Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Docetaxel Accord

Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 21–22

HOS-126777 · Präparat HOS-096309

21 MedDRA System Very common adverse Common adverse Uncommon adverse Organ classes reactions reactions reactions Infections and Infection (G3/4: 2.4%); infestations Neutropenic infection (G3/4: 2.6%) Blood and lymphatic Anaemia (G3/4: 3%); system disorders Neutropenia (G3/4: 59.2%); Thrombocytopenia (G3/4: 1.6%); Febrile neutropenia (G3/4: NA) Immune system Hypersensitivity (G3/4: disorders 0.6%) Metabolism and Anorexia (G3/4: 1.5%) nutrition disorders Nervous system Dysgeusia (G3/4: Peripheral motor Syncope (G3/4: 0%); disorders 0.6%); neuropathy (G3/4: 0%) Neurotoxicity (G3/4: Peripheral sensory 0%); neuropathy (G3/4: Somnolence <0.1%) (G3/4: 0%) Eye disorders Conjunctivitis (G3/4: Lacrimation increased <0.1%) (G3/4: <0.1%) Cardiac disorders Arrhythmia (G3/4: 0.2%) Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: Lymphoedema (G3/4: 0%); 0%) Phlebitis (G3/4: 0%) Respiratory, thoracic Cough (G3/4: 0%) and mediastinal disorders Gastrointestinal Nausea (G3/4: 5.0%); Abdominal pain (G3/4: disorders Stomatitis (G3/4: 0.4%) 6.0%); Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%) Skin and subcutaneous Alopecia ( persisting: tissue disorders <3%); Skin disorder (G3/4: 0.6%); Nail disorders (G3/4: 0.4%) Musculoskeletal and Myalgia (G3/4: 0.7%); connective tissue Arthralgia (G3/4: disorders 0.2%) Reproductive system Amenorrhoea (G3/4: and breast disorders NA) General disorders and Asthenia (G3/4: administration site 10.0%); conditions Pyrexia (G3/4: NA); Oedema peripheral (G3/4: 0.2%)

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