FrancophonIA/ELRC3.0 huggingface dataset:
English: • pain in skeletal system or neck
Croatian: • bol u kostima ili vratu
English: Table 4 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Croatian: Tablica 4 Nuspojave uočene u KML i Ph+ ALL bolesnika - učestalost prijavljena prema incidenciji događaja izazvanih liječenjem
English: In CP-CML patients who achieved MCyR, the median time to MCyR was 2.8 months (range: 1.6 to 11.3 months) and in patients who achieved MMR, the median time to MMR was 5.5 months (range: 1.8 to 55.5 months).
Croatian: Za bolesnike u kroničnoj fazi KML-a koji su postigli MCyR medijan vremena do postizanja MCyR iznosio je 2,8 mjeseci (raspon: 1,6 do 11,3 mjeseci), a u bolesnika koji su postigli MMR medijan vremena do postizanja MMR iznosio je 5,5 mjeseci (raspon: 1,8 do 55,5 mjeseci).
English: • a 15 mg film-coated tablet and a 30 mg film-coated tablet to allow for dose adjustments.
Croatian: • filmom obložene tablete od 15 mg i filmom obložene tablete od 30 mg za prilagođavanje doze.
English: The recommended starting dose is 45 mg of ponatinib once daily.
Croatian: Doziranje Preporučena početna doza iznosi 45 mg ponatiniba, jednom dnevno.
English: Women of childbearing potential/Contraception in males and females Women of childbearing age being treated with Iclusig should be advised not to become pregnant and men being treated with Iclusig should be advised not to father a child during treatment.
Croatian: Ženama reproduktivne dobi koje se liječe lijekom Iclusig treba savjetovati da ne zatrudne, a muškarcima koji se liječe lijekom Iclusiga također treba savjetovati da ne začnu dijete tijekom liječenja.
English: • inability to develop or maintain an erection
Croatian: • nesposobnost postizanja ili održavanja erekcije • zimica, bolest nalik gripi
English: Evidence for pre- and post-implantation loss of embryos was reported in female rats and ponatinib may therefore impair female fertility.
Croatian: U ženki štakora prijavljeni su dokazi gubitka zametaka prije i poslije implantacije, te stoga ponatinib može smanjiti plodnost ženki.
English: If decreased vision or blurred vision occurs, an ophthalmic examination (including fundoscopy) should be performed.
Croatian: Dođe li do slabljenja ili zamagljenja vida, potrebno je obaviti oftalmološki pregled (uključujući oftalmoskopiju).
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: Klinička djelotvornost i sigurnost primjene 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: Table 8 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Croatian: Tablica 8 Djelotvornost lijeka Iclusig u bolesnika u uznapredovaloj fazi KML koji su rezistentni ili ne podnose lijek Ubrzana faza KML
English: Arterial occlusions, including fatal myocardial infarction, stroke, retinal arterial occlusions associated in some cases with permanent visual impairment or vision loss, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, renal artery stenosis (associated with worsening, labile or treatment-resistant hypertension), and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Croatian: U bolesnika liječenih Iclusigom javile su se arterijske okluzije, uključujući i infarkt miokarda sa smrtnim ishodom, moždani udar, arterijske okluzije mrežnice u nekim slučajevima povezane s trajnim pogoršanjem vida ili gubitkom vida, stenozu velikih arterija u mozgu, tešku perifernu vaskularnu bolest, stenozu bubrežne arterije (povezanu s pogoršanjem hipertenzije, graničnom ili refraktornom hipertenzijom), te potrebu za hitnim postupkom revaskularizacije.
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-a 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: In the phase 2 trial (with a minimum of 64 months follow-up), venous thromboembolic adverse reactions have occurred in 6% of patients (treatment-emergent frequencies).
Croatian: U ispitivanju faze 2 (s minimalnim razdobljem praćenja od 64 mjeseca), nuspojave venske tromboembolije zabilježene su u 6% bolesnika (učestalost nuspojava izazvanih liječenjem).
English: • diarrhoea, vomiting, nausea
Croatian: • proljev, povraćanje, mučnina
English: The secondary efficacy endpoints in CP-CML were complete haematological response (CHR) and major molecular response (MMR).
