FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use Dacogen:
Danish: Brug ikke Dacogen:
English: • other infection in any part of the body, caused by bacteria, virus or fungi
Danish: • andre infektioner i enhver del af kroppen, der skyldes bakterier, virus eller svamp
English: Treatment may be delayed at the discretion of the treating physician, if the patient experiences myelosuppression-associated complications, such as those described below:
Danish: Behandlingen kan udsættes efter den behandlende læges skøn, hvis patienten oplever komplikationer af myelosuppression som beskrevet nedenfor:
English: • Women must use effective contraception during treatment.
Danish: • Kvinder skal bruge sikker prævention under behandlingen.
English: Dacogen administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic medicinal products.
Danish: Administration af Dacogen skal initieres under opsyn af en læge der har erfaring i anvendelse af kemoterapeutiske lægemidler.
English: CR = complete remission; CRp = complete remission with incomplete platelet recovery, EFS = event-free survival, PFS = progression-free survival, OR = odds ratio, HR = hazard ratio - = Not evaluable
Danish: CR = komplet remission; CRp = komplet remission med inkomplet normalisering af trombocyttal, EFS = overlevelse uden hændelser, PFS = progressionsfri overlevelse, OR = odds ratio, HR = hazard ratio - = Ikke evaluerbar
English: Based on model simulation, PK parameters were independent of time (i.e., did not change from cycle to cycle) and no accumulation was observed with this dosing regimen.
Danish: Baseret på modelsimulering var PK parametrene uafhængige af tid (dvs. de ændrede sig ikke fra den ene cyklus til den næste), og der forekom ingen akkumulation med dette behandlingsregime.
English: You will be given Dacogen when you are first diagnosed with AML.
Danish: Du vil få Dacogen, når du har fået stillet diagnosen AML.
English: Predicted Value
Danish: Forventet værdi
English: Treatment with Dacogen may be resumed once these conditions have improved or have been stabilised with adequate treatment (anti-infective therapy, transfusions, or growth factors).
Danish: Behandling med Dacogen kan genoptages, når der er opnået bedring af disse tilstande, eller de er stabiliseret med passende behandling (infektionsbekæmpende midler, transfusioner eller vækstfaktorer).
English: Pre-medication for the prevention of nausea and vomiting is not routinely recommended but may be administered if required.
Danish: Præmedicinering til forebyggelse af kvalme og opkastning anbefales ikke rutinemæssigt, men kan gives efter behov.
English: Enterocolitis may lead to septic complications and may be associated with fatal outcome.
Danish: Enterocolitis kan føre til septiske komplikationer og kan være forbundet med dødelig udgang.
English: • Bleeding: including blood in the stools.
Danish: • blødning - herunder blod i afføringen.
English: In clinical studies in AML and myelodysplastic syndrome (MDS), the reporting frequency for hyperbilirubinaemia was 11% for All Grades and 2% for Grade 3-4.
Danish: I kliniske studier i AML og myelodysplastisk syndrom (MDS) var rapporteringshyppigheden for hyperbilirubinæmi 11 % for alle grader og 2 % for grad 3-4.
English: Dacogen will be given to you by a doctor or nurse who is trained in giving this type of medicine.
Danish: Du vil få Dacogen af en læge eller sundhedspersonale, som er uddannet i at give denne type medicin.
English: In clinical studies, approximately one-third of patients receiving Dacogen required a dose-delay.
Danish: I kliniske studier havde ca. en tredjedel af de patienter, der fik Dacogen, behov for udsættelse af en dosis.
English: • Men should use effective contraception during treatment and for up to 3 months after treatment has stopped.
Danish: • Mænd bør bruge sikker prævention under behandlingen og i op til tre måneder efter dens afslutning.
English: The major circulating metabolites are not believed to be pharmacologically active.
Danish: De væsentligste metabolitter i blodcirkulationen formodes ikke at være farmakologisk aktive.
English: What Dacogen is used for
Danish: Hvad Dacogen anvendes til
English: Table 2: Other efficacy endpoints for Study DACO-016 (ITT population)
Danish: Tabel 2: Andre endepunkter til effektvurdering i studiet DACO-016 (ITT-populationen)
English: If Dacogen is used during pregnancy, or if a patient becomes pregnant while receiving this medicinal product, the patient should be apprised of the potential hazard to the foetus.
Danish: Hvis Dacogen anvendes under graviditet, eller hvis en patient bliver gravid under behandlingen med dette lægemiddel, skal patienten oplyses om den mulige risiko for fosteret.
