FrancophonIA/ELRC3.0 huggingface dataset:
English: • nefazodone: a medicine to treat depression.
Croatian: • nefazodon: lijek za liječenje depresije.
English: In order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR in patients with CP-CML, the MAH should conduct and submit the results of a doseranging study.
Croatian: Kako bi se odredila optimalna početna doza Iclusiga i okarakterizirala sigurnost i djelotvornost Iclusiga nakon smanjenja doze u bolesnika s kroničnom fazom KML koji su postigli MCyR, nositelj odobrenja će provesti ispitivanje raspona doze lijeka i podnijeti rezultate.
English: 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.
Croatian: Unutar raspona klinički relevantnih doza koje su ocijenjene u bolesnika (15 mg do 60 mg) ponatinib je iskazao proporcionalne poraste doze kod Cmax i AUC.
English: Dose adjustments to 30 mg once daily or 15 mg once daily were allowed for the management of treatment toxicity.
Croatian: Prilagodbe doze na 30 mg jednom dnevno ili 15 mg jednom dnevno bile su dozvoljene u slučaju toksičnosti.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji iza „Rok valjanosti“.
English: In vitro, ponatinib is an inhibitor of P-gp and BCRP.
Croatian: U in vitro uvjetima ponatinib djeluje kao inhibitor P-gp i BCRP.
English: It is not known if Iclusig passes into breast milk.
Croatian: Nije poznato prelazi li Iclusig u majčino mlijeko.
English: 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”).
Croatian: Istovremenoj primjeni ponatiniba sa lijekovima protiv zgrušavanja treba pristupiti oprezno u bolesnika kod kojih je moguć rizik od događaja krvarenja (vidjeti “Mijelosupresija” i “Hemoragija”).
English: CP-CML (N=270)
Croatian: CP-KML (N=270)
English: The risk of vascular occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Croatian: Rizik od događaja vaskularne okluzije je vjerojatno povezan s dozom (vidjeti dijelove 4.2 i 5.1).
English: Multiple doses of 90 mg per day for 12 days in a patient resulted in pneumonia, systemic inflammatory response, atrial fibrillation, and asymptomatic, moderate pericardial effusion.
Croatian: Višestruke doze od 90 mg dnevno tijekom 12 dana rezultirale su pneumonijom, sistemnim upalnim odgovorom organizma, fibrilacijom atrija i asimptomatskom, umjerenom efuzijom perikarda.
English: • heart problems, including heart failure, irregular heartbeats, and QT prolongation
Croatian: • probleme sa srcem, uključujući zatajenje srca, nepravilan ritam srca, i produljenje QT
English: All patients received 45 mg Iclusig once daily.
Croatian: Svi bolesnici primali su 45 mg lijeka Iclusig jednom dnevno.
English: At the time of reporting, all ongoing patients had a minimum follow-up of 27 months.
Croatian: U vrijeme podnošenja izvješća svi uključeni bolesnici bili su praćeni tijekom najmanje 27 mjeseci.
English: At the time of reporting, 25 CP-CML patients were in MCyR (median duration of MCyR had not been reached).
Croatian: U vrijeme izvještavanja 25 bolesnika u kroničnoj fazi KML bili su u MCyR (medijan trajanja MCyR nije dosegnut).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Iclusig in paediatric patients from 1 year to less than 18 years in CML and Ph+ ALL (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Iclusig u pedijatrijskih bolesnika od godine dana do 18 godina s KML i Ph+ALL (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: (95% CI) Complete (CCyR)
Croatian: (95% CI) Kompletni (CCyR)
English: The most common serious adverse reactions >1% (treatment-emergent frequencies) were pancreatitis (5.6%), pyrexia (4.2%), abdominal pain (4.0%), myocardial infarction (3.6%), atrial fibrillation (3.3%), anaemia, (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), cardiac failure (2.0%), lipase increased (1.8%), dyspnea (1.6%), diarrhoea (1.6%), neutrophil count decreased (1.3%), pancytopenia (1.3%), and pericardial effusion (1.3%).
