FrancophonIA/ELRC3.0 huggingface dataset:
English: In the second part of the study, including patients with prior anticancer therapy but without risk factors for cardiac toxicity, sunitinib was generally tolerable and clinically manageable at the dose of 15 mg/m daily (MTD) on Schedule 4/2.
Danish: I den anden del af studiet, hvor patienter med tidligere behandling mod cancer, men uden risikofaktorer for hjertetoksicitet, blev inkluderet, blev sunitinib generelt tolereret, og det kunne håndteres klinisk ved en dosis på 15 mg/m2 dagligt (maksimal tolereret dosis) i doseringsskema 4/2.
English: An initial open-label, dose-escalation study was conducted in patients with GIST after failure of imatinib (median maximum daily dose 800 mg) due to resistance or intolerance.
Danish: Det første åbne, dosis-eskaleringsstudie blev udført hos patienter med GIST efter behandlingssvigt med imatinib (median maksimal daglig dosis på 800 mg) på grund af resistens eller intolerans.
English: In addition, 24% of sunitinib patients had received somatostatin analogues compared with 22% of placebo patients.
Danish: Derudover havde 24% af sunitinib-patienterne fået somatostatin-analoger sammenlignet med 22% af placebo-patienterne.
English: Summary of progression-free survival
Danish: Sammenfatning af overall-overlevelse
English: Two of these patients on placebo had DVT, 1 with Grade 2 and 1 with Grade 3.
Danish: 2 af disse patienter i placebogruppen havde DVT, 1 var grad 2 og 1 var grad 3.
English: Although sunitinib and its primary metabolite were not eliminated through haemodialysis in subjects with ESRD, the total systemic exposures were lower by 47% for sunitinib and 31% for its primary metabolite compared to subjects with normal renal function.
Danish: Selvom sunitinib og den primære metabolit ikke elimineres ved hæmodialyse, var den systemiske eksponering for sunitinib 47% lavere og for den primære metabolit 31% lavere hos patienter med nyresygdom i slutstadiet sammenlignet med personer med normal nyrefunktion.
English: In this study, the median TTP was 34.0 weeks (95% CI: 22.0, 46.0).
Danish: I dette studie var median TTP 34,0 uger (95% CI = 22,0-46,0).
English: Decreased absolute neutrophil counts and decreased platelet counts were reported in association with sunitinib (see section 4.8).
Danish: Nedsat absolut neutrofiltal og nedsat antal blodplader er rapporteret i forbindelse med sunitinibn (se pkt.
English: In clinical trials, tumour haemorrhage was reported in approximately 2% of patients with GIST.
Danish: I kliniske studier forekom tumorblødning hos ca. 2% af patienterne med GIST.
English: Reduced offspring body weights were observed during the preweaning and postweaning periods at 3 mg/kg/day.
Danish: Der sås reduceret neonatal vægt under og efter afvænningsperioden ved 3 mg/kg/dag.
English: One hundred and 6 patients received at least one 50 mg dose of sunitinib on Schedule 4/2.
Danish: 106 patienter fik mindst en 50 mg dosis af sunitinib efter doseringsskema 4/2.
English: Physicians are advised to weigh this risk against the potential benefits of sunitinib.
Danish: Lægen rådes til at opveje den kardiovaskulære bivirkningsrisiko mod den potentielle fordel ved sunitinib.
English: Pyoderma gangrenosum Toxic epidermal necrolysis*
Danish: Gangrænøs pyoderma Toksisk epidermal nekrolyse
English: The investigator-assessed median PFS was 13.2 months, both in the overall population (95% CI: 10.9, 16.7) and in the treatment-naïve cohort (95% CI: 7.4, 16.8).
Danish: Den investigatorvurderede mediane PFS var 13,2 måneder både i den samlede population (95% CI: 10,9-16,7) og i den behandlingsnaïve population (95% CI: 7,4-16,8).
English: Prolonged treatment with sunitinib did not appear to be associated with new types of TRAEs.
