natgillin/translations-raw huggingface dataset:
Common pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus - CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes) 
Često upala pluća (uključujući bakterijsku, virusnu i gljivičnu), infekcije/upale gornjih dišnih putova, infekcija herpes virusom (uključujući citomegalovirus - CMV),
A total of 109 patients received dasatinib 70 mg twice daily (99 resistant and 10 intolerant to imatinib). 
Ukupno je 109 bolesnika primilo dasatinib u dozi od 70 mg dvaput dnevno (99 s otpornošću i 10 s nepodnošljivošću na imatinib).
Each film-coated tablet contains 27 mg of lactose monohydrate. 
Jedna filmom obložena tableta sadrži 27 mg laktoza hidrata.
NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and 
Nema dokaza leukemije: isti kriteriji kao i za CHR, ali ABN ≥ 500/mm3 i < 1000/mm3, ili trombociti ≥ 20 000/mm3 i
The rate of major molecular response (assessed in 41 patients with a CCyR) was 46% at 24 months. 
Stopa MMR (određenog u 41 bolesnika s CCyR) iznosila je 46% nakon 24 mjeseca.
In these patients grade 3 or 4 pulmonary oedema and pulmonary hypertension were each reported in 1% of patients. 
Među tim je bolesnicima plućni edem 3. ili 4. stupnja bio prijavljen u 1% bolesnika, jednako kao i plućna hipertenzija.
Outer Carton: sprycel 20 mg 
Kutija: sprycel 20 mg
Each film-coated tablet contains 135.0 mg of lactose monohydrate. 
Jedna filmom obložena tableta sadrži 135,0 mg laktoza hidrata.
Not known fatal gastrointestinal haemorrhage* Hepatobiliary disorders 
Nepoznato fatalno gastrointestinalno krvarenje
Each film-coated tablet contains 67.5 mg of lactose monohydrate. 
Jedna filmom obložena tableta sadrži 67,5 mg laktoza hidrata.
Among imatinib-intolerant patients, the estimated rate of PFS was 98% (95% CI: [95%-100%]) at 1 year and 94% (95% CI: [88%-99%]) at 2 years. 
U bolesnika koji nisu podnosili imatinib, procijenjena stopa PFS iznosila je 98% (95% CI: [95%-100%]) nakon 1 godine i 94% (95% CI: [88%-99%]) nakon 2 godine.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release 
Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
How to store SPRYCEL 
Kako čuvati SPRYCEL
Common asthenia, pain, chest pain, generalised oedema*k, chills Uncommon malaise, other superficial oedemal 
Često astenija, bol, bol u prsištu, generalizirani edem*k, zimice Manje često malaksalost, drugi površinski edemil
j Conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, lip oedema, macular oedema, oedema mouth, orbital oedema, periorbital oedema, swelling face. 
j Edem konjunktiva, edem oka, oticanje oka, edem vjeđa, edem lica, edem usana, makularni edem, edem usta, orbitalni edem, periorbitalni edem, oticanje lica.
Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflammation of the skin, persistent noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, bruise, depression, insomnia, flushing, dizziness, contusion (bruising), anorexia, somnolence, generalised oedema Pain: pain in joints, muscular weakness, chest pain, pain around hands and feet, chills, stiffness in muscles and joints, muscle spasm 
Koža, kosa, oko, općenito: trnci u koži, svrbež, suha koža, akne, upalne promjene na koži, neprekidni šum u ušima, gubitak kose, obilno znojenje, poremećaji vida (uključujući zamagljen vid i poremećaj vida), suhoća oka, modrice, depresija, nesanica, naleti crvenila, omaglica, nagnječenja (modrice), anoreksija, pospanost, generalizirani edem Bol: bol u zglobovima, slabost mišića, bol u prsištu, bol u šakama i stopalima, zimica, ukočenost mišića i zglobova, spazam mišića
The use of latex or nitrile gloves is recommended when handling any powder that is inadvertently spilled from the bottle, for appropriate disposal in order to minimise the risk of dermal exposure. 
Pri rukovanju nenamjerno rasutim praškom preporučuje se koristiti rukavice od lateksa ili nitrila, kako bi se minimalizirao rizik od izlaganja putem kože.
Each film-coated tablet contains 189 mg of lactose monohydrate. 
