natgillin/translations-raw huggingface dataset:
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. 
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.
Patienter med eksisterende hypotyreose eller hypertyreose bør behandles efter gældende klinisk praksis, før behandling med sunitinib initieres. 
Patients with pre-existing hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of sunitinib treatment.
Det primære mål var at sammenligne PFS hos patienter, som fik sunitinib, versus patienter, som fik placebo. 
The primary objective was to compare PFS in patients receiving sunitinib versus patients receiving placebo.
Sunitinib og dets primære metabolit metaboliseres hovedsageligt i leveren. 
Sunitinib and its primary metabolite are mainly metabolised by the liver.
Sutent findes i plastikbeholder med 30 kapsler og i en perforeret enkeltdosis-blisterpakning med 28 x 1 kapsel. 
It is available in plastic bottles of 30 capsules and in perforated unit dose blisters containing 28 x 1 capsules.
Fuldstændig blodtælling bør udføres i begyndelsen af hver behandlingscyklus hos patienter, der behandles med sunitinib (se pkt. 
Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with sunitinib (see section 4.8).
I alt fik 225 patienter sunitinib i studiets åben-label fase, inklusive de 99 patienter der blev behandlet med placebo i starten. 
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.
I denne analyse indeholder placebo-armen de patienter, som var randomiseret til placebo, men senere fik åben-label sunitinib-behandling. 
In this analysis, the placebo arm included those patients randomised to placebo who subsequently received open-label sunitinib treatment.
Gennemsigtigt poly(chlortrifluorethylen) PVC endosisblister med aluminiumsfolie belagt med varmeforseglet lak, der indeholder 28 x 1 hårde kapsler. 
Poly(chlorotrifluoroethylene)/PVC transparent perforated unit dose blister with aluminium foil coated with heat seal lacquer containing 28 x 1 hard capsules.
I alt 59 ud af 85 patienter (69,4%) fra placebo-gruppen fik ublindet sunitinibbehandling efter sygdomsprogression eller afblinding ved studieafslutning. 
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.
Den mediane samlede overlevelse (OS) var 5,1 måneder i gruppen med gliom af høj grad og 12,3 måneder i ependymom-gruppen. 
Median overall OS was 5.1 months in the HGG group and 12.3 months in the ependymoma group.
Udfør leverfunktionstest (alanin-aminotransferase [ALAT], aspartat-aminotransferase [ASAT], bilirubinniveau) før behandlingen påbegyndes, under hver behandlingscyklus, og hvis det er klinisk indiceret. 
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.
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). 
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).
Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinase-hæmmere, ATC-kode: L01XE04 
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01XE04
Baseline og regelmæssige vurderinger af LVEF bør overvejes, mens patienterne behandles med sunitinib. 
Baseline and periodic evaluations of LVEF should also be considered while the patient is receiving sunitinib.
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. 
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.
Dysgeusi, ageusi og smagsforstyrrelser 
Dysgeusia, ageusia, and taste disturbance.
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. 
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).
• Tarmbetændelse (colitis, iskæmisk colitis). 
• Inflammation of the colon (colitis, colitis ischaemic).
Disse symptomer kan være tegn på knogleskade i kæben (osteonekrose) (se afsnit 2). 
These could be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.
• Væske omkring hjertet (perikardie-ekssudat). 
• Fluid around the heart (pericardial effusion).
Lægen vil måle blodtrykket under behandlingen med Sutent, og hvis det er nødvendigt, bliver du behandlet med medicin for at sænke blodtrykket. 
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.
Det vides ikke, om sunitinib eller dets aktive hovedmetabolit udskilles i modermælk hos mennesker. 
It is not known whether sunitinib or its primary active metabolite is excreted in human milk.
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. 
In vitro, binding of sunitinib and its primary active metabolite to human plasma protein was 95% and 90%, respectively, with no apparent concentration dependence.
I kliniske studier af sunitinib og fra overvågning efter markedsføring er der rapporteret kramper. 
In clinical studies of sunitinib and from postmarketing surveillance, seizures have been reported.
Hos patienter, som tidligere har fået eller får bisfosfonat intravenøst, bør invasiv tandbehandling undgås, hvis dette er muligt (se pkt. 
In patients who have previously received or are receiving intravenous bisphosphonates, invasive dental procedures should be avoided if possible (see section 4.8).
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. 
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.
Forandringer i uterus (endometrieatrofi) og knoglevækstplade (fortykkelse af epifyse eller dysplasi af brusken) menes at være relateret til den farmakologiske virkning af sunitinib. 
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.