English: Common septic shock* sepsis* sinusitis
Danish: Almindelig septisk chok sepsis sinusitis
English: Excretion of unchanged drug appears to play only a minor role in the elimination of decitabine.
Danish: Udskillelse af uomdannet lægemiddelstof synes kun at spille en mindre rolle i eliminationen af decitabin.
English: No human data on the effect of decitabine on fertility are available.
Danish: Der foreligger ingen humane data for decitabins virkninger på fertilitet.
English: Patients should be advised that they may experience undesirable effects such as anaemia during treatment.
Danish: Patienterne bør oplyses om, at de kan få bivirkninger såsom anæmi under behandlingen.
English: • high level of ‘bilirubin' in the blood
Danish: • forhøjet indhold af ”bilirubin” i blodet.
English: Dacogen has moderate influence on the ability to drive and use machines.
Danish: Dacogen påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: (thrombocytopaenia)
Danish: (trombocytopeni)
English: White to almost white lyophilized powder.
Danish: Et hvidt til næsten hvidt frysetørret pulver.
English: Data from the literature also indicate that decitabine has adverse effects on all aspects of the reproductive cycle, including fertility, embryo-foetal development and post-natal development.
Danish: Data fra litteraturen indikerer desuden, at decitabin har bivirkninger på alle aspekter af reproduktionscyklen, herunder fertilitet, embryoføtal udvikling og postnatal udvikling.
English: It contains the active substance ‘decitabine'.
Danish: Det indeholder det aktive stof ”decitabin”.
English: The remainder of the subjects had intermediate-risk cytogenetics.
Danish: Resten af forsøgspersonerne havde intermediær cytogenetik.
English: Toxicity is likely to manifest as exacerbations of adverse drug reactions, primarily myelosuppression.
Danish: Toksicitet vil sandsynligvis manifestere sig som forværring af bivirkninger, primært myelosuppression.
English: • Fever: this may be a sign of an infection caused by low levels of white blood cells (very common).
Danish: • feber det kan være tegn på en infektion, der skyldes et lavt antal hvide blodlegemer (meget almindelig).
English: Treatment may be continued as long as the patient shows response, continues to benefit or exhibits stable disease, i.e., in the absence of overt progression.
Danish: Behandlingen kan fortsættes, så længe patienten udviser respons eller fortsat har gavn af behandlingen, eller så længe sygdommen er stabiliseret, dvs. ved fravær af åbenlys progression.
English: Population pharmacokinetic analysis showed that decitabine pharmacokinetics are not dependent on age (range studied 40 to 87 years; median 70 years).
Danish: Populationsfarmakokinetiske analyser har vist, at decitabins farmakokinetik ikke er afhængig af alder (det undersøgte interval er 40 til 87 år; median 70 år).
English: Therefore, caution should be recommended when driving a car or operating machines.
Danish: De bør derfor udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner.
English: Neurobehavioural development and reproductive capacity were unaffected when neonatal/juvenile rats were treated at dose levels inducing myelosuppression.
Danish: Neuroadfærdsmæssig udvikling og reproduktionsevne blev ikke påvirket, når neonatale/juvenile rotter blev behandlet ved dosisniveauer, der inducerede myelosuppression.
English: The effects of renal or hepatic impairment, gender, age or race on the pharmacokinetics of decitabine have not been formally studied.
Danish: Virkningerne af nedsat nyre- eller leverfunktion, køn, alder eller race på decitabins farmakokinetik er ikke undersøgt formelt.
English: Plasma protein binding of decitabine is negligible (< 1%).
Danish: Decitabins binding til plasmaprotein er ubetydelig (< 1 %).
English: Decitabine has been shown to be a weak inhibitor of P-gp mediated transport in vitro and is therefore, also not expected to affect P-gp mediated transport of co-administered medicinal products (see section 5.2).
Danish: Decitabin har vist sig at være en svag hæmmer af P-gp-medieret transport in vitro og forventes derfor heller ikke at påvirke P-gp-medieret transport af co administrerede lægemidler (se pkt.
English: In clinical studies, 30% of patients treated with Dacogen and 25% of patients treated in the comparator arm had adverse events with an outcome of death during treatment or within 30 days after the last dose of study drug.
Danish: I kliniske studier fik 30 % af de patienter, der fik Dacogen, og 25 % af patienterne i komparatorgruppen bivirkninger med dødeligt udfald i løbet af behandlingen eller inden for 30 dage efter den sidste dosis studiemedicin.
English: In the Dacogen treatment group, there was a higher incidence of treatment discontinuation due to adverse events in women compared to men (43% versus 32%).
