FrancophonIA/ELRC3.0 huggingface dataset:
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 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: Patients should be tested for HBV infection before initiating treatment with Imatinib Teva.
Croatian: Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja Imatinibom Teva.
English: Major cytogenetic response, haematological response, molecular response (evaluation of minimal residual disease), time to accelerated phase or blast crisis and survival are main secondary endpoints.
Croatian: Veliki citogenetski odgovor, hematološki odgovor, molekularni odgovor (procjena minimalnog zaostatka bolesti), vrijeme do ubrzane faze ili blastične krize i preživljenje, glavni su sekundarni ishodi.
English: Table 2 Response in newly diagnosed CML Study (84-month data)
Croatian: Tablica 2 Odgovor u ispitivanju novodijagnosticiranog KML-a (84-mjesečni podaci) (Najbolje stope odgovora)
English: Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.
Croatian: Bolesnike sa srčanom bolešću, faktorom rizika za zatajenje srca ili ranijim zatajenjem bubrega treba pažljivo pratiti, a svakog bolesnika sa znakovima ili simptomima koji ukazuju na zatajenje srca ili bubrega treba obraditi i liječiti.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Croatian: Farmakoterapijska skupina: ostali antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE01 Mehanizam djelovanja
English: • Hot flushes, chills or night sweats.
Croatian: • Navale vrućine, zimica ili noćno znojenje.
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 IFN+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 IFN+Ara-C-u.
English: Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Croatian: Osim toga, parcijalni citogenetski odgovor (PCyR) uočen je u 16%, a veliki citogenetski odgovor (MCyR) u 81%.
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 ishodnoj tvari.
English: • Eye pain or deterioration in vision, bleeding in the eyes.
Croatian: • Bol u očima ili slabljenje vida, krvarenje u očima.
English: Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.
Croatian: Imatinib Teva inhibira rast ovih stanica u određenoj podvrsti ovih bolesti.
English: Of these 11 patients, 4 patients escalated up to 800 mg daily, 2 of whom regained a cytogenetic response (1 partial and 1 complete, the latter also achieving a molecular response), while of the 7 patients who did not escalate the dose, only one regained a complete cytogenetic response.
Croatian: Od tih 11 bolesnika, 4 bolesnika su prešla na višu dozu do 800 mg na dan te ih je dvoje ponovno postiglo citogenetski odgovor (1 djelomični i 1 potpuni, a taj je također postigao i molekularni odgovor), dok je od 7 bolesnika koji nisu prešli na višu dozu samo jedan ponovno postigao potpuni citogenetski odgovor.
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 bcr-abl prijepisa u bolesnika liječenih imatinibom, nego u kraku koji je primao kemoterapiju, nakon 2 tjedna terapije (p=0,02).
English: The content of the capsule is white to light yellow granulated powder.
Croatian: Sadržaj kapsule je granulirani prašak bijele do svijetložute boje.
English: Danmark Teva Denmark A/S Tlf: +45 44985511
Croatian: Teva Denmark A/S Tlf: +45 44985511
English: ANC = absolute neutrophil count a occurring at least after one month of treatment
Croatian: ABN = apsolutni broj neutrofila a javlja se nakon najmanje 1 mjeseca liječenja
English: For the patients treated at 600 mg, the current estimates for median progression-free-survival and overall survival were 22.9 and 42.5 months, respectively.
Croatian: Za bolesnike liječene dozom od 600 mg, trenutne procjene za medijan vrijednosti preživljenja bez progresije te ukupno preživljenje iznose 22,9, odnosno 42,5 mjeseca.
English: Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Croatian: Imatinib Teva Vam može propisati jedino liječnik koji ima iskustva s lijekovima za liječenje raka krvi ili čvrstih tumora.
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 koje je do sada provedeno, liječenje imatinibom je nastavljeno do progresije bolesti (vidjeti dio 5.1).
