natgillin/translations-raw huggingface dataset:
Pga. interindividuel variabilitet er den anbefalede dosis ikke nødvendigvis optimal for alle individer, og det anbefales derfor at monitorere bivirkninger omhyggeligt. 
Due to between subject variability the recommended dose adjustments may not be optimal in all individuals, therefore close monitoring of side effects is recommended.
Omrør forsigtigt indholdet i glasset med en ske og gå til trin 8 med det samme. 
Gently stir the contents of the glass with a spoon and then proceed immediately to step 8.
Bonferroni-Holmprocedure d 
Statistically significant per Bonferroni-Holm procedure d
Desuden havde alle 8 patienter i Votubia-armen, som havde radiografisk evidens for hydrocephalus, et fald i ventrikulær volumen. 
In addition, all 8 patients on the Votubia arm who had radiographic evidence of hydrocephalus at baseline had a decrease in ventricular volume.
mTORC1-aktivering fører til en downstream kinase-signaleringskaskade, inklusive aktivering af S6-kinaserne. 
mTORC1 activation leads to a downstream kinase signalling cascade, including activation of the S6 kinases.
95 % CI p-værdi (versus placebo) 
95% CI p-value (versus placebo)
De to lægemiddelformer må ikke kombineres for at opnå den ønskede dosis. 
The two pharmaceutical forms must not be combined to achieve the desired dose.
Hyppigere monitorering anbefales når Votubia anvendes sammen med andre lægemidler, som kan inducere hyperglykæmi. 
More frequent monitoring is recommended when Votubia is co-administered with other medicinal products that may induce hyperglycaemia.
• hævelse i ansigtet, læberne, tungen eller halsen (tegn på angioødem) 
• swelling of the face, lips, tongue or throat (signs of angioedema)
mTOR er en vigtig serin-treonin-kinase, hvis aktivitet vides at være opreguleret i et antal humane cancersygdomme. 
mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers.
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. 
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.
Everolimus' non-kliniske sikkerhedsprofil er vurderet hos mus, rotter, minigrise, aber og kaniner. 
The non-clinical safety profile of everolimus was assessed in mice, rats, minipigs, monkeys and rabbits.
Hvis du har haft allergiske reaktioner før, skal du bede lægen om vejledning. 
If you had allergic reactions before, please ask your doctor for advice.
Instruktioner til patienter eller omsorgspersoner om klargøring af suspensionen ved brug af et lille glas: 
Instructions for patients or caregivers preparing the suspension using a small glass:
Dosisjustering skal foretages, hvis en patients levertilstand (Child-Pugh) ændres under behandlingen. 
Dose adjustments should be made if a patient's hepatic (Child-Pugh) status changes during treatment.
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. 
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.
Procentvis reduktion fra baseline, n (%) 
Percentage reduction from baseline, n (%)
Alle patienter, som fik mindst én dosis everolimus, blev fulgt indtil seponering eller studieafslutning. 
All patients receiving at least one dose of everolimus were followed until drug discontinuation or study completion.
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. 
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.
Fortæl det til din læge, hvis du oplever usædvanlig tørst eller øget hyppighed af vandladning. 
Tell your doctor if you experience any excessive thirst or increased frequency of urination.
Fyld et lille glas med vand (vand fra hanen eller flaskevand uden brus). 
Fill a small glass with water (drinkable tap water or non-sparkling bottled water).
Middelværdien af everolimus' eliminations-halveringstid er ca. 30 timer. 
The mean elimination half-life of everolimus is approximately 30 hours.
Hvor meget Votubia du skal tage 
How much Votubia to take
For bivirkninger af Grad 1 er dosisjustering normalt ikke påkrævet. 
For adverse reactions of Grade 1, dose adjustment is usually not required.
Hvis du har feber eller andre symptomer på en infektion, bør du konsultere din læge. 
If you have fever or other signs of an infection, consult with your doctor.
Derfor bør kvinder, der tager everolimus, ikke amme under behandlingen og i 2 uger efter sidste dosis. 
Therefore, women taking everolimus should not breast-feed during treatment and for 2 weeks after the last dose.
Fyld glasset igen med den samme mængde vand (ca. 25 ml). 
Refill the glass with the same amount of water (about 25 ml).
hvis du før har haft hepatitis B, da hepatitis B kan opstå igen under behandling med Votubia (se afsnit 4, ”Bivirkninger”). 
if you have previously had hepatitis B, because this may occur again during treatment with Votubia (see section 4 ‘Possible side effects').
påvirke din nyrefunktion. 
impact your kidney function.
Hvis symptomerne er moderate, bør det overvejes at afbryde behandlingen, indtil symptomerne bedres. 
If symptoms are moderate, consideration should be given to interruption of therapy until symptoms improve.
