natgillin/translations-raw huggingface dataset:
Der er set stigninger i serumlipase- og amylaseaktivitet hos patienter med forskellige solide tumorer i behandling med sunitinib.
Increases in serum lipase and amylase activities were observed in patients with various solid tumours who received sunitinib.
Der blev observeret tilfælde af lungeemboli hos ca. 3,1% af patienterne med GIST og hos ca. 1,2% af patienterne med mRCC i behandling med sunitinib i fase 3 studierne.
Cases of pulmonary embolism were observed in approximately 3.1% of patients with GIST and in approximately 1.2% of patients with MRCC, who received sunitinib in Phase 3 studies.
Tabel 2 - Sammenfatning af effekt-endepunkter for GIST (ITT-populationen) Dobbeltblind behandling
GIST summary of efficacy endpoints (ITT population) Double-blind treatment a
Forlænget QTc-interval til over 500 msek sås hos 0,5%, og ændringer med mere end 60 msek fra baseline sås hos 1,1% af de 450 patienter med solide tumorer.
Increases in the QTc interval to over 500 msec were reported in 0.5%, and changes from baseline in excess of 60 msec were reported in 1.1% of the 450 solid tumour patients; both of these parameters are recognised as potentially significant changes.
Fortæl det til lægen, hvis du får nogle af disse symptomer eller alvorlige blødninger under behandlingen med Sutent: smertende, udspilet mave, kaster blod op, sort, klistret afføring, blod i urinen, hovedpine eller ændret sindstilstand, ophostning af blod eller blodigt opspyt fra lunger eller luftveje.
Tell your doctor if you have any of these symptoms or a serious bleeding problem during treatment with Sutent: painful, swollen stomach (abdomen); vomiting blood; black, sticky stools; bloody urine; headache or change in your mental status; coughing up of blood or bloody sputum from the lungs or airway.
Der sås reduktion af maternel vægstigning under drægtighed og diegivning ved >1 mg/kg/dag, men der sås ikke maternel reproduktionstoksisitet ved doser op til 3 mg/kg/dag (estimeret eksponering > 2,3 gange AUC hos patienter behandlet med ADD).
Maternal body weight gains were reduced during gestation and lactation at ≥ 1 mg/kg/day but no maternal reproductive toxicity was observed up to 3 mg/kg/day (estimate exposure ≥ 2.3 times the AUC in patients administered the RDD).
Der blev udført populationsfarmakokinetiske analyser af et puljet datasæt fra voksne patienter med GIST og solide tumorer, og pædiatriske patienter med solide tumorer.
Population PK analyses of a pooled dataset from adult patients with GIST and solid tumours and paediatric patients with solid tumours were completed.
To patienter (<1%), som fik sunitinib, blev diagnosticeret med kronisk hjerteinsufficiens (CHF).
Two patients (< 1%) who received sunitinib were diagnosed with CHF.
De hyppigste behandlingsrelaterede bivirkninger var diarré, kvalme, nedsat leukocyttal, neutropeni og hovedpine hos 3 (50,0 %) af patienterne primært af alvorlighedsgrad 1 eller 2.
The most frequent adverse drug reactions were diarrhoea, nausea, WBC count decreased, neutropenia, and headache in 3 (50.0%) patients each, primarily Grade 1 or 2 in severity.
Hypotyreose er indberettet som en bivirkning hos 7 patienter (4%), som fik sunitinib i de 2 cytokinrefraktære mRCC-studier; hos 61 patienter (16%) på sunitinib og hos 3 patienter (<1%) i IFN-α-armen i det behandlingsnaive mRCC-studie.
Hypothyroidism was reported as an adverse reaction in 7 patients (4%) receiving sunitinib across the 2 cytokine-refractory MRCC studies; in 61 patients (16%) on sunitinib and 3 patients (< 1%) in the IFN- arm in the treatment-naïve MRCC study.
