FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine works by inhibiting the growth of abnormal cells in the diseases listed below.
Croatian: Ovaj lijek djeluje tako da inhibira rast abnormalnih stanica kod niže navedenih bolesti.
English: Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12 % increase in patients > 65 years old).
Croatian: Na temelju analize farmakokinetike populacije u KML bolesnika, učinak dobi na volumen raspodjele bio je malen (povećanje od 12 % u bolesnika u dobi >65 godina).
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE
English: When needed, discontinuation of imatinib treatment may be considered.
Croatian: Ukoliko je potrebno, može se razmotriti prekid liječenja Imatinib medac.
English: Three of the partial responders were subsequently rendered disease free by surgery.
Croatian: Tri bolesnika s djelomičnim odgovorom su kasnije postigla stanje bez bolesti uz pomoć kirurškog zahvata.
English: One of these intermediates was also positive in the mouse lymphoma assay.
Croatian: Jedan od tih međuproizvoda je također bio pozitivan u pokusu na limfomu miša.
English: 21 patients were treated with imatinib 400 mg daily, while the other 3 patients received lower doses.
Croatian: 21 bolesnik je liječen imatinibom od 400 mg na dan, dok su preostala 3 bolesnika primala niže doze.
English: The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Croatian: Iskustvo s imatinibom u bolesnika s MDS/MPD-om povezanim s preraspodjelom gena za PDGFR vrlo je ograničeno (vidjeti dio 5.1).
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 μM).
Croatian: Imatinib nije ometao biotransformaciju 5-fluorouracila, ali je inhibirao metabolizam paklitaksela, što je bila posljedica kompetitivne inhibicije CYP2C8 (Ki = 34,7 µM).
English: The in vitro results showed that CYP3A4 was the major human P450 enzyme catalysing the biotransformation of imatinib.
Croatian: In vitro rezultati su pokazali da je CYP3A4 bio glavni humani P450 enzim koji katalizira biotransformaciju imatiniba.
English: Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ ALL below 1 year of age (see section 5.1).
Croatian: Primjena u pedijatriji: ne postoji iskustvo s KML-om u djece mlađe od 2 godine i s Ph+ ALL-om u djece mlađe od 1 godine (vidjeti dio 5.1).
English: Increased intracranial pressure, convulsions, optic neuritis
Croatian: Povišen intrakranijalni tlak, konvulzije, optički neuritis
English: If you get any of the above, tell your doctor straight away.
Croatian: Ako se kod Vas javi bilo što od gore navedenog, odmah obavijestite svog liječnika.
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19 - 60) and 47 months (range 16-59), respectively.
Croatian: Hematološki i citogenetski odgovori su se održali za medijan od 49 mjeseci (raspon 19-60), odnosno 47 mjeseci (raspon 16-59).
English: Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p < 0.001; OS p < 0.0001) in two studies (AJP01 and AUS01).
Croatian: Preživljenje bez bolesti (DFS) i ukupno preživljenje (OS) stalno premašuju 1 godinu te su superiorni nad prethodnim kontrolama (DFS p<0,001; OS p<0,0001) u dva ispitivanja (AJP01 i AUS01).
English: As expected on the basis of the study design, no difference was observed in remission duration, disease-free survival or overall survival, although patients with complete molecular response and remaining in minimal residual disease had a better outcome in terms of both remission duration (p = 0.01) and disease-free survival (p = 0.02).
Croatian: Kao što se očekivalo na temelju dizajna studije, nije uočena razlika u trajanju remisije, preživljenju bez bolesti ili ukupnom preživljenju, premda su bolesnici s potpunim molekularnim odgovorom i s minimalnom rezidualnom bolešću imali bolji ishod u smislu dužine remisije (p=0,01) i preživljenja bez bolesti (p=0,02).
English: In addition a further 24 patients with MDS/MPD were reported in 13 publications.
Croatian: Osim toga, dodatnih 24 bolesnika s MDS/MPD-om je zabilježeno u 13 publikacija.
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 μmol/l, respectively.
Croatian: Ki vrijednosti u jetrenim mikrosomima čovjeka bile su 27, 7,5, odnosno 7,9 µmol/l.
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definiraju se kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Patients with severe renal impairment should be treated with caution.
