FrancophonIA/ELRC3.0 huggingface dataset:
English: If signs or symptoms of SJS, TEN, or EM (e.g., progressive skin rash often with blisters or mucosal lesions) are present, sunitinib treatment should be discontinued.
Danish: Hvis der er tegn eller symptomer på SJS, TEN eller EM (f.eks. progressivt hududslæt, ofte med blister eller mukosale læsioner), bør sunitinib seponeres.
English: In this study the ORR was 35.8% (95% CI: 26.8% , 47.5 %).
Danish: I dette studie var ORR 35,8% (95% CI: 26,8%-47,5%.
English: Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Sutent findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Patients should be carefully monitored for clinical signs and symptoms of CHF while receiving sunitinib especially patients with cardiac risk factors and/or history of coronary artery disease.
Danish: Patienterne bør monitoreres omhyggeligt for kliniske tegn og symptomer på CHF, mens de får sunitinib, især patienter som har kardielle risikofaktorer og/eller koronararteriesygdom i anamnesen.
English: Severe cutaneous reactions have been reported, including cases of erythema multiforme (EM), cases suggestive of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some of which were fatal.
Danish: Der er rapporteret tilfælde af alvorlige kutane bivirkninger herunder erythema multiforme (EM), tilfælde, der tyder på Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN), hvoraf nogle var dødelige.
English: No significant changes in the PK of sunitinib or the primary active metabolite are observed with repeated daily administration or with repeated cycles in the dosing schedules tested.
Danish: Der er ikke set nogen signifikante ændringer i farmakokinetikken af sunitinib eller den aktive hovedmetabolit ved gentagen daglig dosis eller ved gentagen cyklus efter det undersøgte doseringsskema.
English: This analysis provided a conservative estimate of the treatment effect of sunitinib and supported the primary analysis, demonstrating a hazard ratio of 0.507 (95% CI: 0.350, 0.733), p=0.000193.
Danish: Denne analyse gav et konservativt skøn over behandlingseffekten af sunitinib og støttede den primære analyse, som viste en hazard ratio på 0,507 (95% CI: 0,350 - 0,733), p = 0,000193.
English: − pNET: the usual dose is 37.5 mg once daily without a rest period.
Danish: • pNET, er den sædvanlige dosis 37,5 mg 1 gang dagligt uden behandlingspause.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturshjemmeside http://www.ema.europa.eu/.
English: Unstratified analysis Hazard ratio (sunitinib versus IFN-) 95% CI for hazard ratio p-value a
Danish: Ustratificeret analyse Hazard ratio (sunitinib versus IFN-) 95% CI for hazard ratio
English: Your doctor may obtain electrocardiograms to evaluate for these problems during your treatment with Sutent.
Danish: Lægen vil muligvis tage et elektrokadiogram, for at undersøge hjertet for disse forstyrrelser under behandlingen med Sutent.
English: Sunitinib and/or its metabolites are excreted in rat milk.
Danish: Sunitinib og/eller dets metabolitter udskilles i mælk hos rotter.
English: Efficacy is based on time-to-tumour progression (TTP) and an increase in survival in GIST, on progression-free survival (PFS) and objective response rates (ORR) for treatment-naïve and cytokine-refractory MRCC respectively, and on PFS for pNET.
Danish: Effekten er baseret på tidspunktet for tumorprogression (TTP) og stigning i overlevelse med GIST på henholdsvis progressions-fri overlevelse (PFS) og objektiv responsrate (ORR) for behandlingsnaiv og cytokin-refraktær mRCC og PFS ved pNET.
English: Other endpoints included OS, ORR, PROs, and safety.
Danish: Andre parametre omfattede OS, ORR, PRO og sikkerhed.
English: The active substance is sunitinib.
Danish: Aktivt stof: sunitinib.
English: One hundred six patients (61 patients in the treatment-naïve cohort and 45 patients in the later-line cohort) received treatment with sunitinib orally at 37.5 mg once a day on a continuous daily dosing (CDD) schedule.
Danish: 106 patienter (61 patienter i den behandlingsnaive kohorte og 45 patienter i kohorten med senere behandlingslinje) fik behandling med 37,5 mg sunitinib oralt en gang dagligt i henhold til en fortløbende daglig doseringsplan (CDD).
English: • Nose bleeding.
Danish: • Næseblod.
English: In these paediatric patients without previous exposure to anthracyclines or cardiac irradiation, the maximum tolerated dose (MTD) has been identified (see section 5.1).
