FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the administration of a single dose of radiolabelled everolimus in conjunction with ciclosporin, 80% of the radioactivity was recovered from the faeces, while 5% was excreted in the urine.
Danish: Efter administration af en enkelt dosis radioaktivt mærket everolimus sammen med ciclosporin genfandtes 80% af radioaktiviteten i fæces, mens 5% blev udskilt i urinen.
English: Therefore, your doctor will monitor your kidney function while you are taking Afinitor.
Danish: Derfor vil din læge tjekke din nyrefunktion, mens du tager Afinitor.
English: cause shortness of breath, cough and fever.
Danish: forårsage åndenød, hoste og feber.
English: Clinical benefit rate = proportion of patients with complete or partial response or stable disease ≥24 weeks d
Danish: Rate for klinisk fordel = andel af patienter med fuldstændig eller delvis respons eller stabil sygdom ≥24 uger d
English: Carbamazepine, phenobarbital, phenytoin
Danish: Carbamazepin, phenobarbital, phenytoin
English: • Menstruation disorders such as absence of periods (amenorrhoea)
Danish: • Menstruationsforstyrrelser, såsom manglende menstruation (amenoré)
English: Your doctor might need to interrupt or discontinue your treatment with Afinitor.
Danish: Din læge vil muligvis afbryde eller helt stoppe din behandling med Afinitor.
English: hypokalaemia, dehydration, hypocalcaemia
Danish: hypokaliæmi, dehydrering, hypokalcæmi
English: Table 3 presents the frequency category of adverse reactions reported in the pooled analysis considered for the safety pooling.
Danish: Tabel 3 viser frekvens-kategorien for bivirkninger, der blev rapporteret i den poolede analyse af de samlede sikkerhedsdata.
English: Afinitor contains lactose (milk sugar).
Danish: Afinitor indeholder lactose (mælkesukker).
English: Table 4 BOLERO-2 efficacy results
Danish: Tabel 4 BOLERO-2 - Resultater af virkning
English: • Passing urine more often during daytime
Danish: • Hyppigere vandladning i dagtimerne
English: *Non-ileum: stomach, colon, rectum, appendix, caecum, duodenum, jejunum, carcinoma of unknown primary origin and other gastrointestinal origin
Danish: *Ikke-ileum: mave, kolon, rektum, appendix, coecum, duodenum, jejunum, karcinom af ukendt oprindelsessted og anden gastrointestinal oprindelse
English: One-sided p-value from a stratified log-rank test
Danish: En-sidet p-værdi fra en stratificeret log-rank-test.
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: Your doctor might restart treatment with Afinitor at the same dose or at a lower dose.
Danish: Din læge kan vælge at starte din behandling med Afinitor igen på samme eller på en lavere dosis.
English: Yes (N=157) No (N=145) Yes (N=77)
Danish: Ja (N=157) Nej (N=145) Ja (N=77)
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 ng/ml, er 17% til 73%.
English: Sensitivity to prior hormonal therapy was defined as either (1) documented clinical benefit (complete response [CR], partial response [PR], stable disease ≥24 weeks) from at least one prior hormonal therapy in the advanced setting or (2) at least 24 months of adjuvant hormonal therapy prior to recurrence.
Danish: Sensitivitet for tidligere hormonbehandling var defineret som enten (1) dokumenteret klinisk fordel (fuldstændig respons [CR], delvis respons [PR], stabil sygdom ≥24 uger) fra mindst en tidligere hormonbehandling i fremskredet stadie eller (2) mindst 24 måneders adjuverende hormonbehandling inden recidiv.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen,og enhver efterfølgende godkendt opdatering af RMP.
English: Light fat meals reduced AUC by 32% and Cmax by 42%.
Danish: Måltider med let fedtindhold nedsatte AUC med 32% og Cmax med 42%.
English: All (N=302) <65 years (N=159) ≥65 years (N=143) 0 (N=216) 1 (N=86)
Danish: Alle (N=302) <65 år (N=159) ≥65 år (N=143) 0 (N=216) (N=86)
English: Pre-existing infections should be treated appropriately and should have resolved fully before starting treatment with Afinitor.
Danish: Præ-eksisterende infektioner skal behandles hensigtsmæssigt og være fuldstændigt elimineret, inden behandling med Afinitor påbegyndes.