”Hjertesvigt”, ”kronisk venstresidig hjerteinsufficiens” eller ”venstre ventrikelsvigt” blev rapporteret hos 1,2% af GIST-patienterne, der blev behandlet med sunitinib, og hos 1% af patienterne, der blev behandlet med placebo.
In GIST patients ‘cardiac failure', ‘cardiac failure congestive', or ‘left ventricular failure' were reported in 1.2% of patients treated with sunitinib and 1% of patients treated with placebo.
• Smerter i muskler og knogler, muskelsvaghed, muskeltræthed, muskelsmerter, muskelkramper.
• Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms.
Erhvervet hypotyreose er set hos 6,2% af GIST-patienterne på sunitinib versus 1% på placebo.
Acquired hypothyroidism was noted in 6.2% of GIST patients on sunitinib versus 1% on placebo.
Anvendelse af anden samtidig medicin med ingen eller minimal mulighed for at inducere eller hæmme CYP3A4 bør overvejes.
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Hos raske forsøgspersoner er eliminationshalveringstiden af sunitinib og den aktive hovedmetabolit, desethylmetabolit, henholdsvis ca. 40-60 timer og 80-110 timer efter oral indtagelse.
Following oral administration in healthy volunteers, the elimination half-lives of sunitinib and its primary active desethyl metabolite are approximately 40-60 hours and 80-110 hours, respectively.
Dosis blev reduceret hos 194 patienter (52%) i sunitinib-behandling og hos 98 patienter (27%) i IFN-α-behandling.
Dose reductions occurred in 194 patients (52%) on sunitinib and 98 patients (27%) on IFN-α.
Venøse tromboemboliske hændelser blev rapporteret hos 1 (1,2%) patient i sunitinib-armen og hos 5 (6,1%) af patienterne i placeboarmen i pNET fase 3-studiet.
Venous thromboembolic events were reported for 1 (1.2%) patient in the sunitinib arm and 5 (6.1%) patients in the placebo arm in the Phase 3 pNET study.
Hos de behandlingsnaive mRCC-patienter, der fik IFN-α, forekom 6 (2%) tromboemboliske hændelser; 1 patient (<1%) oplevede en grad 3 DVT, og 5 patienter (1%) fik lungeemboli, alle grad 4.
In treatment-naïve MRCC patients receiving IFN-, 6 (2%) venous thromboembolic events were reported; 1 patient (< 1%) experienced a Grade 3 DVT and 5 patients (1%) had pulmonary embolisms, all with Grade 4.
De fik behandling med enten sunitinib i en gentagen cyklus på 6 uger, bestående af 4 uger på 50 mg daglig oral administration, efterfulgt af 2 ugers pause (doseringsskema 4/2) eller IFN-α, administreret som en subkutan injektion 3 på hinanden ikke-følgende dage hver uge: 3 millioner enheder (MIE) den første uge, 6 MIE den anden uge og 9 MIE den tredje uge og herefter.
Seven hundred and fifty patients were randomised 1:1 to the treatment arms; they received treatment with either sunitinib in repeated 6-week cycles, consisting of 4 weeks of 50 mg daily oral administration followed by 2 weeks of rest (Schedule 4/2), or IFN-α, administered as a subcutaneous injection of 3 million units (MU) the first week, 6 MU the second week, and 9 MU the third week and thereafter, on 3 nonconsecutive days each week.
De hyppigste bivirkninger var gastrointestinal toksicitet, neutropeni, træthed og forhøjet niveau af ALAT.
The most common adverse drug reactions were gastrointestinal (GI) toxicity, neutropenia, fatigue, and ALT elevation.
Behandling med sunitinib bør seponeres hos patienter med nefrotisk syndrom.
Discontinue sunitinib in patients with nephrotic syndrome.
• Smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, følelsesløshed eller tyngdefornemmelse i kæben, løse tænder.
• 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.
Median OS i ITT-populationen var 72,7 uger og 64,9 uger (HR: 0,876; 95% CI: 0,679-1,129; p = 0,306) i henholdsvis sunitinib-armen og placebo-armen.
