Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · BeneFIX

BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7–8

HOS-086895 · Präparat HOS-083385

7  System organ class Very Common Uncommon Frequency common ≥ 1/100 ≥ 1/1,000 to not known ≥ 1/10 to < 1/10 < 1/100 (cannot be estimated from the available data) Infections and Infusion-site infestations cellulitisa Blood and lymphatic Factor IX system disorders inhibitionb Immune system Hypersensitivityc Anaphylactic disorders reaction* Nervous system Headached Dizziness; Somnolence; disorders Dysgeusia tremor Eye disorders Visual impairmente Cardiac disorders Tachycardiaf Vascular disorders Phlebitis; Hypotensionh Superior vena cava flushingg syndromei,* ; deep vein thrombosis*; thrombosis*; thrombophlebitis* Respiratory, thoracic Coughj and mediastinal disorders Gastrointestinal Vomiting; nausea disorders Skin and subcutaneous Rashk; urticaria tissue disorders Renal and urinary Renal infarctl disorders General disorders and Pyrexia Chest discomforto; Inadequate therapeutic administration site infusion-site response* conditions reactionn; infusion-site painm Investigations Inadequate factor IX recovery p, * * ADR identified post-marketing a including cellulitis b low-titer transient inhibitor formation c including drug hypersensitivity, angioedema, bronchospasm, wheezing, dyspnoea, and laryngospasm d including migraine, sinus headache e including scintillating scotoma and blurred vision f including heart rate increased, sinus tachycardia g including hot flush, feeling hot, skin warm h including blood pressure decreased i superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion of BeneFIX through a central venous catheter j including productive cough k including rash macular, rash papular, rash maculopapular l developed in a hepatitis C antibody-positive patient 12 days after a dose of BeneFIX for a bleeding episode. m including injection site pain, infusion-site discomfort n including infusion-site pruritus, infusion-site erythema o including chest pain and chest tightness p This is a verbatim term. No MedDRA 17.1 PT was retrieved.

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