FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of lenvatinib, carboplatin, and paclitaxel has no significant impact on the pharmacokinetics of any of these 3 substances.
Danish: Samtidig administration af lenvatinib, carboplatin og paclitaxel har ingen signifikant indvirkning på farmakokinetikken for nogen af disse 3 stoffer.
English: Partial responses
Danish: Delvist respons
English: Accidental medication errors resulting in single doses of 40 to 48 mg have also occurred in clinical trials.
Danish: Utilsigtede medicineringsfejl med enkeltdoser på 40 til 48 mg er også forekommet i kliniske studier.
English: • If you become pregnant while being treated with Kisplyx, tell your doctor immediately.
Danish: • Hvis du bliver gravid, mens du er i behandling med Kisplyx, skal du straks fortælle det til din læge.
English: Name and address of the manufacturer responsible for batch release Eisai Manufacturing Ltd.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Eisai Manufacturing Ltd.
English: Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, or the BSEP.
Danish: Lenvatinib er ikke substrat for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2 eller BSEP.
English: Preferred terms have been reassigned to the SOC most relevant to the target organ.
Danish: De foretrukne termer er blevet reorganiseret til de systemorganklasser, der er mest relevant for målorganet.
English: There are no data on the use of lenvatinib immediately following sorafenib or other anticancer treatments and there may be a potential risk for additive toxicities unless there is an adequate washout period between treatments.
Danish: Der foreligger ingen data for anvendelse af lenvatinib umiddelbart efter sorafenib eller andre anticancer-behandlinger, og der kan være en mulig risiko for additiv toksicitet, medmindre der er en tilstrækkelig udvaskningsperiode mellem behandlingerne.
English: The study consisted of a Phase 1b dose finding and a Phase 2 portion.
Danish: Studiet bestod af 2 dele, en fase 1b til fastlæggelse af dosis og en fase 2.
English: Therefore mortality may be attributed to complications related to primary duodenal lesions with possible contribution from additional toxicities in immature target organs.
Danish: Derfor kan mortalitet muligvis tilskrives komplikationer relateret til primære duodenale læsioner med et muligt bidrag fra ekstra toksiciteter i umodne målorganer.
English: Lenvatinib displays minimimal accumulation at steady state.
Danish: Lenvatinib udviser minimal akkumulering ved steady state.
English: Diarrhoea was the most frequent cause of dose interruption/reduction and recurred despite dose reduction.
Danish: Diarré var den hyppigste årsag til doseringsafbrydelse/dosisreduktion og vendte tilbage trods dosisreduktion.
English: (cannot be estimated from the available data)
Danish: • Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
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 under 2 år på grund af sikkerhedsproblemer identificeret i dyrestudier (se pkt.
English: These in vivo metabolic routes align with the data provided in the in vitro studies using human biomaterials.
Danish: Disse metaboliseringsveje in vivo er i overensstemmelse med de data, der foreligger fra in vitro-studier med humant biomateriale.
English: Juvenile animal toxicity studies
Danish: Toksicitetsstudier hos juvenile dyr
English: In case of suspected overdose, lenvatinib should be withheld and appropriate supportive care given as required.
Danish: I tilfælde af en formodet overdosering bør lenvatinib tilbageholdes og passende understøttende behandling gives efter behov.
English: Eight healthy, demographically matched subjects served as controls and received a 10-mg dose.
Danish: Otte raske, demografisk matchede personer var kontroller og fik en dosis på 10 mg.
English: The minimal washout period in clinical trials was of 4 weeks.
Danish: Den korteste udvaskningsperiode i kliniske studier var 4 uger.
English: Resolves to less than 2 gm / 24 hours.
Danish: Fortaget sig til under 2 g/24 timer.
English: Lenvatinib should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Danish: Lenvatinib bør ikke anvendes under graviditet, medmindre det er klart nødvendigt og først efter en nøje afvejning af behovet for at behandle moderen og risikoen for fosteret.
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: The mechanism of action for the worsening of hypercholesterolemia with the combination has not been studied directly and is not fully elucidated.
