英文药品说明书.doc
制药专业英语-药品说明书
第四节 适应症（Indications）
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
偶尔也会见到其他的表示方法。
gram-negative microorganisms（bacteria）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。
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）
常用词及短语举例
名词
ability 能力 activity 活性 distribution 分布 excretion 排泄
action 作用
clearance 廓清率
effect on 对…的作用
英文药品说明书
3．音、意合译：
药品英文名称中只有一部分显示化学 基团者采用音意合译。
如：medemycin ; Indobufen; coumadin(coumarrin 香豆素); codein phosphas;
4．中文译名的转化现象： vitamin ; penicillin; hormone; atropine
翻译药名名称注意：
1）药物与酸形成的盐 中文名是酸在前药名在后，英文相反。
2）药物与碱金属形成的盐 中文药名在前而碱金属在后，英文相同 3）考虑化学名称重点字头，又考虑同类药名的名称的系列 化（即相同的词头、词干或词尾） 如：Ceforanide ceforxadine cefotazidime Cefotetan Pefloxacin Norfloxacin Ofloxacin 4）记住一些药品英文名称的常用词首和词尾
tablets 片剂;
solubility 溶解度 injection 注射剂
• solution 溶液; • sterile 无菌的；
• molecular formular 分子式 molecular weight 分子量 • structure 结构； derivative 衍生物；
例1．
Folic acid is a yellowish to orange, crystalline powder; odourless or almost odourless.
例3． Ursosan Tablet 50mg is a white plain tablet which contains 50mg of ursodesoxycholic 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 vials containing 10mg and 50mg of doxorubicin hydrochloride with lactose.
全英文药品说明书
全英文药品说明书导读：Expiration Date：The expiration date is the last day that the medicine can be used and still be considered effective. It is usually printed on the package or label of the product.Expiration Date：The expiration date is the last day that the medicine can be used and still be considered effective. It is usually printed on the package or label of the product.药品说明书应包括下列内容：1. 首先，确认要修改的药品说明书条款的准确内容，并确定修改的理由。
2. 根据药品法律法规，药品说明书的条款修改必须经过严格的审批流程，由相关部门审批后方可生效。
3. 确定修改后的条款内容，将其写入新的药品说明书中。
4. 进行审批，要求所有审批人对新的药品说明书条款进行签字确认。
5. 把新的药品说明书条款复制到相应的位置，如互联网、报刊、包装上等，以便消费者得到正确的信息。
6. 完成审批，将新的药品说明书条款替换旧的条款，并在药品说明书上注明修改日期，以便消费者得到正确的信息。
药品说明书应包括的条款：答：药品说明书只修改包装规格不能有效地改变药品的功能、用量、剂型、含量和用法等其他内容，仅修改包装规格对药品的有效性是没有影响的。
因此，药品说明书只修改包装规格是有效的。
在此情况下，由于并不改变药品的有效成分及其他有关要求，药品说明书只修改包装规格也依然有效。
岗位说明书填写说明范本示例为进一步完善岗位管理，优化人力资源配置，强化岗位职责和目标考核，明确岗位权责边界，提高岗位人员工作效率，结合公司实际，现将编制岗位说明书有关工作通知如下：一、编制岗位范围各分子公司、各部门所有岗位二、岗位说明书基本结构岗位说明书填写说明1.岗位名称：按本岗位规范名称填写，力求准确、简明、规范。
英文药品说明书的写
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
一、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： Angina pectoris, Prinzmetal’s angina, hypertension 心绞痛，变异性心绞痛，高血压。 2 、 由For（或In等）引出的短语，例如： For prevention of the advance of cataract. 用于预防白内障进展。 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。
intraarterially静脉内给药mouthos口服intragluteallyphleboclysis静脉输液intramuscularlyintramusculariminjection肌肉注射intraperitoneallyintravenousivinjection静脉注射intrapleurallyintraarticataradministration关节内给药intrathecallyintramuscularadministrationrouteintravenously静脉内给药intranasalroutelocally局部给药orally口服给药parenterally肠道外给药intraperitonealadministrationsubconjunctivally结膜下给药intravenousinfusionperfusion静脉输注subcutaneously皮下给药sublingually舌下给药5给药方式的表示法续submucously粘膜下给药intrathecaladministrationaerosol喷雾给药subligualadministration舌下给药dripphleboclysis点滴静脉输液perrectum直肠给药enema灌肠pervaginum阴道给药lumbar腰椎给药prorecto直肠给药6表示投药的常用动词administeradministeredgivebegivenindicateindicated给药投药useusedemploybeemployed用药recommendrecommendedsuggestbesuggested推荐7表示不同的用药方式的动词
药 品 英 文 说 明 书
Administration and dosage
Tableis
adults; 1tablet 3-4 time daily.
Small children; ½ tablet 2-3 time daily.
• 出 厂 日 期 (Manufacturing
(Dosage and Administration) Date)
• 注意事项 (Note)
• 其他 (Others)
• 副作用 (Side Effects)
2020/4/7
药品性状 Description
• Composition(成分) • ingredients(主要成分) • formula(分子式) • molecular weight(分子量) • property（性质） • pharmacological potency(药效); • pharmacological action(药理作用) • Solubility (溶解度)
2020/4/7
注意事项
• Precaution • Remark • Note/notice • warning
2020/4/7
副作用, 禁忌症
• 副作用:After effects, by-effects, side reaction/effects
• 毒性:Toxicity • 耐受性:Tolerance • 禁忌症:contraindication
药品英文说明书
2020/4/7
药品英文说明书的基本结构
• 药品名称（Drug name)
• 禁忌症 (Contraindications)
英文的药品说明书
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Pharmocology（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）。
《英文药品说明书》课件
Adjusting word order
Based on the expression habits of the target language, adjust the word order appropriately to make the translation more natural and fluent.
