FrancophonIA/ELRC3.0 huggingface dataset:
English: No efficacy data available in elderly patients
Danish: Ingen tilgængelige effektdata hos ældre patienter
English: Reactivation of infection is an expected reaction during periods of immunosuppression.
Danish: Reaktivering af infektion er en forventet reaktion i perioder med immunsuppression.
English: Primary analysis for double blind period
Danish: Primæranalyse for dobbeltblinde periode
English: Talk to your doctor if you wish to have children.
Danish: Tal med din læge, hvis du ønsker at få børn.
English: Stable disease Progression
Danish: Stabil sygdom Progression
English: This was manifested as mortality and reduced foetal weight.
Danish: Dette manifesterede sig som mortalitet og reduceret føtalvægt.
English: Exact 95% CI obtained using Clopper-Pearson method b
Danish: Præcist 95 % CI opnået ved brug af Clopper-Pearson-metoden b
English: The use of corticosteroids may be indicated.
Danish: Brug af kortikosteroider kan være indiceret.
English: Patients should be advised to report promptly any new or worsening respiratory symptoms.
Danish: Patienter skal rådes til straks at indberette nye eller forværrede respiratoriske symptomer.
English: Discontinue treatment if failure to recover within 4 weeks.
Danish: Seponer behandlingen, hvis der ikke registreres en bedring inden for 4 uger.
English: Long-term monitoring
Danish: Langtidsmonitorering
English: The amount of water added does not need to be exact.
Danish: Mængden af vand behøver ikke at være helt præcis.
English: Adding water
Danish: Tilsæt vand
English: The grades follow CTCAE Version 3.0 and 4.03.
Danish: Graderne følger CTCAE version 3.0 og 4.03.
English: Nonclinical studies in rats indicate:
Danish: Non-kliniske studier i rotter indikerer:
English: Stomatitis mostly occurs within the first 8 weeks of treatment.
Danish: Stomatitis forekommer oftest inden for de første 8 ugers behandling.
English: General supportive measures should be initiated in all cases of overdose.
Danish: Generel understøttende behandling skal iværksættes i alle tilfælde af overdosering.
English: Diltiazem Dronedarone
Danish: Diltiazem Dronedaron
English: Tell your doctor if you are pregnant or think that you may be pregnant.
Danish: Fortæl det til din læge, hvis du er gravid, eller tror du kan være gravid.
English: Non-infectious pneumonitis
Danish: Non-infektiøs pneumonitis
English: Independent central review
Danish: Uafhængig central gennemgang
English: ≥6 years
Danish: ≥6 år
English: Following oral administration, everolimus is the main circulating component in human blood.
Danish: Efter oral administration er everolimus den væsentligste cirkulerende bestanddel i humant blod.
English: Relative bioavailability/bioequivalence
Danish: Relativ biotilgængelighed/bioækvivalens
English: STOP taking Votubia and seek medical help immediately if you or your child experiences any of the following signs of an allergic reaction:
Danish: STOP med at tage Votubia og søg straks læge, hvis du eller dit barn oplever nogen af følgende tegn på en allergisk reaktion:
English: Not all pack sizes or strengths may be marketed in your country.
Danish: Ikke alle pakningsstørrelser eller styrker er nødvendigvis markedsført i dit land.
English: Reduction from baseline
Danish: Reduktion fra baseline
English: Note: The amount of water in the oral syringe does not need to be exact but all the tablets should be covered.
Danish: Bemærk: Mængden af vand i sprøjten behøver ikke at være helt præcis, men alle tabletter skal være dækket.
English: A complete and illustrated set of instructions for use is provided at the end of the package leaflet “Instructions for use”.
Danish: En komplet og illustreret instruktion for brug er tilgængelig bagerst i indlægssedlen ”Instruktioner for anvendelse”.
English: Single doses of up to 70 mg have been given with acceptable acute tolerability in the adult population.
Danish: Enkeltdoser på op til 70 mg er blevet givet med acceptabel akut tolerabilitet hos den voksne population.
English: Votubia must be administered orally once daily at the same time every day, consistently either with or without food (see section 5.2).
Danish: Votubia skal administreres oralt en gang daglig på samme tidspunkt hver dag, konsekvent enten med eller uden mad (se pkt.
English: No specific excretion studies have been undertaken in cancer patients; however, data are available from the studies in transplant patients.
Danish: Der er ikke udført nogen specifikke ekskretionsstudier for cancerpatienter, men der findes tilgængelige data fra studierne af transplantationspatienter.