Danish: Virkningsmekanismen i forbindelse med forværring af hyperkolesterolæmi med kombinationen er ikke blevet direkte undersøgt og er ikke fuldt belyst.
English: • Take the capsules at about the same time each day.
Danish: • Tag kapslerne på nogenlundea samme tidspunkt hver dag.
English: Further dose adjustments may be necessary on the basis of individual tolerability.
Danish: Yderligere dosisjustering kan være nødvendig på basis af individuel tolerabilitet.
English: Periodic monitoring of ECG and electrolytes (magnesium, potassium and calcium) should be considered during treatment.
Danish: Periodisk monitorering af ekg og elektrolytter (magnesium, kalium og calcium) i løbet af behandlingen bør overvejes.
English: Patients who experience these symptoms should use caution when driving or operating machines.
Danish: Patienter, der oplever sådanne symptomer, skal udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner.
English: See detailed guidance in Table 3 in section 4.4.
Danish: Se detaljeret vejledning i tabel 3 i pkt.
English: Diarrhoea resulted in discontinuation in one patient.
Danish: Diarré medførte seponering hos en patient.
English: You may need to have additional treatment with other medicines, to take a lower dose of Kisplyx, or to take extra care due to an increased risk of side effects.
Danish: Du skal muligvis have behandling med andre lægemidler, tage en lavere dosis Kisplyx eller være ekstra forsigtig på grund af en øget risiko for bivirkninger.
English: A treatment decision should be made based upon an assessment of the individual patient's benefit/risk.
Danish: Der skal tages en beslutning om behandling efter vurdering af den enkelte patients benefit/risk-forhold.
English: Effect of lenvatinib on other medicinal products
Danish: Lenvatinibs indvirkning på andre lægemidler
English: Genotoxicity Lenvatinib was not genotoxic.
Danish: Genotoksicitet Lenvatinib var ikke genotoksisk.
English: • Swallow the capsules whole with water or dissolved.
Danish: • Slug kapslerne hele sammen med vand eller opløs dem.
English: Not Known (the following side effects have been reported since the marketing of lenvatinib but the frequency for them to occur is not known)
Danish: Ikke kendt (nedenstående bivirkninger er blevet rapporteret efter markedsføring af lenvatinib, men hyppigheden af dem kendes ikke):
English: Talk to your doctor before taking Kisplyx if you:
Danish: Kontakt lægen, før du tager Kisplyx, hvis du:
English: The mean terminal exponential half-life of lenvatinib is approximately 28 hours.
Danish: Den gennemsnitlige terminale eksponentielle halveringstid for lenvatinib er omkring 28 timer.
English: CI = confidence interval, NE = not estimable aPoint estimates are based on Kaplan-Meier method and 95% CIs are based on the Greenwood formula using log-log transformation.
Danish: CI = konfidensinterval, NE = kunne ikke estimeres aPoint-estimater er baseret på Kaplan-Meier-metoden, og 95 % CI er baseret på Greenwood-formlen ved brug af log-log-transformation.
English: Kisplyx may cause side effects that can affect your ability to drive or use machines.
Danish: Kisplyx kan forårsage bivirkninger, der kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Kisplyx treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies.
Danish: Behandling med Kisplyx bør påbegyndes og superviseres af sundhedspersonale med erfaring i anticancer-behandling.
English: The study was not powered for the OS analysis.
Danish: Studiet havde ikke styrke til en OS-analyse.
English: The choice of antihypertensive treatment should be individualised to the patient's clinical circumstances and follow standard medical practice.
Danish: Den antihypertensive behandling skal individualiseres i henhold til patientens kliniske omstændigheder og følge standardpraksis.
English: Figure 2: Kaplan-Meier Plot of Overall Survival
Danish: Figur 2: Kaplan-Meier-kurver for samlet overlevelse
English: Diarrhoea‡**
Danish: Diarré‡**
English: The percentage of the dose of lenvatinib excreted in urine was low in all cohorts (<2.16% across treatment cohorts).
