natgillin/translations-raw huggingface dataset:
Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. 
Teški kožni osipi (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem) bili su prijavljeni pri primjeni sunitiniba, pojavljivajući se u početku na trupu u obliku crvenkastih točaka poput mete ili kružnih mrlja često sa središnjim mjehurom.
• High blood pressure. 
• Povišen krvni tlak.
Nine of these patients had pulmonary embolisms; 1 was Grade 2 and 8 were Grade 4. 
Devet od tih bolesnika imalo je plućnu emboliju; 1 bolesnik 2. stupnja, a 8 bolesnika 4. stupnja.
Some of the epistaxis events were severe, but very rarely fatal. 
Neki su slučajevi epistakse bili teški, ali su vrlo rijetko imali smrtni ishod.
The above events were not cumulative, were typically reversible, and generally did not result in treatment discontinuation. 
Navedeni događaji nisu bili kumulativne naravi, već su obično bili reverzibilni i u pravilu nisu uzrokovali prekid liječenja.
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. 
Bolesnike koji se istodobno liječe antikoagulansima (npr. varfarinom ili acenokumarolom) može se povremeno kontrolirati provjeravanjem kompletne krvne slike (trombocita), faktora koagulacije (PV/INR) i fizikalnim pregledom.
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). 
Osim toga, u publikacijama su zabilježene sljedeće nuspojave 3. stupnja koje su se pojavile u 5 bolesnika: umor (2), nuspojave probavnog sustava (uključujući proljev) (2), hematološke nuspojave (uključujući anemiju) (2), kolecistitis (1), hipertireoza (1) i mukozitis (1).
The majority of cases were reported in patients who had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk. 
Većina je slučajeva prijavljena u bolesnika koji su prethodno ili istodobno liječeni intravenski primijenjenim bisfosfonatima, za koje je osteonekroza čeljusti utvrđen rizik.
Patients who develop thyroid dysfunction should be treated as per standard medical practice. 
Bolesnike u kojih se razvije poremećaj funkcije štitnjače treba liječiti u skladu sa standardnom medicinskom praksom.
The maximum dose administered in the Phase 3 pNET study was 50 mg daily. 
Najviša primijenjena doza u ispitivanju pNET-a faze III iznosila je 50 mg na dan.
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. 
Razine šećera u krvi u bolesnika sa šećernom bolesti potrebno je redovito provjeravati kako bi se procijenilo je li potrebno podesiti doziranje lijeka protiv šećerne bolesti da bi se smanjio rizik od niske razine šećera u krvi.
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). 
Bolesnici su morali imati dokumentiranu progresiju bolesti temeljem RECIST kriterija u prethodnih 12 mjeseci te su randomizirani (1:1) da primaju ili 37,5 mg sunitiniba jedanput na dan bez predviđenog razdoblja odmora (N = 86) ili placebo (N = 85).
Median overall OS was 5.1 months in the HGG group and 12.3 months in the ependymoma group. 
Medijan ukupnog OS-a iznosio je 5,1 mjesec u skupini s gliomom visokog gradusa i 12,3 mjeseca u skupini s ependimomom.
Diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, and stomatitis/oral pain were the most commonly reported gastrointestinal adverse reactions; oesophagitis events have been also reported (see section 4.8). 
Proljev, mučnina/povraćanje, bol u abdomenu, dispepsija i stomatitis/bol u ustima bile su najčešće prijavljene gastrointestinalne nuspojave; također su prijavljeni slučajevi upale jednjaka (vidjeti dio 4.8).
Tell your doctor if you have any bleeding while on treatment with Sutent. 
Obavijestite liječnika o svakom krvarenju koje imate tijekom liječenja lijekom Sutent.
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones. 
• Upala (oticanje i crvenilo) žučnog mjehura sa ili bez prisutnosti kamenaca.
Increases in serum lipase and amylase activities were observed in patients with various solid tumours who received sunitinib. 
Opažena je povećana aktivnost serumske lipaze i amilaze u bolesnika s različitim solidnim tumorima liječenih sunitinibom.
• Pain in the stomach (abdomen) caused by inflammation of the pancreas. 
