natgillin/translations-raw huggingface dataset:
Individdet progredierede eller døde ikke [n (%)] Individdet progredierede eller døde [n (%)] PFS (uger) 
Subject did not progress or die [n (%)] Subject observed to have progressed or died [n (%)]
Behandlingen med Sutent bør initieres af en læge med erfaring i administration af lægemidler mod cancer. 
Therapy with Sutent should be initiated by a physician experienced in the administration of anticancer agents.
Visse typer medicin kan påvirke mængden af Sutent i kroppen. 
Some medicines can affect the levels of Sutent in your body.
Disse data tyder på, at sunitinib øger risikoen for kardiomyopati. 
These data suggest that sunitinib increases the risk of cardiomyopathy.
Hvis indiceret, kan elimination af ikke absorberet aktivt stof ske ved opkastning eller maveskylning. 
If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage.
Forlængelse af QT-intervallet kan føre til en øget risiko for ventrikulær arytmi herunder Torsade de pointes. 
QT interval prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de pointes.
Midlertidig afbrydelse af behandlingen anbefales hos patienter med svær hypertension, som ikke er kontrolleret med medicinsk behandling. 
Temporary suspension is recommended in patients with severe hypertension that is not controlled with medical management.
En patient med GIST blev inkluderet med et doseringsniveau på 15 mg/m2 uden tegn på fordel. 
One patient with GIST was enrolled at the 15 mg/m dose level with no evidence of benefit.
Det anbefales at udføre urinanalyse ved baseline og kontrollere patienter for udvikling eller forværring af proteinuri. 
Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria.
Polyploid (numeriske kromosomafvigelser) ses i humane perifere blod-lymfocytter in vitro, både ved tilstedeværelse og fravær af metabolisk aktivering. 
Polyploidy (numerical chromosome aberrations) was observed in human peripheral blood lymphocytes in vitro, both in the presence and absence of metabolic activation.
Tilgængelige data tyder på, at kvinder måske har 30% lavere tilsyneladende sunitinibclearance (CL/F) end mænd; denne forskel kræver imidlertid ingen dosisjustering. 
Available data indicate that females could have about 30% lower apparent clearance (CL/F) of sunitinib than males: this difference, however, does not necessitate starting dose adjustments.
Sutent indeholder det aktive stof sunitinib, som er en proteinkinasehæmmer. 
Sutent contains the active substance sunitinib, which is a protein kinase inhibitor.
En hazard ratio til fordel for sunitinib blev set i alle undergrupper af evaluerede baselinekarakteristika, inklusive en analyse af antallet af forudgående systemiske behandlinger. 
A hazard ratio favouring sunitinib was observed in all subgroups of baseline characteristics evaluated, including an analysis by number of prior systemic therapies.
Effektresultater for de 99 patienter, som krydsede over fra placebo til Sutent efter afblinding. 
b Efficacy results for the 99 subjects who crossed over from placebo to Sutent after unblinding.
- Hvis du skal have foretaget tandudtrækninger eller kirurgisk tandbehandling, skal du fortælle tandlægen, at du bliver behandlet med Sutent, især hvis du også bliver eller er blevet behandlet med indsprøjtninger med bisfosfonater. 
- If you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Sutent in particular when you are also receiving or have received intravenous bisphosphonates.
• Infektioner. 
• Infections.
• Højt blodtryk. 
• High blood pressure.
Normalt bliver behandlingen med Sutent stoppet, hvis du skal opereres. 
You will usually be taken off Sutent if you are having an operation.
Brug af VEGF-hæmmere hos patienter med eller uden hypertension kan fremme dannelsen af aneurismer og/eller arterielle dissektioner. 
The use of vascular endothelial growth factor (VEGF) pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Resultater for ORR (objektive responsrate) er angivet som procent patienter med bekræftet respons med 95% CI. 
Results for ORR are given as percent of subjects with confirmed response with the 95% CI.
Alle thyroidea-relaterede hændelser var grad 1-2 (se pkt. 
All thyroid-related events reported were Grade 1-2 (see section 4.4).
Der er ikke rapporteret letale tilfælde i GIST-, mRCC og pNET-registreringsstudier. 
No cases with fatal outcome were reported in GIST, MRCC, and pNET registrational studies.
Steady state-koncentrationen af sunitinib og dets aktive hovedmetabolit nås inden for 10-14 dage. 
Steady-state concentrations of sunitinib and its primary active metabolite are achieved within 10 to 14 days.
