FrancophonIA/ELRC3.0 huggingface dataset:
English: This outcome was consistent with the results of a linear regression model predicting the log of absolute seizure frequency during the maintenance period of the core phase, which indicated that for a 2-fold increase in TN-Cmin there was a statistically significant 28% reduction (95% CI: 12%, 42%) in absolute seizure frequency.
Danish: Udfaldet var i overensstemmelse med resultaterne af en lineær regressionsmodel til at forudsige logaritmen af absolut anfaldsfrekvens i hovedfasens vedligeholdelsesperiode, som indikerer at der ved en 2-fold stigning i TN-Cmin var en statistisk signifikant reduktion på 28 % (95 % CI: 12 %, 42 %) i den absolutte anfaldsfrekvens.
English: If any tablets get stuck in the dry upper part of the oral syringe, gently tap the oral syringe until they fall down into the water.
Danish: Hvis nogle tabletter sidder fast i den øverste del af den orale sprøjte, kan du banke forsigtigt på den orale sprøjte, indtil de falder ned i vandet.
English: The estimated angiomyolipoma progression-free rates at 24 months and 48 months were 91.6% and 83.1%, respectively.
Danish: De estimerede progressionsfrie rater for angiomyolipom efter 24 måneder og 48 måneder var hhv. 91,6 % og 83,1 %.
English: Serious side effects of Votubia include:
Danish: Alvorlige bivirkninger ved Votubia kan omfatte:
English: Push the plunger up slowly to remove most of the air.
Danish: Skub stemplet op for at fjerne det meste af luften.
English: The p-values for superiority versus placebo were 0.003 (LT) and <0.001 (HT).
Danish: P-værdien for superioritet versus placebo var 0,003 (LT-arm) og <0,001 (HT-arm).
English: The stability of the ready to use suspension has been demonstrated for 60 minutes.
Danish: En suspension, der er gjort klar til brug, er holdbar i 60 minutter.
English: High levels of sugar in the blood (hyperglycaemia)
Danish: Højt niveau af sukker i blodet (hyperglykæmi)
English: Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus.
Danish: Non-infektiøs pneumonitis er en klasseeffekt af rapamycinderivater, inklusive everolimus.
English: If a dose is missed, the patient should not take an additional dose, but take the usual prescribed next dose.
Danish: Hvis en dosis glemmes, må patienten ikke tage en ekstra dosis, men skal tage den næste sædvanlige ordinerede dosis.
English: The parent substance was not detected in urine or faeces.
Danish: Moderstoffet sporedes ikke i urinen eller fæces.
English: Votubia may elevate cholesterol and/or other blood fats.
Danish: Votubia kan øge mængden af kolesterol og/eller andre fedtstoffer i blodet.
English: In the oncology safety pooling, 37% of the patients treated with everolimus were ≥65 years of age.
Danish: For de samlede onkologiske bivirkninger var 37 % af patienterne, som blev behandlet med everolimus ≥65 år.
English: Similarly, at the same timepoints, ≥50% reductions in volume were observed in 44.2%, 63.3%, and 68.9% of the treated patients, respectively.
Danish: Tilsvarende blev der på de samme tidspunkter observeret ≥50 % reduktion i volumen hos hhv. 44,2 %, 63,3 % og 68,9 % af de behandlede patienter.
English: Long-term follow-up to a median duration of 67.8 months (range: 4.7 to 83.2) demonstrated sustained efficacy.
Danish: Langtidsopfølgning ved en median varighed af 67,8 måneder (interval: 4,7 til 83,2) viste vedvarende effekt.
English: The recommended starting dose for Votubia for the treatment of patients with SEGA is 4.5 mg/m 2.
Danish: Den anbefalede startdosis af Votubia til behandling af patienter med SEGA er 4,5 mg/m 2.
English: Votubia may increase the risk of problems with wound healing.
Danish: Votubia kan øge risikoen for problemer med sårheling.
English: Median Cmin normalised to mg/m dose was lower for the younger age groups, indicating that everolimus clearance (normalised to body surface area) was higher in younger patients.
