natgillin/translations-raw huggingface dataset:
Median tid til CR var 4,1 måneder, og median varighed af CR var 18,2 måneder.
The median time to CR was 4.1 months, and the median duration of CR was 18.2 months.
Den samlede dosis pr. cyklus var 100 mg/m
The total dose per cycle was 100 mg/m
I hvert studie blev decitabins PK evalueret på femtedagen i den første behandlingscyklus.
In each study, decitabine PK was evaluated on the fifth day of the first treatment cycle.
Ikke kendt
Not known Not known
Den mediane tid til bedste respons og median varighed af bedste respons hos patienter, der opnåede CR eller CRp, var henholdsvis 4,3 måneder og 8,3 måneder.
The median time to best response and median duration of best response in patients who achieved a CR or CRp were 4.3 months and 8.3 months, respectively.
I det usandsynlige tilfælde at du skulle få for meget (en overdosis), vil lægen holde øje med, om du får bivirkninger, og behandle disse efter behov.
In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects and manage them accordingly.
De fleste patienter i analyserne var kaukasere.
Most of the patients studied were Caucasian.
Patienter med gunstig cytogenetik blev ikke inkluderet i studiet.
Patients with favourable cytogenetics were not included in the study.
Tid (måneder)
Time (Months)
TC (samlet gruppe) n = 243
TC (combined group) n = 243
• Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Myelosuppression, der skyldes Dacogen, er reversibel.
Myelosuppression caused by Dacogen is reversible.
Grad 3-4
Grades 3-4
Forskellen var ikke statistisk signifikant, men der var en tendens til forbedring af overlevelse med 15 % reduktion i risikoen for død hos forsøgspersoner i Dacogen-gruppen (figur 1).
The difference did not reach statistical significance, however, there was a trend for improvement in survival with a 15% reduction in the risk of death for subjects in the Dacogen arm (Figure 1).
Tabellen er baseret på data fra kliniske AML-studier og fra erfaring efter markedsføringen.
The following table reflects data from AML clinical studies and from post-marketing experience.
ELLER = 2,5
OR = 2.5
I så fald må du ikke køre bil eller arbejde med værktøj eller bruge maskiner.
If this happens, do not drive or use any tools or machines.
Der er utilstrækkelige data fra anvendelse af Dacogen til gravide kvinder.
There are no adequate data on the use of Dacogen in pregnant women.
I tilfælde af overdosering bør der gives understøttende behandling.
Treatment for overdose should be supportive.
Denne form for kræft påvirker dine blodlegemer.
This is a type of cancer that affects your blood cells.
Der er ikke påvist afhængighed af alder, kreatininclearance, total bilirubin eller sygdom.
There was no evidence of dependencies on age, creatinine clearance, total bilirubin, or disease.
Børn og unge Dacogen bør ikke anvendes til børn og unge under 18 år.
Children and adolescents Dacogen is not for use in children or adolescents under the age of 18.
• Du må ikke få Dacogen, hvis du er gravid, da det kan skade dit barn.
• You should not use Dacogen if you are pregnant as it may harm your baby.
Komplikationer ved myelosuppression omfatter infektioner og blødning.
Complications of myelosuppression include infections and bleeding.
Det vides ikke, hvornår det er sikkert for kvinder at blive gravide efter behandlingens afslutning.
It is unknown when it is safe for women to become pregnant after treatment has stopped.
• Febril neutropeni (temperatur ≥ 38,5 °C og absolut neutrofiltal < 1.000/µl)
• Febrile neutropaenia (temperature ≥ 38.5°C and absolute neutrophil count < 1,000/µL)
Bivirkningsgrad (Worst National Institute Common Terminology Criteria for Adverse Grade).
Worst National Cancer Institute Common Terminology Criteria for Adverse Events Grade.
• Efter opløsning skal koncentratet fortyndes yderligere inden for 15 minutter ved brug af kold infusionsvæske.
• After reconstitution, the concentrate must be further diluted within 15 minutes using cold infusion fluids.
