FrancophonIA/ELRC3.0 huggingface dataset:
English: Progression was defined as any of the following events: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management.
Croatian: Progresija je definirana kao bilo koji od sljedećih događaja: progresija u ubrzanu fazu ili blastičnu krizu, smrt, gubitak CHR-a ili MCyR-a, ili u bolesnika koji ne postižu CHR povećanje vrijednosti WBC-a unatoč odgovarajućem terapijskom liječenju.
English: Study 0102 38-month data Myeloid blast crisis (n=260)
Croatian: Studija 0102 38-mjesečni podaci Mijeloična blastična kriza (n=260)
English: Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Croatian: Blastična se kriza definira kao blasti  30% u krvi ili koštanoj srži ili postojanje ekstramedularne bolesti osim hepatosplenomegalije.
English: The high rate of CHR is accompanied by the development of a completecytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Croatian: Visoka stopa PHO-a je praćena razvojem potpunog citogenetskog odgovora (CCyR) od 65% što je usporedivo s rezultatima dobivenim u odraslih.
English: A slight to moderate reduction in spermatogenesis was also observed in the dog at oral doses ≥ 30 mg/kg.
Croatian: Malo do umjereno smanjenje spermatogeneze također je zapaženo kod pasa pri oralnoj dozi od ≥ 30 mg/kg.
English: The safety and efficacy of imatinib in children and adolescents with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Croatian: Sigurnost i djelotvornost imatiniba u djece i adolescenata s MDS/MPD-om, DFSP-om i HES/KEL-om mlađe od 18 godina nisu utvrđene u kliničkim ispitivanjima.
English: • Unusual hair loss or thinning.
Croatian: • neuobičajen gubitak ili prorijeđenost kose.
English: Studies on patients receiving Imatinib Accord and its effect on fertility and gametogenesis have not been performed.
Croatian: Nisu provedena ispitivanja na bolesnicima koji primaju Imatinib Accord o njegovom učinku na plodnost i gametogenezu.
English: Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk.
Croatian: Ispitivanja u dvije dojilje su otkrila da se i imatinib i njegov djelatni metabolit mogu distribuirati u majčino mlijeko.
English: Some medicines can interfere with the effect of Imatinib Accord when taken together.
Croatian: Neki lijekovi mogu utjecati na djelovanje Imatinib Accorda kada se uzimaju zajedno.
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 44+ months censored at the time of the reporting).
Croatian: Svih 65 bolesnika s pozitivnom FIP1L1-PDGFRα fuzijskom kinazom postiglo je PHO održan mjesecima (raspon od 1+ do 44+ mjeseci izostavljen u trenutku izvještavanja).
English: What you need to know before you take Imatinib Accord
Croatian: Što morate znati prije nego počnete uzimati Imatinib Accord
English: • Once the tablet has dissolved, drink everything in the glass straight away.
Croatian: • Jednom kad se tablete otope, odmah popijte sav sadržaj čaše.
English: In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
Croatian: U ovom je ispitivanju kod 65% bolesnika postignut veliki citogenetski odgovor koji je bio potpun u 53% (potvrđeno 43%) bolesnika (Tablica 3).
English: Table 3 Response in adult CML studies Study 0110 37-month data Chronic phase, IFN failure (n=532)
Croatian: Tablica 3 Odgovor u ispitivanjima KML-a u odraslih Studija 0110 37-mjesečni podaci Kronična faza, neuspjeh IFN terapije (n=532)
English: Your doctor will tell you exactly how many tablets of Imatinib Accord to take.
Croatian: Liječnik će Vam reći točno koliko tableta Imatinib Accorda trebate uzeti.
English: Resume treatment with Imatinib Accord at previous dose (i.e. before severe adverse reaction).
Croatian: Ponovno uvesti liječenje Imatinib Accordom u prijašnjoj dozi (tj. prije teške nuspojave).
English: Table 2 Response in newly diagnosed CML Study (84-month data)
Croatian: Tablica 2 Odgovor u ispitivanju novodijagnosticiranog KML-a (84-mjesečni podaci)
English: Eleven patients achieved rapid CHR; ten had complete resolution of cytogenetic abnormalities and a decrease or disappearance of fusion transcripts as measured by RT-PCR.
