natgillin/translations-raw huggingface dataset:
The clinical safety and efficacy of sunitinib has been studied in the treatment of patients with GIST who were resistant to imatinib (i.e., those who experienced disease progression during or following treatment with imatinib) or intolerant to imatinib (i.e., those who experienced significant toxicity during treatment with imatinib that precluded further treatment), the treatment of patients with MRCC, and the treatment of patients with unresectable pNET. 
Klinično varnost in učinkovitost sunitiniba so raziskali pri zdravljenju bolnikov z GIST, ki so bili odporni proti imatinibu (tj. jim je bolezen med zdravljenjem z imatinibom ali po njem napredovala) ali imatiniba niso prenašali (tj. so med zdravljenjem z njim imeli pomembne toksične učinke, ki so preprečili nadaljnjo zdravljenje), zdravljenju bolnikov z MRCC in zdravljenju bolnikov s 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. 
Pri bolnikih, ki so prejemali sunitinib v registracijskih študijah 3. faze, so o pljučnih dogodkih (tj. dispneji, plevralnem izlivu, pljučni emboliji ali pljučnem edemu) poročali pri približno 17,8 % bolnikov z GIST, pri približno 26,7 % bolnikov z MRCC in pri 12 % bolnikov s pNET.
In some cases of suspected EM, patients tolerated the reintroduction of sunitinib therapy at a lower dose after resolution of the reaction; some of these patients also received concomitant treatment with corticosteroids or antihistamines (see section 4.8). 
V nekaterih primerih suma na EM so bolniki po izginotju reakcije prenašali ponovno uvedbo zdravljenja s sunitinibom v manjših odmerkih; nekateri od teh bolnikov so sočasno prejemali tudi kortikosteroide in antihistaminike (glejte poglavje 4.8).
Quartile (95% CI) 
Kvartil (95 % IZ)
In addition, the publications reported the following Grade 3 adverse drug reactions experienced by 5 patients: fatigue (2), gastrointestinal adverse drug reactions (including diarrhoea) (2), haematologic adverse drug reactions (including anaemia) (2), cholecystitis (1), hyperthyroidism (1), and mucositis (1). 
Poleg tega so v objavah poročali o naslednjih neželenih učinkih zdravila 3. stopnje, ki so se pojavili pri 5 bolnikih: utrujenost (2), gastrointestinalni neželeni učinki zdravila (vključno z diarejo) (2), hematološki neželeni učinki zdravila (vključno z anemijo) (2), holecistitis (1), hipertiroidizem (1) in mukozitis (1).
- Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery. 
- Nevroendokrini tumorji trebušne slinavke (pNET) (tumorji celic trebušne slinavke, ki izločajo hormone), ki so napredovali ali jih ni mogoče odstraniti z operacijo.
• High level of uric acid in the blood. 
• visoka raven sečne kisline v krvi
In a pancreatic islet cell tumour cohort of 66 patients, the primary endpoint of response rate was 17%. 
V kohorti 66 bolnikov s tumorjem otočkov trebušne slinavke je primarni opazovani dogodek odziva na zdravljenje znašal 17 %.
• Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA). 
• poškodbe najmanjših krvnih žil, znane kot trombotična mikroangiopatija (TMA)
Among age and bodysize related covariates tested, age was a significant covariate on apparent clearance of sunitinib (the younger the age of the paediatric patient, the lower the apparent clearance). 
Med testiranimi sospremenljivkami, povezanimi s starostjo in velikostjo telesa, je bila starost pomembna sospremenljivka navideznega očistka sunitiniba (nižja kot je bila starost pediatričnega bolnika, manjši je bil navidezni očistek).
For pNET, the recommended dose of Sutent is 37.5 mg taken orally once daily without a scheduled rest period. 
Pri pNET priporočeni odmerek zdravila Sutent znaša 37,5 mg peroralno enkrat na dan, brez načrtovanega premora.
In clinical trials, tumour haemorrhage was reported in approximately 2% of patients with GIST. 