Croatian: Bolesnike s teškim oštećenjem bubrega treba liječiti s oprezom.
English: While you are taking Imatinib medac, your doctor will regularly check whether the medicine is working.
Croatian: Dok uzimate Imatinib medac, liječnik će redovito pratiti da li lijek djeluje.
English: Caution should therefore be exercised when using high doses of imatinib and paracetamol concomitantly.
Croatian: Stoga je potreban oprez prilikom istodobne primjene visokih doza imatiniba i paracetamola.
English: For doses of 400 mg and above (see dosage recommendation below) a 400 mg capsule (not divisible) is available.
Croatian: Za doze od 400 mg i više (vidjeti preporuke za doziranje ispod), dostupna je kapsula od 400 mg (ne može se prepoloviti).
English: There is no effect of gender on the kinetics of imatinib.
Croatian: Spol nema učinka na kinetiku imatiniba.
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: In this study, 31 % of patients achieved a haematological response (36 % in previously untreated patients and 22 % in previously treated patients).
Croatian: U tom je ispitivanju 31 % bolesnika postiglo hematološki odgovor (36 % u skupini prethodno neliječenih bolesnika i 22 % u skupini prethodno liječenih bolesnika).
English: • If you are being treated for DFSP:
Croatian: • Ako se liječite zbog DFSP-a:
English: The effect of prior gastrointestinal surgery on imatinib absorption has not been investigated.
Croatian: Učinak prethodnog gastrointestinalnog kirurškog zahvata na apsorpciju imatiniba nije ispitan.
English: Adult population
Croatian: Populacija odraslih osoba
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 CHR održan mjesecima (raspon od 1+ do 44+ mjeseci izostavljen u trenutku izvještavanja).
English: • Unusual hair loss or thinning.
Croatian: • neuobičajen gubitak ili prorijeđenost kose
English: Cytogenetic response criteria:
Croatian: Kriteriji citogenetskog odgovora:
English: • Dry mouth, dry skin or dry eye.
Croatian: • suhoća usta, suhoća kože ili suho oko
English: Imatinib and its metabolites are not excreted via the kidney to a significant extent.
Croatian: Imatinib i njegovi metaboliti ne izlučuju se u značajnoj mjeri putem bubrega.
English: Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Croatian: Osim za novodijagnosticirani KML u kroničnoj fazi, ne postoje kontrolirana ispitivanja koja bi demonstrirala kliničku korist ili povećano preživljenje za ove bolesti.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.
Croatian: Postoje post-marketinška izvješća o spontanim pobačajima i dojenčadi s kongenitalnim anomalijama u žena koje su uzimale Imatinib medac.
English: ANC = absolute neutrophil count a occurring after at least 1 month of treatment
Croatian: ABN = apsolutni broj neutrofila a javlja se nakon najmanje 1 mjeseca liječenja
English: In clinical trials in CML, discontinuation of the investigational medicinal product for treatment-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, ukidanje ispitivanog lijeka zbog nuspojava povezanih s liječenjem, zapaženo je 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: The effect of stopping treatment after the achievement of a complete cytogenetic response has not been investigated.
Croatian: Učinak prekida liječenja nakon postizanja potpunog citogenetskog odgovora nije ispitivan.
English: Imatinib medac will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Croatian: Imatinib medac Vam može propisati jedino liječnik koji ima iskustva s lijekovima za liječenje raka krvi ili čvrstih tumora.
English: The plasma AUC for this metabolite was found to be only 16 % of the AUC for imatinib.
Croatian: Utvrđeno je da AUC za taj metabolit u plazmi iznosi samo 16 % AUC-a imatiniba.
English: An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken.
Croatian: Neočekivani, nagli porast tjelesne težine treba pažljivo ispitati te, ako je potrebno, poduzeti odgovarajuće suportivne i terapijske mjere.
English: Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).
Croatian: Ponovno uvesti liječenje imatinibom u prijašnjoj dozi (tj. prije teške nuspojave).
English: At a dose of 60 mg/kg, female rats had significant postimplantation 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: Patients with renal impairment should be given the minimum starting dose.
Croatian: Bolesnici s oštećenjem bubrega moraju primiti najnižu početnu dozu.
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 otkrila su da se i imatinib i njegov djelatni metabolit mogu distribuirati u majčino mlijeko.
