natgillin/translations-raw huggingface dataset:
Ninety-seven of the 130 paediatric patients with CML-CP were treated with SPRYCEL tablets 60 mg/m2 once daily (maximum dose of 100 mg once daily for patients with high 
Sedemindevetdeset od 130 pediatričnih bolnikov s KML-KO se je zdravilo z zdravilom SPRYCEL v obliki tablet v odmerku 60 mg/m2 enkrat na dan (največji odmerek 100 mg enkrat na dan pri bolnikih z veliko telesno površino).
Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia) 
Zelo pogosti mielosupresija (vključno z anemijo, nevtropenijo in trombocitopenijo)
SPRYCEL is administered orally once daily in the form of either SPRYCEL tablets or SPRYCEL powder for oral suspension. 
Zdravilo SPRYCEL se uporablja peroralno enkrat na dan v obliki SPRYCEL tablet ali SPRYCEL praška za peroralno suspenzijo.
SPRYCEL will only be prescribed to you by a doctor with experience in treating leukaemia. 
Zdravilo SPRYCEL vam sme predpisati le zdravnik z izkušnjami pri zdravljenju levkemije.
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. 
Če je celularnost kostnega mozga <10%, je treba zdravljenje z zdravilom SPRYCEL prekiniti, dokler absolutno število nevtrofilcev ne doseže >500/μl (0,5 x 109/l), v tem trenutku pa se zdravljenje lahko nadaljuje v celotnem odmerku.
How to store SPRYCEL 6. 
Shranjevanje zdravila SPRYCEL 6.
In clinical studies in patients with advanced phase CML receiving the recommended dose of SPRYCEL (n=304), severe central nervous system (CNS) haemorrhage occurred in 1% of patients. 
V kliničnih študijah pri bolnikih s KML v napredovalem obdobju, ki so prejemali priporočeni odmerek zdravila SPRYCEL (n=304), so se hujše krvavitve v osrednjem živčevju pojavile pri 1% bolnikov.
Contains 0.29 g of sucrose per mL of oral suspension. 
Vsebuje 0,29 g saharoze na ml peroralne suspenzije.
SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient. 
Pred izdajo zdravila bolniku mora SPRYCEL prašek za peroralno suspenzijo pripraviti farmacevt ali ustrezno usposobljen zdravstveni delavec.
Make sure the second bottle is shaken before use. 
Poskrbite, da boste pred uporabo pretresli tudi drugo plastenko.
It can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2). 
Bolnik mora zdravilo dosledno jemati zjutraj ali zvečer (glejte poglavje 5.2).
Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study. 
Pri in vitro testih na bakterijskih celicah (Amesov test) dasatinib ni deloval mutageno in tudi ni bil genotoksičen pri in vivo študiji s podganjimi mikronukleusi.
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. 
Po najmanj 12-mesečnem spremljanju je 85% bolnikov, ki so bili randomizirani v skupino z zdravilom SPRYCEL, in 81% bolnikov, ki so bili randomizirani v skupino z imatinibom, še vedno prejemalo zdravilo prve izbire.
SPRYCEL is also available as tablets for use in adults and children from one year of age and weighing more than 10 kg. 
Zdravilo SPRYCEL je na voljo tudi v obliki tablet za uporabo pri odraslih in otrocih, starejših od enega leta, in s telesno maso najmanj 10 kg.
Febrile neutropaenia Nausea 
Febrilna nevtropenija Navzea
Mix the SPRYCEL oral suspension in the closed bottle by shaking for 30 seconds. 
Peroralno suspenzijo zdravila SPRYCEL v zaprti plastenki zmešajte s 30 sekundnim stresanjem.
SPRYCEL is prescribed for adults and children at least 1 year of age. 
Zdravilo SPRYCEL se lahko predpiše odraslim in otrokom, starim najmanj 1 leto.
newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. 
z na novo diagnosticirano Ph+ akutno limfoblastno anemijo (ALL) v kombinaciji s kemoterapijo.
Not known interstitial lung disease 
Neznana pogostnost intersticijska pljučna bolezen
Step 5: Dispense the bottle with inserted PIBA, package leaflet, and oral dosing syringe in the original carton to the patient or caregiver. 
5. korak: Plastenko z vstavljenim nastavkom, navodilom za uporabo in brizgo za peroralno dajanje v originalni ovojnini izdajte bolniku ali osebi, ki zanj skrbi.
Thirty-eight percent of patients had baseline mutations known to confer imatinib resistance. 
Pri 38% bolnikov so bile v izhodišču prisotne mutacije, povezane z odpornostjo na imatinib.