Danish: Hos disse pædiatriske patienter uden tidligere eksponering for antracykliner eller stråling af hjertet er den maksimalt tolererede dosis blevet fastslået (se pkt.
English: Other possible dermatological effects may include dryness, thickness or cracking of the skin, blisters, or rash on the palms of the hands and soles of the feet.
Danish: Andre mulige dermatologiske virkninger kan omfatte tørhed og fortykkelse af hud eller revnet hud, blærer, eller lejlighedsvis udslæt på håndflader og fodsåler.
English: Cases of serious infection (with or without neutropenia), including cases with fatal outcome, have been reported.
Danish: Der er rapporteret tilfælde af alvorlig infektion (med eller uden neutropeni) herunder letale tilfælde.
English: Nine of these patients had pulmonary embolisms; 1 was Grade 2 and 8 were Grade 4.
Danish: 9 af disse patienter havde lungeemboli; 1 var grad 2 og 8 var grad 4.
English: In the Phase 1/2 study, stable disease and disease progression was observed in 3 out of 6 patients each (1 patient received neo adjuvant and 1 patient received adjuvant imatinib, respectively).
Danish: I fase 1/2studiet blev der observeret stabil sygdom og sygdomsprogression hos 3 ud af 6 patienter (1 patient fik neo-adjuverende behandling og 1 fik adjuverende imatinib).
English: Notify your doctor as soon as possible if you have high blood pressure, headache, or loss of sight.
Danish: Fortæl det så hurtigt som muligt til lægen, hvis du har højt blodtryk, hovedpine eller oplever synstab.
English: In patients who received sunitinib in Phase 3 registrational studies, pulmonary events (i.e. dyspnoea, pleural effusion, pulmonary embolism, or pulmonary oedema) were reported in approximately 17.8% of patients with GIST, in approximately 26.7% of patients with MRCC and in 12% of patients with pNET.
Danish: Hos patienter, der fik sunitinib i fase 3-registreringsstudier, blev lungehændelser (dvs. dyspnø, pleural effusion, lungeemboli eller lungeødem) rapporteret hos ca. 17,8% af patierne med GIST, hos ca. 26,7% af patienterne med mRCC og hos 12% af patienterne med pNET.
English: In order to rule out bias in the investigator-based assessment of PFS, a BICR of scans was performed; this review supported the investigator assessment, as shown in Table 4.
Danish: For at udelukke bias i den investigator-baserede PFS-vurdering blev der gennemført en blindet, uafhængig, central gennemgang af scanninger; denne gennemgang understøttede investigatorvurderingen, som vist i tabel 4.
English: Patients receiving concomitant treatment with anticoagulants (e.g., warfarin, acenocoumarole) may be periodically monitored by complete blood counts (platelets), coagulation factors (PT/INR), and physical examination.
Danish: Patienter, der samtidigt behandles med antikoagulantia (f.eks. warfarin; acenocoumarol) bør regelmæssigt have foretaget fuldstændig blodtælling (trombocyttal), koagulationsfaktor (PT/INR) og objektiv undersøgelse.
English: At approximately twice therapeutic concentrations, the maximum QTcF interval change from baseline was 15.4 msec (90% CI: 22.4 msec).
Danish: Ved ca. den dobbelte terapeutiske koncentration var den maksimale ændring af QTcF-intervallet fra baseline 15,4 msek (90% CI: 22,4 msek).
English: These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to your lungs.
Danish: Det kan være symptomer på blodprop i lungen, som opstår når en blodprop føres til lungen.
English: Blood sugar levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicine's dosage needs to be adjusted to minimise the risk of low blood sugar.
Danish: Dit blodsukkerniveau skal kontrolleres jævnligt, så lægen kan vurdere, om dosis af diabetesmedicin skal justeres for at nedsætte risikoen for lavt blodsukker.
English: Sunitinib therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Danish: Sunitinib skal seponeres hos patienter, som udvikler nekrotiserende fasciitis, og passende behandling skal indledes omgående.
English: A higher incidence rate of hypoglycaemia events was reported in patients with pNET in comparison to MRCC and GIST.
Danish: Der er rapporteret højere hyppighed af hypoglykæmiske episoder hos patienter med pNET sammenlignet med patienter med mRCC eller GIST.
English: While you are on this medicine "pyoderma gangrenosum" (painful skin ulceration) or “necrotising fasciitis” (rapidly spreading infection of the skin/soft tissue that may be life-threatening) may occur.
Danish: Mens du tager dette lægemiddel, kan du få smertefulde sår på huden (gangrænøs pyoderma) eller nekrotiserende fasciitis (en infektion, der hurtigt spreder sig i huden/vævet, og som kan være livstruende).
