FrancophonIA/ELRC3.0 huggingface dataset:
English: Age, sex, race, body weight, body mass index, and white blood cell count do not have a clinically important effect on the exposure of total daunorubicin or cytarabine after adjusting dose by body surface area.
Danish: Alder, køn, race, legemsvægt, body mass index og antal hvide blodlegemer har ingen klinisk vigtig effekt på eksponeringen af total daunorubicin eller cytarabin efter justering af dosis efter legemsoverfladeareal.
English: You will receive a first course of treatment and your doctor will decide if you will receive further courses of treatment depending on how you respond to treatment and any side effects you get.
Danish: Du vil få en første behandlingscyklus, og lægen vil beslutte, om du skal have yderligere cyklusser, afhængigt af hvordan du reagerer på behandlingen og af de bivirkninger, du eventuelt får.
English: A high incidence of mammary tumours was observed about 120 days after a single intravenous dose of daunorubicin in rats (at about 1.7 times the human dose on a mg/m basis).
Danish: En høj forekomst af mammatumorer blev observeret cirka 120 dage efter en enkelt intravenøs dosis daunorubicin hos rotter (cirka 1,7 gange den humane dosis på basis af mg/m2).
English: Vyxeos liposomal may also cause heart problems and damage to the heart muscle.
Danish: Vyxeos liposomal kan desuden medføre hjerteproblemer og beskadigelse af hjertemusklen.
English: There are no data on the use of Vyxeos liposomal in pregnant women.
Danish: Der er ingen data fra anvendelse af Vyxeos liposomal til gravide kvinder.
English: Total cumulative exposure of daunorubicin has been described in the table below.
Danish: Den samlede kumulative eksponering for daunorubicin er beskrevet i nedenstående tabel.
English: Cardiotoxicity (18.7)
Danish: Kardiotoksicitet (18,7)
English: The pharmacokinetics of Vyxeos liposomal in patients aged > 85 years has not yet been evaluated.
Danish: Vyxeos liposomal' farmakokinetik hos patienter i alderen > 85 år er endnu ikke undersøgt.
English: First induction
Danish: Første induktion
English: • a fall in the number of red blood cells (anaemia) leading to tiredness and weakness
Danish: • et fald i antallet af røde blodlegemer (anæmi), som forårsager træthed og svækkelse
English: Blood counts should be regularly monitored until recovery (see section 4.8).
Danish: Blodtal bør kontrolleres regelmæssigt, indtil de er genoprettede (se pkt.
English: A single dose of cytarabine in rats, administered on day 14 of gestation, reduced prenatal and postnatal brain size and caused permanent impairment of learning ability.
Danish: En enkelt dosis cytarabin hos rotter, der blev administreret på dag 14 i drægtigheden, reducerede den prænatale og postnatale hjernestørrelse og medførte permanent nedsættelse af indlæringsevnen.
English: All materials used for dilution and administration should be disposed of according to local procedures applicable to the discarding of antineoplastic agents.
Danish: Alle materialer, der er brugt til fortynding og administration, skal kasseres i overensstemmelse med de lokale procedurer, der gælder for bortskaffelse af antineoplastiske midler.
English: Total cumulative doses of non-liposomal daunorubicin greater than 550 mg/m have been associated with an increased incidence of treatment-induced congestive heart failure.
Danish: Samlede kumulative doser ikke-liposomal daunorubicin på over 550 mg/m har været forbundet med en øget forekomst af behandlingsinduceret kongestiv hjerteinsufficiens.
English: Stability of diluted infusion solution
Danish: Stabilitet af den fortyndede infusionsvæske
English: There was no evidence of time-dependent kinetics or major departures from dose proportionality over the range of 1.3 mg/3 mg per m to 59 mg/134 mg per m
Danish: Der var ingen evidens for tidsafhængig kinetik eller væsentlige afvigelser fra dosisproportionalitet inden for intervallet 1,3 mg/3 mg pr. m til 59 mg/134 mg pr. m
English: Store in an upright position.
Danish: Opbevares i opret position.
English: Cytarabine is metabolised by cytidine deaminase to the inactive metabolite 1-β (beta)-D-arabinofuranosyluracil (AraU).
