Nebenwirkungen · Alprolix
ALPROLIX 250 IU powder and solvent for solution for injection ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-135652 · Präparat HOS-097754
Table 2: Adverse reactions reported for ALPROLIX MedDRA System Organ Class Adverse reactions Frequency category Blood and lymphatic system disorders Factor IX inhibition Common1 Immune system disorders Hypersensitivity Common1 Anaphylactic reaction Not known Anaphylactic shock Not known Metabolism and nutrition disorders Decreased appetite Uncommon Nervous system disorders Headache Common Dizziness Uncommon Dysgeusia Uncommon Cardiac disorders Palpitations Uncommon Vascular disorders Hypotension Uncommon Gastrointestinal disorders Paraesthesia oral Common Breath odour Uncommon Renal and urinary disorders Obstructive uropathy Common Haematuria Uncommon Renal colic Uncommon General disorders and administration site Injection site erythema Common conditions Fatigue Uncommon Infusion site pain Uncommon 1 Frequency based on occurrence in PUPs study. Both events of factor IX inhibition and hypersensitivity occurred in a single PUP in Study IV. See Description of selected adverse reactions.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-07-06T02:00:00Z · SHA-256 e42dd716e190b5b1801370fcbf09f24ba5358dc15bf28247721be9dcc9a1d1b1 · Passage 4ef19a24e40a03382344db3b69d0865d96849542af502cca26ad9e717544a287 · Zeichen 2665–4867 im Abschnitt