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6MP: 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: In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4% and 0.7% of patients, respectively, and may have been related to gastrointestinal or intratumoural bleeding in at least some of these patients.
Croatian: U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om, anemija 3. i 4. stupnja zabilježena je u 5,4% odnosno 0,7% bolesnika i mogla je biti povezana s gastrointestinalnim ili intratumorskim krvarenjem barem u nekih od tih bolesnika.
English: At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95% on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Croatian: Kod klinički značajnih koncentracija imatiniba vezanje za proteine plazme bilo je oko 95% na temelju in vitro pokusa, uglavnom za albumin i α-kiseli glikoprotein, uz slabo vezanje za lipoproteine.
English: Haematological response1 Complete haematological response (CHR) No evidence of leukaemia (NEL)
Croatian: Hematološki odgovor1 Potpuni hematološki odgovor (CHR) Nema dokaza leukemije (NEL))
English: The first 77 patients were started at 400 mg, the protocol was subsequently amended to allow higher dosing and the remaining 158 patients were started at 600 mg.
Croatian: Prvih je 77 bolesnika počelo s dozom od 400 mg, protokol je naknadno promijenjen tako da je dozvoljavao veće doziranje, pa je ostalih 158 bolesnika započelo s dozom od 600 mg.
English: What you need to know before you take Imatinib Teva
Croatian: Što morate znati prije nego počnete uzimati Imatinib Teva
English: The pharmacokinetics of imatinib have been evaluated over a dosage range of 25 to 1,000 mg.
Croatian: Farmakokinetika imatiniba evaluirana je u rasponu doza od 25 do 1000 mg.
English: Do not take Imatinib Teva - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na imatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
Croatian: Zbog toga treba izbjegavati istodobnu primjenu jakih induktora CYP3A4 i imatiniba (vidjeti dio 4.5).
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 AUC vrijednosti uz povećanje doze bilo je linearno i proporcionalno dozi u rasponu od 25-1000 mg imatiniba nakon peroralne primjene.
English: - Do not breast-feed during the treatment with Imatinib Teva.
Croatian: - Nemojte dojiti tijekom liječenja Imatinibom Teva.
English: Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Croatian: Istodobnu primjenu rifampicina ili drugih jakih induktora CYP3A4 i imatiniba potrebno je izbjegavati.
English: The more frequent adverse reactions included gastrointestinal haemorrhages, conjunctivitis and elevation of transaminases or bilirubin.
Croatian: Češće nuspojave su uključivale gastrointestinalna krvarenja, konjunktivitis i povišenje transaminaza ili bilirubina.
English: In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg or from 800 mg to 600 mg, and in children 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 s 340 na 260 mg/m2/dan.
English: No specific dose recommendation is necessary in the elderly.
Croatian: Za starije osobe nije potrebna posebna preporuka doziranja.
English: These reactions can usually be managed by withholding imatinib temporarily and with diuretics and other appropriate supportive care measures.
Croatian: Te se reakcije obično mogu liječiti tako da se privremeno ukine imatinib te da se primijene diuretici i druge odgovarajuće suportivne mjere.
English: In eleven patients PDGFR gene rearrangements was detected, 9 of them achieved a CHR and 1 PHR.
Croatian: U jedanaest bolesnika otkrivene su preuredbe gena za PDGFR, od kojih je njih 9 postiglo CHR, a 1 PHR.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Croatian: Prethodno liječenje s višestrukim dozama rifampicina od 600 mg, nakon čega je slijedila jednokratna doza imatiniba od 400 mg, rezultiralo je smanjenjem Cmax i AUC(0-∞) za najmanje 54% odnosno 74% u odnosu na vrijednosti bez liječenja rifampicinom.
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 ukidanje lijeka zbog nuspojava povezanih s njegovom primjenom 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
English: SPECIAL STORAGE CONDITIONS Store below 30°C
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30°C.
English: The primary efficacy variable of the study was the rate of major cytogenetic response (complete plus partial response, 0 to 35% Ph+ metaphases in the bone marrow).
