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Vyxeos liposomal (previously Vyxeos) · 4.8 · Haemorrhage Due to the thrombocytopenia experienced with Vyxeos liposomal a variety of haemorrhagic events wer
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Hypersensitivity Hypersensitivity reactions were very common ADRs in Vyxeos liposomal clinical studies. The mo
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Infections Due to the neutropenia experienced with Vyxeos liposomal, infections of various types were very com
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · No paediatric long-term safety data beyond the study duration (26 months) are available. There is, thus, no pa
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Paediatric population
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Relapsed AML The safety profile of Vyxeos liposomal in 38 paediatric patients with relapsed AML in study AAML1
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Summary of the safety profile The most frequently occurring adverse reactions (ADRs) were hypersensitivity inc
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · System organ class ADRs/Frequency (%) Grade 3-5 ADRs/Frequency (%) Infections and infestations Very common Ver
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Tabulated list of adverse reactions ADRs have been included under the appropriate category in the table below
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · The most serious and frequently occurring ADRs were infection (58.7%), cardiotoxicity (18.7%) and haemorrhage
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Uncommon Chills (0.3) a Arrhythmia group terms includes atrial fibrillation, bradycardia, and the most commonl
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Uncommon Palmar-plantar erythrodysaesthesia syndrome (0.8) Musculoskeletal and Very common Common connective t
Eintrag öffnenVyxeos liposomal (previously Vyxeos) · 4.8 · Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. For classi
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