FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood and lymphatic system disorders febrile neutropenia*, neutropenia, leukopenia, thrombocytopenia, anaemia pancytopenia*, bone marrow failure
Danish: Blod og lymfesystem febril neutropeni*, neutropeni, leukopeni, trombocytopeni, anæmi pancytopeni*, knoglemarvsvigt
English: Serious adverse reactions such as sepsis, including neutropenic sepsis, and pneumonia were reported in patients receiving azacitidine, some with a fatal outcome.
Danish: Alvorlige bivirkninger, såsom sepsis, herunder neutropen sepsis og pneumoni, til tider med dødeligt udfald, blev rapporteret hos patienter, der fik azacitidin.
English: Cardiac and pulmonary disease
Danish: Hjerte- og lungesygdom
English: Data from a clinical trial allowing enrolment of patients with known history of cardiovascular or pulmonary disease showed a statistically significant increase in cardiac events in patients with newly diagnosed AML treated with azacitidine (see section 4.4).
Danish: Data fra et klinisk studie, der tillod inklusion af patienter med kardiovaskulær sygdom eller lungesygdom i anamnesen, viste en statistisk signifikant øget forekomst af kardiale hændelser hos patienter med nydiagnosticeret AML i behandling med azacitidin (se pkt.
English: No formal studies have been conducted in patients with hepatic impairment.
Danish: Der er ikke foretaget nogen regelrette undersøgelser af patienter med nedsat leverfunktion.
English: In animals, adverse reactions with azacitidine use on male fertility have been documented (see section 5.3).
Danish: Hos dyr er uønskede virkninger på fertiliteten hos hanner ved anvendelse af azacitidin blevet dokumenteret (se pkt.
English: This may be due to an infection of the lung called “pneumonia”, and can be life-threatening.
Danish: Det kan skyldes en lungebetændelse (pneumoni) og kan være livstruende.
English: The most commonly reported gastrointestinal adverse reactions associated with azacitidine treatment included constipation, diarrhoea, nausea and vomiting.
Danish: De hyppigst rapporterede bivirkninger i mave-tarm-kanalen relateret til azacitidinbehandling inkluderede konstipation, diarré, kvalme og opkastning.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the sight and reach of children.
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn.
English: Metabolism and nutrition disorders anorexia, decreased appetite, hypokalemia dehydration tumour lysis syndrome
Danish: Metabolisme og ernæring anoreksi, appetitløshed, hypokaliæmi dehydrering
English: Vidaza 25 mg/mL powder for suspension for injection Azacitidine
Danish: Vidaza 25 mg/ml pulver til injektionsvæske, suspension azacitidin
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: • Being confused.
Danish: • Forvirring.
English: PHARMACEUTICAL FORM Powder for suspension for injection.
Danish: LÆGEMIDDELFORM Pulver til injektionsvæske, suspension.
English: Storage of the reconstituted product For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaring af det rekonstituerede præparat Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection
Danish: LÆGEMIDLETS NAVN Vidaza 25 mg/ml pulver til injektionsvæske, suspension
English: • Painless swelling in the finger tips (clubbing).
Danish: • Smertefri hævelse af fingerspidserne (trommestikfingre).
English: This may be accompanied by a fever.
Danish: Du kan samtidig have feber.
English: Unopened vials This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Do not filter the suspension after reconstitution.
Danish: Suspensionen må ikke filtreres efter rekonstitution.
English: For clinical management of infectious adverse reactions, see section 4.8 Infections.
Danish: For klinisk behandling af infektiøse bivirkninger, se pkt.
English: Recent data from a clinical trial in patients with a known history of cardiovascular or pulmonary disease showed a significantly increased incidence of cardiac events with azacitidine (see section 4.8).
Danish: Nylige data fra et klinisk studie hos patienter med kardiovaskulær sygdom eller lungesygdom i anamnesen viste en signifikant øget forekomst af kardiale hændelser med azacitidin (se pkt.
English: After reconstitution with 4 mL of water for injections, the reconstituted suspension contains 25 mg/mL azacitidine.
Danish: Efter opblanding med 4 ml vand til injektionsvæske indeholder den opblandede suspension 25 mg/ml azacitidin.
English: Special populations Elderly patients
Danish: Særlige populationer Ældre personer
English: • A disease affecting the gut which can result in fever, vomiting and stomach pain (diverticulitis).