Danish: Cytarabin metaboliseres ved cytidindeaminase til det inaktive metabolit 1-β (beta)-D-arabinofuranosyluracil (AraU).
English: Your treatment will be given in ‘courses'.
Danish: Din behandling vil blive givet i cyklusser.
English: The relationship between cumulative Vyxeos liposomal dose and the risk of cardiac toxicity has not been determined.
Danish: Sammenhængen mellem kumulativ Vyxeos liposomal-dosis og risikoen for kardiotoksicitet er ikke klarlagt.
English: Vaccination with a live vaccine should be avoided in patients receiving Vyxeos liposomal.
Danish: Vaccination med en levende vaccine skal undgås hos patienter, der får Vyxeos liposomal.
English: Daunorubicin is mostly catalysed by hepatic and non-hepatic aldo-keto reductase and carbonyl reductase to the active metabolite daunorubicinol.
Danish: Daunorubicin katalyseres overvejende ved hepatisk og ikke-hepatisk aldo-keto-reduktase og carbonylreduktase til det aktive metabolit daunorubicinol.
English: A baseline cardiac evaluation with an electrocardiogram (ECG) and a multi-gated radionuclide angiography (MUGA) scan or an echocardiography (ECHO) is recommended, especially in patients with risk factors for increased cardiac toxicity.
Danish: En hjerteundersøgelse ved baseline med elektrokardiogram (ekg) og en MUGA-scanning (multi-gated radionuclide angiography) eller ekkokardiografi (ECHO) anbefales, især hos patienter med risikofaktorer for øget hjertetoksicitet.
English: • Store in an upright position.
Danish: • Opbevares i opret position.
English: If a planned dose of Vyxeos liposomal is missed, the dose should be administered as soon as possible and the dosing schedule adjusted accordingly, maintaining the treatment interval.
Danish: Hvis en planlagt dosis Vyxeos liposomal udelades, skal dosen administreres snarest muligt, og doseringsskemaet skal justeres i overensstemmelse dermed, så behandlingsintervallet opretholdes.
English: Serious side effects which may affect more than 1 in 10 people (very common)
Danish: Alvorlige bivirkninger, der kan ramme mere end 1 ud af 10 personer (meget almindelige)
English: The overall rate of HSCT was 34% (52/153) in the Vyxeos liposomal arm and 25% (39/156) on the control arm.
Danish: Den samlede HSCT-rate var 34% (52/153) i Vyxeos liposomal-armen og 25% (39/156) i kontrolarmen.
English: The most serious and frequently occurring ADRs were infection (58.7%), cardiotoxicity (18.7%) and haemorrhage (13.1%).
Danish: De mest alvorlige og hyppigst forekommende bivirkninger var infektion (58,7%), kardiotoksicitet (18,7% og blødning (13,1%).
English: Dyspepsia (9.6)
Danish: Dyspepsi (9,6)
English: Tell your doctor immediately if you get any of the side effects listed above.
Danish: Fortæl det straks til din læge, hvis du får en eller flere af ovenstående bivirkninger.
English: • headache, dizziness, confusion, difficulty sleeping, anxiety
Danish: • hovedpine, svimmelhed, forvirring, søvnproblemer, angst
English: Incidence of fatal cardiotoxicity events is 0.5%.
Danish: Forekomsten af letale kardiotoksiciteter var 0,5%.
English: In clinical studies with Vyxeos liposomal, one event of extravasation occurred, but no necrosis was observed.
Danish: I kliniske studier med Vyxeos liposomal opstod der en enkelt hændelse med ekstravasation, men der blev ikke observeret nogen nekrose.
English: It is not known whether Vyxeos liposomal is excreted in human milk.
Danish: Det er ukendt, om Vyxeos liposomal udskilles i human mælk.
English: The most common haemorrhagic event was epistaxis, and the majority of these were considered not serious (29.1%).
Danish: De mest almindelige blødningshændelser var epistaxis, og størstedelen af disse hændelser blev anset for at være ikke-alvorlige (29,1%).
English: Cytarabine is a cell cycle phase-specific antineoplastic agent, affecting cells only during the S-phase of cell division.