Alvorlige og til tider letale gastrointestinale komplikationer, herunder gastrointestinal perforation, er set hos patienter med intraabdominal malignitet behandlet med sunitinib. 
Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation were reported in patients with intra-abdominal malignancies treated with sunitinib.
Der ses ingen påvirkning af fertiliteten hos hanner eller hunner i reproduktionstoksicitetsstudierne. 
No effects on male or female fertility were observed in reproductive toxicity studies.
• Ændringer i hjertets elektriske aktivitet eller unormal hjerterytme. 
• Changes in the electrical activity or abnormal rhythm of the heart.
Det skal du vide før du begynder at tage Sutent 
What you need to know before you take Sutent
Der anbefales laboratorieundersøgelse af thyroideafunktionen ved baseline for alle patienter. 
Baseline laboratory measurement of thyroid function is recommended in all patients.
Tag altid Sutent nøjagtigt efter lægens anvisning. 
Always take this medicine exactly as your doctor has told you.
Risikofaktorer relateret til ATE, udover underliggende malign sygdom og alder >65 år, omfatter hypertension, diabetes mellitus og tidligere tromboembolisk sygdom. 
Risk factors associated with ATE, in addition to the underlying malignant disease and age  65 years, included hypertension, diabetes mellitus, and prior thromboembolic disease.
• Tab af protein gennem urinen, hvilket kan føre til hævelser. 
• Loss of protein in the urine sometime resulting in swelling.
Hypertension var rapporteret som en meget almindelig bivirkning, i kliniske studier. 
Hypertension was a very common adverse reaction reported in clinical trials.
Hvis der er tegn eller symptomer på SJS, TEN eller EM (f.eks. progressivt hududslæt, ofte med blister eller mukosale læsioner), bør sunitinib seponeres. 
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.
I dette studie var ORR 35,8% (95% CI: 26,8%-47,5%. 
In this study the ORR was 35.8% (95% CI: 26.8% , 47.5 %).
Yderligere oplysninger om Sutent findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
• pNET, er den sædvanlige dosis 37,5 mg 1 gang dagligt uden behandlingspause. 
− pNET: the usual dose is 37.5 mg once daily without a rest period.
Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturshjemmeside http://www.ema.europa.eu/. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Ustratificeret analyse Hazard ratio (sunitinib versus IFN-) 95% CI for hazard ratio 
Unstratified analysis Hazard ratio (sunitinib versus IFN-) 95% CI for hazard ratio p-value a
Lægen vil muligvis tage et elektrokadiogram, for at undersøge hjertet for disse forstyrrelser under behandlingen med Sutent. 
Your doctor may obtain electrocardiograms to evaluate for these problems during your treatment with Sutent.
Sunitinib og/eller dets metabolitter udskilles i mælk hos rotter. 
Sunitinib and/or its metabolites are excreted in rat milk.
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. 
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.
Andre parametre omfattede OS, ORR, PRO og sikkerhed. 
Other endpoints included OS, ORR, PROs, and safety.
Aktivt stof: sunitinib. 
The active substance is sunitinib.
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). 
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.
• Næseblod. 
• Nose bleeding.
Hos disse pædiatriske patienter uden tidligere eksponering for antracykliner eller stråling af hjertet er den maksimalt tolererede dosis blevet fastslået (se pkt. 
In these paediatric patients without previous exposure to anthracyclines or cardiac irradiation, the maximum tolerated dose (MTD) has been identified (see section 5.1).
Andre mulige dermatologiske virkninger kan omfatte tørhed og fortykkelse af hud eller revnet hud, blærer, eller lejlighedsvis udslæt på håndflader og fodsåler. 
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.
Der er rapporteret tilfælde af alvorlig infektion (med eller uden neutropeni) herunder letale tilfælde. 
Cases of serious infection (with or without neutropenia), including cases with fatal outcome, have been reported.
9 af disse patienter havde lungeemboli; 1 var grad 2 og 8 var grad 4. 
Nine of these patients had pulmonary embolisms; 1 was Grade 2 and 8 were Grade 4.
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). 
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).
Fortæl det så hurtigt som muligt til lægen, hvis du har højt blodtryk, hovedpine eller oplever synstab. 
Notify your doctor as soon as possible if you have high blood pressure, headache, or loss of sight.
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. 
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.
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. 
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.
Patienter, der samtidigt behandles med antikoagulantia (f.eks. warfarin; acenocoumarol) bør regelmæssigt have foretaget fuldstændig blodtælling (trombocyttal), koagulationsfaktor (PT/INR) og objektiv undersøgelse. 
