FrancophonIA/ELRC3.0 huggingface dataset:
English: Total oral clearance (CL/F) was 34-62 L/h.
Danish: Total oral clearance (CL/F) er 34-62 l/time.
English: No patients had a QTc interval > 500 msec.
Danish: Ingen patienter havde et QTc-interval >500 msek.
English: Stable disease was observed in 6 patients (17%).
Danish: Der blev observeret stabil sygdom hos 6 patienter (17 %).
English: If a dose is missed, the patient should not be given an additional dose.
Danish: Hvis en dosis glemmes, bør patienten ikke tage en supplerende dosis.
English: • Extreme tiredness, loss of strength.
Danish: • Ekstrem træthed, manglende kræfter.
English: • Abnormally decreased/increased sensitivity, particularly to touch.
Danish: • Unormal nedsat/øget følsomhed, især ved berøring.
English: - If you are going to have surgery or if you had an operation recently.
Danish: - Hvis du skal opereres eller er blevet det for nylig.
English: It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.
Danish: Sutent bruges til behandling af kræft ved at forebygge aktiviteten af en særlig gruppe af proteiner, som er kendt for at være involveret i væksten og spredningen af kræftcellerne.
English: Sutent is used to treat adults with the following types of cancer:
Danish: Sutent bruges til behandling af voksne med følgende typer af kræft:
English: There were no Grade 5 adverse reactions in either group.
Danish: Der var ingen grad 5 bivirkninger i nogen af grupperne.
English: Frequencies are defined as: 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), not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret som: 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), ikke kendt (kan ikke estimeres fra forhåndenværende data).
English: These LVEF declines do not appear to have been progressive and often improved as treatment continued.
Danish: Disse fald i LVEF synes ikke at have været progressive og forbedredes ofte ved fortsat behandling.
English: Sutent has minor influence on the ability to drive and use machines.
Danish: Sutent påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: • Abnormally coloured urine.
Danish: • Unormalt farvet urin.
English: In both the clinical study and the publications, the safety profile was consistent with the known safety profile in adults.
Danish: I både det kliniske studie og i publikationerne var sikkerhedsprofilen i overensstemmelse med den kendte sikkerhedsprofil hos voksne.
English: Weight, performance status
Danish: Vægt, performancestatus
English: Four of these 7 GIST patients discontinued treatment following first observation of DVT.
Danish: Hos 4 ud af disse 7 GIST-patienter blev behandlingen seponeret efter første observation af DVT.
English: What Sutent contains
Danish: Sutent indeholder
English: Some of the epistaxis events were severe, but very rarely fatal.
Danish: Nogle af disse epistaxistilfælde var alvorlige, men meget sjældent letale.
English: Approximately one-third of the patients in clinical studies who received sunitinib were 65 years of age or over.
Danish: Ca. en tredjedel af patienterne i de kliniske studier som fik sunitinib, var 65 år eller derover.
English: If you forget to take Sutent
Danish: Hvis du har glemt at tage Sutent
English: - If you have high blood pressure.
Danish: - Hvis du har for højt blodtryk.
English: - Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Danish: • Brug ikke lægemidlet, hvis du opdager at pakningen er ødelagt eller viser tegn på forfalskning.
English: - If you have heart problems.
Danish: - Hvis du har hjerteproblemer.
English: Caution should therefore be exercised when Sutent and intravenous bisphosphonates are used either simultaneously or sequentially.
Danish: Der bør derfor udvises forsigtighed, når Sutent og intravenøse bisfosfonater administreres samtidig eller sekventielt.
English: Food has no effect on the bioavailability of sunitinib.
Danish: Fødeindtagelse har ingen effekt på biotilgængeligheden af sunitinib.
English: - If you are allergic to sunitinib or any of the other ingredients of Sutent (listed in section 6).
Danish: Hvis du er allergisk over for sunitinib eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Sunitinib (0.3, 1.0, 3.0 mg/kg/day) was evaluated in a pre-and postnatal development study in pregnant rats.
Danish: Sunitinib (0,3, 1,0, 3,0 mg/kg/dag) blev evalueret i et præ- og postnataludviklingsstudier i drægtige rotter.
English: Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italy
Danish: Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italien
English: Subsequent dose adjustments should be based on individual safety and tolerability (see section 5.2).
Danish: Efterfølgende dosisjusteringer baseres på individuel sikkerhed og tolerabilitet (se pkt.
English: Patients should be screened for hypertension and controlled as appropriate.
Danish: Patienter bør undersøges for hypertension og kontrolleres efter behov.
English: The primary efficacy endpoint of the study was TTP, defined as the time from randomisation to first documentation of objective tumour progression.
Danish: Studiets primære effektendepunkt var TTP, defineret som tiden fra randomisering til første dokumenterede objektive tumorprogression.
