FrancophonIA/ELRC3.0 huggingface dataset:
English: • problems of the blood vessels in the heart muscle
Croatian: • problemi krvnih žila u srčanom mišiću
English: A brain condition called posterior reversible encephalopathy syndrome (PRES) has been reported in patients treated with ponatinib.
Croatian: Stanje mozga pod nazivom sindrom posteriorne reverzibilne encefalopatije (PRES) prijavljeno je u bolesnika koji su liječeni ponatinibom.
English: Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Croatian: (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Following a single oral dose of [14C]-labeled ponatinib, approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine.
Croatian: Nakon pojedinačne doze [14C]-označenog ponatiniba, približno 87% radioaktivne doze odstranjuje se fecesom, a približno 5% mokraćom.
English: Carriers of HBV who require treatment with Iclusig should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Croatian: Nositelje virusa HBV kojima je potrebno liječenje Iclusig potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
English: In a two-year carcinogenicity study in male and female rats, oral administration of ponatinib at 0.05, 0.1 and 0.2 mg/kg/day in males and at 0.2 and 0.4 mg/kg/day in females did not result in any tumorigenic effects.
Croatian: U dvogodišnjoj studiji kancerogenosti u mužjaka i ženki štakora, peroralna primjena ponatiniba u dozama od 0,05, 0,1 i 0,2 mg/kg/dan u mužjaka i dozama od 0,2 i 0,4 mg/kg/dan u ženki nije izazvala tumorogene učinke.
English: • narrowing of the blood vessels, poor blood circulation, sudden increase in blood pressure
Croatian: • suženje krvnih žila, slaba cirkulacija krvi, nagli porast krvnog tlaka
English: Hypertension may contribute to risk of arterial occlusive events.
Croatian: Hipertenzija može doprinijeti riziku za arterijski okluzivni događaj.
English: Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4%, neutropenia and anaemia < 1% each).
Croatian: Prekidi terapije zbog mijelosupresije nisu bili česti (trombocitopenija 4%, neutropenija i anemija <1%
English: Management of toxicities
Croatian: Zbrinjavanje toksičnosti
English: For the overall CP-CML disease group, the probability of survival at 2, 3, 4, and 5 years is estimated as 86.0%, 81.2%, 76.9%, and 73.3%, respectively, as shown in Figure 1.
Croatian: Za sve bolesnike u skupini bolesti kronične faze KML-a, vjerojatnost preživljenja u 2., 3., 4. i 5. godini procijenjena je na 86,0%, 81,2%, 76,9% odnosno 73,3%, kao što je prikazano na Slici 1.
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 oznake „Rok valjanosti“.
English: Symptoms may include sudden onset of severe headache, confusion, seizures, and vision changes.
Croatian: Simptomi mogu uključivati iznenadnu pojavu jake glavobolje, smetenost, napadaje i promjene vida.
English: • changes in blood levels: decreased number of red blood cells (symptoms include: weakness, dizziness, fatigue) decreased number of blood platelets (symptoms include: increased tendency to bleed or bruise) decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection) increased level of the serum protein known as lipase
Croatian: smanjeni broj crvenih krvnih stanica (simptomi uključuju: slabost, omaglicu, umor) smanjeni broj trombocita (simptomi uključuju: povećanu sklonost krvarenju i nastajanju modrica) smanjeni broj bijelih krvnih stanica zvanih neutrofili (simptomi uključuju: povećanu sklonost infekcijama) povišena razina serumskog proteina zvanog lipaza
English: Posterior Reversible Encephalopathy Syndrome
Croatian: Sindrom posteriorne reverzibilne encefalopatije
English: With once-daily dosing, plasma exposures of ponatinib are increased by approximately 1.5-fold between first dose and steady 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: • The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 4000, 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: In juvenile rats, mortality related to inflammatory effects was observed in animals treated with 3 mg/kg/day, and reductions in body weight gain were observed at doses of 0.75, 1.5 and 3 mg/kg/day during the pre-weaning and early post-weaning treatment phases.
Croatian: U mladih štakora, smrtnost povezana s upalnim učincima zabilježena je u životinja liječenih s 3 mg/kg/dan, a smanjenje u dobivanju na tjelesnoj težini zabilježeno je pri dozama 0,75; 1,5 i 3 mg/kg/dan tijekom faza liječenja u razdoblju prije prestanka sisanja i ranom razdoblju poslije prestanka sisanja.
English: Figure 1- Kaplan-Meier estimates for overall survival in the CP-CML population (Treated Population)
Croatian: Slika 1 - Procjene ukupnog preživljenja po Kaplan-Meieru u populaciji s kroničnom fazom KML-a
English: The probability of all patients with CP CML maintaining MCyR and MMR did not change further when the analysis was extended out to 5 years.