Danish: Cytarabin er et cellecyklusfase-specifikt antineoplastisk middel, der kun påvirker cellerne under celledelingens S-fase.
English: Patients may be pre-medicated for nausea and vomiting.
Danish: Patienterne kan præmedicineres mod nausea og opkastning.
English: Daunorubicin has antimitotic and cytotoxic activity, which is achieved by forming complexes with DNA, inhibiting topoisomerase II activity, inhibiting DNA polymerase activity, affecting regulation of gene expression, and producing DNA-damaging free radicals.
Danish: Daunorubicin har antimitotisk og cytotoksisk aktivitet, der opnås ved at danne komplekser med DNA, hæmme topoisomerase II-aktiviteten, hæmme DNA-polymeraseaktiviteten, påvirke reguleringen af genekspression og producere DNA-ødelæggende frie radikaler.
English: Cardiotoxicity is a known risk of anthracycline treatment.
Danish: Kardiotoksicitet er en kendt risiko ved behandling med antracykliner.
English: • if you have ever had a condition known as Wilson's disease or other copper-related disorder, as Vyxeos liposomal contains an ingredient known as 'copper gluconate'.
Danish: • hvis du nogensinde har haft en tilstand, der hedder Wilsons sygdom, eller anden kobberrelateret sygdom, da Vyxeos liposomal har et indholdsstof, der kaldes for kobbergluconat.
English: Women of childbearing potential should not receive treatment until pregnancy is excluded.
Danish: Kvinder i den fertile alder må ikke behandles, før graviditet er udelukket.
English: Prophylactic anti-infectives (including anti-bacterial, anti-virals, anti-fungals) may be administered during the period of profound neutropenia until ANC returns to 500/μL or greater.
Danish: Der kan gives profylaktiske antiinfektiva (herunder antibakterielle, antivirale og antimykotiske lægemidler) i perioden med markant neutropeni, indtil ANC vender tilbage til 500/μl eller derover.
English: Plasma concentration-time profiles obtained from 13 to 26 patients who received Vyxeos liposomal 100 units/m
Danish: De plasmakoncentration-tid-profiler, der er indsamlet fra 13 til 26 patienter, som fik Vyxeos liposomal 100 enheder/m
English: An in-line membrane filter may be used for the intravenous infusion of Vyxeos liposomal, provided the minimum pore diameter of the filter is greater than or equal to 15 µm.
Danish: Der kan anvendes et in-line-membranfilter til intravenøs infusion af Vyxeos liposomal under forudsætning af, at filterets mindste porediameter er større end eller lig med 15 µm.
English: The 1:5 molar ratio has been shown in vitro and in vivo to maximise synergistic antitumour activity in AML.
Danish: Molforholdet på 1:5 har in vitro og in vivo vist sig at optimere den synergistiske antitumoraktivitet ved AML.
English: Laboratory tests
Danish: Laboratorietest
English: Vyxeos liposomal has minor influence on the ability to drive and use machines.
Danish: Vyxeos liposomal påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Infection (78.1)
Danish: Infektion (78,1)
English: The most frequently reported serious ADRs were decreased ejection fraction and congestive cardiac failure.
Danish: De hyppigst indberettede alvorlige bivirkninger var nedsat ejektionsfraktion og kongestiv hjerteinsufficiens.
English: You should use an effective method of contraception to avoid getting (you or your partner) pregnant during the treatment, and for the next 6 months after your last dose.
Danish: Du skal bruge en sikker præventionsmetode, for at du eller din partner undgår at blive gravid under behandlingen og i 6 måneder efter din sidste dosis.
English: • Calculate the volume of reconstituted Vyxeos liposomal required using the following formula: [volume required (mL) = dose of daunorubicin (mg/m 2) x patient's BSA (m 2)/2.2 (mg/mL)].
Danish: • Beregn den nødvendige mængde rekonstitueret Vyxeos liposomal med anvendelse af følgende formel: [nødvendig mængde (ml) = dosis daunorubicin (mg/m 2) x patientens BSA (m 2)/2,2 (mg/ml)].