V kliničnih preskušanjih so o krvavitvah tumorjev poročali pri približno 2 % bolnikov z GIST.
Safety and tolerability 
Varnost in prenašanje
Four of these 7 GIST patients discontinued treatment following first observation of DVT. 
Pri 4 od teh 7 bolnikov z GIST so zdravljenje prekinili po prvih znakih globoke venske tromboze.
• Painful skin ulceration (pyoderma gangrenosum). 
• boleče razjede na koži (gangrenozna pioderma)
- If you have or have had blood disease, bleeding problems, or bruising. 
- Če imate ali ste imeli krvno bolezen, težave s krvavitvami ali modrice.
Kaplan-Meier plot of PFS in the pNET Phase 3 study 
Slika 1 - Kaplan-Meierjev graf preživetja brez napredovanja bolezni (PFS) v študiji 3. faze pri pNET
In the second part of the study, including patients with prior anticancer therapy but without risk factors for cardiac toxicity, sunitinib was generally tolerable and clinically manageable at the dose of 15 mg/m daily (MTD) on Schedule 4/2. 
V drugem delu študije, ki je vključevala bolnike, ki so predhodno prejemali zdravila za zdravljenje raka in niso imeli dejavnikov tveganja za kardiotoksičnost, so bolniki sunitinib na splošno dobro prenašali in je bil klinično obvladljiv v odmerku 15 mg/m2 na dan (MTD) pri shemi 4/2.
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). 
Neželeni učinki, opisani pri bolnikih z GIST, MRCC in pNET s skupnim naborom 7.115 bolnikov, so našteti spodaj po organskih sistemih, pogostnosti in stopnji izraženosti (po merilu NCI-CTCAE).
• Deficiency of blood supply to the heart muscle, due to obstruction or constriction of the coronary arteries. 
• oviran dotok krvi v srčno mišico zaradi zamašitve ali zožitve srčnih arterij
Ninety-seven patients were enrolled at various doses and schedules; 55 patients received 50 mg at the recommended treatment Schedule 4 weeks on /2 weeks off (“Schedule 4/2”). 
Vključenih je bilo 97 bolnikov z različnimi odmerki in shemami; 55 bolnikov je prejemalo 50 mg po priporočeni terapevtski shemi 4 tedne da / 2 tedna ne (''shema 4/2'').
Cases of ONJ have been reported in patients treated with Sutent, most of which occurred in patients who had identified risk factors for ONJ, in particular, exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4). 
Pri bolnikih, zdravljenih z zdravilom Sutent, so poročali o primerih osteonekroze čeljustnic, večinoma pri bolnikih s prisotnimi znanimi dejavniki tveganja za osteonekrozo čeljustnic, zlasti izpostavljenost intravenskim bisfosfonatom in/ali anamneza zobne bolezni, ki je zahtevala invazivne zobozdravstvene posege (glejte tudi poglavje 4.4).
In this analysis, the placebo arm included those patients randomised to placebo who subsequently received open-label sunitinib treatment. 
V tej analizi skupina s placebom vključuje tudi tiste randomizirane bolnike s placebom, ki so v odprti študiji naknadno prejeli zdravljenje s sunitinibom.
What Sutent looks like and contents of the pack 
Izgled zdravila Sutent in vsebina pakiranja
Cases of arterial thromboembolic events (ATE), sometimes fatal, have been reported in patients treated with sunitinib. 
Poročali so o primerih arterijskih trombemboličnih dogodkov (ATE - arterial thromboembolic events), včasih s smrtnim izidom, pri bolnikih, ki so se zdravili s sunitinibom.
Sunitinib and its primary metabolite are mainly metabolised by the liver. 
Sunitinib in njegov primarni presnovek se pretežno presnavljata v jetrih.
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. 
Bolnike je treba med zdravljenjem s sunitinibom skrbno spremljati glede kliničnih znakov in simptomov CHF, zlasti bolnike s srčnimi dejavniki tveganja in/ali anamnezo koronarne bolezni.
There were 9 deaths in the sunitinib arm and 21 deaths in the placebo arm. 
