FrancophonIA/ELRC3.0 huggingface dataset:
English: All events were Grade 1-2.
Danish: Alle hændelser var grad 1-2.
English: Talk to your doctor if you are not sure you can drive.
Danish: Kontakt lægen, hvis du er usikker på, om du må køre.
English: Other contributing factors included diabetes and hypertension.
Danish: Andre medvirkende faktorer omfatter diabetes og hypertension.
English: Therefore, the potential need for dose adjustment cannot be determined.
Danish: Derfor kan det potentielle behov for dosisjustering ikke fastlægges.
English: Then continue taking your capsules at regular times as usual.
Danish: Fortsæt så med at tage kapslerne på de sædvanlige tidspunkter.
English: Partial reversibility of these findings was noted after a 4-week recovery period.
Danish: Der blev set delvis reversibilitet af disse fund efter en 4-ugers rekonvalescensperiode.
English: The capsules are to be swallowed whole with water.
Danish: Kapslerne skal synkes hele med vand.
English: The events were reversible, and no event led to treatment discontinuation.
Danish: Hændelserne var reversible, og ingen hændelser førte til seponering af behandlingen.
English: Nominal p-value
Danish: Nominel p-værdi
English: The efficacy results based on investigator assessment were consistent with the independent central assessment.
Danish: Effektresultaterne baseret på investigatorvurderingen var i overensstemmelse med den uafhængige centrale vurdering.
English: All events occurred in the setting of new or progressive brain metastases.
Danish: Alle hændelser forekom i forbindelse med nye eller progressive hjernemetastaser.
English: In urine, 1.8% of the radioactivity was excreted as encorafenib.
Danish: I urinen blev 1,8 % af radioaktiviteten udskilt som encorafenib.
English: Braftovi is for oral use.
Danish: Braftovi er til oral anvendelse.
English: It is important to take Braftovi for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.
Danish: Det er vigtigt, at du tager Braftovi, så længe lægen foreskriver det. Du må ikke stoppe behandlingen, medmindre lægen siger det.
English: Both patients experienced Grade 3 events.
Danish: Hos begge patienter var hændelserne af grad 3.
English: 450 mg once daily
Danish: 450 mg én gang dagligt
English: Enrolment in Part 2 started after all Part 1 patients were randomised.
Danish: Rekruttering til Del 2 startede, efter at alle Del 1-patienter var blevet randomiseret.
English: Patients should be instructed to immediately inform their physicians if new skin lesions develop.
Danish: Patienter bør instrueres i omgående at informere deres læge, hvis de udvikler nye hudlæsioner.
English: No NOAEL could be established for the 4-week study.
Danish: Der kunne ikke fastslås en NOAEL ved det 4-ugers forsøg.
English: a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Danish: aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
English: Similar results were observed per Investigator assessment.
Danish: Tilsvarende resultater blev observeret ifølge Investigatorvurderingen.
English: Braftovi can be taken with food or between meals.
Danish: Braftovi kan tages sammen med mad eller mellem måltiderne.
English: After oral administration, encorafenib is rapidly absorbed with a median Tmax of 1.5 to 2 hours.
Danish: Efter oral administration absorberes encorafenib hurtigt med en median Tmax på 1,5 til 2 timer.
English: Tell your doctor immediately if you have any of the following serious side effects, either for the first time or if they get worse (see also section 2):
Danish: Kontakt straks lægen, hvis du får en af følgende alvorlige bivirkninger for første gang, eller hvis den bliver værre (se også afsnit 2):
English: Treatment Median PFS (months)
Danish: Median PFS (måneder)
English: Confirmed overall responses
Danish: Bekræftet samlet respons
English: Encorafenib was not genotoxic.
Danish: Encorafenib var ikke genotoksisk.
English: There are limited data for dose reduction to 100mg once daily.
Danish: Der er begrænsede data for dosisreduktion til 100 mg én gang dagligt.