English: Hepatotoxic medicinal products may impair liver function and increase the toxicity.
Danish: Hepatotoksiske lægemidler kan forringe leverfunktionen og øge toksiciteten.
English: If the medicinal product is used during pregnancy, or if the patient becomes pregnant while receiving Vyxeos liposomal, the woman should be informed of the potential hazard to the foetus.
Danish: Hvis lægemidlet bruges under graviditet, eller hvis patienten bliver gravid, mens hun får Vyxeos liposomal, skal hun informeres om den potentielle fare for fosteret.
English: Evaluation of hepatic and renal function using conventional clinical laboratory tests is recommended prior to administration of Vyxeos liposomal and periodically during treatment.
Danish: Undersøgelse af lever- og nyrefunktionen med anvendelse af konventionelle kliniske laboratorietest anbefales inden administration af Vyxeos liposomal og regelmæssigt under behandlingen.
English: • Administer Vyxeos liposomal by constant intravenous infusion over 90 minutes via an infusion pump through a central venous catheter or a peripherally inserted central catheter.
Danish: • Administrér Vyxeos liposomal som en konstant intravenøs infusion i 90 minutter via en infusionspumpe gennem et centralt venekateter eller et perifert indført centralt kateter.
English: Do not administer Vyxeos liposomal in combination with other cardiotoxic agents unless the patient's cardiac function is closely monitored.
Danish: Vyxeos liposomal må ikke administreres i kombination med andre kardiotoksiske midler, medmindre patientens hjertefunktion monitoreres nøje.
English: Vyxeos liposomal dosing is based on the patient's body surface area (BSA) according to the following schedule:
Danish: Doseringen af Vyxeos liposomal er baseret på patientens legemsoverfladeareal (BSA) i henhold til følgende skema:
English: Infection (58.7)
Danish: Infektion (58,7)
English: Copper gluconate Trolamine (for pH adjustment) Sucrose
Danish: Kobbergluconat Trolamin (til pH-justering) Saccharose
English: • chest pain or leg pain
Danish: • brystsmerter eller smerter i benene
English: This is because Vyxeos liposomal may affect the way some other medicines work.
Danish: Det skyldes, at Vyxeos liposomal kan påvirke den måde, anden medicin virker på.
English: Observe the patient carefully over time for signs of cardiotoxicity and provide appropriate supportive therapy as clinically indicated.
Danish: Patienten skal observeres nøje over tid for tegn på kardiotoksicitet og have relevant supportiv behandling efter klinisk behov.
English: Your doctor may pause or stop treatment, or slow the rate of your drip, if any hypersensitivity occurs.
Danish: Din læge vil muligvis afbryde behandlingen midlertidigt eller helt eller sætte droppets hastighed ned, hvis der opstår overfølsomhed.
English: You should not use Vyxeos liposomal during pregnancy as it may be harmful to the baby.
Danish: Du må ikke bruge Vyxeos liposomal under graviditet, da det kan være skadeligt for barnet.
English: At baseline 20% had t-AML, 54% had AML with an antecedent haematological disorder and 25% had de novo AML with myelodysplasia-related cytogenetic abnormalities; 34% had been treated previously with a hypomethylating agent for MDS;54% had an adverse karyotype.
Danish: Ved baseline havde 20% t-AML, 54% havde AML med en forudgående hæmatologisk lidelse, og 25% havde de novo AML med myelodysplasi-relaterede cytogenetiske anomalier; 34% var tidligere behandlet med et hypometylerende middel på grund af MDS; 54% havde en ugunstig karyotype.
English: Daunorubicin has been associated with local tissue necrosis at the site of medicinal product extravasation.
Danish: Daunorubicin har været forbundet med lokal vævsnekrose på stedet for ekstravasation af lægemidlet.
English: Pruritus (17.3) Hyperhidrosis (10.1)
Danish: Pruritus (17,3) Hyperhidrose (10,1)
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 2°C to 8°C.
Danish: Den kemiske og fysiske stabilitet efter åbning er påvist i 4 timer ved 2 °C til 8 °C.
English: Baseline assessment of blood counts should be obtained, and patients should be carefully monitored during treatment with Vyxeos liposomal for possible clinical complications due to myelosuppression.