English: Individualised dose titration can be based on simple proportion:
Danish: Individualiseret dosistitrering kan baseres på simpel forholdsregning:
English: If necessary, drink additional water to wash out any residues in your mouth.
Danish: Hvis nødvendigt, drik yderligere vand for at rense din mund for eventuelle rester.
English: In the total population, 57.3% of patients were male and 93.2% were Caucasian.
Danish: I den totale population var 57,3 % af patienterne mænd og 93,2 % var kaukasere.
English: Thirteen patients (46%) had a secondary smaller SEGA, including 12 in the contralateral ventricle.
Danish: Tretten patienter (46 %) havde en sekundær, mindre SEGA, herunder 12 i den kontralaterale ventrikel.
English: weaken your immune system.
Danish: svække dit immunforsvar.
English: It is reported, however, that CYP3A4 activity is reduced at birth and increases during the first year of life, which could affect the clearance in this patient population.
Danish: Det er dog rapporteret, at CYP3A4-aktivitet er reduceret ved fødslen og stiger i det første leveår, hvilket kan påvirke clearance hos denne patientpopulation.
English: Protein in the urine
Danish: Protein i urinen
English: Patients ≥18 years of age:
Danish: Patienter ≥18 år:
English: There are currently not sufficient data to allow dosing recommendations in this situation.
Danish: Der er på nuværende tidspunkt ikke tilstrækkelige data til at tillade dosisanbefalinger i denne situation.
English: Careful titration may be required to obtain the optimal therapeutic effect.
Danish: Omhyggelig titrering kan være nødvendig for at opnå optimal terapeutisk virkning.
English: Most of the side effects are mild to moderate and will generally disappear if your treatment is interrupted for a few days.
Danish: De fleste bivirkninger er lette til moderate og vil normalt forsvinde, hvis din behandling afbrydes i et par dage.
English: if you have had recent major surgery, or if you still have an unhealed wound following surgery.
Danish: hvis du for nylig har fået foretaget en større operation, eller hvis du stadig har et sår, der ikke er helet efter operationen.
English: Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated.
Danish: Der er ikke påvist nogen yderligere klinisk fordel, såsom forbedring i sygdoms-relaterede symptomer.
English: These metabolites were also identified in animal species used in toxicity studies, and showed approximately 100 times less activity than everolimus itself.
Danish: Disse metabolitter blev også identificeret hos dyrearter, der blev anvendt i toksicitetsstudier, og udviste en ca. 100 gange lavere aktivitet end everolimus selv.
English: Non-clinical studies in rats demonstrated distribution into the brain following administration by both the intravenous and oral routes.
Danish: Non-kliniske studier i rotter demonstrerede distribution ind i hjernen efter både intravenøs og oral administration.
English: Reduction in seizure frequency was sustained over an evaluation period of approximately 2 years.
Danish: Reduktion i anfaldsfrekvens blev opretholdt under en vedligeholdelsesperiode på omtrent 2 år.
English: Not evaluable
Danish: Ikke evaluerbar
English: The tablets must be dispersed in water before administration.
Danish: Tabletterne skal opslæmmes i vand inden administration.
English: The median duration of the double-blind period was 18 weeks.
Danish: Medianvarigheden af den dobbeltblinde behandling var 18 uger.
English: Physicians and patients should be aware of the increased risk of infection with Votubia.
Danish: Læger og patienter skal være opmærksomme på den øgede infektionsrisiko med Votubia.
English: Partial seizures start by only affecting one side of the brain but can spread and extend to larger areas on both sides of the brain (called a “secondary generalisation”).
Danish: Partielle anfald påvirker i begyndelsen kun den ene side af hjernen, men kan sprede sig til større områder i begge hjernehalvdele (dette kaldes sekundær generalisering).
English: Large increase in everolimus concentration is expected.
Danish: Der forventes en stor stigning i koncentrationen af everolimus.
English: Oral clearance (CL/F) is similar in Japanese and Caucasian cancer patients with similar liver functions.
Danish: Oral clearance (CL/F) er omtrent den samme hos japanske og kaukasiske patienter med omtrent samme leverfunktion.
English: Patients <18 years of age:
Danish: Patienter <18 år:
English: Volume indicators
Danish: Volumen indikator
English: If you feel unusually tired (fatigue is a common side effect), take special care when driving or using machines.
Danish: Hvis du føler dig usædvanlig træt (træthed er en almindelig bivirkning), skal du være ekstra forsigtig med at køre eller betjene maskiner.