Danish: Procentdelen af dosis af lenvatinib udskilt i urinen var lav i alle kohorter (< 2,16 % på tværs af behandlingskohorter).
English: There is no specific antidote for overdose with lenvatinib.
Danish: Der er ingen specifik antidot mod overdosering med lenvatinib.
English: The daily doses of lenvatinib and, if necessary, everolimus are to be modified as needed according to the dose/toxicity management plan.
Danish: Den daglige dosis af lenvatinib og om nødvendigt af everolimus skal modificeres i henhold til dosis/toksicitet-behandlingsplanen.
English: The combination should be used in patients with severe hepatic impairment only if the anticipated benefit exceeds the risk.
Danish: Kombinationen må kun anvendes til patienter med svært nedsat leverfunktion, hvis den forventede fordel opvejer risikoen.
English: The mechanism of action for hypothyroidism is not fully elucidated.
Danish: Virkningsmekanismen i forbindelse med hypotyreoidisme er ikke fuldt belyst.
English: • Your doctor may reduce your dose if you experience side effects.
Danish: • Din læge kan nedsætte din dosis, hvis du får bivirkninger.
English: This binding was mainly to albumin with minor binding to α1-acid glycoprotein and γ-globulin.
Danish: Denne binding var primært til albumin med en mindre binding til surt α1glykoprotein og γ-globulin.
English: These proteins can be present in high amounts in cancer cells, and by blocking their action Kisplyx 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 Kisplyx sænke hastigheden, hvormed kræftcellerne formerer sig, og tumoren vokser, og hjælpe med at afskære den nødvendige blodforsyning til kræftcellerne.
English: Kisplyx is a medicine that contains the active substance lenvatinib.
Danish: Kisplyx er et lægemiddel, der indeholder det aktive stof lenvatinib.
English: Reactions were reported at various time points during treatment ranging from two weeks to greater than 1 year from initiation of lenvatinib, with a median latency of about 3 months.
Danish: Reaktionerne blev rapporteret på forskellige tidspunkter under behandlingen, fra to uger til mere end 1 år efter lenvatinib blev påbegyndt, med en median latenstid på ca. 3 måneder.
English: Tumour assessment was based on RECIST 1.1 criteria.
Danish: Tumorbedømmelsen var baseret på RECIST 1.1-kriterier.
English: • loss of body fluids (dehydration)
Danish: • tab af væske i kroppen (dehydrering)
English: • have had recent surgery or radiotherapy
Danish: • for nylig har gennemgået en operation eller fået strålebehandling
English: This includes herbal preparations and medicines without a prescription.
Danish: Dette omfatter også naturlægemidler og lægemidler købt uden recept.
English: No events of hypocalcaemia required dose reduction or interruption, and no patients discontinued treatment due to hypocalcaemia.
Danish: Ingen tilfælde af hypokalcæmi nødvendiggjorde dosisreduktion eller doseringsafbrydelse, og ingen patienter seponerede behandlingen på grund af hypokalcæmi.
English: Within each frequency category, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedskategori er bivirkningerne opstillet efter faldende sværhedsgrad.
English: • Do not breast-feed if you are taking Kisplyx.
Danish: • Du må ikke amme, hvis du tager Kisplyx.
English: Duration of response, months, median (95% CI)
Danish: Responsvarighed, måneder, median (95 % CI)
English: The Phase 2 portion enrolled a total of 153 patients with unresectable advanced or metastatic RCC following 1 prior VEGF-targeted treatment.
Danish: Fase 2 inkluderede i alt 153 patienter med ikke-resekterbar fremskreden eller metastatisk RCC efter 1 tidligere VEGF-målrettet behandling.
English: Based on AUC(0 - inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Danish: Baseret på AUC(0-inf) redegjorde lenvatinib for 60 % og 64 % af den totale radioaktivitet i hhv. plasma og blod.
English: Resolves to <480 ms or baseline
Danish: Fortaget sig til <480 ms eller baseline-niveau.
English: Do not take Kisplyx if:
Danish: Tag ikke Kisplyx:
English: In 1.1% of patients, hypertension led to permanent treatment discontinuation.
