natgillin/translations-raw huggingface dataset:
A prior MCyR or better (MCyR, MMR, or CMR) to dasatinib or nilotinib was only achieved in 26% patients with CP-CML and a prior MaHR or better (MaHR, MCyR, MMR, or CMR) was only achieved in 21%, and 24% of AP-CML, and BP-CML/Ph+ALL patients, respectively. 
Prethodni MCyR ili bolji (MCyR, MMR ili CMR) odgovor na dasatinib ili nilotinib postignut je samo u 26% bolesnika u kroničnoj fazi KML, a prethodni MaHR ili bolji (MaHR, MCyR, MMR ili CMR) postignut je samo u 21% odnosno u 24% bolesnika u ubrzanoj fazi KML odnosno blastičnoj fazi KML/Ph+ ALL.
In vitro studies suggested that ponatinib is either not a substrate or is a weak substrate for both P-gp and breast cancer resistance protein BCRP. 
In vitro ispitivanja ukazala su da ponatinib nije supstrat ili da je slabi supstrat i za P-gp i za protein rezistencije karcinoma dojke BCRP.
• obstruction of the blood vessels in the eye, visual disturbance 
• začepljenje krvnih žila u oku, poremećaj vida
Iclusig should not be used in patients with a history of myocardial infarction, prior revascularization or stroke, unless the potential benefit of treatment outweighs the potential risk (see sections 4.2 and 4.8). 
Iclusig se ne smije koristiti u bolesnika s anamnezom infarkta miokarda, prethodne revaskularizacije ili moždanog udara, osim ako potencijalna korist ne nadjačava potencijalni rizik (vidjeti dio 4.2 i 4.8).
In the case of severe adverse reactions, treatment should be withheld. 
U slučaju teških nuspojava liječenje treba prekinuti.
For every BCR-ABL mutation detected in more than one CP-CML patient at entry, a MCyR was achieved following treatment with Iclusig. 
Za svaku mutaciju BCR-ABL mutaciju uočenu na početku istraživanja u više od jednog bolesnika u kroničnoj fazi KML, MCyR je postignut nakon liječenja lijekom Iclusig.
ALT=alanine aminotransferase, ANC=absolute neutrophil count, AST=aspartate aminotransferase, Hgb=haemoglobin, WBC=white blood cell count. 
ALT=alanin aminotransferaza, ABN=apsolutni broj neutrofila, AST=aspartat aminotransferaza, Hgb=hemoglobin, Lkc= leukociti.
The adverse reactions described in this section were identified in a single-arm, open-label, international, multicenter trial in 449 CML and Ph+ ALL patients who were resistant or intolerant to prior TKI therapy including those with a BCR-ABL T315I mutation. 
Nuspojave navedene u ovom poglavlju opisane su u otvorenom, međunarodnom, multicentričnom ispitivanju na jednoj skupini u kojem je sudjelovalo 449 bolesnika s KML i Ph+ ALL rezistentnih ili intolerantnih na prethodno liječenje TKI uključujući i bolesnike s mutacijom BCR-ABL T3151.
Co administration of strong CYP3A4 inducers such as carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and St. John's Wort with ponatinib should be avoided, and alternatives to the CYP3A4 inducer should be sought, unless the benefit outweighs the possible risk of ponatinib underexposure. 
Istovremenu primjenu snažnih CYP3A4 induktora kao što su karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin, i gospina trava s ponatinibom treba izbjegavati, te potražiti alternative CYP3A4 induktoru, osim ako su koristi veće od mogućeg rizika smanjene izloženosti ponatinibu.
(95% CI) Completeb (CHR) 
(95% CI) Kompletnib (CHR)
In preclinical mutagenesis studies, 40 nM was determined as the concentration of ponatinib sufficient to inhibit viability of cells expressing all tested BCR-ABL mutants by >50% (including T315I) and suppress the emergence of mutant clones. 
U pretkliničkim ispitivanjima mutagenosti, 40 nM je određeno kao koncentracija ponatiniba koja je dovoljna za inhibiciju više od 50% vijabilnosti stanica koje eksprimiraju sve testirane mutacije BCR-ABL (uključujući T315I) i potiskivanje nadiranja mutantskih klonova.
