Nebenwirkungen · Hyrimoz
Hyrimoz 20 mg solution for injection in pre-filled syringe Hyrimoz 40 mg solution for injection in pre-filled syringe Hyrimoz 40 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 24
HOS-137769 · Präparat HOS-098091
In the controlled Phase 3 study 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 2025-11-13T10:00:00Z · SHA-256 bb2e47f3048e41368975094658eb6e77cdd9bd77fdb14fd3af35a8737fa4ae2c · Passage 578fcb69f5446e62a5733b352bf605cfbfa89d53a623b1d6561495cbc2441182 · Zeichen 23402–24041 im Abschnitt