FrancophonIA/ELRC3.0 huggingface dataset:
English: In a male fertility study in rats, testicular morphology was affected at 0.5 mg/kg and above, and sperm motility, sperm head count, and plasma testosterone levels were diminished at 5 mg/kg, which is within the range of therapeutic exposure and which caused a reduction in male fertility.
Danish: I et fertilitetsstudie med hanrotter påvirkedes testikelmorfologien ved 0,5 mg/kg og derover, og sædcellemotilitet, antal sædceller og plasmatestosteronniveau faldt ved 5 mg/kg, hvilket er inden for det terapeutiske eksponeringsområde og medførte et fald i fertilitet hos hanrotterne.
English: Phase III study in SEGA patients
Danish: Fase III-studie med SEGA-patienter
English: Votubia is not to be used in children or adolescents with TSC who have angiomyolipoma of the kidney in the absence of SEGA, as it has not been studied in such patients.
Danish: Votubia må ikke bruges til børn og unge med TSC, som har angiomyolipom i nyrerne, men ikke SEGA, da det ikke er blevet undersøgt hos denne patientgruppe.
English: Assess the everolimus trough level 2 weeks after discontinuation of one of multiple strong CYP3A4 inducers.
Danish: Vurdér everolimus-dal-niveauet 2 uger efter seponering af en af flere potente CYP3A4-induktorer.
English: Baseline seizure frequency was a significant factor in the seizure response (with an odds ratio of 0.978 [95% CI: 0.959, 0.998]).
Danish: Baselineanfaldsfrekvensen var en væsentlig faktor for anfaldsresponset (oddsratio 0,978 [95 % CI: 0,959;
English: Votubia is also an anti-tumour medicine which can block certain cells in the body from growing.
Danish: Votubia er også en medicin mod kræft, som kan forhindre visse celler i kroppen i at vokse.
English: phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to stop seizures or fits.
Danish: phenytoin, carbamazepin eller phenobarbital og andre lægemidler mod epilepsi, som bruges til at standse krampeanfald.
English: Dispersible tablet.
Danish: Dispergibel tablet.
English: The first symptoms may include fever, skin rash, joint pain and inflammation.
Danish: De første symptomer kan omfatte feber, hududslæt, ledsmerter og betændelse.
English: The everolimus trough concentrations should be assessed 2 to 4 weeks later since the natural degradation time of the induced enzymes has to be taken into account (see sections 4.2 and 4.4).
Danish: Dal-everolimus-koncentrationen bør måles 2 til 4 uger senere, eftersom der bør tages højde for den naturlige nedbrydningstid for de inducerede enzymer (se pkt.
English: • 2 clean glasses • Approximately 30 ml of water
Danish: • 2 rene glas • Ca. 30 ml vand
English: Response was defined as: ≥50% reduction in the sum of SEGA volume relative to baseline, plus no unequivocal worsening of non-target SEGA lesions, plus absence of new SEGA ≥1 cm in longest diameter, plus no new or worsening hydrocephalus Primary analysis for double blind period Final analysis includes patients who crossed over from the placebo group; median duration of exposure to everolimus of 204.9 weeks
Danish: Respons var defineret som: ≥50 % reduktion i summen af SEGA-volumen i forhold til baseline, plus ingen utvetydig forværring af ikke-mål-SEGA-læsioner, plus fravær af ny SEGA ≥1 cm for den længste diameter, plus ingen ny eller forværret hydrocephalus Primær analyse for dobbeltblindet periode Endelig analyse inkluderer patienter, som skiftede over fra placebogruppen; median eksponeringsvarighed for everolimus på 204,9 uger
English: Uncommon Blood follicle stimulating hormone increased a
Danish: Forhøjet blodfollikel-stimulerende hormon a
English: Re-initiate Votubia at same dose.
Danish: Genoptag behandlingen med Votubia ved samme dosis.
English: Sustained reductions were evident at week 24, 41.9% (31/74) of patients had ≥50% reductions and 78.4% (58/74) of patients had ≥30% reductions in SEGA volume.
