natgillin/translations-raw huggingface dataset:
However, a thorough QT study has not been performed; therefore a clinically significant effect on QT cannot be excluded. 
Vendar pa celovitih študij v zvezi z intervalom QT niso izvajali, zato klinično pomembnih učinkov na interval QT ni mogoče izključiti.
Do not give this medicine to children under 18 years because no data are available in children. 
Otroci, stari do 18 let, zdravila ne smejo prejemati, saj podatkov ni na voljo.
Your doctor may reduce your dose or tell you to temporarily stop taking Iclusig if: 
Vaš zdravnik lahko odmerek zmanjša ali vam naroči, da začasno prenehate jemati zdravilo Iclusig, če:
Iclusig is available as: 
Zdravilo Iclusig je na voljo kot:
Available pharmacodynamic and toxicological data cannot exclude potential excretion in human milk. 
Razpoložljivi farmakodinamični in toksikološki podatki ne morejo izključiti možnega izločanja v materino mleko.
• pain in one or both legs when walking or exercising, which disappears after some minutes of rest 
• bolečina v eni nogi ali obeh nogah pri hoji ali vadbi, ki po nekaj minutah mirovanja izgine
If dose reduction is undertaken, close monitoring of response is recommended. 
Če se odmerek zmanjša, se priporoča skrbno spremljanje odgovora.
First occurrence: 
Prvi pojav:
Swallow the tablets whole, with a glass of water. 
Tablete pogoltnite cele s kozarcem vode.
Total safety population N=449 
Skupno število populacije za varnost N = 449
The median dose intensity was 36 mg or, 80% of the expected 45 mg dose. 
Mediana intenzivnost odmerka je bila 36 mg ali 80 % pričakovanega 45 mg odmerka.
Only use Iclusig during pregnancy if your doctor tells you it is absolutely necessary, as potential risks exist for the unborn child. 
Zdravilo Iclusig uporabljajte med nosečnostjo le, če vam zdravnik pove, da je to nujno potrebno, saj obstajajo možna tveganja za nerojenega otroka.
There are no adequate data from the use of Iclusig in pregnant women. 
Ni zadostnih podatkov o uporabi zdravila Iclusig pri nosečnicah.
Maintained MMR 
Vzdrževan MMR
Dose reduction in CP-CML patients 
Zmanjšanje odmerka pri bolnikih CP-KML
*ANC = absolute neutrophil count 
*ANC = absolutno število nevtrofilcev
Therefore, caution should be recommended when driving or operating machines. 
Zato je pri vožnji ali upravljanju strojev potrebna previdnost.
Patient characteristics at entry 
Značilnosti bolnikov ob vstopu
If you have been told by your doctor that you have an intolerance to milk sugar (lactose) contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate mlečnega sladkorja (laktoze), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Majora (MaHR) 
Bistvena (MaHR)
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• evaluations of your heart function and the condition of your arteries and veins 
• ocenil delovanje vašega srca in stanje vaših arterij in ven
All Patients (N=449) 
Vsi bolniki (N = 449)
In addition, results from logistic regression analyses of data from patients in the phase 1 trial, suggest a relationship between systemic exposure (AUC) and occurrence of arterial thrombotic events. 
Rezultati analize logistične regresije podatkov za bolnike iz preskušanja 1. faze kažejo tudi na razmerje med sistemsko izpostavljenostjo (AUC) in pojavom arterijskim trombotskih dogodkov.
If abnormal results from blood tests are received, a doctor should be contacted immediately. 
Če so rezultati krvnih preiskav nenormalni, se je treba takoj posvetovati z zdravnikom.
• fever, often with other signs of infection due to decreased number of white blood cells 
• zvišana telesna temperatura, pogosto z drugimi znaki okužbe zaradi zmanjšanega števila belih krvnih celic
At the time of reporting, all ongoing patients had a minimum follow-up of 27 months. 
