关于调整抗新型冠状病毒药物PF-07321332/利托那韦片(Paxlovid)适应症等内容的通知

2022-03-23 国家卫生健康委 网络

300mg奈玛特韦片与100mg利托那韦片同时服用,每12小时一次,连续服用5天。

3月23日,国家卫生健康委发布关于调整抗新型冠状病毒药物PF-07321332/利托那韦片(Paxlovid)适应症等内容的通知,具体内容如下:

各省、自治区、直辖市及新疆生产建设兵团卫生健康委、中医药管理局:

根据国家药品监督管理局批准奈玛特韦片/利托那韦片组合包装时核准的说明书,现对《新型冠状病毒肺炎诊疗方案(试行第九版)》抗病毒治疗中“PF-07321332/利托那韦片(Paxlovid)”相关内容调整如下:

一、药物名称

药物名称调整为“奈玛特韦片/利托那韦片组合包装”。

二、适应症

适应症为发病5天以内的轻型和普通型且伴有进展为重症高风险因素的成人。

三、用法用量

300mg奈玛特韦片与100mg利托那韦片同时服用,每12小时一次,连续服用5天。

四、禁忌症

对本品中的活性成份或任何辅料过敏的患者禁用。本品不得与高度依赖CYP3A进行清除且其血浆浓度升高会导致严重和/或危及生命的不良反应的药物联用。

使用该药品前应详细阅读国家药品监督管理局核准的《奈玛特韦片/利托那韦片组合包装说明书》,按照说明书规定的适应症、用法用量、剂量正确使用药品,对禁忌症、不良反应、药物的相互作用等情况要熟知,并详细询问患者的药物过敏史等情况,避免有禁忌症的患者使用该药品,避免与本品禁止联用的药品联用;各地要严格按照《药品不良反应报告和监测管理办法》要求,做好不良反应监测和报告工作,切实保证用药安全。

国家卫生健康委办公厅

国家中医药管理局办公室

2022年3月23日

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    2022-03-24 ms2000001386604039

    学习

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