Croatian: Jedanaest bolesnika postiglo je brzi PHO; deset je imalo potpun nestanak citogenetskih abnormalnosti te smanjenje ili nestanak fuzijskih transkripcija mjereno RT-PCR-om.
English: Imatinib Accord inhibits the growth of these cells in a certain subtype of these diseases.
Croatian: Imatinib Accord inhibira rast ovih stanica u određenoj podvrsti ovih bolesti.
English: If this applies to you, tell your doctor without taking Imatinib Accord.
Croatian: Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib Accorda.
English: No specific dose recommendation is necessary in elderly.
Croatian: Za starije osobe nije potrebna posebna preporuka doziranja.
English: Major molecular response criteria: in the peripheral blood reduction of ≥ 3 logarithms in the amount of Bcr-Abl transcripts (measured by real-time quantitative reverse transcriptase PCR assay) over a standardised baseline.
Croatian: Kriteriji velikog molekularnog odgovora: u perifernoj krvi, sniženje ≥3 logaritma u količini Bcr-Abl transkripcija (mjereno kvantitativnom real-time PCR metodom pomoću reverzne transkriptaze) u odnosu na standardiziranu osnovnu vrijednost.
English: Although the results of pharmacokinetic analysis showed that there is considerable inter-subject variation, the mean exposure to imatinib did not increase in patients with varying degrees of liver dysfunction as compared to patients with normal liver function (see sections 4.2, 4.4 and 4.8).
Croatian: Iako su rezultati farmakokinetičke analize pokazali da postoji značajna razlika između ispitanika, srednja vrijednost izloženosti imatinibu nije se povećala u bolesnika s različitim stupnjevima poremećaja funkcije jetre, u usporedbi s bolesnicima s normalnom funkcijom jetre (vidjeti dijelove 4.2, 4.4 i 4.8).
English: Patients with Renal impairment should be given the minimum starting dose.
Croatian: Bolesnici s oštećenjem bubrega moraju primiti najnižu početnu dozu.
English: • Anorexia, weight loss or a disturbed sense of taste.
Croatian: • anoreksija, smanjenje tjelesne težine ili poremećaj u osjetu okusa.
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Accord, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13antibody determination, should be completed.
Croatian: Ako se laboratorijski ili klinički nalaz povezan s TMA-om javi u bolesnika koji prima Imatinib Accord, liječenje je potrebno prekinuti i provesti temeljito istraživanje TMA, uključujući ADAMTS13 aktivnost i određivanje anti-ADAMTS13-protutijela.
English: Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Croatian: Bolesnici su liječeni s imatinibom od 340 mg/m2/dan, bez prekida u odsutnosti toksičnosti vezane uz dozu.
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised Imatinib and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Croatian: Nakon 84 mjeseca, procijenjeno ukupno preživljenje iznosi 86,4% (83, 90) u odnosu na 83,3% (80, 87) u randomiziranoj Imatinib, odnosno INF+Ara-C skupini (p=0,073, log-rang test).
English: Posology for DFSP
Croatian: Doziranje za DFSP
English: Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Croatian: Tri bolesnika imala su potpuni hematološki odgovor (PHO), a jedan bolesnik je imao djelomičan hematološki odgovor (DHO).
English: Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
Croatian: Zbog poznatog povećanog rizika od krvarenja povezanog s primjenom imatiniba (npr. hemoragija), bolesnici kojima je potrebna antikoagulacija trebaju primati heparin niske molekularne težine ili standardni heparin, umjesto kumarinskih derivata kao što je varfarin.
English: This clinical effect was associated with a higher reduction in bcr-abl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Croatian: Ovaj klinički učinak povezan je s većim smanjenjem u bcr-abl transkripciji u bolesnika liječenih imatinibom, nego u kraku koji je primao kemoterapiju, nakon 2 tjedna terapije (p=0,02).
English: • adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
Croatian: • odraslih i pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi nakon neuspjeha terapije interferonom-alfa, ili u ubrzanoj fazi ili u blastičnoj krizi.
English: The preclinical safety profile of imatinib was assessed in rats, dogs, monkeys and rabbits.
Croatian: Pretklinički profil sigurnosti primjene imatiniba utvrđivan je u štakora, pasa, majmuna i kunića.
