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Azacitidin
Eintrag öffnenAzacitidine Mylan
Eintrag öffnenAzacitidine Mylan · 4.1 Therapeutic indications · 1
Eintrag öffnenAzacitidine Mylan · 4.3 Contraindications · 1
Eintrag öffnenAzacitidine Mylan · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Advanced malignant
Eintrag öffnenAzacitidine Mylan · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenAzacitidine Mylan · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenAzacitidine Mylan · 4.5 · Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (C
Eintrag öffnenAzacitidine Mylan · 4.5 · Clinically significant inhibitory or inductive effects of azacitidine on cytochrome P450 enzymes are unlikely
Eintrag öffnenAzacitidine Mylan · 4.5 · No formal clinical drug interaction studies with azacitidine have been conducted.
Eintrag öffnenAzacitidine Mylan · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenAzacitidine Mylan · 4.8 Undesirable effects · 1
Eintrag öffnenAzacitidine Mylan · 4.8 · 10 Three subjects experienced a treatment emergent event leading to drug discontinuation (pyrexia, disease pro
Eintrag öffnenAzacitidine Mylan · 4.8 · 7 Table 1: Adverse reactions reported in patients with MDS or AML treated with azacitidine (clinical studies a
Eintrag öffnenAzacitidine Mylan · 4.8 · 8 System Organ Very common Common Uncommon Rare Not Known Class Gastrointestinal diarrhoea, gastrointestinal d
Eintrag öffnenAzacitidine Mylan · 4.8 · 9 Bleeding Bleeding may occur with patients receiving azacitidine. Serious adverse reactions such as gastroint
Eintrag öffnenAzacitidine Mylan · 4.8 · Adult population aged 65 years or older with AML with > 30% marrow blasts The most common serious adverse reac
Eintrag öffnenAzacitidine Mylan · 4.8 · Adult population with MDS, CMML and AML (20-30% marrow blasts) Adverse reactions considered to be possibly or
Eintrag öffnenAzacitidine Mylan · 4.8 · All 28 patients experienced at least 1 adverse event and 17 (60.7%) experienced at least 1 treatment- related
Eintrag öffnenAzacitidine Mylan · 4.8 · All 7 patients experienced at least 1 treatment-related adverse event. The most commonly reported adverse even
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