English: Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue Afinitor therapy without dose adjustments.
Danish: Patienter, der udvikler radiologiske forandringer, der tyder på non-infektiøs pneumonitis, og som har få eller ingen symptomer, kan fortsætte behandlingen med Afinitor uden dosisjustering.
English: No (N=225) Lung (N=90) Ileum (N=71) Non-ileum* (N=141) Grade 1 (N=194) Grade 2 (N=107) ≤10% (N=228) >10% (N=72) >2xULN (N=139) ≤2xULN (N=138) >ULN (N=87) ≤ULN (N=188)
Danish: Nej (N=225) Lunge (N=90) Ileum (N=71) Ikke-ileum* (N=141) Grad 1 (N=194) Grad 2 (N=107) ≤10 % (N=228) >10 % (N=72) >2xULN (N=139) ≤2xULN (N=138) >ULN (N=87) ≤ULN (N=188)
English: Following disease progression or after study unblinding, 172 of the 203 patients (84.7%) initially randomised to placebo crossed over to open-label Afinitor.
Danish: Efter sygdomsprogression eller efter afblinding af studiet krydsede 172 af de 203 patienter (84,7%), der initialt var randomiseret til placebo, over til open-label Afinitor.
English: Co-administration of everolimus and exemestane increased exemestane Cmin and C2h by 45% and 64%, respectively.
Danish: Samtidig administration af everolimus og exemestan øgede Cmin og C2h for exemestan med henholdsvis 45% og 64%.
English: Afinitor may elevate cholesterol and/or other blood fats.
Danish: Afinitor kan øge mængden af kolesterol og/eller andre fedtstoffer i blodet.
English: Plasma protein binding is approximately 74% both in healthy subjects and in patients with moderate hepatic impairment.
Danish: Plasmaproteinbindingen er ca. 74% hos både raske forsøgspersoner og patienter med moderat nedsat leverfunktion.
English: Table 5 RADIANT-3 - efficacy results
Danish: Tabel 5 RADIANT-3 - Effektresultater
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Bivirkningerne står anført efter systemorganklasse og hyppighedskategori i henhold til MedDRA. Hyppighedskategorierne defineres ved brug af følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000).
English: No difference in the time to definitive deterioration of WHO PS (≥1 point) and time to definitive deterioration in quality of life (FACT-G total score ≥7 points) was observed between the two arms.
Danish: Der blev ikke observeret en forskel i tiden til endelig forværring af WHO PS (≥1) og tiden til endelig forværring af livskvalitet (FACT-G totalværdi (≥7)) mellem de to arme.
English: The recommended dose is 10 mg, taken once a day.
Danish: Den anbefalede dosis er 10 mg, som tages en gang daglig.
English: Table 1 summarises the dose adjustment recommendations for specific adverse reactions (see also section 4.4).
Danish: Tabel 1 opsummerer anbefalingerne for dosisjustering ved specifikke bivirkninger (se også pkt.
English: For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for PJP/PCP may be considered.
Danish: Hos patienter, hvor behandling med kortikosteroider af non-infektiøs lungebetændelse er nødvendig, kan profylaktisk behandling mod PJP/PCP overvejes.
English: The following may increase the risk of side effects with Afinitor: ketoconazole, itraconazole, voriconazole, or fluconazole and other antifungals used to treat fungal infections.
Danish: Følgende kan øge risikoen for bivirkninger med Afinitor: ketoconazol, itraconazol, voriconazol eller fluconazol og andre lægemidler til behandling af svampeinfektioner.
English: Afinitor contains lactose
Danish: Afinitor indeholder lactose
English: • swelling of the face, lips, tongue or throat
Danish: • hævelse i ansigtet, læberne, tungen eller halsen
English: Grade 2 If toxicity is tolerable, no dose adjustment required.
Danish: Grad 2 Hvis toksiciteten tolereres, er dosisjustering ikke nødvendig.
English: Do not take Afinitor 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 Afinitor hvis du er allergisk over for everolimus, beslægtede stoffer som fx sirolimus eller temsirolimus eller et af de øvrige indholdsstoffer i Afinitor (angivet i punkt 6).