Danish: Vedvarende reduktion var tydelig ved uge 24; 41,9 % (31/74) af patienterne havde ≥50 % reduktion, og 78,4 % (58/74) af patienterne havde ≥30 % reduktion i SEGA-volumen.
English: Grade 2 (≥1x10
Danish: Grad 2 (≥1x10
English: If a higher dose or number of tablets is required, an additional syringe must be prepared.
Danish: Hvis der kræves en højere dosis eller antal af tabletter, skal der klargøres en ekstra sprøjte.
English: Take the 10 ml oral syringe and pull out the plunger, removing it completely from the barrel of the syringe.
Danish: Tag den orale 10 ml sprøjte og træk stemplet ud, så det adskilles helt fra sprøjtens cylinder.
English: Votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC).
Danish: Votubia er indiceret som supplerende behandling hos patienter i alderen 2 år og ældre med refraktære partielle anfald, med eller uden sekundær generalisering, i forbindelse med tuberøst sklerosekompleks.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Votubia in one or more subsets of the paediatric population in refractory epilepsy associated with tuberous sclerosis complex (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Votubia i en eller flere undergrupper af den pædiatriske population ved refraktær epilepsi i tilknytning til tuberøst sklerosekompleks (se pkt.
English: The major target organs were male and female reproductive systems (testicular tubular degeneration, reduced sperm content in epididymides and uterine atrophy) in several species; lungs (increased alveolar macrophages) in rats and mice; pancreas (degranulation and vacuolation of exocrine cells in monkeys and minipigs, respectively, and degeneration of islet cells in monkeys), and eyes (lenticular anterior suture line opacities) in rats only.
Danish: De store målorganer var reproduktionsorganer hos begge køn (tubulær testikeldegeneration, reduceret mængde sædvæske i bitestikel og uterin atrofi) hos flere arter; og lunger (stigning i alveolære makrofager) hos rotter og mus; pankreas (degranulering og vakuolation af eksokrine celler i henholdsvis aber og minigrise samt degenerering af øceller i aber), og øjne (uklarheder ved lentikulare anteriore suturlinier) hos rotter alene.
English: If Votubia is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride, quinidine, ergot alkaloid derivatives or carbamazepine), the patient should be monitored for undesirable effects described in the product information of the orally administered CYP3A4 substrate (see section 4.5).
Danish: Hvis Votubia tages med orale CYP3A4-substrater med et snævert terapeutisk vindue (fx pimozid, terfenadin, astemizol, cisaprid, kinidin, sekalealkaloider eller carbamazepin), bør patienten monitoreres for de bivirkninger, der er beskrevet i produktinformationen for det orale CYP3A4-substrat (se pkt.
English: The most frequent grade 3-4 adverse reactions (incidence ≥1%) were pneumonia, stomatitis, amenorrhoea, neutropenia, pyrexia, menstruation irregular, hypophosphataemia, diarrhoea, and cellulitis.
Danish: De hyppigste grad 3-4 bivirkninger (incidens ≥1 %) var pneumoni, stomatitis, amenoré, neutropeni, pyreksi, uregelmæssige menstruationer, hypofosfatæmi, diarré og cellulitis.
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis, candidiasis or pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) and viral infections including reactivation of hepatitis B virus, have been described in patients taking everolimus.
Danish: Lokaliserede og systemiske infektioner, herunder pneumoni, andre bakterielle infektioner, invasive svampeinfektioner, såsom aspergillose candidiasis eller pneumocystis jirovecii (carinii) pneumoni (PJP, PCP) og virale infektioner inklusive reaktivering af hepatitis B virus, er beskrevet hos patienter, der tager everolimus.
English: If you stop taking Votubia Do not stop taking Votubia tablets unless your doctor tells you to.
Danish: Hvis du holder op med at tage Votubia Hold ikke op med at tage Votubia tabletter, medmindre lægen siger det.
