Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117300 · Präparat HOS-094569

Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects. Included were 228 epoetin alfa-treated CRF subjects in 4 CRF studies (2 studies in pre-dialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1 404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies. Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these studies are shown in the table below.

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