English: Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Everolimus bør ikke anvendes under graviditet eller til kvinder i den fertile alder, der ikke anvender kontraception.
English: Therefore, you may be at risk of getting an infection while you are taking Afinitor.
Danish: Du kan derfor risikere af få en infektion, mens du tager Afinitor.
English: In patients with advanced solid tumours, Vd was 191 l for the apparent central compartment and 517 l for the apparent peripheral compartment.
Danish: Hos patienter med progressive massive tumorer var Vd 191 l for det synlige centrale kompartment og 157 l for det synlige perifere kompartment.
English: Supportive PFS analyses were based on an independent central radiology review.
Danish: Understøttende PFS-analyser var baseret på en uafhængig, central radiologisk vurdering.
English: Afinitor may have a minor or moderate influence on the ability to drive and use machines.
Danish: Afinitor kan påvirke evnen til at føre motorkøretøj og betjene maskiner i mindre eller moderat grad.
English: Very common Weight decreased * See also subsection “Description of selected adverse reactions”
Danish: * Se også undersektion ”Beskrivelse af udvalgte bivirkninger”
English: The overall safety profile in this study was consistent with that established for everolimus in the oncology and tuberous sclerosis complex (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: Afinitor may have an impact on female fertility.
Danish: Afinitor kan muligvis påvirke kvinders frugtbarhed.
English: Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
Danish: Everolimus nedsætter blodtilførslen til kræftknuden og hæmmer væksten og spredningen af kræftceller.
English: Approximately 20% of the everolimus concentration in whole blood is confined to plasma in cancer patients given everolimus 10 mg/day.
Danish: Ca. 20% af everolimus-koncentrationen i fuldblod er begrænset til plasma hos cancerpatienter, der får everolimus 10 mg/dag.
English: 95% CI [0.27, 0.45] Log-rank p value = <0.001 Kaplan-Meier medians Afinitor : 11.04 months Placebo : 4.60 months
Danish: 95% CI [0,27, 0,45] Log-rank p værdi = <0,001 Kaplan-Meier medianer Afinitor : 11,04 måneder Placebo : 4,60 måneder
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 ingen signifikant alderspåvirkning (27-85 år) på oral clearance af everolimus.
English: Table 7 RECORD-1 - Progression-free survival results
Danish: Tabel 7 RECORD-1 - Resultater for progressionsfri overlevelse
English: Best overall response (%) (95% CI) Objective response rate b
Danish: Bedste totale respons (%) (95% CI) Objektiv responsrate b n/a d e
English: • Feeling weak or tired
Danish: • Følelse af svaghed eller træthed
English: The study did not meet the primary efficacy endpoint (progression-free-survival [PFS]) and the overall survival (OS) interim analysis numerically favoured the placebo plus depot octreotide arm.
Danish: Studiet nåede ikke sit primære effektendepunkt (progressionsfri overlevelse [PFS]), og interimanalysen af den totale overlevelse (overall survival OS) favoriserede numerisk armen med placebo plus depot-octreotid.
English: The primary objective of the study was to estimate the HR of PFS for everolimus + exemestane versus everolimus alone.
Danish: Det primære formål med studiet var at estimere HR for PFS for everolimus + exemestan versus everolimus alene.
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: Steady-state pharmacokinetics
Danish: Steady-state-farmakokinetik
English: AUC ↓63% (range 0-80%) Cmax ↓58% (range 10-70%)
Danish: AUC ↓63% (interval 0-80%) Cmax ↓58% (interval 10-70%)
English: If this is the case, your doctor may need to prescribe a different dose of Afinitor.
Danish: Hvis det er tilfældet, kan det være, at din læge skal ordinere en anden Afinitor-dosis.
English: Results of the secondary endpoint OS were not consistent with the primary endpoint PFS, with a trend observed favouring the everolimus alone arm.
Danish: Resultaterne for det sekundære endepunkt OS var ikke konsistente med det primære endepunkt PFS, da der blev observeret en trend, der favoriserer everolimus alene-armen.
English: No statistically significant treatment-related difference in overall survival was noted (hazard ratio 0.87; confidence interval: 0.65-1.17; p=0.177).
Danish: Der sås ingen statistisk signifikant behandlingsrelateret forskel i overlevelse (hazard ratio 0,87; konfidensinterval: 0,65-1,17; p=0,177).
