FrancophonIA/ELRC3.0 huggingface dataset:
English: The clearance (%CV) is 0.16 L/h (53.3%) for daunorubicin and 0.13 L/h (60.2%) for cytarabine.
Danish: Clearancen (%CV) er 0,16 l/t (53,3%) for daunorubicin og 0,13 l/t (60,2%) for cytarabin.
English: If you are given too much Vyxeos liposomal
Danish: Hvis du har fået for meget Vyxeos liposomal
English: • shortness of breath, cough, fluid in the lungs
Danish: • stakåndethed, hoste, væske i lungerne
English: Each pack contains either 1 vial, 2 vials or 5 vials.
Danish: Hver pakning indeholder enten 1 hætteglas, 2 hætteglas eller 5 hætteglas.
English: Each pack contains 1 vial, 2 vials or 5 vials.
Danish: Hver pakning indeholder 1 hætteglas, 2 hætteglas eller 5 hætteglas.
English: 50 mL vial (type 1 glass) with a stopper (chlorobutyl rubber), and an overseal (aluminium) containing 44 mg daunorubicin and 100 mg cytarabine.
Danish: 50 ml hætteglas (type 1-glas) med prop (chlorobutylgummi) og forsegling (aluminium), der indeholder 44 mg daunorubicin og 100 mg cytarabin.
English: The efficacy of Vyxeos liposomal in the treatment of high risk AML was evaluated in 1 controlled study.
Danish: Klinisk virkning og sikkerhed Vyxeos liposomal' virkning i behandlingen af højrisiko-AML blev undersøgt i et kontrolleret studie.
English: • kidney failure and abnormal blood tests due to massive death of cancer cells (Tumour lysis syndrome).
Danish: • nyresvigt og unormale blodprøver på grund af omfattende kræftcelledød (tumorlysesyndrom)
English: • bleeding or bruising without injury
Danish: • blødning eller blå mærker, uden at du har slået dig
English: Vyxeos liposomal must be given to you by a doctor or nurse with experience in treating AML.
Danish: Vyxeos liposomal skal gives af en læge eller sundhedspersonale, der har erfaring med behandling af AML.
English: History of serious hypersensitivity to the active substances or to any of the excipients listed in section
Danish: Tidligere tilfælde af alvorlig overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: Following the dose administered on day 5, the mean (% coefficient of variation [CV]) maximum plasma concentrations (Cmax) for daunorubicin was 26.0 (32.7%) mcg/mL and cytarabine was 62.2 (33.7%) mcg/mL.
Danish: Efter den dosis, der blev administreret på dag 5, var de gennemsnitlige (% koefficient af variation [CV]) maksimum-plasmakoncentrationer (Cmax) for daunorubicin 26,0 (32,7%) mikrog./ml og 62,2 (33,7%) mikrog./ml for cytarabin.
English: Blood uric acid levels should be monitored and appropriate therapy initiated in the event that hyperuricemia develops.
Danish: Urinsyreniveauer i blodet bør monitoreres, og relevant behandling iværksættes, hvis der opstår hyperurikæmi.
English: Daunorubicin was mutagenic in in vitro tests (Ames assay, V79 hamster cell assay), and clastogenic in vitro (CCRF-CEM human lymphoblasts) and in vivo (SCE assay in mouse bone marrow) tests.
Danish: Daunorubicin var mutagent i tests in vitro (Ames' test, V79-hamstercelle-test) og klastogent i tests in vitro (CCRF-CEM humane lymfoblaster) og in vivo (SCE-test i knoglemarv fra mus) tests.
English: Vyxeos liposomal should be administered intravenously only.
Danish: Vyxeos liposomal må kun administreres intravenøst.
English: • The other ingredients are distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol, copper gluconate, trolamine and sucrose.
Danish: • Øvrige indholdsstoffer: distearoylphosphatidylcholin, distearoylphosphatidylglycerol, cholesterol, kobbergluconat, trolamin og saccharose.
English: Any unused product should be disposed of in accordance with local requirements for cytotoxic agents.
Danish: Ubrugt produkt skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske midler.
English: Vyxeos liposomal is a liposomal formulation of a fixed combination of daunorubicin and cytarabine in a 1:5 molar ratio.
