FrancophonIA/ELRC3.0 huggingface dataset:
English: The study independently tested two different primary endpoints: 1) response rate defined as at least a 50% reduction from baseline in frequency of partial-onset seizures during the maintenance period of the core phase; and 2) percentage reduction from baseline in frequency of partial-onset seizures during the maintenance period of the core phase.
Danish: Studiet undersøgte uafhængigt to forskellige primære endepunkter: 1) responsraten defineret som mindst 50 % reduktion fra baseline i frekvensen af partielle anfald i hovedfasens vedligeholdelsesperiode; og 2) procentvis reduktion fra baseline i frekvensen af partielle anfald i hovedfasens vedligeholdelsesperiode.
English: The non-clinical safety profile of everolimus was assessed in mice, rats, minipigs, monkeys and rabbits.
Danish: Everolimus' non-kliniske sikkerhedsprofil er vurderet hos mus, rotter, minigrise, aber og kaniner.
English: If you had allergic reactions before, please ask your doctor for advice.
Danish: Hvis du har haft allergiske reaktioner før, skal du bede lægen om vejledning.
English: Instructions for patients or caregivers preparing the suspension using a small glass:
Danish: Instruktioner til patienter eller omsorgspersoner om klargøring af suspensionen ved brug af et lille glas:
English: Dose adjustments should be made if a patient's hepatic (Child-Pugh) status changes during treatment.
Danish: Dosisjustering skal foretages, hvis en patients levertilstand (Child-Pugh) ændres under behandlingen.
English: The overall type, frequency and severity of adverse reactions observed in children and adolescents have been generally consistent with those observed in adults, with the exception of infections which were reported at a higher frequency and severity in children below the age of 6 years.
Danish: Overordnet har type, frekvens og sværhedsgrad af bivirkninger observeret hos børn og unge generelt været de samme som observeret hos voksne med undtagelse af infektioner, som blev rapporteret med en højere hyppighed og alvorlighed, især hos børn under 6 år.
English: Percentage reduction from baseline, n (%)
Danish: Procentvis reduktion fra baseline, n (%)
English: All patients receiving at least one dose of everolimus were followed until drug discontinuation or study completion.
Danish: Alle patienter, som fik mindst én dosis everolimus, blev fulgt indtil seponering eller studieafslutning.
English: If this is the case, your doctor may need to prescribe a different dose of Votubia or stop treatment, either for a short time or permanently.
Danish: Hvis det er tilfældet, kan det være, at din læge skal ordinere en anden Votubia-dosis eller stoppe behandling, enten i en kort periode eller permanent.
English: Tell your doctor if you experience any excessive thirst or increased frequency of urination.
Danish: Fortæl det til din læge, hvis du oplever usædvanlig tørst eller øget hyppighed af vandladning.
English: Fill a small glass with water (drinkable tap water or non-sparkling bottled water).
Danish: Fyld et lille glas med vand (vand fra hanen eller flaskevand uden brus).
English: The mean elimination half-life of everolimus is approximately 30 hours.
Danish: Middelværdien af everolimus' eliminations-halveringstid er ca. 30 timer.
English: How much Votubia to take
Danish: Hvor meget Votubia du skal tage
English: For adverse reactions of Grade 1, dose adjustment is usually not required.
Danish: For bivirkninger af Grad 1 er dosisjustering normalt ikke påkrævet.
English: If you have fever or other signs of an infection, consult with your doctor.
Danish: Hvis du har feber eller andre symptomer på en infektion, bør du konsultere din læge.
English: Therefore, women taking everolimus should not breast-feed during treatment and for 2 weeks after the last dose.
Danish: Derfor bør kvinder, der tager everolimus, ikke amme under behandlingen og i 2 uger efter sidste dosis.
English: Refill the glass with the same amount of water (about 25 ml).
Danish: Fyld glasset igen med den samme mængde vand (ca. 25 ml).