English: While taking Afinitor, be vigilant for symptoms and signs of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Afinitor.
Danish: Mens Afinitor tages, skal man være på vagt over for symptomer og tegn på infektion: hvis der stilles en infektionsdiagnose, skal der omgående iværksættes hensigtsmæssig behandling, og afbrydelse eller ophør med Afinitor-behandlingen skal overvejes.
English: Severe hepatic impairment (Child-Pugh C) - Afinitor is only recommended if the desired benefit outweighs the risk.
Danish: Stærkt nedsat leverfunktion (Child-Pugh C): Afinitor er kun anbefalet hvis de ønskede fordele opvejer risiciene.
English: if you need to receive a vaccine while taking Afinitor.
Danish: hvis du skal vaccineres, mens du tager Afinitor.
English: Fifty-eight percent of the patients in both arms received prior systemic therapy.
Danish: I begge arme fik 58% af patienterne systemisk behandling op til studiet.
English: Treatment with Afinitor should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Danish: Behandling med Afinitor bør initieres og superviseres af læger med erfaring inden for cancerterapi.
English: If a diagnosis of invasive systemic fungal infection is made, the Afinitor treatment should be promptly and permanently discontinued and the patient treated with appropriate antifungal therapy.
Danish: Hvis diagnosen invasiv systemisk svampeinfektion stilles, skal Afinitor-behandlingen omgående og permanent seponeres, og patienten skal behandles med et passende antimykotisk lægemiddel.
English: Interaction - Change in Everolimus AUC/Cmax Geometric mean ratio (observed range)
Danish: Interaktion - Ændring i Everolimus AUC/Cmax Geometrisk gennemsnitsratio (observeret interval)
English: Patients were stratified according to Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic score (favourable- vs. intermediate- vs. poor-risk groups) and prior anticancer therapy (1 vs. 2 prior VEGFR-TKIs).
Danish: Patienterne blev stratificeret ifølge Memorial Sloan-Kettering Cancer Center (MSKCC)-prognosescorings-systemet (grupperne favorabel vs. middel vs. dårlig risiko) og tidligere cancerterapi (1 vs. 2 tidligere VEGFR-TKI'er).
English: Progression-free survival, documented using RECIST (Response Evaluation Criteria in Solid Tumours) and assessed via a blinded, independent central review, was the primary endpoint.
Danish: Progressionsfri overlevelse (PFS), dokumenteret ved brug af RECIST (Response Evaluation Criteria in Solid Tumours) og vurderet via en blindet, uafhængig central gennemgang, var det primære endepunkt.
English: Demographics were well balanced (median age 58 years, 55% male, 78.5% Caucasian).
Danish: Der blev taget højde for demografien (median alder 58 år, 55% mænd, 78,5% kaukasier).
English: Everolimus reduces levels of vascular endothelial growth factor (VEGF), which potentiates tumour angiogenic processes.
Danish: Everolimus nedsætter niveauer af VEGF (vascular endothelial growth factor), som potentierer tumorangiogene processer.
English: Women who could potentially become pregnant should use highly effective contraception during treatment.
Danish: Kvinder i den fødedygtige alder skal bruge yderst sikker prævention under behandlingen.
English: Crossover to open-label Afinitor following disease progression for patients allocated to placebo confounded the detection of any treatment-related difference in overall survival.
Danish: Overgang til open-label Afinitor-behandling efter sygdomsprogression for patienter, der var allokeret til placebo, slørede muligheden for at detektere behandlingsrelateret forskel i total overlevelse.
English: Co-administration of everolimus and depot octreotide increased octreotide Cmin with a geometric mean ratio (everolimus/placebo) of 1.47.
Danish: Samtidig administration af everolimus og depot-octreotid øgede Cmin for octreotid med en geometrisk middelratio (everolimus/placebo) på 1,47.
English: There was no indication of kidney toxicity in monkeys or minipigs.
Danish: Der var ingen tegn på nyretoksicitet hos aber eller minigrise.
English: Afinitor is an anticancer medicine containing the active substance everolimus.
Danish: Afinitor er et lægemiddel mod kræft, som indeholder det aktive stof everolimus.
