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江蘇吳中(600200.SH):硫酸阿米卡星注射液通過仿製藥一致性評價
格隆匯 03-07 18:42

格隆匯3月7日丨江蘇吳中(600200.SH)公佈,全資子公司江蘇吳中醫藥集團有限公司下屬分支機構江蘇吳中醫藥集團有限公司蘇州製藥廠收到了國家藥品監督管理局覈準簽發的關於“硫酸阿米卡星注射液”的《藥品補充申請批準通知書》,該藥品通過仿製藥質量和療效一致性評價。硫酸阿米卡星爲氨基糖苷類抗生素,適用於銅綠假單胞菌及其他假單胞菌、大腸埃希菌、變形桿菌屬、克雷伯菌屬、腸桿菌屬、沙雷菌屬、不動桿菌屬等敏感革蘭陰性桿菌與葡萄球菌屬(甲氧西林敏感株)所致嚴重感染,如菌血癥或敗血癥、細菌性心內膜炎、下呼吸道感染、骨關節感染、膽道感染、腹腔感染、複雜性尿路感染、皮膚軟組織感染等。由於本品對多數氨基糖苷類鈍化酶穩定,故尤其適用於治療革蘭陰性桿菌對卡那黴素、慶大黴素或妥布黴素耐藥菌株所致的嚴重感染。本品不用於治療初發的單純尿路感染,除非細菌對於其它低毒性的抗生素不敏感時才使用該類藥物。

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