FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not known if this medicine passes into human milk.
Danish: Det er ukendt, om dette lægemiddel udskilles i modermælken.
English: Patients with severe hepatic organ impairment should be carefully monitored for adverse events.
Danish: Patienter med svært nedsat leverfunktion bør monitoreres nøje for uønskede hændelser.
English: This can cause low levels of red and white blood cells and platelets.
Danish: Det kan forårsage lave niveauer af røde og hvide blodlegemer og blodplader.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Danish: BILAG IV VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: Based on results from animal studies and its mechanism of action, azacitidine should not be used during pregnancy, especially during the first trimester, unless clearly necessary.
Danish: På baggrund af resultater fra dyreforsøg og azacitidins virkningsmekanisme bør dette stof kun anvendes på tvingende indikation til gravide, især i første trimester.
English: In patients with one or more cytogenetic abnormalities at baseline, the percentage of patients with a major cytogenetic response was similar in the azacitidine and combined CCR groups.
Danish: Hos patienter med en eller flere cytogenetiske anomalier ved baseline var procentdelen af de patienter, som opnåede større cytogenetisk respons, ens i azacitidingruppen og den kombinerede CCR-gruppe.
English: Administration of azacitidine to male mice prior to mating with untreated female mice resulted in decreased fertility and loss of offspring during subsequent embryonic and postnatal development.
Danish: Administration af azacitidin til hanmus inden parring med ubehandlede hunmus resulterede i nedsat fertilitet og tab af afkom i løbet af den efterfølgende embryonale og postnatale udvikling.
English: Patients were pre-selected by their physician to 1 of the 3 CCR prior to randomisation.
Danish: Patienter blev udvalgt forud af deres læge til 1 af de 3 CCR'er inden randomiseringen.
English: The two-year survival rates were 50.8 % in patients receiving azacitidine versus 26.2 % in patients receiving CCR (p < 0.0001).
Danish: To-års overlevelsesraterne var 50,8 % hos patienter, der fik azacitidin kontra 26,2 % for patienter, der fik CCR (p < 0,0001).
English: Minor cytogenetic response was statistically significantly (p = 0.0015) higher in the azacitidine group (34 %) compared with the combined CCR group (10 %).
Danish: Mindre cytogenetisk respons var statistisk signifikant (p = 0,0015) højere i azacitidingruppen (34 %) sammenlignet med den kombinerede CCR-gruppe (10 %).
English: Vidaza is used in adults who are not able to have a stem cell transplantation to treat:
Danish: Vidaza anvendes til voksne, som ikke er i stand til at få en knoglemarvstransplantation, til at behandle:
English: The temperature of the suspension at the time of injection should be approximately 20 ºC-25 ºC.
Danish: Suspensionens temperatur på injektionstidspunktet bør være ca. 20 °C-25 °C.
English: • Allergic (hypersensitivity) reaction.
Danish: • Allergisk reaktion (overfølsomhed).
English: • Bleeding due to a catheter line.
Danish: • Blødning på grund af kateteret.
English: Injection sites should be rotated.
Danish: Der bør skiftes mellem injektionsstederne.
English: The most common serious adverse reactions noted from the pivotal study (AZA PH GL 2003 CL 001) included febrile neutropenia (8.0 %) and anaemia (2.3 %), which were also reported in the supporting studies (CALGB 9221 and CALGB 8921).
Danish: De hyppigst rapporterede alvorlige bivirkninger, der blev observeret i det pivotale studie (AZA PH GL 2003 CL 001), omfattede febril neutropeni (8,0 %) og anæmi (2,3 %), som også blev rapporteret i de understøttende studier (CALGB 9221 og CALGB 8921).
English: This could be due to an infection as a result of having low levels of white blood cells, which can be life-threatening.
Danish: Det kan skyldes en infektion som et resultat af, at du har et lavt antal hvide blodlegemer, hvilket kan være livstruende.
English: • Bleeding inside your head.
Danish: • Blødning i hovedet.
English: In studies to assess inhibition of a series of P450 isoenzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4) azacitidine up to 100 μM did not produce inhibition.
Danish: I undersøgelser til vurdering af hæmning af en serie CYP-isoenzymer (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4) fremkaldte azacitidin op til 100 µM ikke hæmning.
English: Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR).
Danish: Azacitidin plus "bedste understøttende behandling" ("best supportive care", BSC) (n = 179) blev sammenlignet med konventionelle behandlingsregimer ("Conventional Care Regimens", CCR).
English: Liver function tests, serum creatinine and serum bicarbonate should be determined prior to initiation of therapy and prior to each treatment cycle.
