Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Aldurazyme

Aldurazyme 100 U/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6–7

HOS-111688 · Präparat HOS-093579

6  MedDRA Very common Common Not known System Organ Class Immune system Anaphylactic reaction Hypersensitivity disorders Psychiatric disorders Restlessness Nervous system Headache Paraesthesia, dizziness disorders Cardiac disorders Tachycardia Bradycardia Vascular disorders Flushing Hypotension, pallor, Hypertension peripheral coldness Respiratory, thoracic Respiratory distress, Cyanosis, hypoxia, and mediastinal dyspnoea, cough tachypnoea, disorders bronchospasm, respiratory arrest, laryngeal oedema, respiratory failure, pharyngeal swelling, stridor, obstructive airways disorder Gastrointestinal Nausea, abdominal pain Vomiting, diarrhoea Lip swelling, swollen disorders tongue Skin and subcutaneous Rash Angioedema, swelling Erythema, facial edema, tissue disorders face, urticaria, pruritus, cold sweat, alopecia, hyperhidrosis Musculoskeletal and Arthropathy, arthralgia, Musculoskeletal pain connective tissue back pain, pain in disorders extremity General disorders and Pyrexia, infusion site Chills, feeling hot, Extravasation, oedema administration site reaction* feeling cold, fatigue, peripheral conditions influenza like illness, injection site pain Investigations Body temperature Drug specific antibody, increased, oxygen neutralizing antibodies, saturation decreased blood pressure increased * During clinical trials and post-marketing experience, infusion/injection site reactions notably included: swelling, erythema, oedema, discomfort, urticaria, pallor, macule, and warmth.

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