Wirkstoffe & Arzneimittelsicherheit

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 Hyrimoz 80 mg solution for injection in pre-filled syringe Hyrimoz 80 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 80

HOS-137846 · Präparat HOS-098091

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 (minus) -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 effect of adalimumab.

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