FrancophonIA/ELRC3.0 huggingface dataset:
English: Four 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).
Croatian: Štetni događaji 3.-4. stupnja povezani s liječenjem pojavili su se u 4 od 6 bolesnika (66,7 %) (hipofosfatemija, neutropenija i trombocitopenija 3. stupnja prijavljene su svaka u 1 bolesnika, dok je neutropenija 4. stupnja prijavljena u 1 bolesnika).
English: 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.
Croatian: Provedeno je i potvrdno, otvoreno, multicentrično ispitivanje djelotvornosti i sigurnosti sunitiniba s jednom skupinom bolesnika s MRCC-om koji nisu reagirali na prethodnu citokinsku terapiju.
English: BLISTER - 37.5 MG CAPSULES
Croatian: BLISTER- 37,5 mg KAPSULE
English: • Decreased activity of thyroid gland (hypothyroidism).
Croatian: • Smanjena aktivnost štitnjače (hipotireoza).
English: Co-administration of sunitinib with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5).
Croatian: Treba izbjegavati istodobnu primjenu sunitiniba sa snažnim inhibitorima CYP3A4, kakav je ketokonazol (vidjeti dijelove 4.4 i 4.5).
English: Cases with fatal outcome have been observed in the postmarketing surveillance.
Croatian: Zabilježeni su slučajevi sa smrtnim ishodom nakon stavljanja lijeka u promet.
English: In patients receiving sunitinib for treatment-naïve MRCC, 39% had bleeding events vs 11% of patients receiving interferon- (IFN-α).
Croatian: Događaje krvarenja imalo je 39% bolesnika koji su za liječenje prethodno neliječenog MRCC-a primali sunitinib, u usporedbi s 11% bolesnika koji su primali interferon alfa (IFN-α).
English: Baseline laboratory measurement of thyroid function is recommended in all patients.
Croatian: Preporučuje se odrediti laboratorijske parametre funkcije štitnjače prije početka liječenja u svih bolesnika.
English: Cytokine-refractory metastatic renal cell carcinoma A Phase 2 study of sunitinib was conducted in patients who were refractory to prior cytokine therapy with interleukin-2 or IFN-.
Croatian: Provedeno je kliničko ispitivanje sunitiniba faze II u bolesnika koji nisu reagirali na prethodnu citokinsku terapiju interleukinom-2 ili IFN-α.
English: - Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery.
Croatian: - metastatski karcinom bubrežnih stanica (MRCC), jednu vrstu raka bubrega koji se proširio u druge dijelove tijela. - neuroendokrine tumore gušterače (pNET) (tumore stanica gušterače koje luče hormone) koji su uznapredovali ili se ne mogu kirurški odstraniti.
English: Treatment-naïve metastatic renal cell carcinoma
Croatian: Metastatski karcinom bubrežnih stanica refraktoran na citokine
English: Sutent 37.5 mg hard capsules
Croatian: Sutent 37,5 mg tvrde kapsule
English: Concomitant administration of sunitinib with potent CYP3A4 inhibitors should be limited because of the possible increase in sunitinib plasma concentrations (see sections 4.2, 4.5 and 4.8).
Croatian: Istodobnu primjenu sunitiniba sa snažnim inhibitorima CYP3A4 treba ograničiti zbog mogućeg povećanja koncentracija sunitiniba u plazmi (vidjeti dijelove 4.2, 4.5 i 4.8).
English: If this is not possible, the dose of sunitinib may need to be increased in 12.5 mg steps (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET) based on careful monitoring of tolerability.
Croatian: Ako to nije moguće, možda će biti potrebno povećavati dozu sunitiniba u koracima od 12,5 mg (do 87,5 mg na dan za GIST i MRCC odnosno 62,5 mg na dan za pNET), uz pažljivo praćenje podnošljivosti.
English: Hyperthyroidism was reported in 4 (1.7%) patients on sunitinib and no patients on capecitabine.
Croatian: Hipertireoza je zabilježena u 4 (1,7%) bolesnika na sunitinibu i niti jednog bolesnika na terapiji kapecitabinom.
English: • Nasal dryness, congested nose.
Croatian: • Suhoća nosa, začepljen nos.
English: Hepatotoxicity has been observed in patients treated with sunitinib.
