FrancophonIA/ELRC3.0 huggingface dataset:
English: Minor kidney changes were seen in the rat (exacerbation of age-related lipofuscin in tubular epithelium, increases in hydronephrosis) and mouse (exacerbation of background lesions).
Danish: Der sås mindre nyreforandringer hos rotter (forværring af aldersrelateret lipofuscin i det tubulære epitel) og mus (forværring af baggrundslæsioner).
English: For patients with TSC who have SEGA and patients with TSC and refractory seizures, once a stable dose is attained, trough concentrations should be monitored every 3 to 6 months in patients with changing body surface area, or every 6 to 12 months in patients with stable body surface area, for the duration of treatment.
Danish: For patienter med TSC, der har SEGA, samt patienter med TSC og refraktære anfald: når en stabil dosis er opnået, skal dal-koncentrationen monitoreres hver 3. til 6. måned hos patienter med vekslende overfladeareal eller hver 6. til 12. måned hos patienter med stabilt overfladeareal, så længe behandlingen står på.
English: The dispersible tablets must not be broken or crushed.
Danish: De dispergible tabletter må ikke knækkes eller knuses.
English: In a post-marketing single-arm study in postmenopausal women with advanced breast cancer (N=92), topical treatment with dexamethasone 0.5 mg/5 ml alcohol-free oral solution was administered as a mouthwash (4 times daily for the initial 8 weeks of treatment) to patients at the time of initiating treatment with Afinitor (everolimus, 10 mg/day) plus exemestane (25 mg/day) to reduce the incidence and severity of stomatitis.
Danish: I et post-marketing, enkeltarms-studie med postmenopausale kvinder med fremskreden brystkræft (N=92) blev der administreret topikal behandling med en alkoholfri oral opløsning med dexamethason 0,5 mg/5 ml som mundskyllevæske (4 gange daglig i de første 8 ugers behandling) til patienter ved opstart af behandling med Afinitor (everolimus, 10 mg/daglig) plus exemestan (25 mg/daglig) for at reducere forekomsten og alvorligheden af stomatitis.
English: The angiomyolipoma best overall response rate had increased to 58.0% (95% CI: 48.3, 67.3), with a rate of stable disease of 30.4% (Table 4).
Danish: Den bedste samlede responsrate for angiomyolipom var steget til 58,0 % (95 % CI: 48,3; 67,3) med en rate på 30,4 % (tabel 4) for stabil sygdom.
English: In healthy subjects taking a single 9 mg dose (3 x 3 mg) of Votubia dispersible tablets in suspension, high fat meals reduced AUC by 11.7% and the peak blood concentration Cmax by 59.8%.
Danish: Hos raske forsøgspersoner, der tog en enkeltdosis på 9 mg (3 x 3 mg) Votubia dispergible tabletter som suspension, reducerede måltider med højt fedtindhold AUC med 11,7 % og peak-koncentrationen i blodet Cmax med 59,8 %.
English: If you stop taking Votubia Do not stop taking Votubia dispersible tablets unless your doctor tells you to.
Danish: Hvis du holder op med at tage Votubia Hold ikke op med at tage Votubia dispergible tabletter, medmindre lægen siger det.
English: Children and adolescents Votubia can be used in children and adolescents with SEGA associated with TSC.
Danish: Børn og unge Votubia kan bruges til børn og unge med SEGA forbundet med TSC.
English: If you have taken too much Votubia, or if someone else accidentally takes your dispersible tablets, see a doctor or go to a hospital immediately.
Danish: Hvis du har taget for meget Votubia, eller hvis andre ved et uheld har taget dine dispergible tabletter, skal du straks tage til lægen eller på hospitalet.
English: Consistent treatment effects were observed across all subgroups evaluated (i.e. enzyme-inducing antiepileptic use versus enzyme-inducing antiepileptic non-use, sex and age) at the primary analysis.
Danish: Konsistent behandlingseffekt sås på tværs af alle evaluerede undergrupper (dvs. brug af enzyminducerende antiepileptika i forhold til ingen brug af enzyminducerende antiepileptika, køn og alder) ved den primære analyse.
