FrancophonIA/ELRC3.0 huggingface dataset:
English: In human liver microsomes, the demethylated form of lenvatinib (M2) was identified as the main metabolite.
Danish: I humane levermikrosomer blev den demethylerede form af lenvatinib (M2) identificeret som den primære metabolit.
English: • anal fistula (a small channel that forms between the anus and the surrounding skin)
Danish: • anal fistel (en lille passage, der dannes mellem endetarmsåbningen og den omgivende hud)
English: Lenvatinib is mainly eliminated via the liver and exposure might be increased in these patient populations.
Danish: Lenvatinib elimineres hovedsageligt via leveren og eksponering vil kunne være forøget hos disse patientpopulationer.
English: Lenvatinib use has been associated with cases of fistulae including reactions resulting in death.
Danish: Anvendelsen af lenvatinib har været forbundet med tilfælde af fistler, herunder reaktioner med døden som følge.
English: These proteins can be present in high amounts in cancer cells, and by blocking their action LENVIMA may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs.
Danish: Disse proteiner kan være til stede i store mængder i kræftceller, og ved at blokere deres virkning kan LENVIMA sænke hastigheden, hvorved kræftcellerne formerer sig, og tumoren vokser, og hjælpe med at afskære den nødvendige blodforsyning for kræften.
English: The M3 metabolite was the predominant analyte in excreta (~17% of the dose), followed by M2' (~11% of the dose) and M2 (~4.4 of the dose).
Danish: M3metabolitten var den primære analyt i excreta (~17 % af dosis), efterfulgt af M2' (~11 % af dosis) og M2 (~4,4 af dosis).
English: Prompt medical management of diarrhoea should be instituted in order to prevent dehydration.
Danish: Medicinsk behandling af diarré skal omgående iværksættes for at undgå dehydrering.
English: Nephrotic syndrome ------
Danish: Nefrotisk syndrom ------
English: Hepatic encephalopathy occurred at more than twice the incidence in patients aged ≥75 years (17.2%) than in those <75 years (7.1%).
Danish: Hepatisk encefalopati forekom mere end to gange så hyppigt hos patienter i alderen ≥ 75 år (17,2 %) end hos dem < 75 år (7,1 %).
English: • increase in lipase and amylase (enzymes involved in digestion)
Danish: • forhøjet lipase og amylase (enzymer, som medvirker ved fordøjelsen)
English: Serious complications of poorly controlled hypertension, including aortic dissection, have been reported.
Danish: Der er rapporteret om alvorlige komplikationer ved dårligt kontrolleret hypertension, herunder aortadissektion.
English: Patients may be at increased risk for the development of fistulae when treated with lenvatinib.
Danish: Patienter kan have en øget risiko for udvikling af fistler, når de behandles med lenvatinib.
English: P-value is for the superiority test of lenvatinib versus sorafenib.
Danish: d P-værdi er for test for superioritet af lenvatinib versus sorafenib.
English: In plasma samples collected up to 24 hours after administration, lenvatinib constituted 97% of the radioactivity in plasma radiochromatograms while the M2 metabolite accounted for an additional 2.5%.
Danish: I plasmaprøver, der blev indsamlet op til 24 timer efter administration, udgjorde lenvatinib 97 % af radioaktiviteten i plasma-radiokromatogrammer, og M2-metabolitten udgjorde yderligere 2,5 %.
English: No adjustment of starting dose is required on the basis of age.
Danish: Ingen dosisjustering af startdosis er nødvendig på basis af alderen.
English: • Absence of MPVI, extra-hepatic tumour spread (EHS) or both: 30%
Danish: • Fravær af MPVI, ekstrahepatisk tumorspredning (EHS) eller begge: 30 %
English: The mean terminal exponential halflife of lenvatinib is approximately 28 hours.
Danish: Den gennemsnitlige terminale eksponentielle halveringstid for lenvatinib er omkring 28 timer.
English: LENVIMA is a medicine that contains the active substance lenvatinib.
Danish: LENVIMA er et lægemiddel, der indeholder det aktive stof lenvatinib.
English: The early detection and effective management of hypertension are important to minimise the need for lenvatinib dose interruptions and reductions.
Danish: Tidlig detektion og effektiv behandling af hypertension er vigtig for at minimere behovet for dosisafbrydelser og dosisreduktioner af lenvatinib.
English: The primary risk factor identified was dehydration and/or hypovolemia due to gastrointestinal toxicity.
Danish: Den primære identificerede risikofaktor var dehydrering og/eller hypovolæmi, der skyldes mave-tarm-toksicitet.