Danish: Langvarig behandling med sunitinib så ikke ud til at være forbundet med nye typer eller øget sværhedsgrad af behandlingsrelaterede bivirkninger.
English: Haematological disorders (e.g., neutropenia, thrombocytopenia, and anaemia) are amongst the most common adverse drug reactions.
Danish: Hæmatologiske forstyrrelser (f.eks. neutropeni, trombocytopeni og anæmi) er blandt de mest almindelige bivirkninger.
English: Based on nonclinical findings, male and female fertility may be compromised by treatment with sunitinib (see section 5.3).
Danish: På baggrund af ikke-kliniske data kan mænds og kvinders fertilitet påvirkes af behandling med sunitinib (se pkt.
English: Risk factors for TLS include high tumour burden, pre-existing chronic renal insufficiency, oliguria, dehydration, hypotension, and acidic urine.
Danish: Risikofaktorer for TLS inkluderer høj tumorbyrde, præeksisterende kronisk nyreinsufficiens, oliguri, dehydrering, hypotension og sur urin.
English: Thrombotic microangiopathyh,*
Danish: Trombotisk mikroangiopati h, *
English: In addition, patients should be observed closely for signs and symptoms of thyroid dysfunction during treatment, and patients who develop any signs and/or symptoms suggestive of thyroid dysfunction should have laboratory testing of thyroid function performed as clinically indicated.
Danish: Desuden bør patienter, der er i sunitinibbehandling, observeres tæt for symptomer på thyroideadysfunktion, og de patienter, som udvikler tegn og/eller symptomer herpå, bør have foretaget laboratorieundersøgelse af thyroideafunktionen.
English: • Abnormal tube like passage from one normal body cavity to another body cavity or the skin.
Danish: • Unormal, rørformet passage mellem to normale hulrum i kroppen eller huden.
English: The above events were not cumulative, were typically reversible, and generally did not result in treatment discontinuation.
Danish: Disse hændelser er ikke kumulative, men er typisk reversible og fører sædvanligvis ikke til seponering af behandlingen.
English: The results of this study demonstrated that sunitinib had an effect on QTc interval (defined as a mean placebo-adjusted change of > 10 msec with a 90% confidence interval [CI] upper limit > 15 msec) at therapeutic concentration (Day 3) using the within-day baseline correction method,
Danish: Resultaterne af dette studie viste, at sunitinib havde en effekt på QTc-intervallet (defineret som middel placebo-justeret ændring på >10 msek med en 90% CI øvre grænse >15 msek) ved terapeutisk koncentration (dag 3) ved brug af ”within-day” baseline-korrektionsmetoden og ved højere end terapeutisk koncentration (dag 9) ved begge baseline-korrektionsmetoder.
English: In addition, the publications reported the following Grade 3 adverse drug reactions experienced by 5 patients: fatigue (2), gastrointestinal adverse drug reactions (including diarrhoea) (2), haematologic adverse drug reactions (including anaemia) (2), cholecystitis (1), hyperthyroidism (1), and mucositis (1).
Danish: Herudover er de følgende grad 3 bivirkninger blevet rapporteret hos 5 patienter i publikationer: træthed (2) og gastrointestinale bivirkninger (herunder diarré)(2), hæmatologiske bivirkninger (herunder anæmi) (2), cholecystitis (1), hypertyroidisme (1) og mucositis
English: Sunitinib was not mutagenic in bacteria using metabolic activation provided by rat liver.
Danish: Sunitinib er ikke mutagent i bakterier ved metabolisk aktivering af lever hos rotter.
English: Post-marketing adverse reactions identified in clinical studies are also included.
Danish: Bivirkninger set efter markedsføring, men også indrapporteret fra kliniske studier, er inkluderet.
English: Hypothyroidism may develop during treatment.
Danish: Symptomerne kan aftage under behandlingen.Hypotyreose kan udvikles under behandlingen.
English: Stevens-Johnson syndrome*
Danish: Erythema multiforme Stevens-Johnsons syndrom
English: The safety of continued sunitinib treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Danish: Der er ikke foretaget systematisk sikkerhedsvurdering ved fortsat behandling med sunitinib hos patienter med moderat til alvorlig proteinuri.
