natgillin/translations-raw huggingface dataset:
See the "Instructions for administration to the patient" at the end of the package leaflet for how to give a dose of SPRYCEL oral suspension. 
Za navodila za dajanje odmerka SPRYCEL peroralne suspenzije glejte "Navodila za dajanje bolniku" na koncu tega navodila.
Carton containing 30 x 1 film-coated tablets in perforated unit dose blisters. 
Škatla s 30 x 1 filmsko obloženo tableto v perforiranih, enoodmernih pretisnih omotih.
The rate of major molecular response (all 22 treated patients with a CCyR) was 50% at 24 months. 
Delež dobrega molekularnega odziva (vseh 22 zdravljenih bolnikov s popolnim citogenetskim odzivom) je bil po 24 mesecih 50%.
Table 4: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP 
Preglednica 4: Prilagoditve odmerka v primeru pojava nevtropenije ali trombocitopenije pri pediatričnih bolnikih s Ph+ KML-KO
Rate of OS was consistently higher in dasatinib treated patients who achieved BCR-ABL level ≤ 10% at 3 months than those who did not. 
Pri bolnikih, ki so se zdravili z dasatinibom, in so v 3. mesecu dosegli vrednost BCR-ABL ≤ 10%, je bil delež celokupnega preživetja konsistentno višji kot pri bolnikih, ki te vrednosti niso dosegli.
The median time from diagnosis to start of treatment was 28 months. 
Od diagnoze do začetka zdravljenja je v povprečju minilo 28 mesecev.
You will also have blood tests regularly while you are taking SPRYCEL. 
Med jemanjem zdravila SPRYCEL je treba redno opravljati krvne preiskave.
Outer Carton: sprycel 50 mg 
Škatla: sprycel 50 mg
Each film-coated tablet contains 189 mg of lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 189 mg laktoze monohidrata.
The powder for oral suspension should be used for patients weighing less than 10 kg and patients who cannot swallow tablets. 
Pri bolnikih s telesno maso, manjšo od 10 kg in bolnikih, ki ne morejo pogoltniti tablet, je treba uporabljati prašek za peroralno suspenzijo.
One randomised non-comparative study was conducted in chronic phase patients who failed initial treatment with 400 or 600 mg imatinib. 
Pri bolnikih v kroničnem obdobju, ki se na začetno zdravljenje z imatinibom v odmerku 400 mg ali 600 mg niso odzvali, je bila izvedena ena randomizirana neprimerjalna študija.
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP 
Preglednica 3: Prilagoditve odmerka v primeru pojava nevtropenije ali trombocitopenije pri pediatričnih bolnikih s Ph+ KML-KO
Each film-coated tablet contains 108 mg of lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 108 mg laktoze monohidrata.
Rare epiphyses delayed fusion,h growth retardationh 
Redki zapoznelo zaprtje epifizgh, zaostanek v rastih
Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma 
Pogosti pljučni edem*, pljučna hipertenzija*, pljučni infiltrati, pnevmonitis, kašelj
Outer Carton: sprycel 100 mg 
Škatla: sprycel 100 mg
Baseline characteristics were well balanced between the two treatment groups with respect to age (median age was 46 years for the SPRYCEL group and 49 years for the imatinib group with 10% and 11% of patients 65 years of age or older, respectively), gender (women 44% and 37%, respectively), and race (Caucasian 51% and 55%; Asian 42% and 37%, respectively). 
V skupini, ki se je zdravila z imatinibom, je bila srednja starost bolnikov 49 let, 11% bolnikov je bilo starih 65 let ali starejših, 37% vključenih oseb je bilo ženskega spola, 55% bolnikov je bilo belcev in 37% bolnikov aziatov.
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, lasje, oči in splošno: zbadanje v koži, srbenje, suha koža, akne, vnetje kože, nenehno piskanje ali zvenenje v ušesih, izguba las, prekomerno znojenje, motnje vida (vključno z zamegljenim in okrnjenim vidom), suhe oči, modrice, depresija, nespečnost, rdečica, omotica, obtolčenine (modrice), neješčnost, somnolenca (bolezenska zaspanost) in generalizirani edem.
Each film-coated tablet contains 67.5 mg of lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 67,5 mg laktoze monohidrata.
Refer to the package leaflet (see section 5 ‘How to store SPRYCEL') for instructions on discarding any unused medicine, syringe and bottle. 
Za navodila glede odstranjevanja neuporabljenega zdravila, brizge in plastenke glejte navodilo za uporabo (poglavje 5 ‘Shranjevanje zdravila SPRYCEL').