Median OS in the ITT population was 72.7 weeks and 64.9 weeks (HR: 0.876; 95% CI: 0.679, 1.129; p=0.306), in the sunitinib and placebo arms, respectively.
Administration af sunitinib sammen med potente CYP3A4-induktorer (f.eks. dexamethason, phenytoin, carbamazepin, rifampin, phenobarbital eller naturlægemidler som indeholder perikon/Hypericum perforatum) kan nedsætte koncentrationen af sunitinib.
Administration of sunitinib with potent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort/Hypericum perforatum) may decrease sunitinib concentrations.
Disse gastrointestinale bivirkninger kan kræve understøttende behandling, som omfatter lægemidler med antiemetiske, obstiperende eller syreneutraliserende egenskaber.
Supportive care for gastrointestinal adverse reactions requiring treatment may include medicinal products with antiemetic, antidiarrhoeal, or antacid properties.
Tal med din læge, hvis du har spørgsmål om, hvordan Sutent virker, eller hvorfor denne medicin er ordineret til dig.
If you have any questions about how Sutent works or why this medicine has been prescribed for you, ask your doctor.
• Nedbrydning af svulst, som kan give hul i tarmene (perforation).
• Tumour destruction leading to hole in the intestine (perforation).
Det EMA har dispenseret fra kravet om at fremlægge resultaterne af studier med Sutent i alle undergrupper af den pædiatriske population ved behandling af nyre- eller nyrebækken-karcinom (eksklusive nefroblastom, nefroblastomatose, clear cell-sarkom, mesoblastisk nefrom, renalt medullært karcinom og rabdoid tumor i nyrerne) (se pkt.
The EMA has waived the obligation to submit the results of studies with Sutent in all subsets of the paediatric population for the treatment of kidney or renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma, and rhabdoid tumour of the kidney) (see section 4.2).
Justering af initialdosis er ikke nødvendig, når sunitinib anvendes til patienter med nedsat nyrefunktion (mild-alvorlig) eller med nyresygdom i slutstadiet i hæmodialyse.
No starting dose adjustment is required when administering sunitinib to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on haemodialysis.
Anæmi optræder både initialt og senere under behandlingen med sunitinib.
Anaemia has been observed to occur early as well as late during treatment with sunitinib.
Et pivotalt fase 3, multicenter, internationalt, randomiseret, dobbeltblindt, placebo-kontrolleret studie med monoterapi med sunitinib blev gennemført på patienter med inoperabel pNET.
A pivotal Phase 3, multi-centre, international, randomised, double-blind, placebo-controlled study of single-agent sunitinib was conducted in patients with unresectable pNET.
Der er rapporteret fald i blodglucose under behandling med sunitinib, i nogle tilfælde med kliniske symptomer, som krævede hospitalsindlæggelse på grund af bevidstløshed.Ved symptomatisk hypoglykæmi skal sunitinib-behandlingen afbrydes midlertidigt.
Decreases in blood glucose, in some cases clinically symptomatic and requiring hospitalisation due to loss of consciousness, have been reported during sunitinib treatment.
• Smertefulde sår på huden (gangrænøs pyoderma).
• Painful skin ulceration (pyoderma gangrenosum).
Fortæl det til lægen, hvis du får nogle af de følgende symptomer på leverproblemer under behandlingen med Sutent: kløe, gulfarvning af øjne eller hud, mørk urin, eller smerter og ubehag i den øvre højre side af maven.
Tell your doctor if you develop any of the following signs and symptoms of liver problems during Sutent treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area.
1 patient med lungeemboli i studiet med cytokin-refraktære mRCC-patienter fik afbrudt behandlingen.
One patient with pulmonary embolism in the cytokine-refractory MRCC study experienced dose interruption.
• Betændelse i galdeblæren med eller uden galdesten.
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
Meget almindelige: hos flere end 1 ud af 10 personer
Very common: may affect more than 1 in 10 people
Pædiatrisk population Erfaringen med anvendelse af sunitinib hos pædiatriske patienter er begrænset (se pkt.
