natgillin/translations-raw huggingface dataset:
Efter administration af en enkelt dosis radioaktivt mærket everolimus sammen med ciclosporin genfandtes 80% af radioaktiviteten i fæces, mens 5% blev udskilt i urinen. 
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.
Derfor vil din læge tjekke din nyrefunktion, mens du tager Afinitor. 
Therefore, your doctor will monitor your kidney function while you are taking Afinitor.
forårsage åndenød, hoste og feber. 
cause shortness of breath, cough and fever.
Rate for klinisk fordel = andel af patienter med fuldstændig eller delvis respons eller stabil sygdom ≥24 uger d 
Clinical benefit rate = proportion of patients with complete or partial response or stable disease ≥24 weeks d
Carbamazepin, phenobarbital, phenytoin 
Carbamazepine, phenobarbital, phenytoin
• Menstruationsforstyrrelser, såsom manglende menstruation (amenoré) 
• Menstruation disorders such as absence of periods (amenorrhoea)
Din læge vil muligvis afbryde eller helt stoppe din behandling med Afinitor. 
Your doctor might need to interrupt or discontinue your treatment with Afinitor.
hypokaliæmi, dehydrering, hypokalcæmi 
hypokalaemia, dehydration, hypocalcaemia
Tabel 3 viser frekvens-kategorien for bivirkninger, der blev rapporteret i den poolede analyse af de samlede sikkerhedsdata. 
Table 3 presents the frequency category of adverse reactions reported in the pooled analysis considered for the safety pooling.
Afinitor indeholder lactose (mælkesukker). 
Afinitor contains lactose (milk sugar).
Tabel 4 BOLERO-2 - Resultater af virkning 
Table 4 BOLERO-2 efficacy results
• Hyppigere vandladning i dagtimerne 
• Passing urine more often during daytime
*Ikke-ileum: mave, kolon, rektum, appendix, coecum, duodenum, jejunum, karcinom af ukendt oprindelsessted og anden gastrointestinal oprindelse 
*Non-ileum: stomach, colon, rectum, appendix, caecum, duodenum, jejunum, carcinoma of unknown primary origin and other gastrointestinal origin
En-sidet p-værdi fra en stratificeret log-rank-test. 
One-sided p-value from a stratified log-rank test
Ritonavir og andre lægemidler, der bruges til behandling af HIV-infektion/AIDS. 
ritonavir and other medicines used to treat HIV infection/AIDS.
Din læge kan vælge at starte din behandling med Afinitor igen på samme eller på en lavere dosis. 
Your doctor might restart treatment with Afinitor at the same dose or at a lower dose.
Ja (N=157) Nej (N=145) Ja (N=77) 
Yes (N=157) No (N=145) Yes (N=77)
Blod-plasma-ratio af everolimus, som er koncentrationsafhængig i området 5 til 5.000 ng/ml, er 17% til 73%. 
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%.
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. 
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.
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. 
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.
Måltider med let fedtindhold nedsatte AUC med 32% og Cmax med 42%. 
Light fat meals reduced AUC by 32% and Cmax by 42%.
Alle (N=302) <65 år (N=159) ≥65 år (N=143) 0 (N=216) (N=86) 
All (N=302) <65 years (N=159) ≥65 years (N=143) 0 (N=216) 1 (N=86)
Præ-eksisterende infektioner skal behandles hensigtsmæssigt og være fuldstændigt elimineret, inden behandling med Afinitor påbegyndes. 
Pre-existing infections should be treated appropriately and should have resolved fully before starting treatment with Afinitor.
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. 
Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue Afinitor therapy without dose adjustments.
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) 
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)
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. 
Following disease progression or after study unblinding, 172 of the 203 patients (84.7%) initially randomised to placebo crossed over to open-label Afinitor.
Samtidig administration af everolimus og exemestan øgede Cmin og C2h for exemestan med henholdsvis 45% og 64%. 
Co-administration of everolimus and exemestane increased exemestane Cmin and C2h by 45% and 64%, respectively.
Afinitor kan øge mængden af kolesterol og/eller andre fedtstoffer i blodet. 
