FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequent adverse reactions (incidence ≥1/10) from the pooled safety data are (in decreasing order): stomatitis, pyrexia, nasopharyngitis, diarrhoea, upper respiratory tract infection, vomiting, cough, rash, headache, amenorrhoea, acne, pneumonia, urinary tract infection, sinusitis, menstruation irregular, pharyngitis, decreased appetite, fatigue, hypercholesterolaemia, and hypertension.
Danish: De hyppigste bivirkninger (incidens ≥1/10) fra de samlede sikkerhedsdata er (i rækkefølge med faldende incidens): stomatitis, pyreksi, nasopharyngitis, diarré, infektion i øvre luftveje, opkastning, hoste, udslæt, hovedpine, amenoré, akne, pneumoni, urinvejsinfektion, sinuitis, uregelmæssige menstruationer, faryngitis, appetitløshed, træthed, hyperkolesterolæmi og hypertension.
English: Ask your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis du er i tvivl.
English: Based on in vitro results, the systemic concentrations obtained after oral daily doses of 10 mg make inhibition of PgP, CYP3A4 and CYP2D6 unlikely.
Danish: Baseret på in vitro resultater, er det usandsynligt, at PgP, CYP3A4 og CYP2D6 hæmmes ved de systemiske koncentrationer, der opnås efter daglig oral dosis af 10 mg. Hæmning af CYP3A4 og PgP i tarmen kan dog ikke udelukkes.
English: A higher starting dose of 7 mg/m is therefore recommended for patients 1 to less than 3 years of age with SEGA (see section 4.2).
Danish: En højere startdosis på 7 mg/m anbefales derfor til patienter mellem 1 og under 3 år med SEGA (se pkt.
English: The median duration of blinded study treatment was 48.1 weeks (range 2 to 115) for patients receiving Votubia and 45.0 weeks (range 9 to 115) for those receiving placebo.
Danish: Medianvarigheden af den blindede studiebehandling var 48,1 uger (interval 2 til 115) for patienter, der fik Votubia, og 45,0 uger (interval 9 til 115) for dem, der fik placebo.
English: In clinical trials and post-marketing spontaneous reports, angioedema has been reported with and without concomitant use of ACE inhibitors (see section 4.4).
Danish: I kliniske forsøg og post-marketing spontane rapporter er angioødem blevet rapporteret både med og uden samtidig behandling med ACE-hæmmere (se pkt.
English: If toxicity recurs at Grade 2, interrupt Votubia until recovery to Grade 1.
Danish: Hvis toksicitet recidiverer ved Grad 2, afbrydes Votubia indtil bedring til Grad 1.
English: Table 4 shows the incidence of adverse reactions based on pooled data of patients receiving everolimus in the three TSC studies (including both the double-blind and open-label extension phase, where applicable).
Danish: Tabel 4 viser incidensen af bivirkninger baseret på poolede data fra patienter, der fik everolimus, fra de tre TSC-studier (inklusive både den dobbeltblindede og den åbne forlængelsesfase, hvis aktuel).
English: Of the enrolled patients, 79.5% had bilateral SEGAs, 42.7% had ≥2 target SEGA lesions, 25.6% had inferior growth, 9.4% had evidence of deep parenchymal invasion, 6.8% had radiographic evidence of hydrocephalus, and 6.8% had undergone prior SEGA-related surgery.
Danish: 79,5 % af de inkluderede patienter havde bilaterale SEGAer, 42,7 % havde ≥2 mål-SEGA-læsioner, 25,6 % havde lavere vækst, 9,4 % havde evidens for dyb parenkymal invasion, 6,8 % havde radiografisk evidens for hydrocefalus, og 6,8 % havde fået foretaget tidligere SEGA-relateret operation.
English: Open the blister just before taking Votubia dispersible tablets.
Danish: Åbn først blisterpakningen lige inden, du tager Votubia dispergible tabletter.
English: Table 1 summarises dose adjustment recommendations for specific adverse reactions (see also section 4.4).
Danish: Tabel 1 opsummerer anbefalinger for dosisjustering ved specifikke bivirkninger (se også pkt.
English: Wipe the glass and spoon with a clean paper towel.
