FrancophonIA/ELRC3.0 huggingface dataset:
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 (japansk versus andet, kaukasisk versus andet) ingen signifikant indvirkning på clearance (se pkt.
English: The final dose level in the combination arm was 18 mg for 29% of patients, 14 mg for 31% of patients, 10 mg for 23% of patients, 8 mg for 16% of patients and 4 mg for 2% of patients.
Danish: Det endelige dosisniveau i kombinationsarmen var 18 mg for 29 % af patienterne, 14 mg for 31 % af patienterne, 10 mg for 23 % af patienterne, 8 mg for 16 % af patienterne og 4 mg for 2 % af patienterne.
English: Hypertension includes: hypertension, hypertensive crisis, increased blood pressure diastolic, and increased blood pressure.
Danish: Hypertension omfatter: hypertension, hypertensiv krise, forhøjet diastolisk blodtryk og forhøjet blodtryk.
English: All patients had a baseline ECOG PS of either 0 (55%) or 1 (45%) with similar distribution across the 3 treatment arms.
Danish: Alle patienterne havde ECOG-PS 0 (55 %) eller 1 (45 %) ved baseline med samme fordeling i de 3 arme.
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 risikoen for doseringsafbrydelse og dosisreduktion af lenvatinib.
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 monitoreres mindst 1 gang om måneden, og calcium skal gives efter behov i løbet af behandlingen med lenvatinib.
English: The safety profile of lenvatinib in combination with everolimus is based on data from 62 subjects, allowing characterisation only of common adverse drug reactions in RCC patients.
Danish: Sikkerhedsprofilen for lenvatinib i kombination med everolimus er baseret på data fra 62 personer, hvilket kun gør det muligt at karakterisere almindelige bivirkninger hos RCC-patienter.
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 (får udpræget væskemangel), hvilket kan føre til nyresvigt.
English: Severe (e.g., Grade 3) or intolerable adverse reactions require interruption of the combination of medicines until improvement of the reaction to Grade 0-1 or baseline.
Danish: Svære (f.eks. grad 3) eller intolerable bivirkninger kræver afbrydelse af lægemiddelkombinationen, indtil reaktionerne forbedres til grad 0-1 eller baseline-niveau.
English: Cardiac dysfunction Grade 3
Danish: Kardial dysfunktion Grad 3
English: Reports of fistulae that involve areas of the body other than stomach or intestines were observed across various indications.
Danish: Fistler, der involverer andre områder end mave eller tarme, blev rapporteret på tværs af forskellige indikationer.
English: Patients with body weight <60 kg
Danish: Patienter med legemsvægt < 60 kg
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 være i væsken i mindst 10 minutter og omrøres i mindst 3 minutter for at opløse kapselskallerne.
English: No adjustment of starting dose is required on the basis of body weight.
Danish: Justering af startdosis er ikke nødvendig på basis af legemsvægt.
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 bør pauseres i tilfælde af forlængelse af QT-intervallet til over 500 ms. Lenvatinib bør genoptages med en reduceret dosis, når QTc-forlængelsen har fortaget sig til < 480 ms eller til baseline-niveau.
English: A total of 62 patients received the combination of lenvatinib and everolimus at the recommended dose.
Danish: I alt 62 patienter fik kombinationen af lenvatinib og everolimus ved den anbefalede dosis.
English: Elevated transaminase levels asociated with signs of hepatotoxicity, were also observed in rats, dogs and monkeys.
Danish: Forhøjede aminotransferaseniveauer forbundet med tegn på hepatotoksicitet blev også observeret hos rotter, hunde og aber.
English: Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness.
Danish: Lenvatinib påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner på grund af bivirkninger som træthed og svimmelhed.
English: Resolves to Grade 0-1.
Danish: Fortaget sig til grad 0-1.
English: Paediatric population See section 4.2 for information on paediatric use.
Danish: 4.2 for oplysninger om pædiatrisk anvendelse.
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 CNS-metastaser ved baseline.
English: It is currently unknown if lenvatinib increases the risk of thromboembolic events when combined with oral contraceptives.
