FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Croatian: Postoji ograničeno iskustvo kod djece s Ph-pozitivnim ALL-om te vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, GIST-om i HES/KEL-om.
English: Chronic phase, newly diagnosed: This phase III study in adult patients compared treatment with either single-agent Glivec or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
Croatian: Kronična faza, novodijagnosticirani: u ovom ispitivanju faze III. u odraslih bolesnika uspoređivalo se liječenje ili samo s jednim agensom - Glivecom ili s kombinacijom interferona-alfa (IFN) plus citarabina (Ara-C).
English: After resection of primary GIST, patients were randomised to one of the two arms: Glivec at 400 mg/day or matching placebo for one year.
Croatian: Nakon resekcije primarnog GIST-a, bolesnici su randomizirani u jedan od dva kraka: Glivec 400 mg/dan ili odgovarajući placebo tijekom jedne godine.
English: Study 0110 37-month data Chronic phase, IFN failure (n=532)
Croatian: Studija 0110 37-mjesečni podaci Kronična faza, neuspjeh IFN terapije (n=532)
English: Acute respiratory failure
Croatian: Akutno zatajenje disanja
English: Glivec was administered intermittently in cohorts 1-5, with increasing duration and earlier start of Glivec from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of Glivec (longest duration in days with continuous daily Glivec dosing during the first chemotherapy treatment courses).
Croatian: Glivec je povremeno primjenjivan u kohortama 1-5, uz progresivno produljenje i raniji početak primjene Gliveca od jedne do druge kohorte, pri čemu je kohorta 1 primala najmanji intenzitet, a kohorta 5 najveći intenzitet Gliveca (najdulje trajanje u danima kontinuiranog uzimanja dnevne doze Gliveca tijekom prvih ciklusa kemoterapije).
English: Posology for CML in children Dosing for children should be on the basis of body surface area (mg/m2).
Croatian: U djece se doziranje treba temeljiti na veličini površine tijela (mg/m2).
English: Similar results were observed in patients with malignant gliomas treated with Glivec while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Croatian: Slični rezultati su uočeni u bolesnika s malignim gliomima koji su liječeni Glivecom dok su uzimali antiepileptičke lijekove koji induciraju enzime, poput karbamazepina, okskarbazepina i fenitoina.
English: Hazard ratio 0.45 (95% Cl, 0.22-0.89)
Croatian: Omjer rizika 0,45 (95% Cl, 0,22-0,89)
English: Imatinib in combination with chemotherapy induction (see Table 4) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Croatian: Imatinib u kombinaciji s indukcijskom kemoterapijom (vidjeti Tablicu 4) rezultira postizanjem stope potpunog hematološkog odgovora od 93% (147 od 158 procijenjenih bolesnika) i stope velikog citogenetskog odgovora od 90% (19 od 21 procijenjenog bolesnika).
English: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m once daily (not exceeding 400 mg once daily) or 340 mg/m once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Croatian: Analizom je potvrđeno da je izloženost imatinibu u pedijatrijskih bolesnika koji su primali 260 mg/m jedanput na dan (najviše 400 mg jedanput na dan) ili 340 mg/m jedanput na dan (najviše 600 mg jedanput na dan) bila slična onoj u odraslih bolesnika koji su primali imatinib 400 mg ili 600 mg jedanput na dan.
English: Treatment duration: In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1).
Croatian: Trajanje liječenja: u jedinom kliničkom ispitivanju provedenom do sada, liječenje Glivecom je nastavljeno do progresije bolesti (vidjeti dio 5.1).
