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contaminated Heparin, remote batch of Clexane

The Presidency of ARCO Marche (Regional Association of Consumer Brands) announces that began the process of withdrawal of the batch number 291, T 6000 IU medicine Clexane, enoxaparin anticoagulant-based, "fired" for the last distribution March 27, 2008 for exclusive use in hospitals. The measure was necessary due to the positivity of a test that revealed the presence of a contaminant: the chondroitin sulfate ipersolfatato. The contaminant was found for the occurrence of severe allergic reactions. Promptly made aware of the withdrawal by the manufacturer, Sanofi Aventis, the Italian Drug Agency has started all procedures requirements: informed the Health Department of the Regions and Autonomous Provinces, as well as all the leaders of the National Network of Pharmacovigilance. And, in collaboration with the National Institute of Health, is conducting all the necessary checks to ensure the safety of medicines based heparin in Italy, while in continuous contact with other European agencies and the European Medicines Agency for monitoring and control of contamination in batches of heparin sold in Europe.

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