English: For paediatric patients who do not require immediate treatment, completion of the recommended childhood series of live virus vaccinations is advised prior to the start of therapy according to local treatment guidelines.
Danish: For pædiatriske patienter, som ikke kræver umiddelbar behandling, anbefales det at færdiggøre det rekommanderede børnevaccinationsprogram med levende virus før start af behandling i henhold til lokale behandlingsvejledninger.
English: 12 to <18 years n=26
Danish: 12 til <18 år n=26
English: Concomitant treatment with potent CYP3A4 inhibitors result in dramatically increased blood concentrations of everolimus (see section 4.5).
Danish: Samtidig behandling med potente CYP3A4-hæmmere resulterer i dramatisk øgede plasmakoncentrationer af everolimus (se pkt.
English: Presence of at least one angiomyolipoma ≥3 cm in longest diameter using CT/MRI (based on local radiology assessment) was required for entry.
Danish: Tilstedeværelse af mindst et angiomyolipom på ≥3 cm for den længste diameter vha. CT/MRI (baseret på lokal radiologisk vurdering) var påkrævet for at deltage.
English: Votubia is not to be used in children below the age of 2 years with TSC and seizures.
Danish: Votubia må ikke anvendes til børn under 2 år med TSC og epileptiske anfald.
English: Primary SEGA volume was reduced at month 6 compared to baseline (p<0.001 [see Table 7]).
Danish: Primært SEGA-volumen var reduceret ved 6. måned sammenlignet med baseline (p<0,001 [se tabel 7]).
English: For example, a patient's current dose based on BSA is 2.5 mg with a steady state concentration of 4 ng/ml.
Danish: For eksempel: en patients aktuelle BSA-baserede dosis er 2,5 mg med en steady state-koncentration på 4 nanogram/ml.
English: Potent and moderate CYP3A4 inducers Rifampicin
Danish: Potente og moderate CYP3A4-induktorer Rifampicin
English: Primary SEGA volume was reduced at month 6 compared to baseline (p<0.001 [see Table 8]).
Danish: Primært SEGA-volumen var reduceret ved 6. måned sammenlignet med baseline (p<0,001 [se tabel 8]).
English: Of the enrolled patients, 83.1% had angiomyolipomas ≥4 cm (28.8% ≥8 cm), 78.0% had bilateral angiomyolipomas, and 39.0% had undergone prior renal embolisation/nephrectomy; 96.6% had skin lesions at baseline and 44.1% had target SEGAs (at least one SEGA ≥1 cm in longest diameter).
Danish: Af de deltagende patienter havde 83,1 % angiomyolipom ≥4 cm (28,8 % ≥8 cm), 78,0 % havde bilateral angiomyolipom, og 39,0 % havde tidligere fået foretaget renal embolisering/nefrektomi; 96,6 % havde hudlæsioner ved baseline, og 44,1 % havde mål-SEGA'er (mindst en SEGA ≥1 cm for den længste diameter).
English: • Moderate hepatic impairment (Child-Pugh B): The recommended dose is 5 mg daily.
Danish: • Moderat nedsat leverfunktion (Child-Pugh B): den anbefalede dosis er 5 mg dagligt.
English: If co-administration of a moderate CYP3A4 and/or PgP inhibitor or inducer cannot be avoided, dose adjustments of Votubia may be required (see section 4.5).
Danish: Hvis samtidig administration af en moderat CYP3A4- og/eller PgP-hæmmer eller induktor ikke kan undgås, kan det være krævet at foretage dosisjusteringer af Votubia (se pkt.
English: Known and theoretical interactions with selected inhibitors and inducers of CYP3A4 and PgP are listed in Table 2 below.
Danish: Kendte og teoretiske interaktioner med udvalgte hæmmere og induktorer af CYP3A4 og PgP er anført i tabel 2 nedenfor.
