natgillin/translations-raw huggingface dataset:
An open-label, single-arm, multicentre study was conducted in patients resistant or intolerant to imatinib (i.e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment). 
Pri bolnikih, ki so bili odporni na imatinib ali ga niso prenašali (to je pri bolnikih, pri katerih se je med zdravljenjem z imatinibom pojavila znatnejša toksičnost, ki je preprečila nadaljnje zdravljenje), je bila izvedena odprta, enoskupinska (“single-arm”), multicentrična študija.
101 were randomised to dasatinib and 49 to imatinib (all imatinib-resistant). 
Rezultati so na voljo za 150 bolnikov: 101 bolnik je bil randomiziran na dasatinib, 49 bolnikov pa na imatinib (vsi odporni na imatinib).
NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG 3. 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM BRISTOL-MYERS SQUIBB PHARMA EEIG
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: bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako “BMS 140” na eni in “857” na drugi strani.
In patients with lymphoid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months, the median PFS was 5 months, and the median overall survival was 11 months. 
Pri bolnikih s KML v obdobju limfoblastne preobrazbe, 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 5 mesecev, srednja vrednost celokupnega preživetja pa 11 mesecev.
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 
Podatke o koncentraciji pri 32 pediatričnih bolnikih, ki so se zdravili s praškom za peroralno suspenzijo v odmerku 72 mg/m2, so združili s podatki pri tabletah za analizo populacijske farmakokinetike, ki je pokazala, da je izpostavljenost prašku za peroralno suspenzijo (izmerjeno s povprečno koncentracijo v stanju dinamičnega ravnovesja v odvisnosti od časa [Cavgss]) pri odmerku 72 mg/m2 bila približno za 30%
The estimated 60-month PFS rate was 88.9% (CI: 84% - 92.4%) for both the dasatinib and imatinib treatment groups. 
Ocenjeni delež 60-mesečnega preživetja brez napredovanja bolezni je bil tako v skupini, ki je prejemala dasatinib, kot v skupini, ki je prejemala imatinib, 88,9% (IZ: 84% - 92,4%).
Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic 
Preglednica 11: Učinkovitost zdravila SPRYCEL v enoskupinskih (“single-arm”) kliničnih preskušanjih II.
SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate). 
SPRYCEL 20 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 20 mg dasatiniba (v obliki monohidrata).
Improvements in haemodynamic and clinical parameters have been observed in dasatinib-treated patients with PAH following cessation of dasatinib therapy. 
Pri bolnikih, pri katerih se je med zdravljenjem z dasatinibom pojavila PAH, so po prekinitvi zdravljenja z dasatinibom poročali o izboljšanju hemodinamskih in kliničnih parametrov.
In patients with CML with resistance or intolerance to prior imatinib therapy, cytopaenias (thrombocytopaenia, neutropaenia, and anaemia) were a consistent finding. 
Pri bolnikih s KML, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali, so praviloma poročali o pojavu citopenij (trombocitopenija, nevtropenija in anemija), vendar pa je bil pojav citopenij tudi jasno povezan s stadijem bolezni.
Very common headache Common neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence Uncommon CNS bleeding*b, syncope, tremor, amnesia, balance disorder 
Občasni krvavitve v centralnem živčevju*b, sinkopa, tremor, amnezija, motnje ravnotežja
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 
Koža, lasje, oči in splošno: kožni izpuščaj, zvišana telesna temperatura, oteklina obraza, dlani in stopal, glavobol, občutek utrujenosti ali šibkosti in krvavitve.
SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate). 
SPRYCEL 70 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 70 mg dasatiniba (v obliki monohidrata).
SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate). 
SPRYCEL 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg dasatiniba (v obliki monohidrata).
SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate). 
SPRYCEL 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg dasatiniba (v obliki monohidrata).
SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate). 
SPRYCEL 80 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 80 mg dasatiniba (v obliki monohidrata).
Table 9: Efficacy results from a phase 3 study of newly diagnosed patients with chronic phase CML 
Preglednica 9: Rezultati učinkovitosti iz študije 3. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju Zdravilo SPRYCEL n = 259
SPRYCEL 100 mg film-coated tablets EU/1/06/363/011 
SPRYCEL 100 mg filmsko obložene tablete EU/1/06/363/011
Imatinib-intolerant patients 
Bolniki, ki imatiniba niso prenašali
e Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalised erythema, genital rash, heat rash, milia, miliaria, pustular psoriaisis, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, toxic skin eruption, urticaria vesiculosa, and vasculitic rash. 
genitalni izpuščaj, vročinski izpuščaj, milium, miliario, pustulozno psoriazo, izpuščaj, eritemski izpuščaj, folikularni izpuščaj, generalizirani izpuščaj, makulozni izpuščaj, makulopapulozni izpuščaj, papulozni izpuščaj, srbeči izpuščaj, pustulozni izpuščaj, vezikulozni izpuščaj, luščenje kože, draženje kože, toksične kožne erupcije, vezikulozno urtikarijo in vaskulitični izpuščaj.
