FrancophonIA/ELRC3.0 huggingface dataset:
English: Dacogen is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
Danish: Dacogen er indiceret til behandling af voksne patienter med nydiagnosticeret de novo eller sekundær akut myeloid leukæmi (AML) i henhold til klassifikationen fra World Health Organisation (WHO), som ikke er kandidater til standard-induktionskemoterapi.
English: Dacogen (n = 242) was compared to treatment choice (TC, n = 243) which consisted of patient's choice with physician's advice of either supportive care alone (n = 28, 11.5%) or 20 mg/m cytarabine subcutaneously once daily for 10 consecutive days repeated every 4 weeks (n = 215, 88.5%).
Danish: Dacogen (n = 242) blev sammenlignet med den valgte behandling (TC, n = 243), der bestod af patientens valg i henhold til lægens råd om enten understøttende pleje alene (n = 28, 11,5 %) eller 20 mg/m2 cytarabin subkutant en gang dagligt 10 dage i træk, hvilket blev gentaget hver 4. uge (n = 215, 88,5 %).
English: Including haemorrhage associated with thrombocytopaenia, including fatal cases.
Danish: Inklusive blødning i forbindelse med trombocytopeni, herunder fatale tilfælde.
English: Evidence from the literature indicates that decitabine has carcinogenic potential.
Danish: Det er påvist i litteraturen, at decitabin potentielt kan være karcinogent.
English: Very common pyrexia
Danish: Meget almindelig pyreksi
English: Myelosuppression and complications of myelosuppression, including infections and bleeding that occur in patients with AML may be exacerbated with Dacogen treatment.
Danish: Myelosuppression og komplikationer af myelosuppression, herunder infektioner og blødninger, der forekommer hos patienter med AML, kan forværres ved behandling med Dacogen.
English: If worsening hepatic function occurs, patients should be carefully monitored (see sections 4.4 and 5.2).
Danish: I tilfælde af en forværring af leverfunktionen bør patienterne monitoreres nøje (se pkt.
English: Haematological adverse drug reactions should be managed by routine monitoring of complete blood counts and early administration of supportive treatments as required.
Danish: Hæmatologiske bivirkninger bør behandles ved hjælp af rutinemæssig monitorering af fuld blodstatus og tidlig administration af understøttende behandling efter behov.
English: Subjects who were considered candidates for standard induction chemotherapy were not included in the study as shown by the following baseline characteristics.
Danish: Personer, der ansås for egnede kandidater til standard-induktionskemoterapi, blev ikke inkluderet i studiet, hvilket fremgår af baselineværdierne nedenfor.
English: The safety assessment in paediatric patients is based on the limited safety data from a Phase I/II study to evaluate pharmacokinetics, safety and efficacy of Dacogen in paediatric patients (aged 1 to 14 years) with relapsed or refractory AML (n = 17) (see section 5.1).
Danish: Sikkerhedsvurderingen hos pædiatriske patienter er baseret på de begrænsede sikkerhedsdata fra et fase I/II-studie til evaluering af Dacogens farmakokinetik, sikkerhed og virkning hos pædiatriske patienter (i alderen 1 til 14 år) med recidiverende eller refraktær AML (n = 17) (se pkt.
English: The population pharmacokinetic (PK) parameters of decitabine were pooled from 3 clinical studies in 45 patients with AML or myelodysplastic syndrome (MDS) utilizing the 5-Day regimen.
Danish: Decitabins populationsfarmakokinetiske (PK) parametre for populationen stammer fra 3 kliniske studier med 45 patienter med AML eller myelodysplastisk syndrom (MDS), der anvendte et 5-døgns regime.
English: A Phase I/II open-label, multicentre study evaluated the safety and efficacy of Dacogen in sequential administration with cytarabine in children aged 1 month to < 18 years with relapsed or refractory AML.
Danish: Et fase I/II åbent multicenterstudie evaluerede Dacogens sikkerhed og virkning ved sekventiel administration med cytarabin hos børn i alderen 1 måned til < 18 år med recidiverende eller refraktær AML.
English: Table 1: Adverse drug reactions identified with Dacogen
Danish: Tabel 1: Bivirkninger påvist med Dacogen
English: Dacogen should not be used in children with AML aged < 18 years, because efficacy was not established.
Danish: Dacogen må ikke anvendes til børn med AML i alderen < 18 år, da virkningen ikke er klarlagt.
English: Dacogen contains potassium and sodium
Danish: Dacogen indeholder kalium og natrium
English: • Your doctor, nurse or pharmacist is responsible for storing Dacogen.
Danish: • Din læge, sundhedspersonalet eller apotekspersonalet er ansvarlige for at opbevare Dacogen.
