Nebenwirkungen · Intelence
INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-119761 · Präparat HOS-095005
In PIANO and TMC125-C234/IMPAACT P1090, the frequency, type and severity of adverse reactions in paediatric patients were comparable to those observed in adults. In PIANO, rash was reported more frequently in female subjects than in male subjects (rash ≥ grade 2 was reported in 13/64 [20.3%] females versus 2/37 [5.4%] males; discontinuations due to rash were reported in 4/64 [6.3%] females versus 0/37 [0%] males) (see section 4.4). Most often, rash was mild to moderate, of macular/papular type, and occurred in the second week of therapy. Rash was mostly self-limiting and generally resolved within 1 week on continued therapy.
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 2024-08-13T16:37:00Z · SHA-256 b6b2c3fd3d600c0f1fd17ddc8f6c1da50bcb8b2181089113d0397c5ec46864c4 · Passage c8b4d5d69136af276196c4c955e2ce2d55c7c9d3dc678921807445770c310752 · Zeichen 7485–8117 im Abschnitt