Afinitor may elevate cholesterol and/or other blood fats.
Plasmaproteinbindingen er ca. 74% hos både raske forsøgspersoner og patienter med moderat nedsat leverfunktion. 
Plasma protein binding is approximately 74% both in healthy subjects and in patients with moderate hepatic impairment.
Tabel 5 RADIANT-3 - Effektresultater 
Table 5 RADIANT-3 - efficacy results
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). 
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).
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. 
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.
Den anbefalede dosis er 10 mg, som tages en gang daglig. 
The recommended dose is 10 mg, taken once a day.
Tabel 1 opsummerer anbefalingerne for dosisjustering ved specifikke bivirkninger (se også pkt. 
Table 1 summarises the dose adjustment recommendations for specific adverse reactions (see also section 4.4).
Hos patienter, hvor behandling med kortikosteroider af non-infektiøs lungebetændelse er nødvendig, kan profylaktisk behandling mod PJP/PCP overvejes. 
For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for PJP/PCP may be considered.
Følgende kan øge risikoen for bivirkninger med Afinitor: ketoconazol, itraconazol, voriconazol eller fluconazol og andre lægemidler til behandling af svampeinfektioner. 
The following may increase the risk of side effects with Afinitor: ketoconazole, itraconazole, voriconazole, or fluconazole and other antifungals used to treat fungal infections.
Afinitor indeholder lactose 
Afinitor contains lactose
• hævelse i ansigtet, læberne, tungen eller halsen 
• swelling of the face, lips, tongue or throat
Grad 2 Hvis toksiciteten tolereres, er dosisjustering ikke nødvendig. 
Grade 2 If toxicity is tolerable, no dose adjustment required.
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). 
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).
Everolimus bør ikke anvendes under graviditet eller til kvinder i den fertile alder, der ikke anvender kontraception. 
Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Du kan derfor risikere af få en infektion, mens du tager Afinitor. 
Therefore, you may be at risk of getting an infection while you are taking Afinitor.
Hos patienter med progressive massive tumorer var Vd 191 l for det synlige centrale kompartment og 157 l for det synlige perifere kompartment. 
In patients with advanced solid tumours, Vd was 191 l for the apparent central compartment and 517 l for the apparent peripheral compartment.
Understøttende PFS-analyser var baseret på en uafhængig, central radiologisk vurdering. 
Supportive PFS analyses were based on an independent central radiology review.
Afinitor kan påvirke evnen til at føre motorkøretøj og betjene maskiner i mindre eller moderat grad. 
Afinitor may have a minor or moderate influence on the ability to drive and use machines.
* Se også undersektion ”Beskrivelse af udvalgte bivirkninger” 
Very common Weight decreased * See also subsection “Description of selected adverse reactions”
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. 
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.
Afinitor kan muligvis påvirke kvinders frugtbarhed. 
Afinitor may have an impact on female fertility.
Everolimus nedsætter blodtilførslen til kræftknuden og hæmmer væksten og spredningen af kræftceller. 
Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
Ca. 20% af everolimus-koncentrationen i fuldblod er begrænset til plasma hos cancerpatienter, der får everolimus 10 mg/dag. 
Approximately 20% of the everolimus concentration in whole blood is confined to plasma in cancer patients given everolimus 10 mg/day.
95% CI [0,27, 0,45] Log-rank p værdi = <0,001 Kaplan-Meier medianer Afinitor : 11,04 måneder Placebo : 4,60 måneder 
95% CI [0.27, 0.45] Log-rank p value = <0.001 Kaplan-Meier medians Afinitor : 11.04 months Placebo : 4.60 months
I en farmakokinetisk populationsevaluering af cancerpatienter sås ingen signifikant alderspåvirkning (27-85 år) på oral clearance af everolimus. 
In a population pharmacokinetic evaluation in cancer patients, no significant influence of age (27-85 years) on oral clearance of everolimus was detected.