Danish: Vyxeos liposomal er en liposomal formulering af en fast kombination af daunorubicin og cytarabin i et molforhold på 1:5.
English: Dyspnoea (36.5) Cough (33.9) Pleural effusion (13.9)
Danish: Dyspnø (36,5) Hoste (33,9) Pleuraeffusion (13,9)
English: Do not administer via an intramuscular, intrathecal, or subcutaneous route (see section 4.2).
Danish: Det må ikke administreres via intramuskulær, intratekal eller subkutan vej (se pkt.
English: Based on findings in animals, male fertility may be compromised by treatment with Vyxeos liposomal (see section 5.3).
Danish: Baseret på fund hos dyr kan der være en risiko for den mandlige fertilitet ved behandling med Vyxeos liposomal (se pkt.
English: Vyxeos liposomal has a different posology than daunorubicin injection and cytarabine injection and it must not be interchanged with other daunorubicin and/or cytarabine containing products (see section
Danish: Vyxeos liposomal har en anden dosering end daunorubicin-injektion og cytarabin-injektion og må ikke bruges skiftevis med andre daunorubicin- og/eller cytarabin-holdige produkter (se pkt.
English: Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Danish: Vyxeos liposomal er indiceret til behandling af voksne med nyligt diagnosticeret behandlingsrelateret akut myeloid leukæmi (t-AML) eller AML med myelodysplasi-relaterede forandringer (AML-MRC).
English: Abbreviations: CI = Confidence interval; CR= Complete response; CRi= Complete response with incomplete recovery a p-value from stratified log rank test stratifying by age and AML sub-type b p-value from stratified Cochran-Mantel-Haenszel test stratified by age and AML sub-type
Danish: Forkortelser: CI = konfidensinterval; CR= komplet respons; CRi= komplet respons med ufuldstændig genoprettelse a p-værdi fra stratificeret log-rank-test, stratificeret efter alder og AML-undertype b p-værdi fra stratificeret Cochran-Mantel-Haenszel-test, stratificeret efter alder og AML-undertype Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Vyxeos liposomal i en eller flere undergrupper af den pædiatriske population med AML (se pkt.
English: Cumulative exposure of daunorubicin per course of Vyxeos liposomal Therapy
Danish: Kumulativ eksponering for daunorubicin pr. cyklus med Vyxeos liposomal Behandling
English: Median survival, months (95% CI) Hazard ratio (95% CI) p-value (2-sided)
Danish: Medianoverlevelse, måneder (95% CI) Hazard ratio (95% CI) p-værdi (2-sidet)
English: Male patients and women of childbearing potential must use an effective method of contraception during treatment and for 6 months following the last dose of Vyxeos liposomal (see section 4.6).
Danish: Mandlige patienter og kvindelige patienter i den fertile alder skal bruge en sikker kontraceptionsmetode under behandlingen og i 6 måneder efter den sidste dosis Vyxeos liposomal (se pkt.
English: Vyxeos liposomal may induce hyperuricemia secondary to rapid lysis of leukaemic cells.
Danish: Vyxeos liposomal kan inducere hyperurikæmi sekundært til hurtig lyse af leukæmiceller.
English: You should not breast-feed while you are receiving treatment with Vyxeos liposomal as it may be harmful to the baby.
Danish: Du må ikke amme, mens du er i behandling med Vyxeos liposomal, da det kan være skadeligt for barnet.
English: CR + CRi, n (%) Odds ratio (95% CI) p-value (2-sided)
Danish: CR + CRi, n (%) Odds ratio (95% CI) p-værdi (2-sidet)
English: Nausea (51.7) Diarrhoea/colitis (49.9) Mucositis (49.9) Constipation (42.7) Abdominal pain (36.3) Decreased appetite (33.9) Vomiting (27.7)
Danish: Nausea (51,7) Diaré/colitis (49,9) Mucositis (49,9) Obstipation (42,7) Abdominalsmerter (36,3) Nedsat appetit (33,9) Opkastning (27,7)
English: In clinical studies only, Vyxeos liposomal 100 units/m2/day (equivalent to 44 mg/100 mg/m2) was administered intravenously over 90 minutes on days 1, 3, and 5 for the first induction and on days 1 and 3 for patients requiring a second induction.
