FrancophonIA/ELRC3.0 huggingface dataset:
English: Maximal plasma concentrations of imatinib in patients are 2-4 mol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered drugs is possible.
Croatian: Maksimalne koncentracije imatiniba u plazmi bolesnika iznose 2-4 mol/l pa je prema tome moguća inhibicija metabolizma istodobno primijenjenih lijekova, koji se odvija posredstvom CYP2D6 i/ili CYP3A4/5.
English: 1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Croatian: 1200 do 1600 mg (trajanje je variralo između jednog i 10 dana): mučnina, povraćanje, proljev, osip, eritem, edem, oticanje, umor, mišićni spazam, trombocitopenija, pancitopenija, bol u trbuhu, glavobolja, smanjeni apetit.
English: Patients concerned about their fertility on Glivec treatment should consult with their physician.
Croatian: Bolesnici zabrinuti radi svoje plodnosti tijekom liječenja Glivecom moraju se posavjetovati sa svojim liječnikom.
English: Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the Glivec and IFN arms, respectively.
Croatian: Sedam godina nakon uključivanja posljednjeg bolesnika, medijan trajanja prve linije liječenja bio je 82 mjeseca u Glivec kraku, odnosno 8 mjeseci u INF kraku.
English: Use in adults Your doctor will tell you exactly how many capsules of Glivec to take.
Croatian: Primjena u odraslih osoba Liječnik će Vam reći točno koliko kapsula Gliveca trebate uzeti.
English: • Use about 200 ml for each 400 mg tablet.
Croatian: • Uzmite oko 200 ml za svaku tabletu od 400 mg.
English: Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomised phase III trial, and were treated with Glivec (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Croatian: U ispitivanju I2301 ukupno 93 djece, adolescenata i mladih odraslih osoba (u dobi od 1 do 22 godine) s Ph+ ALL bilo je uključeno u otvoreno, multicentrično, sekvencijsko kohortno, nerandomizirano ispitivanje faze III u kojem su primali Glivec (340 mg/m2/dan) u kombinaciji s intenzivnom kemoterapijom nakon indukcijskog liječenja.
English: Tumour haemorrhage/tumour necrosis* Immune system disorders Not known:
Croatian: Tumorsko krvarenje/tumorska nekroza* Poremećaji imunološkog sustava Nepoznato:
English: This study included 7 patients with MDS/MPD who were treated with Glivec 400 mg daily.
Croatian: Ovo je kliničko ispitivanje uključivalo 7 bolesnika s MDS/MPD-om koji su liječeni Glivecom 400 mg na dan.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC  1 x 10
Croatian: Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu Gliveca sve dok ABN ne bude 1 x 10
English: A further 6 DFSP patients treated with Glivec were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Croatian: U 5 objavljenih prikaza slučajeva zabilježeno je dodatnih 6 bolesnika s DFSP-om liječenih Glivecom, s rasponom starosti od 18 mjeseci do 49 godina.
English: 3, pulmonary oedema
Croatian: 3, plućni edem
English: Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
Croatian: Dok je otprilike 96% bolesnika s CCyR-om, odnosno 93% bolesnika s PCyR-om nakon 12 mjeseci bilo bez progresije u ubrzanu fazu/blastičnu krizu nakon 84 mjeseca, samo je 81% bolesnika bez MCyR nakon 12 mjeseci bilo bez progresije u uznapredovali KML nakon 84 mjeseca (p<0,001 ukupno, p=0,25 između CCyR-a i PCyR-a).
English: Glivec significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the Glivec group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - nonestimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Croatian: Glivec je značajno produljio preživljenje bez recidiva bolesti, pri čemu je 75% bolesnika bilo bez recidiva nakon 38 mjeseci u Glivec skupini, u odnosu na 20 mjeseci u placebo skupini (95% CIs, [30nije moguće procijeniti], odnosno [14 - nije moguće procijeniti]); (omjer rizika = 0,398 [0,259-0,610], p<0,0001).
English: Glivec is also a treatment for adults for:
Croatian: Glivec se kod odraslih osoba također koristi za liječenje:
English: Accelerated phase is defined by the presence of any of the following: blasts  15% but < 30% in blood or bone marrow, blasts plus promyelocytes  30% in blood or bone marrow (providing < 30% blasts), peripheral blood basophils  20%, platelets < 100 x 10
Croatian: Ubrzana faza se definira prisutnošću bilo kojeg od sljedećih kriterija: blasti 15% ali <30% u krvi ili koštanoj srži, blasti plus promijelociti 30% u krvi ili koštanoj srži (što daje <30% blasta), bazofili u perifernoj krvi 20%, trombociti <100 x 10
English: Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Croatian: Aritmija, fibrilacija atrija, srčani zastoj, infarkt miokarda, angina pektoris, perikardijalna efuzija
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Croatian: Bubrežni adenom/karcinom, papilom mokraćnog mjehura i uretre, adenokarcinomi tankog crijeva, adenomi paratireoidnih žlijezda, dobroćudni i zloćudni medularni tumori nadbubrežnih žlijezda i papilomi/karcinomi nežljezdanog dijela želuca zabilježeni su uz 60 mg/kg/dan, što odgovara otprilike 1,7, odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 1,2 puta dnevne izloženosti u djece (temeljeno na AUC) kod 340 mg/m2/dan.
