FrancophonIA/ELRC3.0 huggingface dataset:
English: In post-marketing surveillance, serious and fatal carotid artery haemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than in DTC or other tumour types.
Danish: Ved overvågning efter markedsføring blev der hyppigere observeret alvorlige og dødelige karotidarterie-blødninger hos patienter med anaplastisk tyreoideakarcinom (ATC) end med DTC eller andre tumortyper.
English: Kaplan-Meier Curve of Overall Survival - HCC
Danish: Figur 2 Kaplan-Meier-kurve med samlet overlevelse - HCC
English: A statistically significant prolongation in PFS was demonstrated in lenvatinib-treated patients compared with those receiving placebo (p<0.0001) (see figure 1).
Danish: En statistisk signifikant forlængelse i PFS blev demonstreret hos lenvatinibbehandlede patienter sammenlignet med patienter, der fik placebo (p < 0,0001) (se figur 1).
English: Patients with hypertension
Danish: Patienter med hypertension
English: Following independent review confirmation of disease progression, 109 (83.2%) patients randomised to placebo had crossed over to open-label lenvatinib at the time of the primary efficacy analysis.
Danish: Ved bekræftelse af sygdomsprogression efter uafhængig gennemgang havde 109 (83,2 %) af patienterne, der blev randomiseret til placebo, overkrydset til åben lenvatinib på tidspunktet for den primære virkningsanalyse.
English: System Organ Class (MedDRA terminology*)
Danish: Systemorganklasse (MedDRAterminologi*)
English: • The active substance is lenvatinib.
Danish: • Aktivt stof: lenvatinib.
English: Lenvatinib should be withheld in the event of development of QT interval prolongation greater than 500 ms. Lenvatinib should be resumed at a reduced dose when QTc prolongation is resolved to < 480 ms or baseline.
Danish: Lenvatinib skal afbrydes i tilfælde af, at der udvikles en forlængelse af QT-intervallet over 500 ms. Lenvatinib bør genoptages med en reduceret dosis, når QTc-forlængelsen har fortaget sig til < 480 ms eller baseline.
English: In most cases, gastrointestinal perforation and fistulae occurred in patients with risk factors such as prior surgery or radiotherapy.
Danish: I de fleste tilfælde opstod mave-tarm-perforation og fistel hos patienter med risikofaktorer, såsom tidligere kirurgi eller strålebehandling.
English: Life-threatening toxicities (Grade 4): Discontinuee a.
Danish: Livstruende toksiciteter (grad 4): Seponeringe a.
English: The positive effect on PFS was seen across the subgroups of age (above or below 65 years), sex, race, histological subtype, geographic region, and those who received 0 or 1 prior VEGF/VEGFR-targeted therapies.
Danish: Den positive virkning på PFS blev set i alle aldersundergrupperne (over eller under 65 år), køn, race, histologisk undertype, geografisk region, og hos dem, der havde fået 0 eller 1 tidligere VEGF/VEGFR-målrettet behandling.
English: Following administration of radiolabelled lenvatinib to 6 patients with solid tumours, approximately two-thirds and one-quarter of the radiolabel were eliminated in the faeces and urine, respectively.
Danish: Efter administration af radioaktivt mærket lenvatinib til 6 patienter med faste tumorer blev ca. to tredjedele og en fjerdedel af den radioaktive mærkning elimineret i hhv. fæces og urin.
English: LENVIMA can also be used on its own to treat liver cancer (hepatocellular carcinoma) in adults who have not previously been treated with another anticancer medicine that travels through the bloodstream.
Danish: LENVIMA kan også bruges alene til at behandle leverkræft (hepatocellulært carcionom) hos voksne, der ikke tidligere har været i behandling med en anden kræftmedicin, der bevæger sig gennem blodstrømmen.
English: There is limited clinical experience regarding the timing of reinitiation of lenvatinib following a major surgical procedure.
Danish: Der er begrænset klinisk erfaring med tidspunktet for genoptagelse af lenvatinib efter et større kirurgisk indgreb.
