natgillin/translations-raw huggingface dataset:
Efficacy is based on time-to-tumour progression (TTP) and an increase in survival in GIST, on progression-free survival (PFS) and objective response rates (ORR) for treatment-naïve and cytokine-refractory MRCC respectively, and on PFS for pNET.
Djelotvornost se temelji na vremenu do progresije tumora (engl. time-to-tumour progression, TTP) i produljenju preživljenja u GIST-u, na preživljenju bez progresije bolesti (engl. progression-free survival, PFS) u prethodno neliječenom MRCC-u odnosno stopama objektivnog odgovora (engl. objective response rates, ORR) u MRCC-u refraktornom na citokine te na PFS-u u pNET-u.
Progression-free survival [median, months (95% CI)] by Investigator Assessment a
Preživljenje bez progresije bolesti [medijan, mjeseci (95% CI)] prema procjeni ispitivača
Abbreviations: CI=confidence interval; INF-α=interferon-alfa; ITT=intent-to-treat; N=number of patients; NA=not applicable; OS=overall survival; PFS=progression-free survival.
Kratice: CI = interval pouzdanosti; INF-α = interferon alfa; ITT = populacija s namjerom liječenja; N = broj bolesnika; NA = nije primjenjivo; OS = ukupno preživljenje; PFS = preživljenje bez progresije bolesti.
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.
U vrijeme unaprijed određene interim analize, medijan TTP-a u bolesnika liječenih sunitinibom bio je 28,9 tjedana (95% CI: 21,3; 34,1) prema procjeni ispitivača, odnosno 27,3 tjedna (95% CI: 16,0; 32,1) prema neovisnoj procjeni, što je statistički značajno dulje nego TTP u bolesnika koji su primali placebo, koji je iznosio 5,1 tjedan (95% CI: 4,4; 10,1) prema procjeni ispitivača odnosno 6,4 tjedna (95% CI: 4,4; 10,0) prema neovisnoj procjeni.
Similarly, among 57 patients in the sunitinib arm (including 28 with 1 prior systemic therapy and 29 with 2 or more prior systemic therapies) and 61 patients in the placebo arm (including 25 with 1 prior systemic therapy and 36 with 2 or more prior systemic therapies), the hazard ratio for PFS was 0.456 (95% CI: 0.264, 0.787), p=0.0036.
Slično tomu, u 57 bolesnika u skupini liječenoj sunitinibom (28 bolesnika koji su primili jednu prethodnu sustavnu terapiju te 29 bolesnika koji su primili dvije ili više prethodnih sustavnih terapija) te u 61 bolesnika u skupini koja je primala placebo (25 bolesnika koji su primili jednu prethodnu sustavnu terapiju te 36 bolesnika koji su primili dvije ili više prethodnih sustavnih terapija), omjer hazarda za PFS iznosio je 0,456 (95% CI: 0,264 0,787), p = 0,0036.
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.
Nije potrebno prilagođavati početnu dozu kada se sunitinib primjenjuje u bolesnika s oštećenjem bubrega (blagim do teškim) ili u bolesnika u terminalnoj fazi bubrežne bolesti na hemodijalizi.
After the interim analysis of efficacy and safety, at the recommendation of the independent Data and Safety Monitoring Board (DSMB), the study was unblinded and patients on the placebo arm were offered open-label sunitinib treatment.
Data and Safety Monitoring Board, DSMB) otkrivena je slijepa šifra terapije te je bolesnicima na placebu ponuđeno otvoreno liječenje sunitinibom.
• Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability to swallow.
• Hemoroidi, bol u završnom dijelu crijevu (rektumu), krvarenje iz desni, otežano gutanje ili nemogućnost gutanja.
Cardiac failure congestive Myocardial infarctionm,* Cardiac failure* Cardiomyopathy*
smanjena istisna frakcija kongestivno zatajenje srca, infarkt miokarda m,*
• Shortness of breath.
• Nedostatak zraka.
However, in repeated-dose toxicity studies performed in rats and monkeys, effects on female fertility were observed in the form of follicular atresia, degeneration of corpora lutea, endometrial changes in the uterus, and decreased uterine and ovarian weights at clinically relevant systemic exposure levels.
Međutim, u istraživanjima toksičnosti ponovljenih doza na štakorima i majmunima, pri klinički značajnoj razini sustavne izloženosti lijeku, uočeni su učinci na plodnost ženki u obliku atrezije folikula, degeneracije žutih tijela, promjena endometrija uterusa te smanjenja težine uterusa i jajnika.