English: if you have previously had hepatitis B, because this may occur again during treatment with Votubia (see section 4 ‘Possible side effects').
Danish: hvis du før har haft hepatitis B, da hepatitis B kan opstå igen under behandling med Votubia (se afsnit 4, ”Bivirkninger”).
English: impact your kidney function.
Danish: påvirke din nyrefunktion.
English: If symptoms are moderate, consideration should be given to interruption of therapy until symptoms improve.
Danish: Hvis symptomerne er moderate, bør det overvejes at afbryde behandlingen, indtil symptomerne bedres.
English: Angiomyolipoma progressions were observed in 14.3% of the patients.
Danish: Progression af angiomyolipom blev observeret hos 14,3 % af patienterne.
English: Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue Votubia therapy without dose adjustments.
Danish: Patienter, der udvikler radiologiske forandringer, der tyder på non-infektiøs pneumonitis, og som har få eller ingen symptomer, kan fortsætte behandlingen med Votubia uden dosisjusteringer.
English: If you are taking Votubia tablets for the treatment of TSC with SEGA and if you are unable to swallow the tablets, you can stir them into a glass of water:
Danish: Hvis du tager Votubia tabletter for behandling af TSC med SEGA og hvis du ikke kan synke tabletterne, kan du røre dem op i et glas vand:
English: • Approximately 50 ml of water to prepare the suspension
Danish: • Ca. 50 ml vand til at klargøre suspensionen
English: Best overall angiomyolipoma response - % Response
Danish: Bedste overordnede angiomyolipom-respons - % Respons
English: Hepatitis B reactivation has been observed in some patients taking everolimus.
Danish: Reaktivering af hepatitis B er blevet set hos nogle patienter, der tager everolimus.
English: Food, however, had no apparent effect on the post absorption phase concentration-time profile 24 hours post-dose of either dosage form.
Danish: Føde havde imidlertid ingen synlig effekt på koncentrations/tidsprofilen efter absorptionsfasen 24 timer post-dosis af de 2 lægemiddelformer.
English: Making sure all of the medicine has been taken
Danish: Vær sikker på, at al medicinen er taget
English: These instructions are for taking a dose between 1 mg and 10 mg.
Danish: Følge disse instruktioner, når du skal tage en dosis mellem 1 mg og 10 mg.
English: When possible optimal glycaemic control should be achieved before starting a patient on Votubia.
Danish: Når det er muligt, skal optimal glykæmisk kontrol være opnået, før en patient sættes i behandling med Votubia.
English: Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor.
Danish: Everolimus er en selektiv hæmmer af mTOR (mammalian target of rapamycin).
English: There are no clinical data on the distribution of everolimus in the human brain.
Danish: Der findes ingen kliniske data på fordelingen af everolimus i den humane hjerne.
English: ciclosporin, a medicine used to stop the body from rejecting organ transplants.
Danish: ciclosporin, et lægemiddel, der bruges til at forhindre kroppen i at afstøde transplanterede organer.
English: Care should be taken to ensure the entire dose is ingested.
Danish: Det skal sikres, at hele dosis indtages.
English: It may be necessary to treat your infection before starting Votubia.
Danish: Det kan være nødvendigt at behandle din infektion, før du begynder at tage Votubia.
English: No patient developed new lesions, worsening hydrocephalus or increased intracranial pressure, and none required surgical resection or other therapy for SEGA.
Danish: Ingen af patienterne udviklede nye læsioner, forværring af hydrocephalus eller øget intrakranielt tryk, og ingen havde behov for kirurgisk resektion eller anden terapi mod SEGA.
English: These findings were generally observed at systemic exposure levels within the range of therapeutic exposure or above, with the exception of the findings in rats, which occurred below therapeutic exposure due to a high tissue distribution.
Danish: Disse resultater blev generelt observeret ved systemiske eksponeringsniveauer inden for det terapeutiske eksponeringsområde eller derover, bortset fra resultaterne hos rotter, som forekom under den terapeutiske eksponering på grund af høj vævsdistribution.