Paediatric population Experience on the use of sunitinib in paediatric patients is limited (see section 4.2).
kvalme, opkastning, diarré, forstoppelse, mavesmerter/udspiling af maven, nedsat appetit.
nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/decrease of appetite.
Sunitinib viste en klinisk signifikant fordel i investigator-vurderet PFS i forhold til placebo.
A clinically significant advantage in investigator-assessed PFS for sunitinib over placebo was observed.
Den genotoksiske virkning af den aktive hovedmetabolit er ikke vurderet.
The major active metabolite was not evaluated for genotoxic potential.
Justering af initialdosis er ikke nødvendig, når sunitinib anvendes til patienter med mildt eller moderat nedsat leverfunktion (Child-Pugh klasse A og B).
No starting dose adjustment is recommended when administering sunitinib to patients with mild or moderate (Child-Pugh class A and B) hepatic impairment.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Sutent i alle undergrupper af den pædiatriske population ved behandling af neuroendokrine gastroentero-pankreatiske tumorer (eksklusive neuroblastom, neuroganglioblastom og fæokromocytom (se pkt.
The EMA has waived the obligation to submit the results of the studies with Sutent in all subsets of the paediatric population for the treatment of gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, and phaeochromocytoma) (see section 4.2).
Reproduktionstoksicitet og udviklingstoksicitet
Reproductive and developmental toxicity
Der er ikke udført egentlige studier på sunitinib-behandlingens indflydelse på sårheling.
No formal clinical studies of the effect of sunitinib on wound healing have been conducted.
Hos raske forsøgspersoner medførte samtidig administration af en enkeltdosis af sunitinib og den potente CYP3A4-hæmmer, ketoconazol, en stigning i samlet (sunitinib + primær metabolit) maksimal koncentration (Cmax) og arealet under kurven (AUC0-) værdi på henholdsvis 49% og 51%.
In healthy volunteers, concomitant administration of a single dose of sunitinib with the potent CYP3A4 inhibitor ketoconazole resulted in an increase of the combined [sunitinib + primary metabolite] maximum concentration (Cmax) and area under the curve (AUC0-) values of 49% and 51%, respectively.
Risikofaktorer relateret til nedsat nyrefunktion/nyresvigt hos patienter i behandling med sunitinib, udover underliggende RCC, omfatter høj alder, diabetes mellitus, underliggende nedsat nyrefunktion, hjertesvigt, hypertension, sepsis, dehydrering/hypovolæmi og Rabdomyolyse.
Risk factors associated with renal impairment/failure in patients receiving sunitinib included, in addition to underlying RCC, older age, diabetes mellitus, underlying renal impairment, cardiac failure, hypertension, sepsis, dehydration/hypovolaemia, and rhabdomyolysis.
• Mundsmerter/-irritation, mundsår/-betændelse/-tørhed, smagsforstyrrelser, mavebesvær,
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset stomach,
Thyroideadysfunktion
Thyroid dysfunction
I fase 3 pNET-studiet er der rapporteret om hypotyreose hos 6 patienter (7,2%), som fik sunitinib, og hos 1 patient (1,2%), som fik placebo.
In the Phase 3 pNET study hypothyroidism was reported in 6 patients (7.2%) receiving sunitinib and in 1 patient (1.2%) on placebo.
Hypotyreose kan opstå både tidligt og sent i behandlingen med sunitinib (se pkt.
Hypothyroidism has been observed to occur early as well as late during treatment with sunitinib (see section 4.8).
Der er rapporteret om alvorlige tilfælde af pankreatitis, nogle letale.
Cases of serious pancreatic events, some with fatal outcome, have been reported.
Ved sygdomsprogression blev randomiseringskoden brudt, og placebo-patienter fik tilbudt ublindet behandling med sunitinib i et særskilt forlængelsesstudie.
Upon disease progression, patients were unblinded and placebo patients were offered access to open-label sunitinib in a separate extension study.
