FrancophonIA/ELRC3.0 huggingface dataset:
English: Daily dose should not exceed 75 mg nor be decreased below 25 mg.
Croatian: Dnevna doza ne smije premašiti 75 mg niti se smije smanjiti na manje od 25 mg.
English: Subsequent dose adjustments should be based on individual safety and tolerability (see section 5.2).
Croatian: Kasnije prilagodbe doze trebaju se zasnivati na individualnoj sigurnosti i podnošljivosti (vidjeti dio 5.2).
English: You must immediately contact your doctor if you experience any of those serious side effects (see also What you need to know before you take Sutent):
Croatian: Morate se odmah javiti svom liječniku ako nastupi bilo koja od ovih ozbiljnih nuspojava (pogledajte i dio Što trebate znati prije nego počnete uzimati Sutent):
English: Stable disease was observed in 6 patients (17%).
Croatian: Stabilna bolest primijećena je u 6 bolesnika (17%).
English: Date of first authorisation: 19 July 2006 Date of latest renewal: 9 November 2016
Croatian: Datum posljednje obnove odobrenja: 9. studenog 2016.
English: Safety and tolerability
Croatian: Sigurnost i podnošljivost
English: • Decreased blood sugar level (see section 2)..
Croatian: • Smanjena razina šećera u krvi (pogledajte dio 2).
English: Other medicines and Sutent
Croatian: Drugi lijekovi i Sutent
English: Sepsis and sepsis shock.
Croatian: Sepsa i septički šok
English: The study was closed at the time of planned interim analysis due to the lack of disease control.
Croatian: Ispitivanje je bilo zaključeno u vrijeme planirane interim analize zbog nedovoljne kontrole bolesti.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da bi ste mogli biti trudni ili planirate imati dijete, pitajte svog liječnika ili ljekarnika za savjet prije uzimanja ovog lijeka.
English: Routine assessment of bleeding events should include complete blood counts and physical examination.
Croatian: Rutinska procjena događaja krvarenja treba obuhvatiti kompletnu krvnu sliku i fizikalni pregled.
English: From a 2-sided log-rank test.
Croatian: a prema dvostranom log-rang testu.
English: • Pain in arms and legs.
Croatian: • Bol u rukama i nogama.
English: If you forget to take Sutent
Croatian: Ako ste zaboravili uzeti Sutent
English: - If you are going to have surgery or if you had an operation recently.
Croatian: - ako se morate podvrgnuti kirurškom zahvatu ili ste nedavno imali operaciju.
English: Most of these findings were reversible after 2 to 6 weeks without treatment.
Croatian: Većina ovih pojava pokazala se reverzibilnima u roku od 2 do 6 tjedana nakon prekida liječenja.
English: Your doctor will decide when to start Sutent again.
Croatian: Liječnik će odlučiti kada možete ponovno početi uzimati Sutent.
English: If the diagnosis of SJS or TEN is confirmed, treatment must not be restarted.
Croatian: Ako je dijagnoza SJS ili TEN potvrđena, liječenje se ne smije ponovno započeti.
English: What Sutent is and what it is used for What you need to know before you take Sutent How to take Sutent
Croatian: Što je Sutent i za što se koristi Što morate znati prije nego počnete uzimati Sutent Kako uzimati Sutent
English: No patients had a QTc interval > 500 msec.
Croatian: Niti jedan bolesnik nije imao QTc-interval > 500 ms.
English: What Sutent looks like and contents of the pack
Croatian: Kako Sutent izgleda i sadržaj pakiranja
English: What you need to know before you take Sutent
Croatian: Što morate znati prije nego počnete uzimati Sutent
English: Patients were treated until disease progression or withdrawal from the study.
Croatian: Bolesnici su liječeni do progresije bolesti ili do izlaska iz ispitivanja.
English: Sutent is used to treat adults with the following types of cancer:
Croatian: Sutent se koristi za liječenje odraslih bolesnika koji imaju sljedeće vrste raka:
English: - If you are allergic to sunitinib or any of the other ingredients of Sutent (listed in section 6).
Croatian: - ako ste alergični na sunitinib ili neki drugi sastojak lijeka Sutent (naveden u dijelu 6.).
English: Heart problems.
Croatian: Srčani problemi.
English: Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italy
Croatian: Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italija
English: The analyses of primary and secondary endpoints in the open-label phase of the study reaffirmed the results obtained at the time of the interim analysis, as shown in Table 2:
Croatian: Analize primarnih i sekundarnih mjera ishoda u otvorenoj fazi ispitivanja potvrdile su rezultate dobivene u vrijeme interim analize, kako je prikazano u tablici 2:
English: If a dose is missed, the patient should not be given an additional dose.