Jedna filmom obložena tableta sadrži 189 mg laktoza hidrata.
An open-label, single-arm, multicentre study was conducted in patients intolerant or resistant to imatinib. 
Multicentrično ispitivanje otvorenog tipa u jednoj skupini provedeno je u bolesnika koji ne podnose ili su otporni na imatinib.
After 60 months of follow-up, median time to cCCyR was 3.1 months in the SPRYCEL group and 5.8 months in the imatinib group in patients with a confirmed CCyR. 
U bolesnika s potvrđenim CCyR, nakon 60 mjeseci praćenja, medijan vremena do cCCyR iznosio je 3,1 mjesec u skupini koja je primala SPRYCEL i 5,8 mjeseci u skupini koja je primala imatinib.
SPRYCEL contains sucrose 
SPRYCEL sadrži saharozu
Each film-coated tablet contains 108 mg of lactose monohydrate. 
Jedna filmom obložena tableta sadrži 108 mg laktoza hidrata.
Guidelines for dose modifications in paediatric patients with CML-CP are summarised in Table 3.Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the table. 
Smjernice za prilagodbu doze u odraslih sažeto su prikazane u Tablici 3, a za pedijatrijske bolesnike s Ph+ KML u kroničnoj fazi u Tablici 4. Smjernice za pedijatrijske bolesnike s Ph+ ALL liječene u kombinaciji s kemoterapijom navedene su u zasebnom odlomku ispod tablica.
In the newly diagnosed chronic phase CML study, grade 3 or 4 hypophosphataemia was reported in 4% of SPRYCEL-treated patients, and grade 3 or 4 elevations of transaminases, creatinine, and bilirubin were reported in ≤ 1% of patients after a minimum of 12 months follow-up. 
U ispitivanju novodijagnosticirane KML u kroničnoj fazi, nakon najmanje 12 mjeseci praćenja, hipofosfatemija 3. ili 4. stupnja bila je zabilježena u 4% bolesnika liječenih lijekom SPRYCEL, dok su povišene vrijednosti transaminaza, kreatinina i bilirubina 3. ili 4. stupnja bile zabilježene u ≤1% bolesnika.
The primary endpoint was MCyR at 12 weeks. 
Primarni ishod bio je značajni citogenetski odgovor (MCyR) u 12. tjednu liječenja.
The proportion of patients who maintained MCyR for 18 months was 90% (95% CI: [82%-98%]) for dasatinib (CCyR 94%, 95% CI: [87%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%). 
Udio bolesnika u kojih se održao značajni citogenetski odgovor tijekom 18 mjeseci iznosio je 90% (95% CI: [82%-98%]) za dasatinib (potpuni citogenetski odgovor, 94%; 95% CI: [87%-100%]) te 74% (95% CI: [49%-100%]) za imatinib (potpuni citogenetski odgovor,
Table 2: Dose escalation for patients with Ph+CML-CP Dose (maximum dose per day) Starting dose 
Tablica 2: Postupno povećanje doze za bolesnike s Ph+ KML u kroničnoj fazi Doza (maksimalna dnevna doza) Početna doza
Breast-feeding should be stopped during treatment with SPRYCEL. 
Za vrijeme liječenja lijekom SPRYCEL dojenje se mora prekinuti.
Rates of MR4.5 over time were consistently higher in dasatinib-treated patients compared with imatinib-treated patients. 
Stope MR4,5 dosljedno su bile više u bolesnika liječenih dasatinibom nego u onih liječenih imatinibom.
Survival (%; Kaplan-Meier estimates) Progression-Free 1 year 2 year Overall 1 year 2 year 
Bez progresije 1 godina 2 godine Ukupno 1 godina 2 godine
Not known interstitial lung disease 
Nepoznato intersticijska bolest pluća Poremećaji probavnog sustava
Outer Carton: sprycel 50 mg 
Kutija: sprycel 50 mg
In healthy subjects administered 100 mg of [14C]-labelled dasatinib, unchanged dasatinib represented 29% of circulating radioactivity in plasma. 
neizmijenjen dasatinib činio je 29% cirkulirajuće radioaktivnosti u plazmi.
Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis 
Često hipertenzija, naleti crvenila Manje često hipotenzija, tromboflebitis, tromboza
The rate of major molecular response (all 25 treated patients with a CCyR) was 52% at 24 months. 
