Nebenwirkungen · MabThera
MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 21
HOS-087579 · Präparat HOS-083527
The most frequent adverse reactions considered due to receipt of MabThera were IRRs. The overall incidence of IRRs in clinical trials was 23% with the first infusion and decreased with subsequent infusions. Serious IRRs were uncommon (0.5% of patients) and were predominantly seen during the initial course. In addition to adverse reactions seen in RA clinical trials for MabThera, progressive multifocal leukoencephalopathy (PML) (see section 4.4) and serum sickness-like reaction have been reported during post marketing experience.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-06T15:15:00Z · SHA-256 595c4e1a263e9a34be8b62842a5fc67f95f6a1b1f2a250341444a2960c6c3962 · Passage abb1f5d60890cd5a11ceda50bb0008dcfe5cb9e3fb11d133a3be3cb31258d5a6 · Zeichen 26396–26930 im Abschnitt