V času poročanja so vse trenutne bolnike spremljali vsaj 27 mesecev.
Fertility The effect of Iclusig on male and female fertility is unknown. 
Plodnost Učinek zdravila Iclusig na plodnost pri moških in ženskah ni znan.
The educational programme is aimed at providing information that helps identify patients eligible for therapy, understand how ponatinib should be used safely, the risks for patients and the important adverse reactions for which monitoring and dose adjustment are recommended. 
Namen izobraževalnega programa je ponuditi informacije, ki pomagajo pri opredelitvi bolnikov, primernih za zdravljenje, pri razumevanju varne uporabe ponatiniba, tveganj za bolnike in pomembnih neželenih učinkov, za katere se priporoča spremljanje in prilagajanje odmerka.
What Iclusig is and what it is used for 
Kaj je zdravilo Iclusig in za kaj ga uporabljamo
Single doses of 165 mg and an estimated 540 mg in two patients did not result in any clinically significant adverse reactions. 
Enkratni odmerki 165 mg in ocenjen odmerek 540 mg pri dveh bolnikih niso povzročili klinično pomembnih neželenih učinkov.
Table 5 Demographics and disease characteristics 
Preglednica 5 Demografske značilnosti in značilnosti bolezni
The safety and efficacy of Iclusig in patients less than 18 years of age have not been established. 
Varnost in učinkovitost zdravila Iclusig pri bolnikih, starih do 18 let, še nista bili dokazani.
In the event of an overdose of Iclusig, the patient should be observed and appropriate supportive treatment given. 
V primeru prevelikega odmerjanja zdravila Iclusig je treba bolnika opazovati in mu nuditi ustrezno podporno zdravljenje.
Iclusig film-coated tablets are white, round and rounded on the upper and lower side. 
Zdravilo Iclusig filmsko obložene tablete so bele, okrogle in zaobljene na zgornji in spodnji strani.
It is unknown whether ponatinib affects the effectiveness of systemic hormonal contraceptives. 
Ni znano, ali ponatinib vpliva na učinkovitost sistemskih hormonskih kontraceptivov.
Of the 449 patients in the clinical study of Iclusig, 155 (35%) were ≥ 65 years of age. 
Med 449 bolniki v klinični študiji z zdravilom Iclusig jih je bilo 155 (35 %) starih ≥ 65 let.
• a severe side effect occurs, not affecting the blood 
• se pojavijo hudi neželeni učinki, ki ne vplivajo na kri
In patients with CML and Ph+ ALL, changes in the DNA trigger a signal that tells the body to produce abnormal white blood cells. 
Pri bolnikih s KML in Ph+ ALL spremembe v DNK sprožijo signal, ki telesu pove, naj proizvaja nenormalne bele krvne celice.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use are described below. 
Neželenih učinkov v kliničnih študijah niso opazili, vendar so jih opazili pri živalih pri izpostavljenosti, podobni ravni klinične izpostavljenosti, in z možnim pomenom za klinično uporabo, in so opisani spodaj.
• Instructions on management of adverse events based on monitoring and dose modifications or treatment withdrawal. 
• Navodila o obravnavi neželenih učinkov na podlagi spremljanja in prilagajanja odmerka ali ukinitve zdravljenja.
Iclusig blocks this signal, thereby stopping the production of these cells. 
Zdravilo Iclusig ta signal zavre, s čimer prepreči nastajanje teh celic.
• Obligation to conduct post-authorisation measures 
• Obveznosti izvajanja ukrepov po pridobitvi dovoljenja za promet
Frequency categories are very common (≥ 1/10), common (≥1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), and not known (cannot be estimated from the available data). 
Kategorije pogostnosti so zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana pogostnost
- gamma-glutamyltransferase 
- gama-glutamiltransferaze
In these patients, alternative treatment options should also be considered before starting treatment with ponatinib. 
