FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, there were two studies in a total of 161 paediatric patients with Ph+ ALL in which SPRYCEL was administered in combination with chemotherapy.
Croatian: Nadalje, provedena su dva ispitivanja s ukupno 161 bolesnikom s Ph+ ALL koji je primao SPRYCEL u kombinaciji s kemoterapijom.
English: In patients in whom rifampicin or other CYP3A4 inducers are indicated, alternative medicinal products with less enzyme induction potential should be used.
Croatian: U bolesnika u kojih je indicirana primjena rifampicina ili drugih induktora CYP3A4 moraju se koristiti zamjenski lijekovi koji slabije induciraju taj enzim.
English: With a minimum of 24 months follow-up, 21 of the 240 patients who had achieved a MCyR had progressed and the median duration of MCyR had not been reached.
Croatian: Nakon najmanje 24 mjeseca praćenja, progresija bolesti nastupila je u 21 od 240 bolesnika koji su postigli značajni citogenetski odgovor (MCyR) i u njih medijan trajanja MCyR nije dostignut.
English: The estimated 60-month survival rates for dasatinib and imatinib-treated patients were 90.9% (CI: 86.6% - 93.8%) and 89.6% (CI: 85.2% - 92.8%), respectively.
Croatian: Procijenjena 60-mjesečna stopa preživljenja za bolesnike liječene dasatinibom i imatinibom bila je 90,9% (CI: 86,6% - 93,8%) odnosno 89,6% (CI: 85,2% - 92,8%).
English: Remove child-resistant closure and foil seal.
Croatian: Skinite zatvarač siguran za djecu i zaštitnu foliju.
English: This medicinal product contains 2.1 mg sodium (main component of cooking/table salt) per mL of SPRYCEL oral suspension.
Croatian: Ovaj lijek sadrži 2,1 mg natrija (glavni sastojak kuhinjske soli) po ml SPRYCEL oralne suspenzije.
English: In a study in healthy subjects, a single 100 mg dose of dasatinib increased AUC and Cmax exposure to simvastatin, a known CYP3A4 substrate, by 20 and 37% respectively.
Croatian: U ispitivanju u zdravih ispitanika, pojedinačna doza od 100 mg dasatiniba povećala je AUC i Cmax izloženosti simvastatinu, poznatom supstratu CYP3A4, za 20% odnosno za 37%.
English: Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and pericardial effusion with or without superficial oedema may be collectively described as “fluid retention”.
Croatian: Razne nuspojave poput pleuralnog izljeva, ascitesa, plućnog edema i perikardijalnog izljeva sa ili bez površinskih edema mogu se zajednički opisati kao “zadržavanje tekućine”.
English: Crossover to the alternative treatment arm was allowed if patients showed evidence of disease progression or intolerance that could not be managed by dose modification.
Croatian: Prelazak iz jedne u drugu terapijsku skupnu bio je dopušten u slučaju znakova progresije bolesti ili nepodnošenja lijeka koje se nije moglo riješiti prilagodbom doze.
English: Guidelines for dose reduction for paediatric patients in whom SPRYCEL powder for oral suspension must be administered with a strong CYP3A4 inhibitor are shown in Table 4.
Croatian: Smjernice za smanjenje doze u pedijatrijskih bolesnika u kojih se SPRYCEL prašak za oralnu suspenziju mora primjenjivati zajedno sa snažnim inhibitorom CYP3A4 prikazane su u Tablici 4.
English: Dasatinib was clastogenic in vitro to dividing Chinese Hamster Ovary (CHO) cells.
Croatian: Dasatinib je in vitro imao klastogeno djelovanje na dijeljenje stanica jajnika kineskog hrčka (CHO stanice).
English: Concomitant use of dexamethasone, a weak CYP3A4 inducer, with dasatinib is allowed; dasatinib AUC is predicted to decrease approximately 25% with concomitant use of dexamethasone, which is not likely to be clinically meaningful.
Croatian: Dopuštena je istodobna primjena dasatiniba s deksametazonom, slabim induktorom CYP3A4; kod istodobne primjene s deksametazonom očekuje se smanjenje AUC dasatiniba za približno 25%, što vjerojatno nije klinički značajno.
English: These data should be considered if patients are to switch from powder for oral suspension to tablets or vice versa.
