FrancophonIA/ELRC3.0 huggingface dataset:
English: For doses of 400 mg and above (see dosage recommendation above) a 400 mg tablet (not divisible) is available.
Croatian: Za doze od 400 mg i više (vidi niže navedenu preporuku doziranja) dostupna je tableta od 400 mg (koja se ne može podijeliti).
English: NEL Same criteria as for CHR but ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB,
Croatian: NEL Isti kriteriji kao i za CHR, ali je ABN ≥1 x 109/l i/ili trombociti ≥20 x 109/l RTC <15% blasta u KS i PK, <30% blasta+promijelocita u KS i PK, <20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri.
English: Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation.
Croatian: Pozitivni su genotoksični učinci dobiveni za imatinib u in vitro testu na stanicama sisavca (jajnik kineskog hrčka) na klastogenost (aberacija kromosoma) u prisutnosti metaboličke aktivacije.
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 120 film-coated tablets 180 film-coated tablets
Croatian: 10 filmom obloženih tableta 20 filmom obloženih tableta 30 filmom obloženih tableta 60 filmom obloženih tableta 90 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta
English: In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP.
Croatian: Učinkovitost imatiniba u odraslih i pedijatrijskih bolesnika temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez napredovanja bolesti u bolesnika sa KML-om, na hematološkim i citogenetskim stopama odgovora u bolesnika s Ph+ ALL-om i MDS/MPD-om, na hematološkim stopama odgovora u bolesnika s HES/KEL-om i na objektivnim stopama odgovora u odraslih bolesnika s inoperabilnim i/ili metastazirajućim DFSP-om.
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Croatian: Bubrežni adenom/karcinom, papilom mokraćnog mjehura i uretre, adenokarcinomi tankog crijeva, adenomi paratireoidnih žlijezda, dobroćudni i zloćudni medularni tumori nadbubrežnih žlijezda i papilomi/karcinomi nežljezdanog dijela želuca zabilježeni su uz 60 mg/kg/dan, što odgovara otprilike 1,7 odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 1,2 puta dnevne izloženosti u djece (temeljeno na AUC) kod 340 mg/m2/dan.
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events.
Croatian: Imatinib je također inhibitor receptorskih tirozin kinaza za faktor rasta koji potječe od trombocita (PDGF), PDGF-R, te inhibira stanične događaje do kojih dolazi posredstvom PDGF-a.
English: MESNA IV days 29-33
Croatian: MESNA i.v., dani 29-33
English: What Imatinib Actavis contains
Croatian: Što Imatinib Actavis sadrži
English: For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Croatian: Bolesnicima koji ne mogu progutati filmom obložene tablete, sadržaj tablete se može otopiti u čaši obične vode ili soka od jabuke.
English: Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Croatian: Pokazalo se da je imatinib in vitro kompetitivni inhibitor supstrata markera za CYP2C9, CYP2D6 i
English: Each film-coated tablet contains 0.19 mg lecithin (soya) (E322) Imatinib Actavis 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate).
Croatian: Svaka filmom obložena tableta sadrži 0,19 mg sojinog lecitina (E322) Imatinib Actavis 400 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: Pack containing either 10, 30, 60, or 90 capsules.
Croatian: Pakiranje sadrži 10, 30, 60 ili 90 kapsula.
English: No new target organs were identified in the rat juvenile development toxicology study (day 10 to 70 postpartum) with respect to the known target organs in adult rats.
Croatian: Nisu bili uočeni novi ciljni organi u toksikološkom ispitivanju juvenilnog razvoja u štakora (10 do 70
English: Hepatitis B reactivation*
Croatian: Ponovna aktivacija hepatitisa B *
English: If you forget to take Imatinib Actavis
Croatian: Ako ste zaboravili uzeti Imatinib Actavis
English: If this applies to you, tell your doctor without taking Imatinib Actavis.
Croatian: Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib Actavisa.
English: This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Croatian: Ovo je kliničko ispitivanje uključivalo 7 bolesnika s MDS/MPD-om koji su liječeni imatinibom 400 mg na dan.