English: In patients with TSC and refractory seizures, a conditional logistic regression analysis based on the core phase of Study CRAD001M2304 to estimate the probability of seizure response versus Time Normalized(TN)-Cmin stratified by age sub-group, indicated that a 2-fold increase in TN-Cmin was associated with a 2.172-fold increase (95% CI: 1.339, 3.524) in the odds for a seizure response over the observed TN-Cmin ranges of 0.97 ng/ml to 16.40 ng/ml.
Danish: Hos patienter med TSC og refraktære anfald indikerede en betinget logistisk regressionsanalyse, baseret på hovedfasen i studie CRAD001M2304, med formålet at estimere sandsynligheden for anfaldsrespons versus Time Normalized (TN)-Cmin, stratificeret efter aldersundergruppe, at en 2-fold stigning i TN-Cmin var forbundet med en 2,172-fold stigning (95 % CI: 1,339; 3,524) i odds for et anfaldsrespons over det observerede TN-Cmin-interval på 0,97 ng/ml til 16,40 ng/ml.
English: Do not take a double dose to make up for the forgotten dispersible tablets.
Danish: Du må ikke tage en dobbeltdosis som erstatning for de glemte dispergible tabletter.
English: • The co-administration of the PgP inhibitor, cyclosporine, enhances the exposure of everolimus in the brain cortex, which is consistent with the inhibition of PgP at the blood-brain barrier.
Danish: • Samtidig administration af af PgP-hæmmeren cyclosporin forøger eksponeringen af everolimus i hjernebarken, hvilket er konsistent med hæmningen af PgP ved blod-hjernebarrieren.
English: In patients with SEGA, the geometric mean Cmin values normalised to mg/m dose in patients aged <10 years and 10-18 years were lower by 54% and 40%, respectively, than those observed in adults (>18 years of age), suggesting that everolimus clearance was higher in younger patients.
Danish: Hos patienter med SEGA var de geometriske middel-Cmin-værdier, normaliseret til mg/m dosis, hos patienter i alderen <10 år og 10-18 år henholdsvis 54 % og 40 % lavere end dem, der var observeret hos voksne (>18 år).
English: The best overall SEGA response rate had increased to 57.7% (95% CI: 47.9, 67.0) at the final analysis.
Danish: Den bedste samlede SEGA-responsrate var steget til 57,7 % (95 % CI: 47,9; 67,0) ved den endelige analyse.
English: Open the blister just before taking the Votubia tablets.
Danish: Åbn først blisterpakningen lige inden, du tager Votubia tabletter.
English: INSTRUCTIONS FOR USE
Danish: INSTRUKTIONER FOR ANVENDELSE
English: Dyslipidaemia (including hypercholesterolaemia and hypertriglyceridaemia) has been reported in patients taking Votubia.
Danish: Dyslipidæmi (inklusive hyperkolesterolæmi og hypertriglyceridæmi) er rapporteret hos patienter, der tager Votubia.
English: Similarly, the proportion of patients achieving at least 30% reductions in SEGA volume was 71.4% (70/98) and 77.3% (51/66) at weeks 96 and 192 after start of everolimus treatment.
Danish: Tilsvarende var andelen af patienter, som opnåede mindst 30 % reduktion af SEGA-volumen, 71,4 % (70/98) og 77,3 % (51/66) ved uge 96 og 192 efter start af everolimus.
English: • 30 ml dose cup for measuring water
Danish: • En 30 ml doseringskop til at afmåle vand
English: Pull the plunger slowly down to draw in air until it is at the 9 ml mark on the syringe.
Danish: Træk stemplet tilbage for at trække luft ind, indtil det står ud for 9 ml-mærket på sprøjten.
English: The proportion of patients achieving at least 50% reductions in SEGA volume was 45.9% (45/98) and 62.1% (41/66) at weeks 96 and 192 after start of everolimus treatment.
Danish: Andelen af patienter, som opnåede mindst 50 % reduktion af SEGA-volumen, var 45,9 % (45/98) og 62,1 % (41/66) ved uge 96 og 192 efter start af everolimus.
