FrancophonIA/ELRC3.0 huggingface dataset:
English: The major target organs for non-neoplastic lesions were the skin (epidermal hyperplasia), the growing teeth (degeneration/atrophy of the enamel organ of upper incisors and inflammation of the gingiva/odontogenic epithelium of incisors) and the thymus (increased incidence and/or severity of decreased lymphocytes).
Croatian: Glavni ciljni organi za ne-neoplastične lezije bili su koža (epidermalna hiperplazija), rastući zubi (degeneracija/atrofija cakline gornjih sjekutića i upala zubnog mesa/odontogenog epitela sjekutića) i timus (povećana incidencija i/ili težina smanjenja broja limfocita).
English: Tasigna contains lactose
Croatian: Tasigna sadrži laktozu
English: Table 4 Adverse reactions in adult patients in Tasigna clinical studies (<5% of all patients)
Croatian: Tablica 4 Nuspojave u odraslih bolesnika u kliničkim ispitivanjima Tasigne (<5% svih bolesnika)
English: Nilotinib is also a substrate for the multi-drug efflux pump, P-glycoprotein (P-gp).
Croatian: Nilotinib je također supstrat za P-glikoprotein (P-gp), efluks pumpu za mnoge lijekove.
English: What Tasigna is used for
Croatian: Za što se Tasigna koristi
English: Grapefruit juice and other foods that are known to inhibit CYP3A4 should be avoided.
Croatian: Treba izbjegavati sok od grejpa i drugu hranu za koju se zna da inhibira CYP3A4.
English: In adult patients with newly diagnosed CML in chronic phase The median duration of exposure was 60.5 months (range 0.1-70.8 months).
Croatian: Odrasli bolesnici s novodijagnosticiranim KML-om u kroničnoj fazi Medijan trajanja izloženosti lijeku bio je 60,5 mjeseci (raspon od 0,1-70,8 mjeseci).
English: Dose adjustment is not considered necessary in patients with hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem jetre.
English: Efficacy data in patients with CML-BC are not yet available.
Croatian: Podaci o djelotvornosti u bolesnika s KML-om u blastičnoj krizi još nisu dostupni.
English: Nilotinib is mainly metabolised in the liver with CYP3A4 expected to be the main contributor to the oxidative metabolism.
Croatian: Nilotinib se pretežno metabolizira u jetri pri čemu se očekuje da CYP3A4 daje glavni doprinos oksidativnom metabolizmu.
English: Eligible patients who discontinue nilotinib therapy must have their BCR-ABL transcript levels and complete blood count with differential monitored monthly for one year, then every 6 weeks for the second year, and every 12 weeks thereafter.
Croatian: Kod podobnih bolesnika koji prekinu terapiju nilotinibom moraju se pratiti razine BCR-ABL transkripcija i kompletna krvna slika s diferencijalnom krvnom slikom svakog mjeseca tijekom godine dana, zatim svakih 6 tjedana tijekom druge godine, a nakon toga svakih 12 tjedana.
English: - if you suffer from lack of potassium or magnesium.
Croatian: - ako patite od pomanjkanja kalija ili magnezija. - ako bolujete od poremećaja jetre ili gušterače.
English: Tasigna is available in a pack containing 120 hard capsules (3 packs of 40 hard capsules).
Croatian: Tasigna je dostupna u pakiranjima koja sadrže 120 tvrdih kapsula (3 pakiranja po 40 tvrdih kapsula).
English: Therefore the risk that nilotinib causes photosensitisation in patients is considered very low.
Croatian: Radi toga je rizik od fotosenzibilnosti uzrokovane nilotinibom vrlo nizak.
English: After discontinuation of nilotinib therapy within the framework of attempting TFR, patients may experience musculoskeletal symptoms more frequently than before treatment discontinuation, e.g., myalgia, pain in extremity, arthralgia, bone pain, spinal pain or musculoskeletal pain.