English: A further 6 DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Croatian: U 5 objavljenih prikaza slučajeva zabilježeno je dodatnih 6 bolesnika s DFSP-om liječenih imatinibom, s rasponom starosti od 18 mjeseci do 49 godina.
English: Weight increased
Croatian: Povećana tjelesna težina
English: - Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
Croatian: - mučnina uz gubitak apetita, tamno obojenje mokraće, žutilo kože ili očiju (znakovi problema s jetrom).
English: The age of these patients ranged from 2 to 79 years.
Croatian: Starost tih bolesnika se kretala od 2 do 79 godina.
English: In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8).
Croatian: U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om zabilježena su i gastrointestinalna i intratumorska krvarenja (vidjeti dio 4.8).
English: G-CSF (5 μg/kg, SC): days 34-43
Croatian: G-CSF (5 μg/kg, s.c.): dani 34-43
English: L-ASP (6000 IUnits/m2, IM): day 44
Croatian: L-ASP (6000 IU/m2, i.m.): dan 44
English: Haemolytic anaemia, thrombotic microangiopathy
Croatian: Hemolitička anemija, trombotična mikroangiopatija
English: Very common (may affect more than 1 in 10 people): - Headache or feeling tired.
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba): - glavobolja ili umor.
English: This clinical effect was associated with a higher reduction in bcrabl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Croatian: Ovaj klinički učinak povezan je s većim smanjenjem u bcr-abl transkripciji u bolesnika liječenih imatinibom, nego u kraku koji je primao kemoterapiju, nakon 2 tjedna terapije
English: The suspension should be administered immediately after complete disintegration of the tablet(s).
Croatian: Lijek se mora iskoristiti odmah nakon potpunog otapanja tablete.
English: 10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Croatian: 10 Mišićno-koštana bol i srodni događaji su češće uočeni u bolesnika s KML-om, nego u GIST
English: If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.
Croatian: Ako citopenija ustraje 2 tjedna, dozu dodatno smanjiti na 200 mg/m2.
English: The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Croatian: Sigurnost i djelotvornost imatiniba u djece s MDS/MPD-om, DFSP-om i HES/KEL-om mlađe od 18
English: DAUN (45 mg/m2/day bolus, IV): days 1 and 2
Croatian: DAUN (45 mg/m2/dan bolus, i.v.): dani 1 i 2
English: The age of these patients ranged from 25 to 72 years.
Croatian: Starost tih bolesnika kretala se od 25 do 72 godine.
English: Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
Croatian: Svrbež, edem lica, suhoća kože, eritem, alopecija, noćno znojenje, reakcija preosjetljivosti na svjetlo
English: The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Croatian: AUC imatiniba u plazmi smanjio se za 73% u usporedbi s bolesnicima koji nisu primali antiepileptičke lijekove koji induciraju enzime.
English: Acute respiratory failure11*, interstitial lung disease*
Croatian: Akutno zatajenje disanja11*, intersticijska plućna bolest* Poremećaji probavnog sustava Vrlo često
English: Paediatric chronic phase CML (at dose 340 mg/m2)
Croatian: Pedijatrijska kronična faza KML-a (doza od 340 mg/m2)
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2.).
English: A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Croatian: Opsežno međunarodno otvoreno i nekontrolirano ispitivanje faze II provedeno je u bolesnika s KMLom s pozitivnim Philadelphia (Ph+) kromosomom u fazi blastične krize.
English: 30 hard capsules 90 hard capsules
Croatian: 30 tvrdih kapsula 90 tvrdih kapsula
English: For doses other than 400 mg and 800 mg (see dosage recommendation above) a 100 mg divisible tablet is available.
Croatian: Za doze, osim 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) dostupna je tableta od 100 mg koja se može prepoloviti
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg.
Croatian: Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 400 mg.
English: - If you are being treated for HES/CEL:
Croatian: - Ako se liječite zbog HES/KEL-a:
English: F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Croatian: F1 fertilnost, dok je pri 45 mg/kg/dan zapažen povećani broj resorpcija i smanjeni broj fetusa sposobnih za život.
