natgillin/translations-raw huggingface dataset:
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs. 31.6%, respectively). 
Stalna svakodnevna izloženost imatinibu u ranoj fazi liječenja u kombinaciji s kemoterapijom dovela je u bolesnika iz kohorte 5 (n=50) do poboljšanja stope 4-godišnjeg preživljavanja bez događaja (EFS) u usporedbi s bolesnicima iz kontrolne kohorte (n=120), koji su primali standardnu kemoterapiju bez imatiniba (69,6% u odnosu na 31,6%).
The safety database for children with Ph+ALL is very limited though no new safety concerns have been identified. 
vrlo je ograničena iako nisu uočena nikakva nova sigurnosna pitanja.
For doses of 400 mg and above (see dosage recommendation above) a 400 mg tablet (not divisible) is available. 
Za doze od 400 mg i više (vidi niže navedenu preporuku doziranja) dostupna je tableta od 400 mg (koja se ne može podijeliti).
NEL Same criteria as for CHR but ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, 
NEL Isti kriteriji kao i za CHR, ali je ABN ≥1 x 109/l i/ili trombociti ≥20 x 109/l RTC <15% blasta u KS i PK, <30% blasta+promijelocita u KS i PK, <20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri.
Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation. 
Pozitivni su genotoksični učinci dobiveni za imatinib u in vitro testu na stanicama sisavca (jajnik kineskog hrčka) na klastogenost (aberacija kromosoma) u prisutnosti metaboličke aktivacije.
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 120 film-coated tablets 180 film-coated tablets 
10 filmom obloženih tableta 20 filmom obloženih tableta 30 filmom obloženih tableta 60 filmom obloženih tableta 90 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta
In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. 
Učinkovitost imatiniba u odraslih i pedijatrijskih bolesnika temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez napredovanja bolesti u bolesnika sa KML-om, na hematološkim i citogenetskim stopama odgovora u bolesnika s Ph+ ALL-om i MDS/MPD-om, na hematološkim stopama odgovora u bolesnika s HES/KEL-om i na objektivnim stopama odgovora u odraslih bolesnika s inoperabilnim i/ili metastazirajućim DFSP-om.
The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day. 
Bubrežni adenom/karcinom, papilom mokraćnog mjehura i uretre, adenokarcinomi tankog crijeva, adenomi paratireoidnih žlijezda, dobroćudni i zloćudni medularni tumori nadbubrežnih žlijezda i papilomi/karcinomi nežljezdanog dijela želuca zabilježeni su uz 60 mg/kg/dan, što odgovara otprilike 1,7 odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 1,2 puta dnevne izloženosti u djece (temeljeno na AUC) kod 340 mg/m2/dan.
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events. 
Imatinib je također inhibitor receptorskih tirozin kinaza za faktor rasta koji potječe od trombocita (PDGF), PDGF-R, te inhibira stanične događaje do kojih dolazi posredstvom PDGF-a.
MESNA IV days 29-33 
MESNA i.v., dani 29-33
What Imatinib Actavis contains 
Što Imatinib Actavis sadrži
For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice. 
Bolesnicima koji ne mogu progutati filmom obložene tablete, sadržaj tablete se može otopiti u čaši obične vode ili soka od jabuke.
Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5. 
Pokazalo se da je imatinib in vitro kompetitivni inhibitor supstrata markera za CYP2C9, CYP2D6 i
Each film-coated tablet contains 0.19 mg lecithin (soya) (E322) Imatinib Actavis 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate). 
Svaka filmom obložena tableta sadrži 0,19 mg sojinog lecitina (E322) Imatinib Actavis 400 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
Pack containing either 10, 30, 60, or 90 capsules. 
Pakiranje sadrži 10, 30, 60 ili 90 kapsula.
No new target organs were identified in the rat juvenile development toxicology study (day 10 to 70 postpartum) with respect to the known target organs in adult rats. 
Nisu bili uočeni novi ciljni organi u toksikološkom ispitivanju juvenilnog razvoja u štakora (10 do 70
Hepatitis B reactivation* 
Ponovna aktivacija hepatitisa B *
If you forget to take Imatinib Actavis 
Ako ste zaboravili uzeti Imatinib Actavis
If this applies to you, tell your doctor without taking Imatinib Actavis. 
Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib Actavisa.
This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily. 
Ovo je kliničko ispitivanje uključivalo 7 bolesnika s MDS/MPD-om koji su liječeni imatinibom 400 mg na dan.
A further 6 DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years. 
U 5 objavljenih prikaza slučajeva zabilježeno je dodatnih 6 bolesnika s DFSP-om liječenih imatinibom, s rasponom starosti od 18 mjeseci do 49 godina.
Weight increased 
Povećana tjelesna težina
- Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems). 
- mučnina uz gubitak apetita, tamno obojenje mokraće, žutilo kože ili očiju (znakovi problema s jetrom).
The age of these patients ranged from 2 to 79 years. 
Starost tih bolesnika se kretala od 2 do 79 godina.
In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8). 
U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om zabilježena su i gastrointestinalna i intratumorska krvarenja (vidjeti dio 4.8).
G-CSF (5 μg/kg, SC): days 34-43 
G-CSF (5 μg/kg, s.c.): dani 34-43
L-ASP (6000 IUnits/m2, IM): day 44 
L-ASP (6000 IU/m2, i.m.): dan 44
Haemolytic anaemia, thrombotic microangiopathy 
Hemolitička anemija, trombotična mikroangiopatija
Very common (may affect more than 1 in 10 people): - Headache or feeling tired. 
Vrlo česte (mogu se javiti u više od 1 na 10 osoba): - glavobolja ili umor.
This clinical effect was associated with a higher reduction in bcrabl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02). 
Ovaj klinički učinak povezan je s većim smanjenjem u bcr-abl transkripciji u bolesnika liječenih imatinibom, nego u kraku koji je primao kemoterapiju, nakon 2 tjedna terapije
The suspension should be administered immediately after complete disintegration of the tablet(s). 
Lijek se mora iskoristiti odmah nakon potpunog otapanja tablete.
10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients. 
10 Mišićno-koštana bol i srodni događaji su češće uočeni u bolesnika s KML-om, nego u GIST
If cytopenia persists for 2 weeks, reduce further to 200 mg/m2. 
Ako citopenija ustraje 2 tjedna, dozu dodatno smanjiti na 200 mg/m2.
The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials. 
Sigurnost i djelotvornost imatiniba u djece s MDS/MPD-om, DFSP-om i HES/KEL-om mlađe od 18
DAUN (45 mg/m2/day bolus, IV): days 1 and 2 
DAUN (45 mg/m2/dan bolus, i.v.): dani 1 i 2
The age of these patients ranged from 25 to 72 years. 
Starost tih bolesnika kretala se od 25 do 72 godine.
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction 
Svrbež, edem lica, suhoća kože, eritem, alopecija, noćno znojenje, reakcija preosjetljivosti na svjetlo
The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs. 
AUC imatiniba u plazmi smanjio se za 73% u usporedbi s bolesnicima koji nisu primali antiepileptičke lijekove koji induciraju enzime.
Acute respiratory failure11*, interstitial lung disease* 
Akutno zatajenje disanja11*, intersticijska plućna bolest* Poremećaji probavnog sustava Vrlo često
Paediatric chronic phase CML (at dose 340 mg/m2) 
Pedijatrijska kronična faza KML-a (doza od 340 mg/m2)
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2.).
A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease. 
Opsežno međunarodno otvoreno i nekontrolirano ispitivanje faze II provedeno je u bolesnika s KMLom s pozitivnim Philadelphia (Ph+) kromosomom u fazi blastične krize.
30 hard capsules 90 hard capsules 
30 tvrdih kapsula 90 tvrdih kapsula
For doses other than 400 mg and 800 mg (see dosage recommendation above) a 100 mg divisible tablet is available. 
Za doze, osim 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) dostupna je tableta od 100 mg koja se može prepoloviti
If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg. 
Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 400 mg.
- If you are being treated for HES/CEL: 
- Ako se liječite zbog HES/KEL-a:
F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day. 
F1 fertilnost, dok je pri 45 mg/kg/dan zapažen povećani broj resorpcija i smanjeni broj fetusa sposobnih za život.