Croatian: U bolesnika liječenih sunitinibom zabilježena je hepatotoksičnost.
English: Blood TSH increase was reported in 1 (0.9%) patient on sunitinib and no patients on standard of care.
Croatian: Povećanje TSH-a u krvi zabilježeno je u 1 (0,9%) bolesnika na sunitinibu i ni u jednog bolesnika na standardnom liječenju.
English: Seizures have been observed in patients with or without radiological evidence of brain metastases (see section
Croatian: Napadaji su zabilježeni u bolesnika koji su imali, kao i u onih koji nisu imali radiološki potvrđene metastaze u mozgu (vidjeti dio 4.4).
English: A clinically significant advantage in investigator-assessed PFS for sunitinib over placebo was observed.
Croatian: Opažena je klinički značajna prednost sunitiniba u odnosu na placebo u pogledu PFS-a kojeg su procijenili ispitivači.
English: Sutent 12.5 mg hard capsules
Croatian: Sutent 12,5 mg tvrde kapsule
English: BLISTER - 50 MG CAPSULES
Croatian: BLISTER- 50 mg KAPSULE
English: Sutent 50 mg hard capsules
Croatian: Sutent 50 mg tvrde kapsule
English: BLISTER - 25 MG CAPSULES
Croatian: BLISTER- 25 MG KAPSULE
English: Uncommon cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported (see section 4.8).
Croatian: Slučajevi nekrotizirajućeg fasciitisa, uključujući i perineuma, ponekad sa smrtnim ishodom, prijavljeni su manje često (vidjeti dio 4.8).
English: Periorbital oedema Eyelid oedema Lacrimation increased
Croatian: Poremećaji oka periorbitalni edem edem vjeđa pojačano suzenje
English: Other endpoints included OS, ORR, PROs, and safety.
Croatian: Ostale mjere ishoda obuhvaćale su OS, ORR, ishode koje su prijavili bolesnici te sigurnost primjene.
English: Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with sunitinib (see section 4.8).
Croatian: U bolesnika koji se liječe sunitinibom treba provjeriti kompletnu krvnu sliku na početku svakog ciklusa liječenja (vidjeti dio 4.8).
English: Sutent 25 mg hard capsules
Croatian: Sutent 25 mg tvrde kapsule
English: - If you have or have had pancreatic or gallbladder disorders.
Croatian: - ako imate ili ste ranije imali poremećaje gušterače ili žučnog mjehura.
English: However, the discontinuation rates due to adverse events were 20% for sunitinib and 23% for IFN-α.
Croatian: Međutim, stope bolesnika koji su prekinuli liječenje zbog nuspojava bile su 20% u skupini koja je primala sunitinib i 23% u skupini koja je primala interferon alfa.
English: Aspartate aminotransferase increased Alanine aminotransferase increased Blood creatinine increased Blood pressure increased Blood uric acid increased
Croatian: Pretrage smanjenje tjelesne težine smanjen broj bijelih krvnih stanica povišene razine lipaze smanjen broj trombocita snižene vrijednosti hemoglobina povišene razine amilaze povišene razine aspartat aminotransferaze povišene razine alanin aminotransferaze povišene vrijednosti kreatinina u krvi povišeni krvni tlak povišene vrijednosti mokraćne kiseline u krvi povišene vrijednosti kreatin fosfokinaze u krvi povišene razine hormona koji stimulira štitnjaču u krvi
English: Impaired wound healing Cases of impaired wound healing have been reported during sunitinib therapy.
Croatian: Otežano cijeljenje rana Tijekom liječenja sunitinibom zabilježeni su slučajevi otežanog cijeljenja rana.
English: Effects on male fertility in rat were observed in the form of tubular atrophy in the testes, reduction of spermatozoa in epididymides, and colloid depletion in prostate and seminal vesicles at plasma exposure levels 25 times the systemic exposure in humans.
Croatian: Opažen je učinak na plodnost mužjaka štakora pri izloženosti koncentracijama u plazmi 25 puta većima od sistemske izloženosti u ljudi, koji se ispoljio u obliku tubularne atrofije testisa, smanjenja spermatozoida u epididimisima te koloidnoj depleciji u prostati i sjemenim mjehurićima.