Danish: Tør glasset og skeen med et rent stykke køkkenrulle.
English: SEGA volume should be evaluated approximately 3 months after commencing Votubia therapy, with subsequent dose adjustments taking changes in SEGA volume, corresponding trough concentration, and tolerability into consideration.
Danish: SEGA-volumen bør evalueres ca. hver 3. måned efter påbegyndelse af Votubia-behandling, og ved efterfølgende dosisjusteringer skal ændringer i SEGA-volumen, tilhørende trough-koncentrationer er og tolerabilitet tages i betragtning.
English: High level of the hormone that triggers ovulation (blood luteinising hormone increased) Weight loss
Danish: Højt niveau af det hormon, der sætter ægløsning i gang (forhøjet luteiniserende hormon) Vægttab
English: For patients with TSC who have SEGA, SEGA volume should be evaluated approximately 3 months after commencing Votubia therapy, with subsequent dose adjustments taking changes in SEGA volume, corresponding trough concentration, and tolerability into consideration.
Danish: For patienter med TSC, der har SEGA, bør SEGA-volumen evalueres ca. hver 3. måned efter påbegyndelse af Votubia-behandling, og ved efterfølgende dosisjusteringer skal ændringer i SEGA-volumen, tilhørende trough-koncentrationer og tolerabilitet tages i betragtning.
English: Blood tests will also be carried out to check your kidney function (levels of creatinine, blood urea nitrogen or urinary protein), liver function (level of transaminases) and your blood sugar and lipid levels.
Danish: Der vil også blive taget blodprøver for at kontrollere din nyrefunktion (måling af kreatinin, blod-urea-nitrogen eller urinprotein) og leverfunktion (aminotransferase-tal) samt dit blodsukker og lipidtal, fordi disse tal også kan påvirkes af Votubia.
English: Consistent treatment effects on angiomyolipoma response rate were observed across all subgroups evaluated (i.e. enzyme-inducing antiepileptic use versus enzyme-inducing antiepileptic non-use, sex, age and race) at the primary efficacy analysis.
Danish: Konsistent behandlingseffekt på angiomyolipom-responsrate sås på tværs af alle evaluerede undergrupper (dvs. brug af enzyminducerende antiepileptika i forhold til ingen brug af enzyminducerende antiepileptika, køn, alder og race) ved den primære analyse.
English: The median age for the total population was 9.5 years (age range for the Votubia arm: 1.0 to 23.9; age range for the placebo arm: 0.8 to 26.6), 69.2% of the patients were aged 3 to <18 years and 17.1% were <3 years at enrolment.
Danish: Medianalderen for den totale population var 9,5 år (aldersinterval for Votubia-armen: 1,0 til 23,9; aldersinterval for placebo-armen: 0,8 til 26,6), 69,2 % af patienterne var 3 til <18 år og 17,1 % var <3 år ved inklusion.
English: The primary efficacy endpoint was angiomyolipoma response rate based on independent central radiology review.
Danish: Det primære endepunkt for virkning var responsraten på angiomyolipom baseret på en uafhængig central radiologisk gennemgang.
English: Table 3 shows the incidence of adverse reactions based on pooled data of patients receiving everolimus in the three TSC studies (including both the double-blind and open-label extension phase, where applicable).
Danish: Tabel 3 viser incidensen af bivirkninger baseret på poolede data fra patienter, der fik everolimus, fra de tre TSC-studier (inklusive både den dobbeltblindede og den åbne forlængelsesfase, hvis aktuel).
English: For further details on handling, see section 6.6.
Danish: For yderligere detaljer, se pkt.
English: Use caution when co-administration of moderate CYP3A4 inhibitors or PgP inhibitors cannot be avoided.
Danish: Der bør udvises forsigtighed, når samtidig administration af moderate CYP3A4-hæmmere eller PgP-hæmmere ikke kan undgås.
English: Table 2 summarises dose adjustment recommendations for specific adverse reactions (see also section 4.4).
Danish: Tabel 2 opsummerer anbefalinger for dosisjustering ved specifikke bivirkninger (se også pkt.