3 If platelets < 25 x 109/L and/or recurrence of ANC < 0.5 x 109/L for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode. 
3 Če se število trombocitov zmanjša pod 25 x 109/l in/ali absolutno število nevtrofilcev ponovno zmanjša pod 0,5 x 109/l za > 7 dni, ponovite postopek, opisan pod zaporedno številko 1, in nato ponovno uvedite zdravljenje, in sicer z zmanjšanim odmerkom 80 mg enkrat na dan (druga ponovitev).
Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased 
Občasni miokardni infarkt (tudi s smrtnim izidom)*, podaljšanje intervala QT na elektrokardiogramu*, perikarditis, ventrikularna aritmija (vključno z ventrikularno tahikardijo), angina pektoris, kardiomegalija, nenormalni val T na elektrokardiogramu, zvišana vrednost troponina
A statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose females and of prostate adenoma in low-dose males was noted. 
Opazili so statistično značilno povečanje v skupni pojavnosti ploščatoceličnega karcinoma in papiloma maternice in materničnega vratu pri samicah, ki so prejemale velike odmerke in adenoma prostate pri samcih, ki so prejemali majhne odmerke.
Your pharmacist or qualified healthcare professional will constitute (mix to form a liquid) SPRYCEL powder for oral suspension to form SPRYCEL oral suspension before dispensing to you. 
Pred izdajo zdravila bo farmacevt ali ustrezno usposobljen zdravstveni delavec SPRYCEL prašek za peroralno suspenzijo najprej pripravil (zmešal tako, da nastane tekočina) in vam zdravilo nato izdal v obliki SPRYCEL peroralne suspenzije.
For patients with chronic phase CML who received 100 mg once daily, dose reduction to 80 mg once daily with further reduction from 80 mg once daily to 50 mg once daily, if needed, is recommended. 
Pri bolnikih s KML v kroničnem obdobju, ki so prejemali odmerek 100 mg enkrat na dan, se priporoča zmanjšanje odmerka na 80 mg enkrat na dan in nato po potrebi nadaljnje zmanjšanje z odmerka 80 mg enkrat na dan na odmerek 50 mg enkrat na dan.
OUTER CARTON AND LABEL FOR BOTTLE PACK 
ŠKATLA IN NALEPKA ZA VSEBNIK ŠKATLA ZA PRETISNE OMOTE
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate 
Jedro tablete laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat hidroksipropilceluloza magnezijev stearat
The starting dose of SPRYCEL is calculated by body weight as shown below: 
Začetni odmerek zdravila SPRYCEL se izračuna na osnovi telesne mase, kot je prikazano v nadaljevanju:
Accelerated phase (n= 157)c 
Obdobje pospešenega poteka (n= 157)c
In clinical studies, treatment with SPRYCEL in paediatric patients with Ph+ ALL was administered continuously, added to successive blocks of backbone chemotherapy, for a maximum duration of two years. 
V kliničnih študijah je zdravljenje z zdravilom SPRYCEL pri pediatričnih bolnikih s Ph+ ALL trajalo neprekinjeno, dodano je bilo k zaporednim blokom osnovne kemoterapije, zdravljenje pa je trajalo največ dve leti.
Minimum of 7 years follow up 
Najmanj 7-letno spremljanje
Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the tables. 
Smernice za pediatrične bolnike s Ph+ ALL, ki se zdravijo v kombinaciji s kemoterapijo, so navedene v ločenem odstavku, ki sledi preglednici.
Lymphoid blast phase and Ph+ ALL (n= 168)c 
Obdobje limfoblastne preobrazbe in Ph+ ALL (n= 168)c
The median time from diagnosis to randomisation was 64 months in the dasatinib group and 52 months in the imatinib group. 
V skupini, ki je prejemala dasatinib je od diagnoze do randomizacije minilo v povprečju 64 mesecev, v skupini, ki je prejemala imatinib, pa 52 mesecev.
Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders 
Redki hipertiroidizem, tiroiditis Presnovne in prehranske motnje
How to take SPRYCEL 
Kako jemati zdravilo SPRYCEL
PFS was analysed on an intent-to-treat principle and patients were followed to events including subsequent therapy. 
Preživetje brez napredovanja bolezni je bilo analizirano po principu vseh vključenih bolnikov (“intent-to-treat”), bolnike pa so spremljali do pojava dogodkov, vključno s kasnejšim zdravljenjem.
The median time to first occurrence of grade ≥ 3 dasatinib-related pleural effusion was 175 weeks (range: 114 to 274 weeks). 