English: - Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Croatian: - Tinta za označavanje: šelak, propilenglikol, kalijev hidroksid i crni željezov oksid (E172).
English: The most common adverse drug reactions were gastrointestinal (GI) toxicity, neutropenia, fatigue, and ALT elevation.
Croatian: Najčešće nuspojave bile su toksični učinak na probavni sustav, neutropenija, umor i povišenje ALT-a.
English: Cases of renal impairment, renal failure and/or acute renal failure, in some cases with fatal outcome, have been reported (see section 4.8).
Croatian: Zabilježeni su slučajevi oštećenja bubrega, zatajivanja bubrega i/ili akutnog zatajenja bubrega, u nekim slučajevima sa smrtnim ishodom (vidjeti dio 4.8).
English: HDPE BOTTLE - 12.5 MG CAPSULES
Croatian: HDPE BOČICA - 12,5 mg KAPSULE
English: If this is not possible, the dose of Sutent may need to be increased in 12.5 mg increments (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET), based on careful monitoring of tolerability (see section 4.2).
Croatian: Ako to nije moguće, možda će biti potrebno povećavati dozu lijeka Sutent u koracima od 12,5 mg (do 87,5 mg na dan za GIST i MRCC odnosno 62,5 mg na dan za pNET), uz pažljivo praćenje podnošljivosti (vidjeti dio 4.2).
English: Abbreviations: CI=confidence interval; N=number of patients; NA=not applicable; pNET=pancreatic neuroendocrine tumours; RECIST=response evaluation criteria in solid tumours.
Croatian: Kratice: CI = interval pouzdanosti, N = broj bolesnika, NA = nije primjenjivo, pNET = neuroendokrini tumori gušterače; RECIST = kriteriji za ocjenu odgovora kod solidnih tumora. dvostrani nestratificirani log-rang test Fisherov egzaktni test
English: Blood TSH increase was reported in 12 (5.0%) patients on sunitinib and no patients on capecitabine.
Croatian: Povećanje TSH-a u krvi zabilježeno je u 12 (5,0%) bolesnika na sunitinibu i niti jednog bolesnika na terapiji kapecitabinom.
English: 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.
Croatian: Karcinomi Brunnerovih žlijezda dvanaesnika javili su se u ženki pri dozi od ≥ 1 mg/kg na dan, a u mužjaka pri dozi od 3 mg/kg na dan, dok se hiperplazija mukoznih stanica vidjela u glandularnom tkivu želuca u mužjaka pri dozi od 3 mg/kg na dan.
English: Hyperthyroidism Thyroiditis
Croatian: Endokrini poremećaji hipotireoza hipertireoza tiroiditis
English: Co-administration of sunitinib with potent CYP3A4 inducers or inhibitors should be avoided because the plasma levels of sunitinib may be altered (see sections 4.4 and 4.5).
Croatian: Treba izbjegavati istodobnu primjenu sunitiniba sa snažnim induktorima ili inhibitorima CYP3A4 jer se mogu promijeniti plazmatske razine sunitiniba (vidjeti dijelove 4.4 i 4.5).
English: Your thyroid function should be checked before you take Sutent and regularly while you are taking it.
Croatian: Liječnik će Vam kontrolirati funkciju štitnjače prije i redovito tijekom liječenja lijekom Sutent.
English: T3 increase was reported in 1 (0.8%) patient on sunitinib and no patients on capecitabine.
Croatian: Povećanje T3 zabilježeno je u 1 (0,8%) bolesnika na sunitinibu i niti jednog bolesnika na terapiji kapecitabinom.
English: HDPE BOTTLE - 37.5 MG CAPSULES
Croatian: HDPE BOČICA - 37,5 mg KAPSULE
English: Reduced offspring body weights were observed during the preweaning and postweaning periods at 3 mg/kg/day.
Croatian: Pri dozi od 3 mg/kg na dan opaženo je smanjenje tjelesne težine mladunčadi u razdoblju prije i nakon odbijanja od sisanja.
English: Hypersensitivity Angioedema
Croatian: Poremećaji imunološko g sustava preosjetljivost angioedem
English: If this is not possible, the dose of Sutent may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of tolerability (see section 4.2).