An initial open-label, dose-escalation study was conducted in patients with GIST after failure of imatinib (median maximum daily dose 800 mg) due to resistance or intolerance.
Provedeno je inicijalno otvoreno ispitivanje s eskalirajućim dozama u bolesnika s GIST-om nakon neuspješnog liječenja imatinibom zbog rezistencije ili nepodnošenja (medijan maksimalne dnevne doze 800 mg).
A Phase 4 multinational, multi-centre, single-arm, open-label study evaluating the efficacy and safety of sunitinib was conducted in patients with progressive, advanced/metastatic, well-differentiated, unresectable pNET.
Multinacionalno, multicentrično, otvoreno ispitivanje faze 4 s jednom skupinom bolesnika u svrhu ocjene djelotvornosti i sigurnosti sunitiniba provedeno je u bolesnika s progresivnim, uznapredovalim/metastatskim, dobro diferenciranim, neoperabilnim pNET-om.
Treatment-related serious adverse events (TRSAEs) were reported in 23.7% of patients receiving sunitinib and in 6.9% of patients receiving IFN-α.
Ozbiljne nuspojave povezane s liječenjem prijavljene su u 23,7% bolesnika koji su primali sunitinib te u 6,9% bolesnika koji su dobivali IFN-α.
The observed adverse drug reactions were similar overall to those seen in adults (see section 4.8).
Zabilježene nuspojave na lijek sveukupno su bile slične onima zabilježenima u odraslih (vidjeti dio
Sunitinib therapy should be discontinued in patients who develop TMA and prompt treatment is required.
Terapija sunitinibom mora se prekinuti u bolesnika koji razviju TMA te je potrebno hitno liječenje.
In the Phase 3 pNET study hypothyroidism was reported in 6 patients (7.2%) receiving sunitinib and in 1 patient (1.2%) on placebo.
U ispitivanju pNET-a faze III hipotireoza je zabilježena u 6 bolesnika (7,2%) koji su primali sunitinib i u 1 bolesnika (1,2%) koji je primao placebo.
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.
U prethodno neliječenih bolesnika koji su za liječenje MRCC-a primali IFN-α zabilježeno je 6 (2%) venskih tromboembolijskih događaja; 1 je bolesnik (< 1%) razvio duboku vensku trombozu 3. stupnja, dok je 5 bolesnika (1%) razvilo plućnu emboliju, svi 4. stupnja.
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).
Smanjen broj trombocita 3. odnosno 4. stupnja težine, prijavljen je u 3,7% i 0,4% bolesnika u ispitivanju GIST-a faze III, u 8,2% i 1,1% bolesnika u ispitivanju MRCC-a faze III te u 3,7% i 1,2% bolesnika u ispitivanju pNET-a faze III (vidjeti dio 4.4).
No development toxicity was observed at 1 mg/kg/day (approximate exposure ≥ 0.9 times the AUC in patients administered the RDD).
Pri dozi od 1 mg/kg na dan nije zabilježena toksičnost za razvoj (približna ekspozicija ≥ 0,9 puta od AUC-a u bolesnika koji su dobivali preporučenu dnevnu dozu).
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.
Istodobna primjena jedne doze sunitiniba i induktora CYP3A4 rifampicina u zdravih dobrovoljaca rezultirala je smanjenjem Cmax kompleksa [sunitinib+primarni metabolit] za 23% te smanjenjem vrijednosti AUC0- za 46%.
If you have any questions about how Sutent works or why this medicine has been prescribed for you, ask your doctor.
Ako imate pitanja o tome kako Sutent djeluje ili zašto
Furthermore, according to the published literatures in paediatric patients with GIST, the calculated starting dose ranged from 16.6 mg/m to 36 mg/m increased to doses as high as 40.4 mg/m
Nadalje, prema objavljenoj literaturi se izračunata početna doza u pedijatrijskih bolesnika s GIST-om kretala u rasponu od 16,6 mg/m2 do
A Phase 1/2 single-arm, study was conducted in 6 paediatric patients (aged 13 years to 16 years) with advanced unresectable GIST.
Ispitivanje faze 1/2 s jednom skupinom bolesnika provedeno je u 6 pedijatrijskih bolesnika (u dobi od 13 do 16 godina) s uznapredovalim neoperabilnim GIST-om.
reductions in gravid uterine weights and number of live foetuses were due to increases in the number of resorptions, increases in postimplantation loss and complete litter loss in 4 of 6 pregnant females at plasma exposure levels 3 times the systemic exposure in humans.