English: Upon reconstitution, each ml contains approximately 5 mg of decitabine at pH 6.7 to 7.3.
Danish: Efter rekonstitution indeholder 1 ml ca. 5 mg decitabin med pH 6,7 til 7,3.
English: • Difficulty breathing, swelling of the lips, itching or rash: This may be due to an allergic (hypersensitivity) reaction (common).
Danish: • besvær med at trække vejret, hævede læber, kløe eller udslæt: dette kan være en reaktion, der skyldes allergi eller overfølsomhed (almindelig).
English: If you get side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Method of administration Dacogen is administered by intravenous infusion.
Danish: Dacogen administreres som intravenøs infusion.
English: Impact of decitabine on co-administered medicinal products Given its low in vitro plasma protein binding ( 1%), decitabine is unlikely to displace co-administered medicinal products from their plasma protein binding.
Danish: Decitabins virkning på co-administrerede lægemidler På grund af decitabins lave binding til plasmaproteiner in vitro (< 1 %) er det usandsynligt, at co-administrerede lægemidler displaceres fra deres plasmaproteinbindingssted.
English: Excluding pneumonia, urinary tract infection, sepsis, septic shock and sinusitis.
Danish: Undtagen lungebetændelse, urinvejsinfektion, sepsis, septisk chok og sinusitis.
English: In clinical studies, the majority of patients had baseline Grade 3/4 myelosuppression.
Danish: I kliniske studier havde de fleste patienter grad 3/4-myelodepression ved baseline.
English: There is the potential for a drug-drug interaction with other agents which are also activated by sequential phosphorylation (via intracellular phosphokinase activities) and/or metabolised by enzymes implicated in the inactivation of decitabine (e.g., cytidine deaminase).
Danish: Der kan potentielt opstå lægemiddelinteraktion med andre lægemidler, der også aktiveres af sekventiel fosforylering (via intracellulære phosphokinase-aktiviteter) og/eller metaboliseres af enzymer, der indgår i inaktiveringen af decitabin (f.eks. cytidindeaminase).
English: • Chest pain or shortness of breath (with or without fever or cough): these may be signs of an infection of the lung called “pneumonia” (very common) or inflamed lungs (interstitial lung disease [frequency not known]) or cardiomyopathy (heart muscle disease [uncommon]) which can be accompanied with swelling of ankles, hands, legs and feet.
Danish: • smerter i brystet eller åndenød (med eller uden feber og hoste): det kan være tegn på lungebetændelse (pneumoni) (meget almindelig) eller betændelse i lungerne (interstitiel lungesygdom [hyppighed ikke kendt]) eller sygdom i hjertemusklen (kardiomyopati [ikke almindelig]), der kan være ledsaget af hævede ankler, hænder, ben og fødder.
English: Supportive treatments include, administration of prophylactic antibiotics and/or growth factor support (e.g., G-CSF) for neutropaenia and transfusions for anaemia or thrombocytopaenia according to institutional guidelines.
Danish: Understøttende behandling omfatter administration af profylaktiske antibiotika og/eller vækstfaktorer (fx G-CSF) ved neutropeni og transfusioner i tilfælde af anæmi eller trombocytopeni i henhold til institutionens retningslinjer.
English: , e anaemia leukopaenia
Danish: *, e anæmi leukopeni
English: Patients should be monitored for signs and symptoms of infection and treated promptly.
Danish: Patienterne bør monitoreres for symptomer på infektion og i givet fald omgående sættes i behandling.
English: Caution should be exercised in the administration of Dacogen to patients with hepatic impairment and in patients who develop signs or symptoms of hepatic impairment.
Danish: Forsigtighed tilrådes ved administration af Dacogen til patienter med nedsat leverfunktion og til patienter, som udvikler tegn eller symptomer på nedsat leverfunktion.
English: Occurrences of enterocolitis, including neutropaenic colitis, caecitis have been reported during treatment with decitabine.
Danish: Forekomster af enterocolitis, herunder neutropen colitis, caecitis, er blevet rapporteret under behandling med decitabin.
English: Multi-cycle repeat-dose toxicity studies in rats and rabbits indicated that the primary toxicity was myelosuppression, including effects on bone marrow, which was reversible on cessation of treatment.
Danish: Toksicitetsstudier med gentagne doser over flere cyklusser til rotter og kaniner har indikeret, at den primære toksicitet var myelosuppression, hvilket omfatter påvirkning af knoglemarven, som var reversibel efter indstilling af behandlingen.
