[Posted 07/05/2007]
Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. The product was recalled because of two incidents of finding broken glass pieces in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. No other lots are affected by this recall.
相關資訊：http://www.fda.gov/medwatch/safety/2007/INVANZ_DHCP.pdf
Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. The product was recalled because of two incidents of finding broken glass pieces in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. No other lots are affected by this recall.
相關資訊：http://www.fda.gov/medwatch/safety/2007/INVANZ_DHCP.pdf
行政院衛生署新聞稿
日期 | 96.07.06 | 單位 | 藥政處 | 編號 |
美國回收 Invanz 藥品部分批次，衛生署證實該等不良品並未輸入臺灣
用於治療感受性微生物所引起的中度到重度感染藥物ertapenem sodium（中/英文品名：益滿治注射劑/Invanz），因為發現批號為0803930、0803940、0803950等之藥品有破碎玻璃片，故美國FDA於2007年7月5日公布警訊，美國默沙東藥廠並主動回收這些批號之藥品。 衛生署核准Invanz藥品（衛署藥輸字第023749號）之適應症為適用 於下列具感受性之微生物所引起的中度至重度感染：1.複雜的腹腔內感染 2.複雜的皮膚和皮膚組織感染 3.感染性肺炎(COMMUNITY ACQUIRED PNEUMONIA) 4.複雜的尿道感染，包括腎盂腎炎 5.急性 骨盆感染，包括產後子宮內肌炎、敗血性流產和手術後婦科感染，經 查該等批號之不良品並未輸入臺灣，請醫療人員及病患毋須恐慌。
衛生署已建立藥物安全主動監控機制，除有「全國藥物不良品通報系統」及「全國藥物不良反應通報系統」之外，對於安全有關訊息，隨時進行瞭解，以保障民眾之用藥安全，提醒醫療人員或病患疑似因為使用（服用）藥品導致不良反應發生時，或發現藥物不良品時，請立即通報給衛生署所建置之全國藥物不良反應通報中心，藥物不良反 應或藥物不良品通報專線 02-2396-0100，網站：http://recall.doh.gov.tw。
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