Stopa značajnog molekularnog odgovora (svih 25 liječenih bolesnika s potpunim citogenetskim odgovorom) iznosila je 52% nakon 24 mjeseca.
Phase III clinical studies in patients with CML in chronic, accelerated, or myeloid blast phase, and Ph+ ALL who were resistant or intolerant to imatinib 
Klinička ispitivanja faze III u bolesnika s KML u kroničnoj fazi, uznapredovaloj fazi ili fazi mijeloične blastne krize i Ph+ ALL koji ne podnose prethodnu terapiju imatinibom ili su otporni na imatinib
Outer Carton: sprycel 100 mg 
Kutija: sprycel 100 mg
BRISTOL-MYERS SQUIBB PHARMA EEIG 
SQUIBB PHARMA EEIG
Among imatinib-resistant patients, the estimated rate of PFS was 88% (95% CI: [84%-92%]) at 1 year and 75% (95% CI: [69%-81%]) at 2 years. 
Među bolesnicima otpornima na imatinib, procijenjena stopa preživljenja bez progresije bolesti (PFS) iznosila je 88% (95% CI: [84%-92%]) nakon 1 godine i 75% (95% CI: [69%-81%]) nakon 2 godine.
The following can all be signs of serious side effects: if you have chest pain, difficulty breathing, coughing and fainting if you experience unexpected bleeding or bruising without having an injury if you find blood in your vomit, stools or urine, or have black stools if you get signs of infections such as fever, severe chills if you get fever, sore mouth or throat, blistering or peeling of your skin and/or mucous membranes Contact your doctor immediately if you notice any of the above. 
Neočekivano krvarenje ili modrice, a da se niste ozlijedili Krv u povraćenom sadržaju, stolici ili mokraći ili crna stolica Znakovi infekcije poput vrućice i jake zimice Vrućica, upala usta ili grla, pojava mjehurića ili ljuštenje kože i/ili sluznica Odmah obavijestite liječnika ako primijetite nešto od gore navedenog.
In the Phase III dose-optimisation study in chronic phase CML, grade 3 or 4 elevations of transaminases or bilirubin were reported in ≤ 1% of patients with similar low incidence in the four treatment groups. 
U ispitivanju optimizacije doze faze III, povišenje 3. ili 4. stupnja vrijednosti transaminaza ili bilirubina bilo je prijavljeno u ≤1% bolesnika s KML u kroničnoj fazi uz slično nisku incidenciju u sve četiri liječene skupine.
SPRYCEL 70 mg tablets dasatinib 
SPRYCEL 70 mg tablete dasatinib
Each film-coated tablet contains 94.5 mg of lactose monohydrate. 
Jedna filmom obložena tableta sadrži 94,5 mg laktoza hidrata.
Efficacy results are presented in Table 9. 
Rezultati ispitivanja djelotvornosti prikazani su u Tablici 9.
10 to less than 20 kg 
od 10 do manje od 20 kg
c Includes brain natriuretic peptide increased, ventricular dysfunction, left ventricular dysfunction, right ventricular dysfunction, cardiac failure, cardiac failure acute, cardiac failure chronic, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased and ventricular failure, left ventricular failure, right ventricular failure, and ventricular hypokinesia. 
disfunkciju lijeve klijetke, disfunkciju desne klijetke, srčano zatajenje, akutno zatajenje srca, kronično zatajenje srca, kongestivno zatajenje srca, kardiomiopatiju, kongestivnu kardiomiopatiju, dijastoličku disfunkciju, smanjenje ejekcijske frakcije i zatajenje klijetke, zatajenje lijeve klijetke, zatajenje desne klijetke i ventrikularnu hipokineziju.
Outer Carton: sprycel 80 mg 
Kutija: sprycel 80 mg
20 to less than 30 kg 
od 20 do manje od 30 kg
The median time from diagnosis to start of treatment was 28 months. 
Medijan vremena od dijagnoze do početka liječenja iznosio je 28 mjeseci.
CCyR (95% CI) 54% (48-59) 33% (26-41) 27% (19-36) 46% (31-61) 54% (39-69) 
2 godine n/p Citogenetski odgovorc (%) Značajan (95% CI) 62% (5767) 40% (33-48) 34% (25-44) 52% (37-67) 57% (41-71) Potpun (95%
Laboratory test abnormalities Haematology 
Poremećaji laboratorijskih nalaza Hematologija
within 48 months (95% CI) 
unutar 48 mjeseci (95% CI)
A 70 mg twice daily regimen was also studied. 