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Croatian: Papilom/karcinom žlijezde prepucija/klitorisa su zabilježeni pri dozama od 30 mg/kg/dan na više, što odgovara otprilike 0,5, odnosno 0,3 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 0,4 puta dnevne izloženosti u djece (temeljeno na AUC) kod 340 mg/m2/dan.
English: Figure 1 Kaplan-Meier estimates for primary recurrence-free survival endpoint (ITT population)
Croatian: Slika 1 Kaplan-Meierova procjena preživljenja bez recidiva bolesti kao primarnog ishoda (ITT populacija)
English: Intermediate 25.7 4/75 vs. 6/78
Croatian: 25,7 4/75 vs. 6/78
English: In addition, thirty-six (36) months of Glivec treatment significantly prolonged overall survival (OS) compared to 12 months of Glivec treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 8, Figure 2).
Croatian: Osim toga, trideset i šest (36) mjeseci liječenja Glivecom značajno je produljilo ukupno preživljenje (OS) u usporedbi s 12 mjeseci liječenja Glivecom (omjer rizika = 0,45 [0,22, 0,89], p=0,0187) (Tablica 8, Slika 2).
English: The risk of recurrence was thus reduced by approximately 89% as compared with placebo (hazard ratio = 0.113
Croatian: Rizik od recidiva bolesti je smanjen za otprilike 89% u usporedbi s placebom (omjer rizika = 0,113 [0,049-0,264]).
English: For doses of 400 mg and above (see dosage recommendation below) a 400 mg tablet (not divisible) is available.
Croatian: Za doze od 400 mg i više (vidjeti niže navedenu preporuku doziranja) postoji tableta od 400 mg koja se ne može prepoloviti.
English: Packs containing 20, 60, 120 or 180 film-coated tablets
Croatian: Pakiranja sadrže 20, 60, 120 ili 180 filmom obloženih tableta
English: Active substances that may have their plasma concentration altered by Glivec Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Croatian: Djelatne tvari čije bi koncentracije u plazmi Glivec mogao promijeniti Imatinib povećava srednju vrijednost Cmax i AUC simvastatina (CYP3A4 supstrat) za 2, odnosno 3,5 puta, što ukazuje na to da imatinib inhibira CYP3A4.
English: Daunorubicin 30 mg/m i.v., days 1-3, 15-16;
Croatian: Daunorubicin 30 mg/m i.v., dani 1-3, 15-16;
English: 10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Croatian: 10 Mišićno-koštana bol i srodni događaji su češće uočeni u bolesnika s KML-om, nego u GIST bolesnika.
English: Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Croatian: Novodijagnosticirani Ph+ ALL: U kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib korišten samostalno izazvao je značajno višu stopu potpunog hematološkog odgovora nego kemoterapija (96,3% u odnosu na 50%; p=0,0001).
English: Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
Croatian: Nakon pronalaska antigena, imunohistokemijske pretrage su rutinski provedene s Kit protutijelom (A-4502, poliklonski antiserum kunića, 1:100; DAKO Corporation, Carpinteria, Kalifornija) prema analizi metodom kompleksa avidin-biotin-peroksidaze.
English: AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Croatian: Ukupni bilirubin: = 1,5 GGN AST: >GGN (može biti normalan ili <GGN ako je ukupni bilirubin >GGN)
English: In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST.
Croatian: Učinkovitost Gliveca u odraslih i pedijatrijskih bolesnika temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez napredovanja bolesti u bolesnika sa KML-om, na hematološkim i citogenetskim stopama odgovora u bolesnika s Ph+ ALL-om i MDS/MPD-om, na hematološkim stopama odgovora u bolesnika s HES/KEL-om, na objektivnim stopama odgovora u odraslih bolesnika s inoperabilnim i/ili metastazirajućim GIST-om i DFSP-om te na preživljenju bez recidiva bolesti kod adjuvantnog liječenja GIST-a.
English: 9/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC  1.5 x 10
Croatian: 9/l, mijelociti+metamijelociti <5% u krvi, u krvi nema blasta i promijelocita, bazofili <20%, nema ekstramedularne zahvaćenosti], a u studijama 0102 i 0109 [ABN ≥1,5 x 10
English: One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing Glivec in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Croatian: Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) za ispitivanje Gliveca u raznim populacijama bolesnika koji pate od bolesti opasnih po život povezanih s Abl, Kit ili PDGFR protein tirozin kinazama.
