natgillin/translations-raw huggingface dataset:
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. 
Neželene učinke, opisane v tem poglavju, so opredelili v odprtem, mednarodnem, multicentričnem preskušanju z eno skupino s 449 bolniki s KML in Ph+ ALL, ki se na predhodno zdravljenje s TKI niso odzivali ali ga niso prenašali, vključno s tistimi z mutacijo BCR-ABL T315I.
Women of childbearing potential/Contraception in males and females Women of childbearing age being treated with Iclusig should be advised not to become pregnant and men being treated with Iclusig should be advised not to father a child during treatment. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženskam v rodni dobi, ki se zdravijo z zdravilom Iclusig, je treba svetovati, da naj v času zdravljenja z zdravilom Iclusig ne zanosijo, moškim pa, da naj v času zdravljenja z zdravilom Iclusig ne zaplodijo otroka.
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 formalna priporočila glede spreminjanja odmerkov v odsotnosti neželenega dogodka, kot strategijo za zmanjšanje tveganj, je potrebnih več podatkov o vzdrževanju odgovora (glejte poglavji 4.2 in 4.4).
Patients aged 65 and over are more likely to be affected by side effects. 
Pri bolnikih, starih 65 let in več, je bolj verjetno, da se bodo pojavili neželeni učinki.
Following single and multiple 45 mg doses of Iclusig, the terminal elimination half-life of ponatinib was 22 hours, and steady state conditions are typically achieved within 1 week of continuous dosing. 
Po enkratnem in večkratnih odmerkih 45 mg zdravila Iclusig je bil končni razpolovni čas ponatiniba 22 ur, stanje dinamičnega ravnovesja pa je bilo običajno doseženo v 1 tednu od začetka stalnega odmerjanja.
Pancreatitis and serum lipase 
Pankreatitis in serumska lipaza
The recommended starting dose is one 45 mg film-coated tablet once daily. 
Priporočeni začetni odmerek je ena 45 mg filmsko obložena tableta enkrat na dan.
Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled (see section 4.2). 
Zdravljenje z zdravilom Iclusig je treba začasno prekiniti, če hipertenzija ni pod zdravniškim nadzorom (glejte poglavje 4.2).
Overall (N=83) 
Skupaj (N = 83)
You should take special care when driving and using machines as patients taking Iclusig may experience visual disturbance, dizziness, sleepiness, and tiredness. 
Pri vožnji ali upravljanju strojev bodite posebno pozorni, saj se lahko pri bolnikih, ki jemljejo zdravilo Iclusig, pojavijo motnje vida, omotica, zaspanost in utrujenost.
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. 
Sočasni uporabi močnih induktorjev CYP3A4, kot so karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin in šentjanževka s ponatinibom se je treba izogniti in poiskati alternative induktorju CYP3A4, razen če so koristi večje od možnega tveganja za premajhno izpostavljenost ponatinibu.
Occurrence at 45 mg: 
Pojav pri 45 mg:
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. 
Bolnike so dodelili v eno od šestih kohort na podlagi faze bolezni (CP-KML; AP-KML ali BP-KML/Ph+ ALL), odpornost ali neprenašanje (O/N) dasatiniba ali nilotiniba in prisotnost mutacije T315I.
• digoxin: a medicine to treat heart weakness. 
• digoksin: zdravilo za zdravljenje šibkega srca
Overall (N=62) 
Skupaj (N = 62)
- increased levels of the serum proteins lipase or amylase. 
- zvišane ravni serumskih beljakovin lipaze ali amilaze
• liver damage, jaundice (symptoms include: yellowing of the skin and eyes) 
• poškodba jeter, zlatenica (simptomi vključujejo: porumenelost kože in oči)
• stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations) 
• možganska kap (simptomi vključujejo težave z govorom ali premikanjem, zaspanost, migreno, nenormalne občutke)
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-∞. 
Sočasna uporaba zdravila Iclusig z močnimi zaviralci izločanja želodčne kisline je povzročila manjše zmanjšanje Cmax ponatiniba in nobenega zmanjšanja AUC0-∞.
This medicinal product contains lactose monohydrate. 
To zdravilo vsebuje laktozo monohidrat.
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. 
Varnost in učinkovitost zdravila Iclusig pri bolnikih s KML in Ph+ ALL, ki so bili na predhodno zdravljenje z zaviralci tirozin-kinaze (TKI, tyrosine kinase inhibitor) odporni ali ga niso prenašali, so ocenili v odprtem, mednarodnem multicentričnem preskušanju z eno skupino.
Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and anaemia. 