Croatian: Sekundarni ishodi za bolesnike u kroničnoj fazi KML-a bili su kompletni hematološki odgovor i veliki molekularni odgovor (MMR, engl. major molecular response).
English: Achieved MCyR at 45 mg (N=86)
Croatian: Postignut MCyR pri 45 mg (N=86)
English: Bottles of Iclusig 15 mg contain either 30, 60 or 180 film-coated tablets.
Croatian: Boca Iclusiga 15 mg sadrži 30, 60 ili 180 filmom obloženih tableta.
English: The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 0.7 months (range: 0.4 to 5.8 months), 1.0 months (range: 0.4 to 3.7 months), and 0.7 months (range: 0.4 to 5.5 months),
Croatian: Medijan vremena do MaHR za bolesnike u ubrzanoj fazi, blastičnoj fazi i Ph+ ALL bio je 0,7 mjeseci (raspon: 0,4 do 5,8 mjeseci), 1,0 mjeseci (raspon: 0,4 do 3,7 mjeseci) i 0,7 mjeseci (raspon: 0,4 do 5,5 mjeseci).
English: A MCyR at the 3-month landmark correlated strongly and statistically significantly with PFS and OS (p<0.0001 and p=0.0006, respectively).
Croatian: MCyR na kontrolnoj točki od 3 mjeseca bio je u snažnoj i statistički značajnoj korelaciji s PFS-om i OS-om (p<0,0001
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Croatian: • proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije)
English: In the phase 2 trial, serious arterial occlusive adverse reactions occurred in 20% of patients (treatment-emergent frequencies).
Croatian: U ispitivanju faze 2, ozbiljne nuspojave arterijske okluzije javile su se u 20% bolesnika (učestalost nuspojava izazvanih liječenjem).
English: Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase
Croatian: Tablica 2 Prilagodba doze u slučaju pankreatitisa i povišenja serumske lipaze/amilaze
English: 6.6 Special precautions for disposal and other handling Disposal
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: The incidence of severe bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Croatian: Incidencija događaja teškog krvarenja bila je viša u bolesnika s AP-KML, BP-KML, i Ph+ ALL.
English: Of 43 CP-CML patients, 31 CP-CML patients achieved a MCyR with a median duration of follow-up of 55.5 months (range: 1.7 to 91.4 months).
Croatian: Od 43 bolesnika u kroničnoj fazi KML-a, 31 je postigao MCyR s medijanom praćenja od 55,5 mjeseci (raspon: 1,7 do
English: Resistant or Intolerant R/I Cohort (N=203)
Croatian: Rezistentan ili intolerantan R/I kohorta (N=203)
English: Very common rash, dry skin, pruritus
Croatian: Vrlo često osip, suha koža, pruritus
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
English: 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.
Croatian: Bolesnici u kroničnoj fazi KML-a 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.
English: The frequency of pancreatitis is greater in the first 2 months of use.
Croatian: Učestalost pankreatitisa je veća u prva
English: Overall arterial occlusive adverse reactions have occurred in 25% of Iclusig-treated patients from the phase 2 trial, with serious adverse reactions occurring in 20% of patients.
Croatian: U ispitivanju faze 2, nuspojave arterijske okluzije javile su se u ukupno 25% bolesnika liječenih Iclusigom, s ozbiljnim nuspojavama koje su se javile u 20% bolesnika.
English: The median duration of treatment with Iclusig was 32.2 months in CP-CML patients, 19.4 months in AP-CML patients, and 2.9 months in BP-CML/Ph+ ALL patients.
Croatian: Medijan trajanja liječenja Iclusigom bio je 32,2 mjeseca za bolesnike u kroničnoj fazi (CP-KML), 19,4 mjeseca za bolesnike u ubrzanoj fazi (AP-KML) i 2,9 mjeseci za bolesnike u blastičnoj fazi (BP-KML) /Ph+ ALL.
English: Arterial occlusion and venous thromboembolism
Croatian: Arterijska okluzija i venska tromboembolija
English: • obstruction of the blood vessels in the eye
Croatian: • začepljenje krvnih žila u oku
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
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
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: The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BPCML/Ph+ ALL than in patients with CP-CML (see Table 5).
