药学英语药学英语 (44).ppt

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1、 Unit Fourteen The New Drug Package Insert-lmplications for Patient Safety Part three v3.Recent Major Changes,Indications and Usage,Dosage and Administration,Dosage Forms and Strengths 最新主要变化、适应证、用法、用量、给药方法、剂型和规格vThe Recent Major Changes section lists only major changes in the boxed warning,indicati

2、ons and usage,dosage and administration,contraindications kntrndken and warnings,and precautions sections.v“最新主要变化”部分只列举“黑框警告”“适应证”“用法用量”“禁忌证”“警告和注意事项”等部分的主要变化。vThe three sections following Recent Major Changes are practical information giving indications and usage,dosage and administration,and dosa

3、ge forms and strengths.vThese informational sections placed after the most serious warning issues have been identified to facilitate practical use of the label,whose major purpose is to provide dosage information for routine use.v“最新主要变化”后面的三个部分提供实用的信息，表明药物的适应证、药物的用法用量以及药物的剂型和规格。v这些提供重要信息的部分放在警告部分之后

4、保证了标签的方便实用，药品标签的主要目的就是为常规用药提供剂量信息。vThe sections following the routine use information are warning or risk information of high importance.vThese sections include contraindications,warnings and precautions,adverse reactions,drug interactions,and use in specific populations.v在这些常规使用信息之后的部分是重要的警告信息或者风险信

5、息。v这些信息包括：禁忌证、警告和注意事项、不良反应、药物相互作用以及特定人群用药。4.Contraindications 禁忌证禁忌证vA drug is classified as contraindicated in the clinical situation for which the risks outweigh any possible therapeutic benefit of the drug.vOnly known hazards,and not theoretical possibilities,can be listed.vIf there are no known

6、contraindications for a drug,“none”must be designated 标明 in this section.v当临床环境下治疗风险超过可能的治疗益处时，药物应禁用v只有已知的危险，而不是理论上的可能性，才能够被列举出来。v如果某种药物没有已知的禁忌证，在这部分就必须写上无。vThe order in which the contraindications are presented in the text reflects the relative public health risk.vThe significance of the contraindications is based on the likelihood of occurrence and the size of the population potentially affected.v这部分文字中列出的禁忌证的顺序反映出相关的公共健康风险。v禁忌证的重要性是以其发生率和潜在影响人群大小所决定的。