FrancophonIA/ELRC3.0 huggingface dataset:
English: - Imatinib Teva B.V. is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Croatian: - Imatinib Teva B.V. se ne smije upotrebljavati tijekom trudnoće, osim ako to nije neophodno.
English: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Croatian: - Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
English: Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance.
Croatian: Iz skupine potencijalnih lijekova za istodobnu primjenu (acetaminofen, aciklovir, alopurinol, amfotericin, citarabin, eritromicin, flukonazol, hidroksiureja, norfloksacin, penicilin V) samo su eritromicin (IC50 50 µM) i flukonazol (IC50 118 µM) pokazali da inhibiraju metabolizam imatiniba što bi moglo biti klinički značajno.
English: Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Croatian: Daunorubicin 45 mg/m2 i.v., dani 6-7, 13-14
English: There were a total of 397 patients consented and randomised to the study (199 patients on 12-month arm and 198 patients on 36-month arm), median age was 61 years (range 22 to 84 years).
Croatian: (199 bolesnika u 12-mjesečni krak i 198 bolesnika u 36-mjesečni krak), pri čemu je medijan starosti bio 61 godina (raspon od 22 do 84 godina).
English: Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
Croatian: Daunorubicin 30 mg/m2 i.v., dani 1-3, 15-16;
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see
Croatian: Zbog moguće pojave sindroma lize tumora, prije početka terapije imatinibom preporučuje se korekcija klinički značajne dehidracije i liječenje visokih razina mokraćne kiseline (vidjeti dio 4.8).
English: ULN = upper limit of normal for the institution
Croatian: GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
English: Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
Croatian: nekim je slučajevima došlo do akutnog zatajenja jetre ili fulminantnog hepatitisa, što je dovelo do transplantacije jetre ili smrtnog ishoda (vidjeti dio 4.4).
English: Thirty-six (36) months of imatinib treatment significantly prolonged RFS compared to 12 months of imatinib treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 7, Figure 1).
Croatian: Trideset i šest (36) mjeseci liječenja imatinibom značajno je produljilo preživljenje bez recidiva bolesti u usporedbi s 12 mjeseci liječenja imatinibom (uz ukupan omjer rizika = 0,46 [0,32, 0,65], p<0,0001) (Tablica 7, Slika 1).
English: Start 6-MP the 1st day after cranial irradiation completion.)
Croatian: 6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1-og dana nakon završetka kranijalne iradijacije.)
English: Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Croatian: Imatinib je mala molekula, inhibitor protein-tirozin kinaze, koji potentno inhibira aktivnost Bcr-Abl tirozin kinaze (TK), kao i nekoliko TK receptora: Kit, receptor za faktor matičnih stanica (SCF, engl. stem cell factor) kodiran c-Kit protoonkogenom, receptore za diskoidinsku domenu (DDR1 i DDR2, engl. discoidin domain receptors), receptor za faktor stimulacije kolonija (CSF-1R, engl. colony stimulating factor receptor) te alfa i beta receptore za faktor rasta koji potječe od trombocita (PDGFR-alfa i PDGFR-beta).
English: The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Croatian: Najčešće zabilježene nuspojave (≥10%), u obje bolesti, koje su povezane s primjenom lijeka, bile su blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
English: Clinical studies in adjuvant GIST
Croatian: Klinička ispitivanja kod adjuvantnog liječenja GIST-a
English: For doses of 400 mg and above (see dosage recommendation below) a 400 mg film-coated tablet is available.
Croatian: Za doze od 400 mg i više (vidjeti niže navedenu preporuku doziranja) postoji filmom obložena tableta
English: 5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed
Croatian: Pleuralni izljev je češće zabilježen u bolesnika s GIST-om i u bolesnika s transformiranim
English: CHR: In study 0102 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease]
Croatian: CHR: Studija 0102 [ABN ≥1,5 x 109/l, trombociti ≥100 x 109/l, nema blasta u krvi, blasti u KS <5% i nema ekstramedularne bolesti]
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m2 i.v.
Croatian: DEX 40 mg/dan na dane 1-4 i 11-14, izmjenjivano s MTX 1 g/m2 i.v. (24 h), dan 1,
English: • Itching.
Croatian: • Osip.
English: 1 Pneumonia was reported most commonly in patients with transformed CML and in patients with
Croatian: 1 Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s
English: Imatinib Teva B.V. is indicated for
Croatian: Imatinib Teva B.V. je indiciran za
English: In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Croatian: Abnormalne vrijednosti laboratorijskih testova U KML-u, citopenije su, osobito neutropenija i trombocitopenija, bile stalan nalaz u svim ispitivanjima, s naznakom da je učestalost veća uz visoke doze ≥750 mg (ispitivanje faze I).