Danish: Hos 1,1 % af patienterne medførte hypertension permanent seponering.
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 Kisplyx (angivet i punkt 6)
English: Figure 1: Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment)
Danish: Figur 1: Kaplan-Meier-kurver for progressionsfri overlevelse (investigators bedømmelse)
English: Resolves to Grade 0, 1 or 2.
Danish: Fortaget sig til grad 0, 1 eller 2.
English: Store in the original blister in order to protect from moisture.
Danish: Opbevares i den originale blister for at beskytte mod fugt.
English: bStratified hazard ratio is based on a stratified Cox regression model including treatment as a covariate factor and haemoglobin and corrected serum calcium as strata.
Danish: bStratificeret hazard ratio er baseret på en stratificeret Cox-regressionsmodel, som inkluderer behandling som en kovariat og hæmoglobin og korrigeret serum-calcium som strata.
English: • If it is 12 hours or more until your next dose: take the missed dose as soon as you remember.
Danish: • Hvis der er 12 timer eller længere indtil din næste dosis: tag den glemte dosis, så snart du kommer i tanker om det.
English: • Use highly effective contraception while taking this medicine, and for at least one month after you finish treatment.
Danish: • Anvend meget sikker prævention, mens du tager dette lægemiddel og i mindst en måned efter,
English: Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells.
Danish: Lad dem ligge i mindst 10 minutter og omrør i mindst 3 minutter for at opløse kapselskallerne.
English: In vitro studies indicate that lenvatinib is a substrate for P-gp and BCRP.
Danish: In vitro-studier indikerer, at lenvatinib er substrat for P-gp og BCRP.
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 lenvatinib-kapslerne, uden at knække eller knuse dem, kommes i en spiseskefuld vand eller æblejuice i et lille glas, for at danne en suspension.
English: Prompt medical management of diarrhoea should be instituted in order to prevent dehydration.
Danish: Behandling af diarré skal straks iværksættes for at undgå dehydrering.
English: Kisplyx 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: Kisplyx blokerer virkningen af nogle 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: The European Medicines Agency has waived the obligation to submit the results of studies with lenvatinib in all subsets of the paediatric population in Renal Cell Carcinoma (RCC).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med lenvatinib i alle undergrupper af den pædiatriske population med nyrecellekarcinom (RCC).
English: *Grade 4 laboratory abnormalities judged to be non-life-threatening, may be managed as severe reactions (e.g., Grade 3)
Danish: *Grad 4 laboratorieanomalier, der bedømmes som ikke livstruende, kan håndteres som svære reaktioner (f.eks. grad 3)
English: Hypothyroidism should be treated according to standard medical practice to maintain euthyroid state.
Danish: Hypotyreoidisme bør behandles i henhold til standardpraksis for at opretholde en eutyroid tilstand.
English: Liver function tests should be monitored before initiation of treatment, then every 2 weeks for the first 2 months and monthly thereafter during treatment.
Danish: Leverfunktionsprøver bør monitoreres, før behandling indledes, derefter hver 2. uge i de første 2 måneder og derefter månedligt under behandlingen.
English: cData cut-off date = 31 Jul 2015
Danish: cData-afskæringsdato = 31. juli 2015
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 gastrointestinal perforation og fisteldannelse hos patienter med risikofaktorer, såsom tidligere kirurgi eller strålebehandling.
English: Limited data are available for patients of ethnic origin other than Caucasian or Asian, and in patients aged ≥75 years.
Danish: Der foreligger kun begrænsede data for patienter af anden etnisk oprindelse end kaukasisk eller asiatisk og for patienter ≥ 75 år.
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: Thyreoideastimulerende hormon (TSH) bør monitoreres regelmæssigt, og behandling med thyreoideahormon bør justeres, så der opnås passende TSH-niveauer i henhold til patientens terapeutiske mål.
English: Patients with an ECOG (Eastern Cooperative Oncology Group) performance status of 2 or higher were excluded from the RCC study (see section 5.1).