Pri teh bolnikih je treba pred začetkom zdravljenja s ponatinibom razmisliti tudi o alternativnih možnostih zdravljenja.
Iclusig has a minor influence on the ability to drive and use machines. 
Zdravilo Iclusig ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
BCR-ABL mutation detected at entry, n (%) None 
Mutacija BCR-ABL, odkrita ob vstopu, n (%) Brez
Handling: 
Ravnanje:
A reduction in dose is therefore expected to reduce the risk of vascular occlusive events, however, the analysis suggested that there may be a ‘carry over' effect of higher doses such that it might take up to several months before a dose reduction manifests in risk reduction. 
Zato se pričakuje, da bo zmanjšanje odmerka zmanjšalo tveganje vaskularnih okluzivnih dogodkov, vendar je iz analize razvidno, da obstaja morda preneseni učinek iz večjih odmerkov, zato lahko traja do več mesecev, preden se zmanjšanje odmerjanja odrazi pri zmanjšanju tveganja.
Haematological Response Rate 
Stopnja hematološkega odgovora
The majority of patients who underwent dose reduction maintained response (MCyR and MMR) for the duration of currently available follow-up. 
Večina bolnikov, pri katerih je bil odmerek zmanjšan, je odgovor ohranila (MCyR in MMR) za obdobje spremljanja, ki je trenutno na voljo.
Inform your doctor immediately if pancreas inflammation occurs. 
Svojemu zdravniku takoj povejte, če se pojavi vnetje trebušne slinavke.
ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD United Kingdom 
ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD Velika Britanija
Dose interruption or reduction may be required. 
Morda bo treba odmerek prekiniti ali zmanjšati.
See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 Situations where an alternative treatment may be considered. 
Pred začetkom zdravljenja glejte poglavje 4.2 Ocena kardiovaskularnega statusa in 4.4 Situacije, v katerih je treba razmisliti o alternativnem zdravljenju.
Other covariates that show a statistically significant association with the occurrence of vascular occlusive events in this analysis are medical history of ischemia and age. 
Drugi sospremenljivki, ki kažeta na statistično značilno povezavo s pojavom vaskularnih okluzivnih dogodkov v tej analizi, sta anamneza ishemije in starost.
A complete blood count should be performed every 2 weeks for the first 3 months and then monthly or as clinically indicated. 
Prve 3 mesece je treba vsaka 2 tedna opraviti pregled celotne krvne slike, nato pa mesečno ali kot je klinično indicirano.
For all patients, additional secondary efficacy endpoints included: confirmed MCyR, time to response, duration of response, progression free survival, and overall survival. 
Za vse bolnike so dodatni opazovani dogodki učinkovitosti vključevali: potrjen MCyR, čas do odgovora, trajanje odgovora, preživetje brez napredovanja bolezni in celokupno preživetje.
Take your next dose at your regular time. 
Vzemite naslednji odmerek, ko je čas zanj.
The effects were shown to be reversible after withdrawal of the treatment. 
Učinki so bili po prenehanju zdravljenja reverzibilni.
Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities. 
O mielosupresiji so poročali pri bolnikih z normalnimi izhodiščnimi laboratorijskimi vrednostmi, pa tudi pri bolnikih z obstoječimi laboratorijskimi nenormalnostmi.
* of 427 patients reporting prior TKI therapy with dasatinib or nilotinib 
* od 427 bolnikov, ki so prejeli predhodno zdravljenje s TKI z dasatinibom ali nilotinibom
The analysis of the dose intensity-safety relationship in the phase 2 trial concluded that after adjusting for covariates, the overall dose intensity is significantly associated with an increased risk of vascular occlusion, with an odds ratio of approximately 1.6 for each 15 mg increase. 
Analiza razmerja med intenzivnostjo odmerjanja in varnostjo v preskušanju 2. faze je pokazala, da je po prilagoditvi za sospremenljivke celokupna intenzivnost odmerjanja značilno povezana z večjim tveganjem za vaskularno okluzijo z razmerjem obetov približno 1,6 za vsakih 15 mg povečanja.
