FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown.
Croatian: No, ispitivanja na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3), dok potencijalni rizik za fetus nije poznat.
English: Marszalka J. Pilsudskiego 5
Croatian: Marszałka Józefa Piłsudskiego 5
English: In the clinical study 38 % of patients were ≥ 60 years of age and 12 % of patients were ≥ 70 years of age.
Croatian: U kliničkom ispitivanju, 38 % bolesnika bilo je u dobi ≥60 godina, a 12 % bolesnika bilo je u dobi ≥70 godina.
English: • If you are being treated for Ph-positive ALL:
Croatian: • Ako se liječite zbog Ph-pozitivnog ALL-a:
English: The complete molecular response rate was 48 % (49 out of 102 evaluable patients).
Croatian: Potpuni molekularni odgovor postignut je u 48 % (49 od 102 procijenjena bolesnika).
English: Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Croatian: prednizolon 200 mg peroralno, 5 dana na mjesec tijekom 13 mjeseci Svi režimi liječenja uključuju primjenu steroida radi CNS profilakse.
English: Considering the limited safety database, the adverse events thus far reported in children are consistent with the known safety profile in adult patients with Ph+ ALL.
Croatian: Imajući na umu ograničenost baze podataka o sigurnosti primjene, dosad prijavljeni štetni događaji u djece odgovaraju poznatome sigurnosnom profilu u odraslih bolesnika s Ph+ ALL-om.
English: As reported in a recent publication 21 of these 65 patients also achieved complete molecular remission with a median follow-up of 28 months (range 13-67 months).
Croatian: Kao što je zabilježeno u nedavnoj publikaciji, 21 od tih 65 bolesnika također je postigao potpunu molekularnu remisiju s medijanom praćenja od 28 mjeseci (raspon 13-67 mjeseci).
English: Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to imatinib exposure.
Croatian: Budući da su te reakcije zabilježene u populaciji nepoznate veličine, nije uvijek moguće pouzdano procijeniti njihovu učestalost ili utvrditi uzročnu povezanost s izloženošću imatinibu.
English: *, interstitial lung disease*
Croatian: *, intersticijska plućna bolest*
English: Some children and adolescents taking Imatinib medac may have slower than normal growth.
Croatian: Kod neke djece i adolescenata koji uzimaju Imatinib medac, rast može biti sporiji od normalnog.
English: No new target organs were identified in the rat juvenile development toxicology study (day 10 to 70 postpartum) with respect to the known target organs in adult rats.
Croatian: Nisu identificirani novi ciljni organi u toksikološkim ispitivanjima razvoja mladih štakora (od 10. dana do 70. dana postpartalno) s obzirom na poznate ciljne organe kod odraslih štakora.
English: The safety and efficacy of imatinib in children 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 s MDS/MPD-om, DFSP-om i HES/KEL-om mlađe od 18 godina nisu ustanovljene u kliničkim ispitivanjima.
English: • Women who might become pregnant are advised to use effective contraception during
Croatian: • Ženama koje mogu zatrudnjeti se savjetuje primjena učinkovite kontracepcije tijekom liječenja.
English: Do not store above 30 ºC.
Croatian: Ne čuvati na temperaturi iznad 30°C.
English: Imatinib medac can reduce the number of white blood cells, so you might get infections more easily.
Croatian: Imatinib medac može smanjiti broj bijelih krvnih stanica, pa možete lakše dobiti infekciju
English: In 61 of these 117 patients FIP1L1-PDGFRα fusion kinase was identified.
Croatian: U 61 od tih 117 bolesnika identificirana je FIP1L1-PDGFRα fuzijska kinaza.
English: The overall survival is 65 months since diagnosis (range 25-234).
Croatian: Ukupno preživljenje iznosi 65 mjeseci od dijagnoze (raspon 25-234).
English: 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: In non-clinical studies, the fertility of male and female rats was not affected (see section 5.3).
Croatian: U nekliničkim ispitivanjima, nije bilo utjecaja na plodnost mužjaka i ženki štakora (vidjeti dio 5.3).
English: 8 g to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Croatian: 8 do 10 g (jednokratna doza): zabilježeni su povraćanje i bolovi u trbuhu.