Croatian: Primarna varijabla djelotvornosti ispitivanja bila je stopa većeg citogenetskog odgovora (potpuni plus djelomični odgovor, 0 do 35% Ph+ metafaza u koštanoj srži).
English: When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Croatian: Kada se imatinib kombinirao s visokim dozom kemoterapije u Ph+ ALL bolesnika, uočeno je prolazno jetreno oštećenje u obliku povišenja transaminaza i hiperbilirubinemije.
English: Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
Croatian: Metabolizam imatiniba odvija se većinom preko jetre, dok se samo 13% izlučuje preko bubrega.
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 kraku koji je primao imatinib 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 broja leukocita i 10 (1,8%) smrtnih slučajeva nevezanih uz KML.
English: Table 5 Chemotherapy regimen used in combination with imatinib in study I2301
Croatian: Tablica 5 Režim kemoterapije primijenjen u kombinaciji s imatinibom u ispitivanju I2301
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 kraku koji je primao IFN+Ara-C bilo je 165 (29,8%) događaja, od kojih se 130 javilo tijekom prve linije liječenja IFN+Ara-C-om.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 January 2013
Croatian: Datum prvog odobrenja: 8. siječnja 2013
English: Anaphylactic shock* Blood and lymphatic system disorders Very common
Croatian: Anafilaktički šok* Poremećaji krvi i limfnog sustava Vrlo često
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 sa supstratima CYP2D6, međutim, savjetuje se oprez kod supstrata CYP2D6 s uskom terapijskom širinom, poput metoprolola.
English: • Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Croatian: • Odraslih bolesnika s uznapredovalim hipereozinofilnim sindromom (HES) i/ili kroničnom eozinofilnom leukemijom (KEL) s preuredbom FIP1L1-PDGFRα.
English: The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Croatian: Ukupna dnevna doza u djece i adolescenata ne smije prijeći 800 mg kod KML-a i 600 mg kod Ph+ALL-a.
English: 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
Croatian: 18 Gy u 10 frakcija za bolesnike koji imaju CNS3 u trenutku dijagnoze VCR (1,5 mg/m2/dan, i.v.): dani 1, 29
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 je kod 46% prethodno učinjena transplantacija koštane srži (BMT), a 73% bolesnika primalo je kemoterapiju s više lijekova.
English: The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Croatian: AUC imatiniba u plazmi smanjio se za 73% u usporedbi s bolesnicima koji nisu primali navedene antiepileptičke lijekove.
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 trebaju se primjenjivati postupci za kontrolu i liječenje krvarenja.
English: Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the underlying disease, its progression, and the co-administration of numerous medicinal products.
Croatian: Bolesnici s uznapredovalim stadijima zloćudnih bolesti mogu imati brojne komorbiditete koji otežavaju utvrđivanje uzročnosti nuspojava zbog niza simptoma vezanih za osnovnu bolest, njezinu progresiju te istodobnu primjenu mnogobrojnih lijekova.
English: Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Croatian: Povišene serumske koncentracije ureje i kreatinina zapažene su u nekoliko od tih životinja.
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Teva (see section 4.8).
Croatian: Inhibitori BCR-ABL tirozin kinaze (TKI-jevi) povezani su s trombotičnom mikroangiopatijom (TMA), uključujući izvješća o pojedinačnom slučaju za Imatinib Teva (vidjeti dio 4.8).
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 3) rezultira postizanjem stope kompletnog hematološkog odgovora od 93% (147 od 158 evaluiranih bolesnika) i stope velikog citogenetskog odgovora od 90% (19 od 21 evaluiranog bolesnika).
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 preuredbom gena za PDGFR je vrlo ograničeno (vidjeti dio 5.1).
English: Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Croatian: Mijelodisplastične/mijeloproliferativne bolesti s preuredbom gena za PDGFR mogu biti povezane s visokim razinama eozinofila.