English: Pharmacokinetics in children
Croatian: Farmakokinetika u djece
English: PVDC/alu blisters Packs containing 60, 120 or 180 film-coated tablets
Croatian: PVDC/Al blisteri Pakiranja sadrže 60, 120 ili 180 filmom obloženih tableta
English: Glivec is indicated for the treatment of
Croatian: Glivec je indiciran za liječenje
English: Patients had received a median of 14 months of prior IFN therapy at doses  25 x 10
Croatian: Bolesnici su prethodno primali IFN terapiju u medijanu trajanja od 14 mjeseci u dozama ≥25 x 10
English: 9/l, then resume treatment at 200 mg/m
Croatian: 9/l, nakon toga nastaviti liječenje u dozi od 200 mg/m
English: In vitro, imatinib inhibits proliferation and induces apoptosis in gastrointestinal stromal tumour (GIST) cells, which express an activating kit mutation.
Croatian: In vitro, imatinib inhibira proliferaciju te inducira apoptozu u stanicama gastrointestinalnog stromalnog tumora (GIST) koje ispoljavaju aktivaciju kit mutacije.
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Croatian: Ara-C: citozin arabinozid; CP: ciklofosfamid; DEX: deksametazon; MTX: metotreksat; 6-MP: 6merkaptopurin; VM26: tenipozid; VCR: vinkristin; IDA: idarubicin; i.v.: intravenski
English: EU/1/01/198/009 10 tablets EU/1/01/198/010 30 tablets EU/1/01/198/013 90 tablets
Croatian: EU/1/01/198/009 10 tableta EU/1/01/198/010 30 tableta EU/1/01/198/013 90 tableta
English: For adult patients with relapsed or refractory Ph+ALL Glivec monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Croatian: Za odrasle bolesnike s recidivirajućim ili refraktornim Ph+ ALL-om, monoterapija Glivecom u dozi od 600 mg/dan je sigurna, učinkovita te se može davati do pojave progresije bolesti.
English: Glivec is also a treatment for children with CML.
Croatian: Glivec se kod djece također koristi za liječenje KML-a.
English: Carriers of HBV who require treatment with Glivec should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Croatian: Nositelje virusa HBV kojima je potrebno liječenje Glivecom potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
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: Ukupno 397 bolesnika je pristalo sudjelovati i biti randomizirano u ispitivanju (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: How to take Glivec
Croatian: Kako uzimati Glivec
English: • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement.
Croatian: • odraslih bolesnika s uznapredovalim hipereozinofilnim sindromom (HES) i/ili kroničnom eozinofilnom leukemijom (KEL) s FIP1L1-PDGFR preraspodjelom.
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: Kod KML-a, 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: EU/1/01/198/007 20 tablets (PVC/alu blisters) EU/1/01/198/008 60 tablets (PVC/alu blisters) EU/1/01/198/011 120 tablets (PVC/alu blisters) EU/1/01/198/012 180 tablets (PVC/alu blisters) EU/1/01/198/014 60 tablets (PVDC/alu blisters) EU/1/01/198/015 120 tablets (PVDC/alu blisters) EU/1/01/198/016 180 tablets (PVDC/alu blisters)
Croatian: EU/1/01/198/007 20 tableta (PVC/Al blisteri) EU/1/01/198/008 60 tableta (PVC/Al blisteri) EU/1/01/198/011 120 tableta (PVC/Al blisteri) EU/1/01/198/012 180 tableta (PVC/Al blisteri) EU/1/01/198/014 60 tableta (PVDC/Al blisteri) EU/1/01/198/015 120 tableta (PVDC/Al blisteri) EU/1/01/198/016 180 tableta (PVDC/Al blisteri)
English: No. of events / No. of patients
Croatian: Broj događaja / broj bolesnika
English: Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 10
Croatian: Kronična faza KML-a se definira kada su ispunjeni svi navedeni kriteriji: blasti <15% u krvi i koštanoj srži, bazofili u perifernoj krvi <20%, trombociti >100 x 10
English: Stop Glivec until ANC  1.5 x 10
Croatian: Ukinuti Glivec sve dok ABN ne bude 1,5 x 10
English: Complete response Partial response Stable disease Progressive disease Not evaluable Unknown
Croatian: Potpuni odgovor Djelomični odgovor Stabilna bolest
English: • the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Croatian: • liječenje odraslih bolesnika s Kit (CD 117) pozitivnim inoperabilnim i/ili metastazirajućim malignim gastrointestinalnim stromalnim tumorima (GIST).
