natgillin/translations-raw huggingface dataset:
Table 5: Tabulated summary of adverse reactions 
Tablica 5: Tablični sažetak nuspojava
A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the tablet, in section 4.2, is expected to provide similar exposure to a tablet dose of 60 mg/m2. 
Prema simulaciji utemeljenoj na populacijskom farmakokinetičkom modelu, očekuje se da će preporučeno doziranje tableta prema kategorijama tjelesne težine navedeno u dijelu 4.2 dovesti do slične izloženosti kao tablete u dozi od 60 mg/m2.
Digestive problems: loss of vital nutrients such as protein from your digestive tract, bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus), impairment of kidney function, diabetes 
Probavni problemi: gubitak vitalnih hranjivih tvari kao što su proteini iz probavnog trakta, začepljenje crijeva, analna fistula (abnormalan otvor koji vodi od anusa do kože oko anusa), poremećaj funkcije bubrega, šećerna bolest
Other secondary endpoints included duration of MCyR, PFS, and overall survival. 
Drugi sekundarni ishodi bili su trajanje značajnog citogenetskog odgovora, PFS i ukupno preživljenje.
In the paediatric ALL studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults, within the context of an acute leukaemia patient receiving a background chemotherapy regimen. 
U ispitivanjima liječenja ALL u pedijatrijskih bolesnika stope odstupanja u laboratorijskim nalazima odgovarale su poznatom profilu za laboratorijske parametre u odraslih, u kontekstu bolesnika s akutnom leukemijom liječenog osnovnim kemoterapijskim režimom.
Of the 126 Ph+ ALL paediatric patients on a continuous dosing regimen, 2 (1.6%) experienced adverse reactions leading to treatment discontinuation. 
Od 126 pedijatrijskih bolesnika s Ph+ ALL liječenih prema režimu kontinuirane primjene, 2 (1,6%) bolesnika imala su nuspojave koje su dovele do prekida liječenja.
Temporary dose reductions for intermediate degrees of cytopaenia and disease response should be implemented as needed. 
Po potrebi treba privremeno smanjiti dozu u slučaju citopenije srednjeg stupnja i odgovora bolesti.
In the newly diagnosed chronic phase CML study after a minimum of 60 months follow-up, dasatinib-related fluid retention adverse reactions included pleural effusion (28%), superficial oedema (14%), pulmonary hypertension (5%), generalised oedema (4%), and pericardial effusion (4%). 
Nakon najmanje 60 mjeseci praćenja u ispitivanju provedenom u bolesnika s novodijagnosticiranom KML u kroničnoj fazi, nuspojave zadržavanja tekućine uzrokovani primjenom dasatiniba uključivali su pleuralni izljev (28%), površinski edem (14%), plućnu hipertenziju (5%), generalizirani edem (4%) i perikardijalni izljev (4%).
Lymphoid toxicity in rats consisted of lymphoid depletion of the lymph nodes, spleen, and thymus, and decreased lymphoid organ weights. 
Limfoidna toksičnost u štakora sastojala se od limfoidne deplecije u limfnim čvorovima, slezeni i timusu, te smanjene težine limfnih organa.
What SPRYCEL contains The active substance is dasatinib. 
Što SPRYCEL sadrži Djelatna tvar je dasatinib.
For paediatric patients with Ph+ CML-CP, if Grade ≥3 neutropaenia or thrombocytopaenia recurs during complete haematologic response (CHR), SPRYCEL should be interrupted, and may be subsequently resumed at a reduced dose. 
Ako u pedijatrijskih bolesnika s Ph+ KML u kroničnoj fazi ponovno nastupe neutropenija ili trombocitopenija ≥ 3. stupnja tijekom potpunog hematološkog odgovora, primjenu lijeka SPRYCEL potrebno je privremeno prekinuti, a zatim nastaviti liječenje smanjenom dozom.
Data from healthy subjects administered a single 100 mg dose of dasatinib 30 minutes following a high-fat meal indicated a 14% increase in the mean AUC of dasatinib. 
Podaci prikupljeni u zdravih ispitanika koji su primili pojedinačnu dozu dasatiniba od 100 mg 30 minuta nakon obroka bogatog masnoćama ukazuju na 14%-tno povećanje prosječne AUC dasatiniba.
The recommended starting dose for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL is 140 mg once daily (see section 4.4). 
