Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 14–15

HOS-089888 · Präparat HOS-083941

14  Not known: Vaccine breakthrough infection (after in utero exposure to infliximab)*. Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare: Lymphoma, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukaemia, melanoma, cervical cancer. Not known: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn’s disease or ulcerative colitis), Merkel cell carcinoma, Kaposi’s sarcoma. Blood and lymphatic system disorders Common: Neutropenia, leucopenia, anaemia, lymphadenopathy. Uncommon: Thrombocytopenia, lymphopenia, lymphocytosis. Rare: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura. Immune system disorders Common: Allergic respiratory symptom. Uncommon: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction. Rare: Anaphylactic shock, vasculitis, sarcoid-like reaction. Metabolism and nutrition disorders Uncommon: Dyslipidaemia. Psychiatric disorders Common: Depression, insomnia. Uncommon: Amnesia, agitation, confusion, somnolence, nervousness. Rare: Apathy. Nervous system disorders Very common: Headache. Common: Vertigo, dizziness, hypoaesthesia, paraesthesia. Uncommon: Seizure, neuropathy. Rare: Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy). Not known: Cerebrovascular accidents in close temporal association with infusion. Eye disorders Common: Conjunctivitis. Uncommon: Keratitis, periorbital oedema, hordeolum. Rare: Endophthalmitis. Not known: Transient visual loss occurring during or within 2 hours of infusion. Cardiac disorders Common: Tachycardia, palpitation. Uncommon: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia. Rare: Cyanosis, pericardial effusion. Not known: Myocardial ischaemia/myocardial infarction. Vascular disorders Common: Hypotension, hypertension, ecchymosis, hot flush, flushing. Uncommon: Peripheral ischaemia, thrombophlebitis, haematoma. Rare: Circulatory failure, petechia, vasospasm.

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