English: In healthy subjects, high fat meals reduced systemic exposure to Votubia 10 mg tablets (as measured by AUC) by 22% and the peak blood concentration Cmax by 54%.
Danish: Hos raske forsøgspersoner nedsatte måltider med højt fedtindhold eksponeringen for Votubia 10 mg tabletter (målt ved AUC) med 22 % og peak-koncentrationen i blodet Cmax med 54 %.
English: Very common side effects (may affect more than 1 in 10 people) Upper respiratory tract infection
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter) Infektioner i de øvre luftveje
English: Known and theoretical interactions with selected inhibitors and inducers of CYP3A4 and PgP are listed in Table 3 below.
Danish: Kendte og teoretiske interaktioner med udvalgte hæmmere og induktorer af CYP3A4 og PgP er anført i tabel 3 nedenfor.
English: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with Votubia (see section 4.8).
Danish: Der er observeret tilfælde af nyresvigt (inklusive akut nyresvigt), nogle med letalt udfald, hos patienter behandlet med Votubia (se pkt.
English: St. John's wort (Hypericum perforatum), a herbal product used to treat depression and other conditions.
Danish: perikon (Hypericum perforatum) - et naturlægemiddel, der bruges til behandling af depression og andre tilstande.
English: Cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome, have been reported in patients who received everolimus.
Danish: Der er rapporteret tilfælde af pneumocystis jirovecii (carinii) pneumoni (PJP, PCP) med fatal udgang hos patienter, der fik behandling med everolimus.
English: Starting dose and target trough concentrations in TSC with refractory seizures The recommended starting dose for Votubia for the treatment of patients with seizures is shown in Table 1.
Danish: Startdosis og mål-dal-koncentration ved TSC med refraktære anfald Den anbefalede startdosis af Votubia til behandling af patienter med anfald er vist i tabel 1.
English: • Mild hepatic impairment (Child-Pugh A): The recommended dose is 7.5 mg daily.
Danish: • Let nedsat leverfunktion (Child-Pugh A): den anbefalede dosis er 7,5 mg dagligt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Votubia in all subsets of the paediatric population in angiomyolipoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Votubia i alle undergrupper af den pædiatriske population ved angiomyolipom (se pkt.
English: 75% resp. 75 to <100
Danish: 75 % resp. 75 til <100
English: A total of 366 patients were randomised in a 1:1.09:1 ratio to Votubia (n=117) low trough (LT) range (3 to 7 ng/ml), Votubia (n=130) high trough (HT) range (9 to 15 ng/ml) or placebo (n=119).
Danish: I alt blev 366 patienter randomiseret i forholdet 1:1,09:1 til Votubia (n=117) med lavt dal-niveau (LT) (3 til 7 nanogram/ml), Votubia (n=130) med højt dal-niveau (HT) (9 til 15 nanogram/ml) eller placebo (n=119).
English: Special information for caregivers
Danish: Særlig information til omsorgspersoner
English: • Mild hepatic impairment (Child-Pugh A): 75% of the recommended starting dose calculated based on BSA (rounded to the nearest strength)
Danish: • Let nedsat leverfunktion (Child-Pugh A): 75 % af den anbefalede start dosis beregnet på baggrund af BSA (afrundet til nærmeste styrke)
English: Different strengths of Votubia dispersible tablets can be combined to attain the desired dose.
Danish: Forskellige styrker af Votubia dispergible tabletter kan kombineres for at opnå den ønskede dosis.
English: If patients require co-administration of a moderate CYP3A4 or PgP inhibitor, reduce the daily dose by approximately 50%.
Danish: Hvis patienten har brug for samtidig administration af en moderat CYP3A4- eller PgP-hæmmer, reduceres dosis med ca. 50 %.
English: Votubia is not recommended for patients <18 years of age with SEGA and hepatic impairment.
Danish: Votubia anbefales ikke til patienter <18 år med SEGA og nedsat leverfunktion.
English: Remove the dispersible tablets from the blister.
Danish: Tag de dispergible tabletter ud af blisteren.