Srednja vrednost časa do prvega pojava z dasatinibom povezanega plevralnega izliva stopnje ≥ 3 je bila 175 tednov (razpon: 114 do 274 tednov).
Two randomised, open-label Phase III studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily. 
Izvedeni sta bili dve randomizirani odprti študiji III. faze, ki sta vrednotili učinkovitost uporabe dasatiniba enkrat na dan v primerjavi z uporabo dasatiniba dvakrat na dan.
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%. 
Učinkovine, ki lahko zmanjšajo plazemske koncentracije dasatiniba Pri bolnikih, ki so dasatinib prejeli po 8-dnevnem dajanju rifampicina (močan induktor CYP3A4) v odmerku 600 mg zvečer, se je vrednost AUC dasatiniba zmanjšala za 82%.
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). 
Izpostaviti velja, da je bil dober hematološki odziv dosežen hitro (pri bolnikih s KML v obdobju limfoblastne preobrazbe večinoma v 35 dneh po prejemu prvega odmerka dasatiniba, pri bolnikih s Ph+ ALL pa v 55 dneh).
In these patients grade 3 or 4 pulmonary oedema and pulmonary hypertension were each reported in 1% of patients. 
Pri teh bolnikih so tako o pljučnem edemu kot pljučni hipertenziji stopnje 3 ali 4 poročali pri 1% bolnikov.
They are also available in bottles with child-resistant closure containing 30 film-coated tablets. 
Na voljo je tudi v plastenkah z za otroke varnimi zaporkami, ki vsebujejo 30 filmsko obloženih tablet.
Treatment with SPRYCEL is associated with anaemia, neutropaenia and thrombocytopaenia. 
Zdravljenje z dasatinibom je povezano z anemijo, nevtropenijo in trombocitopenijo.
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) 
Pogosti pljučnica (vključno z bakterijsko, virusno in mikotično pljučnico), okužba/vnetje zgornjih dihal, okužba z virusi herpesa (vključno s citomegalovirusom - CMV), enterokolitis, sepsa (tudi občasni primeri s smrtnimi izidi)
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. 
Simulacija na osnovi modeliranja populacijske farmakokinetike (PPK) kaže, da se s priporočenim odmerjanjem na osnovi telesne mase, opisanim za tableto v poglavju 4.2, lahko pričakuje podobno izpostavljenost kot pri uporabi tablete v odmerku 60 mg/m2.
The oral suspension should not be taken with grapefruit or grapefruit juice (see section 4.5). 
Peroralne suspenzije se ne sme jemati skupaj z grenivko ali s sokom grenivke (glejte poglavje 4.5).
Patients with BCR-ABL > 10% at 3 months 
Bolniki z vrednostjo BCR-ABL > 10% v 3. mesecu
Each pack also contains a low-density polyethylene press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe (polypropylene syringe barrel with high-density polyethylene syringe plunger rod) in a sealed plastic bag. 
Vsako pakiranje vsebuje tudi nastavek iz polietilena nizke gostote, ki se ga potisne v plastenko in 12 ml brizgo za peroralno dajanje (brizga iz polipropilena in bat iz polietilena visoke gostote) v zapečateni plastični vreči.
Among the dasatinib-treated patients with pleural effusion, 96% achieved a cCCyR, 82% achieved a MMR, and 50% achieved a MR4.5 despite dose interruptions or dose adjustment. 
Med bolniki s plevralnim izlivom, ki so se zdravili z dasatinibom, je kljub prekinitvam zdravljenja ali prilagoditvi odmerka cCCyR doseglo 96% bolnikov, MMR 82% bolnikov, MR4.5 pa 50% bolnikov.
Cumulative rates of selected adverse reactions that were reported in the 100 mg once daily recommended starting dose are shown in Table 6a. 
Kumulativni deleži izbranih neželenih učinkov, o katerih so poročali pri uporabi priporočenega začetnega odmerka 100 mg enkrat na dan, so prikazani v preglednici 6a.
If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you or your child, ask your doctor. 
Če imate o delovanju zdravila SPRYCEL kakršno koli vprašanje, ali če vas zanima, zakaj je bilo to zdravilo predpisano vam ali vašemu otroku, se posvetujte z zdravnikom.
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%). 
V dodatni analizi je zgodnji molekularni odziv (opredeljen kot vrednosti BCR-ABL ≤ 10% v 3. mesecu) doseglo več bolnikov, ki so se zdravili z dasatinibom (84%), v primerjavi z bolniki, ki so se zdravili z imatinibom (64%).