English: The entire contents of the glass should be administered.
Danish: Hele indholdet af glasset administreres.
English: New everolimus dose = current dose x (target concentration / current concentration)
Danish: Ny everolimusdosis = aktuel dosis x (målkoncentration/aktuel koncentration)
English: Adverse reactions are listed according to MedDRA system organ class.
Danish: Bivirkningerne er opstillet ifølge MedDRA-systemorganklasse.
English: Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Danish: Grad-inddelingen er baseret på National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
English: Votubia is not recommended for use in patients:
Danish: Votubia anbefales ikke til patienter:
English: Talk to your doctor before taking Votubia: if you have any problems with your liver or if you have ever had any disease which may have affected your liver.
Danish: Kontakt lægen, før du tager Votubia: hvis du har nogle problemer med din lever, eller hvis du nogensinde har haft en sygdom, som kan have påvirket din lever.
English: Non-responders - n (%)
Danish: Ikke-respondenter - n (%)
English: Tell your doctor immediately if you experience these symptoms.
Danish: Fortæl det straks til din læge, hvis du oplever nogen af disse symptomer.
English: Itraconazole, posaconazole, voriconazole
Danish: Itraconazol, posaconazol, voriconazol
English: Efavirenz, nevirapine
Danish: Efavirenz, nevirapin
English: Primary analysis
Danish: Primær analyse
English: Statistic
Danish: Statistik
English: Male patients should not be prohibited from attempting to father children.
Danish: Mandlige patienter bør ikke forhindres i at få børn.
English: A higher or lower dose may be recommended by your doctor based on your individual treatment needs, for example if you have problems with your liver or if you are taking certain other medicines in addition to Votubia.
Danish: En større eller mindre dosis kan anbefales af lægen ud fra dine individuelle behandlingsbehov, f.eks. hvis du har leverproblemer, eller hvis du tager visse andre lægemidler foruden Votubia.
English: A limited number of paediatric patients have been exposed to doses higher than 10 mg/m 2/day.
Danish: Et begrænset antal pædiatriske patienter er blevet eksponeret for doser på over 10 mg/m 2/dag.
English: The same pharmaceutical form must be used consistently, as appropriate for the indication being treated.
Danish: Den samme lægemiddelform skal anvendes konsekvent og i overensstemmelse med den indikation, der behandles.
English: Dosing is individualised based on Body Surface Area (BSA) using the Dubois formula, where weight (W) is in kilograms and height (H) is in centimetres:
Danish: Dosis er individuel, baseret på overfladeareal (Body Surface Area (BSA)) ved brug af Dubois formel, hvor vægt (W) angives i kilogram og højde (H) angives i centimeter:
English: Hence, everolimus is considered to contribute the majority of the overall pharmacological activity.
Danish: Følgelig menes everolimus at udgøre hovedparten af den overordnede farmakologiske aktivitet.
English: You will have blood tests before and periodically during treatment.
Danish: Du vil få taget blodprøver før og regelmæssigt i løbet af behandlingen.
English: 25 ml of water
Danish: 25 ml vand
English: • Scissors to open the blister
Danish: • En saks til at åbne blisteren
English: Do not use this medicine if the pack is damaged or shows signs of tampering.
Danish: Brug ikke lægemidlet, hvis emballagen er beskadiget eller viser tegn på at have været åbnet.
English: There was a significant correlation between AUC0-τ and pre-dose trough concentration at steady-state.
Danish: Der var en signifikant korrelation mellem AUC0-τ og prædosis-trough-koncentration ved steady state.
English: Frequency categories are defined using the following 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: Hyppighedskategorierne defineres ved brug af følgende konvention: 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: Median duration of treatment was 18 weeks for all three arms in the core phase and 90 weeks (21 months) when considering both the core and extension phases.
Danish: Den mediane behandlingsvarighed var 18 uger for alle tre arme i hovedfasen og 90 uger (21 måneder), når både hoved- og udvidelsesfasen tages i betragtning.
English: If, despite these measures, you think you may have become pregnant, ask your doctor for advice before taking any more Votubia.
Danish: Hvis du på trods af denne forholdsregel tror, du kan være blevet gravid, skal du spørge din læge til råds, før du tager mere Votubia.
English: Votubia with food and drink Avoid grapefruit and grapefruit juice while you are on Votubia.
Danish: Brug af Votubia sammen med mad og drikke Undgå grapefrugt og grapefrugtjuice, mens du tager Votubia.
