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哈三聯(002900.SZ):氯化鉀氯化鈉注射液通過仿製藥質量和療效一致性評價
格隆匯 05-09 15:46

格隆匯5月9日丨哈三聯(002900.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的藥品補充申請批准通知書,公司藥品氯化鉀氯化鈉注射液通過仿製藥質量和療效一致性評價(以下簡稱“一致性評價”)。

氯化鉀氯化鈉注射液用於:(1)治療各種原因引起的低鉀血癥,如進食不足、嘔吐、嚴重腹瀉、應用排鉀性利尿藥、低鉀性家族週期性麻痺、長期應用糖皮質激素和補充高滲葡萄糖後引起的低鉀血癥等。(2)預防低鉀血癥,當患者存在失鉀情況,尤其是如果發生低鉀血癥對患者危害較大時(如果用洋地黃類藥物的患者),需預防性補充鉀鹽,如進食很少、嚴重或慢性腹瀉、長期服用腎上腺皮質激素、失鉀性腎病、Bartter綜合徵等。(3)洋地黃中毒引起頻發性、多源性早搏或快速心律失常。

截止目前,公司氯化鉀氯化鈉注射液三個規格均為國內首家通過一致性評價。

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