English: At the time of the original analysis, three of the four patients with detected PDGFR gene rearrangements developed haematological response (2 CHR and 1 PHR).
Croatian: U vrijeme početne analize, kod tri od četiri bolesnika s utvrđenom PDGFR preraspodjelom gena razvio se hematološki odgovor (2 PHO i 1 DHO).
English: • Do not use this medicine after the expiry date which is stated on the carton and blister after
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
English: Treatment schedule: On the basis of the existing data, imatinib has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL.
Croatian: Plan liječenja: na temelju postojećih podataka, imatinib se pokazao učinkovitim i sigurnim u dozi od600 mg/dan u kombinaciji s kemoterapijom u indukcijskoj fazi te u konsolidacijskoj fazi i fazi održavanja kemoterapije (vidjeti dio 5.1) u odraslih bolesnika s novodijagnosticiranim Ph+ ALL-om.
English: What Imatinib Accord looks like and contents of the pack
Croatian: Kako Imatinib Accord izgleda i sadržaj pakiranja
English: The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Croatian: Učinkovitost imatiniba temelji se na općim hematološkim i citogenetskim stopama odgovora i preživljenju bez progresije.
English: Total bilirubin: > 1.5-3.0 ULN AST: any
Croatian: Ukupni bilirubin: > 1,5-3,0 GGN AST: bilo koja vrijednost
English: • Numbness of the hands or feet.
Croatian: • utrnulost šaka ili stopala.
English: At a dose of 60 mg/kg, female rats had significant post-implantation foetal loss and a reduced number of live foetuses.
Croatian: Pri dozi od 60 mg/kg, ženke štakora su imale značajan postimplantacijski gubitak fetusa te smanjeni broj živih fetusa.
English: In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Croatian: U Ph+ ALL bolesnika postoji kliničko iskustvo istodobne primjene imatinibas kemoterapijom (vidjeti dio 5.1), no lijek-lijek interakcije između imatiniba i režima kemoterapije nisu dobro karakterizirane.
English: Using this approach, the estimated cumulative response rates for first-line treatment with Imatinib improved from 12 months of therapy to 84 months of therapy as follows: CHR from 96.4% to 98.4% and CCyR from 69.5% to 87.2%, respectively.
Croatian: Korištenjem tog pristupa, procijenjene kumulativne stope odgovora za prvu liniju liječenja Imatinibom su se poboljšale od 12 mjeseci do 84 mjeseca terapije kako slijedi: CHR od 96,4% do 98,4% i CCyR od 69,5% do 87,2%.
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Accord (see section 4.8).
Croatian: Inhibitori BCR-ABL tirozin kinaze (TKI-evi) povezani su s trombotičnom mikroangiopatijom (TMA), uključujući izvješća o pojedinačnom slučaju za Imatinib Accord (vidjeti dio 4.8).
English: The effect of Imatinib treatment on survival in chronic phase, newly diagnosed CML has been further examined in a retrospective analysis of the above reported Imatinib data with the primary data from another Phase III study using IFN+Ara-C (n=325) in an identical regimen.
Croatian: Učinak liječenja Imatinib Accordom na preživljenje u kroničnoj fazi novodijagnosticiranog KML-a je dodatno ispitivan u retrospektivnoj analizi gore navedenih Imatinib podataka uz primarne podatke iz drugog ispitivanja faze III u kojem je primjenjivan INF+Ara-C (n=325) u identičnom režimu.
English: The effect of bodyweight on the clearance of imatinib is such that for a patient weighing 50 kg the mean clearance is expected to be 8.5 l/h, while for a patient weighing 100 kg the clearance will rise to 11.8 l/h.
Croatian: Učinak tjelesne težine na klirens imatiniba takav je da se za bolesnika koji teži 50 kg očekuje da će srednjavrijednost klirensa biti 8,5 l/h, dok će se za bolesnika od 100 kg klirens povećati na 11,8 l/h.
English: • Eye pain or deterioration in vision, bleeding in the eyes.
Croatian: • bol u očima ili slabljenje vida, krvarenje u očima.
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Croatian: Povećanje je otprilike 1,5- do 2 puta veće, a odgovara 1,5 puta većem povećanju α-kiselog glikoproteina u plazmi, za koji se imatinib snažno veže.
