FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating dasatinib therapy.
Slovenian: Pri vsakem bolniku s simptomi bolezni srca je pred uvedbo zdravljenja z dasatinibom treba izvesti elektrokardiografijo.
English: Additionally, dasatinib inhibits SRC family kinases at subnanomolar concentrations.
Slovenian: Dasatinib pri subnanomolarnih koncentracijah zavira tudi kinaze iz družine SRC.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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%]).
English: However, in an in vivo single-dose study in conscious telemetered monkeys, there were no changes in QT interval or ECG wave form.
Slovenian: 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.
English: SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Slovenian: SPRYCEL 140 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 140 mg dasatiniba (v obliki monohidrata).
English: Censored
Slovenian: Ocenjeni
English: By 4 years 34%, p<.0055
Slovenian: V 4 letih p<0,0055
English: What SPRYCEL contains
Slovenian: Kaj vsebuje zdravilo SPRYCEL
English: The median time from diagnosis to start of treatment was 82 months.
Slovenian: Od diagnoze do začetka zdravljenja je v povprečju minilo 82 mesecev.
English: within 60 months (95% CI)
Slovenian: v 60 mesecih (95% IZ)
English: 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
Slovenian: Gastrointestinalne krvavitve a Rezultati študije 3. faze za določitev optimalnega odmerka pri uporabi priporočenega začetnega odmerka 100 mg enkrat na dan (n=165).
English: SPRYCEL 70 mg film-coated tablets
Slovenian: SPRYCEL 70 mg filmsko obložene tablete
English: SPRYCEL 80 mg film-coated tablets EU/1/06/363/013
Slovenian: SPRYCEL 80 mg filmsko obložene tablete EU/1/06/363/013
English: 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.
Slovenian: 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.
English: l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling, testicular swelling, vulvovaginal swelling.
Slovenian: l Oteklina genitalij, edem na mestu kirurškega reza, genitalni edem, edem penisa, oteklina penisa, edem modnika, otekanje kože, otekanje mod, otekanje vulve in vagine.
English: SPRYCEL contains sodium
Slovenian: Zdravilo SPRYCEL vsebuje natrij
English: SPRYCEL 70 mg film-coated tablets EU/1/06/363/006
Slovenian: SPRYCEL 70 mg filmsko obložene tablete EU/1/06/363/006
English: Improvements in haemodynamic and clinical parameters have been observed in patients with PAH following discontinuation of dasatinib.
Slovenian: Pri bolnikih s PAH so po prekinitvi zdravljenja z dasatinibom poročali o izboljšanju hemodinamskih in kliničnih parametrov.
English: Two clinical studies were conducted in patients resistant or intolerant to imatinib; the primary efficacy endpoint in these studies was Major Cytogenetic Response (MCyR).
Slovenian: Primarni opazovani dogodek učinkovitosti v teh dveh študijah je bil pomemben citogenetski odziv (MCyR).
English: MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG Plaza 254
Slovenian: Imetnik dovoljenja za promet z zdravilom Bristol-Myers Squibb Pharma EEIG Plaza 254
English: PHARMACEUTICAL FORM AND CONTENTS 30 x 1 film-coated tablets
Slovenian: 30 x 1 filmsko obložena tableta 30 filmsko obloženih tablet
English: SPRYCEL 140 mg film-coated tablets EU/1/06/363/015
Slovenian: SPRYCEL 140 mg filmsko obložene tablete EU/1/06/363/015
English: Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
Slovenian: Zdravljenje z dasatinibom je v povprečju trajalo 3,5 mesece, pri 12% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
English: SPRYCEL 50 mg film-coated tablets EU/1/06/363/005
Slovenian: SPRYCEL 50 mg filmsko obložene tablete EU/1/06/363/005
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Table 12: Efficacy of SPRYCEL in phase III dose-optimization study: imatinib resistant or intolerant chronic phase CML (2-year results)a
Slovenian: 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
English: Abdominal pain Diarrhoea
Slovenian: Perikardialni izliv Pljučni edem
English: 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).
Slovenian: 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.
English: 101 were randomised to dasatinib and 49 to imatinib (all imatinib-resistant).
Slovenian: Rezultati so na voljo za 150 bolnikov: 101 bolnik je bil randomiziran na dasatinib, 49 bolnikov pa na imatinib (vsi odporni na imatinib).
English: NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG 3.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM BRISTOL-MYERS SQUIBB PHARMA EEIG
English: 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.
Slovenian: SPRYCEL 140 mg: bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako “BMS 140” na eni in “857” na drugi strani.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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%
English: The estimated 60-month PFS rate was 88.9% (CI: 84% - 92.4%) for both the dasatinib and imatinib treatment groups.
Slovenian: 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%).
English: Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic
Slovenian: Preglednica 11: Učinkovitost zdravila SPRYCEL v enoskupinskih (“single-arm”) kliničnih preskušanjih II.
English: SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Slovenian: SPRYCEL 20 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 20 mg dasatiniba (v obliki monohidrata).
English: Improvements in haemodynamic and clinical parameters have been observed in dasatinib-treated patients with PAH following cessation of dasatinib therapy.
Slovenian: 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.
English: In patients with CML with resistance or intolerance to prior imatinib therapy, cytopaenias (thrombocytopaenia, neutropaenia, and anaemia) were a consistent finding.
Slovenian: 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.
English: Very common headache Common neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence Uncommon CNS bleeding*b, syncope, tremor, amnesia, balance disorder
Slovenian: Občasni krvavitve v centralnem živčevju*b, sinkopa, tremor, amnezija, motnje ravnotežja
English: 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
Slovenian: Koža, lasje, oči in splošno: kožni izpuščaj, zvišana telesna temperatura, oteklina obraza, dlani in stopal, glavobol, občutek utrujenosti ali šibkosti in krvavitve.