Danish: Kun i kliniske studier blev Vyxeos liposomal 100 enheder/m2/dag (svarende til 44 mg/100 mg/m administreret intravenøst i 90 minutter på dag 1, 3 og 5 i den første induktion og på dag 1 og 3 for patienter, der havde behov for endnu en induktion.
English: Fatigue and dizziness have been reported with the use of Vyxeos liposomal.
Danish: Der er rapporteret træthed og svimmelhed efter anvendelse af Vyxeos liposomal.
English: Hepatic function should be monitored more frequently when Vyxeos liposomal is coadministered with hepatoxic agents.
Danish: Leverfunktionen skal monitoreres oftere, hvis Vyxeos liposomal administreres samtidig med hepatotoksiske midler.
English: An anti-hyperuricemic therapy should be considered (e.g., allopurinol) prior to initiating Vyxeos liposomal.
Danish: Behandling mod hyperurikæmi bør overvejes (fx allopurinol) inden initiering af Vyxeos liposomal.
English: Dose adjustment is not required for patients with a bilirubin level less than or equal to 50 µmol/L.
Danish: Der er ikke behov for justering af dosis til patienter med et bilirubinniveau, der er under eller lig med 50 µmol/l.
English: Intravenous diphenhydramine (20-25 mg or equivalent) and intravenous dexamethasone (10 mg) should be given.
Danish: Der bør gives intravenøs diphenhydramin (20-25 mg eller tilsvarende) samt intravenøs dexamethason (10 mg).
English: Unlike non-liposomal daunorubicin and cytarabine, which are quickly metabolised to the respective metabolites, daunorubicin and cytarabine after Vyxeos liposomal administration are free bases encapsulated in liposomes.
Danish: I modsætning til ikke-liposomal daunorubicin og cytarabin, der metaboliseres hurtigt til de respektive metabolitter, er daunorubicin og cytarabin efter administration af Vyxeos liposomal frie baser, indkapslet i liposomer.
English: Pyrexia (3.2) Oedema (2.7)
Danish: Pyreksi (3,2) Ødem (2,7)
English: Discard unused portion.
Danish: Kassér den ubrugte del.
English: • fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection
Danish: • feber, kulderystelser, ondt i halsen, hoste, mundsår eller andre symptomer på en infektion
English: Keep the vial in the original carton in order to protect from light.
Danish: Hætteglasset skal opbevares i den originale karton for at beskytte mod lys.
English: The incidence of infection events was 78.1%; the incidence of non-serious events of infections was 73.1%, the incidence of serious events of infections was 28.5%; the incidence of infections which led to discontinuation is 0.5%.
Danish: Forekomsten af infektionsreaktioner var 78,1%; forekomsten af ikke-alvorlige infektionsreaktioner var 73,1%, forekomsten af alvorlige infektionsreaktioner var 28,5%; forekomsten af infektioner, der førte til seponering, var 0,5%.
English: Vyxeos liposomal is a purple powder for concentrate for solution for infusion supplied in a glass vial.
Danish: Vyxeos liposomal er et violet pulver til koncentrat til infusionsvæske, opløsning, der leveres i et hætteglas.
English: Vyxeos liposomal is for intravenous use only.
Danish: Vyxeos liposomal er kun beregnet til intravenøs anvendelse.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic agents.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske midler.
English: • Determine the dose and number of vials of Vyxeos liposomal based on the individual patient's BSA as outlined in section 4.2.
Danish: • Bestem dosis og antal hætteglas med Vyxeos liposomal baseret på den enkelte patients legemsoverfladeareal (BSA) og som beskrevet i pkt.
English: Pleural effusion (0.8)
Danish: Pleuraeffusion (0,8)
English: CR, n (%) Odds ratio (95% CI) p-value (2-sided)
Danish: CR, n (%) Odds ratio (95% CI) p-værdi (2-sidet)
English: Chills (0.3) a Arrhythmia group terms includes atrial fibrillation, bradycardia, and the most commonly reported arrhythmia was tachycardia
Danish: Termerne i arytmiklassen omfatter atriefibrillering og bradykardi, og den hyppigst indberettede arytmi var takykardi.