Croatian: Nakon prekida terapije nilotinibom u sklopu pokušaja ostvarivanja remisije bez liječenja (TFR), bolesnici bi mogli osjetiti mišićno-koštane simptome učestalije nego prije prekida liječenja, npr. mijalgiju, bol u ekstremitetima, artralgiju, bol u kostima, bol u kralježnici ili mišićno-koštanu bol.
English: In paediatric patients, the frequency, type and severity of adverse reactions observed have been generally consistent with those observed in adults, with the exception of the laboratory abnormalities hyperbilirubinaemia (Grade 3/4: 13.0%) and transaminase elevation (AST Grade 3/4: 1.4%, ALT Grade 3/4: 8.7%) which were reported at a higher frequency than in adult patients.
Croatian: U pedijatrijskih bolesnika učestalost, vrsta i težina opaženih nuspojava uglavnom su bile u skladu s onima opaženima kod odraslih, uz iznimku laboratorijskih abnormalnosti hiperbilirubinemije (3./4. stupnja: 13,0%) i povećane vrijednosti transaminaza (AST 3./4. stupnja: 1,4%, ALT 3./4. stupnja: 8,7%) koje su bile zabilježene s većom učestalošću nego kod odraslih bolesnika.
English: The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), 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: Nuspojave su podijeljene prema učestalosti u sljedeće kategorije: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: PVC/PVDC/Alu blisters
Croatian: PVC/PVDC/Al blisteri
English: This dose is achieved by taking two hard capsules of 200 mg twice a day.
Croatian: Ta doza se postiže uzimanjem dvije tvrde kapsule od 200 mg dva puta na dan.
English: In an interim analysis in a study in the CML paediatric population, with a median exposure of 33 months in each cohort (newly diagnosed and resistant or intolerant Ph+ CML-CP), growth retardation (crossing two main percentile lines from baseline) has been documented in 12.1%.
Croatian: U interim analizi u ispitivanju u pedijatrijskoj populaciji s KML-om, s medijanom izloženosti od 33 mjeseca u svakoj kohorti (novodijagnosticirani i rezistentni ili intolerantni s Ph+ KML-om u kroničnoj fazi), zastoj u rastu (veći od dvije glavne percentilne linije od početne vrijednosti) bio je zabilježen u 12,1% bolesnika.
English: Therefore, if necessary, an antacid may be administered approximately 2 hours before or approximately 2 hours after the dose of Tasigna.
Croatian: Stoga se, ako je potrebno, antacid može primijeniti oko 2 sata prije ili oko 2 sata nakon doze Tasigne.
English: Separate treatment arms were also included in the Phase II study to investigate Tasigna in a group of CP and AP patients who had been extensively pre-treated with multiple therapies including a tyrosine kinase inhibitor agent in addition to imatinib.
Croatian: Odvojeni kraci liječenja također su bili uključeni u fazu II ispitivanja kako bi se ispitala Tasigna u skupini bolesnika u kroničnoj i ubrzanoj fazi koji su ranije bili liječeni mnogobrojnim lijekovima, uključujući inhibitore tirozin kinaze uz dodatak imatinibu.
English: The apparent elimination half-life estimated from the multiple-dose pharmacokinetics with daily dosing was approximately 17 hours.
Croatian: Prividno poluvrijeme eliminacije procijenjeno je na približno 17 sati prema farmakokinetici višestrukih doza pri doziranju jednom dnevno.
English: The proportion of patients who had a molecular response of ≤0.01% and ≤0.0032% by IS at different time points are presented in Table 8 and the proportion of patients who had a molecular response of ≤0.01% and ≤0.0032% by IS by different time points are presented in Figures 2 and 3.
Croatian: Udio bolesnika čiji je molekularni odgovor bio ≤0,01% i ≤0,0032% prema međunarodnoj ljestvici u različitim vremenskim točkama prikazan je u Tablici 8, dok je udio bolesnika čiji je molekularni odgovor bio ≤0,01% i ≤0,0032% prema međunarodnoj ljestvici u različitim vremenskim točkama prikazan na Slikama 2 i 3.
