FrancophonIA/ELRC3.0 huggingface dataset:
English: Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled (see section 4.2).
Croatian: Liječenje Iclusigom se mora privremeno prekinuti ako se hipertenzija ne kontrolira lijekovima (vidjeti dio 4.2).
English: Discontinue Iclusig *IULN = institution upper limit of normal
Croatian: Prekid liječenja lijekom Iclusig *IGGN = gornja granica normalnih vrijednosti ustanove
English: Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4.5%, neutropenia and anaemia <1% each).
Croatian: Prekid terapije zbog mijelosupresije nisu bili česti (trombocitopenija 4,5%, neutropenija i anemija <1% svaka).
English: 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.
Croatian: 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.
English: Common erectile dysfunction
Croatian: Često erektilna disfunkcija
English: Bottles of Iclusig 15 mg contain either 60 or 180 film-coated tablets.
Croatian: Boca Iclusiga 15 mg sadrži 60 ili 180 filmom obloženih tableta.
English: • low calcium, phosphate or potassium levels in the blood
Croatian: • niske razine kalcija, fosfata ili kalija u krvi
English: ANC* < 1.0 x 109/L or platelet < 50 x 109/L
Croatian: ABN* < 1,0 x 109/l ili trombociti < 50 x 109/l
English: 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.
Croatian: 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.
English: 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-∞.
Croatian: Istovremena primjena lijeka Iclusig s jakim inhibitorima izlučivanja želučane kiseline rezultirala je manjim smanjenjem Cmax ponatiniba bez smanjenja AUC0-∞.
English: 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.
Croatian: 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.
English: Alkaline phosphatase increased
Croatian: Povišena alkalna fosfataza
English: Ponatinib Cmax was comparable in patients with mild hepatic impairment and healthy volunteers with normal hepatic function.
Croatian: Cmax ponatiniba bio je sličan u bolesnika s blagim oštećenjem jetre i zdravih dobrovoljaca s normalnom funkcijom jetre.
English: The recommended starting dose is 45 mg of ponatinib once daily.
Croatian: Preporučena početna doza iznosi 45 mg ponatiniba, jednom dnevno.
English: Patients should be advised not to swallow the desiccant canister found in the bottle.
Croatian: Bolesnike treba savjetovati da ne progutaju spremnik sa sredstvom za sušenje koji se nalazi u boci.
English: Liver function tests should be performed prior to treatment initiation and monitored periodically, as clinically indicated.
Croatian: Potrebne su kontrole jetrene funkcije prije uvođenja liječenja i povremeno praćenje, kako je klinički indicirano.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Skin changes in the form of crusts, hyperkeratosis, or erythema were observed in toxicity studies in cynomolgus monkeys.
Croatian: Kožne promjene u obliku krasta, hiperkeratoze ili eritema uočene su u studijama toksičnosti u makaki majmuna.
English: AP-CML (N=85)
Croatian: AP-KML (N=85)
English: Recurrence at 30 mg:
Croatian: Ponovna pojava uz 30 mg:
English: Unchanged ponatinib accounted for 24% and <1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Croatian: Nepromijenjeni ponatinib predstavlja 24% i manje od 1% primijenjene doze u fecesu odnosno u mokraći s preostalom doza koju sačinjavaju metaboliti.
English: Medicinal product interactions
Croatian: Interakcije lijekova
English: Gender, race and body weight were not predictive in explaining ponatinib pharmacokinetic intersubject variability.
Croatian: Spol, rasa i tjelesna masa nisu bile predskazujuće u farmakokinetskoj varijabilnosti ponatiniba između ispitanika.
English: The primary efficacy endpoint in CP-CML was major cytogenetic response (MCyR), which included complete and partial cytogenetic responses (CCyR and PCyR).
Croatian: 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).
English: • methotrexate: a medicine to treat severe joint inflammation (rheumatoid arthritis), cancer and the skin disease psoriasis.
Croatian: • metotreksat: lijek za liječenje teške upale zglobova (reumatoidni artritis), karcinoma i kožne bolesti psorijaze.
English: Iclusig is available in plastic bottles, each containing one canister of molecular sieve desiccant.
Croatian: Iclusig je dostupan u plastičnim bocama, od kojih svaka sadrži jedan spremnik s molekularnim sitom kao sredstvom za sušenje.
English: • insomnia
Croatian: • nesanica
English: Overall (N=62)
Croatian: Ukupno (N=62)
English: • mini stroke, cerebral infarction
Croatian: • mali moždani udar, moždani infarkt
English: Glucose increased
Croatian: Povišena glukoza
English: • a severe side effect occurs, not affecting the blood
Croatian: • ako dođe do teških nuspojava koje ne zahvaćaju krv
English: Common blood bilirubin increased, blood alkaline phosphatase increased, gammaglutamyltransferase increased
Croatian: Često povišen bilirubin u krvi, povišena alkalna fosfataza u krvi, povišena gama-glutamil transferaza
English: • stomach bleeding (symptoms include: stomach pain, vomiting blood)
Croatian: • krvarenje iz želuca (simptomi uključuju: bol u želucu, povraćanje krvi)
English: • 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)
Croatian: • krvni ugrušak u dubokim venama, iznenadno začepljenje vena, krvni ugrušak u krvnim žilama pluća (simptomi uključuju: navale vrućine, nalete crvenila, crvenilo lica, otežano disanje)
English: The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Croatian: Incidencija događaja ozbiljnog krvarenja bila je viša u bolesnika s AP-KML, BPKML, i Ph+ ALL.
