FrancophonIA/ELRC3.0 huggingface dataset:
English: In total 459 patients were enrolled into the study, with 152 patients randomised to MPR+R, 153 patients randomised to MPR+p and 154 patients randomised to MPp+p.
Danish: I alt indgik 459 patienter i studiet, hvor 152 patienter blev randomiseret til MPR+R, 153 patienter blev randomiseret til MPR+p, og 154 patienter blev randomiseret til MPp+p.
English: Elderly No dedicated clinical studies have been conducted to evaluate pharmacokinetics of lenalidomide in the elderly.
Danish: Der er ikke udført specifikke kliniske studier til evaluering af lenalidomids farmakokinetik hos ældre.
English: The median age was 71 in the MPR+R and MPR+p arms and 72 in the MPp+p arm.
Danish: Medianalderen var 71 i MPR+R- og MPR+p-armene, og 72 i MPp+parmen.
English: Some of these cases have progressed to acute hepatic failure resulting in discontinuation of lenalidomide and adequate antiviral treatment.
Danish: Nogle af disse tilfælde udviklede sig til akut leversvigt og førte til seponering af lenalidomid og passende antiviral behandling.
English: Very Common Hypokalaemia
Danish: Meget almindelig Hypokaliæmi
English: A complete blood cell count, including white blood cell count with differential count, platelet count, haemoglobin, and haematocrit should be performed at baseline, every week for the first 8 weeks of lenalidomide treatment and monthly thereafter to monitor for cytopenias.
Danish: Der skal foretages komplet blodtælling, herunder tælling af hvide blodlegemer med differentialtælling, trombocyttal, hæmoglobin og hæmatokrit ved baseline, hver uge i de første 8 uger af lenalidomidbehandlingen og derefter månedligt for at kontrollere for cytopeni.
English: • press only one end of the capsule out to push it through the foil
Danish: • ved kun at trykke på den ene ende af kapslen, når den presses gennem folien.
English: In the presence of lenalidomide, cereblon binds substrate proteins Aiolos and Ikaros which are lymphoid transcriptional factors, leading to their ubiquitination and subsequent degradation resulting in cytotoxic and immunomodulatory effects.
Danish: Når lenalidomid er til stede, binder cereblon substratproteinerne Aiolos og Ikaros, som er lymfoide transkriptionsfaktorer, og fører til deres ubiquitinering og efterfølgende nedbrydning med cytotoksiske og immunmodulerende virkninger som resultat.
English: Newly diagnosed multiple myeloma (NDMM)
Danish: Nydiagnosticeret myelomatose (NDMM)
English: Population pharmacokinetic analyses indicate that body weight (33- 135 kg), gender, race and type of haematological malignancy do not have a clinically relevant effect on lenalidomide clearance in adult patients.
Danish: Populationsfarmakokinetiske analyser indikerer, at kropsvægt (33-135 kg), køn, race og typen af hæmatologisk malignitet ikke har nogen klinisk relevant virkning på lenalidomids clearance hos voksne patienter.
English: In both studies, the baseline demographic and disease-related characteristics were comparable between the len/dex and placebo/dex groups.
Danish: I begge studier blev baseline-demografiske og sygdomsrelaterede karakteristika sammenlignet mellem len/dex-og placebo/dex-grupperne.
English: If any of these apply to you, do not take lenalidomide .
Danish: Hvis noget af ovenstående passer på dig, må du ikke tage lenalidomid.
English: Initial dose and regimen for Rd and Rd18 were adjusted according to age and renal function (see section 4.2).
Danish: Indledende dosis og program for Rd og Rd18 blev justeret i henhold til alder og nyrefunktion (se pkt.
English: • That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans
Danish: • At lenalidomid er teratogent hos dyr og forventes at have teratogen virkning hos mennesker
English: Patients with newly diagnosed multiple myeloma aged 75 years and older should be carefully assessed before treatment is considered (see section 4.4).
Danish: Patienter med nydiagnosticeret myelomatose i alderen 75 år og derover bør vurderes nøje, før behandling overvejes (se pkt.
English: Repeated oral administration of 75, 150 and 300 mg/kg/day to rats for up to 26 weeks produced a reversible treatment-related increase in kidney pelvis mineralisation in all 3 doses, most notably in females.
Danish: Gentagen oral administration af 75, 150 og 300 mg/kg/dag til rotter i op til 26 uger gav en reversibel behandlingsrelateret stigning i nyre-bækken-mineralisering ved alle 3 doser, navnlig hos hunnerne.
