natgillin/translations-raw huggingface dataset:
The results of this study demonstrated that sunitinib had an effect on QTc interval (defined as a mean placebo-adjusted change of > 10 msec with a 90% confidence interval [CI] upper limit > 15 msec) at therapeutic concentration (Day 3) using the within-day baseline correction method, 
Rezultati te študije so pokazali, da sunitinib vpliva na interval QTc (opredeljeno kot povprečna, glede na placebo korigirana sprememba za > 10 milisekund in z zgornjo mejo 90 % intervala zaupanja > 15 milisekund); vpliv se je izkazal pri terapevtski koncentraciji (3. dan), z uporabo znotrajdnevnega postopka korekcije glede na izhodišče, ter v več kot terapevtski koncentraciji (9. dan), z uporabo obeh postopkov korekcije glede na izhodišče.
Your thyroid function should be checked before you take Sutent and regularly while you are taking it. 
Delovanje vaše ščitnice je treba pred pričetkom jemanja zdravila Sutent in med jemanjem redno preverjati.
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. 
Gastrointestinalni stromalni tumor (GIST - gastrointestinal stromal tumour) Zdravilo Sutent je indicirano za zdravljenje neizrezljivega in/ali metastatskega malignega gastrointestinalnega stromalnega tumorja (GIST) pri odraslih, če zdravljenje z imatinibom zaradi odpornosti ali neprenašanja ni bilo uspešno.
Progression-free survival [median, months (95% CI)] by Investigator Assessment a 
Preživetje brez napredovanja bolezni [mediana, meseci (95 % IZ)] po oceni raziskovalca
Polyploidy (numerical chromosome aberrations) was observed in human peripheral blood lymphocytes in vitro, both in the presence and absence of metabolic activation. 
V limfocitih iz človeške periferne krvi so in vitro tako v prisotnosti presnovne aktivacije kot brez nje opazili poliploidijo (aberacije števila kromosomov).
The other ingredients are: - Capsule content: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate. 
Druge sestavine zdravila so: - Vsebina kapsule: manitol (E421), premreženi natrijev karmelozat, povidon (K-25) in magnezijev stearat.
In a 1-month, oral gavage dose-range finding study (0, 10, 25, 75, or 200 mg/kg/day) with continuous daily dosing in rasH2 transgenic mice, carcinoma and hyperplasia of Brunner's glands of the duodenum were observed at the highest dose (200 mg/kg/day) tested. 
V 1-mesečni študiji z gastrično sondo za določitev razpona odmerkov (0, 10, 25, 75, ali 200 mg/kg/dan) s CDD pri rasH2 transgenih miših, so opazili karcinom in hiperplazijo Brunnerjevih žlez dvanajstnika pri največjem preskušenem odmerku (200 mg/kg/dan).
The investigator-assessed median PFS was 13.2 months, both in the overall population (95% CI: 10.9, 16.7) and in the treatment-naïve cohort (95% CI: 7.4, 16.8). 
Mediano PFS po oceni raziskovalca je bilo 13,2 meseca pri celotni populaciji (95 % IZ: 10,9; 16,7) kot tudi pri predhodno nezdravljeni kohorti (95 % IZ: 7,4; 16,8).
Abbreviations: CI=confidence interval; N=number of patients; NA=not applicable; pNET=pancreatic neuroendocrine tumours; RECIST=response evaluation criteria in solid tumours. 
Okrajšave: IZ = interval zaupanja, n = število bolnikov, N/A = navedba smiselno ni potrebna, pNET = nevroendokrini tumorji trebušne slinavke, RECIST = merila za ocenjevanje odziva pri čvrstih tumorjih (Response Evaluation Criteria in Solid Tumours)
A total of 66% of sunitinib patients received prior systemic therapy compared with 72% of placebo patients. 
Skupno 66 % s sunitinibom zdravljenih bolnikov je bilo deležnih predhodnega sistemskega zdravljenja, v skupini s placebom pa je bilo takega zdravljenja deležnih 72 % bolnikov.
The most common adverse reactions of any grade (experienced by patients in RCC, GIST, and pNET registrational trials) included decreased appetite, taste disturbance, hypertension, fatigue, gastrointestinal disorders (i.e. diarrhoea, nausea, stomatitis, dyspepsia, and vomiting), skin discolouration, and palmar-plantar erythrodysaesthesia syndrome. 
