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金城醫藥(300233.SZ):金城金素的克林黴素磷酸酯注射液獲批上市
格隆匯 05-16 21:00

格隆匯5月16日丨金城醫藥(300233.SZ)公佈,公司於近日收到控股子公司廣東金城金素製藥有限公司(簡稱“金城金素”)的通知,金城金素收到國家藥品監督管理局下發的克林黴素磷酸酯注射液藥品註冊證書(證書編號:2022S00422、2022S00423、2022S00424)。本次克林黴素磷酸酯注射液按照化學藥品3類申報並獲批,視同通過一致性評價。

克林黴素磷酸酯注射液適用於由敏感厭氧菌引起的嚴重感染,如下列嚴重感染:下呼吸道感染、皮膚和皮膚軟組織感染、敏感厭氧菌感染引起的婦科感染、敏感厭氧菌引起的腹腔內感染、敗血症、金黃色葡萄球菌引起的包括急性血源性骨髓炎在內的骨和關節感染,作為敏感微生物引起的慢性骨和關節感染的手術治療的輔助治療。

為了減少耐藥細菌的產生,維持克林黴素磷酸酯和其它抗生素的藥效,克林黴素磷酸酯只能用於治療或者預防已被證明或者極度懷疑的細菌感染。如果能獲得細菌培養和敏感度的信息,應當在調整治療方案時予以考慮。如果缺乏這些數據,應當考慮當地流行病學和細菌敏感模式。

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