natgillin/translations-raw huggingface dataset:
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.
• Manglende blodtilførsel til hjertemusklen på grund af blokering eller forsnævring af kranspulsårerne.
• Deficiency of blood supply to the heart muscle, due to obstruction or constriction of the coronary arteries.
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.
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.
Bakterieinfektioner
Bacterial infectionsg
Sutent er indiceret til behandling af voksne med inoperabel eller metastaserende, veldifferentieret pankreatisk neuroendokrin tumor (pNET) med sygdomsprogression.
Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
Dette kan skyldes betændelse i bugspytkirtlen eller galdeblæren.
These may be caused by inflammation of the pancreas or gallbladder.
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.
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.
Der er ikke rapporteret lungeemboli hos pNET-patienter, som fik sunitinib, i fase 3 studiet.
No pulmonary embolism was reported for patients with pNET who received sunitinib in the Phase 3 study.
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).
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).
Samlet svarede de observerede bivirkninger til de, der blev set hos voksne (se pkt.
The observed adverse drug reactions were similar overall to those seen in adults (see section 4.8).
Objektiv responsrate [%, (95% CI)]
Objective response rate [%, (95% CI)]
Kvinder i den fertile alder skal rådes til at anvende sikker prævention og undgå graviditet under behandlingen med Sutent.
Women of childbearing potential should be advised to use effective contraception and avoid becoming pregnant while receiving treatment with Sutent.
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.
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.
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).
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).
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.
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.
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.
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-.