Tilsvarende var legemsoverfladeareal en signifikant kovariat for den tilsyneladende clearance af den aktive metabolit (jo mindre legemsoverfladeareal, jo lavere tilsyneladende clearance). 
Similarly, body surface area was a significant covariate on the apparent clearance of the active metabolite (the lower the body surface area, the lower the apparent clearance).
Størstedelen af disse bivirkninger observeret i kliniske studier, kunne dog ikke relateres til behandlingen i de kliniske studier (se pkt. 
Nevertheless, most of these adverse events observed in clinical studies were not considered related to study treatment (see section 4.4).
Hos patienter uden kardielle risikofaktorer bør en vurdering af uddrivningsfraktionen ved baseline overvejes. 
In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.
• Hjerteanfald på grund af afbrudt eller nedsat blodtilførsel til hjertet. 
• Heart attack caused by an interrupted or decreased blood supply to the heart.
Lægen beslutter, hvornår du kan starte med Sutent-behandlingen igen. 
Your doctor will decide when to start Sutent again.
Beslutning om genoptagelse af sunitinib-behandlingen efter et større kirurgisk indgreb bør tages på grundlag af klinisk bedømmelse af restitution efter indgrebet. 
Therefore, the decision to resume sunitinib therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.
Der blev observeret dosisbegrænsende kardiotoksicitet i den første del af studiet, hvorfor det blev ændret, så patienter med tidligere eksponering for potentielt kardiotoksiske behandlinger (herunder antracykliner) eller stråling af hjertet blev ekskluderet. 
Dose-limiting cardiotoxicity was observed in the first part of the study which was therefore amended to exclude patients with previous exposure to potentially cardiotoxic therapies (including anthracyclines) or cardiac radiation.
Det virkede ikke som om, at sunitinibs benefit/risk-forhold blev negativt påvirket af en yngre alder og mindre legemsstørrelse, og det var primært afhængigt af plasma-eksponeringen. 
Sunitinib benefit/risk did not appear to be negatively affected by younger age or lower body size, and was mainly driven by its plasma exposure.
Inden indledning af behandling med sunitinib, bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme. 
Before initiating sunitinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pivotal-studiet af NET i pancreas blev afsluttet før tid efter anbefaling fra en uafhængig lægemiddel-monitorerings-komité, og den primære parameter var baseret på investigatorvurdering, begge faktorer kan have haft indflydelse på skønnet over behandlingseffekten. 
The pivotal study in pancreatic NET was terminated prematurely at the recommendation of an independent drug monitoring committee and the primary endpoint was based upon investigator assessment, both of which may have affected the estimates of the treatment effect.
Bivirkningerne er inden for hver hyppighed anført efter faldende alvorlighed. 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Ved dosisintervallet 25-100 mg øges både arealet under plasmakoncentrationstidskurven (AUC) og Cmax proportionalt med dosis. 
In the dosing ranges of 25 to 100 mg, the area under the plasma concentration-time curve (AUC) and Cmax increase proportionally with dose.
Andre endepunkter omfattede ORR, OS og sikkerhed. 
Other endpoints included ORR, OS, and safety.
I en kohorte på 66 patienter med ø-celle tumorer var responsraten - det primære endepunkt - 17%. 
In a pancreatic islet cell tumour cohort of 66 patients, the primary endpoint of response rate was 17%.
Sutent bør derfor ikke anvendes ved graviditet eller hos kvinder, der ikke anvender sikker antikonception, medmindre den potentielle fordel for kvinden opvejer den potentielle risiko for fostret. 
Sutent should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus.
Administration af sunitinib bør afbrydes og/eller dosis bør reduceres hos patienter unden kliniske tegn på CHF, men med en uddrivningsfraktion på <50%->20% under baseline. 
The administration of sunitinib should be interrupted and/or the dose reduced in patients without clinical evidence of CHF but with an ejection fraction < 50% and > 20% below baseline.
Dosis af sunitinib blev reduceret, eller administration af sunitinib blev midlertidtigt indstillet hos ca. 2,7% af patienterne, som fik hypertension. 
The dose of sunitinib was reduced or its administration temporarily suspended in approximately 2.7% of the patients who experienced hypertension.
Analyser af populationsfarmakokinetik tyder på, at sunitinibs tilsyneladende clearance (CL/F) ikke er påvirket af kreatininclearence (CrCl) inden for det vurderede område (42-347 ml/min). 
Population PK analyses indicated that sunitinib apparent clearance (CL/F) was not affected by creatinine clearance (CLcr) within the range evaluated (42-347 ml/min).
