FrancophonIA/ELRC3.0 huggingface dataset:
English: With the possible exception of the rat-specific lens finding (where young animals appeared to be more susceptible), it appears that there is no significant difference in the sensitivity of juvenile animals to the adverse reactions of everolimus as compared to adult animals.
Danish: Muligvis med undtagelse af det rotte-specifikke linsefund (hvor unge dyr syntes at være mere modtagelige) synes der ikke at være signifikant forskel mellem unge og voksne dyrs følsomhed over for bivirkningerne ved everolimus.
English: Healthcare professionals and patients should be vigilant for signs and symptoms of bleeding throughout the treatment period, especially if risk factors for haemorrhage are combined.
Danish: Sundhedspersonale og patienter skal være opmærksomme på tegn og symptomer på blødning i behandlingsperioden, specielt hvis der er flere risikofaktorer for hæmoragi.
English: Haematological parameters
Danish: Hæmatologiske parametre
English: If you miss a dose, take your next dose as scheduled.
Danish: Hvis du glemmer en dosis, skal du tage din næste dosis efter planen.
English: Temporary dose interruption.
Danish: Midlertidig behandlingspause.
English: Agents whose plasma concentration may be altered by everolimus
Danish: Forbindelser hvis plasmakoncentration kan blive påvirket af everolimus
English: Fluconazole
Danish: Fluconazol
English: Table 1 Votubia starting dose for patients with TSC and refractory seizures
Danish: Tabel 1 Votubia-startdosis til patienter med TSC og refraktære anfald
English: Do not take Votubia if you are allergic to everolimus, to related substances such as sirolimus or temsirolimus, or to any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Votubia hvis du er allergisk over for everolimus, beslægtede stoffer som fx sirolimus eller temsirolimus eller et af de øvrige indholdsstoffer i Votubia (angivet i afsnit 6).
English: When possible, the same assay and laboratory for therapeutic drug monitoring should be used throughout the treatment.
Danish: Når det er muligt, bør den samme analysemetode og det samme laboratorie til terapeutisk lægemiddelmonitorering anvendes i løbet af behandlingen.
English: Therefore, your doctor will monitor your kidney function while you are taking Votubia.
Danish: Derfor vil din læge tjekke din nyrefunktion, mens du tager Votubia.
English: Secondary endpoints included seizure freedom, proportion of patients with >25% seizure frequency reduction from baseline, distribution of reduction from baseline in seizure frequency (≤-25%, >-25% to <25%; ≥25% to <50%; ≥50% to <75%; ≥75% to <100%; 100%), long-term evaluation of seizure frequency and overall quality of life.
Danish: De sekundære endepunkter inkluderede anfaldsfrihed, andel af patienter med >25 % reduktion i anfaldsfrekvens fra baseline, fordeling af reduktion fra baseline i anfaldsfrekvens (≤-25 %; >-25 % til <25 %; ≥25 % til <50 %; ≥50 % til <75 %; ≥75 % til <100 %; 100 %), langsigtet evaluering af anfaldsfrekvens og overordnet livskvalitet.
English: ritonavir, and other medicines used to treat HIV infection/AIDS.
Danish: ritonavir og andre lægemidler, der bruges til behandling af HIV-infektion/AIDS.
English: Genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of clastogenic or mutagenic activity.
Danish: Genotoksicitetsstudier dækkende relevante genotoksicitets-endepunkter viste ingen tegn på klastogen eller mutagen aktivitet.
English: Time-averaged Cmin category
Danish: Tidsgennemsnitlig Cmin kategori
English: Figure 1 EXIST-3 - Distribution of reduction from baseline in seizure frequency
Danish: Figur 1 EXIST-3 - Fordeling af reduktion i anfaldsfrekvens i forhold til baseline
English: However products containing alcohol, hydrogen peroxide, iodine and thyme derivatives should be avoided as they may exacerbate the condition.
Danish: Mundskyllevæsker, der indeholder alkohol, hydrogenperoxid, iod eller timianekstrakt skal dog undgås, da de kan forværre tilstanden.