English: If you forget to take Imatinib Teva - If you forget a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili dozu, uzmite ju čim se sjetite.
English: • Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
Croatian: • Mišićna slabost i grčevi mišića s abnormalnim srčanim ritmom (znakovi promjena količine kalija u krvi).
English: • Numb or cold toes and fingers (signs of Raynaud's syndrome).
Croatian: • Utrnuli ili hladni prsti na nogama i rukama (znakovi Raynaudovog sindroma).
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 izlučuju u majčino mlijeko.
English: • Chest pain, irregular heart rhythm (signs of heart problems).
Croatian: • Bolovi u prsima, nepravilan srčani ritam (znakovi srčanih problema).
English: For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Croatian: Za odrasle bolesnike s recidivirajućom ili refraktornom Ph+ ALL, monoterapija imatinibom u dozi od 600 mg/dan je sigurna, učinkovita te se može davati do pojave progresije bolesti.
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 interakcije lijekova između imatiniba i onih u kemoterapijskim protokolima nisu dobro definirane.
English: Imatinib is mainly metabolised through the liver.
Croatian: Imatinib se većinom metabolizira preko jetre.
English: 2 Headache was the most common in GIST patients.
Croatian: 2 Glavobolja je bila najčešća u bolesnika s GIST-om.
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 broja leukocita, 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 drugi terapijski krak.
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: U KML-u, citopenije su, osobito neutropenija i trombocitopenija, bile stalan nalaz u svim ispitivanjima, s naznakom da je učestalost veća uz visoke doze ≥750 mg (ispitivanje faze I).
English: Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Croatian: Bolesnici koji se liječe imatinibom, a zabrinuti su radi svoje plodnosti, moraju se posavjetovati sa svojim liječnikom.
English: If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Croatian: Ako je povećanje bilirubina >3 x institucionalne gornje granice normale (IGGN), ili jetrenih transaminaza >5 x IGGN, primjenu imatiniba treba ukinuti sve dok se razine bilirubina ne vrate na vrijednost <1,5 x IGGN, a razine transaminaze na vrijednost <2,5 x IGGN.
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 vrijednostiod 58,5 mikromol/l.
English: Clinical studies in MDS/MPD
Croatian: Klinička ispitivanja kod MDS/MPB-a
English: The tablet is debossed with “IT” and “4” at each side of the score line.
Croatian: Oznake “IT” i “4” utisnute su sa svake strane ureza.
English: In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥30 mg/kg/day.
Croatian: U 2-godišnjoj studiji kancerogenosti u štakora primjena imatiniba od 15, 30 i 60 mg/kg/dan rezultirala je statistički značajnim smanjenjem dužine života mužjaka uz 60 mg/kg/dan i ženki uz ≥30 mg/kg/dan.
English: However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML.
Croatian: Međutim, pojava ovih citopenija vjerojatno ovisi o stadiju liječene bolesti, a mnogo su češće u bolesnika s ubrzanom fazom KML-a ili blastičnom krizom, u odnosu na bolesnike s kroničnom fazom KML-a.
English: This Ki value is far higher than the expected plasma levels of imatinib in patients; consequently no interaction is expected upon co-administration of either 5-fluorouracil or paclitaxel and imatinib.
Croatian: Ta Ki vrijednost je daleko viša nego što su očekivane razine imatiniba u plazmi bolesnika, pa se prema tome ne očekuje nikakva interakcija nakon istodobne primjene bilo 5-fluorouracila bilo paklitaksela i imatiniba.
English: Active substances that may increase imatinib plasma concentrations
Croatian: Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti
English: Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
Croatian: U nekim je slučajevima došlo do akutnog zatajenja jetre ili fulminantnog hepatitisa, što je dovelo do transplantacije jetre ili smrtnog ishoda (vidjeti dio 4.4).
English: Deutschland AbZ-Pharma GmbH Tel: +49 73140205
Croatian: AbZ-Pharma GmbH Tel: +49 73140205