FrancophonIA/ELRC3.0 huggingface dataset:
English: Dasatinib is rapidly absorbed in patients following oral administration, with peak concentrations between 0.5-3 hours.
Croatian: Dasatinib se brzo apsorbira u bolesnika nakon peroralne primjene, a vršnu koncentraciju postiže između 0,5-3 sata.
English: Look at the measurements on the side of the syringe so you can see how much to fill it before you begin.
Croatian: Prije nego što počnete, pogledajte mjerne oznake na bočnoj strani štrcaljke da vidite koliko je morate napuniti.
English: In a two-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day.
Croatian: U dvogodišnjem ispitivanju karcinogenosti, štakori su dobivali oralne doze dasatiniba od 0,3; 1 i 3 mg/kg dnevno.
English: SPRYCEL has minor influence on the ability to drive and use machines.
Croatian: SPRYCEL malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGFβ receptor.
Croatian: Dasatinib inhibira djelovanje BCR-ABL kinaze i obitelji SRC kinaza, kao i mnogih drugih pojedinih onkogenih kinaza, uključujući c-KIT, kinaze receptora efrina (EPH) i receptora PDGFβ.
English: The geometric means of dosenormalized dasatinib Cmax, AUC (0-T), and AUC (INF) appeared to be similar between children and adolescents at different dose levels.
Croatian: Geometrijske srednje vrijednosti Cmax, AUC (0-T) i AUC (INF) dasatiniba normalizirane za dozu bile su slične u djece i adolescenata pri različitim razinama doze.
English: Major molecular response All patients
Croatian: Značajan molekularni odgovor svi bolesnici
English: SPRYCEL is mainly handled by the liver.
Croatian: SPRYCEL se uglavnom razgrađuje u jetri.
English: A total of 2,712 patients were evaluated in clinical studies; of these 23% were ≥ 65 years of age and 5% were ≥ 75 years of age.
Croatian: Klinička su ispitivanja uključila ukupno 2712 bolesnika, od kojih je 23% bilo u dobi od ≥65 godina, a 5% u dobi od ≥75 godina.
English: 3 If recurrence of cytopaenia, repeat step 1 and resume treatment at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
Croatian: 3 Ako se ponovno javi citopenija, ponoviti 1. korak, a liječenje nastaviti dozom manjom od 100 mg jedanput dnevno (druga epizoda) ili 80 mg jedanput dnevno (treća epizoda).
English: These reduced doses of SPRYCEL are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data are not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors.
Croatian: Predviđa se da će tako smanjene doze lijeka SPRYCEL prilagoditi područje ispod krivulje (AUC) do raspona zabilježenog bez inhibitora CYP3A4; međutim, nisu dostupni klinički podaci za takve prilagođene doze u bolesnika koji primaju snažne inhibitore CYP3A4.
English: Patients achieving early molecular response had a lower risk of transformation, higher rate of progression-free survival (PFS) and higher rate of overall survival (OS), as shown in Table 10.
Croatian: U bolesnika koji su postigli rani molekularni odgovor postojao je manji rizik od transformacije, veća stopa preživljenja bez progresije bolesti (PFS) i veća stopa ukupnog preživljenja (OS), kao što je prikazano u Tablici 10.
English: Complete haematologic response or MCyR was achieved in patients harbouring a variety of BCR-ABL mutations associated with imatinib resistance except T315I.
Croatian: Potpuni hematološki odgovor (CHR) ili MCyR postigao se u bolesnika koji su imali niz raznih BCR-ABL mutacija povezanih s otpornošću na imatinib, osim T315I.
English: Mean Tmax was observed between 0.5 and 6 hours and mean half-life ranged from 2 to 5 hours across all dose levels and age groups.
Croatian: Srednja vrijednost Tmax opažena je između 0,5 i 6 sati nakon primjene, a srednja vrijednost poluvijeka kretala se od 2 do 5 sati kod svih razina doze i u svim dobnim skupinama.
English: 6.6 Special precautions for disposal and other handling The film-coated tablets consist of a core tablet, surrounded by a film-coating to prevent exposure of healthcare professionals to the active substance.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Filmom obložene tablete se sastoje od jezgre tablete obložene film ovojnicom kako bi se spriječilo izlaganje zdravstvenih radnika djelatnoj tvari.