English: • a drop in the number of red blood cells, white blood cells and platelets (pancytopaenia)
Danish: • et fald i antallet af røde og hvide blodlegemer samt blodplader (pancytopeni)
English: Dacogen should not be infused through the same intravenous access/line with other medicinal products.
Danish: Dacogen må ikke gives som infusion gennem samme intravenøse drop som andre lægemidler.
English: This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule.
Danish: Dette skyldes, at det er vigtigt at overholde doseringsplanen, for at lægemidlet skal kunne virke så effektivt som muligt.
English: Infuse the reconstituted solution intravenously over 1 hour.
Danish: Den rekonstituerede opløsning gives som intravenøs infusion over 1 time.
English: Population pharmacokinetic analysis of decitabine did not show any clinically relevant difference between men and women.
Danish: Populationsfarmakokinetisk analyse af decitabin har ikke påvist kliniske relevante forskelle mellem mænd og kvinder.
English: • Men should not father a child while using Dacogen.
Danish: • En mand bør ikke gøre en kvinde gravid, mens han får Dacogen.
English: It is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial remission may take longer than 4 cycles to be obtained.
Danish: Imidlertid kan det tage mere end 4 cyklusser at opnå en komplet eller partiel remission.
English: What Dacogen is Dacogen is an anti-cancer medicine.
Danish: Sådan virker Dacogen Dacogen er et lægemiddel til behandling af kræft.
English: (anaemia)
Danish: (anæmi)
English: Read the leaflet for the shelf-life of the reconstituted and diluted product.
Danish: Se indlægssedlen for information om holdbarheden af det rekonstituerede og fortyndede lægemiddel.
English: The median overall survival in the ITT population was 7.6 months (95% CI: 5.7, 11.5).
Danish: Median samlet overlevelse i ITT-populationen var 7,6 måneder (95 % CI: 5,7, 11,5).
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan berøre flere end 1 ud af 10 personer):
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must use effective contraceptive measures and avoid becoming pregnant while being treated with Dacogen.
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder Kvinder i den fertile alder skal anvende sikker kontraception for at undgå at blive gravide, mens de er i behandling med Dacogen.
English: Very common pneumonia* urinary tract infection* All other infections (viral, bacterial, fungal)*
Danish: Meget almindelig pneumoni urinvejsinfektion alle andre infektioner (virale, bakterielle, mykotiske)
English: Results from a mass balance study with radioactive
Danish: Resultaterne af et studie af den totale omsætning af radioaktivt
English: In the presence of myelosuppression or its complications, treatment with Dacogen may be interrupted and/or supportive measures instituted (see sections 4.2 and
Danish: I tilfælde af myelosuppression eller dets komplikationer kan behandling med Dacogen afbrydes, og/eller der kan iværksættes understøttende behandling (se pkt.
English: • Your doctor will work out your dose of Dacogen.
Danish: • Lægen fastsætter den rette dosis Dacogen til dig.
English: Analysis of mature overall survival data (ITT population).
Danish: Figur 2 Analyse af modne samlede overlevelsesdata (ITT-populationen)
English: Table 3: Summary of population PK analysis for a typical patient receiving daily 1-hour infusions of Dacogen 20 mg/m2 over 5 days every 4 weeks
Danish: Tabel 3: Oversigt over populationsfarmakokinetisk analyse af en typisk patient, der fik en daglig infusion over 1 time af Dacogen 20 mg/m2 i 5 dage hver 4. uge
English: After reconstitution and dilution of the solution for intravenous infusion, this medicine contains between 13.8 mg-138 mg (0.6-6 mmol) sodium per dose (depending on the infusion fluid for dilution), equivalent to 0.7-7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Efter rekonstitution og fortynding af opløsningen til intravenøs infusion indeholder dette lægemiddel mellem 13,8 mg og 138 mg (0,6 - 6 mmol) natrium pr. dosis (afhængigt af infusionsvæsken til fortynding), svarende til 0,7-7 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natruim for en voksen.
English: The population PK analysis on the limited decitabine data indicated no significant PK parameter dependencies on normalized creatinine clearance, an indicator of renal function.
Danish: Den populations PK analyse af de begrænsede decitabindata indikerede, at ingen PK parametre var signifikant afhængige af normaliseret kreatininclearance, som er en indikator for nyrefunktionen.
English: If after 4 cycles, the patient's haematological values (e.g., platelet counts or absolute neutrophil count), have not returned to pre-treatment levels or if disease progression occurs (peripheral blast counts are increasing or bone marrow blast counts are worsening), the patient may be considered to be a non-responder and alternative therapeutic options to Dacogen should be considered.