Croatian: Najčešće ozbiljne nuspojave (>1%) (učestalost nuspojava izazvanih liječenjem) bile su pankreatitis (5,6%), pireksija (4,2%), bol u abdomenu (4,0%), infarkt miokarda (3,6%), fibrilacija atrija (3,3%), anemija (3,3%), smanjenje broja trombocita (3,1%), febrilna neutropenija (2,9%), zatajenje srca (2,0%), porast lipaze (1,8%), dispneja (1,6%), proljev (1,6%), smanjenje broja neutrofila (1,3%), pancitopenija (1,3%) i efuzija perikarda (1,3%).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: Dose modifications for neutropenia (ANC* < 1.0 x 109/L) and thrombocytopenia (platelet < 50 x 109/L) that are unrelated to leukaemia are summarized in Table 1.
Croatian: Prilagođavanje doze zbog neutropenije (ABN* < 1,0 x 109/l) i trombocitopenije (trombociti < 50 x 109/l) koje nisu povezane s leukemijom prikazane su u Tablici 1.
English: There is insufficient data available to make formal recommendations on dose reduction (in the absence of an adverse event) in patients with chronic phase (CP) CML patients who have achieved Major Cytogenetic Response.
Croatian: Nema dovoljno dostupnih podataka za formalnu preporuku smanjenja doze (u odsutstvu štetnih događaja) u bolesnika s kroničnom fazom KML koji su postigli veći citogenetički odgovor.
English: At doses of 30 mg or greater plasma steady state trough concentrations of ponatinib typically exceed 21 ng/mL (40 nM).
Croatian: Pri dozama od 30 mg ili većim u stanju dinamičke ravnoteže koncentracija ponatiniba obično prelazi 21 ng/ml (40 nM).
English: • digoxin: a medicine to treat heart weakness.
Croatian: • digoksin: lijek za liječenje slabosti srca.
English: Although renal excretion is not a major route of ponatinib elimination, the potential for moderate or severe renal impairment to affect hepatic elimination has not been determined (see section 4.2).
Croatian: Iako izlučivanje putem bubrega nije glavni put eliminacije ponatiniba, moguć utjecaj umjerenog ili teškog oštećenja bubrega na eliminaciju putem jetre nije utvrđen (vidjeti dio 4.2).
English: Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled.
Croatian: Liječenje Iclusigom se mora privremeno prekinuti ako se hipertenzija ne kontrolira lijekovima.
English: 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.
Croatian: Za sve bolesnike u ispitivanju faze 2, odnos jačina doze-sigurnost ukazao je na značajna povećanja štetnih događaja stupnja ≥ 3 (zatajenje srca, arterijska tromboza, hipertenzija, trombocitopenija, pankreatitis, neutropenija, osip, povećanje ALT, povećanje AST, povećanje lipaze, mijelosupresija) u rasponu doze od 15 do 45 mg jednom dnevno.
English: All patients were administered 45 mg of Iclusig once-daily with the possibility of dose de-escalations and dose interruptions followed by dose resumption and re-escalation.
Croatian: Svi bolesnici primili su 45 mg lijeka Iclusig jednom dnevno s mogućnosti smanjenja doze i prekida doze, a potom ponovni nastavak doziranja i povišenje doze.
English: Grade 3 or 4 asymptomatic elevation of lipase/amylase (> 2.0 x IULN*) only
Croatian: Samo asimptomatsko povišenje lipaze/amilaze 3. ili 4. stupnja (> 2,0 x IGGN*)
English: Fatal and serious heart failure or left ventricular dysfunction occurred in Iclusig-treated patients, including events related to prior vascular occlusive events.
Croatian: Smrtonosno i ozbiljno zatajenje srca ili disfunkcija lijeve klijetke javili su se u bolesnika liječenih Iclusigom, uključujući i događaje povezane s ranijim događajima vaskularne okluzije.
English: Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig.
Croatian: Pratite bolesnike zbog otkrivanja znakova i simptoma koji ukazuju na zatajenje srca i liječite ih sukladno kliničkoj indikaciji, uključujući i prekid davanja Iclusiga.
English: • narrowing of the arteries in the brain
Croatian: • suženje arterija u mozgu
English: In the event of an overdose of Iclusig, the patient should be observed and appropriate supportive treatment given.
Croatian: U slučaju predoziranja lijekom Iclusig bolesnike treba nadzirati i primijeniti odgovarajuće potporne mjere liječenja.
English: Anaemia (Hgb decreased)
Croatian: Anemija (snižen Hgb)
English: Liver function abnormality
Croatian: Abnormalna jetrena funkcija
English: Multiple foetal soft tissue and skeletal alterations were also observed at maternal nontoxic dosages.