English: The objective response rate (complete response [CR] plus partial response [PR]) per independent radiological review was significantly (p<0.0001) higher in the lenvatinib-treated group (64.8%) than in the placebo-treated group (1.5%).
Danish: Den objektive responsrate (fuldstændigt respons [CR] plus delvist respons [PR]) pr. uafhængig radiologisk gennemgang var signifikant (p<0,0001) højere i den lenvatinibbehandlede gruppe (64,8 %) end i den placebobehandlede gruppe (1,5 %).
English: One fatal case of hepatic tumour haemorrhage in a patient with HCC has been reported.
Danish: Et letalt tilfælde af hepatisk tumorblødning hos en patient med HCC er rapporteret.
English: After drinking, the same amount of water or apple juice (one tablespoon) must be added to the glass and swirled a few times.
Danish: Efter at den er drukket, skal den samme mængde vand eller æblejuice (en skefuld) tilsættes glasset og hvirvles rundt nogle gange.
English: In vitro, cytochrome P450 3A4 was demonstrated as the predominant (>80%) isoform involved in the P450-mediated metabolism of lenvatinib.
Danish: Cytokrom P450 3A4 blev in vitro demonstreret som den primære (> 80 %) isoform involveret i den P450-medierede metabolisme af lenvatinib.
English: Cases of fatal intracranial haemorrhage have been reported in some patients with or without brain metastases.
Danish: Tilfælde af dødelig intrakranial blødning er blevet rapporteret hos nogle patienter med eller uden hjernemetastaser.
English: Therefore, the decision to resume lenvatinib following a major surgical procedure should be based on clinical judgment of adequate wound healing.
Danish: Derfor skal beslutningen om at genoptage lenvatinib efter et større kirurgisk indgreb baseres på en klinisk vurdering af tilstrækkelig sårheling.
English: Based on a population pharmacokinetic analysis of patients receiving up to 24 mg lenvatinib once daily, age, sex, weight, and race (Japanese vs. other, Caucasian vs. other) had no significant effects on clearance (see section 4.2).
Danish: Baseret på en populationsfarmakokinetisk analyse af patienter, der fik op til 24 mg lenvatinib én gang dagligt, havde alder, køn, vægt og race (japanske versus andet, kaukasiske versus andet) ingen signifikant virkning på clearance (se pkt.
English: There was no statistically significant difference in overall survival between the treatment groups at the time of the primary efficacy analysis (HR=0.73; 95% CI: 0.50, 1.07, p=0.1032).
Danish: Der var ingen statistisk signifikant forskel i samlet overlevelse mellem behandlingsgrupperne på tidspunktet for den primære virkningsanalyse (HR=0,73, 95 % CI: 0,50; 1,07, p=0,1032).
English: Some reports of fistula and pneumothorax occurred in association with tumour regression or necrosis.
Danish: Nogle rapporter om fistler og pneumothorax opstod i forbindelse med tumorregression eller -nekrose.
English: The capsules must be left in the liquid for at least 10 minutes and stirred for at least 3 minutes to dissolve the capsule shells.
Danish: Kapslerne skal ligge i væsken i mindst 10 minutter og omrøres i mindst 3 minutter for at opløse kapselskallerne.
English: Pancreatitis includes: pancreatitis and acute pancreatitis.
Danish: Pankreatitis omfatter: pankreatitis og akut pankreatitis.
English: Manufacturer Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.
Danish: Fremstiller Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, Storbritannien.
English: These findings indicate that lenvatinib has a teratogenic potential, likely related to the pharmacologic activity of lenvatinib as an antiangiogenic agent.
Danish: Disse fund indikerer, at lenvatinib har et teratogent potentiale, der sandsynligvis er relateret til den farmakologiske aktivitet af lenvatinib som et antiangiogent stof.
English: Of the 392 patients randomised, 76.3% were naïve to prior VEGF/VEGFR-targeted therapies, 49.0% were female, 49.7% were European, and the median age was 63 years.
