natgillin/translations-raw huggingface dataset:
Other grade 3 or 4 haemorrhage occurred in 2% of patients with advanced phase CML. 
Druga krvarenja 3. ili 4. stupnja javila su se u 2% bolesnika s KML u uznapredovaloj fazi.
Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating SPRYCEL. 
Potrebno je razdoblje ispiranja od približno 1 tjedna između prekida primjene inhibitora i ponovnog uvođenja lijeka SPRYCEL.
SPRYCEL oral suspension may be mixed with milk, yogurt, apple juice, or applesauce. 
SPRYCEL oralna suspenzija može se pomiješati s mlijekom, jogurtom ili bistrim/gustim sokom od jabuke.
Active substances that may decrease dasatinib plasma concentrations When dasatinib was administered following 8 daily evening administrations of 600 mg rifampicin, a potent CYP3A4 inducer, the AUC of dasatinib was decreased by 82%. 
Kad se dasatinib primijenio nakon 8 dana svakodnevne primjene 600 mg rifampicina, potentnog induktora CYP3A4, AUC dasatiniba smanjio se za 82%.
OUTER CARTON AND LABEL FOR BOTTLE PACK 
KUTIJA I NALJEPNICA BOCE
Therefore, CYP3A4 substrates known to have a narrow therapeutic index (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving dasatinib (see section 4.4). 
Zbog toga se supstrate CYP3A4 za koje se zna da imaju uski terapijski indeks (npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil ili ergot alkaloidi [ergotamin, dihidroergotamin]) mora primjenjivati s oprezom u bolesnika koji primaju dasatinib (vidjeti dio 4.4).
This medicinal product contains 2.1 mg sodium per mL of SPRYCEL oral suspension. 
Ovaj lijek sadrži 2,1 mg natrija po ml SPRYCEL oralne suspenzije.
Cumulative rates of selected adverse reactions that were reported in the 100 mg once daily recommended starting dose are shown in Table 6a. 
Kumulativne stope odabranih nuspojava prijavljenih u skupini liječenoj preporučenom početnom dozom od 100 mg jedanput dnevno prikazane su u Tablici 6a.
Contrada Fontana del Ceraso 03012 Anagni (FR) Italy 
Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR)
b Includes ventricular dysfunction, cardiac failure, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and ventricular failure. 
b Uključuje ventrikularnu disfunkciju, srčano zatajenje, kongestivno zatajenje srca, kardiomiopatiju, kongestivnu kardiomiopatiju, dijastoličku disfunkciju, smanjenje ejekcijske frakcije i zatajivanje ventrikula.
The safety profile of SPRYCEL administered as single-agent therapy in paediatric patients with Ph+ CML-CP was comparable to the safety profile in adults. 
Sigurnosni profil lijeka SPRYCEL u monoterapiji u pedijatrijskih bolesnika s Ph+ KML u kroničnoj fazi bio je usporediv sa sigurnosnim profilom u odraslih.
Accelerated (n= 158) 
Faza ubrzanja (n= 158)
In the subset of 130 chronic phase CML SPRYCEL-treated paediatric patients, the median duration of therapy was 42.3 months (range 0.1 to 99.6 months). 
U podskupini od 130 pedijatrijskih bolesnika s KML u kroničnoj fazi liječenih lijekom SPRYCEL, medijan trajanja liječenja iznosio je 42,3 mjeseca (raspon 0,1-99,6 mjeseci).
The same dose should be resumed if this is the first occurrence and the dose should be reduced if this is a recurrent adverse reaction. 
Ako se nuspojava pojavila prvi put, liječenje treba nastaviti istom dozom, a ako se radilo o ponovnom nastupu nuspojave, dozu treba smanjiti.
101 were randomised to dasatinib and 49 to imatinib (all imatinib-resistant). 
49 bolesnika u skupini koja je primala imatinib (svi otporni na imatinib).
The proportion of patients achieving BCR-ABL ratio of ≤0.01% (4-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (54.1% versus 45%). 
Udio bolesnika koji su postigli omjer BCR-ABL ≤0,01% (smanjene 4-log) u bilo koje vrijeme bila je viša u SPRYCEL skupini u usporedbi sa imatinib skupinom (54,1% nasuprot 45%).