U kunića je smanjenje težine gravidnih uterusa te broja živih fetusa bilo posljedica povećanog broja resorpcija, povećanih gubitaka ploda nakon implantacije te gubitka čitavog legla u 4 od 6 gravidnih ženki, pri ekspoziciji koncentracijama u plazmi 3 puta većima od sistemske izloženosti u ljudi.
Dose interruptions occurred in 202 patients (54%) on sunitinib and 141 patients (39%) on IFN-α.
Do privremenog prekida primjene lijeka došlo je u 202 bolesnika (54%) liječena sunitinibom i 141 bolesnika (39%) liječenog IFN-α.
Paediatric population Experience on the use of sunitinib in paediatric patients is limited (see section 4.2).
Pedijatrijska populacija Iskustvo s primjenom sunitiniba kod pedijatrijskih bolesnika je ograničeno (vidjeti dio 4.2).
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.
Među bolesnicima s GIST-om nuspojave "zatajenje srca", "kongestivno zatajenje srca" ili "'zatajenje lijeve klijetke" prijavljene su u 1,2% onih liječenih sunitinibom i u 1% onih koji su primali placebo.
In rabbits, developmental effects consisted of increased incidence of cleft lip at plasma exposure levels approximately equal to that observed in clinic, and cleft lip and cleft palate at plasma exposure levels 2.7 times the systemic exposure in humans.
U kunića su učinci na razvoj obuhvaćali povećanu incidenciju rascjepa usne pri ekspoziciji koncentracijama u plazmi približno jednakim kliničkima te rascjepa usne i nepca pri ekspoziciji koncentracijama lijeka 2,7 puta većima od sistemske izloženosti u ljudi.
Gastrointestinal stromal tumour (GIST)
Gastrointestinalni stromalni tumor (GIST)
In addition, 24% of sunitinib patients had received somatostatin analogues compared with 22% of placebo patients.
Nadalje, analoge somatostatina je primilo 24% bolesnika liječenih sunitinibom u usporedbi s 22% bolesnika na placebu.
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.
(engl. hazard ratio, HR): 0,491; (95% CI: 0,290; 0,831)]; rizik od smrti bio je dvostruko veći u skupini bolesnika koji su primali placebo u usporedbi sa skupinom na sunitinibu.
Treatment-naïve mRCC summary of efficacy endpoints (ITT population)
Tablica 3 Sažetak mjera ishoda djelotvornosti za prethodno neliječen MRCC (ITT populacija)
T4 increase was reported in 2 (0.8%) patients on sunitinib and 1 (0.4%) patient on capecitabine.
Povećanje T4 zabilježeno je u 2 (0,8%) bolesnika na sunitinibu i 1 (0,4%) bolesnika na kapecitabinu.
• Abnormal sensation of the skin, itching, flaking and inflammation of the skin, blisters, acne, nail discolouration, hair loss.
• Neuobičajeni osjeti na koži, svrbež, perutanje i upala kože, mjehurići, akne, promjena boje noktiju, opadanje kose.
Gastroduodenal carcinomas, an increased incidence of background haemangiosarcomas, and/or gastric mucosal hyperplasia were observed at doses of ≥ 25 mg/kg/day following 1- or 6-months duration (≥ 7.3 times the AUC in patients administered the recommended daily dose RDD).
Zabilježeni su gastroduodenalni karcinomi, povećana incidencija hemangiosarkoma i/ili hiperplazija želučane sluznice pri dozama od ≥ 25 mg/kg/dan nakon 1 ili 6 mjeseci primjene (što predstavlja ≥ 7,3 puta veći AUC nego u bolesnika koji su dobivali preporučenu dnevnu dozu).
The pivotal study in pancreatic NET was terminated prematurely at the recommendation of an independent drug monitoring committee and the primary endpoint was based upon investigator assessment, both of which may have affected the estimates of the treatment effect.
Pivotalno ispitivanje neuroendokrinih tumora gušterače završeno je prije vremena po preporuci neovisnog odbora za praćenje lijekova te se primarna mjera ishoda temeljila na procjeni ispitivača.
Hypertension was reported in approximately 33.9% of patients receiving sunitinib for treatment-naïve MRCC compared to 3.6% of patients receiving IFN-.
Hipertenzija je prijavljena u približno 33,9% bolesnika koji su za liječenje prethodno neliječenog MRCC-a primali sunitinib u odnosu na 3,6% bolesnika koji su primali IFN-α.
