FrancophonIA/ELRC3.0 huggingface dataset:
English: Sutent can cause heart problems.
Danish: Sutent kan give hjerteproblemer.
English: • Swelling caused by fluid under the skin and around the eye, deep allergic rash.
Danish: • Hævelse af væv på grund af væske under huden og omkring øjnene, dybtliggende allergisk udslæt.
English: Hair colour changes Dry skin
Danish: Ændring i hårfarve Tør hud
English: 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.
Danish: 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.
English: Moxifloxacin (400 mg) used as a positive control showed a 5.6 msec maximum mean QTcF interval change from baseline.
Danish: Moxifloxacin (400 mg), der blev brugt som positiv kontrol, viste en maksimal middelændring af QTcF-intervallet på 5,6 msek fra baseline.
English: 28 x 1 hard capsules
Danish: 28 x 1 hård kapsel
English: Lung or breathing problems.
Danish: Lunge- eller vejrtrækningsproblemer.
English: However, the discontinuation rates due to adverse events were 20% for sunitinib and 23% for IFN-α.
Danish: Alligevel var seponeringsraten på grund af bivirkninger 20% for sunitinib og 23% for IFN-α.
English: Patients who presented with pulmonary embolism within the previous 12 months were excluded from sunitinib clinical studies.
Danish: Patienter, som havde haft lungeemboli indenfor de seneste 12 måneder, blev ekskluderet fra de kliniske studier med sunitinib.
English: 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).
Danish: 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).
English: 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.
Danish: Sunitinib metaboliseres hovedsageligt af CYP3A4, CYP-isoformen, som producerer dets aktive hovedmetabolit, desethylsunitinib, og som derefter metaboliseres yderligere af det samme isoenzym.
English: This analysis was based on data collected from adults with GIST or solid tumours and from paediatric patients with solid tumours.
Danish: Denne analyse var baseret på data indsamlet fra voksne med GIST eller solide tumorer samt fra pædiatriske patienter med solide tumorer.
English: 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.
Danish: 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.
English: The primary efficacy endpoint was ORR, based on Response Evaluation Criteria in Solid Tumours (RECIST).
Danish: Det primære effektendepunkt var den objektive responsrate (ORR) baseret på Response Evaluation Criteria in Solid Tumours (RECIST = respons evaluering af kriterier for solide tumorer).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: All findings occurred at clinically relevant sunitinib plasma exposure levels.
Danish: Alle fund opstod ved klinisk relevante sunitinib-plasmaeksponeringsniveauer.
English: Patients should be advised that depigmentation of the hair or skin may occur during treatment with sunitinib.
Danish: Patienter bør informeres om, at depigmentering af hår eller hud kan forekomme under behandling med sunitinib.
English: • Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
Danish: • Unormal nedbrydning af muskelvæv, som kan give nyreproblemer (rhabdomyolyse).
English: • Influenza-like syndrome.
Danish: • Influenzalignende symptomer.
English: a 2-sided unstratified log-rank test b
Danish: 2-sidet ustratificeret logrank test b
English: The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays.
Danish: Hovedmetabolitten udviser samme styrke sammenlignet med sunitinib i biokemiske analyser og celleanalyser.
English: These patients should be monitored closely and treated as clinically indicated, and prophylactic hydration should be considered.
Danish: Disse patienter bør følges nøje og behandles efter gældende praksis, og profylaktisk hydrering bør overvejes.
English: High-density polyethylene (HDPE) bottle with a polypropylene closure containing 30 hard capsules.
Danish: High-density polyethylen (HDPE) beholder med et polypropylenlåg, indeholdende 30 hårde kapsler.
English: 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.
Danish: 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.
English: • Complication of severe infection (infection is present in the bloodstream) that can lead to tissue damage, organ failure, and death.
Danish: • Komplikationer i forbindelse med alvorlig infektion (infektion i blodbanen) der kan resultere i vævsskade, organsvigt og dødsfald.
English: There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention.
Danish: Der er begrænset klinisk erfaring med, hvornår behandling skal genoptages efter større kirurgiske indgreb.
English: Sutent is not approved for use in patients with lung cancer.
Danish: Sutent er ikke godkendt til behandling af patienter med lungecancer.