Progression af angiomyolipom blev observeret hos 14,3 % af patienterne. 
Angiomyolipoma progressions were observed in 14.3% of the patients.
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. 
Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue Votubia therapy without dose adjustments.
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: 
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:
• Ca. 50 ml vand til at klargøre suspensionen 
• Approximately 50 ml of water to prepare the suspension
Bedste overordnede angiomyolipom-respons - % Respons 
Best overall angiomyolipoma response - % Response
Reaktivering af hepatitis B er blevet set hos nogle patienter, der tager everolimus. 
Hepatitis B reactivation has been observed in some patients taking everolimus.
Føde havde imidlertid ingen synlig effekt på koncentrations/tidsprofilen efter absorptionsfasen 24 timer post-dosis af de 2 lægemiddelformer. 
Food, however, had no apparent effect on the post absorption phase concentration-time profile 24 hours post-dose of either dosage form.
Vær sikker på, at al medicinen er taget 
Making sure all of the medicine has been taken
Følge disse instruktioner, når du skal tage en dosis mellem 1 mg og 10 mg. 
These instructions are for taking a dose between 1 mg and 10 mg.
Når det er muligt, skal optimal glykæmisk kontrol være opnået, før en patient sættes i behandling med Votubia. 
When possible optimal glycaemic control should be achieved before starting a patient on Votubia.
Everolimus er en selektiv hæmmer af mTOR (mammalian target of rapamycin). 
Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor.
Der findes ingen kliniske data på fordelingen af everolimus i den humane hjerne. 
There are no clinical data on the distribution of everolimus in the human brain.
ciclosporin, et lægemiddel, der bruges til at forhindre kroppen i at afstøde transplanterede organer. 
ciclosporin, a medicine used to stop the body from rejecting organ transplants.
Det skal sikres, at hele dosis indtages. 
Care should be taken to ensure the entire dose is ingested.
Det kan være nødvendigt at behandle din infektion, før du begynder at tage Votubia. 
It may be necessary to treat your infection before starting Votubia.
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. 
No patient developed new lesions, worsening hydrocephalus or increased intracranial pressure, and none required surgical resection or other therapy for SEGA.
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. 
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.
Ingen patienter krævede kirugiske indgreb for SEGA under studieforløbet. 
No patient required surgical intervention for SEGA during the entire course of the study.
Sammenfattende er everolimus meget aktivt i denne neuronale model af TSC og med fordele, der tilsyneladende kan tilskrives effekten på hæmning af mTORC1. 
In summary, everolimus is highly active in this neuronal model of TSC, with benefit apparently attributable to effects on mTORC1 inhibition.
Skub stemplet op for at fjerne det meste af luften (der må gerne være en lille smule luft tilbage omkring spidsen). 
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).
Det anbefales at behandle og monitorere for svampeinfektion særligt hos patienter, der behandles med steroidbaserede lægemidler. 
Monitoring for and treatment of fungal infection is recommended, especially in patients being treated with steroid-based medicinal products.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Novartis Pharma GmbH 
Name and address of the manufacturer responsible for batch release Novartis Pharma GmbH
Desuden oplevede næsten dobbelt så mange patienter i placeboarmen anfaldsforværring i forhold til Votubia LT- og HT-armene. 
Furthermore, almost twice as many patients in the placebo arm experienced seizure exacerbation relative to the Votubia LT and HT arms.
Votubia kan også: forårsage mundsår (orale ulcerationer). 
Votubia may also: cause mouth sores (oral ulcerations).
Hos rotter passerer everolimus og/eller dets metabolitter imidlertid let over i mælken (se pkt. 
However, in rats, everolimus and/or its metabolites readily pass into the milk (see section 5.3).
Resultaterne viste, at Votubia var bedre end placebo for det primære endepunkt for bedste overordnede SEGA-respons (p<0,0001). 
Results showed that Votubia was superior to placebo for the primary endpoint of best overall SEGA response (p<0.0001).
Oddsratio (versus placebo) 
Odds ratio (versus placebo)
Kvinder i den fødedygtige alder skal bruge meget sikker prævention under behandlingen og op til 8 uger efter endt behandling. 
Women who could potentially become pregnant must use highly effective contraception during treatment, and for up to 8 weeks after ending treatment.
Hos patienter med fremskredne massive tumorer var Vd 191 l for det synlige centrale kompartment og 517 l for det synlige perifere kompartment. 
In patients with advanced solid tumours, Vd was 191 l for the apparent central compartment and 517 l for the apparent peripheral compartment.
Samtidig anvendelse af ketogen diæt 
Concomitant ketogenic diet
imatinib, der bruges til at hæmme væksten af unormale celler. 
imatinib, used to inhibit the growth of abnormal cells.