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 5).
English: Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively (see section 4.8).
Croatian: Ozbiljne nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 10%, 7%, odnosno 9% bolesnika liječenih Iclusigom (vidjeti dio 4.8).
English: Discontinuation of ponatinib should be considered in patients who develop serious heart failure (see sections 4.2 and 4.8).
Croatian: Potrebno je razmotriti prekid davanja ponatiniba u bolesnika kod kojih se razvije ozbiljno zatajenje srca (vidjeti dijelove 4.2 i 4.8).
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-a (CP-KML).
English: Table 10 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 45 mg
Croatian: Tablica 10 Prvi štetni događaji vaskularne okluzije u bolesnika u kroničnoj fazi KML-a koji su postigli MCyR pri dozi od 45 mg ili 30 mg (podatci od 7. travnja 2014.)
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 64 months, the median duration of MaHR for AP-CML (median duration of treatment: 19.4 months) BP-CML (median duration of treatment: 2.9 months), and Ph+ ALL (median duration of treatment: 2.7 months) patients was estimated as 12.9 months (range: 1.2 to 68.4 months), 6.0 months (range: 1.8 to 59.6 months), and 3.2 months (range: 1.8 to 12.8 months), respectively.
Croatian: MaHR za bolesnike s AP-KML (medijan trajanja liječenja: 19,4 mjeseci), BP-KML (medijan trajanja liječenja: 2,9 mjeseci), i Ph+ ALL (medijan trajanja liječenja: 2,7 mjeseci) procijenjen je na 12,9 mjeseci (raspon: 1,2 do 68,4 mjeseca), 6,0 mjeseci (raspon: 1,8 do 59,6 mjeseci) i 3,2 mjeseca (raspon: 1,8 do 12,8 mjeseci).
English: Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 13%, 9%, and 11% of Iclusig-treated patients, respectively.
Croatian: Nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 13%, 9%, odnosno 11% bolesnika liječenih Iclusigom.
English: Bottles of Iclusig 30 mg contain 30 film-coated tablets.
Croatian: Boca Iclusiga 30 mg sadrži 30 filmom obloženih tableta.
English: CP-CML patients who received fewer prior TKIs attained higher cytogenetic, haematological, and molecular responses.
Croatian: Bolesnici u kroničnoj fazi KML-a koji su prethodno primali manje TKI terapija postigli su bolji citogenetičke, hematološke i molekularne odgovore.
English: Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased, acute coronary syndrome, atrial flutter
Croatian: Često zatajenje srca, infarkt miokarda, kongestivno zatajenje srca, bolest koronarnih arterija, angina pectoris, efuzija perikarda, fibrilacija atrija, smanjena ejekcijska frakcija, akutni koronarni sindrom, undulacija atrija
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Croatian: bolesnica mora biti obaviještena o potencijalnoj opasnosti za fetus.
English: 60 tablets
Croatian: 30 tableta
English: Dose reduction to 30 mg only ≥ 3 month reduction at 30 mg
Croatian: Bez smanjenja doze Smanjenje doze samo na 30 mg
English: • inflammation of hair follicles, swollen, red area of skin or underneath skin that feels hot and tender
Croatian: • upala folikula kose, natečena, crvena područja na površini kože ili ispod kože, vruća i osjetljiva na dodir • smanjena aktivnost štitne žlijezde
English: • lung infection (may cause breathing difficulty)
Croatian: • infekcija pluća (može izazvati otežano disanje)
English: Hepatic failure (including fatal outcome) has been observed.
Croatian: Uočeno je zatajenje jetre (uključujući i ono sa smrtnim ishodom).
English: Table 6 Demographics and disease characteristics
Croatian: Tablica 6 Demografske karakteristike te karakteristike bolesti Karakteristike bolesnika kod ulaska u ispitivanje
English: Uncommon cerebral artery stenosis, cerebral haemorrhage, haemorrhage intracranial, posterior reversible encephalopathy syndrome *
Croatian: Manje često stenoza cerebralne arterije, cerebralna hemoragija, intrakranijska hemoragija, sindrom posteriorne reverzibilne encefalopatije *
English: Cardiovascular status should continue to be monitored and medical and supportive therapy for conditions that contribute to cardiovascular risk should be optimised during treatment with ponatinib.