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 dozu od 60 mg/kg/dan, što odgovara otprilike 1,7, odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan,
English: VCR 1 mg i.v., days 7, 14;
Croatian: VCR 1 mg i.v., dani 7, 14;
English: Table 7 12-month and 36-month imatinib treatment (SSGXVIII/AIO Trial)
Croatian: Tablica 7 12-mjesečno i 36-mjesečno liječenje imatinibom (SSGXVIII/AIO ispitivanje) Krak s 36-mjesečnim liječenjem
English: Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Croatian: Imatinib je povremeno primjenjivan u kohortama 1-5, uz progresivno produljenje i raniji početak primjene imatiniba od jedne do druge kohorte, pri čemu je kohorta 1 primala najmanji intenzitet, a kohorta 5 najveći intenzitet
English: could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: Imatinib Teva B.V. može uzrokovati ponovnu aktivaciju hepatitisa B, što u nekim slučajevima može rezultirati smrtnim ishodom.
English: After correcting for the BSA effect, other demographics such as age, body weight and body mass index did not have clinically significant effects on the exposure of imatinib.
Croatian: Nakon korekcije s obzirom na učinak tjelesne površine, ostale demografske odrednice kao što su dob, tjelesna težina i indeks tjelesne mase,
English: Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
Croatian: Teška jetrena toksičnost zapažena je u pasa koji su liječeni 2 tjedna, uz povišene jetrene enzime, hepatocelularnu nekrozu, nekrozu žučnih vodova te
English: Active substances that may increase imatinib plasma concentrations:
Croatian: Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti
English: The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)-positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Croatian: Europska Agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka imatiniba u svim podskupinama pedijatrijske populacije s Ph+ KML-om (vidjeti dio 4.2 za informacije o
English: Prednisolone 200 mg oral, 5 days per month for 13
Croatian: Prednizolon 200 mg peroralno, 5 dana na mjesec
English: Table 1 Tabulated summary of adverse reactions
Croatian: Tablica 1 Tablični sažetak nuspojava
English: Experience with imatinib in this indication is very limited and is based on haematological and cytogenetic response rates.
Croatian: Klinička ispitivanja kod MDS/MPB-a Iskustvo s imatinibom u ovoj indikaciji je vrlo ograničeno te se temelji na hematološkom i citogenetskom odgovoru.
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: Novodijagnosticirana Ph+ ALL: U kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib je kao monoterapija izazvao značajno višu stopu kompletnog hematološkog odgovora od kemoterapije (96,3% u odnosu na 50%; p=0,0001).
English: 0.16 (0.03; 0.70) 97.9 vs. 90.8 97.9 vs. 73.3 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs. 41.5
Croatian: 100 vs. 100 97,8 vs. 100 0,16 (0,03; 0,70) 97,9 vs. 90,8 97,9 vs. 73,3 29,7 16/84 vs. 39/81 0,27 (0,15; 0,48) 98,7 vs. 56,1 79,9 vs. 41,5
English: Imatinib Teva B.V. inhibits the growth of these cells.
Croatian: Imatinib Teva B.V. inhibira rast ovih stanica.
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: Recidivirajuća ili refraktorna Ph+ ALL: Primjena imatiniba kao monoterapije u bolesnika s recidivirajućom ili refraktornom Ph+ ALL, rezultirala je s odgovorom u 53 od 411 evaluirana bolesnika, sa stopom hematološkog odgovora od 30% (9% kompletni) i stopom većeg citogenetskog odgovora od 23%.
English: Clinical studies in unresectable and/or metastatic GIST One phase II, open-label, randomised, uncontrolled multinational study was conducted in patients with unresectable or metastatic malignant gastrointestinal stromal tumours (GIST).
Croatian: Klinička ispitivanja kod inoperabilnog i/ili metastazirajućeg GIST-a Kod bolesnika s inoperabilnim ili metastazirajućim malignim gastrointestinalnim stromalnim tumorima (GIST) provedeno je jedno otvoreno, randomizirano, nekontrolirano, multinacionalno ispitivanje faze II.
English: The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the
Croatian: Razina kod koje se ne uočava učinak (NOEL-no observed effect) i za roditeljske ženke i za F1 generaciju bila je 15 mg/kg/dan (jedna četvrtina maksimalne doze
English: (starting dose 340 mg/m2)
Croatian: (početna doza 600 mg)
English: DEX 10 mg/m2 oral, days 6-7, 13-16;
Croatian: DEX 10 mg/m2 peroralno, dani 6-7, 13-16;
English: Median time to treatment failure in responders was 122 weeks (95% C.I 106-147), while in the overall study population it was 84 weeks (95% C.I 71-109).