Croatian: Ako bolesnik propusti dozu lijeka, ne smije mu se dati dodatna doza.
English: Your doctor will monitor your kidney function.
Croatian: Liječnik će Vam nadzirati rad bubrega.
English: Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be treated.
Croatian: Liječnik će Vam propisati odgovarajuću dozu, ovisno o vrsti raka koji se liječi.
English: PFS (weeks)
Croatian: PFS (tjedni)
English: Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: What Sutent contains
Croatian: Što Sutent sadrži
English: Sutent can be taken with or without food.
Croatian: Sutent se može uzimati s hranom ili bez nje.
English: It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.
Croatian: Koristi se za liječenje raka jer sprečava djelovanje posebne skupine proteina koji su uključeni u rast i širenje tumorskih stanica.
English: IT-63100 Marino del Tronto (Ascoli Piceno) Italy
Croatian: IT-63100 Marino del Tronto (Ascoli Piceno) Italija
English: Invasive dental procedures are also an identified risk factor.
Croatian: I invazivni stomatološki zahvati prepoznati su kao faktor rizika.
English: Secondary endpoints included TTP, duration of response (DR) and OS.
Croatian: Sekundarne mjere ishoda obuhvaćale su TTP, trajanje odgovora (DR, od engl. duration of response) i OS.
English: • Changes in the electrical activity or abnormal rhythm of the heart.
Croatian: • Promjene u električnoj aktivnosti ili nepravilan ritam otkucaja srca.
English: • Complication of severe infection (infection is present in the bloodstream) that can lead to tissue damage, organ failure, and death.
Croatian: • Komplikacija teške infekcije (infekcija je prisutna u krvotoku) koja može dovesti do oštećenja tkiva, zatajenja organa i smrti.
English: • Swelling caused by fluid under the skin and around the eye, deep allergic rash.
Croatian: • Oticanje uzrokovano tekućinom ispod kože i oko očiju, duboki alergijski osip.
English: • Extreme tiredness, loss of strength.
Croatian: • Izrazit umor, gubitak snage.
English: • High level of uric acid in the blood.
Croatian: • Visoka razina mokraćne kiseline u krvi.
English: In both the clinical study and the publications, the safety profile was consistent with the known safety profile in adults.
Croatian: U kliničkom ispitivanju i publikacijama sigurnosni profil je bio u skladu s poznatim sigurnosnim profilom u odraslih.
English: • Painful skin ulceration (pyoderma gangrenosum).
Croatian: • Bolna ulceracija kože (pyoderma gangrenosum).
English: Paediatric population The safety and efficacy of Sutent in patients below 18 years of age have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost lijeka Sutent u bolesnika mlađih od 18 godina nisu ustanovljene.
English: These data suggest that sunitinib increases the risk of cardiomyopathy.
Croatian: Ovi podaci upućuju na to da sunitinib povećava rizik od kardiomiopatije.
English: If you take more Sutent than you should
Croatian: Ako uzmete više Sutent kapsula nego što ste trebali
English: 30 capsules
Croatian: 30 kapsula
English: Available data indicate that females could have about 30% lower apparent clearance (CL/F) of sunitinib than males: this difference, however, does not necessitate starting dose adjustments.
Croatian: Dostupni podaci pokazuju da žene mogu imati 30% niži prividni klirens (CL/F) sunitiniba nego muškarci, no ta razlika ne zahtijeva prilagodbu početne doze.
English: Sutent can raise blood pressure.
Croatian: Sutent može povisiti krvni tlak.
English: Approximately one-third of the patients in clinical studies who received sunitinib were 65 years of age or over.
Croatian: Otprilike trećina bolesnika koji su u kliničkim ispitivanjima primali sunitinib imala je 65 ili više godina.
English: Nevertheless, most of these adverse events observed in clinical studies were not considered related to study treatment (see section 4.4).
Croatian: Usprkos tome, za većinu tih štetnih događaja opaženih u kliničkim ispitivanjima ne smatra se da su povezani s ispitivanim liječenjem (vidjeti dio 4.4).
English: o Stomatitis and aphtous stomatitis.
Croatian: Stomatitis i aftozni stomatitis
English: • Loss of protein in the urine sometime resulting in swelling.
Croatian: • Gubitak proteina u mokraći što ponekad rezultira oticanjem.
English: The apparent volume of distribution (Vd) for sunitinib was large, 2230 L, indicating distribution into the tissues.
Croatian: Prividni volumen raspodjele (Vd) sunitiniba je bio velik, 2230 l, što ukazuje da se raspodjeljuje u tkiva.
