引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| Hong Kong: Adverse Drug Reaction of Acute Pancreatitis with GalvusMet Tab 50/850mg (vildagliptin/metformin)
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The Department of Health (DH) has received a local case report of suspected serious adverse drug reaction (ADR) of acute pancreatitis with GalvusMet Tab 50/850mg (HK-59044), a registered pharmaceutical product containing vildagliptin and metformin for the treatment of diabetes mellitus. According to the worldwide post-marketing reports provided by the product manufacturer, a total of 98 reports of GalvusMet with acute pancreatitis or pancreatitis have been received between 14 November 2007 and 20 September 2012.
In Hong Kong, there are 4 pharmaceutical products containing vildagliptin, namely Galvus Tab 50mg (HK-57309), GalvusMet Tab 50/500mg (HK-59813), GalvusMet Tab 50/850mg (HK-59044) and GalvusMet Tab 50/1000mg (HK-59043). They are prescription-only medicines registered by Novartis Pharmaceuticals (HK) Ltd. (Novartis) . DH has contacted Novartis about the ADR report. Novartis has replied and committed to enhance the safety information on acute pancreatitis in the package inserts of the 4 registered pharmaceutical products containing vildagliptin.
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