English: Clinical studies have excluded patients with alanine transaminase (ALT) and/or aspartate transaminase (AST) >2.5 (or >5, if related to disease) times the upper limit of the normal range and/or total bilirubin >1.5 times the upper limit of the normal range.
Croatian: Bolesnici s vrijednostima alanin transaminaze (ALT) i/ili aspartat transaminaze (AST) >2,5 (ili >5 ako je povezano s bolešću) i/ili ukupnog bilirubina >1,5 puta većim od gornje granice referentnog raspona bili su isključeni iz kliničkih ispitivanja.
English: Of the 190 patients who entered the TFR phase, 98 patients (51.6% [95% CI: 44.2, 58.9]) were in MMR at 48 weeks.
Croatian: Od 190 bolesnika koji su ušli u TFR fazu, 98 bolesnika (51,6% [95% CI: 44,2; 58,9]) bilo je u MMR-u u 48. tjednu.
English: No decrease from baseline in mean left ventricular ejection fraction (LVEF) was observed at any time during treatment.
Croatian: U bilo kojem trenutku tijekom liječenja nije bio zapažen pad srednje ejekcijske frakcije lijeve klijetke (LVEF - engl. left ventricular ejection fraction) u odnosu na početnu vrijednost.
English: Elevated serum lipase: For Grade 3-4 serum lipase elevations, doses in adult patients should be reduced to 400 mg once daily or interrupted.
Croatian: Povećanje vrijednosti serumske lipaze: kod povećanja vrijednosti serumske lipaze 3.-4. stupnja, u odraslih bolesnika dozu treba smanjiti na 400 mg jedanput na dan ili prekinuti doziranje.
English: In resistant or intolerant CML patients, the cumulative MMR rate was 47.7% by cycle 12.
Croatian: U bolesnika s KML-om s rezistencijom ili intolerancijom, kumulativna stopa MMR-a bila je 47,7% do 12. ciklusa.
English: Severe forms of drug-related fluid retention such as pleural effusion, pulmonary oedema, and pericardial effusion were uncommonly (0.1 to 1%) observed in a Phase III study of newly diagnosed CML patients.
Croatian: Teški oblici zadržavanja tekućine povezani s primjenom lijeka kao što su pleuralni izljev, plućni edem i perikardijalni izljev bili su manje često (0,1 do 1%) uočeni u ispitivanju faze III na bolesnicima s novodijagnosticiranim KML-om.
English: In healthy volunteers, Cmax and area under the serum concentration-time curve (AUC) of nilotinib are increased by 112% and 82%, respectively, compared to fasting conditions when Tasigna is given with food.
Croatian: U zdravih dobrovoljaca, Cmax povećan je za 112%, a površina ispod krivulje serumske koncentracije u ovisnosti o vremenu (AUC) za 82%, uspoređujući uzimanje Tasigne natašte i sa hranom.
English: 230 mg/m once daily, and recovery to Grade 1 takes longer than 28 days, treatment should be discontinued.
Croatian: Ako je prijašnja doza bila 230 mg/m jedanput na dan, a oporavak do ≤1. stupnja traje duže od 28 dana, liječenje treba trajno obustaviti.
English: Appropriate monitoring and dose adjustment may be necessary for medicinal products that are CYP3A4 substrates and have a narrow therapeutic index (including but not limited to alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, sirolimus and tacrolimus) when co-administered with nilotinib.
Croatian: Moglo bi biti potrebno odgovarajuće praćenje i prilagođavanje doze lijekova koji su supstrati CYP3A4 i imaju uzak terapijski indeks (uključujući, između ostalih, alfentanil, ciklosporin, dihidroergotamin, ergotamin, fentanil, sirolimus i takrolimus) kada se primjenjuju istodobno s nilotinibom.
English: In patients for whom CYP3A4 inducers are indicated, alternative agents with less enzyme induction potential should be selected.
Croatian: U bolesnika u kojih je indicirana primjena induktora CYP3A4 treba primijeniti druge lijekove koji imaju manji potencijal indukcije enzima.
