and can't be modified or supplemented by sticking, cutting or altering.No.7 The standard Ch. Character published by State Spoken and Written Language Committee should be used for the insert and labels of drug, the Ch. Character expression will be the criterion when has additional other language for reference.No.8 For the purpose of protecting the public health and guiding the drug to be used by a right and rational way, the pharmaceutical manufacturer may raises forwardly to add the warnings on the drug’s insert or labels, SFDA also may require relevant pharmaceutical manufacturer to add the warnings on the insert or labels.Section II Drug’s insertNo.9 Drug’s insert should contain the important and scientific data, results and information about the safety and efficacy of drug, so that can be able to guide the safe and rational uses of drug.The detail format, contents and written requirement for drug’s insert are drafted and issued by SFDA.No.10 The expression of the disease names, pharmaceutical specialized nouns, drug name, clinical test names and results in the drug’s insert should use the special and standard vocabulary or that one issued by state, and the weights and measures to be in line with the requirements of national standard.No.11 All the APIs or crude drugs in the formula to be listed in the drug’s insert. All the excipients for the injection and OTC drugs are also to be listed in the insert.That’s to be indicated if the formula contains the ingredient(s) or excipient(s) which may cause a serious adverse reaction.No.12 The pharmaceutical manufacturer should track forwardly the safety and efficacy status of drug post market, and should raise the application in time for the modification of drug’s insert if necessary.According to the monitor results for the adverse reactions of drug and the re-evaluation of drug, SFDA also may require the pharmaceutical manufacturer to modify the drug’s insert. No.13 The pharmaceutical manufacturer should inform the modified contents to relevant pharmaceutical business companies, used units and the concerned depts. immediately after the modified insert was approved, and implement the modified insert and labels in time as per the requirements.No.14 Drug’s insert should contain enough information of adverse reactions of drug, and indicate the adverse reactions in detail. If the pharmaceutical manufacturer had not modified the insert in time on the basis of the safety and efficacy status of drug post market or didn’t indicate enough the adverse reactions of drug in the insert, the harmful result caused to be borne by relevant manufacturer.No.15 The approval date and revised date of drug’s insert to be indicated clearly in the insert.Section III Labels of drugNo.16 The labels of drug refer to the contents which are printed or pasted in the package of drug, it divides into internal label or outer label. The internal label refers to that label used for immediate pack, and the outer label refers to that labels used for other packs except internal label.No.17 The internal label of drug should contain the contents of generic name, indications or efficacy, strength, dosage and administration of drug, mfg date, batch No. expiry date, manufacturer etc.If the pack size is too small and can’t be able to cover all the contents above, at least, that contents of generic name of drug, strength, batch No., expiry date etc. should be indicated. No.18 The outer label of drug should indicate the contents of the generic name of drug, ingredient(s), description, indications or efficacy, strength, dosage and administration, adverse reactions, contraindication, warnings & precautions, storage, mfg date, batch No.permission No., manufacturer etc. If the full contents of indications or efficacy, dosage and administration, adverse reactions, contraindication and warnings & precautions can’t be able to be covered, then the major contents to be indicated and note “that details are exhibited in the insert”.No.19 Shipper label should indicate the necessary contents of the generic name of drug, strength, storage, mfg date, batch No., expiry date, permission No., manufacturer etc., also may indicate the package quantity and transport warnings and other mark if necessary.No.20 The label for API should indicate the necessary contents of drug name, storage, mfg date, batch No., expiry date, specification No., permission No., manufacturer etc., and also indicate the pack side and the transport warnings.No.21 For the same drug with same strength and pack size from the same pharmaceutical manufacturer, the text, format and color of the label to be same, for the different strength or pack size, the label should be clearly different or the strength to be indicated clearly.The same drug from the same