In rats, inflammatory changes accompanied by increases in neutrophils, monocytes, eosinophils, and fibrinogen levels were found in the preputial and clitoral glands following chronic dosing. 
U štakora su uočene upalne promjene popraćene porastom broja neutrofila, monocita, eozinofila i fibrinogena u žlijezdama prepucija i klitorisa nakon kroničnog doziranja.
Defined as a ≤0.1% ratio of BCR-ABL to ABL transcripts on the International Scale (IS) (ie, ≤0.1% BCR-ABLIS; patients must have the b2a2/b3a2 (p210) transcript), in peripheral blood measured by quantitative reverse transcriptase polymerase chain reaction (qRT PCR). 
Definiran kao omjer ≤0,1% BCR-ABL na ABL prijepise na međunarodnoj ljestvici (IS) (primjerice, ≤0,1% BCR-ABLIS; bolesnici moraju imati prijepis b2a2/b3a2 (p210)), u perifernoj krvi mjeren kvantitativno pomoću reakcije lančane polimeraze (qRT PCR).
The safety and efficacy of Iclusig in CML and Ph+ ALL patients who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy were evaluated in a single-arm, open-label, international, multicenter trial. 
Sigurnost i djelotvornost primjene ponatiniba u bolesnika s KML i Ph+ALL koji su bili rezistentni ili intolerantni na prethodna liječenja inhibitorima tirozin kinaze (TKI) procijenjeni su u otvorenom, međunarodnom, multicentričnom ispitivanju s jednom skupinom bolesnika.
At daily doses of 45 mg, the geometric mean (CV%) apparent steady state volume of distribution is 1101 L (94%) suggesting that ponatinib is extensively distributed in the extravascular space. 
Pri dnevnim dozama od 45 mg geometrijska sredina (CV%) prividnog volumena distribucije u stanju dinamičke ravnoteže je 1101 l (94%) što govori da se ponatinib široko raspodjeljuje u ekstravaskularni prostor.
A reduction of the starting dose of Iclusig in patients with hepatic impairment is not necessary (see sections 4.2 and 4.4). 
Smanjenje početne doze lijeka Iclusig u bolesnika s oštećenjem jetre nije potrebno (vidjeti dijelove 4.2 i 4.4).
• fatigue, accumulation of fluid in arms and/or legs, fever, pain 
• umor, nakupljanje tekućine u rukama i/ili nogama, vrućica, bol
Patients were assigned to one of six cohorts based on disease phase (CP-CML; AP-CML; or BP-CML/Ph+ ALL), resistance or intolerance (R/I) to dasatinib or nilotinib, and the presence of the T315I mutation. 
Bolesnici su dodijeljeni u jednu od 6 kohorti na temelju faze bolesti (KML-kronična faza; KML-ubrzana faza; ili KML-blastična kriza/Ph+ ALL), rezistencija ili intolerancija (R/I) na dasatinib ili nilotinib i na prisutnost mutacije T315I.
Further data on maintenance of response are required in order to make a formal recommendation for dose modifications in the absence of an adverse event as a risk minimisation strategy (see sections 4.2 and 4.4). 
Za formalnu preporuku prilagodbe doze u odsustvu štetnih događaja kao strategije minimizacije rizika potrebni su daljnji podatci o održavanju odgovora (vidjeti dijelove 4.2 i 4.4).
Very common rash, dry skin 
Vrlo često osip, suha koža
The rates of treatment-related adverse events resulting in discontinuation were 14% in CP-CML, 7% in APCML and 4% in BP-CML/Ph+ ALL. 
Stope nuspojava povezanih s liječenjem koje su rezultirale u prekidu liječenja iznosile su 14% u CP-KML, a 7% u AP-KML te 4% u BP-KML/Ph+ALL.
Haematological Response Rate 
Stopa hematološkog odgovora
Lipase increased 
Povišena lipaza
Table 3 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class 
Tablica 3 Nuspojave uočene u KML i Ph+ ALL bolesnika - učestalost prijavljena prema incidenciji događaja izazvanih liječenjem Klasifikacija organskih sustava
Bottles of Iclusig 45 mg contain either 30 or 90 film-coated tablets. 
Boca Iclusiga 45 mg sadrži 30 ili 90 filmom obloženih tableta.
Ponatinib at doses of 3, 10, and 30 mg/kg produced increases in urine output and electrolyte excretions and caused a decrease in gastric emptying in safety pharmacology studies in rats. 
