Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-150446 · Präparat HOS-100320

MedDRA system organ class Adverse reactions Frequency category 1 Blood and lymphatic system disorders Factor VIII inhibition Very common (PUPs)2 Uncommon (PTPs)3 Immune system disorders Hypersensitivity, Not known anaphylactic reactions1 Nervous system disorders Headache4 Very common Gastrointestinal disorders Vomiting Common Skin and subcutaneous tissue disorders Eczema Common Rash5 Common Urticaria6 Common Musculoskeletal and connective tissue disorders Arthralgia Very common Pain in extremity Common Back pain Common General disorders and administration site Pyrexia Common conditions Injection site reaction7 Uncommon 1 Reported in post-marketing setting. 2 PUPs = Previously-Untreated Patients. Frequency is based on studies with other Factor VIII products which included PUPs with severe haemophilia A. 3 PTPs = Previously-Treated Patients. Frequency is based on studies with all Factor VIII products which included PTPs with severe haemophilia A. 4 Headache, including migraine. 5 Rash, including rash maculo papular. 6 Urticaria, including urticaria papular. 7 Injection site reaction, including injection site haematoma and injection site dermatitis.

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