Croatian: (95% CI 106-147), odnosno 84 tjedana (95% CI 71-109) u ukupno ispitivanoj populaciji.
English: 4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
Croatian: 4 Crvenilo uz osjećaj vrućine je bilo najčešće u bolesnika s GIST-om, a krvarenje (hematomi, hemoragija) je bilo najčešće u bolesnika s GIST-om i s transformiranim KML-om (ubrzana faza
English: The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Croatian: Primarna varijabla djelotvornosti bila je stopa hematološkog odgovora, koja je zabilježena ili kao kompletni hematološki odgovor, stanje bez znakova leukemije ili kao vraćanje u kroničnu fazu KMLa, uz primjenu istih kriterija kao i kod ispitivanja u ubrzanoj fazi.
English: Resume treatment with imatinib at 600 mg. 3.
Croatian: Nastaviti imatinib u dozi od 600 mg.
English: 10000 Zagreb Croatia
Croatian: 50016 Zaragoza Španjolska
English: Treatment duration: In clinical trials in GIST patients, treatment with imatinib was continued until disease progression.
Croatian: Trajanje liječenja: u kliničkim ispitivanjima na bolesnicima s GIST-om, liječenje imatinibom nastavljeno je sve do progresije bolesti.
English: However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/l) and thrombocytopenias (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Croatian: stupnja (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (59-64% i 44-63% za neutropeniju odnosno trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7% neutropenija i 8,9% trombocitopenija).
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Croatian: MESNA (360 mg/m2/doza svaka 3 sata x 8 doza/dan, i.v.): dani 1-5 G-CSF (5 μg/kg, s.c.): dani 6-15 ili do porasta ANC >1500 nakon i.t. metotreksat (prilagođeno dobi): SAMO dan 1 Trostruka i.t. terapija (prilagođena dobi): dan 8, 15
English: There is very limited experience in children with MDS/MPD, DFSP, GIST
Croatian: Postoji vrlo ograničeno iskustvo kod djece s MDS/MPBom, DFSP-om, GIST-om i HES/KEL-om.
English: VCR 2 mg i.v., days 6, 13, 20;
Croatian: VCR 2 mg i.v., dani 6, 13, 20;
English: Patients concerned about their fertility on imatinib treatment should consult with their physician.
Croatian: Bolesnici koji se liječe imatinibom, a zabrinuti su radi svoje plodnosti, moraju se posavjetovati sa svojim liječnikom.
English: • Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of
Croatian: Imatinib Teva B.V. je indiciran za liječenje • Pedijatrijskih bolesnika s novodijagnosticiranom kroničnom mijeloičnom leukemijom (KML) s pozitivnim Philadelphia (Ph+) kromosomom (bcr-abl), u kojih se transplantacija koštane srži ne smatra prvom linijom liječenja.
English: Musculoskeletal and connective tissue disorders Muscle spasm and cramps, musculoskeletal pain including myalgia9,
Croatian: Spazam mišića i grčevi, mišićno-koštana bol uključujući mialgiju9, artralgiju,
English: Liver function tests
Croatian: Oštećenje funkcije organa
English: Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Croatian: Prednizon 60 mg/m2 peroralno, dani 1-7, 15-21; IDA 9 mg/m2 peroralno, dani 1-28;
English: EU/1/17/1243/001 20x1 film-coated tablets EU/1/17/1243/002 60 film-coated tablets EU/1/17/1243/003 60x1 film-coated tablets EU/1/17/1243/004 120 film-coated tablets EU/1/17/1243/005 120x1 film-coated tablets EU/1/17/1243/006 180x1 film-coated tablets EU/1/17/1243/007 20x1 film-coated tablets EU/1/17/1243/008 60 film-coated tablets EU/1/17/1243/009 60x1 film-coated tablets EU/1/17/1243/010 120 film-coated tablets EU/1/17/1243/011 120x1 film-coated tablets EU/1/17/1243/012 180x1 film-coated tablets imatinib teva b.v. 100 mg film-coated tablets
Croatian: EU/1/17/1243/001 20x1 filmom obloženih tableta EU/1/17/1243/002 60 filmom obloženih tableta EU/1/17/1243/003 60x1 filmom obloženih tableta EU/1/17/1243/004 120 filmom obloženih tableta EU/1/17/1243/005 120x1 filmom obloženih tableta EU/1/17/1243/006 180x1 filmom obloženih tableta EU/1/17/1243/007 20x1 filmom obloženih tableta EU/1/17/1243/008 60 filmom obloženih tableta EU/1/17/1243/009 60x1 filmom obloženih tableta EU/1/17/1243/010 120 filmom obloženih tableta EU/1/17/1243/011 120x1 filmom obloženih tableta EU/1/17/1243/012 180x1 filmom obloženih tableta