Zdravilo Iclusig je povezano s hudo (3. ali 4. stopnje po Poenotenih kriterijih za neželene učinke Nacionalnega inštituta za raka) trombocitopenijo, nevtropenijo in anemijo.
Ponatinib is mainly eliminated via faeces. 
Ponatinib se v glavnem izloča z blatom.
• palpitation 
• palpitacije
Of 43 CP-CML patients, 31 CP-CML patients achieved a MCyR with a median duration of follow-up of 25.3 months (range: 1.7 to 38.4 months). 
Med 43 bolniki s CP-KML je 31 bolnikov s CP-KML doseglo MCyR z mediano trajanja spremljanja 25,3 mesece (razpon: 1,7 do 38,4 mesecev).
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. 
Pri bolnikih z zmerno do hudo okvaro jeter sta bila Cmax in AUC0-∞ ponatiniba manjša, razpolovni čas izločanja ponatiniba iz plazme pa je bil daljši pri bolnikih z blago, zmerno in hudo okvaro jeter, vendar ni bil klinično pomembno drugačen kot pri zdravih prostovoljcih z normalnim delovanjem jeter.
Grade 4 pancreatitis 
Pankreatitis 4. stopnje
Iclusig therapy should be prescribed by a doctor experienced in leukaemia treatment. 
Zdravljenje z zdravilom Iclusig mora predpisati zdravnik z izkušnjami v zdravljenju levkemije.
During Iclusig treatment, blood pressure should be monitored and managed at each clinic visit and hypertension should be treated to normal. 
Med zdravljenjem z zdravilom Iclusig je treba ob vsakem obisku zdravnika spremljati krvni tlak in zdraviti hipertenzijo, da se vrne na normalno raven.
Within the range of clinically relevant doses evaluated in patients (15 mg to 60 mg), ponatinib exhibited dose proportional increases in both Cmax and AUC. 
V klinično pomembnem razponu odmerkov, ki so ga ocenili pri bolnikih (15 mg do 60 mg), je ponatinib pokazal zvišanja Cmax in AUC, sorazmerna z odmerkom.
Table 4 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥2% of patients in any disease group Laboratory Test 
stopnje* pri ≥ 2 % bolnikov v vsaki skupini bolezni Laboratorijski test
• narrowing of the arteries in the brain 
• zoženje arterij v možganih
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). 
Pri bolnikih s CP-KML, ki so dosegli MCyR, je bila mediana časa do MCyR 84 dni (razpon: 49 do 334 dni), pri bolnikih, ki so dosegli MMR, pa je bila mediana časa do MMR 167 dni (razpon: 55 do 421 dni).
At doses of 30 mg or greater plasma steady state trough concentrations of ponatinib typically exceed 21 ng/mL (40 nM). 
Pri odmerkih 30 mg ali več je koncentracija ponatiniba v stanju dinamičnega ravnovesja običajno presegla 21 ng/ml (40 nM).
AP-CML (N=85) 
AP-KML (N = 85)
• increased blood sugar or uric acid levels in the blood, high blood fat values of triglycerides 
• zvišane ravni sladkorja ali sečne kisline v krvi, visoke vrednosti maščob (trigliceridov) v krvi
If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2). 
Če zvišanje ravni lipaz spremljajo abdominalni simptomi, je treba z uporabo zdravila Iclusig prenehati in preveriti, ali ima bolnik pankreatitis (glejte poglavje 4.2).
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. 
Študije in vitro kažejo, da ni verjetno, da bi se pojavilo klinično medsebojno delovanje med zdravili kot posledica zaviranja presnove substratov za CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A ali CYP2D6, pri kateri posreduje ponatinib.
ARIAD Pharma Ltd. 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM ARIAD Pharma Ltd.
• lung infection, blood infection, inflammation of hair follicles 
• okužba pljuč, okužba krvi, vnetje lasnih foliklov
• a liver or pancreas disorder or reduced kidney function. 
• bolezen jeter ali trebušne slinavke ali zmanjšano delovanje ledvic.
CP-CML patients who received fewer prior TKIs attained higher cytogenetic, haematological, and molecular responses. 
Bolniki s CP-KML, ki so se predhodno zdravili s TKI, so dosegali višje citogenetske, hematološke in molekularne odgovore.
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. 
Stopnje pojavnosti neželenih učinkov zaradi zdravljenja, zaradi katerih je bilo treba zdravljenje prekiniti, so bile 14 % za CP-KML, 7 % za AP-KML in 4 % za BP-KML/Ph+ ALL.
• night sweats, increased sweating 
• nočno potenje, povečano potenje
High density polyethylene (HDPE) bottles with screw-top closures, containing either 60 or 180 film-coated tablets, together with one plastic canister containing molecular sieve desiccant. 