Preporučena početna doza dasatiniba u fazi ubrzanja, fazi mijeloidne ili limfoidne blastne krize (uznapredovala faza) KML ili Ph+ ALL iznosi 140 mg jedanput dnevno (vidjeti dio 4.4).
Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropaenia, gastrointestinal bleeding, high uric acid levels in the blood 
Pretrage mogu pokazati: tekućina oko srca, tekućina u plućima, aritmija (poremećaj srčanog ritma), febrilna neutropenija, krvarenje u probavni sustav, velika koncentracija mokraćne kiseline u krvi
The other ingredients are: sucrose, carmellose sodium, simethicone emulsion (consisting of simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides, methylcellulose, xanthan gum, benzoic acid, sorbic acid, sulfuric acid), tartaric acid, trisodium citrate anhydrous, sodium benzoate (E211), silica hydrophobic colloidal, mixed berry flavour (containing: benzyl alcohol, sulphur dioxide) (see section 2 "What you need to know before you take SPRYCEL"). 
Drugi sastojci su: saharoza, karmelozanatrij, simetikon emulzija (sastoji se od simetikona, polietilenglikolsorbitantristearata, polietoksilatstearata, glicerida, metilceluloze, ksantanske gume, benzoatne kiseline, sorbatne kiseline i sumporne kiseline), tartaratna kiselina, bezvodni trinatrijev citrat, natrijev benzoat (E211), hidrofobni koloidni silicijev dioksid, aroma miješanog bobičastog voća (koja sadrži benzilni alkohol i sumporov dioksid) (vidjeti dio 2."Što morate znati prije nego počnete uzimati SPRYCEL").
Treatment with dasatinib is associated with anaemia, neutropaenia and thrombocytopaenia. 
Liječenje dasatinibom povezano je s anemijom, neutropenijom i trombocitopenijom.
c Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial (>0%-35%). 
c Kriteriji citogenetskog odgovora: potpuni (0% Ph+ metafaze) ili djelomični (> 0%-35%).
Constituted oral suspension may be further mixed with milk, yogurt, apple juice, or applesauce. 
Rekonstituirana oralna suspenzija može se dodatno pomiješati s mlijekom, jogurtom ili bistrim/gustim sokom od jabuke.
Unopened bottle 2 years. 
Neotvorena boca
An open-label, randomised, non-comparative multicentre study was conducted in patients who failed initial treatment with 400 or 600 mg imatinib. 
Randomizirano, multicentrično, nekomparativno ispitivanje otvorenog tipa provelo se u bolesnika u kojih početno liječenje imatinibom u dozi od 400 ili 600 mg nije bilo uspješno.
ANC < 0.5 x 109/L and/or platelets < 10 x 109/L 
ABN <0,5×109/l i/ili trombociti <10×109/l
Second dose (mL) 
Druga doza (ml)
SPRYCEL should not be taken with grapefruit or grapefruit juice (see section 4.5). 
SPRYCEL se ne smije uzimati s grejpom ni sokom od grejpa (vidjeti dio 4.5).
A statistically significantly greater proportion of patients in the SPRYCEL group achieved a cCCyR compared with patients in the imatinib group within the first 12 months of treatment. 
Udio bolesnika koji su postigli cCCyR bio je statistički značajno veći u skupini koja je primala SPRYCEL nego u skupini koja je primala imatinib u prvih 12 mjeseci liječenja.
In the Phase II paediatric study, 1 newly diagnosed patient and 2 imatinib-resistant or intolerant patients progressed to blast phase CML. 
U pedijatrijskom ispitivanju faze II, u 1 bolesnika s novodijagnosticiranom bolešću i 2 bolesnika koja su bila otporna na imatinib ili ga nisu podnosila došlo je do progresije KML do faze blastne krize.
Your doctor will decide the right dose based on your weight. 
Liječnik će odrediti pravu dozu za Vas na temelju
Patients with BCR-ABL > 10% at 3 months 
Bolesnici koji su imali BCR-ABL > 10% u 3. mjesecu
In addition, one open-label, randomised, comparative Phase III study was conducted in adult patients with newly diagnosed chronic phase CML. 
Uz to je provedeno i jedno otvoreno, randomizirano, komparativno ispitivanje faze III u odraslih bolesnika s novodijagnosticiranom KML u kroničnoj fazi.