English: Single-dose administration of 400 mg nilotinib, using 2 hard capsules of 200 mg whereby the content of each hard capsule was dispersed in one teaspoon of apple sauce, was shown to be bioequivalent with a single-dose administration of 2 intact hard capsules of 200 mg.
Croatian: Pokazalo se da je primjena jednokratne doze od 400 mg nilotiniba koristeći 2 tvrde kapsule od 200 mg kod kojih je sadržaj svake tvrde kapsule pomiješan u jednoj čajnoj žličici kaše od jabuke bioekvivalentna primjeni jednokratne doze od 2 neotvorene tvrde kapsule od 200 mg.
English: Not more than one teaspoon of apple sauce and no food other than apple sauce must be used (see sections 4.4 and 5.2).
Croatian: Ne smije se uzeti više od jedne čajne žličice kaše od jabuke niti bilo koja druga hrana osim kaše od jabuke (vidjeti dijelove 4.4 i 5.2).
English: Biochemistry parameters - Elevated creatinine - Elevated lipase - Elevated SGOT (AST) - Elevated SGPT (ALT) - Hypophosphataemia - Elevated bilirubin (total) - Elevated glucose - Elevated cholesterol (total) - Elevated triglycerides *Percentages with one decimal precision are used and rounded to integer for presentation in this table.
Croatian: Biokemijski parametri - Povišenje kreatinina - Povišenje lipaze - Povišenje SGOT (AST) - Povišenje SGPT (ALT) - Hipofosfatemija - Povišenje bilirubina (ukupnog) - Povišena glukoza - Povišeni kolesterol (ukupni) - Povišeni trigliceridi *Postotci s točnošću od jedne decimale su zaokruženi na cijeli broj u svrhu navođenja u ovoj tablici.
English: Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Croatian: Potreban je oprez u bolesnika s relevantnim srčanim poremećajima (vidjeti dio 4.4).
English: 392 hard capsules
Croatian: 392 tvrde kapsule
English: Increased exposure to nilotinib might also be expected with moderate CYP3A4 inhibitors.
Croatian: Povećana izloženost nilotinibu može se također očekivati s umjerenim inhibitorima CYP3A4.
English: This dose is achieved by taking two hard capsules of 150 mg twice a day.
Croatian: Ta doza se postiže uzimanjem dvije tvrde kapsule od 150 mg dva puta na dan.
English: ANC* <0.5 x 10
Croatian: ABN* <1,0 x 10
English: Single dose administration of 200 mg of nilotinib resulted in increases in AUC of 35%, 35% and 19% in subjects with mild, moderate and severe hepatic impairment, respectively, compared to a control group of subjects with normal hepatic function.
Croatian: Jednokratno primijenjena doza od 200 mg nilotiniba dovela je do povećanja AUC-a od 35% u ispitanika s blagim, 35% u ispitanika s umjerenim i 19% u ispitanika s teškim oštećenjem jetre u usporedbi s kontrolnom skupinom ispitanika s normalnom funkcijom jetre.
English: MMRat 12 months Response (95% CI) MMR at 24 months Response (95% CI) MMR at 36 months Response (95% CI) MMR at 48 months Response (95% CI) MMR at 60 months Response (95% CI) MMR at 72 months Response (95% CI) Cochran-Mantel-Haenszel (CMH) test p-value for response rate (vs. imatinib 400 mg) <0.0001 Only patients who were in MMR at a specific time point are included as responders for that time point.
Croatian: MMR u 12. mjesecu Odgovor (95% CI) MMR u 24. mjesecu Odgovor (95% CI) MMR u 36. mjesecu Odgovor (95% CI) MMR u 48 mjesecu Odgovor (95% CI) MMR u 60. mjesecu Odgovor (95% CI) MMR u 72. mjesecu Odgovor (95% CI) P-vrijednost na temelju Cochran-Mantel-Haenszelovog (CMH) testa za stopu odgovora (u odnosu na imatinib 400 mg) <0,0001 Samo oni bolesnici koji su imali MMR u određenoj vremenskoj točki su uključeni kao osobe s odgovorom za tu vremensku točku.