English: Table 3 Effects of other active substances on everolimus
Danish: Tabel 3 Andre aktive stoffers effekt på everolimus
English: 25% resp. 25 to <50
Danish: 25 % resp. 25 til <50
English: Substances that are inducers of CYP3A4 or PgP may decrease everolimus blood concentrations by increasing metabolism or the efflux of everolimus from intestinal cells.
Danish: Stoffer, der inducerer CYP3A4 eller PgP, kan nedsætte blodkoncentrationer af everolimus ved at øge metabolismen eller effluks af everolimus ud af tarmcellerne.
English: Monitoring of complete blood count is recommended prior to the start of Votubia therapy and periodically thereafter.
Danish: Det anbefales at foretage en komplet blodtælling før opstart af behandling med Votubia og med jævne mellemrum herefter.
English: If you receive Votubia for the treatment of TSC with SEGA, 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: Hvis du får Votubia til behandling af TSC med SEGA, vil din læge afgøre, hvilken dosis Votubia du skal tage ud fra: din alder din kropsstørrelse hvor sund, din lever er anden medicin, du tager
English: For children with SEGA or seizures, it is important to have a discussion with the doctor about the childhood vaccination program before treatment with Votubia.
Danish: For børn med TSC og SEGA eller epileptiske anfald, er det vigtigt at tale med lægen om børnevaccinationsprogrammet, inden behandling med Votubia.
English: Swollen, bleeding gums (signs of gum inflammation, also known as gingivitis) Skin inflammation (cellulitis)
Danish: Hævet, blødende tandkød (tegn på tandkødsbetændelse, også kendt som gingivitis) Hudbetændelse (cellulitis)
English: Concomitant treatment of Votubia and potent inhibitors is not recommended.
Danish: Samtidig behandling med Votubia og potente hæmmere frarådes.
English: Table 2 Effects of other active substances on everolimus
Danish: Tabel 2 Andre aktive stoffers effekt på everolimus
English: Everolimus is a substrate of CYP3A4, and also a substrate and moderate inhibitor of PgP.
Danish: Everolimus er et substrat for CYP3A4 og er desuden substrat for og moderat hæmmer af PgP.
English: An inflammatory condition of the skin characterised by redness, itching, and oozing liquidfilled cysts which become scaly, crusted, or hardened (dermatitis acneiform) Loss of hair (alopecia)
Danish: En betændelsestilstand i huden, karakteriseret ved rødme, kløe, sivende, væskefyldte cyster, der bliver skællede, danner skorpe eller bliver hårde (dermatitis akneiform) Hårtab (alopeci)
English: The median duration of blinded study treatment was 9.6 months (range: 5.5 to 18.1) for patients receiving Votubia and 8.3 months (range: 3.2 to 18.3) for those receiving placebo.
Danish: Medianvarigheden af blindet studiebehandling var 9,6 måneder (interval: 5,5 til 18,1) for patienter, der fik Votubia og 8,3 måneder (interval: 3,2 til 18,3) for patienter, der fik placebo.
English: The syringe should be gently inverted 5 times immediately prior to administration.
Danish: Sprøjten vendes forsigtigt op og ned 5 gange lige inden administration.
English: You must drink the suspension immediately after preparing it.
Danish: Du skal drikke suspensionen med det samme efter den er gjort klar.
English: EXIST-1 (Study CRAD001M2301), a randomised, double-blind, multicentre phase III study of Votubia versus placebo, was conducted in patients with SEGA, irrespective of age.
Danish: EXIST-1 (studie CRAD001M2301), et randomiseret, dobbeltblindet, multicenter fase III-studie med Votubia versus placebo blev udført med patienter med SEGA, uanset alder.
English: Substances that are inhibitors of CYP3A4 or PgP may increase everolimus blood concentrations by decreasing metabolism or the efflux of everolimus from intestinal cells.
Danish: Stoffer, der hæmmer CYP3A4 eller PgP, kan øge blodkoncentrationer af everolimus ved at nedsætte metabolismen eller effluksen af everolimus fra tarmcellerne.
English: Increased exposure expected.
Danish: Eksponeringen forventes forhøjet.
English: Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered depending on the individual clinical circumstances.