English: Hypothyroidism should be treated according to standard medical practice to maintain euthyroid state.
Danish: Hypotyreoidisme bør behandles i henhold til standard medicinsk praksis for at opretholde en eutyroid tilstand.
English: • have had recent surgery or radiotherapy
Danish: • for nylig har gennemgået en operation eller strålebehandling
English: The safety profile of lenvatinib is based on data from 452 DTC patients and 496 HCC patients; allowing characterisation only of common adverse drug reactions in DTC and HCC patients.
Danish: Lenvatinibs sikkerhedsprofil er baseret på data fra 452 patienter med DTC og 496 patienter med HCC, hvilket tillader, at kun almindelige bivirkningsreaktioner hos patienter med DTC og HCC karakteriseres.
English: Patients with body weight <60 kg
Danish: Patienter med en legemsvægt < 60 kg
English: People get LENVIMA when their liver cancer has spread or cannot be taken out by surgery.
Danish: Patienter får LENVIMA, når deres leverkræft har spredt sig, eller når den ikke kan tages opereres væk.
English: Clinical data are not available in this population (see section 4.2).
Danish: Der foreligger ikke kliniske data for denne population (se pkt.
English: Alternatively, the lenvatinib capsules may be added without breaking or crushing them to a tablespoon of water or apple juice in a small glass to produce a suspension.
Danish: Alternativt kan leventinib-kapslerne tilsættes, uden at de deles eller knuses, til en skefuld vand eller æblejuice i et lille glas for at lave en suspension.
English: The Rac in HCC subjects with mild and moderate liver impairment was similar to that reported for other solid tumours.
Danish: Rac hos personer med HCC med let eller moderat leversvigt var tilsvarende det, der var rapporteret for andre solide tumorer.
English: Lenvatinib should not be used in children younger than 2 years of age because of safety concerns identified in animal studies (see section 5.3).
Danish: Lenvatinib bør ikke anvendes til børn i alderen under 2 år på grund af problemstillinger identificeret i dyrestudier (se pkt.
English: Approximately half of the events of hepatic failure and one third of the events of the hepatic encephalopathy were reported in patients with disease progression.
Danish: Omtrent halvdelen af hændelserne med nedsat leverdunktion og en tredjedel af hændelserne med hepatisk encefalopati blev rapporteret hos patienter med sygdomsprogression.
English: This is because the medicine passes into breast milk and may seriously harm your breastfed baby.
Danish: Dette skyldes, at lægemidlet udskilles i modermælken og kan skade det ammede barn alvorligt.
English: The main efficacy outcome measure was progression-free survival (PFS) as determined by blinded independent radiologic review using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Danish: Det primære virkningsudfald var progressionsfri overlevelse (PFS) bestemt via blindet, uafhængig radiologisk gennemgang ved brug af Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
English: Anal fistula Flatulence Increased lipase Increased amylase
Danish: Anal fistel Flatulens Forhøjet lipase Forhøjet amylase
English: PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules 60 hard capsules 90 hard capsules METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 hårde kapsler 60 hårde kapsler 90 hårde kapsler ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: Patients with HCC should be monitored for worsening liver function including hepatic encephalopathy.
Danish: Patienter med HCC skal monitoreres for forværring af leverfunktion inklusive hepatisk encefalopati.
English: The results for surrogate endpoints (PFS and ORR) are presented in Table 7 below.
Danish: Resultaterne for surrogate endepunkter (PFS og QRR) vises i Tabel 7 herunder.
English: LENVIMA treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies.
Danish: Behandling med LENVIMA bør påbegyndes og overvåges af sundhedspersonale med erfaring i anvendelsen af anticancer-behandlinger.
English: LENVIMA may cause side effects that can affect your ability to drive or use machines.
Danish: LENVIMA kan forårsage bivirkninger, der kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Magnetic resonance imaging is necessary to confirm the diagnosis of PRES.
Danish: MR-scanning er nødvendig for at bekræfte diagnosen PRES.
English: Arterial thromboembolic events also occurred at an increased incidence in this age group.
Danish: Arterielle tromboemboliske hændelser forekom også med en forøget hyppighed i denne aldersgruppe.
English: • Do not use this medicine after the expiry date which is stated on the carton and on each blister after ‘EXP'.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og hvert blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Reactions were reported at various time points during treatment ranging from two weeks to greater than 1 year from initiation of lenvatinib, with median latency of about 3 months.
Danish: Reaktionerne blev rapporteret på forskellige tidspunkter under behandlingen, fra to uger til over 1 år fra lenvatinib blev påbegyndt, med en median latenstid på ca. 3 måneder.