In clinical studies, treatment with SPRYCEL in adults with Ph+ CML-CP, accelerated, myeloid or lymphoid blast phase (advanced phase) CML, or Ph+ ALL and paediatric patients with Ph+ CML-CP was continued until disease progression or until no longer tolerated by the patient. 
U kliničkim se ispitivanjima liječenje lijekom SPRYCEL u odraslih s Ph+ KML u kroničnoj fazi, KML u fazi ubrzanja, fazi mijeloidne ili limfoidne blastne krize (uznapredovala faza) ili Ph+ ALL te u pedijatrijskih bolesnika s Ph+ KML u kroničnoj fazi nastavilo do progresije bolesti ili dok ga bolesnik više nije mogao podnositi.
SPRYCEL contains the active substance dasatinib. 
SPRYCEL sadrži djelatnu tvar dasatinib.
The starting dose recommended for adult patients with accelerated or blast crisis CML or Ph+ ALL is 140 mg once a day. 
Početna doza koja se preporučuje u odraslih bolesnika s KML u fazi ubrzanja ili blastnoj krizi ili Ph+ ALL iznosi 140 mg jedanput dnevno.
The starting dose recommended for adult patients with chronic phase CML is 100 mg once a day. 
Početna doza koja se preporučuje u odraslih bolesnika u kroničnoj fazi KML iznosi 100 mg jedanput dnevno.
100 mg a The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients. 
100 mg a Tableta se ne preporučuje za bolesnike koji teže manje od 10 kg; u tih bolesnika treba koristiti prašak za oralnu suspenziju.
Further efficacy results are reported in Table 11. 
Daljnji rezultati djelotvornosti prikazani su u tablici 11.
Active substances that may have their plasma concentrations altered by dasatinib Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate. 
Djelatne tvari čije su koncentracije u plazmi promijenjene zbog dasatiniba Istodobna primjena dasatiniba i supstrata CYP3A4 može povećati izloženost supstratu CYP3A4.
In 5 Phase II clinical studies in patients with resistance or intolerance to prior imatinib therapy, repeated baseline and on-treatment ECGs were obtained at pre-specified time points and read centrally for 865 patients receiving SPRYCEL 70 mg twice daily. 
U 5 kliničkih ispitivanja faze II u bolesnika koji ne podnose prethodnu terapiju imatinibom ili su rezistentni na imatinib učinjeni su EKG pregledi prije početka i za vrijeme trajanja liječenja u unaprijed određenim vremenskim točkama, uz centralno očitavanje nalaza, u svih 865 bolesnika koji su primali SPRYCEL u dozi od 70 mg dvaput dnevno.
The recommended starting daily dosage of SPRYCEL powder for oral suspension for paediatric patients with Ph+ CML-CP or Ph+ ALL and adult patients with Ph+ CML-CP who cannot swallow tablets is shown in Table 1. 
Preporučena početna dnevna doza SPRYCEL praška za oralnu suspenziju za pedijatrijske bolesnike s Ph+ KML u kroničnoj fazi ili Ph+ ALL i odrasle bolesnike s Ph+ KML u kroničnoj fazi koji ne mogu progutati tablete prikazana je u Tablici 1.
Use the oral syringe included in the package. 
Treba koristiti štrcaljku za usta uključenu u pakiranje.
The data described below reflect the exposure to SPRYCEL as single-agent therapy at all doses tested in clinical studies (N=2,900), including 324 adult patients with newly diagnosed chronic phase CML, 2,388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase CML or Ph+ ALL, and 188 paediatric patients. 
Podaci navedeni u nastavku odražavaju izloženost lijeku SPRYCEL u monoterapiji u svim dozama koje su se ispitivale u kliničkim ispitivanjima (N=2900), a obuhvaćaju 324 odrasla bolesnika s novodijagnosticiranim KML u kroničnoj fazi, 2388 odraslih bolesnika s Ph+ ALL ili KML u kroničnoj ili uznapredovaloj fazi koji su bili otporni na imatinib ili ga nisu podnosili te 188 pedijatrijskih bolesnika.
If a pleural effusion is diagnosed, dasatinib should be interrupted until patient is examined, asymptomatic or has returned to baseline. 