English: The demographics and disease-related baseline characteristics of the patients were well balanced in all 3 arms.
Danish: Demografi og sygdomsrelaterede baselinekarakteristika for patienterne var velafbalancerede i alle 3 arme.
English: Follow-up
Danish: Opfølgning
English: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential).
Danish: • Alder ≥ 50 år med naturlig amenorre i ≥ 1 år (amenorre som følge af cancerbehandling eller under amning udelukker ikke fertilitet).
English: In plasma, the relative exposures of the S- and Renantiomers of lenalidomide are approximately 56% and 44%, respectively.
Danish: Den relative eksponering af lenalidomids S- og R-enantiomerer i plasma er ca. henholdsvis 56 % og 44 %.
English: The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
Danish: Risikoen for venøs tromboemboli vedvarer i 4−6 uger efter ophør med p-piller af kombinationstypen.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking lenalidomide
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager lenalidomid:
English: • Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice
Danish: • Nødvendigheden af at opsøge en læge med speciale eller erfaring i teratologi og diagnosticering heraf til vurdering og rådgivning
English: There is an increased risk of rhabdomyolysis when statins are administered with lenalidomide, which may be simply additive.
Danish: Der er en øget risiko for rabdomyolyse, når statiner administreres samtidigt med lenalidomid, muligvis blot en additiv risiko.
English: It is not known whether the effect will be different in the clinical use (higher lenalidomide doses and concomitant treatment with dexamethasone).
Danish: Det vides ikke, om virkningen er anderledes ved klinisk anvendelse (højere lenalidomid-doser og samtidig behandling med dexamethason).
English: Population pharmacokinetic analyses included patients with ages ranging from 39 to 85 years old and indicate that age does not influence lenalidomide clearance (exposure in plasma).
Danish: Populationsfarmakokinetiske analyser omfattede patienter i alderen fra 39 til 85 år og indikerede, at alder ikke påvirker lenalidomids clearance (eksponering i plasma).
English: Lenalidomide maintenance should be initiated after adequate haematologic recovery following ASCT in patients without evidence of progression.
Danish: Lenalidomid-vedligeholdelsesbehandling initieres efter tilstrækkelig hæmatologisk restitution efter ASCT hos patienter uden tegn på progression.
English: • Pregnancy reporting form
Danish: • Formularer til rapportering af graviditet
English: For women taking lenalidomide Before starting the treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.
Danish: Før du begynder på behandlingen, skal du spørge lægen, om du er i stand til at blive gravid, selv hvis du mener, det er usandsynligt.
English: • Impaired balance, difficulty moving
Danish: • Balanceproblemer, bevægelsesbesvær
English: There was no increase in peripheral neuropathy observed with long term use of lenalidomide for the treatment of newly diagnosed multiple myeloma.
Danish: Der er ikke observeret nogen stigning i tilfælde af perifer neuropati ved langvarig anvendelse af lenalidomid til behandling af nydiagnosticeret myelomatose.
English: Common Hypokalaemia, Dehydration
Danish: Almindelig Hypokaliæmi, dehydrering
English: Mild suppression of white blood cell count was observed at 1 mg/kg/day corresponding to approximately the same human dose based on AUC comparisons.
Danish: Der blev observeret en svag suppression af antallet af hvide blodlegemer ved 1 mg/kg/dag, hvilket nogenlunde svarer til dosis hos mennesker på basis af AUC-sammenligninger.
English: Co-administration with a high-fat and high-calorie meal in healthy volunteers reduces the extent of absorption, resulting in an approximately 20% decrease in area under the concentration versus time curve (AUC) and 50% decrease in Cmax in plasma.
Danish: Administration samtidig med kalorierige måltider med højt fedtindhold hos raske frivillige reducerer absorptionsgraden, hvilket resulterer i ca. 20 % reduktion i arealet under kurven (AUC) for koncentration versus tid og 50 % reduktion af plasma-Cmax.
English: If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Danish: Hvis lenalidomid indtages under graviditet, forventes det, at lenalidomid har en teratogen virkning hos mennesker.
English: Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia.
Danish: Spiraler, som afgiver kobber, bør som hovedregel ikke bruges på grund af den potentielle risiko for infektion på opsætningstidspunktet og blodtab ved menstruation, hvilket kan indebære risiko for patienter med neutropeni eller trombocytopeni.