English: 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).
Croatian: 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).
English: Breast-feeding should be stopped during treatment with Iclusig.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom Iclusig.
English: An effective method of contraception should be used during treatment.
Croatian: Za vrijeme liječenja potrebno je koristiti učinkovite metode kontracepcije.
English: • heart problems, problems of the blood vessels in the heart muscle, left sided chest pain, dysfunction of the left heart chamber
Croatian: • problemi sa srcem, problemi s krvnim žilama u srčanom mišiću, bol na lijevoj strani prsišta,
English: Achieved MCyR at 30 mg (N=45)
Croatian: Postignut MCyR pri 30 mg (N=45)
English: Treatment was interrupted, the events resolved, and Iclusig was restarted at 45 mg, once daily.
Croatian: Nakon prekida liječenja došlo je do povlačenja opisanih štetnih događaja te je nastavljeno liječenje lijekom Iclusig 45 mg, jednom dnevno.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Caution is recommended when administering Iclusig to patients with severe hepatic impairment (see section 5.2).
Croatian: Preporučuje se oprez prilikom primjene lijeka Iclusig u bolesnika s teškim oštećenjem jetre (vidjeti dio 5.2).
English: • Consider discontinuing Iclusig
Croatian: • Razmotrite prekid liječenja Iclusigom
English: 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.
Croatian: 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.
English: • a 45 mg film-coated tablet for the recommended dose.
Croatian: • filmom obložene tablete od 45 mg za preporučenu dozu.
English: This medicinal product contains lactose monohydrate.
Croatian: Ovaj lijek sadrži laktozu hidrat.
English: • circulatory problems in the spleen
Croatian: • problemi s cirkulacijom u slezeni
English: The recommended starting dose is one 45 mg film-coated tablet once daily.
Croatian: Preporučena početna doza je jedna filmom obložena tableta od 45 mg jednom dnevno.
English: With once daily dosing, plasma exposures of ponatinib are increased by approximately 1.5-fold between first dose andsteady state conditions.
Croatian: Pri doziranju jednom dnevno izloženost ponatinibu u plazmi povećava se za približno 1,5 puta između prve doze i stanja dinamičke ravnoteže.
English: • a complete blood count This will be repeated every 2 weeks for the first 3 months after starting the therapy.
Croatian: To će se ponavljati svaka 2 tjedna tijekom prva 3 mjeseca nakon početka liječenja.
English: Dose interruption or reduction may be required.
Croatian: Možda će biti potrebno prekinuti liječenje ili smanjiti dozu.
English: Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and anaemia.
Croatian: 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.
English: How to store Iclusig
Croatian: Kako čuvati Iclusig
English: Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively.
Croatian: Ponatinib inhibira aktivnost tirozin kinaze ABL I T315I mutanta ABL s vrijednostima IC50 od 0,4 odnosno 2,0 nM.
English: 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.
Croatian: 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.
English: 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.
Croatian: Prije početka liječenja ponatinibom, mora se ocijeniti kardiovaskularno stanje bolesnika, uključujući povijest bolesti i fizikalni pregled, a kardiovaskularni čimbenici rizika moraju se aktivno zbrinuti.
English: 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).
Croatian: 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).
English: • blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs)
Croatian: • problemi s cirkulacijom krvi (simptomi uključuju: bolove u nogama ili rukama, hladnoću na krajevima udova)
English: Poly(vinyl alcohol) Titanium dioxide (E171)
Croatian: Ovojnica tablete talk makrogol 4000 poli(vinilni alkohol) titanijev dioksid (E171)
English: It is unknown whether Iclusig is excreted in human milk.
Croatian: Nije poznato izlučuje li se Iclusig u majčino mlijeko u ljudi.
English: Grade 4 pancreatitis
Croatian: Pankreatitis 4. stupnja
English: Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.
Croatian: 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.
English: • 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.
Croatian: • 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.
English: • a 15 mg film-coated tablet to allow for dose adjustments.
Croatian: • filmom obložene tablete od 15 mg za prilagođavanje doze.
English: • sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation.
Croatian: • sulfasalazin: lijek za liječenje teške upale crijeva i reumatske upale zglobova.
English: In 67% of CP-CML patients in the R/I cohort, no mutations were detected at study entry.
Croatian: U 67% bolesnika u kroničnoj fazi KML u kohorti R/I nisu uočene mutacije prilikom uključivanja.
English: • colchicine: a medicine to treat gout attacks.
Croatian: • kolhicin: lijek za liječenje napadaja gihta.