The dose can be reduced if not tolerated (see sections 4.2 and 5.2). 
Doza se može smanjiti ako se ne podnosi (vidjeti dijelove 4.2 i 5.2).
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, 
Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis,
The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash. 
Najčešće zabilježene nuspojave (≥10%) koje su povezane s primjenom lijeka, bile su u obje situacije blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
Resume treatment with imatinib at 600 mg. 
Ponovno uvesti liječenje imatinibom u dozi od 600 mg.
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first. 
Unutar svake grupe učestalosti nuspojave su prikazane prema redosljedu učestalosti, najučestalije su prve.
If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m2. 
Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 260 mg/m2.
Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day. 
Papilom/karcinom žlijezde prepucija/klitorisa su zabilježeni pri dozama od 30 mg/kg/dan na više, što odgovara otprilike 0,5, odnosno 0,3 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 0,4 puta dnevne izloženosti u djece (temeljeno na AUC) kod
When and how to take Imatinib Actavis 
Kada i kako uzimati Imatinib Actavis
Induction therapy (de novo Ph+ ALL) 
Indikcijska terapija (de novo Ph+ ALL)
Patients should be advised that they may experience undesirable effects such as dizziness,blurred vision or somnolence during treatment with imatinib. 
Bolesnike treba obavijestiti o postojanju mogućnosti da tijekom liječenja imatinibom nastupe nuspojave poput omaglice, zamagljenog vida ili somnolencije.
Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response. 
Povećanje doze od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s blastičnom krizom može se razmotriti u odsustvu teške nuspojave i teške neutropenije ili trombocitopenije nepovezanih s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
The age of these patients ranged from 20 to 72 years. 
Starost tih bolesnika se kretala od 20 do 72 godine.
11 Ion Mihalache Blvd Bucharest 
S.C. Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd Bucharest
Imatinib Actavis will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours. 
Što morate znati prije nego počnete uzimati Imatinib Actavis Imatinib Actavis Vam može propisati jedino liječnik koji ima iskustva s lijekovima za liječenje raka krvi ili čvrstih tumora.
Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions 
Pustularni osip, kontuzije, pojačano znojenje, urtikarija, ekhimoza, povećana sklonost modricama, hipotrihoza, hipopigmentacija kože, eksfolijativni dermatitis, onihoklazija, folikulitis, petehije, psorijaza, purpura, hiperpigmentacija kože, bulozne erupcije
Metabolism and nutrition disorders 
Poremećaji metabolizma i prehrane Često
10 hard capsules 30 hard capsules 60 hard capsules 90 hard capusles 
10 tvrdih kapsula 30 tvrdih kapsula 60 tvrdih kapsula 90 tvrdih kapsula
6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5. 
6-MP (75 mg/m2/dan, p.o.): dani 11-56 (Uskratiti 6-MP tijekom 6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1-og dana nakon završetka kranijalne iradijacije.)
Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin. 
Slični rezultati su uočeni u bolesnika s malignim gliomima koji su liječeni imatinibom dok su uzimali antiepileptičke lijekove koji induciraju enzime, poput karbamazepina,
There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease. 
U KML bolesnika uočen je veći postotak mijelosupresije, nego u bolesnika s GIST-om, što je vjerojatno uzrokovano osnovnom bolešću.
Patients were treated at doses of imatinib of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5). 
Bolesnici su liječeni dozama imatiniba od 260 mg/m2/dan (n=5), 340 mg/m2/dan (n=9),
Events that have been reported at different dose ranges are as follows: 
Zabilježeni su sljedeći događaji s različitim rasponima doza: Populacija odraslih osoba
- Bruising. 
- modrice.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4). 
U bolesnika u kojih je obavljena tireoidektomija i koji primaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena, kada se imatinib istodobno primjenjuje (vidjeti dio 4.4).
Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations. 