English: Confusional state Nervous system disorders Very common:
Croatian: Konfuzno stanje Poremećaji živčanog sustava Vrlo često:
English: EU/1/01/198/002 24 capsules EU/1/01/198/003 48 capsules EU/1/01/198/004 96 capsules EU/1/01/198/005 120 capsules EU/1/01/198/006 180 capsules
Croatian: EU/1/01/198/002 24 kapsula EU/1/01/198/003 48 kapsula EU/1/01/198/004 96 kapsula EU/1/01/198/005 120 kapsula EU/1/01/198/006 180 kapsula
English: Chronic phase CML, MDS/MPD and GIST (starting dose 400 mg) HES/CEL (at dose 400 mg)
Croatian: Kronična faza KML-a, MDS/MPD-a i GIST-a (početna doza 400 mg) HES/KEL (doza od 400 mg)
English: When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions.
Croatian: Kada im je doza dana uz obrok s velikim sadržajem masti, brzina apsorpcije imatiniba se minimalno smanjila (11% smanjenje vrijednosti Cmax i produženje tmax za 1,5 h), uz malo smanjenje AUC vrijednosti (7,4%) u usporedbi kod stanja natašte.
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 10
Croatian: Međutim, pojava citopenija također je jasno ovisila o fazi bolesti, kod čega je učestalost neutropenije stupnja 3 i 4 (ABN <1,0 x 10
English: • Muscle cramps or joint, muscle or bone pain, during Glivec treatment or after you have stopped taking Glivec.
Croatian: • grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja Glivecom ili nakon prekida uzimanja Gliveca.
English: A total of 71 (12.8%) and 85 (15.4%) patients died in the Glivec and IFN+Ara-C groups, respectively.
Croatian: Ukupno je umro 71 (12,8%) bolesnik iz Glivec skupine i 85 (15,4%) bolesnika iz INF+Ara-C skupine.
English: • Chest pain, irregular heart rhythm (signs of heart problems).
Croatian: • bolovi u prsima, nepravilan srčani ritam (znakovi srčanih problema).
English: If a severe non-haematological adverse reaction develops with Glivec use, treatment must be withheld until the event has resolved.
Croatian: Ako se tijekom primjene Gliveca razvije teška nehematološka nuspojava, liječenje se mora prekinuti sve dok se događaj ne razriješi.
English: • Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza „Rok valjanosti“ ili na blisteru iza oznake „EXP“.
English: The dose of 340 mg/m daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Croatian: Doza od 340 mg/m na dan preporučuju se za djecu s kroničnom fazom KML-a i s uznapredovalom fazom KML-a (ne smije se prekoračiti ukupna doza od 800 mg).
English: The doctor will tell you how many tablets of Glivec to give to your child.
Croatian: Liječnik će Vam reći koliko tableta Gliveca trebate dati djetetu.
English: At the time of analysis, the treatment duration was a median of 47 months (24 days - 60 months).
Croatian: U vrijeme analize, medijan trajanja liječenja bio je 47 mjeseci (24 dana - 60 mjeseci).
English: If you are being treated for HES/CEL:
Croatian: Ako se liječite zbog HES/KEL-a:
English: These patients received Glivec for a median of 47 months (range 24 days - 60 months).
Croatian: Ti su bolesnici primali Glivec za medijan od 47 mjeseci (raspon 24 dana - 60 mjeseci).
English: This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to Glivec.
Croatian: Na to vrijeme-dodogađaja kao cilj ispitivanja je snažno utjecala visoka stopa prelazaka sa INF+Ara-C na Glivec.