Tabel 7 RECORD-1 - Resultater for progressionsfri overlevelse 
Table 7 RECORD-1 - Progression-free survival results
Bedste totale respons (%) (95% CI) Objektiv responsrate b n/a d e 
Best overall response (%) (95% CI) Objective response rate b
• Følelse af svaghed eller træthed 
• Feeling weak or tired
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. 
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.
Det primære formål med studiet var at estimere HR for PFS for everolimus + exemestan versus everolimus alene. 
The primary objective of the study was to estimate the HR of PFS for everolimus + exemestane versus everolimus alone.
Nedsat nyrefunktion efter transplantation (kreatininclearance 11-107 ml/min) påvirkede ikke everolimus' farmakokinetik hos transplantationspatienter. 
Post-transplant renal impairment (creatinine clearance range 11-107 ml/min) did not affect the pharmacokinetics of everolimus in transplant patients.
Steady-state-farmakokinetik 
Steady-state pharmacokinetics
AUC ↓63% (interval 0-80%) Cmax ↓58% (interval 10-70%) 
AUC ↓63% (range 0-80%) Cmax ↓58% (range 10-70%)
Hvis det er tilfældet, kan det være, at din læge skal ordinere en anden Afinitor-dosis. 
If this is the case, your doctor may need to prescribe a different dose of Afinitor.
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. 
Results of the secondary endpoint OS were not consistent with the primary endpoint PFS, with a trend observed favouring the everolimus alone arm.
Der sås ingen statistisk signifikant behandlingsrelateret forskel i overlevelse (hazard ratio 0,87; konfidensinterval: 0,65-1,17; p=0,177). 
No statistically significant treatment-related difference in overall survival was noted (hazard ratio 0.87; confidence interval: 0.65-1.17; p=0.177).
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. 
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.
Stærkt nedsat leverfunktion (Child-Pugh C): Afinitor er kun anbefalet hvis de ønskede fordele opvejer risiciene. 
Severe hepatic impairment (Child-Pugh C) - Afinitor is only recommended if the desired benefit outweighs the risk.
hvis du skal vaccineres, mens du tager Afinitor. 
if you need to receive a vaccine while taking Afinitor.
I begge arme fik 58% af patienterne systemisk behandling op til studiet. 
Fifty-eight percent of the patients in both arms received prior systemic therapy.
Behandling med Afinitor bør initieres og superviseres af læger med erfaring inden for cancerterapi. 
Treatment with Afinitor should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Hvis diagnosen invasiv systemisk svampeinfektion stilles, skal Afinitor-behandlingen omgående og permanent seponeres, og patienten skal behandles med et passende antimykotisk lægemiddel. 
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.
Interaktion - Ændring i Everolimus AUC/Cmax Geometrisk gennemsnitsratio (observeret interval) 
Interaction - Change in Everolimus AUC/Cmax Geometric mean ratio (observed range)
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). 
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).
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. 
Progression-free survival, documented using RECIST (Response Evaluation Criteria in Solid Tumours) and assessed via a blinded, independent central review, was the primary endpoint.
Der blev taget højde for demografien (median alder 58 år, 55% mænd, 78,5% kaukasier). 
Demographics were well balanced (median age 58 years, 55% male, 78.5% Caucasian).
Everolimus nedsætter niveauer af VEGF (vascular endothelial growth factor), som potentierer tumorangiogene processer. 
Everolimus reduces levels of vascular endothelial growth factor (VEGF), which potentiates tumour angiogenic processes.
Kvinder i den fødedygtige alder skal bruge yderst sikker prævention under behandlingen. 
Women who could potentially become pregnant should use highly effective contraception during treatment.
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. 
Crossover to open-label Afinitor following disease progression for patients allocated to placebo confounded the detection of any treatment-related difference in overall survival.
Samtidig administration af everolimus og depot-octreotid øgede Cmin for octreotid med en geometrisk middelratio (everolimus/placebo) på 1,47. 
Co-administration of everolimus and depot octreotide increased octreotide Cmin with a geometric mean ratio (everolimus/placebo) of 1.47.
Der var ingen tegn på nyretoksicitet hos aber eller minigrise. 
There was no indication of kidney toxicity in monkeys or minipigs.