Ispitivan je i režim liječenja dozom od 70 mg dvaput dnevno.
Table 2: Dose escalation for paediatric patients with Ph+ CML-CP Dose (maximum dose per day) Starting dose 
Tablica 2: Postupno povećanje doze za pedijatrijske bolesnike Ph+ KML u kroničnoj fazi Doza (maksimalna dnevna doza) Početna doza
Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date. 
Medijan trajanja liječenja dasatinibom iznosio je 3,5 mjeseci s time da je 12% bolesnika do tada bilo liječeno >24 mjeseca.
Uncommon side effects (may affect up to 1 in 100 people) Heart and lungs: heart attack (including fatal outcome), inflammation of the lining (fibrous sack) surrounding the heart, irregular heartbeat, chest pain due to lack of blood supply to the heart (angina), low blood pressure, narrowing of airway that may cause breathing difficulties, asthma, increased blood pressure in the arteries (blood vessels) of the lungs Digestive problems: inflammation of the pancreas, peptic ulcer, inflammation of the food pipe, swollen tummy (abdomen), tear in the skin of the anal canal, difficulty in swallowing, inflammation of the gallbladder, blockage of bile ducts, gastro-oesophageal reflux (a condition where acid and other stomach contents come back up into the throat) Skin, hair, eye, general: allergic reaction including tender, red lumps on the skin (erythema nodosum), anxiety, confusion, mood swings, lower sexual drive, fainting, tremor, inflammation of the eye which causes redness or pain, a skin disease characterized by tender, red, well-defined blotches with the sudden onset of fever and raised white blood cell count (neutrophilic dermatosis), loss of hearing, sensitivity to light, visual impairment, increased eye tearing, disturbance in skin colour, inflammation of fatty tissue under the skin, skin ulcer, blistering of the skin, nail disorder, hair disorder, hand-foot disorder, renal failure, urinary frequency, breast enlargement in men, menstrual disorder, general weakness and discomfort, low thyroid function, losing balance while walking, osteonecrosis (a disease of reduced blood flow to the bones, which can cause bone loss and bone death), arthritis, skin swelling anywhere in the body 
Probavni problemi: upala gušterače, peptički ulkus, upala jednjaka, otečen trbuh, rascjep kože na analnom kanalu, poteškoće pri gutanju, upala žučnog mjehura, začepljenje žučnih kanala, gastroezofagealni refluks (stanje kod kojega se želučana kiselina i sadržaj želuca vraćaju u grlo) Koža, kosa, oko, općenito: alergijska reakcija, uključujući blage, crvene kvržice na koži (erythema nodosum), anksioznost, zbunjenost, promjene raspoloženja, smanjenje seksualnog nagona, malaksalost, tremor, upala oka koja uzrokuje crvenilo ili bol, kožna bolest karakterizirana mekim, crvenim, dobro definiranim mrljama s iznenadnim nastupom vrućice i povišenjem bijelih krvnih stanica (neutrofilna dermatoza), gubitak sluha, osjetljivost na svjetlo, oštećenje vida, pojačano suzenje oka, poremećaj u boji kože, upala potkožnog masnog tkiva, ulkus kože, plikovi na koži, poremećaj noktiju, poremećaj kose, poremećaj ruku-nogu, zatajenje bubrega, učestalo mokrenje, povećanje grudi u muškaraca, poremećaj mjesečnice, opća slabost i nelagoda, smanjena funkcija štitnjače, gubitak ravnoteže u hodu, osteonekroza (bolest kod koje je smanjen dotok krvi u kosti, što može uzrokovati gubitak i odumiranje kosti), artritis, oticanje kože na bilo kojem dijelu tijela
The median time from diagnosis to start of treatment was 48 months. 
Medijan vremena od dijagnoze do početka liječenja iznosio je 48 mjeseci.
DO NOT USE A DISHWASHER 
Nemojte uzimati SPRYCEL
Based on the Kaplan-Meier estimates, the proportion of patients who had progression-free survival (PFS) for 1 year was 91% (95% CI: [85%-97%]) for dasatinib and 73% (95% CI: [54%-91%]) for imatinib. 
