natgillin/translations-raw huggingface dataset:
BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Teva (see section 4.8). 
Inhibitori BCR-ABL tirozin kinaze (TKI-jevi) povezani su s trombotičnom mikroangiopatijom (TMA), uključujući izvješća o pojedinačnom slučaju za Imatinib Teva (vidjeti dio 4.8).
Imatinib in combination with chemotherapy induction (see Table 4) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients). 
Imatinib u kombinaciji s indukcijskom kemoterapijom (vidjeti Tablicu 3) rezultira postizanjem stope kompletnog hematološkog odgovora od 93% (147 od 158 evaluiranih bolesnika) i stope velikog citogenetskog odgovora od 90% (19 od 21 evaluiranog bolesnika).
The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). 
Iskustvo s imatinibom u bolesnika s MDS/MPD-om povezanim s preuredbom gena za PDGFR je vrlo ograničeno (vidjeti dio 5.1).
Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels. 
Mijelodisplastične/mijeloproliferativne bolesti s preuredbom gena za PDGFR mogu biti povezane s visokim razinama eozinofila.
If you forget to take Imatinib Teva - If you forget a dose, take it as soon as you remember. 
Ako ste zaboravili dozu, uzmite ju čim se sjetite.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood). 
• Mišićna slabost i grčevi mišića s abnormalnim srčanim ritmom (znakovi promjena količine kalija u krvi).
• Numb or cold toes and fingers (signs of Raynaud's syndrome). 
• Utrnuli ili hladni prsti na nogama i rukama (znakovi Raynaudovog sindroma).
Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk. 
Ispitivanja u dvije dojilje su otkrila da se i imatinib i njegov djelatni metabolit izlučuju u majčino mlijeko.
• Chest pain, irregular heart rhythm (signs of heart problems). 
• Bolovi u prsima, nepravilan srčani ritam (znakovi srčanih problema).
For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs. 
Za odrasle bolesnike s recidivirajućom ili refraktornom Ph+ ALL, monoterapija imatinibom u dozi od 600 mg/dan je sigurna, učinkovita te se može davati do pojave progresije bolesti.
In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised. 
U Ph+ ALL bolesnika postoji kliničko iskustvo istodobne primjene imatiniba s kemoterapijom (vidjeti dio 5.1), no interakcije lijekova između imatiniba i onih u kemoterapijskim protokolima nisu dobro definirane.
Imatinib is mainly metabolised through the liver. 
Imatinib se većinom metabolizira preko jetre.
2 Headache was the most common in GIST patients. 
2 Glavobolja je bila najčešća u bolesnika s GIST-om.
Patients showing lack of response (lack of complete haematological response (CHR) at 6 months, increasing WBC, no major cytogenetic response (MCyR) at 24 months), loss of response (loss of CHR or MCyR) or severe intolerance to treatment were allowed to cross over to the alternative treatment arm. 
Bolesnicima koji su pokazivali izostanak odgovora (izostanak potpunog hematološkog odgovora (CHR) nakon 6 mjeseci, porast broja leukocita, nikakav veliki citogenetski odgovor (MCyR) nakon 24 mjeseca), gubitak odgovora (gubitak CHR-a ili MCyR-a) ili tešku nepodnošljivost liječenja, odobreno je da prijeđu u drugi terapijski krak.
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study). 
U KML-u, citopenije su, osobito neutropenija i trombocitopenija, bile stalan nalaz u svim ispitivanjima, s naznakom da je učestalost veća uz visoke doze ≥750 mg (ispitivanje faze I).
Patients on imatinib treatment who are concerned about their fertility should consult with their physician. 
Bolesnici koji se liječe imatinibom, a zabrinuti su radi svoje plodnosti, moraju se posavjetovati sa svojim liječnikom.
If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN. 
Ako je povećanje bilirubina >3 x institucionalne gornje granice normale (IGGN), ili jetrenih transaminaza >5 x IGGN, primjenu imatiniba treba ukinuti sve dok se razine bilirubina ne vrate na vrijednost <1,5 x IGGN, a razine transaminaze na vrijednost <2,5 x IGGN.
In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l. 
In vitro, imatinib inhibira paracetamol O-glukuronidaciju s Ki vrijednostiod 58,5 mikromol/l.
Clinical studies in MDS/MPD 
Klinička ispitivanja kod MDS/MPB-a
The tablet is debossed with “IT” and “4” at each side of the score line. 
Oznake “IT” i “4” utisnute su sa svake strane ureza.