Croatian: Ako to nije moguće, možda će biti potrebno smanjiti dozu lijeka Sutent do najmanje 37,5 mg na dan za GIST i MRCC odnosno 25 mg na dan za pNET), uz pažljivo praćenje podnošljivosti (vidjeti dio 4.2).
English: Sutent 37.5 mg hard capsules sunitinib
Croatian: Sutent 37,5 mg tvrde kapsule sunitinib
English: - Capsule shell: gelatin, red iron oxide (E172), and titanium dioxide (E171).
Croatian: - Ovojnica kapsule: želatina, crveni željezov oksid (E172) i titanijev dioksid (E171).
English: Propylene glycol Potassium hydroxide Black iron oxide (E172)
Croatian: Tinta za označavanje šelak propilenglikol kalijev hidroksid željezov oksid, crni (E172)
English: Sutent 50 mg hard capsules sunitinib
Croatian: Sutent 50 mg tvrde kapsule sunitinib
English: If this is not possible, the dose of sunitinib may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of tolerability.
Croatian: Ako to nije moguće, možda će biti potrebno smanjiti dozu sunitiniba do najmanje 37,5 mg na dan za GIST i MRCC odnosno 25 mg na dan za pNET), uz pažljivo praćenje podnošljivosti.
English: Necrotising fasciitis*
Croatian: nekrotizirajući fasciitis* bakterijske infekcije
English: • Cough.
Croatian: • Kašalj.
English: HDPE BOTTLE - 25 MG CAPSULES
Croatian: HDPE BOČICA - 25 mg KAPSULE
English: b Bronchitis, lower respiratory tract infection, pneumonia, and respiratory tract infection.
Croatian: Infekcije i infestacije virusne infekcije a infekcije dišnog sustava b,
English: Cases of TLS, some fatal, have been rarely observed in clinical trials and have been reported in postmarketing surveillance in patients treated with sunitinib.
Croatian: Sindrom lize tumora (engl. tumour lysis syndrome, TLS) U bolesnika liječenih sunitinibom rijetko su u kliničkim ispitivanjima opaženi i u praćenju nakon stavljanja lijeka na tržište prijavljeni slučajevi TLS-a, ponekad sa smrtnim ishodom.
English: Thirteen patients (3%) receiving sunitinib in the Phase 3 treatment-naïve MRCC study and 4 patients (2%) on the 2 cytokine-refractory MRCC studies had venous thromboembolic events reported.
Croatian: Venski tromboembolijski događaji prijavljeni su u 13 bolesnika (3%) liječenih sunitinibom u ispitivanju prethodno neliječenog MRCC-a faze III i u 4 bolesnika (2%) u 2 ispitivanja MRCC-a refraktornog na citokine.
English: Cases of pulmonary embolism with fatal outcome have been observed in postmarketing surveillance.
Croatian: U praćenju nakon stavljanja lijeka u promet zabilježeni su slučajevi plućne embolije sa smrtnim ishodom.
English: HDPE BOTTLE - 50 MG CAPSULES
Croatian: HDPE BOČICA - 50 mg KAPSULE
English: Medicinal products that may decrease sunitinib plasma concentrations Effect of CYP3A4 inducers
Croatian: Lijekovi koji mogu sniziti koncentracije sunitiniba u plazmi
English: Sutent 25 mg hard capsules sunitinib
Croatian: Sutent 25 mg tvrde kapsule sunitinib
English: Sutent 12.5 mg hard capsules sunitinib
Croatian: Sutent 12,5 mg tvrde kapsule sunitinib
English: GIST summary of efficacy endpoints (ITT population) Double-blind treatment a
Croatian: Tablica 2 Sažetak mjera ishoda djelotvornosti za GIST (ITT populacija)
English: 37.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
Croatian: Tvrde kapsule od 37,5 mg Jedna kapsula sadrži 37,5 mg sunitiniba u obliku sunitinibmalata.
English: Venous thromboembolic events were reported for 1 (1.2%) patient in the sunitinib arm and 5 (6.1%) patients in the placebo arm in the Phase 3 pNET study.
Croatian: U ispitivanju pNET-a faze III, venski tromboembolijski događaji prijavljeni su u 1 (1,2%) bolesnika u skupini na sunitinibu i u 5 (6,1%) bolesnika u placebo skupini.