Svær hypertension (>200 mmHg systolisk eller 110 mmHg diastolisk) sås hos 4,7% af patienterne med solide tumorer. 
Severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic) was reported in 4.7% of patients with solid tumours.
Hvis skjoldbruskkirtlen ikke producerer nok hormon, kan du blive behandlet med skjoldbruskkirtelhormon-erstatning. 
If your thyroid gland is not producing enough thyroid hormone, you may be treated with thyroid hormone replacement.
Baseret på modelleringsanalyser virkede det ikke som om, at yngre alder og mindre legemsstørrelse påvirkede sikkerheds- og virkningsresponse på plasma-eksponeringen for sunitinib negativt. 
Based on the modelling analyses, the younger age and lower body size did not appear to affect negatively the safety and efficacy responses to sunitinib plasma exposures.
Placebo cross-over gruppe 
Placebo cross-over group treatment b
Sutent kan give hjerteproblemer. 
Sutent can cause heart problems.
• Hævelse af væv på grund af væske under huden og omkring øjnene, dybtliggende allergisk udslæt. 
• Swelling caused by fluid under the skin and around the eye, deep allergic rash.
Ændring i hårfarve Tør hud 
Hair colour changes Dry skin
Ændringer i sunitinibs farmakokinetiske parametre havde ingen klinisk signifikans og viste ingen interaktioner, men i betragtning af det relativt lave antal forsøgspersoner (dvs. N=7+4) og den moderat til store forskel i de farmakokinetiske parametre patienterne imellem, bør der dog udvises forsigtighed ved fortolkning af fundene vedrørende farmakokinetisk interaktion fra dette studie. 
Changes in sunitinib PK parameters were of no clinical significance and did not indicate any drug-drug interactions; however, considering the relatively low number of subjects (i.e. N=7+4) and the moderate-large interpatient variability in the pharmacokinetic parameters, caution needs to be taken when interpreting the PK drug-drug interaction findings from this study.
Moxifloxacin (400 mg), der blev brugt som positiv kontrol, viste en maksimal middelændring af QTcF-intervallet på 5,6 msek fra baseline. 
Moxifloxacin (400 mg) used as a positive control showed a 5.6 msec maximum mean QTcF interval change from baseline.
28 x 1 hård kapsel 
28 x 1 hard capsules
Lunge- eller vejrtrækningsproblemer. 
Lung or breathing problems.
Alligevel var seponeringsraten på grund af bivirkninger 20% for sunitinib og 23% for IFN-α. 
However, the discontinuation rates due to adverse events were 20% for sunitinib and 23% for IFN-α.
Patienter, som havde haft lungeemboli indenfor de seneste 12 måneder, blev ekskluderet fra de kliniske studier med sunitinib. 
Patients who presented with pulmonary embolism within the previous 12 months were excluded from sunitinib clinical studies.
Data fra non-kliniske studier (in vivo og in vitro) med doser, der var højere end de anbefalede humane doser, tyder på, at sunitinib potentielt kan hæmme hjertets repolarisering (f.eks forlængelse af QTintervallet). 
Data from non clinical (in vitro and in vivo) studies, at doses higher than the recommended human dose, indicated that sunitinib has the potential to inhibit the cardiac action potential repolarisation process (e.g., prolongation of QT interval).
Sunitinib metaboliseres hovedsageligt af CYP3A4, CYP-isoformen, som producerer dets aktive hovedmetabolit, desethylsunitinib, og som derefter metaboliseres yderligere af det samme isoenzym. 
Sunitinib is metabolised primarily by CYP3A4, the CYP isoform which produces its primary active metabolite, desethyl sunitinib, which is then further metabolised by the same isoenzyme.
Denne analyse var baseret på data indsamlet fra voksne med GIST eller solide tumorer samt fra pædiatriske patienter med solide tumorer. 
This analysis was based on data collected from adults with GIST or solid tumours and from paediatric patients with solid tumours.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager Sutent. 
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Det primære effektendepunkt var den objektive responsrate (ORR) baseret på Response Evaluation Criteria in Solid Tumours (RECIST = respons evaluering af kriterier for solide tumorer). 
The primary efficacy endpoint was ORR, based on Response Evaluation Criteria in Solid Tumours (RECIST).