Each film-coated tablet contains 27 mg of lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 27 mg laktoze monohidrata.
SPRYCEL contains lactose 
Zdravilo SPRYCEL vsebuje laktozo
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. 
Delež bolnikov z 2-letnim preživetjem brez progresije bolezni je bil pri zdravljenju z dasatinibom 86% (95% interval zaupanja: [78% - 93%]), pri zdravljenju z imatinibom pa 65% (95% interval zaupanja: [43%-87%]).
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. 
Pri bolnikih s KML v obdobju pospešenega poteka, ki so se zdravili z odmerkom 140 mg enkrat na dan, srednja vrednost trajanja dobrega hematološkega odziva in srednja vrednost celokupnega preživetja nista bili doseženi, srednja vrednost preživetja brez napredovanja bolezni pa je znašala 25 mesecev.
Uncommon hepatitis, cholecystitis, cholestasis Skin and subcutaneous tissue disorders 
Občasni hepatitis, vnetje žolčnika, holestaza Bolezni kože in podkožja
10 to less than 20 kg 
10 do manj kot 20 kg
Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date. 
Zdravljenje z dasatinibom je v povprečju trajalo 24 mesecev, pri 51% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
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%). 
Pri zdravljenju z dasatinibom se je dober citogenetski odziv ohranil 18 mesecev pri 90% bolnikov (95% interval zaupanja: [82% - 98%]) (popoln citogenetski odziv pri 94% bolnikov, 95% interval zaupanja: [87% - 100%]), pri zdravljenju z imatinibom pa pri 74% bolnikov (95% interval zaupanja: [49% - 100%]) (popoln citogenetski odziv pri 100% bolnikov).
Each film-coated tablet contains 135.0 mg of lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 135,0 mg laktoze monohidrata.
Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate). 
En ml peroralne suspenzije vsebuje 10 mg dasatiniba (v obliki monohidrata).
A total of 43% of the patients in the dasatinib arm, and 82% in the imatinib arm had treatment failure, defined as disease progression or cross-over to the other treatment (lack of response, intolerance of study medicinal product, etc.). 
Neuspeh zdravljenja je bil definiran kot napredovanje bolezni ali prehod na drugo obliko zdravljenja (pomanjkanje odziva, neprenašanje študijskega zdravila, itd.).
Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorder 
Pogosti krvavitve v prebavilih*, kolitis (vključno z nevtropeničnim kolitisom), gastritis, vnetje sluznic (vključno z mukozitisom/stomatitisom), dispepsija, napihnjenost trebuha, obstipacija, spremembe na mehkih tkivih ust
within 24 months (95% CI) 
v 24 mesecih (95% IZ)
within 48 months (95% CI) 
v 48 mesecih (95% IZ)
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 osnovi Kaplan-Meierjeve ocene se je dober citogenetski odziv ohranil 18 mesecev pri 93% bolnikov (95% IZ: [88% - 98%]), ki so dasatinib prejemali v odmerku 100 mg enkrat na dan.
Six percent of dasatinib-treated patients discontinued treatment due to drug-related pleural effusion. 
Zaradi z zdravilom povezanega plevralnega izliva je bilo zdravljenje z dasatinibom prekinjeno pri 6% bolnikov.
1 Stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L. 
1 Prekinite zdravljenje, dokler absolutno število nevtrofilcev ne doseže ≥ 1,0 x 109/l in trombocitov ≥ 50 x 109/l.
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 osnovi Kaplan-Meierjeve ocene se je pri zdravljenju z dasatinibom dober citogenetski odziv ohranil 1 leto pri 92% bolnikov (95% interval zaupanja: [85% - 100%]) (popoln citogenetski odziv pri 97% bolnikov, 95% interval zaupanja: [92% - 100%]), pri zdravljenju z imatinibom pa pri 74% bolnikov (95% interval zaupanja: [49% - 100%]) (popoln citogenetski odziv pri 100% bolnikov).
In SPRYCEL-treated patients with newly diagnosed chronic phase CML who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 1.6% of patients after a minimum of 12 months follow-up. 
Pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju, pri katerih se je med zdravljenjem z zdravilom SPRYCEL pojavila mielosupresija stopnje 3 ali 4, je običajno prišlo do izboljšanja že po kratkotrajni prekinitvi zdravljenja in/ali zmanjšanju odmerka.
Outer Carton: sprycel 80 mg 
Škatla: sprycel 80 mg
Each film-coated tablet contains 94.5 mg of lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 94,5 mg laktoze monohidrata.
SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. 