Ako se dijagnosticira pleuralni izljev, treba prekinuti primjenu dasatiniba sve dok se bolesnika ne pregleda, do povlačenja simptoma ili do povratka na početno stanje.
Patients with BCR-ABL ≤ 10% at 3 months 
Bolesnici koji su imali BCR-ABL ≤ 10% u 3. mjesecu
Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism 
Rijetko anafilaktički šok Endokrini poremećaji Manje često hipotireoza
Based on the Kaplan-Meier estimates, 95% (95% CI: [92%-98%]) of the patients maintained MCyR for 1 year and 88% (95% CI: [83%-93%]) maintained MCyR for 2 years. 
Na temelju procjene preživljenja po Kaplan-Meieru, 95% (95% CI: [92%-98%]) bolesnika održalo je MCyR tijekom 1 godine, dok je 88% (95% CI: [83%-93%]) održalo MCyR tijekom 2 godine.
Common appetite disturbancesa, hyperuricaemia Uncommon tumour lysis syndrome, dehydration, hypoalbuminemia, hypercholesterolemia 
Često poremećaji apetitaa, hiperuricemija Manje često sindrom lize tumora, dehidracija, hipoalbuminemija, hiperkolesterolemija
Additionally, in vitro and in vivo platelet assays suggest that SPRYCEL treatment reversibly affects platelet activation. 
Dodatno, određivanje trombocita in vitro i in vivo sugerira da liječenje lijekom SPRYCEL reverzibilno utječe na aktivaciju trombocita.
Allow a washout period of approximately 1 week after the inhibitor is stopped before the SPRYCEL dose is increased. 
Nakon prekida liječenja inhibitorom potrebno je razdoblje ispiranja od približno 1 tjedna prije nego što se poveća doza lijeka SPRYCEL.
In the 2,712 adult patients with either chronic phase CML, advanced phase CML or Ph+ ALL, the median duration of therapy was 19.2 months (range 0 to 93.2 months). 
U 2712 odraslih bolesnika s KML u kroničnoj fazi, KML u uznapredovaloj fazi ili Ph+ ALL, medijan trajanja liječenja iznosio je 19,2 mjeseca (raspon 0-93,2 mjeseca).
The median duration of therapy in 1,618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months). 
Medijan trajanja liječenja u 1618 odraslih bolesnika s KML u kroničnoj fazi iznosio je 29 mjeseci (raspon 0-92,9 mjeseci).
MEDIAN (95% CI) 
MEDIJAN (95% CI)
• 40 mg daily for patients taking SPRYCEL 140 mg tablet daily. 
• 40 mg na dan u bolesnika koji uzimaju SPRYCEL tablete u dozi od 140 mg dnevno
Shake bottle repeatedly for 30 seconds. 
Tresite bocu neprekidn o tijekom sekundi.
In these patients, CCyR and MMR were CCyR: 87.9% [95% CI: (71.8-96.6)] and MMR: 45.5% [95% CI: (28.1-63.6)] at 12 months. 
U tih je bolesnika CCyR nakon 12 mjeseci iznosio 87,9% [95% CI: (71,8 - 96,6)], a MMR 45,5% [95% CI: (28,1 63,6)].
One randomised non-comparative study was conducted in chronic phase patients who failed initial treatment with 400 or 600 mg imatinib. 
Jedno randomizirano nekomparativno ispitivanje provedeno je u bolesnika s KML u kroničnoj fazi u kojih prethodno liječenje imatinibom u dozi od 400 ili 600 mg nije bilo uspješno.
Grade 3/4 
3./4. stupanj
A total of 387 patients received dasatinib 70 mg twice daily (288 resistant and 99 intolerant). 
Ukupno je 387 bolesnika primilo dasatinib u dozi od 70 mg dvaput dnevno (288 s rezistencijom i 99 s nepodnošljivošću).
Myeloid blast (n= 109) 
mijeloidna blastna (n= 109)
Table 1: Dosage of SPRYCEL tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL Body weight (kg)a 
Tablica 1: Doza SPRYCEL tableta za pedijatrijske bolesnike s Ph+ KML u kroničnoj fazi ili Ph+ ALL Tjelesna težina (kg)a
SPRYCEL powder for oral suspension contains approximately 0.29 g/mL of sucrose upon constitution with water. 