Long-term suppression of gastric acid secretion by H2 antagonists or proton pump inhibitors (e.g. famotidine and omeprazole) is likely to reduce dasatinib exposure. 
Dugotrajna supresija sekrecije želučane kiseline antagonistima H2 receptora ili inhibitorima protonske pumpe (npr. famotidin ili omeprazol) vjerojatno će smanjiti izloženost dasatinibu.
No clinically relevant age-related pharmacokinetic differences have been observed in these patients. 
U starijih bolesnika nisu primijećene klinički važne razlike u farmakokinetici povezane s dobi.
Myeloid blast phase (n= 74)c 
Mijeloidna blastna kriza (n= 74)c
Grade 3 or 4 elevations in creatinine were reported in < 1% of patients with chronic phase CML and were reported with an increased frequency of 1 to 4% of patients with advanced phase CML. 
Povišenje kreatinina 3. ili 4. stupnja bilo je prijavljeno u <1% bolesnika s KML u kroničnoj fazi te uz povećanu učestalost od 1 do 4% u bolesnika u uznapredovaloj fazi KML.
Table 14: Efficacy of SPRYCEL in phase III dose-optimisation study: advanced phase CML and Ph+ ALL (2 year results)a 
Tablica 14: Djelotvornost lijeka SPRYCEL u ispitivanju optimizacije doze faze III: uznapredovala faza KML i Ph+ ALL (2-godišnji rezultati)a
The dose for the use of powder for oral suspension in adult patients with accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL has not been determined. 
Doza praška za oralnu suspenziju za primjenu u odraslih bolesnika u fazi ubrzanja ili fazi mijeloidne ili limfoidne blastne krize (uznapredovala faza) KML ili Ph+ ALL nije utvrđena.
At clinically relevant concentrations, binding of dasatinib to plasma proteins is approximately 96% on the basis of in vitro experiments. 
Na temelju ispitivanja in vitro, vezanje dasatiniba za proteine plazme pri klinički značajnim koncentracijama iznosi oko 96%.
The mean Cmax and AUC of dasatinib adjusted for the 70 mg dose were decreased by 47% and 8%, respectively, in subjects with moderate hepatic impairment compared to subjects with normal hepatic function. 
Srednja vrijednost Cmax i AUC dasatiniba prilagođenu za dozu od 70 mg bila je smanjena za 47% kod bolesnika sa umjerenim oštećenjem jetre u odnosu na 8% kod bolesnika sa normalnom jetrenom funkcijom.
The median time from diagnosis to randomisation was 64 months in the dasatinib group and 52 months in the imatinib group. 
Medijan vremena od dijagnoze do randomizacije iznosio je 64 mjeseca u skupini koja je primala dasatinib te 52 mjeseca u skupini koja je primala imatinib.
Approximately 5% of the SPRYCEL-treated patients who had normal baseline levels experienced grade 3 or 4 transient hypocalcaemia at some time during the course of the study. 
U oko 5% bolesnika liječenih lijekom SPRYCEL, koji su imali normalne početne vrijednosti kalcija, u nekom je trenutku tijekom trajanja ispitivanja nastupila prolazna hipokalcijemija 3. ili 4. stupnja.
SPRYCEL contains 0.017 mg benzyl alcohol in each mL of oral suspension. 
SPRYCEL sadrži 0,017 mg benzilnog alkohola u jednom ml oralne suspenzije.
All patients Imatinib-resistant patients a Results reported in recommended starting dose of 100 mg once daily. 
Svi bolesnici Bolesnici otporni na imatinib a Rezultati prijavljeni uz primjenu preporučene početne doze od 100 mg jedanput dnevno.
This medicine is used to treat chronic myeloid leukaemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adolescents and children from at least one year of age. 
Ovaj se lijek koristi za liječenje kronične mijeloične leukemije (KML) te akutne limfoblastične leukemije (ALL) s pozitivnim Philadelphia kromosomom (Ph+) u adolescenata i djece u dobi od najmanje godinu dana.
PROPORTION RESPONDERS 
Način primjene
Thus, H2 antagonists and proton pump inhibitors are not recommended and aluminium hydroxide/magnesium hydroxide products should be administered up to 2 hours prior to, or 2 hours following the administration of dasatinib (see section 4.5). 