English: The dose can be reduced if not tolerated (see sections 4.2 and 5.2).
Croatian: Doza se može smanjiti ako se ne podnosi (vidjeti dijelove 4.2 i 5.2).
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis,
Croatian: Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis,
English: The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Croatian: Najčešće zabilježene nuspojave (≥10%) koje su povezane s primjenom lijeka, bile su u obje situacije blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
English: Resume treatment with imatinib at 600 mg.
Croatian: Ponovno uvesti liječenje imatinibom u dozi od 600 mg.
English: Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.
Croatian: Unutar svake grupe učestalosti nuspojave su prikazane prema redosljedu učestalosti, najučestalije su prve.
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m2.
Croatian: Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 260 mg/m2.
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Croatian: Papilom/karcinom žlijezde prepucija/klitorisa su zabilježeni pri dozama od 30 mg/kg/dan na više, što odgovara otprilike 0,5, odnosno 0,3 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 0,4 puta dnevne izloženosti u djece (temeljeno na AUC) kod
English: When and how to take Imatinib Actavis
Croatian: Kada i kako uzimati Imatinib Actavis
English: Induction therapy (de novo Ph+ ALL)
Croatian: Indikcijska terapija (de novo Ph+ ALL)
English: Patients should be advised that they may experience undesirable effects such as dizziness,blurred vision or somnolence during treatment with imatinib.
Croatian: Bolesnike treba obavijestiti o postojanju mogućnosti da tijekom liječenja imatinibom nastupe nuspojave poput omaglice, zamagljenog vida ili somnolencije.
English: Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Croatian: Povećanje doze od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s blastičnom krizom može se razmotriti u odsustvu teške nuspojave i teške neutropenije ili trombocitopenije nepovezanih s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
English: The age of these patients ranged from 20 to 72 years.
Croatian: Starost tih bolesnika se kretala od 20 do 72 godine.
English: 11 Ion Mihalache Blvd Bucharest
Croatian: S.C. Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd Bucharest
English: Imatinib Actavis will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Croatian: Što morate znati prije nego počnete uzimati Imatinib Actavis Imatinib Actavis Vam može propisati jedino liječnik koji ima iskustva s lijekovima za liječenje raka krvi ili čvrstih tumora.
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
Croatian: Pustularni osip, kontuzije, pojačano znojenje, urtikarija, ekhimoza, povećana sklonost modricama, hipotrihoza, hipopigmentacija kože, eksfolijativni dermatitis, onihoklazija, folikulitis, petehije, psorijaza, purpura, hiperpigmentacija kože, bulozne erupcije
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane Često
English: 10 hard capsules 30 hard capsules 60 hard capsules 90 hard capusles
Croatian: 10 tvrdih kapsula 30 tvrdih kapsula 60 tvrdih kapsula 90 tvrdih kapsula
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
Croatian: 6-MP (75 mg/m2/dan, p.o.): dani 11-56 (Uskratiti 6-MP tijekom 6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1-og dana nakon završetka kranijalne iradijacije.)
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Croatian: Slični rezultati su uočeni u bolesnika s malignim gliomima koji su liječeni imatinibom dok su uzimali antiepileptičke lijekove koji induciraju enzime, poput karbamazepina,
English: There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
Croatian: U KML bolesnika uočen je veći postotak mijelosupresije, nego u bolesnika s GIST-om, što je vjerojatno uzrokovano osnovnom bolešću.
English: Patients were treated at doses of imatinib of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Croatian: Bolesnici su liječeni dozama imatiniba od 260 mg/m2/dan (n=5), 340 mg/m2/dan (n=9),
English: Events that have been reported at different dose ranges are as follows:
Croatian: Zabilježeni su sljedeći događaji s različitim rasponima doza: Populacija odraslih osoba
English: - Bruising.
Croatian: - modrice.
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Croatian: U bolesnika u kojih je obavljena tireoidektomija i koji primaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena, kada se imatinib istodobno primjenjuje (vidjeti dio 4.4).