Najpogostejši neželeni učinki katerekoli stopnje (ki so se pojavili pri bolnikih v RCC, GIST in pNET registracijskih preskušanjih) so zmanjšan tek, motnje okušanja, hipertenzija, utrujenost, prebavne motnje (npr. diareja, navzea, stomatitis, dispepsija in bruhanje), obarvanje kože in sindrom palmarno-plantarne eritrodizestezije.
Experience on the use of sunitinib in paediatric patients is limited (see section 4.2). 
Izkušnje z uporabo sunitiniba pri pediatričnih bolnikih so omejene (glejte poglavje 4.2).
Brunner's glands carcinoma occurred in the duodenum at ≥ 1 mg/kg/day in females and at 3 mg/kg/day in males, and mucous cell hyperplasia was evident in the glandular stomach at 3 mg/kg/day in males, which occurred at ≥ 0.9, 7.8, and 7.8 times the AUC in patients administered the RDD, respectively. 
Karcinom Brunnerjevih žlez v dvanajstniku se je pojavil pri odmerjanju ≥ 1 mg/kg/dan pri samicah in pri 3 mg/kg/dan pri samcih, zasledili so hiperplazijo želodčne sluznice pri odmerjanju 3 mg/kg/dan pri samcih, ki se je pojavila pri ≥ 0,9-, 7,8- in 7,8-kratniku vrednosti AUC bolnikov, ki prejemajo RDD.
GIST summary of efficacy endpoints (ITT population) Double-blind treatment a 
Preglednica 2 - Povzetek opazovanih dogodkov učinkovitosti pri GIST (populacija ITT) Dvojno slepo zdravljenjea Mediana (95 % IZ)
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. 
Pri bolnikih z GIST so o ''srčnem popuščanju'', ''kongestivnem srčnem popuščanju'' oz. ''levostranskem srčnem popuščanju'' poročali pri 1,2 % bolnikov, ki so prejemali sunitinib, in pri 1 % bolnikov, ki so prejemali placebo.
In the presence of clinical manifestations of CHF, discontinuation of sunitinib is recommended. 
Če se pojavijo klinični znaki CHF, je priporočljivo prekiniti zdravljenje s sunitinibom.
The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays. 
Primarni presnovek ima v biokemičnih in celičnih preskusih podobno jakost kot sunitinib.
Dose interruptions occurred in 202 patients (54%) on sunitinib and 141 patients (39%) on IFN-α. 
Do izpuščanja odmerkov je prišlo pri 202 bolnikih (54 %), ki so prejemali sunitinib, in pri 141 bolnikih (39 %), ki so prejemali IFN-.
Your doctor may obtain electrocardiograms to evaluate for these problems during your treatment with Sutent. 
Med zdravljenjem z zdravilom Sutent vam bo zdravnik morda za oceno teh težav predpisal elektrokardiogram.
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). 
EMA je odstopila od zahteve za predložitev rezultatov študij z zdravilom Sutent za vse podskupine pediatrične populacije pri zdravljenju rakavih bolezni ledvic ali ledvičnega meha (pelvis renalis) (z izjemo nefroblastoma, nefroblastomatoze, svetloceličnega sarkoma, mezoblastnega nefroma, raka ledvične sredice in rabdoidnega tumorja ledvice) (glejte poglavje 4.2).
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. 
Sočasna uporaba posamičnega odmerka sunitiniba z močnim zaviralcem CYP3A4 ketokonazolom je pri zdravih prostovoljcih zvečala sestavljeno [sunitinib + primarni presnovek] največjo koncentracijo (Cmax) za 49 % in sestavljeno površino pod krivuljo (AUC0-) za 51 %.
In the Phase 3 pNET study hypothyroidism was reported in 6 patients (7.2%) receiving sunitinib and in 1 patient (1.2%) on placebo. 
V študiji 3. faze pri pNET so o hipotiroidizmu poročali pri 6 bolnikih (7,2 %), ki so prejemali sunitinib, in pri 1 bolniku (1,2 %), ki je prejemal placebo.
In case of symptomatic hypoglycaemia, sunitinib should be temporarily interrupted. 
