国产仿制与原研注射用伏立康唑药品说明书对比分析

Comparison and Analysis of Instructions of Domestic Generic and Original Voriconazole for Injection

目的:比较不同厂家注射用伏立康唑药品说明书内容,为药品说明书完善和合理使用提供参考。方法:将原研注射用伏立康唑药品说明书与截至2017年12月批准上市的国产仿制注射用伏立康唑药品说明书中各项内容进行调查和统计,并对不同批准文号药品说明书内容差异较大的项目进行重点分析。结果:5份说明书结构基本一致,在内容上国产仿制注射用伏立康唑说明书缺少治疗非中性粒细胞减少患者中的念珠菌血症和预防接受异基因造血干细胞移植的高危患者中的侵袭性真菌感染两项适应证,在特殊人群用药、不良反应、禁忌、注意事项、药物相互作用、临床试验、药理毒理和药动学方面没有原研注射用伏立康唑说明书描述的全面和详细。结论:原研与国产仿制注射用伏立康唑说明书存在差异,医师及药师应严格按相应药品说明书的信息对照使用;国产仿制注射用伏立康唑说明书的内容完整程度有待提高。

Objective:To provide reference for the improvement and guidance for clinical rational drug use by comparing the package inserts of voriconazole for injection from different manufacturers.Methods:A set of instructions of original voriconazole for injection and domestic generic voriconazole for injection approved up to December 2017 were compared and analyzed,and the items with great differences in different approval number were analyzed comparatively.Results:The structure of domestic generic instruction was similar to that of original one,while in content,domestic voriconazole for injection lacked two indications including candida in patients with nonneutrophils reduction and prevention of invasive fungal infections in high-risk patients receiving allogeneic hematopoietic stem cell transplantation.As for drug use of special population,ADR,contraindication,matters needing attention,drug interaction,clinical trial,pharmacology and toxicology,and pharmacokinetics,the instruction of domestic generic voriconazole for injection was incomplete when compared with that of original product.Conclusion:There are differences in the instruction between domestic generic and original voriconazole for injection,and doctors and pharmacists should strictly follow the instructions.It is suggested that the domestic enterprises should modify and perfect the instruction contents of voriconazole for injection.