English: Rare: Not known:
Croatian: Rijetko: Nepoznato:
English: Pharmacotherapeutic group: protein kinase inhibitor, ATC code: L01XE01
Croatian: Farmakoterapijska skupina: inhibitor protein kinaze, ATK oznaka: L01XE01
English: The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal irritations.
Croatian: Preporučenu dozu treba primjenjivati peroralno, uz obrok i veliku čašu vode, kako bi se rizik od gastrointestinalnih iritacija sveo na najmanju moguću mjeru.
English: The rate of response was also higher in the patients treated at 600 mg (33 %) as compared to the patients treated at 400 mg (16 %, p = 0.0220).
Croatian: Stopa odgovora također je bila viša u bolesnika koji su liječeni dozom od 600 mg (33 %) u usporedbi s bolesnicima koji su liječeni s 400 mg (16 %, p=0,0220).
English: Patients with cardiac disease
Croatian: Bolesnici sa srčanom bolešću
English: Do not use any pack that is damaged or shows signs of tampering.
Croatian: Ne koristiti pakiranje koje je oštećeno ili na kojem su vidljivi znakovi otvaranja.
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a
Croatian: • Ponovna pojava (ponovna aktivacija) infekcije virusom hepatitisa B ako ste u prošlosti imali hepatitis B (infekciju jetre).
English: These events can usually be managed with either a reduction of the dose or an interruption of treatment with imatinib, but can in rare cases lead to permanent discontinuation of treatment.
Croatian: Te se epizode obično mogu liječiti ili smanjenjem doze ili prekidanjem liječenja imatinibom, no u rijetkim slučajevima mogu dovesti i do trajnog ukidanja liječenja.
English: The first 37 patients were started at 400 mg, the protocol was subsequently amended to allow higher dosing and the remaining 223 patients were started at 600 mg.
Croatian: Kod prvih 37 bolesnika liječenje je započelo s dozom od 400 mg, protokol je naknadno promijenjen tako da je dozvoljavao veće doziranje, pa je ostalih 223 bolesnika započelo s dozom od 600 mg.
English: In addition, paediatric patients have been treated in two phase I studies and one phase II study.
Croatian: Osim toga, pedijatrijski bolesnici liječeni su u dva ispitivanja faze I i jednom ispitivanju faze II.
English: • Imatinib medac is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Croatian: • Imatinib medac se ne smije upotrebljavati tijekom trudnoće, osim ako to nije neophodno, jer može naškoditi Vašemu djetetu.
English: Treatment with imatinib may then be continued at a reduced daily dose.
Croatian: Tada se liječenje imatinibom može nastaviti uz sniženu dnevnu dozu.
English: At the time of analysis, the median treatment duration was 47 months (24 days - 60 months).
Croatian: U vrijeme analize, medijan trajanja liječenja bio je 47 mjeseci (24 dana - 60 mjeseci).
English: • Slowing of growth in children and adolescents.
Croatian: • usporen rast kod djece i adolescenata.
English: Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1 % of CML patients.
Croatian: Liječenje je trajno ukinuto zbog abnormalnih laboratorijskih vrijednosti jetre u manje od 1 % bolesnika s KML-om.
English: No histopathological changes were seen in rat liver.
Croatian: U jetri štakora nisu uočene histopatološke promjene.
English: The majority of patients who achieved a CCyR developed the CCyR between months 3 and 10 with a median time to response based on the Kaplan-Meier estimate of 5.6 months.
Croatian: Većina bolesnika koja je postigla CCyR razvila je CCyR između 3 i 10 mjeseci, uz medijan vremena do odgovora od 5,6 mjeseci temeljeno na Kaplan-Meierovoj procjeni.
English: Total bilirubin: >1.5-3.0 ULN
Croatian: Ukupni bilirubin: >1,5-3,0 GGN
English: The doctor will tell you how many capsules of Imatinib medac to give to your child.
Croatian: Liječnik će Vam reći koliko kapsula Imatinib medaca trebate dati djetetu.
English: Description of selected adverse reactions:
Croatian: Opis odabranih nuspojava:
English: However, since the effects of low-dose exposure of the infant to imatinib are unknown, women taking imatinib should not breast-feed.
Croatian: Međutim, budući da učinci izloženosti niskim dozama imatiniba u dojenčadi nisu poznati, žene koje uzimaju imatinib ne smiju dojiti.
