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

HOS-091581 · Präparat HOS-084365

MedDRA system organ class Subject incidence Adverse reaction Blood and lymphatic system Not known2 Pure red cell aplasia disorders Immune system disorders Very common Hypersensitivitya Nervous system disorders Common Strokeb Uncommon1 Convulsions Cardiac disorders Very common Hypertension Vascular disorders Uncommon Thromboembolic eventsc Uncommon1 Dialysis vascular access thrombosisd Skin and subcutaneous tissue Common Rash/erythemae disorders Not known2 SJS/TEN, erythema multiforme, blistering, skin exfoliation General disorders and administration Common Injection site pain site conditions Uncommon1 Injection site bruising Injection site haemorrhage Source: Includes 5 randomised, double-blind, active-controlled studies (970200, 970235, 980117, 980202, and 980211) except for the adverse reaction of stroke which was identified as an adverse reaction in the TREAT study (study 20010184). 1 Adverse reactions identified in the post-marketing environment. Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of adverse reactions identified in the post-marketing setting was determined using the “Rule of three”. 2 Frequency cannot be estimated from the available data. a Hypersensitivity events includes all events under the hypersensitivity SMQ. b Stroke events includes PT haemorrhagic stroke, ischaemic stroke, cerebrovascular accident, and stroke in evolution. c Thromboembolic events adverse reaction includes PT embolism arterial, thrombophlebitis, thrombosis, venous thrombosis limb. d Dialysis vascular access thrombosis includes all adverse reactions under the dialysis vascular access thrombosis AMQ e Rash/erythema adverse reaction includes PT rash, rash pruritic, rash macular, rash generalised, erythema.

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