Afinitor er et lægemiddel mod kræft, som indeholder det aktive stof everolimus. 
Afinitor is an anticancer medicine containing the active substance everolimus.
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. 
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.
Kaplan-Meier-medianer Everolimus/Exemestan: 36,57 [28,71;42,29] uger Everolimus: 29,43 [24,00;31,29] uger 
Kaplan-Meier medians Everolimus/Exemestane: 36.57 [28.71;42.29] weeks Everolimus: 29.43 [24.00;31.29] weeks
Håndtering af stomatitis kan derfor inkludere profylaktisk og/eller terapeutisk brug af topikale behandlinger, som fx en alkoholfri oral opløsning med kortikosteroid som mundskyllevæske. 
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.
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. 
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.
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). 
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).
Efter administration af everolimus til patienter med progressive massive tumorer var steady-state-AUC0-τ dosisproportional i området 5 til 10 mg daglig dosis. 
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.
Vaskulære sygdomme Almindelig Hæmoragi b, hypertension 
Common Haemorrhage b, hypertension
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. 
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).
Det kunne ikke påvises, om dette havde en klinisk signifikant effekt på virkningsresponset for everolimus hos patienter med progressive neuroendokrine tumorer. 
A clinically significant effect on the efficacy response to everolimus in patients with advanced neuroendocrine tumours could not be established.
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. 
If you are taking any of them, your doctor may switch you to a different medicine, or may change your dose of Afinitor.
Fortæl det straks til din læge, hvis du oplever nogen af disse bivirkninger, da det kan have livstruende konsekvenser. 
If you experience any of these side effects, tell your doctor immediately as this might have life-threatening consequences.
Kaplan-Meier medianer Everolimus: 4,90 måneder Placebo: 1,87 måneder 
Kaplan-Meier medians Everolimus: 4.90 months Placebo: 1.87 months
Moderstoffet sporedes ikke i urin eller fæces. 
The parent substance was not detected in urine or faeces.
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. 
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.
- fremskreden nyrekræft (fremskreden renalcellekarcinom), hvor andre behandlinger (såkaldt VEGF-rettet behandling) ikke har kunnet standse din sygdom. 
advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-called “VEGF-targeted therapy”) have not helped stop your disease.
Tabel 1 Anbefalinger for dosisjustering af Afinitor 
Table 1 Afinitor dose adjustment recommendations
Dyrestudier har påvist reproduktionstoksicitet, herunder embryotoksicitet og føtotoksicitet (se pkt. 
Studies in animals have shown reproductive toxicity effects including embryotoxicity and foetotoxicity (see section 5.3).
Patienter i placebo-armen overgik ikke til everolimus på tidspunktet for progression. 
Patients in the placebo arm did not cross-over to everolimus at the time of progression.
Resultatet af den endelige PFS-analyse med 154 hændelser, observeret baseret på lokal investigator-vurdering, viste en estimeret HR på 0,74 (90 % CI: 0,57; 0,97) til fordel for everolimus + exemestan-armen i forhold til everolimus-armen. 
The result of the final PFS analysis with 154 PFS events observed based on local investigator assessment showed an estimated HR of 0.74 (90% CI: 0.57, 0.97) in favour of the everolimus + exemestane arm relative to everolimus arm.
Det vigtigste sekundære formål var at estimere HR for PFS for everolimus + exemestan versus capecitabin. 
The key secondary objective was to estimate the HR of PFS for everolimus + exemestane versus capecitabine.
Neuroendokrine tumorer udgået fra pancreas 
Neuroendocrine tumours of pancreatic origin
Der skal udvises forsigtighed, når Afinitor tages i kombination med oralt administrerede CYP3A4-substrater med et snævert terapeutisk vindue på grund af risiko for lægemiddelinteraktioner. 
Caution should be exercised when Afinitor is taken in combination with orally administered CYP3A4 substrates with a narrow therapeutic index due to the potential for drug interactions.
Afinitor kan øge risikoen for problemer med sårheling. 
Afinitor may increase the risk of problems with wound healing.