Danish: Behandling med Votubia kan genoptages i en daglig dosis, der er ca. 50 % lavere end den tidligere administrerede dosis, afhængig af de individuelle kliniske omstændigheder.
English: Temporary dose interruption until recovery to Grade 1.
Danish: Midlertidig behandlingspause indtil bedring til Grad 1.
English: Anaemia, neutropenia, leucopenia, thrombocytopenia, lymphopenia Immune system disorders
Danish: Almindelig Anæmi, neutropeni, leukopeni, trombocytopeni, lymfopeni Immunsystemet
English: Refractory seizures associated with tuberous sclerosis complex (TSC)
Danish: Refraktære anfald i forbindelse med tuberøst sklerosekompleks (TSC)
English: Patients with SEGA associated with TSC:
Danish: Patienter med SEGA i tilknytning til TSC:
English: Everolimus whole blood trough concentrations should be assessed at least 1 week after any change in hepatic status (Child-Pugh).
Danish: Koncentrationen af everolimus i fuldblod skal måles mindst 1 uge efter enhver ændring i leverstatus (Child-Pugh).
English: Consider interruption of therapy until symptoms improve to Grade 1.
Danish: Overvej pause i behandlingen, indtil symptomerne forbedres til Grad 1.
English: Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) (see section 4.5).
Danish: Hos patienter, der samtidig behandles med en ACE-hæmmer (fx ramipril), kan der være forhøjet risiko for angioødem (fx hævelse af luftvejene eller tungen med eller uden respiratorisk svækkelse) (se pkt.
English: Excess amount of gas in the bowels (flatulence)
Danish: Store mængder luft i maven (flatulens)
English: Phase III study in patients with TSC and refractory seizures EXIST-3 (Study CRAD001M2304), a randomised, double-blind, multicentre, three-arm, parallel-group phase III study of Votubia versus placebo as adjunctive therapy was conducted in TSC patients with refractory partial-onset seizures.
Danish: Fase III-studie med patienter med TSC og refraktære anfald EXIST-3 (studie CRAD001M2304), et randomiseret, dobbeltblindt fase III-multicenterstudie med 3 arme og parallelle grupper undersøgte Votubia versus placebo som supplerende behandling hos TSCpatienter med refraktære partielle anfald.
English: Primary tumour volume Mean (standard deviation)
Danish: Primært tumorvolumen Middelværdi (standardafvigelse)
English: • ≥18 years of age and concomitant severe hepatic impairment (Child-Pugh C) unless the potential benefit outweighs the risk (see sections 4.2 and 5.2).
Danish: • ≥18 år og samtidig svært nedsat leverfunktion (Child-Pugh C) med mindre den potentielle fordel opvejer risikoen (se pkt.
English: If you are being treated for SEGA associated with TSC, Votubia will only be prescribed by a doctor with experience in treating patients with SEGA and with access to blood tests which will measure how much Votubia is in your blood.
Danish: Hvis du behandles for SEGA forbundet med TSC, ordineres Votubia kun af en læge, der har erfaring i behandling af patienter med SEGA, og som har adgang til blodprøveanalyser, som kan måle, hvor meget Votubia du har i blodet.
English: Votubia exists as tablets and dispersible tablets.
Danish: Votubia fås som både tabletter og dispergible tabletter.
English: In vitro, everolimus is a competitive inhibitor of CYP3A4 and a mixed inhibitor of CYP2D6.
Danish: In vitro er everolimus en kompetitiv hæmmer af CYP3A4 og både en kompetitiv og non-kompetitiv hæmmer af CYP2D6.
English: The prescribed dose of Votubia dispersible tablets should be placed in a 10 ml oral dosing syringe graduated in 1 ml increments.
Danish: Den ordinerede dosis af Votubia dispergible tabletter lægges i en 10 ml doseringssprøjte med inddelinger á 1 ml.
English: In a relative bioavailability study, AUC0-inf of 5 x 1 mg everolimus tablets when administered as suspension in water was equivalent to 5 x 1 mg everolimus tablets administered as intact tablets, and Cmax of 5 x 1 mg everolimus tablets in suspension was 72% of 5 x 1 mg intact everolimus tablets.