Ponatinib u dozama 3, 10 i 30 mg/kg proizveo je porast u stvaranju mokraće i izlučivanju elektrolita te je uzrokovao smanjenje u pražnjenju želuca u studijama sigurnosne farmakologije u štakora.
Overall (N=83) 
Ukupno (N=83)
• lethargy, migraine 
• letargija, migrena
• breathing difficulties 
• otežano disanje
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%). 
Najčešće mutacije su: T315I (29%), F317L (8%), E255K (4%) i E359V (4%).
Check serum lipase every 2 weeks for the first 2 months and then periodically thereafter. 
Serumsku lipazu treba kontrolirati svaka 2 tjedna tijekom prva 2 mjeseca a zatim periodično.
Effective contraception must be used during treatment. 
Tijekom liječenja potrebno je koristiti djelotvornu kontracepciju.
Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled (see section 4.2). 
Liječenje Iclusigom se mora privremeno prekinuti ako se hipertenzija ne kontrolira lijekovima (vidjeti dio 4.2).
Discontinue Iclusig *IULN = institution upper limit of normal 
Prekid liječenja lijekom Iclusig *IGGN = gornja granica normalnih vrijednosti ustanove
Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4.5%, neutropenia and anaemia <1% each). 
Prekid terapije zbog mijelosupresije nisu bili česti (trombocitopenija 4,5%, neutropenija i anemija <1% svaka).
Of the CP-CML patients previously treated with one, two, or three prior TKIs, 81% (13/16), 61% (65/105), and 46% (66/143) achieved a MCyR while on Iclusig, respectively. 
Od bolesnika u kroničnoj fazi KML koji su prethodno liječeni s jednim, dva ili tri TKI, 81% (13/16), 61% (65/105) odnosno s 46% (66/143) postigli su MCyR dok su se liječili lijekom Iclusig.
Common erectile dysfunction 
Često erektilna disfunkcija
Bottles of Iclusig 15 mg contain either 60 or 180 film-coated tablets. 
Boca Iclusiga 15 mg sadrži 60 ili 180 filmom obloženih tableta.
• low calcium, phosphate or potassium levels in the blood 
• niske razine kalcija, fosfata ili kalija u krvi
ANC* < 1.0 x 109/L or platelet < 50 x 109/L 
ABN* < 1,0 x 109/l ili trombociti < 50 x 109/l
In the phase 2 trial, 87 CP-CML patients achieved MCyR at a dose of 45 mg, 45 CP-CML patients achieved MCyR after a dose reduction to 30 mg, mostly for adverse events. 
U ispitivanju faze 2, 87 bolesnika u kroničnoj fazi KML postiglo je MCyR pri dozi od 45 mg , 45 bolesnika s kroničnom fazom KML postiglo je MCyR nakon smanjenja doze na 30 mg, uglavnom zbog štetnih događaja.
Co-administration of Iclusig with a potent inhibitor of gastric acid secretion resulted in a minor reduction in ponatinib Cmax without a reduction in AUC0-∞. 
Istovremena primjena lijeka Iclusig s jakim inhibitorima izlučivanja želučane kiseline rezultirala je manjim smanjenjem Cmax ponatiniba bez smanjenja AUC0-∞.
In rats, embryo-foetal toxicity in the form of post-implantation loss, reduced foetal body weight, and multiple soft tissue and skeletal alterations were observed at maternal toxic dosages. 
U štakora je embriofetalna toksičnost u obliku propadanja zametka nakon implantacije, smanjenje tjelesne težine fetusa i višestruke izmjene na mekom tkivu i kosturu uočene su pri dozama koje su bile toksične za majku.
Alkaline phosphatase increased 
Povišena alkalna fosfataza
Ponatinib Cmax was comparable in patients with mild hepatic impairment and healthy volunteers with normal hepatic function. 
Cmax ponatiniba bio je sličan u bolesnika s blagim oštećenjem jetre i zdravih dobrovoljaca s normalnom funkcijom jetre.
The recommended starting dose is 45 mg of ponatinib once daily. 
Preporučena početna doza iznosi 45 mg ponatiniba, jednom dnevno.
Patients should be advised not to swallow the desiccant canister found in the bottle. 