English: The use of live vaccines should be avoided during treatment with Votubia (see section 4.5).
Danish: Anvendelse af levende vacciner bør undgås under behandling med Votubia (se pkt.
English: A prospective, open-label, single-arm phase II study (Study CRAD001C2485) was conducted to evaluate the safety and efficacy of Votubia in patients with SEGA.
Danish: Der er blevet udført et prospektivt, open-label, enkelt-arm fase II-studie (studie CRAD001C2485) til evaluering af Votubias sikkerhed og effekt hos patienter med SEGA.
English: What you need to know before you take Votubia
Danish: Det skal du vide, før du begynder at tage Votubia
English: Non-infectious pneumonitis (including interstitial lung disease) was described very commonly in patients taking everolimus in the advanced renal cell carcinoma (RCC) setting (see section 4.8).
Danish: Non-infektiøs pneumonitis (herunder interstitiel lungesygdom) er beskrevet som værende meget almindeligt hos patienter, der tager everolimus i forbindelse med renalcellecarcinom (RCC) (se pkt.
English: Votubia could harm a breast-fed baby.
Danish: Votubia kan skade et barn, der ammes.
English: For cases where symptoms of non-infectious pneumonitis are severe, Votubia therapy should be discontinued and the use of corticosteroids may be indicated until clinical symptoms resolve.
Danish: Behandling med Votubia skal afbrydes i tilfælde, hvor der opstår svære symptomer på non-infektiøs pneumonitis, og brug af kortikosteroider kan være indiceret, indtil de kliniske symptomer forsvinder.
English: The dose may be increased to attain a higher trough concentration within the target range to obtain optimal efficacy, subject to tolerability.
Danish: Dosis kan øges, for at opnå en højere dal-koncentration inden for det målrettede interval, for at opnå optimal effekt under hensyntagen til tolerabiliteten.
English: Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Votubia (see section 4.8).
Danish: Stomatitis, herunder mundsår og oral mucositis, er den hyppigst rapporterede bivirkning hos patienter, der blev behandlet med Votubia (se pkt.
English: A single-arm study in postmenopausal breast cancer patients treated with Afinitor (everolimus) plus exemestane suggested that an alcohol-free corticosteroid oral solution, administered as a mouthwash during the initial 8 weeks of treatment, may decrease the incidence and severity of stomatitis (see section 5.1).
Danish: Et enkeltarms-studie med postmenopausale brystkræftpatienter, der blev behandlet med Afinitor (everolimus) plus exemestan, tyder på, at en alkoholfri oral opløsning med kortikosteroid, administreret som mundskyllevæske i de første 8 ugers behandling, kan nedsætte forekomsten og alvorligheden af stomatitis (se pkt.
English: Take Votubia dispersible tablets as a suspension only.
Danish: Tag kun Votubia dispergible tabletter som en suspension.
English: • CRAD001C2485: This was a prospective, open-label, single-arm phase II study of everolimus in patients with SEGA (n=28).
Danish: • CRAD001C2485: Dette var et prospektivt, åbent, enkelt-arm fase II-studie med everolimus hos patienter med SEGA (n=28).
English: Among patients treated with everolimus during the study, no cases of angiomyolipoma-related nephrectomy and only one case of renal embolisation were reported.
Danish: Der blev ikke rapporteret tilfælde af angiomyolipomrelateret nefrektomi blandt patienter behandlet med everolimus i løbet af studiet, og der blev kun rapporteret et tilfælde af renal embolisering.
English: Wort should not be used during treatment with everolimus
Danish: Formuleringer indeholdende perikon, må ikke anvendes under behandling med everolimus
English: The median age for the total population was 10.1 years (range: 2.2-56.3; 28.4% <6 years, 30.9% 6 to <12 years, 22.4% 12 to <18 years and 18.3% >18 years).