Resultater fra spørgeskema (EORTC QLQ-C30) om livskvalitet fra den europæiske kræftforskningsorganisation, European Organisation for Research and Treatment of Cancer, viser, at den samlede totale helbredsrelaterede livskvalitet og de 5 funktionsevner (fysik, karakter, kognitiv, følelsesmæssig og social) blev opretholdt hos patienter i behandling med sunitinib i sammenligning med placebo med begrænsede symptomatiske bivirkninger. 
Results from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) showed that the overall global health-related quality of life and the 5 functioning domains (physical, role, cognitive, emotional, and social) were maintained for patients on sunitinib treatment as compared to placebo with limited adverse symptomatic effects.
De kalkulerede in vitro Ki-værdier for alle undersøgte cytokrom-isoformer (CYP) (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 og CYP4A9/11) tyder på, at det er usandsynligt, at sunitinib og dets aktive hovedmetabolit inducerer metaboliseringen af lægemidler, der metaboliseres af disse enzymer i klinisk relevant grad. 
The calculated in vitro Ki values for all cytochrome P450 (CYP) isoforms tested (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, and CYP4A9/11) indicated that sunitinib and its primary active metabolite are unlikely to induce metabolism, to any clinically relevant extent, of other actives substances that may be metabolised by these enzymes.
Alle fund opstod ved klinisk relevante sunitinib-plasmaeksponeringsniveauer. 
All findings occurred at clinically relevant sunitinib plasma exposure levels.
Patienter bør informeres om, at depigmentering af hår eller hud kan forekomme under behandling med sunitinib. 
Patients should be advised that depigmentation of the hair or skin may occur during treatment with sunitinib.
• Unormal nedbrydning af muskelvæv, som kan give nyreproblemer (rhabdomyolyse). 
• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
• Influenzalignende symptomer. 
• Influenza-like syndrome.
2-sidet ustratificeret logrank test b 
a 2-sided unstratified log-rank test b
Hovedmetabolitten udviser samme styrke sammenlignet med sunitinib i biokemiske analyser og celleanalyser. 
The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays.
Disse patienter bør følges nøje og behandles efter gældende praksis, og profylaktisk hydrering bør overvejes. 
These patients should be monitored closely and treated as clinically indicated, and prophylactic hydration should be considered.
High-density polyethylen (HDPE) beholder med et polypropylenlåg, indeholdende 30 hårde kapsler. 
High-density polyethylene (HDPE) bottle with a polypropylene closure containing 30 hard capsules.
Da aktive stoffer almindeligvis udskilles i modermælk, og da der er risiko for alvorlige bivirkninger hos det ammede barn, bør Sutent ikke anvendes i ammeperioden. 
Because active substances are commonly excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants, women should not breast-feed while taking Sutent.
• Komplikationer i forbindelse med alvorlig infektion (infektion i blodbanen) der kan resultere i vævsskade, organsvigt og dødsfald. 
• Complication of severe infection (infection is present in the bloodstream) that can lead to tissue damage, organ failure, and death.
Der er begrænset klinisk erfaring med, hvornår behandling skal genoptages efter større kirurgiske indgreb. 
There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention.
Sutent er ikke godkendt til behandling af patienter med lungecancer. 
Sutent is not approved for use in patients with lung cancer.
Stigningerne i lipaseaktiviteten var forbigående og var sædvanligvis ikke ledsaget af symptomer på pankreatitis hos forsøgspersoner med forskellige solide tumorer (se pkt. 
Increases in lipase activities were transient and were generally not accompanied by signs or symptoms of pancreatitis in subjects with various solid tumours (see section
Patienter skulle have dokumenteret progression, baseret på RECIST inden for de sidste 12 måneder, og blev randomiseret (1:1) til at få enten 37,5 mg sunitinib 1 gang dagligt uden planlagte pauser (n = 86) eller placebo (n = 85). 
Patients were required to have documented progression, based on RECIST, within the prior 12 months and were randomised (1:1) to receive either 37.5 mg sunitinib once daily without a scheduled rest period (N = 86) or placebo (N = 85).
Ingen patienter oplevede en effekt på QTc-intervallet større end grad 2 (CTCAE-version 3,0) (se pkt. 
No subjects experienced an effect on the QTc interval greater than Grade 2 (CTCAE version 3.0) (see section 4.4).
Desuden havde 49% af sunitinib-patienterne tumorer uden funktion versus 52% af placebo-patienterne, og 92% af patienterne i begge behandlingsarme havde levermetastaser. 
Additionally, 49% of sunitinib patients had nonfunctioning tumours versus 52% of placebo patients and 92% of patients in both arms had liver metastases.