Danish: Det er aktuelt ukendt, om lenvatinib øger risikoen for tromboemboliske hændelser, når det kombineres med orale kontraceptiva.
English: • other types of fistulae (an abnormal connection between different organs in the body or from the skin to an underlying structure such as throat and windpipe).
Danish: • andre typer fistler (en unormal forbindelse mellem forskellige organer i kroppen eller fra huden til en underliggende struktur som halsen eller luftrøret).
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: It is used in combination with everolimus to treat patients with advanced kidney cancer (advanced renal cell carcinoma) where other treatments (so-called “VEGF-targeted therapy”) have not helped stop the disease.
Danish: Det anvendes i kombination med everolimus til at behandle patienter med fremskreden nyrekræft (fremskredent nyrecellekarcinom), når andre behandlinger (såkaldt ”VEGF-målrettet behandling”) ikke har stoppet sygdommen.
English: Body weight below 60 kg
Danish: Legemsvægt under 60 kg
English: Patients were stratified by haemoglobin level (≤13 g/dL vs. >13 g/dL for males and ≤11.5 g/dL vs >11.5 g/dL for females) and corrected serum calcium (≥10 mg/dL vs. <10 mg/dL).
Danish: Patienterne blev stratificeret efter hæmoglobinniveau (≤13 g/dl vs >13 g/dl for mænd og ≤11,5 g/dl vs >11,5 g/dl for kvinder) og korrigeret serum-calcium (≥10 mg/dl vs <10 mg/dl).
English: Do not resume
Danish: Må ikke genstartes.
English: Adverse reactions observed in clinical trials and reported from post-marketing use of lenvatinib are listed in Table 4..
Danish: Bivirkninger observeret i kliniske studier og rapporteret ved anvendelse af lenvatinib efter markedsføring er opstillet i tabel 4.
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: Hos patienter, der allerede får antihypertensiva, kan dosis af det aktuelle antihypertensivum eventuelt øges, eller et eller flere stoffer fra en anden klasse tilføjes.
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: M3-metabolitten var den primære metabolit i fæces og urin (~17 % af dosis), efterfulgt af M2' (~11 % af dosis) og M2 (~4,4 af dosis).
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 og hos personer med normal leverfunktion og lå i intervallet fra 26 timer til 31 timer.
English: Metastases were present in 95% of the patients and unresectable advanced disease was present in 5%.
Danish: 95 % af patienterne havde metastaser, og 5 % have ikke-resekterbar fremskreden sygdom.
English: There was one Grade 4 TEAE.
Danish: Der var en grad 4 reaktion.
English: • Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hver blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Resolves to Grade 0-1 or baseline.
Danish: Fortaget sig til grad 0-1 eller baseline-niveau.
English: Baseline diabetes
Danish: Diabetes ved baseline
English: If you are not sure talk to your doctor before taking Kisplyx.
Danish: Hvis du er i tvivl, skal du kontakte lægen, før du tager Kisplyx.
English: See section 4.8 Description of selected adverse reactions for further characterisation.
Danish: 4.8 ”Beskrivelse af udvalgte bivirkninger” for yderligere karakterisering.
English: A multicentre, randomised, open-label, trial was conducted to determine the safety and efficacy of lenvatinib administered alone or in combination with everolimus in subjects with unresectable advanced or metastatic RCC.
Danish: Der blev udført et randomiseret, åbent multicenterstudie for at bestemme lenvatinibs sikkerhed og virkning, når det blev administreret alene eller i kombination med everolimus hos personer med ikkeresekterbar fremskreden eller metastatisk RCC.
English: Data cut-off date = 13 Jun 2014
Danish: Data-afskæringsdato: 13. juni 2014
English: Microcrystalline cellulose Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Talc
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Lav-substitueret hydroxypropylcellulose Talcum
English: Plasma concentrations decline bi-exponentially following Cmax.
Danish: Plasmakoncentrationen falder bieksponentielt efter Cmaks.
English: Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia.
Danish: Lenvatinibbehandlingen bør afbrydes eller dosis justeres efter behov, afhængigt af sværhedsgrad og persistens af hypokalcæmi samt tilstedeværelse af ekg-ændringer.
