OBJECTIVE: To provide reference for improving instruction contents by drug administration departments and pharmaceutical production enterprises through finding the problems and deficiencies of the instructions for domestic Ceftriaxone sodium for injection. METHODS: The instructions of Yingpaiqi were selected from Qilu Pharmaceutical Co., Ltd. website as the representative of domestic Ceftriaxone sodium for injection; the instructions of Rocephin were selected from Shanghai Roche Pharmaceutical Co., Ltd. website as the representative of original drugs. They were analyzed comparatively in terms of structure and content. RESULTS: The structure of domestic instruction was similar to that of original one in respects of revision date, components, indication, usage and dosage, ADR, contraindication, precautions, drug interaction, warning, etc.; but in content, some aspects of the domestic instruction, such as drug use of special population, ADR, drug interaction, were not provided a rather complete description. CONCLUSIONS: It is suggested that drug administration departments should timely urge relevant pharmaceutical enterprises to revise drug instructions and implement relevant laws and regulations and further standardize and improve the instructions of Ceftriaxone sodium for injection, especially the relevant safety information; pharmaceutical enterprises should strengthen the awareness of first responsibility and undertake relevant legal liability and social responsibility, collect drug safety information actively, update the content of instruction and strengthen the content management in terms of ADR, precaution, drug interactions, contraindication and so on.
关键词
注射用头孢曲松钠药品说明书国产药原研药对比
Keywords
Ceftriaxone sodium for injectionInstructionDomestic drugOriginal drugComparison