Recommendation for close monitoring of response if a dose reduction is undertaken. 
Priporočilo za skrbno spremljanje odgovora ob zmanjšanju odmerka.
• metabolic disorders caused by the break-down products of dying cancer cells 
• presnovna bolezen zaradi razgradnih produktov umirajočih rakavih celic
Patients with hepatic impairment may receive the recommended starting dose. 
Bolniki z okvaro jeter lahko prejemajo priporočeni začetni odmerek.
Most patients who ultimately reduced dose to 15 mg initially had their dose reduced to 30 mg for a period. 
Pri večini bolnikov, katerim je bil odmerek končno zmanjšan na 15 mg, je bil odmerek za nekaj časa zmanjšan na 30 mg.
• checks of the serum protein known as lipase A serum protein called lipase will be checked every 2 weeks for the first 2 months, then periodically. 
• preveril serumsko beljakovino, znano kot lipaza Pregledi serumske beljakovine, imenovane lipaza, bodo prva 2 meseca opravljeni vsaka 2 tedna, nato pa občasno.
In the phase 2 trial, dose reductions were recommended following adverse events; in addition in October 2013 new recommendations for prospective dose reduction in all CP-CML patients in the absence of adverse events were introduced in this trial with the aim of reducing the risk of vascular occlusive events. 
V preskušanju 2. faze so po neželenih učinkih priporočali zmanjšanje odmerka; poleg tega so oktobra 2013 v tem preskušanju uvedli nova priporočila za prospektivno zmanjšanje odmerka za vse bolnike s CP-KML brez neželenih učinkov, s ciljem zmanjšati tveganje vaskularnih okluzivnih dogodkov.
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus. 
Če se zdravilo uporablja med nosečnostjo, je treba bolnico obvestiti o možnem tveganju za plod.
• liver tests Liver function tests will be performed periodically, as indicated by your doctor. 
• opravil jetrne teste Teste delovanja jeter vam bodo opravljali periodično po navodilih vašega zdravnika.
• the number of white blood cells called neutrophils is reduced. 
• se število belih krvnih celic, imenovanih nevtrofilci, zmanjša
Preliminary data from the phase 2 trial are available on the maintenance of response (MCyR and MMR) in all CP-CML patients who underwent dose reduction for any reason. 
Preliminarni podatki iz preskušanja 2. faze so na voljo za vzdrževanje odgovora (MCyR in MMR) pri vseh bolnikih s CP-KML, pri katerih je bil odmerek zmanjšan zaradi katerega koli razloga.
- alanine aminotransferase 
- alanin-aminotransferaze
In this kind of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, the Philadelphia chromosome. 
Pri tej vrsti levkemije se je del DNK (genetski material) prerazporedil in oblikoval nenormalen kromosom, ki se imenuje kromosom Philadelphia.
Liver function tests should be performed prior to treatment initiation and monitored periodically, as clinically indicated. 
Teste delovanja jeter je treba opraviti pred uvedbo zdravljenja in nato periodično, kot je klinično indicirano.
Make sure you take Iclusig daily for as long as it is prescribed. 
Zdravilo Iclusig morate jemati vsak dan, dokler je predpisano.
Table 10 shows these data for patients who achieved MCyR and MMR at 45 mg; similar data are available for patients who achieved MCyR and MMR at 30 mg. 
V preglednici 10 so prikazani ti podatki za bolnike, ki so dosegli MCyR in MMR pri 45 mg; podobni podatki so na voljo za bolnike, ki so dosegli MCyR in MMR pri 30 mg.