V skupini, ki je prejemala sunitinib, je bilo 9 primerov smrti, 21 primerov smrti pa je bilo v skupini, ki je prejemala placebo.
The long-term safety of sunitinib in patients with MRCC was analysed across 9 completed clinical studies conducted in the first-line, bevacizumab-refractory, and cytokine-refractory treatment settings in 5,739 patients, of whom 807 (14%) were treated for ≥ 2 years up to 6 years. 
Dolgoročno varnost sunitiniba pri bolnikih z MRCC so analizirali v 9 dokončanih kliničnih študijah, izvedenih v okviru prve linije zdravljenja MRCC, odpornega proti bevacizumabu, in zdravljenja MRCC, odpornega proti citokinom, pri 5.739 bolnikih, od katerih se je 807 (14 %) zdravilo ≥ 2 leti do največ 6 let.
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). 
Celokupno preživetje, opaženo po 5-letnem spremljanju bolnikov v razširjeni študiji, je pokazalo razmerje ogroženosti 0,730 (95 % IZ: 0,504, 1,057).
High-density polyethylene (HDPE) bottle with a polypropylene closure containing 30 hard capsules. 
Plastenka iz polietilena visoke gostote (HDPE) s polipropilensko zaporko, ki vsebuje 30 trdih kapsul.
At approximately twice therapeutic concentrations, sunitinib has been shown to prolong the QTcF interval (Fridericia corrected QT interval). 
Dokazali so, da sunitinib v približno dvakratni terapevtski koncentraciji podaljša interval QTcF (interval QT s popravkom Fridericia).
Medicinal products that may decrease sunitinib plasma concentrations Effect of CYP3A4 inducers 
Zdravila, ki lahko zmanjšajo koncentracijo sunitiniba v plazmi Učinek induktorjev CYP3A4
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. 
Nemudoma obvestite zdravnika, če dobite simptome, kot so bolečine v prsnem košu ali pritisk, bolečine v rokah, hrbtu, vratu ali čeljusti, zasoplost, odrevenelost ali šibkost na 1 strani telesa, težave z govorom, glavobol ali vrtoglavico med zdravljenjem z zdravilom Sutent.
Risk factors for TLS include high tumour burden, pre-existing chronic renal insufficiency, oliguria, dehydration, hypotension, and acidic urine. 
Med dejavnike tveganja za TLS sodijo velika tumorska masa, obstoječa kronična ledvična insuficienca, oligurija, dehidracija, hipotenzija in kisel urin.
The difference in overall survival (OS) was statistically in favour of sunitinib [hazard ratio (HR): 0.491; (95% CI: 0.290, 0.831)]; the risk of death was 2 times higher in patients in the placebo arm compared to the sunitinib arm. 
Razlika v celokupnem preživetju je bila statistično v prid sunitinibu [razmerje ogroženosti (HR - hazard ratio): 0,491; 95 % IZ: 0,290-0,831]; tveganje za smrt je bilo v skupini s placebom 2-krat večje kot v skupini s sunitinibom.
Evidence from a Phase 1/2 study of oral sunitinib conducted in 6 paediatric patients with GIST aged 13 years to 16 years who received sunitinib on Schedule 4/2, at doses ranging between 15 mg/m daily and 30 mg/m daily, and available published data (20 paediatric or young adult patients with GIST) indicated that sunitinib treatment resulted in disease stabilization in 18 of 26 (69.2%) patients, either after imatinib failure or intolerance (16 patients with stable disease out of 21), or de novo/after surgery (2 patients with stable disease out of 5). 
faze s peroralnim sunitinibom, ki je potekala pri 6 pediatričnih bolnikih z GIST, starih od 13 let do 16 let, ki so prejemali sunitinib po shemi 4/2 v odmerkih v razponu med 15 mg/m na dan in 30 mg/m na dan, ter razpoložljivi objavljeni podatki (pri 20 pediatričnih ali mlajših odraslih bolnikih z GIST) so pokazali, da je zdravljenje s sunitinibom stabiliziralo bolezen pri 18 od 26 (69,2 %) bolnikov, bodisi po neuspešnem zdravljenju z imatinibom ali neprenašanju imatiniba (16 bolnikov s stabilno boleznijo od 21 bolnikov) ali pri bolezni de novo/po kirurškem posegu (2 bolnika s stabilno boleznijo od 5 bolnikov).