English: Put the tip of the syringe into the water.
Danish: Sæt spidsen af sprøjten ned i vandet.
English: Votubia is not recommended for patients <18 years of age with SEGA or refractory seizures and hepatic impairment.
Danish: Votubia anbefales ikke til patienter <18 år med SEGA eller refraktære anfald og nedsat leverfunktion.
English: If the total prescribed dose is more than 10 mg or has to be prepared using more than 5 dispersible tablets, repeat steps 2 to 17 to finish giving the dose.
Danish: Hvis den samlede udskrevne dosis er højere end 10 mg eller skal klargøres med mere end 5 dispergible tabletter, skal trin 2 til 17 gentages for at give hele dosis.
English: Dispersible tablet
Danish: Dispergibel tablet
English: If you receive Votubia for the treatment of SEGA associated with TSC, 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: Hvis du får Votubia til behandling af SEGA forbundet med TSC, er regelmæssige blodprøver 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: Patients initially treated with placebo were allowed to cross over to everolimus at the time of angiomyolipoma progression and upon recognition that treatment with everolimus was superior to treatment with placebo.
Danish: Det var tilladt, at patienter, der initialt blev behandlet med placebo, krydsede over til everolimus ved tidspunktet for progression af angiomyolipom og ved erkendelse af, at behandling med everolimus var overlegen i forhold til placebo.
English: Therapeutic drug monitoring of everolimus blood concentrations, using a validated assay, is required for patients treated for SEGA.
Danish: Terapeutisk lægemiddelmonitorering af blod-everolimus ved brug af en valideret analyse er nødvendig hos patienter, der behandles for SEGA.
English: The suspension must be administered immediately after preparation.
Danish: Suspensionen skal administreres straks efter klargøring.
English: This will look like a cloudy liquid (known as an oral suspension).
Danish: Det færdige lægemiddel vil være en uklar væske (kaldet oral suspension).
English: 6 to <12 years n=37
Danish: 6 til <12 år n=37
English: Switching pharmaceutical forms
Danish: Skift af lægemiddelform
English: 94.0% had skin lesions at baseline and 37.6% had target renal angiomyolipoma lesions (at least one angiomyolipoma ≥1 cm in longest diameter).
Danish: 94,0 % havde hudlæsioner ved baseline og 37,6 % havde renal angiomyolipom-læsioner (mindst et angiomyolipom ≥1 cm for den længste diameter).
English: For patients with SEGA associated with TSC:
Danish: For patienter med SEGA forbundet med TSC:
English: For paediatric patients with SEGA who do not require immediate treatment, completion of the recommended childhood series of live virus vaccinations is advised prior to the start of therapy according to local treatment guidelines.
Danish: For pædiatriske patienter med SEGA, som ikke kræver umiddelbar behandling, anbefales det at færdiggøre det rekommanderede børnevaccinationsprogram med levende virus før start af behandling i henhold til lokale behandlingsvejledninger.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Therapeutic drug monitoring of everolimus blood concentrations, using a validated assay, is required.
Danish: Terapeutisk lægemiddelmonitorering af blod-everolimus ved brug af en valideret analyse er nødvendig.
English: If concentrations are below 5 ng/ml, the daily dose may be increased by 2.5 mg every 2 weeks, checking the trough level and assessing tolerability before increasing the dose.
Danish: Hvis koncentrationerne er under 5 nanogram/ml, kan den daglige dosis øges til 2,5 mg hver 2. uge, idet trough-værdierne kontrolleres, og tolerabiliteten vurderes, inden dosis øges.
English: Hyperglycaemia has been reported in patients taking Votubia (see section 4.8).
Danish: Hyperglykæmi er rapporteret hos patienter, der tager Votubia (se pkt.
English: Based on a sensitivity analysis considering patients who prematurely discontinued everolimus as nonresponders, response rates of 38.4% (95% CI: 33.4, 43.7) and 44.4% (95% CI: 38.2, 50.7) were observed after 1 and 2 years of exposure to everolimus, respectively.