English: Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
Croatian: Tvari koje inhibiraju djelovanje CYP3A4 izoenzima citokroma P450 (npr. inhibitori proteaze kao što su indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotici uključujući ketokonazol, itrakonazol, posakonazol, vorikonazol; određeni makrolidi kao što su eritromicin, klaritromicin i telitromicin) mogle bi smanjiti metabolizam i povećati koncentracije imatiniba.
English: monthly for 13 months; prednisolone 200 mg oral, 5 days per month for 13 months
Croatian: VCR 2 mg i.v. mjesečno tijekom 13 mjeseci; prednizolon 200 mg peroralno, 5 dana na mjesec tijekom 13 mjeseci
English: Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Croatian: Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra, žlijezda prepucija i klitorisa, tanko crijevo, paratireoidne žlijezde, nadbubrežne žlijezde i ne-žljezdani želudac.
English: If cytopenia persists for 2 weeks, reduce further to 300 mg.
Croatian: Ako citopenija ustraje 2 tjedna, dozu ponovno smanjiti na 300 mg.
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Croatian: U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL-om je liječeno imatinibom od 100 mg do 1000 mg na dan.
English: - If you are being treated for DFSP:
Croatian: Ako se liječite zbog DFSP-a:
English: There is very limited experience in children with MDS/MPD, DFSP, and HES/CEL.
Croatian: Postoji vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om i
English: Maximal plasma concentrations of imatinib in patients are 2-4 μmol/L, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered drugs is possible.
Croatian: Maksimalne koncentracije imatiniba u plazmi bolesnika iznose 2-4 μmol/l pa je prema tome moguζa inhibicija metabolizma istodobno primijenjenih lijekova, koji se odvija posredstvom CYP2D6 i/ili CYP3A4/5.
English: HES/CEL (at dose 400 mg)
Croatian: HES/KEL (doza od 400 mg)
English: Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Croatian: Liječenje imatinibom izazvalo je brzi odgovor u novodijagnosticiranih pedijatrijskih KML bolesnika sa CHR-om od 78%
English: - The active substance is imatinib (as mesilate).
Croatian: - Djelatna tvar je imatinib (u obliku imatinibmesilata).
English: Consolidation therapy
Croatian: Konsolidacijska terapija
English: - Rash.
Croatian: - osip.
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Croatian: Dodatnih 162 bolesnika s HES/KEL-om, zabilježenih u 35 objavljenih prikaza slučajeva i serija slučajeva, primalo je imatinib u dozama od 75
English: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Croatian: - odraslih i pedijatrijskih bolesnika s novodijagnosticiranom akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) uz kemoterapiju.
English: Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemiarelated neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Croatian: U djece se mogu razmotriti povećanja doze od 340 mg/m2 na dan do 570 mg/m2 na dan (ne smije se prekoračiti ukupna doza od 800 mg) u odsustvu teške nuspojave i teške neutropenije ili trombocitopenije nepovezanih s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
English: Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Croatian: GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
English: Hyperkalaemia, hypomagnesaemia
Croatian: Hiperkalijemija, hipomagnezijemija
English: - Dry mouth, dry skin or dry eye. - Decreased or increased skin sensitivity.
Croatian: - suha usta, suhoća kože ili suho oko. - smanjena ili povećana osjetljivost kože. - navale vrućine, zimica ili noćno znojenje.
English: However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/L) and thrombocytopenias (platelet count < 50 x 109/L) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Croatian: 4 (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (5964% i 4463% za neutropeniju odnosno trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7% neutropenija i 8,9% trombocitopenija).
English: In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses ≥ 6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
Croatian: U ispitivanju kod štakora koje je trajalo 13 tjedana zapažena je hiperplazija prijelaznog epitela u bubrežnoj papili te u mokraćnom mjehuru uz doze ≥6 mg/kg, bez promjena parametara za serum ili mokraću.
English: Weight decreased
Croatian: Smanjena tjelesna težina
English: EU/1/13/825/001 30 capsules EU/1/13/825/002 90 capsules
Croatian: EU/1/13/825/001 30 kapsula EU/1/13/825/002 90 kapsula
English: 1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
Croatian: 1 Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s