Danish: En vurdering af blodtal bør indhentes ved baseline, og patienterne skal overvåges nøje under behandling med Vyxeos liposomal for eventuelle kliniske komplikationer, der skyldes myelosuppression.
English: Second induction
Danish: Anden induktion
English: • On further courses - you will have an infusion on days 1 and 3.
Danish: • I yderligere behandlingscyklusser vil du få en infusion på dag 1 og 3.
English: You may feel sleepy or dizzy after having Vyxeos liposomal.
Danish: Du kan føle dig søvnig eller svimmel, efter du har fået Vyxeos liposomal.
English: Consolidation therapy is recommended for patients achieving remission who have recovered to absolute neutrophil count (ANC) > 500/µL and the platelet count has recovered to greater than 50,000/µL in the absence of unacceptable toxicity.
Danish: Konsolideringsbehandling anbefales til patienter, der opnår remission, og som har fået genoprettet et absolut neutrofiltal (ANC) på > 500/µl, og hvor trombocyttallet er genoprettet til over 50.000/µl uden uacceptabel toksicitet.
English: Intracellularly, cytarabine is converted into cytarabine-5-triphosphate (ara-CTP), which is the active metabolite.
Danish: Cytarabin omdannes intracellulært til cytarabin-5-triphosphat (ara-CTP), der er den aktive metabolit.
English: It contains two active substances, called ‘daunorubicin' and ‘cytarabine', in the form of tiny particles known as ‘liposomes'.
Danish: Det indeholder to aktive stoffer, daunorubicin og cytarabin, i form af bittesmå partikler, der kaldes for liposomer.
English: Dyspnoea (13.1)
Danish: Dyspnø (13,1)
English: Vyxeos liposomal is a cytotoxic medicinal product.
Danish: Vyxeos liposomal er et cytotoksisk lægemiddel.
English: • Do not mix Vyxeos liposomal with, or administer as an infusion with, other medicinal products.
Danish: • Vyxeos liposomal må ikke blandes med andre lægemidler eller administreres som en infusion med andre lægemidler.
English: The median survival for the Vyxeos liposomal treatment group was 9.56 months compared with 5.95 months for the 7+3 treatment group (Hazard Ratio = 0.69, 95% CI = 0.52, 0.90, two-sided log-rank test p = 0.005).
Danish: Medianoverlevelsen for behandlingsgruppen på Vyxeos liposomal var 9,56 måneder sammenlignet med 5,95 måneder for 7+3-gruppen (hazard ratio = 0,69, 95% CI = 0,52; 0,90, tosidet log-rank-test, p = 0,005).
English: The dilution of the reconstituted product results in a deep purple, translucent, homogeneous dispersion.
Danish: Fortyndingen af det rekonstituerede produkt giver en mørkviolet, gennemsigtig, homogen dispersion.
English: Vyxeos liposomal is administered by intravenous infusion over a period of 90 minutes.
Danish: Vyxeos liposomal administreres som en intravenøs infusion i et tidsrum på 90 minutter.
English: Febrile neutropenia (63.5)
Danish: Febril neutropeni (63,5)
English: Based on data in animals, Vyxeos liposomal liposomes accumulate and persist in high concentration in the bone marrow, where they are preferentially taken up intact by leukaemia cells in an active engulfment process.
Danish: Baseret på data fra dyr akkumuleres Vyxeos liposomal-liposomerne og bevares i en høj koncentration i knoglemarv, hvor de fortrinsvis optages intakt af leukæmiceller i en aktiv opslugningsproces.
English: Vyxeos liposomal treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products.
Danish: Behandling med Vyxeos liposomal skal initieres og monitoreres under tilsyn af en læge med erfaring inden for anvendelse af kemoterapeutika.
English: Care should be taken to ensure that there is no extravasation of medicinal product when Vyxeos liposomal is administered.
Danish: Der skal udvises forsigtighed for at sikre, at der ikke er nogen ekstravasation af lægemidlet, når Vyxeos liposomal administreres.
English: Cytarabine caused the transformation of hamster embryo cells and rat H43 cells in vitro.