Zbog toga se ne preporučuje istodobna primjena antagonista H2 receptora i inhibitora protonske pumpe, dok se pripravci s aluminijevim hidroksidom ili magnezijevim hidroksidom moraju primijeniti najmanje 2 sata prije ili 2 sata poslije primjene dasatiniba (vidjeti dio 4.5).
The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients. 
Tableta se ne preporučuje za bolesnike koji teže manje od 10 kg; u tih bolesnika treba koristiti prašak za oralnu suspenziju.
The majority of SPRYCEL-treated patients experienced adverse reactions at some time. 
Većina bolesnika koji su primali SPRYCEL u nekom je trenutku tijekom liječenja razvila nuspojave.
SPRYCEL 20 mg, SPRYCEL 50 mg and SPRYCEL 70 mg film-coated tablets Alu/Alu blisters (calendar blisters or perforated unit dose blisters). 
SPRYCEL 20 mg, SPRYCEL 50 mg i SPRYCEL 70 mg filmom obložene tablete Alu/Alu blisteri (kalendarski blisteri ili perforirani blisteri djeljivi na jedinične doze).
ANC < 0.5 x 109/L and/or platelets < 50 x 109/L 
ABN <0,5×109/l i/ili trombociti <50×109/l
In the Phase I paediatric study, after a minimum of 7 years of follow-up among the 17 patients with imatinib-resistant or intolerant CML-CP, the median duration of PFS was 53.6 months and the rate of OS was 82.4%. 
Nakon minimalno 7 godina praćenja u pedijatrijskom ispitivanju faze I, medijan trajanja PFS među 17 bolesnika s KML u kroničnoj fazi koji su bili otporni na imatinib ili ga nisu podnosili iznosio je 53,6 mjeseci, dok je stopa OS iznosila 82,4%.
If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor. 
Ako imate dodatnih pitanja o načinu djelovanja lijeka SPRYCEL ili razlogu zašto Vam je propisan ovaj lijek, obratite se liječniku.
Patients aged 65 years and older are more likely than younger patients to experience pleural effusion, dyspnoea, cough, pericardial effusion and congestive heart failure, and should be monitored closely. 
U bolesnika u dobi od 65 ili više godina veća je vjerojatnost pleuralnog izljeva, dispneje, kašlja, perikardijalnog izljeva i kongestivnog zatajenja srca nego u mlađih bolesnika, pa stoga stariji bolesnici moraju biti strogo nadzirani.
There is insufficient/limited information on the excretion of dasatinib in human or animal breast milk. 
Informacije o izlučivanju dasatiniba u majčino mlijeko u ljudi ili životinja nedostatne su ili ograničene.
If marrow cellularity is <10%, treatment with SPRYCEL should be interrupted until ANC >500/μL (0.5 x 109/L), at which time treatment may be resumed at full dose. 
Ako je celularnost koštane srži < 10%, liječenje lijekom SPRYCEL potrebno je privremeno prekinuti dok ABN ne bude > 500//μl (0,5 x 109/l), kada se liječenje može nastaviti punom dozom.
Lymphoid blast phase CML and Ph+ ALL 
Limfoidna blastna kriza KML i Ph+ ALL
SPRYCEL is also used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents and children at least 1 year of age, and lymphoid blast CML in adults who are not benefiting from prior therapies. 
SPRYCEL se koristi i za liječenje akutne limfoblastične leukemije (ALL) s pozitivnim Philadelphia kromosomom (Ph+) u odraslih, adolescenata i djece u dobi od najmanje godinu dana te limfoidne blastne KML u odraslih u kojih prethodno liječenje nije dovelo do poboljšanja.
Advise patients who are or may become pregnant of the potential risk to the foetus from dasatinib and the excipient benzyl alcohol, which may accumulate over time and cause metabolic acidosis. 
Trudnice i bolesnice koje bi mogle zatrudnjeti treba upozoriti na mogući rizik za dijete povezan s dasatinibom i pomoćnom tvari benzilnim alkoholom, koji se s vremenom može nakupljati i uzrokovati metaboličku acidozu.
If a severe grade 3 or 4, non-haematologic adverse reaction develops with dasatinib, treatment must be withheld until the adverse reaction has resolved. 
Ako se uz liječenje dasatinibom razvije teška nehematološka nuspojava 3. ili 4. stupnja, liječenje se mora obustaviti sve dok se nuspojava ne povuče.