Croatian: Vjerojatnost održavanja MCyR-a i MMR-a u svih bolesnika u kroničnoj fazi KMLa nije se dodatno promijenila kad je analiza produljena na 5 godina.
English: SPECIAL STORAGE CONDITIONS Store in the original container in order to protect from light.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnom spremniku radi zaštite od svjetlosti.
English: Hypertension may contribute to risk of arterial thrombotic events, including renal artery stenosis.
Croatian: Hipertenzija može doprinijeti riziku za arterijski trombotski događaj, uključujući stenozu bubrežne arterije.
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: At the time of reporting, all ongoing patients had a minimum follow-up of 64 months.
Croatian: U vrijeme podnošenja izvješća svi uključeni bolesnici bili su praćeni tijekom najmanje 64 mjeseca.
English: Patients with hepatic impairment may receive the recommended starting dose.
Croatian: Oštećenje funkcije jetre Bolesnici s oštećenjem jetre mogu primiti preporučenu početnu dozu.
English: BCR-ABL mutation detected at entry, n (%)b None a* of 427 patients reporting prior TKI therapy with dasatinib or nilotinib b Of the patients with one or more BCR-ABL kinase domain mutations detected at entry, 37 unique mutations were detected.
Croatian: BCR-ABL mutacija otkrivena pri ulasku u ispitivanje, n (%)b Nema a* od 427 bolesnika koji su prijavili prethodnu TKI terapiju dasatinibom ili nilotinibom b Među bolesnicima u kojih je pri uključivanju u ispitivanje uočena jedna ili više mutacija u domeni BCR-ABL kinaze, uočeno je 37 jedinstvenih mutacija.
English: The risk of arterial occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Croatian: Rizik od događaja arterijske okluzije je vjerojatno povezan s dozom (vidjeti dijelove 4.2 i 5.1).
English: The most common serious adverse reactions >2% (treatment-emergent frequencies) were pneumonia (7.3%), pancreatitis (5.8%), abdominal pain (4.7%), atrial fibrillation (4.5%), pyrexia (4.5%), myocardial infarction (4.0%), peripheral arterial occlusive disease (3.8%), anaemia (3.8%), angina pectoris (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), hypertension (2.9%), coronary artery disease (2.7%), cardiac failure congestive (2.4%), cerebrovascular accident (2.4%), sepsis (2.4%), cellulitis (2.2%), acute kidney injury (2.0%), urinary tract infection (2.0%) and lipase increased (2.0%).
Croatian: (7,3%), pankreatitis (5,8%), bol u abdomenu (4,7%), fibrilacija atrija (4,5%), pireksija (4,5%), infarkt miokarda (4,0%), periferna arterijska okluzivna bolest (3,8%), anemija (3,8%), angina pectoris (3,3%), smanjenje broja trombocita (3,1%), febrilna neutropenija (2,9%), hipertenzija (2,9%), bolest koronarnih arterija (2,7%), kongestivno zatajenje srca (2,4%), cerebrovaskularni incident (2,4%),
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: Statistical significance was achieved in the correlation of PFS and OS with a MCyR at the 12-month landmark (p=<0.0001 and p=0.0012, respectively).
Croatian: Statistički značajna korelacija PFS-a i OS-a s MCyR postignuta je na kontrolnoj točki od 12 mjeseci (p=<0,0001 odnosno p=0,0012).
English: Arterial occlusion
Croatian: Arterijska okluzija
English: Monitoring for evidence of thromboembolism should be performed.
Croatian: Potrebno je praćenje na pokazatelje pojave tromboembolije.
English: • troubling skin rashes involving blisters or peeling and spread across the body, and involving tiredness.
Croatian: • problematični osipi na koži koji uključuju mjehuriće ili ljuštenje i šire se tijelom, a popraćeni su i umorom.
English: After a minimum follow-up of 64 months, the rates of adverse reactions resulting in discontinuation were 20% in CP-CML, 11% in AP-CML, 15% in BP-CML and 9% in Ph+ ALL.
Croatian: Nakon minimalnog praćenja od 64 mjeseca, stope nuspojava koje su rezultirale prekidom liječenja iznosile su 20% u CP-KML, 11% u AP-KML, 15% u BP-KML i 9% u Ph+ALL.
English: • sodium decrease in the blood
Croatian: • smanjenje natrija u krvi
English: In the event of significant worsening, labile or treatment-resistant hypertension, treatment should be interrupted and evaluation for renal artery stenosis should be considered.
Croatian: U slučaju značajnog pogoršanja hipertenzije ili granične ili refraktorne hipertenzije potrebno je prekinuti liječenje i razmotriti dijagnostičku obradu zbog suspektne stenoze bubrežne arterije.