Če se pojavi simptomatska hipoglikemija, je treba zdravljenje s sunitinibom začasno prekiniti.
Patients were required to have documented progression, based on RECIST, within the prior 12 months and were randomised (1:1) to receive either 37.5 mg sunitinib once daily without a scheduled rest period (N = 86) or placebo (N = 85). 
Bolniki so bili v razmerju 1:1 randomizirani v skupino, ki je prejemala 37,5 mg sunitiniba enkrat na dan brez načrtovanega obdobja premora (n = 86), oziroma placebo (n = 85).
(based on the MTD identified in the Phase 1 dose-escalation study, see section 5.1), which in paediatric patients with GIST increased to 22.5 mg/m and subsequently to 30 mg/m 
V pediatričnih študijah je bil začetni odmerek sunitiniba 15 mg/m2 (na podlagi MTD, ugotovljenega v študiji s povečevanjem odmerka 1. faze, glejte poglavje 5.1), ki so ga pri pediatričnih bolnikih z GIST povečali na 22,5 mg/m2 in kasneje na 30 mg/m
Two patients (< 1%) who received sunitinib were diagnosed with CHF. 
Pri 2 bolnikih (< 1 %), ki sta prejemala sunitinib, so diagnosticirali kongestivno srčno popuščanje.
Haemorrhagic events, some of which were fatal, reported in clinical studies with sunitinib and during postmarketing surveillance have included gastrointestinal, respiratory, urinary tract, and brain haemorrhages (see section 4.8). 
Med opisanimi krvavitvami, v nekaterih primerih s smrtnim izidom, o katerih so poročali v kliničnih študijah s sunitinibom in med nadzorom v obdobju trženja zdravila, so bile krvavitve v prebavilih, dihalih, sečilih in možganih (glejte poglavje 4.8).
Events of tumour haemorrhage, sometimes associated with tumour necrosis, have been reported; some of these haemorrhagic events were fatal. 
Poročali so o primerih krvavitve tumorja, včasih povezanih z nekrozo tumorja; nekatere od teh krvavitev so se končale s smrtnim izidom.
A Phase 2 open-label study was conducted in 29 patients comprised of 27 paediatric patients (aged 3 years to 16 years) and 2 young adult patients (aged 18 years to 19 years) with HGG or ependymoma. 
Odprta študija 2. faze je potekala pri 29 bolnikih, od katerih je bilo 27 pediatričnih bolnikov (starih od 3 let do 16 let) in 2 mlajša odrasla bolnika (stara od 18 let do 19 let) s HGG ali ependimomom.
Physicians are advised to weigh this risk against the potential benefits of sunitinib. 
Zdravnik mora to tveganje pretehtati v primerjavi z možnimi koristmi zdravila.
A clinically significant advantage in investigator-assessed PFS for sunitinib over placebo was observed. 
V primerjavi s placebom je bila ugotovljena klinično pomembna prednost z raziskovalcem ocenjenega PFS za sunitinib.
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. 
Med bolniki s še nezdravljenim MRCC, ki so prejemali IFN-, se je pojavilo 6 (2 %) venskih trombemboličnih dogodkov; pri 1 bolniku (< 1 %) je šlo za globoko vensko trombozo 3. stopnje, 5 bolnikov (1 %) pa je imelo pljučno embolijo 4. stopnje.
Pancreatic neuroendocrine tumours (pNET) 
Nevroendokrini tumorji trebušne slinavke (pNET)
If fistula formation occurs, sunitinib treatment should be interrupted. 
Če nastane fistula, je treba zdravljenje s sunitinibom prekiniti.
Urinary tract infection Skin infectionse Sepsisf,* 
glivične okužbe okužbe sečil okužbe kože sepsa f,*
Sunitinib should be used with caution in patients with a known history of QT interval prolongation, patients who are taking antiarrhythmics or medicinal products that can prolong QT interval, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. 
Pri bolnikih z znano anamnezo podaljšanja intervala QT, tistih, ki jemljejo antiaritmike ali zdravila, ki lahko podaljšajo interval QT, in tistih z relevantno obstoječo srčno boleznijo, bradikardijo ali elektrolitskimi motnjami je treba sunitinib uporabljati previdno.