English: No patient required surgical intervention for SEGA during the entire course of the study.
Danish: Ingen patienter krævede kirugiske indgreb for SEGA under studieforløbet.
English: In summary, everolimus is highly active in this neuronal model of TSC, with benefit apparently attributable to effects on mTORC1 inhibition.
Danish: Sammenfattende er everolimus meget aktivt i denne neuronale model af TSC og med fordele, der tilsyneladende kan tilskrives effekten på hæmning af mTORC1.
English: Push the plunger up slowly to remove most of the air (it is okay for a small amount of air to remain around the tip).
Danish: Skub stemplet op for at fjerne det meste af luften (der må gerne være en lille smule luft tilbage omkring spidsen).
English: Monitoring for and treatment of fungal infection is recommended, especially in patients being treated with steroid-based medicinal products.
Danish: Det anbefales at behandle og monitorere for svampeinfektion særligt hos patienter, der behandles med steroidbaserede lægemidler.
English: Name and address of the manufacturer responsible for batch release Novartis Pharma GmbH
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Novartis Pharma GmbH
English: Furthermore, almost twice as many patients in the placebo arm experienced seizure exacerbation relative to the Votubia LT and HT arms.
Danish: Desuden oplevede næsten dobbelt så mange patienter i placeboarmen anfaldsforværring i forhold til Votubia LT- og HT-armene.
English: Votubia may also: cause mouth sores (oral ulcerations).
Danish: Votubia kan også: forårsage mundsår (orale ulcerationer).
English: D-90429 Nuremberg
Danish: D-90429 Nürnberg
English: However, in rats, everolimus and/or its metabolites readily pass into the milk (see section 5.3).
Danish: Hos rotter passerer everolimus og/eller dets metabolitter imidlertid let over i mælken (se pkt.
English: Results showed that Votubia was superior to placebo for the primary endpoint of best overall SEGA response (p<0.0001).
Danish: Resultaterne viste, at Votubia var bedre end placebo for det primære endepunkt for bedste overordnede SEGA-respons (p<0,0001).
English: Odds ratio (versus placebo)
Danish: Oddsratio (versus placebo)
English: Women who could potentially become pregnant must use highly effective contraception during treatment, and for up to 8 weeks after ending treatment.
Danish: Kvinder i den fødedygtige alder skal bruge meget sikker prævention under behandlingen og op til 8 uger efter endt behandling.
English: In patients with advanced solid tumours, Vd was 191 l for the apparent central compartment and 517 l for the apparent peripheral compartment.
Danish: Hos patienter med fremskredne massive tumorer var Vd 191 l for det synlige centrale kompartment og 517 l for det synlige perifere kompartment.
English: Concomitant ketogenic diet
Danish: Samtidig anvendelse af ketogen diæt
English: imatinib, used to inhibit the growth of abnormal cells.
Danish: imatinib, der bruges til at hæmme væksten af unormale celler.
English: Everolimus crossed the placenta and was toxic to the foetus.
Danish: Everolimus passerede placenta og var toksisk for fostret.
English: Manufacturer Novartis Pharma GmbH Roonstrasse 25
Danish: Novartis Pharma GmbH Roonstrasse 25
English: Votubia tablets are to be swallowed whole with a glass of water.
Danish: Votubia tabletter skal synkes hele med et glas vand.
English: • Ask your doctor or pharmacist about how to split the dose if you are not sure.
Danish: • Spørg lægen eller apotekspersonalt om, hvordan du skal dele dosis, hvis du er i tvivl.
English: No change >-25 to <25
Danish: Ingen ændring >-25 til <25
English: c p-values computed from the Cochran-Mantel-Haenszel test stratified by age subgroup d
Danish: c p-værdier udregnet vha. Cochran-Mantel-Haenszel-test stratificeret efter aldersundergruppe d
English: SEGA response rate 95% CI Best overall SEGA response - (%) Response Stable disease Progression Not evaluable according to independent central radiology review SEGA responses were confirmed with a repeat scan.