English: • Blood clots in the blood vessels.
Danish: • Blodpropper i blodkarrene.
English: A total of 66% of sunitinib patients received prior systemic therapy compared with 72% of placebo patients.
Danish: I alt 66% af sunitinib-patienterne fik forudgående systemisk behandling sammenlignet med 72% af placebo-patienterne.
English: Cholecystitis and acalculous cholecystitis.
Danish: Cholecystitis og akalkuløs cholecystitis t
English: Fatal gastrointestinal bleeding was reported in 0.98% of patients receiving placebo in the GIST Phase 3 study.
Danish: Letal gastrointestinal blødning blev rapporteret hos 0.98% af patienterne, der fik placebo i fase 3 GIST-studiet.
English: Additionally, thyroid-stimulating hormone (TSH) elevations were reported in 4 cytokine-refractory MRCC patients (2%).
Danish: Derudover er der rapporteret stigninger i thyroideastimulerende hormon (TSH) hos 4 cytokinrefraktære mRCC-patienter (2%).
English: After oral administration of sunitinib, Cmax are generally observed from 6 to 12 hours time to maximum concentration (tmax) postadministration.
Danish: Absorption Efter oral anvendelse af sunitinib ses Cmax sædvanligvis 6-12 timer (Tmax) efter administration.
English: Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice (see section 4.4).
Danish: Patienter med tegn eller symptomer på muskeltoksicitet skal behandles i henhold til gældende medicinsk praksis (se pkt.
English: Studies in animals have shown reproductive toxicity including foetal malformations (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet, inklusive føtale malformationer (se pkt.
English: Paediatric population The safety and efficacy of Sutent in patients below 18 years of age have not been established.
Danish: Sutents sikkerhed og virkning hos patienter under 18 år er ikke klarlagt.
English: Epistaxis was the most common haemorrhagic adverse reaction, having been reported for approximately half of the patients with solid tumours who experienced haemorrhagic events.
Danish: Epistaxis var den mest almindelige blødningsrelaterede bivirkning, og blev rapporteret hos ca. halvdelen af de patienter med solide tumorer, som oplevede blødningsepisoder.
English: The overall PFS and OS, observed in the ITT population, as determined by the core radiology laboratory assessment, are summarised in Table 3.
Danish: Det primære effekt-endepunkt og overall-overlevelse, observeret i ITT- populationen, bestemt ved den radiologiske undersøgelse, er sammenfattet i tabel 3:
English: - If you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, tell your doctor and dentist immediately.
Danish: - Hvis du har eller har haft smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, følelsesløshed eller tyngdefornemmelse i kæben, eller hvis tænderne bliver løse, skal du straks fortælle det til deres læge og tandlæge.
English: Seizures have been observed in patients with or without radiological evidence of brain metastases (see section
Danish: Kramper er set hos patienter med eller uden radiologiske tegn på hjernemetastaser (se pkt.
English: In this study, 312 patients were randomised (2:1) to receive either 50 mg sunitinib or placebo, orally once daily on Schedule 4/2 until disease progression or withdrawal from the study for another reason (207 patients received sunitinib and 105 patients received placebo).
Danish: I dette studie blev 312 patienter randomiseret (2:1) til enten 50 mg sunitinib eller placebo, oralt 1 gang dagligt med doseringsskema 4/2 indtil sygdomsprogression, eller til de udgik af studiet af anden årsag (207 patienter fik sunitinib, og 105 patienter fik placebo).
English: • Abnormal changes in the brain that can cause a collection of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
Danish: • Forstyrrelser i hjernen, der kan give forskellige symptomer som hovedpine, forvirring, kramper og synstab (reversibel posterior leukoencefalopati syndrom).
English: • Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Danish: • Alvorlige reaktioner i hud og/eller slimhinder (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og erythema multiforme).
English: Tell your doctor if you have any bleeding while on treatment with Sutent.
Danish: Fortæl det til lægen, hvis der opstår blødninger under behandlingen med Sutent.
English: Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.
Danish: Sutent er indiceret til behandling af voksne med inoperabel og/eller metastaserende malign gastrointestinal stromal tumor (GIST) efter behandlingssvigt med imatinib på grund af resistens eller intolerans.
English: After the interim analysis of efficacy and safety, at the recommendation of the independent Data and Safety Monitoring Board (DSMB), the study was unblinded and patients on the placebo arm were offered open-label sunitinib treatment.