Severe hypertension was reported in 10% of pNET patients on sunitinib and 3% of patients on placebo. 
O hudi hipertenziji so poročali pri 10 % bolnikov s pNET, ki so prejemali sunitinib, in pri 3 % bolnikov, ki so prejemali placebo.
What Sutent contains 
Kaj vsebuje zdravilo Sutent
Dose reductions occurred in 194 patients (52%) on sunitinib and 98 patients (27%) on IFN-α. 
Do zdravljenja z manjšimi odmerki je prišlo pri 194 bolnikih (52 %), ki so prejemali sunitinib, in pri 98 bolnikih (27 %), ki so prejemali IFN-.
For GIST and MRCC, the recommended dose of Sutent is 50 mg taken orally once daily, for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2) to comprise a complete cycle of 6 weeks. 
Pri GIST in MRCC priporočeni odmerek zdravila Sutent znaša 50 mg peroralno enkrat na dan, 4 tedne zapored; temu sledi 2-tedenski premor (shema 4/2), tako da celotni cikel traja 6 tednov.
In this study, the median TTP was 34.0 weeks (95% CI: 22.0, 46.0). 
V tej študiji je bil mediani čas do napredovanja tumorja (TTP - time to tumor progression) 34,0 tedna (95 % IZ: 22,0-46,0).
In the same study, 4 out of 6 patients (66.7%) experienced Grade 3-4 treatment-related adverse events (Grade 3 hypophosphataemia, neutropenia, and thrombocytopenia in 1 patient each and a Grade 4 neutropenia in 1 patient). 
V isti študiji so se pri 4 od 6 bolnikov (66,7 %) pojavili z zdravljenjem povezani neželeni učinki 3.-4. stopnje (hipofosfatemija, nevtropenija in trombocitopenija 3. stopnje, vsaka pri 1 bolniku, in nevtropenija 4. stopnje pri 1 bolniku).
In clinical studies of sunitinib and from postmarketing surveillance, there have been few reports (< 1%), some fatal, of subjects presenting with seizures and radiological evidence of RPLS. 
V kliničnih študijah in med nadzorom v obdobju trženja zdravila so poročali o nekaj primerih (< 1 %) preskušancev s konvulzijami in radiološkimi znaki sindroma RPLS, v nekaterih primerih s smrtnim izidom.
Sixty-three patients received a starting dose of 50 mg sunitinib orally, once daily for 4 consecutive weeks followed by a 2-week rest period, to comprise a complete cycle of 6 weeks (Schedule 4/2). 
Triinšestdeset bolnikov je prejemalo začetni odmerek 50 mg sunitiniba peroralno enkrat na dan 4 tedne zapored, čemur je sledil 2-tedenski premor, tako da je celotni cikel trajal 6 tednov (shema 4/2).
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. 
Dejavniki tveganja, povezani z zmanjšanim delovanjem ledvic/odpovedjo ledvic pri bolnikih, ki so prejemali sunitinib, so poleg predhodno prisotnega karcinoma ledvičnih celic (RCC - renal cell carcinoma) vključevali višjo starost, sladkorno bolezen, predhodno ledvično okvaro, srčno popuščanje, hipertenzijo, sepso, dehidracijo/hipovolemijo in rabdomiolizo.
In study A6181038 the co-administration of gefitinib, a BCRP inhibitor, did not result in a clinically relevant effect on the Cmax and AUC for sunitinib or total drug (sunitinib + metabolite) (see section 4.5). 
V študiji A6181038 sočasna uporaba gefitiniba, zaviralca BCRP, ni povzročila klinično pomembnega učinka na vrednosti Cmax in AUC
Approximately 22.2% of patients with solid tumours, including GIST and MRCC, who received sunitinib in clinical trials experienced pulmonary events. 
Pljučni dogodki so se pojavili pri približno 22,2 % bolnikov s čvrstimi tumorji, vključno z GIST in MRCC, ki so prejemali sunitinib v kliničnih preskušanjih.
A confirmatory, open-label, single-arm, multi-centre study evaluating the efficacy and safety of sunitinib was conducted in patients with MRCC who were refractory to prior cytokine therapy. 