English: After repeat once-daily dosing, steady-state conditions were reached within 15 days.
Danish: Efter gentagen dosering én gang dagligt blev steady state nået i løbet af 15 dage.
English: Do not have grapefruit juice during your treatment with Braftovi.
Danish: Drik ikke grapefrugtjuice i forbindelse med din behandling med Braftovi.
English: Table 5 and Figure 1 summarize the PFS and other efficacy results based on central review of the data by a blinded independent radiology committee.
Danish: Tabel 5 og figur 1 opsummerer PFS og andre effektresultater baseret på en central datagennemgang udført af en blindet uafhængig radiologikomité.
English: Suspicious skin lesions should be managed with dermatological excision and dermatopathologic evaluation.
Danish: Mistænkelige hudlæsioner bør håndteres med dermatologisk excision og dermatopatologisk evaluering.
English: Braftovi is not recommended for children and adolescents under 18 years of age.
Danish: Det frarådes at anvende Braftovi til børn og unge under 18 år.
English: You should use another reliable method of birth control such as a barrier method (e.g. condom) so you do not become pregnant while you are taking this medicine.
Danish: Du skal bruge en anden sikker præventionsmetode, såsom en barrieremetode (f.eks. kondom), så du ikke bliver gravid, mens du tager dette lægemiddel.
English: As the clinical relevance of this is unknown, male patients should be informed of the potential risk for impaired spermatogenesis.
Danish: Eftersom den kliniske relevans af disse fund er ukendt, bør mandlige patienter informeres om den potentielle risiko for nedsat spermatogenese.
English: Encorafenib undergoes minimal renal elimination.
Danish: Encorafenib gennemgår minimal renal elimination.
English: Drink plenty of fluids during treatment.
Danish: Drik rigelig væske under behandlingen.
English: Mutations in the BRAF gene can produce proteins that cause the melanoma to grow.
Danish: Mutationer i BRAF-genet kan producere proteiner, der får melanomet til at vokse.
English: Treatment continued until disease progression or unacceptable toxicity.
Danish: Behandlingen blev givet indtil sygdomsprogression eller uacceptabel toksicitet.
English: Dermatologic reactions
Danish: Dermatologiske reaktioner
English: Besides the serious side effects mentioned above, people taking Braftovi may also get other side effects.
Danish: Udover ovenstående alvorlige bivirkninger kan personer, der tager Braftovi, også få andre bivirkninger.
English: Quality of Life (QoL) (cut-off date: 19 May 2016)
Danish: Livskvalitet (QoL) (skæringsdato: 19. maj 2016)
English: This translates into a 55% increase of the unbound encorafenib exposure.
Danish: Dette udmønter sig i en stigning på 55 % i eksponeringen for ubundet encorafenib.
English: Gastrointestinal disorders were typically managed with standard therapy.
Danish: Gastrointestinale forstyrrelser blev typisk håndteret med standardbehandling.
English: Symptomatic treatment and supportive care should be provided as needed.
Danish: Der bør gives symptomatisk og understøttende behandling efter behov.
English: CI=Confidence interval; CR=Complete Response; DCR=Disease Control Rate (CR+PR+SD+Non-CR/Non-PD; Non-CR/Non-PD applies only to patients without a target lesion who did not achieve CR or have PD); HR=hazard ratio; NE=Not estimable; PFS=progression-free survival; PR=Partial response; SD=stable disease.
Danish: CI = konfidensinterval; CR = komplet respons; DCR = sygdomskontrolrate (CR+PR+SD+Non-CR/Non-PD; Non-CR/Non-PD gælder kun patienter uden en target-læsion, som ikke opnåede CR eller havde PD); HR = hazard ratio; NE = ikke-estimerbar; PFS = progressionsfri overlevelse; PR = delvist respons; SD = stabil sygdom.
English: Treatment should continue until the patient no longer derives benefit or the development of unacceptable toxicity.