English: The mTOR regulates protein synthesis and multiple downstream cellular functions that may influence neuronal excitability and epileptogenesis.
Danish: mTOR regulerer proteinsyntesen og flere downstream-cellulære funktioner, der kan påvirke neuronexcitabiliteten og epileptogenesen.
English: Push the plunger in until it touches the dispersible tablets.
Danish: Skub stemplet ind, indtil det rører ved de dispergible tabletter.
English: If you forget to take Votubia
Danish: Hvis du har glemt at tage Votubia
English: Renal function of patients should be monitored particularly where patients have additional risk factors that may further impair renal function.
Danish: Patientens nyrefunktion skal monitoreres, specielt hos patienter med risikofaktorer, der kan svække nyrefunktionen yderligere.
English: The incidence of Grade 1 stomatitis was 18.8% (n=16/85) and no cases of Grade 3 or 4 stomatitis were reported.
Danish: Forekomsten af stomatitis af grad 1 var 18,8 % (n=16/85) og der blev ikke rapporteret tilfælde af stomatitis af grad 3 eller 4.
English: clarithromycin, telithromycin or erythromycin, antibiotics used to treat bacterial infections.
Danish: clarithromycin, telithromycin eller erythromycin, antibiotika, der bruges til behandling af bakterieinfektioner.
English: verapamil or diltiazem, used to treat heart conditions or high blood pressure.
Danish: verapamil eller diltiazem, der bruges til behandling af hjertelidelser eller for højt blodtryk.
English: if you have high cholesterol.
Danish: hvis du har forhøjet kolesteroltal.
English: Votubia contains lactose (milk sugar).
Danish: Votubia indeholder lactose (mælkesukker).
English: Therapeutic drug monitoring
Danish: Terapeutisk lægemiddelmonitorering
English: if you need to receive a vaccine while taking Votubia as vaccination may be less effective.
Danish: hvis du skal vaccineres, mens du tager Votubia, da vaccinationen kan være mindre effektiv.
English: The majority of patients (67%) failed 5 or more antiepileptics prior to the study and 41.0% and 47.8% of patients were taking 2 and ≥3 antiepileptics during the study.
Danish: Størstedelen af patienterne (67 %) havde ikke opnået behandlingskontrol med 5 eller flere antiepileptika forud for studiet, og 41,0 % og 47,8 % af patienterne tog henholdsvis 2 og ≥3 antiepileptika under studiet.
English: In the final analysis, reduction in angiomyolipoma volume improved with longer term treatment with Votubia.
Danish: I den endelige analyse forbedredes reduktion af angiomyolipomvolumen med længere tids behandling med Votubia.
English: According to independent central radiology review Angiomyolipoma responses were confirmed with a repeat scan.
Danish: I henhold til uafhængig central radiologisk gennemgang Angiomyolipom-respons blev bekræftet med en yderligere scanning.
English: In the pivotal phase III study in patients with TSC and refractory seizures, 299 of the 366 patients studied were below the age of 18 years.
Danish: I det pivotale fase III-studie med patienter med TSC og refraktære anfald var 299 ud af de 366 undersøgte patienter under 18 år.
English: At the end of the core phase, overall quality of life in patients aged 2 to <11 years (as measured by the mean change from baseline in overall Quality Of Life score [total score] in the Childhood Epilepsy Questionnaire [QOLCE]) was maintained in each Votubia treatment arm as well as in the placebo arm.
Danish: Ved afslutningen af hovedfasen var den overordnede livskvalitet hos patienter i alderen 2 til <11 år (målt ved gennemsnitlig ændring fra baseline i den totale Quality Of Life score [totale score] i Childhood Epilepsy Questionnaire [QOLCE]) opretholdt i de 2 Votubia-arme såvel som i placeboarmen.
English: Put the required number of tablets into a glass of water (approximately 30 ml).
Danish: Læg det anviste antal tabletter i et glas vand (ca. 30 ml).
English: The extent of absorption of everolimus through topical exposure is not known.
Danish: Det vides ikke i hvor høj grad everolimus absorberes gennem topikal eksponering.