Bolesnike treba savjetovati da ne progutaju spremnik sa sredstvom za sušenje koji se nalazi u boci.
Liver function tests should be performed prior to treatment initiation and monitored periodically, as clinically indicated. 
Potrebne su kontrole jetrene funkcije prije uvođenja liječenja i povremeno praćenje, kako je klinički indicirano.
Factors to take into account if considering dose reduction in CP-CML patients who have achieved a MCyR in the absence of an adverse event. 
Čimbenici koje treba uzeti u obzir ako se razmatra smanjenje doze u bolesnika s kroničnom fazom KML koji su postigli MCyR u odsustvu štetnog događaja.
Ponatinib-related microscopic findings in the ovaries (increased follicular atresia) and testes (minimal germ cell degeneration) in animals treated with 5 mg/kg ponatinib were noted in repeat-dose toxicity studies in cynomolgus monkeys. 
S ponatinibom povezani mikroskopski nalazi jajnika (povećana atrezija folikula) i testisa (minimalna degeneracija spolnih stanica) u životinja liječenih s 5 mg/kg ponatiniba uočeni su u studijama toksičnosti ponovljene doze u makaki majmuna.
In cynomolgus monkeys, systolic heart murmurs with no macroscopic or microscopic correlates were noted in individual animals treated with 5 and 45 mg/kg in the single dose toxicity study and at 1, 2.5 and 5 mg/kg in the 4-week repeat-dose toxicity study. 
U makaki majmuna uočeni su sistolički šumovi srca bez makroskopkih ili mikroskopskih povezanosti s pojedinim životinjama liječenih s 5 i 45 mg/kg u studiji toksičnosti pojedinačne doze i u studiji toksičnosti ponovljene doze koja je trajala 4 tjedna i uključivala doze od 1, 2,5 i 5 mg/kg.
Skin changes in the form of crusts, hyperkeratosis, or erythema were observed in toxicity studies in cynomolgus monkeys. 
Kožne promjene u obliku krasta, hiperkeratoze ili eritema uočene su u studijama toksičnosti u makaki majmuna.
Recurrence at 30 mg: 
Ponovna pojava uz 30 mg:
Unchanged ponatinib accounted for 24% and <1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites. 
Nepromijenjeni ponatinib predstavlja 24% i manje od 1% primijenjene doze u fecesu odnosno u mokraći s preostalom doza koju sačinjavaju metaboliti.
Medicinal product interactions 
Interakcije lijekova
Gender, race and body weight were not predictive in explaining ponatinib pharmacokinetic intersubject variability. 
Spol, rasa i tjelesna masa nisu bile predskazujuće u farmakokinetskoj varijabilnosti ponatiniba između ispitanika.
The primary efficacy endpoint in CP-CML was major cytogenetic response (MCyR), which included complete and partial cytogenetic responses (CCyR and PCyR). 
Primarni ishod za bolesnike u kroničnoj fazi KML bio je značajni citogenetički odgovor (MCyR, engl. major cytogenetic response) koji je uključivao kompletni i parcijalni citogenetički odgovor (CCyR i PCyR, engl. complete and partial cytogenetic responses).
• methotrexate: a medicine to treat severe joint inflammation (rheumatoid arthritis), cancer and the skin disease psoriasis. 
• metotreksat: lijek za liječenje teške upale zglobova (reumatoidni artritis), karcinoma i kožne bolesti psorijaze.
Iclusig is available in plastic bottles, each containing one canister of molecular sieve desiccant. 
Iclusig je dostupan u plastičnim bocama, od kojih svaka sadrži jedan spremnik s molekularnim sitom kao sredstvom za sušenje.
• insomnia 
• nesanica
Overall (N=62) 
Ukupno (N=62)
• mini stroke, cerebral infarction 
• mali moždani udar, moždani infarkt
Glucose increased 
Povišena glukoza
• a severe side effect occurs, not affecting the blood 
• ako dođe do teških nuspojava koje ne zahvaćaju krv
Common blood bilirubin increased, blood alkaline phosphatase increased, gammaglutamyltransferase increased 
Često povišen bilirubin u krvi, povišena alkalna fosfataza u krvi, povišena gama-glutamil transferaza
• stomach bleeding (symptoms include: stomach pain, vomiting blood) 
• krvarenje iz želuca (simptomi uključuju: bol u želucu, povraćanje krvi)
• blood clot in a deep vein, sudden vein obstruction, blood clot in a blood vessel of the lung (symptoms include: hot flush, flushing, redness of the face, breathing difficulty) 
• krvni ugrušak u dubokim venama, iznenadno začepljenje vena, krvni ugrušak u krvnim žilama pluća (simptomi uključuju: navale vrućine, nalete crvenila, crvenilo lica, otežano disanje)
The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL. 