Danish: Behandlingen bør fortsættes, indtil patienten ikke får nogen gavn af den længere, eller indtil der opstår uacceptabel toksicitet.
English: There are insufficient data to evaluate potential differences in the exposure of encorafenib by race or ethnicity.
Danish: Der er utilstrækkelige data til at evaluere potentielle forskelle i eksponeringen for encorafenib på baggrund af race eller etnicitet.
English: Patients should ensure adequate fluid intake during treatment.
Danish: Patienterne skal sørge for at indtage tilstrækkelig væske under behandlingen.
English: New primary malignancies
Danish: Nye primære maligniteter
English: Tell your doctor immediately if you vomit and become dehydrated.
Danish: Kontakt omgående lægen, hvis du kaster op og bliver dehydreret.
English: If you get serious side effects (such as heart, eye or bleeding problems) your doctor may lower the dose or stop treatment temporarily or permanently.
Danish: Hvis du får alvorlige bivirkninger (såsom hjerte-, øjen- eller blødningsproblemer), kan lægen beslutte at nedsætte din dosis eller stoppe behandlingen midlertidigt eller permanent.
English: In the small group of patients aged ≥75 years (n=15), patients were more likely to experience serious adverse events and adverse events leading to discontinuation of treatment.
Danish: I den lille gruppe af patienter, der var ≥75 år (n=15), havde patienterne større sandsynlighed for at opleve alvorlige uønskede hændelser og uønskede hændelser, der førte til seponering af behandlingen.
English: Patients should be assessed at each visit for symptoms of new or worsening visual disturbance.
Danish: Patienterne bør vurderes for symptomer på nye eller forværrede synsforstyrrelser ved alle besøg.
English: You will also receive treatment with another medicine, binimetinib.
Danish: Du vil også blive behandlet med et andet lægemiddel, binimetinib.
English: Uveitis and visual impairment were generally reversible.
Danish: Uveitis og synsnedsættelse var som regel reversibel.
English: No overall differences in safety or efficacy were observed between elderly patients (≥ 65) and younger patients.
Danish: Der blev ikke set nogen overordnede forskelle i sikkerheden eller virkningen mellem ældre patienter (≤ 65) og yngre patienter.
English: Copovidone (E1208) Poloxamer 188
Danish: Copovidon (E1208) Poloxamer 188
English: Braftovi is an anti-cancer medicine that contains the active substance encorafenib.
Danish: Braftovi er et lægemiddel mod kræft, som indeholder det aktive stof encorafenib.
English: The data suggest that hepatic uptake transporters are not involved in encorafenib distribution into primary human hepatocytes.
Danish: Dataene tyder på, at leveroptagelsestransportørerne ikke er involveret i fordelingen af encorafenib til primære humane hepatocytter.
English: Tell your doctor if you have had a different type of cancer than melanoma, as Braftovi may worsen certain other types of cancers.
Danish: Fortæl det til lægen, hvis du har haft en anden type kræft end melanom, da Braftovi kan forværre visse andre kræfttyper.
English: As a result, no major changes in encorafenib exposure are expected based upon gender.
Danish: Der forventes derfor ingen betydelige ændringer i eksponeringen for encorafenib på baggrund af køn.
English: The predominant biotransformation reaction of encorafenib was N-dealkylation.
Danish: Den primære biotransformationsreaktion for encorafenib var N-dealkylering.
English: Some people taking Braftovi may also notice new melanomas.
Danish: Nogle personer, der tager Braftovi, kan også få nye melanomer.
English: Encorafenib should be permanently discontinued if patient is unable to tolerate 100mg once daily.
Danish: Encorafenib bør seponeres permanent, hvis patienten ikke kan tolerere 100 mg én gang dagligt.
English: If you miss a dose of Braftovi, take it as soon as you remember.
Danish: Hvis du har glemt at tage en dosis Braftovi, skal du tage den, så snart du kommer i tanke om det.
English: The NOAEL for the 13-week study was at 14- to 32-times human therapeutic exposures.