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). 
V tej študiji so312 bolnikov randomizirali (2:1) na peroralno uporabo 50 mg sunitiniba ali placeba enkrat na dan po shemi 4/2; bolnike so spremljali do napredovanja bolezni ali do umika iz študije zaradi kakšnega drugega razloga (sunitinib je prejemalo 207 bolnikov in placebo 105 bolnikov).
Cases of hepatic failure, some with a fatal outcome, were observed in < 1% of solid tumour patients treated with sunitinib. 
Primere odpovedi delovanja jeter, nekatere s smrtnim izidom, so opažali pri < 1 % bolnikov s čvrstimi tumorji, ki so se zdravili s sunitinibom.
In this study the objective response rate was 36.5% (95% CI: 24.7%, 49.6%) and the median TTP was 37.7 weeks (95% CI: 24.0, 46.4). 
V tej študiji je objektivni odziv na zdravljenje znašal 36,5 % (95 % IZ: 24,7 %; 49,6 %) in mediani TTP 37,7 tedna (95 % IZ: 24,0; 46,4).
Cases of serious pancreatic events, some with fatal outcome, have been reported. 
Opisali so primere resnih pankreatičnih pojavov, včasih s smrtnim izidom.
Furthermore, based on an integrated population PK analysis of pooled data from the 3 paediatric studies (2 paediatric solid tumour studies and 1 paediatric GIST study; ages: 6 years to 11 years and 12 years to 17 years), baseline body surface area (BSA) was a significant covariate on apparent clearance of sunitinib and its active metabolite. 
Nadalje je bila na podlagi celovite populacijske FK analize združenih podatkov iz 3 pediatričnih študij (2 študij pri pediatričnih bolnikih s čvrstimi tumorji in 1 študije pri pediatričnih bolnikih z GIST; starost od 6 let do 11 let in od 12 let do 17 let) izhodiščna telesna površina (BSA - body surface area) pomembna sospremenljivka navideznega očistka sunitiniba in njegovega aktivnega presnovka.
• Infections. 
• okužbe
Treatment-related venous thromboembolic events were reported in approximately 1.0% of patients with solid tumours who received sunitinib on clinical trials, including GIST and RCC. 
Z zdravljenjem povezane venske trombembolične dogodke so zabeležili pri približno 1,0 % bolnikov s čvrstimi tumorji, ki so prejemali sunitinib v kliničnih preskušanjih, vključno z GIST in RCC.
In clinical studies of sunitinib and from postmarketing surveillance, seizures have been reported. 
V kliničnih študijah s sunitinibom in med nadzorom v obdobju trženja zdravila so poročali o konvulzijah.
Prolonged treatment with sunitinib did not appear to be associated with new types of TRAEs. 
Podaljšano zdravljenje s sunitinibom ni bilo povezano z novimi vrstami z zdravljenjem povezanih neželenih učinkov.
Sutent may affect the way your wounds heal. 
Zdravilo Sutent lahko vpliva na celjenje vaših ran.
You should not breast-feed during treatment with Sutent. 
Med zdravljenjem z zdravilom Sutent ne smete dojiti.
Using comprehensive serial ECG assessments at times corresponding to either therapeutic or greater than therapeutic exposures, none of the patients in the evaluable or intent-to-treat (ITT) populations were observed to develop QTc interval prolongation considered as “severe” (i.e. equal to or greater than Grade 3 by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0). 
Med tem ovrednotenjem pri nobenem bolniku v ocenljivi populaciji ali populaciji z-namenom-zdravljenja (ITT - Intent-To-Treat) niso opazili podaljšanja intervala QTc, ki bi veljalo za ''hudo'' (tj. enako ali večje od stopnje 3 po merilih za poenoteno terminologijo neželenih dogodkov [CTCAE - Common Terminology Criteria for Adverse Events], različica 3.0).
