Nebenwirkungen · Hulio
Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 103
HOS-138982 · Präparat HOS-098248
Not known Weight increased2 Injury, poisoning and Common Impaired healing procedural complications * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies 1) including spontaneous reporting data 2) The mean weight change from baseline for adalimumab ranged from 0.3 kg to 1.0 kg across adult indications compared to -0.4 kg to 0.4 kg for placebo over a treatment period of 4-6 months. Weight increase of 5-6 kg has also been observed in long-term extension studies with mean exposures of approximately 1-2 years without control group, particularly in patients with Crohn’s disease and ulcerative colitis. The mechanism behind this effect is unclear but could be associated with the anti- inflammatory effects of adalimumab.
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 2026-07-30T10:07:00Z · SHA-256 52f13e987d7f56f9469be0c97cb08298d55918c256d40a958b2e53f25def7ca4 · Passage 3a9f643b15bef0f89e790038f1e6f162f6197dac5711003b0e06f3bf4f2e4d68 · Zeichen 15503–16336 im Abschnitt