English: The overall survival analysis was confounded by the fact that placebo-treated subjects with confirmed disease progression had the option to cross over to open-label lenvatinib.
Danish: Den samlede overlevelsesanalyse var kompliceret af den kendsgerning, at de placebobehandlede personer med bekræftet sygdomsprogression havde muligheden for at overkrydse til åben lenvatinib.
English: Tell your doctor straight away if you notice any of the side effects above.
Danish: Fortæl det straks til lægen, hvis du bemærker nogle af de ovenstående bivirkninger.
English: These patients also had a higher incidence of renal reactions and arterial thromboembolic events.
Danish: Disse patienter havde også en højere forekomst af nyrereaktioner og arterielle thromboemboliske hændelser.
English: • If you could become pregnant, use highly effective contraception while taking this medicine, and for at least one month after you finish treatment.
Danish: • Hvis du kan blive gravid, skal du anvende meget sikker prævention, mens du tager dette lægemiddel, og i mindst en måned efter du afslutter behandlingen.
English: Lenvatinib has not been studied in patients who have had an arterial thromboembolism within the previous 6 months, and therefore should be used with caution in such patients.
Danish: Lenvatinib er ikke blevet undersøgt hos patienter, som har haft en arteriel tromboemboli inden for de seneste 6 måneder og bør derfor anvendes med forsigtighed hos sådanne patienter.
English: Blood calcium levels should be monitored at least monthly and calcium should be replaced as necessary during lenvatinib treatment.
Danish: Calciumniveauet i blodet bør overvåges mindst månedligt, og calcium skal erstattes efter behov i løbet af behandlingen med lenvatinib.
English: Lenvatinib should be discontinued in the event of persistence of Grade 4 diarrhoea despite medical management.
Danish: Lenvatinib bør seponeres i tilfælde af vedvarende grad 4 diarré trods medicinsk behandling.
English: • diarrhoea, feeling and being sick - these are very common side effects that can become serious if they cause you to become dehydrated, which can lead to kidney failure.
Danish: • diarré, kvalme og opkastning - det er meget almindelige bivirkninger, der kan blive alvorlige, hvis de medfører, at du bliver dehydreret, hvilket kan føre til nyresvigt.
English: In addition, pneumothorax has been reported with and without clear evidence of a bronchopleural fistula.
Danish: Pneumothorax er ligeledes blevet rapporteret med og uden tydelig evidens for en bronkopleural fistel.
English: Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells.
Danish: Lad det stå i mindst 10 minutter og rør så rundt i mindst 3 minutter for at opløse kapselskallerne.
English: It is not known whether lenvatinib is excreted in human milk.
Danish: Det er ukendt, om lenvatinib udskilles i human mælk.
English: Adverse reactions observed in clinical trials in DTC and HCC and reported from post-marketing use of lenvatinib are listed in Table 5.
Danish: Bivirkninger observeret i kliniske studier med DTC og HCC og rapporteret ved anvendelse af lenvatinib efter markedsføring er opstillet i tabel 5.
English: See section 4.8 Description of selected adverse reactions for further characterisation.
Danish: 4.8 Beskrivelse af udvalgte bivirkninger for yderligere karakterisering.
English: Kaplan-Meier Curve of Progression-Free Survival - DTC
Danish: Figur 1 Kaplan-Meier-kurve for progressionsfri overlevelse - DTC
English: • you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for lenvatinib eller et af de øvrige indholdsstoffer i LENVIMA (angivet i punkt 6)
English: Median OS was longer by approximately 2.5 months in the lenvatinib compared with the sorafenib arm in both subsets of subjects (with or without post-treatment anticancer therapy).
Danish: Median OS var ca. 2,5 måneder længere i lenvatinib-armen sammenlignet med sorafenib-armen i begge undergrupper af forsøgspersoner (med eller uden post-behandling med anticancerterapi).
English: Before taking LENVIMA, your doctor may carry out some tests, for example to check your blood pressure and your liver or kidney function and to see if you have low levels of salt and high levels of thyroid stimulating hormone in your blood.
Danish: Før du tager LENVIMA kan din læge lave nogle undersøgelser, for eksempel kontrollere dit blodtryk og din lever- eller nyrefunktion og se, om du har et lavt niveau af salt og et højt niveau af skjoldbruskkirtel-stimulerende hormon.
English: Patients in the placebo arm could opt to receive lenvatinib treatment at the time of confirmed disease progression.