English: (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
Croatian: U ispitivanjima u pedijatrijskih bolesnika početna doza sunitiniba iznosila je 15 mg/m2 (na temelju maksimalne podnošljive doze zapažene u ispitivanju faze I u kojem se ispitivalo povećanje doze, vidjeti dio 5.1) te je u pedijatrijskih bolesnika s GIST-om bila povećana na 22,5 mg/m2, a potom na 30 mg/m2 (bez prekoračenja ukupne doze od 50 mg/dan), na temelju sigurnosti primjene/podnošljivosti u pojedinog bolesnika.
English: 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.
Croatian: Ako dođe do pojave hemolitičke anemije, trombocitopenije, umora, fluktuirajućih neuroloških manifestacija, oštećenja bubrega i vrućice, potrebno je uzeti u obzir dijagnozu TMA, uključujući trombotičku trombocitopeničnu purpuru (TTP) i hemolitički uremički sindrom (HUS), što ponekad rezultira zatajenjem bubrega ili smrtnim ishodom.
English: Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation were reported in patients with intra-abdominal malignancies treated with sunitinib.
Croatian: U bolesnika s intraabdominalnim malignim tumorima liječenih sunitinibom prijavljene su ozbiljne gastrointestinalne komplikacije, ponekad sa smrtnim ishodom, uključujući i gastrointestinalne perforacije.
English: Blood TSH decrease was reported in 3 (1.3%) patients on sunitinib and no patients on capecitabine.
Croatian: Pad TSH-a u krvi zabilježen je u 3 (1,3%) bolesnika na sunitinibu i niti jednog bolesnika na terapiji kapecitabinom.
English: Seventeen (4.5%) patients on sunitinib versus 5 (1.7%) patients on IFN-α experienced Grade 3 or greater bleeding events.
Croatian: Krvarenje 3. ili većeg stupnja imalo je 17 bolesnika (4,5%) koji su dobivali sunitinib naspram 5 bolesnika (1,7%) liječenih interferonom alfa.
English: Red iron oxide (E172) Titanium dioxide (E171)
Croatian: Ovojnica kapsule želatina željezov oksid, crveni (E172) titanijev dioksid (E171)
English: 12.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
Croatian: Tvrde kapsule od 12,5 mg Jedna kapsula sadrži 12,5 mg sunitiniba u obliku sunitinibmalata.
English: h Thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and haemolytic uraemic syndrome.
Croatian: Abdominalni apsces, abdominalna sepsa, divertikulitis i osteomijelitis Trombotička mikroangiopatija, trombotička trombocitopenična purpura, hemolitički uremički sindrom Smanjen tek i anoreksija
English: The other ingredients are: - Capsule content: mannitol, croscarmellose sodium, povidone (K-25), and magnesium stearate.
Croatian: - Sadržaj kapsule: manitol, umrežena karmelozanatrij, povidon (K-25) i magnezijev stearat.
English: c Abscess, abscess limb, anal abscess, gingival abscess, liver abscess, pancreatic abscess, perineal abscess, perirectal abscess, rectal abscess, subcutaneous abscess, and tooth abscess.
Croatian: Bronhitis, infekcija donjih dišnih putova, pneumonija i infekcija dišnih putova Apsces, apsces na ekstremitetu, analni apsces, gingivalni apsces, apsces jetre, apsces gušterače, perinealni apsces, perirektalni apsces, rektalni apsces, potkožni apsces i zubni apsces Ezofagealna kandidijaza i kandidijaza usne šupljine
English: Uncommon: may affect up to 1 in 100 people
Croatian: Manje česte nuspojave: mogu se javiti u manje od 1 na 100 osoba
English: Other endpoints included ORR, OS, and safety.
Croatian: Ostale mjere ishoda obuhvaćale su stopu objektivnog odgovora, OS i sigurnost primjene.
English: Co-administration with potent CYP3A4 inducers should be avoided because it may decrease sunitinib plasma concentration (see sections 4.2 and 4.5).
Croatian: Treba izbjegavati istodobnu primjenu sa snažnim induktorima CYP3A4 jer oni mogu smanjiti koncentraciju sunitiniba u plazmi (vidjeti dijelove 4.2 i 4.5).