Zdravilo SPRYCEL je indicirano za zdravljenje pediatričnih bolnikov: z na novo diagnosticirano Ph+ KML v kroničnem obdobju (Ph+ KML-KO) ali s Ph+ KML-KO, ki se na predhodno zdravljenje, vključno z imatinibom, ni odzvala ali pa bolniki zdravljenja niso prenašali.
In addition, 46 patients with Ph+ ALL received dasatinib 70 mg twice daily (44 resistant and 2 intolerant to imatinib). 
Dasatinib v odmerku 70 mg dvakrat na dan je skupaj prejemalo tudi 46 bolnikov s Ph+ ALL (44 rezistentnih in 2 intolerantna na imatinib).
The median time from diagnosis to start of treatment was 48 months. 
Od diagnoze do začetka zdravljenja je v povprečju minilo 48 mesecev.
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date. 
Zdravljenje z dasatinibom je v povprečju trajalo 14 mesecev, pri 31% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib exposure. 
V povezavi z uporabo dasatiniba so poročali o pojavu PAH (prekapilarni pljučni arterijski hipertenziji, potrjeni s kateterizacijo desne strani srca).
The cardiac adverse reactions of congestive heart failure/cardiac dysfunction, pericardial effusion, arrhythmias, palpitations, QT prolongation and myocardial infarction (including fatal) were reported in patients taking dasatinib. 
Pri bolnikih, ki so prejemali dasatinib, so poročali o pojavu neželenih učinkov za srce, kot so kongestivno srčno popuščanje/srčna disfunkcija, perikardialni izliv, aritmije, palpitacije, podaljšanje intervala QT in miokardni infarkt (vključno z usodnimi izidi).
There were no discontinuations of SPRYCEL therapy due to these biochemical laboratory parameters. 
Zaradi teh biokemijskih parametrov zdravljenje z zdravilom SPRYCEL pri nobenem bolniku ni bilo prekinjeno.
In this population of patients who received 100 mg once daily, MCyR was achieved in 77% and CCyR in 67%. 
V tej skupini bolnikov je bil dober citogenetski odziv dosežen pri 77% bolnikov, popoln citogenetski odziv pa pri 67% bolnikov, ki so zdravilo prejemali v odmerku 100 mg enkrat na dan.
Among 130 patients with chronic phase CML (CML-CP) treated in two paediatric studies, a Phase I, open-label, nonrandomized dose-ranging trial and a Phase II, open-label, nonrandomized trial, 84 patients (exclusively from the Phase II trial) were newly diagnosed with CML-CP and 46 patients (17 from the Phase I trial and 29 from the Phase II trial) were resistant or intolerant to previous treatment with imatinib. 
Od 130 bolnikov s KML v kroničnem obdobju (KML-KO), ki so se zdravili v dveh pediatričnih študijah, odprtem, nerandomiziranem preskušanju I. faze za določitev odmerka in odprtem, nerandomiziranem preskušanju II.
By 2 years 19%, p<.0008 
V 2 letih p<0,0008
Dose modifications were allowed for improving activity or management of toxicity (see section 4.2). 
Začetni odmerek je bil 70 mg dasatiniba dvakrat na dan. Dovoljene so bile prilagoditve odmerka, in sicer zaradi izboljšanja učinkovitosti ali ukrepanja v primeru toksičnosti (glejte poglavje 4.2).
b Progression was defined as increasing WBC count, loss of CHR or MCyR, ≥30% increase in Ph+ metaphases, confirmed AP/BP disease or death. 
metafaz za ≥ 30%, potrjena AP/BP bolezen ali smrt.
The median time from diagnosis to start of treatment was 18 months. 
Od diagnoze do začetka zdravljenja je v povprečju minilo 18 mesecev.
In patients with myeloid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 8 months, the median PFS was 4 months, and the median overall survival was 8 months. 
Pri bolnikih s KML v obdobju mieloblastne preobrazbe, ki so se zdravili z odmerkom 140 mg enkrat na dan, je srednja vrednost trajanja dobrega hematološkega odziva znašala 8 mesecev, srednja vrednost preživetja brez napredovanja bolezni 4 mesece, srednja vrednost celokupnega preživetja pa 8 mesecev.
Carriers of HBV who require treatment with SPRYCEL should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8). 
in bolnikih, pri katerih se med zdravljenjem test glede okužbe z virusom hepatitisa B izkaže za pozitivnega, se je treba pred začetkom zdravljenja posvetovati s strokovnjaki za obolenja jeter in zdravljenje hepatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom SPRYCEL, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glejte poglavje 4.8).
