Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Remsima

Remsima 100 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 17

HOS-127145 · Präparat HOS-096377

Vascular disorders Common: Hypotension, hypertension, ecchymosis, hot flush, flushing. Uncommon: Peripheral ischaemia, thrombophlebitis, haematoma. Rare: Circulatory failure, petechia, vasospasm. Respiratory, thoracic and mediastinal disorders Very common: Upper respiratory tract infection, sinusitis. Common: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis. Uncommon: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion. Rare: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis). Gastrointestinal disorders Very common: Abdominal pain, nausea. Common: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation. Uncommon: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis. Hepatobiliary disorders Common: Hepatic function abnormal, transaminases increased. Uncommon: Hepatitis, hepatocellular damage, cholecystitis. Rare: Autoimmune hepatitis, jaundice. Not known: Liver failure. Skin and subcutaneous tissue disorders Common: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia. Uncommon: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation. Rare: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions. Not known: Worsening of symptoms of dermatomyositis. Musculoskeletal and connective tissue disorders Common: Arthralgia, myalgia, back pain. Renal and urinary disorders Common: Urinary tract infection. Uncommon: Pyelonephritis. Reproductive system and breast disorders Uncommon: Vaginitis.

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