Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Abseamed

Abseamed 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 2 000 IU/1 mL solution for injection in a pre-filled syringe Abseamed 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Abseamed 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Abseamed 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Abseamed 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Abseamed 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Abseamed 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Abseamed 10 000 IU/1 mL solution for injection in a pre-filled syringe Abseamed 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Abseamed 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 17

HOS-117338 · Präparat HOS-094577

Adult patients with low- or intermediate-1-risk MDS In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis). All TVEs occurred in the epoetin alfa group and in the first 24 weeks of the study. Three were confirmed TVE and in the remaining case (sudden death), the thromboembolic event was not confirmed. Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis).

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