English: Before and during the treatment with lenalidomide you will have regular blood tests as it may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets).
Danish: Før og under behandlingen med lenalidomid vil du få taget regelmæssige blodprøver, da lenalidomid kan forårsage et fald i antallet af de blodlegemer, der bekæmper infektioner (hvide blodlegemer) og får blodet til at størkne (blodplader).
English: • She understands the need to commence the treatment as soon as lenalidomide is dispensed following a negative pregnancy test
Danish: • Kvinden forstår nødvendigheden af at påbegynde behandlingen, så snart lenalidomid er blevet ordineret efter en negativ graviditetstest
English: Do not dose below 5 mg once daily.
Danish: Dosér ikke under 5 mg/dag.
English: Interruption or discontinuation of lenalidomide should be considered for other forms of skin reaction depending on severity.
Danish: Afbrydelse eller seponering af lenalidomidbehandling bør overvejes ved andre former for hudreaktion, afhængigt af sværhedsgraden.
English: Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking lenalidomide .
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, hvis du føler dig svimmel, træt eller døsig, har en følelse af at snurre rundt (vertigo), eller dit syn er sløret, efter du har taget lenalidomid.
English: Reactivation of hepatitis B has been reported rarely in patients receiving lenalidomide who have previously been infected with the hepatitis B virus (HBV).
Danish: Der er i sjældne tilfælde blevet rapporteret om reaktivering af hepatitis B hos patienter, der fik lenalidomid, og som tidligere har været inficeret med hepatitis B-virus (HBV).
English: There are no data available for patients with moderate to severe hepatic impairment.
Danish: Der foreligger ingen data for patienter med moderat til svært nedsat leverfunktion.
English: • Pregnancy test regime o Advice on suitable tests o Before commencing treatment o During treatment based on method of contraception o After finishing treatment
Danish: • Graviditetstest-regime o Rådgivning om passende test o Før behandlingen påbegyndes o Under behandlingen baseret på præventionsmetoden o Efter behandlingens afslutning
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential should use effective method of contraception.
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder Kvinder i den fertile alder skal anvende en sikker kontraceptionsmetode.
English: Lenalidomide is structurally related to thalidomide.
Danish: Lenalidomid er strukturelt i familie med thalidomid.
English: Common Deep vein thrombosis^,◊,d
Danish: Almindelig Dyb venetrombose^,◊,d
English: In total 614 patients were randomised: 307 patients to lenalidomide and 307 patients to placebo.
Danish: I alt 614 patienter blev randomiseret: 307 patienter til lenalidomid og 307 til placebo.
English: Monitoring of liver function is recommended, particularly when there is a history of or concurrent viral liver infection or when lenalidomide is combined with medicinal products known to be associated with liver dysfunction.
Danish: Monitorering af leverfunktionen anbefales især ved en anamnese med eller en pågående viral leverinfektion, eller når lenalidomid anvendes i kombination med lægemidler, der vides at være forbundet med leverdysfunktion.
English: The adverse reactions from CALGB 100104 included events reported post-high dose melphalan and ASCT (HDM/ASCT) as well as events from the maintenance treatment period.
Danish: Bivirkningerne fra CALGB 100104 omfattede bivirkninger, der blev rapporteret efter højdosis melphalan og ASCT (HDM/ASCT), samt bivirkninger fra perioden med vedligeholdelsesbehandling.
English: For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met:
Danish: Lenalidomid er kontraindiceret til kvinder i den fertile alder, medmindre alle følgende kriterier opfyldes:
English: Common Pulmonary embolism◊,*
Danish: Almindelig Lungeemboli◊,*
English: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it would be prudent to monitor renal function.
Danish: Da ældre patienter hyppigere har nedsat nyrefunktion, skal dosis vælges med omhu, og det tilrådes at monitorere nyrefunktionen.
English: • Breathlessness especially when lying down (which may be a symptom of heart failure)
Danish: • Åndenød, især i liggende stilling (hvilket kan være et symptom på hjertesvigt)
English: After initiation of lenalidomide therapy, subsequent lenalidomide dose modification in renally impaired patients should be based on individual patient treatment tolerance, as described above.
Danish: Efter påbegyndelse af lenalidomidbehandling hos patienter med nedsat nyrefunktion bør efterfølgende justeringer af lenalidomiddosis baseres på den enkelte patients tolerance over for behandingen som beskrevet ovenfor.
