摘要
目的掌握进口药品说明书信息。方法对2003年6月~2006年3月我院门诊药房具备进口药品注册证号的说明书进行调查与分析。结果与结论部分进口药品说明书中存在暗示疗效、误导使用和中、英文标注不对应等问题;进口药品认证管理部门应认真审核进口药品相关报批资料;医疗机构应加强对进口药品相关资料的收集工作,认真对待进口药品说明书中存在的问题。
OBJECTIVE:To make out the difference between Chinese and English specifications of imported medicine .METHODS:To choose the specification with imported medicine registration(June, 2003-March,2006), then contrastively analyse the Chinese and English part .RESULTS: In the specification of some imported medicine, inconsistency exists between the Chinese part and English part. It' s serious for the problem on incompatibilities, contraindications and pharmacological properties.CONCLUSION :The manufacturers of imported medicine, approval and managing department and medicine useunits must resolve the problem of inconsistency in imported medicine's specifications together.
出处
《中国药房》
CAS
CSCD
北大核心
2007年第5期396-397,共2页
China Pharmacy
关键词
说明书
进口药品
不一致性
Specification
Imported drug
Inconsistency