Nebenwirkungen · Epclusa
Epclusa 400 mg/100 mg film-coated tablets Epclusa 200 mg/50 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-136154 · Präparat HOS-097846
The safety profile of Epclusa has been determined in pooled Phase 3 clinical studies of patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and in the postmarketing setting. No adverse drug reactions to Epclusa were identified from clinical studies. In the postmarketing setting, cases of severe bradycardia and heart block have been observed when SOF-containing products are used in combination with amiodarone, and HBV reactivation has been observed in patients coinfected with HCV/HBV following treatment with DAAs (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 2023-08-14T16:16:00Z · SHA-256 5a15459ef6523a9cfa2e141592af073eabefab68f2b8f9dc006f477858a7fe66 · Passage 0a6b489414b20ae065bebcc28236a50c017962554bd3b4aab34291b8201791b1 · Zeichen 31–571 im Abschnitt