English: Therefore, you may be at risk of getting an infection while you are taking Votubia.
Danish: Du kan derfor risikere at få en infektion, mens du tager Votubia.
English: The increase in the pre-dose concentrations of these antiepileptics may not be clinically significant but dose adjustments for antiepileptics with a narrow therapeutic index, e.g carbamazepine, may be considered.
Danish: Stigningen i præ-doseringskoncentrationen af disse antiepileptika er muligvis ikke klinisk signifikant, men dosisjustering af antiepileptika med et snævert terapeutisk indeks, fx carbamazepin, kan overvejes.
English: Six main metabolites of everolimus have been detected in human blood, including three monohydroxylated metabolites, two hydrolytic ring-opened products, and a phosphatidylcholine conjugate of everolimus.
Danish: Der er fundet seks hovedmetabolitter af everolimus i humant blod, herunder tre monohydroxylerede metabolitter, to hydrolytiske produkter med åbnet ring og et fosfatidylcholin-konjugat af everolimus.
English: When switching pharmaceutical forms, the dose should be adjusted to the closest milligram strength of the new pharmaceutical form and the everolimus trough concentration should be assessed at least 1 week later (see section “Therapeutic drug monitoring” above).
Danish: Når der skiftes mellem lægemiddelformer, skal dosis justeres til nærmeste milligram styrke af den nye lægemiddelform, og everolimus dal-koncentrationen skal vurderes mindst 1 uge efter (se ”Terapeutisk lægemiddelmonitorering” ovenfor).
English: Loss of either TSC1 or TSC2 leads to elevated rheb-GTP levels, a ras family GTPase, which interacts with the mTORC1 complex to cause its activation.
Danish: Tab af enten TSC1 eller TSC2 forhøjer koncentrationerne af rheb-GTP, en GTPase af ras-familien, som interagerer med mTORC1-komplekset, så dette aktiveres.
English: Concomitant antiepileptic therapy may affect the metabolism of everolimus and may contribute to this variance (see section 4.5).
Danish: Samtidig antiepileptisk behandling kan påvirke metabolismen af everolimus og kan bidrage til denne forskel (se pkt.
English: Higher proportions of responders were evident for all response categories in the Votubia LT and HT arms relative to placebo (Figure 1).
Danish: Der var højere andele af respondenter for alle responskategorier i Votubia LT- og HT-armene i forhold til placeboarmen (figur 1).
English: If the dose of your anti-seizure medicine changes, please inform your doctor.
Danish: Hvis dosis af din medicin mod krampeanfald ændres, skal du informere din læge.
English: Important information for caregivers
Danish: Vigtig information til omsorgspersoner
English: Everolimus had no impact on pre-dose concentrations of antiepileptics that are substrates of CYP3A4 (clonazepam, diazepam, felbamate and zonisamide).
Danish: Everolimus havde ingen indvirkning på præ-doseringskoncentrationen af antiepileptika, som er CYP3A4-substrater (clonazepam, diazepam, felbamat og zonisamid).
English: Everolimus binds to the intracellular protein FKBP-12, forming a complex that inhibits mTOR complex-1 (mTORC1) activity.
Danish: Everolimus binder til det intracellulære protein FKBP-12 og danner et kompleks, der hæmmer aktiviteten af mTOR kompleks-1 (mTORC1).
English: Please read the detailed instructions at the end of this leaflet to find out how to do this.
Danish: Læs omhyggeligt de detaljerede instruktioner, som står sidst i denne indlægsseddel, for at se, hvad du skal gøre.
English: • 1 small glass (maximum size 100 ml)
Danish: • Et lille glas (med en størrelse på højst 100 ml)
English: Post-transplant renal impairment (creatinine clearance range 11-107 ml/min) did not affect the pharmacokinetics of everolimus in transplant patients.
Danish: Nedsat nyrefunktion efter transplantation (kreatininclearance 11-107 ml/min) påvirkede ikke everolimus farmakokinetik hos transplantationspatienter.
English: The incidence of Grade ≥2 stomatitis at 8 weeks was 2.4% (n=2/85 evaluable patients) which was lower than historically reported.