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥30 mg/kg/day. 
U 2-godišnjoj studiji kancerogenosti u štakora primjena imatiniba od 15, 30 i 60 mg/kg/dan rezultirala je statistički značajnim smanjenjem dužine života mužjaka uz 60 mg/kg/dan i ženki uz ≥30 mg/kg/dan.
However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML. 
Međutim, pojava ovih citopenija vjerojatno ovisi o stadiju liječene bolesti, a mnogo su češće u bolesnika s ubrzanom fazom KML-a ili blastičnom krizom, u odnosu na bolesnike s kroničnom fazom KML-a.
This Ki value is far higher than the expected plasma levels of imatinib in patients; consequently no interaction is expected upon co-administration of either 5-fluorouracil or paclitaxel and imatinib. 
Ta Ki vrijednost je daleko viša nego što su očekivane razine imatiniba u plazmi bolesnika, pa se prema tome ne očekuje nikakva interakcija nakon istodobne primjene bilo 5-fluorouracila bilo paklitaksela i imatiniba.
Active substances that may increase imatinib plasma concentrations 
Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4). 
U nekim je slučajevima došlo do akutnog zatajenja jetre ili fulminantnog hepatitisa, što je dovelo do transplantacije jetre ili smrtnog ishoda (vidjeti dio 4.4).
Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR). 
Tri bolesnika postigla su kompletni hematološki odgovor (CHR), a jedan bolesnik parcijalni hematološki odgovor
All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response. 
Svi su bolesnici postigli kompletan hematološki odgovor, kompletan citogenetski odgovor i/ili kompletan molekularni odgovor.
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose). 
Na temelju izlučivanja spoja(eva) nakon oralne, 14C-označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
In a 39-week monkey study, no NOAEL (no observed adverse effect level) was established at the lowest dose of 15 mg/kg, approximately one-third the maximum human dose of 800 mg based on body surface. 
U 39-tjednom ispitivanju na majmunima, razina kod koje se ne uočava štetan učinak (NOAEL - no observed adverse effect) nije utvrđen pri najnižoj dozi od 15 mg/kg, koja iznosi približno jednu trećinu maksimalne doze za ljude od 800 mg temeljeno na veličini površine tijela.
If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy. 
Ako je bilo što od navedenog abnormalno, na početku terapije je potrebno razmisliti o profilaktičkoj primjeni sistemskih steroida (1-2 mg/kg) tijekom jednog do dva tjedna istodobno uz imatinib te redovitim kardiološkim kontrolama.
Keep this medicine out of the sight and reach of children. 
Kako čuvati Imatinib Teva Lijek čuvajte izvan pogleda i dohvata djece.
Close monitoring of growth in children under imatinib treatment is recommended (see section 4.8). 
Preporučuje se pažljivo praćenje rasta kod djece koja se liječe imatinibom (vidjeti dio 4.8).
3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML. 
3 Na temelju procjene bolesnik-godina, srčani događaji uključujući kongestivno zatajenje srca su bili češće uočeni u bolesnika s transformiranim KML-om, nego u bolesnika s kroničnim
C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza Spain 
4, Poligono Industrial Malpica, 50016 Zaragoza Španjolska
Study ADE04 Prephase 
Studija ADE04
The diameter of the film-coated tablet is approximately 9 mm. 
Promjer filmom obložene tablete je približno 9 mm.
Partial CyR n (%) 
Djelomični CyR n (%)
The estimated rate of progression-free survival at 84 months was 81.2% in the imatinib arm and 60.6% in the control arm (p<0.001). 
Procijenjena stopa preživljenja bez progresije nakon 84 mjeseca bila je 81,2% u kraku koji je primao imatinib i 60,6% u kontrolnom kraku (p<0,001%).
The percentage of some adverse reactions was higher in the 40 patients in whom the dose was increased to 800 mg daily compared to the population of patients before dose increase (n=551). 
bolesnika u kojih je doza povećana na 800 mg na dan, u usporedbi s populacijom bolesnika prije povećanja doze (n=551).
The tablet is debossed with “IT” and “1” at each side of the score line. 
Oznake “IT” i “1” utisnute su sa svake strane ureza.
After 42 months of follow-up, 11 patients experienced a confirmed loss (within 4 weeks) of their cytogenetic response. 
Nakon 42 mjeseca praćenja, 11 bolesnika doživjelo je potvrđeni gubitak
There is limited information on imatinib distribution on human milk. 