Danish: Hvis patientens hæmatologiske værdier (fx trombocyttal eller neutrofile), efter 4 cykler, ikke er faldet til niveauet før behandlingen, eller hvis sygdommen progredierer (stigning i blaster i perifert blod eller forværring af blaster i knoglemarv), må patienten anses for at være en ”non-responder”, og andre behandlingsformer end Dacogen bør overvejes.
English: • This medicine contains 0.29 mmol (6.67 mg) sodium (main component of cooking/table salt) in each vial.
Danish: • Dette lægemiddel indeholder 0,29 mmol (6,67 mg) natrium (hoved komponent af madlavnings/bordsalt) i hvert hætteglas.
English: When censored for potentially disease modifying subsequent therapy (i.e., induction chemotherapy or hypomethylating agent) the analysis for overall survival showed a 20% reduction in the risk of death for subjects in the Dacogen arm [HR = 0.80, (95% CI: 0.64, 0.99), p-value = 0.0437)].
Danish: Efter censurering af potentielt sygdomsmodificerende behandling (dvs. induktionskemoterapi eller hypometylerende middel) viste analysen for samlet overlevelse 20 % reduktion af risikoen for død hos forsøgspersoner i Dacogen-gruppen [HR = 0,80, (95 % CI: 0,64, 0,99, p-værdi = 0,0437)].
English: Based on these negative results, Dacogen should not be used in children with AML aged < 18 years, because efficacy was not established (see section 4.2).
Danish: På baggrund af disse negative resultater må Dacogen ikke anvendes til børn med AML i alderen < 18 år, da virkningen ikke er klarlagt (se pkt.
English: This medicine contains 0.29 mmol (6.67 mg) sodium per vial.
Danish: Dette lægemiddel indeholder 0,29 mmol (6,67 mg) natrium pr. hætteglas.
English: Information on special populations was derived from pharmacokinetic data from the 3 studies noted above, and from one Phase I study in MDS subjects, (N = 14; 15 mg/m2 x 3-hours q8h x 3 days).
Danish: Oplysninger om særlige populationer stammede fra farmakokinetiske data fra de 3 studier angivet ovenfor og fra et fase 1-studie med forsøgspersoner med MDS (N = 14; 15 mg/m2 over 3 timer hver 8. time i 3 dage).
English: In addition, the limited data from the population PK analysis indicated no significant PK parameter dependencies on total bilirubin concentration despite a wide range of total bilirubin levels.
Danish: Desuden indikerede de begrænsede data fra de populationsfarmakokinetiske analyser, at de PK parametre ikke i væsentlig grad afhang af den totale bilirubinkoncentration, til trods for de meget varierede værdier for total bilirubin.
English: 20 ml clear colourless Type I glass vial sealed with a butyl rubber stopper and an aluminium seal with plastic flip-off cap containing 50 mg decitabine.
Danish: Klart, farveløst, 20 ml hætteglas af type I-glas, forseglet med en butylgummiprop og en aluminiumsforsegling med flip-off plasthætte, der indeholder 50 mg decitabin.
English: Tell your doctor or nurse immediately if you notice any of the following serious side effects
Danish: Kontakt straks din læge eller sundhedspersonalet, hvis du bemærker en eller flere af følgende alvorlige bivirkninger:
English: The use of Dacogen was studied in an open-label, randomised, multicentre Phase III study (DACO-016) in subjects with newly diagnosed de novo or secondary AML according to the WHO classification.
Danish: Anvendelse af Dacogen blev studeret i et åbent, randomiseret fase III-multicenterstudie (DACO-016) hos forsøgspersoner med nydiagnosticeret de novo eller sekundær AML i henhold til WHO-klassifikationen.
English: • inflamed gut (enterocolitis, colitis and caecitis), with symptoms of abdominal pain, bloating, or diarrhoea.
Danish: • tarmbetændelse (enterocolitis, colitis og caecitis) med symptomer som mavesmerter, oppustethed eller diarré.
English: Gastrointestinal toxicity was also observed and in males, testicular atrophy which did not reverse over the scheduled recovery periods.
Danish: Gastrointestinal toksicitet forekom også, og hos handyr sås testikulær atrofi, som ikke blev normaliseret i løbet af den tid, der var fastsat til bedring.
English: Dacogen is used to treat a type of cancer called ‘acute myeloid leukaemia' or ‘AML'.
Danish: Dacogen anvendes til behandling af en kræftform, der kaldes akut myeloid leukæmi eller AML.
English: The use of Dacogen as initial therapy was also evaluated in an open-label, single-arm, Phase II study (DACO-017) in 55 subjects > 60 years with AML according to the WHO classification.