English: Treatment resulted in worsening of normally suppressed malarial infections in these animals.
Croatian: Rezultat liječenja u tih životinja bilo je pogoršanje malarijskih infekcija koje se u normalnim okolnostima suprimirane.
English: Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Croatian: Farmakokinetički profili u plazmi analizirani su 1. dan te ili 7. dan ili 28. dan , a do toga su vremena koncentracije u plazmi postigle stanje dinamičke ravnoteže.
English: When female rats were dosed 14 days prior to mating and through to gestational day 6, there was no effect on mating or on number of pregnant females.
Croatian: Kada su ženke štakora dobivale dozu tijekom 14 dana prije parenja pa sve do 6. gestacijskog dana, nije bilo učinka na parenje ili na broj skotnih ženki.
English: Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.
Croatian: Specijalisti hematolozi uključeni u liječenje ove bolesti trebaju nadzirati terapiju kroz sve faze liječenja.
English: Poland medac
Croatian: Poljska medac
English: Imatinib and the N-demethyl metabolite together accounted for about 65 % of the circulating radioactivity (AUC(0-48h)).
Croatian: Imatinib i N-demetil metabolit zajedno su bili odgovorni za oko 65 % cirkulirajuće radioaktivnosti (AUC(0-48h)).
English: Dose increases from 100 mg to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Croatian: Povećanje doze od 100 mg do 400 mg može se razmotriti u odsutnosti nuspojava, ako se pregledom utvrdi nedovoljan odgovor na terapiju.
English: However, always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Croatian: Međutim, uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik, ljekarnik ili medicinska sestra.
English: 11) Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
Croatian: 11) Smrtni slučajevi zabilježeni su u bolesnika s uznapredovalom bolešću, teškim infekcijama, teškom neutropenijom i drugim ozbiljnim popratnim stanjima.
English: There is limited experience in children and adolescents with Ph-positive ALL.
Croatian: Postoji ograničeno iskustvo u djece i adolescenata s Ph pozitivnim ALL-om.
English: The duration of imatinib therapy can vary with the treatment program selected, but generally longer exposures to imatinib have yielded better results.
Croatian: Trajanje terapije imatinibom može se razlikovati s obzirom na odabrani program liječenja, no općenito se može reći da su se dužom izloženošću imatinibu dobivali bolji rezultati.
English: Therefore, the use of imatinib in combination with other chemotherapeutic agents requires special precaution.
Croatian: Stoga primjena imatiniba u kombinaciji s drugim kemoterapijskim lijekovima zahtijeva posebne mjere opreza.
English: The high rate of CHR is accompanied by the development of a complete cytogenetic response (CCyR) of 65 % which is comparable to the results observed in adults.
Croatian: Visoka stopa CHR-a praćena je razvojem potpunog citogenetskog odgovora (CCyR) od 65 % što je usporedivo s rezultatima dobivenim u odraslih.
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: • Dermatofibrosarcoma protuberans (DFSP).
Croatian: • Dermatofibrosarkoma protuberans (DFSP).
English: In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.
Croatian: U kliničkim je ispitivanjima zabilježena povećana incidencija tih događaja u starijih ljudi te u onih koji su ranije bolovali od bolesti srca.
English: No specific dose recommendation is necessary in older people.
Croatian: Za starije ljude nije potrebna posebna preporuka doziranja.
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, nisu imale klinički značajne učinke na izloženost imatinibu.
English: Consolidation therapy I, III, V
Croatian: Konsolidacijska terapija I, III, V
English: All patients received imatinib and consolidation chemotherapy (see Table 3) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Croatian: Svi su bolesnici primili imatinib i konsolidacijsku kemoterapiju (vidjeti tablicu 3) nakon indukcije, a razine bcr-abl transkripcije bile su identične u dva kraka nakon 8 tjedana.
English: Experience with imatinib in this indication is very limited and is based on haematological and cytogenetic response rates.
Croatian: Iskustvo s imatinibom u ovoj indikaciji vrlo je ograničeno i temelji se na hematološkom i citogenetskom odgovoru.
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib.
Croatian: Funkciju jetre (transaminaze, bilirubin, alkalna fosfataza) treba redovito kontrolirati u bolesnika koji primaju imatinib.
