摘要
目的为规范眼用制剂开启使用期限的标注提供参考建议。方法对我院2011年1月～12月38种眼用制剂说明书中的名称、规格、产地、有效期、开启使用期限标注等信息进行统计、分析。结果 38种眼用制剂说明书中标注开启后使用期限的有18种,占47.4%。在药品说明书的注意事项中标注开启使用期限的有10种,在贮存项标注有6种,药品有效期标注的1种,药品包装上标注的1种。结论有超过一半的眼用制剂未标明开启后的使用期限,药监部门应加强标注的管理,减少药品使用风险。
Objective To provide reference for standard management of the marks of ophthalmic preparations extended period after use. Methods The related information of 38 kinds of ophthalmic preparations were analyzed statistically, such as drug names, specification, producing area, ophthalmic preparations were marked the extend marked on the precautions of package insert; 6 of period of validity and 1 of them was marked on the validity period and extended period after use. Results 1B kinds of period after used in all, accounting for 47.4%. 10 of them were them were marked on the storage; 1 of them was marked on the package box. Conclusion More than half of ophthalmic preparations were not marked the extended period after use. We propose to strengthen the supervision of such products, standardize labeling information and prevent risk of drug use.
出处
《中国药物警戒》
2012年第11期698-700,共3页
Chinese Journal of Pharmacovigilance
关键词
眼用制剂
说明书
调查分析
ophthalmic preparations
package insert
investigation