Danish: Ud af de 392 randomiserede patienter var 76,3 % naive med hensyn til tidligere VEGF/VEGFR-målrettede behandlinger, 49,0 % var kvinder, 49,7 % var fra Europa, og medianalderen var 63 år.
English: The majority of patients had an ECOG performance status of 0; 42.1% had a status of 1; 3.9% had a status above 1.
Danish: Hovedparten af patienterne havde en ECOG-præstationsstatus på 0, 42,1 % havde en status på 1, 3,9 % havde en status over 1.
English: • other types of fistulae (an abnormal connection between different organs in the body or between the skin and an underlying structure such as throat and windpipe).
Danish: • andre typer fistler (en unormal forbindelse mellem forskellige kropsorganer eller mellem huden og en underliggende struktur som halsen eller luftrøret).
English: Resolves to Grade 0-1 or baseline.
Danish: Fortager sig til grad 0-1 eller baseline.
English: The highest doses of lenvatinib studied clinically were 32 mg and 40 mg per day.
Danish: De højeste doser af lenvatinib, der er undersøgt klinisk, er 32 mg og 40 mg dagligt.
English: It is currently unknown if lenvatinib increases the risk of thromboembolic events when combined with oral contraceptives.
Danish: Det er på nuværende tidspunkt ukendt, om lenvatinib øger risikoen for tromboemboliske hændelser, når det kombineres med oral kontraception.
English: Stratified by region (Region 1: Asia-Pacific; Region 2: Western), macroscopic portal vein invasion or extrahepatic spread or both (yes, no), ECOG PS (0, 1) and body weight (<60 kg, ≥60 kg).
Danish: b Stratificeret efter region (Region 1: Asien-Stillehavet; Region 2: Vesten), makroskopisk portalvene invasion eller ekstrahepatisk spredning eller begge (ja, nej), ECOG PS (0, 1) og kropsvægt (<60 kg, ≥60 kg).
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE29
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE29
English: This leaflet was last revised in 09/2019
Danish: Denne indlægsseddel blev senest ændret september 2019.
English: The safety and efficacy of lenvatinib in children aged 2 to <18 years have not yet been established (see section 5.1).
Danish: Lenvatinibs sikkerhed og virkning hos børn i alderen 2 til < 18 år er endnu ikke klarlagt (se pkt.
English: • bleeding (most commonly nose bleeds, but also other types of bleeding such as blood in the urine, bruising, bleeding from the gums or gut wall)
Danish: • blødning (mest almindeligt næseblod, men også andre typer blødninger, såsom blod i urinen, blå mærker, blødning fra tandkød eller tarmvæggen)
English: There was a higher incidence of decreased neutrophil count in patients with HCC (8.7% on lenvatinib than in other nonHCC tumour types (1.4%)), which was not associated with infection, sepsis or bacterial peritonitis.
Danish: Der var en højere forekomst af nedsat neutrofil-tal hos patienter med HCC (8,7 %) på lenvatinib end hos andre ikke-HCC tumortyper (1,4 %), hvilket ikke associeredess med infektion, sepsis eller bakteriel peritonitis.
English: In human liver cytosol, lenvatinib did not inhibit aldehyde oxidase activity.
Danish: I humant levercytosol hæmmede lenvatinib ikke aldehydoxidase-aktiviteten.
English: CI, confidence interval; NE, not estimable; OS, overall survival; PFS, progression-free survival; RPSFT, rank preserving structural failure time model; VEGF/VEGFR, vascular endothelial growth factor / vascular endothelial growth factor receptor.
Danish: CI: konfidensinterval, NE: kunne ikke estimeres, OS: samlet overlevelse, PFS: progressionsfri overlevelse, RPSFT: rank preserving structural failure time-model, VEGF/VEGFR: vaskulær endotelvækstfaktor/vaskulær endotel vækstfaktorreceptor.
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances.
Danish: PRES er en neurologisk sygdom, der kan vise sig som hovedpine, krampeanfald, letargi, konfusion, ændret psykisk funktion, blindhed og andre visuelle eller neurologiske forstyrrelser.
