Nebenwirkungen · Remsima
Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 58
HOS-127253 · Präparat HOS-096377
In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn’s disease. Nine of these patients developed malignancies, including 1 lymphoma. The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%]. There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]). The majority of the malignancies developed in the lung or head and neck.
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
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