English: The primary efficacy endpoint of the study was TTP, defined as the time from randomisation to first documentation of objective tumour progression.
Croatian: Primarna mjera ishoda djelotvornosti u ispitivanju bio je TTP, definiran kao vrijeme od randomizacije do prve dokumentirane objektivne tumorske progresije.
English: Prior to treatment with Sutent, a dental examination and appropriate preventive dentistry should be considered.
Croatian: Prije liječenja lijekom Sutent treba razmotriti stomatološki pregled i odgovarajuće preventivne stomatološke postupke.
English: You will usually be taken off Sutent if you are having an operation.
Croatian: Obično ćete prekinuti liječenje lijekom Sutent ako idete na operaciju.
English: If you might get pregnant, you should use a reliable method of contraception during treatment with Sutent.
Croatian: Ako biste mogli zatrudnjeti, morate koristiti pouzdanu metodu kontracepcije tijekom liječenja lijekom Sutent.
English: These patients should be monitored closely and treated as clinically indicated, and prophylactic hydration should be considered.
Croatian: Ove bolesnike treba pomno nadzirati i liječiti kako je klinički indicirano, a treba razmotriti i profilaktičku hidrataciju.
English: Caution should therefore be exercised when Sutent and intravenous bisphosphonates are used either simultaneously or sequentially.
Croatian: Stoga je potreban oprez kada se Sutent i intravenski bisfosfonati primjenjuju istodobno ili jedan iza drugoga.
English: Population PK analyses of demographic data indicate that no starting dose adjustments are necessary for weight or Eastern Cooperative Oncology Group (ECOG) performance status.
Croatian: Populacijske FK analize demografskih podataka ispitanika ukazuju na to da nije potrebno prilagođavati početnu dozu s obzirom na tjelesnu težinu ili ocjenu funkcionalnog stanja prema ECOG (Eastern Cooperative Oncology Group) ljestvici.
English: These symptoms may diminish as treatment continues.
Croatian: Ovi simptomi mogu oslabjeti s nastavkom liječenja.
English: Metabolic interactions
Croatian: Metaboličke interakcije
English: - Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Croatian: - Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili se vidi da je otvarano.
English: • Increased blood level of enzyme (creatine phosphokinase) from muscle.
Croatian: • Povišena razina enzima u krvi (kreatin fosfokinaze) iz mišića.
English: If you develop a rash or these skin symptoms, seek immediate advice from a doctor.
Croatian: Ako primijetite osip ili neki navedenih kožnih simptoma, potražite odmah liječnički savjet.
English: All study participants experienced adverse drug reactions; most of these were severe (toxicity grade ≥ 3) and included cardiac toxicity.
Croatian: Svi sudionici u ispitivanju imali su nuspojave na lijek; većina ih je bila teška (stupanj toksičnosti ≥ 3) i uključivali su kardijalnu toksičnost.
English: During sunitinib treatment, routine monitoring of thyroid function should be performed every 3 months.
Croatian: Tijekom liječenja sunitinibom treba provoditi rutinske kontrole funkcije štitnjače svaka 3 mjeseca.
English: Sutent has minor influence on the ability to drive and use machines.
Croatian: Sutent malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: If you experience dizziness or you feel unusually tired, take special care when driving or using machines.
Croatian: Ako imate omaglice ili osjećate neuobičajen umor, budite posebno oprezni pri upravljanju vozilima i strojevima.
English: - If you have high blood pressure.
Croatian: - ako imate povišen krvni tlak.
English: These LVEF declines do not appear to have been progressive and often improved as treatment continued.
Croatian: Čini se da ta smanjenja LVEF-a nisu bila progresivna, a često su se poboljšala s nastavkom liječenja.
English: • Inflammation of the liver (hepatitis).
Croatian: • Upala jetre (hepatitis).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01XE04
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein-kinaze, ATK oznaka: L01XE04
English: The median DR and OS had not yet been reached.
Croatian: Medijani za trajanje odgovora i OS još nisu dostignuti.
English: - If you have abnormal heart rhythm changes.
Croatian: - ako imate neuobičajene promjene srčanog ritma.
English: The primary efficacy endpoint of this study was ORR.
Croatian: Primarna mjera ishoda djelotvornosti u ovom je ispitivanju bio je ORR.
English: Overall survival [5 years follow-up] [median, months (95% CI)]
Croatian: Ukupno preživljenje [5 godina praćenja] [medijan, mjeseci (95% CI)]
English: Food has no effect on the bioavailability of sunitinib.
Croatian: Hrana ne utječe na bioraspoloživost sunitiniba.