Danish: Forekomsten af stomatitis af grad ≥2 efter 8 uger var 2,4 % (n=2/85 evaluérbare patienter), hvilket var lavere end tidligere rapporteret.
English: The pharmacokinetics of everolimus have not been studied in patients younger than 1 year of age.
Danish: Everolimus' farmakokinetik er ikke undersøgt hos patienter under 1 år.
English: • Severe hepatic impairment (Child-Pugh C): Votubia is only recommended if the desired benefit outweighs the risk.
Danish: • Svært nedsat leverfunktion (Child-Pugh C): Votubia anbefales kun, hvis den ønskede fordel opvejer risikoen.
English: Patients were randomised in a 2:1 ratio to receive either Votubia or matching placebo.
Danish: Patienterne blev randomiseret i en 2:1 ratio til enten Votubia eller tilsvarende placebo.
English: Efficacy, safety, concomitant therapy, and the current trough concentration should be considered when planning for dose titration.
Danish: Effekt, sikkerhed, samtidig behandling og den aktuelle dal-koncentration bør tages i betragtning ved planlægning af dosistitrering.
English: The evidence is based on analysis of change in sum of angiomyolipoma volume.
Danish: Evidensen er baseret på analyse af ændringen i summen af angiomyolipom-volumen.
English: Preclinical studies in models of mTOR dysregulation in the brain demonstrated that treatment with an mTOR inhibitor such as everolimus could prolong survival, suppress seizures, prevent the development of new-onset seizures and prevent premature death.
Danish: Prækliniske studier i modeller af mTOR-dysregulering i hjernen viste, at behandling med en mTORhæmmer, såsom everolimus, kunne forlænge overlevelsen, undertrykke anfald, forhindre udvikling af nye anfald og forebygge tidlig død.
English: Wash the glass and the spoon thoroughly with clean water.
Danish: Vask glasset og skeen grundigt med vand.
English: AUC ↓63% (range 0-80%) Cmax ↓58% (range 10-70%)
Danish: AUC ↓63 % (interval 0-80 %) Cmax ↓58 % (interval 10-70 %)
English: One patient met the pre-specified criteria for treatment success (>75% reduction in SEGA volume) and was temporarily taken off trial therapy; however, SEGA re-growth was evident at the next assessment at 4.5 months and treatment was restarted.
Danish: En enkelt patient opfyldte de foruddefinerede kriterier for behandlingssucces (>75 % reduktion i SEGA-volumen) og blev midlertidigt taget af forsøgsbehandlingen; ved næste vurdering efter 4,5 måneder sås der imidlertid fornyet SEGA-vækst, og behandlingen blev genoptaget.
English: Hands should be washed thoroughly before and after preparation of the suspension.
Danish: Hænder skal vaskes grundigt før og efter klargøring af suspensionen.
English: You must mix the dispersible tablets with water to create a cloudy liquid (known as an oral suspension).
Danish: Du skal blande de dispergible tabletter med vand for at lave en uklar væske (kaldet en oral suspension).
English: Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Everolimus bør ikke anvendes under graviditet og af kvinder i den fertile alder, som ikke anvender kontraception.
English: If a diagnosis of invasive systemic fungal infection is made, Votubia treatment should be promptly and permanently discontinued and the patient treated with appropriate antifungal therapy.
Danish: Hvis diagnosen invasiv systemisk svampeinfektion stilles, skal Votubia-behandling omgående og permanent seponeres, og patienten skal behandles med et passende antimykotisk lægemiddel.
English: Fertility Votubia may affect male and female fertility.
Danish: Votubia kan påvirke den mandlige og kvindelige frugtbarhed.
English: The entire contents of the syringe should be administered.
Danish: Hele indholdet af sprøjten administreres.
English: Ask your pharmacist how to throw away the oral syringe.
Danish: Spørg på apoteket, hvordan du skal bortskaffe den orale sprøjte.
English: Take Votubia tablets once a day.
