natgillin/translations-raw huggingface dataset:
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 0,25 mg benzoatne kiseline u jednom ml oralne suspenzije i 0,25 mg natrijeva benzoata u jednom ml oralne suspenzije.
Efficacy was achieved across all dasatinib treatment groups with the once daily schedule demonstrating comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MCyR 1.9%; 95% confidence interval [-6.8% - 10.6%]); however, the 100 mg once daily regimen demonstrated improved safety and tolerability. 
Dasatinib se pokazao djelotvornim u svim skupinama koje su primale dozu jedanput dnevno, s time da mu je djelotvornost s obzirom na primarni ishod (razlika u značajnom citogenetskom odgovoru 1,9%; 95% interval pouzdanosti [-6,8% - 10,6%]); međutim, režim liječenja dozom od 100 mg jedanput dnevno pokazao je bolju sigurnost i podnošljivost.
At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments. 
Na temelju in vitro ispitivanja, vezanje dasatiniba za proteine plazme pri klinički značajnim koncentracijama iznosilo je oko 96%.
5 to less than 10 kg 
od 5 do manje od 10 kg
SPRYCEL film-coated tablets 
SPRYCEL filmom obložene tablete
• 20 mg daily for patients taking SPRYCEL 70 mg tablet daily. 
• 20 mg na dan u bolesnika koji uzimaju SPRYCEL tablete u dozi od 70 mg dnevno
With a minimum of 60 months follow-up, 60% of patients randomised to the SPRYCEL group and 63% of patients randomised to the imatinib group were still receiving first-line treatment. 
Uz najmanje 60 mjeseci praćenja, 60% bolesnika randomiziranih u skupinu koja je primala SPRYCEL i 63% bolesnika randomiziranih u skupinu koja je primala imatinib i dalje je primalo terapiju prve linije.
The proportion of patients achieving BCR-ABL ratio of ≤0.0032% (4.5-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (44% versus 34%). 
Udio bolesnika koji su postigli omjer BCR-ABL ≤0,0032% (smanjenje 4,5-log) u bilo koje vrijeme bila je viša u SPRYCEL skupini u usporedbi sa imatinib skupinom (44% nasuprot 34%).
The median duration of therapy in 1,094 adult patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0 to 93.2 months). 
Medijan trajanja liječenja u 1094 odrasla bolesnika s KML u uznapredovaloj fazi ili Ph+ ALL iznosio je 6,2 mjeseca (raspon 0-93,2 mjeseca).
In 258 dasatinib-treated patients and 258 imatinib-treated patients with a minimum of 60 months follow-up in the Phase III study in newly diagnosed chronic phase CML, 1 patient (< 1%) in each group had QTc prolongation reported as an adverse reaction. 
Od 258 bolesnika liječenih dasatinibom i 258 bolesnika liječenih imatinibom u ispitivanju faze III terapije novodijagnosticirane KML u kroničnoj fazi, nakon najmanje 60 mjeseci praćenja, po 1 bolesnik (<1%) u svakoj skupini imao je produljenje QTc intervala koje je bilo prijavljeno kao nuspojava.
Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate). 
Jedan ml oralne suspenzije sadrži 10 mg dasatiniba (u obliku hidrata).
Among patients who had received imatinib 400 mg prior to study entry, MCyR was achieved in 61% of patients in the dasatinib arm and 50% in the imatinib arm. 
Među bolesnicima koji su primali imatinib u dozi od 400 mg prije uključenja u ispitivanje, značajni citogenetski odgovor postiglo je 61% bolesnika u skupini na dasatinibu te 50% bolesnika u skupini na imatinibu.
Your doctor will check for some of these effects during your treatment. 
Liječnik će Vas pregledavati tijekom trajanja liječenja na navedene nuspojave.
In an additional analysis, more dasatinib-treated patients (84%) achieved early molecular response (defined as BCR-ABL levels ≤ 10% at 3 months) compared with imatinib-treated patients (64%). 
U dodatnoj je analizi rani molekularni odgovor (definiran kao razine BCR-ABL ≤ 10% u 3. mjesecu) postigao veći broj bolesnika liječenih dasatinibom (84%) nego bolesnika liječenih imatinibom (64%).