Understanding logical relationships
When translating drug instructions, one should understand the logical relationships in the original text to ensure that the translation is clear and logically rigorous.
Well written English drug instructions can enhance the credibility and attraction of drugs, increasing sales opportunities
They provide detailed information about the usage, dosage, side effects, and storage of bugs, ensuring that sales representatives can present accurate and related information to potential customers
药 品 英 文 说 明 书
• 分为三份，每八小时一次
➢ Divided into… doses ,every … hours
• 分为若干份，每…时一次
➢ Into two or three equally divided doses
➢ 2 g per day in 2 equally divided doses
• 每日2克，分为二等份
➢ Parenterally（肠道外给药）
➢ Intramuscularly（肌肉注射）
➢ Intravenously（静脉注射）
➢ Subcutaneously (皮下注射）
精选pห้องสมุดไป่ตู้t
6
注意事项
• Precaution • Remark • Note/notice • warning
精选ppt
7
成人：每次1片， 一日3－4次。 小儿：每次1/2片， 一日1次。 本片剂应在餐间 服用，以少许水 整个吞服。 针剂 每次1瓶，一日2 －3次，肌肉或缓 慢静注射。儿童 剂量应相应减少。
12
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batch批号antistineantistineantihistamineallergicaffectionsantihistamineallergicaffections安替司丁治疗过敏性病症的抗组胺剂治疗过敏性病症的抗组胺剂propertiesantistineeitherattenuates削histamine组胺whichplaysmajorroleprovokingallergic过敏的disorders
Ampoules
1 ampoule, given by
英文药品说明书范文
英文药品说明书范文Drug Name: Acitretin CapsulesDescription: Acitretin is a retinoid, related to vitamin A. It is used to treat severe psoriasis, and other skin conditions, as well as nail dystrophies.Indications: Acitretin capsules are indicated for the treatment of severe psoriasis and other skin conditions. It is also used to treat nail dystrophies.Dosage and Administration: The dosage of Acitretin should be individualized. The usual starting dose is 10 to 25 mg oncedaily on an empty stomach. The dose may be increased or reduced depending on the response. The maximum daily dose should not exceed 50 mg.Contraindications: Acitretin is contraindicated in patients with a history of porphyria, sensitivity to any retinoid, hepatic failure, or a history of alcohol abuse.Warnings and Precautions: Acitretin should be used with caution in patients with liver or kidney disease. It should also be used with caution in pregnant women and nursing mothers. Women of childbearing potential should use adequate contraception during treatment and for three years after stopping treatment.Overdose: In case of an overdose, immediately seek medical attention.Storage: Acitretin should be stored at room temperature, away from heat and direct light.Conclusion: Acitretin is an effective and well-tolerated treatment for severe psoriasis, other skin conditions, and nail dystrophies. Patients should closely follow their doctor’s instructions for receiving the best results from the treatment.。
专业英语药品说明书
Medemycin（麦迪霉素）
➢ 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。
Reserpine（利血平）; Webilin（胃必灵） ; Legalon（利肝隆 ）
3
2024/6/27
ENGLISH FOR SUTDENTS OF VETERINARY SCIENCE
药品的化学名称反映出该药品的化学结构组成成分
动
物 ➢ 2 g per day in 2 equally divided doses
医
学 • 每日2克，分为二等份
院
➢ 100 units twice daily
• 每日2次，每次100 单位
➢ 100 to 200 units per kg body weight in 6 divided doses
南
农 业
毒性
大
学 动
➢ Toxicity
物 医
耐受性
学
院 ➢ Tolerance
禁忌症
➢ contraindication
12
2024/6/27
ENGLISH FOR SUTDENTS OF VETERINARY SCIENCE
包 装 Package
剂型
➢ Tablets(糖衣片，sugar-coated tablets), dragees（糖衣丸）,
Administration and dosage（用法和剂量）
Tables
湖 南
adults; 1tablet 3-4 time daily.
农 业
Small children; ½ tablet 2-3 time daily.
大 学
The tablets should be taken during meals and
英文药品说明书共66页文档
中药药名的翻译
P90
中药名英译：
保和丸 泻白散 肾气丸 消风散
玉女煎 桃花汤 紫雪丹 白虎汤
中药名英译：
保和丸 泻白散 肾气丸 消风散
Digestion-promoting Pill Lung-Heat Expelling Powder
Pill for Invigorating Kidney Energy
常用的词语
表示性质的一些词类，如：
crystalline 结晶的
injection 注射剂
insoluble 不溶的
soluble 可溶的
odo(u)r 气味ess 无色的
sterile 无菌的
solution 溶液
tablets 片剂
liquid 液体 solid 固体
2．Intralipid is a white opaque fat emulsion for intravenous injection. 本品为白色，不透明，供静脉注射用脂肪乳剂。
常见的句型
3．熊去氧胆酸片为白色素片，每片含50mg熊去氧胆 酸(ursodesoxycholic acid) 。 Ursosan Tablet is a white plain tablet which contains 50mg of ursodesoxycholic acid.