English: For haematologic toxicity, dosing can restart when resolved to Grade 2; proteinuria, resume when resolves to less than 2g/24 hours e.
Danish: For hæmatologisk toksicitet kan dosering genstarte, når bivirkningen har fortaget sig til grad 2; ved proteinuri genstartes behandlingen, nårdet er fortaget til under 2g/24 timer e.
English: Interrupt
Danish: Afbryd
English: Over this range, the median accumulation index (Rac) ranged from 0.96 (20 mg) to 1.54 (6.4 mg).
Danish: I dette interval var det mediane akkumulationsindeks (Rac) i intervallet fra 0,96 (20 mg) til 1,54 (6,4 mg).
English: • Caregivers should not open the capsules to avoid exposure to the contents of the capsule.
Danish: • Plejepersonale bør ikke åbne kapslerne for at undgå at blive udsat for indholdet i kapslen.
English: Pulmonary embolism†,
Danish: Lungeemboli†,
English: Temporary interruption of lenvatinib should be considered in patients undergoing major surgical procedures.
Danish: Midlertidig afbrydelse af lenvatinib bør overvejes hos patienter, der skal igennem større kirurgiske indgreb.
English: All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended 24 mg dose, following which the dose should be further adjusted on the basis of individual tolerability.
Danish: Alle andre patienter end dem med svært nedsat lever- eller nyrefunktion (se nedenfor) bør påbegynde behandlingen med den anbefalede dosis på 24 mg, hvorefter dosis bør justeres yderligere på basis af individuel tolerabilitet.
English: Eligible patients with measurable disease according to RECIST 1.1 were randomised 2:1 to receive lenvatinib 24 mg once daily (n=261) or placebo (n=131).
Danish: Egnede patienter, hvor sygdommen kunne måles i henhold til RECIST 1.1, blev randomiseret i forholdet 2:1 til at få lenvatinib 24 mg én gang dagligt (n = 261) eller placebo (n = 131).
English: Includes all haemorrhage terms.
Danish: Inkluderer alle termer for blødning.
English: Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia.
Danish: Lenvatinib-dosis bør afbrydes eller dosisjusteres efter behov afhængig af sværhedsgraden, tilstedeværelsen af EKG-ændringer og vedvarende hypocalcæmi.
English: Carcinogenicity studies have not been conducted with lenvatinib.
Danish: Der er ikke udført karcinogenicitetsstudier med lenvatinib.
English: • Do not breast-feed if you are taking LENVIMA.
Danish: • Du må ikke amme, hvis du tager LENVIMA.
English: Continue lenvatinib and increase the dose of the current antihypertensive therapy or initiate additional antihypertensive therapy
Danish: Fortsæt med lenvatinib og forhøj dosis af den aktuelle antihypertensive behandling eller påbegynd yderligere antihypertensiv behandling
English: Consequently, in vivo, inducers and inhibitors of CYP 3A4 had a minimal effect on lenvatinib exposure (see section 4.5).
Danish: Som følge heraf havde inducere og hæmmere af CYP 3A4 in vivo en minimal virkning på lenvatinib-eksponeringen (se pkt.
English: Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule.
Danish: Plejepersonale bør ikke åbne kapslen for at undgå gentagen eksponering for indholdet i kapslen.
English: See section 4.2 for dosing recommendation.
Danish: 4.2 for doseringsvejledning.
English: • Swallow the capsules whole with water or dissolved.
Danish: • Slug kapslerne opløste eller hele sammen med vand.
English: INFORMATION IN BRAILLE LENVIMA 4 mg
Danish: INFORMATION I BRAILLESKRIFT LENVIMA 4 mg
English: These cases were associated with adverse reactions consistent with the known safety profile of lenvatinib (i.e., renal and cardiac failure), or were without adverse reactions.