Danish: Baseret på en sensitivitetsanalyse, hvor patienter som seponerede everolimus før tid betragtes som ikkerespondenter, blev der observeret en responsrate på 38,4 % (95 % CI: 33,4, 43,7) og 44,4 % (95 % CI: 38,2, 50,7) efter henholdvis 1 og 2 års eksponering af everolimus.
English: Votubia will only be prescribed by a doctor with experience in treating patients with SEGA or seizures and with access to blood tests which will measure how much Votubia is in your blood.
Danish: Votubia ordineres kun af en læge, der har erfaring i behandling af patienter med TSC og SEGA eller epileptiske anfald, og som har adgang til blodprøveanalyser, som kan måle, hvor meget Votubia du har i blodet.
English: In the absence of clinical data, the possibility of an additive effect on adverse events cannot be excluded when everolimus is given in conjunction with a ketogenic diet.
Danish: Effekten af en ketogen diæt kan være medieret gennem hæmning af mTOR. På grund af manglende kliniske data kan risikoen for en additiv effekt på en bivirkning ikke udelukkes, når everolimus administreres sammen med en ketogen diæt.
English: Individualised dosing should be titrated by increasing the dose by increments of 1 to 4 mg to attain the target trough concentration for optimal clinical response.
Danish: Individualiseret dosering bør titreres ved at øge dosis i trin af 1 til 4 mg for at nå mål-dalkoncentrationen for optimalt klinisk respons.
English: Potent CYP3A4/PgP inhibitors Ketoconazole
Danish: Potente CYP3A4/PgP-hæmmere Ketoconazol
English: Take Votubia dispersible tablets once a day.
Danish: Tag Votubia dispergible tabletter en gang om dagen.
English: Taking the medicine
Danish: Tag medicinen
English: Table 1 Votubia dose adjustment recommendations
Danish: Tabel 1 Anbefalinger for dosisjustering af Votubia
English: Individualised dosing should be titrated by increasing the dose by increments of 2.5 mg to attain the target trough concentration for optimal clinical response.
Danish: Individualiseret dosering bør titreres ved at øge dosis i trin af 2,5 mg for at nå mål-dal-koncentrationen for optimalt klinisk respons.
English: Elevations of serum creatinine, usually mild, and proteinuria have been reported in patients treated with Votubia (see section 4.8).
Danish: Forhøjet serumkreatinin, som regel let, og proteinuri er rapporteret hos patienter i behandling med Votubia (se pkt.
English: If concentrations are below 5 ng/ml, the daily dose may be increased by increments of 1 to 4 mg, checking the trough level and assessing tolerability before increasing the dose.
Danish: Hvis koncentrationen er under 5 nanogram/ml, kan den daglige dosis øges i trin af 1 til 4 mg, med kontrol af dal-niveau og vurdering af tolerabilitet, før dosis øges.
English: The adverse events considered to be associated with the use of Votubia (adverse reactions), based upon the review and medical assessment of all adverse events reported in the above studies, are described below.
Danish: Nedenfor beskrives bivirkninger, som på basis af gennemgang og medicinsk vurdering af alle rapporterede bivirkninger fra ovennævnte studier anses for relateret til administration af Votubia.
English: Add the dispersible tablets into the water.
Danish: Læg de dispergible tabletter ned i vandet.
English: On rare occasions, fatal outcomes were observed in the oncology setting (see section 4.4).
Danish: I sjældne tilfælde er der observeret dødelige tilfælde i forbindelse med onkologiske diagnoser (se pkt.
English: Cough with phlegm, chest pain, fever (signs of inflammation of airways, also known as bronchitis viral)
Danish: Hoste med slim, smerter i brystet, feber (tegn på betændelse i luftvejene, også kendt som viral bronkitis)
English: Patients initially treated with placebo were allowed to cross over to everolimus at the time of SEGA progression and upon recognition that treatment with everolimus was superior to treatment with placebo.