Plastenke iz polietilena visoke gostote (HDPE) z navojno zaporko, ki vsebujejo 60 ali 180 filmsko obloženih tablet, skupaj s plastično posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
No clinically significant changes in the mean QTc interval (i.e., > 20 ms) from baseline were detected in the study. 
V študiji niso ugotovili klinično pomembnih sprememb povprečnega intervala QTc (tj. > 20 ms) glede na izhodišče.
• a complete blood count This will be repeated every 2 weeks for the first 3 months after starting the therapy. 
• opravil pregled celotne krvne slike Prve 3 mesece po uvedbi zdravljenja se bo ta preiskava ponavljala vsaka 2 tedna.
Overall arterial and venous occlusive adverse reactions have occurred in 23% of Iclusig-treated patients from the phase 2 trial, with serious adverse reactions occurring in 18% of patients. 
Splošni arterijski in venski okluzivni neželeni dogodki so se pojavili pri 23 % bolnikov, zdravljenih z zdravilom Iclusig v preskušanju 2. faze, pri čemer so se resin neželeni učinki pojavili pri 18 % bolnikov.
Table 3 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class 
Preglednica 3 Neželeni učinki, ki so jih opazili pri bolnikih s KML in Ph+ ALL - pogostnost incidenc glede na poročila o dogodkih Organski sistem
For a dose of 30 mg or 15 mg once daily, 15 mg film-coated tablets are available. 
Za odmerek 30 mg ali 15 mg enkrat na dan so na voljo 15 mg filmsko obložene tablete.
Ponatinib is metabolized to an inactive carboxylic acid by esterases and/or amidases, and metabolized by CYP3A4 to an N-desmethyl metabolite that is 4 times less active than ponatinib. 
Ponatinib se z esterazami in/ali amidazami presnavlja v neaktivno karboksilno kislino, CYP3A4 pa ga presnovi v presnovek N-desmetil, ki je 4-krat manj aktiven kot ponatinib.
Concomitant use of ponatinib with anti-clotting agents should be approached with caution in patients who may be at risk of bleeding events (see “Myelosuppression” and “Haemorrhage”). 
Pri sočasni uporabi ponatiniba z zdravili proti strjevanju je pri bolnikih, pri katerih obstaja tveganje za krvavitev, potrebna previdnost (glejte "Mielosupresija" in "Krvavitev").
Grade 3 pancreatitis 
Pankreatitis 3. stopnje
In vitro, ponatinib is an inhibitor of P-gp and BCRP. 
Ponatinib je in vitro zaviralec P-gp in BCRP.
Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Colloidal anhydrous silica Magnesium stearate 
Jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karboksimetilškrob kolodni brezvodni silicijev dioksid magnezijev stearat
- amylase 
- amilaze
• narrowing of the blood vessels, poor blood circulation 
• zoženje krvnih žil, slab krvni obtok
(95% CI) Completeb (CHR) 
(95 % IZ) Celovitb (CHR)
At therapeutic serum concentrations, ponatinib did not inhibit OATP1B1 or OATP1B3, OCT1 or OCT2, organic anion transporters OAT1 or OAT3, or bile salt export pump (BSEP) in vitro. 
V terapevtskih koncentracijah ponatinib in vitro ni zaviral OATP1B1 ali OATP1B3, OCT1 ali OCT2, organska anionska prenašalca OAT1 ali OAT3 ali črpalke žolčnih soli (BSEP, bile salt export pump).
Myelosuppression was commonly reported in all patient populations. 
Pri vseh skupinah bolnikov so pogosto poročali o mielosupresiji.
Ponatinib Cmax was comparable in patients with mild hepatic impairment and healthy volunteers with normal hepatic function. 
Cmax ponatiniba je bil pri bolnikih z blago okvaro jeter in pri zdravih prostovoljcih z normalnim delovanjem jeter primerljiv.
Each film-coated tablet contains 120 mg of lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 120 mg laktoze monohidrata.
Ponatinib did not adversely affect important developmental parameters in the juvenile toxicity study. 
V študiji juvenilne toksičnosti ponatinib ni neželeno vplival na pomembne razvojne parametre.
• lethargy, migraine 
• otopelost, migrena
It is unknown whether Iclusig is excreted in human milk. 
Ni znano, ali se zdravilo Iclusig izloča v materino mleko pri človeku.
Breast-feeding should be stopped during treatment with Iclusig. 
Z dojenjem je treba med zdravljenjem z zdravilom Iclusig prenehati.
Iclusig has not been studied in patients with renal impairment. 
