Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Adynovi

ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection ADYNOVI 1 000 IU / 2 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 25

HOS-136072 · Präparat HOS-097816

Blood and lymphatic system disorders Factor VIII inhibition Uncommon (PTPs)1 Very common (PUPs)1 Immune system disorders Hypersensitivity Uncommon Anaphylactic reaction2 Not known Nervous system disorders Headache Common Dizziness Common Eye disorders Ocular hyperaemia Uncommon Vascular disorders Flushing Uncommon Gastrointestinal disorders Diarrhoea Common Vomiting Common Nausea Common Respiratory, thoracic and mediastinal Cough Very common disorders Skin and subcutaneous tissue disorders Rash Common Rash pruritic Uncommon Urticaria Common Eyelid rash Uncommon Investigations Eosinophil count Uncommon increased Injury, poisoning and procedural Infusion related reaction Uncommon complications 1 Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients Frequencies presented were calculated using all adverse events, related and unrelated. 2 Adverse reaction identified in post-marketing surveillance.

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