Nebenwirkungen · Amsparity
Amsparity 40 mg/0.8 ml solution for injection · Abschnitt 4.8 · PDF-Seite 56
HOS-291380 · Präparat HOS-287470
Investigations* Common Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double-stranded DNA antibody), blood lactate dehydrogenase increased 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.
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 2025-10-22T10:44:00Z · SHA-256 a0544bd76241c9842cd0e5dfac32db18daa27ce23ef620c004be7f5a8d89460b · Passage b4b328616e22ae34fddec02feb6756ff55dbb494479ca3156e52a68d1aa2a3a8 · Zeichen 15229–16681 im Abschnitt