• Bol u trbuhu (abdomenu) izazvana upalom gušterače.
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. 
Venski tromboembolijski događaji povezani s liječenjem prijavljeni su u približno 1,0% bolesnika sa solidnim tumorima koji su primali sunitinib u kliničkim ispitivanjima, uključujući GIST i RCC.
- If you have heart problems. 
- ako imate srčanih tegoba.
Results from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) showed that the overall global health-related quality of life and the 5 functioning domains (physical, role, cognitive, emotional, and social) were maintained for patients on sunitinib treatment as compared to placebo with limited adverse symptomatic effects. 
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30) pokazali su da se u bolesnika liječenih sunitinibom u usporedbi s bolesnicima koji su primali placebo održala opća kvaliteta života vezana uz zdravlje kao i kvaliteta u 5 funkcionalnih domena (fizičkoj, funkcionalnoj, kognitivnoj, emocionalnoj i socijalnoj), uz ograničene neželjene simptomatske učinke.
A higher incidence rate of hypoglycaemia events was reported in patients with pNET in comparison to MRCC and GIST. 
Viša stopa incidencije događaja hipoglikemije prijavljena je u bolesnika s pNET-om u usporedbi s onima s MRCC-om i GIST-om.
Fatal gastrointestinal bleeding was reported in 0.98% of patients receiving placebo in the GIST Phase 3 study. 
Smrtonosno gastrointestinalno krvarenje prijavljeno je u 0,98% bolesnika koji su primali placebo u ispitivanju GIST-a faze III.
The primary efficacy endpoint was ORR, based on Response Evaluation Criteria in Solid Tumours (RECIST). 
Primarna mjera ishoda djelotvornosti bio je ORR prema Kriterijima za ocjenu odgovora kod solidnih tumora (engl.
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. 
Kako bi se isključila pristranost u procjeni PFS-a od strane ispitivača, provedena je slijepa neovisna središnja procjena snimki; ta je ocjena potvrdila procjenu ispitivača, što je prikazano u Tablici 4.
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. 
Ova je analiza pružila konzervativnu procjenu učinka liječenja sunitinibom te je poduprla primarnu analizu, pokazavši omjer hazarda od 0,507 (95% CI: 0,350-0,733), p= 0,000193.
• Abnormal tube like passage from one normal body cavity to another body cavity or the skin. 
• Stvaranje neuobičajenog kanala u obliku cjevčice koji vodi od jedne normalne tjelesne šupljine do druge tjelesne šupljine ili kože.
k Acute coronary syndrome, angina pectoris, angina unstable, coronary artery occlusion, and myocardial ischaemia. 
Akutni koronarni sindrom, angina pektoris, nestabilna angina, okluzija koronarnih arterija, ishemija miokarda
One hundred and 6 patients received at least one 50 mg dose of sunitinib on Schedule 4/2. 
106 bolesnika je dobilo najmanje jednu dozu od 50 mg sunitiniba prema shemi 4/2.
Final 
Konačni
Although sunitinib and its primary metabolite were not eliminated through haemodialysis in subjects with ESRD, the total systemic exposures were lower by 47% for sunitinib and 31% for its primary metabolite compared to subjects with normal renal function. 
Premda se sunitinib i njegov primarni metabolit nisu uklonili hemodijalizom u bolesnika u terminalnoj fazi bubrežne bolesti, ukupna sustavna izloženost sunitibu bila je niža za 47%, a izloženost primarnom metabolitu za 31% u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
Temporary suspension is recommended in patients with severe hypertension that is not controlled with medical management. 
Preporučuje se privremeno prekinuti liječenje u bolesnika s teškom hipertenzijom koja nije regulirana lijekovima.
Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. 
Sutent je indiciran za liječenje neoperabilnih ili metastatskih, dobro diferenciranih neuroendokrinih tumora gušterače (pNET) u odraslih bolesnika u kojih je došlo do progresije bolesti.
- If you have or have had skin and subcutaneous tissue disorders. 
- ako imate ili ste imali poremećaje kože i potkožnog tkiva.
No specific additional risk factors for sunitinib-induced cardiomyopathy apart from the drug-specific effect have been identified in the treated patients. 