Each pack also contains a press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe in a sealed plastic bag. 
Svako pakiranje sadrži nastavak za bocu i dozirnu štrcaljku za usta od 12 ml u zatvorenoj plastičnoj vrećici.
It was usually managed with dose reduction or interruption. 
Vrijednosti su se obično normalizirale nakon smanjenja doze ili privremenog prekida liječenja.
One-level dose reduction 
Smanjenje doze za jednu razinu
What you need to know before you take SPRYCEL 3. 
Što morate znati prije nego počnete uzimati SPRYCEL 3. Kako uzimati SPRYCEL 4. Moguće nuspojave
In the Phase III clinical study in patients with newly diagnosed chronic phase CML, grade 3 or 4 fluid retention was reported in 13 patients (5%) in the dasatinib-treatment group and in 2 patients (1%) in the imatinib-treatment group after a minimum of 60 months follow-up (see section 4.8). 
U kliničkom ispitivanju faze III u bolesnika s novodijagnosticiranom KML u kroničnoj fazi, nakon najmanje 60 mjeseci praćenja, 3. ili 4. stupanj zadržavanja tekućine bio je zabilježen u 13 bolesnika (5%) u skupini liječenoj dasatinibom te u 2 bolesnika (1%) u skupini liječenoj imatinibom (vidjeti dio 4.8).
Table 9: Efficacy results from a phase 3 study of newly diagnosed patients with chronic phase CML 
Tablica 9: Rezultati djelotvornosti u novodijagnosticiranih bolesnika s KML u kroničnoj fazi iz ispitivanja faze 3
In paediatric trials of SPRYCEL in combination with chemotherapy in newly diagnosed Ph+ ALL paediatric patients after a maximum of 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 1 (0.6%) patient. 
U ispitivanjima lijeka SPRYCEL u kombinaciji s kemoterapijom provedenima u pedijatrijskih bolesnika s novodijagnosticiranim Ph+ ALL, lijekom uzrokovani štetni događaji povezani s rastom i razvojem kostiju su nakon najviše 2 godine liječenja prijavljeni u 1 (0,6%) bolesnika.
MCyR was achieved in 55% of imatinib-resistant patients and 82% of imatinib-intolerant patients. 
Rezultati djelotvornosti prikazani su u tablici 11. Značajni citogenetski odgovor postigao se u 55% bolesnika otpornih na imatinib i 82% bolesnika koji nisu podnosili imatinib.
A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively. 
Značajni citogenetski odgovor na prethodno liječenje imatinibom postiglo je 28% bolesnika u skupini koja je primala dasatinib i 29% bolesnika u skupini koja je primala imatinib.
HAZARD RATIO (95% CI) 
OMJER HAZARDA (95% CI)
At baseline, the distribution of Hasford Scores was similar in the SPRYCEL and imatinib treatment groups (low risk: 33% and 34%; intermediate risk 48% and 47%; high risk: 19% and 19%, respectively). 
Stratifikacija po Hasfordu na početku ispitivanja bila je slična u obje terapijske skupine (niski rizik: 33% u skupini koja je primala SPRYCEL i 34% u skupini koja je primala imatinib; umjereni rizik: 48% u skupini koja je primala SPRYCEL i 47% u skupini koja je primala imatinib; visoki rizik: 19% u skupini koja je primala SPRYCEL i 19% u skupini koja je primala imatinib).
Excipients: contains lactose monohydrate. 
Pomoćne tvari: sadrži laktozu hidrat.
Two randomised, open-label studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily. 
Provedena su dva randomizirana ispitivanja otvorenog tipa da bi se ispitala djelotvornost primjene dasatiniba jedanput dnevno u usporedbi s primjenom dvaput dnevno.
They were randomised (2:1) to either dasatinib (70 mg twice daily) or imatinib (400 mg twice daily). 
Bolesnici su bili randomizirani (2:1) u dvije skupine, jednu koja je primala dasatinib (70 mg dvaput dnevno) i drugu koja je primala imatinib (400 mg dvaput dnevno).
Efficacy of SPRYCEL was consistently demonstrated across different subgroups, including age, gender, and baseline Hasford score. 