Incidencija događaja ozbiljnog krvarenja bila je viša u bolesnika s AP-KML, BPKML, i Ph+ ALL.
In CP-CML patients who achieved MCyR, the median time to MCyR was 84 days (range: 49 to 334 days) and in patients who achieved MMR, the median time to MMR was 167 days (range: 55 to 421 days). 
Za bolesnike u kroničnoj fazi KML koji su postigli MCyR medijan vremena do postizanja MCyR iznosio je 84 dana (raspon: 49 do 334 dana), a u bolesnika koji su postigli MMR medijan vremena do postizanja MMR iznosio je 167 dana (raspon: 55 do 421 dana).
Breast-feeding should be stopped during treatment with Iclusig. 
Dojenje treba prekinuti za vrijeme liječenja lijekom Iclusig.
An effective method of contraception should be used during treatment. 
Za vrijeme liječenja potrebno je koristiti učinkovite metode kontracepcije.
• heart problems, problems of the blood vessels in the heart muscle, left sided chest pain, dysfunction of the left heart chamber 
• problemi sa srcem, problemi s krvnim žilama u srčanom mišiću, bol na lijevoj strani prsišta,
Achieved MCyR at 30 mg (N=45) 
Postignut MCyR pri 30 mg (N=45)
Treatment was interrupted, the events resolved, and Iclusig was restarted at 45 mg, once daily. 
Nakon prekida liječenja došlo je do povlačenja opisanih štetnih događaja te je nastavljeno liječenje lijekom Iclusig 45 mg, jednom dnevno.
In patients with moderate or severe hepatic impairment, ponatinib Cmax and AUC0-∞ were lower and ponatinib plasma elimination half-life was longer in patients with mild, moderate, and severe hepatic impairment but not clinically significantly different than in healthy volunteers with normal hepatic function. 
U bolesnika s umjerenim ili teškim oštećenjem jetre, Cmax i AUC0-∞ ponatiniba bili su sniženi a poluvijek eliminacije ponatiniba iz plazme u bolesnika s blagim, umjerenim i teškim oštećenjem jetre bio je dulji ali ne klinički značajno različit od onog u zdravih dobrovoljaca s normalnom funkcijom jetre.
An in vitro study in human hepatocytes indicated that clinical medicinal product interactions are also unlikely to occur as a result of ponatinib-mediated induction of the metabolism of substrates for CYP1A2, CYP2B6, or CYP3A. 
In vitro ispitivanja na humanim hepatocitima ukazuju da kliničke interakcije lijekova također nisu vjerojatne kao rezultat indukcije metabolizma supstrata za CYP1A2, CYP2B6 ili CYP3A posredovane ponatinibom.
Caution is recommended when administering Iclusig to patients with severe hepatic impairment (see section 5.2). 
Preporučuje se oprez prilikom primjene lijeka Iclusig u bolesnika s teškim oštećenjem jetre (vidjeti dio 5.2).
• Consider discontinuing Iclusig 
• Razmotrite prekid liječenja Iclusigom
In vitro studies indicate that clinical medicinal product interactions are unlikely to occur as a result of ponatinib-mediated inhibition of the metabolism of substrates for CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A or CYP2D6. 
In vitro ispitivanja ukazuju da kliničke interakcije lijekova nisu vjerojatne kao rezultat inhibicije metabolizma supstrata enzima CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A ili CYP2D6 koji je posredovan ponatinibom.
• a 45 mg film-coated tablet for the recommended dose. 
• filmom obložene tablete od 45 mg za preporučenu dozu.
This medicinal product contains lactose monohydrate. 
Ovaj lijek sadrži laktozu hidrat.
• circulatory problems in the spleen 
• problemi s cirkulacijom u slezeni
The recommended starting dose is one 45 mg film-coated tablet once daily. 
Preporučena početna doza je jedna filmom obložena tableta od 45 mg jednom dnevno.