Zdravila Iclusig niso preučevali pri bolnikih z okvarjenim delovanjem ledvic.
In the case of severe adverse reactions, treatment should be withheld. 
V primeru hudih neželenih učinkov je treba z zdravljenjem začasno prenehati.
Bottles of Iclusig 15 mg contain either 60 or 180 film-coated tablets. 
Plastenke zdravila Iclusig 15 mg vsebujejo 60 ali 180 filmsko obloženih tablet.
• Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): a type of leukaemia involving too many immature white blood cells in the blood and blood forming bone marrow. 
• akutna limfoblastna levkemija s prisotnim kromosomom Philadelphia (Ph+ ALL): vrsta levkemije, ki vključuje preveč nezrelih belih krvnih celic v krvi in krvotvornem kostnem mozgu.
Patients should be advised not to swallow the desiccant canister found in the bottle. 
Bolnikom je treba svetovati, naj posode s sušilnim sredstvom, ki je v plastenki, ne pogoltnejo.
• a heart rhythm disorder, abnormal pulse 
• motnja srčnega ritma, nenormalen srčni utrip
Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase. 
Zdravilo Iclusig lahko zviša ravni ALT, AST, bilirubina in alkalne fosfataze.
It is not known if Iclusig passes into breast milk. 
Ni znano, ali zdravilo Iclusig prehaja v materino mleko.
Bottles of Iclusig 45 mg contain either 30 or 90 film-coated tablets. 
Plastenke zdravila Iclusig 45 mg vsebujejo 30 ali 90 filmsko obloženih tablet.
Achieved MMR at 45 mg (N=63) 
Dosežen MMR pri 45 mg (N=63)
Achieved MCyR at 30 mg (N=45) 
Dosežen MCyR pri 30 mg (N=45)
Men receiving treatment with Iclusig are advised not to father a child during treatment. 
Moškim, ki se zdravijo z zdravilom Iclusig, svetujemo, naj med zdravljenjem ne zaplodijo otroka.
The following medicines can affect or be affected by Iclusig: 
Naslednja zdravila lahko vplivajo na način delovanja zdravila Iclusig ali pa lahko zdravilo Iclusig vpliva na delovanje teh zdravil:
Table 6 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267) 
Preglednica 6 Učinkovitost zdravila Iclusig pri bolnikih s kronično fazo KML, ki so na zdravljenje odporni ali ga ne prenašajo Skupaj (N = 267)
Treatment was interrupted, the events resolved, and Iclusig was restarted at 45 mg, once daily. 
Zdravljenje je bilo prekinjeno, zdravilo Iclusig pa je bilo ponovno uvedeno z odmerkom 45 mg enkrat na dan, ko je dogodek izzvenel.
Table 9 Vascular Occlusive First Adverse Events in CP-CML Patients who Achieved MCyR at 45 mg or 30 mg (data extraction 7 April 2014) Most Recent Dose at Onset of First Vascular Occlusive Event 
Preglednica 9 Vaskularni okluzivni prvi neželeni učinki pri bolnikih s CP-KML, ki so dosegli MCyR pri 45 mg ali 30 mg (ekstrakcija podatkov 7. aprila 2014) Zadnji odmerek pri začetku prvega vaskularnega okluzivnega dogodka
• 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 strdek v globokih venah, nenadna zapora ven, krvni strdek v krvni žili pljuč (simptomi vključujejo vročinske valove, zardevanje, pordelost obraza, težave z dihanjem)
Caution should be exercised with concurrent use of Iclusig and moderate and strong CYP3A inhibitors and moderate and strong CYP3A inducers (see section 4.5). 
Pri sočasni uporabi zdravila Iclusig in zmernimi in močnimi zaviralci CYP3A ter zmernimi in močnimi induktorji CYP3A je potrebna previdnost(glejte poglavje 4.5).
Blast Phase CML 
KML v blastni fazi
Iclusig with food and drink Avoid grapefruit products such as grapefruit juice. 
Ne uporabljajte izdelkov iz grenivke, kot je na primer sok grenivke.
CP-CML patients who experienced a loss of response or development of a kinase domain mutation in the absence of a complete cytogenetic response or progression to AP-CML or BP-CML at any time on dasatinib or nilotinib were also considered resistant. 
Bolniki s CP-KML z izgubo odgovora, z razvojem mutacije domene kinaze v odsotnosti celovitega citogenetskega odgovora ali z napredovanjem do AP-KML ali BP-KML kadar koli v času prejemanja dasatiniba ali nilotiniba so bili prav tako obravnavani kot odporni.