English: In the phase 2 trial, dose reductions were recommended following adverse events; in addition in October 2013 new recommendations for prospective dose reduction in all CP-CML patients in the absence of adverse events were introduced in this trial with the aim of reducing the risk of vascular occlusive events.
Croatian: Smanjivanje doze u bolesnika u kroničnoj fazi KML-a U ispitivanju faze 2, smanjenja doze preporučena su nakon pojave štetnih događaja; osim toga u listopadu 2013. u ovom ispitivanju uvedene su nove preporuke za prospektivno smanjenje doze za sve bolesnike u kroničnoj fazi KML-a bez štetnih događaja s ciljem smanjenja rizika za događaje vaskularne okluzije.
English: There were no effects on male rat fertility parameters.
Croatian: Nije bilo nikakvih učinaka na parametre plodnosti u mužjaka štakora.
English: Elevation of AST or ALT ≥ 3 × ULN concurrent with an elevation of bilirubin > 2 × ULN and alkaline phosphatase < 2 × ULN
Croatian: Porast vrijednosti AST-a ili ALTa ≥ 3 x GGN istodobno uz povišenje bilirubina > 2 x GGN i alkalne fosfataze < 2 x GGN
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),
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
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-a, MCyR je postignut nakon liječenja lijekom Iclusig.
English: Monitoring for evidence of arterial occlusion should be performed and if decreased vision or blurred vision occurs, an ophthalmic examination (including fundoscopy) should be performed.
Croatian: Potrebno je praćenje na pokazatelje pojave arterijske okluzije, a ako dođe do pojave slabljenja vida ili zamagljenja vida potrebno je obaviti oftalmološki pregled (uključujući fundoskopiju).
English: • bleeding in the brain
Croatian: • krvarenje u mozgu
English: • heart problems, left sided chest pain, dysfunction of the left heart chamber
Croatian: • problemi sa srcem, bol na lijevoj strani prsnog koša, poremećaj rada lijeve srčane komore
English: Patients were assigned to one of six cohorts based on disease phase (CP-CML; AP-CML; or BPCML/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: Stop breast-feeding during treatment with Iclusig.
Croatian: Prestanite dojiti tijekom liječenja lijekom Iclusig.
English: Patients should be monitored for signs or symptoms consistent with heart failure and they should be treated as clinically indicated, including interruption of Iclusig.
Croatian: Potrebno je pratiti bolesnike zbog otkrivanja znakova i simptoma koji ukazuju na zatajenje srca i liječiti ih sukladno kliničkoj indikaciji, uključujući i prekid davanja Iclusiga.
English: If diagnosed, interrupt Iclusig treatment and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of PRES.
Croatian: Ako se dijagnosticira, prekinite liječenje lijekom Iclusigom i nastavite liječenje tek nakon što se poremećaj povuče te ako je korist od nastavka liječenja veća od rizika od PRES-a.
English: Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporter 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: • Iclusig discontinuation should be considered
Croatian: • Potrebno je razmotriti prekid primjene lijeka Iclusig
English: A statistically significant increased incidence of squamous cell carcinoma of the clitoral gland was observed at that dose.
Croatian: Pri toj dozi opažena je statistički značajno povećana incidencija karcinoma skvamoznih stanica klitoralne žlijezde.
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, 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: 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: *Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version
Croatian: *prema Zajedničkim kriterijima terminologije za nuspojave Nacionalnog instituta za karcinome,
English: The median dose intensity was 28 mg/day in CP-CML patients or, 63% of the expected 45 mg dose; median dose intensity was greater in advanced disease states (32 mg/day in the AP-CML patients and 44 mg/day in the BP CML/Ph+ ALL patients).
Croatian: Medijan intenziteta doze iznosio je 28 mg/dan za bolesnike u CP-KML fazi ili 63% od očekivane doze od 45 mg; medijan intenziteta doze bio je veći u stanjima uznapredovale bolesti (32 mg/dan za bolesnike u AP-KML fazi i 44 mg/dan za bolesnike u fazi BP-KML/Ph+ ALL).
English: The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is completed.
Croatian: Antileukemična aktivnost lijeka Iclusig također je procijenjena u ispitivanju faze 1 povišenja doze koja je uključivala 65 bolesnika s KML i Ph+ALL.