English: Patients were treated at doses of imatinib 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 imatiniba od 260 mg/m2/dan (n=5), 340 mg/m2/dan (n=9), 440 mg/m2/dan (n=7), te 570 mg/m2/dan (n=5).
English: Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Croatian: Imatinib 400 mg dvaput na dan imao je inhibitorni učinak na metabolizam metoprolola posredovan CYP2D6, pri čemu su se Cmax i AUC metoprolola povećali za otprilike 23%(90%CI [1,16-1,30]).
English: In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
Croatian: U kliničkim ispitivanjima KML-a je ukidanje lijeka zbog nuspojava povezanih s njegovom primjenom zapaženo u 2,4% novodijagnosticiranih bolesnika, 4% bolesnika u kasnoj kroničnoj fazi nakon neuspjeha terapije interferonom, 4% bolesnika u ubrzanoj fazi nakon neuspjeha terapije interferonom i 5% bolesnika u blastičnoj krizi nakon neuspjeha terapije interferonom.
English: - Patients who are concerned about their fertility while taking Imatinib Accord are advised to consult with their doctor.
Croatian: - Bolesnicima koji su zabrinuti za svoju plodnost tijekom uzimanja Imatinib Accorda se preporučuje da se posavjetuju sa svojim liječnikom.
English: Imatinib Accord may cause your body to retain water (severe fluid retention).
Croatian: Imatinib Accord može izazvati zadržavanje vode u tijelu (teška retencija tekućine).
English: Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Croatian: Liječenje imatinibom izazvalo je brzi odgovor u novodijagnosticiranih pedijatrijskih KML bolesnika sa PHOom od 78% nakon 8 tjedana terapije.
English: The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter.
Croatian: Do smanjenja broja leukocita i broja neutrofila uglavnom je došlo tijekom prvih šest tjedana terapije, a vrijednosti su nakon toga ostale relativno stabilne.
English: The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Croatian: Omjer koncentracije u mlijeku i plazmi ispitivan u jedne bolesnice bio je 0,5 za imatinib i 0,9 za metabolit, što ukazuje na veću raspodjelu metabolita u majčino mlijeko.
English: This phase III study in adult patients compared treatment with either single-agent Imatinib or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
Croatian: U ovom ispitivanju faze III. u odraslih bolesnika uspoređivalo se liječenje ili samo s jednim agensomImatinibom ili s kombinacijom interferona-alfa (IFN) plus citarabina (Ara-C).
English: In this retrospective analysis, the superiority of Imatinib over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) Imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
Croatian: U toj retrospektivnoj analizi pokazana je superiornost Imatiniba nad INF+Ara-C-om u ukupnom preživljenju (p<0,001); unutar 42 mjeseca, umrlo je 47 (8,5%) bolesnika na Imatinibu i 63 (19,4%) bolesnika na INF+Ara-C-u.
English: In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children and adolescents from 340 to 260 mg/m2/day.
Croatian: Dozu u odraslih treba sniziti s 400 na 300 mg ili s 600 na 400 mg, ili s 800 mg na 600 mg, a u djece i adolescenata s 340 na 260 mg/m2/dan.
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: Imatinib should not be used during pregnancy unless clearly necessary.
Croatian: - Imatinib Accord se ne smije upotrebljavati tijekom trudnoće, osim ako to nije neophodno.
English: Patients showing lack of response (lack of complete haematological response (CHR) at 6 months, increasing WBC, no major cytogenetic response (MCyR) at 24 months), loss of response (loss of CHR or MCyR) or severe intolerance to treatment were allowed to cross over to the alternative treatment arm.
Croatian: Bolesnicima koji su pokazivali izostanak odgovora (izostanak potpunog hematološkog odgovora (CHR) nakon 6 mjeseci, porast vrijednosti WBC-a, nikakav veliki citogenetski odgovor (MCyR) nakon 24 mjeseca), gubitak odgovora (gubitak CHR-a ili MCyR-a) ili tešku nepodnošljivost liječenja, odobreno je da prijeđu u alternativni krak liječenja.
English: The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Croatian: Povećanje srednje vrijednostiAUC uz povećanje doze bilo je linearno i proporcionalno prema dozi u rasponu od 25-1000 mg imatiniba nakon peroralne primjene.