U bolesnika nisu utvrđeni posebni dodatni faktori rizika za kardiomiopatiju uzrokovanu sunitinibom osim učinaka koji su svojstveni samom lijeku.
Immune system disorders Hypersensitivity reactions, including angioedema, have been reported (see section 4.4). 
Poremećaji imunološkog sustava Prijavljene su reakcije preosjetljivosti, uključujući angioedem (vidjeti dio 4.4).
Although an effect on QTcF interval was observed on Day 3 at 24 hours postdose (i.e., at therapeutic plasma concentration expected after the recommended starting dose of 50 mg) with the within-day baseline correction method, the clinical significance of this finding is unclear. 
Iako je primjenom unutardnevne metode korekcije u odnosu na početne vrijednosti opažen učinak na QTcF-interval 3. dana 24 sata nakon primjene doze (tj. pri terapijskoj koncentraciji u plazmi koja se očekivala nakon primjene preporučene početne doze od 50 mg), nije jasan klinički značaj ovog nalaza.
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. 
Klinička sigurnost i djelotvornost sunitiniba ispitivane su u liječenju bolesnika s GIST-om koji su bili otporni na imatinib (tj. oni u kojih je bolest progredirala tijekom ili nakon liječenja imatinibom) ili koji imatinib nisu podnosili (tj. oni u kojih je tijekom liječenja imatinibom nastupila značajna toksičnost zbog koje se liječenje nije moglo nastaviti), liječenju bolesnika s MRCC-om i liječenju bolesnika s neoperabilnim pNET-om.
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. 
Drugi mogući dermatološki učinci obuhvaćaju suhoću, zadebljanje ili pucanje kože, mjehuriće ili osip na dlanovima i tabanima.
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. 
Pretpostavlja se da su promjene na uterusu (atrofija endometrija) i epifiznoj ploči rasta (zadebljanje fize ili displazija hrskavice) povezane s farmakološkim djelovanjem sunitiniba.
Increases in lipase activities were transient and were generally not accompanied by signs or symptoms of pancreatitis in subjects with various solid tumours (see section 
Porast aktivnosti lipaze bio je prolazan i uglavnom nije bio popraćen znakovima ili simptomima pankreatitisa u bolesnika s različitim solidnim tumorima (vidjeti dio 4.8).
Temporary suspension of sunitinib is recommended; following resolution, treatment may be resumed at the discretion of the treating physician (see section 4.8). 
Preporučuje se privremen prekid primjene sunitiniba; nakon što se stanje popravi, prema odluci nadležnog liječnika liječenje se može nastaviti (vidjeti dio 4.8).
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). 
Sustavna izloženost nakon jedne doze sunitiniba bila je podjednaka u ispitanika s teškim oštećenjem bubrežne funkcije (CLcr <30 ml/min) i ispitanika s normalnom bubrežnom funkcijom (CLcr >80 ml/min).
Population PK analyses indicated that sunitinib apparent clearance (CL/F) was not affected by creatinine clearance (CLcr) within the range evaluated (42-347 ml/min). 
Populacijske FK analize ukazuju na to da klirens kreatinina (CLcr) unutar ispitivanog raspona (42347 ml/min) ne utječe na prividni klirens sunitiniba (CL/F).
No effects on male or female fertility were observed in reproductive toxicity studies. 
U istraživanjima reproduktivne toksičnosti nisu opaženi učinci na plodnost mužjaka ni ženki.
Additionally, 49% of sunitinib patients had nonfunctioning tumours versus 52% of placebo patients and 92% of patients in both arms had liver metastases. 
Uz to, 49% bolesnika liječenih sunitinibom te 52% bolesnika koji su dobivali placebo imalo je nefunkcionalne tumore, a 92% bolesnika u obje skupine imalo je jetrene metastaze.
Blood glucose levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicinal product's dosage needs to be adjusted to minimise the risk of hypoglycaemia (see section 4.8). 
Razine glukoze u krvi u bolesnika sa šećernom bolesti potrebno je redovito provjeravati kako bi se procijenilo je li potrebno podesiti doziranje lijeka protiv dijabetesa da bi se smanjio rizik od hipoglikemije (vidjeti dio 4.8).
