Nebenwirkungen · Amgevita
AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 23
HOS-224915 · Präparat HOS-217372
In the controlled phase 3 trial of adalimumab in patients with paediatric ulcerative colitis (N=93) which evaluated efficacy and safety of a maintenance dose of 0.6 mg/kg (maximum of 40 mg) every other week (N=31) and a maintenance dose of 0.6 mg/kg (maximum of 40 mg) every week (N=32), following body weight adjusted induction dosing of 2.4 mg/kg (maximum of 160 mg) at week 0 and week 1, and 1.2 mg/kg (maximum of 80 mg) at week 2 (N=63), or an induction dose of 2.4 mg/kg (maximum of 160 mg) at week 0, placebo at week 1, and 1.2 mg/kg (maximum of 80 mg) at week 2 (N=30), ALT elevations ≥ 3 X ULN occurred in 1.1% (1/93) of patients.
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 2026-04-23T02:00:00Z · SHA-256 e60d722f3b6745489b45f5c78ae97b6371cdaa2129d753a34a831ca4ba40a8b5 · Passage 0ba951105ad1faf1feac4cb01e36a04bc18ac7fa9f9d1a5eca4430320de9d755 · Zeichen 22908–23546 im Abschnitt