Common febrile neutropaenia Uncommon lymphadenopathy, lymphopaenia 
Občasni limfadenopatija, limfopenija
within 36 months (95% CI) 
v 36 mesecih (95% IZ)
Special handling instructions for SPRYCEL 
Shranjevanje zdravila SPRYCEL
SPRYCEL 140 mg film-coated tablets 
SPRYCEL 140 mg filmsko obložene tablete
Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended (see section 4.2). 
Pri bolnikih, ki jemljejo dasatinib, sistemska uporaba močnih zaviralcev CYP3A4 ni priporočljiva (glejte poglavje 4.2).
NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and ≤ 100,000/mm3. 
Brez znakov levkemije (NEL): isti kriteriji kot za popoln hematološki odziv (CHR), vendar absolutno število nevtrofilcev ≥ 500/mm3 in < 1.000/mm3 ali trombocitov ≥ 20.000/mm3 in ≤ 100.000/mm3.
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. 
Zdravilo SPRYCEL je indicirano za zdravljenje pediatričnih bolnikov: z na novo diagnosticirano kronično mieloično levkemijo (KML) s prisotnostjo kromosoma Philadelphia (Ph+) v kroničnem obdobju (Ph+ KML-KO) ali s Ph+ KML-KO, ki se na predhodno zdravljenje, vključno z imatinibom, ni odzvala ali pa bolniki zdravljenja niso prenašali.
Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm Uncommon rhabdomyolysis, osteonecrosis, muscle inflammation, tendonitis, arthritis 
Občasni rabdomioliza, osteonekroza, vnetje mišic, tendinitis, artritis
A total of 670 patients, of whom 497 were imatinib-resistant, were randomised to the dasatinib 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily group. 
Na dasatinib v odmerku 100 mg enkrat na dan, 140 mg enkrat na dan, 50 mg dvakrat na dan ali 70 mg dvakrat na dan je bilo skupaj randomiziranih 670 bolnikov, od katerih jih je bilo 497 odpornih na imatinib.
Table 2: Dose escalation for patients with Ph+CML-CP Dose (maximum dose per day) Starting dose 
Povečevanje odmerka pri bolnikih s Ph+ KML-KO Odmerek (največji odmerek na dan) Začetni odmerek
Chronic phase CML - Resistance or intolerance to prior imatinib therapy 
KML v kroničnem obdobju - bolniki, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali
Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating dasatinib therapy. 
Pri vsakem bolniku s simptomi bolezni srca je pred uvedbo zdravljenja z dasatinibom treba izvesti elektrokardiografijo.
Additionally, dasatinib inhibits SRC family kinases at subnanomolar concentrations. 
Dasatinib pri subnanomolarnih koncentracijah zavira tudi kinaze iz družine SRC.
The same dose should be resumed if this is the first occurrence and the dose should be reduced if this is a recurrent adverse reaction. 
Če se je neželeni učinek pojavil prvič, se lahko zdravljenje nadaljuje z istim odmerkom, če pa se je neželeni učinek pred tem že pojavil, je treba zdravljenje nadaljevati z zmanjšanim odmerkom.
In 5 Phase II clinical studies in patients with resistance or intolerance to prior imatinib therapy, repeated baseline and on-treatment ECGs were obtained at pre-specified time points and read centrally for 865 patients receiving SPRYCEL 70 mg twice daily. 
faze pri bolnikih, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali, so bili pri 865 bolnikih, ki so prejemali zdravilo SPRYCEL v odmerku 70 mg dvakrat na dan, v izhodišču in vnaprej določenih časovnih točkah med zdravljenjem pridobljeni elektrokardiogrami, ki so bili nato ovrednoteni centralno.
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. 
Pri bolnikih, ki imatiniba niso prenašali, je bil ocenjen delež preživetja brez progresije bolezni po 1 letu 98% (95% interval zaupanja: [95% - 100%]), po 2 letih pa 94% (95% interval zaupanja: [88%-99%]).
However, in an in vivo single-dose study in conscious telemetered monkeys, there were no changes in QT interval or ECG wave form. 
Aktivnost dasatiniba pri hERG testih in testih na Purkynjevih vlaknih in vitro kaže na možnost podaljšanja repolarizacije ventriklov (QT interval), vendar pa in vivo pri študiji z enkratnim odmerkom na zavestnih opicah niso opazili sprememb QT intervala ali oblike zobcev na elektrokardiogramu.
SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate). 
SPRYCEL 140 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 140 mg dasatiniba (v obliki monohidrata).
