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Epoetin Alfa Hexal · 4.8 · Adult patients with low- or intermediate-1-risk MDS In the randomised, double-blind, placebo-controlled, multi
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Antibody-mediated pure red cell aplasia has been very rarely reported in < 1/10 000 cases per patient year aft
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Description of selected adverse reactions
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Frequency estimate: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angione
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and int
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · MedDRA System Organ Adverse Reaction (Preferred Frequency Classification (SOC) Term Level) Blood and lymphatic
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, th
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Paediatric population with chronic renal failure on haemodialysis The exposure of paediatric patients with chr
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion an
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · SCARs including SJS and TEN, which can be life-threatening or fatal, have been reported in association with ep
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Summary of the safety profile
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blo
Eintrag öffnenEpoetin Alfa Hexal · 4.8 · The most frequently occurring adverse drug reactions observed in clinical studies of epoetin alfa are diarrhoe
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