Djelotvornost lijeka SPRYCEL dosljedno je pokazana u svim podskupinama prema dobi, spolu i početnoj razini rizika po Hasfordu.
Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting) Skin, hair, eye, general: skin rash, fever, swelling around the face, hands and feet, headache, feeling tired or weak, bleeding 
Probavni problemi: proljev, loše osjećanje (mučnina, povraćanje) Koža, kosa, oko, općenito: kožni osip, vrućica, oticanje lica, šaka i stopala, glavobolja, osjećaj umora ili slabosti, krvarenje
Dose adjustment for adverse reactions Myelosuppression 
Prilagodba doze lijeka zbog nuspojava Mijelosupresija
A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib). 
Ukupno 48 bolesnika u limfoidnoj blastnoj fazi KML primilo je dasatinib u dozi 70 mg dvaput dnevno (42 s otpornošću na imatinib i 6 s nepodnošljivošću).
2 If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 20 x 109/L and resume at the original starting dose. 
2 Ako citopenija nije povezana s leukemijom, prekinuti liječenje dok ABN ne bude ≥1,0×109/l i trombociti ≥20×109/l pa nastaviti liječenje dozom kojom se i započelo.
Uncommon hypersensitivity (including erythema nodosum) 
Poremećaji imunološkog sustava Manje često preosjetljivost (uključujući nodozni eritem)
The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended, to minimise the risk of dermal exposure. 
Pri rukovanju nenamjerno zdrobljenim ili prelomljenim tabletama preporučuje se koristiti rukavice od lateksa ili nitrila, kako bi se minimalizirao rizik od izlaganja putem kože.
• 20 mg daily for patients taking SPRYCEL 100 mg tablet daily. 
• 20 mg na dan u bolesnika koji uzimaju SPRYCEL tablete u dozi od 100 mg dnevno
oral syringe bottle 
štrcaljka za usta boca
Warnings and precautions Talk to your doctor or pharmacist before using SPRYCEL if you are taking medicines to thin the blood or prevent clots (see "Other medicines and SPRYCEL") if you have a liver or heart problem, or used to have one if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older), or due to changes in the blood vessels supplying the lungs if you have ever had or might now have a hepatitis B infection. 
“Drugi lijekovi i SPRYCEL”) ako imate ili ste imali problema s jetrom ili srcem ako počnete otežano disati, osjetite bol u prsištu ili počnete kašljati dok uzimate SPRYCEL: to može biti znak da se u plućima ili prsištu zadržava voda (što se zna češće javljati u bolesnika u dobi od 65 godina i starijih) ili znak promjena na krvnim žilama koje opskrbljuju pluća ako ste ikada imali ili možda sada imate infekciju virusom hepatitisa B.
In the Phase III study in patients with newly diagnosed chronic phase CML, one patient (< 1%) of the SPRYCEL-treated patients had a QTcF > 500 msec after a minimum of 12 months follow-up (see section 4.4). 
U ispitivanju faze III u bolesnika s novodijagnosticiranom KML u kroničnoj fazi, nakon najmanje 12 mjeseci praćenja (vidjeti dio 4.4), jedan bolesnik (<1%) u skupini liječenoj lijekom SPRYCEL imao je QTcF >500 msek.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate 
Jezgra tablete laktoza hidrat mikrokristalična celuloza, karmelozanatrij, umrežena hidroksipropilceluloza magnezijev stearat
There were no mutations detected in newly diagnosed CML-CP patients at the end of treatment. 
Među bolesnicima s novodijagnosticiranim KML u kroničnoj fazi nisu pronađene nikakve mutacije na kraju razdoblja liječenja.
Concomitant use of dasatinib and medicinal products or substances which potently inhibit CYP3A4 (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, grapefruit juice) may increase exposure to dasatinib. 
Istodobna primjena dasatiniba i lijekova ili tvari koje potentno inhibiraju CYP3A4 (npr. ketokonazol, itrakonazol, eritromicin, klaritromicin, ritonavir, telitromicin, sok od grejpa) može povećati izloženost dasatinibu.
The rate of major molecular response (assessed in 19 patients with a CCyR) was 68% at 24 months. 