English: SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Slovenian: SPRYCEL 70 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 70 mg dasatiniba (v obliki monohidrata).
English: SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Slovenian: SPRYCEL 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg dasatiniba (v obliki monohidrata).
English: SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Slovenian: SPRYCEL 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg dasatiniba (v obliki monohidrata).
English: SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Slovenian: SPRYCEL 80 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 80 mg dasatiniba (v obliki monohidrata).
English: Table 9: Efficacy results from a phase 3 study of newly diagnosed patients with chronic phase CML
Slovenian: Preglednica 9: Rezultati učinkovitosti iz študije 3. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju Zdravilo SPRYCEL n = 259
English: SPRYCEL 100 mg film-coated tablets EU/1/06/363/011
Slovenian: SPRYCEL 100 mg filmsko obložene tablete EU/1/06/363/011
English: Imatinib-intolerant patients
Slovenian: Bolniki, ki imatiniba niso prenašali
English: 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.
Slovenian: 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.
English: 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.
Slovenian: SPRYCEL 70 mg: bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako “BMS” na eni in “524” na drugi strani.
English: Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
Slovenian: Zdravljenje z dasatinibom je v povprečju trajalo 3 mesecev, pri 7% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
English: SPRYCEL 50 mg film-coated tablets
Slovenian: SPRYCEL 50 mg filmsko obložene tablete
English: White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side.
Slovenian: Bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako "BMS 140" na eni in "857" na drugi strani.
English: Data described in this table are from studies using a starting dose of 70 mg twice daily.
Slovenian: 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.
English: SPRYCEL 80 mg film-coated tablets
Slovenian: SPRYCEL 80 mg filmsko obložene tablete
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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")
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila SPRYCEL se posvetujte z zdravnikom ali s farmacevtom:
English: SPRYCEL 100 mg film-coated tablets
Slovenian: SPRYCEL 100 mg filmsko obložene tablete
English: By 3 years 67%, p<.0055
Slovenian: V 3 letih p<0,0055
English: Therefore, in patients receiving dasatinib, coadministration of a potent CYP3A4 inhibitor is not recommended (see section 4.5).
Slovenian: Pri bolnikih, ki se zdravijo z dasatinibom, sočasnega zdravljenja z močnimi zaviralci CYP3A4 ne priporočamo (glejte poglavje 4.5).
English: Not known hepatitis B reactivation
Slovenian: Neznana pogostnost reaktivacija hepatitisa B Bolezni krvi in limfatičnega sistema
English: SPRYCEL 20 mg film-coated tablets
Slovenian: SPRYCEL 20 mg filmsko obložene tablete
English: Table 1: Dosage of SPRYCEL tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL Body weight (kg)a
Slovenian: Odmerjanje zdravila SPRYCEL v obliki tablet pri pediatričnih bolnikih s Ph+ KML-KO ali Ph+ ALL
English: 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.
Slovenian: 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.
English: 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.
Slovenian: SPRYCEL 50 mg: bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako “BMS” na eni in “528” na drugi strani.
English: 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.
Slovenian: SPRYCEL 80 mg: bele do sivobele, bikonveksne in trikotne filmsko obložene tablete z oznako “BMS 80” na eni in “855” na drugi strani.
English: By 3 years 24%, p<.0013
Slovenian: V 3 letih p<0,0013
English: Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism
Slovenian: Redki anafilaktični šok Bolezni endokrinega sistema
English: Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating SPRYCEL.
Slovenian: Pred ponovno uvedbo zdravljenja z zdravilom SPRYCEL naj obdobje izpiranja po prekinitvi zdravljenja z zaviralcem traja približno 1 teden.
English: 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.
Slovenian: SPRYCEL 100 mg: bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako “BMS 100” na eni in “852” na drugi strani.
English: CHR Cytogenetic responsec (%) (95% CI)
Slovenian: Citogenetski odzivc (%) (95% IZ)
English: White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side.
Slovenian: Bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako "BMS 100" na eni in "852" na drugi strani.
English: SPRYCEL 70 mg film-coated tablets dasatinib
Slovenian: SPRYCEL 70 mg filmsko obložene tablete dasatinib
English: Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 70 mg dasatiniba (v obliki monohidrata).
English: 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)
Slovenian: 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)
English: Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic (n= 387)
Slovenian: Učinkovitost zdravila SPRYCEL v enoskupinskih (“single-arm”) kliničnih preskušanjih II fazea
English: 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)
Slovenian: 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)
English: Cardiac adverse reactions
Slovenian: Neželeni učinki za srce
English: PROPORTION RESPONDERS
Slovenian: RAZMERJE
English: SPRYCEL 50 mg film-coated tablets dasatinib
Slovenian: SPRYCEL 50 mg filmsko obložene tablete dasatinib
English: 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.
Slovenian: 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.
English: 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)
Slovenian: 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)
English: White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Slovenian: Bele do sivobele, bikonveksne in trikotne filmsko obložene tablete z oznako "BMS 80" na eni in "855" na drugi strani.
English: 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.
Slovenian: 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%.
English: Not known fatal gastrointestinal haemorrhage* Hepatobiliary disorders
Slovenian: Neznana pogostnost usodna gastrointestinalna krvavitev* Bolezni jeter, žolčnika in žolčevodov
English: Haematologic response rateb (%) (95% CI)
Slovenian: Delež hematološkega odzivab (%) (95% IZ)
English: Table 10: Dasatinib patients with BCR-ABL ≤ 10% and > 10% at 3 months
Slovenian: Bolniki, ki so se zdravili z dasatinibom, in so imeli v 3. mesecu vrednost BCR-ABL ≤ 10% in > 10%