English: An increased rate of opportunistic infections was observed with chronic imatinib treatment.
Croatian: Povećana stopa oportunističkih infekcija zapažena je kod kroničnog liječenja imatinibom.
English: Imatinib should not be used during pregnancy unless clearly necessary.
Croatian: Imatinib se ne smije primjenjivati u trudnoći osim ako je njegova primjena izrazito neophodna.
English: An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
Croatian: Dodatna četiri HES bolesnika su otkrivena kao FIP1L1-PDGFRα-pozitivni u druga 3 objavljenja slučaja.
English: Some medicines can interfere with the effect of Imatinib medac when taken together.
Croatian: Neki lijekovi mogu utjecati na djelovanje Imatinib medaca kada se uzimaju zajedno.
English: Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44 %) and 3 (33 %) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77 %.
Croatian: Od 9 bolesnika s kroničnom fazom KML-a i raspoloživim citogenetskim podacima, 4 (44 %) i 3 (33 %) je postiglo potpuni, odnosno djelomični citogenetski odgovor, za stopu MCyR-a od 77 %.
English: The main circulating metabolite in humans is the N-demethylated piperazine derivative, which shows similar in vitro potency to the parent.
Croatian: Glavni metabolit u cirkulaciji u ljudi je N-demetilirani piperazinski derivat, koji je po in vitro potentnosti sličan roditeljskoj tvari.
English: DFSP (at dose 800 mg)
Croatian: DFSP (doza od 800 mg)
English: • Chronic myeloid leukaemia (CML) in blast crisis.
Croatian: • Kronične mijeloične leukemije (KML) u blastičnoj krizi.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze-galaktoze, ne smiju se liječiti ovim lijekom.
English: Patients should be tested for HBV infection before initiating treatment with imatinib.
Croatian: Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja imatiniba.
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 izloženost 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: 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, funkciju bubrega treba ispitati prije početka terapije imatinibom i pažljivo pratiti tijekom terapije, uz posebnu pozornost na one bolesnike koji posjeduju faktore rizika za bubrežnu disfunkciju.
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 potpuni hematološki odgovor, bez dokaza leukemije (tj. klirens blasta iz koštane srži i krvi, ali bez potpunog oporavka periferne krvi kao kod potpunih odgovora), ili kao vraćanje na kroničnu fazu KML-a.
English: In GIST patients (study B2222), 6.8 % of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8 % of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Croatian: U bolesnika s GIST-om (studija B2222), zapaženo je 6,8 % ALT (alanin-aminotransferaza) povišenja 3. ili 4. stupnja, kao i 4,8 % AST (aspartataminotransferaza) povišenja 3. ili 4. stupnja.
English: DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.
Croatian: DFSP je rak tkiva ispod kože u kojem neke stanice počinju nekontrolirano rasti.
English: • If you are being treated for HES/CEL:
Croatian: • Ako se liječite zbog HES/KEL-a:
English: In an observational study in the CML paediatric population, a statistically significant decrease (but of uncertain clinical relevance) in median height standard deviation scores after 12 and 24 months of treatment was reported in two small subsets irrespective of pubertal status or gender.
Croatian: U opservacijskom ispitivanju u pedijatrijskoj populaciji s KML-om prijavljeno je statistički značajno smanjenje (nejasnog kliničkog značaja) medijana skora standardne devijacije za tjelesnu visinu nakon 12 i 24 mjeseca liječenja u dvije male podskupine bez obzira na pubertetski status ili spol.
English: Pabianickie Zaklady Farmaceutyczne Polfa S.A. ul.
Croatian: Pabianickie Zakłady Farmaceutyczne Polfa S.A.
English: Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening.
Croatian: Terapija se može primjenjivati kao doza koja se daje jednom na dan, ili se dnevna doza može podijeliti u dvije primjene - jedna ujutro, a jedna navečer.
English: 5, pharyngolaryngeal pain, pharyngitis
Croatian: 5, faringolaringealna bol, faringitis
English: Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.
Croatian: S obzirom na to da je povećana vaskularizacija i sklonost krvarenju dio prirode i kliničkog tijeka GIST-a, u svih bolesnika mora se provoditi standardna praksa i postupci za kontrolu i liječenje krvarenja.