Danish: • En sygdom, der påvirker tarmen, hvilket kan føre til feber, opkastning og mavesmerter
English: • Fever.
Danish: • Feber.
English: Cardiac disorders pericardial effusion pericarditis
Danish: Hjerte perikardieeffusion perikarditis
English: Uncommon Rare
Danish: Ikke almindelig
English: Proportion Surviving
Danish: Overlevelsessandsynlighed
English: Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents.
Danish: Nyrepåvirkning, der rækker fra forhøjet serumkreatinin til decideret nyresvigt og død, er blevet rapporteret hos patienter i kombinationsbehandling med intravenøs azacitidin og andre kemoterapeutika.
English: Haematological toxicity is defined as the lowest count reached in a given cycle (nadir) if platelets ≤ 50.0 x 109/l and/or absolute neutrophil count (ANC) ≤ 1 x 109/l.
Danish: Hæmatologisk toksicitet defineres som den laveste hæmatologiske parameter i en given cyklus (nadirtal), såfremt trombocytterne ≤ 50,0 x 109/l, og/eller det absolutte neutrofiltal (Absolute
English: Patients without reduced baseline blood counts (i.e. White Blood Cells (WBC) ≥ 3.0 x 109/l and ANC ≥ 1.5 x 109/l, and platelets ≥ 75.0 x 109/l) prior to the first treatment
Danish: Patienter uden reducerede hæmatologiske parametre ved baseline (dvs. hvide blodlegemer (White Blood Cells, WBC) ≥ 3,0 x 109/l, ANC ≥1,5 x 109/l og trombocytter ≥ 75,0 x 109/l) inden første behandling
English: • Reduced white blood cell count.
Danish: • Nedsat antal hvide blodlegemer.
English: gastrointestinal haemorrhage* (includes mouth haemorrhage), haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia
Danish: gastrointestinal blødning* (herunder blødning i munden), hæmorideblødnin g, stomatitis, gingival blødning, dyspepsi
English: Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 45.0 % of these patients became RBC transfusion independent during the treatment period, compared with 11.4 % of the patients in the combined CCR groups (a statistically significant (p < 0.0001) difference of 33.6 % (95 % CI: 22.4, 44.6).
Danish: Af de patienter i azacitidingruppen, som var afhængige af transfusion af røde blodlegemer ved baseline, blev 45,0 % uafhængige af transfusion med røde blodlegemer under behandlingsperioden, sammenlignet med 11,4 % af patienterne i den kombinerede CCR-gruppe (en statistisk signifikant (p < 0,0001) forskel på 33,6 % (95 % CI: 22,4; 44,6)).
English: Health- Related Quality of Life (HRQoL) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Danish: Sundhedsrelateret livskvalitet (Health- Related Quality of Life, HRQoL) blev vurderet ved hjælp af
English: Grounds for the variation to the terms of the marketing authorisation(s)
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 109/l or ANC < 1.5 x 109/l or platelets < 75.0 x 109/l) prior to the first treatment
Danish: Patienter med reducerede hæmatologiske parametre ved baseline (dvs. WBC < 3,0 x 109/ eller ANC < 1,5 x 109/l eller trombocytter < 75,0 x 109/l) inden første behandling
English: These may be symptoms of liver failure and can be life-threatening.
Danish: Det kan være symptomer på leversvigt og kan være livstruende.
English: Renal and urinary disorders renal failure*, haematuria, elevated serum creatinine renal tubular acidosis
Danish: Nyrer og urinveje nyresvigt*, hæmaturi, forhøjet serumkreatinin renal tubulær acidose
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Celgene Europe B.V.
English: An in vitro study of azacitidine with cultured human hepatocytes indicates that at concentrations of 1.0 µM to 100 µM (i.e. up to approximately 30-fold higher than clinically achievable concentrations), azacitidine does not induce CYP 1A2, 2C19, or 3A4 or 3A5.
Danish: En in vitro-undersøgelse af azacitidin med dyrkede, humane hepatocytter indikerer, at azacitadin ikke inducerer CYP1A2, 2C19 eller 3A4 eller 3A5 ved koncentrationer på 1,0 µM til 100 µM (dvs. op til ca. 30 gange højere end klinisk tilgængelige koncentrationer).
English: Incompatibilities
Danish: Uforligeligheder
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: • if you have kidney disease.