English: How to store Glivec
Croatian: Kako čuvati Glivec
English: Relapsed/refractory Ph+ ALL: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
Croatian: Recidivirajući ili refraktorni Ph+ ALL: Kada je imatinib samostalno korišten u bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om, rezultirao je s odgovorom u 53 od 411 procijenjenih bolesnika, sa stopom hematološkog odgovora od 30% (9% potpuni) i stopom većeg citogenetskog odgovora od 23%.
English: The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the Glivec arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Croatian: Procijenjena stopa bolesnika bez progresije u ubrzanu fazu ili blastičnu krizu nakon 84 mjeseca bila je značajno viša u Glivec kraku u usporedbi s IFN krakom (92,5% prema 85,1%, p<0,001).
English: In the Glivec arm, patients were treated with 400 mg daily.
Croatian: U Glivec kraku, bolesnici su liječeni dozom od 400 mg na dan.
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Glivec is co-administered (see section 4.4).
Croatian: U bolesnika u kojih je obavljena tireoidektomija i koji primaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena, kada se Glivec istodobno primjenjuje (vidjeti dio 4.4).
English: Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Croatian: Zbog toga se preporučuje oprezno postupati kada se Glivec primjenjuje s CYP3A4 supstratima s uskim terapijskim prozorom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel i kvinidin).
English: Table 7 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Croatian: Tablica 7 Sažetak analiza preživljenja bez recidiva bolesti u ispitivanju Z9001 prema NIH i AFIP klasifikacijama rizika
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of Glivec daily.
Croatian: U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL-om je liječeno Glivecom od 100 mg do 1000 mg na dan.
English: Vincristine 1.3 mg/m i.v., days 1, 8, 15, 21;
Croatian: Vinkristin 1,3 mg/m i.v., dani 1, 8, 15, 21;
English: Complete blood counts must be performed regularly during therapy with Glivec.
Croatian: Tijekom terapije Glivecom mora se redovito kontrolirati kompletna krvna slika.
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Croatian: Pedijatrijska ubrzana faza KML-a i blastična kriza (početna doza 340 mg/m
English: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Croatian: Flatulencija, abdominalna distenzija, gastroezofagealni refluks, konstipacija, suhoća usta, gastritis
English: • Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
Croatian: • bol u zdjelici ponekad s mučninom i povraćanjem te neočekivanim krvarenjem iz rodnice, omaglica ili nesvjestica zbog sniženog krvnog tlaka (znakovi problema s jajnicima ili maternicom).
English: Palpitations, tachycardia, cardiac failure congestive
Croatian: Palpitacije, tahikardija, kongestivno zatajenje srca
English: This inhibition has not been observed in vivo after the administration of Glivec 400 mg and paracetamol 1000 mg. Higher doses of Glivec and paracetamol have not been studied.
Croatian: Ovakva inhibicija nije uočena in vivo nakon primjene Gliveca u dozi od 400 mg i paracetamola u dozi od 1000 mg.
English: 5, pharyngolaryngeal pain, pharyngitis
Croatian: Pleuralni izljev 5, faringolaringealna bol, faringitis
English: High
Croatian: Visoka
English: Treatment of CML patients with Glivec has been associated with neutropenia or thrombocytopenia.
Croatian: Liječenje Glivecom je kod bolesnika s KML-om povezano s neutropenijom ili trombocitopenijom.
English: Not applicable
Croatian: nije primjenjivo
English: Very dark yellow to brownish-orange film-coated tablet, round with “NVR” on one side and “SA” and score on the other side.
Croatian: Jako tamnožuta do smećkastonarančasta okrugla filmom obložena tableta, s oznakom „NVR“ na jednoj te oznakom „SA“ i urezom na drugoj strani.
English: The total number of deaths were 25 for the 12-month treatment arm and 12 for the 36-month treatment arm.
Croatian: U kraku s 12-mjesečnim liječenjem umrlo je ukupno 25 bolesnika, a u kraku s 36-mjesečnim liječenjem 12.
English: Pharmacokinetics of Glivec
Croatian: Farmakokinetika Gliveca
English: Prednisolone 60 mg/m 2/day oral
Croatian: Prednizolon 60 mg/m 2/dan peroralno
English: Treatment duration: In clinical trials, treatment with Glivec was continued until disease progression.
Croatian: Trajanje liječenja: u kliničkim ispitivanjima se liječenje Glivecom nastavljalo sve do progresije bolesti.
English: If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 260 mg/m 3.
