Changes to the Summary of Product Characteristics for Novastan®/Argatra®/Arganova®, November 2009
The Summary of Product Characteristics (SmPC) has been updated to provide additional dosing information for the use of argatroban in Special Populations with heparin–induced thrombocytopenia type II (HIT type II) who require anticoagulation, including critically ill patients and postoperative cardiac surgery patients. Further dosing information is provided for HIT type II patients undergoing haemodialysis or percutaneous coronary interventions (PCI). There is only limited data on the use of argatroban in children but the SmPC now contains some information on dosing from a study carried out in children.
Please consult the detailed dosing information in the appropriate country SmPC.
Final versions of the SmPC incorporating the changes are available on this website for Denmark, Germany, Iceland, Netherlands, Norway and Sweden. The final SmPC text for Austria and Italy is awaited.
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