English: Haemorrhage
Danish: Vævsnekrose
English: Your doctor will assess how you respond to treatment after each course.
Danish: Efter hver cyklus vil din læge vurdere, hvordan du reagerer på behandlingen.
English: Headache (1.1)
Danish: Hovedpine (1,1)
English: Hypersensitivity reactions were very common ADRs in Vyxeos liposomal clinical studies.
Danish: Overfølsomhedsreaktioner var meget almindelige bivirkninger i kliniske studier med Vyxeos liposomal.
English: Dyspepsia (0.5) Vomiting (0.3)
Danish: Dyspepsi (0,5) Opkastning (0,3)
English: Sleep disorders (0.5)
Danish: Søvnforstyrrelser (0,5)
English: For severe/life-threatening hypersensitivity symptoms (e.g., hypotension requiring vasopressor therapy, angioedema, respiratory distress requiring bronchodilation therapy, generalised urticaria), the treatment should be stopped.
Danish: Behandlingen bør afbrydes ved alvorlige/livstruende overfølsomhedssymptomer (fx hypotension, der kræver behandling med vasopressorer, angioødem, åndedrætsbesvær, der kræver behandling med bronkodilator, generaliseret urticaria).
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential should avoid becoming pregnant while receiving Vyxeos liposomal.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Kvinder i den fertile alder skal undgå at blive gravide, mens de får Vyxeos liposomal.
English: Fatigue (10.4)
Danish: Træthed (10,4)
English: It is unlikely that you will be given too much, however, tell your doctor or nurse if you have any concerns.
Danish: Fortæl det alligevel til lægen eller sygeplejersken, hvis der er noget, du er bekymret over.
English: • fever, often with other signs of infection, due to very low white blood cells (febrile neutropenia)
Danish: • et fald i antallet af blodplader (celler, der får blodet til at størkne), som kan medføre blå mærker eller blødningfeber, ofte med andre tegn på infektion, som skyldes et meget lavt antal hvide blodlegemer (febril neutropeni)
English: Event free survival
Danish: Hændelsesfri overlevelse
English: Vyxeos liposomal delivers a synergistic combination of daunorubicin and cytarabine to leukaemia cells for a prolonged period of time.
Danish: Vyxeos liposomal tilfører en synergistisk kombination af daunorubicin og cytarabin til leukæmiceller i lang tid.
English: Grade 3-5 ADRs/Frequency (%)
Danish: Bivirkninger/hyppighed (%) Bivirkninger grad 3-5/hyppighed
English: The incidence of all hypersensitivity events was 66.9%; the incidence of non-serious events of hypersensitivity was 66.4 %, of which 38.9 % were rash; the incidence of serious events of hypersensitivity is 1.1%; the frequency of hypersensitivity which led to discontinuation is 0.
Danish: Forekomsten af alle overfølsomhedsreaktioner var 66,9%; forekomsten af ikke-alvorlige overfølsomhedsreaktioner var 66,4%, hvoraf 38,9% var udslæt; forekomsten af alvorlige overfølsomhedsreaktioner var 1,1%; forekomsten af overfølsomhedsreaktioner, der førte til seponering, var 0.
English: Do not reinitiate infusion, and do not retreat.
Danish: Infusionen må ikke reinitieres, og patienten må ikke behandles igen.
English: Oedema (52.3) Fatigue (46.4) Chills (31.2) Pyrexia (29.6)
Danish: Ødem (52,3) Træthed (46,4) Kulderystelser (31,2) Pyreksi (29,6)
English: If myelosuppressive complications occur, appropriate supportive measures should be used, e.g., anti-infectives, colonystimulating factors, transfusions.
Danish: Relevante supportive foranstaltninger bør tages i brug, for eksempel antiinfektiva, kolonistimulerende faktorer eller transfusioner, hvis der opstår myelosuppressive komplikationer.
English: Administration instructions
Danish: Instruktioner til administration
English: Thrombocytopenia (4.5) Neutropenia (3.7) Anaemia (3.2)
Danish: Trombocytopeni (4,5) Neutropeni (3,7) Anæmi (3,2)
English: Vyxeos liposomal treatment should be discountinued in patients who develop signs or symptoms of cardiomyopathy, unless the benefits outweigh the risks (see section
Danish: Behandling med Vyxeos liposomal bør seponeres hos patienter, der udvikler tegn eller symptomer på kardiomyopati, medmindre fordelene opvejer risiciene (se pkt.