Danish: Tag Votubia tabletter en gang om dagen
English: In addition, serial radiological evidence of SEGA growth, presence of a new SEGA lesion ≥1 cm in longest diameter, or new or worsening hydrocephalus was required for entry.
Danish: Desuden var seriel radiologisk evidens for SEGA-vækst, tilstedeværelse af ny SEGA-læsion ≥1,0 cm for den længste diameter eller ny eller forværret hydrocephalus påkrævet for at deltage.
English: The blood-to-plasma ratio of everolimus, which is concentration-dependent over the range of 5 to 5,000 ng/ml, is 17% to 73%.
Danish: Blod-plasma-ratio af everolimus, som er koncentrationsafhængig i området 5 til 5.000 nanogram/ml, er 17 % til 73 %.
English: Do not shake it. Use the oral suspension immediately.
Danish: Brug den orale suspension med det samme.
English: Carefully remove the oral syringe from the patient's mouth.
Danish: Fjern forsigtigt den orale sprøjte fra patientens mund.
English: In patients with TSC, treatment with everolimus increases VEGF-A and decreases VEGF-D levels.
Danish: Hos patienter med TSC forøger everolimus VEGF-A og nedsætter VEGF-D-niveauer.
English: Management of stomatitis may therefore include prophylactic (in adults) and/or therapeutic use of topical treatments, such as an alcohol-free corticosteroid oral solution as a mouthwash.
Danish: Håndtering af stomatitis kan derfor inkludere profylaktisk (hos voksne) og/eller terapeutisk brug af topikale behandlinger, som fx en alkoholfri oral opløsning med kortikosteroid som mundskyllevæske.
English: It is not known whether everolimus is excreted in human breast milk.
Danish: Det vides ikke, om everolimus udskilles i human modermælk.
English: In clinical studies, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
Danish: I kliniske studier er everolimus blevet forbundet med alvorlige tilfælde af hepatitis B reaktivering, inklusive dødelige tilfælde.
English: Phase II study in patients with SEGA
Danish: Fase II-studie hos patienter med SEGA
English: Regular blood tests are also necessary to measure how much Votubia is in your blood since this will help your doctor decide how much Votubia you need to take.
Danish: Regelmæssige blodprøver er også nødvendige for at måle, hvor meget Votubia du har i blodet, da det kan hjælpe din læge med at afgøre, hvor meget Votubia du skal tage.
English: In a population pharmacokinetic evaluation in cancer patients, no significant influence of age (27-85 years) on oral clearance of everolimus was detected.
Danish: I en farmakokinetisk populationsevaluering af cancerpatienter sås der ingen signifikant alderspåvirkning (27-85 år) på oral clearance af everolimus.
English: After the dispersion has been swallowed, any residue must be re-dispersed in the same volume of water and swallowed (see section 5.2).
Danish: Efter opløsningen er sunket skal enhver rest genopløses i samme volumen vand og synkes (se pkt.
English: All medicines listed above should be avoided during your treatment with Votubia.
Danish: Alle de typer medicin, som er anført ovenfor, skal undgås under din behandling med Votubia.
English: The study consisted of three phases: an 8-week baseline observation phase; an 18-week double-blind, placebo-controlled core treatment phase (composed of titration and maintenance periods), an extension phase of ≥48 weeks in which all patients received Votubia and a post-extension phase of ≤48 weeks in which all patients received Votubia.
Danish: Studiet bestod af tre faser: en 8 ugers baseline-observationsperiode; en 18 ugers dobbeltblind placebokontrolleret hovedbehandlingsfase (bestående af titrering og vedligeholdelsesperiode), en udvidelsesfase på ≥48 uger hvor alle patienter fik Votubia, og en post-udvidelsesfase på ≤48 uger hvor alle patienter fik Votubia.
English: The median baseline seizure frequency across the treatment arms was 35, 38, and 42 seizures per 28 days for the Votubia LT, Votubia HT, and placebo groups, respectively.
Danish: Den mediane anfaldsfrekvens ved baseline på tværs af behandlingsarmene var 35, 38, og 42 anfald pr. 28 dage for hhv. Votubia LT, Votubia HT og placebogruppen.