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.
Ved ca. den dobbelte terapeutiske koncentration var den maksimale ændring af QTcF-intervallet fra baseline 15,4 msek (90% CI: 22,4 msek). 
At approximately twice therapeutic concentrations, the maximum QTcF interval change from baseline was 15.4 msec (90% CI: 22.4 msec).
Det kan være symptomer på blodprop i lungen, som opstår når en blodprop føres til lungen. 
These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to your lungs.
Dit blodsukkerniveau skal kontrolleres jævnligt, så lægen kan vurdere, om dosis af diabetesmedicin skal justeres for at nedsætte risikoen for lavt blodsukker. 
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.
Sunitinib skal seponeres hos patienter, som udvikler nekrotiserende fasciitis, og passende behandling skal indledes omgående. 
Sunitinib therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Der er rapporteret højere hyppighed af hypoglykæmiske episoder hos patienter med pNET sammenlignet med patienter med mRCC eller GIST. 
A higher incidence rate of hypoglycaemia events was reported in patients with pNET in comparison to MRCC and GIST.
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). 
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.
• Blodpropper i blodkarrene. 
• Blood clots in the blood vessels.
I alt 66% af sunitinib-patienterne fik forudgående systemisk behandling sammenlignet med 72% af placebo-patienterne. 
A total of 66% of sunitinib patients received prior systemic therapy compared with 72% of placebo patients.
Cholecystitis og akalkuløs cholecystitis t 
Cholecystitis and acalculous cholecystitis.
Letal gastrointestinal blødning blev rapporteret hos 0.98% af patienterne, der fik placebo i fase 3 GIST-studiet. 
Fatal gastrointestinal bleeding was reported in 0.98% of patients receiving placebo in the GIST Phase 3 study.
Derudover er der rapporteret stigninger i thyroideastimulerende hormon (TSH) hos 4 cytokinrefraktære mRCC-patienter (2%). 
Additionally, thyroid-stimulating hormone (TSH) elevations were reported in 4 cytokine-refractory MRCC patients (2%).
Absorption Efter oral anvendelse af sunitinib ses Cmax sædvanligvis 6-12 timer (Tmax) efter administration. 
After oral administration of sunitinib, Cmax are generally observed from 6 to 12 hours time to maximum concentration (tmax) postadministration.
Patienter med tegn eller symptomer på muskeltoksicitet skal behandles i henhold til gældende medicinsk praksis (se pkt. 
Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice (see section 4.4).
Dyreforsøg har påvist reproduktionstoksicitet, inklusive føtale malformationer (se pkt. 
Studies in animals have shown reproductive toxicity including foetal malformations (see section 5.3).
Sutents sikkerhed og virkning hos patienter under 18 år er ikke klarlagt. 
Paediatric population The safety and efficacy of Sutent in patients below 18 years of age have not been established.
Epistaxis var den mest almindelige blødningsrelaterede bivirkning, og blev rapporteret hos ca. halvdelen af de patienter med solide tumorer, som oplevede blødningsepisoder. 
Epistaxis was the most common haemorrhagic adverse reaction, having been reported for approximately half of the patients with solid tumours who experienced haemorrhagic events.
Det primære effekt-endepunkt og overall-overlevelse, observeret i ITT- populationen, bestemt ved den radiologiske undersøgelse, er sammenfattet i tabel 3: 
The overall PFS and OS, observed in the ITT population, as determined by the core radiology laboratory assessment, are summarised in Table 3.
- 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. 
- 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.
Kramper er set hos patienter med eller uden radiologiske tegn på hjernemetastaser (se pkt. 
Seizures have been observed in patients with or without radiological evidence of brain metastases (see section
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). 
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).
• Forstyrrelser i hjernen, der kan give forskellige symptomer som hovedpine, forvirring, kramper og synstab (reversibel posterior leukoencefalopati syndrom). 
• Abnormal changes in the brain that can cause a collection of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Alvorlige reaktioner i hud og/eller slimhinder (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og erythema multiforme). 
• Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Fortæl det til lægen, hvis der opstår blødninger under behandlingen med Sutent. 
Tell your doctor if you have any bleeding while on treatment with Sutent.
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. 
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.
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. 
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.
Ved 5-årsopfølgning i forlængelsesstudiet viste OS en hazard ratio på 0,730 (95% CI 0,504; 1,057). 
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).
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). 
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).
I tilfælde af fisteldannelse skal behandlingen med sunitinib afbrydes. 
If fistula formation occurs, sunitinib treatment should be interrupted.