Danish: • Hvis du har nyresygdom.
English: General disorders and administration site conditions pyrexia*, fatigue, asthenia, chest pain, injection site erythema, injection site pain, injection site reaction (unspecified)
Danish: Almene symptomer og reaktioner på administrations stedet pyreksi*, træthed, asteni, brystsmerter, erytem på injektionsstedet, smerte på injektionsstedet, reaktion på injektionsstedet (uspecificeret)
English: The most commonly reported (≥ 30%) adverse reactions with azacitidine treatment were gastrointestinal events, including constipation (41.9%), nausea (39.8%), and diarrhoea (36.9%), (usually Grade 1-2), general disorders and administration site conditions including pyrexia (37.7%; usually Grade 1-2) and haematological events, including febrile neutropenia (32.2%) and neutropenia (30.1%), (usually Grade 3-4).
Danish: De hyppigst rapporterede (≥ 30 %) bivirkninger ved behandlingen med azacitidin var gastrointestinale hændelser, herunder forstoppelse (41,9 %), kvalme (39,8 %) og diarré (36,9 %) (normalt grad 12), almene symptomer og reaktioner på administrationsstedet, herunder pyreksi (37,7 %, normalt grad 1-2) og hæmatologiske hændelser, herunder febril neutropeni (32,2 %) og neutropeni (30,1 %) (normalt grad 3-4).
English: Respiratory, thoracic and mediastinal disorders dyspnoea, epistaxis pleural effusion, dyspnoea exertional, pharyngolaryngeal pain interstitial lung disease
Danish: Luftveje, thorax og mediastinum dyspnø, epistaxis pleuraeffusion, dyspnø ved anstrengelse, pharyngolaryngeal smerte interstitiel lungesygdom
English: 2 vials
Danish: 2 hætteglas
English: Azacitidine has minor or moderate influence on the ability to drive and use machines.
Danish: Azacitidin påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.Træthed er blevet rapporteret med anvendelsen af azacitidin.
English: After reconstitution each mL of suspension will contain 25 mg of azacitidine (100 mg/4 mL).
Danish: Hver ml suspension vil efter rekonstitution indeholde 25 mg azacitidin (100 mg/4 ml).
English: One vial contains 100 mg azacitidine.
Danish: Et hætteglas indeholder 100 mg azacitidin.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE
English: Clinically significant inhibitory or inductive effects of azacitidine on cytochrome P450 enzymes are unlikely (see section 5.2).
Danish: Klinisk signifikant inhibitorisk eller induktiv virkning af azacitidin på CYP-isoenzymer er usandsynlig (se pkt.
English: No formal studies have been conducted in patients with hepatic impairment (see section 4.4).
Danish: Der er ikke foretaget nogen regelrette undersøgelser af patienter med nedsat leverfunktion (se pkt.
English: • Collection of fluid around the heart (pericardial effusion)..
Danish: • Ansamling af væske omkring hjertet (perikardieeffusion).
English: Studies in mice have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg med mus har påvist reproduktionstoksicitet (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection Azacitidine STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains100 mg azacitidine.
Danish: LÆGEMIDLETS NAVN Vidaza 25 mg/ml pulver til injektionsvæske, suspension azacitidin ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 100 mg azacitidin.
English: A patient was considered RBC or platelet transfusion independent during the treatment period if the subject had no RBC or platelet transfusions during any consecutive 56 days during the reporting period, respectively.
Danish: En patient blev anset for ikke at være afhængig af transfusion af røde blodlegemer eller blodplader i løbet af behandlingsperioden, hvis personen ikke havde fået transfusion af hhv. røde blodlegemer eller blodplader i løbet af nogen af de fortløbende 56 dage i rapporteringsperioden.
English: • acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to
Danish: • akut myeloid leukæmi (AML) med 20-30 % blaster og multilinjedysplasi i henhold til klassifikationen fra World Health Organisation (WHO).
English: Patients received the pre-selected regimen if not randomised to Vidaza.
Danish: Patienterne fik det tildelte behandlingsprogram, hvis de ikke blev randomiseret til Vidaza.
English: • Difficulty breathing, swelling of the lips, itching or rash.
Danish: • Vejrtrækningsbesvær, hævede læber, kløe eller udslæt.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for suspension for injection.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til injektionsvæske, suspension.