English: • The radioactive metabolites of [3H]everolimus do not significantly cross the blood-brain barrier.
Danish: • De radioaktive metabolitter af [3H]everolimus passerer ikke blod-hjernebarrieren i væsentlig grad
English: Take the carton and this leaflet, so that the doctor knows what has been taken.
Danish: Tag pakning og indlægsseddel med, så lægen ved, hvad der er blevet taget.
English: Some cases were severe and on rare occasions, a fatal outcome was observed.
Danish: Nogle tilfælde var alvorlige, og i sjældne tilfælde var udgangen letal.
English: Votubia may have a minor or moderate influence on the ability to drive and use machines.
Danish: Votubia kan i mindre eller i moderat grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Read and follow these instructions carefully so that you know how to correctly prepare the medicine.
Danish: Læs og følg disse instruktioner nøje, så du ved, hvordan du skal klargøre lægemidlet korrekt.
English: Patients should be advised to be cautious when driving or using machines if they experience fatigue during treatment with Votubia.
Danish: Patienter bør rådes til at være forsigtige ved kørsel eller betjening af maskiner, hvis de oplever træthed under behandlingen med Votubia.
English: The immune response to vaccination may be affected and, therefore, vaccination may be less effective during treatment with Votubia.
Danish: Immunresponset på vaccination kan påvirkes, og derfor kan vaccination være mindre effektiv under behandling med Votubia.
English: • 10 ml oral syringe with 1 ml increments (for single use): see figure below
Danish: • 10 ml oral sprøjte med inddelinger á 1 ml (til engangsbrug): se figuren nedenfor
English: These will check the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see if Votubia is having an unwanted effect on these cells.
Danish: Det sker for at kontrollere antallet af blodlegemer (hvide blodlegemer, røde blodlegemer og blodplader) i din krop for at se, om Votubia har en uønsket virkning på disse celler.
English: No signs of acute toxicity have been reported in these cases.
Danish: Der blev ikke rapporteret tegn på akut toksicitet i disse tilfælde.
English: Laboratory tests and monitoring
Danish: Laboratorietest og monitorering
English: Tell your doctor if you experience symptoms of hepatitis B during treatment with everolimus.
Danish: Fortæl det til din læge, hvis du oplever symptomer på hepatitis B under behandling med everolimus.
English: This is to measure the amount of Votubia in your blood and find the best daily dose for you.
Danish: Dette gøres for at måle, hvor meget Votubia du har i blodet, og for at finde den bedste daglige dosis til dig.
English: Everolimus is not considered dialysable to any relevant degree (less than 10% was removed within 6 hours of haemodialysis).
Danish: Everolimus betragtes ikke som værende dialyserbar i relevant omfang (mindre end 10 % blev fjernet inden for 6 timers hæmodialyse).
English: Refill the glass with the same amount of water (approximately 30 ml), gently stir the remaining content and drink the whole amount to make sure that you get the full dose of Votubia tablets.
Danish: Fyld igen glasset med samme mængde vand (ca. 30 ml), omrør forsigtigt det resterende indhold og drik det hele for at være sikker på, at du får hele din dosis Votubia tabletter.
English: Odds ratio and its 95% CI obtained using logistic regression stratified by age subgroup.
Danish: Oddsratio og dens 95 % CI opnået ved brug af logistisk regression stratificeret efter aldersundergruppe.
English: Toxicity study with juvenile monkeys did not show any relevant toxicity.
Danish: Toksicitetsstudier med unge aber viste ingen relevant toksicitet.
English: In this case, 25% of the dose calculated based on BSA (rounded to the nearest strength) must not be exceeded.
Danish: I så fald må 25 % af dosis, beregnet på baggrund af BSA (afrundet til nærmest styrke), ikke overskrides.
English: Clinical study results did not show an impact of Votubia on growth and pubertal development.
Danish: Resultater fra kliniske studier viste ingen negativ effekt af Votubia på vækst- og pubertetsudvikling.
English: Use an oral syringe or a small glass for preparing and taking the Votubia suspension only - do not use it for anything else.
Danish: Brug kun en oral sprøjte eller et lille glas til at klargøre og tage Votubia suspensionen - brug det ikke til noget andet.
English: Consistently take only the tablets or only the dispersible tablets, and never a combination of both.
Danish: Tag konsekvent kun enten tabletter eller dispergible tabletter, aldrig en kombination af begge.
English: However, the exact mechanism of action in the reduction of seizures associated with TSC is not fully elucidated.