English: Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Croatian: Mijeloična blastična kriza: u ispitivanje je uključeno 260 bolesnika s mijeloičnom blastičnom krizom.
English: Use in adults Your doctor will tell you exactly how many capsules of Imatinib medac to take.
Croatian: Primjena u odraslih osoba Liječnik će Vam reći točno koliko kapsula Imatinib medaca trebate uzeti.
English: Following oral administration in healthy volunteers, the t½ was approximately 18 h, suggesting that once-daily dosing is appropriate.
Croatian: Nakon peroralne primjene u zdravih dobrovoljaca, t½ bilo je oko 18 h, što navodi na zaključak da je doziranje jedanput na dan primjereno.
English: Due to the observational nature of this registry, haematologic, cytogenetic and molecular assessment data were available for 22, 9 and 17 of the 23 enrolled patients, respectively.
Croatian: Zbog opservacijske prirode ovog registra, podaci hematološke, citogenetske i molekularne procjene bili su dostupni za 22, 9 odnosno 17 od 23 uključena bolesnika.
English: In a recent publication updated information from 6 of these 11 patients revealed that all these patients remained in cytogenetic remission (range 32 - 38 months).
Croatian: U nedavnoj publikaciji, novije informacije o 6 od tih 11 bolesnika otkrile su da su svi ti bolesnici ostali u citogenetskoj remisiji (raspon 32-38 mjeseci).
English: Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).
Croatian: Provjeriti je li citopenija povezana s leukemijom (aspirat ili biopsija koštane srži).
English: They may increase or decrease the effect of Imatinib medac, either leading to increased side effects or making Imatinib medac less effective.
Croatian: Oni mogu povećati ili smanjiti učinak Imatinib medaca bilo povećanjem nuspojava ili smanjenjem učinka Imatinib medaca.
English: Severe elevation of transaminases (< 5 %) or bilirubin (< 1 %) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Croatian: Veliko povišenje vrijednosti transaminaza (<5 %) ili bilirubina (<1 %) uočeno je u bolesnika s KML-om i obično je liječeno smanjenjem doze ili prekidom terapije (medijan trajanja tih epizoda bio je približno tjedan dana).
English: The estimated 4-year OS in cohort 5-patients was 83.6 % compared to 44.8 % in the historical controls.
Croatian: Procijenjeno 4godišnje ukupno preživljenje u bolesnika u kohorti 5 bilo je 83,6 % u usporedbi s 44,8 % u kontrolnoj kohorti.
English: The dose recommendation is currently based on a small number of paediatric patients (see sections 5.1 and 5.2).
Croatian: Postojeća preporuka doziranja temeljena je na malom broju pedijatrijskih bolesnika (vidjeti dijelove 5.1 i 5.2).
English: The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively.
Croatian: Medijan trajanja neutropenijskih i trombocitopenijskih epizoda obično se kretao od 2 do 3 tjedna, odnosno od 3 do 4 tjedna.
English: The results observed in a population of 211 newly diagnosed Ph+ ALL patients in four uncontrolled clinical studies (AAU02, ADE04, AJP01 and AUS01) are consistent with the results described above.
Croatian: Rezultati uočeni u populaciji od 211 novodijagnosticiranih Ph+ ALL bolesnika u četiri nekontrolirana klinička ispitivanja (AAU02, ADE04, AJP01 i AUS01) su u skladu s rezultatima opisanim gore.
English: Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Croatian: Imatinib može također inhibirati i stanične događaje posredovane aktivacijom tih receptorskih kinaza.
English: Events that have been reported at different dose ranges are as follows:
Croatian: Zabilježeni su sljedeći događaji s različitim rasponima doza:
English: During treatment with Imatinib medac, tell your doctor straight away if you put on weight very quickly.
Croatian: Tijekom liječenja Imatinib medacom odmah obavijestite svog liječnika ako vrlo brzo dobivate na težini.
English: RTC: < 15 % blasts BM and PB, < 30 % blasts+promyelocytes in BM and PB, < 20 % basophils in PB, no extramedullary disease other than spleen and liver.
Croatian: RTC: <15 % blasta u KS i PK, <30 % blasta+promijelocita u KS i PK, <20 % bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri.
English: Your doctor has prescribed Imatinib medac because you suffer from a serious condition.