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: bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako “BMS” na eni in “524” na drugi strani.
Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date. 
Zdravljenje z dasatinibom je v povprečju trajalo 3 mesecev, pri 7% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
SPRYCEL 50 mg film-coated tablets 
SPRYCEL 50 mg filmsko obložene tablete
White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side. 
Bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako "BMS 140" na eni in "857" na drugi strani.
Data described in this table are from studies using a starting dose of 70 mg twice daily. 
Podatki, predstavljeni v tej preglednici, izhajajo iz študij z uporabo začetnega odmerka 70 mg dvakrat na dan. Za priporočene začetne odmerke glejte poglavje 4.2. a Številke v krepkem tisku so rezultati primarnih opazovanih dogodkov.
SPRYCEL 80 mg film-coated tablets 
SPRYCEL 80 mg filmsko obložene tablete
Grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% of patients with chronic phase CML (resistant or intolerant to imatinib), but elevations were reported with an increased frequency of 1 to 7% of patients with advanced phase CML and Ph+ ALL. 
O stopnji 3 ali 4 povišanja vrednosti transaminaz ali bilirubina so poročali pri 1% bolnikov s KML v kroničnem obdobju, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali.
The following adverse reactions, excluding laboratory abnormalities, were reported in patients treated with SPRYCEL used as single-agent therapy in clinical studies and post-marketing experience (Table 5). 
V kliničnih študijah in po pridobitvi dovoljenja za promet so pri bolnikih, ki so se zdravili z zdravilom SPRYCEL kot samostojnim zdravilom, poročali o pojavu naslednjih neželenih učinkov (preglednica 5).
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") 
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila SPRYCEL se posvetujte z zdravnikom ali s farmacevtom:
SPRYCEL 100 mg film-coated tablets 
SPRYCEL 100 mg filmsko obložene tablete
By 3 years 67%, p<.0055 
V 3 letih p<0,0055
Therefore, in patients receiving dasatinib, coadministration of a potent CYP3A4 inhibitor is not recommended (see section 4.5). 
Pri bolnikih, ki se zdravijo z dasatinibom, sočasnega zdravljenja z močnimi zaviralci CYP3A4 ne priporočamo (glejte poglavje 4.5).
Not known hepatitis B reactivation 
Neznana pogostnost reaktivacija hepatitisa B Bolezni krvi in limfatičnega sistema
SPRYCEL 20 mg film-coated tablets 
SPRYCEL 20 mg filmsko obložene tablete
Table 1: Dosage of SPRYCEL tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL Body weight (kg)a 
Odmerjanje zdravila SPRYCEL v obliki tablet pri pediatričnih bolnikih s Ph+ KML-KO ali Ph+ ALL
b Haematologic response criteria (all responses confirmed after 4 weeks): Complete haematologic response (CHR) (chronic CML): WBC ≤ institutional ULN, platelets <450,000/mm3, no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <20%, and no extramedullary involvement. 
Vsi bolniki Bolniki, odporni na imatinib a Rezultati pri uporabi priporočenega začetnega odmerka 100 mg enkrat na dan. b Kriteriji hematološkega odziva (vsi odzivi potrjeni po 4 tednih): Popoln hematološki odziv (CHR) (KML v kroničnem obdobju): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, trombociti < 450.000/mm3, brez blastov ali promielocitov v periferni krvi, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS” debossed on one side and “528” on the other side. 
SPRYCEL 50 mg: bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako “BMS” na eni in “528” na drugi strani.
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: bele do sivobele, bikonveksne in trikotne filmsko obložene tablete z oznako “BMS 80” na eni in “855” na drugi strani.
By 3 years 24%, p<.0013 
V 3 letih p<0,0013
Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism 
Redki anafilaktični šok Bolezni endokrinega sistema
Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating SPRYCEL. 
Pred ponovno uvedbo zdravljenja z zdravilom SPRYCEL naj obdobje izpiranja po prekinitvi zdravljenja z zaviralcem traja približno 1 teden.
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side. 
SPRYCEL 100 mg: bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako “BMS 100” na eni in “852” na drugi strani.
CHR Cytogenetic responsec (%) (95% CI) 
Citogenetski odzivc (%) (95% IZ)
White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side. 
Bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako "BMS 100" na eni in "852" na drugi strani.
SPRYCEL 70 mg film-coated tablets dasatinib 
SPRYCEL 70 mg filmsko obložene tablete dasatinib
Each film-coated tablet contains 70 mg dasatinib (as monohydrate). 
Ena filmsko obložena tableta vsebuje 70 mg dasatiniba (v obliki monohidrata).