Danish: I et studie for relativ biotilgængelighed, var AUC0-inf for 5 x 1 mg everolimus tabletter, når de blev administreret som suspension i vand, ækvivalent med 5 x 1 mg everolimus tabletter, administreret som intakte tabletter og Cmax for 5 x 1 mg everolimus tabletter i suspension var 72 % af 5 x 1 mg intakte everolimus tabletter.
English: In order to achieve a target concentration above the lower Cmin limit of 5 ng/ml, e.g. 8 ng/ml, the new everolimus dose would be 8 mg (an increase of 4 mg from the current daily dose).
Danish: For at opnå en målkoncentration over den nedre Cmin-grænse på 5 nanogram/ml, fx 8 nanogram/ml, skal den nye everolimusdosis være 8 mg (en stigning på 4 mg i forhold til den aktuelle daglige dosis).
English: Grade 4 (<0.5x10
Danish: Grad 4 (<0,5x10
English: Grade 4
Danish: Grad 4
English: Fever, sore throat or mouth ulcers due to infections (signs of low level of white blood cells, also known as leucopenia, lymphopenia, neutropenia) Spontaneous bleeding or bruising (signs of low level of platelets, also known as thrombocytopenia)
Danish: Feber, ondt i halsen eller mundsår pga. infektioner (tegn på et lavt niveau af hvide blodlegmer, også kendt som leukopeni, lymfopeni, neutropeni) Spontan blødning eller blå mærker (tegn på lavt niveau af blodplader, også kendt som trombocytopeni)
English: Light fat meals reduced AUC by 29.5% and Cmax by 50.2%.
Danish: Måltider med let fedtindhold reducerede AUC med 29,5 % og Cmax med
English: Common side effects (may affect up to 1 in 10 people) Swelling, feeling of heaviness or tightness, pain, limited mobility of body parts (this could occur anywhere in the body and is a potential sign of an abnormal build-up of fluid in soft tissue due to a blockage in the lymphatic system, also known as lymphoedema) Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic reaction, also known as hypersensitivity) Fever, cough, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter) Hævelse, tyngdefornemmelse eller stivhed, smerte, begrænset bevægelighed af kropsdele (kan forekomme hvilket som helst sted i kroppen og kan være tegn på en unormal væskeophobning i bløddelene pga. blokade i lymfesystemet, også kaldet lymfødem) Udslæt, kløe, nældefeber, vejtræknings- eller synkebesvær, svimmelhed (tegn på en alvorlig allergisk reaktion, også kendt som overfølsomhed) Feber, hoste, vejrtrækningsbesvær, hiven efter vejret (tegn på inflammation i lungen på grund af infektion, også kaldet lungebetændelse)
English: The effect is likely to be due to inhibition of intestinal CYP3A4 by everolimus.
Danish: Effekten skyldes formentlig, at everolimus hæmmer intestinal CYP3A4.
English: Draw up about 5 ml of water by slowly pulling the plunger out until it is at the 5 ml mark on the syringe.
Danish: Træk ca. 5 ml vand op ved at trække stemplet tilbage, så det står ud for 5 ml-mærket på sprøjten.
English: Dosing should be titrated to attain trough concentrations of 5 to 15 ng/ml as described below.
Danish: Doseringen bør titreres, så der opnås dal-koncentrationer på 5 til 15 nanogram/ml som beskrevet nedenfor.
English: Patients receiving concomitant potent CYP3A4 inducers may require an increased Votubia dose to achieve the same exposure as patients not taking potent inducers.
Danish: Det kan være nødvendigt at øge Votubia-dosen for patienter, der samtidig får potente CYP3A4-induktorer, for at opnå samme eksponering som hos patienter, der ikke tager potente induktorer.
English: • Blister with Votubia dispersible tablets
Danish: • Blisteren med Votubia dispergible tabletter
English: Temporary dose interruption until recovery to Grade 1 (≥75x10
Danish: Midlertidig behandlingspause indtil bedring til Grad 1 (≥75x10
English: In order to achieve a target concentration above the lower Cmin limit of 5 ng/ml, e.g. 8 ng/ml, the new everolimus dose would be 5 mg (an increase of 2.5 mg from the current daily dose).
