Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Advate

ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7–8

HOS-112447 · Präparat HOS-093675

7 a) Calculated based on total number of patients who received ADVATE (418) in clinical trials, except for adverse reactions identified in post-marketing surveillance marked with *. b) Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients. c) ADR explained in the section below. d) The unexpected decrease in coagulation factor VIII levels occurred in one patient during continuous infusion of ADVATE following surgery (post-operative days 10-14). Haemostasis was maintained at all times during this period and both plasma factor VIII levels and clearance rates returned to appropriate levels by post-operative day 15. Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.