Croatian: Te podatke treba uzeti u obzir ako se bolesnike planira prebaciti s praška za oralnu suspenziju na tablete ili obrnuto.
English: Most bleeding related adverse reactions in these patients were typically associated with grade 3 or 4 thrombocytopaenia (see section 4.8).
Croatian: U tih bolesnika većina nuspojava povezanih s krvarenjima bila je povezana s trombocitopenijom 3. ili 4. stupnja (vidjeti dio 4.8).
English: A total of 46 dasatinib-treated patients had recurrent pleural effusions.
Croatian: Ukupno je 46 bolesnika liječenih dasatinibom imalo rekurentne pleuralne izljeve.
English: Myelosuppression was also reported less frequently in the 100 mg once daily treatment group (see Laboratory test abnormalities below).
Croatian: Manja učestalost mijelosupresije prijavljena je u skupini liječenoj dozom od 100 mg jednom dnevno (vidjeti niže pod Laboratorijski poremećaji).
English: The efficacy of SPRYCEL in combination with chemotherapy was evaluated in a pivotal study in paediatric patients over one year of age with newly diagnosed Ph+ ALL.
Croatian: Djelotvornost lijeka SPRYCEL u kombinaciji s kemoterapijom ocjenjivala se u pivotalnom ispitivanju provedenom u pedijatrijskih bolesnika starijih od godinu dana s novodijagnosticiranim Ph+ ALL.
English: • Paper towel
Croatian: • papirnati ručnik
English: g Musculoskeletal pain reported during or after discontinuing treatment.
Croatian: g Mišićno koštana bol prijavljena tijekom liječenja ili nakon njegova prekida.
English: The backbone chemotherapy regimen was the same as used in the AIEOP-BFM ALL 2000 trial (chemotherapeutic standard multi-agent chemotherapy protocol).
Croatian: Osnovni kemoterapijski režim bio je jednak onom koji se primjenjivao u ispitivanju AIEOP-BFM ALL 2000 (standardni kemoterapijski protokol sastavljen od više lijekova).
English: If neutropaenia and/or thrombocytopaenia result in delay of the next block of treatment by more than 14 days, SPRYCEL should be interrupted and resumed at the same dose level once the next block of treatment is started.
Croatian: Ako se zbog neutropenije i/ili trombocitopenije sljedeći blok terapije mora odgoditi za više od 14 dana, primjenu lijeka SPRYCEL potrebno je privremeno prekinuti, a zatim nastaviti s primjenom iste doze kada se započne novi blok terapije.
English: Median duration of treatment for all patients at 7 years of follow-up was 29.8 months (range < 1-92.9 months).
Croatian: Medijan trajanja liječenja za sve bolesnike u 7. godini praćenja iznosio je 29,8 mjeseci (raspon <1-92,9 mjeseci).
English: Dose increase or reduction is recommended based on patient response and tolerability.
Croatian: Preporučuje se povećanje ili smanjenje doze na temelju kliničkog odgovora bolesnika i podnošljivosti lijeka.
English: MR4.5 rates over time are displayed graphically in Figure 3.
Croatian: Stope MR4,5 tijekom vremena grafički su prikazane na Slici 3.
English: Myelosuppression is generally reversible and usually managed by withholding dasatinib temporarily or by dose reduction.
Croatian: Mijelosupresija je obično reverzibilna i najčešće se zbrinjava privremenim prekidom primjene ili smanjenjem doze dasatiniba.
English: Dasatinib was considered to be non-phototoxic in vivo after a single oral administration to female hairless mice at exposures up to 3-fold the human exposure following administration of the recommended therapeutic dose (based on AUC).
Croatian: Dasatinib se nije smatrao fototoksičnim in vivo nakon primjene pojedinačne doze u ženki bezdlakog miša, pri čemu je njihova izloženost bila trostruko veća od izloženosti ljudi nakon primjene preporučene terapijske doze (na temelju AUC).