Danish: For at opnå en målkoncentration over den nedre Cmin-grænse på 5 nanogram/ml, fx 8 nanogram/ml, skal den nye everolimusdosis være 5 mg (en stigning på 2,5 mg i forhold til den aktuelle daglige dosis).
English: Starting dose and target trough concentrations in SEGA associated with TSC The recommended starting dose for Votubia for the treatment of patients with SEGA is 4.5 mg/m2.
Danish: Startdosis og mål-dal-koncentration ved SEGA i forbindelse med tuberøst sklerosekompleks Den anbefalede startdosis af Votubia til behandling af patienter med SEGA er 4,5 mg/m2.
English: AUC ↑ 3.7-fold Cmax ↑ 2.2-fold
Danish: AUC ↑ 3,7 gange Cmax ↑ 2,2 gange
English: In a bioequivalence study, AUC0-inf of the 5 mg dispersible tablet when administered as suspension in water was equivalent to 5 x 1 mg intact everolimus tablets, and Cmax of the 5 mg dispersible tablet in suspension was 64% of 5 x 1 mg intact everolimus tablets.
Danish: I et studie for bioækvivalens, var AUC0-inf for den 5 mg dispergible tablet, når den blev administreret som suspension i vand, ækvivalent med 5 x 1 mg intakte everolimus tabletter og Cmax for den 5 mg dispergible tablet i suspension var 64 % af 5 x 1 mg intakte everolimus tabletter.
English: higher starting dose of 7 mg/m is recommended for patients 1 to less than 3 years of age based on pharmacokinetic simulations (see section 5.2).
Danish: Hos patienter fra 1 år til under 3 år anbefales en højere startdosis på 7 mg/m2, baseret på farmakokinetiske simuleringer (se pkt.
English: Includes (very common) stomatitis, mouth ulceration, aphthous ulcer; (common) tongue ulceration, lip ulceration and (uncommon) gingival pain, glossitis c
Danish: Inklusive (meget almindelig) stomatitis, mundulceration, aftøs ulcus; (almindelig) tungeulceration, læbeulceration og (ikke almindelig) gingivalsmerter, glossitis c
English: The median duration of exposure was 67.8 months (range 4.7 to
Danish: Den mediane eksponeringvarighed var 67,8 måneder (interval 4,7 til 83,2).
English: • EXIST-2 (CRAD001M2302): This was a randomised, double-blind, controlled, phase III trial of everolimus (n=79) versus placebo (n=39) in patients with either TSC plus renal angiomyolipoma (n=113) or sporadic lymphangioleiomyomatosis (LAM) plus renal angiomyolipoma (n=5).
Danish: • EXIST-2 (CRAD001M2302): Dette var et randomiseret, dobbeltblindet, kontrolleret fase III-forsøg med everolimus (n=79) versus placebo (n=39) hos patienter med enten TSC plus renal angiomyolipom (n=113) eller sporadisk lymfangioleiomyomatose (LAM) plus renal angiomyolipom (n=5).
English: Two fatal cases due to infection were reported in 409 patients aged <18 years receiving everolimus.
Danish: Ud af 409 patienter i alderen 18 år, som blev behandlet med everolimus, blev der indberettet to dødsfald som følge af infektion.
English: Grade 3 (<1, ≥0.5x10
Danish: Grad 3 (<1, ≥0,5x10
English: How to take Votubia
Danish: Sådan skal du tage Votubia
English: The seizure-free rate (the proportion of patients who became seizure-free during the maintenance period of the core phase) was 5.1% (95% CI: 1.9, 10.8) and 3.8% (95% CI: 1.3, 8.7) in the Votubia LT and HT arms, respectively, versus 0.8% (95% CI: 0.0, 4.6) of patients in the placebo arm.
Danish: Frekvensen for anfaldsfrihed (andelen af patienter, der blev anfaldsfrie under hovedfasens vedligeholdelsesperiode) var 5,1 % (95 % CI: 1,9; 10,8) og 3,8 % (95 % CI: 1,3; 8,7) i hhv. Votubia LT- og HT-armen versus 0,8 % (95 % CI: 0,0; 4,6) i placeboarmen.