English: 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
Danish: Stigningerne i lipaseaktiviteten var forbigående og var sædvanligvis ikke ledsaget af symptomer på pankreatitis hos forsøgspersoner med forskellige solide tumorer (se pkt.
English: 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).
Danish: 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).
English: No subjects experienced an effect on the QTc interval greater than Grade 2 (CTCAE version 3.0) (see section 4.4).
Danish: Ingen patienter oplevede en effekt på QTc-intervallet større end grad 2 (CTCAE-version 3,0) (se pkt.
English: Additionally, 49% of sunitinib patients had nonfunctioning tumours versus 52% of placebo patients and 92% of patients in both arms had liver metastases.
Danish: Desuden havde 49% af sunitinib-patienterne tumorer uden funktion versus 52% af placebo-patienterne, og 92% af patienterne i begge behandlingsarme havde levermetastaser.
English: Oral discomfort Eructation
Danish: Oralt ubehag Eruktation
English: In the presence of clinical manifestations of CHF, discontinuation of sunitinib is recommended.
Danish: Ved tilstedeværelse af kliniske manifestationer på CHF anbefales seponering af sunitinib.
English: 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.
Danish: 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.
English: Tumour destruction leading to hole in the intestine.
Danish: Nedbrydning af svulst, som fører til hul i tarmene.
English: Your doctor will determine the appropriate dose you need to take, as well as if and when you need to stop treatment with Sutent.
Danish: Lægen vil fastsætte den dosis du har brug for samt, hvornår du skal stoppe behandlingen med Sutent.
English: 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.
Danish: 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.
English: Hypertension has been reported in association with sunitinib, including severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic).
Danish: Hypertension er rapporteret i forbindelse med sunitinib, herunder alvorlig hypertension (>200 mmHg diastolisk systolisk eller > 100 mmHg).
English: The PK of sunitinib were evaluated in 135 healthy volunteers and 266 patients with solid tumours.
Danish: Farmakokinetikken af sunitinib blev vurderet hos 135 raske forsøgspersoner og 266 patienter med solide tumorer.
English: Overall survival [5 years follow-up] [median, months (95% CI)]
Danish: Samlet overlevelse [5-årsopfølgning] [median, måneder (95% CI)]
English: 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.
Danish: 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.
English: The rash may progress to widespread blistering or peeling of the skin and may be life-threatening.
Danish: Udslættet kan udvikle sig til udbredt blæredannelse eller afskalning af huden og kan være livstruende.
English: CYP3A4 inhibitors/inducers
Danish: CYP3A4-hæmmere/induktorer
English: 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).
Danish: 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).
English: Treatment may be resumed once hypertension is appropriately controlled (see section 4.8).
Danish: Behandlingen kan genoptages, når hypertensionen er under passende kontrol (se pkt.
English: These may be symptoms of heart problems that may include heart failure and heart muscle problems (cardiomyopathy).
Danish: Dette kan være symptomer på hjerteproblemer som hjertesvigt eller hjertemuskelproblemer (kardiomyopati).
English: 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.
Danish: 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.
English: The most frequent events included cerebrovascular accident, transient ischaemic attack, and cerebral infarction.
Danish: De hyppigste hændelser omfattede cerebrovaskulær hændelse, transitorisk cerebral iskæmi og cerebralt infarkt.
English: Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, and metastatic progression of cancer.
Danish: Sunitinib hæmmer gentagne RTK'er, som indgår i tumorvækst, neoangiogenese og metastaserende progression af cancer.
English: Stepwise covariate modelling analyses were performed to evaluate the effect of age and body size (total body weight or body surface area) as well as other covariates on important PK parameters for sunitinib and its active metabolite.
Danish: Der blev udført trinvise kovariatmodelleringsanalyser for at evaluere indvirkningen af alder og legemsstørrelse (total legemsvægt eller legemsoverfladeareal) samt andre kovariater på vigtige farmakokinetiske parametre for sunitinib og den aktive metabolit.
English: Patients with pre-existing hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of sunitinib treatment.
Danish: Patienter med eksisterende hypotyreose eller hypertyreose bør behandles efter gældende klinisk praksis, før behandling med sunitinib initieres.
English: The primary objective was to compare PFS in patients receiving sunitinib versus patients receiving placebo.
Danish: Det primære mål var at sammenligne PFS hos patienter, som fik sunitinib, versus patienter, som fik placebo.