With once daily dosing, plasma exposures of ponatinib are increased by approximately 1.5-fold between first dose andsteady state conditions. 
Pri doziranju jednom dnevno izloženost ponatinibu u plazmi povećava se za približno 1,5 puta između prve doze i stanja dinamičke ravnoteže.
• a complete blood count This will be repeated every 2 weeks for the first 3 months after starting the therapy. 
To će se ponavljati svaka 2 tjedna tijekom prva 3 mjeseca nakon početka liječenja.
Dose interruption or reduction may be required. 
Možda će biti potrebno prekinuti liječenje ili smanjiti dozu.
Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and anaemia. 
Liječenje lijekom Iclusig je povezano je s teškom (Opći kriteriji toksičnosti 3. ili 4. stupnja Nacionalnog instituta za karcinome - National Cancer Institute) trombocitopenijom, neutropenijom i anemijom.
How to store Iclusig 
Kako čuvati Iclusig
Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively. 
Ponatinib inhibira aktivnost tirozin kinaze ABL I T315I mutanta ABL s vrijednostima IC50 od 0,4 odnosno 2,0 nM.
The median duration of treatment with Iclusig was 866 days in CP-CML patients, 590 days in AP-CML patients, and 86 days in BP-CML/Ph+ ALL patients. 
Medijan trajanja liječenja bio je 866 dana za bolesnike u kroničnoj fazi (CP-KML), 590 dana za bolesnike u ubrzanoj fazi (AP-KML) i 86 dana za bolesnike u blastičnoj fazi (BP-KML) /Ph+ ALL.
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. 
Prije početka liječenja ponatinibom, mora se ocijeniti kardiovaskularno stanje bolesnika, uključujući povijest bolesti i fizikalni pregled, a kardiovaskularni čimbenici rizika moraju se aktivno zbrinuti.
The frequency of these events is greater in patients with accelerated phase CML (AP-CML) or blast phase CML (BP-CML)/Ph+ ALL than in chronic phase CML (CP-CML). 
Učestalost tih događaja veća je u bolesnika s ubrzanom fazom KML (AP-KML) ili blastičnom fazom KML (BP-KML)/Ph+ ALL nego u kroničnoj fazi KML (CP-KML).
• blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs) 
• problemi s cirkulacijom krvi (simptomi uključuju: bolove u nogama ili rukama, hladnoću na krajevima udova)
Poly(vinyl alcohol) Titanium dioxide (E171) 
Ovojnica tablete talk makrogol 4000 poli(vinilni alkohol) titanijev dioksid (E171)
It is unknown whether Iclusig is excreted in human milk. 
Nije poznato izlučuje li se Iclusig u majčino mlijeko u ljudi.
Grade 4 pancreatitis 
Pankreatitis 4. stupnja
Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities. 
Mijelosupresija je opisana i kod bolesnika koji su na početku liječenja imali uredne laboratorijske nalaze kao i kod bolesnika s već postojećim patološkim laboratorijskim nalazima.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. 
• akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) koji su rezistentni na dasatinib; koji ne podnose dasatinib i za koje naknadno liječenje imatinibom nije klinički opravdano; ili koji imaju T315I mutaciju.
• a 15 mg film-coated tablet to allow for dose adjustments. 
• filmom obložene tablete od 15 mg za prilagođavanje doze.
• sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation. 
• sulfasalazin: lijek za liječenje teške upale crijeva i reumatske upale zglobova.
In 67% of CP-CML patients in the R/I cohort, no mutations were detected at study entry. 
U 67% bolesnika u kroničnoj fazi KML u kohorti R/I nisu uočene mutacije prilikom uključivanja.
• colchicine: a medicine to treat gout attacks. 
• kolhicin: lijek za liječenje napadaja gihta.
Uncommon tumour lysis syndrome 
Manje često sindrom lize tumora
• stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations) 
• moždani udar (simptomi uključuju: otežan govor i pokrete, pospanost, migrenu, abnormalne osjete)
• heartburn caused by reflux of stomach juices, inflammation in the mouth, abdominal swelling or discomfort or indigestion, dry mouth 
• žgaravica uzrokovana povratom sokova iz želuca, upala u ustima, nadutost trbuha ili nelagoda ili probavne tegobe, suha usta