English: The other ingredients are: Tablet core: lactose monohydrate (see section 2 "SPRYCEL contains lactose"); microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide (E171); macrogol 400
Croatian: Drugi sastojci su: Jezgra tablete: laktoza hidrat (vidjeti dio 2 "SPRYCEL sadrži laktozu"); mikrokristalična celuloza; umrežena karmelozanatrij; hidroksipropilceluloza; magnezijev stearat Film ovojnica: hipromeloza; titanijev dioksid (E171); makrogol 400
English: In a paediatric pharmacokinetics study, dose-normalized dasatinib exposure (Cavg, Cmin and Cmax) appears similar between 21 patients with CP-CML and 16 patients with Ph+ ALL.
Croatian: U ispitivanju farmakokinetike u pedijatrijskih bolesnika izloženost dasatinibu normalizirana za dozu (Cavg, Cmin i Cmax) činila se sličnom u 21 bolesnika s KML u kroničnoj fazi i 16 bolesnika s Ph+ ALL.
English: There is no experience with SPRYCEL treatment in children under 1 year of age.
Croatian: Nema iskustva s liječenjem lijekom SPRYCEL u djece mlađe od godinu dana.
English: The estimated 60-month PFS rate was 88.9% (CI: 84% - 92.4%) for both the dasatinib and imatinib treatment groups.
Croatian: Procijenjena 60-mjesečna stopa PFS bila je 88,9% (CI: 84% - 92,4%) i u skupini liječenoj dasatinibom i u skupini liječenoj imatinibom.
English: Following a single oral dose of [14C]-labelled dasatinib, approximately 89% of the dose was eliminated within 10 days, with 4% and
Croatian: Nakon peroralne primjene pojedinačne doze dasatiniba obilježenog sa [14C], oko 89% doze eliminiralo se u roku od 10
English: Ninety-seven of the 130 paediatric patients with CML-CP were treated with SPRYCEL tablets 60 mg/m2 once daily (maximum dose of 100 mg once daily for patients with high
Croatian: Devedeset i sedam od 130 pedijatrijskih bolesnika s KML u kroničnoj fazi bilo je liječenoj SPRYCEL tabletama u dozi od 60 mg/m2 jedanput dnevno (maksimalna doza od 100 mg jedanput dnevno za bolesnike koji su imali veliku tjelesnu površinu).
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja ovog lijeka.
English: What SPRYCEL looks like and contents of the pack SPRYCEL is supplied as a white to off-white powder for oral suspension which forms a white to yellow opaque suspension after constitution with water.
Croatian: SPRYCEL dolazi kao bijeli do bjelkasti prašak za oralnu suspenziju koji nakon miješanja s vodom tvori bijelu do žutu neprozirnu suspenziju.
English: The effect of hepatic impairment on the single-dose pharmacokinetics of dasatinib was assessed in 8 moderately hepatic-impaired subjects who received a 50 mg dose and 5 severely hepatic-impaired subjects who received a 20 mg dose compared to matched healthy subjects who received a 70 mg dose of dasatinib.
Croatian: Učinak na farmakokinetiku dasatiniba u jednostrukoj dozi procjenjivan je kod 8 bolesnika s umjerenim oštećenjem jetre koji su primali dozu od 50 mg i 5 bolesnika sa teškim oštećenjem jetre koji su primali dozu od 20 mg u odnosu na odgovarajuće zdrave ljude koji su primali dozu od 70 mg dasatiniba.
English: In patients with chronic phase CML (n=548), 5 patients (1%) receiving dasatinib had grade 3 or 4 haemorrhage.
Croatian: U bolesnika s KML u kroničnoj fazi (n=548), 5 bolesnika (1%) koji su primali dasatinib imali su 3. ili 4. stupanj krvarenja.
English: The safety profile of SPRYCEL administered in combination with chemotherapy in paediatric patients with Ph+ ALL was consistent with the known safety profile of SPRYCEL in adults and the expected effects of chemotherapy, with the exception of a lower pleural effusion rate in paediatric patients as compared to adults.
Croatian: Sigurnosni profil lijeka SPRYCEL koji se primjenjuje u kombinaciji s kemoterapijom u pedijatrijskih bolesnika s Ph+ ALL bio je u skladu s poznatim sigurnosnim profilom lijeka SPRYCEL u odraslih i očekivanim učincima kemoterapije, uz izuzetak niže stope pleuralnog izljeva u pedijatrijskih bolesnika u odnosu na odrasle.