Chronic phase CML - Resistance or intolerance to prior imatinib therapy 
Kronična faza KML - nepodnošenje prethodne terapije imatinibom ili otpornost na imatinib
120-mL high-density polyethylene bottle with polypropylene child-resistant closure containing 33 g of powder for oral suspension. 
Boca od polietilena visoke gustoće volumena 120 ml s polipropilenskim zatvaračem sigurnim za djecu koja sadrži 33 g praška za oralnu suspenziju.
Uncommon hepatitis, cholecystitis, cholestasis Skin and subcutaneous tissue disorders 
Manje često hepatitis, kolecistitis, kolestaza Poremećaji kože i potkožnog tkiva
For patients taking SPRYCEL 60 mg or 40 mg daily, consider interrupting the dose of SPRYCEL until the CYP3A4 inhibitor is discontinued, or switching to a lower dose with the powder for oral suspension formulation (see Summary of Product Characteristics for SPRYCEL powder for oral suspension). 
U bolesnika koji uzimaju SPRYCEL u dozi od 60 mg ili 40 mg dnevno potrebno je razmotriti privremeni prekid primjene lijeka SPRYCEL do prestanka liječenja inhibitorom CYP3A4 ili prelazak na nižu dozu primjenom praška za oralnu suspenziju (vidjeti sažetak opisa svojstava lijeka za SPRYCEL prašak za oralnu suspenziju).
Adults with accelerated and blast phase CML and Ph+ ALL (starting dose 140 mg once daily) 
Odrasli u fazi ubrzanja i blastnoj fazi KML i Ph+ ALL (početna doza od 140 mg jedanput dnevno)
A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the powder for oral suspension, in section 4.2 of the Summary of Product Characteristics for the powder for oral suspension, is expected to provide similar exposure to a tablet dose of 60 mg/m2. 
Prema simulaciji utemeljenoj na populacijskom farmakokinetičkom modelu, očekuje se da će preporučeno doziranje praška za oralnu suspenziju prema kategorijama tjelesne težine, navedeno u dijelu 4.2 sažetka opisa svojstava lijeka za tu formulaciju dovesti do slične izloženosti kao tablete u dozi od 60 mg/m2.
The concomitant use of dasatinib and a histamine-2 (H2) antagonist (e.g. famotidine), proton pump inhibitor (e.g. omeprazole), or aluminium hydroxide/magnesium hydroxide may reduce the exposure to dasatinib. 
Istodobna primjena dasatiniba i antagonista histaminskih H2 receptora (npr. famotidin), inhibitora protonske pumpe (npr. omeprazol) ili aluminijevog hidroksida/magnezijevog hidroksida može smanjiti izloženost dasatinibu.
Grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% of patients with chronic phase CML (resistant or intolerant to imatinib), but elevations were reported with an increased frequency of 1 to 7% of patients with advanced phase CML and Ph+ ALL. 
Povišenje 3. ili 4. stupnja u vrijednostima transaminaza ili bilirubina bilo je prijavljeno u 1% bolesnika s KML u kroničnoj fazi (koji ne podnose prethodnu terapiju imatinibom ili su otporni na imatinib) te uz zabilježeno povišenu učestalost od 1 do 7% u bolesnika u uznapredovaloj fazi KML i Ph+ ALL.
The rates of cCCyR in the SPRYCEL and imatinib treatment groups, respectively, within 3 months (54% and 30%), 6 months (70% and 56%), 9 months (75% and 63%), 24 months (80% and 74%), 36 months (83% and 77%), 48 months (83% and 79%) and 60 months (83% and 79%) were consistent with the primary endpoint. 
Stope cCCyR u terapijskoj skupini koja je primala SPRYCEL odnosno terapijskoj skupini koja je primala imatinib nakon 3 mjeseca (54% odnosno 30%), 6 mjeseci (70% odnosno 56%), 9 mjeseci (75% odnosno 63%), 24 mjeseca (80% i 74%), 36 mjeseci (83% i 77%), 48 mjeseci (83% i 79%) i 60 mjeseci (83% i 79%) bile su dosljedne primarnoj mjeri ishoda.
In the study in chronic phase CML, the primary endpoint was MCyR in imatinib-resistant patients. 
U ispitivanju KML u kroničnoj fazi, za primarni ishod ispitivanja odabran je značajan citogenetski odgovor u bolesnika otpornih na imatinib.