Censored 
Ocenjeni
By 4 years 34%, p<.0055 
V 4 letih p<0,0055
What SPRYCEL contains 
Kaj vsebuje zdravilo SPRYCEL
The median time from diagnosis to start of treatment was 82 months. 
Od diagnoze do začetka zdravljenja je v povprečju minilo 82 mesecev.
within 60 months (95% CI) 
v 60 mesecih (95% IZ)
Diarrhoea Fluid retention Superficial oedema Pleural effusion Generalised oedema Pericardial effusion Pulmonary hypertension Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported in recommended starting dose of 100 mg once daily (n=165) population 
Gastrointestinalne krvavitve a Rezultati študije 3. faze za določitev optimalnega odmerka pri uporabi priporočenega začetnega odmerka 100 mg enkrat na dan (n=165).
SPRYCEL 70 mg film-coated tablets 
SPRYCEL 70 mg filmsko obložene tablete
SPRYCEL 80 mg film-coated tablets EU/1/06/363/013 
SPRYCEL 80 mg filmsko obložene tablete EU/1/06/363/013
In patients with Ph+ ALL treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months the median PFS was 4 months, and the median overall survival was 7 months. 
Pri bolnikih s Ph+ ALL, ki so se zdravili z odmerkom 140 mg enkrat na dan, je srednja vrednost trajanja dobrega hematološkega odziva znašala 5 mesecev, srednja vrednost preživetja brez napredovanja bolezni 4 mesece, srednja vrednost celokupnega preživetja pa 7 mesecev.
l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling, testicular swelling, vulvovaginal swelling. 
l Oteklina genitalij, edem na mestu kirurškega reza, genitalni edem, edem penisa, oteklina penisa, edem modnika, otekanje kože, otekanje mod, otekanje vulve in vagine.
SPRYCEL contains sodium 
Zdravilo SPRYCEL vsebuje natrij
SPRYCEL 70 mg film-coated tablets EU/1/06/363/006 
SPRYCEL 70 mg filmsko obložene tablete EU/1/06/363/006
Improvements in haemodynamic and clinical parameters have been observed in patients with PAH following discontinuation of dasatinib. 
Pri bolnikih s PAH so po prekinitvi zdravljenja z dasatinibom poročali o izboljšanju hemodinamskih in kliničnih parametrov.
Two clinical studies were conducted in patients resistant or intolerant to imatinib; the primary efficacy endpoint in these studies was Major Cytogenetic Response (MCyR). 
Primarni opazovani dogodek učinkovitosti v teh dveh študijah je bil pomemben citogenetski odziv (MCyR).
MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG Plaza 254 
Imetnik dovoljenja za promet z zdravilom Bristol-Myers Squibb Pharma EEIG Plaza 254
PHARMACEUTICAL FORM AND CONTENTS 30 x 1 film-coated tablets 
30 x 1 filmsko obložena tableta 30 filmsko obloženih tablet
SPRYCEL 140 mg film-coated tablets EU/1/06/363/015 
SPRYCEL 140 mg filmsko obložene tablete EU/1/06/363/015
Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date. 
Zdravljenje z dasatinibom je v povprečju trajalo 3,5 mesece, pri 12% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
SPRYCEL 50 mg film-coated tablets EU/1/06/363/005 
SPRYCEL 50 mg filmsko obložene tablete EU/1/06/363/005
The following dose escalations shown in Table 2 are recommended in paediatric patients with Ph+ CML-CP who do not achieve a haematologic, cytogenetic and molecular response at the recommended time points, per current treatment guidelines, and who tolerate the treatment. 
Pri pediatričnih bolnikih s Ph+ KML-KO, ki zdravljenje prenašajo, vendar pa v priporočenih časovnih točkah glede na trenutne smernice zdravljenja ne dosežejo hematološkega, citogenetskega in molekularnega odziva, priporočamo naslednja povečanja odmerka, ki so prikazana v preglednici 2.
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. 
V študiji III. faze za določitev optimalnega odmerka pri bolnikih s KML v kroničnem obdobju so o povišanju vrednosti transaminaz ali bilirubina stopnje 3 ali 4 poročali pri ≤ 1% bolnikov.
Table 12: Efficacy of SPRYCEL in phase III dose-optimization study: imatinib resistant or intolerant chronic phase CML (2-year results)a 
Preglednica 12: Učinkovitost zdravila SPRYCEL v študiji III. faze za določitev optimalnega odmerka: bolniki s KML v kroničnem obdobju, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali (rezultati po 2 letih)a
Abdominal pain Diarrhoea 
Perikardialni izliv Pljučni edem