Danish: Median-Cmin (normaliseret til dosis i mg/m2) var lavere for de yngre aldersgrupper, hvilket indikerer, at clearance af everolimus (normaliseret til kroppens overfladeareal) er højere hos yngre patienter.
English: It may reduce the size of brain tumours called subependymal giant cell astrocytomas (SEGA) which are also caused by TSC.
Danish: Det kan mindske størrelsen af hjernesvulster, kaldet subependymale kæmpecelle-astrocytomer (SEGA), som ligeledes er forårsaget af TSC.
English: Antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin)
Danish: Antiepileptika (fx carbamazepin, phenobarbital, phenytoin)
English: The effect of everolimus on infantile/epileptic spasms or on seizures associated with Lennox-Gastaut syndrome has not been studied and is not established for generalised-onset seizures and subjects without cortical tubers.
Danish: Effekten af everolimus på infantile/epileptiske spasmer og på anfald relateret til Lennox-Gastaut syndrom er ikke undersøgt og er ikke fastlagt for anfald med primær generalisering og hos forsøgspersoner uden kortikale tubera.
English: Votubia dispersible tablets are to be taken as a suspension only and must not be swallowed whole, chewed, or crushed.
Danish: Votubia dipergible tabletter skal kun tages som en suspension og må ikke synkes hele, tygges eller knuses.
English: The evidence is based on analysis of change in SEGA volume.
Danish: Evidensen er baseret på analyse af ændringen i SEGA-volumen.
English: Caution should be exercised when Votubia is taken in combination with orally administered CYP3A4 substrates with a narrow therapeutic index due to the potential for drug interactions.
Danish: Der skal udvises forsigtighed, når Votubia tages i kombination med oralt administrerede CYP3A4-substrater med et snævert terapeutisk vindue på grund af risiko for lægemiddelinteraktioner.
English: For patients not receiving concomitant strong inducers at the start of everolimus treatment, the co-administration may require an increased Votubia dose.
Danish: Patienter, der ikke samtidig får potente induktorer i starten af everolimus-behandlingen, skal ved samtidig administration muligvis have en højere Votubia-dosis.
English: A population pharmacokinetic analysis including 111 patients with SEGA who ranged from 1.0 to 27.4 years (including 18 patients 1 to less than 3 years of age with BSA 0.42 m to 0.74 m 2) showed that BSA-normalised clearance is in general higher in younger patients.
Danish: En farmakokinetisk populationsanalyse, der inkluderede 111 patienter med SEGA i alderen 1,0 til 27,4 år (inklusive 18 patienter mellem 1 og under 3 år med BSA 0,42 m til 0,74 m 2) viste, at BSAnormaliseret clearance generelt er højere hos yngre patienter.
English: Other studies
Danish: Andre studier
English: dexamethasone, a corticosteroid used to treat a wide variety of conditions including inflammatory or immune problems.
Danish: dexamethason, et kortikosteroid, som bruges til behandling af en række tilstande, blandt andet betændelse og problemer med immunforsvaret.
English: For patients with TSC who have SEGA and are unable to swallow tablets, Votubia tablet(s) can be dispersed completely in a glass with approximately 30 ml of water by gently stirring until the tablet(s) is(are) fully disintegrated (approximately 7 minutes), immediately prior to drinking.
Danish: For patienter med TSC, som har SEGA og ikke er i stand til at synke tabletter, kan Votubia tabletten/tabletterne opslemmes fuldstændigt i et glas med ca. 30 ml vand ved forsigtig omrøring indtil tabletten/tabletterne er helt opløst (ca. 7 minutter) og drikkes umiddelbart derefter.
English: Votubia may increase blood sugar levels and worsen diabetes mellitus.
Danish: Votubia kan øge mængden af sukker i blodet og forværre sukkersyge.
English: • A dose-dependent brain penetration of everolimus, which is consistent with the hypothesis of saturation of an efflux pump present in the brain capillary endothelial cells.