EU/1/06/363/004 - 56 film-coated tablets (blisters) EU/1/06/363/007 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/001 - 60 film-coated tablets (bottle) 
EU/1/06/363/004 - 56 filmsko obloženih tablet (pretisni omoti) EU/1/06/363/007 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/001 - 60 filmsko obloženih tablet (plastenka)
Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic (n= 387) 
Učinkovitost zdravila SPRYCEL v enoskupinskih (“single-arm”) kliničnih preskušanjih II fazea
EU/1/06/363/005 - 56 film-coated tablets (blisters) EU/1/06/363/008 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/002 - 60 film-coated tablets (bottle) 
EU/1/06/363/005 - 56 filmsko obloženih tablet (pretisni omoti) EU/1/06/363/008 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/002 - 60 filmsko obloženih tablet (plastenka)
Cardiac adverse reactions 
Neželeni učinki za srce
PROPORTION RESPONDERS 
RAZMERJE
SPRYCEL 50 mg film-coated tablets dasatinib 
SPRYCEL 50 mg filmsko obložene tablete dasatinib
Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm. With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover. 
Pri daljšem zdravljenju in spremljanju (v povprečju 24 mesecev) je bil dober citogenetski odziv dosežen pri 53% bolnikov, ki so se zdravili z dasatinibom (popoln citogenetski odziv pri 44%), in 33% bolnikov, ki so se zdravili z imatinibom (popoln citogenetski odziv pri 18%) pred zamenjavo zdravljenja.
EU/1/06/363/006 - 56 film-coated tablets (blisters) EU/1/06/363/009 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/003 - 60 film-coated tablets (bottle) 
EU/1/06/363/006 - 56 filmsko obloženih tablet (pretisni omoti) EU/1/06/363/009 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/003 - 60 filmsko obloženih tablet (plastenka)
White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side. 
Bele do sivobele, bikonveksne in trikotne filmsko obložene tablete z oznako "BMS 80" na eni in "855" na drugi strani.
The mean Cmax and AUC of dasatinib adjusted for the 70 mg dose were decreased by 47% and 8%, respectively, in subjects with moderate hepatic impairment compared to subjects with normal hepatic function. 
V primerjavi z osebami z normalnim delovanjem jeter sta bili pri osebah z zmerno okvaro jeter srednji vrednosti Cmax in AUC dasatiniba, prilagojeni na 70 mg odmerek dasatiniba, manjši, in sicer Cmax za 47%, AUC pa za 8%.
Not known fatal gastrointestinal haemorrhage* Hepatobiliary disorders 
Neznana pogostnost usodna gastrointestinalna krvavitev* Bolezni jeter, žolčnika in žolčevodov
Haematologic response rateb (%) (95% CI) 
Delež hematološkega odzivab (%) (95% IZ)
Table 10: Dasatinib patients with BCR-ABL ≤ 10% and > 10% at 3 months 
Bolniki, ki so se zdravili z dasatinibom, in so imeli v 3. mesecu vrednost BCR-ABL ≤ 10% in > 10%
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 in pljuča: razbijanje srca, motnje srčnega ritma, kongestivno srčno popuščanje, oslabelost srčne mišice, visok krvni tlak, zvišan krvni tlak v pljučih in kašelj.
CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement. 
Popoln hematološki odziv (KML v napredovalem obdobju/Ph+ ALL): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, absolutno število nevtrofilcev ≥ 1.000/mm3, trombociti ≥ 100.000/mm3, brez blastov ali promielocitov v periferni krvi, blasti v kostnem mozgu ≤ 5%, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle) 
EU/1/06/363/015 - 30 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/014 - 30 filmsko obloženih tablet (plastenka)
SPRYCEL 20 mg film-coated tablets dasatinib 
SPRYCEL 20 mg filmsko obložene tablete dasatinib
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side. 
Bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako "BMS" na eni in "527" na drugi strani.
EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle) 
EU/1/06/363/011 - 30 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/010 - 30 filmsko obloženih tablet (plastenka)
Each film-coated tablet contains 20 mg dasatinib (as monohydrate). 
Ena filmsko obložena tableta vsebuje 20 mg dasatiniba (v obliki monohidrata).
SPRYCEL contains sucrose 
Zdravilo SPRYCEL vsebuje saharozo
Dasatinib is extensively metabolised in humans with multiple enzymes involved in the generation of the metabolites. 
Pri nastanku presnovkov so vključeni številni encimi.
By 4 years 73%, p<.0021 
V 4 letih p<0,0021
Imatinib-intolerant patients 100% (100, 100) 95% (88, 100) 
SMRTI / Št. zajetih bolnikov MEDIANA (95% IZ) RAZMERJE OGROŽENOSTI (95% IZ)
j Conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, lip oedema, macular oedema, oedema mouth, orbital oedema, periorbital oedema, swelling face. 
ij Edem veznic, očesni edem, oteklina oči, edem očesnih vek, edem obraza, edem ustnic, makularni edem, edem ust,
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. 