Danish: NOAEL for det 13 ugers forsøg var 14 til 32 gange behandlingseksponeringen for mennesker.
English: Collectively, these data indicate that encorafenib has a risk of phototoxic potential and minimal risk for sensitization at therapeutic doses in patients.
Danish: Samlet set tyder disse data på, at encorafenib er forbundet med en risiko for fototoksisk potentiale og minimal risiko for sensibilisering ved brug af terapeutiske doser hos patienter.
English: No event required discontinuation, dose modification or interruption.
Danish: Ingen hændelser krævede seponering, dosisændring eller pausering.
English: BRAF mutation testing
Danish: Test for BRAF-mutation
English: In the 13-week study, partial reversibility was noted at the highest dose level (60 mg/kg/d).
Danish: I studiet af 13 ugers varighed blev der set delvis reversibilitet ved det højeste dosisniveau (60 mg/kg/dag).
English: Given the small magnitude of these changes and high variability, these are unlikely to be clinically meaningful, and no dose adjustments are needed for elderly patients.
Danish: Med udgangspunkt i det lille omfang og den høje variabilitet af disse forandringers, vil de sandsynligvis ikke være af klinisk betydning, og det er ikke nødvendigt at justere dosis hos ældre patienter.
English: An additional secondary endpoint included PFS of Combo 450 compared with Enco 300.
Danish: Et yderligere sekundært endepunkt omfattede PFS med Combo 450 sammenlignet med Enco 300.
English: If encorafenib is used during pregnancy or if the patient becomes pregnant while taking encorafenib, the patient should be informed of the potential hazard to the foetus.
Danish: Hvis encorafenib anvendes under graviditeten, eller hvis patienten bliver gravid, mens hun tager encorafenib, skal hun oplyses om de mulige risici for fostret.
English: Cardiac Electrophysiology
Danish: Kardiel elektrofysiologi
English: Dose reduction recommendations for encorafenib are presented in Table 1.
Danish: De anbefalede dosisreduktioner for encorafenib er anført i tabel 1.
English: Braftovi with food and drink
Danish: Brug af Braftovi sammen med mad og drikke
English: Contact your doctor straightaway if you become pregnant while taking Braftovi.
Danish: Kontakt omgående lægen, hvis du bliver gravid, mens du tager Braftovi.
English: It is not known if Braftovi passes into breast milk.
Danish: Det vides ikke, om Braftovi går over i modermælken.
English: Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor.
Danish: Encorafenib er en potent og højselektiv ATP-kompetitiv småmolekylær RAF-kinasehæmmer.
English: However, given the small magnitude of change in clearance and the high variability in the predicted volume of distribution in the model, weight is unlikely to have a clinically relevant influence on the exposition of encorafenib.
Danish: Med udgangspunkt i det lille omfang af ændringen i clearance og den høje variabilitet i det beregnede distributionsvolumen i modellen er det imidlertid usandsynligt, at vægt har en klinisk relevant indvirkning på eksponeringen for encorafenib.
English: Prior treatment with BRAF/ MEK inhibitors was not allowed.
Danish: Forudgående behandling med BRAF-/MEK-hæmmere var ikke tilladt.
English: Left ventricular dysfunction (LVD)
Danish: Dysfunktion af venstre ventrikel (LVD)
English: Dose modifications in case of adverse reactions are provided below and in Table 2.
Danish: Dosisjusteringer i tilfælde af bivirkninger er anført nedenfor og i tabel 2.
English: If you vomit at any time after taking Braftovi, do not take an additional dose.
Danish: Hvis du kaster op, efter du har taget Braftovi, skal du ikke tage en ekstra dosis.
English: An evaluation of change over time in score yielded the same trend for EORTC QLQ-C30 and at all visit for FACT-M.
Danish: En evaluering af ændringer i scoren over tid viste samme tendens for EORTC QLQ-C30 og ved alle besøg for FACT-M.