Stopa značajnog molekularnog odgovora (MMR) (određenog u 19 bolesnika s CCyR) bila je 68% nakon 24 mjeseca.
Bleeding drug-related adverse reactions, ranging from petechiae and epistaxis to grade 3 or 4 gastrointestinal haemorrhage and CNS bleeding, were reported in patients taking SPRYCEL (see section 4.4). 
U bolesnika koji su uzimali SPRYCEL zabilježene su nuspojave krvarenje povezane s lijekom u rasponu od petehija i epistakse do gastrointestinalnog krvarenja i krvarenja u središnji živčani sustav (CNS) 3. ili 4. stupnja (vidjeti dio 4.4).
Carton containing 30 x 1 film-coated tablets in perforated unit dose blisters. 
Kutija sadrži 30 x 1 filmom obloženu tabletu u perforiranim blisterima djeljivima na jedinične doze.
Figure 3: MR4.5 rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML 
Stope MR4,5 tijekom vremena - svi randomizirani bolesnici u ispitivanju faze 3 provedenom u bolesnika s novodijagnosticiranom KML u kroničnoj fazi
In paediatric trials of SPRYCEL in imatinib-resistant/intolerant Ph+ CML-CP paediatric patients and treatment-naive Ph+ CML-CP paediatric patients after at least 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 6 (4.6%) patients, one of which was severe in intensity (Growth Retardation Grade 3). 
U ispitivanjima lijeka SPRYCEL provedenima u pedijatrijskih bolesnika s Ph+ KML u kroničnoj fazi koji su bili otporni na imatinib/nisu podnosili imatinib i prethodno neliječenih pedijatrijskih bolesnika s Ph+ KML u kroničnoj fazi, lijekom uzrokovani štetni događaji povezani s rastom i razvojem kostiju su nakon najmanje 2 godine liječenja prijavljeni u 6 (4,6%) bolesnika, a jedan od njih bio je teškog intenziteta (zastoj u rastu 3. stupnja).
Table 13: Long term efficacy of SPRYCEL in phase 3 dose optimisation study: imatinib resistant or intolerant chronic phase CML patientsa Minimum follow-up period 
Tablica 13: Dugoročna djelotvornost lijeka SPRYCEL u ispitivanju optimizacije doze faze 3: bolesnici s KML u kroničnoj fazi koji su otporni na imatinib ili ga ne podnosea Minimalno razdoblje praćenja
Concentration data in 32 paediatric patients treated with the powder for oral suspension dose of 72 mg/m2 was pooled with data from the tablet for a population pharmacokinetic 
Podaci o koncentracijama prikupljeni u 32 pedijatrijska bolesnika liječena praškom za oralnu suspenziju u dozi od 72 mg/m2
Carton containing 60 x 1 film-coated tablets in perforated unit dose blisters. 
Kutija sadrži 60 x 1 filmom obloženu tabletu u perforiranim blisterima djeljivima na jedinične doze.
Concomitant use of dasatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John's Wort) may substantially reduce exposure to dasatinib, potentially increasing the risk of therapeutic failure. 
Istodobna primjena dasatiniba i lijekova koji induciraju CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital ili biljni pripravci koji sadrže Hypericum perforatum, također poznatu pod imenom „gospina trava“) mogu znatno smanjiti izloženost dasatinibu i time povećati rizik od neuspjeha liječenja.
The proportion of patients who maintained CCyR for 1 year was 97% (95% CI: [94%-99%]) and for 2 years was 90% (95% CI: [86%-95%]). 
Potpuni citogenetski odgovor (CCyR) tijekom 1 godine održalo je 97% bolesnika (95% CI: [94%-99%]) a tijekom 2 godine 90% bolesnika (95% CI: [86%-95%]).
Among the 126 Ph+ ALL paediatric patients treated with SPRYCEL on a continuous dosing regimen, the median duration of therapy was 23.6 months (range 1.4 to 33 months). 
Medijan trajanja liječenja među 126 pedijatrijskih bolesnika s Ph+ ALL liječenih lijekom SPRYCEL prema režimu kontinuirane primjene iznosio je 23,6 mjeseci (raspon 1,4 do 33 mjeseca).