Na temelju procjene preživljenja po Kaplan-Meieru, PFS tijekom 1 godine iznosilo je 91% (95% CI: [85%-97%]) za dasatinib i 73% (95% CI: [54%-91%]) za imatinib.
Common febrile neutropaenia Uncommon lymphadenopathy, lymphopaenia 
Često febrilna neutropenija Manje često limfadenopatija, limfopenija
In patients with accelerated phase CML treated with the 140 mg once daily regimen, the median duration of MaHR and the median overall survival was not reached and the median PFS was 25 months. 
U bolesnika s KML u fazi ubrzanja liječenih dozom od 140 mg jedanput dnevno nije postignut ni medijan trajanja
SPRYCEL contains lactose 
SPRYCEL sadrži laktozu.
SPRYCEL 20 mg tablets dasatinib 
SPRYCEL 20 mg tablete dasatinib
Based on the Kaplan-Meier estimates, the proportion of patients who maintained MCyR for 1 year was 92% (95% CI: [85%-100%]) for dasatinib (CCyR 97%, 95% CI: [92%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%). 
Na temelju procjene po Kaplan-Meieru, udio bolesnika u kojih se održao značajni citogenetski odgovor tijekom 1 godine iznosio je 92% (95% CI: [85%-100%]) za dasatinib (potpuni citogenetski odgovor, 97%; 95% CI: [92%-100%]) te 74% (95% CI: [49%-100%]) u skupini za imatinib (potpuni citogenetski odgovor, 100%).
NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and ≤ 100,000/mm3. 
NEL: isti kriteriji kao i za CHR, ali ABN ≥ 500/mm3 i < 1000/mm3, ili trombociti ≥ 20 000/mm3 i ≤ 100 000/mm3. c MCyR uključuje i potpun (0% Ph+ metafaze) i djelomičan (> 0%-35%) odgovor.
PROPORTION ALIVE 
UDIO ŽIVIH ISPITANIKA
Myeloid blast phase CML 
Mijeloidna blastna kriza KML
SPRYCEL 140 mg film-coated tablets 
SPRYCEL 140 mg filmom obložene tablete
The rate of major molecular response (all 22 treated patients with a CCyR) was 50% at 24 months. 
Stopa značajnog molekularnog odgovora (sva 22 liječena bolesnika s potpunim citogenetskim odgovorom) iznosila je 50% nakon 24 mjeseca.
Results are available for 150 patients: 
Rezultati su dostupni za 150 bolesnika: 101 bolesnika u skupini koja je primala dasatinib i
SPRYCEL 50 mg tablets dasatinib 
SPRYCEL 50 mg tablete dasatinib
SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate). 
SPRYCEL 140 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 140 mg dasatiniba (u obliku hidrata).
Sucrose Carmellose sodium Simethicone emulsion consisting of: simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides, methylcellulose, xanthan gum, benzoic acid, sorbic acid, sulfuric acid. 
6.1 Popis pomoćnih tvari saharoza karmelozanatrij simetikon emulzija koja se sastoji od: simetikona polietilenglikolsorbitantristearata polietoksilatstearata glicerida metilceluloze ksantanske gume benzoatne kiseline,
Table 12: Efficacy of SPRYCEL in phase III dose-optimization study: imatinib resistant or intolerant chronic phase CML (2-year results)a 
Tablica 12: Djelotvornost lijeka SPRYCEL u ispitivanju optimizacije doze faze III: bolesnici s KML u kroničnoj fazi koji su otporni na imatinib ili ga ne podnose (2-godišnji rezultati)a
The median time from diagnosis to start of treatment was 18 months. 
Medijan vremena od dijagnoze do početka liječenja iznosio je 18 mjeseci.
within 24 months (95% CI) 
unutar 24 mjeseca (95% CI)
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date. 
Medijan trajanja liječenja dasatinibom iznosio je 14 mjeseci uz 31% bolesnika liječenih >24 mjeseca do tada.