Danish: SEGA responsrate 95 % CI Bedste overordnede SEGA respons - (%) Respons Stabil sygdom Progression Ikke evaluerbar I henhold til uafhængig central radiologisk gennemgang SEGA-respons blev bekræftet med en yderligere scanning.
English: The suspension can be prepared either in an oral syringe or in a small glass.
Danish: Suspensionen kan klargøres enten i en oral sprøjte eller et lille glas.
English: Frequency based upon number of women from 10 to 55 years of age while on treatment in the pooled data
Danish: Hyppigheden er baseret på antallet af kvinder i de samlede data, der var mellem 10 og 55 år, mens de var i behandling
English: Mean (standard deviation) Median
Danish: Middelværdi (standardafvigelse) Median
English: Final analysis
Danish: Endelig analyse
English: Other non-haematological toxicities (excluding metabolic events)
Danish: Anden non-hæmatologisk toksicitet (eksklusive metaboliske bivirkninger)
English: After the core treatment phase, patients could be enrolled into an extension phase where SEGA volume was assessed every 6 months.
Danish: Efter den centrale behandlingsfase kunne patienterne indtræde i en udvidelsesfase, hvor SEGA-volumenet blev bestemt hver 6. måned.
English: The two treatment arms were generally well balanced with respect to demographic and baseline disease characteristics and history of prior anti-SEGA therapies.
Danish: De to behandlingsarme var generelt balancerede med hensyn til demografiske og baseline sygdomskarakteristika og anti-SEGA terapier i anamnesen.
English: In rabbits, embryotoxicity was evident in an increase in late resorptions.
Danish: Hos kaniner viste embryotoksiciteten sig ved øgning i sene resorptioner.
English: Following the administration of a single dose of radiolabelled everolimus in conjunction with ciclosporin, 80% of the radioactivity was recovered from the faeces, while 5% was excreted in the urine.
Danish: Efter administration af en enkelt dosis radioaktivt mærket everolimus sammen med ciclosporin genfandtes 80 % af radioaktiviteten i fæces, mens 5 % blev udskilt i urinen.
English: If you experience certain side effects (see section 4) while you are taking Votubia, your doctor may lower your dose or stop treatment, either for a short time or permanently.
Danish: Hvis du får visse bivirkninger (se afsnit 4), mens du tager Votubia, kan det være, at din læge vil nedsætte dosis eller stoppe behandlingen enten i en kort periode eller permanent.
English: Caution should therefore be exercised with the use of Votubia in the peri-surgical period.
Danish: Der skal derfor udvises forsigtighed med brugen af Votubia i den perioperative periode.
English: SEGA volume (cm
Danish: SEGAvolumen (cm
English: Patients were treated with concomitant and stable dose of 1 to 3 antiepileptics prior to study entry.
Danish: Patienterne var i behandling med 1 til 3 antiepileptika i stabil dosis forud for indtræden i studiet.
English: Treatment with Votubia should be initiated by a physician experienced in the treatment of patients with TSC and therapeutic drug monitoring.
Danish: Behandling med Votubia bør initieres af en læge med erfaring i behandling af patienter med TSC og terapeutisk lægemiddelmonitorering.
English: Push the plunger in slowly to release the full contents of the oral syringe.
Danish: Skub stemplet langsomt ind for at frigive hele indholdet af den orale sprøjte.
English: • A rapid uptake of everolimus in the brain followed by a slow efflux.
Danish: • Et hurtigt optag af everolimus i hjernen efterfulgt af langsom effluks
English: The incidence of skeletal variations and malformations (e.g. sternal cleft) was increased at 0.3 and 0.9 mg/kg.
Danish: Forekomsten af skeletale variationer og deformationer (fx ribbensspaltning) var forøget ved 0,3 og 0,9 mg/kg.