The overall safety profile of SPRYCEL in the paediatric Ph+ CML-CP population was similar to that of the adult population, regardless of formulation, with the exception of no reported pericardial effusion, pleural effusion, pulmonary oedema, or pulmonary hypertension in the paediatric population. 
Pri pediatrični populaciji s Ph+ KML-KO je bil celokupen varnostni profil zdravila SPRYCEL podoben tistemu pri odraslih, ne glede na farmacevtsko obliko, z izjemo perikardialnega izliva, plevralnega izliva, pljučnega edema ali pljučne hipertenzije, o katerih pri pediatrični populaciji niso poročali.
Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)] 
vinska kislina brezvodni trinatrijev citrat natrijev benzoat (E211) koloidni hidrofobni silicijev dioksid aroma mešanega jagodičevja [vsebuje benzilalkohol, žveplov dioksid (E220)]
In a study of 14 healthy subjects, administration of a single 100-mg dose of SPRYCEL 22 hours following a 4-day, 40-mg omeprazole dose at steady state reduced the AUC of dasatinib by 43% and the Cmax of dasatinib by 42%. 
V študiji pri 14 zdravih osebah je uporaba enkratnega 100 mg odmerka zdravila SPRYCEL 22 ur po 4-dnevnem odmerjanju omeprazola v odmerku 40 mg v stanju dinamičnega ravnovesja zmanjšala AUC dasatiniba za 43% in Cmax za 42%.
Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack. 
Po rekonstituciji se peroralno suspenzijo lahko daje le s pomočjo brizge za peroralno dajanje, ki je priložena vsakemu pakiranju.
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. 
Pri teh bolnikih so bile vrednosti CCyR in MMR po 12 mesecih naslednje: CCyR: 87,9% [95% IZ: (71,8-96,6)] in MMR: 45,5% [95% IZ: (28,1-63,6)].
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. 
Simulacija na osnovi modeliranja populacijske farmakokinetike (PPK) kaže, da se s priporočenim odmerjanjem na osnovi telesne mase, opisanim za prašek za peroralno suspenzijo v poglavju 4.2 povzetka glavnih značilnosti zdravila za prašek za peroralno suspenzijo, lahko pričakuje podobno izpostavljenost kot pri uporabi tablete v odmerku 60 mg/m2.
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. 
Deleži cCCyR v skupini, ki je prejemala zdravilo SPRYCEL in v skupini, ki je prejemala imatinib, so bili v 3 mesecih (54% oziroma 30%), 6 mesecih (70% oziroma 56%), 9 mesecih (75% oziroma 63%), 24 mesecih (80% oziroma 74%), 36 mesecih (83% in 77%), 48 mesecih (83% in 79%) ter 60 mesecih (83% in 79%) konsistentni s primarnim opazovanim dogodkom.
The active substance is dasatinib. 
Učinkovina je dasatinib.
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. 
Podatki pri zdravih osebah, ki so prejele enkraten 100 mg odmerek dasatiniba 30 minut po obroku z visoko vsebnostjo maščob, kažejo, da se je srednja vrednost AUC povečala za 14%.
A low-fat meal 30 minutes prior to dasatinib resulted in a 21% increase in the mean AUC of dasatinib. 
Zaužitje obroka z nizko vsebnostjo maščob 30 minut pred prejemom dasatiniba je posledično povečalo srednjo vrednost AUC za 21%.
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. 
Po najmanj 60-mesečnem obdobju spremljanja je 60% bolnikov, ki so bili randomizirani v skupino z zdravilom SPRYCEL, in 63% bolnikov, ki so bili randomizirani v skupino z imatinibom, še vedno prejemalo zdravilo prve izbire.
QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena plastenka praška za peroralno suspenzijo vsebuje 990 mg dasatiniba (v obliki monohidrata).
While the safety profile of SPRYCEL in elderly was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions such as fatigue, pleural effusion, dyspnoea, cough, lower gastrointestinal haemorrhage, and appetite disturbance and more likely to experience less frequently reported adverse reactions such as abdominal distention, dizziness, pericardial effusion, congestive heart failure, and weight decrease and should be monitored closely (see section 4.4). 
Varnostni profil zdravila SPRYCEL je pri starostnikih sicer podoben kot pri mlajših osebah, vendar pa pri bolnikih, starih 65 let in starejših, obstaja večja verjetnost za pojav pogostejših neželenih učinkov, kot so utrujenost, plevralni izliv, dispneja, kašelj, krvavitve v spodnjih prebavilih in motnje apetita, pa tudi manj pogostih neželenih učinkov, kot so distenzija abdomna, omotica, perikardialni izliv, kongestivno srčno popuščanje in zmanjšanje telesne mase, zato je treba te bolnike skrbno nadzirati (glejte poglavje 4.4).