English: Based on the results of a post-hoc exploratory analysis in a limited number of patients per subgroup, the positive effect on PFS was seen regardless of which prior VEGF-targeted therapy was used: sunitinib (Hazard ratio [HR] = 0.356 [95% CI: 0.188, 0.674] or other therapies (HR = 0.350 [95% CI: 0.148, 0.828]).
Danish: Baseret på resultaterne af en posthoc eksploratorisk analyse hos et begrænset antal patienter pr. undergruppe blev den positive virkning på PFS observeret uanset hvilken tidligere VEGF-målrettet behandling, patienten havde fået: sunitinib (Hazard ratio [HR] = 0,356 [95 % CI: 0,188; 0,674] eller andre behandlinger (HR = 0,350 [95 % CI: 0,148; 0,828).
English: How long to takeKisplyx You will usually carry on taking this medicine as long as you are getting benefit.
Danish: Du skal normalt blive ved med at tage dette lægemiddel, så længe du har fordele af det.
English: However, in vivo data indicated that non-P450-mediated pathways contributed to a significant portion of the overall metabolism of lenvatinib.
Danish: In vivo-data indikerede imidlertid, at ikke-CYP-medierede metaboliseringsveje i signifikant grad bidrog til den samlede lenvatinibmetabolisme.
English: Marketing Authorisation Holder Eisai GmbH
Danish: Indehaver af markedsføringstilladelsen Eisai GmbH
English: 18 September 2019
Danish: DATO FOR ÆNDRING AF TEKSTEN 18. september 2019
English: Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not warrant interruption of the combination, unless intolerable to the patient despite optimal management.
Danish: Ved lette til moderate bivirkninger (f.eks. grad 1 eller 2) er det normalt ikke nødvendigt at afbryde kombinationsbehandlingen, medmindre bivirkningerne ikke kan tolereres af patienten trods optimal behandling.
English: Continue lenvatinib and initiate antihypertensive therapy, if not already receiving
Danish: Fortsæt lenvatinib og påbegynd antihypertensiv behandling, hvis patienten ikke allerede får det
English: Gastrointestinal toxicity should be actively managed in order to reduce the risk of development of renal impairment or renal failure.
Danish: Gastrointestinal toksicitet skal behandles aktivt for at reducere risikoen for udvikling af nedsat nyrefunktion eller nyresvigt.
English: Anal fistula Flatulence Lipase increased Amylase increased
Danish: Analfistel Flatulens Forhøjet lipase Forhøjet amylase
English: • high levels of protein in the urine and urinary infections (increased frequency in urination and pain in passing urine)
Danish: • højt indhold af protein i urinen og blærebetændelse (øget vandladningshyppighed og smerter ved vandladning)
English: The incidence of serious haemorrhage was 4.8% (cerebral haemorrhage, gastric haemorrhage and haemarthrosis).
Danish: Forekomsten af alvorlig blødning var 4,8 % (cerebral blødning, gastrisk blødning og hæmartrose).
English: Of the 153 patients randomly allocated, 73% were male, the median age was 61 years, 37% were 65 years or older, 7% were 75 years or older, and 97% were Caucasian.
Danish: Af de 153 randomiserede patienter var 73 % mænd, medianalderen var 61 år, 37 % var ≥ 65 år, og 7 % var ≥ 75 år.
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 i større blodkar (f.eks. karotidarterien) bør tages i betragtning på grund af den mulige risiko for svær blødning forbundet med tumorsvind/nekrose efter behandling med lenvatinib.
English: All events of hypothyroidism in the lenvatinib plus everolimus-treated group were of Grade 1 or 2.
Danish: Alle tilfælde af hypotyreoidisme i lenvatinib plus everolimus-gruppen var grad 1 eller 2.
English: • are a woman able to become pregnant (see the section “Contraception, pregnancy and breast-feeding”
Danish: • er kvinde og kan blive gravid (se punktet om Prævention, graviditet og amning nedenfor)
English: Bleeding in sites other than the brain (e.g. trachea, intra-abdominal, lung) has also been reported.