English: EU/1/17/1243/025 30 film-coated tablets EU/1/17/1243/026 30x1 film-coated tablets EU/1/17/1243/027 90 film-coated tablets EU/1/17/1243/028 90x1 film-coated tablets EU/1/17/1243/029 30 film-coated tablets EU/1/17/1243/030 30x1 film-coated tablets EU/1/17/1243/031 90 film-coated tablets EU/1/17/1243/032 90x1 film-coated tablets imatinib teva b.v. 400 mg film-coated tablets
Croatian: EU/1/17/1243/025 30 filmom obloženih tableta EU/1/17/1243/026 30x1 filmom obloženih tableta EU/1/17/1243/027 90 filmom obloženih tableta EU/1/17/1243/028 90x1 filmom obloženih tableta EU/1/17/1243/029 30 filmom obloženih tableta EU/1/17/1243/030 30x1 filmom obloženih tableta EU/1/17/1243/031 90 filmom obloženih tableta EU/1/17/1243/032 90x1 filmom obloženih tableta
English: (3 h, q 12 h), day 5
Croatian: i.v. (3 h, svakih 12 h), dan 5
English: Results are provided in Table 5.
Croatian: Rezultati su prikazani u
English: Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Croatian: Povećanja doze od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s blastičnom krizom može se razmotriti u odsustvu teške nuspojave povezane s lijekom i teške neutropenije ili trombocitopenije nepovezane s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
English: - The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal anhydrous.
Croatian: - Ostali sastojci su manitol, krospovidon, magnezijev stearat i bezvodni koloidni silicijev dioksid.
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Croatian: U bolesnika koji su tireidektomirani i uzimaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena, uz istodobnu primjenu imatiniba(vidjeti dio 4.4) te se stoga preporučuje oprez.
English: The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Croatian: Supstancija selektivno inhibira proliferaciju te inducira apoptozu u Bcr-Abl pozitivnim staničnim linijama, kao i u svježim leukemijskim stanicama osoba s Ph+KML-om i ALL
English: The doctor will tell you how many capsules of Imatinib Teva B.V. to give to your child.
Croatian: Liječnik će Vam reći koliko kapsula Imatiniba Teva B.V. trebate dati djetetu.
English: Vindesine 3 mg/m2 i.v., day 1;
Croatian: Vindezin 3 mg/m2 i.v., dan 1;
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22;
Croatian: VCR 2 mg ukupna doza i.v., dani 1, 8, 15, 22;
English: The age of these patients ranged from 8 to 18 years and imatinib was given in both adjuvant and metastatic settings at doses ranging from 300 to 800 mg daily.
Croatian: Dob tih bolesnika bila je u rasponu od 8 do 18 godina, a imatinib se primjenjivao kao adjuvantno liječenje i za liječenje metastaza u dozama od 300 do 800 mg na dan.
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
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients
Croatian: U bolesnika koji primaju imatinib potrebno je redovito kontrolirati parametre jetrene funkcije (transaminaze, bilirubin, alkalna fosfataza).
English: The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Croatian: Kaplan-Meierova procjena za preživljenje nakon 36
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
Croatian: Imatinib je također inhibitor receptorskih tirozin kinaza za faktor rasta koji potječe od trombocita (PDGF), PDGF-R, te inhibira stanična zbivanja posredovana PDGF-om.
English: Your doctor will tell you exactly how many tablets of Imatinib Teva B.V. to take.
Croatian: Liječnik će Vam reći točno koliko tableta Imatiniba Teva B.V. trebate uzeti.
English: If you forget to take Imatinib Teva B.V. - If you forget a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili dozu, uzmite ju čim se sjetite.
English: The doctor will tell you how many tablets of Imatinib Teva B.V. to give to your child.
Croatian: Liječnik će Vam reći koliko tableta Imatiniba Teva B.V. trebate dati djetetu.
English: Active substances that may have their plasma concentration altered by imatinib 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: Imatinib povećava srednu vrijednost Cmax i AUC simvastatina (supstrat CYP3A4) za 2-, odnosno 3,5-puta, što ukazuje na to da imatinib inhibira CYP3A4.