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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| Canada: Updated safety information for the use of Innohep (tinzaparin sodium) in elderly patients with renal impairment – the IRIS clinical trial(English Only) |
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Health Canada informs of important updated safety information regarding Innohep (tinzaparin sodium) related to results from a clinical study that was stopped prematurely (IRIS – Innohep in Renal Insufficiency Study) due to the observance of increased mortality. This study involved the use of therapeutic doses of Innohep for the treatment of acute venous thromboembolism (VTE) in elderly patients with renal impairment.
Please refer to the following website in FDA for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/innohep_hpc-cps-eng.php
In Hong Kong, six Innohep products with different strength/packing have been registered. All these products are prescription drugs. The package insert is being updated to include the following with reference to Demark’s summary of product characteristics:
“Precaution is recommended in the treatment of elderly patients with renal impairment. Renal function should be assessed and in patients with severe renal impairment (creatinine clearance ＜30ml/min), monitoring of an anti-factor Xa activity should be considered.”
Ends/Wednesday, October 20, 2010
Issued at HKT 14:30
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