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 is a white to off-white, crystalline solid, poorly soluble in water, dilute acid and most organic solvents.
药 品 英 文 说 明 书
药品英文说明书的基本结构
• 药品名称（Drug name) • 禁忌症 (Contraindications)
• 药品性状 (Description)
• 药品的适用症 (Indications) • 剂量与用法
• 包装 (Packing)
• 失效期 (Expiry Ding Date)
剂量与用法
• • • • • Divided into three, eight-hourly doses 分为三份，每八小时一次 Divided into… doses ,every … hours 分为若干份，每…时一次 Into two or three equally divided doses 2 g per day in 2 equally divided doses 每日2克，分为二等份 100 units twice daily 每日2次，每次100 单位 100 to 200 units per kg body weight in 6 divided doses 每公斤体重用100～200 单位，分6次给药
• warning
副作用, 禁忌症
• 副作用:After effects, by-effects, side reaction/effects
• 毒性:Toxicity
• 耐受性:Tolerance • 禁忌症:contraindication
包 装 Package
剂型 Tablets (糖衣片，sugar-coated tablets), dragees（糖衣 丸）, capsules（胶囊）; Injection（注射剂), drops（滴剂）, suppository（栓剂） 包装
药品说明书英文
英文的药品说明书Drug InstructionIf you are going to use this medicine, please read the following instructions carefully before use.1、Dosage and UsageThe recommended dosage for adults and children over 12 years of age is 100mg taken orally once a day. Children between 6 and 12 years of age should take 50mg once a day. The maximum daily dosage for all age groups should not exceed 400mg.2、Precautions and Cautionsa. This medicine is only for oral use and should be taken on an empty stomach.b. This medicine should be used within 48 hours after opening the bottle. Unused medicine should be discarded.c. This medicine is not recommended for use in children under6 years of age, pregnant women, breastfeeding mothers, or people with liver or kidney disease.d. If you experience any adverse reactions after taking this medicine, please stop using it immediately and consult a doctor.3、StorageThis medicine should be stored at room temperature and protected from light. Keep the medicine out of the reach of children.4、Expiration DateThe expiration date of this medicine is 24 months after production.5、Manufacturer WarrantyThis medicine is produced by ABC Pharmaceutical Co., Ltd., and is distributed by XYZ Pharmacy. If you have any questions or concerns, please contact the manufacturer for more information and support.Please note that the above information is provided as a reference only, and should not be used as medical advice. If you have any medical questions or concerns, please consult a doctor or medical professional.英文药品说明书English Drug Instruction ManualIntroduction: This drug instruction manual is designed to provide valuable information for consumers, including usage, safety注意事项以及possible side effects of the drug. It is recommended that consumers consult a doctor or pharmacist before using any medication.Composition: The drug consists of active ingredients and excipients. The active ingredients are responsible for the therapeutic effects of the drug, while the excipients are used to maintain the drug's stability and improve its pharmacokinetic properties.Usage: The drug should be taken according to the doctor's instructions. The usual dosage is [amount] per [interval], either by mouth or via injection. Drugs should be taken with food or water to avoid gastric irritation. If the drug is taken on an empty stomach, it may cause stomach discomfort. The duration of treatment depends on the condition being treated and the doctor's recommendations.Safety Precautions: Taking this drug may cause [side effects], including [effects on the nervous system], [effects on the digestive system], [effects on the cardiovascular system], [effects on the respiratory system], [effects on the urinary system], [effects on the endocrine system], etc. These side effects are generally mild and can be alleviated after停药，but if you experience severe side effects, such as difficulty breathing, chest pain, or unexplained bleeding, please seek medical attention immediately.This drug should not be used during pregnancy or lactation unless otherwise directed by a doctor. This drug should also not be used if you are allergic to any of its ingredients. Drugs should be stored at room temperature and protected from light and moisture.Conclusion: This drug instruction manual provides consumers with essential information on usage, safety注意事项以及possible side effects of the drug. It is recommended that consumers consult a doctor or pharmacist before using any medication to ensure its safety and effectiveness.