Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-089611 · Präparat HOS-083891

System Organ Class Very common Common Uncommon ≥ 1/10 ≥ 1/100 ≥ 1/1,000 to to < 1/10 < 1/100 Blood and lymphatic FVIII inhibition FVIII inhibition system disorders (PUPs)* (PTPs)* Immune system Anaphylactic reaction disorders Metabolism and Decreased appetite nutrition disorders Nervous system Headache Dizziness Neuropathy peripheral; disorders somnolence; dysgeusia Cardiac disorders Angina pectoris; tachycardia; palpitations Vascular disorders Haemorrhage; Hypotension; thrombophlebitis; haematoma flushing Respiratory, thoracic Cough Dyspnoea and mediastinal disorders Gastrointestinal Diarrhoea; vomiting; disorders abdominal pain; nausea Skin and subcutaneous Urticaria; rash; pruritus Hyperhidrosis tissue disorders Musculoskeletal and Arthralgia Myalgia connective tissue disorders General disorders and Pyrexia Chills; catheter site Asthenia; injection site reaction; administration site related reaction injection site pain; injection site conditions inflammation Investigations Antibody test positive; Aspartate aminotransferase Anti-factor VIII increased; alanine antibody test positive aminotransferase increased; blood bilirubin increased; blood creatinine phosphokinase increased * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients

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