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 tegn 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: Kaplan-Meier medians Everolimus/Exemestane: 36.57 [28.71;42.29] weeks Everolimus: 29.43 [24.00;31.29] weeks
Danish: Kaplan-Meier-medianer Everolimus/Exemestan: 36,57 [28,71;42,29] uger Everolimus: 29,43 [24,00;31,29] uger
English: Management of stomatitis may therefore include prophylactic 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 og/eller terapeutisk brug af topikale behandlinger, som fx en alkoholfri oral opløsning med kortikosteroid som mundskyllevæske.
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis, candidiasis or PJP/PCP and viral infections including reactivation of hepatitis B virus, have been described in patients taking Afinitor.
Danish: Lokaliserede og systemiske infektioner, herunder pneumoni, andre bakterielle infektioner, invasive svampeinfektioner, såsom aspergillose, candidiasis eller PJP/PCP og virale infektioner inklusive reaktivering af hepatitis B virus, er beskrevet hos patienter, der tager Afinitor.
English: The estimated HR for the comparison of OS in the everolimus + exemestane combination arm relative to capecitabine arm was 1.33 (90% CI: 0.99, 1.79).
Danish: Den estimerede HR for sammenligningen af OS i everolimus + exemestan kombinations-armen i forhold til capecitabin-armen var 1,33 (90 % CI: 0,99; 1,79).
English: After administration of everolimus in patients with advanced solid tumours, steady-state AUC0-τ was dose-proportional over the range of 5 to 10 mg daily dose.
Danish: Efter administration af everolimus til patienter med progressive massive tumorer var steady-state-AUC0-τ dosisproportional i området 5 til 10 mg daglig dosis.
English: Common Haemorrhage b, hypertension
Danish: Vaskulære sygdomme Almindelig Hæmoragi b, hypertension
English: Exposure to everolimus was increased in patients with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment (see section 5.2).
Danish: Eksponering af everolimus var øget i patienter med let (Child-Pugh A), moderat (Child-Pugh B) og stærkt (Child-Pugh C) nedsat leverfunktion (se pkt.
English: A clinically significant effect on the efficacy response to everolimus in patients with advanced neuroendocrine tumours could not be established.
Danish: Det kunne ikke påvises, om dette havde en klinisk signifikant effekt på virkningsresponset for everolimus hos patienter med progressive neuroendokrine tumorer.
English: If you are taking any of them, your doctor may switch you to a different medicine, or may change your dose of Afinitor.
Danish: Hvis du tager en eller flere af dem, vil din læge måske ændre din behandling til en anden medicin eller ændre din dosis af Afinitor.
English: If you experience any of these side effects, tell your doctor immediately as this might have life-threatening consequences.
Danish: Fortæl det straks til din læge, hvis du oplever nogen af disse bivirkninger, da det kan have livstruende konsekvenser.
English: Kaplan-Meier medians Everolimus: 4.90 months Placebo: 1.87 months
Danish: Kaplan-Meier medianer Everolimus: 4,90 måneder Placebo: 1,87 måneder
English: The parent substance was not detected in urine or faeces.
Danish: Moderstoffet sporedes ikke i urin eller fæces.
English: The safety profile is based on pooled data from 2,879 patients treated with Afinitor in eleven clinical studies, consisting of five randomised, double-blind, placebo controlled phase III studies and six open-label phase I and phase II studies, related to the approved indications.
Danish: Sikkerhedsprofilen er baseret på de samlede data fra 2.879 patienter, der blev behandlet med Afinitor i elleve kliniske studier bestående af fem randomiserede, dobbeltblindede, placebokontrollerede fase III-studier og seks open-label (ublindet) fase I og fase II-studier, som var relaterede til de godkendte indikationer.
English: advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-called “VEGF-targeted therapy”) have not helped stop your disease.
Danish: - fremskreden nyrekræft (fremskreden renalcellekarcinom), hvor andre behandlinger (såkaldt VEGF-rettet behandling) ikke har kunnet standse din sygdom.
English: Table 1 Afinitor dose adjustment recommendations
Danish: Tabel 1 Anbefalinger for dosisjustering af Afinitor
English: Studies in animals have shown reproductive toxicity effects including embryotoxicity and foetotoxicity (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet, herunder embryotoksicitet og føtotoksicitet (se pkt.