In the course of treatment with preparations containing the prothrombin complex, thromboembolic events may occur particularly after high doses and/or in patients with thrombotic risk factors.
After application of high doses (single infusion of 100 units per kg of body weight, and daily doses of 200 units per kg of body weight) of FEIBA VH (AICC), laboratory and/or clinical signs of DIC have occasionally been observed.
In individual instances myocardial infarction was found to occur after high doses and/or prolonged administration and/or in the presence of risk factors predisposing to myocardial infarction.
As with all human plasma products, any kind of allergic reaction may be seen ranging from mild, short-term urticarial rashes to severe anaphylactoid reactions. Administration of FEIBA VH (AICC), Vapor Heated should be discontinued immediately, if such signs appear. Allergic reactions should be treated with antihistamines and glucocorticoids. Shock should be treated in the usual way.