Wechselwirkungen · Votubia
Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets · Abschnitt 4.5 · PDF-Seite 13
HOS-214264 · Präparat HOS-155312
Based on in vitro results, the systemic concentrations obtained after oral daily doses of 10 mg make inhibition of PgP, CYP3A4 and CYP2D6 unlikely. However, inhibition of CYP3A4 and PgP in the gut cannot be excluded. An interaction study in healthy subjects demonstrated that co-administration of an oral dose of midazolam, a sensitive CYP3A substrate probe, with everolimus resulted in a 25% increase in midazolam Cmax and a 30% increase in midazolam AUC(0-inf). The effect is likely to be due to inhibition of intestinal CYP3A4 by everolimus. Hence everolimus may affect the bioavailability of orally co-administered CYP3A4 substrates. However, a clinically relevant effect on the exposure of systemically administered CYP3A4 substrates is not expected (see section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-20T17:40:00Z · SHA-256 252b066ec590fdab1f3eb7eccacdb5c7e91ec79421c970096d1b5261820faba4 · Passage 71c5231892af91763d28f46bd933d8020ec44c41002fd1ce09bf8de3139f4a85 · Zeichen 14205–14978 im Abschnitt