中国药物警戒 ›› 2011, Vol. 8 ›› Issue (10): 603-605.

• 管理及工作研究 • 上一篇    下一篇

国内外含可待因和羟考酮复方制剂说明书的比较

刘维1, 栾嵘2, 翟所迪1   

  1. 1 北京大学第三医院药剂科,北京 100191;
    2 北京大学药学院,北京 100191
  • 收稿日期:2011-01-24 出版日期:2011-10-10 发布日期:2015-07-30
  • 通讯作者: 翟所迪,男,主任药师,临床药学和药剂学。E-mail:zhaisuodi@163.com
  • 作者简介:刘维,女,在读博士,临床药学。

Comparison of the Drug Package Inserts of Domestic and Foreign Compound Preparations Containing Narcotic Drugs

LIU Wei1, LUAN Rong2, ZHAI Suo-di1   

  1. 1 Department of Pharmacy, Peking University Third Hospital, Beijing 100191,China;
    2 Department of Pharmaceutical Sciences, Peking University, Beijing 100191, China
  • Received:2011-01-24 Online:2011-10-10 Published:2015-07-30

PDF (PC)

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摘要： 目的 规范国内含麻醉药品复方制剂说明书,指导安全合理用药。方法 从安全用药的角度,如药物滥用与依赖、禁忌、注意事项等方面,对国内外的说明书进行比较。结果 国内该类制剂说明书中警示信息不足;国内和国外说明书大多禁忌描述不全;中、英文说明书不对应。结论 可以参照麻醉药品单方制剂和国外含麻醉药品复方制剂的说明书来修订国内的该类制剂说明书。

关键词: 麻醉药品, 复方制剂, 说明书, 警示

Abstract: Objective To regulate the drug package inserts of domestic compound preparations containing narcotic drugs and improve rational use of these drugs. Methods From the safe medication's angle, choose drug abuse and dependence, contraindications, precautions and so on from the drug package inserts, and then contrastively analyse the domestic and foreign part. Results The domestic drug package inserts are lack of warnings. Both the domestic and the foreign ones are not all-inclusive about contraindications. The Chinese and English drug package inserts do not correspond. Conclusion We can reference package inserts of the narcotic drugs unilaterally preparations and foreign compound preparations containing narcotic drugs to revise domestic ones.

Key words: narcotic drugs, compound preparations, drug package inserts, warnings

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