English: Your doctor will check your skin for any new skin cancers before treatment, every 2 months during treatment, and for up to 6 months after you stop taking Braftovi.
Danish: Lægen kontrollerer din hud for eventuel ny hudkræft inden behandlingen, hver anden måned under behandlingen og i op til seks måneder, efter du er stoppet med at tage Braftovi.
English: Model based predictions indicate that the effect of posaconazole after repeated administrations could be similar for AUC (3-fold increase) and slightly greater for Cmax (2.7-fold increase).
Danish: Modelbaserede beregninger tyder på, at indvirkningen af posaconazol efter gentagen administration kan være af samme størrelsesorden, hvad angår AUC (3-foldig stigning) og lidt større, hvad angår Cmax (2,7-foldig stigning).
English: The accumulation ratio of approximately 0.5 is likely due to auto-induction of CYP3A4.
Danish: Akkumulationsratioen på cirka 0,5 skyldes sandsynligvis auto-induktion af CYP3A4.
English: The mean (CV%) apparent clearance (CL/F) of encorafenib was 27.9 L/h (9.15%).
Danish: Den gennemsnitlige (CV %) tilsyneladende clearance (CL/F) af encorafenib var 27,9 l/t (9,15 %).
English: In addition, encorafenib may inhibit P-gp in the gut and BCRP at the expected clinical concentrations.
Danish: Derudover kan encorafenib hæmme P-gp i tarmen og BCRP ved de forventede kliniske koncentrationer.
English: • QTcF>500 ms and increased by >60 ms from pre-treatment values
Danish: • QTcF > 500 ms og øget med > 60 ms i forhold til værdien inden behandling
English: There are insufficient data to exclude a clinically significant exposure dependent QT prolongation.
Danish: Der er ikke tilstrækkelige data til at udelukke en klinisk signifikant, eksponeringsafhængig QTforlængelse.
English: Number of events (%)
Danish: Antal hændelser (%)
English: Adverse reactions are listed below by MedDRA body system organ class and the following frequency convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er angivet efter systemorganklasse i henhold til MedDRA, og der er benyttet følgende konvention til klassificering af hyppigheden: meget almindelig ≤1/10, almindelig ≤1/100 til <1/10, ikke almindelig ≤1/1.000 til <1/100, sjælden ≥1/10.000 til <1/1.000, meget sjælden <1/10.000, ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is unknown whether encorafenib or its metabolites are excreted in human milk.
Danish: Det er ukendt, om encorafenib/metabolitter udskilles i human mælk.
English: Other major metabolic pathways involved hydroxylation, carbamate hydrolysis, indirect glucuronidation and glucose conjugate formation.
Danish: Andre vigtige metaboliseringsveje omfattede hydroxylering, carbamathydrolyse, indirekte glukuronidering og dannelse af glucosekonjugat.
English: When Braftovi is used in combination with binimetinib, which targets another protein that stimulates cancer cell growth, the combination slows down or stops the growth of your cancer.
Danish: Når Braftovi anvendes i kombination med binimetinib, der retter sig mod et andet protein, der stimulerer væksten af kræftceller, hæmmer eller stopper kombinationen væksten af din kræft.
English: Encorafenib potentially inhibits a number of transporters.
Danish: Encorafenib kan hæmme en række transportører.
English: Renal failure was generally reversible with dose interruption, rehydration and other general supportive measures.
Danish: Nyreinsufficiens var som regel reversibel med pausering af behandlingen, rehydrering og andre almene understøttende tiltag.
English: The proportions of patients experiencing adverse events (AE) and serious adverse events (SAE) were similar in patients aged <65 years and those aged ≥65 years.
Danish: Andelen af patienter, der oplevede uønskede hændelser (AE) og alvorlige uønskede hændelser (SAE) var ens hos patienter < 65 år og patienter ≥ 65 år.
English: The inter-subject variability (CV%) of AUC is ranged from 12.3% to 68.9%.