Danish: Leverfunktion, serumkreatinin og serumhydrogencarbonat skal kontrolleres inden behandlingsstart og forud for hver behandlingscyklus.
English: • acute myeloid leukaemia (AML).
Danish: • akut myeloid leukæmi (AML)
English: Due to the potential serious adverse reactions in the nursing child, breast-feeding is contraindicated during azacitidine therapy.
Danish: På grund af de potentielt alvorlige bivirkninger hos det ammede barn er amning kontraindiceret under behandling med azacitidin.
English: A fresh subcutaneous needle (recommended 25-gauge) should then be firmly attached to the syringe.
Danish: En ny subkutan kanyle (anbefalet 25 gauge) skal nu sættes godt fast på sprøjten.
English: Reconstitution procedure
Danish: Rekonstitutionsprocedure
English: No specific dose adjustments are recommended for the elderly.
Danish: Der foreligger ingen anbefalinger vedrørende dosisjusteringer til ældre patienter.
English: Serious hypersensitivity reactions have been reported in patients receiving azacitidine.
Danish: Der er rapporteret alvorlige overfølsomhedsreaktioner hos patienter, der får azacitidin.
English: The efficacy and safety of Vidaza was studied in an international, multicentre, controlled, open-label, parallel group Phase 3 study in patients 65 years and older with newly diagnosed de novo or secondary AML with >30% bone marrow blasts according to the WHO classification, who were not eligible for HSCT.
Danish: Vidazas virkning og sikkerhed blev undersøgt i et internationalt, kontrolleret, åbent fase IIImulticenterstudie med parallelle grupper hos patienter i alderen 65 år og derover med nydiagnosticeret de novo eller sekundær AML med > 30 % knoglemarvsblaster i henhold til WHO-klassifikationen, som ikke var egnede til HSCT.
English: Azacitidine induces both gene mutations and chromosomal aberrations in bacterial and mammalian cell systems in vitro.
Danish: Azacitidin inducerer både genmutationer og kromosomale forandringer i cellesystemer hos bakterier og pattedyr in vitro.
English: You are more prone to bleeding and bruising.
Danish: Du har større tendens til blødning og blå mærker.
English: Azacitidine can be administered to patients with renal impairment without initial dose adjustment provided these patients are monitored for toxicity since azacitidine and/or its metabolites are primarily excreted by the kidney.
Danish: Azacitidin kan administreres til patienter med nedsat nyrefunktion uden indledende dosisjustering, hvis disse patienter monitoreres for toksicitet, da azacitidin og/eller dets metabolitter primært udskilles af nyrerne.
English: Table 1: ADRs reported in patients with MDS or AML treated with azacitidine (clinical studies and post- marketing)
Danish: Tabel 1: Bivirkninger rapporteret hos patienter med MDS eller AML i behandling med azacitidin (kliniske studier og erfaring efter markedsføring)
English: These actions are thought to correct problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Danish: Disse virkninger menes at korrigere problemet med modningen og væksten af nye blodlegemer i knoglemarven, hvilket fører til myelodysplastiske sygdomme, og til at kræftcellerne dræbes ved leukæmi.
English: Infections may be managed with the use of antiinfectives plus growth factor support (e.g. G-CSF) for neutropenia.
Danish: Infektioner kan håndteres med anvendelse af antiinfektiva samt understøttende behandling med vækstfaktorer (f. eks. G-CSF) mod neutropeni.
English: The plunger should then be pulled back to withdraw the amount of medicinal product required for the proper dose, making sure to purge any air trapped within the syringe.
Danish: Stemplet trækkes nu tilbage for at trække den nødvendige mængde lægemiddel til den korrekte dosis op. Sørg for at tømme evt. luft ud af sprøjten.
English: • An infection of the nose and throat, or sore throat.
Danish: • Betændelse i næse og hals, eller ondt i halsen.
English: If unexplained reductions in serum bicarbonate levels to less than 20 mmol/l occur, the dose should be reduced by 50 % on the next cycle.
Danish: Hvis der forekommer uforklarlige fald i serumhydrogencarbonat til under 20 mmol/l, bør dosis reduceres med 50 % i den næste behandlingscyklus.
English: What you need to know before you use Vidaza
Danish: Det skal du vide, før du begynder at bruge Vidaza
English: Azacitidine induced tumours of the haematopoietic system in female mice, when administered intraperitoneally 3 times per week for 52 weeks.
Danish: Azacitidin inducerede tumorer i det hæmatopoietiske system hos hunmus, når det blev administreret intraperitonealt 3 gange om ugen i 52 uger.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: In human liver S9 fractions, formation of metabolites was independent of NADPH implying that azacitidine metabolism was not mediated by cytochrome P450 isoenzymes.