Croatian: Tijekom liječenja ponatinibom mora se nastaviti pratiti kardiovaskularno stanje i optimizirati medicinsko i suportivno liječenje za stanja koja doprinose kardiovaskularnom riziku.
English: Therefore, ponatinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) or BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine) and may increase their therapeutic effect and adverse reactions.
Croatian: kolhicina, pravastatina) ili BCRP (poput metotreksata, rosuvastatina, sulfasalazina) i može povećati njihov terapijski učinak i nuspojave.
English: For CP-CML patients overall (N=267), as well as for CP-CML R/I Cohort A patients (N=203) and T315I Cohort B patients (N=64), the median OS has not yet been reached.
Croatian: kohorte A (N=203) te bolesnike T315I kohorte B (N=64), medijan ukupnog preživljenja još nije postignut.
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 5% of patients.
Croatian: Ozbiljne nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 5% bolesnika.
English: • Iclusig should be resumed at 30 mg after recovery to ≤ Grade 1 (< 3 × ULN), or recovery to pre-treatment grade Occurrence at 30 mg:
Croatian: • Potrebno je nastaviti primjenu lijeka Iclusig s dozom od 30 mg nakon oporavka na ≤ stupanj 1 (< 3 x GGN) ili oporavka na stupanj prije liječenja Pojava uz 30 mg:
English: Iclusig 30 mg film-coated tablets are approximately 8 mm in diameter with "C7" on one side.
Croatian: Iclusig 30 mg filmom obložene tablete su promjera oko 8 mm s oznakom "C7" na jednoj strani.
English: Venous thromboembolic reactions (treatment-emergent frequencies) occurred in 6% of patients.
Croatian: Reakcije venske tromboembolije (učestalost nuspojava izazvanih liječenjem) javile su se u 6,0% bolesnika.
English: The incidence of thromboembolic events is higher in patients with Ph+ ALL or BP-CML than those with AP-CML or CP-CML.
Croatian: Incidencija tromboembolijskih događaja viša je u bolesnika s Ph+ALL ili BP-KML u odnosu na one s AP-KML-om ili CP-KML-om.
English: Iclusig 45 mg film-coated tablets EU/1/13/839/003
Croatian: Iclusig 45 mg filmom obložene tablete EU/1/13/839/003
English: Occurrence at 15 mg:
Croatian: Pojava uz 15 mg:
English: Arterial occlusion adverse events were more frequent with increasing age and in patients with history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Croatian: Štetni događaji arterijske okluzije bivali su češći s porastom godina i u bolesnika s anamnezom ishemije, hipertenzije, dijabetesa, ili hiperlipidemije.
English: Post-marketing cases of Posterior Reversible Encephalopathy Syndrome (PRES) have been reported in Iclusig-treated patients.
Croatian: Nakon stavljanja lijeka u promet, u bolesnika liječenih lijekom Iclusig prijavljeni su slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES).
English: • fluid in the thorax (may cause breathing difficulty)
Croatian: • tekućina u prsnom košu (može uzrokovati otežano disanje)
English: Also, post-hoc analyses to assess the relationship of shorter-term cytogenetic (MCyR) and molecular (MMR) response outcomes with longer-term outcomes of PFS and OS, maintenance of response (MCyR and MMR) after dose reductions, and PFS and OS by Arterial Occlusive Event status were conducted.
Croatian: Također, provedene su post hoc analize radi procjene odnosa ishoda kratkoročnih citogenetičkih (MCyR) i molekularnih (MMR) odgovora prema dugoročnim ishodima preživljenja bez napredovanja bolesti
English: Occurrence at 30 mg:
Croatian: Pojava uz 30 mg:
English: • a history of renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
Croatian: • anamnezu stenoze bubrežne arterije (suženje krvnih žila koje vode do jednog ili oba bubrega)
English: • upper airway infection (may cause breathing difficulty)
Croatian: • infekcija gornjih dišnih putova (može izazvati otežano disanje)
English: *ULN = Upper Limit of Normal for the lab
Croatian: Potrebno je prekinuti primjenu lijeka Iclusig *GGN = gornja granica normalnih vrijednosti laboratorija
English: Talk to your doctor or pharmacist before taking Iclusig if you have:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Iclusig ako imate: • poremećaj jetre ili gušterače ili smanjenu funkciju bubrega.