English: Population PK analyses of demographic data indicate that no starting dose adjustments are necessary for weight or Eastern Cooperative Oncology Group (ECOG) performance status.
Danish: Populationsfarmakokinetiske analyser af demografiske data tyder på, at dosisjustering ikke er nødvendig med hensyn til vægt eller Eastern Cooperative Oncology Group (ECOG) score.
English: The apparent volume of distribution (Vd) for sunitinib was large, 2230 L, indicating distribution into the tissues.
Danish: Det tilsyneladende distributionsvolumen (Vd) er stort for sunitinib - 2230 l - som tyder på distribution ind i vævene.
English: Sutent can raise blood pressure.
Danish: Sutent kan få blodtrykket til at stige.
English: Demographics were comparable between the sunitinib and placebo groups.
Danish: Demografiske data var sammenlignelige mellem sunitinib- og placebogrupperne.
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser eller pakningstyper er nødvendigvis markedsført.
English: Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Danish: Der er rapporteret om tilfælde af proteinuri og sjældne tilfælde af nefrotisk syndrom.
English: c The interim PFS numbers have been updated based on a recalculation of the original data.
Danish: Interim PFS (progressions-fri overlevelse)-tallene er blevet opdateret baseret på rekalkulering af de originale data.
English: The genotoxic potential of sunitinib was assessed in vitro and in vivo.
Danish: Sunitinibs genotoksiske potentiale er vurderet in vitro og in vivo.
English: Minor metabolites were identified in urine and faeces, but generally were not found in plasma.
Danish: Mindre metabolitter er identificeret i urin og fæces, men er sædvanligvis ikke genfundet i plasma.
English: The maximum dose administered in the Phase 3 pNET study was 50 mg daily.
Danish: Den maksimale dosis, som blev givet i et fase 3 pNET-studie, var 50 mg dagligt.
English: • Fluid retention including around the lungs.
Danish: • Væskeophobning, også omkring lungerne
English: Routine assessment of bleeding events should include complete blood counts and physical examination.
Danish: Rutinemæssig vurdering af denne blødningsbivirkning bør omfatte fuldstændig blodtælling og objektiv undersøgelse.
English: Talk to your doctor before taking Sutent:
Danish: Kontakt lægen før du tager Sutent:
English: Kaplan-Meier plot of PFS in the pNET Phase 3 study
Danish: Figur 1 - Kaplan-Meier plot af PFS i pNET fase 3-Studiet
English: Sunitinib treatment was associated with longer survival compared to IFN-α.
Danish: Sunitinib-behandling var associeret med længere overlevelse sammenlignet med IFN-α-behandling.
English: A sensitivity analysis of PFS was conducted where progression was based upon investigator-reported tumour measurements and where all subjects censored for reasons other than study termination were treated as PFS events.
Danish: En følsomhedsanalyse af PFS blev udført, hvor progression var baseret på investigator-rapporterede tumormålinger, og hvor alle individer, censureret efter årsager andre end afslutning af studiet, blev opgjort som PFS-hændelser.
English: Table 4 - pNET efficacy results from the Phase 3 study Efficacy parameter
Danish: Tabel 4 - pNET effektresultater fra fase 3-studiet Effektparameter
English: There is no specific antidote for overdose with Sutent and treatment of overdose should consist of general supportive measures.
Danish: Der er ingen specifik antidot for overdosering med Sutent, og behandling af overdosis er generelt understøttende.
English: Overall, 7% of the MRCC population had either clinical or laboratory evidence of treatment-emergent hypothyroidism.
Danish: Samlet havde 7% af mRCC-populationen enten kliniske eller laboratoriemæssige tegn på behandlingsinduceret hypotyreose.
English: Prior to treatment with Sutent, a dental examination and appropriate preventive dentistry should be considered.
Danish: Før behandling med Sutent bør tandstatus vurderes og passende forebyggende tandbehandling bør overvejes.
English: - You may be advised to have a dental check-up before you start treatment with Sutent.
Danish: - Du vil muligvis blive anbefalet at få foretaget et tandeftersyn, før du begynder behandlingen med Sutent:
English: During sunitinib treatment, routine monitoring of thyroid function should be performed every 3 months.
Danish: Under behandling med sunitinib skal der udføres rutinemæssig monitorering af thyroideafunktionen hver 3. måned.
English: The analyses of primary and secondary endpoints in the open-label phase of the study reaffirmed the results obtained at the time of the interim analysis, as shown in Table 2:
Danish: Analysen af primære og sekundære endepunkter i studiets åben-label fase bekræftede resultaterne fra interimanalysen, som vist i tabel 2:
English: All study participants experienced adverse drug reactions; most of these were severe (toxicity grade ≥ 3) and included cardiac toxicity.