Age Median, years (range) Gender, n (%) Male Race, n (%) Asian Black/African American White Other ECOG Performance Status, n (%) ECOG=0 or 1 Disease History Median time from diagnosis to first dose, years (range) Resistant to Prior TKI Therapy*, n (%) Prior TKI therapy- number of regimens, n (%) 
Starost Mediana, leta (razpon) Spol, n (%) Moški Rasa, n (%) Azijci Črnci/afriški Američani Belci Drugo Status zmogljivosti po ECOG, n (%) ECOG = 0 ali 1 Zgodovina bolezni Mediana časa od diagnoze do prvega odmerka, leta (razpon) Odpornost na predhodno zdravljenje s TKI*, n (%) Predhodno zdravljenje s TKI - število režimov, n (%)
Formal studies of ponatinib with anti-clotting medicinal products have not been conducted. 
Formalnih študij s ponatinibom in zdravili proti strjevanju krvi niso opravili.
The risk of vascular occlusive events is likely to be dose-related. 
Tveganje žilnih okluzivnih dogodkov je verjetno povezano z odmerkom.
Before starting treatment with ponatinib, the cardiovascular status of the patient should be assessed, including history and physical examination, and cardiovascular risk factors should be actively managed. 
Pred začetkom zdravljenja s ponatinibom je treba oceniti kardiovaskularni status bolnika, vključno z anamnezo in telesnim pregledom, in aktivno obravnavati kardiovaskularne dejavnike tveganja.
All patients received 45 mg Iclusig once daily. 
Vsi bolniki so prejemali 45 mg zdravila Iclusig enkrat na dan.
• nerve disorder in the arms and/or legs (often causes numbness and pain in the hands and feet) 
• bolezni živcev v rokah in/ali nogah (pogosto povzročijo omrtvelost in bolečine dlani in stopal)
Important adverse reactions 
Pomembne neželene reakcije
The blood/plasma ratio of ponatinib is 0.96. 
Razmerje ponatiniba v krvi/plazmi je 0,96.
At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median durations of MCyR and MMR had not yet been reached. 
V času posodobljenega poročanja z minimalnim spremljanjem za vse trenutne bolnike 27 mesecev mediano trajanje MCyR in MMR še ni bilo doseženo.
Renal excretion is not a major route of ponatinib elimination. 
Izločanje skozi ledvice ni glavna pot izločanja ponatiniba.
Ponatinib inhibits the activity of other clinically relevant kinases with IC50 values below 20 nM and has demonstrated cellular activity against RET, FLT3, and KIT and members of the FGFR, PDGFR, and VEGFR families of kinases. 
Ponatinib zavira aktivnost drugih klinično pomembnih kinaz z vrednostmi IC50 pod 20 nM in je pokazal celično aktivnost proti RET, FLT3 in KIT ter članom družin kinaz FGFR, PDGFR in VEGFR.
For every BCR-ABL mutation detected in more than one CP-CML patient at entry, a MCyR was achieved following treatment with Iclusig. 
Za vsako mutacijo BCR-ABL, odkrito pri več kot enem bolniku s CP-KML ob vstopu, je bil po zdravljenju z zdravilom Iclusig dosežen MCyR.
In addition, the pharmacokinetic-pharmacodynamic models show no exposure-effect relationship, with an estimated QTcF mean change of -6.4 ms (upper confidence interval -0.9 ms) at Cmax for the 60 mg group. 
Poleg tega farmakokinetični-farmakodinamični modeli ne kažejo na povezavo med izpostavljenostjo in učinkom, z ocenjeno povprečno spremembo QTcF za -6,4 ms (zgornji interval zaupanja -0,9 ms) pri Cmax za skupino, ki je prejemala 60 mg.
Neutropenia (ANC decreased) 
Nevtropenija (zmanjšanje ANC)
• uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris) 
• nelagodno tiščanje, občutek polnosti, stiskanje ali bolečina v sredini prsnega koša (angina pektoris)
In order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR in patients with CP-CML, the MAH should conduct and submit the results of a doseranging study. 