Potrditveno odprto multicentrično študijo z eno skupino za oceno učinkovitosti in varnosti sunitiniba so opravili pri bolnikih z MRCC, odpornih proti prejšnjemu citokinskemu zdravljenju.
Based on this analysis, a dose of approximately 20 mg/m daily in paediatric patients, with BSA values between 1.10 and 1.87 m2, is expected to provide plasma exposures to sunitinib and its active metabolite comparable (between 75 and 125% of the AUC) to those in adults with GIST administered sunitinib 50 mg daily on Schedule 4/2 (AUC 1233 ng.hr/mL). 
BSA med 1,10 m in 1,87 m povzročil izpostavljenosti sunitinibu in njegovemu aktivnemu presnovku v plazmi, primerljive (med 75 in 125 % AUC) s tistimi pri odraslih z GIST, ki prejemajo 50 mg sunitiniba na dan po shemi 4/2 (AUC 1.233 ng.hr/ml).
• Decreased activity of thyroid gland (hypothyroidism). 
• zmanjšano delovanje žleze ščitnice (hipotiroidizem)
Eight of these patients had DVT; 1 with Grade 1, 2 with Grade 2, 4 with Grade 3, and 1 with Grade 4. 
Osem od teh bolnikov je imelo globoko vensko trombozo: pri 1 bolniku je bila 1. stopnje, pri 2 bolnikih 2. stopnje, pri 4 bolnikih 3. stopnje in pri 1 bolniku 4. stopnje.
Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures. 
Obvestite zdravnika, če se vam pojavi vročina, utrujenost, modrice, krvavitev, oteklina, zmedenost, izguba vida in epileptični krči.
In 1 study, hypothyroidism was reported in 15 (13.6%) patients on sunitinib and 3 (2.9%) patients on standard of care. 
V 1 študiji so o hipotiroidizmu poročali pri 15 bolnicah (13,6 %), ki so prejemale sunitinib, in pri 3 bolnicah (2,9 %), ki so prejemale standardno zdravljenje.
Impaired wound healing Cases of impaired wound healing have been reported during sunitinib therapy. 
Slabše celjenje ran Poročali so o primerih slabšega celjenja ran med zdravljenjem s sunitinibom.
Post-marketing adverse reactions identified in clinical studies are also included. 
Našteti so tudi neželeni učinki, opaženi v kliničnih študijah v obdobju trženja zdravila.
Steady-state concentrations of sunitinib and its primary active metabolite are achieved within 10 to 14 days. 
Sunitinib in njegov primarni aktivni presnovek dosežeta koncentracijo v stanju dinamičnega ravnovesja v 10 do 14 dneh.
The most serious adverse reactions associated with sunitinib, some fatal, are renal failure, heart failure, pulmonary embolism, gastrointestinal perforation, and haemorrhages (e.g., respiratory tract, gastrointestinal, tumour, urinary tract, and brain haemorrhages). 
Najresnejši neželeni učinki, povezani s sunitinibom (nekateri s smrtnim izidom), so odpoved ledvic, srčno popuščanje, pljučna embolija, gastrointestinalna perforacija in krvavitve (npr. v dihalih, prebavilih, tumorju, sečilih in možganih).
A phase 2 open-label study was conducted in 29 patients comprised of 27 paediatric patients (aged 3 years to 16 years) and 2 young adult patients (aged 18 years to 19 years) with recurrent/progressive/refractory high grade glioma (HGG) or ependymoma. 
Odprta študija 2. faze je potekala pri 29 bolnikih, od katerih je bilo 27 pediatričnih bolnikov (starih od 3 let do 16 let) in 2 mlajša odrasla bolnika (stara od 18 let do 19 let) s ponovljenim/napredovalim/ neodzivnim gliomom visoke stopnje malignosti (HGG - high-grade glioma) ali ependimomom.
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). 
V študiji 3. faze pri GIST so o zmanjšanju števila trombocitov 3. stopnje poročali pri 3,7 % bolnikov, 4. stopnje pa pri 0,4 % bolnikov; v študiji 3. faze pri MRCC o zmanjšanju 3. stopnje pri 8,2 % bolnikov in 4. stopnje pri 1,1 % bolnikov, in v študiji 3. faze pri pNET pri 3,7 % oziroma 1,2 % bolnikov (glejte poglavje 4.4).
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). 