Danish: Alle studiedeltagere oplevede bivirkninger; de fleste bivirkninger var alvorlige (toksicitetsgrad ≥3) og inkluderede kardiel toksicitet.
English: Thyroid function was monitored prospectively in 2 studies in patients with breast cancer; Sutent is not approved for use in breast cancer.
Danish: Thyroideafunktionen blev monitoreret prospektivt i 2 studier hos patienter med brystkræft; Sutent er ikke godkendt til behandling af brystkræft.
English: There were 9 deaths in the sunitinib arm and 21 deaths in the placebo arm.
Danish: Der var 9 dødsfald i sunitinib-grupppen og 21 dødsfald i placebo-gruppen.
English: It is unknown whether patients with these concomitant conditions may be at a higher risk of developing sunitinib-related left ventricular dysfunction.
Danish: Det er uvist om patienter med disse underliggende tilstande har en større risiko for at udvikle sunitinib-relateret venstre ventrikel-dysfunktion.
English: Heart problems.
Danish: Hjerteproblemer.
English: IT-63100 Marino del Tronto (Ascoli Piceno) Italy
Danish: IT-63100 Marino del Tronto (Ascoli Piceno) Italien
English: If Sutent is used during pregnancy or if the patient becomes pregnant while on treatment with Sutent, the patient should be apprised of the potential hazard to the foetus.
Danish: Hvis Sutent anvendes under graviditet, eller patienten bliver gravid under behandling med Sutent, skal patienten underrettes om den potentielle risiko for fostret.
English: Baseline was reset at cross-over and efficacy analyses were based on investigators assessment.
Danish: Baseline blev nulstillet ved cross-over, og effektanalyser blev baseret på investigators vurdering.
English: Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be treated.
Danish: Lægen vil fastsætte, hvilken dosis du skal have afhængig af den type kræft, du skal behandles for.
English: a Results of double-blind treatment are from the ITT population and using central radiologist measurement, as appropriate.
Danish: Resultaterne af dobbelblind behandling er fra ITT-populationen ved brug af radiologiske målinger, efter behov.
English: Subject did not progress or die [n (%)] Subject observed to have progressed or died [n (%)]
Danish: Individdet progredierede eller døde ikke [n (%)] Individdet progredierede eller døde [n (%)] PFS (uger)
English: Therapy with Sutent should be initiated by a physician experienced in the administration of anticancer agents.
Danish: Behandlingen med Sutent bør initieres af en læge med erfaring i administration af lægemidler mod cancer.
English: Some medicines can affect the levels of Sutent in your body.
Danish: Visse typer medicin kan påvirke mængden af Sutent i kroppen.
English: These data suggest that sunitinib increases the risk of cardiomyopathy.
Danish: Disse data tyder på, at sunitinib øger risikoen for kardiomyopati.
English: If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage.
Danish: Hvis indiceret, kan elimination af ikke absorberet aktivt stof ske ved opkastning eller maveskylning.
English: QT interval prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de pointes.
Danish: Forlængelse af QT-intervallet kan føre til en øget risiko for ventrikulær arytmi herunder Torsade de pointes.
English: Temporary suspension is recommended in patients with severe hypertension that is not controlled with medical management.
Danish: Midlertidig afbrydelse af behandlingen anbefales hos patienter med svær hypertension, som ikke er kontrolleret med medicinsk behandling.
English: One patient with GIST was enrolled at the 15 mg/m dose level with no evidence of benefit.
Danish: En patient med GIST blev inkluderet med et doseringsniveau på 15 mg/m2 uden tegn på fordel.
English: Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria.
Danish: Det anbefales at udføre urinanalyse ved baseline og kontrollere patienter for udvikling eller forværring af proteinuri.
English: Polyploidy (numerical chromosome aberrations) was observed in human peripheral blood lymphocytes in vitro, both in the presence and absence of metabolic activation.
Danish: Polyploid (numeriske kromosomafvigelser) ses i humane perifere blod-lymfocytter in vitro, både ved tilstedeværelse og fravær af metabolisk aktivering.
English: 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.
Danish: Tilgængelige data tyder på, at kvinder måske har 30% lavere tilsyneladende sunitinibclearance (CL/F) end mænd; denne forskel kræver imidlertid ingen dosisjustering.
English: Sutent contains the active substance sunitinib, which is a protein kinase inhibitor.
Danish: Sutent indeholder det aktive stof sunitinib, som er en proteinkinasehæmmer.
English: A hazard ratio favouring sunitinib was observed in all subgroups of baseline characteristics evaluated, including an analysis by number of prior systemic therapies.
Danish: En hazard ratio til fordel for sunitinib blev set i alle undergrupper af evaluerede baselinekarakteristika, inklusive en analyse af antallet af forudgående systemiske behandlinger.