Danish: Patienter i placeboarmen kunne vælge at få lenvatinibbehandling på tidspunktet for bekræftet sygdomsprogression.
English: For those patients already on antihypertensive medication, the dose of the current agent may be increased, if appropriate, or one or more agents of a different class of antihypertensive should be added.
Danish: For de patienter, der allerede får antihypertensive lægemidler, kan dosis af det aktuelle stof hvis relevant øges, eller en eller flere stoffer fra en anden klasse af antihypertensiva bør tilføjes.
English: Lenvatinib is rapidly absorbed after oral administration with tmax typically observed from 1 to 4 hours postdose.
Danish: Lenvatinib absorberes hurtigt efter oral administration med tmaks, der typisk observeres fra 1 til 4 timer efter dosering.
English: The analogous median apparent volume of distribution at steady-state (Vz/Fss) was also generally consistent and ranged from 43.2 L to 121 L.
Danish: Det analoge mediane tilsyneladende fordelingsvolumen ved steady-state (Vz/Fss) var også generelt konsistent og i intervallet fra 43,2 l til 121 l.
English: The daily dose is to be modified as needed according to the dose/toxicity management plan.
Danish: Den daglige dosis skal modificeres efter behov i henhold til dosis/toksicitetbehandlingsplanen.
English: It is used on its own to treat progressive or advanced thyroid cancer in adults when radioactive iodine treatment has not helped to stop the disease.
Danish: Det anvendes alene til at behandle progressiv eller fremskreden kræft i skjoldbruskkirtlen hos voksne, når radioaktiv jodbehandling ikke har hjulpet med at stoppe sygdommen.
English: The additional liquid must be swallowed.
Danish: Den ekstra væske skal synkes.
English: Data from a human mass balance/excretion study indicate lenvatinib is extensively metabolised in humans.
Danish: Data fra et masse-balance/udskillelsesstudie hos mennesker indikerer, at lenvatinib i omfattende grad metaboliseres hos mennesker.
English: Elevated transaminase levels asociated with signs of hepatotoxicity, were also observed in rats, dogs and monkeys.
Danish: Forhøjede transaminaseniveauer forbundet med tegn på hepatotoksicitet blev også observeret hos rotter, hunde og aber.
English: In 1.1% of patients, hypertension led to permanent treatment discontinuation.
Danish: Hos 1,1 % af patienterne førte hypertension til permanent behandlingsseponering.
English: Before initiating lenvatinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med lenvatinib bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: No specific studies with lenvatinib have been conducted in animals to evaluate the effect on fertility.
Danish: Der er ikke udført nogen specifikke studier med lenvatinib hos dyr for at evaluere virkningen på fertilitet.
English: Consider resuming at reduced dose if resolves to Grade 0-1.
Danish: Overvej at genstarte ved en reduceret dosis, hvis det fortager sig til grad 0-1.
English: The majority of Grade 3 to 4 adverse reactions occurred during the first 6 months of treatment except for diarrhoea, which occurred throughout treatment, and weight loss, which tended to be cumulative over time.
Danish: Hovedparten af grad 3 til 4 bivirkninger forekom i løbet af de første 6 måneders behandling, undtagen diarré som forekom i løbet af hele behandlingen, og vægttab, der havde en tendens til at akkumulere med tiden.
English: These patients also had a higher incidence of renal reactions and a trend towards a higher incidence of liver reactions.
Danish: Disse patienter havde også en større forekomst af nyrereaktioner og en tendens til en større forekomst af leverreaktioner.
English: LENVIMA blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow.
Danish: LENVIMA blokerer virkningen af proteiner, der kaldes receptor tyrosinkinaser (RTK'er), som er involveret i udviklingen af nye blodkar, der forsyner cellerne med ilt og næringsstoffer og hjælper dem med at vokse.
English: Similar adverse reactions were observed in clinical trials in DTC and HCC.
Danish: Tilsvarende bivirkninger blev observeret i kliniske studier med DTC og HCC.
English: Thyroid stimulating hormone (TSH) levels should be monitored on a regular basis and thyroid hormone administration should be adjusted to reach appropriate TSH levels, according to the patient's therapeutic target.
Danish: Niveauet af tyreoideastimulerende hormon (TSH) bør overvåges regelmæssigt, og tyroid erstatningsbehandling bør justeres, så der opnås passende TSH-niveauer, i henhold til patientens terapeutiske mål.
English: Hepatic encephalopathy tended to be associated with adverse disease characteristics at baseline or with the use of concomitant medications.
Danish: Hepatisk encefalopati tenderede til at være forbundet med ugunstige sygdomskarakteristika ved baseline eller med brug af samtidig medicin.