Za določitev optimalnega začetnega odmerka zdravila Iclusig in karakterizacijo varnosti in učinkovitosti zdravila Iclusig po zmanjšanju odmerka po doseženem MCyR pri bolnikih s CP-KML, bo imetnik dovoljenja za promet z zdravilom izvedel in predložil rezultate študije o razponu odmerka.
Other medicines and Iclusig 
Druga zdravila in zdravilo Iclusig
An integrated population pharmacokinetic analysis completed for ponatinib suggests that age may be predictive of variability for ponatinib apparent oral clearance (CL/F). 
Integrirana analiza populacijske farmakokinetike, opravljena za ponatinib, kaže, da starost lahko napoveduje spremenljivost navideznega peroralnega očistka ponatiniba (CL/F).
• breathing difficulties 
• težave z dihanjem
• chest pain not in connection with the heart 
• bolečine v prsnem košu, ki niso povezane s srcem
Overall, 55% of patients had one or more BCR-ABL kinase domain mutation at entry with the most frequent being: T315I (29%), F317L (8%), E255K (4%) and E359V (4%). 
Skupaj je imelo 55 % bolnikov eno ali več mutacij domene kinaze BCR-ABL ob vstopu, pri čemer so bile najpogostejše: T315I (29 %), F317L (8 %), E255K (4 %) in E359V (4 %).
• pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels. 
• pravastatin, rosuvastatin: zdravila za zniževanje zvišanih ravni holesterola
The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients and no clinically significant QT prolongation was observed (see section 5.1). 
Možnost za podaljšanje intervala QT zdravila Iclusig so ocenili pri 39 bolnikih z levkemijo, pri čemer niso opazili pomembnega podaljšanja intervala QT (glejte poglavje 5.1).
Iclusig should be used during pregnancy only when clearly necessary. 
Zdravilo Iclusig je dovoljeno med nosečnostjo uporabljati le, če je to nujno potrebno.
Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 D-93055 Regensburg Germany 
Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 D-93055 Regensburg Nemčija
Maintained MCyR 
Vzdrževan MCyR
The Marketing Authorisation Holder shall ensure that in each Member State where ICLUSIG is marketed all physicians who are expected to prescribe ICLUSIG are provided with the Healthcare Professional 
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo v vsaki državi članici, v kateri se trži zdravilo ICLUSIG, vsi zdravniki, za katere se pričakuje, da bodo zdravilo ICLUSIG predpisovali,
Do not take Iclusig • if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na ponatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• carbamazepine: a medicine to treat epilepsy, euphoric/depressive stages and certain pain conditions. 
• karbamazepin: zdravilo za zdravljenje epilepsije, evforičnih/depresivnih faz in določenih bolečin
Compared to healthy volunteers with normal liver function, no major differences in ponatinib PK were observed in patients with varying degrees of hepatic impairment. 
V primerjavi z zdravimi prostovoljci z normalnim delovanjem jeter niso opazili bistvenih razlik v FK ponatiniba pri bolnikih z različnimi stopnjami okvare jeter.
Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase 
Preglednica 2 Prilagajanje odmerka pri pankreatitisu in zvišani ravni lipaze/amilaze Pankreatitis 2. stopnje in/ali asimptomatsko zvišanje ravni lipaze/amilaze
The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is ongoing. 
Protilevkemična aktivnost zdravila Iclusig je bila ocenjena tudi v študiji 1. faze s povečevanjem odmerka, v katero je bilo vključenih 65 bolnikov s KML in Ph+ ALL; študija še poteka.
At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥50% reduction of CRKL phosphorylation, a biomarker of BCR-ABL inhibition, in peripheral blood mononuclear cells. 
Pri odmerkih 15 mg ali več se je pri 32 od 34 bolnikov (94 %) pokazalo ≥ 50 % zmanjšanje fosforilacije encima CRKL, biomarkerja zaviranja BCR-ABL, v periferni krvi mononuklearnih celic.