Croatian: Liječnik Vam je propisao Imatinib medac jer bolujete od ozbiljne bolesti.
English: • If you are a woman who is pregnant or might get pregnant and are trying to open the capsules for your children or another patient unable to swallow, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
Croatian: • Ako ste trudni ili možete ostati trudni, a pokušavate otvoriti kapsule za svoje dijete ili nekog drugog bolesnika koji ne može progutati kapsulu, sadržajem kapsule morate rukovati pažljivo te izbjegavati kontakt s kožom i očima ili udisanje.
English: The age of the DFSP patients ranged from 23 to 75 years; DFSP was metastatic, locally recurrent following initial resective surgery and not considered amenable to further resective surgery at the time of study entry.
Croatian: Dob bolesnika s DFSPom kretala se od 23 do 75 godina; DFSP je bio metastazirajući, lokalno recidivirajući nakon inicijalnog resekcijskog kirurškog zahvata te nije smatran podobnim za dodatni resekcijski kirurški zahvat u trenutku uključivanja u studiju.
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 (WBC) i broja neutrofila uglavnom je došlo tijekom prvih šest tjedana terapije, a vrijednosti su nakon toga ostale relativno stabilne.
English: Consolidation (de novo Ph+ ALL)
Croatian: Konsolidacija (de novo Ph+ ALL)
English: However, some of these reactions may be serious or lifethreatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Croatian: No, neke od tih reakcija mogu biti ozbiljne ili opasne po život, pa je nekoliko bolesnika s blastičnom krizom umrlo s kompleksnom kliničkom anamnezom pleuralnog izljeva, kongestivnog zatajenja srca i zatajenja bubrega.
English: Imatinib medac may do the same to some other medicines.
Croatian: Imatinib medac može to isto napraviti nekim drugim lijekovima.
English: The median time to progression in the overall population of 411 patients with relapsed/refractory Ph+ ALL ranged from 2.6 to 3.1 months, and median overall survival in the 401 evaluable patients ranged from 4.9 to 9 months.
Croatian: Medijan vremena do progresije u ukupnoj populaciji od 411 bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om kretao se od 2,6 do 3,1 mjesec, a medijan ukupnog preživljenja kod 401 procijenjenog bolesnika kretao se od 4,9 do 9 mjeseci.
English: • Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Croatian: • iznenadno oticanje i crvenilo kože (znakovi kožne infekcije zvane celulitis)
English: When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
Croatian: Kad se stopa odgovora računa u bolesnika s barem jednom valjanom procjenom, stopa odgovora za CHR, CCyR i MR bila je 20/22 (90,9%), 9/9 (100%) odnosno 11/17 (64,7%).
English: • The other ingredients are crospovidone (type A), lactose monohydrate, magnesium stearate.
Croatian: • Drugi sastojci su krospovidon (vrste A), laktoza hidrat, magnezijev stearat.
English: There is very limited experience in children with MDS/MPD and DFSP.
Croatian: Postoji vrlo ograničeno iskustvo u djece s MDS/MPD-om i DFSP-om.
English: There have been cases of cytolytic and cholestatic hepatitis and hepatic failure; in some of them outcome was fatal, including one patient on high dose paracetamol.
Croatian: Bilo je slučajeva citolitičkog i kolestatskog hepatitisa i zatajenja jetre; neki su od njih završili smrtnim ishodom, uključujući jednog bolesnika na visokoj dozi paracetamola.
English: Non-neoplastic lesions not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth.
Croatian: Neneoplastičke lezije koje nisu identificirane u prethodnim nekliničkim ispitivanjima javile su se kod kardiovaskularnog sustava, gušterače, endokrinih organa i zuba.
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 (CHR), a jedan bolesnik je imao djelomičan hematološki odgovor (PHR).
English: • Pain in your hips or difficulty walking.
Croatian: • bol u kukovima ili otežano hodanje
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 CHR; deset je imalo potpun nestanak citogenetskih abnormalnosti te smanjenje ili nestanak fuzijskih transkripcija mjereno RT-PCR-om.
English: • Do not breast-feed during the treatment with Imatinib medac as there is limited information on the distribution of imatinib into the breast milk.
Croatian: • Nemojte dojiti tijekom liječenja Imatinib medacom jer postoje ograničeni podaci o prijelazu imatiniba u majčino mlijeko.