Croatian: 2. Ako citopenija nije povezana s leukemijom, dozu Gliveca treba smanjiti na 260 mg/m
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Croatian: Hipokalemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija, giht, hiperuricemija, hiperkalcemija, hiperglikemija, hiponatremija
English: IDA 9 mg/m oral, days 1-28;
Croatian: IDA 9 mg/m peroralno, dani 1-28;
English: • adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Croatian: • odraslih i pedijatrijskih bolesnika s novodijagnosticiranom akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) uz kemoterapiju.
English: The most commonly reported ( 10%) drugrelated adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Croatian: Najčešće zabilježene nuspojave (10%) koje su povezane s primjenom lijeka, bile su u obje situacije blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
English: In the adjuvant setting, Glivec was investigated in a multicentre, double-blind, long-term, placebocontrolled phase III study (Z9001) involving 773 patients.
Croatian: Klinička ispitivanja kod adjuvantnog liječenja GIST-a U sklopu adjuvantnog liječenja, Glivec je ispitivan u multicentričnom, dvostrukoslijepom, dugotrajnom placebo kontroliranom ispitivanju faze III (Z9001) koje je uključivalo 773 bolesnika.
English: Thirty-six (36) months of Glivec treatment significantly prolonged RFS compared to 12 months of Glivec treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 8, Figure 1).
Croatian: Trideset i šest (36) mjeseci liječenja Glivecom značajno je produljilo preživljenje bez recidiva bolesti u usporedbi s 12 mjeseci liječenja Glivecom (uz ukupan omjer rizika = 0,46 [0,32, 0,65], p<0,0001) (Tablica 8, Slika 1).
English: 1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Croatian: 1, sinusitis, celulitis, infekcija gornjih dišnih puteva, gripa, infekcija mokraćnog sustava, gastroenteritis, sepsa
English: Very dark yellow to brownish-orange, ovaloid, biconvex film-coated tablet with bevelled edges, debossed with “glivec” on one side.
Croatian: Jako tamnožuta do smećkastonarančasta, ovalna, bikonveksna filmom obložena tableta ukošenih rubova te s utisnutom oznakom „glivec“ na jednoj strani.
English: Induction therapy (de novo Ph+ ALL)
Croatian: Studija AAU02 Indukcijska terapija (de novo Ph+ ALL)
English: They are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Croatian: Nalaze se u pakiranjima koja sadrže 20, 60, 120 ili 180 tableta, ali ona sva ne moraju biti dostupna u Vašoj zemlji.
English: G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Croatian: = u mišić, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2merkaptoetan sulfonat, iii= ili dok vrijednost MTX-a ne bude <0,1 µm, Gy= Gray
English: If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 400 mg. 3.
Croatian: 2. Ako citopenija nije povezana s leukemijom, dozu Gliveca treba smanjiti na 400 mg.
English: Patients were treated at doses of Glivec of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Croatian: Bolesnici su liječeni dozama Gliveca od 260 mg/m2/dan (n=5), 340 mg/m2/dan (n=9),
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with Glivec 800 mg daily.
Croatian: Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) koje je uključivalo 12 bolesnika s DFSP-om liječenih Glivecom 800 mg na dan.
English: Caution should be used when taking Glivec with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section
Croatian: Potreban je oprez kada se Glivec uzima s inhibitorima proteaze, azolnim antimikoticima, određenim makrolidima (vidjeti dio 4.5), CYP3A4 supstratima s uskim terapijskim prozorom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel, kvinidin) ili varfarinom i drugim derivatima kumarina (vidjeti dio 4.5).
English: In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses  6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
Croatian: U ispitivanju kod štakora koje je trajalo 13 tjedana zapažena je hiperplazija prijelaznog epitela u bubrežnoj papili te u mokraćnom mjehuru uz doze ≥6 mg/kg, bez promjena parametara za serum ili mokraću.
English: The starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Croatian: Početna doza je 600 mg, koja se uzima kao jedna tableta od 400 mg i 2 tablete od 100 mg jednom na dan.
English: Glivec 100 mg hard capsules EU/1/01/198/002-006
Croatian: Glivec 100 mg tvrde kapsule EU/1/01/198/002-006
English: Resume treatment with Glivec at 600 mg. 3.
Croatian: 2. Ponovno uvesti liječenje Glivecom u dozi od 600 mg.
English: ANC < 1.0 x 10
Croatian: ABN < 1,0 x 10
English: Partial 1 Haematological response criteria (all responses to be confirmed after  4 weeks): CHR: Study 0110 [WBC < 10 x 10 9/l, platelets < 450 x 10
Croatian: 3) [95% CI] Djelomični Kriteriji hematološkog odgovora (svi se odgovori moraju potvrditi nakon ≥4 tjedna): CHR: Studija 0110 [WBC <10 x 10