English: For mild hypersensitivity symptoms (e.g., mild flushing, rash, pruritus), the treatment should be stopped, and the patient should be supervised, including monitoring of vital signs.
Danish: Behandlingen bør afbrydes ved lette symptomer på overfølsomhed (fx let flushing, udslæt, pruritus), og patienten skal monitoreres med kontrol af vitale tegn.
English: Cytarabine was mutagenic in in vitro tests and was clastogenic in vitro (chromosome aberrations and SCE in human leukocytes) and in vivo (chromosome aberrations and SCE assay in rodent bone marrow, mouse micronucleus assay).
Danish: Cytarabin var mutagent i tests in vitro og var klastogent i tests in vitro (kromosomaberrationer og SCE i humane leukocytter) og in vivo (kromosomaberrationer og SCE-test i knoglemarv hos gnavere, mikronukleustest på mus).
English: Cytarabine was clastogenic to meiotic cells.
Danish: Cytarabin var klastogent over for delingsceller.
English: Contents of the pack and other information What Vyxeos liposomal contains
Danish: Pakningsstørrelser og yderligere oplysninger Vyxeos liposomal indeholder
English: Name and address of the manufacturer(s) responsible for batch release Jazz Pharmaceuticals Ireland Limited 5th Floor
Danish: Jazz Pharmaceuticals Ireland Limited 5th Floor
English: Thrombocytopenia (3.7) Neutropenia (3.5) Anaemia (2.1)
Danish: Trombocytopeni (3,7) Neutropeni (3,5) Anæmi (2,1)
English: Cardiotoxicities were seen in Vyxeos liposomal clinical studies.
Danish: Der er observeret kardiotoksiciteter i kliniske studier med Vyxeos liposomal.
English: The mean (%CV) area under the curve (AUC) during one dosing interval for daunorubicin was 637 (38.4%) mcg.h/mL and cytarabine was 1900 (44.3%) mcg.h/mL.
Danish: Det gennemsnitlige (% CV) area under the curve (AUC) i løbet af ét doseringsinterval var 637 (38,4%) mikrog.t/ml for daunorubicin og 1.900 (44,3%) mikrog.t/ml for cytarabin.
English: Consolidation daunorubicin 29 mg/m and cytarabine 65 mg/m on days 1 and 3
Danish: Konsolidering daunorubicin 29 mg/m og cytarabin 65 mg/m på dag 1 og 3
English: Package leaflet: Information for the patient Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion daunorubicin and cytarabine
Danish: Indlægsseddel: Information til patienten Vyxeos liposomal 44 mg/100 mg pulver til koncentrat til infusionsvæske, opløsning daunorubicin og cytarabin
English: After reconstitution the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes in a fixed combination in a 1:5 molar ratio.
Danish: Efter rekonstituering indeholder opløsningen 2,2 mg/ml daunorubicin og 5 mg/ml cytarabin, indkapslet i liposomer i en fast kombination i et molforhold på 1:5.
English: There is no experience with Vyxeos liposomal in patients with hepatic impairment resulting in a bilirubin level greater than 50 µmol/L.
Danish: Der er ingen erfaring med anvendelse af Vyxeos liposomal til patienter med nedsat leverfunktion, som medfører et bilirubinniveau på over 50 µmol/l.
English: • Store in a refrigerator (2°C to 8°C).
Danish: • Opbevares i køleskab (2 °C til 8 °C).
English: Recommended dosing schedule for induction of remission
Danish: Anbefalet doseringsskema for induktion af remission
English: While you are receiving treatment with Vyxeos liposomal your doctor will perform regular blood tests to assess how you respond to the treatment and to check it is well tolerated.
Danish: Mens du er i behandling med Vyxeos liposomal, vil din læge regelmæssigt tage blodprøver fra dig for at vurdere, hvordan du reagerer på behandlingen, og for at kontrollere, at du godt kan tåle den. Din læge vil muligvis også undersøge din hjerte, da Vyxeos liposomal kan påvirke hjertet.