Danish: Cytarabin forårsagede omdannelse af embryoceller hos hamstre og H43-celler hos rotter in vitro.
English: Hyperhidrosis (0.3)
Danish: Hyperhidrose (0,3)
English: In particular, tell your doctor or nurse if you are taking any of the following medicines:
Danish: Fortæl det især til lægen eller sundhedspersonalet, hvis du bruger følgende medicin:
English: Urinary excretion of daunorubicin and daunorubicinol accounts for 9% of the administered dose of daunorubicin, and urinary excretion of cytarabine and AraU accounts for 71% of the administered dose of cytarabine.
Danish: Udskillelsen i urin af daunorubicin og daunorubicinol udgør 9% af den administrerede dosis daunorubicin, og udskillelsen i urin af cytarabin og AraU udgør 71% af den administrerede dosis cytarabin.
English: • Flush the line after administration with sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: • Skyl slangen efter administration med natriumchlorid 9 mg/ml (0,9%) injektionsvæske.
English: Febrile neutropenia (62.4)
Danish: Febril neutropeni (62,4)
English: Treatment should be continued as long as the patient continues to benefit or until disease progression, up to maximum of 2 consolidation courses.
Danish: Behandlingen bør fortsætte, så længe patienten fortsat opnår en fordel eller indtil sygdomsprogression, op til maksimalt 2 konsolideringscyklusser.
English: From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal lægemidlet bruges med det samme, medmindre den metode, der er anvendt til åbning/rekonstituering/fortynding, udelukker risikoen for mikrobiel kontaminering.
English: Hepatic or renal impairment may increase the risk of toxicity associated with daunorubicin and cytarabine.
Danish: Nedsat lever- eller nyrefunktion kan forhøje risikoen for toksicitet forbundet med daunorubicin og cytarabin.
English: Intravenous use after dilution.
Danish: Til intravenøs anvendelse efter fortynding.
English: • if you are allergic to the active substances (daunorubicin or cytarabine) or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for de aktive stoffer (daunorubicin eller cytarabin) eller et af de øvrige indholdsstoffer i Vyxeos liposomal (angivet i afsnit 6),
English: The safety and efficacy of Vyxeos liposomal in children aged 0-18 years have not yet been established.
Danish: Vyxeos liposomal' sikkerhed og virkning hos børn i alderen 0-18 år er endnu ikke klarlagt.
English: • During your first course - you will have an infusion on days 1, 3, and 5.
Danish: • I den første behandlingscyklus vil du få en infusion på dag 1, 3 og 5.
English: The fatal infections experienced were sepsis and pneumonia (see section 4.4).
Danish: De letale infektioner, der opstod, var sepsis og pneumoni (se pkt.
English: Recommended dose adjustments during treatment
Danish: Anbefalede dosisjusteringer under behandling
English: • Then, reconstitute each vial with 19 mL of sterile water for injections using a 20 mL syringe,
Danish: • Rekonstituér derefter hvert hætteglas med 19 ml sterilt vand til injektionsvæsker med anvendelse af en 20 ml sprøjte.
English: Daunorubicin per course
Danish: Daunorubicin pr. cyklus
English: Repeat-dose toxicity of Vyxeos liposomal was tested in two-cycle intravenous infusion toxicity studies with 28-day recovery periods conducted in rats and dogs.
Danish: Vyxeos liposomal' toksicitet efter gentagne doser som intravenøse infusioner blev undersøgt i to cyklusser med 28 dages restitueringsperioder, der blev gennemført på rotter og hunde.
English: Due to the long plasma half-life of Vyxeos liposomal, time to recovery of ANC and platelets may be prolonged and require additional monitoring.
Danish: På grund af Vyxeos liposomal' lange plasmahalveringstid kan det vare lang tid, før ANC og trombocytter er genoprettet, og yderligere monitorering er påkrævet.
English: Treatment with Vyxeos liposomal should be permanently discontinued.
Danish: Behandling med Vyxeos liposomal bør seponeres permanent.
English: • Do not heat, vortex, or shake vigorously.
Danish: • Må ikke opvarmes, hvirvles eller omrystes kraftigt.