English: Among the dasatinib-treated patients with pleural effusion, 96% achieved a cCCyR, 82% achieved a MMR, and 50% achieved a MR4.5 despite dose interruptions or dose adjustment.
Croatian: Među bolesnicima s pleuralnim izljevom liječenima dasatinibom, njih 96% postiglo je cCCyR, 82% postiglo je MMR, a njih 50% postiglo je MR4,5 unatoč privremenom prekidu primjene lijeka ili prilagodbi doze.
English: n/a
Croatian: n/p
English: Minimum of 5 years follow up
Croatian: Minimalno 5 godina praćenja
English: Body Weight (kg)a
Croatian: Tjelesna težina (kg)a
English: CI = confidence interval
Croatian: CI = raspon pouzdanosti.
English: In accordance with recommendations for management of non-haematologic adverse reactions (see section 4.2) the dose of dasatinib should be reduced or therapy interrupted during this evaluation.
Croatian: U skladu s preporukama za liječenje nehematoloških nuspojava (vidjeti dio 4.2), za vrijeme ove evaluacije mora se smanjiti dozu dasatiniba ili prekinuti njegovu primjenu.
English: If cytopaenia recurs, repeat marrow aspirate/biopsy and resume treatment at a reduced dose.
Croatian: Ako se citopenija ponovno javi, ponoviti aspirat/biopsiju koštane srži i nastaviti liječenje smanjenom dozom.
English: One case was fatal and was associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopaenia.
Croatian: Jedan je slučaj imao smrtni ishod i bio je povezan s trombocitopenijom 4. stupnja prema općim kriterijima toksičnosti (engl.
English: In a supportive study, of 55 paediatric patients, 35 received SPRYCEL in combination with chemotherapy on a discontinuous dosing regimen (two weeks on treatment followed by one to two weeks off) and 20 received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
Croatian: U potpornom ispitivanju, u kojem je sudjelovalo 55 pedijatrijskih bolesnika, njih 35 primalo je SPRYCEL u kombinaciji s kemoterapijom prema režimu isprekidane primjene (dva tjedna liječenja, a zatim jedan do dva tjedna bez liječenja), dok je 20 bolesnika primalo SPRYCEL u kombinaciji s kemoterapijom prema režimu kontinuirane primjene.
English: The mean apparent oral clearance is 363.8 L/hr (CV% 81.3%).
Croatian: Srednja vrijednost prividnog klirensa nakon peroralne primjene iznosi 363,8 l/h (CV% 81,3%).
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Croatian: Naime, u tijelu se mogu nakupiti velike količine benzilnog alkohola i uzrokovati nuspojave (što se naziva "metaboličkom acidozom").
English: The primary endpoint was the rate of confirmed complete cytogenetic response (cCCyR) within 12 months.
Croatian: Primarna mjera ishoda bila je udio potvrđenog potpunog citogenetskog odgovora (cCCyR) unutar 12 mjeseci.
English: Rare deep vein thrombosis, embolism, livedo reticularis
Croatian: Rijetko duboka venska tromboza, embolija, livedo reticularis
English: If possible, an alternative concomitant medication with no or minimal enzyme inhibition potential should be selected.
Croatian: Ako je moguće, za istodobnu primjenu treba odabrati neki drugi lijek, koji ne inhibira ili minimalno inhibira enzimsku aktivnost.
English: Based on the findings from a single-dose pharmacokinetic study, patients with mild, moderate or severe hepatic impairment may receive the recommended starting dose (see section 5.2).
Croatian: Prema podacima iz farmakokinetičkih ispitivanja jednokratne doze bolesnici s blagim, umjerenim ili teškim oštećenjem jetre mogu primiti preporučenu početnu dozu (vidjeti dio 5.2).
English: A bioequivalence study evaluating the powder for oral suspension to the reference tablet formulation in 77 adult patients showed that the exposure for the powder for oral suspension was 19% less than that of reference tablets.