Danish: Patienter, som oprindelig fik placebo, fik lov til at skifte over til everolimus ved SEGA-progression og efter erkendelse af, at behandling med everolimus var overlegen i forhold til placebo.
English: Your doctor will determine the dose of Votubia you need to take depending on: your age your body size the health of your liver other medicines you are taking.
Danish: Hvor meget Votubia du skal tage Din læge afgører, hvilken dosis Votubia du skal tage afhængig af: - din alder - din kropsstørrelse - hvor sund, din lever er - anden medicin, du tager.
English: Uncommon side effects (may affect up to 1 in 100 people) Muscle spasms, fever, red-brown urine which may be symptoms of a muscle disorder (rhabdomyolysis)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter) Muskelkramper, feber, rødbrun urin, som kan være symptomer på en muskelsygdom (rabdomyolyse)
English: If you have taken too much Votubia, or if someone else accidentally takes your tablets, see a doctor or go to a hospital immediately.
Danish: Hvis du har taget for mange Votubia-tabletter, eller hvis andre ved et uheld har taget dine tabletter, skal du straks tage til lægen eller på hospitalet.
English: EXIST-2 (study CRAD001M2302), a randomised, controlled phase III study was conducted to evaluate the efficacy and safety of Votubia in patients with TSC plus renal angiomyolipoma.
Danish: EXIST-2 (studie CRAD001M2302), et randomiseret, kontrolleret fase III-studie, blev udført for at evaluere Votubias virkning og sikkerhed hos patienter med TSC plus renal angiomyolipom.
English: No dose adjustment is required (see section 5.2).
Danish: Der er ikke behov for dosisjustering (se pkt.
English: Votubia contains lactose
Danish: Votubia indeholder lactose
English: Everolimus whole blood trough concentrations should be assessed at least 1 week after commencing treatment.
Danish: Everolimus-dal-koncentrationer i fuldblod skal vurderes mindst 1 uge efter behandlinsstart.
English: Mean CL/F of everolimus after 10 mg daily dose in patients with advanced solid tumours was 24.5 l/h.
Danish: Middelværdien af CL/F for everolimus efter en daglig dosis på 10 mg var 24,5 l/t hos patienter med fremskredne solide tumorer.
English: No data are available (see sections 5.1 and
Danish: Der foreligger ingen data (se pkt.
English: The recommended dose is 10 mg of everolimus once daily.
Danish: Den anbefalede dosis af everolimus er 10 mg en gang dagligt.
English: 50% resp. 50 to <75
Danish: 50 % resp. 50 til <75
English: Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, andre rapamycinderivater eller over for et eller flere af hjælpestofferne anført i pkt.
English: If the total prescribed dose is more than 10 mg or has to be prepared using more than 5 dispersible tablets, repeat steps 2 to 10 to finish taking the dose.
Danish: Hvis den samlede udskrevne dosis er højere end 10 mg eller skal klargøres med mere end 5 dispergible tabletter, skal trin 2 til 10 gentages for at give hele dosis.
English: Blood lactate dehydrogenase increased, blood luteinising hormone increased, weight decreased
Danish: Almindelig Forhøjet blod-laktatdehydrogenase, forhøjet luteiniserende hormon, nedsat vægt Ikke almindelig
English: Very common side effects (may affect more than 1 in 10 people) Fever, cough, difficulty breathing, wheezing (signs of inflammation of the lung due to infection, also known as pneumonia)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter) Feber, hoste, vejrtrækningsbesvær, hiven efter vejret (tegn på inflammation i lungen på grund af infektion, også kendt som lungebetændelse)
English: Table 2 Votubia dose adjustment recommendations
Danish: Tabel 2 Anbefalinger for dosisjustering af Votubia
English: Prepare the oral suspension by mixing the dispersible tablets with water either in an oral syringe or in a small glass.
Danish: Sådan laver og indtager du din orale suspension Gør den orale suspension klar ved at blande de dispergible tabletter med vand, enten i en sprøjte (til at sprøjte ind i munden), eller i et lille glas.