English: BM = bone marrow, PB = peripheral blood Cytogenetic response criteria: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%) Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Croatian: KS = koštana srž, PK = periferna krv Kriteriji citogenetskog odgovora: Veliki odgovor je kombinacija potpunih i djelomičnih odgovora: potpuni (0% Ph+ metafaza), djelomični (1-35%) Potpuni citogenetski odgovor potvrđen drugom citogenetskom procjenom koštane srži koja je provedena najmanje jedan mjesec nakon početnog ispitivanja koštane srži.
English: 9/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Croatian: 9/l, mijelociti+metamijelociti <5% u krvi, nema blasta i promijelocita u krvi, bazofili < 20%, nema ekstramedularne zahvaćenosti Kriteriji citogenetskog odgovora: potpun (0% Ph+ metafaza), djelomičan (1-35%), manji (36-65%) ili minimalan (66-95%).
English: The estimated rate of progression-free survival at 84 months was 81.2% in the Glivec arm and 60.6% in the control arm (p<0.001).
Croatian: Procijenjena stopa preživljenja bez progresije nakon 84 mjeseca bila je 81,2% u Glivec kraku i 60,6% u kontrolnom kraku (p<0,001%).
English: Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced, blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
Croatian: Tri velika, internacionalna, otvorena, nekontrolirana klinička ispitivanja faze II provedena su u bolesnika s KML-om s pozitivnim Philadelphia (Ph+) kromosomom, u uznapredovaloj, blastičnoj ili ubrzanoj fazi bolesti, s drugim Ph+ leukemijama ili u bolesnika s KML-om u kroničnoj fazi, ali u kojih nije uspjela prethodna terapija interferonom-alfa (IFN).
English: Use in adults Your doctor will tell you exactly how many tablets of Glivec to take.
Croatian: Primjena u odraslih osoba Liječnik će Vam reći točno koliko tableta Gliveca trebate uzeti.
English: Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Croatian: Glivec može povećati koncentraciju drugih lijekova u plazmi koje metabolizira CYP3A4 (npr. triazolo-benzodiazepini, dihidropiridinski blokatori kalcijevih kanala, određeni inhibitori HMG-CoA reduktaze odnosno statini, itd.).
English: Haematological response CHR rate n (%)
Croatian: Hematološki odgovor CHR stopa n (%)
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 Glivec (see section 4.8).
Croatian: Zbog moguće pojave sindroma lize tumora, prije početka terapije Glivecom preporučuje se korekcija klinički značajne dehidracije i liječenje visokih razina mokraćne kiseline (vidjeti dio 4.8).
English: There is very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Croatian: Postoji vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, GIST-om ili HES/KEL-om.
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: Medijan vremena do neuspjeha liječenja u bolesnika koji su odgovorili na terapiju bio je 122 tjedna (95% CI 106-147), odnosno 84 tjedana (95% CI 71-109) u ukupno ispitivanoj populaciji.
English: The doctor will tell you how many capsules of Glivec to give to your child.
Croatian: Liječnik će Vam reći koliko kapsula Gliveca trebate dati djetetu.
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with Glivec.
Croatian: Proveden je opservacijski registar (ispitivanje L2401) da bi se prikupili podaci o dugoročnoj sigurnosti primjene i djelotvornosti u bolesnika s mijeloproliferativnim novotvorinama s PDGFR- β preraspodjelom, a koji su liječeni Glivecom.
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, koja 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: What Glivec contains - The active substance is imatinib mesilate.
Croatian: Što Glivec sadrži - Djelatna tvar je imatinibmesilat.
English: They are supplied in packs containing 24, 48, 96, 120 or 180 capsules, but these may not all be available in your country.
Croatian: Nalaze se u pakiranjima koja sadrže 24, 48, 96, 120 ili 180 kapsula, ali ona sva ne moraju biti dostupna u Vašoj zemlji.