Reversal of the effects of TMA has been observed after treatment discontinuation (see section 4.8).
Povlačenje učinaka TMA primijećeno je nakon prekida liječenja (vidjeti dio 4.8).
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules
Sutent 12,5 mg tvrde kapsule Sutent 25 mg tvrde kapsule Sutent 37,5 mg tvrde kapsule Sutent 50 mg tvrde kapsule
Rare: may affect up to 1 in 1,000 people
Rijetke nuspojave: mogu se javiti u manje od 1 na 1000 osoba
If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage.
Ako za to postoji indikacija, eliminacija neapsorbiranog lijeka može se postići izazivanjem povraćanja ili ispiranjem želuca.
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.
Obavijestite liječnika ako se tijekom liječenja lijekom Sutent razvije bilo koji od sljedećih znakova i simptoma: svrbež, žutilo bjeloočnica ili kože, tamna mokraća te bol ili neugoda u gornjem desnom dijelu trbuha.
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.
Kratice: CI = interval pouzdanosti; ITT = populacija s namjerom liječenja; NA = nije primjenjivo; ORR = stopa objektivnog odgovora; OS = ukupno preživljenje; PFS = preživljenje bez progresije bolesti; TTP = vrijeme do progresije tumora.
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Treba razmotriti odabir drugog lijeka za istodobnu primjenu, a koji nema ili ima neznatan potencijal za indukciju ili inhibiciju CYP3A4.
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.
Najčešće nuspojave prvenstveno 1. ili 2. stupnja težine bile su proljev, mučnina, smanjenje broja leukocita, neutropenija i glavobolja te se svaka od njih pojavila u 3 (50,0 %) bolesnika.
• Fluid around the heart (pericardial effusion).
• Tekućina oko srca (perikardijalni izljev).
Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria.
Preporučuje se analiza mokraće prije početka liječenja kao i praćenje bolesnika u smislu pojave ili pogoršanja proteinurije.
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).
Medijan ukupnog preživljenja iznosio je 114,6 tjedana u skupini liječenoj sunitinibom (95% CI: 100,1; 142,9), a 94,9 tjedana skupini liječenoj IFN-α (95% CI: 77,7; 117,0), uz omjer hazarda od 0,821 (95% CI: 0,673; 1,001, p = 0,0510 po nestratificiranom log-rang testu).
If fistula formation occurs, sunitinib treatment should be interrupted.
Dođe li do formiranja fistule, treba privremeno prekinuti liječenje sunitinibom.
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.
Smanjenje apsolutnog broja neutrofila 3. odnosno 4. stupnja težine, prijavljeno je u 10% i 1,7% bolesnika u ispitivanju GIST-a faze III, u 16% i 1,6% bolesnika u ispitivanju MRCC-a faze III te u 13% i 2,4% bolesnika u ispitivanju pNET-a faze III.
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).
Medijan PFS-a koji je ocijenio ispitivač iznosio je 13,2 mjeseca, i u sveukupnoj populaciji (95% CI: 10,9; 16,7) i u kohorti bolesnika koji prethodno nisu bili liječeni (95% CI: 7,4; 16,8).
Pancreatic neuroendocrine tumours (pNET)
Neuroendokrini tumori gušterače (engl. pancreatic neuroendocrine tumours, pNET)
Risk factors associated with ATE, in addition to the underlying malignant disease and age  65 years, included hypertension, diabetes mellitus, and prior thromboembolic disease.
Uz postojeću zloćudnu bolest i dob od ≥65 godina, faktori rizika povezani s arterijskim tromboembolijskim događajima uključivali su hipertenziju, šećernu bolest i prethodnu tromboembolijsku bolest.
There were no serious adverse events (SAEs) or Grade 5 adverse drug reactions reported in this study.
U ovom ispitivanju nisu prijavljeni ozbiljni štetni događaji ili nuspojave 5. stupnja.
- If you have or have had liver problems.
- ako imate ili ste ranije imali tegoba s jetrom.
Abbreviations: CI=confidence interval; N=number of patients; PFS=progression-free survival; pNET=pancreatic neuroendocrine tumours.
Kratice: CI = interval pouzdanosti, N = broj bolesnika, PFS = preživljenje bez progresije, pNET = neuroendokrini tumori gušterače
Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
Obavijestite liječnika ako nastupe vrućica, umor, modrice, krvarenje, oticanje, smetenost, gubitak vida i napadaji.
