[關(guān)鍵詞]
[摘要]
歐洲藥品局(EMA)于2018年11月發(fā)布了"人用藥品輔料右旋糖酐的包裝說明書資料",該文件引用大量文獻(xiàn)全面評(píng)價(jià)了右旋糖酐的安全性,特別指出含有右旋糖酐輔料的注射和吸入制劑的疫苗與藥品,應(yīng)在說明書中描述有關(guān)其過敏反應(yīng)信息的新要求。介紹該文件的主要內(nèi)容,期望對(duì)我國這類藥品說明書的撰寫和監(jiān)管有所幫助。
[Key word]
[Abstract]
EMA issued Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use (Draft) in November 2018. Citing a large number of references, the document comprehensively evaluated the safety of dextran, and pointed out in particular that vaccines and drugs containing dextran excipients for injection and inhalation should be described in the package leaflets for new requirements for information on their allergic reactions. This document is described in detail in the article and is expected to be helpful for the writing and supervision of such drug labeling in our country.
[中圖分類號(hào)]
R951;R943
[基金項(xiàng)目]