Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Torisel

Torisel 30 mg concentrate and solvent for solution for infusion · Abschnitt 4.8 · PDF-Seite 13

HOS-209003 · Präparat HOS-154221

System Frequency Adverse reactions All grades Grade organ class n (%) 3&4 n (%) Infections and Very common Bacterial and viral infections 91 (28.3) 18 (5.6) infestations (including infection, viral infection, cellulitis, herpes zoster, oral herpes, influenza, herpes simplex, herpes zoster ophthalmic, herpes virus infection, bacterial infection, bronchitis*, abscess, wound infection, post-operative wound infections) Pneumoniaa (including interstitial 35 (10.9) 16 (5.0) pneumonia) Common Sepsis* (including septic shock) 5 (1.6) 5 (1.6) Candidiasis (including oral and anal 16 (5.0) 0 (0.0) candidiasis) and fungal infection/fungal skin infections Urinary tract infection (including 29 (9.0) 6 (1.9) cystitis) Upper respiratory tract infection 26 (8.1) 0 (0.0) Pharyngitis 6 (1.9) 0 (0.0) Sinusitis 10 (3.1) 0 (0.0) Rhinitis 7 (2.2) 0 (0.0) Folliculitis 4 (1.2) 0 (0.0) Uncommon Laryngitis 1 (0.3) 0 (0.0) Blood and Very common Neutropenia 46 (14.3) 30 (9.3) lymphatic system Thrombocytopenia** 97 (30.2) 56 (17.4) disorders Anaemia 132(41.1) 48 (15) Common Leukopenia ** 29 (9.0) 10 (3.1) Lymphopenia 25 (7.8) 16 (5.0) Immune system Common Hypersensitivity reactions / drug 24 (7.5) 1 (0.3) disorders hypersensitiviy Metabolism and Very common Hyperglycaemia 63 (19.6) 31 (9.7) nutrition disorders Hypercholesterolaemia 60 (18.7) 1 (0.3) Hypertriglyceridaemia 56 (17.4) 8 (2.5) Decreased appetite 107 (33.3) 9 (2.8) Hypokalaemia 44 (13.7) 13 (4.0) Common Diabetes mellitus 10 (3.1) 2 (0.6) Dehydration 17 (5.3) 8 (2.5) Hypocalcaemia 21 (6.5) 5 (1.6) Hypophosphataemia 26 (8.1) 14 (4.4) Hyperlipidaemia 4 (1.2) 0 (0.0) Psychiatric Very Common Insomnia 45 (14.0) 1 (0.3) disorders Common Depression 16 (5.0) 0 (0.0) Anxiety 28 (8.7) 0 (0.0)

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