Oralt ubehag Eruktation 
Oral discomfort Eructation
Ved tilstedeværelse af kliniske manifestationer på CHF anbefales seponering af sunitinib. 
In the presence of clinical manifestations of CHF, discontinuation of sunitinib is recommended.
Sunitinibs sikkerhedsprofil er blevet undersøgt i et fase 1-dosiseskaleringsstudie, et ublindet fase 2studie, et fase 1/2-enkeltarmsstudie og i publikationerne, som beskrevet herunder. 
The safety profile of sunitinib has been derived from a Phase 1 dose-escalation study, a Phase 2 open-label study, a Phase 1/2 single-arm study and from publications as described below.
Nedbrydning af svulst, som fører til hul i tarmene. 
Tumour destruction leading to hole in the intestine.
Lægen vil fastsætte den dosis du har brug for samt, hvornår du skal stoppe behandlingen med Sutent. 
Your doctor will determine the appropriate dose you need to take, as well as if and when you need to stop treatment with Sutent.
Sunitinib bør anvendes med forsigtighed hos patienter med kendt forlængelse af QT-intervallet i anamnesen, patienter der tager antiarytmika eller lægemidler der kan forlænge QT-intervallet, eller patienter med relevant præeksisterende hjertesygdom, bradykardi eller elektrolytforstyrrelser. 
Sunitinib should be used with caution in patients with a known history of QT interval prolongation, patients who are taking antiarrhythmics or medicinal products that can prolong QT interval, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances.
Hypertension er rapporteret i forbindelse med sunitinib, herunder alvorlig hypertension (>200 mmHg diastolisk systolisk eller > 100 mmHg). 
Hypertension has been reported in association with sunitinib, including severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic).
Farmakokinetikken af sunitinib blev vurderet hos 135 raske forsøgspersoner og 266 patienter med solide tumorer. 
The PK of sunitinib were evaluated in 135 healthy volunteers and 266 patients with solid tumours.
Samlet overlevelse [5-årsopfølgning] [median, måneder (95% CI)] 
Overall survival [5 years follow-up] [median, months (95% CI)]
Risikoen for kardielle bivirkninger forekom at være højere hos pædiatriske patienter med tidligere eksponering for stråling af hjertet eller antracyklin, sammenlignet med pædiatriske patienter uden tidligere eksponering. 
The risk of cardiac adverse drug reactions appeared to be higher in paediatric patients with previous exposure to cardiac irradiation or anthracycline compared to those paediatric patients without previous exposure.
Udslættet kan udvikle sig til udbredt blæredannelse eller afskalning af huden og kan være livstruende. 
The rash may progress to widespread blistering or peeling of the skin and may be life-threatening.
CYP3A4-hæmmere/induktorer 
CYP3A4 inhibitors/inducers
Blandt de testede kovariater, der var relaterede til alder og legemsstørrelse, var alder en signifikant kovariat for den tilsyneladende clearance af sunitinib (jo yngre den pædiatriske patient var, jo lavere tilsyneladende clearance). 
Among age and bodysize related covariates tested, age was a significant covariate on apparent clearance of sunitinib (the younger the age of the paediatric patient, the lower the apparent clearance).
Behandlingen kan genoptages, når hypertensionen er under passende kontrol (se pkt. 
Treatment may be resumed once hypertension is appropriately controlled (see section 4.8).
Dette kan være symptomer på hjerteproblemer som hjertesvigt eller hjertemuskelproblemer (kardiomyopati). 
These may be symptoms of heart problems that may include heart failure and heart muscle problems (cardiomyopathy).
Selvom der sås en effekt på QTcF-intervallet 24 timer efter indtagelse af dosis på dag 3 (dvs. ved den forventede terapeutiske plasmakoncentration efter den anbefalede startdosis på 50 mg) ved brug af ”within-day” baseline-korrektionsmetoden, er den kliniske betydning af dette fund uklart. 
Although an effect on QTcF interval was observed on Day 3 at 24 hours postdose (i.e., at therapeutic plasma concentration expected after the recommended starting dose of 50 mg) with the within-day baseline correction method, the clinical significance of this finding is unclear.
De hyppigste hændelser omfattede cerebrovaskulær hændelse, transitorisk cerebral iskæmi og cerebralt infarkt. 
The most frequent events included cerebrovascular accident, transient ischaemic attack, and cerebral infarction.
Sunitinib hæmmer gentagne RTK'er, som indgår i tumorvækst, neoangiogenese og metastaserende progression af cancer. 
Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, and metastatic progression of cancer.