natgillin/translations-raw huggingface dataset:
The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BP-CML/Ph+ ALL than in patients with CP-CML (see Table 4). 
Učestalost stupnja 3 ili 4 trombocitopenije, neutropenije i anemije bila je viša u bolesnika s AP-KML i BP-KML/Ph+ ALL nego u bolesnika s CP-KML (vidjeti tablicu 4).
For a dose of 30 mg or 15 mg once daily, 15 mg film-coated tablets are available. 
Za dozu od 30 mg ili 15 mg jednom dnevno dostupne su filmom obložene tablete od 15 mg.
• phenobarbital, phenytoin: medicines to treat epilepsy. 
• fenobarbital, fenitoin: lijekovi za liječenje epilepsije.
Resistant or Intolerant R/I Cohort (N=10) 
Rezistentan ili intolerantan R/I kohorta (N=10)
Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 3. 
Nuspojave prijavljene kod svih KML i Ph+ ALL bolesnika prikazane su u Tablici
• skin rash, itching, peeling of the skin, redness, bruising, skin pain, hair loss 
• kožni osip, svrbež, ljuštenje kože, crvenilo, nastanak modrica, bol po koži, gubitak kose
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 
Tablica 9 Prvi štetni događaji vaskularne okluzije u bolesnika u kroničnoj fazi KML koji su postigli MCyR pri dozi od 45 mg ili 30 mg (podatci od 7. travnja 2014.) Zadnja doza pri pojavi prvog štetnog događaja vaskularne okluzije
Achieved MCyR at 45 mg (N=87) 
Postignut MCyR pri 45 mg (N=87)
• liver damage, jaundice (symptoms include: yellowing of the skin and eyes) 
• oštećenje jetre, žutica (simptomi uključuju: žutilo kože i bjeloočnica)
6.6 Special precautions for disposal and other handling Disposal: 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Zbrinjavanje:
No clinically significant changes in the mean QTc interval (i.e., > 20 ms) from baseline were detected in the study. 
Nisu uočene kliničke promjene u prosječnom intervalu QTc (primjerice > 20 ms) od početne vrijednosti.
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). 
Od 43 bolesnika u kroničnoj fazi KML, 31 je postigao MCyR s medijanom praćenja od 25,3 mjeseca (raspon: 1,7 da 38,4 mjeseca).
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. 
Pri terapijskim koncentracijama u serumu ponatinib nije inhibirao OATP1B1 ili OATP1B3, OCT1 ili OCT2 transportere organskih aniona OATP1B1 ili OATP1B3, transportere organskih kationa OCT1 ili OCT2, organskih aniona OAT1 ili OAT3 ili crpku za izbacivanje žučne soli (BSEP) u in vitro uvjetima.
The blood/plasma ratio of ponatinib is 0.96. 
Omjer ponatiniba u krvi i plazmi iznosio je 0,96.
• clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections. 
• klaritromicin, telitromicin, troleandomicin: lijekovi za liječenje bakterijskih infekcija.
- alanine aminotransferase 
alanin aminotransferaze aspartat aminotransferaze
Each film-coated tablet contains 120 mg of lactose monohydrate. 
Svaka filmom obložena tableta sadrži 120 mg laktoze hidrata.
Vascular occlusive adverse events were more frequent with increasing age and in patients with prior history of ischaemia, hypertension, diabetes, or hyperlipidaemia. 
Štetni događaji vaskularne okluzije bivali su češći s porastom godina i u bolesnika s prethodnom anamnezom ishemije, hipertenzije, dijabetesa, ili hiperlipidemije.
Hyper-/hypoplastic changes of the chondrocytes in the physis were noted in repeat-dose toxicity studies in rats. 
Hiper/hipoplastične promjene hondrocita u hrskavičnim pločama rasta kosti uočene su u studijama ponovljene toksičnosti u štakora.
In cellular assays, ponatinib was able to overcome imatinib, dasatinib, and nilotinib resistance mediated by BCR-ABL kinase domain mutations. 
U kulturama stanica ponatinib je nadvladao rezistenciju na imatinib, dasatinib i nilotinib posredovanu mutacijama u domeni BCR-ABL kinaze.
Common chills, influenza like illness, non-cardiac chest pain, mass, face oedema 
Često zimica, bolest nalik influenci, nekardijalna bol u prsištu, masa, edem lica
Serious vascular occlusion has occurred in patients treated with Iclusig, including cardiovascular, cerebrovascular and peripheral vascular events, and venous thrombotic events. 
