Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Advate

ADVATE 250 IU/2 ml powder and solvent for solution for injection ADVATE 500 IU/2 ml powder and solvent for solution for injection ADVATE 1 000 IU/2 ml powder and solvent for solution for injection ADVATE 1 500 IU/2 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 20–21

HOS-112469 · Präparat HOS-093675

20  Table 2. Frequency of adverse reactions in clinical trials and from spontaneous reports MedDRA Standard System Organ Class Adverse reaction Frequencya Injury, poisoning and procedural complications Post-procedural complication Uncommon Post-procedural haemorrhage Uncommon Procedural site reaction Uncommon 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.

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