Everolimus passerede placenta og var toksisk for fostret. 
Everolimus crossed the placenta and was toxic to the foetus.
Votubia tabletter skal synkes hele med et glas vand. 
Votubia tablets are to be swallowed whole with a glass of water.
• Spørg lægen eller apotekspersonalt om, hvordan du skal dele dosis, hvis du er i tvivl. 
• Ask your doctor or pharmacist about how to split the dose if you are not sure.
Ingen ændring >-25 til <25 
No change >-25 to <25
c p-værdier udregnet vha. Cochran-Mantel-Haenszel-test stratificeret efter aldersundergruppe d 
c p-values computed from the Cochran-Mantel-Haenszel test stratified by age subgroup d
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. 
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.
Suspensionen kan klargøres enten i en oral sprøjte eller et lille glas. 
The suspension can be prepared either in an oral syringe or in a small glass.
Hyppigheden er baseret på antallet af kvinder i de samlede data, der var mellem 10 og 55 år, mens de var i behandling 
Frequency based upon number of women from 10 to 55 years of age while on treatment in the pooled data
Middelværdi (standardafvigelse) Median 
Mean (standard deviation) Median
Endelig analyse 
Final analysis
Anden non-hæmatologisk toksicitet (eksklusive metaboliske bivirkninger) 
Other non-haematological toxicities (excluding metabolic events)
Efter den centrale behandlingsfase kunne patienterne indtræde i en udvidelsesfase, hvor SEGA-volumenet blev bestemt hver 6. måned. 
After the core treatment phase, patients could be enrolled into an extension phase where SEGA volume was assessed every 6 months.
De to behandlingsarme var generelt balancerede med hensyn til demografiske og baseline sygdomskarakteristika og anti-SEGA terapier i anamnesen. 
The two treatment arms were generally well balanced with respect to demographic and baseline disease characteristics and history of prior anti-SEGA therapies.
Hos kaniner viste embryotoksiciteten sig ved øgning i sene resorptioner. 
In rabbits, embryotoxicity was evident in an increase in late resorptions.
Efter administration af en enkelt dosis radioaktivt mærket everolimus sammen med ciclosporin genfandtes 80 % af radioaktiviteten i fæces, mens 5 % blev udskilt i urinen. 
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.
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. 
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.
Der skal derfor udvises forsigtighed med brugen af Votubia i den perioperative periode. 
Caution should therefore be exercised with the use of Votubia in the peri-surgical period.
SEGAvolumen (cm 
SEGA volume (cm
Patienterne var i behandling med 1 til 3 antiepileptika i stabil dosis forud for indtræden i studiet. 
Patients were treated with concomitant and stable dose of 1 to 3 antiepileptics prior to study entry.
Behandling med Votubia bør initieres af en læge med erfaring i behandling af patienter med TSC og terapeutisk lægemiddelmonitorering. 
Treatment with Votubia should be initiated by a physician experienced in the treatment of patients with TSC and therapeutic drug monitoring.
Skub stemplet langsomt ind for at frigive hele indholdet af den orale sprøjte. 
Push the plunger in slowly to release the full contents of the oral syringe.
• Et hurtigt optag af everolimus i hjernen efterfulgt af langsom effluks 
• A rapid uptake of everolimus in the brain followed by a slow efflux.
Forekomsten af skeletale variationer og deformationer (fx ribbensspaltning) var forøget ved 0,3 og 0,9 mg/kg. 
The incidence of skeletal variations and malformations (e.g. sternal cleft) was increased at 0.3 and 0.9 mg/kg.
I et reproduktionsdyrestudie påvirkedes fertiliteten hos hunnerne ikke. 
In animal reproductive studies female fertility was not affected.
Må ikke opbevares ved temperaturer over 25ºC. 
Do not store above 25°C.
Hvilke doser, der vil kunne tolereres og være virkningsfulde, varierer fra patient til patient. 
Doses that will be tolerated and effective vary between patients.
Hvis toksiciteten tolereres, er dosisjustering ikke nødvendig. 
If toxicity is tolerable, no dose adjustment required.
Følgende lægemiddelstoffer kan nedsætte virkningen af Votubia: rifampicin, som bruges til behandling af tuberkulose (TB). 
The following may reduce the effectiveness of Votubia: rifampicin, used to treat tuberculosis (TB).
Forhøjet niveau i blodet af et enzym, der kaldes laktatdehydrogenase, som giver oplysninger om tilstanden i visse organer 
High level of an enzyme called blood lactate dehydrogenase that gives information about the health of certain organs
Interaktion - Ændring i everolimus' AUC/Cmax Geometrisk middelratio (observeret interval) 
Interaction - Change in Everolimus AUC/Cmax Geometric mean ratio (observed range)
Følgende bivirkninger er rapporteret hos patienter, der tager everolimus til behandling af andre sygdomme end TSC: 
The following side effects have been reported in patients taking everolimus for the treatment of conditions other than TSC:
Vask hænderne grundigt både før og efter klargøring af suspensionen. 
