Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Tevimbra

Tevimbra 100 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 13–14

HOS-150215 · Präparat HOS-100272

13 General disorders and administration site conditions Fatigue32 Very common Very common Pyrexia33 Very common Very common Decreased appetite Very common* Very common Investigations Aspartate aminotransferase increased Very common Very common Alanine aminotransferase increased Very common Very common Blood bilirubin increased 34 Very common Very common Blood alkaline phosphatase increased Common Common Blood creatinine increased Common Very common Injury, poisoning and procedural complications Infusion-related reaction 35 Common Common 1 Pneumonia includes preferred terms (PTs) of pneumonia, lower respiratory tract infection, lower respiratory tract infection bacterial, pneumonia bacterial, pneumonia fungal, pneumocystis jirovecii pneumonia, bronchopulmonary aspergillosis, candida pneumonia, pneumonia mycoplasmal, pneumonia staphylococcal and pneumonia viral. 2 Anaemia includes PTs of anaemia and haemoglobin decreased. 3 Thrombocytopenia includes PTs of thrombocytopenia, platelet count decreased and immune thrombocytopenia. 4 Neutropenia includes PTs of neutropenia and neutrophil count decreased. 5 Lymphopenia includes PTs of lymphopenia, lymphocyte count decreased and lymphocyte percentage decreased. 6 Hypothyroidism includes PTs of hypothyroidism, anti-thyroid antibody increased, immune-mediated hypothyroidism, thyroid hormones decreased, thyroxine free decreased, tri-iodothyronine free decreased, tri-iodothyronine decreased, primary hypothyroidism, central hypothyroidism and thyroxine decreased. 7 Hyperthyroidism includes PTs of blood thyroid stimulating hormone decreased, hyperthyroidism, immune- mediated hyperthyroidism, thyroxine free increased, thyroxine increased, tri-iodothyronine free increased, and tri-iodothyronine increased. 8 Thyroiditis includes PTs of thyroiditis, autoimmune thyroiditis, immune-mediated thyroiditis, silent thyroiditis and thyroiditis subacute. 9 Adrenal insufficiency includes PTs of Addison's disease, adrenal insufficiency, glucocorticoid deficiency, immune-mediated adrenal insufficiency, primary adrenal insufficiency, and secondary adrenocortical insufficiency. 10 Hypophysitis includes PTs of hypophysitis and hypopituitarism. 11 Hyperglycaemia includes PTs of hyperglycaemia and blood glucose increased. 12 Hyponatraemia includes PTs of hyponatraemia and blood sodium decreased. 13 Hypokalaemia includes PTs of hypokalaemia and blood potassium decreased. 14 Diabetes mellitus includes PTs of diabetes mellitus, diabetic ketoacidosis, diabetic ketosis, ketoacidosis, type 1 diabetes mellitus and latent autoimmune diabetes in adults. 15 Encephalitis includes the PT of immune-mediated encephalitis.16 Uveitis includes PTs of chorioretinitis, iridocyclitis, uveitis and iritis. 17 Myocarditis includes PTs of myocarditis, immune-mediated myocarditis and autoimmune myocarditis. 18 Hypertension includes PTs of hypertension, blood pressure increased and essential hypertension. 19 Pneumonitis includes PTs of pneumonitis, immune-mediated lung disease, interstitial lung disease and organising pneumonia. 20 Diarrhoea includes PTs of diarrhoea and frequent bowel movements. 21 Stomatitis includes PTs of stomatitis, mouth ulceration, oral mucosa erosion and aphthous ulcer. 22 Pancreatitis includes PTs of, amylase increased, lipase increased, pancreatitis and pancreatitis acute. 23 Colitis includes PTs of autoimmune colitis, colitis, colitis ulcerative and immune-mediated enterocolitis. 24 Hepatitis includes PTs of hepatitis, drug-induced liver injury, hepatotoxicity, hepatic function abnormal, immune-mediated hepatitis, liver injury and autoimmune hepatitis.

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