Danish: Efter interimanalysen af virkning og sikkerhed blev studiet afblindet på anbefaling af det uafhængige Data Safety Monitoring Board, og patienterne i placebo-armen fik tilbudt åben-label sunitinibbehandling.
English: OS observed after 5 years of follow-up in the extension study showed a hazard ratio of 0.730 (95% CI: 0.504, 1.057).
Danish: Ved 5-årsopfølgning i forlængelsesstudiet viste OS en hazard ratio på 0,730 (95% CI 0,504; 1,057).
English: A Phase 3, randomised, double-blind, placebo-controlled study of sunitinib was conducted in patients with GIST who were intolerant to, or had experienced disease progression during or following treatment with imatinib (median maximum daily dose 800 mg).
Danish: Et fase 3, randomiseret, dobbelt-blind, placebokontrolleret studie med sunitinib blev udført hos patienter med GIST, som udviste intolerans over for, eller havde udviklet sygdomsprogression under eller efter behandling med imatinib (median maksimal daglig dosis på 800 mg).
English: If fistula formation occurs, sunitinib treatment should be interrupted.
Danish: I tilfælde af fisteldannelse skal behandlingen med sunitinib afbrydes.
English: • Deficiency of blood supply to the heart muscle, due to obstruction or constriction of the coronary arteries.
Danish: • Manglende blodtilførsel til hjertemusklen på grund af blokering eller forsnævring af kranspulsårerne.
English: Treatment with Sutent may lead to a higher risk of bleeding or lead to changes in the number of certain cells in the blood which may lead to anaemia or affect the ability of your blood to clot.
Danish: Under behandlingen med Sutent kan du risikere at have større tendens til blødning eller ændringer i blodet, som kan medføre blodmangel eller påvirke blodets evne til at størkne.
English: Bacterial infectionsg
Danish: Bakterieinfektioner
English: Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
Danish: Sutent er indiceret til behandling af voksne med inoperabel eller metastaserende, veldifferentieret pankreatisk neuroendokrin tumor (pNET) med sygdomsprogression.
English: These may be caused by inflammation of the pancreas or gallbladder.
Danish: Dette kan skyldes betændelse i bugspytkirtlen eller galdeblæren.
English: In the treatment-naïve MRCC study, 27% of patients on sunitinib and 15% of patients on IFN- had an LVEF value below the lower limit of normal.
Danish: I det behandlingsnaive mRCC-studie havde 27% af patienterne på sunitinib og 15% af patienterne på IFN-α en LVEF-værdi, der var under den nedre referenceværdi.
English: No pulmonary embolism was reported for patients with pNET who received sunitinib in the Phase 3 study.
Danish: Der er ikke rapporteret lungeemboli hos pNET-patienter, som fik sunitinib, i fase 3 studiet.
English: A population pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analysis was conducted with the scope to extrapolate the PK and key safety and efficacy endpoints of sunitinib in paediatric patients with GIST (aged: 6 years to 17 years).
Danish: Der blev udført en populationsfarmakokinetisk og farmakokinetisk/- farmakodynamisk analyse med henblik på at ekstrapolere farmakokinetikken og de vigtigste endepunkter for sikkerhed og virkning af sunitinib hos pædiatriske patienter med GIST (aldersgruppe 6-17 år).
English: The observed adverse drug reactions were similar overall to those seen in adults (see section 4.8).
Danish: Samlet svarede de observerede bivirkninger til de, der blev set hos voksne (se pkt.
English: Objective response rate [%, (95% CI)]
Danish: Objektiv responsrate [%, (95% CI)]
English: Women of childbearing potential should be advised to use effective contraception and avoid becoming pregnant while receiving treatment with Sutent.
Danish: Kvinder i den fertile alder skal rådes til at anvende sikker prævention og undgå graviditet under behandlingen med Sutent.
English: Patients with seizures and signs/symptoms consistent with posterior reversible leukoencephalopathy syndrome (RPLS), such as hypertension, headache, decreased alertness, altered mental functioning and visual loss, including cortical blindness, should be controlled with medical management including control of hypertension.
Danish: Patienter med kramper og tegn/symptomer i overensstemmelse med reversibelt posteriort leukoencefalopatisk syndrom (RPLS), som f.eks. hypertension, hovedpine, nedsat opmærksomhed, ændret psykisk funktion og synstab, herunder kortikalblindhed bør kontrolleres med medicinsk behandling herunder kontrol af hypertension.
English: Systemic exposures after a single dose of sunitinib were similar in subjects with severe renal impairment (CLcr < 30 ml/min) compared to subjects with normal renal function (CLcr > 80 ml/min).