English: Use of somatostatin analogues was allowed in the study.
Croatian: U ispitivanju je bilo dozvoljeno korištenje analoga somatostatina.
English: Sutent should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus.
Croatian: Sutent se ne smije primjenjivati u trudnoći niti u žena koje ne koriste učinkovitu kontracepciju, osim ako moguća korist od liječenja ne opravdava mogući rizik za plod.
English: The PK were similar in all solid tumours populations tested and in healthy volunteers.
Croatian: FK je bila podjednaka u svim solidnim tumorima i u zdravih dobrovoljaca.
English: There is no specific antidote for overdose with Sutent and treatment of overdose should consist of general supportive measures.
Croatian: Ne postoji specifični antidot za predoziranje lijekom Sutent te se liječenje predoziranja sastoji od općih potpornih mjera.
English: The dose of sunitinib was reduced or its administration temporarily suspended in approximately 2.7% of the patients who experienced hypertension.
Croatian: Doza sunitiniba bila je smanjena ili je njegova primjena privremeno prekinuta u približno 2,7% bolesnika u kojih je nastupila hipertenzija.
English: You should avoid drinking grapefruit juice while on treatment with Sutent.
Croatian: Morate izbjegavati sok od grejpa dok se liječite lijekom Sutent.
English: Hypothyroidism may develop during treatment.
Croatian: Tijekom liječenja može se razviti hipotireoza.
English: Based on the modelling analyses, the younger age and lower body size did not appear to affect negatively the safety and efficacy responses to sunitinib plasma exposures.
Croatian: Na temelju analiza modeliranjem, čini se da mlađa dob i manja tjelesna veličina nisu negativno utjecali na sigurnost i djelotvornost izloženosti sunitinibu u plazmi.
English: Hypertension was a very common adverse reaction reported in clinical trials.
Croatian: Hipertenzija je bila vrlo česta nuspojava prijavljena u kliničkim ispitivanjima.
English: One patient with GIST was enrolled at the 15 mg/m dose level with no evidence of benefit.
Croatian: Jedan bolesnik s GIST-om uključen je u ispitivanje pri razini doze od 15 mg/m bez dokaza o koristi.
English: In the dosing ranges of 25 to 100 mg, the area under the plasma concentration-time curve (AUC) and Cmax increase proportionally with dose.
Croatian: U rasponu doza od 25 do 100 mg, površina ispod krivulje koncentracija: vrijeme u plazmi (AUC) i Cmax rastu proporcionalno s dozom.
English: If you are taking warfarin or acenocoumarole, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
Croatian: Ako uzimate varfarin ili acenokumarol, lijekove koji sprečavaju nastanak krvnih ugrušaka, rizik od krvarenja može biti povećan.
English: Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Croatian: Zabilježeni su slučajevi proteinurije te rijetki slučajevi nefrotskog sindroma.
English: e Cellulitis and skin infection.
Croatian: Celulitis i kožne infekcije
English: It is available in plastic bottles of 30 capsules and in perforated unit dose blisters containing 28 x 1 capsules.
Croatian: Lijek je dostupan u plastičnim bočicama koje sadrže 30 kapsula i u perforiranim blisterima djeljivima na jedinične doze koji sadrže 28 x 1 kapsulu.
English: A sensitivity analysis of PFS was conducted where progression was based upon investigator-reported tumour measurements and where all subjects censored for reasons other than study termination were treated as PFS events.
Croatian: Provedena je analiza osjetljivosti za PFS u kojoj se progresija temeljila na mjerenjima tumora koja su proveli ispitivači i u kojoj su svi ispitanici u kojih je liječenje prekinuto zbog drugog razloga osim završetka ispitivanja tretirani kao da se kod njih radi o PFS događajima.
English: - Do not use this medicine after the expiry date which is stated on carton, bottle and blister foil after “EXP”.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, bočici i blisteru iza „Rok valjanosti“/“EXP“
English: Prolonged treatment with sunitinib did not appear to be associated with new types of TRAEs.
Croatian: Čini se da produljeno liječenje sunitinibom nije povezano s novim tipovima TRAE.
English: − pNET: the usual dose is 37.5 mg once daily without a rest period.
Croatian: - pNET-a: uobičajena doza je 37,5 mg jedanput na dan bez razdoblja odmora.
English: • Dehydration.
Croatian: • Dehidracija.
English: - If you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Sutent in particular when you are also receiving or have received intravenous bisphosphonates.
Croatian: - Ako se morate podvrgnuti invazivnom stomatološkom postupku ili operaciji zuba, recite stomatologu da uzimate Sutent, a naročito ako primate ili ste primali intravenske bisfosfonate.