English: The study was closed at the time of planned interim analysis due to the lack of disease control.
Danish: På grund af manglende sygdomskontrol blev studiet lukket ned ved tidspunktet for den planlagte interimanalyse.
English: In study A6181038 the co-administration of gefitinib, a BCRP inhibitor, did not result in a clinically relevant effect on the Cmax and AUC for sunitinib or total drug (sunitinib + metabolite) (see section 4.5).
Danish: I studie A6181038 havde samtidig administration af BCRP-hæmmeren gefitinib ingen klinisk relevant virkning på Cmax og AUC-værdien for sunitinib eller sunitinib + metabolit (se pkt.
English: Sunitinib did not induce structural chromosome aberrations in human peripheral blood lymphocyte cells in vitro.
Danish: Sunitib inducerer ikke strukturelle kromosomafvigelser i humane perifere blod-lymfocytter in vitro.
English: With repeated daily administration, sunitinib accumulates 3- to 4-fold and its primary active metabolite accumulates 7- to 10-fold.
Danish: Ved gentagen daglig dosis akkumuleres sunitinib 3-4 gange, og dets aktive hovedmetabolit akkumuleres 7-10 gange.
English: Patients should be advised that they may experience dizziness during treatment with sunitinib.
Danish: Patienter bør informeres om, at de kan opleve svimmelhed under behandling med sunitinib.
English: In this study the objective response rate was 36.5% (95% CI: 24.7%, 49.6%) and the median TTP was 37.7 weeks (95% CI: 24.0, 46.4).
Danish: I dette studie var den objektive responsrate 36,5% (95% CI: 24,7%-49,6%) og medianTTP var 37,7 uger (95% CI: 24,0-46,4).
English: Haemorrhoids Glossodynia Oral pain
Danish: Hæmorroider Glossodyni Oral smerte Mundtørhed Flatulens
English: • Problems with wound healing after surgery.
Danish: • Problemer med sårheling efter operation.
English: Treatment-related venous thromboembolic events were reported in approximately 1.0% of patients with solid tumours who received sunitinib on clinical trials, including GIST and RCC.
Danish: Behandlingsrelaterede, venøse tromboemboliske hændelser er rapporteret hos ca. 1,0% af patienterne med solide tumorer, som blev behandlet med sunitinib i kliniske studier, herunder GIST og RCC.
English: Sunitinib has not been studied in subjects with severe (Child-Pugh class C) hepatic impairment and therefore its use in patients with severe hepatic impairment cannot be recommended (see section 5.2).
Danish: Sunitinib er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) og kan derfor ikke anbefales til denne patientgruppe (se pkt.
English: Your thyroid function should be checked before you take Sutent and regularly while you are taking it.
Danish: Dit stofskifte skal måles, inden du begynder at tage Sutent og regelmæssigt under behandlingen.
English: Median PFS was 2.3 months in the HGG group and 2.7 months in the ependymoma group.
Danish: Den mediane progressionsfrie overlevelse var 2,3 måneder i gruppen med gliom af høj grad og 2,7 måneder i ependymom-gruppen.
English: If you develop a rash or these skin symptoms, seek immediate advice from a doctor.
Danish: Hvis du udvikler disse hudsymptomer, skal du straks kontakte en læge.
English: - Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib.
Danish: - Bindevævssvulst i mave-tarmkanalen (GIST), hvor imatinib (anden medicin mod kræft) ikke virker, eller hvor imatinib ikke kan bruges.
English: There are no studies in pregnant women using sunitinib.
Danish: Der foreligger ikke data vedrørende anvendelsen af sunitinib hos gravide kvinder.
English: In the 807 patients who received long-term sunitinib treatment, most treatment-related adverse events (TRAEs) occurred initially in the first 6 months-1 year and then were stable or decreased in frequency over time, with the exception of hypothyroidism, which gradually increased over time, with new cases occurring over the 6 year period.