Danish: • En dosisafhængig hjernepenetration af everolimus, hvilket er konsistent med hypotesen om mætning af effluks-pumpen, der er til stede i hjernens kapillære endotelceller
English: The number of oncology patients with an adverse reaction leading to discontinuation of everolimus was higher in patients ≥65 years of age (20% versus 13%).
Danish: Antallet af onkologiske patienter med en bivirkning, som medførte seponering af everolimus, var højere hos patienter ≥65 år (20 % versus 13 %).
English: Kidney disorders: altered frequency or absence of urination may be symptoms of kidney failure and have been observed in some patients receiving everolimus.
Danish: Nyresygdomme: ændret vandladningshyppighed eller manglende vandladning kan være symptomer på nyresvigt og er observeret hos visse patienter, der får everolimus.
English: The use of live vaccines should be avoided during treatment with Votubia.
Danish: Anvendelse af levende vacciner bør undgås under behandling med Votubia.
English: Cmax is dose-proportional between 5 and 10 mg. tmax occurs at 1 to 2 hours post-dose.
Danish: Cmax er dosisproportional mellem 5 og 10 mg. tmax indtræffer 1 til 2 timer efter dosering.
English: For dose reductions below the lowest available strength, alternate day dosing should be considered.
Danish: For dosisreduktioner under den lavest tilgængelige styrke, kan dosering hver anden dag overvejes.
English: The prescribed dose of Votubia dispersible tablets should be placed in a small glass (maximum size 100 ml) containing approximately 25 ml of water.
Danish: Den ordinerede dosis af Votubia dispergible tabletter lægges i et lille glas (med en størrelse på højst 100 ml), der indeholder ca. 25 ml vand.
English: Serious cases of haemorrhage, some with a fatal outcome, have been reported in patients treated with everolimus in the oncology setting.
Danish: Der er blevet rapporteret alvorlige tilfælde af hæmoragi, nogle med dødelig udgang, hos patienter behandlet med everolimus i forbindelse med onkologiske diagnoser.
English: Caution is advised in patients taking Votubia, particularly during concomitant use with active substances known to affect platelet function or that can increase the risk of haemorrhage as well as in patients with a history of bleeding disorders.
Danish: Det anbefales at udvise forsigtighed hos patienter, der får Votubia, specielt ved samtidig behandling med aktive substanser, der er kendt for at påvirke blodpladefunktionen, eller som kan øge risikoen for hæmoragi, samt hos patienter med blødersygdom i anamnesen.
English: In total, 28 patients received treatment with Votubia; median age was 11 years (range 3 to 34), 61% male, 86% Caucasian.
Danish: I alt blev 28 patienter behandlet med Votubia; medianalderen var 11 år (fra 3 til 34), 61 % mænd, 86 % kaukasier.
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors
Danish: Samtidig brug af angiotensin-konverteringsenzym (ACE)-hæmmere
English: Three minutes must be allowed for suspension to occur.
Danish: Regn med, at der går mindst tre minutter, før suspensionen dannes.
English: How to take this medicine
Danish: Sådan skal du tage dette lægemiddel
English: The analysis was stratified by use of enzyme-inducing antiepileptics at randomisation (yes/no).
Danish: Analysen var stratificeret i forhold til brug af enzyminducerende antiepileptika ved randomiseringen (ja/nej).
English: Cmax is dose-proportional between 5 and 10 mg. Everolimus is a substrate and moderate inhibitor of PgP.
Danish: Cmax er dosisproportional mellem 5 og 10 mg. Everolimus er et substrat for og en moderat hæmmer af PgP.
English: Approximately 5 ml of water and 4 ml of air should be drawn into the syringe.
Danish: Ca. 5 ml vand og 4 ml luft trækkes ind i sprøjten.
English: In the pivotal phase II study, 22 of the 28 SEGA patients studied were below the age of 18 years and in the pivotal phase III study, 101 of the 117 SEGA patients studied were below the age of 18 years.
Danish: I det pivotale fase II-studie, var 22 af de 28 undersøgte SEGA-patienter under 18 år og i det pivotale fase III-studie, var 101 af de 117 undersøgte SEGA-patienter under 18 år.