English: Sutent 12.5 mg hard capsules EU/1/06/347/001
Croatian: Sutent 12,5 mg tvrde kapsule EU/1/06/347/001
English: A Phase 3, randomised, multi-centre, international study evaluating the efficacy and safety of sunitinib compared with IFN- in treatment-naïve MRCC patients was conducted.
Croatian: Prethodno neliječen metastatski karcinom bubrežnih stanica Provedeno je randomizirano, multicentrično, međunarodno ispitivanje faze III u svrhu procjene djelotvornosti i sigurnosti sunitiniba u usporedbi s IFN-α u bolesnika s metastatskim karcinomom bubrežnih stanica koji prethodno nisu bili liječeni.
English: 50 mg hard capsules Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
Croatian: Tvrde kapsule od 50 mg Jedna kapsula sadrži 50 mg sunitiniba u obliku sunitinibmalata.
English: - Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Croatian: - Ovojnica kapsule: želatina, titanijev dioksid (E171) i žuti željezov oksid (E172).
English: p Abdominal pain, abdominal pain lower, and abdominal pain upper.
Croatian: Bol u abdomenu, bol u donjem dijelu abdomena i bol u gornjem dijelu abdomena Gastrointestinalna perforacija i intestinalna perforacija Kolitis i ishemijski kolitis
English: Sutent 37.5 mg hard capsules EU/1/06/347/007
Croatian: Sutent 37,5 mg tvrde kapsule EU/1/06/347/007
English: The other ingredients are: - Capsule content: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.
Croatian: - Sadržaj kapsule: manitol (E421), umrežena karmelozanatrij, povidon (K-25) i magnezijev stearat.
English: The PK of gefitinib (250 mg daily) and sunitinib (37.5 mg [Cohort 1, n=4] or 50 mg [Cohort 2, n=7] daily on a 4-weeks on followed by 2 weeks-off schedule) when co-administered was evaluated as a secondary study objective.
Croatian: U multicentričnom, otvorenom ispitivanju faze I/II, tijekom kojeg se ispitivala sigurnost/podnošljivost, maksimalna podnošljiva doza i antitumorska aktivnost sunitiniba u kombinaciji s gefitinibom u ispitanika s MRCC-om, farmakokinetika gefitiniba (250 mg na dan) kod istodobne primjene sa sunitinibom (37,5 mg [kohorta 1, n = 4] ili 50 mg [kohorta 2, n = 7] na dan prema shemi liječenja s 4 tjedna primjene lijeka nakon kojih slijedi 2 tjedna bez lijeka) procijenjena je kao sekundarni cilj ispitivanja.
English: Sutent 25 mg hard capsules EU/1/06/347/002
Croatian: Sutent 25 mg tvrde kapsule EU/1/06/347/002
English: Medicinal products that may increase sunitinib plasma concentrations Effect of CYP3A4 inhibitors
Croatian: Lijekovi koji mogu povisiti koncentracije sunitiniba u plazmi
English: 25 mg hard capsules Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.
Croatian: Tvrde kapsule od 25 mg Jedna kapsula sadrži 25 mg sunitiniba u obliku sunitinibmalata.
English: You should not breast-feed during treatment with Sutent.
Croatian: Nemojte dojiti dok uzimate Sutent.
English: • Dizziness.
Croatian: • Omaglica.
English: Sutent 50 mg hard capsules EU/1/06/347/003
Croatian: Sutent 50 mg tvrde kapsule EU/1/06/347/003
English: Co-administration with potent CYP3A4 inhibitors should be avoided because it may increase the plasma concentration of sunitinib (see sections 4.2 and 4.5).
Croatian: Treba izbjegavati istodobnu primjenu sa snažnim inhibitorima CYP3A4 jer oni mogu povećati koncentraciju sunitiniba u plazmi (vidjeti dijelove 4.2 i 4.5).
English: Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules.
Croatian: Na kapici je bijelom tintom otisnuta oznaka "Pfizer", a na tijelu "STN 12.5 mg".
English: Hypothyroidism
Croatian: Hipoglikemija
English: Gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, and containing yellow to orange granules.
Croatian: Na kapici je crnom tintom otisnuta oznaka "Pfizer", a na tijelu "STN 37.5 mg".