English: Uncommon tumour lysis syndrome
Croatian: Manje često sindrom lize tumora
English: • stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations)
Croatian: • moždani udar (simptomi uključuju: otežan govor i pokrete, pospanost, migrenu, abnormalne osjete)
English: • heartburn caused by reflux of stomach juices, inflammation in the mouth, abdominal swelling or discomfort or indigestion, dry mouth
Croatian: • žgaravica uzrokovana povratom sokova iz želuca, upala u ustima, nadutost trbuha ili nelagoda ili probavne tegobe, suha usta
English: 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).
Croatian: 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).
English: For a dose of 30 mg or 15 mg once daily, 15 mg film-coated tablets are available.
Croatian: Za dozu od 30 mg ili 15 mg jednom dnevno dostupne su filmom obložene tablete od 15 mg.
English: • phenobarbital, phenytoin: medicines to treat epilepsy.
Croatian: • fenobarbital, fenitoin: lijekovi za liječenje epilepsije.
English: Resistant or Intolerant R/I Cohort (N=10)
Croatian: Rezistentan ili intolerantan R/I kohorta (N=10)
English: Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 3.
Croatian: Nuspojave prijavljene kod svih KML i Ph+ ALL bolesnika prikazane su u Tablici
English: • skin rash, itching, peeling of the skin, redness, bruising, skin pain, hair loss
Croatian: • kožni osip, svrbež, ljuštenje kože, crvenilo, nastanak modrica, bol po koži, gubitak kose
English: 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
Croatian: 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
English: Achieved MCyR at 45 mg (N=87)
Croatian: Postignut MCyR pri 45 mg (N=87)
English: • liver damage, jaundice (symptoms include: yellowing of the skin and eyes)
Croatian: • oštećenje jetre, žutica (simptomi uključuju: žutilo kože i bjeloočnica)
English: 6.6 Special precautions for disposal and other handling Disposal:
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Zbrinjavanje:
English: No clinically significant changes in the mean QTc interval (i.e., > 20 ms) from baseline were detected in the study.
Croatian: Nisu uočene kliničke promjene u prosječnom intervalu QTc (primjerice > 20 ms) od početne vrijednosti.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: The blood/plasma ratio of ponatinib is 0.96.
Croatian: Omjer ponatiniba u krvi i plazmi iznosio je 0,96.
English: • clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections.
Croatian: • klaritromicin, telitromicin, troleandomicin: lijekovi za liječenje bakterijskih infekcija.
English: - alanine aminotransferase
Croatian: alanin aminotransferaze aspartat aminotransferaze
English: Each film-coated tablet contains 120 mg of lactose monohydrate.
Croatian: Svaka filmom obložena tableta sadrži 120 mg laktoze hidrata.
English: Vascular occlusive adverse events were more frequent with increasing age and in patients with prior history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Croatian: Štetni događaji vaskularne okluzije bivali su češći s porastom godina i u bolesnika s prethodnom anamnezom ishemije, hipertenzije, dijabetesa, ili hiperlipidemije.
English: Hyper-/hypoplastic changes of the chondrocytes in the physis were noted in repeat-dose toxicity studies in rats.
Croatian: Hiper/hipoplastične promjene hondrocita u hrskavičnim pločama rasta kosti uočene su u studijama ponovljene toksičnosti u štakora.
English: In cellular assays, ponatinib was able to overcome imatinib, dasatinib, and nilotinib resistance mediated by BCR-ABL kinase domain mutations.
Croatian: U kulturama stanica ponatinib je nadvladao rezistenciju na imatinib, dasatinib i nilotinib posredovanu mutacijama u domeni BCR-ABL kinaze.
English: Common chills, influenza like illness, non-cardiac chest pain, mass, face oedema
Croatian: Često zimica, bolest nalik influenci, nekardijalna bol u prsištu, masa, edem lica
English: Serious vascular occlusion has occurred in patients treated with Iclusig, including cardiovascular, cerebrovascular and peripheral vascular events, and venous thrombotic events.
Croatian: U bolesnika liječenih Iclusigom javila se ozbiljna vaskularna okluzija, uključujući kardiovaskularne, cerebrovaskularne i periferne vaskularne događaje, te venske trombotske događaje.
English: 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.
Croatian: 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.
English: Dry flaky skin was observed in toxicity studies in rats.
Croatian: Suha, ljuskava koža uočena je u studijama toksičnosti u štakora.
English: • tissue swelling in eyelid or around the eyes, caused by excess fluid
Croatian: • oticanje tkiva očnih kapaka ili područja oko očiju, uzrokovano prekomjernim nakupljanjem tekućine
English: If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2).
Croatian: 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).
English: • increased blood levels of several liver enzymes called:
Croatian: • povišene razine nekoliko jetrenih enzima u krvi:
English: Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporters OCT-1.
Croatian: Ponatinib nije supstrat za polipeptide koji transportiraju humane organske anione OATP1B1, OATP1B3 i OCT-1 i transporter organskih kationa OCT-1.
English: Caution is recommended when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min, or end-stage renal disease.
Croatian: Preporučuje se oprez prilikom primjene lijeka Iclusig bolesnicima s klirensom kreatinina < 50 ml/min ili s terminalnom fazom bubrežnog zatajenja.
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients (see section 4.8).
Croatian: Ozbiljne nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 4,5% bolesnika (vidjeti dio 4.8).