Danish: Disse tilfælde var forbundet med bivirkninger, der stemmer overens med den kendte sikkerhedsprofil for lenvatinib (dvs. nyre- og hjertesvigt), eller de var ikke forbundet med bivirkninger.
English: The clinical efficacy and safety of lenvatinib have been evaluated in an international, multicenter, open-label, randomised phase 3 study (REFLECT) in patients with unresectable hepatocellular carcinoma (HCC).
Danish: Den kliniske virkning og sikkerhed af lenvatinib er blevet evalueret i et internationalt, open-label, randomiseret fase III-multicenterstudie (REFLECT) hos patienter med ikke-resektabelt hepatocellulært carcinom (HCC).
English: • have liver or kidney problems
Danish: • har problemer med lever eller nyrer
English: Hepatic failure events were observed in male patients only.
Danish: Leversvigt blev kun observeret hos mandlige patienter.
English: • changes in blood test results for potassium levels (low) and calcium levels (low)
Danish: • ændringer i blodprøveresultater for kaliumniveauer (lave) og calciumniveauer (lave)
English: Initiate medical management for nausea, vomiting, or diarrhoea prior to interruption or dose reduction.
Danish: Initier medicinsk behandling for kvalme, opkast, eller diarré før en afbrydelse eller dosisreduktion.
English: • dry skin, thickening and itching of the skin
Danish: • tør hud, fortykning og kløe af huden
English: Haematologic toxicity or proteinuria-no dose adjustment required for first occurrence.
Danish: Hæmatologisk toksicitet eller toxicity eller proteinuri - ingen dosisjustering nødvendig ved første hæmdelse.
English: Men had a higher incidence (26.5%) of dysphonia than women (12.3%), decreased weight and decreased platelet count.
Danish: Mænd have højere forekomst (26,5 %) af dysfoni end kvinder (12,3 %), vægttab og nedsat trombocyttal.
English: If you are not sure talk to your doctor before taking LENVIMA.
Danish: Hvis du ikke er sikker, skal du kontakte lægen, før du tager LENVIMA.
English: The median half-life was comparable in subjects with mild, moderate, and severe hepatic impairment as well as those with normal hepatic function and ranged from 26 hours to 31 hours.
Danish: Den mediane halveringstid var sammenlignelig hos personer med let, moderat og svært nedsat leverfunktion samt hos personer med normal leverfunktion og lå i intervallet fra 26 timer til 31 timer.
English: Radioiodine-refractory was defined as one or more measurable lesions either with a lack of iodine uptake or with progression in spite of radioactive-iodine (RAI) therapy, or having a cumulative activity of RAI of >600 mCi or 22 GBq with the last dose at least 6 months prior to study entry.
Danish: Den refraktære egenskab over for radioaktivt jod blev defineret som en eller flere målelige læsioner enten med manglende jodoptagelse eller med progression trods behandling med radioaktivt jod (radioactive-iodine, RAI) eller med en kumulativ aktivitet af RAI på > 600 mCi eller 22 GBq med den sidste dosis mindst 6 måneder før indgåelse i studiet.
English: Target lesions previously treated with radiotherapy or locoregional therapy had to show radiographic evidence of disease progression.
Danish: Mål-læsionerne, der tidligere var blevet behandlet med strålebehandling eller lokal/regional behandling, skulle vise radiografiske tegn på sygdomsprogression.
English: The degree of tumour invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
Danish: Graden af tumorinvasion/infiltration af større blodkar (f.eks. karotidarterien) bør tages i betragtning på grund af den mulige risiko for svær blødning forbundet med svind/nekrose efter behandling med lenvatinib.
English: A risk to newborns or infants cannot be excluded and, therefore, lenvatinib is contraindicated during breast-feeding (see section 4.3).
Danish: En risiko for nyfødte eller spædbørn kan ikke udelukkes, og derfor er lenvatinib kontraindiceret under amning (se pkt.
English: • severe pain in the upper left part of the belly (abdomen) which may be associated with fever,
Danish: • svære smerter i den øvre venstre side af maven, hvilket kan være forbundet med feber,
English: In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg.