English: In patients with TSC and refractory seizures receiving Votubia dispersible tablets, a trend was observed toward lower Cmin normalised to dose (as mg/m2) in younger patients.
Danish: Hos patienter med TSC og refraktære anfald, der fik Votubia dispergible tabletter, sås en tendens i retning af lavere Cmin (normaliseret til dosis i mg/m2) hos yngre patienter.
English: Wait for 3 minutes - until the dispersible tablets have completely broken apart.
Danish: Vent i 3 minutter - indtil de dispergible tabletter er faldet fuldstændigt fra hinanden.
English: Key secondary endpoints included time to angiomyolipoma progression and skin lesion response rate.
Danish: De væsentlige sekundære endepunkter omfattede tid til progression af angiomyolipom og responsraten for hudlæsioner.
English: The filled syringe should be placed into a container (with the tip pointing up) for 3 minutes, until the Votubia dispersible tablets are in suspension.
Danish: Den fyldte sprøjte placeres i en beholder (med spidsen opad) i 3 minutter indtil Votubia dispergible tabletter er i suspension.
English: Studies in animals have shown reproductive toxicity effects including embryotoxicity and foetotoxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksiske effekter, herunder embryotoksicitet og føtotoksicitet (se pkt.
English: Table 5 EXIST-2 - Angiomyolipoma response rates by time-averaged Cmin category, at primary analysis
Danish: Tabel 5 EXIST-2 - Angiomyolipom-responsrate per tidsgennemsnitlig-Cmin kategori ved den primære analyse
English: The long-term follow-up of patients randomised to everolimus and patients randomised to placebo who thereafter crossed over to everolimus demonstrated durable responses.
Danish: Langtidsopfølgning hos patienter, som blev randomiseret til everolimus, og patienter, som blev randomiseret til placebo, og som herefter skiftede over til everolimus, viste varigt respons.
English: At the final analysis, the skin lesion response rate had increased to 68.2% (95% CI: 58.5, 76.9), with one patient reporting a confirmed complete clinical skin lesion response and no patients experiencing progressive disease as their best response.
Danish: Ved den endelige analyse var responseraterne for hudlæsioner steget til 68,2 % (95 % CI: 58,5;76,9) med en patient, der rapporterede bekræftet fuldstændigt klinisk hudlæsionsrespons, og ingen patienter, der oplevede progressiv sygdom som deres bedste respons.
English: If you are taking other medicines at the same time as Votubia, your doctor may need to change the dose of Votubia or the other medicines.
Danish: Hvis du tager anden medicin samtidig med Votubia, skal din læge måske ændre dosis af Votubia eller den anden medicin.
English: angiotensin-converting enzyme (ACE) inhibitors (such as ramipril) used to treat high blood pressure or other cardiovascular problems.
Danish: angiotensin-konverteringsenzym (ACE)-hæmmere (som fx ramipril), som bruges til at behandle for højt blodtryk eller andre hjerte-kar-problemer.
English: Response rate (95% CI)
Danish: Responsrate (95 % CI)
English: These tumours are caused by a genetic disorder called tuberous sclerosis complex (TSC).
Danish: Disse tumorer er forårsaget af en genetisk lidelse, der kaldes tuberøst sclerose-kompleks (TSC).
English: Draw up 5 ml of water by slowly pulling the plunger up.
Danish: Træk 5 ml vand op ved langsomt at trække stemplet tilbage.
English: efavirenz or nevirapine, used to treat HIV infection/AIDS.
Danish: efavirenz eller nevirapin, der bruges til behandling af HIV-infektion/AIDS.
English: Table 8 Change in primary SEGA volume over time
Danish: Tabel 8 Forandring i primær SEGA-volumen over tid
English: Votubia dispersible tablets are given together with other medicines for epilepsy.
Danish: Votubia dispergible tabletter skal tages sammen med anden medicin mod epilepsi.
English: Mix the medicine by slowly turning the oral syringe upside down and back again five times just before using the dose.
Danish: Bland medicinen ved langsomt at vende den orale sprøjte op og ned fem gange, lige inden dosis gives.