English: c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells)
Croatian: c MCyR kombinira i potpune (bez uočenih Ph+ stanica) i djelomične (1% do 35% Ph+ stanica)
English: • nosebleed, difficulty producing voice sounds, hypertension in the lungs
Croatian: • krvarenje iz nosa, poteškoće u nastanku glasa, plućna hipertenzija
English: • Iclusig should be interrupted and hepatic function should be monitored
Croatian: • Potrebno je prekinuti primjenu lijeka Iclusig i pratiti funkciju jetre
English: • blurred vision, dry eye, infection in the eye, visual disturbance
Croatian: • zamagljen vid, suhe oči, infekcija oka, poremećaj vida
English: Severe Cutaneous Adverse Reactions (SCARs)
Croatian: Teške kožne nuspojave (SCAR)
English: Iclusig should be discontinued *IULN = institution upper limit of normal Hepatic toxicity
Croatian: Potrebno je prekinuti primjenu lijeka Iclusig *IGGN (engl. institution upper limit of normal) = gornja granica normalnih vrijednosti ustanove
English: cytogenetic responses.
Croatian: citogenetske odgovore.
English: In 67% of CP-CML patients in the R/I cohort, no mutations were detected at study entry.
Croatian: 67% bolesnika u kroničnoj fazi KML-a u kohorti R/I nisu uočene mutacije prilikom uključivanja.
English: 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).
Croatian: Ispitivanje je uključivalo 449 bolesnika od kojih su 444 bili podobni za analizu: 267 bolesnika u kroničnoj fazi KML-a (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 kohorta: n=24), i 32 bolesnika s Ph+ ALL (R/I kohorta: n=10, T315I kohorta: n=22).
English: Common blood bilirubin increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased
Croatian: Često povišen bilirubin u krvi, povišena alkalna fosfataza u krvi, povišena gama-glutamil transferaza
English: Not known aneurysms and artery dissections
Croatian: Nepoznato aneurizme i disekcije arterije
English: • or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
Croatian: • ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile
English: Common pneumonia, sepsis, folliculitis, cellulitis
Croatian: Često pneumonija, sepsa, folikulitis, celulitis
English: b CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/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).
Croatian: 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).
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-a 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: Of the CP-CML patients previously treated with one, two, three or four prior TKIs, 75% (12/16), 68% (66/97), 44% (63/142), and 58% (7/12)) achieved a MCyR while on Iclusig, respectively.
Croatian: Od bolesnika u kroničnoj fazi KML-a koji su prethodno liječeni s jednim, dva, tri ili četiri TKI, 75% (12/16), 68% (66/97), 44% (63/142) odnosno
English: Fatal and serious heart failure or left ventricular dysfunction occurred in Iclusig-treated patients, including events related to prior vascular occlusive events.
Croatian: Zatajenje srca sa smrtnim ishodom 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: No human data on the effect of ponatinib on fertility are available.
Croatian: Nisu dostupni podaci o učinku ponatiniba na plodnost u ljudi.
English: ≥ 12 month reduction at 30 mg 8 ≥ 18 month reduction at 30 mg 7 ≥ 24 month reduction at 30 mg 6 ≥ 36 month reduction at 30 mg 1 Any dose reduction to 15 mg ≥ 3 month reduction at 15 mg
Croatian: ≥ 3 mjeseca smanjenje na 30 mg ≥ 6 mjeseci smanjenje na 30 mg ≥ 12 mjeseci smanjenje na 30 mg ≥ 18 mjeseci smanjenje na 30 mg ≥ 24 mjeseca smanjenje na 30 mg 6 ≥ 36 mjeseci smanjenje na 30 mg
English: With a minimum follow-up of 64 months, 3.4% (9/267) of CP-CML patients experienced transformation of their disease to AP-CML or BP-CML.
Croatian: Uz minimalno praćenje u razdoblju od 64 mjeseca, u 3,4% (9/267) bolesnika sa CP-KML bolest se transformirala na AP-KML ili BP-KML.
English: Iclusig should be discontinued
Croatian: Iclusiga treba odmah prekinuti.
English: Iclusig should be interrupted and patients evaluated for serious or severe haemorrhage.
Croatian: Potrebno je prekinuti davanje Iclusiga i izvršiti dijagnostičku obradu pacijenta zbog suspektne ozbiljne ili teške hemoragije.
English: Iclusig is available in plastic bottles, each containing one canister of a molecular sieve desiccant.
Croatian: Iclusig je dostupan u plastičnim bocama, od kojih svaka sadrži jedan spremnik s molekularnim sitom kao sredstvom za sušenje.
English: For a dose of 30 mg or 15 mg once daily, 15 mg and 30 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 i 30 mg.
English: Serious venous thromboembolic adverse reactions occurred in 5% of patients (treatment-emergent frequencies) (see section 4.8).
Croatian: Nuspojave ozbiljne venske tromboembolije javile su se u 5% bolesnika (učestalost nuspojava izazvanih liječenjem) (vidjeti dio 4.8).