30 to less than 45 kg 
od 30 do manje od 45 kg
The proportion of patients who had PFS at 2 years was 86% (95% CI: [78%-93%]) for dasatinib and 65% (95% CI: [43%-87%]) for imatinib. 
PFS nakon 2 godine iznosilo je 86% (95% CI: [78%-93%]) za dasatinib i 65% (95% CI: [43%-87%]) za imatinib.
This dose represents 30% lower exposure compared to the recommended dose (see section 5.2. of Summary of Product Characteristics for SPRYCEL powder for oral suspension). 
Uz tu je dozu postignuta 30% manja izloženost od one koja se postiže uz preporučenu dozu (vidjeti dio 5.2 sažetka opisa svojstava lijeka za
Skin, hair, eye, general: convulsion, inflammation of the optic nerve that may cause a complete or partial loss of vision, blue-purple mottling of the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (a condition associated with lack of muscular coordination), difficulty walking, miscarriage, inflammation of the skin blood vessels, skin fibrosis 
Koža, kosa, oko, općenito: grčevi, upala optičkog živca koja može izazvati potpuni ili djelomični gubitak vida, plavo ljubičaste mrlje na koži, neuobičajeno pojačana funkcija štitnjače, upala štitnjače, ataksija (stanje povezano s nedostatkom mišićne koordinacije), poteškoće pri hodanju, spontani pobačaj, upala krvnih žila u koži, kožna fibroza
MCyR (95% CI) Newly diagnosed (N = 51)a 
MCyR (95% CI) Novodijagnosticira na bolest (N = 51)a
MMR (95% CI) Newly diagnosed (N = 51)a 
MMR (95% CI) Novodijagnosticira na bolest (N = 51)a
Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)] 
sorbatne kiseline sumporne kiseline tartaratna kiselina trinatrijev citrat, bezvodni natrijev benzoat (E211) silicijev dioksid, hidrofobni, koloidni aroma miješanog bobičastog voća [sadrži benzilni alkohol, sumporov dioksid (E220)] 6.2 Inkompatibilnosti
Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack. 
Oralna suspenzija se nakon rekonstitucije smije primijeniti samo štrcaljkom za usta koja dolazi u svakom pakiranju lijeka.
Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm Uncommon rhabdomyolysis, osteonecrosis, muscle inflammation, tendonitis, arthritis 
Često artralgija, mialgija, mišićna slabost, mišićno-koštana ukočenost, spazam mišića Manje često rabdomioliza, osteonekroza, upala mišića, tendinitis, artritis
The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily. 
Preporučena početna doza dasatiniba u kroničnoj fazi KML iznosi 100 mg jedanput dnevno.
Pain: inflammation of vein which can cause redness, tenderness and swelling, inflammation of the tendon 
Bol: upala vena koja može uzrokovati crvenilo, osjetljivost i oteklinu, upala tetiva Mozak: gubitak pamćenja
Myeloid blast (n= 75) 
Mijeloidna blastna kriza (n= 75)
Outer Carton: sprycel 140 mg 
Kutija: sprycel 140 mg
Number of patients (%) Transformation at 60 months, n/N (%) Rate of PFS at 60 months (95% CI) Rate of OS at 60 months (95% CI) 
Stopa PFS-a u 60. mjesecu (95% CI) Stopa OS-a u 60. mjesecu (95% CI)
A total of 174 patients received dasatinib 70 mg twice daily (161 resistant and 13 intolerant to imatinib). 
Ukupno su 174 bolesnika primila dasatinib u dozi od 70 mg dvaput dnevno (161 s otpornošću i 13 s nepodnošljivošću na imatinib).
Make sure the adapter provided on the bottle for syringe placement is firmly pressed into the bottle. 
Provjerite je li nastavak na boci namijenjen za uvođenje štrcaljke čvrsto uglavljen u grlo boce.
