Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 12–13

HOS-091585 · Präparat HOS-084365

12 MedDRA system organ class Subject incidence Adverse reaction Skin and subcutaneous tissue Common Rash/erythemac disorders Not known2 SJS/TEN, erythema multiforme, blistering, skin exfoliation General disorders and administration Common Oedemad site conditions Common Injection site paine Uncommon1 Injection site bruising Injection site haemorrhage 1 ADRs identified in the post marketing environment. Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of ADRs identified in the post marketing setting was determined using the “Rule of three”. 2 Frequency cannot be estimated from the available data. Source: includes 8 randomised, double-blind, placebo-controlled studies (980291-schedule 1 and 2, 980297, 990114, 20000161, 20010145, 20030232, and 20070782) a Hypersensitivity events includes all events under the hypersensitivity SMQ. b Thromboembolic events adverse reactions includes PT embolism, thrombosis, deep vein thrombosis, jugular vein thrombosis, venous thrombosis, arterial thrombosis, pelvic venous thrombosis, peripheral embolism, pulmonary embolism, as well as thrombosis in device from SOC product issues. c Rash adverse reactions includes PT rash, rash pruritic, rash generalised, rash papular, erythema, exfoliative rash, rash maculo-papular, rash vesicular as well as rash pustular from SOC Infections and Infestations. d Oedema: includes PT Oedema Peripheral, Oedema, Generalised Oedema, Oedema due to Cardiac Disease, Face oedema e Injection site pain adverse reaction includes PT injection site pain, administration site pain, catheter site pain, infusion site pain and vessel puncture site pain.

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