English: Tasigna is also available in multipacks of: - 112 (4 wallets of 28) hard capsules.
Croatian: Tasigna je također dostupna u višestrukim pakiranjima od: - 112 (4 džepna pakiranja po 28) tvrdih kapsula.
English: Not more than one teaspoon of apple sauce and no food other than apple sauce must be used (see section 5.2).
Croatian: Ne smije se uzeti više od jedne čajne žličice kaše od jabuke niti bilo koja druga hrana osim kaše od jabuke (vidjeti dio 5.2).
English: Most of these adverse events were mild to moderate in severity.
Croatian: Većina ovih nuspojava bila je blaga do umjerena s obzirom na težinu.
English: Total* (n=137)
Croatian: Ukupno* (n=137)
English: No sudden deaths or episodes of torsade de pointes (transient or sustained) were observed.
Croatian: Nisu primijećeni slučajevi iznenadne smrti ili epizode torsade de pointes (prolazne ili dugotrajne).
English: The majority of patients had a long history of CML that included extensive prior treatment with other antineoplastic agents, including imatinib, hydroxyurea, interferon, and some had even failed organ transplant (Table 11).
Croatian: Većina bolesnika dulje je bolovala od KML-a, uz opsežno prethodno liječenje antineoplasticima, uključujući imatinib, hidroksiureju, interferon, dok je u nekih bolesnika učinjena transplantacija koštane srži ali neuspješno (Tablica 11).
English: In CML patients, nilotinib administered at 400 mg twice daily for 12 days increased the systemic exposure (AUC and Cmax) of oral midazolam (a substrate of CYP3A4) 2.6-fold and 2.0-fold, respectively.
Croatian: U bolesnika s KML-om, nilotinib primijenjen u dozi od 400 mg dvaput na dan tijekom 12 dana povećao je sistemsku izloženost (AUC i Cmax) peroralnom midazolamu (supstratu CYP3A4) 2,6 puta, odnosno 2,0 puta.
English: One resistant or intolerant CML patient progressed to AP/BC after about 10 months on treatment.
Croatian: U jednog je rezistentnog ili intolerantnog bolesnika s KML-om došlo do napredovanja do ubrzane faze/blastične krize nakon otprilike 10 mjeseci liječenja.
English: Inter-patient variability in nilotinib pharmacokinetics was moderate to high.
Croatian: Razlike u farmakokinetici nilotiniba među bolesnicima bile su umjereno do visoko izražene.
English: Nilotinib therapy should be re-initiated at either 300 mg or 400 mg twice daily.
Croatian: Terapiju nilotinibom potrebno je ponovno započeti u dozi od ili 300 mg ili 400 mg dvaput na dan.
English: In the 26-week Tg.rasH2 mouse carcinogenicity study, in which nilotinib was administered at 30, 100 and 300 mg/kg/day, skin papillomas/carcinomas were detected at 300 mg/kg, representing approximately 30 to 40 times (based on AUC) the human exposure at the maximum approved dose of 800 mg/day (administered as 400 mg twice daily).
Croatian: U 26-tjednom ispitivanju karcinogenosti na Tg.rasH2 miševima, u kojem je nilotinib primjenjivan u dozi od 30, 100 i 300 mg/kg/dan, otkriveni su kožni papilomi/karcinomi pri 300 mg/kg, što predstavlja otprilike 30 do 40 puta (temeljeno na AUC-u) veću izloženost od one u ljudi pri najvišoj odobrenoj dozi od 800 mg/dan (primijenjenoj kao 400 mg dvaput dnevno).
English: Thereafter, if the prior dose was 230 mg/m twice daily, treatment can be resumed at 230 mg/m once daily.
Croatian: Nakon toga, ako je prijašnja doza bila 230 mg/m dva puta na dan, liječenje se može nastaviti u dozi od 230 mg/m jedanput na dan.
English: - the level of sugar and fats in the blood.