Danish: I gruppen, der blev behandlet med Dacogen, blev behandlingen hyppigere seponeret på grund af bivirkninger hos kvinder end hos mænd (43 % versus 32 %).
English: If you forget your appointment to have Dacogen If you miss an appointment, make another one as soon as possible.
Danish: Hvis du glemmer en aftale, hvor du skal have Dacogen Hvis du kommer til at springe en aftale over, skal du hurtigst muligt træffe en ny aftale.
English: Studies have shown that decitabine is teratogenic in rats and mice (see section 5.3).
Danish: Studier har påvist, at decitabin er teratogent i rotter og mus (se pkt.
English: These may be signs of bleeding inside your head (common).
Danish: Dette kan være et tegn på blødning i hovedet (almindelig).
English: The reasons for treatment discontinuation included disease progression (12 [70.6%] subjects), subjects proceeding to transplant (3 [17.6%]), investigator decision (1 [5.9%]), and “other” (1 [5.9%]).
Danish: Årsagerne til seponering af behandlingen omfattede sygdomsprogression (12 [70,6 %] forsøgspersoner), at forsøgspersonerne overgik til transplantation (3 [17,6 %]), investigators beslutning (1 [5,9 %]) og "andet" (1 [5,9 %]).
English: • The dose is 20 mg/m2 body surface area.
Danish: • Dosis er 20 mg/m2 legemsoverflade.
English: The primary endpoint of the study was overall survival.
Danish: Studiets primære endepunkt var samlet overlevelse.
English: Caution should be exercised in the administration of Dacogen to patients with severe renal impairment (Creatinine Clearance [CrCl] < 30 ml/min).
Danish: Forsigtighed tilrådes ved administration af Dacogen til patienter med svært nedsat nyrefunktion (kreatininclearance [CrCl] < 30 ml/min).
English: The primary endpoint was complete remission (CR) rate that was assessed by independent expert review.
Danish: Det primære endepunkt var komplet remission (CR), og det blev vurderet af uafhængige eksperter.
English: • if you are allergic to decitabine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for decitabin eller et af de øvrige indholdsstoffer i Dacogen (angivet i punkt 6).
English: The pharmacokinetics of decitabine following intravenous administration as a 1-hour infusion were described by a linear two-compartment model, characterised by rapid elimination from the central compartment and by relatively slow distribution from the peripheral compartment.
Danish: Decitabins farmakokinetik efter intravenøs administration over 1 time blev beskrevet ved hjælp af en lineær 3-kompartmentmodel kendetegnet ved hurtig elimination fra det centrale kompartment og ved relativt langsom distribution fra det perifere kompartment.
English: For situations where decitabine administration should be delayed, see section 4.2.
Danish: Vedrørende situationer, hvor administration af decitabin bør udskydes, se pkt.
English: Decitabine (5-aza-2-deoxycytidine) is a cytidine deoxynucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation of tumour suppressor genes, induction of cellular differentiation or cellular senescence followed by programmed cell death.
Danish: Decitabin (5-aza-2-deoxycytidin) er et cytidindeoxynukleosid-analog, som i lave doser selektivt hæmmer DNA-methyltransferaser, hvilket resulterer i genaktiverende hypometylering, der kan føre til genaktivering af tumorundertrykkende gener, induktion af celledifferentiering eller fremadskridende aldring af celler efterfulgt af programmeret celledød.
English: Thirty-six percent of subjects had poor-risk cytogenetics at baseline.
Danish: 36 % af forsøgspersonerne havde ugunstig cytogenetik ved baseline.
English: Because of the possibility of infertility as a consequence of Dacogen therapy, men should seek advice on conservation of sperm and female patients of childbearing potential should seek consultation regarding oocyte cryopreservation prior to initiation of treatment.
Danish: På grund af potentiel infertilitet som følge af behandling med Dacogen bør mænd søge rådgivning om nedfrysning af sæd, og fertile kvinder bør søge rådgivning om kryopræservation af oocytter før indledning af behandling.
English: The total daily dose must not exceed 20 mg/m 2 and the total dose per treatment cycle must not exceed
Danish: Den totale døgndosis må ikke overstige 20 mg/m2, og den totale dosis pr. behandlingscyklus må ikke overstige 100 mg/m2.
English: In addition, in vitro data show that decitabine is a poor P-gp substrate.
Danish: Desuden viser in vitro-data, at decitabin er et dårligt substrat for P-gp.
English: Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.
Danish: Kontakt lægen eller sundhedspersonalet, hvis du har spørgsmål om, hvordan Dacogen virker, eller hvorfor du har fået dette lægemiddel.