Croatian: Ispitivanje bioekvivalentnosti u kojem se prašak za oralnu suspenziju ocjenjivao u odnosu na tabletu kao referentnu formulaciju u 77 odraslih bolesnika pokazalo je da je izloženost kod primjene praška za oralnu suspenziju bila 19% manja nego kod primjene referentnih tableta.
English: Patients with PAH reported during dasatinib treatment were often taking concomitant medicinal products or had co-morbidities in addition to the underlying malignancy.
Croatian: Bolesnici s PAH prijavljenim tijekom liječenja dasatinibom često su istodobno uzimali druge lijekove ili imali komorbiditet uz osnovnu malignu bolest.
English: SPRYCEL can be taken with or without a meal.
Croatian: SPRYCEL se može uzimati uz obrok ili bez njega.
English: If you have any questions on how to prepare or give a dose of SPRYCEL oral suspension, talk to your doctor, pharmacist or nurse.
Croatian: Ako imate bilo kakvih pitanja o tome kako pripremiti ili primijeniti dozu SPRYCEL oralne suspenzije, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: If these clinical signs or symptoms develop, physicians are advised to interrupt dasatinib administration and consider the need for alternative CML-specific treatment.
Croatian: Ako se razviju ti klinički znakovi ili simptomi, liječnicima se savjetuje da privremeno prekinu primjenu dasatiniba i razmotre potrebu za primjenom neke druge terapije specifične za KML.
English: At the maximum daily dose of 16 mL oral suspension, this is equivalent to 1.7% of the WHO recommended maximum daily dietary intake of 2 g sodium for an adult.
Croatian: Pri najvećoj dnevnoj dozi od 16 ml oralne suspenzije, to odgovara 1,7% maksimalnog dnevnog unosa od 2 g natrija prema preporukama Svjetske zdravstvene organizacije za odraslu osobu.
English: These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signalling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.
Croatian: Ova neklinička ispitivanja pokazuju da dasatinib može nadvladati otpornost na imatinib koja proizlazi iz prekomjerne ekspresije BCR-ABL, mutacija u domeni BCR-ABL kinaze, aktivacije alternativnih puteva signalizacije koji uključuju obitelj SRC kinaza (LYN, HCK) i prekomjerne ekspresije gena za otpornost na više lijekova (engl. multidrug resistance gene overexpression).
English: In vitro, dasatinib is active in leukaemic cell lines representing variants of imatinib-sensitive and resistant disease.
Croatian: Dasatinib in vitro djeluje na linije stanica leukemije koje predstavljaju varijante bolesti osjetljive i otporne na imatinib.
English: Dasatinib is extensively metabolised in humans with multiple enzymes involved in the generation of the metabolites.
Croatian: Dasatinib se u ljudi opsežno metabolizira, s mnogim enzimima uključenim u stvaranje njegovih metabolita.
English: If neutropaenia and/or thrombocytopaenia persist and the next block of treatment is delayed another 7 days, a bone marrow assessment should be performed to assess cellularity and percentage of blasts.
Croatian: Ako neutropenija i/ili trombocitopenija ustraju, pa se sljedeći blok terapije odgodi za još 7 dana, potrebno je provesti ocjenu koštane srži kako bi se odredili celularnost i postotak blasta.
English: i Gravitational oedema, localised oedema, oedema peripheral.
Croatian: i Gravitacijski edem, lokalizirani edem, periferni edem.
English: In patients who report disease progression or discontinue dasatinib or imatinib therapy, BCR-ABL sequencing was performed on blood samples from patients where these are available.
Croatian: U bolesnika koji prijavljuju pogoršanje bolesti ili prekid liječenja dasatinibom ili imatinibom, provedeno je BCR-ABL sekvencioniranje na uzorcima krvi bolesnika gdje su uzorci bili dostupni.
English: The rate of MMR at any time in each risk group determined by Hasford score was higher in the SPRYCEL group compared with the imatinib group (low risk: 90% and 69%; intermediate risk: 71% and 65%; high risk: 67% and 54%, respectively).