U bolesnika liječenih Iclusigom javila se ozbiljna vaskularna okluzija, uključujući kardiovaskularne, cerebrovaskularne i periferne vaskularne događaje, te venske trombotske događaje.
Resistance in CP-CML was defined as failure to achieve either a complete haematological response (by 3 months), a minor cytogenetic response (by 6 months), or a major cytogenetic response (by 12 months) while on dasatinib or nilotinib. 
Rezistencija bolesnika u kroničnoj fazi KML definirana je izostankom postizanja potpunog hematološkog odgovora (do 3 mjeseca), manjeg citogenetičkog odgovora (do 6 mjeseci) ili većeg citogenetičkog odgovora (do 12 mjeseci) za vrijeme liječenja dasatinibom ili nilotinibom.
Dry flaky skin was observed in toxicity studies in rats. 
Suha, ljuskava koža uočena je u studijama toksičnosti u štakora.
• tissue swelling in eyelid or around the eyes, caused by excess fluid 
• oticanje tkiva očnih kapaka ili područja oko očiju, uzrokovano prekomjernim nakupljanjem tekućine
If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2). 
Ako je povišenje lipaza praćeno s abdominalnim simptomima, liječenje lijekom Iclusig se mora obustaviti a bolesnika dodatno dijagnostički obraditi zbog suspektnog pankreatitisa (vidjeti dio 4.2).
• increased blood levels of several liver enzymes called: 
• povišene razine nekoliko jetrenih enzima u krvi:
Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporters OCT-1. 
Ponatinib nije supstrat za polipeptide koji transportiraju humane organske anione OATP1B1, OATP1B3 i OCT-1 i transporter organskih kationa OCT-1.
Caution is recommended when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min, or end-stage renal disease. 
Preporučuje se oprez prilikom primjene lijeka Iclusig bolesnicima s klirensom kreatinina < 50 ml/min ili s terminalnom fazom bubrežnog zatajenja.
Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients (see section 4.8). 
Ozbiljne nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 4,5% bolesnika (vidjeti dio 4.8).
Depletion of lymphoid organs was observed in repeat-dose toxicity studies in rats and cynomolgus monkeys. 
Razaranje limfoidnih organa uočeno je u studijama ponovljene toksičnosti u štakora i makaki majmuna.
Adverse reactions such as lethargy, dizziness, and vision blurred have been associated with Iclusig. 
Nuspojave poput letargije, omaglice i zamagljenog vida povezane su s lijekom Iclusig.
OUTER CARTON AND BOTTLE LABEL 
KUTIJA I NALJEPNICA NA BOCI
• 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. 
• akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ALL): tipa leukemije s previše nezrelih bijelih krvnih stanica u krvi i koštanoj srži, tkivu u kojem nastaju krvne stanice.
• fluid in the thorax (may cause breathing difficulty), nosebleed, difficulty producing voice sounds, 
• tekućina u prsištu (može uzrokovati otežano disanje), krvarenje iz nosa, poteškoće u nastanku glasa, plućna hipertenzija
The secondary efficacy endpoints in CPCML were complete haematological response (CHR) and major molecular response (MMR). 
Sekundarni ishodi za bolesnike u kroničnoj fazi KML bili su kompletni hematološki odgovor i veliki molekularni odgovor (MMR, engl. major molecular response).
• pain in muscles, skeletal system, neck or chest 
• bol u mišićima, kostima, vratu ili prsištu
Occurrence at 45 mg: 
Pojava uz 45 mg:
Periodic safety update reports 
Periodička izvješća o neškodljivosti
A benefit-risk consideration should guide a decision to restart Iclusig therapy (see sections 4.4 and 4.8) after the event is resolved. 
Odluka za ponovno uvođenje terapije Iclusigom mora biti vođena razmatranjem omjera koristi i rizika (vidjeti dio 4.4 i 4.8) nakon povlačenja štetnog događaja.
Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone. 
Istovremena peroralna primjena 15 mg lijeka Iclusig s ketokonazolom (400 mg dnevno), snažnim CYP3A inhibitorom uzrokovala je skromni porast u sistemskoj izloženosti ponatinibu s vrijednostima AUC0-∞ i Cmax ponatiniba koje su bile za 78% odnosno 47% više od onih uočenih kad se ponatinib primjenjivao sam.
Method of use 
Način upotrebe
Monitoring for evidence of thromboembolism and vascular occlusion should be performed and Iclusig should be interrupted immediately in case of vascular occlusion. 
Mora se provoditi praćenje na prisutnost tromboembolije i vaskularne okluzije, a u slučaju vaskularne okluzije liječenje Iclusigom se mora odmah prekinuti.