Two randomised, open-label studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily. 
Izvedeni sta bili dve randomizirani, odprti študiji, ki sta vrednotili učinkovitost uporabe dasatiniba enkrat na dan v primerjavi z uporabo dasatiniba dvakrat na dan.
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. 
Pri bolnikih, starih 65 let in starejših, je pojav plevralnega izliva, dispneje, kašlja, perikardialnega izliva in kongestivnega srčnega popuščanja verjetnejši kot pri mlajših bolnikih, zato je treba te bolnike skrbno nadzirati.
Twenty-one patients (1%) experienced a QTcF > 500 msec (see section 4.4). 
Pri 21 bolnikih (1%) je bila vrednost QTcF > 500 milisekund (glejte poglavje 4.4).
One 120-mL plastic bottle (with child-resistant closure) contains 33 g of powder for oral suspension. 
120 ml plastenka (z za otroke varno zaporko) vsebuje 33 g praška za peroralno suspenzijo.
No additional patients were reported to have QTcF > 500 msec after a minimum of 60 months follow-up. 
Po najmanj 60-mesečnem obdobju spremljanja o pojavu vrednosti QTcF > 500 milisekund pri dodatnih bolnikih niso poročali.
Make sure that you read and understand these instructions before using the oral suspension. 
Pred začetkom uporabe peroralne suspenzije natančno preberite ta navodila.
Rare diabetes mellitus Psychiatric disorders 
Redki sladkorna bolezen Psihiatrične motnje
Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate. 
Učinkovine, ki lahko zvečajo plazemske koncentracije dasatiniba In vitro študije kažejo, da je dasatinib substrat za CYP3A4.
MCyR was achieved in 55% of imatinib-resistant patients and 82% of imatinib-intolerant patients. 
Dober citogenetski odziv je bil dosežen pri 55% bolnikov, ki so bili odporni na imatinib, in 82% bolnikov, ki zdravljenja z imatinibom niso prenašali.
They are also available in bottles with child-resistant closure containing 60 film-coated tablets. 
Na voljo je tudi v plastenkah z za otroke varnimi zaporkami, ki vsebujejo 60 filmsko obloženih tablet.
After resolution, a functional assessment should be performed prior to resuming treatment with dasatinib. 
Po okrevanju je treba izvesti testiranje delovanja srca, preden se zdravljenje z dasatinibom nadaljuje.
The median duration of therapy in the 100 mg once daily group was 37 months (range 1-91 months). 
V skupini z odmerkom 100 mg enkrat na dan je srednja vrednost časa trajanja zdravljenja znašala 37 mesecev (razpon 1-91 mesecev).
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in adults 
Preglednica 3: Prilagoditve odmerka v primeru pojava nevtropenije ali trombocitopenije pri odraslih
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%. 
V pediatrični študiji I. faze je po najmanj 7 letih spremljanja pri 17 bolnikih s KML-KO, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali, mediana trajanja preživetja brez napredovanja bolezni (PFS) znašala 53,6 meseca, delež celokupnega preživetja (OS) pa 82,4%.
It was usually managed with dose reduction or interruption. 
Povišanja so običajno nadzirali s prilagoditvijo odmerka ali prekinitvijo zdravljenja.
Median duration of treatment was 23 months for dasatinib (with 44% of patients treated for > 24 months to date) and 3 months for imatinib (with 10% of patients treated for > 24 months to date). 
Zdravljenje z dasatinibom je v povprečju trajalo 23 mesecev (pri 44% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev), zdravljenje z imatinibom pa 3 mesece (pri 10% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev).
Common tinnitus 
Pogosti tinitus
Hypokalaemia or hypomagnesaemia should be corrected prior to dasatinib administration. 
Pred začetkom zdravljenja z dasatinibom je treba popraviti hipokaliemijo ali hipomagneziemijo.
Outer Carton: sprycel 10 mg/mL 
Škatla: sprycel 10 mg/ml
Dasatinib and its metabolites are minimally excreted via the kidney. 
Izločanje dasatiniba in njegovih presnovkov preko ledvic je minimalno.
Patients with BCR-ABL ≤ 10% at 3 months 
Bolniki z vrednostjo BCR-ABL ≤ 10% v 3. mesecu