Danish: Anvendelse af Dacogen til initial behandling blev også evalueret i et åbent fase 2-studie med en enkelt gruppe (DACO-017) hos 55 forsøgspersoner > 60 år med AML i henhold til WHO-klassifikationen.
English: Serious bleeding-related adverse drug reactions, some of which lead to a fatal outcome, such as central nervous system (CNS) haemorrhage (2%) and gastrointestinal (GI) haemorrhage (2%), in the context of severe thrombocytopaenia, were reported in patients receiving decitabine.
Danish: Der blev rapporteret alvorlige blødningsrelaterede bivirkninger, hvoraf nogle havde dødeligt udfald, såsom blødning i centralnervesystemet (CNS) (2 %) og mave-tarm-blødning (GI) (2 %), i forbindelse med svær trombocytopeni hos patienter, der fik decitabin.
English: Talk to your doctor, pharmacist or nurse before using Dacogen if you have
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Dacogen, hvis du
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, fx naturlægemidler.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Formal carcinogenicity studies have not been performed with decitabine.
Danish: Der er ikke udført formelle karcinogenicitetsstudier med decitabin.
English: Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD.
Danish: Patienter med akut opståede lungesymptomer eller uforklaret forværring af sådanne skal evalueres nøje med henblik på at udelukke ILS.
English: Therefore, patients are at increased risk for severe infections (due to any pathogen such as bacterial, fungal and viral), with potentially fatal outcome (see section 4.8).
Danish: Derfor har patienterne en øget risiko for alvorlige infektioner (der skyldes patogener af f.eks. bakteriel, mykotisk eller viral oprindelse), der potentielt kan være fatale (se pkt.
English: Results from a human mass-balance study and in vitro experiments mentioned above indicated that the CYP enzymes are unlikely to be involved in the metabolism of decitabine.
Danish: Resultaterne af et studie af total omsætning hos mennesker og de ovennævnte in vitro-forsøg indikerede, at CYP-enzymer sandsynligvis ikke indgår i metabolismen af decitabin.
English: The primary route of metabolism is likely through deamination by cytidine deaminase in the liver, kidney, intestinal epithelium and blood.
Danish: Decitabin omdannes formentlig primært gennem deaminering ved cytidindeaminase i lever, nyrer, tarmepitel og blod.
English: • Talk to your doctor if you wish to conserve your sperm before starting treatment.
Danish: • Tal med din læge, hvis du ønsker at nedfryse din sæd før behandlingens start.
English: This medicine will be given by your doctor or nurse.
Danish: Du får dette lægemiddel af lægen eller sundhedspersonalet.
English: The number of patients treated with Dacogen by racial group was White 209 (86.4%) and Asian 33 (13.6%).
Danish: Inddelt efter race fik 209 (86,4 %) hvide patienter og 33 (13,6 %) asiatiske patienter Dacogen.
English: Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: In vitro metabolism data and the human mass balance study results indicated that the cytochrome P450 system is not involved in the metabolism of decitabine.
Danish: In vitro-data vedrørende metabolisme og resultaterne af et studie af den totale omsætning hos mennesker indikerer, at cytokrom P450-systemet ikke er involveret i decitabins metabolisme.
English: Decitabine exhibits linear PK and following the intravenous infusion, steady-state concentrations are reached within 0.5 hour.
Danish: Decitabin udviser lineær PK og når steady state-koncentrationer i løbet af ½ time efter den intravenøse infusion.
English: Eighty-one percent of subjects had significant comorbidities (e.g., infection, cardiac impairment, pulmonary impairment).
Danish: 88 % af forsøgspersonerne havde signifikant komorbiditet (fx infektion, nedsat hjertefunktion, nedsat lungefunktion).
English: Within 15 minutes of reconstitution, the concentrate (in 10 ml of sterile water for injections) must be further diluted with cold (2°C - 8°C) infusion fluids.
Danish: Inden for 15 minutter efter rekonstitution (i 10 ml steril vand til injektionsvæsker) skal koncentratet fortyndes yderligere med kold (2 °C - 8 °C) infusionsvæske.
English: However, the population pharmacokinetic analysis of decitabine indicated that race had no apparent effect on the exposure to decitabine.
Danish: De populationsfarmakokinetiske analyser af decitabin indikerede, at race tilsyneladende ikke påvirker eksponeringen for decitabin.
English: • a heart disorder.
Danish: • har en hjertesygdom.
English: In the ITT analysis, a CR rate of 23.6% (95% CI: 13.2, 37) was observed in 13/55 subjects treated with Dacogen.
Danish: I ITT-analysen var forekomsten af komplet remission på 23,6 % (95 % CI: 13,2, 37) hos 13/55 forsøgspersoner, der fik Dacogen.