科倫藥業(002422.SZ):注射用比阿培南/氯化鈉注射液獲得藥品註冊批準
格隆匯5月21日丨科倫藥業(002422.SZ)公佈,公司子公司湖南科倫製藥有限公司的化學藥品“注射用比阿培南/氯化鈉注射液”於近日獲得國家藥品監督管理局的藥品註冊批準。
粉液雙室袋是國際上先進的輸液產品,其中粉體和液體分別位於兩個獨立的腔室,保證混合前各腔室藥品的穩定性,臨牀使用時即開、即混、即用,可有效避免配製過程中的錯配和污染風險,同時節約配製時間、減少配製工作量並降低醫護人員暴露風險,尤其適用於緊急狀態下的快速救治。
比阿培南爲碳青黴烯類抗菌藥,具有抗菌譜廣、對β-內酰胺酶穩定、抗菌活性強等特點。與其它碳青黴烯類相比,比阿培南腎毒性和中樞神經系統毒性更低,已被《SIS:腹腔感染管理指南(2024)》《JSICM/JAAM:膿毒症和感染性休克管理臨牀實踐指南(2024)》《成人膿毒症患者β-內酰胺類抗生素延長輸注專家共識(2024)》《中國銅綠假單胞菌下呼吸道感染診治專家共識(2022)》等國內外權威指南或專家共識推薦,且臨牀廣泛用於呼吸內科、外科等科室。比阿培南粉針2024年中國銷售額2.2億元。本次注射用比阿培南/氯化鈉注射液爲國內首家獲批粉液雙室袋包裝形式。
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