Abstract：Objective To explore the problems and deficiencies of Ceftriaxone Sodium for Injection′s domestic drug instructions in medication safety and to provide reference for clinical safety of medication and medicine production enterprise to revise and perfect instruction. Methods Shandong Lukang Pharmaceutical Co., Ltd. and Hoffmann-La Roche Inc. were separately selected as the representatives of domestic and foreign manufacturers. The safety related items in the specifications of the latest edition of the two manufacturers (both revised in 2015) were compared and analyzed to look for differences, and the potential safety risks were discussed, the countermeasures were proposed. Results There were differences between the two instructions in usage and dosage, adverse drug reactions, indications, warning signs, contraindications, announcements, and intormation for the patients. Domestic instruction was simpler than foreign instruction, the guidance for safe medication especially for children was not specific enough, even key items of safe medication, such as contraindication, were missing informations. Conclusion This study suggests that domestic instructions are lack of informations on drug safety and there are risks and hidden dangers; it is suggested that drug manufacturers should take initiative and timely revise and improve the safety information in the instructions.
王芳 李永辉 郭瑞锋 刘欣欣. 从用药安全的视角分析国内外注射用头孢曲松钠说明书差异[J]. 中国医药导报, 2018, 15(29): 157-160.
WANG Fang LI Yonghui GUO Ruifeng LIU Xinxin. Analysis of the differences between instructions for domestic and foreign Ceftriaxone Sodium for Injection from the perspective of medication safety. 中国医药导报, 2018, 15(29): 157-160.
2018, Vol. 15 
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