Croatian: Stopa MMR u bilo kojem trenutku u svakoj rizičnoj skupini bila je određena Hasford rezultatom koji je bio veći u SPRYCEL skupini u usporedbi sa imatinib skupinom (nizak rizik: 90% i 69%; srednji rizik: 71% i 65%; visok rizik: 67% i 54%).
English: You will also have blood tests regularly while you are taking SPRYCEL.
Croatian: Također ćete tijekom uzimanja lijeka SPRYCEL redovito obavljati krvne pretrage.
English: SPRYCEL is prescribed for adults and children at least 1 year of age.
Croatian: SPRYCEL se propisuje odraslim osobama i djeci u dobi od najmanje godinu dana.
English: 12 months p< 0.00003*
Croatian: 12 mjeseci p< 0,00003*
English: Uncommon blood creatine phosphokinase increased, gamma-glutamyltransferase increased Injury, poisoning, and procedural complications
Croatian: Manje često povišene vrijednosti kreatin fosfokinaze, povišene vrijednosti gama-glutamiltransferaze Ozljede, trovanja i proceduralne komplikacije
English: CTC grades: neutropaenia (Grade 3 ≥ 0.5- < 1.0 × 109/l, Grade 4 < 0.5 × 109/l); thrombocytopaenia (Grade 3 ≥ 25 - < 50 × 109/l, Grade 4 < 25 × 109/l); anaemia (haemoglobin Grade 3 ≥ 65 - < 80 g/l, Grade 4 < 65 g/l).
Croatian: CTC stupnjevi: neutropenija (stupanj 3 ≥ 0.5- < 1.0 × 109/l, stupanj 4 < 0.5 × 109/l); trombocitopenija (stupanj 3 ≥ 25 - < 50 × 109/l, stupanj 4 < 25 × 109/l); anemija (hemoglobin stupanj 3 ≥ 65 - < 80 g/l, stupanj 4 < 65 g/l).
English: Chronic phase CML - Newly diagnosed
Croatian: Kronična faza KML - novodijagnosticirana
English: The non-clinical safety profile of dasatinib was assessed in a battery of in vitro and in vivo studies in mice, rats, monkeys, and rabbits.
Croatian: Neklinički sigurnosni profil dasatiniba ocijenjen je u nizu ispitivanja in vitro i in vivo u miševa, štakora, majmuna i kunića.
English: Following resolution of a severe (grade 3 or 4) episode, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the adverse reaction.
Croatian: Nakon povlačenja teške (3. ili 4. stupanj) epizode, liječenje se može prema potrebi nastaviti smanjenom dozom, ovisno o početnoj težini nuspojave.
English: BCR-ABL tyrosine kinase inhibitors have been associated with thrombotic microangiopathy (TMA), including individual case reports for SPRYCEL (see section 4.8).
Croatian: Inhibitori BCR-ABL tirozin kinaze povezani su s trombotičnom mikroangiopatijom (TMA), uključujući pojedinačne slučajeve prijavljene kod primjene lijeka SPRYCEL (vidjeti dio 4.8).
English: Data described in this table are from studies using a starting dose of 70 mg twice daily.
Croatian: Podaci prikazani u ovoj tablici su iz ispitivanja u kojima se kao početna doza koristilo 70 mg dva puta dnevno.
English: After constitution, one bottle contains 99 mL of oral suspension.
Croatian: Nakon rekonstitucije jedna boca sadrži 99 ml oralne suspenzije.
English: PFS was analysed on an intent-to-treat principle and patients were followed to events including subsequent therapy.
Croatian: PFS se analizirao na temelju broja bolesnika uključenih u ispitivanje s ciljem liječenja te su u bolesnika praćeni događaji, uključujući naknadnu terapiju.
English: Congestive heart failure/cardiac dysfunction and pulmonary oedema were reported in < 2% of patients.
Croatian: Kongestivno zatajenje srca/srčana disfunkcija i plućni edem prijavljeni su u < 2% bolesnika.
English: Physico-chemical and available pharmacodynamic/toxicological data on dasatinib point to excretion in breast milk and a risk to the suckling child cannot be excluded.
Croatian: Fizikalno-kemijski i dostupni farmakodinamski/toksikološki podaci ukazuju na to da se dasatinib u ljudi izlučuje u majčino mlijeko i ne može se isključiti rizik za dojenče.