Danish: Hos de 807 patienter, som fik langvarig behandling med sunitinib, forekom de fleste behandlingsrelaterede bivirkninger initialt i de første 6 måneder til 1 år og var derefter stabile eller faldt i hyppighed over tid.
English: Pancreatic neuroendocrine tumours (pNET)
Danish: Neuroendokrine tumorer i pancreas (pNET)
English: No specific additional risk factors for sunitinib-induced cardiomyopathy apart from the drug-specific effect have been identified in the treated patients.
Danish: Udover den lægemiddelspecifikke virkning er der er ikke identificeret andre specifikke risikofaktorer for sunitinib-induceret kardiomyopati hos de behandlede patienter.
English: Blood glucose levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicinal product's dosage needs to be adjusted to minimise the risk of hypoglycaemia (see section 4.8).
Danish: Blodglucose skal kontrolleres jævnligt hos diabetespatienter, og om nødvendigt justeres dosis af antidiabetika for at minimere risikoen for hypoglykæmi (se pkt.
English: A total of 29 patients in the sunitinib arm and 24 in the placebo arm had received no prior systemic treatment; among these patients, the hazard ratio for PFS was 0.365 (95% CI: 0.156, 0.857), p=0.0156.
Danish: I alt 29 sunitinib-behandlede patienter og 24 placebo-behandlede patienter havde ikke fået forudgående systemisk behandling; blandt disse patienter var hazard ratio for PFS 0,365 (95% CI: 0,156 - 0,857), p = 0,0156.
English: Based on this analysis, a dose of approximately 20 mg/m daily in paediatric patients, with BSA values between 1.10 and 1.87 m2, is expected to provide plasma exposures to sunitinib and its active metabolite comparable (between 75 and 125% of the AUC) to those in adults with GIST administered sunitinib 50 mg daily on Schedule 4/2 (AUC 1233 ng.hr/mL).
Danish: Baseret på denne analyse forventes en dosis på ca. 20 mg/m2 dagligt (BSA-interval: 1,10-1,87 m2) hos pædiatriske patienter at resultere i plasmaeksponeringer for sunitinib og dets aktive metabolit (mellem 75 og 125% af AUC), der er sammenlignelige med voksnes med GIST, der får sunitinib 50 mg dagligt i dosisskema 4/2 (AUC 1233 ng.time/ml).
English: Abbreviations: CI=confidence interval; N=number of patients; NA=not applicable; pNET=pancreatic neuroendocrine tumours; RECIST=response evaluation criteria in solid tumours.
Danish: Forkortelser: CI=konfidensinterval; N=antal patienter; NA=ikke relevant; pNET= neuroendokrine tumorer i pancreas; RECIST=respons evaluering af kriterier for solide tumorer.
English: In the pivotal Phase 3 GIST study (N = 312), treatment-related fatal cardiac reactions were reported in 1% of patients on each arm of the study (i.e. sunitinib and placebo arms).
Danish: I det pivotale fase 3 GIST-studie (n = 312) forekom behandlingsrelaterede letale hjertebivirkninger hos 1% af patienterne i hver behandlingsgruppe i studiet (dvs. sunitinib og placebogruppen).
English: Other medicines and Sutent
Danish: Brug af anden medicin sammen med Sutent
English: As a result of the early study closure, remaining patients were unblinded and offered access to open-label sunitinib in an extension study.
Danish: Som følge af den tidlige lukning af studiet blev koden for de resterende patienter brudt, og de blev tilbudt behandling med sunitinib i et åbent forlængelsesstudie.
English: The above reactions were not cumulative, were typically reversible, and generally did not result in treatment discontinuation.
Danish: Disse reaktioner er ikke kumulative, men er typisk reversible og fører sædvanligvis ikke til seponering.
English: Pancreatitis has been observed uncommonly (< 1%) in patients receiving sunitinib for GIST or MRCC. No treatment-related pancreatitis was reported in the Phase 3 pNET study (see section 4.4).