Danish: Patienter med ECOG- (Eastern Cooperative Oncology Group) præstationsstatus på 2 eller derover blev ekskluderet fra RCC-studiet (se pkt.
English: Hepatocellular damage/hepatitisi
Danish: Hepatocellulær skade/hepatitisi
English: This is because the medicine passes into breast milk and may seriously harm your breastfed baby.
Danish: Dette skyldes, at lægemidlet kan udskilles i mælken og kan skade det ammede barn alvorligt.
English: • heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs
Danish: • hjerteproblemer eller blodprop i lungerne (vejrtrækningsbesvær, brystsmerter) eller i andre organer
English: The median time to onset was 6.7 weeks.
Danish: Mediantiden til start var 6,7 uger.
English: Aspartate aminotransferase increased‡ Hypoalbuminaemia‡
Danish: Forhøjet aspartataminotransferase‡ Hypoalbuminæmi‡
English: No specific studies with lenvatinib have been conducted in animals to evaluate the effect on fertility.
Danish: Der er ikke udført specifikke studier med lenvatinib hos dyr for at evaluere indvirkningen på fertilitet.
English: Following administration of radiolabelled lenvatinib to 6 patients with solid tumours, approximately two-thirds and one-fourth of the radiolabel were eliminated in the faeces and urine, respectively.
Danish: Efter administration af radiomærket lenvatinib til 6 patienter med faste tumorer blev ca. to tredjedele og en fjerdedel af radiomærkningen elimineret i hhv. fæces og urin.
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 behandling.
English: These findings indicate that lenvatinib has a teratogenic potential, likely related to the pharmacologic activity of lenvatinib as an antiangiogenic agent.
Danish: Disse resultater indikerer, at lenvatinib har et teratogent potentiale, der sandsynligvis er relateret til lenvatinibs farmakologiske aktivitet som et antiangiogent stof.
English: Alanine aminotransferase increased‡
Danish: Forhøjet alaninaminotransferase‡
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 med hovedpine, krampeanfald, letargi, konfusion, ændret psykisk funktion, blindhed og andre visuelle eller neurologiske forstyrrelser.
English: Patients were required, among others, to have histological confirmation of predominant clear cell RCC, radiographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1), one prior VEGF-targeted therapy and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Danish: Det var et krav, at patienterne blandt andet skulle have histologisk bekræftet primært clearcelle-RCC, radiografisk bevis for sygdomsprogression i henhold til RECIST 1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1), en tidligere VEGF-målrettet behandling og ECOG- (Eastern Cooperative Oncology Group) PS (præstationsstatus) 0 eller 1.
English: Tumour assessments were evaluated according to RECIST 1.1.
Danish: Tumorbedømmelser blev udført i henhold til RECIST 1.1.
English: Kisplyx is not recommended for use in children and adolescents.
Danish: Børn og unge Kisplyx må ikke anvendes til børn og unge.
English: Before taking Kisplyx, your doctor may carry out some blood 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 Kisplyx, vil din læge muligvis kontrollere dit blodtryk og tage nogle blodprøver, for eksempel kontrollere din lever- eller nyrefunktion og se, om du har et lavt indhold af visse salte og et højt indhold af skjoldbruskkirtel-stimulerende hormon (TSH) i dit blod.
English: Lenvatinib shows minimal or no inhibitory activities toward P-gp mediated and BCRP mediated transport activities.
Danish: Lenvatinib viser minimal eller ingen hæmmende aktivitet mod P-gp-medierede og BCRP-medierede transportaktiviteter.
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 forekom alvorlige og dødelige karotidarterieblødninger hyppigere hos patienter med anaplastisk thyreoideakarcinom (ATC) end med DTC eller andre tumortyper.
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 højere forekomst af nyrerelaterede bivirkninger og tendens til højere forekomst af leverrelaterede bivirkninger.
English: Your doctor may consider stopping Kisplyx if you will be undergoing a major surgical procedure as Kisplyx may affect wound healing.
Danish: Lægen kan overveje at stoppe Kisplyx, hvis du skal igennem en større operation, da Kisplyx kan påvirke sårhelingen.