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. 
Bolesnici u kroničnoj fazi KML koji nisu odgovorili na liječenje ili su razvili mutacije u domeni BCR-ABL kinaze u odsutnosti potpunog citogenetičkog odgovora ili progresije bolesti u ubrzanu ili blastičnu fazu u bilo koje vrijeme liječenja dasatinibom ili nilotinibom također se smatraju rezistentnim.
Iclusig contains lactose 
Iclusig sadrži laktozu
INFORMATION IN BRAILLE Outer Carton: 
16. PODACI NA BRAILLEOVOM PISMU Kutija:
Do not swallow the desiccant canister contained in the bottle. 
Nemojte progutati spremnik sa sredstvom za sušenje koji se nalazi u boci.
• ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections. 
• ketokonazol, itrakonazol, vorikonazol: lijekovi za liječenje gljivičnih infekcija.
Table 7 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML 
Tablica 7 Djelotvornost lijeka Iclusig u bolesnika u uznapredovaloj fazi KML koji su rezistentni ili ne podnose lijek Ubrzana faza KML
Cytogenetic Response Major (MCyR) a 
Citogenetički odgovor Značajni(MCyR) a
This is a long-term treatment. 
Liječenje lijekom Iclusig je dugotrajno.
Common musculoskeletal pain, neck pain, musculoskeletal chest pain 
Često muskuloskeletalna bol, bol u vratu, muskuloskeletalna bol u prsištu
• lung infection, blood infection, inflammation of hair follicles 
• upala pluća, infekcija krvi, upala folikula kose
Following either a high-fat and low-fat meal, plasma ponatinib exposures (Cmax and AUC) were not different versus fasting conditions. 
Izloženosti ponatinibu u plazmi (Cmax i AUC) nakon punomasnog i niskomasnog obroka nisu bile različite u odnosu na uvjete natašte.
Myelosuppression was generally reversible and usually managed by withholding Iclusig temporarily or reducing the dose (see section 4.2). 
Mijelosupresija je obično reverzibilna i najčešće prolazi nakon privremenog prestanka primjene lijeka Inclusig ili nakon smanjenja doze (vidjeti dio
• chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation 
• kroničnom mijeloičnom leukemijom (KML) u kroničnoj, ubrzanoj ili blastičnoj fazi bolesti koji su rezistentni na liječenje dasatinibom ili nilotinibom; koji ne podnose dasatinib ili nilotinib i za koje naknadno liječenje imatinibom nije klinički opravdano; ili koji imaju T315I mutaciju.
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) 
Tablica 10 Održavanje odgovora u bolesnika u kroničnoj fazi KML koji su postigli MCyR ili MMR pri dozi od 45 mg (podatci od 7. travnja 2014.) Postignut MCyR pri 45 mg (N=87)
• fluid retention 
• zadržavanje tekućine
• you develop heart or blood vessel problems. 
• ako se jave problemi sa srcem ili krvnim žilama.
Achieved MMR at 45 mg (N=63) 
Postignut MMR pri 45 mg (N=63)
Grade 3 pancreatitis 
Pankreatitis 3. stupnja
A single dose of 30 mg ponatinib was administered to patients with mild, moderate, or severe hepatic impairment and to healthy volunteers with normal hepatic function. 
Jednokratna doza ponatiniba od 30 mg primijenjena je u bolesnika s blagim, umjerenim, ili teškim oštećenjem jetre i u zdravih dobrovoljaca s normalnom funkcijom jetre.
Resistance in AP-CML and BP-CML/Ph+ ALL was defined as failure to achieve either a major haematological response (AP-CML by 3 months, BP-CML/Ph+ ALL by 1 month), loss of major haematological response (at any time), or development of kinase domain mutation in the absence of a major haematological response while on dasatinib or nilotinib. 
Rezistencija bolesnika u ubrzanoj fazi KML i blastičnoj fazi KML/Ph+ALL definirana je kao neuspjeh u postizanju bilo glavnog hematološkog odgovora (bolesnici u ubrzanoj fazi KML do 3 mjeseca, u blastičnoj fazi KML/Ph+ALL do 1 mjesec), ili kao gubitak glavnog hematološkog odgovora (bilo kada) ili razvoj mutacija u domeni BCR-ABL kinaze u odsutnosti glavnog hematološkog odgovora za vrijeme liječenja dasatinibom ili nilotinibom.
CP-CML patients who received fewer prior TKIs attained higher cytogenetic, haematological, and molecular responses. 