English: • an infection,
Danish: • har en infektion,
English: • Difficultly with moving, speaking or understanding or seeing; sudden severe headache, seizure, numbness or weakness in any part of the body.
Danish: • besvær med at bevæge sig, tale, forstå eller se, en pludselig voldsom hovedpine, krampeanfald, følelsesløshed eller svaghed i en legemsdel.
English: • urine infection
Danish: • urinvejsinfektion
English: • Active viral, bacterial or fungal infection (i.e., requiring intravenous anti-infectives or extensive supportive care)
Danish: • Aktiv viral eller bakteriel infektion eller mykose (med behov for intravenøs behandling af infektionen eller omfattende understøttende pleje)
English: A vial is for single use only and any remaining solution must be discarded.
Danish: Hvert hætteglas er kun til engangsbrug, og ikke anvendt opløsning skal bortskaffes.
English: Impact of co-administered medicinal products on decitabine Cytochrome (CYP) 450-mediated metabolic interactions are not anticipated as decitabine metabolism is not mediated by this system but by oxidative deamination.
Danish: Co-administrerede lægemidlers virkning på decitabin Cytokrom (CYP) 450-medierede metaboliske interaktioner forventes ikke, da decitabins metabolisme ikke medieres af dette system men af oxidativ deaminering.
English: Common hypersensitivity including anaphylactic reaction
Danish: Almindelig overfølsomhed inklusive anafylaktisk reaktion
English: The use of decitabine with hormonal contraceptives has not been studied.
Danish: Anvendelse af decitabin sammen med hormonal kontraception er ikke undersøgt.
English: The powder should be aseptically reconstituted with 10 ml of water for injections.
Danish: Pulveret bør rekonstitueres under aseptiske betingelser med 10 ml vand til injektionsvæsker.
English: Results from the human mass-balance study showed that unchanged decitabine in plasma accounted for approximately 2.4% of total radioactivity in plasma.
Danish: Resultaterne af studiet af total omsætning hos mennesker viste, at uomdannet decitabin udgjorde ca. 2,4 % af den totale radioaktivitet i plasma.
English: Overall survival and complete remission rates in pre-specified disease-related sub-groups (i.e., cytogenetic risk, Eastern Cooperative Oncology Group [ECOG] score, age, type of AML, and baseline bone marrow blast count) were consistent with results for the overall study population.
Danish: Samlet overlevelse og komplet remission i præspecificerede sygdomsrelaterede undergrupper (dvs. cytogenetisk risiko, ECOG-score [Eastern Cooperative Oncology Group], alder, AML-type og baselineværdier for blaster i knoglemarv) stemte overens med resultaterne i den samlede studiepopulation.
English: The efficacy and safety of Dacogen has not been evaluated in patients with acute promyelocytic leukaemia or CNS leukaemia.
Danish: Dacogens sikkerhed og virkning er ikke blevet evalueret hos patienter med akut promyelocytisk leukæmi eller CNS-leukæmi.
English: In vitro studies show that decitabine does not inhibit nor induce CYP 450 enzymes up to more than 20-fold of the therapeutic maximum observed plasma concentration (Cmax).
Danish: In vitro-studier viser, at decitabin ikke hæmmer eller inducerer CYP450-enzymer i et omfang, der overstiger 20 gange den maksimale observerede plasmakoncentration (Cmax).
English: Based on results from animal studies and its mechanism of action, Dacogen should not be used during pregnancy and in women of childbearing potential not using effective contraception.
Danish: Baseret på resultater af dyrestudier og decitabins virkningsmekanisme bør Dacogen ikke anvendes under graviditet eller til kvinder i den fertile alder, der ikke anvender sikker kontraception.
English: • Your doctor, nurse or pharmacist is responsible for disposing of any unused Dacogen correctly.
Danish: • Din læge, sundhedspersonalet eller apotekspersonalet er ansvarlige for at bortskaffe ikke anvendt Dacogen korrekt.
English: Patients with a history of severe congestive heart failure or clinically unstable cardiac disease were excluded from clinical studies and therefore, the safety and efficacy of Dacogen in these patients has not been established.
Danish: Patienter med svært kongestivt hjertesvigt eller klinisk ustabil hjertesygdom i anamnesen blev ekskluderet fra kliniske studier, og Dacogens sikkerhed og virkning hos disse patienter er derfor ikke klarlagt.
English: Reported adverse events were consistent with the known safety profile of Dacogen in adults (see section 4.8).
Danish: De rapporterede bivirkninger var i overensstemmelse med Dacogens kendte sikkerhedsprofil hos voksne (se pkt.