English: Other symptoms may include fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), and pain in the upper right abdomen.
Danish: Andre symptomer kan omfatte træthed, nedsat appetit, kvalme, gulsot (gullig hud) og smerter i den øverste højre del af maven.
English: Estimated progression-free rates at 6 months were 100% for the Votubia arm and 85.7% for the placebo arm.
Danish: Den estimerede progressionsfrie rate efter 6 måneder var 100 % for Votubia-armen og 85,7 % for placebo-armen.
English: Age category
Danish: Aldersgruppe
English: For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) may be considered.
Danish: Hos patienter, hvor behandling med kortikosteroider af non-infektiøs lungebetændelse er nødvendig, kan profylaktisk behandling af pneumocystisk jirovecii (carinii) pneumoni (PJP, PCP) overvejes.
English: At baseline, 19.4% of patients had focal seizures with retained awareness (sensory previously confirmed on EEG or motor), 45.1% had focal seizures with impaired awareness (predominantly nonmotor), 69.1% had focal motor seizures (i.e. focal motor seizures with impaired awareness and/or secondary generalised seizures), and 1.6% had generalised onset seizures (previously confirmed by EEG).
Danish: Ved baseline havde 19,4 % af patienterne fokale anfald med bevaret bevidsthed (sensoriske anfald tidligere bekræftet på EEG eller motoriske anfald), 45,1 % havde fokale anfald med nedsat bevidsthed (overvejende ikke-motoriske anfald), 69,1 % havde fokale motoriske anfald (dvs. fokale motoriske anfald med nedsat bevidsthed og/eller sekundært generaliserede anfald), og 1,6 % havde primært generaliserede anfald (tidligere bekræftet i EEG).
English: 10 The patient must drink all of the oral suspension from the glass.
Danish: Patienten skal drikke hele den orale suspension fra glasset.
English: Therefore, absorption and subsequent elimination of everolimus may be influenced by products that affect CYP3A4 and/or PgP.
Danish: Derfor kan absorption og efterfølgende udskillelse af everolimus påvirkes af lægemidler, der påvirker CYP3A4 og/eller PgP.
English: Pour the water from the dose cup into the small glass.
Danish: Hæld vandet fra doseringskoppen ned i det lille glas.
English: After administration of everolimus in patients with advanced solid tumours, steady-state AUC0-τ was dose-proportional over the range of 5 to 10 mg daily dose.
Danish: Efter administration af everolimus til patienter med fremskredne solide tumorer var steady state-AUC0-τ dosisproportional i området 5 til 10 mg daglig dosis.
English: After administration of the prepared suspension, 25 ml of water should be added and be stirred with the same spoon to re-suspend any remaining particles.
Danish: Efter administration af den klargjorte suspension tilføjes 25 ml vand og med den samme ske omrøres for at opslæmme de resterende partikler.
English: At weeks 12, 96 and 192, ≥ 30% reductions in volume were observed in 75.0%, 80.6%, and 85.2% of the treated patients, respectively.
Danish: Ved uge 12, 96 og 192 blev der observeret ≥ 30 % reduktion i volumen hos hhv. 75,0 %, 80,6 % og 85,2 % af de behandlede patienter.
English: Table 4 EXIST-2 - Angiomyolipoma response
Danish: Tabel 4 EXIST-2 - Angiomyolipom-respons
English: Stir the contents with the spoon to remove any medicine left on the glass and spoon.
Danish: Omrør indholdet med en ske for at fjerne det af lægemidlet, der kunne være tilbage i glasset og på skeen.
English: PJP/PCP may be associated with concomitant use of corticosteroids or other immunosuppressive agents.
Danish: PJP/PCP kan være associeret til samtidig behandling med kortikosteroider eller andre immunosupressive lægemidler.
English: The safety, tolerability and pharmacokinetics of Votubia were evaluated in two single oral dose studies of Votubia tablets in 8 and 34 adult subjects with impaired hepatic function relative to subjects with normal hepatic function.