Bolesnici u kroničnoj fazi KML koji su prethodno primali manje TKI terapija postigli su bolji citogenetičke, hematološke i molekularne odgovore.
Recurrence at 15 mg: 
Ponovna pojava uz 15 mg:
Very common insomnia 
Vrlo često nesanica
How to store Iclusig Keep this medicine out of the sight and reach of children. 
Ovaj lijek čuvajte izvan pogleda i dohvata djece.
Peak concentrations of ponatinib are observed approximately 4 hours after oral administration. 
Ponatinib doseže vršnu koncentraciju u plazmi približno četiri sata nakon peroralne primjene.
For the standard dose of 45 mg once daily, a 45 mg film-coated tablet is available. 
Za standardnu dozu od 45 mg jednom dnevno, dostupne su 45 mg filmom obložene tablete.
• blurred vision, dry eye 
• zamagljen vid, suhe oči
High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 or 90 film-coated tablets, together with one plastic canister containing molecular sieve desiccant. 
Bočice od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 30 ili 90 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
Common pneumonia, sepsis, folliculitis 
Često pneumonija, sepsa, folikulitis
• tissue swelling in face caused by excess fluid 
• oticanje tkiva lica uzrokovano prekomjernim nakupljanjem tekućine
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. 
Intolerancija se definira kao prekid liječenja dasatinibom ili nilotinibom zbog toksičnosti unatoč optimalnom liječenju u odsutnosti potpunog citogenetičkog odgovora za bolesnike u kroničnoj fazi ili glavnog hematološkog odgovora za bolesnike u ubrzanoj fazi, blastičnoj fazi ili s ALL.
b CHR: WBC ≤ institutional ULN, ANC ≥1000/mm3, platelets ≥100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils <5% in peripheral blood, No extramedullary involvement (including no hepatomegaly or splenomegaly). 
b CHR: Leukociti ≤ GGN ustanove, ABN ≥1000/mm3, trombociti ≥100,000/mm3, bez blasta ili promijelocita u perifernoj krvi, blasta u koštanoj srži ≤5%, <5% mijelocita plus metamijelocita u perifernoj krvi, bazofila <5% u perifernoj krvi bez uključenosti organa i tkiva van koštane srži (bez hepatomegalije ili splenomegalije).
- gamma-glutamyltransferase 
amilaze alkalne fosfataze gama-glutamiltrasnferaze
Very common side effects (affects more than 1 per 10 users): 
Vrlo česte nuspojave (javljaju se u više od 1 na 10 korisnika):
The trial enrolled 449 patients of which 444 were eligible for analysis: 267 CP-CML patients (R/I Cohort: n=203, T315I Cohort: n=64), 83 AP-CML patients (R/I Cohort: n=65, T315I Cohort: n=18), 62 BP-CML (R/I Cohort: n=38, T315I Cohort: n=24) and 32 Ph+ ALL patients (R/I Cohort: n=10, T315I Cohort: n=22). 
Ispitivanje je uključivalo 449 bolesnika od kojih su 444 bili podobni za analizu: 267 bolesnika u kroničnoj fazi KML (R/I kohorta: n=203, T315I kohorta: N=64) 83 bolesnika u ubrzanoj fazi KML (R/I kohorta: n=65, T315I kohorta: n=18), 62 u blastičnoj fazi KML (R/I kohorta: n=38, T315I
Common peripheral arterial occlusive disease, peripheral ischaemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing 
Često periferna okluzivna arterijska bolest, periferna ishemija, stenoza perifernih arterija, intermitentna klaudikacija, duboka venska tromboza, navale vrućine, naleti crvenila
Ponatinib did not adversely affect important developmental parameters in the juvenile toxicity study. 
U ispitivanjima toksičnosti u mladih štakora ponatinib nije štetno djelovao na važne parametre razvoja.
• pain in bones, joints, back, arms or legs, muscle spasms 
• bolovi u kostima, zglobovima, leđima, rukama ili nogama, grčevi mišića
Dose reduction in CP-CML patients 
Smanjivanje doze u bolesnika u kroničnoj fazi KML
Common cerebrovascular accident, cerebral infarction, neuropathy peripheral, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack 
Često cerebrovaskularni incident, moždani infarkt, periferna neuropatija, letargija, migrena, hiperestezija, hipoestezija, parestezija, tranzitorna ishemijska ataka
Handling: 
Rukovanje:
• upper airway infection 
• infekcija gornjih dišnih putova
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). 
Preporučuje se oprez prilikom primjene lijeka Iclusig bolesnicima s klirensom kreatinina < 50 ml/min ili bolesnicima u terminalnoj fazi bubrežnog zatajenja (vidjeti dio 4.2).