English: If a higher dose or number of tablets is required, an additional glass must be prepared.
Danish: Hvis der kræves en højere dosis eller antal af tabletter, skal der klargøres et ekstra glas.
English: Grapefruit juice or other food affecting CYP3A4/PgP
Danish: Grapefrugtjuice eller andre fødevarer, der påvirker CYP3A4/PgP
English: Other possible side effects of Votubia include:
Danish: Andre bivirkninger ved Votubia kan omfatte:
English: Key secondary endpoints in hierarchal order of testing included the absolute change in frequency of total seizure events per 24-hour EEG from baseline to week 24, time to SEGA progression, and skin lesion response rate.
Danish: De væsentlige sekundære endepunkter i hierakisk, testet rækkefølge omfattede den absolutte ændring i frekvens af totale anfaldshændelser pr. 24-timer EEG fra baseline til uge 24, tid til SEGA-progression, og hudlæsion responsrate.
English: In patients with SEGA, everolimus Cmin was approximately dose-proportional within the dose range from 1.35 mg/m to 14.4 mg/m
Danish: Hos patienter med SEGA, var everolimus Cmin tilnærmelsesvis dosisproportional inden for dosisintervallet 1,35 mg/m to 14,4 mg/m
English: The overall safety profile in this study was consistent with that established for everolimus in the oncology and TSC settings, with the exception of a slightly increased frequency of oral candidiasis which was reported in 2.2% (n=2/92) of patients.
Danish: Den samlede sikkerhedsprofil i dette studie var i overensstemmelse med den etablerede sikkerhedsprofil for everolimus til behandling af onkologiske sygdomme og tuberøst sklerosekompleks (TSC) med undtagelse af en let forhøjet forekomst af oral candidiasis, der blev rapporteret hos 2,2 % (2/92) af patienterne.
English: The following may increase the risk of side effects with Votubia: ketoconazole, itraconazole, voriconazole, or fluconazole and other antifungals used to treat fungal infections.
Danish: Følgende lægemiddelstoffer kan øge risikoen for bivirkninger med Votubia: ketoconazol, itraconazol, voriconazol eller fluconazol og andre lægemidler til behandling af svampeinfektioner.
English: However, a clinically relevant effect on the exposure of systemically administered CYP3A4 substrates is not expected (see section 4.4).
Danish: Der forventes dog ikke en klinisk relevant effekt på eksponeringen af systemisk administrerede CYP3A4-substrater (se pkt.
English: In the study, partial-onset seizures were defined as all electroencephalogram (EEG)-confirmed sensory seizures or motor seizures in which a generalised onset had not been demonstrated on a past EEG.
Danish: I studiet blev partielle anfald defineret som alle sensoriske anfald, bekræftet i elektroencefalogram (EEG), eller motoriske anfald, hvor primær generalisering ikke tidligere var blevet påvist i EEG.
English: ≥18 years b n=21
Danish: ≥18 år b n=21
English: A diagnosis of non-infectious pneumonitis should be considered in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough or dyspnoea, and in whom infectious, neoplastic and other non-medicinal causes have been excluded by means of appropriate investigations.
Danish: Diagnosen non-infektiøs pneumonitis skal overvejes hos patienter med uspecifikke respiratoriske fund og symptomer såsom hypoksi, pleuraekssudat, hoste eller dyspnø, og hos hvem infektiøse, neoplastiske eller andre ikke-medicinske årsager er blevet udelukket ved hjælp af passende undersøgelser.
English: Management of severe and/or intolerable suspected adverse reactions may require dose reduction and/or temporary interruption of Votubia therapy.
Danish: Håndtering af svære og/eller uacceptable formodede bivirkninger kan kræve dosisreduktion og/eller midlertidig afbrydelse af Votubia-behandlingen.
English: Only use water (drinkable tap water or non-sparkling bottled water) to prepare the oral suspension.
Danish: Brug kun vand (vand fra hanen eller flaskevand uden brus) til at klargøre den orale suspension.
English: if you have diabetes (high level of sugar in your blood).
Danish: hvis du har sukkersyge (højt blodsukker).