English: Table 3 Response in adult CML studies
Croatian: Tablica 3 Odgovor u ispitivanjima KML-a u odraslih
English: At one year the overall RFS was significantly better for Glivec (97.7%) vs. placebo (82.3%), (p<0.0001).
Croatian: Nakon jedne godine ukupno preživljenje bez recidiva bolesti bilo je značajno bolje za Glivec (97,7%) u odnosu na placebo (82,3%), (p<0,0001).
English: Elimination Based on the recovery of compound(s) after an oral
Croatian: Na temelju izlučivanja spoja(eva) nakon oralne,
English: • Use about 50 ml for each 100 mg tablet.
Croatian: • Uzmite oko 50 ml za svaku tabletu od 100 mg.
English: 20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets
Croatian: 20 filmom obloženih tableta 60 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta
English: Anaphylactic shock* Blood and lymphatic system disorders Very common:
Croatian: Anafilaktički šok* Poremećaji krvi i limfnog sustava Vrlo često:
English: Packs containing 10, 30 or 90 film-coated tablets
Croatian: Pakiranja sadrže 10, 30 ili 90 filmom obloženih tableta
English: A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day Glivec 12 months treatment vs. 36 months treatment in patients after surgical resection of GIST and one of the following: tumour diameter > 5 cm and mitotic count > 5/50 high power fields (HPF); or tumour diameter > 10 cm and any mitotic count or tumour of any size with mitotic count > 10/50 HPF or tumours ruptured into the peritoneal cavity.
Croatian: Drugo otvoreno multicentrično ispitivanje faze III (SSG XVIII/AIO) uspoređivalo je 12 mjeseci liječenja Glivecom 400 mg/dan u odnosu na 36 mjeseci liječenja u bolesnika nakon kirurške resekcije GIST-a i jednog od sljedećeg: promjer tumora >5 cm i broj mitoza >5/50 u vidnom polju mikroskopa pri velikom povećanju (HPF, engl. high power fields); ili promjer tumora >10 cm i bilo koji broj mitoza ili tumor bilo koje veličine s brojem mitoza >10/50 HPF ili ruptura tumora u peritonealnu šupljinu.
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common:
Croatian: Sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS)*, pseudoporfirija* Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često:
English: 6-MP 60 mg/m oral, days 26-46
Croatian: 6-MP 60 mg/m peroralno, dani 26-46
English: 9/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: 9/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: In vitro Glivec inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Croatian: Glivec in vitro inhibira aktivnost CYP2D6 izoenzima citokroma P450 u koncentracijama koje su slične onima što utječu na djelovanje CYP3A4.
English: Continuous daily exposure to Glivec early in the course of treatment in combination with chemotherapy in cohort 5patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without Glivec (69.6% vs. 31.6%, respectively).
Croatian: Stalna svakodnevna izloženost Glivecu u ranoj fazi liječenja u kombinaciji s kemoterapijom dovela je u bolesnika iz kohorte 5 (n=50) do poboljšanja stope 4-godišnjeg preživljavanja bez događaja (EFS) u usporedbi s bolesnicima iz kontrolne kohorte (n=120), koji su primali standardnu kemoterapiju bez Gliveca (69,6% u odnosu na 31,6%).
English: For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg divisible tablet is available.
Croatian: Za doze, osim 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) dostupna je tableta od 100 mg koja se može prepoloviti.
English: To conduct an observational registry collecting efficacy and safety data in newly diagnosed paediatric Ph+ Acute Lymphoblastic Leukaemia (ALL) patients treated with chemotherapy + imatinib ± HSCT.
Croatian: Provesti registar promatranja prikupljanjem podataka o djelotvornosti i sigurnosti u novodijagnosticiranih pedijatrijskih Ph+ akutna limfoblastična leukemija (ALL) bolesnika liječenih kemoterapijom + imatinib ± HSCT.
English: - If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.
Croatian: - Ako niste u stanju progutati kapsule, možete ih otvoriti i istresti prašak u čašu negazirane vode ili soka od jabuke.