Danish: Pankreatitis er set med hyppigheden ikke-almindelig (<1%) hos patienter, der fik sunitinib for GIST eller mRCC. Der er ikke rapporteret om behandlingsrelateret pankreatitis i fase 3 pNET-studiet (se pkt.
English: The median PFS was 11.4 months for the sunitinib arm compared to 5.5 months for the placebo arm [hazard ratio: 0.418 (95% CI: 0.263, 0.662), p-value=0.0001]; similar results were observed when derived tumour response assessments based upon application of RECIST to investigator tumour measurements were used to determine disease progression, as shown in Table 4.
Danish: Den mediane PFS var 11,4 måneder for sunitinib og 5,5 måneder for placebo [hazard ratio: 0,418 (95% CI: 0,263- 0,662), p = 0,0001]; lignende resultater blev set, når responsvurdering baseret på RECIST, sammenholdt med investigator-tumor-måling blev brugt til at bestemme sygdomsprogression, som vist i tabel 4.
English: • Pain in the stomach (abdomen) caused by inflammation of the pancreas.
Danish: • Smerter i maven (mavepine) på grund af betændelse i bugspytkirtlen.
English: Dose interruptions may be required based on individual safety and tolerability.
Danish: På baggrund af individuel sikkerhed og tolerabilitet kan dosisafbrydelse blive nødvendig.
English: Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
Danish: Sutent er indiceret til behandling af voksne med avanceret/metastaserende renalcellekarcinom (mRCC).
English: - Do not use this medicine after the expiry date which is stated on carton, bottle and blister foil after “EXP”.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP” Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Increased blood level of enzyme (creatine phosphokinase) from muscle.
Danish: • Forhøjet indhold af muskelenzym (kreatinkinase) i blodet.
English: Additional effects observed in other studies included: QTc interval prolongation, LVEF reduction and testicular tubular atrophy, increased mesangial cells in kidney, haemorrhage in gastrointestinal tract and oral mucosa, and hypertrophy of anterior pituitary cells.
Danish: Yderligere påvirkninger, som blev set i andre studier omfatter forlængelse af QTc-intervallet, LVEFnedsættelse og testikel tubulær atrofi, øget mesangialceller i nyren, blødning i gastrointestinalkanalen og oral mukosa, og hypertrofi af hypofyseforlapceller.
English: Tumour haemorrhage may occur suddenly, and in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage.
Danish: I tilfælde af pulmonale tumorer kan der være tale om alvorlig og livstruende hæmoptyse eller pulmonal blødning.
English: Dehydration Hypoglycaemia
Danish: Dehydrering Hypoglykæmi
English: At therapeutic plasma concentrations, the maximum QTcF interval (Frederica's correction) mean change from baseline was 9 msec (90% CI: 15.1 msec).
Danish: Ved terapeutisk plasmakoncentration var den maksimale middelændring af QTcF-intervallet (Fridericias korrektion) fra baseline 9 msek (90% CI: 15,1 msek).
English: Using comprehensive serial ECG assessments at times corresponding to either therapeutic or greater than therapeutic exposures, none of the patients in the evaluable or intent-to-treat (ITT) populations were observed to develop QTc interval prolongation considered as “severe” (i.e. equal to or greater than Grade 3 by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).
Danish: Ved brug af omfattende gentagne EKG-målinger på tidspunkter svarende til enten terapeutisk eksponering eller højere end terapeutisk ekponering sås ikke udvikling af alvorlig forlængelse af QTcintervallet (dvs. lig med eller større end grad 3 ifølge CTCAE version 3,0) hos nogen af patienterne i den evaluerbare population eller i ITT-populationen.
English: - If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Danish: - Hvis du har eller har haft et aneurisme (udvidelse ogsvækkelse af en blodårevæg) eller en rift i en blodårevæg.
English: Studies in cancer patients have excluded patients with ALT or AST > 2.5 x ULN (upper limit of normal) or > 5.0 x ULN if due to liver metastasis.
Danish: Studier af cancerpatienter ekskluderede patienter med ALAT eller ASAT >2,5 x den øvre referenceværdi, eller hvis levermetastaser var årsag til tallene >5,0 x den øvre referenceværdi.