Danish: Medianalderen for den samlede population var 10,1 år (2,2-56,3 år; 28,4 % <6 år; 30,9 % 6 til <12 år; 22,4 % 12 til <18 år og 18,3 % >18 år).
English: Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein or serum creatinine, is recommended prior to the start of Votubia therapy and periodically thereafter.
Danish: Det anbefales at monitorere nyrefunktionen, herunder måling af blodureanitrogen (BUN), urinprotein eller serumkreatinin, inden opstart af behandling med Votubia og med jævne mellemrum herefter.
English: This may result in the need for insulin and/or oral antidiabetic agent therapy.
Danish: Dette kan resultere i behov for behandling med insulin og/eller orale midler til behandling af sukkersyge.
English: Votubia is an anti-tumour medicine which can block certain cells in the body from growing.
Danish: Votubia er en medicin mod kræft, som kan forhindre visse celler i kroppen i at vokse.
English: Therefore it is assumed that steady-state could be reached earlier in patients <3 years of age (see section 4.2 for dosing recommendations).
Danish: Det antages derfor, at steady state kan opnås tidligere hos patienter <3 år (se pkt.
English: SEGA associated with TSC
Danish: SEGA i tilknytning til TSC
English: Grade 3 & 4 (<50x10
Danish: Grad 3 & 4 (<50x10
English: Grade 2 (<75, ≥50x10
Danish: Grad 2 (<75, ≥50x10
English: Table 5 EXIST-3 - Seizure frequency response rate (primary endpoint)
Danish: Tabel 5 EXIST-3 -Responsrate for anfaldsfrekvens (primært endepunkt)
English: Table 6 EXIST-3 - Seizure frequency response rate by age
Danish: Tabel 6 EXIST-3 - Responsrate for anfaldsfrekvens efter alder
English: Median time to angiomyolipoma progression was 11.4 months in the placebo arm and was not reached in the everolimus arm (HR 0.08; 95% CI: 0.02, 0.37; p<0.0001).
Danish: Medianvarigheden til progression af angiomyolipom var 11,4 måneder i placebo-armen og blev ikke nået i everolimus-armen (HR 0,08; 95 % CI: 0,02; 0,37; p<0,0001).
English: Caregivers should try to avoid skin contact with the oral suspension.
Danish: Omsorgspersoner bør undgå hudkontakt med den orale suspension.
English: Additional adverse reactions of relevance observed in oncology clinical studies and post-marketing spontaneous reports, were cardiac failure, pulmonary embolism, deep vein thrombosis, impaired wound healing and hyperglycaemia.
Danish: Yderligere relevante bivirkninger, observeret i kliniske, onkologiske studier og postmarketing spontane rapporter omfattede hjertesvigt, lungeemboli, dyb venetrombose, nedsat sårheling og hyperglykæmi.
English: Patients with seizures receiving concomitant strong CYP3A4 inducers (e.g., enzyme inducing antiepileptics carbamazepine, phenobarbital, and phenytoin) at the start of treatment with everolimus require an increased starting dose to attain trough concentrations of 5 to 15 ng/ml (see Table 1).
Danish: Patienter med anfald, der samtidig får potente CYP3A4-induktorer (fx de enzyminducerende antiepileptika carbamazepin, phenobarbital og phenytoin) i starten af behandlingen med everolimus, skal have en højere startdosis for at opnå en dalkoncentration på 5 til 15 nanogram/ml (se tabel 1).
English: Everolimus is a substrate of CYP3A4 and PgP.
Danish: Everolimus er et substrat for CYP3A4 og PgP.
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome), proteinuria and increased serum creatinine.
Danish: I kliniske studier og post-marketing spontane rapporter er everolimus blevet forbundet med tilfælde af nyresvigt (inklusive letale tilfælde), proteinuria og stigning i serumkreatinin.
English: Insert the tip of the oral syringe into the glass filled with water.
Danish: Sæt spidsen af den orale sprøjte ned i det fyldte glas vand.
English: If dose reduction is required, the recommended dose is approximately 50% lower than the daily dose previously administered.