English: Intracellularly, decitabine is activated through sequential phosphorylation via phosphokinase activities to the corresponding triphosphate, which is then incorporated by the DNA polymerase.
Danish: Intracellulært aktiveres decitabin gennem sekventiel phosphorylering via phosphokinase til det tilsvarende triphosphat, som så inkorporeres af DNA-polymerase.
English: • red, raised painful patches on the skin, fever, an increase in white blood cells - these may be signs of ‘Acute Febrile Neutrophilic Dermatosis' or ‘Sweet's Syndrome'
Danish: • røde, hævede, smertefulde plamager på huden, feber, et øget antal hvide blodlegemer - det kan være tegn på ”akut febril neutrofil dermatose” eller ”Sweets syndrom”.
English: • Do not use this medicine after the expiry date, which is stated on the carton and on the vial label after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og på hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: However, early clinical study data in published literature at doses greater than 20 times higher than the current therapeutic dose, reported increased myelosuppression including prolonged neutropaenia and thrombocytopaenia.
Danish: Tidlige kliniske studiedata offentliggjort i litteraturen med doser, der var over 20 gange højere end den aktuelle terapeutiske dosis, medførte dog en stigning i myelosuppression inklusive langvarig neutropeni og trombocytopeni.
English: Mean plasma clearance following intravenous administration in cancer subjects was > 200 L/h with moderate inter-subject variability (coefficient of variation [CV] is approximately 50%).
Danish: Middeltallet for plasmaclearance efter intravenøs administration hos forsøgspersoner med cancer var > 200 l/time med moderate interindividuelle variationer (variationskoefficient [CV] ca. 50 %).
English: C-decitabine in cancer patients showed that 90% of the administered dose of decitabine (4% unchanged drug) is excreted in the urine.
Danish: C-decitabin hos cancerpatienter viste, at 90 % af den administrerede dosis decitabin (4 % uomdannet stof) udskilles i urinen.
English: The available data from in vitro and in vivo studies provide sufficient evidence that decitabine has genotoxic potential.
Danish: De foreliggende data fra in vitro- og in vivo-studier udgør tilstrækkelig dokumentation for, at decitabin har genotoksisk potentiale.
English: The most frequently reported "other infections" in study DACO-016 were: oral herpes, oral candidiasis, pharyngitis, upper respiratory tract infection, cellulitis, bronchitis, nasopharyngitis.
Danish: De hyppigst indberettede ”andre infektioner” i studiet DACO-016 var: oral herpes, oral candidiasis, faryngitis, øvre luftvejsinfektion, cellulitis, bronkitis, nasofaryngitis.
English: In patients with baseline Grade 2 abnormalities, worsening of myelosuppression was seen in most patients and more frequently than in patients with baseline Grade 1 or 0 abnormalities.
Danish: Ved grad 2-anomalier forekom der forværring af myelosuppression hos de fleste patienter og hyppigere end hos patienter med anomalier af grad 1 eller 0 ved baseline.
English: The secondary endpoint of the study was overall survival.
Danish: Studiets sekundære endepunkt var samlet overlevelse.
English: Standard procedures for dealing with cytotoxic medicinal products should be adopted.
Danish: Standardprocedurer for håndtering af cytostatika skal følges.
English: How Dacogen works Dacogen works by stopping cancer cells from growing.
Danish: Sådan virker Dacogen Dacogen virker ved at hindre kræftceller i at vokse.
English: The secondary endpoint was complete remission rate that was assessed by independent expert review.
Danish: Det sekundære endepunkt var komplet remission, hvilket blev vurderet ved gennemgang af uafhængige eksperter.
English: If ILD is confirmed, appropriate treatment should be initiated (see section 4.8).
Danish: Hvis ILS bekræftes, skal passende behandling initieres (se pkt.
English: The presence of these metabolites in urine together with the high total body clearance and low urinary excretion of unchanged decitabine in the urine (~4% of the dose) indicate that decitabine is appreciably metabolized in vivo.
Danish: Forekomst af disse metabolitter i urinen sammen med en høj total clearance fra organismen og lav udskillelse med urinen af uomdannet decitabin (~4 % af dosis) indikerer, at decitabin i væsentlig grad omdannes in vivo.
English: Percent of Subjects Alive
Danish: Procentdel forsøgspersoner i live
English: Patients, especially those with cardiac disease history, should be monitored for signs and symptoms of heart failure.
Danish: Patienterne, især dem med hjertesygdom i anamnesen, skal overvåges for tegn og symptomer på hjertesvigt.
English: • low numbers of platelets, red blood cells or white blood cells,
Danish: • har et lavt antal blodplader, røde blodlegemer eller hvide blodlegemer,