English: b Efficacy results for the 99 subjects who crossed over from placebo to Sutent after unblinding.
Danish: Effektresultater for de 99 patienter, som krydsede over fra placebo til Sutent efter afblinding.
English: - 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.
Danish: - 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.
English: • Infections.
Danish: • Infektioner.
English: • High blood pressure.
Danish: • Højt blodtryk.
English: You will usually be taken off Sutent if you are having an operation.
Danish: Normalt bliver behandlingen med Sutent stoppet, hvis du skal opereres.
English: 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.
Danish: Brug af VEGF-hæmmere hos patienter med eller uden hypertension kan fremme dannelsen af aneurismer og/eller arterielle dissektioner.
English: Results for ORR are given as percent of subjects with confirmed response with the 95% CI.
Danish: Resultater for ORR (objektive responsrate) er angivet som procent patienter med bekræftet respons med 95% CI.
English: All thyroid-related events reported were Grade 1-2 (see section 4.4).
Danish: Alle thyroidea-relaterede hændelser var grad 1-2 (se pkt.
English: No cases with fatal outcome were reported in GIST, MRCC, and pNET registrational studies.
Danish: Der er ikke rapporteret letale tilfælde i GIST-, mRCC og pNET-registreringsstudier.
English: Steady-state concentrations of sunitinib and its primary active metabolite are achieved within 10 to 14 days.
Danish: Steady state-koncentrationen af sunitinib og dets aktive hovedmetabolit nås inden for 10-14 dage.
English: 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).
Danish: Tilsvarende var legemsoverfladeareal en signifikant kovariat for den tilsyneladende clearance af den aktive metabolit (jo mindre legemsoverfladeareal, jo lavere tilsyneladende clearance).
English: Nevertheless, most of these adverse events observed in clinical studies were not considered related to study treatment (see section 4.4).
Danish: Størstedelen af disse bivirkninger observeret i kliniske studier, kunne dog ikke relateres til behandlingen i de kliniske studier (se pkt.
English: In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.
Danish: Hos patienter uden kardielle risikofaktorer bør en vurdering af uddrivningsfraktionen ved baseline overvejes.
English: • Heart attack caused by an interrupted or decreased blood supply to the heart.
Danish: • Hjerteanfald på grund af afbrudt eller nedsat blodtilførsel til hjertet.
English: Your doctor will decide when to start Sutent again.
Danish: Lægen beslutter, hvornår du kan starte med Sutent-behandlingen igen.
English: Therefore, the decision to resume sunitinib therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.
Danish: Beslutning om genoptagelse af sunitinib-behandlingen efter et større kirurgisk indgreb bør tages på grundlag af klinisk bedømmelse af restitution efter indgrebet.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Before initiating sunitinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med sunitinib, bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: 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.
Danish: 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.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne er inden for hver hyppighed anført efter faldende alvorlighed.
English: In the dosing ranges of 25 to 100 mg, the area under the plasma concentration-time curve (AUC) and Cmax increase proportionally with dose.
Danish: Ved dosisintervallet 25-100 mg øges både arealet under plasmakoncentrationstidskurven (AUC) og Cmax proportionalt med dosis.
English: Other endpoints included ORR, OS, and safety.
Danish: Andre endepunkter omfattede ORR, OS og sikkerhed.
English: In a pancreatic islet cell tumour cohort of 66 patients, the primary endpoint of response rate was 17%.
Danish: I en kohorte på 66 patienter med ø-celle tumorer var responsraten - det primære endepunkt - 17%.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The dose of sunitinib was reduced or its administration temporarily suspended in approximately 2.7% of the patients who experienced hypertension.
Danish: Dosis af sunitinib blev reduceret, eller administration af sunitinib blev midlertidtigt indstillet hos ca. 2,7% af patienterne, som fik hypertension.
English: 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).
Danish: 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).
English: Severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic) was reported in 4.7% of patients with solid tumours.
Danish: Svær hypertension (>200 mmHg systolisk eller 110 mmHg diastolisk) sås hos 4,7% af patienterne med solide tumorer.
English: If your thyroid gland is not producing enough thyroid hormone, you may be treated with thyroid hormone replacement.
Danish: Hvis skjoldbruskkirtlen ikke producerer nok hormon, kan du blive behandlet med skjoldbruskkirtelhormon-erstatning.
English: 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.
Danish: Baseret på modelleringsanalyser virkede det ikke som om, at yngre alder og mindre legemsstørrelse påvirkede sikkerheds- og virkningsresponse på plasma-eksponeringen for sunitinib negativt.
English: Placebo cross-over group treatment b
Danish: Placebo cross-over gruppe