- If you have or have had blood disease, bleeding problems, or bruising. 
- ako imate ili ste ranije imali neku bolest krvi, probleme s krvarenjem ili modricama.
No formal clinical studies of the effect of sunitinib on wound healing have been conducted. 
Nisu provedena formalna ispitivanja utjecaja sunitiniba na cijeljenje rana.
Sunitinib was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), VEGF receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET). 
Utvrđeno je da je sunitinib inhibitor receptora trombocitnog faktora rasta (PDGFRα i PDGFRβ), receptora vaskularnog endotelnog faktora rasta (VEGFR1, VEGFR2 i VEGFR3), receptora faktora rasta matičnih stanica (KIT), Fms-slične tirozin kinaze 3 (FLT3), receptora faktora rasta kolonija (CSF-1R) te receptora glijalnog neurotrofnog faktora (RET).
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). 
U ovom je ispitivanju stopa objektivnog odgovora bila 36,5% (95% CI: 24,7%; 49,6%), a medijan TTP-a 37,7 tjedana (95% CI: 24,0; 46,4).
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. 
Sigurnosni profil sunitiniba proizašao je iz ispitivanja faze I u kojem se ispitivalo povećanje doze, otvorenog ispitivanja faze 2, ispitivanja faze 1/2 s jednom skupinom bolesnika i iz publikacija, kako je opisano u nastavku.
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. 
Medijan trajanja liječenja iznosio je 11,1 mjesec (raspon: 0,4 - 46,1) kod liječenja sunitinibom te 4,1 mjesec (raspon: 0,1 - 45,6) kod liječenja IFN-α.
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. 
U bolesnika koji su primali sunitinib u registracijskim ispitivanjima faze III, plućni događaji (tj. dispneja, pleuralni izljev, plućna embolija ili plućni edem) prijavljeni su u približno 17,8% bolesnika s GIST-om, približno 26,7% bolesnika s MRCC-om i u 12% bolesnika s pNET-om.
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). 
Ukupno preživljenje zabilježeno nakon 5 godina praćenja u produljenju ispitivanja pokazalo je omjer hazarda od 0,730 (95% CI 0,504; 1,057).
Lung or breathing problems. 
Tegobe s plućima ili disanjem.
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. 
Događaji sa smrtnim ishodom koji nisu prethodno navedeni u dijelu 4.4 ili u nastavku dijela 4.8, a za koje se smatralo da bi mogli biti povezani s primjenom sunitiniba, uključivali su: zatajenje više organa, diseminiranu intravaskularnu koagulaciju, peritonealno krvarenje, insuficijenciju nadbubrežnih žlijezda, pneumotoraks, šok i iznenadnu smrt.
QTc interval prolongation was investigated in a trial in 24 patients, ages 20-87 years, with advanced malignancies. 
Produljenje QTc-intervala proučavalo se u ispitivanju s 24 bolesnika s uznapredovalim zloćudnim bolestima, u dobi od 20 do 87 godina.
Interim 6.8 (3.7, 11.1) 
ORR (%) Interim 6,8 (3,7; 11,1)
Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, and metastatic progression of cancer. 
Suntinib inhibira višestruke receptorske tirozin kinaze (RTK) koje imaju ulogu u rastu tumora, neoangiogenezi i metastatskoj progresiji karcinoma.
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). 
EMA je izuzela obvezu podnošenja rezultata ispitivanja lijeka Sutent u svim podskupinama pedijatrijske populacije u liječenju gastroenteropankreatičnih neuroendokrinih tumora (osim neuroblastoma, neuroganglioblastoma i feokromocitoma) (vidjeti dio 4.2).
Risk factors for TLS include high tumour burden, pre-existing chronic renal insufficiency, oliguria, dehydration, hypotension, and acidic urine. 
Faktori rizika za TLS uključuju visoko opterećenje tumorom, postojeću kroničnu bubrežnu insuficijenciju, oliguriju, dehidraciju, hipotenziju i kiseli urin.