English: Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia)
Croatian: Vrlo često mijelosupresija (uključujući anemiju, neutropeniju, trombocitopeniju)
English: Common weight decreased, weight increased
Croatian: Često smanjenje tjelesne težine, povećanje tjelesne težine
English: Dasatinib may be resumed at the original dose for mild/moderate adverse reactions (≤ grade 2) and resumed at a dose level reduction for severe adverse reactions (≥ grade 3) (see section 4.2).
Croatian: Dasatinib se može nastaviti primjenjivati u prethodnoj dozi u slučaju da su nuspojave bile blage/umjerene (≤2 stupnja) ili u smanjenoj dozi u slučaju teških nuspojava (≥3 stupnja) (vidjeti dio 4.2).
English: b Haematologic response criteria (all responses confirmed after 4 weeks): Major haematologic response (MaHR) = complete haematologic response (CHR) + no evidence of leukaemia (NEL).
Croatian: b Kriteriji hematološkog odgovora (svi odgovori potvrđeni nakon 4 tjedna): Značajan hematološki odgovor (MaHR) = potpun hematološki odgovor (CHR) + nema znakova leukemije (NEL, engl no evidence of leukaemia).
English: Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in adults
Croatian: Tablica 3: Prilagodbe doze zbog neutropenije i trombocitopenije u odraslih
English: Cutaneous haemorrhage was observed in an acute, single-dose oral study in monkeys but was not observed in repeat-dose studies in either monkeys or rats.
Croatian: Krvarenja u kožu zabilježena su u akutnom ispitivanju pojedinačne peroralne doze u majmuna, ali nisu zabilježena u ispitivanjima ponovljene doze ni u majmuna ni u štakora.
English: SPRYCEL tablets are not recommended for patients weighing less than 10 kg.
Croatian: SPRYCEL tablete ne preporučuju se za bolesnike tjelesne težine manje od 10 kg.
English: Two clinical studies were conducted in patients resistant or intolerant to imatinib; the primary efficacy endpoint in these studies was Major Cytogenetic Response (MCyR).
Croatian: Dva klinička ispitivanja provedena su u bolesnika koji su otporni na imatinib ili ga ne podnose; primarni ishod za procjenu djelotvornosti u ovim je ispitivanjima bio značajni citogenetski odgovor
English: For paediatric patients with Ph+ ALL, no dose modification is recommended in cases of haematologic Grade 1 to 4 toxicities.
Croatian: U pedijatrijskih bolesnika s Ph+ ALL ne preporučuje se prilagođavanje doze u slučaju hematoloških toksičnosti 1. - 4. stupnja.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici boce i kutiji iza oznake “EXP".
English: The frequency of grade 3 and 4 haematological abnormalities is presented in Table 8.
Croatian: Učestalost hematoloških poremećaja 3. ili 4. stupnja prikazana je u Tablici 8.
English: Table 7: Adverse reactions reported in ≥10% of paediatric patients with Ph+ ALL treated with SPRYCEL on a continuous dosing regimen in combination with chemotherapy (N=126)a
Croatian: Tablica 7: Nuspojave prijavljene u ≥ 10% pedijatrijskih bolesnika s Ph+ ALL liječenih lijekom SPRYCEL prema režimu kontinuirane primjene u kombinaciji s kemoterapijom (N=126)a
English: Physicians and other healthcare providers should counsel male patients of appropriate age about possible effects of SPRYCEL on fertility, and this counseling may include consideration of semen deposition.
Croatian: Liječnici i drugi zdravstveni radnici trebaju savjetovati muškarce odgovarajuće dobi o mogućim učincima lijeka SPRYCEL na plodnost.
English: Elimination is predominantly in the faeces, mostly as metabolites.
Croatian: Dasatinib se pretežno eliminira putem stolice, uglavnom u obliku metabolita.
English: A total of 519 patients were randomised to a treatment group: 259 to SPRYCEL and 260 to imatinib.
Croatian: Ukupno je 519 bolesnika bilo randomizirano u dvije terapijske skupine: 259 u skupinu koja je primala SPRYCEL i 260 u skupinu koja je primala imatinib.
English: While the safety profile of SPRYCEL in elderly was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions such as fatigue, pleural effusion, dyspnoea, cough, lower gastrointestinal haemorrhage, and appetite disturbance and more likely to experience less frequently reported adverse reactions such as abdominal distention, dizziness, pericardial effusion, congestive heart failure, and weight decrease and should be monitored closely (see section 4.4).
