四環醫藥(00460.HK)小兒複方氨基酸注射液獲得藥品註冊批件
格隆匯3月23日丨四環醫藥(00460.HK)公佈,集團的小兒複方氨基酸注射液(18AA-II)已獲得中國國家藥品監督管理局頒發的藥品註冊批件。此產品的獲批劑型為注射劑,規格為100毫升:6.0克和250毫升:15.0克,是氨基酸組成的複方製劑。此產品由18種常見蛋白氨基酸和牛磺酸組成。
此產品的配方特點主要模擬人乳中的同類氨基酸。除了維持小兒體內蛋白質平衡外,還可以滿足小兒生長和器官發育的需要。此產品的配方中具有高濃度的支鏈氨基酸,且含有精氨酸、組氨酸、半胱氨酸、酪氨酸和非蛋白氨基酸牛磺酸。此產品能夠為小兒機體提供氮源,糾正機體的負氮平衡,更能為疾病狀態下嬰幼兒提供重要的營養支援兼治療。
此產品為靜脈用胃腸外營養輸液,可以用於以下幾方面:早產兒、低體重兒及各種病因所致不能經口攝入蛋白質或攝入量不足的新生兒;各種創傷:如燒傷、外傷及手術後等高代謝狀態的小兒;及各種不能經口攝食或攝食不足的急性及慢性營養不良的小兒,如壞死性小腸結腸炎、急性壞死性胰腺炎及化療藥物反應等。
集團為中國第二家獲得此產品藥品註冊批件的公司。集團相信此產品將與集團其他已經獲得批件的注射液產品產生協同效應,並將助力集團在輸液領域的發展。
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