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. 
U ispitivanju faze 2, nuspojave arterijske i venske okluzije javile su se u ukupno 23% bolesnika liječenih Iclusigom, s ozbiljnim nuspojavama koje su se javile u 18% bolesnika.
Iclusig has not been studied in patients with renal impairment. 
Iclusig nije ispitivan kod bolesnika s oštećenjem funkcije bubrega.
Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension 
Često plućna embolija, pleuralni izljev, epistaksa, disfonija, plućna hipertenzija
Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in Iclusig-treated patients. 
U bolesnika liječenih Iclusigom javile su se arterijske i venske tromboze i okluzije, uključujući i infarkt miokarda sa smrtnom posljedicom, moždani udar, stenozu velikih arterija u mozgu, tešku perifernu vaskularnu bolest, te potrebu za hitnim postupkom revaskularizacije.
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. 
Medijan vremena do MaHR za bolesnike u ubrzanoj fazi, blastičnoj fazi i Ph+ ALL bio je 21 dan (raspon: 12 do 176 dana), 29 dana (raspon: 12 do 113 dana) i 20 dana (raspon: 11 do 168 dana).
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. 
Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 60 ili 180 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased 
Često dehidracija, retencija tekućine, hipokalcijemija, hiperglikemija, hiperuricemija, hipofosfatemija, hipertrigliceridemija, hipokalijemija, smanjenje tjelesne težine
Iclusig 45 mg film-coated tablets are approximately 9 mm in diameter with "AP4" on one side. 
Iclusig 45 mg filmom obložene tablete su promjera oko 9 mm s oznakom "AP4" na jednoj strani.
No specific studies have been performed to evaluate the effects of gender, age, race, and body weight on ponatinib pharmacokinetics. 
Intrinzični faktori koji djeluju na farmakokinetiku ponatiniba Nisu provedena ispitivanja za ocjenu utjecaja spola, dobi, rase i tjelesne težine na farmakokinetiku ponatiniba.
Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth 
Često pankreatitis, povišena amilaza u krvi, gastroezofagealna refluksna bolest, stomatitis, dispepsija, distenzija abdomena, nelagoda u abdomenu, suha usta
Substances that may increase ponatinib serum concentrations 
Tvari koje mogu povećati serumske koncentracije ponatiniba
Calcium decreased 
Snižen kalcij
• the number of blood platelets is reduced. 
• ako je smanjen broj krvnih pločica (trombocita).
Very common fatigue, asthenia, oedema peripheral, pyrexia, pain 
Vrlo često umor, astenija, periferni edem, pireksija, bol
Iclusig 15 mg film-coated tablets are approximately 6 mm in diameter with "A5" on one side. 
Iclusig 15 mg filmom obložene tablete su promjera oko 6 mm s oznakom "A5" na jednoj strani.
Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased 
Često zatajenje srca, infarkt miokarda, kongestivno zatajenje srca, bolest koronarnih arterija, angina pectoris, efuzija perikarda, fibrilacija atrija, smanjena ejekcijska frakcija
Duration of use 
Trajanje primjene
Amylase increased 
Povišena amilaza
Substances that may decrease ponatinib serum concentrations 
Tvari koje mogu smanjiti serumske koncentracije ponatiniba
Each film-coated tablet contains 40 mg of lactose monohydrate. 
Svaka filmom obložena tableta sadrži 40 mg laktoze hidrata.
• heart failure (symptoms include: weakness, fatigue, swollen legs) 
• zatajenje srca (simptomi uključuju: slabost, umor, oticanje nogu)
Very common abdominal pain, diarrhoea, vomiting, constipation, nausea, lipase increased 
Vrlo često bol u abdomenu, proljev, povraćanje, konstipacija, mučnina, povišena lipaza
• a history of blood clots in your blood vessels 
• anamnezu krvnih ugrušaka u krvnim žilama
Based on the Kaplan-Meier estimates, 87% (95% CI: [78%-92%]) of CP-CML patients (median duration of treatment: 866 days) who achieved a MCyR and 66% (95% CI: [55%- 75%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 24 months. 
Temeljem Kaplan-Meierovih analiza predviđa se da će 87% (95% CI: [78%-92%]) bolesnika u kroničnoj fazi KML (medijan trajanja liječenja: 866 dana) koji su postigli MCyR i 66% (95% CI: [55%- 75%]) bolesnika u kroničnoj fazi KML koji su postigli MMR održati postignuti odgovor nakon 24 mjeseca.