English: Based on human experience, dasatinib is suspected to cause congenital malformations including neural tube defects, and harmful pharmacological effects on the foetus when administered during pregnancy.
Croatian: Iskustva u ljudi ukazuju na sumnju da dasatinib uzrokuje kongenitalne malformacije uključujući oštećenje neuralne cijevi i štetan farmakološki učinak na fetus ako se primjenjuje tijekom trudnoće.
English: 3 If platelets < 25 x 109/L and/or recurrence of ANC < 0.5 x 109/L for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
Croatian: 3 Ako su trombociti <25×109/l i/ili se ABN smanjio na <0,5×109/l tijekom >7 dana, ponoviti 1. korak, a liječenje nastaviti smanjenom dozom od 80 mg jedanput dnevno za drugu epizodu.
English: Following oral administration, the increase in the mean exposure (AUCτ) is approximately proportional to the dose increment across doses ranging from 25 mg to 120 mg twice daily.
Croatian: Nakon peroralne primjene, povećanje prosječne izloženosti (AUCτ) otprilike je proporcionalno povećanju doze u doznom rasponu od 25 mg do 120 mg dvaput dnevno.
English: These include patients with hypokalaemia or hypomagnesaemia, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicinal products or other medicinal products which lead to QT prolongation, and cumulative high dose anthracycline therapy.
Croatian: To uključuje bolesnike s hipokalijemijom ili hipomagnezijemijom, bolesnike s kongenitalnim sindromom dugog QT intervala, bolesnike koji uzimaju antiaritmike ili druge lijekove koji mogu dovesti do produženja QT intervala te bolesnike na kumulativno visokoj dozi antraciklinske terapije.
English: Dosing for children with chronic phase CML or Ph+ ALL is on the basis of body weight.
Croatian: Doziranje za djecu s KML u kroničnoj fazi ili Ph+ ALL temelji se na tjelesnoj težini.
English: Durability of cCCyR
Croatian: Trajanje cCCyR
English: Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM.
Croatian: Dasatinib je potentni, subnanomolarni inhibitor BCR-ABL kinaze s djelotvornošću već pri koncentraciji od samo 0,6-0,8 nM.
English: Original dose
Croatian: Prvobitna doza
English: Minimum of 7 years follow up
Croatian: Minimalno 7 godina praćenja
English: You or your child will also have blood tests regularly while taking SPRYCEL.
Croatian: Tijekom uzimanja lijeka SPRYCEL Vi ili Vaše dijete redovito ćete obavljati i krvne pretrage.
English: Before each use, make sure the syringe plunger is pushed to the bottom of the syringe barrel.
Croatian: Prije svake primjene provjerite je li klip štrcaljke gurnut sve do kraja tijela štrcaljke.
English: The median duration of treatment for all patients still on therapy with a minimum of 5 years of follow-up (n=205) was 59 months (range 28-66 months).
Croatian: Medijan trajanja liječenja za sve bolesnike koji su još primali terapiju uz najmanje 5 godina praćenja (n=205) iznosio je 59 mjeseci (raspon: 28-66 mjeseci).
English: Patients should be tested for HBV infection before initiating treatment with SPRYCEL.
Croatian: Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja SPRYCELOM.
English: The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary.
Croatian: Svaka 3 mjeseca, a po potrebi i češće, dozu treba ponovno izračunati na temelju promjena u tjelesnoj težini.
English: GROUP
Croatian: SKUPINA
English: The starting dose of SPRYCEL for children is calculated by body weight as shown below:
Croatian: Početna doza lijeka SPRYCEL za djecu izračunava se na temelju tjelesne težine kako je prikazano u nastavku:
English: at least 45 kg
Croatian: najmanje 45 kg
English: The median duration of dasatinib-related pleural effusion (all grades) was 283 days (~40 weeks).
Croatian: Medijan trajanja pleuralnog izljeva (svih stupnjeva) uzrokovanoga primjenom dasatiniba iznosio je 283 dana (~40 tjedana).