Tvari koje inhibiraju djelovanje CYP3A4 izoenzima citokroma P450 (npr. inhibitori proteaze kao što su indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotici uključujući ketokonazol, itrakonazol, posakonazol, vorikonazol; određeni makrolidi kao što su eritromicin, klaritromicin i telitromicin) mogle bi smanjiti metabolizam i povećati koncentracije imatiniba.
monthly for 13 months; prednisolone 200 mg oral, 5 days per month for 13 months 
VCR 2 mg i.v. mjesečno tijekom 13 mjeseci; prednizolon 200 mg peroralno, 5 dana na mjesec tijekom 13 mjeseci
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach. 
Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra, žlijezda prepucija i klitorisa, tanko crijevo, paratireoidne žlijezde, nadbubrežne žlijezde i ne-žljezdani želudac.
If cytopenia persists for 2 weeks, reduce further to 300 mg. 
Ako citopenija ustraje 2 tjedna, dozu ponovno smanjiti na 300 mg.
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily. 
U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL-om je liječeno imatinibom od 100 mg do 1000 mg na dan.
- If you are being treated for DFSP: 
Ako se liječite zbog DFSP-a:
There is very limited experience in children with MDS/MPD, DFSP, and HES/CEL. 
Postoji vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om i
Maximal plasma concentrations of imatinib in patients are 2-4 μmol/L, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered drugs is possible. 
Maksimalne koncentracije imatiniba u plazmi bolesnika iznose 2-4 μmol/l pa je prema tome moguζa inhibicija metabolizma istodobno primijenjenih lijekova, koji se odvija posredstvom CYP2D6 i/ili CYP3A4/5.
HES/CEL (at dose 400 mg) 
HES/KEL (doza od 400 mg)
Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy. 
Liječenje imatinibom izazvalo je brzi odgovor u novodijagnosticiranih pedijatrijskih KML bolesnika sa CHR-om od 78%
- The active substance is imatinib (as mesilate). 
- Djelatna tvar je imatinib (u obliku imatinibmesilata).
Consolidation therapy 
Konsolidacijska terapija
- Rash. 
- osip.
A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily. 
Dodatnih 162 bolesnika s HES/KEL-om, zabilježenih u 35 objavljenih prikaza slučajeva i serija slučajeva, primalo je imatinib u dozama od 75
- adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. 
- odraslih i pedijatrijskih bolesnika s novodijagnosticiranom akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) uz kemoterapiju.
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemiarelated neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response. 
U djece se mogu razmotriti povećanja doze od 340 mg/m2 na dan do 570 mg/m2 na dan (ne smije se prekoračiti ukupna doza od 800 mg) u odsustvu teške nuspojave i teške neutropenije ili trombocitopenije nepovezanih s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase 
GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
Hyperkalaemia, hypomagnesaemia 
Hiperkalijemija, hipomagnezijemija
- Dry mouth, dry skin or dry eye. - Decreased or increased skin sensitivity. 
- suha usta, suhoća kože ili suho oko. - smanjena ili povećana osjetljivost kože. - navale vrućine, zimica ili noćno znojenje.
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/L) and thrombocytopenias (platelet count < 50 x 109/L) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia). 
4 (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (5964% i 4463% za neutropeniju odnosno trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7% neutropenija i 8,9% trombocitopenija).
In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses ≥ 6 mg/kg in the 13-week study, without changes in serum or urinary parameters. 
U ispitivanju kod štakora koje je trajalo 13 tjedana zapažena je hiperplazija prijelaznog epitela u bubrežnoj papili te u mokraćnom mjehuru uz doze ≥6 mg/kg, bez promjena parametara za serum ili mokraću.
Weight decreased 
Smanjena tjelesna težina
EU/1/13/825/001 30 capsules EU/1/13/825/002 90 capsules 
EU/1/13/825/001 30 kapsula EU/1/13/825/002 90 kapsula
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST. 
1 Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s
No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included over 20% of patients age 65 and older. 
U kliničkim ispitivanjima koja su uključivala preko 20% bolesnika u dobi od 65 godina i više nisu zapažene značajne farmakokinetičke razlike vezane uz dob kod odraslih bolesnika.
- Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision. 
- iscjedak iz oka sa svrbežom, crvenilom ili oteklinom (konjunktivitis), suzne oči ili zamućen vid.
MDS/MPD (starting dose 400 mg) 
MDS/MPD (početna doza