英文药品说明书的英文药品说明书A typical English pharmaceutical manual contns important information that is essential for understanding how to use a medication properly. These documents are written in a formal, strghtforward language to provide accurate and unbiased information. They typically include detls about the drug’s composition, usage, side effects, and warnings.Drug CompositionThe first section of an English pharmaceutical manual is usually dedicated to providing detailed information about the drug’s composition. It lists all the ingredients found in the medication, including active ingredients and inactive ingredients. The purpose of this section is to provide users with a clear understanding of what they are taking and how it works.UsageThe usage section explains how to take the medication properly. It provides dosage instructions, whether the drug should be taken on an empty stomach or with food, and any special instructions for administration. For example, this sectionmight indicate whether the medicine should be taken with plenty of water or whether it should be avoided in the event of an allergic reaction.Side EffectsPharmaceutical manuals also include information about possible side effects that may occur as a result of taking the medication. These effects can range from mild (such as headaches or nausea) to more severe (such as life-threatening allergic reactions). The manual usually indicates the frequency and severity of these effects and provides guidelines on what to do if they occur.WarningsThe warnings section is designed to highlight any potential safety issues associated with using the medication. It provides important information about interactions with other drugs or medical conditions and cautions agnst using the drug in specific situations. For instance, this section might advise agnst using the medication while pregnant or breastfeeding or in patients with certn heart conditions.In conclusion, English pharmaceutical manuals are an essentialsource of information for patients taking medication. They provide crucial detls about drug composition, usage, side effects, and warnings, which help users understand how to use the medication properly and safely. By reading these manuals carefully and following the instructions provided, patients can ensure optimal drug efficacy and minimize the risk of adverse reactions.药品说明书英文药品说明书英文Medicine说明书英文The use of medicine is a very common way to maintain health and treat illnesses. However, it is very important to read the medicine说明书英文 before using the medicine to ensure that you are using it correctly and safely.在日常生活中，使用药品是维护健康和治疗疾病的常见方法，但在使用药品之前，阅读药品说明书英文非常重要，以确保正确、安全地使用药品。
英文药品说明书
英文药品说明书英文药品说明书本文档旨在提供对药品的详细说明和使用指导。
请在使用本药品之前，请仔细阅读本文档，并严格按照说明进行使用。
如果您对本文档中的内容有任何疑问，请咨询医生或药剂师。
注意事项1：药品名称：_________________________________________________ 2：药品成分：_________________________________________________ 3：药品适应症：_______________________________________________4：禁忌症：_________________________________________________ 5：使用方法：_________________________________________________ 6：用量：_____________________________________________________7：不良反应：_________________________________________________ 8：注意事项：_________________________________________________ 9：药物相互作用：_____________________________________________适应症及用法用量指导1：适应症：- 详细描述适应症一- 详细描述适应症二- 详细描述适应症三2：用法用量：- 详细描述用法用量一- 详细描述用法用量二- 详细描述用法用量三- 详细描述用法用量四禁忌症及注意事项1：禁忌症：- 详细描述禁忌症一- 详细描述禁忌症二- 详细描述禁忌症三2：注意事项：- 详细描述注意事项一- 详细描述注意事项二- 详细描述注意事项三- 详细描述注意事项四不良反应及药物相互作用1：不良反应：- 详细描述不良反应一- 详细描述不良反应二- 详细描述不良反应三2：药物相互作用：- 详细描述药物相互作用一 - 详细描述药物相互作用二- 详细描述药物相互作用三附件本文档附有以下附件供参考：1、详细药物成分列表2、用法用量图示3、不良反应统计数据报告法律名词及注释1、法律名词一、详细解释或定义2、法律名词二、详细解释或定义3、法律名词三、详细解释或定义。
英文药品说明书：适应症的各种表达方法.doc
英文药品说明书：适应症的各种表达方法英文药品说明书：适应症的各种表达方法一、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。
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, Prinzmetal s angina,hypertension心绞痛，变异性心绞痛，高血压。
例 2 The following diseases caused by bacteria including gram-positive and gram-negative bacteria such as Staphylococcus，Streptcoccus, Escherichia 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2 由For(或In等)引出的短语，例如：例3 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 tubercuosis in association with other antitubercular drugs.与其他抗结核药配伍，治疗各种类型肺结核。
3.To+动词原形构成的短语，如：例5 To prevent the formation of urinary calculi，especially in cases where they tend torecur.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 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。
奥普力农注射液药品说明书(英文)
Revised: July 2008 (7th version) Standard Commodity Classification No. of Japan872119- Agent for acute heart failure -Coretec Injection 5 mg<Olprinone hydrochloride hydrate preparation>Designated drug and Prescription drugCaution : Use only as directed by a physician.CONTRAINDICATIONS (CORETEC is contraindicatedin the following patients.)1. Patients with hypertrophic obstructive cardiomyopathy[CORETEC may aggravate outflow tract stenosis of theleft ventricle.]2. Pregnant women or women suspected of being pregnant[See “Use during Pregnancy, Delivery or Lactation” sec-tion.]DESCRIPTIONCORETEC Injection is a colorless, clear injection containingthe following ingredients, and contained in colorless ampules(one-point-cut type).Component Content per ampule(5mL)Active ingredient Olprinone hydro-chloride hydrate5mg Citric acid hydrate 2.1mg Sodium hydroxide q.s.Inactive ingredientsD-Sorbitol 250mg Description CORETEC Injection is a colorless, clear liquid.pH 3.0 - 5.0Osmotic pressure ratio about 1 (ratio relative to isotonic sodium chlo-ride solution)INDICATIONSThe following condition when the effect of other drugs is insufficient:Acute heart failureDOSAGE AND ADMINISTRATIONUsually for adults, CORETEC Injection is undiluted or diluted with isotonic sodium chloride solution, glucose injection or other diluent, and administered intravenously at a dose of 10 µg/kg of olprinone hydrochloride hydrate, gradually over 5 min, and then drip-infused intravenously at a rate of 0.1 - 0.3 µg/kg/min. The dosage for drip infusion should be varied ac-cording to the patient’s condition and, if necessary, may be in-creased up to 0.4 µg/kg/min. PRECAUTIONS1. Careful Administration (CORETEC should be adminis-tered with care in the following patients.)