Median alder for ”intent-to-treat-populationen” (ITT) var 73 år (interval 64 til 91 år).
The median age for the intent-to-treat (ITT) population was 73 years (range 64 to 91 years).
• Tal med din læge, hvis du ønsker at nedfryse dine æg før behandlingens start.
• Talk to your doctor if you wish to freeze your eggs before starting treatment.
Det er ukendt, om decitabin eller dets metabolitter udskilles i human mælk.
It is not known whether decitabine or its metabolites are excreted in breast milk.
Brug ikke Dacogen:
Do not use Dacogen:
• andre infektioner i enhver del af kroppen, der skyldes bakterier, virus eller svamp
• other infection in any part of the body, caused by bacteria, virus or fungi
Behandlingen kan udsættes efter den behandlende læges skøn, hvis patienten oplever komplikationer af myelosuppression som beskrevet nedenfor:
Treatment may be delayed at the discretion of the treating physician, if the patient experiences myelosuppression-associated complications, such as those described below:
• Kvinder skal bruge sikker prævention under behandlingen.
• Women must use effective contraception during treatment.
Administration af Dacogen skal initieres under opsyn af en læge der har erfaring i anvendelse af kemoterapeutiske lægemidler.
Dacogen administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic medicinal products.
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
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
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.
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.
Du vil få Dacogen, når du har fået stillet diagnosen AML.
You will be given Dacogen when you are first diagnosed with AML.
Forventet værdi
Predicted Value
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).
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).
Præmedicinering til forebyggelse af kvalme og opkastning anbefales ikke rutinemæssigt, men kan gives efter behov.
Pre-medication for the prevention of nausea and vomiting is not routinely recommended but may be administered if required.
Enterocolitis kan føre til septiske komplikationer og kan være forbundet med dødelig udgang.
Enterocolitis may lead to septic complications and may be associated with fatal outcome.
• blødning - herunder blod i afføringen.
• Bleeding: including blood in the stools.
I kliniske studier i AML og myelodysplastisk syndrom (MDS) var rapporteringshyppigheden for hyperbilirubinæmi 11 % for alle grader og 2 % for grad 3-4.
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.
Du vil få Dacogen af en læge eller sundhedspersonale, som er uddannet i at give denne type medicin.
Dacogen will be given to you by a doctor or nurse who is trained in giving this type of medicine.
I kliniske studier havde ca. en tredjedel af de patienter, der fik Dacogen, behov for udsættelse af en dosis.
In clinical studies, approximately one-third of patients receiving Dacogen required a dose-delay.
• Mænd bør bruge sikker prævention under behandlingen og i op til tre måneder efter dens afslutning.
• Men should use effective contraception during treatment and for up to 3 months after treatment has stopped.
De væsentligste metabolitter i blodcirkulationen formodes ikke at være farmakologisk aktive.
The major circulating metabolites are not believed to be pharmacologically active.
Hvad Dacogen anvendes til
What Dacogen is used for
Tabel 2: Andre endepunkter til effektvurdering i studiet DACO-016 (ITT-populationen)
Table 2: Other efficacy endpoints for Study DACO-016 (ITT population)
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.
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.
Almindelig septisk chok sepsis sinusitis
Common septic shock* sepsis* sinusitis
Udskillelse af uomdannet lægemiddelstof synes kun at spille en mindre rolle i eliminationen af decitabin.
Excretion of unchanged drug appears to play only a minor role in the elimination of decitabine.
Der foreligger ingen humane data for decitabins virkninger på fertilitet.
No human data on the effect of decitabine on fertility are available.
Patienterne bør oplyses om, at de kan få bivirkninger såsom anæmi under behandlingen.
Patients should be advised that they may experience undesirable effects such as anaemia during treatment.
• forhøjet indhold af ”bilirubin” i blodet.
• high level of ‘bilirubin' in the blood
Dacogen påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
Dacogen has moderate influence on the ability to drive and use machines.