Danish: Intervallet for interindividuel AUC-variabilitet (CV %) er 12,3 % til 68,9 %.
English: A definitive 10% deterioration in FACT-M and in EORTC QLQC30 was significantly delayed in patients treated with Combo 450 relative to other treatments.
Danish: En definitiv 10 % forværring i FACT-M og EORTC QLQ-C30 blev signifikant udskudt hos de patienter, der blev behandlet med Combo 450, i forhold til andre behandlinger.
English: It should be resumed at a reduced dose.
Danish: Herefter genoptages i samme dosis.
English: Therefore, female patients using hormonal contraception are advised to use an additional or alternative method such as a barrier method (e.g. condom) during treatment with encorafenib and for at least 1 month following the last dose.
Danish: Derfor skal kvindelige patienter, der bruger hormonelle kontraceptiva, rådes til at anvende en ekstra eller en anden metode, såsom en barrieremetode (f.eks. kondom), under behandlingen med encorafenib og i mindst en måned efter sidste dosis.
English: Administration of a single 100 mg dose of encorafenib with a highfat, high-calorie meal decreased the Cmax by 36%, while the AUC was unchanged.
Danish: Administration af en enkelt dosis af 100 mg encorafenib sammen med et måltid med et højt fedt- og kalorieindhold reducerede Cmax med 36 %, hvorimod AUC forblev uændret.
English: Supraventricular tachycardiad
Danish: Supraventrikulær takykardid
English: The safety of encorafenib in combination with binimetinib has not been established in patients with a baseline LVEF that is either below 50% or below the institutional lower limits of normal.
Danish: Sikkerheden af encorafenib i kombination med binimetinib er ikke blevet klarlagt hos patienter med LVEF ved baseline, som enten er under 50 % eller under den nedre normalgrænse.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Unstratified subgroup analyses demonstrated point estimates in favour of Combo 450, including LDH at baseline, ECOG performance status and AJCC stage.
Danish: I ustratificerede undergruppeanalyser blev der påvist punktestimater til Combo 450's fordel, herunder LDH ved baseline, ECOG-performancestatus og AJCC-stadie.
English: There is no known antidote for encorafenib.
Danish: Der er ingen kendt antidot mod encorafenib.
English: Each pack contains either 28 or 112 hard capsules.
Danish: Hver pakning indeholder enten 28 eller 112 hårde kapsler.
English: All the PPES adverse reactions were either Grade 1 (3.3%) or Grade 2 (2.9%).
Danish: Alle PPES-reaktioner var enten af grad 1 (3,3 %) eller grad 2 (2,9 %).
English: If you continue Braftovi on its own while the other medicine (binimetinib) is temporarily stopped based on your doctor's decision, you may get some of the side effects given in the lists above, although the frequency may change (increase or decrease).
Danish: Hvis du fortsætter med Braftovi alene, mens den anden medicin (binimetinib) er midlertidigt stoppet på grundlag af din læges beslutning, kan du få nogle af de bivirkninger, der er nævnt ovenfor, men hyppigheden kan være anderledes (højere eller lavere).
English: Additionally, your doctor needs to check for squamous cell carcinoma on your head, neck, mouth and lymph glands, and you will have CT scans regularly.
Danish: Derudover skal lægen undersøge dit hoved, din hals, din mund og dine lymfekirtler for planocellulært karcinom, og du skal have regelmæssige CT-scanninger.
English: Patients receiving Combo 450 reported no change or a slight improvement in the mean change from baseline EQ-5D-5L index score at all visits, whilst patients receiving vemurafenib or encorafenib reported decreases at all visits (with statistical significant differences).
Danish: De patienter, der fik Combo 450, rapporterede ingen ændring eller en let forbedring i den gennemsnitlige ændring i forhold til baseline i EQ-5D-5L-indeksscoren ved alle besøg, hvorimod de patienter, der fik vemurafenib eller encorafenib, rapporterede om forværring ved alle besøg (med statistisk signifikante forskelle).