Mediano OS je bilo 114,6 tedna v skupini s sunitinibom (95 % IZ: 100,1-142,9) in 94,9 tedna v skupini z IFN- (95 % IZ: 77,7-117,0) z razmerjem ogroženosti 0,821 (95 % IZ: 0,673; 1,001, z nestratificirano log-rang vrednostjo p = 0,0510).
The diagnosis of TMA, including thrombotic thrombocytopaenic purpura (TTP) and haemolytic uraemic syndrome (HUS), sometimes leading to renal failure or a fatal outcome, should be considered in the occurrence of haemolytic anaemia, thrombocytopenia, fatigue, fluctuating neurological manifestation, renal impairment, and fever. 
Na TMA, vključno s trombotično trombocitopenično purpuro (TTP) in hemolitično-uremičnim sindromom (HUS), ki so v nekaterih primerih privedli do odpovedi ledvic ali smrti, je treba pomisliti ob pojavu hemolitične anemije, trombocitopenije, utrujenosti, nihajočih nevroloških manifestacij, okvare ledvic in povišane telesne temperature.
• Increased blood level of enzyme (creatine phosphokinase) from muscle. 
• zvišana raven mišičnega encima (kreatin-fosfokinaze) v krvi
Talk to your doctor before taking Sutent: 
Pred začetkom jemanja zdravila Sutent se posvetujte z zdravnikom:
Sunitinib did not induce structural chromosome aberrations in human peripheral blood lymphocyte cells in vitro. 
V limfocitih iz človeške periferne krvi sunitinib in vitro ni povzročil strukturnih kromosomskih aberacij.
- You may be advised to have a dental check-up before you start treatment with Sutent. 
- Preden boste pričeli zdravljenje z zdravilom Sutent, vam bodo morda svetovali, da opravite zobozdravniški pregled.
Systemic exposures after a single dose of sunitinib were similar in subjects with mild or moderate (Child-Pugh Class A and B) hepatic impairment compared to subjects with normal hepatic function. 
Sistemska izpostavljenost po enem samem odmerku sunitiniba je v primerjavi z bolniki z normalno jetrno funkcijo pri bolnikih z blago ali zmerno jetrno okvaro (razred A in B po Child-Pughu) podobna.
These complications are caused by the break-down products of dying cancer cells and may include the following: nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorous levels and low calcium levels in the blood) that can lead to changes in kidney function and acute renal failure. 
• sindrom lize tumorja (TLS) - TLS sestavlja skupina presnovnih zapletov, ki se lahko pojavijo med zdravljenjem raka; ti zapleti so posledica razkrojnih produktov propadajočih rakavih celic in lahko vključujejo naslednje: siljenje na bruhanje, zasoplost, neredno bitje srca, mišične krče, epileptične krče, motnost urina in utrujenost v povezavi z nenormalnimi rezultati laboratorijskih testov (povečane vrednosti kalija, sečne kisline in fosforja ter zmanjšane vrednosti kalcija v krvi), kar lahko vodi do sprememb v delovanju ledvic in do akutne odpovedi ledvic;
A supportive Phase 2, open-label, multi-centre study evaluated the efficacy and safety of single-agent sunitinib 50 mg daily on Schedule 4/2 in patients with unresectable pNET. 
Pri bolnikih z neizrezljivim pNET so opravili podporno, odprto, multicentrično študijo 2. faze za oceno učinkovitosti in varnosti samostojno uporabljanega zdravila sunitinib v odmerku 50 mg na dan po shemi 4/2.
In healthy volunteers, concomitant administration of a single dose of sunitinib with the CYP3A4 inducer rifampicin resulted in a reduction of the combined [sunitinib + primary metabolite] Cmax and AUC0- values of 23% and 46%, respectively. 
Sočasna uporaba posamičnega odmerka sunitiniba z induktorjem CYP3A4 rifampicinom je pri zdravih prostovoljcih zmanjšala sestavljeno [sunitinib + primarni presnovek] Cmax za 23 % in sestavljeno AUC0- za 46 %.
• Life-threatening infection of the soft tissue including the ano-genital region (see section 2). 
• življenjsko nevarna okužba mehkega tkiva, vključno s predelom spolovil in zadnjika (glejte poglavje 2)