pharmaceutical manufacturer which is administered for prescription drug as well as OTC drug, the color for both packages should be clearly distinguished respectively.No.22 For the drug which storage has special requirement, the storage to be indicated in a striking place of the label.No.23 The expiry date in the label of drug should be labeled as per the sequence of year-month-date, the year is expressed as 4 numerals, the month and the date is expressed as 2 numerals respectively. The detail format is labeled as expiry by “XXXX year XX month” or “expiry by XXXX year XX month XX date”, also may be labeled as “expiry by XXXX.XX.”or “expiry by XXXX/XX/XX” etc. with the numeral or other symbol.The expiry period for preventative biological products should be labeled as per the SFDA approval specification. For the biological products for treatment, the expiry period to be counted since the repackaging date, but for other drugs, that to be counted since mfg. Date.If the expiry period is labeled up to the date, then the expiry date should be the previous date corresponding the year-month-date against the initial date. If the expiry period is labeled up to the month, then the expiry date should be the previous month corresponding the year-month against the initial date.Section IV Use of drug name and registered trademarkNo.24 The drug name labeled in the insert and labels should be in line with the nominated principle for drug generic name and brand name which is issued by SFDA, and identical with the approval certificate.No.25 The generic name of drug should be notable and outstanding, its font, size and color should be accordant, and in line with the requirements below:(1)For the horizontal label, the generic name of drug should be exhibited within the upperthird area at a marked place.For the standing label, the generic name of drug should be exhibited within the third areaof right at a marked place.(2)The font which is not easy to be identified, i.e. grass hand, seal character can’t beselected, and the font can’t be modified with italic, central emptily, hatching forms etc.(3)The color of font should be black or white, to produce a strong contrast against the tintor dark background.(4)The generic name can’t be written in different rows except the pack size is too small andthe full name can’t be exhibited.No.26 The brand name can’t be set in the same row with the generic name, the font and color of brand name is not more extrusive and distinct than the generic name, the area of single font is not more than the half area of the font of generic name.No.27 The trademark which is not registered and other drug name which is not approved by SFDA are inhibitive to be used for the insert and labels of drug.The registered trademark which is used for drug label should be printed in the side cornerof drug label, if it contains the character, then the area of single font is not more than thequadrant area of the generic name.Section V Other regulationNo.28 For the anaesthetic, psychoactive, medical toxicity drug, radioactive drug and the drug for exterior use and OTC etc. which has special mark issued by state, their inserts and labelsshould print the special mark. The insert and labels which have special requirement will be identified by SFDA.No.29 The administrative regulation for the labels of crude Chinese traditional medicine or dry pieces will be drafted by SFDA by supplementary document.No.30 The insert and labels of drug which didn’t complied with this regulation to be punished as per relevant requirements Drug Administration law of the P. R. of China.Section VI Supplementary articlesNo.31 This regulation will be implemented since June 01, 2006. The SFDA Order No.23 issued by Oct 15, 2000 will be disused synchronously.。
药品说明书翻译资料
中药材GAP是Good Agricultural Practice的缩写，直译为"良好的农业规范",GAP是中药材生产质量规范的简称.GMP是"Good Manufacture Practice"的缩写，中文即药品生产质量管理规范，是国际通用的药品生产质量管理标准。
美国食品和药物管理局（简称FDA）率先颁布了GMP，为规范制药开创了先河.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,principalindications,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)八.adverse reactions（不良反应）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 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）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。
英语药品说明书的翻译
英语药品说明书的翻译英语药品说明书由以下12项内容组成，大多数英语药品说明书结构基本相同。
1. Pakage Insert (Insert) 说明书2. Drug Name (Medicine) 药品名称3. Description 性状4. Action 作用5. Indication 适应症6. Contraindications 禁忌症7. Precaution 注意事项8. Side Effects 副作用9. Dosage and Administration 剂量和用法10. Dacking 包装11.Expiry 失效期12. Manufactring Date (Manu.date)出厂日期13.Reference 参考文献药品名称一、英语药品说明书一般用商品名，由生产厂家向该国政府有关部门申请注册正式名称，受该国政府法律保护，在药品名称的右上角有个○R的符号，意思是已经申请注册的法定名称，不可随意改变名称。
○R=Recive在药品之后有时Issued to(for) the Medical profession only短语，意：仅供医界参考。