Croatian: Dok je sigurnosni profil lijeka SPRYCEL u starijih osoba bio sličan onome u mlađoj populaciji, u bolesnika u dobi od 65 i više godina veća je vjerojatnost nastupa često prijavljenih nuspojava poput umora, pleuralnog izljeva, dispneje, kašlja, krvarenja u donjem dijelu gastrointestinalnog sustava i poremećaja apetita, kao i manje često prijavljenih nuspojava poput distenzije abdomena, omaglice, perikardijalnog izljeva, kongestivnog zatajenja srca i smanjenja tjelesne težine, pa stoga starije osobe moraju biti strogo nadzirane (vidjeti dio 4.4).
English: Dasatinib PK showed dose proportionality with a dose-related increase in exposure observed in paediatric patients.
Croatian: Farmakokinetika dasatiniba pokazala je proporcionalnost dozi, a u pedijatrijskih je bolesnika opaženo povećanje izloženosti povezano s dozom.
English: At 3 months, a MCyR occurred more often in the dasatinib arm (36%) than in the imatinib arm (29%).
Croatian: Nakon 3 mjeseca, značajni citogenetski odgovor je bio češći u skupini koja je primala dasatinib (36%) nego u skupini koja je primala imatinib (29%).
English: The powder for oral suspension should be used for patients weighing less than 10 kg and patients who cannot swallow tablets.
Croatian: Prašak za oralnu suspenziju treba primijeniti u bolesnika koji teže manje od 10 kg i koji ne mogu gutati tablete.
English: Brain: stroke, temporary episode of neurologic dysfunction caused by loss of blood flow, facial nerve paralysis, dementia
Croatian: Mozak: moždani udar, privremena epizoda poremećaja neurološke funkcije uzrokovana gubitkom krvi, paraliza živca lica, demencija
English: An open-label, single-arm, multicentre study was conducted in patients resistant or intolerant to imatinib (i.e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment).
Croatian: Multicentrično ispitivanje otvorenog tipa u jednoj skupini provedeno je u bolesnika koji su otporni na imatinib ili ga ne podnose (tj. bolesnici u kojih su značajni toksični učinci nastali tijekom liječenja imatinibom onemogućili daljnje liječenje).
English: To achieve the recommended dose, SPRYCEL is available as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg film-coated tablets and powder for oral suspension (10 mg/mL suspension upon constitution).
Croatian: Da bi se postigla preporučena doza, SPRYCEL je dostupan u obliku filmom obloženih tableta od 20 mg, 50 mg, 70 mg, 80 mg, 100 mg i 140 mg te u obliku praška za oralnu suspenziju (koncentracija suspenzije nakon rekonstitucije iznosi 10 mg/ml).
English: Stevens-Johnson syndromef Musculoskeletal and connective tissue disorders Very common musculoskeletal paing
Croatian: Stevens-Johnson sindromf Poremećaji mišićno-koštanog sustava i veznog tkiva
English: SPRYCEL will only be prescribed by a doctor with experience in treating leukaemia.
Croatian: SPRYCEL će propisati samo liječnik s iskustvom u liječenju leukemije.
English: Table 15: Efficacy of SPRYCEL in paediatric patients with CML-CP Cumulative response over time by minimum follow-up period 3 months
Croatian: Tablica 15: Djelotvornost lijeka SPRYCEL u pedijatrijskih bolesnika s KML u kroničnoj fazi Kumulativni odgovor tijekom vremena prema minimalnom razdoblju praćenja 3 mjeseca
English: A total of 43% of the patients in the dasatinib arm, and 82% in the imatinib arm had treatment failure, defined as disease progression or cross-over to the other treatment (lack of response, intolerance of study medicinal product, etc.).
Croatian: Liječenje nije uspjelo u 43% bolesnika u skupini koja je primala dasatinib i u 82% u skupini koja je primala imatinib, a neuspjeh liječenja definirao se kao progresija bolesti ili prelazak u drugu terapijsku skupinu (izostanak odgovora, nepodnošenje ispitivanog lijeka, itd.).
