Nebenwirkungen · Remsima
Remsima 40 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 98
HOS-127322 · Präparat HOS-096377
Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients. Anti-dsDNA antibodies were newly detected in approximately 17% of infliximab-treated patients compared with 0% of placebo-treated patients. At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive. Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4).
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 2026-05-08T11:20:00Z · SHA-256 5f1b2b895f1e310b8eb529b3b18f60969b899952e26ddab3cd95ccea13a0dd8b · Passage 150ea9a0f7ea0ae628a3a66bfac666fa4eea150dca0df9be3d22f14a51b33869 · Zeichen 23420–23948 im Abschnitt