中国药房2016，Vol.27Issue(27)：3748-3750,3.DOI:10.6039/j.issn.1001-0408.2016.27.02
国产克林霉素磷酸酯注射液药品说明书项目标注的调查
Investigation of the Item Labeling in the Instructions of Domestic Clindamycin Phosphate Injection
摘要
Abstract
OBJECTIVE:To provide reference for the instructions of domestic Clindamycin phosphate injection. METHODS:The contents in the instructions of domestic Clindamycin phosphate injection approved the listing from Jan. 2006 to Dec. 2015 were statistically investigated according to Regulation for Drug Package Inserts and Label Management and Regulatory Guidelines for Chemicals and Biologicals,and the items with great differences in different approval number were analyzed comparatively. RE-SULTS:The labeling rate of clinical experiment in the collected 25 instructions of domestic Clindamycin phosphate injection was 0,the labeling rate of validity was 44%,the labeling rate of use for elderly patients was 68%,the labeling rate of overdosage was 76%,and the labeling rate of others was 100%. The items with great differences were mainly special populations,usage and dos-age,adverse reactions,validity,storage conditions and precautions. CONCLUSIONS:There are great differences in instructions of domestic Clindamycin phosphate injection,some items are inaccurate,incomplete and lack of scientificity,which may result in ir-rational drug use in patients and increase the risk of medication. It is suggested that the domestic enterprises should modify and per-fect the contents of the instructions of domestic Clindamycin phosphate injections referring to the instructions of foreign brand name drug;and the drug regulatory department should strengthen the monitoring of drug instructions.关键词
克林霉素磷酸酯注射液/药品说明书/调查分析Key words
Clindamycin phosphate injection/Drug instruction/Investigation and analysis分类
医药卫生引用本文复制引用
周鹏,王娇,崔岚..国产克林霉素磷酸酯注射液药品说明书项目标注的调查[J].中国药房,2016,27(27):3748-3750,3.基金项目
“十二五”国家科技支撑计划课题 （）