Croatian: Višestruke izmjene mekog tkiva i kostura fetusa također su uočene pri dozama koje nisu bile toksične za majku.
English: In a cell-based accelerated mutagenesis assay, no mutation in BCR-ABL was detected that could confer resistance to 40 nM ponatinib.
Croatian: U ubrzanom testu mutagenosti provedenom na stanicama nisu uočene BCR-ABL mutacije koje bi prouzrokovale rezistenciju na 40 nM ponatiniba.
English: Overall, the most common adverse reactions (≥20%) were platelet count decreased, rash, dry skin, and abdominal pain.
Croatian: Ukupno gledano najčešće nuspojave (≥20%) bile su pad broja trombocita, osip, suha koža i bol u abdomenu.
English: Consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days).
Croatian: Razmotrite prekid davanja ponatiniba ako se potpuni hematološki odgovor ne javi za 3 mjeseca (90 dana).
English: Ponatinib is mainly eliminated via faeces.
Croatian: Ponatinib se uglavnom uklanja fecesom.
English: Of the CP-CML patients with no mutation detected at entry, 46% (63/136) achieved a MCyR.
Croatian: Od ukupnog broja bolesnika u kroničnoj fazi KML bez mutacija prilikom uključivanja, 46% (63/136) postiglo je MCyR.
English: • The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 3000, polyvinyl alcohol, titanium dioxide (E171).
Croatian: • Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, natrijev škroboglikolat, silicijev dioksid (koloidni bezvodni), magnezijev stearat, talk, makrogol 4000, poli(vinilni alkohol), titanijev dioksid (E171).
English: • narrowing of the blood vessels, poor blood circulation
Croatian: • suženje krvnih žila, slaba cirkulacija krvi
English: The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients and no clinically significant QT prolongation was observed (see section 5.1).
Croatian: Utjecaj lijeka Inclusig na produljenje QT intervala ispitano je u 39 bolesnika s leukemijom te nije uočeno značajno produljenje QT intervala (vidjeti dio 5.1).
English: ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD United Kingdom
Croatian: Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD Velika Britanija
English: Haematological Response Rate Majora (MaHR)
Croatian: Stopa hematološkog odgovora Značajana (MaHR)
English: Consider discontinuation of ponatinib in patients who develop serious heart failure (see sections 4.2 and 4.8).
Croatian: Razmotrite prekid davanja ponatiniba u bolesnika kod kojih se razvije ozbiljno zatajenje srca (vidjeti dijelove 4.2 i 4.8).
English: • chronic myeloid leukaemia (CML): a blood cancer involving too many abnormal white blood cells in the blood and the bone marrow (where blood cells are formed).
Croatian: • kroničnom mijeloičnom leukemijom (KML): rakom krvi s previše nenormalnih bijelih krvnih stanica u krvi i koštanoj srži (u kojoj se stvaraju krvne stanice).
English: Ponatinib inhibits the activity of other clinically relevant kinases with IC50 values below 20 nM and has demonstrated cellular activity against RET, FLT3, and KIT and members of the FGFR, PDGFR, and VEGFR families of kinases.
Croatian: Ponatinib inhibira aktivnost drugih klinički značajnih kinaza s vrijednostima IC50 ispod 20 nM i dokazano smanjuje aktivnost RET, FLT3 i KIT te članova obitelji kinaza FGFR, PDGFR i VEGFR.
English: • increased blood sugar or uric acid levels in the blood, high blood fat values of triglycerides
Croatian: • povišene razine šećera ili mokraćne kiseline u krvi, visoke razine triglicerida u krvi
English: Patients with estimated creatinine clearance of ≥ 50 mL/min should be able to safely receive Iclusig with no dosage adjustment.
Croatian: Bolesnici s klirensom kreatinina ≥ 50 ml/min mogu primati Iclusig bez prilagodbe doze.
English: • a liver or pancreas disorder or reduced kidney function.
Croatian: • poremećaj jetre ili gušterače ili smanjenu funkciju bubrega
English: Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
Croatian: Liječenje treba provesti liječnik s iskustvom u dijagnosticiranju i liječenju bolesnika s leukemijom.