例：Mobic ○R Issued to(for) the medical prfession.二、译法：分四种译法1. 音译：按英语读音用相应的汉字译出例：Mobic 莫比可Rifampicin 利福平2. 意译：按药品名称各组成部份的英语意义译成汉语例：Streptomycine 是由Strepto和mycine组成，其中Strepto(链球状)，mycine(霉素)，则按英语意思，译成：链霉素。
因此必须掌握大量前、后缀，才以准确翻译，此种译法多数是抗生素类药物。
Nitroglycerine 由Nitro(硝基)+glycerin(甘油)组成，则意为硝酸甘油Aminophylline由Amino+phylline 译:氨茶碱3. 音意并译：按英语药名组成，前面部份按音译，后面部份按意译。
药品说明书翻译
药理作用
药理作用(Pharmacological Actions)。其内 容主要包括药理作用、临床药理(Clinical Parmacology)、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： Pharmacological Action 药理作用 Pharmacological Properties 药理性质 Pharmacology 药理学 Clinical Pharmacology 临床药理
Description（性状）
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 特点：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。
相关法律法规
中华人民共和国药品管理法 药品包装、标签和说明书管理规定 进口药品管理办法 第六章 药品名称、包装、标签和说明书 第三十四条 进口药品必须使用中文药品名称，必须符合 中国药品命名原则的规定。 第三十五条 进口药品的包装和标签，必须用中文注明药 品名称、主要成分以及注册证号，进口药品必须使用中文 说明书。 第三十六条 进口药品的包装、标签和说明书，必须符合 中国《药品包装、标签和说明书管理规定》，并经国家药 品监督管理局批准后使用。一经有： Actions 作用 Actions and 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 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
用药说明书英语翻译
用药说明书英语翻译小编为大家整理了用药说明书英语翻译。
一起来学习一下吧!一、For skin patches:皮肤膏Apply the patch to a clean, dry skin area that has little or no hair and is free of scars, cuts, or irritation. Remove the previous patch before applying a new one.将膏药贴在没有毛发或毛发很少、无疤痕、无伤口、无发炎、干净、干燥的皮肤部位。
Apply a new patch if the first one becomes loose or falls off.如所贴膏药已松开或脱落，请更换新膏药。
Apply each patch to a different area of skin to prevent skin irritation or other problems.每贴膏药应贴在不同部位，以避免刺激皮肤或导致其他问题。
Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.不要因为药量大小而裁剪膏药。
如药物作用不够，可咨询医生。
二、For inhalers:吸入器Medicines that come in inhalers usually come with patient directions. Read the directions carefully before using the medicine. If you do not understand the directions, or if you are not sure how to use the inhaler, check with your doctor.吸入性药物通常伴有病人用药说明。
英语药品说明书的翻译
-英语药品说明书的翻译英语药品说明书由以下12项内容组成，大多数英语药品说明书结构基本相同。
1. Pakage Insert (Insert) 说明书2. Drug Name (Medicine) 药品名称3. Description 性状4. Action 作用5. Indication 适应症6. Contraindications 禁忌症7. Precaution 注意事项8. Side Effects 副作用9. Dosage and Administration 剂量和用法10. Dacking 包装11.Expiry 失效期12. Manufactring Date (Manu.date)出厂日期13.Reference 参考文献药品名称一、英语药品说明书一般用商品名，由生产厂家向该国政府有关部门申请注册正式名称，受该国政府法律保护，在药品名称的右上角有个○R的符号，意思是已经申请注册的法定名称，不可随意改变名称。
○R=Recive在药品之后有时Issued to(for) the Medical profession only短语，意：仅供医界参考。
例：Mobic ○R Issued to(for) the medical prfession.二、译法：分四种译法1. 音译：按英语读音用相应的汉字译出例：Mobic 莫比可Rifampicin 利福平2. 意译：按药品名称各组成部份的英语意义译成汉语例：Streptomycine 是由Strepto和mycine组成，其中Strepto(链球状)，mycine(霉素)，则按英语意思，译成：链霉素。
因此必须掌握大量前、后缀，才以准确翻译，此种译法多数是抗生素类药物。
Nitroglycerine 由Nitro(硝基)+glycerin(甘油)组成，则意为硝酸甘油Aminophylline由Amino+phylline 译:氨茶碱3. 音意并译：按英语药名组成，前面部份按音译，后面部份按意译。
药品英文说明书翻译
药品英文说明书翻译篇一：英语药品说明书的翻译英语药品说明书的翻译英语药品说明书由以下12项内容组成，大多数英语药品说明书结构基本相同。
1. Pakage Insert (Insert)说明书2. Drug Name (Medicine) 药品名称3. Description 性状4. Action 作用5. Indication适应症6. Contraindications 禁忌症7. Precaution注意事项 8. Side Effects副作用9. Dosage and Administration 剂量和用法10. Dacking 包装11.Expiry 失效期 12. Manufactring Date (Manu.date)出厂日期13.Reference 参考文献药品名称一、英语药品说明书一般用商品名，由生产厂家向该国政府有关部门申请注册正式名称，受该国政府法律保护，在药品名称的右上角有个○R的符号，意思是已经申请注册的法定名称，不可随意改变名称。
○R=Recive在药品之后有时Issued to(for) the Medical profession only短语，意：仅供医界参考。
R例：Mobic ○Issued to(for) the medical prfession.二、译法：分四种译法1. 音译：按英语读音用相应的汉字译出例： Mobic莫比可 Rifampicin利福平2. 意译：按药品名称各组成部份的英语意义译成汉语例： Streptomycine是由Strepto和mycine组成，其中Strepto(链球状)，mycine(霉素)，则按英语意思，译成：链霉素。
因此必须掌握大量前、后缀，才以准确翻译，此种译法多数是抗生素类药物。
Nitroglycerine 由Nitro(硝基)+glycer(本文来自： 小草范文网:药品英文说明书翻译)in(甘油)组成，则意为硝酸甘油 Aminophylline由Amino+phylline译:氨茶碱3. 音意并译：按英语药名组成，前面部份按音译，后面部份按意译。
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药品说明书翻译指南10：贮存 Storage
发布日期：2011-08-03 浏览次数：131
核心提示：药品说明书——贮存的语言特点及翻译方法。
“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) 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
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 Stroe 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 at a emperature below +20℃.
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 in a dry place at a temperature 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 be stored at 4℃or up to one week.
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 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. Store at controlled room temperature (59一86F, 15℃一30℃). Dispense in al tight, light-resistant 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℃一30℃）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 the refrigerator, protected against exposure to light. The concentrate may be stored in the dark, at room temperature for 24 hours, or at refrigerator temperatures for one week with minimal loss of potency and clarity. Any unused 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。