English: Life-threatening consequences (malignant hypertension, neurological deficit, or hypertensive crisis)
Danish: Livstruende konsekvenser (malign hypertension, neurologisk funktionsforstyrrelse eller hypertensiv krise)
English: Hepatic encephalopathy also occurred more frequently in patients aged 75 years and older.
Danish: Hepatisk encefalopati forekom også oftere hos patienter på 75 år og derover.
English: In vitro binding of lenvatinib to human plasma proteins is high and ranged from 98% to 99% (0.3 - 30 μg/mL, mesylate).
Danish: In vitro-binding af lenvatinib til humane plasmaproteiner er høj og i intervallet fra 98 % til 99 % (0,3 - 30 μg/ml, mesilat).
English: In addition, lenvatinib had selective, direct antiproliferative activity in hepatocellular cell lines dependent on activated FGFR signalling, which is attributed to the inhibition of FGFR signalling by lenvatinib.
Danish: Derudover havde lenvatinib selektiv, direkte antiproliferativ aktivitet i de hepatocellulære cellelinjer afhængig af aktiveret FGFR signalering, som tilskrives lenvatinibs hæmning af FGFR signalering.
English: Lenvatinib is a multikinase inhibitor which has shown mainly antiangiogenic properties in vitro and in vivo, and direct inhibition of tumour growth was also observed in in vitro models.
Danish: Lenvatinib er en multikinasehæmmer, som har vist hovedsageligt antiangiogene egenskaber in vitro og in vivo, og direkte hæmning af tumorvæksten blev også observeret i in vitro-modeller.
English: Reduce dose in succession based on the previous dose level (12 mg, 8 mg, 4 mg or 4 mg every other day).
Danish: Reducér dosis i rækkefølge baseret på det forrige dosisniveau (12 mg, 8 mg, 4 mg eller 4 mg hver anden dag).
English: • Underlying cirrhosis (by independent imaging review): 75%
Danish: • Underliggende cirrose (ved en uafhængig vurdering af billeddiagnostik): 75 %
English: Myocardial infarctionc,†
Danish: Myokardieinfarktc,†
English: In this trial, there was 1 case of fatal intracranial haemorrhage among 16 patients who received lenvatinib and had CNS metastases at baseline.
Danish: I dette studie var der 1 tilfælde af dødelig intrakranial blødning blandt 16 patienter, der fik lenvatinib og havde CNSmetastaser ved baseline.
English: For the following transporters, OAT1, OAT3, OATP1B1, OCT1, OCT2, and BSEP, clinically relevant inhibition was excluded based on a cutoff of IC50> 50  Cmax,unbound.
Danish: For de følgende transportere, OAT1, OAT3, OATP1B1, OCT1, OCT2, eller BSEP, blev klinisk relevant hæmning ekskluderet på basis af en afskæring påIC50 > 50  Cmax, ubundet.
English: • heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs
Danish: • hjerteproblemer eller blodpropper i lungerne (vejrtrækningsbesvær, brystsmerter) eller i andre organer
English: • redness, soreness and swelling of the skin on the hands and feet (hand-foot syndrome)
Danish: • rødme, ømhed og hævelse af huden på hænder og fødder (hånd-fod-syndrom)
English: A clinical drug-drug interaction (DDI) study in cancer patients showed that plasma concentrations of midazolam (a sensitive CYP3A and Pgp substrate) were not altered in the presence of lenvatinib.
Danish: Et klinisk studie af lægemiddelinteraktion hos cancerpatienter viste, at plasmakoncentrationerne af midazolam (et følsomt CYP3A- og Pgp-substrat) ikke blev ændret ved tilstedeværelse af lenvatinib.
English: Talk to your doctor before taking LENVIMA if you:
Danish: Kontakt lægen, før du tager LENVIMA, hvis du:
English: One subject (0.2%) discontinued lenvatinib due to hypertension.
Danish: En patient (0,2 %) seponerede lenvantinib på grund af hypertension.
English: • are a woman able to become pregnant (see the section below on Contraception, pregnancy and breast-feeding)
Danish: • er en kvinde, der kan blive gravid (se punktet nedenfor om Prævention, graviditet og amning)
English: • If it is less than 12 hours until your next dose: skip the missed dose.
Danish: • Hvis der er mindre end 12 timer til din næste dosis: spring den glemte dosis over.
English: Myocardial infarction includes myocardial infarction and acute myocardial infarction.
Danish: Myokardieinfarkt omfatter myokardieinfarkt og akut myokardieinfarkt.