Eight of these patients had DVT; 1 with Grade 1, 2 with Grade 2, 4 with Grade 3, and 1 with Grade 4. 
Osam od tih bolesnika imalo je DVT; 1 bolesnik 1. stupnja, 2 bolesnika 2. stupnja, 4 bolesnika 3. i 1 bolesnik 4. stupnja.
With repeated daily administration, sunitinib accumulates 3- to 4-fold and its primary active metabolite accumulates 7- to 10-fold. 
Nakon ponovljene svakodnevne primjene kumulacija sunitiniba je trostruka do četverostruka, a kumulacija njegova primarnog aktivnog metabolita sedmerostruka do deseterostruka.
• Life-threatening infection of the soft tissue including the ano-genital region (see section 2). 
• Po život opasne infekcije mekog tkiva, uključujući i područje spolnih organa i anusa (pogledajte dio 2.).
These may be caused by inflammation of the pancreas or gallbladder. 
Njihov uzrok može biti upala gušterače ili žučnog mjehura.
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. 
U ispitivanju prethodno neliječenog MRCC-a, 27% bolesnika liječenih sunitinibom i 15% bolesnika koji su primali IFN-α imalo je vrijednost LVEF-a ispod donje granice normalnih vrijednosti.
In a pancreatic islet cell tumour cohort of 66 patients, the primary endpoint of response rate was 17%. 
U kohorti od 66 bolesnika s tumorom stanica otočića gušterače stopa odgovora na liječenje, što je bila primarna mjera ishoda, iznosila je 17%.
Steady-state concentrations of sunitinib and its primary active metabolite are achieved within 10 to 14 days. 
Koncentracije sunitiniba i njegova primarnog aktivnog metabolita dosežu stanje dinamičke ravnoteže unutar 10 do 14 dana.
Primary TTP (weeks) Interim 27.3 (16.0, 32.1) 6.4 (4.4, 10.0) 0.329 (0.233, 0.466) < 0.001 Final 
Primarna TTP (tjedni) Interim 27,3 (16,0; 32,1) 6,4 (4,4; 10,0) 0,329 (0,233;
Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. 
Metastatski karcinom bubrežnih stanica (engl. metastatic renal cell carcinoma, MRCC) Sutent je indiciran za liječenje uznapredovalog/metastatskog karcinoma bubrežnih stanica (MRCC-a) u odraslih bolesnika.
All thyroid-related events reported were Grade 1-2 (see section 4.4). 
Svi zabilježeni događaji povezani sa štitnjačom bili su 1.do 2. stupnja (vidjeti dio 4.4).
Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations. 
Primjena sunitiniba sa snažnim inhibitorima CYP3A4 (npr. ritonavirom, itrakonazolom, eritromicinom, klaritromicinom, sokom od grejpa) može povećati koncentracije sunitiniba.
A hazard ratio favouring sunitinib was observed in all subgroups of baseline characteristics evaluated, including an analysis by number of prior systemic therapies. 
4. Omjer hazarda u prilog sunitinibu zabilježen je u svim podskupinama ocijenjenima na temelju početnih obilježja, uključujući i analizu prema broju prethodnih sustavnih terapija.
• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis). 
• Neuobičajeno oštećenje mišićnih vlakana koje može dovesti do problema s bubrezima (rabdomioliza).
Sunitinib benefit/risk did not appear to be negatively affected by younger age or lower body size, and was mainly driven by its plasma exposure. 
Čini se da na omjer koristi i rizika sunitiniba nisu negativno utjecali mlađa dob i manja tjelesna veličina, i uglavnom je zavisio o izloženosti lijeku u plazmi.
• Abnormal blood tests including pancreatic and liver enzymes. 
• Poremećene krvne pretrage, uključujući enzime gušterače i jetre.
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). 
Prijavljeni su slučajevi osteonekroze čeljusti u bolesnika liječenih lijekom Sutent, većinom u onih koji su imali poznate faktore rizika za osteonekrozu čeljusti, osobito izloženost intravenskim bisfosfonatima i/ili bolest zuba koja je zahtijevala invazivne stomatološke zahvate (vidjeti i dio 4.4).