(1) Patients with serious tachyarrhythmia[Since CORETEC has a positive chronotropic actionand triggers the baroreceptor reflex due to its vasodila-tive actions, arrythmia may be aggravated.](2) Patients with serious coronary arterial disease[Since CORETEC has a positive inotropic action,coronary arterial disease may be aggravated.](3) Patients with renal function disorders[The elimination half-life of CORETEC may be pro-longed due to impaired renal function. Renal functionmay also be impaired.](4) Patients with severe hypotension[Since CORETEC has a vasodilative action, it mayfurther decrease blood pressure.](5) Elderly patients[See “Use in the Elderly” section.]2. Important Precautions(1) The use of CORETEC should be considered when theeffects of other drugs are insufficient.(2) Prior to the use of CORETEC, measures, such as cor-rection of decreased body fluids and electrolytes, orrespiration control, should be taken as necessary.(3) CORETEC should be administered while monitoringthe patient’s condition, such as blood pressure, heartrate, ECG, urine volume, body fluids and electrolytes,and, where possible, pulmonary capillary wedge pres-sure, cardiac output and blood gas.(4) If there is no improvement within 120 min of initiatingtreatment with CORETEC, treatment should be discon-tinued and appropriate measures taken.StorageCORETEC should be stored at room temperature.Expiration dateCORETEC should be used before the expiration date indicated on the package or label. Approval No. 8AM-77 Date of listing in the NHI reimbursement price Apr 1996 Date of initial marketing in Japan Apr 1996 Date of latest reexamination Jun 2008 International birth date Jan 1996(5) Although there has not been much experience in ad-ministering CORETEC for a long term, the incidenceof adverse reactions tends to increase when the durationof administration exceeds 3 hr. Therefore, caution shouldbe exercised when administering it for more than 3 hr.(see “Clinical Studies” section.)(6) When clinical symptoms have improved and the pa-tient’s condition has stabilized (the patient has passedthrough the acute phase of the condition) after admini-stration of CORETEC, it should be changed for othertherapies. A cumulative daily dose of CORETECshould not exceeded 0.6 mg/kg (equivalent to 24 hr ofadministration at a rate of 0.4 µg/kg/min).(7) An excessive increase in heart rate or decrease in bloodpressure during the course of treatment with CORE-TEC could mean overdosage. If such marked changesoccur, appropriate measures, such as reduction in dos-age or discontinuation of the medication, should betaken.(8) CORETEC may not improve the condition of patientswith severe aortic stenosis, mitral stenosis, etc.(9) The elimination half-life of CORETEC is expected tobe prolonged in patients with renal function disorders.Therefore, it should be administered with caution tosuch patients, monitoring the patient’s condition, suchas blood pressure, heart rate, ECG, urine volume, bodyfluids and electrolytes, and, where possible, pulmonarycapillary wedge pressure, cardiac output and blood gas.The intravenous drip infusion should be started at a rateof 0.1 µg/kg/min to avoid overdosage.(10) Caution should be exercised that patients receiving diu-retics at high doses may not respond well to CORETEC.(11) Since CORETEC may cause excessive diuresis andhypokalemia, caution should be exercised with patientson digitalization.(12) Arrythmia may occur in patients with acute heart fail-ure. Since the use of CORETEC may increase the riskof arrhythmia, caution should be exercised with suchpatients.3. Drug InteractionsPrecautions for coadministration (CORETEC should be administered with care when coadministered with the following drugs.)Signs, Symptoms, and Treatment Mechanism and Risk FactorsCardiotonics of the catecholamine type: Dopamine hydro-chloride Dobutamine hy-drochloride, etc. Adenyl cyclase acti-vatorColforsin daropate hydrochloride When coadministered, bothagents enhance cardiotonicaction, but coadministrationmay make arrhythmia morelikely.Both CORTEC andthe opponent drughave a cardiotonicaction.Disopyramide It has been reported thatone case in which it wascoadministered with ananalogue compound (amri-none) outside Japan, anexcessive decrease in bloodpressure