Postoje ograničene informacije o izlučivanju imatiniba u majčino mlijeko.
All patients achieved complete haematological response, cytogenetic response and/or clinical response. 
Svi su bolesnici postigli kompletni hematološki odgovor, citogenetski odgovor i/ili klinički odgovor.
Ara-C 60 mg/m2 i.v., days 22-25, 29-32 
Ara-C 60 mg/m2 i.v., dani 22-25, 29-32
GI tumour sites may have been the source of the GI bleeds (see section 4.4). 
Uzrok GI krvarenja mogle bi biti lokalizacija GI tumora (vidjeti dio 4.4).
Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate. 
Terapiju treba započeti liječnik s iskustvom u liječenju bolesnika s hematološkim zloćudnim bolestima, odnosno malignim sarkomima.
The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib. 
Utvrđeno je da AUC za taj metabolit u plazmi iznosi samo 16%
When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions. 
Kada im je doza dana uz obrok s velikim sadržajem masti, brzina apsorpcije imatiniba se minimalno smanjila (11% smanjenje vrijednosti Cmax i produženje tmax za 1,5 h), uz malo smanjenje AUC vrijednosti (7,4%) u odnosu kada je lijek dan natašte.
Carriers of HBV who require treatment with Imatinib Teva should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8). 
Nositelje virusa HBV kojima je potrebno liječenje Imatinibom Teva potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. 
Osim kod novodijagnosticirane kronične faze KML-a, ne postoje kontrolirana ispitivanja koja demonstriraju kliničku korist, kao što je poboljšanje simptoma povezanih s bolešću ili povećano preživljenje.
Renal toxicity was observed in monkeys treated for 2 weeks, with focal mineralisation and dilation of the renal tubules and tubular nephrosis. 
Nefrotoksičnost je uočena u majmuna koji su liječeni 2 tjedna, uz fokalnu mineralizaciju i dilataciju bubrežnih kanalića i tubularnu nefrozu.
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225). 
Ista publikacija je objavila i podatke dugotrajnog praćenja 12 bolesnika s MDS/MPB-om s preuredbom gena za PDGFR (5 bolesnika iz studije B2225).
There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor). 
U zdravih je ispitanika došlo do značajnog povećanja izloženosti imatinibu (srednji Cmax i AUC imatiniba povećali su se za 26%, odnosno 40%), kada je imatinib primjenjivan istodobno s jednokratnom dozom ketokonazola (inhibitor CYP3A4).
Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose. 
Bolesnici s poremećajem funkcije bubrega ili na dijalizi trebaju primati minimalnu preporučenu dozu od 400 mg na dan kao početnu dozu.
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases. 
Osim kod novodijagnosticirane kronične faze KML-a, ne postoje kontrolirana ispitivanja koja bi demonstrirala kliničku korist ili povećano preživljenje za ove bolesti.
Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening. 
Terapija se može primjenjivati jedanput na dan ili se dnevna doza može podijeliti u dvije primjene - ujutro i navečer.
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 moguća inhibicija metabolizma istodobno primijenjenih lijekova, koji se odvija posredstvom CYP2D6 i/ili CYP3A4/5.
Pregnancy, breast-feeding and fertility - If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001). 
U kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib je kao monoterapija izazvao značajno višu stopu kompletnog hematološkog odgovora od kemoterapije (96,3% u odnosu na 50%; p=0,0001).
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/MPB-om koji su liječeni imatinibom 400 mg na dan.
• Cough, having difficulty breathing or painful breathing (signs of lung problems). 
• Kašalj, otežano disanje ili bolno disanje (znakovi plućnih problema).
The length of the film-coated tablet is approximately 20 mm and the width is approximately 10 mm. 
Duljina filmom obložene tablete je približno 20 mm, a širina je približno 10 mm.
Study AJP01 Induction therapy 
Studija AJP01
Chronic phase, newly diagnosed This phase III study in adult patients compared treatment with either single-agent imatinib or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C). 
U ovom ispitivanju faze III. u odraslih bolesnika uspoređivalo se liječenje ili monoterapijom imatinibom ili kombinacijom interferona-alfa (IFN) plus citarabina (Ara-C).
6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases. 
6400 mg (jednokratna doza): u literaturi je zabilježen jedan slučaj bolesnika s mučninom, povraćanjem, bolovima u trbuhu, vrućicom, oticanjem lica, smanjenim brojem neutrofila, povišenjem vrijednosti transaminaza.
Imatinib Teva is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD). 