English: Common Fall, Contusion^
Danish: Almindelig Faldtendens, kontusion^
English: Pancreatitis, Gastrointestinal perforation (including diverticular, intestinal and large intestine perforations)^
Danish: Pankreatitis, gastrointestinal perforation (herunder divertikulær og intestinal perforation samt tyktarmsperforation)^
English: Hydroxylenalidomide and N-acetyl-lenalidomide represent 4.59% and 1.83% of the excreted dose, respectively.
Danish: Hydroxylenalidomid og N-acetyl-lenalidomid udgør hhv. 4,59 % og 1,83 % af den udskilte dosis.
English: d The p-value is based on the unstratified log-rank test of Kaplan-Meier curve differences between the indicated treatment arms.
Danish: d P-værdien er baseret på den ikke stratificerede log-rank-test af forskelle i Kaplan-Meier-kurver mellem de indikerede behandlingsarme.
English: • Description and management of thromboembolic risk including incidence rates from clinical trials and post-marketing experience
Danish: • Beskrivelse og håndtering af tromboembolisk risiko, herunder frekvensen i kliniske forsøg og i erfaringerne efter markedsføringen
English: Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors.
Danish: Der er rapporteret om myokardieinfarkt hos patienter, der får lenalidomid, især hos patienter med kendte risikofaktorer.
English: Recommended course
Danish: Anbefalet forløb
English: Lenalidomide efficacy and safety have been evaluated in five phase III studies in newly diagnosed multiple myeloma, two phase III studies in relapsed refractory multiple myelomaas described below.
Danish: Lenalidomids virkning og sikkerhed er blevet evalueret i 5 fase III-studier af nydiagnosticeret myelomatose og i to fase III-studier af recidiverende refraktær myelomatose som beskrevet nedenfor.
English: Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see ‘Contraception' below).
Danish: Derfor skal du benytte sikre præventionsmetoder, hvis du er kvinde og kan blive gravid (se ”Prævention” nedenfor).
English: As a precaution and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide must meet the following conditions:
Danish: Som forholdsregel og under hensyntagen til særlige patientpopulationer med forlænget eliminationstid såsom ved nedsat nyrefunktion skal alle mandlige patienter, som tager lenalidomid, opfylde følgende betingelser:
English: The Educational brochures for patients should be of 3 types:
Danish: Der bør være tre typer af oplysningsbrochurer til patienterne:
English: In total 1623 patients were enrolled into the study, with 535 patients randomised to Rd, 541 patients randomised to Rd18 and 547 patients randomised to MPT.
Danish: I alt 1623 patienter indgik i studiet, hvoraf 535 patienter blev randomiseret til Rd, 541 patienter blev randomiseret til Rd18, og 547 patienter blev randomiseret til MPT.
English: The half-life of lenalidomide increased from approximately 3.5 hours in subjects with creatinine clearance > 50 mL/min to more than 9 hours in subjects with reduced renal function < 50 mL/min.
Danish: Lenalidomids halveringstid stiger fra ca. 3,5 timer hos forsøgspersoner med kreatininclearance > 50 ml/min til mere end 9 timer hos forsøgspersoner med nedsat nyrefunktion < 50 ml/min.
English: Lenalidomide Accord contains the active substance ‘lenalidomide'.
Danish: Lenalidomide Accord indeholder det aktive stof 'lenalidomid'.
English: In vitro (bacterial mutation, human lymphocytes, mouse lymphoma, Syrian Hamster Embryo cell transformation) and in vivo (rat micronucleus) mutagenicity studies revealed no drug related effects at either the gene or chromosomal level.
Danish: Mutagenicitets-studier in vitro (bakteriel mutation, humane lymfocytter, muselymfomer, Syrisk Hamster-fostercelle-transformation) og in vivo (mikronukleustest i rotter) viste ingen lægemiddelrelaterede virkninger på hverken gen- eller kromosom-niveau.
English: The risk of occurrence of hematologic SPM must be taken into account before initiating treatment with lenalidomide either in combination with melphalan or immediately following high-dose melphalan and ASCT.
Danish: Risikoen for forekomst af hæmatologisk SPM skal overvejes, før behandling med lenalidomid indledes, enten i kombination med melphalan eller umiddelbart efter højdosis melphalan og ASCT.
English: The demographic and disease-related characteristics were balanced across both arms.
Danish: Demografiske og sygdomsrelaterede karakteristika var velafbalancerede mellem de 2 arme.