occurred. Mechanissm un-known4. Adverse ReactionsAdverse reactions including abnormal changes in labora-tory examination values were reported in 379 of 3,899 pa-tients (9.72%). (At the time of the reexamination)(1) Clinically significant adverse reactions1) Ventricular fibrillation, ventricular tachycardia(including torsades de pointes) and hypotensionVentricular fibrillation (5%> ≥0.1%), ventriculartachycardia (including torsades de pointes) (5%>≥0.1%) or decrease in blood pressure (5%> ≥0.1%)may occur. In the event of such symptoms, appropri-ate measures, such as reduction in dosage or discon-tinuation of the medication, should be taken.2) Renal function disordersRenal function disorders (5%> ≥0.1%) may occur.Patients should be monitored carefully. In the eventof such symptoms, medication should be discontin-ued and appropriate measures be taken.(2) Other adverse reactions5% > ≥0.1% < 0.1%Cardiovascular note1)Tachycardia and arrhythmiassuch as supraventricular orventricular extrasystoleGastrointestinal VomitingPsychoneurologic Headache and dullheadacheHematologic Thrombocytopenia,anemia,leucopenia and leukocytosisUrinary Decrease in urine volumeHypersensitivity note2) RashRespiratory Hypoxemianote3)Others Feeling of warmthNote1) Patients should be carefully observed. In the event ofsuch symptoms, appropriate measures, such as reduc-tion in dosage and discontinuation of the medication,should be taken.Note2) In the event of such symptoms, appropriate measuressuch as discontinuation of the medication should betaken.Note3) Decrease in arterial oxygen tension may be caused bythe vasodilative action. So respiratory function shouldbe carefully managed. In the event of such symptoms,appropriate measures, such as reduction in dosage anddiscontinuation of the medication, should be taken.5. Use in the ElderlySince the elderly often have hepatic/renal hypofunction,they are more likely to have adverse reactions. Therefore,caution should be exercised when administrating CORE-TEC in the elderly monitoring the patient’s condition, suchas blood pressure, heart rate, ECG, urine volume, bodyfluids and electrolytes, and where possible, pulmonary cap-illary wedge pressure, cardiac output and blood gas. Theintravenous drip infusion should be started at a rate of 0.1µg/kg/min to avoid overdosage.6. Use during Pregnancy, Delivery or Lactation(1) CORETEC should not be administered in pregnantwomen or women suspected of being pregnant.[An animal study (rats, i.v.) has shown inhibition ofweight gain and retarded ossification in fetuses.](2) Nursing mothers should discontinue breast feeding dur-ing treatment.[An animal study (rats, i.v.) has shown that CORETECis excreted in breast milk.]7. Pediatric UseThe safety in children has not been established (insufficient clinical experience).8. Precautions concerning Use(1) Preparation1) Since it has been demonstrated that CORETEC maycause changes of compatibility when mixed with thefollowing injections, it should not be mixed withthem: Soldactone, Urokinase Injection-Wf, Flumarin in-travenous injection2) It is desirable to use CORETEC without mixing withother injections (the rate of intravenous drip infusionmust be adjusted according to patient’s condition). IfCORETEC is to be diluted, isotonic sodium chloridesolution, glucose injection or other diluent should beused.(2) Opening the ampuleCORETEC is supplied in one-point-cut ampules. Thecut point of the ampule should be wiped with an alco-hol swab before opening. PHARMACOKINETICS1. Blood concentrationWhen 1.25 to 50 µg/kg note) of olprinone hydrochloride hy-drate was administered intravenously to healthy adult male volunteers (3 to 4 men) at a constant rate for 5 min, plasma concentration of the unchanged drug elevated dose-depen-dently, and also AUC increased in proportion to the dose.The elimination of the unchanged drug from the plasma after intravenous injection occurred in 2 phases with half-lives of 7.0 min at α phase and 57 min at β phase. 1)Note) Doses higher than 10 µg/kg are unapproved.Changes in plasma concentration of the unchanged drug after single intravenous administration of olprinone hydrochloride hydrate (10 µg/kg of the olprinone base) to healthy adult male male volunteers (Each point indicates the average of 4 men)2. ExcretionWhen 2.5 to 50 µg/kg note) of olprinone hydrochloride hy-drate was administered intravenously to healthy adult male volunteers at a constant rate over 5 min, excretion of the unchanged drug in the urine accounted for 70 to 80% of the dose within 48 hr after administration. 1)Note) Doses exceeding 10 µg/kg are unapproved. CLINICAL STUDIES1. Clinical efficacyCORETEC was shown to be effective in 77.6% (83 of 107 patients) in clinical trials, which included a double-blind clinical trial in patients with acute heart failure. Hemody-namic evaluation in a placebo-controlled double-blind clinical trial showed that CORETEC was significantly su-perior to the placebo in terms of decreasing pulmonary cap-illary wedge pressure and increasing cardiac output. 