English: How to take Sutent
Danish: Sådan skal du tage Sutent
English: In rat and monkey repeated-dose toxicity studies up to 9-months duration, the primary target organ effects were identified in the gastrointestinal tract (emesis and diarrhoea in monkeys); adrenal gland (cortical congestion and/or haemorrhage in rats and monkeys, with necrosis followed by fibrosis in rats); haemolymphopoietic system (bone morrow hypocellularity and lymphoid depletion of thymus, spleen, and lymph node); exocrine pancreas (acinar cell degranulation with single cell necrosis); salivary gland (acinar hypertrophy); bone joint (growth plate thickening); uterus (atrophy); and ovaries (decreased follicular development).
Danish: I gentagne dosistoksicitetsstudier af op til 9 måneders varighed på rotter og aber var påvirkninger af det primære målorgan identificeret i den gastrointestinale kanal (emesis og diarré hos aber); binyre (kortikal kongestion og/eller blødning hos rotter og aber og nekrose efterfulgt af fibrose hos rotter); blod-og lymfesystem (knoglemarvshypocellularitet og lymfoid udtømning i thymus, milt og lymfeknuder); eksokrin pancreas (acinar celledegranulering med enkeltcelle nekrose); spytkirtler (acinar hypertrofi); led (fortykkelse af vækstplade); uterus (atrofi) og ovarier (nedsat follikeludvikling).
English: The diagnosis of TMA, including thrombotic thrombocytopaenic purpura (TTP) and haemolytic uraemic syndrome (HUS), sometimes leading to renal failure or a fatal outcome, should be considered in the occurrence of haemolytic anaemia, thrombocytopenia, fatigue, fluctuating neurological manifestation, renal impairment, and fever.
Danish: Diagnosen TMA, herunder trombotisk trombocytopenisk purpura (TTP) og hæmolytisk uræmisk syndrom (HUS), som indimellem har medført nyresvigt eller dødsfald, skal overvejes ved forekomst af hæmolytisk anæmi, trombocytopeni, træthed, fluktuerende neurologiske manifestationer, nedsat nyrefunktion og feber.
English: Increases in serum lipase and amylase activities were observed in patients with various solid tumours who received sunitinib.
Danish: Der er set stigninger i serumlipase- og amylaseaktivitet hos patienter med forskellige solide tumorer i behandling med sunitinib.
English: Cases of pulmonary embolism were observed in approximately 3.1% of patients with GIST and in approximately 1.2% of patients with MRCC, who received sunitinib in Phase 3 studies.
Danish: Der blev observeret tilfælde af lungeemboli hos ca. 3,1% af patienterne med GIST og hos ca. 1,2% af patienterne med mRCC i behandling med sunitinib i fase 3 studierne.
English: GIST summary of efficacy endpoints (ITT population) Double-blind treatment a
Danish: Tabel 2 - Sammenfatning af effekt-endepunkter for GIST (ITT-populationen) Dobbeltblind behandling
English: Increases in the QTc interval to over 500 msec were reported in 0.5%, and changes from baseline in excess of 60 msec were reported in 1.1% of the 450 solid tumour patients; both of these parameters are recognised as potentially significant changes.
Danish: Forlænget QTc-interval til over 500 msek sås hos 0,5%, og ændringer med mere end 60 msek fra baseline sås hos 1,1% af de 450 patienter med solide tumorer.
English: Tell your doctor if you have any of these symptoms or a serious bleeding problem during treatment with Sutent: painful, swollen stomach (abdomen); vomiting blood; black, sticky stools; bloody urine; headache or change in your mental status; coughing up of blood or bloody sputum from the lungs or airway.
Danish: Fortæl det til lægen, hvis du får nogle af disse symptomer eller alvorlige blødninger under behandlingen med Sutent: smertende, udspilet mave, kaster blod op, sort, klistret afføring, blod i urinen, hovedpine eller ændret sindstilstand, ophostning af blod eller blodigt opspyt fra lunger eller luftveje.