Danish: Imidlertid er den nøjagtige virkningsmekanisme bag reduktionen af anfald i forbindelse med TSC ikke fuldt ud belyst.
English: Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Danish: Behandling bør fortsætte, så længe der observeres en klinisk fordel eller indtil uacceptabel toksicitet.
English: This dose of Votubia is predicted to adjust the AUC to the range observed without inducers.
Danish: Denne dosis af Votubia forventes at tilpasse AUC til det interval, der er observeret uden induktorer.
English: Votubia could harm an unborn baby and is not recommended during pregnancy.
Danish: Votubia kan skade dit ufødte barn og frarådes under graviditet.
English: Pale stools or dark urine may also be signs of hepatitis.
Danish: Lys afføring og mørk urin kan også være tegn på hepatitis.
English: In cases where the revised dose is not a multiple of 2.5 mg, it should be rounded to the next available tablet strength.
Danish: I tilfælde, hvor den reviderede dosis ikke er et multiplum af 2,5 mg, skal den rundes op til næste tilgængelige tablet-styrke.
English: Baseline seizure frequency and TN-Cmin were both significant factors (α=0.05) in predicting the absolute seizure frequency in the linear regression model.
Danish: Baseline-anfaldsfrekvens og TN-Cmin var begge væsentlige faktorer (α= 0,05) til at forudsige den absolutte anfaldsfrekvens i den lineære regressionsmodel.
English: There are no adequate data from the use of everolimus in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af everolimus hos gravide kvinder.
English: Everolimus can reduce levels of vascular endothelial growth factor (VEGF).
Danish: Everolimus kan nedsætte niveauer af VEGF (vascular endothelial growth factor).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i henhold til lokale retningslinjer.
English: Administration of everolimus for up to 2 years did not indicate any oncogenic potential in mice and rats up to the highest doses, corresponding respectively to 4.3 and 0.2 times the estimated clinical exposure.
Danish: Administration af everolimus i op til 2 år viste intet onkogent potentiale hos mus og rotter op til højeste dosis, svarende til henholdsvis 4,3 og 0,2 gange den estimerede kliniske eksponering.
English: Two primary regulators of mTORC1 signalling are the oncogene suppressors tuberin-sclerosis complexes 1 & 2 (TSC1, TSC2).
Danish: To primære regulatorer af mTORC1-signalering er onkogen-suppressorerne tuberin-sclerosis complex 1 & 2 (TSC1, TSC2).
English: Due to between subject variability the recommended dose adjustments may not be optimal in all individuals, therefore close monitoring of side effects is recommended.
Danish: Pga. interindividuel variabilitet er den anbefalede dosis ikke nødvendigvis optimal for alle individer, og det anbefales derfor at monitorere bivirkninger omhyggeligt.
English: Gently stir the contents of the glass with a spoon and then proceed immediately to step 8.
Danish: Omrør forsigtigt indholdet i glasset med en ske og gå til trin 8 med det samme.
English: Statistically significant per Bonferroni-Holm procedure d
Danish: Bonferroni-Holmprocedure d
English: In addition, all 8 patients on the Votubia arm who had radiographic evidence of hydrocephalus at baseline had a decrease in ventricular volume.
Danish: Desuden havde alle 8 patienter i Votubia-armen, som havde radiografisk evidens for hydrocephalus, et fald i ventrikulær volumen.
English: mTORC1 activation leads to a downstream kinase signalling cascade, including activation of the S6 kinases.
Danish: mTORC1-aktivering fører til en downstream kinase-signaleringskaskade, inklusive aktivering af S6-kinaserne.
English: 95% CI p-value (versus placebo)
Danish: 95 % CI p-værdi (versus placebo)
English: The two pharmaceutical forms must not be combined to achieve the desired dose.
Danish: De to lægemiddelformer må ikke kombineres for at opnå den ønskede dosis.
English: More frequent monitoring is recommended when Votubia is co-administered with other medicinal products that may induce hyperglycaemia.
Danish: Hyppigere monitorering anbefales når Votubia anvendes sammen med andre lægemidler, som kan inducere hyperglykæmi.
English: • swelling of the face, lips, tongue or throat (signs of angioedema)
Danish: • hævelse i ansigtet, læberne, tungen eller halsen (tegn på angioødem)
English: mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers.
Danish: mTOR er en vigtig serin-treonin-kinase, hvis aktivitet vides at være opreguleret i et antal humane cancersygdomme.