English: Cumulative grade 3 or 4 cytopaenias among patients treated with 100 mg once daily were similar at 2 and 5 years including: neutropaenia (35% vs. 36%), thrombocytopaenia (23% vs. 24%) and anaemia (13% vs. 13%).
Croatian: Među bolesnicima liječenima dozom od 100 mg jednom dnevno kumulativna incidencija citopenije 3. ili 4. stupnja bila je slična u 2. i 5. godini, uključujući: neutropeniju (35% nasuprot 36%), trombocitopeniju (23% nasuprot 24%) i anemiju (13% nasuprot 13%).
English: Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 20 mg, 50 mg, 70 mg, 80 mg,100 mg ili 140mg dasatiniba (u obliku hidrata).
English: Your doctor will decide the right dose based on age and weight.
Croatian: Liječnik će odrediti pravu dozu na temelju dobi i tjelesne težine.
English: c Major molecular response (at any time) was defined as BCR ABL ratios ≤ 0.1% by RQ PCR in peripheral blood samples standardised on the International scale.
Croatian: c Značajni molekularni odgovor (u bilo kojem trenutku) definirao se kao BCR-ABL omjer ≤ 0,1% na RQ-PCR u uzorcima periferne krvi standardiziran prema Međunarodnoj ljestvici.
English: Dasatinib did not affect male or female fertility in a conventional rat fertility and early embryonic development study, but induced embryolethality at dose levels approximating human clinical exposures.
Croatian: Dasatinib nije utjecao na plodnost mužjaka i ženki štakora u konvencionalnom ispitivanju plodnosti niti na rani embrionalni razvoj u štakora, ali je izazvao embrioletalne učinke pri dozama sličnim kliničkim dozama u ljudi.
English: The minimal residual disease (MRD) negativity rate assessed by Ig/TCR rearrangement was 71.7% by the end of consolidation in all treated patients.
Croatian: Stopa negativnih nalaza na minimalnu rezidualnu bolest (engl. minimal residual disease, MRD), utvrđena prema prerazmještaju baza u genu za Ig/TCR do kraja konsolidacije, iznosila je 71,7% u svih liječenih bolesnika.
English: If SPRYCEL must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to:
Croatian: Ako se SPRYCEL mora primjenjivati istodobno sa snažnim inhibitorom CYP3A4, potrebno je razmotriti smanjenje doze na:
English: In healthy subjects, the concomitant use of aluminium hydroxide/magnesium hydroxide antacids with SPRYCEL reduced the AUC of a single dose of SPRYCEL by 55% and the Cmax by 58%.
Croatian: U zdravih je ispitanika istodobna primjena antacida od aluminijevog hidroksida ili magnezijevog hidroksida i lijeka SPRYCEL smanjila AUC lijeka SPRYCEL nakon pojedinačne doze za 55% te Cmax za 58%.
English: Do not use this medicine after the expiry date which is stated on the bottle label, blister or carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici boce, blisteru ili kutiji iza oznake “EXP".
English: In vitro data suggest that dasatinib has the potential to prolong cardiac ventricular repolarisation (QT Interval) (see section 5.3).
Croatian: Podaci iz ispitivanja in vitro pokazuju da dasatinib može produžiti repolarizaciju srčane klijetke (QT interval) (vidjeti dio 5.3).
English: In the Phase III dose-optimisation study in patients with advanced phase CML and Ph+ ALL, the median duration of treatment was 14 months for accelerated phase CML, 3 months for myeloid blast CML, 4 months for lymphoid blast CML and 3 months for Ph+ ALL.
Croatian: U ispitivanju optimizacije doze faze III u bolesnika u uznapredovaloj fazi KML i Ph+ ALL, medijan trajanja liječenja bio je 14 mjeseci za fazu ubrzanja KML, 3 mjeseca za mijeloidnu blastnu krizu KML, 4 mjeseca za limfoidnu blastnu krizu KML i 3 mjeseca za Ph+ ALL.
English: Therefore, concomitant use of potent CYP3A4 inducers with dasatinib is not recommended.
Croatian: Stoga se ne preporučuje istodobna primjena potentnih induktora CYP3A4 i dasatiniba.
English: b CA180-034 study results in recommended starting dose of 100 mg once daily.
Croatian: b Rezultati ispitivanja CA180-034 uz preporučenu početnu dozu od 100 mg jedanput dnevno.