English: When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected.
Croatian: Kada se imatinib kombinirao s režimima visokih doza kemoterapije otkriveno je povećanje ozbiljnih jetrenih reakcija.
English: Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Croatian: Potpuni citogenetski odgovor potvrđen drugom citogenetskom procjenom koštane srži koja je provedena najmanje jedan mjesec nakon početnog ispitivanja koštane srži.
English: Women of childbearing potential Women of childbearing potential must be advised to use effective contraception during treatment.
Croatian: Žene reproduktivne dobi treba savjetovati da koriste učinkovitu kontracepciju tijekom liječenja.
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 patients with newly diagnosed Ph+ ALL.
Croatian: Plan liječenja: na temelju postojećih podataka, imatinib se pokazao učinkovitim i sigurnim u dozi od 600 mg/dan u kombinaciji s kemoterapijom u indukcijskoj fazi te u konsolidacijskoj fazi i fazi održavanja kemoterapije (vidjeti dio 5.1) u bolesnika s novodijagnosticiranim Ph+ ALL-om.
English: In addition, mortality was observed in juvenile animals (around weaning phase) at approximately 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m
Croatian: Pored toga, mortalitet je uočen kod mladih životinja (u vrijeme faze odbijanja od sisanja) kod približno 2 puta veće izloženosti od pedijatrijske pri najvišoj preporučenoj dozi od 340 mg/m².
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 CHR i 1 PHR).
English: 20 out of the 50 (40 %) patients in cohort 5 received haematopoietic stem cell transplant.
Croatian: Od 50 bolesnika u kohorti 5, 20 (40 %) ih je primilo transplantirane hematopoetske matične stanice.
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: Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Croatian: Potrebno je postupati oprezno kada se imatinib primjenjuje s inhibitorima porodice CYP3A4.
English: • Hot flushes, chills or night sweats.
Croatian: • navale vrućine, zimica ili noćno znojenje.
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: 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: 6-merkaptopurin; VM26: tenipozid; VCR: vinkristin; IDA: idarubicin; i.v.: intravenski
English: The 23 patients enrolled in this registry received imatinib at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
Croatian: 23 bolesnika uključena u ovaj registar primala su Imatinib medac s medijanom dnevne doze od 264 mg (raspon: 100 do 400 mg) i medijanom vremena trajanja od 7,2 godine (raspon od 0,1 do 12,7 godina).
English: Table 4 Chemotherapy regimen used in combination with imatinib in study I2301
Croatian: Tablica 4 Režim kemoterapije primijenjen u kombinaciji s imatinibom u ispitivanju I2301
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 imatiniba s kemoterapijom (vidjeti dio 5.1), no lijek-lijek interakcije između imatiniba i režima kemoterapije nisu dobro karakterizirane.
English: There is no experience in children with CML below 2 years of age.
Croatian: Ne postoji iskustvo s KML-om u djece mlađe od 2 godine.
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 srednji klirens biti 8,5 l/h, dok će se za bolesnika od 100 kg klirens povećati na 11,8 l/h.
English: • If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still mineral 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.
English: BM = bone marrow, PB = peripheral blood
Croatian: KS = koštana srž, PK = periferna krv
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Croatian: Ista publikacija je objavila i podatke dugotrajnog praćenja od 12 MDS/MPD bolesnika s preraspodjelom PDGFR gena (5 bolesnika iz studije B2225).
English: Histopathological examination of decedents revealed cardiomyopathy (both sexes), chronic progressive nephropathy (females) and preputial gland papilloma as principal causes of death or reasons for sacrifice.
Croatian: Histopatološko ispitivanje mrtvih životinja otkrilo je kardiomiopatiju (kod oba spola), kroničnu progresivnu nefropatiju (ženke) i papilom prepucijske žlijezde kao glavne uzroke smrti ili razloge za žrtvovanje.
English: Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Croatian: Bolesnici koji se liječe imatinibom, a zabrinuti su za svoju plodnost, moraju se posavjetovati sa svojim liječnikom.
English: Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Croatian: Trajanje liječenja: u jedinom kliničkom ispitivanju provedenom do sada, liječenje imatinibom nastavljeno je do progresije bolesti (vidjeti dio 5.1).