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中外药品说明书格式大致相同,内容千差万别,但主要条款大同小异。说明书一般包括以下内容:
Name of product 品名
Compositions; main iugredieuts 主要成分
Properties性质(特性)
Pharmacology or pharmacological action 药理作用
Precautions注意事项
Adverse reaction 不良反应
Specification 规格
Expiry使用期限
Manufacturer生产厂家
Actions 主治
Indications 适用症
Warnings 警告.
Usage用法
Contraindication 禁忌
Side effect or adverse events 副作用(不良反应)
Shelf life保存期
Ratification No 批准号
例1 对药物性状说明
It is a white or a faintly yellow powder to which appropriate amounts of water are added to prepare an off white suspension for intramuscular use or a yellowish solution for intravenous administration.
译文:它是一种白色或淡黄色粉末,加适量水可配制成近乎白色的悬浊液,供肌肉注射用,或配制成黄色的溶液,供静脉注射用。
例2 对药品作用说明
It is a bactericidal antihiotic which is resistant to most B - Lastamases and is active against a wide range of Grampostive and Gramnegative organism.
译文:它是一种抗菌素,不但能抵抗大多数B内酰胺酶,而且抵抗各种格兰氏阳性和阴性细菌。
例3 对适应症说明
It is indicated for the treatment of infection before, the infecting organism has been identified or when caused by sensitive bacteria.
译文:在感染的细菌未被确认出来,或有敏感细菌引起感染时,适于用它来治疗。
例4 对不良反应说明
This drug is generally well tolerated. The commonest side effects associated with it are symptoms related to the gastrointestinal tract.
译文:通常该药忍耐性好,最常见的副作用与胃肠道症状有关。
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