Danish: I S9-fraktioner fra human lever var dannelsen af metabolitter uafhængig af NADPH, hvilket antyder, at azacitidinmetabolisme ikke er medieret af CYP-isoenzymer.
English: • A low blood platelet count (thrombocytopenia).
Danish: • Et lavt antal blodplader (trombocytopeni).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Therefore, CYP enzyme induction or inhibition by azacitidine at clinically achievable plasma concentrations is unlikely.
Danish: Derfor er det usandsynligt, at azacitidin inducerer eller hæmmer CYP-isoenzymer ved klinisk opnåelige plasmakoncentrationer.
English: • Large plum-coloured, raised painful patches on the skin with fever.
Danish: • Store blommefarvede, hævede, smertefulde plamager på huden i kombination med feber.
English: In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to < 20 mmol/L in association with an alkaline urine and hypokalaemia (serum potassium < 3 mmol/L) developed in 5 subjects with chronic myelogenous leukaemia (CML) treated with azacitidine and etoposide.
Danish: Derudover er der blevet konstateret renal tubulær acidose, der defineres som et fald i serumhydrogencarbonat til < 20 mmol/l ved samtidig forekomst af alkalisk urin og hypokalæmi (serumkalium < 3 mmol/l) hos 5 personer med kronisk myeloid leukæmi (CML) i behandling med azacitidin og etoposid.
English: At baseline 60.7% were classified as AML not otherwise specified, 32.4% AML with myelodysplasia-related changes, 4.1% therapy-related myeloid neoplasms and 2.9% AML with recurrent genetic abnormalities according to the WHO classification.
Danish: Ved baseline blev 60,7 % klassificeret til at have AML uden nærmere specifikation, 32,4 % havde AML med myelodysplasi-relaterede ændringer, 4,1 % havde behandlingsrelaterede myeloide neoplasmer, og 2,9 % havde AML med tilbagevendende genetiske anomalier i henhold til WHO-klassifikationen.
English: Azacitidine is believed to exert its antineoplastic effects by multiple mechanisms including cytotoxicity on abnormal haematopoietic cells in the bone marrow and hypomethylation of DNA.
Danish: Det vurderes, at Azacitidin udøver sine antineoplastiske virkninger ved flere mekanismer, herunder cytotoksicitet på abnorme hæmatopoietiske celler i knoglemarven og hypometylering af DNA.
English: Patients should be premedicated with anti-emetics for nausea and vomiting.
Danish: Patienten bør præmedicineres med antiemetika mod kvalme og opkastning.
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential and men have to use effective contraception during and up to 3 months after treatment.
Danish: Kvinder i den fertile alder / Kontraception til mænd og kvinder Kvinder i den fertile alder og mænd skal anvende sikker kontraception under behandlingen og i 3 måneder efter behandlingen.
English: Bone marrow cellularity % Dose in the next cycle if recovery is not achieved within 14 days Recovery* ≤ 21 days
Danish: % dosis i næste cyklus, hvis restituering ikke opnås inden for 14 dage Restituering* ≤ 21 dage
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET PÅ HÆTTEGLAS
English: • Fluid around the lungs (pleural effusion).
Danish: • Væske omkring lungerne (pleuraeffusion).
English: Use an effective method of contraception during and up to 3 months after treatment with this medicine.
Danish: Brug en sikker præventionsmetode under behandlingen og op til 3 måneder efter behandlingen med dette lægemiddel.
English: KEY: AZA = azacitidine; CCR = conventional care regimens; CI = confidence interval;
Danish: FORKORTELSER: AZA = azacitidin; CCR = konventionelle behandlingsregimer (conventional care regimens); CI = konfidensinterval; HR = hazard ratio
English: • The active substance is azacitidine.
Danish: • Aktivt stof: azacitidin.
English: Most haematological adverse reactions were managed by routine monitoring of complete blood counts and delaying azacitidine administration in the next cycle, prophylactic antibiotics and/or growth factor support (e.g. G-CSF) for neutropenia and transfusions for anaemia or thrombocytopenia as required.
Danish: De fleste hæmatologiske bivirkninger blev håndteret ved hjælp af rutinemæssig komplet blodtælling kombineret med udsættelse af næste cyklus af azacitidin, profylaktiske antibiotika og/eller understøttende behandling med vækstfaktorer (f.eks. G-CSF) mod neutropeni samt transfusioner mod anæmi eller trombocytopeni efter behov.