English: Iclusig 15 mg film-coated tablets EU/1/13/839/001
Croatian: Iclusig 15 mg filmom obložene tablete EU/1/13/839/001
English: Treatment-emergent hypertension (including hypertensive crisis) occurred in Iclusig-treated patients.
Croatian: U bolesnika liječenih Iclusigom javila se hipertenzija izazvana liječenjem (uključujući hipertenzivnu krizu).
English: Iclusig 30 mg film-coated tablets EU/1/13/839/006
Croatian: Iclusig 30 mg filmom obložene tablete EU/1/13/839/006
English: Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth, gastric haemorrhage
Croatian: Često pankreatitis, povišena amilaza u krvi, gastroezofagealna refluksna bolest, stomatitis, dispepsija, distenzija abdomena, nelagoda u abdomenu, suha usta, krvarenje iz želuca
English: Severe skin reactions (such as Stevens-Johnson Syndrome) have been reported with some BCR-ABL Tyrosine Kinase Inhibitors.
Croatian: U vezi s nekim inhibitorima BCR-ABL tirozin kinaze prijavljene su teške kožne nuspojave (poput Stevens-Johnsonova sindroma).
English: Other possible side effects that may occur with the following frequencies are:
Croatian: • povećana sklonost krvarenju ili nastajanju modrica Druge moguće nuspojave koje se mogu pojaviti sa sljedećom učestalosti su:
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: 50% vijabilnosti stanica koje eksprimiraju sve testirane mutacije BCR-ABL (uključujući T315I) i potiskivanje nadiranja mutantskih klonova.
English: Table 9 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Croatian: Tablica 9 Djelotvornost lijeka Iclusig u bolesnika s Ph+ ALL koji su rezistentni ili ne podnose lijek
English: A majority of these ongoing patients (82/110 patients; 75%) were reported to be receiving 15 mg at the last dose, while 24/110 patients (22%) were receiving 30 mg, and 4/110 (4%) were receiving 45 mg. At the time of study closure initiation (minimum follow-up of 64 months, and more than 3 years after the recommendation for prospective dose reduction), 99 CP-CML patients were ongoing and 77 (78%) of these patients received 15 mg as their last dose on study.
Croatian: Za većinu tih bolesnika (82/110 bolesnika; 75%) prijavljeno je da su kao zadnju dozu primali 15 mg, dok su 24/110 bolesnika (22%) primali 30 mg, a 4/110 (4%) 45 mg.
English: • had a prior heart attack or stroke
Croatian: • anamnezu srčanog ili moždanog udara
English: Cytogenetic Response Major (MCyR) a
Croatian: Značajni (MCyR) a
English: (95% CI) Major Molecular Response b
Croatian: Značajni molekularni odgovor b %
English: Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased, hyponatraemia
Croatian: hiperglikemija, hiperuricemija, hipofosfatemija, hipertrigliceridemija, hipokalijemija, smanjenje tjelesne težine, hiponatremija
English: 90 tablets
Croatian: 30 tableta 90 tableta
English: Table 11 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 6 February 2017) Achieved MCyR at 45 mg (N=86)
Croatian: MMR pri dozi od 45 mg (podatci od 06. veljače 2017.) Postignut MCyR pri 45 mg (N=86)
English: ≥ 18 month day reduction at 15 mg ≥ 24 month reduction at 15 mg 32
Croatian: ≥ 3 mjeseca smanjenje na 15 mg ≥ 6 mjeseci smanjenje na 15 mg ≥ 12 mjeseci smanjenje na 15 mg 44 ≥ 18 mjeseci smanjenje na 15 mg 38 ≥ 24 mjeseci smanjenje na 15 mg 32 ≥ 36 mjeseci smanjenje na 15 mg