4. 8), skal denne risiko omhyggeligt afvejes mod de fordele, behandlingen (med epoetin alfa) giver, især hos cancerpatienter med øget risiko for trombotiske vaskulære hændelser – f. eks. patienter, der lider af fedme, og patienter, der før har haft tromboser (f. eks. dyb venetrombose eller lungeemboli).
As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoiesis-stimulating agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with epoetin alfa) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e. g. deep vein thrombosis or pulmonary embolism).