English: None of these adverse reactions led to discontinuation of azacitidine, or reduction of azacitidine dose in the pivotal studies.
Danish: I de pivotale studier førte ingen af disse bivirkninger til seponering eller dosisreduktion af azacitidin.
English: Pregnancy, breast-feeding and fertility
Danish: Graviditet, amning og frugtbarhed
English: As part of the inclusion criteria, patients were required to have an ECOG performance status of 0-2 and intermediate- or poor-risk cytogenetic abnormalities.
Danish: Som en del af inklusionskriterierne skulle patienterne have en ECOG-præstationsstatus på 0-2
English: Reconstituted Vidaza should be injected subcutaneously into the upper arm, thigh or abdomen.
Danish: Efter rekonstitution skal Vidaza injiceres subkutant i overarmen, låret eller maven.
English: • Being short of breath when you move.
Danish: • Kortåndethed ved bevægelse.
English: Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs).
Danish: På baggrund af in vitro-data ser azacitidinmetabolismen ikke ud til at være medieret af CYPisoenzymer (CYP'er), UDP-glucuronosyltransferaser (UGT'er), sulfotransferaser (SULT'er) eller glutathiontransferaser (GST'er).
English: After reconstitution, each mL suspension contains 25 mg azacitidine.
Danish: Efter rekonstitution indeholder hver ml suspension 25 mg azacitidin.
English: Patients with hepatic impairment
Danish: Patienter med nedsat nyrefunktion
English: Musculoskeletal and connective tissue disorders arthralgia, musculoskeletal pain (includes back, bone and pain in extremity)
Danish: Knogler, led, muskler og bindevæv artralgi, muskuloskeletal e smerter (herunder ryg, knogler og ekstremiteter)
English: Renal adverse reactions
Danish: Renale bivirkninger
English: Not known (frequency cannot be estimated from the available data) Infection of the deeper layers of skin, which spreads quickly, damaging the skin and tissue, which can be life-threatening (necrotizing fasciitis).
Danish: • Infektion i de dybere hudlag, som spredes hurtigt og beskadiger huden og vævet, hvilket kan være livstruende (nekrotiserende fasciitis).
English: Renal abnormalities, ranging from elevated serum creatinine and haematuria to renal tubular acidosis, renal failure and death were reported in patients treated with azacitidine (see section 4.4).
Danish: Unormal nyrefunktion, der rækker fra forhøjet serumkreatinin og hæmaturi til renal tubulær acidose, nyresvigt og død, er blevet rapporteret hos patienter i behandling med azacitidin (se pkt.
English: If unexplained elevations in serum creatinine or blood urea nitrogen (BUN) to ≥ 2-fold above baseline values and above upper limit of normal (ULN) occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50 % on the next treatment cycle (see section 4.4).
Danish: Hvis der forekommer uforklarlige stigninger i serumkreatinin eller blodureanitrogen (BUN) til ≥ 2 gange over baseline-værdierne og over den øvre grænse for normalværdien (upper limit of normal, ULN), bør den næste behandlingscyklus udsættes.
English: BSA value of 1.8 m2 Number of vials required
Danish: Samlet dosis baseret på en BSA-værdi på 1,8 m2
English: In the ITT analysis of 358 patients (179 azacitidine and 179 CCR), Vidaza treatment was associated with a median survival of 24.46 months versus 15.02 months for those receiving CCR treatment, a difference of 9.4 months, with a stratified log-rank p-value of 0.0001.
Danish: I ITT-analysen af 358 patienter (179 azacitidin og 179 CCR), var behandling med Vidaza associeret med en medianoverlevelse på 24,46 måneder kontra 15,02 måneder for de patienter, der fik CCRbehandling.
English: In patients who were platelet transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of platelet transfusion independence was 10.8 months in the Vidaza group and 19.2 months in the CCR group.
Danish: Hos patienter, der var afhængige af transfusion af blodplader ved baseline, og som opnåede transfusionsuafhængighed i løbet af behandlingen, var den mediane varighed af transfusionsuafhængigheden af blodplader 10,8 måneder i Vidaza-gruppen, og 19,2 måneder i CCRgruppen.
English: Patients with extensive tumour burden due to metastatic disease have been reported to experience hepatic failure, progressive hepatic coma and death during azacitidine treatment (see section 4.4).