English: Very common alanine aminotransferase increased, aspartate aminotransferase increased
Croatian: Vrlo često povišena alanin aminotransferaza, povišena aspartat aminotransferaza
English: Very common hypertension
Croatian: Vrlo često hipertenzija
English: The geometric mean (CV%) Cmax and AUC(0-τ) exposures achieved for ponatinib 45 mg daily at steady state were 77 ng/mL (50%) and 1296 ng•hr/mL (48%), respectively.
Croatian: Geometrijska sredina (CV%) Cmax i AUC(0-τ) izloženosti postignute za ponatinib 45 mg dnevno u stanju dinamičke ravnoteže je 77 ng/ml (50%) odnosno 1296 ng•hr/ml (48%).
English: • increased blood level of bilirubin - the yellow breakdown substance of the blood pigment
Croatian: • povišena razina bilirubina u krvi - žuti razgradni produkt krvnog pigmenta
English: Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase.
Croatian: Iclusig može uzrokovati porast vrijednosti ALT-a, AST-a, bilirubina i alkalne fosfataze.
English: PHARMACEUTICAL FORM AND CONTENTS 60 tablets
Croatian: OBLIK I SADRŽAJ 60 tableta
English: • dabigatran: a medicine to prevent the formation of blood clots.
Croatian: • dabigatran: lijek za sprječavanje nastanka krvnih ugrušaka.
English: - increased levels of the serum proteins lipase or amylase.
Croatian: - povišene razine proteina lipaza ili amilaza u serumu.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: • obstruction of the blood vessels in the eye, visual disturbance
Croatian: • začepljenje krvnih žila u oku, poremećaj vida
English: 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).
Croatian: 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).
English: In the case of severe adverse reactions, treatment should be withheld.
Croatian: U slučaju teških nuspojava liječenje treba prekinuti.
English: For every BCR-ABL mutation detected in more than one CP-CML patient at entry, a MCyR was achieved following treatment with Iclusig.
Croatian: 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.
English: ALT=alanine aminotransferase, ANC=absolute neutrophil count, AST=aspartate aminotransferase, Hgb=haemoglobin, WBC=white blood cell count.
Croatian: ALT=alanin aminotransferaza, ABN=apsolutni broj neutrofila, AST=aspartat aminotransferaza, Hgb=hemoglobin, Lkc= leukociti.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: (95% CI) Completeb (CHR)
Croatian: (95% CI) Kompletnib (CHR)
English: 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.
Croatian: 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.
English: 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.
Croatian: U štakora su uočene upalne promjene popraćene porastom broja neutrofila, monocita, eozinofila i fibrinogena u žlijezdama prepucija i klitorisa nakon kroničnog doziranja.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: A reduction of the starting dose of Iclusig in patients with hepatic impairment is not necessary (see sections 4.2 and 4.4).
Croatian: Smanjenje početne doze lijeka Iclusig u bolesnika s oštećenjem jetre nije potrebno (vidjeti dijelove 4.2 i 4.4).
English: • fatigue, accumulation of fluid in arms and/or legs, fever, pain
Croatian: • umor, nakupljanje tekućine u rukama i/ili nogama, vrućica, bol
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Very common rash, dry skin
Croatian: Vrlo često osip, suha koža
English: 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.
Croatian: 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.
English: Haematological Response Rate
Croatian: Stopa hematološkog odgovora
English: Lipase increased
Croatian: Povišena lipaza
English: Table 3 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Croatian: Tablica 3 Nuspojave uočene u KML i Ph+ ALL bolesnika - učestalost prijavljena prema incidenciji događaja izazvanih liječenjem Klasifikacija organskih sustava
English: Bottles of Iclusig 45 mg contain either 30 or 90 film-coated tablets.
Croatian: Boca Iclusiga 45 mg sadrži 30 ili 90 filmom obloženih tableta.
English: 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.
Croatian: 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.
English: Overall (N=83)
Croatian: Ukupno (N=83)
English: • lethargy, migraine
Croatian: • letargija, migrena
English: • breathing difficulties
Croatian: • otežano disanje
English: 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%).
Croatian: Najčešće mutacije su: T315I (29%), F317L (8%), E255K (4%) i E359V (4%).
English: Check serum lipase every 2 weeks for the first 2 months and then periodically thereafter.
Croatian: Serumsku lipazu treba kontrolirati svaka 2 tjedna tijekom prva 2 mjeseca a zatim periodično.
English: Effective contraception must be used during treatment.
Croatian: Tijekom liječenja potrebno je koristiti djelotvornu kontracepciju.