Behandlingsrelaterede venøse tromboemboliske hændelser er rapporteret hos patienter, som blev behandlet med sunitinib herunder dyb venetrombose og lungeemboli (se pkt.
Treatment-related venous thromboembolic events were reported in patients who received sunitinib including deep venous thrombosis and pulmonary embolism (see section 4.8).
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne, som er angivet i pkt.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hvis der opstår angioødem på grund af overfølsomhed, afbrydes sunitinibbehandlingen, og standardbehandling iværksættes (se pkt.
If angioedema due to hypersensitivity occurs, sunitinib treatment should be interrupted and standard medical care provided (see section 4.8).
- Svulster i bugspytkirtlen (i de hormonproducerende celler) (pNET), som er fremadskreden eller ikke kan opereres
- Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery.
I kliniske studier forekom fald i venstre ventrikels ejektionsfraktion (LVEF) på  20% og under den nedre referenceværdi hos ca. 2% af sunitinib-behandlede GIST-patienter, hos 4% af cytokinrefraktære mRCC-patienter og hos 2% af placebobehandlede GIST-patienter.
In clinical trials, decreases in left ventricular ejection fraction (LVEF) of  20% and below the lower limit of normal were reported in approximately 2% of sunitinib-treated GIST patients, 4% of cytokine-refractory MRCC patients, and 2% of placebo-treated GIST patients.
Nedsat absolut neutrofiltal henholdsvis af sværhedsgrad 3 og 4 er rapporteret hos 10% og 1,7% af patienterne i fase 3 GIST-studiet, hos 16% og 1,6% af patienterne i fase 3 mRCC-studiet og hos 13% og 2,4% af patienterne i fase 3 pNET-studiet.
Decreased absolute neutrophil counts of Grade 3 and 4 severities, respectively, were reported in 10% and 1.7% of patients on the Phase 3 GIST study, in 16% and 1.6% of patients on the Phase 3 MRCC study, and in 13% and 2.4% of patients on the Phase 3 pNET study.
• GIST eller kræft i nyrerne (MRCC), er den sædvanlige dosis 50 mg 1 gang dagligt i 28 dage (4 uger), efterfulgt af en pause på 14 dage (2 uger) (uden medicin).
− GIST or MRCC: the usual dose is 50 mg once daily taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine), in 6-week cycles.
I et 2-års karcinogenicitetsstudier i rotter (0, 0,33, 1, eller 3 mg/kg/dag) resulterede administration af sunitinib i cykli på 28 dage efterfulgt af en 7-dages doseringsfri periode i en øgning af fæokromocytom og binyremarvhyperplasi hos hanrotter, der fik 3 mg/kg/dag efter > 1 års dosering (> 7,8 gange AUC hos patienter behandlet med ADD).
In a 2-year rat carcinogenicity study (0, 0.33, 1, or 3 mg/kg/day), administration of sunitinib in 28-day cycles followed by 7-day dose-free periods resulted in increases in the incidence of phaeochromocytomas and hyperplasia in the adrenal medulla of male rats given 3 mg/kg/day following > 1 year of dosing (≥ 7.8 times the AUC in patients administered the RDD).
Der er rapporteret om tilfælde af fisteldannelse, i nogle tilfælde ledsaget af tumornekrose og regression, i nogle tilfælde med letal udgang (se pkt.
Cases of fistula formation, sometimes associated with tumour necrosis and regression, in some cases with fatal outcomes, have been reported (see section 4.4).
Venstre ventrikelsvigt Torsades de pointes
Left ventricular failure*
Virkning og anvendelse Det skal du vide før du begynder at tage Sutent Sådan skal du tage Sutent Bivirkninger
What Sutent is and what it is used for What you need to know before you take Sutent How to take Sutent
Fortæl det til lægen, hvis du føler dig meget træt, har vejtrækningsbesvær (stakåndethed) eller hævede ankler eller fødder.
Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles.
Forkortelser: CI=konfidensinterval; N=antal patienter; PFS=progressionsfri overlevelse; pNET= neuroendokrine tumorer i pancreas.