Danish: Hos patienter med omfattende tumorbyrde pga. metastatisk sygdom er leversvigt, progressiv leverkoma og død under behandlingen med azacitidin blevet rapporteret (se pkt.
English: When Vidaza is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Danish: Når Vidaza rekonstitueres med nedkølet (2 °C til 8 °C) vand til injektionsvæsker, er der påvist kemisk og fysisk stabilitet under brug efter opbevaring af det rekonstituerede lægemiddel ved 2 °C til 8 °C i 22 timer.
English: The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Danish: Det er de patienter, der har stor tumorbyrde inden behandlingen, som har risiko for at få tumorlysesyndrom.
English: Azacitidine is contraindicated in patients with advanced malignant hepatic tumours (see section 4.3).
Danish: Azacitidin er kontraindiceret hos patienter med fremskredne, maligne levertumorer (se pkt.
English: The most commonly reported (≥ 10%) haematological adverse reactions associated with azacitidine treatment include anaemia, thrombocytopenia, neutropenia, febrile neutropenia and leukopenia, and were usually Grade 3 or 4.
Danish: De hyppigst rapporterede (≥ 10 %) hæmatologiske bivirkninger, der blev relateret til behandling med azacitidin, omfatter anæmi, trombocytopeni, neutropeni, febril neutropeni og leukopeni.
English: The relative importance of DNA hypomethylation versus cytotoxicity or other activities of azacitidine to clinical outcomes has not been established.
Danish: Det er ikke fastlagt, hvordan vægtningen af azacitidins forskellige effekter på henholdsvis DNA-hypometylering, cytotoksicitet og andre virkninger kan relateres til de kliniske resultater.
English: Use an effective method of contraception during and up to 3 months after treatment.
Danish: Du skal bruge en sikker præventionsmetode under behandlingen og op til 3 måneder efter behandlingen.
English: Of the patients in the Vidaza group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups.
Danish: Ud af patienterne i Vidaza-gruppen, som var afhængige af transfusion af blodplader ved baseline, blev 40,6% (95 % CI=30,9; 50,8) uafhængige af transfusion af blodplader i løbet af behandlingsperioden, sammenlignet med 29,3% (95 % CI=19,7; 40,4) af patienterne i de kombinerede CCR-grupper.
English: • Pneumonia.
Danish: • Lungebetændelse.
English: Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer Vidaza er indiceret til behandling af voksne patienter, som ikke er egnede til hæmatopoietisk stamcelletransplantation (HSCT), og som lider af:
English: bruising, haematoma, induration, rash, pruritus, inflammation, discoloration, nodule and haemorrhage (at injection site), malaise, chills, catheter site hemorrhage injection site necrosis (at injection site)
Danish: blå mærker, hæmatom, induration, udslæt, pruritus, inflammation, misfarvning, noduli og blødning (på injektionsstedet), utilpashed, kulderystelser, blødning på kateterstedet nekrose ved injektionsstedet
English: Complete blood counts should be performed prior to initiation of therapy and as needed to monitor response and toxicity, but at a minimum, prior to each treatment cycle.
Danish: Komplet blodtælling skal foretages inden behandlingsstart og efter behov for at monitorere respons og toksicitet, men som minimum forud for hver behandlingscyklus.
English: Gastrointestinal disorders diarrhoea, vomiting, constipation, nausea, abdominal pain (includes upper and abdominal discomfort)
Danish: Mave-tarmkanalen diarré, opkastning, konstipation, kvalme, mavesmerter (herunder smerter i øvre abdomen og mavebesvær)
English: Reconstituted suspension For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer)
English: The most commonly reported adverse reactions with azacitidine treatment were haematological reactions (71.4 %) including thrombocytopenia, neutropenia and leukopenia (usually Grade 3-4), gastrointestinal events (60.6 %) including nausea, vomiting (usually Grade 1-2) or injection site reactions (77.1 %; usually Grade 1-2).
Danish: De hyppigst rapporterede bivirkninger ved behandlingen med azacitidin var hæmatologiske (71,4 %), herunder trombocytopeni, neutropeni og leukopeni (oftest grad 3-4), symptomer fra mave-tarmkanalen (60,6 %), herunder kvalme og opkastning (oftest grad 1-2) eller reaktioner på injektionsstedet (77,1 %; oftest grad 1-2).