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Medicine recalls

 
台灣:回收緩壓膜衣錠 50 毫克 Losacar 50 Tablets (Chinese Only)
 
台灣衛生福利部食品藥物管理署公布,因案內批號藥品使用之部分原料藥經檢驗含有不純物「N-亞硝基-N-甲基-4-氨基丁酸(NMBA)」,回收9個批次由CADILA HEALTHCARE LIMITED製造的緩壓膜衣錠 50 毫克 Losacar 50 Tablets (批號:M602151、M602152、M604956、M604957、M604958、M612544、M612545、M806500、M808598)。

詳情請按以下連結:http://consumer.fda.gov.tw/../ProductDetail.aspx?nodeID=420&id=1402

在香港,上述產品並非註冊藥劑製品。 台灣衛生福利部食品藥物管理署早前已公布有關消息,而相關資訊已在2019年3月4日刊登於藥物辦公室的網頁。

在香港,共有248種註冊藥劑製品含有纈沙坦(valsartan)(83種產品)、坎地沙坦(candesartan)(19種產品)、依貝莎坦(irbesartan)(62種產品)、氯沙坦(losartan)(67種產品)及奧美沙坦(olmesartan)(17種產品)。所有產品屬醫生處方藥物。

關於沙坦產品中的雜質,衞生署已於2018年7月6日發出公告,並已於2018年7月6日、2018年7月9日、2018年7月25日及2018年8月3日發信通知本地醫護專業人員。各海外藥物監管局早前已公布有關消息,而相關資訊已從2018年7月6日起刊登於藥物辦公室的網頁,最新的更新亦已於2019年3月22日刊登。

就各海外藥物監管局公布沙坦產品中檢測到的「N-亞硝基二甲胺」(NDMA)及「N-亞硝基二乙胺」(NDEA),在香港共有5種纈沙坦產品及1種依貝莎坦產品受影響,並分別於2018年7月6日及2018年12月20日從香港市面上回收: HK-61786,HK-61787,HK-61784,HK-61785,HK-60794及HK-63378。衞生署知悉所有相關的回收已經完成。

衞生署已在本地市場收集沙坦產品的樣本進行化驗。未檢測到NDMA和NDEA。

就各海外藥物監管局公布在氯沙坦檢測到的「N-亞硝基-N-甲基-4-氨基丁酸」(NMBA),衞生署於2019年3月11日同意從市面回收4種氯沙坦產品(HK-61932,HK-61933,HK-62634及 HK-62635)作為預防措施,因為相關產品可能含有NMBA雜質。衞生署會繼續密切監察有關回收。

至今,衞生署接獲16宗涉及纈沙坦、氯沙坦、依貝莎坦、坎地沙坦及奧美沙坦的藥物不良反應個案,但當中並沒有結論是與NDMA、NDEA及/或NMBA等雜質有關。衞生署會對其他海外藥物監管局就沙坦類藥物檢測到雜質發出的安全更新保持警惕。

正在服用上述產品的病人不應自行停止服用藥物,他們應盡快向其醫護人員諮詢意見,以作適當安排。



2019年3月23日 (星期六)
香港時間12時正
 
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