Teva se kod odraslih osoba također koristi za liječenje: - Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML. 
Primarna varijabla djelotvornosti bila je stopa hematološkog odgovora, koja je zabilježena bilo kao potpuni hematološki odgovor, bez dokaza leukemije (tj. klirens blasta iz koštane srži i krvi, ali bez potpunog oporavka periferne krvi kao kod potpunih odgovora), ili kao vraćanje na kroničnu fazu KML-a.
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, tablete se mogu dispergirati u čaši obične vode ili soka od jabuke.
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. 
Nije bilo utjecaja na fertilnost F1 potomaka, dok je pri 45 mg/kg/dan zapažen povećani broj resorpcija i smanjeni broj fetusa sposobnih za život.
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 dozu od 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.
A total of 71 (12.8%) and 85 (15.4%) patients died in the imatinib and IFN+Ara-C groups, respectively. 
Ukupno je umro 71 (12,8%) bolesnik iz skupine koja je primala imatinib i 85 (15,4%) bolesnika iz skupine koja je primala IFN+Ara-C.
Imatinib is a protein-tyrosine kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels. 
Imatinib je inhibitor protein-tirozin kinaze koji snažno inhibira Bcr-Abl tirozin kinazu na in vitro, staničnoj te in vivo razini.
Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg) 
Ubrzana faza KML-a i blastična kriza te Ph+ ALL (početna doza
Treatment of CML patients with imatinib has been associated with neutropenia or thrombocytopenia. 
Liječenje imatinibom kod bolesnika s KML-om povezano je s neutropenijom ili trombocitopenijom.
Superficial oedemas were a common finding in all studies and were described primarily as periorbital or lower limb oedemas. 
U svim su ispitivanjima površinski edemi bili čest nalaz, a opisani su u prvome redu kao periorbitalni ili kao edemi donjih ekstremiteta.
30 hard capsules 30x1 hard capsules 90 hard capsules 90x1 hard capsules 
30 tvrdih kapsula 30x1 tvrdih kapsula 90 tvrdih kapsula 90x1 tvrdih kapsula
Imatinib Teva is a medicine containing an active substance called imatinib. 
Teva je lijek koji sadrži djelatnu tvar zvanu imatinib.
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells. 
Supstancija pokazuje in vivo antitumorsko djelovanje kao monoterapija na životinjskim modelima u kojima se koriste Bcr-Abl pozitivne tumorske stanice.
MTX 12 mg intrathecal, day 1 
MTX 12 mg intratekalno, dan 1
ULN = upper limit of normal for the institution AST = aspartate aminotransferase 
Ukupni bilirubin: >3-10 GGN AST: bilo koja vrijednost GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m2/day subcutaneously in combination with subcutaneous Ara-C 20 mg/m2/day for 10 days/month. 
U kraku koji je primao IFN, bolesnici su liječeni ciljanom dozom IFN-a od 5 MIU/m2/dan supkutano u kombinaciji sa supkutanim Ara-C u dozi od 20 mg/m2/dan u trajanju od 10 dana/mjesec.
The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg). 
Razina kod koje se ne uočava učinak (NOEL-no observed effect) i za roditeljske ženke i za F1 generaciju bila je 15 mg/kg/dan (jedna četvrtina maksimalne doze za ljude od 800 mg).
In the event of overdose, the patient should be observed and appropriate supportive treatment given. 
U slučaju predoziranja, potrebno je pratiti bolesnika i provoditi odgovarajuće suportivno liječenje.
Polyvinyl alcohol partially hydrolysed Macrogol 
- Ovojnica tablete sastoji se od polivinilnog alkohola djelomično hidroliziranog, makrogola,
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. 
Genotoksični učinci imatiniba (klastogenost) dobiveni su u in vitro testu na stanicama sisavca (jajnik kineskog hrčka) u prisutnosti metaboličke aktivacije.
• 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.
In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area. 
U ispitivanju fertilnosti, u mužjaka štakora koji su primali lijek tijekom 70 dana prije parenja, smanjila se težina testisa i epididimisa te postotak pokretljivih spermija uz dozu od 60 mg/kg, što je približno jednako maksimalnoj kliničkoj dozi od 800 mg/dan, temeljeno na veličini površine tijela.
The tablets are approximately 9 mm in diameter. 
Tablete su približno 9 mm u promjeru.
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people): 
Manje česte (mogu se javiti kod manje od 1 na 100 ljudi) ili rijetke (mogu se javiti kod manje od 1 na 1000 ljudi):