English: • Low levels of potassium in your blood.
Danish: • Lavt indhold af kalium i blodet.
English: Vidaza treatment was associated with a median time to death or transformation to AML of 13.0 months versus 7.6 months for those receiving CCR treatment, an improvement of 5.4 months with a stratified log-rank p-value of 0.0025.
Danish: Behandling med Vidaza var associeret med en median tid til dødsfald eller transformation til AML på 13,0 måneder kontra 7,6 måneder for de patienter, der fik CCR-behandling, hvilket er en forbedring på 5,4 måneder med en stratificeret log-rank p-værdi på 0,0025.
English: These may be symptoms of having low levels of platelets in your blood.
Danish: De kan være symptomer på, at du har et lavt antal blodplader i blodet.
English: Haematological toxicity
Danish: Hæmatologisk toksicitet
English: The efficacy and safety of Vidaza were studied in an international, multicenter, controlled, open-label, randomised, parallel-group, Phase 3 comparative study (AZA PH GL 2003 CL 001) in adult patients with: intermediate-2 and high-risk MDS according to the International Prognostic Scoring System (IPSS), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T) and modified chronic myelomonocytic leukaemia (mCMML) according to the French American British (FAB) classification system.
Danish: Vidazas virkning og sikkerhed blev undersøgt i et international, kontrolleret, open-label, randomiseret, komparativ, parallel-gruppe, fase 3-multicenterstudie (AZA PH GL 2003 CL 001) hos voksne patienter med: intermediær-2 og højrisiko MDS i henhold til International Prognostic Scoring System (IPSS), refraktær anæmi med overskud af blaster (RAEB), refraktær anæmi med overskud af blaster i transformation (RAEB-T) og modificeret kronisk myelomonocytleukæmi (mCMML) i henhold til French American British-(FAB-) klassifikationen.
English: If unexplained reductions in serum bicarbonate (< 20 mmol/L) or elevations of serum creatinine or BUN occur, the dose should be reduced or administration delayed (see section 4.2).
Danish: Hvis der forekommer uforklarlige fald i serumhydrogencarbonat (< 20 mmol/l) eller stigning i serumkreatinin eller BUN, bør dosis reduceres, eller administrationen udsættes (se pkt.
English: These adverse reactions were managed symptomatically with anti-emetics for nausea and vomiting; anti-diarrhoeals for diarrhoea, and laxatives and/or stool softeners for constipation.
Danish: Disse bivirkninger blev behandlet symptomatisk med antiemetika mod kvalme og opkastning, anti-diarré midler mod diarré og laksantia og/eller blødgørende afføringsmidler mod konstipation.
English: Winthontlaan 6 N 3526 KV Utrecht Netherlands
Danish: Winthontlaan 6 N 3526 KV Utrecht Holland
English: The effects of hepatic impairment (see section 4.2), gender, age, or race on the pharmacokinetics of azacitidine have not been formally studied.
Danish: 4.2), køn, alder eller race på azacitidins farmakokinetiske egenskaber er ikke blevet formelt undersøgt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
English: Table 1 below contains adverse reactions associated with azacitidine treatment obtained from the main clinical studies in MDS and AML and post marketing surveillance.
Danish: Nedenstående tabel 1 indeholder bivirkninger forbundet med behandlingen med azacitidin registreret i de primære kliniske studier af MDS og AML og overvågning efter markedsføring.
English: • Constipation, diarrhoea, nausea, vomiting.
Danish: • Forstoppelse, diarré, kvalme, opkastning.
English: An increased incidence of tumours in the lymphoreticular system, lung, mammary gland, and skin was seen in mice treated with azacitidine administered intraperitoneally for 50 weeks.
Danish: Der sås en øget incidens af tumorer i det lymferetikulære system, lunge, brystvorte og hud hos mus, der blev behandlet med azacitidin, administreret intraperitonealt i 50 uger.
English: The cytotoxic effects of azacitidine may result from multiple mechanisms, including inhibition of DNA, RNA and protein synthesis, incorporation into RNA and DNA, and activation of DNA damage pathways.
Danish: Azacitidins cytotoksiske virkninger kan forklares ud fra flere mekanismer, herunder hæmning af DNA-, RNA- og proteinsyntese, inkorporering i RNA og DNA og aktivering af mekanismer, der fører til DNA-skade.
English: In addition, although the study was not powered to demonstrate a statistically significant difference when comparing azacitidine to the preselection CCR treatment groups, the survival of Vidaza treated patients was longer when compared to CCR treatment options BSC alone, low-dose cytarabine plus BSC and were similar when compared to standard intensive chemotherapy plus BSC.