English: Sunitinib and its primary metabolite are mainly metabolised by the liver.
Danish: Sunitinib og dets primære metabolit metaboliseres hovedsageligt i leveren.
English: It is available in plastic bottles of 30 capsules and in perforated unit dose blisters containing 28 x 1 capsules.
Danish: Sutent findes i plastikbeholder med 30 kapsler og i en perforeret enkeltdosis-blisterpakning med 28 x 1 kapsel.
English: Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with sunitinib (see section 4.8).
Danish: Fuldstændig blodtælling bør udføres i begyndelsen af hver behandlingscyklus hos patienter, der behandles med sunitinib (se pkt.
English: A total of 255 patients received sunitinib in the open-label treatment phase of the study, including 99 patients who were initially treated with placebo.
Danish: I alt fik 225 patienter sunitinib i studiets åben-label fase, inklusive de 99 patienter der blev behandlet med placebo i starten.
English: In this analysis, the placebo arm included those patients randomised to placebo who subsequently received open-label sunitinib treatment.
Danish: I denne analyse indeholder placebo-armen de patienter, som var randomiseret til placebo, men senere fik åben-label sunitinib-behandling.
English: Poly(chlorotrifluoroethylene)/PVC transparent perforated unit dose blister with aluminium foil coated with heat seal lacquer containing 28 x 1 hard capsules.
Danish: Gennemsigtigt poly(chlortrifluorethylen) PVC endosisblister med aluminiumsfolie belagt med varmeforseglet lak, der indeholder 28 x 1 hårde kapsler.
English: A total of 59 out of 85 patients (69.4%) from the placebo arm crossed over to open-label sunitinib following disease progression or unblinding at study closure.
Danish: I alt 59 ud af 85 patienter (69,4%) fra placebo-gruppen fik ublindet sunitinibbehandling efter sygdomsprogression eller afblinding ved studieafslutning.
English: Median overall OS was 5.1 months in the HGG group and 12.3 months in the ependymoma group.
Danish: Den mediane samlede overlevelse (OS) var 5,1 måneder i gruppen med gliom af høj grad og 12,3 måneder i ependymom-gruppen.
English: Monitor liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) before initiation of treatment, during each cycle of treatment, and as clinically indicated.
Danish: Udfør leverfunktionstest (alanin-aminotransferase [ALAT], aspartat-aminotransferase [ASAT], bilirubinniveau) før behandlingen påbegyndes, under hver behandlingscyklus, og hvis det er klinisk indiceret.
English: Adverse reactions that were reported in GIST, MRCC, and pNET patients in a pooled dataset of 7,115 patients are listed below, by system organ class, frequency and grade of severity (NCI-CTCAE).
Danish: Bivirkninger indberettet hos patienter med GIST, mRCC og hos pNET-patienter i et samlet datasæt på 7.115 patienter er anført nedenfor efter organklasse, hyppighed og sværhedsgrad (NCI-CTCAE).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01XE04
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinase-hæmmere, ATC-kode: L01XE04
English: Baseline and periodic evaluations of LVEF should also be considered while the patient is receiving sunitinib.
Danish: Baseline og regelmæssige vurderinger af LVEF bør overvejes, mens patienterne behandles med sunitinib.
English: Sunitinib and its primary active metabolite were the major compounds identified in plasma, urine, and faeces, representing 91.5%, 86.4%, and 73.8% of radioactivity in pooled samples, respectively.
Danish: Sunitinib og dets hovedmetabolit er de vigtigste forbindelser identificeret i plasma, urin og fæces med henholdsvis 91,5%, 86,4% og 73,8% af radioaktivitet i poolede prøver.
English: Dysgeusia, ageusia, and taste disturbance.
Danish: Dysgeusi, ageusi og smagsforstyrrelser
English: Effect of Breast Cancer Resistance Protein (BCRP) inhibitors Limited clinical data are available on the interaction between sunitinib and BCRP inhibitors and the possibility of an interaction between sunitinib and other BCRP inhibitors cannot be excluded (see section 5.2).
Danish: Virkningen af hæmmere af brystcancer-resistensprotein (BCRP) Der foreligger kun begrænsede kliniske data om interaktionen mellem sunitinib og BCRP-hæmmere, og muligheden for interaktion mellem sunitinib og andre BCRP-hæmmere kan ikke udelukkes (se pkt.