2 - 6)2. Incidence of adverse reactions with time after admini-strationTime after administration≤ 3 hr 3 hr < ≤ 72 hr Incidence rate ofadverse reactions (%)33/233 cases(14.16%)6/21 cases(28.57%) PHARMACOLOGY1. Pharmacological actions(1) Increase in myocardial contractilityOlprinone hydrochloride hydrate increases concentra-tion-dependently the myocardial contractility of iso-lated guinea pig and dog cardiac muscles. When olpri-none hydrochloride hydrate is administered intrave-nously, it increases dose-dependently the myocardialcontractility (LV dP/dt max) in anesthetized and con-scious dogs. 7 - 9)(2) VasodilationOlprinone hydrochloride hydrate inhibits concentra-tion-dependently noradrenaline- and KCl-induced con-traction of isolated rat aorta, and phenylephrine-inducedcontraction of isolated dog femoral artery and saphe-nous vein. It also decreases dose-dependently systemicvascular resistance when administered intravenously toanesthetized dogs, and increases local blood flow whenadministered intra-arterially to anesthetized dogs. 9, 10)(3) Alleviation of heart failureOlprinone hydrochloride hydrate markedly alleviatesheart failure, by increasing myocardial contractility,enhancing cardiac output, and decreasing afterload andpreload in several anesthetized dog models of heartfailure: propranolol-induced heart failure, heart failureinduced by volume loading and ligation of the coronaryartery, and heart failure due to mitral regurgitation. Ol-prinone hydrochloride hydrate also markedly mitigatesexpansion of the left ventricular internal diameter anddecrease in fractional shortening in animal models ofpropranolol-induced heart failure, and the vasodilativeaction of olprinone hydrochloride hydrate on capaci-tance vessels has been suggested by animal models ofheart failure due to mitral regurgitation. 9, 11, 12)2. Mechanism of action(1) Increase in myocardial contractilityThe main mechanism of action of olprinone hydrochlo-ride hydrate is selective inhibition of PDE III specificto cAMP. It is considered that this action causes an in-crease in intracellular cAMP levels and peak Ca2+ lev-els, thereby increasing myocardial contractility. 7, 8, 13, 14)(2) VasodilationThe main mechanism of action of olprinone hydrochlo-ride hydrate is selective inhibition of PDE III. It is con-sidered that this action causes an increase in intracellu-lar cAMP levels and a decrease in intracellular Ca2+levels, which cause vasodilation. 10, 15, 16) PHYSICOCHEMISTRYNonproprietary name: Olprinone Hydrochloride Hydrate (JAN) Olprinone(INN) Chemical name:1,2-dihydro-5-(imidazo [1,2-α] pyridin-6-yl)-6-methyl-2-oxo-3-pyridinecarbonitrile hydrochloride monohydrate Molecular formula: C14H10N4O ⋅ HCl ⋅ H2OMolecular weight: 304.73Structural formula:⋅HCl⋅H2ODescription:Olprinone hydrochloride hydrate occurs as a white to light yellowish, white crystalline powder. It is odorless. It is freely soluble in formic acid, sparingly soluble in water, slightly soluble in methanol, and practically insoluble in ethanol (99.5), in acetic anhydride, in acetic acid (100) and in diethyl ether.PACKAGINGCORETEC Injection 5 mg (5 mL):Boxes of 10 ampulesREFERENCES1) Atarashi H. et al.: Jpn. J. Clin. Pharmacol., 21, 613,1990.2) Kimata S. et al.: Jpn. J. Clin. Exp. Med., 69,2260,1992.3) Kimata S. et al.: ibid., 69, 3984, 1992.4) Kimata S. et al.: ibid., 70, 903, 1993.5) Murakami R. et al.: ibid., 70, 1265, 1993.6) Azuma A. et al.: ibid., 70, 1307, 1993.7) Ogawa T. et al.: Arzneim. Forsch., 39(I), 33, 1989.8) Satoh H. et al.: Jpn. J. Pharmacol., 52, 215, 1990.9) Ohhara H. et al.: Arzneim. Forsch., 39(I), 38, 1989.10) Tajimi M. et al.: Naunyn Schmiedeberg’s Arch. Phar-macol., 344, 602, 1991.11) Tanio H et al.: Jpn. Circ. J., 55, 1068, 1991.12) Ohara H. et al.: Folia pharmacol. japon., 99, 421, 1992.13) Honda M. et al.: Clin. Exp. Pharmacol. Physiol., 21,1001, 1994.14) Sugioka M. et al.: Naunyn Schmiedeberg’s Arch.Pharmacol., 350, 284, 1994.15) Ohoka M. et al.: Jpn. Circ. J., 54, 679, 1990.16) Itoh H. et al.: Eur. J. Pharmacol., 240, 57, 1993. REQUEST FOR LITERATURE SHOULD BE MADE TO: Safety Management DepartmentFax: 03-3811-2710Eisai Co., Ltd.REQUEST FOR PRODUCT INFORMATION SHOULD BE MADE TO:Customer Information Services SectionFree Dial: 0120-419-497Eisai Co., Ltd.Manufactured and marketed by:Eisai Co., Ltd.6-10, Koishikawa 4-chome, Bunkyo-ku, Tokyo, 112-8088。
tivicay英文说明书
tivicay英文说明书摘要：1.Tivicay 概述2.Tivicay 的适应症3.Tivicay 的用法用量4.Tivicay 的副作用与注意事项5.Tivicay 的禁忌症6.Tivicay 的药物相互作用7.Tivicay 的储存与处理正文：1.Tivicay 概述Tivicay（dolutegravir）是一种抗病毒药物，主要用于治疗人类免疫缺陷病毒（HIV）-1 感染。
它属于整合酶链转移抑制剂（INSTIs）类药物，通过阻止病毒复制过程中的整合酶活性，从而减少病毒在体内的繁殖。
2.Tivicay 的适应症Tivicay 主要用于治疗年龄在12 岁以上的HIV-1 感染者，且对至少一种其他抗逆转录病毒药物产生耐药性的患者。
此外，Tivicay 还可以与其他抗逆转录病毒药物联合使用，以实现对HIV-1 的完全抑制。
3.Tivicay 的用法用量Tivicay 的推荐剂量为每次50mg，每日一次，空腹或与食物同时服用。
对于治疗初治患者，建议使用Tivicay 与其他抗逆转录病毒药物联合治疗；对于经治患者，可以根据患者病毒载量、CD4 细胞计数等因素，在医生的指导下调整治疗方案。