MCyR All patients Imatinib-resistant patients CCyR All patients Imatinib-resistant patients Major molecular response in patients achieving CCyRd (%) (95% CI) 
Značajan (MCyR) svi bolesnici bolesnici otporni na imatinib Potpun (CCyR) svi bolesnici bolesnici otporni na imatinib
Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 0800 0752002 (+49 (0)89 121 42 350) 
KGaA Tel: + 0800 0752002 (+49 (0)89 121 42 350)
Not known hepatitis B reactivation 
Nepoznato ponovna aktivacija hepatitisa B Poremećaji krvi i limfnog sustava
NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG 3. 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bristol-Myers Squibb Pharma EEIG
Table 6a: Selected adverse reactions reported in a phase 3 dose optimisation study (imatinib intolerant or resistant chronic phase CML)a 
Tablica 6a: Odabrane nuspojave prijavljene u ispitivanju optimizacije doze faze 3 (bolesnici s KML u kroničnoj fazi koji ne podnose imatinib ili su otporni na njega)a Minimalno 2 godine praćenja
SPRYCEL 140 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS 140” debossed on one side and “857” on the other side. 
SPRYCEL 140 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, okrugla, s oznakom “BMS 140” utisnutom s jedne i oznakom “857” s druge strane.
within 36 months (95% CI) 
unutar 36 mjeseci (95% CI)
If a moderate, grade 2, non-haematologic adverse reaction develops with dasatinib, treatment should be interrupted until the adverse reaction has resolved or returned to baseline. 
Ako se javi umjerena, nehematološka nuspojava 2. stupnja na dasatinib, liječenje treba obustaviti sve do povlačenja nuspojave ili povratka na početno stanje.
Rates of MMR were consistently higher in dasatinib-treated patients compared with imatinib-treated patients. 
Stope MMR dosljedno su bile više u bolesnika liječenih dasatinibom nego u onih liječenih imatinibom.
SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate). 
SPRYCEL 70 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 70 mg dasatiniba (u obliku hidrata).
Imatinib-resistant patients 
Bolesnici otporni na imatinib
SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient. 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prije izdavanja bolesniku SPRYCEL prašak za oralnu suspenziju mora rekonstituirati ljekarnik ili kvalificirani zdravstveni radnik.
Non-haematologic adverse reactions 
Nehematološke nuspojave
The median time from diagnosis to start of treatment was 82 months. 
Medijan vremena od dijagnoze do početka liječenja iznosio je 82 mjeseca.
SPRYCEL 70 mg film-coated tablets 
SPRYCEL 70 mg filmom obložene tablete
Time-to cCCyR 
Vrijeme do cCCyR
SPRYCEL 80 mg film-coated tablets EU/1/06/363/013 
SPRYCEL 80 mg filmom obložene tablete EU/1/06/363/013
Based on the Kaplan-Meier estimates, the proportion of patients treated with dasatinib 100 mg once daily who maintained MCyR for 18 months was 93% (95% CI: [88%-98%]). 
Na temelju procjene po Kaplan-Meieru, značajan citogenetski odgovor održao se tijekom 18 mjeseci u 93% (95% CI: [88%-98%]).
SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. 
SPRYCEL je indiciran u liječenju pedijatrijskih bolesnika kod: novodijagnosticirane kronične mijeloične leukemije (KML) s pozitivnim Philadelphia kromosomom (Ph+) u kroničnoj fazi ili Ph+ KML u kroničnoj fazi u bolesnika koji ne podnose ili su otporni na prethodnu terapiju, uključujući imatinib. novodijagnosticirane Ph+ akutne limfoblastične leukemije (ALL) u kombinaciji s kemoterapijom.
SPRYCEL 70 mg film-coated tablets EU/1/06/363/006 
SPRYCEL 70 mg filmom obložene tablete EU/1/06/363/006
Haematologic response rateb (%) (95% CI) 
Stopa hematološkog odgovorab (%) (95% CI)
SPRYCEL 140 mg film-coated tablets EU/1/06/363/015 
SPRYCEL 140 mg filmom obložene tablete EU/1/06/363/015
within 60 months (95% CI) 
unutar 60 mjeseci (95% CI)
Grade 
Nuspojava
SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with “BMS 80” debossed on one side and “855” on the other side. 
SPRYCEL 80 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, trokutasta, s oznakom “BMS 80” utisnutom s jedne i oznakom “855” s druge strane.
SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “524” on the other side. 
SPRYCEL 70 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, okrugla, s oznakom “BMS” utisnutom s jedne i oznakom “524” s druge strane.