English: These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death.
Danish: Disse komplikationer skyldes nedbrydningsprodukter fra døende cancerceller og kan omfatte følgende: ændringer i blodkemi såsom høj kalium, fosfor, urinsyre og lav calcium førende til ændringer i nyrefunktion, hjerterytme, krampeanfald og nogle gange død
English: The AUC was increased by approximately 2.5, 4 and 5-fold in subjects with moderate renal impairment, severe renal impairment, and end-stage renal disease, respectively, compared to the group combining subjects with normal renal function and subjects with mild renal impairment.
Danish: AUC var ca. 2,5, 4 og 5 gange større hos personer med henholdsvis moderat nedsat nyrefunktion, svært nedsat nyrefunktion og nyresygdom i slutstadie, sammenlignet med en gruppe, der omfatter personer med normal nyrefunktion og personer med let nedsat nyrefunktion.
English: Common Headache
Danish: Almindelig Hovedpine
English: 7.5 mg once daily2 15 mg every other day
Danish: 7,5 mg/dag2 15 mg hver anden dag
English: After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
Danish: Efter 3 cyklusser med lenalidomid-vedligeholdelsesbehandling kan dosis øges til 15 mg oralt én gang dagligt, hvis dette tolereres.
English: Results from human in vitro metabolism studies indicate that lenalidomide is not metabolised by cytochrome P450 enzymes suggesting that administration of lenalidomide with medicinal products that inhibit cytochrome P450 enzymes is not likely to result in metabolic medicinal product interactions in humans.
Danish: Resultater fra humane in vitro metaboliseringsstudier tyder på, at lenalidomid ikke metaboliseres af CYP-enzymer, hvilket indikerer, at administration af lenalidomid sammen med lægemidler, som hæmmer CYP-enzymer, formentlig ikke medfører metaboliske lægemiddelinteraktioner hos mennesker.
English: Talk to your doctor if you are not sure.
Danish: Kontakt lægen, hvis du er i tvivl.
English: Care should be taken in dose selection and monitoring of renal function is advised.
Danish: Dosis bør vælges med omhu, og det tilrådes at monitorere nyrefunktionen.
English: Lenalidomide combined therapy was less tolerated in newly diagnosed multiple myeloma patients older than 75 years of age compared to the younger population.
Danish: Kombinationsbehandling med lenalidomid var mindre tolereret hos patienter med nydiagnosticeret myelomatose, der var over 75 år, sammenlignet med den yngre population.
English: Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with lenalidomide.
Danish: Der er rapporteret tilfælde af progressiv multifokal leukoencefalopati (PML), herunder letale tilfælde, i forbindelse med lenalidomid.
English: Lenalidomide maintenance in patients who have undergone autologous stem cell transplantation (ASCT)
Danish: Lenalidomid-vedligeholdelsesbehandling hos patienter, der har gennemgået autolog stamcelletransplantation (ASCT)
English: The patient card shall contain the following elements:
Danish: Patientkortet skal indeholde følgende elementer:
English: Patients in the placebo/dexamethasone (placebo/dex) group took 1 placebo capsule on days 1 to 28 of each 28-day cycle.
Danish: Patienter i placebo/dexamethason-(placebo/dex)-gruppen tog 1 placebokapsel på dag 1-28 i hver 28-dages cyklus.
English: No dose adjustments are required for patients with mild renal impairment and multiple myeloma.
Danish: Der kræves ingen dosisjusteringer for patienter med let nedsat nyrefunktion og myelomatose.
English: Leukocytoclastic vasculitis, Drug Reaction with Eosinophilia and Systemic Symptoms^
Danish: Leukocytoklastisk vaskulitis, lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer^
English: Lenalidomide may be continued in patients with Grade 1 or 2 tumour flare reaction (TFR) without interruption or modification, at the physician's discretion.
Danish: Lenalidomid kan fortsættes hos patienter med grad 1 eller 2 tumor-flare-reaktion (TFR) uden behandlingsafbrydelse eller dosisjustering, i henhold til lægens skøn.
English: • Increase in pain, tumour size, redness around the tumour
Danish: • Flere smerter, øget tumorstørrelse, rødme rundt om tumor
English: • Passing much more or much less urine than usual, which may be a symptom of a type of kidney problem (called renal tubular necrosis)
Danish: • En større eller meget mindre vandladning end normalt, hvilket kan være et symptom på en form for nyreproblem (som kaldes tubulær nekrose)