Nakon rekonstitucije s vodom, SPRYCEL prašak za oralnu suspenziju sadrži približno 0,29 g/ml saharoze.
In the Phase III dose-optimisation study in advanced phase CML and Ph+ALL, grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% to 5% of patients across treatment groups. 
U ispitivanju optimizacije doze faze III u uznapredovaloj fazi KML i Ph+ ALL, povišene vrijednosti transaminaza ili bilirubina 3. ili 4. stupnja bile su zabilježene u 1% do 5% bolesnika u svim terapijskim skupinama.
PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib exposure. 
Prijavljena je PAH (prekapilarna plućna arterijska hipertenzija potvrđena desnostranom kateterizacijom srca) povezana s izloženošću dasatinibu.
In adult patients with advanced phase CML or Ph+ ALL treated with dasatinib as monotherapy, complete blood counts (CBCs) should be performed weekly for the first 2 months, and then monthly thereafter, or as clinically indicated. 
U odraslih bolesnika u uznapredovaloj fazi KML ili Ph+ ALL liječenih dasatinibom u monoterapiji, potrebno je raditi kompletnu krvnu sliku svakog tjedna tijekom prva 2 mjeseca liječenja, a nakon toga jedanput mjesečno ili prema kliničkoj indikaciji.
The active substance is dasatinib. 
Djelatna tvar je dasatinib.
With a minimum of 12 months follow-up, 85% of patients randomised to the SPRYCEL group and 81% of patients randomised to the imatinib group were still receiving first-line treatment. 
Uz najmanje 12 mjeseci praćenja, 85% bolesnika randomiziranih u skupinu koja je primala SPRYCEL i 81% bolesnika randomiziranih u skupinu koja je primala imatinib i dalje je primalo terapiju prve linije.
SPRYCEL contains benzoic acid and sodium benzoate SPRYCEL contains 0.25 mg benzoic acid in each mL of oral suspension and 0.25 mg sodium benzoate in each mL of oral suspension. 
SPRYCEL sadrži benzoatnu kiselinu i natrijev benzoat SPRYCEL sadrži 0,25 mg benzoatne kiseline u jednom ml oralne suspenzije i 0,25 mg natrijeva benzoata u jednom ml oralne suspenzije.
Tests may show: abnormal blood test results and possibly impaired kidney function caused by the waste products of the dying tumour (tumour lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell) in the blood, high level of cholesterol in the blood, swollen lymph nodes, bleeding in the brain, irregularity of the electrical activity of the heart, enlarged heart, inflammation of the liver, protein in the urine, raised creatine phosphokinase (an enzyme mainly found in the heart, brain and skeletal muscles), raised troponin (an enzyme mainly found in the heart and skeletal muscles), raised gamma-glutamyltransferase (an enzyme mainly found in the liver) 
Pretrage mogu pokazati: abnormalni rezultati krvnih pretraga i moguća oslabljena funkcija bubrega uzrokovana otpadnim proizvodima od umirućeg tumora (sindrom lize tumora), niske razine albumina u krvi, niske razine limfocita (jedne vrste bijelih krvnih stanica) u krvi, visoke razine kolesterola u krvi, otečene limfne žlijezde, krvarenje u mozgu, nepravilna električna aktivnost srca, prošireno srce, upala jetre, proteini u urinu, povećana kreatin fosfokinaza (enzim koji se većinom nalazi u srcu, mozgu i skeletnim mišićima), povišene razine troponina (enzima koji se pretežno nalazi u srcu i mišićima kostura), povišene razine gama-glutamiltransferaze (enzima koji se pretežno nalazi u jetri)
In clinical studies in patients with advanced phase CML or Ph+ ALL receiving SPRYCEL at the recommended dose (n=304), grade 3 or 4 fluid retention was reported in 8% of patients, including grade 3 or 4 pleural and pericardial effusion reported in 7% and 1% of patients, respectively. 
U kliničkim ispitivanjima u bolesnika s KML u uznapredovaloj fazi ili Ph+ ALL koji su primali SPRYCEL u preporučenoj dozi (n=304), zadržavanje tekućine 3. ili 4. stupnja bilo je prijavljeno u 8% bolesnika, uključujući pleuralni izljev 3. ili 4. stupnja u 7% i perikardijalni izljev 3.ili 4.stupnja u 1% bolesnika.
