Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · MabThera

MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 23

HOS-087587 · Präparat HOS-083527

Infections The overall rate of infection reported from clinical trials was approximately 94 per 100 patient years in MabThera treated patients.The infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections and urinary tract infections. The incidence of infections that were serious or required IV antibiotics was approximately 4 per 100 patient years. The rate of serious infections did not show any significant increase following multiple courses of MabThera. Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the MabThera arms compared to control arms.

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