Intolerance was defined as the discontinuation of dasatinib or nilotinib due to toxicities despite optimal management in the absence of a complete cytogenetic response for CP CML patients or major haematological response for AP CML, BP CML, or Ph+ ALL patients. 
Neprenašanje so opredelili kot prekinitev uporabe dasatiniba ali nilotiniba zaradi toksičnosti kljub optimalni obravnavi, v odsotnosti celovitega citogenetskega odgovora pri bolnikih CP KML ali bistvenega hematološkega odgovora pri bolnikih z AP KML, BP KML ali Ph+ ALL.
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. 
Med bolniki s CP-KML, predhodno zdravljenimi z enim, dvema ali tremi TKI, jih je med uporabo zdravila Iclusig MCyR doseglo 81 % (13/16) oz. 61 % (65/105) oz. 46 % (66/143).
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 povezane mikroskopske izsledke na jajčnikih (vključno z atrezijo foliklov) in modih (minimalna degeneracija zarodnih celic) pri živalih, ki so dobivale 5 mg/kg ponatiniba, so opazili v študiji toksičnosti pri ponavljajočih se odmerkih pri opicah cynomolgus.
For patients whose adverse reactions are resolved or attenuated in severity, Iclusig may be restarted and escalation of the dose back to the daily dose used prior to the adverse reaction may be considered, if clinically appropriate. 
Pri bolnikih, pri katerih neželeni učinki izzvenijo ali se njihova resnost zmanjša, se lahko zdravljenje z zdravilom Iclusig nadaljuje in če je klinično ustrezno, se lahko odmerek stopnjuje nazaj do dnevnega odmerka, doseženega pred neželenim učinkom.
The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL. 
Incidenca resnih krvavitev je bila večja pri bolnikih z AP-KML, BP-KML in Ph+ ALL.
Caution is recommended in when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min or end-stage renal disease (see section 4.2). 
Previdnost se priporoča pri dajanju zdravila Iclusig bolnikom z ocenjenim očistkom kreatinina < 50 ml/min ali ledvično boleznijo v zadnjem stadiju (glejte poglavje 4.2).
A break in treatment or a decrease in dose may be required when lipase is increased. 
Pri zvišanju lipaze bo morda treba zdravljenje prekiniti ali zmanjšati odmerek.
For all patients in the phase 2 trial, the dose intensity-safety relationship indicated that there are significant increases in grade ≥ 3 adverse events (cardiac failure, arterial thrombosis, hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression) over the dose range of 15 to 45 mg once-daily. 
Za vse bolnike v preskušanju 2. faze razmerje med intenzivnostjo odmerjanja in varnostjo kaže, da v razponu odmerkov od 15 do 45 mg enkrat na dan obstaja značilno povečanje neželenih učinkov stopnje ≥ 3 (srčno popuščanje, arterijska tromboza, hipertenzija, trombocitopenija, pankreatitis, nevtropenija, izpuščaj, povečanje vrednosti ALT, povečanje vrednosti AST, povečanje vrednosti lipaze, mielosupresija).
• you develop heart or blood vessel problems. 
• se pojavijo težave s srcem ali krvnimi žilami
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. 
Študija in vitro s človeškimi hepatociti kaže, da ni verjetno, da bi se pojavilo klinično medsebojno delovanje med zdravili kot posledica indukcije presnove substratov za CYP1A2, CYP2B6 ali CYP3A, pri kateri posreduje ponatinib.
Table 10 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 7 April 2014) Achieved MCyR at 45 mg (N=87) 
Preglednica 10 Vzdrževanje odgovora pri bolnikih s CP-KML, ki so dosegli MCyR ali MMR pri odmerku 45 mg (ekstrakcija podatkov 7. aprila 2014) Dosežen MCyR pri 45 mg (N=87)
• pain in muscles, skeletal system, neck or chest 
• bolečine v mišicah, kosteh, vratu ali prsnem košu
The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 21 days (range: 12 to 176 days), 29 days (range: 12 to 113 days), and 20 days (range: 11 to 168 days), respectively. 
Mediana časa do MaHR pri bolnikih z AP-KML, BP-KML in Ph+ ALL je bila 21 dni (razpon: 12 do 176 dni), 29 dni (razpon: 12 do 113 dni) oz. 20 dni (razpon: 11 do 168 dni).
Haematologic support such as platelet transfusion and haematopoietic growth factors can be used during treatment if clinically indicated. 
Med zdravljenjem se lahko bolniku nudi hematološka podpora v obliki transfuzije trombocitov in hematopoetskega rastnega faktorja, če je to klinično indicirano.
• blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs) 
• težave s krvnim obtokom (simptomi vključujejo bolečino v rokah ali nogah, hladnost oddaljenih delov udov)