SPRYCEL 80 mg, 100 mg or 140 mg film-coated tablets are available in cartons containing 30 x 1 film-coated tablets in perforated unit dose blisters. 
SPRYCEL filmom obložene tablete od 80 mg, 100 mg ili 140 mg dostupne su u kutijama s 30 x 1 filmom obloženom tabletom u perforiranim blisterima djeljivima na jedinične doze.
Among 188 patients in paediatric studies, the median duration of therapy was 26.3 months (range 0 to 99.6 months). 
Medijan trajanja liječenja među 188 bolesnika u pedijatrijskim ispitivanjima iznosio je 26,3 mjeseca (raspon 0-99,6 mjeseci).
If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥1.0 × 109/L and platelets ≥75 × 109/L and resume at the original starting dose or at a reduced dose. 
Ako citopenija nije povezana s leukemijom, prekinuti liječenje dok ABN ne bude ≥1,0×109/l i trombociti ≥75×109/l pa nastaviti liječenje početnom dozom ili smanjenom dozom.
Lymphoid blast (n= 48) 
limfoidna blastna (n= 48)
Rare side effects (may affect up to 1 in 1,000 people) Heart and lungs: enlargement of the right ventricle in the heart, inflammation of the heart muscle, collection of conditions resulting from blockage of blood supply to the heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from the heart), coronary (heart) artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs 
Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) Srce i pluća: povećanje desne klijetke u srcu, upala srčanog mišića, skupina stanja koja proizlaze iz blokade opskrbe srčanog mišića krvlju (akutni koronarni sindrom), srčani zastoj (prekid protoka krvi iz srca), bolest koronarnih (srčanih) arterija, upala tkiva koje obavija srce i pluća, krvni ugrušci, krvni ugrušci u plućima
Decreased appetite Fatigue a In the pivotal study, among 106 total patients, 24 patients received the powder for oral suspension at least once, 8 of whom received the powder for oral suspension formulation exclusively. 
Proljev pireksija glavobolja smanjen apetit umor a Od ukupno 106 bolesnika u pivotalnom ispitivanju, 24 bolesnika primila su prašak za oralnu suspenziju najmanje jednom, dok je njih 8 primalo isključivo prašak za oralnu suspenziju.
In the paediatric CML studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults. 
U ispitivanjima liječenja KML u pedijatrijskih bolesnika stope odstupanja u laboratorijskim nalazima odgovarale su poznatom profilu za laboratorijske parametre u odraslih.
Figure 2: MMR rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML 
Slika 2: Stope MMR tijekom vremena - svi randomizirani bolesnici u ispitivanju faze 3 provedenom u bolesnika s novodijagnosticiranom KML u kroničnoj fazi
In SPRYCEL-treated patients with newly diagnosed chronic phase CML who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 1.6% of patients after a minimum of 12 months follow-up. 
Nakon najmanje 12 mjeseci praćenja bolesnika s novodijagnosticiranom KML u kroničnoj fazi liječenih lijekom SPRYCEL u kojih je nastupila mijelosupresija 3. ili 4. stupnja oporavak je općenito nastupio nakon kratkog prekida terapije i/ili nakon smanjenja doze lijeka, dok je do trajnog prekida liječenja došlo u 1,6% bolesnika.
In the study in advanced phase CML and Ph+ ALL, the primary endpoint was MaHR. 
U ispitivanju uznapredovale faze KML i Ph+ ALL, primarni ishod ispitivanja bio je značajan hematološki odgovor.
Do not crush, cut or chew them. 
Tablete se ne smiju drobiti, lomiti ni žvakati.
Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5). 
Stoga je u bolesnika koji primaju dasatinib potrebno odabrati zamjenske lijekove s manjim potencijalom za indukciju CYP3A4 (vidjeti dio 4.5).
In Ph+ ALL paediatric patients with non-haematologic adverse reactions, if needed, one level of dose reduction should be followed, according to the dose reduction recommendations for haematologic adverse reactions that are described above. 
U pedijatrijskih bolesnika s Ph+ ALL koji imaju nehematološke nuspojave po potrebi treba smanjiti dozu za jednu razinu, u skladu s prethodno navedenim preporukama za smanjenje doze u slučaju hematoloških nuspojava.