Smernice za pediatrične bolnike s Ph+ ALL, ki se zdravijo v kombinaciji s kemoterapijo, so navedene v ločenem odstavku, ki sledi preglednicam.
Common weight decreased, weight increased 
Pogosti zmanjšanje telesne mase, povečanje telesne mase
Forty-two percent of the imatinib-resistant patients with no prior MCyR to imatinib (n= 188) achieved a MCyR with dasatinib. 
Pri uporabi dasatiniba je bil dober citogenetski odziv dosežen pri 42% bolnikov, odpornih na imatinib, pri katerih dober citogenetski odziv na zdravljenje z imatinibom (n = 188) ni bil dosežen.
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side. 
Bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako "BMS" na eni in "524" na drugi strani.
CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement. 
Popoln hematološki odziv (CHR): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, absolutno število nevtrofilcev ≥ 1.000/mm3, trombociti ≥ 100.000/mm3, brez blastov ali promielocitov v periferni krvi, blasti v kostnem mozgu ≤ 5%, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
EU/1/06/363/013 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/012 - 30 film-coated tablets (bottle) 
EU/1/06/363/013 - 30 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/012 - 30 filmsko obloženih tablet (plastenka)
Pain: pain in the muscles (during or after discontinuing treatment), tummy (abdominal) pain Tests may show: low blood platelet count, low white blood cells count (neutropaenia), anaemia, fluid around the lungs 
Preiskave lahko pokažejo: zmanjšano število trombocitov, zmanjšano število belih krvnih celic (nevtropenija), anemijo in tekočino okrog pljuč.
Escalation 
Povečanje
CHR (chronic CML): WBC ≤ institutional ULN, platelets < 450,000/mm3, no blasts or promyelocytes in peripheral blood, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement. 
Popoln hematološki odziv (KML v kroničnem obdobju): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, trombociti < 450.000/mm3, brez blastov ali promielocitov v periferni krvi, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
One-level dose reduction 
Odmerek, zmanjšan za eno stopnjo
Four single-arm, uncontrolled, open-label Phase II clinical studies were conducted to determine the safety and efficacy of dasatinib in patients with CML in chronic, accelerated, or myeloid blast phase, who were either resistant or intolerant to imatinib. 
Za določitev varnosti in učinkovitosti dasatiniba pri bolnikih s KML v kroničnem obdobju, obdobju pospešenega poteka ali obdobju mieloblastne preobrazbe, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali, so bile izvedene štiri enoskupinske (“single-arm”), nenadzorovane, odprte klinične študije II.
Each film-coated tablet contains 50 mg dasatinib (as monohydrate). 
Ena filmsko obložena tableta vsebuje 50 mg dasatiniba (v obliki monohidrata).
SPRYCEL must be administered orally. 
Zdravilo SPRYCEL je namenjeno za peroralno uporabo.
White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side. 
Bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako "BMS" na eni in "528" na drugi strani.
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 
Predhodno imatinib (N = 46)b a Bolniki iz pediatričnih študij II.
Not known thrombotic microangiopathy Respiratory, thoracic and mediastinal disorders Very common pleural effusion*, dyspnoea 
Neznana pogostnost trombotična mikroangiopatija Bolezni dihal, prsnega koša in mediastinalnega prostora
An open-label, single-arm, multicentre study was conducted in patients intolerant or resistant to imatinib. 
Pri bolnikih, ki imatiniba niso prenašali ali so bili nanj odporni, je bila izvedena odprta, enoskupinska (“single-arm”), multicentrična študija.
The majority of SPRYCEL-treated patients experienced adverse reactions at some time. 
V določenem času so se neželeni učinki pojavili pri večini z zdravilom SPRYCEL zdravljenih bolnikov.
Progression-free survivalb 
Preživetje brez napredovanja boleznib
achieved in 93% of the overall patient population. 
Predhodni popolni hematološki odziv na imatinib je bil dosežen pri 93% vseh bolnikov.
You cannot be sure you will receive the correct dose if you crush, cut, chew or disperse the tablets. 
Če zdrobite, razpolovite, žvečite ali raztopite tablete, ne morete vedeti zagotovo, če boste prejeli pravi odmerek.
CHR (95% CI) NEL (95% CI) 
MaHRb (95% IZ) CHRb (95% IZ) NELb (95% IZ) MCyRc (95% IZ) CCyR (95% IZ)
By 1 year 46%, p<.0001 
V 1 letu p<0,0001
Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis 
Občasni hipotenzija, tromboflebitis, tromboza
By 2 years 64%, p<.0001 
V 2 letih p<0,0001