Wash hands thoroughly before and after preparation of the suspension.
Symptomer kan omfatte hævelse og/eller smerte i et af benene, ofte i læggen, rødme eller varm hud i det berørte område 
Symptoms may include swelling and/or pain in one of your legs, usually in the calf, redness or warm skin in the affected area
Blokering eller obstruktion af et blodkar (vene) i benet (dyb venetrombose). 
Blockage or obstruction of a blood vessel (vein) in the leg (deep vein thrombosis).
Votubia er tilgængelig i to lægemiddelformer: tabletter og dispergible tabletter. 
Votubia is available in two pharmaceutical forms: tablets and dispersible tablets.
Brug en saks til at åbne blisteren langs den stiplede linje. 
Use scissors to open the blister along the dotted line.
Endelig analyse inkluderer patienter, der krydsede over fra placebo-gruppen; median eksponeringsvarighed for everolimus på 204,1 uger 
Final analysis includes patients who crossed over from the placebo group; median duration of exposure to everolimus of 204.1 weeks
Du må ikke amme under behandlingen og i 2 uger efter den sidste dosis af Votubia. 
You should not breast-feed during treatment and for 2 weeks after the last dose of Votubia.
forårsage åndenød, hoste og feber (se afsnit 4 ”Bivirkninger”). 
cause shortness of breath, cough and fever (see section 4 ‘Possible side effects').
Præ-eksisterende infektioner skal behandles på behørig vis og være fuldstændigt elimineret, inden behandling med Votubia påbegyndes. 
Pre-existing infections should be treated appropriately and should have resolved fully before starting treatment with Votubia.
dronedaron, et lægemiddel, der bruges til at regulere din hjerterytme. 
dronedarone, a medicine used to help regulate your heart beat.
Du vil få taget blodprøver under behandlingen med Votubia. 
You will have blood tests during treatment with Votubia.
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. 
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.
Simuleringer af multiple-dosisfarmakokinetik støtter anbefalingerne af dosering til personer med nedsat leverfunktion baseret på deres Child-Pugh status. 
Simulations of multiple dose pharmacokinetics support the dosing recommendations in subjects with hepatic impairment based on their Child-Pugh status.
Inklusive pneumocystis jirovecii (carinii) pneumoni (PJP, PCP) 
Includes pneumocystis jirovecii (carinii) pneumonia (PJP, PCP)
Plasmaproteinbindingen er ca. 74 % hos både raske forsøgspersoner og patienter med moderat nedsat leverfunktion. 
Plasma protein binding is approximately 74% both in healthy subjects and in patients with moderate hepatic impairment.
Kvinder i den fertile alder/Kontraception til mænd og kvinder 
Women of childbearing potential/Contraception in males and females
Oddsratio >1 til fordel for everolimus-armen. 
Odds ratio >1 favours everolimus arm.
Hos rotter forårsagede everolimus embryo/føtotoksicitet ved systemisk eksponering under det terapeutiske område. 
In rats, everolimus caused embryo/foetotoxicity at systemic exposure below the therapeutic level.
• stærk hudkløe med et rødt udslæt eller hævede knopper 
• severe itching of the skin, with a red rash or raised bumps
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. 
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.
Baseret på en farmakokinetisk populationsanalyse er oral clearance (CL/F) i gennemsnit 20 % højere hos transplantationspatienter af negroid afstamning. 
Based on analysis of population pharmacokinetics, oral clearance (CL/F) is on average 20% higher in black transplant patients.
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. 
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.
Progression blev observeret hos 3,8 % af patienterne i everolimus-armen sammenlignet med 20,5 % i placebo-armen. 
Progressions were observed in 3.8% of patients in the everolimus arm compared with 20.5% in the placebo arm.
Ca. 20 % af everolimus-koncentrationen i fuldblod er begrænset til plasmaet hos cancerpatienter, der får Votubia 10 mg/dag. 
Approximately 20% of the everolimus concentration in whole blood is confined to plasma of cancer patients given Votubia 10 mg/day.
Der foreligger dog ikke kliniske data for denne dosisjustering. 
However, there are no clinical data with this dose adjustment.
Baseret på resultaterne fra de to studier anbefales det at justere dosis hos patienter med nedsat leverfunktion (se pkt 4.2 og 4.4). 
Based on the results of the two studies, dose adjustment is recommended for patients with hepatic impairment (see sections 4.2 and 4.4).
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. 
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.