English: The genotoxic potential of sunitinib was assessed in vitro and in vivo.
Croatian: Genotoksični potencijal sunitiniba ispitivan je in vitro i in vivo.
English: Cases of overdose have been reported; some cases were associated with adverse reactions consistent with the known safety profile of sunitinib.
Croatian: Prijavljeni su slučajevi predoziranja; neki od slučajeva bili su povezani s nuspojavama koje su u skladu s poznatim sigurnosnim profilom sunitiniba.
English: No subjects experienced an effect on the QTc interval greater than Grade 2 (CTCAE version 3.0) (see section 4.4).
Croatian: Niti u jednog ispitanika učinak na QTc-interval nije bio veći od 2. stupnja (CTCAE verzija 3.0) (vidjeti dio 4.4).
English: Therefore, the decision to resume sunitinib therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.
Croatian: Stoga se odluka o nastavku liječenja sunitinibom nakon većeg kirurškog zahvata treba temeljiti na kliničkoj procjeni oporavka od operacije.
English: It is unknown whether patients with these concomitant conditions may be at a higher risk of developing sunitinib-related left ventricular dysfunction.
Croatian: Nije poznato jesu li bolesnici s ovim popratnim bolestima izloženi većem riziku za razvoj poremećaja funkcije lijeve klijetke povezanih s sunitinibom.
English: • Abnormal sensations in extremities.
Croatian: • Neuobičajeni osjeti u udovima.
English: Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.
Croatian: Bifosfonati su lijekovi za sprečavanje komplikacija na kostima koji su Vam možda propisani za liječenje neke druge bolesti.
English: Four of these 7 GIST patients discontinued treatment following first observation of DVT.
Croatian: Četiri od spomenutih 7 bolesnika s GIST-om prekinula su liječenje nakon prve pojave simptoma DVT-a.
English: In these paediatric patients without previous exposure to anthracyclines or cardiac irradiation, the maximum tolerated dose (MTD) has been identified (see section 5.1).
Croatian: U ovih pedijatrijskih bolesnika bez prethodne izloženosti antraciklinima ili zračenju srca određena je maksimalna podnošljiva doza (engl. maximum tolerated dose, MTD) (vidjeti dio 5.1).
English: Minor metabolites were identified in urine and faeces, but generally were not found in plasma.
Croatian: Sporedni metaboliti nađeni su u mokraći i fecesu, ali u pravilu nisu uočeni u plazmi.
English: a Results of double-blind treatment are from the ITT population and using central radiologist measurement, as appropriate.
Croatian: a Rezultati dvostruko slijepog liječenja odnose se na ITT populaciju i centralnu radiološku ocjenu, kad je primjereno.
English: • Weight loss.
Croatian: • Gubitak tjelesne težine.
English: After oral administration of sunitinib, Cmax are generally observed from 6 to 12 hours time to maximum concentration (tmax) postadministration.
Croatian: Nakon peroralne primjene sunitiniba Cmax se u pravilu bilježi u roku od 6 do 12 sati do maksimalne koncentracije (tmax) nakon uzimanja.
English: Before initiating sunitinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka Sutent potrebno je pažljivo razmotriti ovaj rizik u bolesnika s faktorima rizika poput hipertenzije ili aneurizme u anamnezi.
English: Dose-limiting cardiotoxicity was observed in the first part of the study which was therefore amended to exclude patients with previous exposure to potentially cardiotoxic therapies (including anthracyclines) or cardiac radiation.
Croatian: Kardiotoksičnost koja ograničava dozu zabilježena je u prvom dijelu ispitivanja koje je stoga izmijenjeno kako bi se isključili bolesnici s prethodnom izloženošću potencijalno kardiotoksičnim terapijama (uključujući antracikline) ili zračenju srca.
English: • Heart attack caused by an interrupted or decreased blood supply to the heart.
Croatian: • Srčani udar prouzročen prekidom ili smanjenjem opskrbe srca krvlju.
English: 28 x 1 hard capsules
Croatian: 28 x 1 tvrda kapsula
English: - If you have had a recent problem with blood clots in your veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Croatian: - ako ste nedavno imali tegobe s krvnim ugrušcima u venama i/ili arterijama (vrste krvnih žila), uključujući moždani udar, srčani udar, emboliju ili trombozu.
English: • Reduction in the number of platelets, red blood cells and/or white blood cells (e.g. neutrophils).
Croatian: • Smanjenje broja krvnih pločica, crvenih krvnih stanica i/ili bijelih krvnih stanica (primjerice neutrofila).