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Azacitidine Mylan · 4.8 · Description of selected adverse reactions
Eintrag öffnenAzacitidine Mylan · 4.8 · Elderly population There is limited safety information available with azacitidine in patients ≥ 85 years (with
Eintrag öffnenAzacitidine Mylan · 4.8 · Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Eintrag öffnenAzacitidine Mylan · 4.8 · Gastrointestinal adverse reactions The most commonly reported gastrointestinal adverse reactions associated wi
Eintrag öffnenAzacitidine Mylan · 4.8 · Haematologic adverse reactions The most commonly reported (≥ 10%) haematological adverse reactions associated
Eintrag öffnenAzacitidine Mylan · 4.8 · Hepatic adverse reactions Patients with extensive tumour burden due to metastatic disease have been reported t
Eintrag öffnenAzacitidine Mylan · 4.8 · Hypersensitivity Serious hypersensitivity reactions have been reported in patients receiving azacitidine. In c
Eintrag öffnenAzacitidine Mylan · 4.8 · In Study AZA-AML-004, 7 paediatric patients (aged 2 to 12 years) were treated with azacitidine for AML in mole
Eintrag öffnenAzacitidine Mylan · 4.8 · Infections Myelosuppression may lead to neutropenia and an increased risk of infection. Serious adverse reacti
Eintrag öffnenAzacitidine Mylan · 4.8 · No new safety signals were identified in the limited number of paediatric patients treated with azacitidine du
Eintrag öffnenAzacitidine Mylan · 4.8 · Paediatric population In Study AZA-JMML-001, 28 paediatric patients (1 month to less than 18 years of age) wer
Eintrag öffnenAzacitidine Mylan · 4.8 · Renal adverse reactions Renal abnormalities, ranging from elevated serum creatinine and haematuria to renal tu
Eintrag öffnenAzacitidine Mylan · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenAzacitidine Mylan · 4.8 · Skin and subcutaneous tissue adverse reactions The majority of skin and subcutaneous adverse reactions were as
Eintrag öffnenAzacitidine Mylan · 4.8 · Summary of the safety profile
Eintrag öffnenAzacitidine Mylan · 4.8 · System Organ Very common Common Uncommon Rare Not Known Class Infections and pneumonia* sepsis* (including nec
Eintrag öffnenAzacitidine Mylan · 4.8 · Table 1 below contains adverse reactions associated with azacitidine treatment obtained from the main clinical
Eintrag öffnenAzacitidine Mylan · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenAzacitidine Mylan · 4.8 · The most common serious adverse reactions noted from the pivotal study (AZA PH GL 2003 CL 001) included febril
Eintrag öffnenAzacitidine Mylan · 4.8 · The most commonly reported (≥ 30%) adverse reactions with azacitidine treatment were gastrointestinal events,
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