Danish: Votubias sikkerhed, tolerabilitet og farmakokinetik blev vurderet i to enkeltdosisstudier med Votubia tabletter hos 8 og 34 voksne personer med nedsat leverfunktion i forhold til personer med normal leverfunktion.
English: Light fat meals reduced AUC by 32% and Cmax by 42%.
Danish: Måltider med let fedtindhold nedsatte AUC med 32 % og Cmax med 42 %.
English: Headache, dizziness, signs of high blood pressure (hypertension)
Danish: Hovedpine, svimmelhed, tegn på forhøjet blodtryk (hypertension)
English: It is essential to assess everolimus blood levels in cases of suspected overdose.
Danish: Det er yderst vigtigt at vurdere blodkoncentrationer af everolimus ved mistanke om overdosering.
English: A total of 118 patients were randomised, 79 to Votubia 10 mg daily and 39 to placebo.
Danish: I alt 118 patienter blev randomiseret, 79 til Votubia 10 mg dagligt og 39 til placebo.
English: Using an oral syringe
Danish: Brug af oral sprøjte
English: Impaired wound healing is a class effect of rapamycin derivatives, including Votubia.
Danish: Nedsat sårheling er en klasseeffekt af rapamycinderivater, inklusive Votubia.
English: Wait for 3 minutes until the dispersible tablets have completely broken apart.
Danish: Vent i 3 minutter, indtil de dispergible tabletter er faldet fuldstændigt fra hinanden.
English: Analysis of the first key secondary endpoint, change in seizure frequency, was inconclusive; thus, despite the fact that positive results were observed for the two subsequent secondary endpoints (time to SEGA progression and skin lesion response rate), they could not be declared formally statistically significant.
Danish: Analysen af det første væsentlige sekundære endepunkt, ændring i anfaldsfrekvens, var ikke entydig; derfor kunne de ikke erklæres formelt statistisk signifikante, selvom der blev observeret positive resultater for de to øvrige sekundære endepunkter (tid til SEGA-progression og hudlæsions-responsrate).
English: Large decrease in exposure expected.
Danish: Stort fald i eksponering forventes.
English: Monitoring of renal function is recommended (see section 4.4).
Danish: Det anbefales at monitorere nyrefunktionen (se pkt.
English: A total of 49 out of 137 patients (36%) aged <6 years had Grade 3/4 infections, compared to 53 out of 272 patients (19%) aged 6 to <18 years and 27 out of 203 patients (13%) aged ≥18 years.
Danish: I alt havde 49 ud af 137 patienter (36 %) i alderen <6 år grad 3-4 infektioner, sammenlignet med 53 ud af 272 patienter (19 %) i alderen 6 til <18 år og 27 ud af 203 patienter (13 %) i alderen ≥18 år.
English: Presence of at least one SEGA lesion ≥1.0 cm in longest diameter using MRI (based on local radiology assessment) was required for entry.
Danish: Tilstedeværelse af mindst en SEGA-læsion ≥1,0 cm for den længste diameter ved MRI (baseret på lokal radiologisk vurdering) var påkrævet for at deltage.
English: If you are taking any of them, your doctor may switch you to a different medicine, or may change your dose of Votubia.
Danish: Hvis du tager en eller flere af dem, vil din læge måske ændre din behandling til en anden medicin eller ændre din dosis af Votubia.
English: Three randomised, double-blind, placebo-controlled pivotal phase III studies, including double-blind and open label treatment periods, and a non-randomised, open-label, single-arm phase II study contribute to the safety profile of Votubia (n=612, including 409 patients <18 years of age; median duration of exposure 36.8 months [range 0.5 to 83.2]).
Danish: Tre randomiserede, dobbeltblinde, placebokontrollerede pivotale fase III-studier, herunder med dobbeltblinde og åbne behandlingsperioder, og et ikke-randomiseret, åbent, enkelt-armet fase II-studie har bidraget til Votubias bivirkningsprofil (n=612, herunder 409 patienter <18 år; den mediane eksponeringsvarighed var 36,8 måneder [interval 0,5 til 83,2]).