The use of antacids should be considered in place of H2 antagonists or proton pump inhibitors in patients receiving SPRYCEL therapy (see section 4.4). 
U bolesnika koji primaju SPRYCEL mora se razmotriti primjena antacida umjesto antagonista H2 receptora ili inhibitora protonske pumpe (vidjeti dio 4.4).
For patients taking SPRYCEL 60 mg or 40 mg daily, consider interrupting the dose of SPRYCEL until the CYP3A4 inhibitor is discontinued, or switching to a lower dose with the powder for oral suspension formulation. 
U bolesnika koji uzimaju SPRYCEL u dozi od 60 mg ili 40 mg dnevno potrebno je razmotriti privremeni prekid primjene lijeka SPRYCEL do prestanka liječenja inhibitorom CYP3A4 ili prelazak na nižu dozu primjenom praška za oralnu suspenziju.
Table 1: Dosage of SPRYCEL powder for oral suspension for patients with Ph+ CML-CP and paediatric patients with Ph+ ALL (10 mg/mL suspension upon constitution) Body weight (kg) 
Tablica 1: Doza SPRYCEL praška za oralnu suspenziju za bolesnike s Ph+ KML u kroničnoj fazi i pedijatrijske bolesnike s Ph+ ALL (10 mg/ml suspenzije nakon rekonstitucije) Tjelesna težina (kg)
SPRYCEL 80 mg, SPRYCEL 100 mg and SPRYCEL 140 mg film-coated tablets Alu/Alu blisters (perforated unit dose blisters). 
SPRYCEL 80 mg, SPRYCEL 100 mg i SPRYCEL 140 mg filmom obložene tablete Alu/Alu blisteri (perforirani blisteri djeljivi na jedinične doze).
There is no dose recommendation for SPRYCEL with children under 1 year of age. 
Nema preporuke za doziranje lijeka SPRYCEL u djece mlađe od godinu dana.
Other medicinal products that induce CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John´s Wort) may also increase metabolism and decrease dasatinib plasma concentrations. 
Drugi lijekovi koji induciraju aktivnost CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, fenobarbital ili biljni pripravci koji sadrže Hypericum perforatum, poznatu i kao „gospina trava“) također mogu pojačati metabolizam i smanjiti koncentraciju dasatiniba u plazmi.
Powder Store below 25°C. 
Prašak Čuvati na temperaturi ispod 25°C.
Pericardial effusion Pulmonary oedema Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported at the recommended starting dose of 140 mg once daily (n=304) population at 2 year final study follow up. 
Krvarenje gastrointestinalno krvarenje a Rezultati ispitivanja optimizacije doze faze 3 u populaciji liječenoj preporučenom početnom dozom od 140 mg jedanput dnevno (n=304) prijavljeni nakon 2 godine praćenja u sklopu ispitivanja.
SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each, and in cartons containing 60 x 1 film-coated tablets in perforated unit dose blisters. 
SPRYCEL filmom obložene tablete od 20 mg, 50 mg ili 70 mg dostupne su u kutijama s 56 filmom obloženih tableta u 4 kalendarska blistera s 14 filmom obloženih tableta u svakom te u kutijama sa 60 x 1 filmom obloženom tabletom u perforiranim blisterima djeljivima na jedinične doze.
In the Phase III newly diagnosed chronic phase CML study, the following grade 3 or 4 laboratory abnormalities were reported after a minimum of 12 months follow-up in patients taking SPRYCEL: neutropaenia (21%), thrombocytopaenia (19%), and anaemia (10%). 
U ispitivanju faze III novodijagnosticirane KML u kroničnoj fazi, nakon najmanje 12 mjeseci praćenja bili su zabilježeni sljedeći poremećaji laboratorijskih nalaza 3. i 4. stupnja u bolesnika koji su uzimali SPRYCEL: neutropenija (21%), trombocitopenija (19%) i anemija (10%).
A different spectrum of mutation was detected in the imatinib treatment arm. Dasatinib does not appear to be active against the T315I mutation, based on in vitro data. 
Na temelju in vitro podataka, čini se da dasatinib nije aktivan protiv T315I mutacija.
Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the tables. 
3. Smjernice za pedijatrijske bolesnike s Ph+ ALL liječene u kombinaciji s kemoterapijom navedene su u zasebnom odlomku ispod tablice.