Temporary suspension of sunitinib is recommended; following resolution, treatment may be resumed at the discretion of the treating physician (see section 4.8). 
Priporočljiva je začasna prekinitev uporabe sunitiniba; po izboljšanju stanja je mogoče zdravljenje po presoji lečečega zdravnika znova uvesti (glejte poglavje 4.8).
CYP3A4 inhibitors/inducers 
Zaviralci/induktorji CYP3A4
If you might get pregnant, you should use a reliable method of contraception during treatment with Sutent. 
Če lahko zanosite, morate med zdravljenjem z zdravilom Sutent uporabljati učinkovito kontracepcijo.
Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations. 
Uporaba sunitiniba z močnimi zaviralci CYP3A4 (npr. z ritonavirjem, itrakonazolom, eritromicinom, klaritromicinom, sokom grenivke) lahko zviša koncentracijo sunitiniba.
• Burning or painful sensation in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine. 
• pekoč ali boleč občutek v jeziku, vnetje sluznice prebavnega trakta, prekomerna količina plinov v želodcu ali črevesu
• Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms. 
• mišično-skeletna bolečina (bolečina v mišicah in kosteh), šibkost mišic, utrujenost mišic,
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. 
Bolniki s konvulzijami in znaki oz. simptomi, ki se skladajo s sindromom reverzibilne posteriorne levkoencefalopatije (RPLS - reversible posterior leukoencephalopathy syndrome), npr. hipertenzijo, glavobolom, zmanjšano pozornostjo, duševnimi motnjami in prizadetostjo vida (vključno s kortikalno slepoto), potrebujejo medicinski nadzor, ki naj obsega tudi obvladovanje hipertenzije.
Poly(chlorotrifluoroethylene)/PVC transparent perforated unit dose blister with aluminium foil coated with heat seal lacquer containing 28 x 1 hard capsules. 
Prozorni perforirani enoodmerni pretisni omot iz poliklorotrifluoretilena/PVC z aluminijsko folijo, prekrito z lakom za toplotno lepljenje, ki vsebuje 28 x 1 trdih kapsul.
For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability. 
Pri GIST in MRCC je odmerek mogoče prilagajati v korakih po 12,5 mg, upoštevaje varnost in prenašanje pri posameznem bolniku.
• Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability to swallow. 
• hemoroidi, bolečina v rektumu, krvavitev dlesni, težave pri požiranju ali nezmožnost požiranja
A total of 29 patients in the sunitinib arm and 24 in the placebo arm had received no prior systemic treatment; among these patients, the hazard ratio for PFS was 0.365 (95% CI: 0.156, 0.857), p=0.0156. 
Skupno 29 bolnikov v skupini, ki je prejemala sunitinib, in 24 bolnikov v skupini, ki je prejemala placebo, ni bilo deležnih nobenega predhodnega sistemskega zdravljenja; med temi bolniki je razmerje ogroženosti za PFS znašalo 0,365 (95 % IZ: 0,156, 0,857), p = 0,0156.
The safety profile of sunitinib has been derived from a Phase 1 dose-escalation study, a Phase 2 open-label study, a Phase 1/2 single-arm study and from publications as described below. 
Varnostni profil sunitiniba so pridobili iz študije s povečevanjem odmerka 1. faze, odprte študije 2. faze, študije z eno skupino 1./2.
The most common adverse drug reactions were gastrointestinal (GI) toxicity, neutropenia, fatigue, and ALT elevation. 
Najpogostejši neželeni učinki zdravila so bili gastrointestinalna toksičnost, nevtropenija, utrujenost in zvišanje ravni ALT.
Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibly related to sunitinib included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, adrenal insufficiency, pneumothorax, shock, and sudden death. 
Med dogodki s smrtnim izidom (razen naštetih v poglavju 4.4 zgoraj ali v poglavju 4.8 spodaj), ki so jih ocenili kot morda povezane s sunitinibom, so bili: odpoved več organov, diseminirana intravaskularna koagulacija, peritonealna krvavitev, adrenalna insuficienca, pnevmotoraks, šok in nenadna smrt.