4.Tivicay 的副作用与注意事项Tivicay 的常见副作用包括头痛、发热、咳嗽、恶心、呕吐、腹泻等。
在用药过程中，应密切关注患者的临床状况，如出现严重不良反应，应立即停药并就医。
此外，Tivicay 可能会与其他药物产生相互作用，导致药效减弱或增强，因此在使用Tivicay 时，应告知医生患者正在使用的其他药物。
5.Tivicay 的禁忌症Tivicay 禁用于对本品活性成分或其他辅料过敏的患者。
同时，对于孕妇和哺乳期妇女，使用Tivicay 的安全性尚未完全确定，需在医生指导下权衡利弊后决定是否使用。
6.Tivicay 的药物相互作用Tivicay 与其他药物的相互作用可能会导致药效减弱或增强，因此在使用Tivicay 时，应告知医生患者正在使用的其他药物。
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Drug Instructions英文药品说明书InstructionsDirectionsDescriptionPackage Insert 或简称Insert，LeafletData SheetsFDA规定的药物说明书：一般为10项。
较简单的说明书仅介绍：成分、适应证、禁忌、用法与用量等内容较长复杂的说明书：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、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,可达20多项美国FDA批准上市的药品:1.CDER的drug@FDA是首选,/scripts/cder/drugsatfda/index.cfm，2./dailymed/about.cfm3. /script/main/hp.asp欧洲上市批准的药品1http://www.emea.europa.eu/。
2.EMC:/3./mrindex/index.html日本上市的药品上生产商的网站上去找,一般大的公司会把自家产品的说明书放在网站上,而且是最新版的。
专利全文的获取专利的检索（不提倡进SIPO、USPTO）百度专利搜索：/Google patent /patents欧洲专利局：/专利PDF全文获取：（Drugfuture）/主要内容①Drug Names②Description③Pharmacological Actions④Indications⑤Contraindications⑥Dosage and Administration⑦Adverse Reactions⑧Precautions⑨Package⑩Storage药品名称（Drug Names）②性状（Description）③药理作用（Pharmacological Actions）④适应证（Indications）⑤禁忌（Contraindications⑥用量用法（Dosage and Administration）⑦不良反应（Adverse Reactions）⑧注意（Precautions）⑨包装（Package）⑩贮存(Storage）⑾其他项目（Others）第一节药品名称商品名（Trade Name 或Proprietary Name）通用名（Generic Name）化学名（Chemical Name）其中最常见的是商品名。
商品名受法律保护。
有时同一种药品，不同的厂家使用不同的商品名称。
有时在药品商品名右上角（或左上角）有一®标记例：ADRIBLASTNA®（阿霉素）TEGRETOL®（痛痉宁）“R”是Register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）。
Rulide（罗力得）之下列有（Roxithromycin，罗红霉素）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他莫西芬，Amoxycillin 阿莫西林音译较为方便，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：Tetracycline 四环素Streptomycin 链霉素也可按其药理作用翻译．如：Minidiab灭糖尿（治疗糖尿病药物）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：Kanamycin 卡那霉素谐音译意：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：Reserpine 利血平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。
Uraly消石素（治疗尿路结石药物）等。
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。
药物的化学名与化学结构是呈一一对应关系例如：Catalin（卡他林）化学名称是1-Hydroxy-5-oxo-5H-pyrido（3，2-a）-Phenoxazine-3-carboxylic acid1-羟基-5-氧-5H-吡啶并(3，2-a)吩嗪-3-羧酸。
18常用酸、碱、盐、基团、化合物的英文名称及常用的前后缀chloride 氯化物; sulfate (sulphate)硫化物acetyl 乙酰基; amino 氨基; di-二nitro- 硝基; –ester 酯; -oxide 氧化物carbonyl 羰基; hydroxyl 羟基例：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 ：3α,7βdihydroxy -5β-Cholanoic acid (3α,7β二羟基5β胆烷酸）第二节性状DescriptionChemical StructureCompositionPhysical and Chemical Properties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。
常用的词语表示组成、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）表示性质的一些词类，如：colo(u)r 颜色colo(u)rless 无色的odo(u)r 气味odourless无臭的taste 味道tasteless 无味的常见的句型例1．Folic acid is a yellowish to orange, crystalline powder; odourless or almost odourless.例2．Intralipos is a white opaque fat emulsion for intravenous injection, containing 10 W/V % of purified soybean oil.例3．熊去氧胆酸片为白色素片，每片含50mg熊去氧胆酸。
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 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 导致形容词(be) active (effective) against 对…有效be related to 与…有关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.例2. Nembutal Sodium exerts a depressant action on the CNS and shares the sedative-hypnotic actions typical of the barbiturates.例3. 熊去氧胆酸的生物半衰期时3.5-5.8天第四节适应症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：CancerDiabeteshypertension [,haɪpə`tenʃən]高血压hypotension[,haipəu`tenʃən] 低血压Gram-positive bacteria 革兰氏阳性菌Gram-negative bacteria革兰氏阴性菌Microorganism 微生物Virus 病毒表示与“其他药物合用”的结构有：be associated within association withbe combined within combination withbe compatible within conjunction withconcomitant withtogether 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。
例2 The following diseases caused by bacteria including gram－positive and gram－negative bacteria such as Staphylococcus，Streptcoccus……2. 由For（或In等）引出的短语，例如：例1 For prevention of the advance of cataract.用于白内障的预防例2 In the treatment of all forms of pulmonary tuberculosis （肺结核）in association with other antitubercular drugs.3. To+动词原形构成的短语，如：例1 To protect the liver cell during administration of drugs hazardous to the liver．4. 完整的句子结构或段落，有时结构很复杂；例1 Nebcin is indicated for the treatment of the following infections caused by susceptible microorganisms.第五节禁忌症ContraindicationsRestrictions on UseContraindications 禁忌症Precautions (Note) 注意事项Warning 警告Pregnancy and Lactation 妊娠与哺乳一、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1、孕妇、妊娠期或哺乳期，幼童等：pregnant woman 孕妇/in pregnancy 妊娠期lactation 哺乳期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2、对…..过敏或者患有….疾病如：allergic (hypersensitive) to…对…过敏的allergic reaction 过敏反应patients with…(who…) 患有…的患者二、本项中常出现一些疾病名称cardiac failure 心力衰竭hypertension 高血压cardiac (renal) insufficiency 心（肾）功能不全severe hypotension 严重低血压impairment of kidney (renal function) 肾功能损伤常用的结构有：contraindications are…禁忌症是…be contraindicated 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。