Danish: Blødning andre steder end i hjernen (f.eks. trakealt, intraabdominalt, i lunge) er også blevet rapporteret.
English: The hepatic failure cases were generally reported in patients with progressive liver metastases.
Danish: Tilfældene med leversvigt blev generelt rapporteret hos patienter med progressive levermetastaser.
English: For toxicities thought to be related to both lenvatinib and everolimus, lenvatinib should be reduced (see Table 2) prior to reducing everolimus.
Danish: For toksiciteter, der menes at være forbundet med både lenvatinib og everolimus, bør lenvatinib reduceres (se tabel 2), før everolimus reduceres.
English: Lenvatinib should be discontinued in the event of nephrotic syndrome.
Danish: Lenvatinib skal seponeres i tilfælde af nefrotisk syndrom.
English: Growth retardation, secondary delay of physical development, and lesions attributable to pharmacologic effects (incisors, femur [epiphyseal growth plate], kidneys, adrenals, and duodenum) were also observed in juvenile rats.
Danish: Vækstretardering, sekundær forsinkelse af fysisk udvikling og læsioner, der kan tilskrives farmakologiske virkninger (fortænder, femur [epifyse-vækstplade], nyrer, binyrer og duodenum) blev også observeret hos juvenile rotter.
English: Blood pressure (BP) should be well controlled prior to treatment with lenvatinib and, if patients are known to be hypertensive, they should be on a stable dose of antihypertensive therapy for at least 1 week prior to treatment with lenvatinib.
Danish: Blodtrykket (BT) skal være velkontrolleret før behandling med lenvatinib, og patienter, der vides at være hypertensive, skal have været i stabil antihypertensiv behandling i mindst 1 uge før behandling med lenvatinib.
English: The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE.
Danish: De hyppigst observerede bivirkninger ved disse doser var hypertension, kvalme, diarré, træthed, stomatitis, proteinuri, hovedpine og forværring af PPE.
English: Cases of fatal intracranial haemorrhage have been reported in some patients with or without brain metastases.
Danish: Der er blevet rapporteret dødelige tilfælde af intrakranial blødning hos patienter med eller uden hjernemetastaser.
English: No reports of QTc interval prolongation greater than 500 ms or increases greater than 60 ms occurred in the everolimus-treated group.
Danish: Der er ingen rapporter om et længere QTc-interval end 500 ms eller forlængelse på over 60 ms i everolimus-gruppen.
English: P Value lenvatinib + everolimus vs everolimus
Danish: P-værdi lenvatinib + everolimus vs everolimus
English: • The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30, 60 or 90 hard capsules.
Danish: • Kapslerne leveres i blistre af polyamid/aluminium/PVC i pakninger med 30, 60 eller 90 hårde kapsler dækket med aluminiumfolie, hvorigennem kapslerne kan trykkes ud.
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 blandingen er drukket, skal den samme mængde vand eller æblejuice (en spiseskefuld) hældes i glasset, og det hvirvles rundt et par gange, hvorefter væsken sluges.
English: • The other ingredients are calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc.
Danish: • Øvrige indholdsstoffer: calciumcarbonat, mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, lav-substitueret hydroxypropylcellulose, talcum.
English: Dehydration Hypomagnesaemiab
Danish: Dehydrering Hypomagnesiæmib
English: Kisplyx is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
Danish: Kisplyx er i kombination med everolimus indiceret til behandling af voksne patienter med fremskredent nyrecellekarcinom (RCC) efter én forudgående behandling rettet mod vaskulær endotelvækstfaktor (VEGF).
English: The Phase 1b portion included 11 patients who received the combination of 18 mg of lenvatinib plus 5 mg of everolimus.
Danish: Fase 1b inkluderede 11 patienter, som fik kombinationen 18 mg lenvatinib plus 5 mg everolimus.
English: Thyroid function should be monitored before initiation of, and periodically throughout, treatment with lenvatinib.
Danish: Thyreoideafunktionen bør monitoreres, før behandling med lenvatinib indledes og periodisk derefter.
English: Refer also to section 4.8, Other special populations.