English: In animal reproductive studies female fertility was not affected.
Danish: I et reproduktionsdyrestudie påvirkedes fertiliteten hos hunnerne ikke.
English: Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25ºC.
English: Doses that will be tolerated and effective vary between patients.
Danish: Hvilke doser, der vil kunne tolereres og være virkningsfulde, varierer fra patient til patient.
English: If toxicity is tolerable, no dose adjustment required.
Danish: Hvis toksiciteten tolereres, er dosisjustering ikke nødvendig.
English: The following may reduce the effectiveness of Votubia: rifampicin, used to treat tuberculosis (TB).
Danish: Følgende lægemiddelstoffer kan nedsætte virkningen af Votubia: rifampicin, som bruges til behandling af tuberkulose (TB).
English: High level of an enzyme called blood lactate dehydrogenase that gives information about the health of certain organs
Danish: Forhøjet niveau i blodet af et enzym, der kaldes laktatdehydrogenase, som giver oplysninger om tilstanden i visse organer
English: Interaction - Change in Everolimus AUC/Cmax Geometric mean ratio (observed range)
Danish: Interaktion - Ændring i everolimus' AUC/Cmax Geometrisk middelratio (observeret interval)
English: The following side effects have been reported in patients taking everolimus for the treatment of conditions other than TSC:
Danish: Følgende bivirkninger er rapporteret hos patienter, der tager everolimus til behandling af andre sygdomme end TSC:
English: Wash hands thoroughly before and after preparation of the suspension.
Danish: Vask hænderne grundigt både før og efter klargøring af suspensionen.
English: Symptoms may include swelling and/or pain in one of your legs, usually in the calf, redness or warm skin in the affected area
Danish: Symptomer kan omfatte hævelse og/eller smerte i et af benene, ofte i læggen, rødme eller varm hud i det berørte område
English: Blockage or obstruction of a blood vessel (vein) in the leg (deep vein thrombosis).
Danish: Blokering eller obstruktion af et blodkar (vene) i benet (dyb venetrombose).
English: Votubia is available in two pharmaceutical forms: tablets and dispersible tablets.
Danish: Votubia er tilgængelig i to lægemiddelformer: tabletter og dispergible tabletter.
English: Use scissors to open the blister along the dotted line.
Danish: Brug en saks til at åbne blisteren langs den stiplede linje.
English: Final analysis includes patients who crossed over from the placebo group; median duration of exposure to everolimus of 204.1 weeks
Danish: Endelig analyse inkluderer patienter, der krydsede over fra placebo-gruppen; median eksponeringsvarighed for everolimus på 204,1 uger
English: You should not breast-feed during treatment and for 2 weeks after the last dose of Votubia.
Danish: Du må ikke amme under behandlingen og i 2 uger efter den sidste dosis af Votubia.
English: cause shortness of breath, cough and fever (see section 4 ‘Possible side effects').
Danish: forårsage åndenød, hoste og feber (se afsnit 4 ”Bivirkninger”).
English: Pre-existing infections should be treated appropriately and should have resolved fully before starting treatment with Votubia.
Danish: Præ-eksisterende infektioner skal behandles på behørig vis og være fuldstændigt elimineret, inden behandling med Votubia påbegyndes.
English: dronedarone, a medicine used to help regulate your heart beat.
Danish: dronedaron, et lægemiddel, der bruges til at regulere din hjerterytme.
English: You will have blood tests during treatment with Votubia.
Danish: Du vil få taget blodprøver under behandlingen med Votubia.
English: Limited data in patients <3 years of age (n=13) indicate that BSA-normalised clearance is about two-fold higher in patients with low BSA (BSA of 0.556 m2) than in adults.
Danish: Begrænsede data hos patienter <3 år (n=13) tyder på, at BSA-normaliseret clearence er ca. dobbelt så høj hos patienter med lav BSA (BSA på 0,556 m2) som hos voksne.