English: 1 bottle of 33 g powder 1 bottle adapter 1 oral syringe
Croatian: 1 boca s 33 g praška 1 nastavak za bocu 1 štrcaljka za usta
English: Dose modifications were allowed for improving activity or management of toxicity (see section 4.2).
Croatian: Bile su dopuštene prilagodbe doze radi poboljšanja djelotvornosti i smanjenja toksičnosti (vidjeti dio 4.2).
English: a Results reported in recommended starting dose of 140 mg once daily (see section 4.2).
Croatian: Rezultati prijavljeni uz primjenu preporučene početne doze od 140 mg jedanput dnevno (vidjeti dio 4.2).
English: Patients developing grade 3 or 4 hypocalcaemia often had recovery with oral calcium supplementation.
Croatian: Bolesnici koji su razvili hipokalcijemiju 3. ili 4. stupnja često bi se oporavili uz uzimanje oralnih pripravaka za nadoknadu kalcija.
English: In these cases, PAH was reported after initiation of dasatinib therapy, including after more than one year of treatment.
Croatian: U ovim je slučajevima PAH bio zabilježen nakon početka terapije dasatinibom, uključujući i nakon više od jedne godine liječenja.
English: The overall mean terminal half-life of dasatinib is approximately 5-6 hours in patients.
Croatian: Ukupni prosječni terminalni poluvijek dasatiniba u bolesnika iznosi oko 5-6 sati.
English: Among dasatinib-treated CML-CP paediatric patients previously exposed to imatinib, the mutations detected at the end of treatment were: T315A, E255K and F317L.
Croatian: Među pedijatrijskim bolesnicima s KML u kroničnoj fazi liječenima dasatinibom koji su prethodno bili izloženi imatinibu, na kraju razdoblja liječenja utvrđene su sljedeće mutacije: T315A, E255K i F317L.
English: Rare leukocytoclastic vasculitis, skin fibrosis
Croatian: Rijetko leukocitoklastični vaskulitis, kožna fibroza
English: The pharmacokinetics of dasatinib have been evaluated in 104 paediatric patients with leukaemia or solid tumours (72 who received the tablet formulation and 32 who received the powder for oral suspension).
Croatian: Farmakokinetika dasatiniba ocjenjivala se u 104 pedijatrijska bolesnika s leukemijom ili solidnim tumorima (72 su primala lijek u obliku tablete, a 32 u obliku praška za oralnu suspenziju).
English: QT Prolongation
Croatian: Produženje QT intervala
English: The starting dose of SPRYCEL is calculated by body weight as shown below:
Croatian: Početna doza lijeka SPRYCEL izračunava se na temelju tjelesne težine kako je prikazano u nastavku:
English: Rare pulmonary embolism, acute respiratory distress syndrome
Croatian: Rijetko plućna embolija, akutni respiratorni distres sindrom
English: If you are pregnant or may be pregnant, tell your doctor immediately.
Croatian: Ako ste trudni ili biste mogli biti trudni, odmah o tome obavijestite liječnika.
English: Less than 10% of patients with pleural effusion had severe (grade 3 or 4) dasatinib-related pleural effusions.
Croatian: Manje od 10% bolesnika s pleuralnim izljevom imalo je teške pleuralne izljeve (3. ili 4. stupnja) uzrokovane primjenom dasatiniba.
English: Imatinib-resistant patients n=124
Croatian: Bolesnici otporni na imatinib n=124
English: SPRYCEL can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2).
Croatian: SPRYCEL se može uzimati uz obrok ili bez njega, ali se mora uzimati uvijek dosljedno ili ujutro ili navečer (vidjeti dio 5.2).
English: At 60 months, transformation to accelerated or blast phase occurred in fewer dasatinib-treated patients (n=8; 3%) compared with imatinib-treated patients (n=15; 5.8%).
Croatian: U 60. mjesecu, transformacija u ubrzanu ili blastnu fazu javila se u manje bolesnika liječenih dasatinibom (n=8; 3%) u usporedbi s bolesnicima liječenim imatinibom (n=15; 5,8%).
English: 2 year follow-up
Croatian: 2 godine praćenja
English: • Do not wash in a dishwasher.
Croatian: • Nemojte je prati u perilici posuđa.