Danish: Selvom studiet ikke havde styrke til at vise en statistisk signifikant forskel ved sammenligning af azacitidin med præselektions-CCR-behandlingsgrupperne, var overlevelsesfordelen ved Vidaza desuden længere ved sammenligning med CCR-behandlingsmulighederne BSC alene, lavdosiscytarabin plus BSC, og den var sammenlignelig med standard intensiv kemoterapi plus BSC.
English: Absorption Following subcutaneous administration of a single 75 mg/m2 dose, azacitidine was rapidly absorbed with peak plasma concentrations of 750 ± 403 ng/mL occurring at 0.5 h after dosing (the first sampling point).
Danish: Absorption Efter subkutan administration af en enkelt dosis på 75 mg/m2 blev azacitidin hurtigt absorberet med peak-plasma-koncentrationer på 750 ± 403 ng/ml ½ time efter dosering (det første prøvetagningstidspunkt).
English: Before starting treatment, male patients should be advised to seek counselling on sperm storage.
Danish: Mandlige patienter bør opfordres til at søge rådgivning om opbevaring af sæd, inden behandlingen påbegyndes.
English: Blood test
Danish: Blodprøver
English: • An infection of the blood caused by bacteria (sepsis).
Danish: • En betændelse i blodet, der er forårsaget af bakterier (blodforgiftning).
English: Adult population aged 65 years or older with AML with > 30% marrow blasts
Danish: Voksenpopulation i alderen 65 år eller derover med AML med > 30 % knoglemarvsblaster
English: Adult population (MDS, CMML and AML [20-30% marrow blasts])
Danish: Voksenpopulation (MDS, CMML og AML [20-30 % knoglemarvsblaster])
English: • Bleeding gums, bleeding in the stomach or gut, bleeding from around your back passage due to piles (haemorrhoidal haemorrhage), bleeding in your eye, bleeding under your skin, or into your skin (haematoma).
Danish: • Blødende gummer, blødning i maven eller tarmen, blødning ved endetarmsåbningen på grund af hæmorider (hæmorideblødning), blødning i øjet, blødning under huden eller blodansamlinger i huden (hæmatom).
English: Other medicines and Vidaza
Danish: Brug af anden medicin sammen med Vidaza
English: Vidaza treatment led to a reduced need for red blood cell (RBC) and platelet transfusions.
Danish: Behandling med Vidaza førte til et reduceret behov for transfusioner med røde blodlegemer (RBC) og trombocytter.
English: In a few pre-specified subgroups, the OS HR reached statistical significance including patients with poor cytogenetic risk, patients with AML with myelodysplasia-related changes, patients < 75 years, female patients and white patients.
Danish: cytogenetisk risiko, patienter med AML med myelodysplasi-relaterede ændringer, patienter < 75 år, kvindelige patienter og hvide patienter.
English: Necrotising fasciitis, including fatal cases, have been reported in patients treated with Vidaza.
Danish: Nekrotiserende fasciitis, herunder med dødeligt udfald, er blevet rapporteret hos patienter i behandling med Vidaza.
English: • White coating covering tongue, inner cheeks, and sometimes on the roof of your mouth, gums and tonsils (oral fungal infection).
Danish: • Hvide belægninger på tungen, indersiden af kinderne og nogle gange på gane, gummer og mandler (svampeinfektion i munden).
English: Renal impairment has no major effect on the pharmacokinetic exposure of azacitidine after single and multiple subcutaneous administrations.
Danish: Nedsat nyrefunktion har ingen større indvirkning på den farmakokinetiske eksponering af azacitidin efter subkutane enkeltdoser og gentagne doser.
English: Vascular disorders hypotension*, hypertension, orthostatic hypotension, haematoma
Danish: Vaskulære sygdomme hypotension*, hypertension, ortostatisk hypotension, hæmatom
English: Therefore, based on the assessment of all available information for pericarditis, including spontaneous reports identified in the Safety Topic Review, the already listed ADR of pericardial effusion in the Vidaza SmPC and the fact that pericarditis is a listed term for some other products of the same class, the SmPC section 4.8 should be updated by including the term pericarditis under the SOC cardiac disorders with frequency ‘uncommon'.
Danish: På baggrund af vurderingen af al tilgængelig information om perikarditis, herunder spontane indberetninger identificeret i sikkerhedsvurderingen af emnet, den allerede nævnte bivirkning perikardieeffusion i produktresuméet for Vidaza samt at perikarditis er nævnt som bivirkning for nogle andre produkter i samme klasse, skal produktresuméets pkt.