English: Simulations of multiple dose pharmacokinetics support the dosing recommendations in subjects with hepatic impairment based on their Child-Pugh status.
Danish: Simuleringer af multiple-dosisfarmakokinetik støtter anbefalingerne af dosering til personer med nedsat leverfunktion baseret på deres Child-Pugh status.
English: Includes pneumocystis jirovecii (carinii) pneumonia (PJP, PCP)
Danish: Inklusive pneumocystis jirovecii (carinii) pneumoni (PJP, PCP)
English: Plasma protein binding is approximately 74% both in healthy subjects and in patients with moderate hepatic impairment.
Danish: Plasmaproteinbindingen er ca. 74 % hos både raske forsøgspersoner og patienter med moderat nedsat leverfunktion.
English: Women of childbearing potential/Contraception in males and females
Danish: Kvinder i den fertile alder/Kontraception til mænd og kvinder
English: Odds ratio >1 favours everolimus arm.
Danish: Oddsratio >1 til fordel for everolimus-armen.
English: In rats, everolimus caused embryo/foetotoxicity at systemic exposure below the therapeutic level.
Danish: Hos rotter forårsagede everolimus embryo/føtotoksicitet ved systemisk eksponering under det terapeutiske område.
English: • severe itching of the skin, with a red rash or raised bumps
Danish: • stærk hudkløe med et rødt udslæt eller hævede knopper
English: Besides pathological changes in brain tissue (such as cortical tubers) which may cause seizures, the mTOR pathway is also implicated in the pathogenesis of epilepsy in TSC.
Danish: Foruden patalogiske forandringer i hjernevævet (såsom kortikale tubera), som kan medfører kramper, er mTOR-signalvejen også impliceret i patogenesen for epilepsi i forbindelse med TSC.
English: Based on analysis of population pharmacokinetics, oral clearance (CL/F) is on average 20% higher in black transplant patients.
Danish: Baseret på en farmakokinetisk populationsanalyse er oral clearance (CL/F) i gennemsnit 20 % højere hos transplantationspatienter af negroid afstamning.
English: While taking Votubia, be vigilant for symptoms and signs of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Votubia.
Danish: Mens Votubia tages, skal man være på vagt over for symptomer og tegn på infektion; hvis der stilles en infektionsdiagnose, skal der omgående iværksættes hensigtsmæssig behandling, og afbrydelse eller ophør med Votubia-behandlingen skal overvejes.
English: Progressions were observed in 3.8% of patients in the everolimus arm compared with 20.5% in the placebo arm.
Danish: Progression blev observeret hos 3,8 % af patienterne i everolimus-armen sammenlignet med 20,5 % i placebo-armen.
English: Approximately 20% of the everolimus concentration in whole blood is confined to plasma of cancer patients given Votubia 10 mg/day.
Danish: Ca. 20 % af everolimus-koncentrationen i fuldblod er begrænset til plasmaet hos cancerpatienter, der får Votubia 10 mg/dag.
English: However, there are no clinical data with this dose adjustment.
Danish: Der foreligger dog ikke kliniske data for denne dosisjustering.
English: Based on the results of the two studies, dose adjustment is recommended for patients with hepatic impairment (see sections 4.2 and 4.4).
Danish: Baseret på resultaterne fra de to studier anbefales det at justere dosis hos patienter med nedsat leverfunktion (se pkt 4.2 og 4.4).
English: Inhibition of the mTORC1 signalling pathway interferes with the translation and synthesis of proteins by reducing the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic elongation factor 4E-binding protein (4EBP-1) that regulate proteins involved in the cell cycle, angiogenesis and glycolysis.
Danish: Hæmning af mTORC1-signaleringen griber ind i translation og syntese af proteiner ved at reducere aktiviteten af S6 ribosomal proteinkinase (S6K1) og eukaryotic elongation factor 4E-binding protein (4EBP-1), der regulerer proteiner involveret i cellecyklus, angiogenese og glykolyse.