English: Serious or fatal haemorrhagic events, including fatal central nervous system (CNS) haemorrhages, associated with severe thrombocytopenia, have occurred in patients treated with Vyxeos liposomal.
Danish: Der har været tilfælde af alvorlige eller letale blødningshændelser, herunder letale blødninger i centralnervesystemet (CNS), forbundet med alvorlig trombocytopeni, hos patienter, der blev behandlet med Vyxeos liposomal.
English: Care should be taken to ensure there is no extravasation to prevent the risk of tissue necrosis.
Danish: For at forebygge risikoen for vævsnekrose skal der udvises forsigtighed for at sikre, at der ikke er nogen ekstravasation.
English: Renal insufficiency (6.4)
Danish: Nyreinsufficiens (6,4)
English: For moderate hypersensitivity symptoms (e.g., moderate rash, flushing, mild dyspnoea, chest discomfort) the treatment should be stopped.
Danish: Behandlingen bør afbrydes ved moderate overfølsomhedssymptomer (fx moderat udslæt, flushing, mild dyspnø, ubehag i brystet).
English: Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion daunorubicin/cytarabine
Danish: Vyxeos liposomal 44 mg/100 mg pulver til koncentrat til infusionsvæske, opløsning daunorubicin/cytarabin
English: There is no experience with Vyxeos liposomal in patients with baseline serum bilirubin greater than 50 µmol/L, severe renal impairment (creatinine clearance less than 30 mL/min), or end stage renal disease.
Danish: Der er ingen erfaring med anvendelse af Vyxeos liposomal til patienter med serumbilirubin ved baseline på over 50 µmol/l, svært nedsat nyrefunktion (kreatininclearance under 30 ml/min.)
English: Each 50 ml vial contains 44 mg of daunorubicin and 100 mg of cytarabine.
Danish: Hvert 50 ml hætteglas indeholder 44 mg daunorubicin og 100 mg cytarabin.
English: Each vial contains 44 mg of daunorubicin and 100 mg of cytarabine.
Danish: Hvert hætteglas indeholder 44 mg daunorubicin og 100 mg cytarabin.
English: The incidence of all cardiotoxicity events was 72.0%; the incidence of non-serious events of cardiotoxicity was 68.5 %; the incidence of serious events of cardiotoxicity was 9.1%; the incidence of cardiotoxicity which led to discontinuation is 0.
Danish: Forekomsten af alle kardiotoksiciteter var 72,0%; forekomsten af ikke-alvorlige kardiotoksiciteter var 68,5%; forekomsten af alvorlige kardiotoksiciteter var 9,1%; forekomsten af kardiotoksiciteter, der førte til seponering, var 0,5%.
English: Chest pain (17.6)
Danish: Brystsmerter (17,6)
English: Preparation instructions
Danish: Instruktioner til klargøring
English: Other medicines and Vyxeos liposomal
Danish: Brug af anden medicin sammen med Vyxeos liposomal
English: Visual impairment (0.3)
Danish: Synsforringelse (0,3)
English: The pharmacokinetics of daunorubicin and cytarabine administered as Vyxeos liposomal were investigated in adult patients who received a dose of daunorubicin 44 mg/m and cytarabine 100
Danish: Farmakokinetikken for daunorubicin og cytarabin, administreret som Vyxeos liposomal, blev undersøgt hos voksne patienter, der fik en dosis daunorubicin 44 mg/m og cytarabin 100 mg/m administreret som en 90-minutters intravenøs infusion på dag 1, 3 og 5.
English: The potential effects of severe renal impairment (CrCL 15 mL/min ≥ to ≤ 29 mL/min, C-G) and end-stage renal disease on the pharmacokinetics of daunorubicin and cytarabine administered as Vyxeos liposomal are unknown (see section 4.2).
Danish: til 29 mL/min., C G) og nyresygdom i slutstadiet på farmakokinetikken for daunorubicin og cytarabin, administreret som Vyxeos liposomal, kendes ikke (se pkt.
English: Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion.
Danish: Vyxeos liposomal 44 mg/100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: First induction daunorubicin 44 mg/m and cytarabine 100 mg/m on days 1, 3, and 5
Danish: Første induktion daunorubicin 44 mg/m og cytarabin 100 mg/m på dag 1, 3 og 5