Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Gobivaz

GOBIVAZ 50 mg solution for injection in pre-filled syringe. · Abschnitt 4.8 · PDF-Seite 11–12

HOS-153471 · Präparat HOS-101000

11  Table 2 Tabulated list of ARs Infections and infestations Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis) Common: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis Neoplasms, benign, malignant and unspecified Uncommon: Neoplasms (such as skin cancer, squamous cell carcinoma and melanocytic naevus) Rare: Lymphoma, leukaemia, melanoma, Merkel cell carcinoma Not known: Hepatosplenic T-cell lymphoma*, Kaposi’s sarcoma Blood and lymphatic system disorders Common: Leukopenia (including neutropenia), anaemia Uncommon: Thrombocytopenia, pancytopenia Rare: Aplastic anaemia, agranulocytosis Immune system disorders Common: Allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive Rare: Serious systemic hypersensitivity reactions (including anaphylactic reaction), vasculitis (systemic), sarcoidosis Endocrine disorders Uncommon: Thyroid disorder (such as hypothyroidism, hyperthyroidism and goitre) Metabolism and nutrition disorders Uncommon: Blood glucose increased, lipids increased Psychiatric disorders Common: Depression, insomnia Nervous system disorders Common: Dizziness, headache, paraesthesia Uncommon: Balance disorders Rare: Demyelinating disorders (central and peripheral), dysgeusia Eye disorders Uncommon: Visual disorders (such as blurred vision and decreased visual acuity), conjunctivitis, eye allergy (such as pruritus and irritation) Cardiac disorders Uncommon: Arrhythmia, ischaemic coronary artery disorders Rare: Congestive heart failure (new onset or worsening)

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