(trombocytopeni)
(thrombocytopaenia)
Et hvidt til næsten hvidt frysetørret pulver.
White to almost white lyophilized powder.
Data fra litteraturen indikerer desuden, at decitabin har bivirkninger på alle aspekter af reproduktionscyklen, herunder fertilitet, embryoføtal udvikling og postnatal udvikling.
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.
Det indeholder det aktive stof ”decitabin”.
It contains the active substance ‘decitabine'.
Resten af forsøgspersonerne havde intermediær cytogenetik.
The remainder of the subjects had intermediate-risk cytogenetics.
Toksicitet vil sandsynligvis manifestere sig som forværring af bivirkninger, primært myelosuppression.
Toxicity is likely to manifest as exacerbations of adverse drug reactions, primarily myelosuppression.
• feber det kan være tegn på en infektion, der skyldes et lavt antal hvide blodlegemer (meget almindelig).
• Fever: this may be a sign of an infection caused by low levels of white blood cells (very common).
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.
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.
Populationsfarmakokinetiske analyser har vist, at decitabins farmakokinetik ikke er afhængig af alder (det undersøgte interval er 40 til 87 år; median 70 år).
Population pharmacokinetic analysis showed that decitabine pharmacokinetics are not dependent on age (range studied 40 to 87 years; median 70 years).
De bør derfor udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner.
Therefore, caution should be recommended when driving a car or operating machines.
Neuroadfærdsmæssig udvikling og reproduktionsevne blev ikke påvirket, når neonatale/juvenile rotter blev behandlet ved dosisniveauer, der inducerede myelosuppression.
Neurobehavioural development and reproductive capacity were unaffected when neonatal/juvenile rats were treated at dose levels inducing myelosuppression.
Virkningerne af nedsat nyre- eller leverfunktion, køn, alder eller race på decitabins farmakokinetik er ikke undersøgt formelt.
The effects of renal or hepatic impairment, gender, age or race on the pharmacokinetics of decitabine have not been formally studied.
Decitabins binding til plasmaprotein er ubetydelig (< 1 %).
Plasma protein binding of decitabine is negligible (< 1%).
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.
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).
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.
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.
I gruppen, der blev behandlet med Dacogen, blev behandlingen hyppigere seponeret på grund af bivirkninger hos kvinder end hos mænd (43 % versus 32 %).
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%).
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.
If you forget your appointment to have Dacogen If you miss an appointment, make another one as soon as possible.
Studier har påvist, at decitabin er teratogent i rotter og mus (se pkt.
Studies have shown that decitabine is teratogenic in rats and mice (see section 5.3).
Dette kan være et tegn på blødning i hovedet (almindelig).
These may be signs of bleeding inside your head (common).
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 %]).
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%]).
• Dosis er 20 mg/m2 legemsoverflade.
• The dose is 20 mg/m2 body surface area.
Studiets primære endepunkt var samlet overlevelse.
The primary endpoint of the study was overall survival.
Forsigtighed tilrådes ved administration af Dacogen til patienter med svært nedsat nyrefunktion (kreatininclearance [CrCl] < 30 ml/min).
Caution should be exercised in the administration of Dacogen to patients with severe renal impairment (Creatinine Clearance [CrCl] < 30 ml/min).
Det primære endepunkt var komplet remission (CR), og det blev vurderet af uafhængige eksperter.
The primary endpoint was complete remission (CR) rate that was assessed by independent expert review.
• hvis du er allergisk over for decitabin eller et af de øvrige indholdsstoffer i Dacogen (angivet i punkt 6).
• if you are allergic to decitabine or any of the other ingredients of this medicine (listed in section 6).
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.
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.
Vedrørende situationer, hvor administration af decitabin bør udskydes, se pkt.
For situations where decitabine administration should be delayed, see section 4.2.
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.
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.
36 % af forsøgspersonerne havde ugunstig cytogenetik ved baseline.
Thirty-six percent of subjects had poor-risk cytogenetics at baseline.
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.