Danish: Hvis dosisreduktion er nødvendig, er den anbefalede dosis ca. 50 % lavere end den tidligere anvendte daglige dosis.
English: Votubia dispersible tablets contain an active substance called everolimus.
Danish: Votubia dispergible tabletter indeholder det aktive stof everolimus.
English: Votubia tablets and Votubia dispersible tablets are not to be used interchangeably.
Danish: Votubia tabletter og Votubia dispergible tabletter kan ikke anvendes tilsvarende.
English: Monitoring of blood cholesterol and triglycerides prior to the start of Votubia therapy and periodically thereafter, as well as management with appropriate medical therapy, is also recommended.
Danish: Monitorering af kolesterol og triglycerider i blodet før opstart af behandling med Votubia og regelmæssigt herefter samt passende medicinsk behandling anbefales også.
English: • Moderate hepatic impairment (Child-Pugh B): 50% of the recommended starting dose calculated based on BSA (rounded to the nearest strength)
Danish: • Moderat nedsat leverfunktion (Child-Pugh B): 50 % af den anbefalede start dosis beregnet på baggrund af BSA (afrundet til nærmeste styrke)
English: Do not use this medicine after the expiry date which is stated on the carton and blister foil.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterfolien efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The tablets must not be chewed or crushed.
Danish: Tabletterne må ikke tygges eller knuses.
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with everolimus (see section 5.3).
Danish: Baseret på prækliniske fund kan mandlig og kvindelig fertilitet blive nedsat ved behandling med everolimus (se pkt.
English: Different strengths of Votubia tablets can be combined to attain the desired dose.
Danish: Forskellige styrker af Votubia tabletter kan kombineres for at opnå den ønskede dosis.
English: Reduction from baseline in seizure frequency (%)
Danish: Reduktion i anfaldsfrekvens i forhold til baseline (%)
English: Take Votubia dispersible tablets as an oral suspension only Do not chew or crush the dispersible tablets.
Danish: Tag kun Votubia dispergible tabletter som en oral suspension Du må ikke tygge eller knuse de dispergible tabletter.
English: It is used to treat children aged 2 years and above and adults with partial seizures with or without secondary generalisation (epilepsy) associated with a genetic disorder called tuberous sclerosis complex (TSC) and which are not controlled by other antiepileptic medicines.
Danish: Det anvendes til behandling af børn fra alderen 2 år og opefter og voksne med en genetisk sygdom, der kaldes tuberøst sklerosekompleks (TSC), og partielle anfald med eller uden sekundær generalisering (epilepsi), som ikke kan kontrolleres med anden epileptisk medicin.
English: Number of patients
Danish: Andel af patienter
English: For example, a patient's current dose based on BSA is 4 mg with a steady-state concentration of 4 ng/ml.
Danish: For eksempel: en patients aktuelle BSA-baserede dosis er 4 mg med en steady state-koncentration på 4 nanogram/ml.
English: Votubia is indicated for the treatment of adult and paediatric patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.
Danish: Votubia er indiceret til behandling af voksne og pædiatriske patienter med subependymalt kæmpecelle-astrocytom (subependymal giant cell astrocytoma [SEGA]) i tilknytning til tuberøst sklerosekompleks, som kræver terapeutisk intervention, men som ikke er egnet til operation.
English: In patients with advanced solid tumours, peak everolimus concentrations (Cmax) are reached at a median time of 1 hour after daily administration of 5 and 10 mg everolimus under fasting conditions or with a light fat-free snack.
Danish: Hos patienter med fremskredne massive tumorer blev maksimum-koncentrationer (Cmax) af everolimus nået ved en mediantid på 1 time efter daglig administration af 5 og 10 mg everolimus fastende eller sammen med et let fedtfrit mellemmåltid.
English: Common side effects (may affect up to 1 in 10 people) Middle ear infection
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter) Mellemørebetændelse
English: Angiomyolipoma response rate 95% CI
Danish: Angiomyolipom-responsrate 95 % CI