English: • Inflammation of the colon (colitis, colitis ischaemic).
Danish: • Tarmbetændelse (colitis, iskæmisk colitis).
English: These could be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.
Danish: Disse symptomer kan være tegn på knogleskade i kæben (osteonekrose) (se afsnit 2).
English: • Fluid around the heart (pericardial effusion).
Danish: • Væske omkring hjertet (perikardie-ekssudat).
English: Your doctor may check your blood pressure during treatment with Sutent, and you may be treated with medicines to reduce the blood pressure, if needed.
Danish: Lægen vil måle blodtrykket under behandlingen med Sutent, og hvis det er nødvendigt, bliver du behandlet med medicin for at sænke blodtrykket.
English: It is not known whether sunitinib or its primary active metabolite is excreted in human milk.
Danish: Det vides ikke, om sunitinib eller dets aktive hovedmetabolit udskilles i modermælk hos mennesker.
English: In vitro, binding of sunitinib and its primary active metabolite to human plasma protein was 95% and 90%, respectively, with no apparent concentration dependence.
Danish: In vitro-binding af sunitinib og dets aktive hovedmetabolit til human plasmaprotein er i in vitro studier henholdsvis 95% og 90%, og der er tilsyneladende ingen koncentrationsafhængighed.
English: In clinical studies of sunitinib and from postmarketing surveillance, seizures have been reported.
Danish: I kliniske studier af sunitinib og fra overvågning efter markedsføring er der rapporteret kramper.
English: In patients who have previously received or are receiving intravenous bisphosphonates, invasive dental procedures should be avoided if possible (see section 4.8).
Danish: Hos patienter, som tidligere har fået eller får bisfosfonat intravenøst, bør invasiv tandbehandling undgås, hvis dette er muligt (se pkt.
English: The median duration of treatment was 11.1 months (range: 0.4-46.1) for sunitinib treatment and 4.1 months (range: 0.1-45.6) for IFN-α treatment.
Danish: Middelvarighed af behandlingen var 11,1 måned (interval: 0,4-46,1) for sunitinib-behandling og 4,1 måned (interval: 0,1-45,6) for IFN-α-behandling.
English: Changes in the uterus (endometrial atrophy) and bone growth plate (physeal thickening or dysplasia of cartilage) are thought to be related to the pharmacological action of sunitinib.
Danish: Forandringer i uterus (endometrieatrofi) og knoglevækstplade (fortykkelse af epifyse eller dysplasi af brusken) menes at være relateret til den farmakologiske virkning af sunitinib.
English: Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation were reported in patients with intra-abdominal malignancies treated with sunitinib.
Danish: Alvorlige og til tider letale gastrointestinale komplikationer, herunder gastrointestinal perforation, er set hos patienter med intraabdominal malignitet behandlet med sunitinib.
English: No effects on male or female fertility were observed in reproductive toxicity studies.
Danish: Der ses ingen påvirkning af fertiliteten hos hanner eller hunner i reproduktionstoksicitetsstudierne.
English: • Changes in the electrical activity or abnormal rhythm of the heart.
Danish: • Ændringer i hjertets elektriske aktivitet eller unormal hjerterytme.
English: What you need to know before you take Sutent
Danish: Det skal du vide før du begynder at tage Sutent
English: Baseline laboratory measurement of thyroid function is recommended in all patients.
Danish: Der anbefales laboratorieundersøgelse af thyroideafunktionen ved baseline for alle patienter.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Sutent nøjagtigt efter lægens anvisning.
English: Risk factors associated with ATE, in addition to the underlying malignant disease and age  65 years, included hypertension, diabetes mellitus, and prior thromboembolic disease.
Danish: Risikofaktorer relateret til ATE, udover underliggende malign sygdom og alder >65 år, omfatter hypertension, diabetes mellitus og tidligere tromboembolisk sygdom.
English: • Loss of protein in the urine sometime resulting in swelling.
Danish: • Tab af protein gennem urinen, hvilket kan føre til hævelser.
English: Hypertension was a very common adverse reaction reported in clinical trials.
Danish: Hypertension var rapporteret som en meget almindelig bivirkning, i kliniske studier.