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.
Den totale døgndosis må ikke overstige 20 mg/m2, og den totale dosis pr. behandlingscyklus må ikke overstige 100 mg/m2.
The total daily dose must not exceed 20 mg/m 2 and the total dose per treatment cycle must not exceed
Desuden viser in vitro-data, at decitabin er et dårligt substrat for P-gp.
In addition, in vitro data show that decitabine is a poor P-gp substrate.
Kontakt lægen eller sundhedspersonalet, hvis du har spørgsmål om, hvordan Dacogen virker, eller hvorfor du har fået dette lægemiddel.
Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.
• har en infektion,
• an infection,
• besvær med at bevæge sig, tale, forstå eller se, en pludselig voldsom hovedpine, krampeanfald, følelsesløshed eller svaghed i en legemsdel.
• Difficultly with moving, speaking or understanding or seeing; sudden severe headache, seizure, numbness or weakness in any part of the body.
• urinvejsinfektion
• urine infection
• Aktiv viral eller bakteriel infektion eller mykose (med behov for intravenøs behandling af infektionen eller omfattende understøttende pleje)
• Active viral, bacterial or fungal infection (i.e., requiring intravenous anti-infectives or extensive supportive care)
Hvert hætteglas er kun til engangsbrug, og ikke anvendt opløsning skal bortskaffes.
A vial is for single use only and any remaining solution must be discarded.
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.
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.
Almindelig overfølsomhed inklusive anafylaktisk reaktion
Common hypersensitivity including anaphylactic reaction
Anvendelse af decitabin sammen med hormonal kontraception er ikke undersøgt.
The use of decitabine with hormonal contraceptives has not been studied.
Pulveret bør rekonstitueres under aseptiske betingelser med 10 ml vand til injektionsvæsker.
The powder should be aseptically reconstituted with 10 ml of water for injections.
Resultaterne af studiet af total omsætning hos mennesker viste, at uomdannet decitabin udgjorde ca. 2,4 % af den totale radioaktivitet i plasma.
Results from the human mass-balance study showed that unchanged decitabine in plasma accounted for approximately 2.4% of total radioactivity in plasma.
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.
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.
Dacogens sikkerhed og virkning er ikke blevet evalueret hos patienter med akut promyelocytisk leukæmi eller CNS-leukæmi.
The efficacy and safety of Dacogen has not been evaluated in patients with acute promyelocytic leukaemia or CNS leukaemia.
In vitro-studier viser, at decitabin ikke hæmmer eller inducerer CYP450-enzymer i et omfang, der overstiger 20 gange den maksimale observerede plasmakoncentration (Cmax).
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).
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.
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.
• Din læge, sundhedspersonalet eller apotekspersonalet er ansvarlige for at bortskaffe ikke anvendt Dacogen korrekt.
• Your doctor, nurse or pharmacist is responsible for disposing of any unused Dacogen correctly.
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.
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.
De rapporterede bivirkninger var i overensstemmelse med Dacogens kendte sikkerhedsprofil hos voksne (se pkt.
Reported adverse events were consistent with the known safety profile of Dacogen in adults (see section 4.8).
Intracellulært aktiveres decitabin gennem sekventiel phosphorylering via phosphokinase til det tilsvarende triphosphat, som så inkorporeres af DNA-polymerase.
Intracellularly, decitabine is activated through sequential phosphorylation via phosphokinase activities to the corresponding triphosphate, which is then incorporated by the DNA polymerase.
• røde, hævede, smertefulde plamager på huden, feber, et øget antal hvide blodlegemer - det kan være tegn på ”akut febril neutrofil dermatose” eller ”Sweets syndrom”.
• 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'
• 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.
• Do not use this medicine after the expiry date, which is stated on the carton and on the vial label after EXP.
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.
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.
Middeltallet for plasmaclearance efter intravenøs administration hos forsøgspersoner med cancer var > 200 l/time med moderate interindividuelle variationer (variationskoefficient [CV] ca. 50 %).
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%).