Danish: Systemisk eksponering efter en enkelt dosis sunitinib var den samme hos patienter med alvorligt nedsat nyrefunktion (CrCl <30 ml/min) som hos personer med normal nyrefunktion (CrCl >80 ml/min).
English: A 6-month, oral gavage carcinogenicity study (0, 8, 25, 75 [reduced to 50] mg/kg/day), with daily dosing was conducted in rasH2 transgenic mice.
Danish: Der blev udført et 6-måneders oralt gavage karcinogenicitetsstudie (0, 8, 25, 75 [nedsat til 50] mg/kg/dag), med daglig dosering hos rasH2 transgene mus.
English: Cytokine-refractory metastatic renal cell carcinoma A Phase 2 study of sunitinib was conducted in patients who were refractory to prior cytokine therapy with interleukin-2 or IFN-.
Danish: Cytokin-refraktær, metastaserende renalcellekarcinom Et fase 2 studie af sunitinib blev udført hos patienter, som var refraktære før cytokinbehandling med interleukin-2 eller IFN-α.
English: Sunitinib was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), VEGF receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
Danish: Sunitinib er identificeret som en hæmmer af receptorerne for trombocytafledte vækstfaktorer (PDGFR og PDGF), vaskulære endotel- vækstfaktorer (VEGFR1, VEGFR2 og VEGF3), stamcellefaktor (KIT), Fms-lignende tyrosinkinase-3 (FLT3), kolonistimulerende faktor (CSF-1R) og gliacelleafledt neurotrof faktor (RET).
English: If you have accidentally taken too many capsules, talk to your doctor straight away.
Danish: Hvis du har taget for mange kapsler, skal du omgående kontakte lægen eller skadestuen.
English: • High level of uric acid in the blood.
Danish: • Forhøjet indhold af urinsyre i blodet.
English: Cases of myopathy and/or rhabdomyolysis, some with acute renal failure, have been reported.
Danish: Der er rapporteret tilfælde af myopati og/eller Rabdomyolyse, nogle med akut nyresvigt.
English: Eight of these patients had DVT; 1 with Grade 1, 2 with Grade 2, 4 with Grade 3, and 1 with Grade 4.
Danish: 8 af disse patienter havde DVT; 1 var grad 1, 2 var grad 2, 4 var grad 3 og 1 var grad 4.
English: Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations.
Danish: Administration af sunitinib sammen med potente CYP3A4-hæmmere (f.eks. ritonavir, itraconazol, erythromycin, clarithromycin, grapefrugtjuice) kan øge sunitinibkoncentrationen.
English: Cases of hepatic failure, some with a fatal outcome, were observed in < 1% of solid tumour patients treated with sunitinib.
Danish: Der er set tilfælde af leversvigt, nogle med letalt udfald, hos <1% af de patienter med solide tumorer, der blev behandlet med sunitinib.
English: Call your doctor immediately if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness while on treatment with Sutent.
Danish: Ring straks til lægen, ved symptomer som smerter eller trykken i brystet, smerter i armene, ryggen, nakken eller kæben, åndenød, følelsesløshed eller svaghed i den ene side af kroppen, problemer med at gå, hovedpine eller svimmelhed, mens du bliver behandlet med Sutent.
English: Diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, and stomatitis/oral pain were the most commonly reported gastrointestinal adverse reactions; oesophagitis events have been also reported (see section 4.8).
Danish: Diarré, kvalme/opkastning, mavesmerter, dyspepsi og stomatitis/orale smerter er de hyppigst rapporterede gastrointestinale bivirkninger; der er også set tilfælde af øsofagitis (se pkt.
English: k Acute coronary syndrome, angina pectoris, angina unstable, coronary artery occlusion, and myocardial ischaemia.
Danish: Akut koronarsyndrom, angina pectoris, ustabil angina pectoris, koronararterieokklusion og myokardieiskæmi
English: For pNET, the recommended dose of Sutent is 37.5 mg taken orally once daily without a scheduled rest period.
Danish: Til pNET er den anbefalede dosis af Sutent 37,5 mg 1 gang dagligt indtaget oralt uden planlagte behandlingspauser.
English: No development toxicity was observed at 1 mg/kg/day (approximate exposure ≥ 0.9 times the AUC in patients administered the RDD).
Danish: Der sås ingen udviklingstoksisitet ved 1 mg/kg/dag (eksponering ca. >0,9 gange AUC hos patienter behandlet med ADD).