English: With 7 years follow-up, there were 93 (16.8%) progression events in the Imatinib arm: 37 (6.7%) involving progression to accelerated phase/blast crisis, 31 (5.6%) loss of MCyR, 15 (2.7%) loss of CHR or increase in WBC, and 10 (1.8%) CML unrelated deaths.
Croatian: Nakon 7 godina praćenja, u Imatinib kraku bilo je 93 (16,8%) događaja progresije: 37 (6,7%) je uključivalo progresiju u ubrzanu fazu/blastičnu krizu, 31 (5,6%) gubitak MCyR-a, 15 (2,7%) gubitak CHR-a ili povećanje WBC-a i 10 (1,8%) smrtnih slučajeva nevezanih uz KML.
English: In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Croatian: In vitro, Imatinib inhibira paracetamol O-glukuronidaciju s Ki vrijednosti od 58,5 mikromol/l.
English: Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Croatian: Imatinib je bio teratogen u štakora kada je primjenjivan tijekom organogeneze u dozama ≥ 100 mg/kg, koje su približno jednake maksimalnoj kliničkoj dozi od 800 mg/dan, temeljeno na veličini površine tijela.
English: Renal function should, therefore, be evaluated prior to the start of imatinib therapy and closely monitored during therapy, with particular attention to those patients exhibiting risk factors for renal dysfunction.
Croatian: Stoga je potrebno procijeniti funkciju bubrega prije početka liječenja imatinibom te je pratiti tijekom liječenja, a posebnu pažnju je potrebno posvetiti bolesnicima koji pokazuju faktore rizika disfunkcije bubrega.
English: Haematological response Complete haematological response (CHR) No evidence of leukaemia
Croatian: Potpuni hematološki odgovor (CHR) Nema dokaza leukemije (NEL)
English: These patients received imatinib for a median of 47 months (range 24 days - 60 months).
Croatian: Ti su bolesnici primali imatinib za medijan od 47 mjeseci (raspon 24 dana - 60 mjeseci).
English: Table 4 Chemotherapy regimen used in combination with imatinib
Croatian: Tablica 4 Režim kemoterapije korišten u kombinaciji s imatinibom
English: Packs containing 10, 30, or 90 film-coated tablets.
Croatian: Pakiranja sadrže 10, 30 or 90 filmom obloženih tableta.
English: Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
Croatian: Metabolizam imatiniba odvija se uglavnom preko jetre, dok se samo 13% izlučuje preko bubrega.
English: This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
Croatian: To je bila populacija bolesnika koja je ranije intenzivno liječena, budući da ih je 46% ranije primilo transplantaciju koštane srži, a 73% kemoterapiju s više lijekova.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.
Croatian: Postoje izvješća nakon stavljanja lijeka u promet o spontanim pobačajima i dojenčadi s kongenitalnim anomalijama u žena koje su uzimale imatinib.
English: If renal dysfunction is observed, appropriate management and treatment should be prescribed in accordance with standard treatment guidelines.
Croatian: Ako se zapazi disfunkcija bubrega, potrebno je propisati odgovarajuće liječenje sukladno smjernicama standardnog liječenja.
English: The free drug clearance of imatinib is probably similar between renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
Croatian: Klirens slobodnog lijeka za imatinib je vjerojatno sličan između bolesnika s oštećenjem bubrega i onih s normalnom funkcijom bubrega, budući da izlučivanje bubregom predstavlja samo manji metabolički put eliminacije za imatinib (vidjeti dijelove 4.2 i 4.4).
English: Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Croatian: Izgleda da prilagođavanje doze nije neophodno kada se imatinib istodobno primjenjuje s CYP2D6 supstratima, međutim, savjetuje se oprez kod CYP2D6 supstrata s uskom terapijskom širinom, poput metoprolola.
English: Lymphoid blast crisis
Croatian: Limfoidna blastična kriza
English: In contrast, there were 165 (29.8%) events in the IFN+Ara-C arm, of which 130 occurred during first-line treatment with IFN+Ara-C.
Croatian: S druge strane, u INF+Ara-C kraku bilo je 165 (29,8%) događaja, od kojih se 130 javilo tijekom prve linije liječenja INF+Ara-C-om.