Danish: Hos patienterne lå det mediane tilsyneladende fordelingsvolumen (Vz/F) for den første dosis i intervallet fra 50,5 l til 92 l, og det var generelt konsistent i dosisgrupperne fra 3,2 mg til 32 mg.
English: • drowsiness, confusion, poor concentration, loss of consciousness that may be signs of liver failure
Danish: • døsighed, forvirring, dårlig koncentrationsevne, bevidsthedstab, der kan være tegn på leversvigt
English: Dehydration Hypomagnesaemiab Hypercholesterolaemia b
Danish: Dehydrering Hypomagnesæmib Hyperkolesterolæmib
English: Histologically, 66.1% had a confirmed diagnosis of papillary thyroid cancer and 33.9% had follicular thyroid cancer which included Hürthle cell 14.8% and clear cell 3.8%.
Danish: Histologisk havde 66,1 % en bekræftet diagnose på papillær tyreoideacancer, og 33,9 % havde follikulær tyreoideacancer, som omfattede Hürthle-celle 14,8 % og clear-celle 3,8 %.
English: 18th September 2019
Danish: DATO FOR ÆNDRING AF TEKSTEN 18. september 2019
English: Hypertension includes: hypertension, hypertensive crisis, increased diastolic blood pressure , , orthostatic hypertension, and increased blood pressure.
Danish: Hypertension omfatter: hypertension, hypertensiv krise, forhøjet diastolisk blodtryk, ortostatisk hypertension og forhøjet blodtryk.
English: Since lenvatinib is mainly eliminated by hepatic metabolism, an increase in exposure in patients with moderate to severe hepatic impairment is expected.
Danish: Da lenvatinib hovedsageligt elimineres ved hepatisk matabolisme, kan en stigning i eksponering hos patienter med moderat til svært nedsat leverfunktion forventes.
English: Microcrystalline cellulose Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Talc
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Lavsubstitueret hydroxypropylcellulose Talcum
English: The adverse reactions presented in this section are based on safety data of both DTC and HCC patients (see section 5.1).
Danish: De bivirkninger, der præsenteres i dette afsnit, er baseret på sikkerhedsdata fra både patienter med DTC og HCC (se pkt.
English: M2' and M3', the major metabolites in human faeces, were formed from M2 and lenvatinib, respectively, by aldehyde oxidase.
Danish: M2' og M3', de primære metabolitter i human fæces, blev dannet fra hhv. M2 og lenvatinib af aldehydoxidase.
English: This includes herbal preparations and medicines without a prescription.
Danish: Dette omfatter naturlægemidler og receptfrie lægemidler.
English: Hepatotoxicity events and haemorrhage events also occurred at a higher incidence in CP score 6 patients compared to CP score 5 patients.
Danish: Hændelser med hepatotoksicitet og hændelser med blødning forekom også med en højere hyppighed i CP score 6-patienter sammenlignet med CP score 5-patienter.
English: The SELECT study was a multicentre, randomised, double-blind, placebo-controlled trial that was conducted in 392 patients with radioiodine-refractory differentiated thyroid cancer with independent, centrally reviewed, radiographic evidence of disease progression within 12 months (+1 month window) prior to enrolment.
Danish: SELECT-studiet var et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie, der blev udført med 392 patienter med radioaktivt jod-refraktær differentieret tyreoideacancer, hvor der var uafhængigt, centralt gennemgået, radiografisk evidens for sygdomsprogression inden for 12 måneder (+ vindue på 1 måned) før inklusion.
English: Because it is not known if LENVIMA can reduce the effect of the oral contraceptive pill, if this is your normal method of contraception you should ensure you also add a barrier method such as the cap or condoms if you have sex during treatment with LENVIMA.
Danish: Da det er ukendt, om LENVIMA kan nedsætte virkningen af p-piller, hvis det er din normale præventionsmetode, bør du også tilføje en barrieremetode som et pessar eller et kondom, hvis du har sex i løbet af behandlingen med LENVIMA.