The median PFS was 11.4 months for the sunitinib arm compared to 5.5 months for the placebo arm [hazard ratio: 0.418 (95% CI: 0.263, 0.662), p-value=0.0001]; similar results were observed when derived tumour response assessments based upon application of RECIST to investigator tumour measurements were used to determine disease progression, as shown in Table 4. 
Mediana vrednost PFS je znašala 11,4 meseca pri skupini, ki je prejemala sunitinib, v primerjavi s 5,5 meseci pri skupini, ki je prejemala placebo [razmerje ogroženosti: 0,418 (95 % IZ: 0,263, 0,662), vrednost p = 0,0001]; podobne rezultate so opažali, kadar so bila za določitev napredovanja bolezni uporabljena izpeljana ocenjevanja odziva tumorja, izvedena po merilih RECIST pri meritvah tumorja s strani raziskovalcev, kot je prikazano v Preglednici 4.
At the time of the prespecified interim analysis, the median TTP on sunitinib was 28.9 weeks (95% CI: 21.3, 34.1) as assessed by the investigator and 27.3 weeks (95% CI: 16.0, 32.1) as assessed by the independent review and was statistically significantly longer than the TTP on placebo of 5.1 weeks (95% CI: 4.4, 10.1) as assessed by the investigator and 6.4 weeks (95% CI: 4.4, 10.0) as assessed by the independent review. 
Pri vnaprej določeni vmesni analizi je mediani TTP s sunitinibom znašal 28,9 tedna (95 % IZ: 21,3-34,1), kot ga je ocenil raziskovalec, in 27,3 tedna (95 % IZ = 16,0-32,1), kot je bil ocenjen pri neodvisnem pregledu, in je bil statistično pomembno daljši kot TTP s placebom pri 5,1 tedna (95 % IZ: 4,4-10,1), kot ga je ocenil raziskovalec, in 6,4 tedna (95 % IZ = 4,4-10,0), kot je bil ocenjen pri neodvisnem pregledu.
Number of subjects at risk 
Razmerje ogroženosti
Patients who develop thyroid dysfunction should be treated as per standard medical practice. 
Bolnike, pri katerih se pojavi moteno delovanje ščitnice, je treba zdraviti v skladu z običajno medicinsko prakso.
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. 
Najpogostejši neželeni učinki zdravila so bili diareja, navzea, zmanjšanje števila belih krvnih celic, nevtropenija in glavobol, pri čemer se je vsak pojavil pri 3 (50,0 %) bolnikih, po resnosti pa so bili predvsem 1. ali 2. stopnje.
Therapy with Sutent should be initiated by a physician experienced in the administration of anticancer agents. 
Zdravljenje z zdravilom Sutent mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
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. 
Primere pljučne embolije so opazili pri približno 3,1 % bolnikov z GIST in približno 1,2 % bolnikov z MRCC, ki so prejemali sunitinib v študijah 3. faze.
Patients should be advised that depigmentation of the hair or skin may occur during treatment with sunitinib. 
Bolnikom je treba svetovati, da lahko med zdravljenjem s sunitinibom pride do depigmentacije las in dlak ali kože.
At approximately twice therapeutic concentrations, the maximum QTcF interval change from baseline was 15.4 msec (90% CI: 22.4 msec). 
Pri približno dvakratni terapevtski koncentraciji je bila največja sprememba intervala QTcF od izhodišča 15,4 milisekunde (90 % IZ, 22,4 milisekunde).
It may be taken with or without food. 
Bolnik lahko zdravilo vzame s hrano ali brez nje.
Hepatic dysfunction has been reported and may include Liver Function Test abnormalities, hepatitis, or liver failure (see section 4.4). 
Poročali so o nepravilnem delovanju jeter, kar lahko vključuje nenormalnosti v rezultatih testov jetrne funkcije, hepatitis ali odpoved jeter (glejte poglavje 4.4).