Hyperthyroidism was reported in no sunitinib-treated patients and 1 (1.0%) patient receiving standard of care.
Hipertireoza nije zabilježena ni u jednog bolesnika liječenog sunitinibom, ali je zabilježena u 1 (1,0%) bolesnika na standardnom liječenju.
Skin and tissue disorders
Poremećaji kože i potkožnog tkiva
Events of tumour haemorrhage, sometimes associated with tumour necrosis, have been reported; some of these haemorrhagic events were fatal.
Prijavljeni su slučajevi krvarenja tumora, ponekad udruženi s nekrozom tumorskog tkiva; neka od tih krvarenja završila su smrću.
QT interval prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de pointes.
Produljenje QT-intervala i torsade de pointes opaženi su u bolesnika izloženih sunitinibu.Produljenje QT-intervala može dovesti do povišenog rizika od ventrikularnih aritmija, uključujući torsade de pointes.
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.
U suportivnom, otvorenom, multicentričnom ispitivanju faze II procjenjivala se djelotvornost i sigurnost sunitiniba kao jedinog lijeka u dozi od 50 mg na dan prema shemi 4/2 u bolesnika s neoperabilnim pNET-om.
Severe hypertension was reported in 10% of pNET patients on sunitinib and 3% of patients on placebo.
Teška hipertenzija prijavljena je u 10% bolesnika s pNET-om koji su primali sunitinib i u 3% bolesnika koji su primali placebo.
- Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide
- Tinta za označavanje: šelak, propilenglikol, natrijev hidroksid, povidon i titanijev dioksid
Limited information is available on the continued use of sunitinib in patients with fistulae (see section 4.8).
Ograničeni su podaci o nastavku primjene sunitiniba u bolesnika s fistulama (vidjeti dio 4.8).
• Hot flushes.
• Navale vrućine.
The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays.
Primarni metabolit u biokemijskim i staničnim testovima pokazuje sličnu potentnost kao i sunitinib.
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).
Najozbiljnije nuspojave povezane sa sunitinibom, od kojih su neke fatalne, su zatajenje bubrega, zatajenje srca, plućna embolija, gastrointestinalna perforacija i krvarenja (npr. krvarenja u dišnom sustavu, probavnom sustavu, tumorska krvarenja te krvarenja u urinarnom traktu i krvarenje u mozgu).
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.
Otvoreno ispitivanje faze 2 provedeno je u 29 bolesnika te je obuhvaćalo 27 pedijatrijskih bolesnika (u dobi od 3 do 16 godina) i 2 mlađa odrasla bolesnika (u dobi od 18 do 19 godina) s rekurentnim/progresivnim/refraktornim gliomom visokog gradusa ili ependimomom.
Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles.
Obavijestite liječnika ako osjećate izrazit umor, nedostaje Vam daha ili Vam otiču stopala i zglobovi.
Therapy with Sutent should be initiated by a physician experienced in the administration of anticancer agents.
Liječenje lijekom Sutent mora započeti liječnik s iskustvom u primjeni antineoplastičnih lijekova.
Sunitinib was not clastogenic in rat bone marrow in vivo.
Sunitinib se nije pokazao klastogenim u koštanoj srži štakora in vivo.
Changes in sunitinib PK parameters were of no clinical significance and did not indicate any drug-drug interactions; however, considering the relatively low number of subjects (i.e. N=7+4) and the moderate-large interpatient variability in the pharmacokinetic parameters, caution needs to be taken when interpreting the PK drug-drug interaction findings from this study.
Međutim, s obzirom na relativno mali broj ispitanika (tj. N = 7 + 4) i umjerenu do veliku varijabilnost među bolesnicima u farmakokinetičkim parametrima, potrebno je oprezno interpretirati rezultate FK interakcije između lijekova dobivene u ovom ispitivanju.
Cases of fistula formation, sometimes associated with tumour necrosis and regression, in some cases with fatal outcomes, have been reported (see section 4.4).
Prijavljeni su slučajevi stvaranja fistule, ponekad povezani s nekrozom i regresijom tumora, u nekim slučajevima sa smrtnim ishodom (vidjeti dio 4.4).
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).
Hemoragični događaji prijavljeni tijekom kliničkih ispitivanja sunitiniba i za vrijeme praćenja nakon stavljanja lijeka u promet, od kojih su neki imali smrtni ishod, obuhvaćali su krvarenja u probavnom traktu, dišnom sustavu, mokraćnom sustavu i mozgu (vidjeti dio 4.8).