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Azacitidine Accord · 4.8 · Summary of the safety profile
Eintrag öffnenAzacitidine Accord · 4.8 · Summary of the safety profile Adult population with MDS, CMML and AML (20-30% marrow blasts) Adverse reactions
Eintrag öffnenAzacitidine Accord · 4.8 · System Organ Very common Common Uncommon Rare Not Known Class Infections and pneumonia* sepsis* necrotising in
Eintrag öffnenAzacitidine Accord · 4.8 · Table 1: Adverse reactions reported in patients with MDS or AML treated with azacitidine (clinical studies and
Eintrag öffnenAzacitidine Accord · 4.8 · Table 2 presents the frequency category of ADRs reported in the pivotal Phase 3 study with Azacitidine Accord.
Eintrag öffnenAzacitidine Accord · 4.8 · Table 2: Adverse drug reactions (ADRs) in AML patients receiving Azacitidine Accord maintenance therapy System
Eintrag öffnenAzacitidine Accord · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenAzacitidine Accord · 4.8 · Tabulated list of adverse reactions Table 1 below contains adverse reactions associated with azacitidine treat
Eintrag öffnenAzacitidine Accord · 4.8 · The most common adverse reactions are nausea (64.8%), vomiting (59.7%), diarrhoea (50.4%), neutropenia (44.5%)
Eintrag öffnenAzacitidine Accord · 4.8 · The most common serious adverse reactions noted from the pivotal study (AZA PH GL 2003 CL 001) included febril
Eintrag öffnenAzacitidine Accord · 4.8 · The most commonly reported (≥ 30%) adverse reactions with azacitidine treatment were gastrointestinal events,
Eintrag öffnenAzacitidine Accord · 4.8 · Three (3) subjects experienced a treatment emergent event leading to drug discontinuation (pyrexia, disease pr
Eintrag öffnenAzacitidine Accord · 4.8 · Vascular disorders hypotension*, hypertension, orthostatic hypotension, haematoma Respiratory, dyspnoea, pleur
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
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