Prior imatinib (N = 46)b a Patients from Phase II paediatric study of newly diagnosed CML-CP receiving oral tablet formulation b Patients from Phase I and Phase II paediatric studies of imatinib-resistant or intolerant CML-CP receiving oral tablet formulation 
Prethodno liječenje imatinibom (N = 46)b a Bolesnici s novodijagnosticiranim KML u kroničnoj fazi iz pedijatrijskog ispitivanja faze II koji su primali lijek peroralno u obliku tablete b Bolesnici s KML u kroničnoj fazi iz pedijatrijskih ispitivanja faze I i faze II koji su bili otporni na liječenje imatinibom ili ga nisu podnosili, a primali su lijek peroralno u obliku tablete
Rate of OS was consistently higher in dasatinib treated patients who achieved BCR-ABL level ≤ 10% at 3 months than those who did not. 
Stopa OS u specifičnim vremenskim točkama grafički je prikazana na Slici 4. Stopa OS dosljedno je bila viša u bolesnika liječenih dasatinibom koji su postigli razinu BCR-ABL ≤ 10% u 3. mjesecu nego u onih koji nisu.
The median time from diagnosis to start of treatment was 61 months. 
Medijan vremena od dijagnoze do početka liječenja iznosio je 61 mjesec.
Outer Carton: sprycel 70 mg 
Kutija: sprycel 70 mg
Powder for oral suspension Outer Carton: 
Prašak za oralnu suspenziju Kutija:
Of note, major haematologic responses (MaHR) were achieved quickly (most within 35 days of first dasatinib administration for patients with lymphoid blast CML, and within 55 days for patients with Ph+ ALL). 
Daljnji rezultati djelotvornosti prikazani su u Tablici 11. Valja napomenuti da se značajan hematološki odgovor (engl. major hematologic response, MaHR) brzo dostigao (uglavnom unutar 35 dana od prve primjene dasatiniba u bolesnika s KML u limfocitnoj blastnoj krizi te unutar 55 dana u bolesnika s Ph+ ALL).
CCyR (95% CI) Newly diagnosed (N = 51)a 
CCyR (95% CI) Novodijagnosticira na bolest (N = 51)a
In CML-CP paediatric patients with non-haematologic adverse reactions, the dose reduction recommendations for haematologic adverse reactions that are described above should be followed. 
U pedijatrijskih bolesnika s KML u kroničnoj fazi koji imaju nehematološke nuspojave treba se pridržavati prethodno navedenih preporuka za smanjenje doze u slučaju hematoloških nuspojava.
Fluid retention Superficial oedema Pleural effusion Generalised oedema Congestive heart failure /cardiac dysfunctionb 
Zadržavanje tekućine površinski edem pleuralni izljev generalizirani edem kongestivno zatajenje srca /srčana disfunkcijab perikardijalni izljev plućni edem
Therefore, in patients receiving dasatinib, coadministration of a potent CYP3A4 inhibitor is not recommended (see section 4.5). 
Stoga se u bolesnika koji primaju dasatinib ne preporučuje istodobna primjena potentnih inhibitora CYP3A4 (vidjeti dio 4.5).
Your doctor will decide the right formulation and dose based on your weight, any side effects and response to treatment. 
Vaše tjelesne težine, bilo kakvih nuspojava i odgovora na liječenje.
Twenty-one of these patients (1%) experienced a QTcF > 500 msec. 
U 21 bolesnika (<1%) zabilježen je QTcF >500 msek.
Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, increased blood pressure in the lungs, cough Digestive problems: appetite disturbances, taste disturbance, bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis 
Srce i pluća: palpitacije (jako lupanje srca), nepravilni otkucaji srca, zastojno zatajenje srca, oslabljen srčani mišić, visoki krvni tlak, povišen krvni tlak u plućima, kašalj Probavni problemi: poremećaj apetita, poremećaj osjeta okusa, nadutost ili nadimanje trbuha, upala debelog crijeva, zatvor, žgaravica, vrijed u ustima, povećanje tjelesne težine, gubitak tjelesne težine, gastritis
A total of 611 patients were randomised to either the dasatinib 140 mg once daily or 70 mg twice daily group. 
Ukupno je randomizirano 611 bolesnika u dvije skupine, jednu koja je primala 140 mg dasatiniba jedanput dnevno i drugu koja je primala 70 mg dasatiniba dvaput dnevno.
QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate). 
SPRYCEL 10 mg/ml prašak za oralnu suspenziju 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna boca praška za oralnu suspenziju sadrži 990 mg dasatiniba (u obliku hidrata).