Abbreviations: CI=confidence interval; N=number of patients; PFS=progression-free survival; pNET=pancreatic neuroendocrine tumours.
Median OS var 114,6 uger for sunitinib-armen (95% CI: 100,1-142,9) og 94,9 uger for IFN-α-armen (95% CI: 77,7-117,0) med hazard ratio 0,821 (95% CI: 0,673-1,001; p = 0,0510 ved ustratificeret logrank).
The median OS was 114.6 weeks for the sunitinib arm (95% CI: 100.1, 142.9) and 94.9 weeks for the IFN-α arm (95% CI: 77.7, 117.0) with a hazard ratio of 0.821 (95% CI: 0.673, 1.001; p=0.0510 by unstratified log-rank).
Nedsat antal hvide blodlegemer Forhøjet lipase Nedsat antal trombocytter Nedsat hæmoglobin Forhøjet amylase Forhøjet aspartataminotransferase Forhøjet alaninaminotransferase Forhøjet blodkreatinin
Aspartate aminotransferase increased Alanine aminotransferase increased Blood creatinine increased Blood pressure increased Blood uric acid increased
Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
If you get any side effects, talk to your doctor.
Nedsat trombocyttal af henholdsvis sværhedsgrad 3 og 4 er rappporteret hos 3,7% og 0,4 % af patienterne i fase 3-GIST-studiet, hos 8,2% og 1,1% af patienterne i fase 3 mRCC-studiet og hos 3,7% og 1,2% af patienterne i fase 3 pNET-studiet (se pkt.
Decreased platelet counts of Grade 3 and 4 severities, respectively, were reported in 3.7% and 0.4% of patients on the Phase 3 GIST study, in 8.2% and 1.1% of patients on the Phase 3 MRCC study, and in 3.7% and 1.2% of patients on the Phase 3 pNET study (see section 4.4).
Forkortelser: CI=konfidensinterval; ITT=intent to treat; NA=ikke relevant; ORR=objektiv responsrate; OS=samlet overlevelse ; PFS= progressions-fri overlevelse; TTP=tidspunkt til tumorprogression.
Abbreviations: CI=confidence interval; ITT=intent-to-treat; NA=not applicable; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; TTP=time-to-tumour progression.
Behandlingen blev afbrudt hos 202 patienter (54%) i sunitinib-behandling og hos 141 patienter (39%) i IFN-α-behandling.
Dose interruptions occurred in 202 patients (54%) on sunitinib and 141 patients (39%) on IFN-α.
Hypertension blev rapporteret hos 26,5% af de patienter, som fik sunitinib i et fase 3 pNET-studie, og hos 4,9% af de patienter, der fik placebo.
Hypertension was reported in 26.5% of patients receiving sunitinib in a Phase 3 pNET study, compared to 4.9% of patients receiving placebo.
Hvis du tager blodfortyndende medicin som warfarin eller coumarin, har du en større risiko for blødninger.
If you are taking warfarin or acenocoumarole, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
• Brændende eller smertende fornemmelse i tungen, betændelseslignende reaktion i mave tarmkanalens slimhinde, for meget luft i maven eller tarmene.
• Burning or painful sensation in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine.
39% af de patienter, der fik sunitinib for tidligere ubehandlet mRCC, fik blødningsepisoder sammenlignet med 11% af de patienter, der fik interferon-α (IFN-α).
In patients receiving sunitinib for treatment-naïve MRCC, 39% had bleeding events vs 11% of patients receiving interferon- (IFN-α).
Af forsigtighedsmæssige årsager anbefales det at afbryde behandlingen med sunitinib midlertidigt hos patienter, der skal have foretaget større kirurgiske indgreb.
Temporary interruption of sunitinib therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Ved symptomer på pankreatitis, bør behandling med sunitinib seponeres, og patienterne bør have relevant medicinsk behandling.
If symptoms of pancreatitis are present, patients should have sunitinib discontinued and be provided with appropriate supportive care.