Danish: 4.8, Andre særlige populationer).
English: In patients with solid tumours administered single and multiple doses of lenvatinib once daily, exposure to lenvatinib (Cmax and AUC) increased in direct proportion to the administered dose over the range of 3.2 to 32 mg once-daily.
Danish: Hos patienter med faste tumorer, der fik administreret enkeltdosis eller gentagne doser af lenvatinib én gang dagligt, steg eksponeringen for lenvatinib (Cmaks og AUC) direkte proportionalt med den administrerede dosis i intervallet fra 3,2 til 32 mg én gang dagligt.
English: • feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy - these may be signs of a stroke, bleeding in your brain, or the effect on your brain of a severe increase in blood pressure.
Danish: • følelsesløshed eller svækkelse i den ene side af kroppen, svær hovedpine, krampeanfald, forvirring, talebesvær, synsændringer eller svimmelhedsfølelse - dette kan være tegn på et slagtilfælde, blødning i hjernen eller være virkninger i hjernen i forbindelse med en kraftig stigning i blodtrykket.
English: However, testicular (hypocellularity of the seminiferous epithelium) and ovarian changes (follicular atresia) were observed in repeated-dose toxicity studies in animals at exposures 11 to 15 times (rat) or 0.6 to 7 times (monkey) the anticipated clinical exposure (based on AUC) at the maximum tolerated human dose.
Danish: Ændringer i testikler (hypocellularitet af det seminiferøse epitel) og ovarier (follikulær atresi) blev imidlertid observeret i toksicitetsstudier med gentagne doser hos dyr ved eksponeringer, der var 11 til 15 gange (rotte) eller 0,6 til 7 gange (abe) den forventede kliniske eksponering (baseret på AUC) ved den maksimalt tolererede humane dosis.
English: Electrocardiograms should be monitored in all patients with a special attention for those with congenital long QT syndrome, congestive heart failure, bradyarrhythmics, and those taking medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics.
Danish: Der skal tages elektrokardiogram på alle patienter med speciel bevågenhed hos patienter med medfødt langt QT-syndrom, kongestivt hjertesvigt, bradyarytmi og patienter i behandling med lægemidler, der vides at forlænge QT-intervallet, herunder klasse Ia- og III-antiarytmika.
English: Blood pressure should be well controlled prior to treatment with lenvatinib, and should be regularly monitored during treatment (see section 4.4).
Danish: Blodtrykket skal være velkontrolleret før behandling med lenvatinib, og det bør monitoreres regelmæssigt under behandlingen (se pkt.
English: • changes in blood test results for potassium levels (low), calcium levels (low), cholesterol (high) and thyroid stimulating hormone (high)
Danish: • ændringer i blodprøveresultater for kalium (lavt), calcium (lavt), kolesterol (højt) og skjoldbruskkirtel-stimulerende hormon (højt)
English: Overall survival was longer in the lenvatinib plus everolimus arm (see Table 5 and Figure 2).
Danish: Samlet overlevelse var længere i armen med lenvatinib plus everolimus (se tabel 5 og figur 2).
English: Gastrointestinal and abdominal painsf
Danish: Gastrointestinale og abdominale smerterf
English: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal antihypertensive therapy
Danish: Systolisk blodtryk ≥ 160 mmHg eller diastolisk blodtryk ≥ 100 mmHg trods optimal antihypertensiv behandling
English: • changes in blood test results for liver enzymes, white blood cells (low), blood magnesium (low)
Danish: • ændrede resultater af blodprøver for leverenzymer, hvide blodlegemer (lavt) og magnesium i blodet (lavt)
English: • severe pain in the upper left part of the belly (abdomen) which may be associated with fever, chills,
Danish: • svære smerter i den øvre venstre side af maven, hvilket kan være forbundet med feber,
English: No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment.
Danish: Justering af startdosis på basis af nyrefunktion er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: There are limited data on patients of age ≥75 years with RCC.
Danish: Der er begrænsede data for patienter ≥ 75 år med RCC.
English: What you need to know before you take Kisplyx
Danish: Det skal du vide, før du begynder at tage Kisplyx