In the Phase II paediatric study, in patients receiving the tablet formulation, estimated 24-month PFS rate among the 51 patients with newly diagnosed CML-CP was 94.0% (82.6, 98.0), and 81.7% (61.4, 92.0) among the 29 patients with imatinib-resistant/intolerant CML-CP. After 24 months of follow-up, OS in newly diagnosed patients was 100%, and 96.6% in imatinib-resistant or intolerant patients. 
U bolesnika koji su primali lijek u obliku tableta u pedijatrijskom ispitivanju faze II, procijenjena 24-mjesečna stopa PFS u 51 bolesnika s novodijagnosticiranim KML u kroničnoj fazi iznosila je 94,0% (82,6; 98,0), dok je u 29 bolesnika s KML u kroničnoj fazi koji su bili otporni na imatinib ili ga nisu podnosili ta stopa iznosila 81,7% (61,4; 92,0).
1 Stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L. 
1 Prekinuti liječenje dok ABN ne bude ≥1,0×109/l i trombociti ≥50×109/l.
Instructions for constitution of powder for oral suspension 
Upute za pripremu praška za oralnu suspenziju
Discontinuation within 60 months due to disease progression occurred in 11% of SPRYCEL-treated patients and 14% of imatinib-treated patients. 
Prekid liječenja unutar 60 mjeseci zbog napredovanja bolesti dogodio se u 11% bolesnika liječenih lijekom SPRYCEL i 14% bolesnika liječenih imatinibom.
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets 
SPRYCEL 20 mg filmom obložene tablete SPRYCEL 50 mg filmom obložene tablete SPRYCEL 70 mg filmom obložene tablete SPRYCEL 80 mg filmom obložene tablete SPRYCEL 100 mg filmom obložene tablete SPRYCEL 140 mg filmom obložene tablete dasatinib
In addition, 46 patients with Ph+ ALL received dasatinib 70 mg twice daily (44 resistant and 2 intolerant to imatinib). 
Također, 46 bolesnika s Ph+ ALL primilo je dasatinib u dozi od 70 mg dvaput dnevno (44 s otpornošću i 2 s nepodnošljivošću imatiniba).
The time to MMR was consistently shorter in dasatinib-treated patients compared with imatinib-treated patients. 
Vrijeme do MMR dosljedno je bilo kraće u bolesnika liječenih dasatinibom nego u onih liječenih imatinibom.
Their occurrence is earlier and more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML (see section 4.4). 
Te se promjene ranije i češće javljaju u bolesnika s KML u uznapredovaloj fazi i bolesnika s Ph+ ALL nego u bolesnika s KML u kroničnoj fazi (vidjeti dio 4.4).
Lymphoid blast (n= 33) 
Limfoidna blastna kriza (n= 33)
Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received dasatinib in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction. 
Od 2182 bolesnika koji ne podnose prethodnu terapiju imatinibom ili su otporni na imatinib i primali su SPRYCEL u kliničkim ispitivanjima, 15 (1%) je imalo produljenje QTc intervala koje je zabilježeno kao nuspojava.
Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended (see section 4.2). 
Stoga se u bolesnika koji primaju dasatinib ne preporučuje sistemska primjena potentnog inhibitora CYP3A4 (vidjeti dio 4.2).
Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma 
Često plućni edem*, plućna hipertenzija, plućni infiltrati, pneumonitis, kašalj Manje često plućna arterijska hipertenzija, bronhospazam, astma
Carton containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each. 
Kutija sadrži 56 filmom obloženih tableta u 4 kalendarska blistera sa 14 filmom obloženih tableta po blisteru.
Holding the syringe tip firmly into the bottle, turn the bottle with the syringe upside down. 
Držeći vrh štrcaljke čvrsto u boci, preokrenite bocu i štrcaljku.
Of the 130 SPRYCEL-treated paediatric subjects with CML-CP, 2 (1.5%) experienced adverse reactions leading to treatment discontinuation. 
Od 130 pedijatrijskih ispitanika s KML u kroničnoj fazi liječenih lijekom SPRYCEL, u 2 (1,5%) bolesnika javile su se nuspojave koje su dovele do prekida liječenja.