Croatian: Oni su važni za funkciju srca. - razina šećera i masnoća u krvi.
English: Resistant
Croatian: Rezistencija
English: The hard capsules are red.
Croatian: Tvrde kapsule su crvene boje.
English: Total (n=321)
Croatian: Ukupno (n=321)
English: In the newly diagnosed CML patients, the MMR rate was 60.0% (95% CI: 38.7, 78.9) at 12 cycles, with 15 patients achieving MMR.
Croatian: U novodijagnosticiranih bolesnika s KML-om, stopa MMR-a bila je 60,0% (95% CI: 38,7; 78,9) nakon 12 ciklusa, pri čemu je 15 bolesnika postiglo MMR.
English: Dizziness, hypoaesthesia, peripheral neuropathy
Croatian: Omaglica, hipoestezija, periferna neuropatija
English: Among the 21 resistant or intolerant CML patients who were in MMR at any time on treatment, the median time to first MMR was 2.76 months (95% CI: 0.03, 5.55).
Croatian: Među 21 rezistentnim ili intolerantnim bolesnikom s KML-om koji su bili u MMR-u u bilo kojem trentuku tijekom terapije, medijan vremena do prvog MMR-a bio je 2,76 mjeseci (95% CI: 0,03; 5,55).
English: If event occurs after dose reduction, consider discontinuing treatment.
Croatian: Ako do nuspojave dođe nakon smanjenja doze, razmotriti trajni prekid liječenja.
English: Folliculitis, upper respiratory tract infection (including pharyngitis, nasopharyngitis, rhinitis)
Croatian: Folikulitis, infekcija gornjeg dišnog sustava (uključujući faringitis, nazofaringitis, rinitis)
English: Of the 126 patients who entered the TFR phase, 73 patients (57.9%, [95% CI: 48.8, 66.7]) had no loss of MMR, no confirmed loss of MR4.0, and no re-initiation of nilotinib within 48 weeks.
Croatian: Od 126 bolesnika koji su ušli u TFR fazu, u 73 bolesnika (57,9%, [95% CI: 48,8; 66,7]) nije došlo do gubitka MMR-a, nije došlo do potvrđenog gubitka MR4,0 ni do ponovnog početka terapije nilotinibom unutar 48 tjedana.
English: Use in adults - The recommended dose is 800 mg per day.
Croatian: Primjena u odraslih - Preporučena doza je 800 mg na dan.
English: There are no data in newly diagnosed paediatric patients below 10 years of age and limited data in imatinib-resistant or intolerant paediatric patients below 6 years of age.
Croatian: Nema podataka u novodijagnosticiranih pedijatrijskih bolesnika mlađih od 10 godina, a podaci su ograničeni za pedijatrijske bolesnike s rezistencijom ili intolerancijom na imatinib koji su mlađi od 6 godina.
English: The exposure to nilotinib in healthy subjects was increased 3-fold when co-administered with the strong CYP3A4 inhibitor ketoconazole.
Croatian: Izloženost nilotinibu u zdravih ispitanika bila je 3 puta veća pri istodobnoj primjeni snažnog inhibitora CYP3A4 ketokonazola.
English: For the 17 newly diagnosed CML patients who achieved MMR, the median time to first MMR was 5.55 months (95% CI: 5.52, 5.75).
Croatian: Za 17 bolesnika s novodijagnosticiranim KML-om koji su postigli MMR, medijan vremena do prvog MMR-a bio je 5,55 mjeseci (95% CI: 5,52; 5.75).
English: In a healthy volunteer study with exposures that were comparable to the exposures observed in patients, the time-averaged mean placebo-subtracted QTcF change from baseline was 7 msec (CI ± 4 msec).
Croatian: U ispitivanju zdravih dobrovoljaca u kojih je izloženost bila usporediva s izloženošću u bolesnika, vremenski uprosječena srednja vrijednost placebo-oduzete QTcF promjene u odnosu na početnu vrijednost bio je 7 msek (CI ± 4 msek).
English: Table 1 Paediatric dosing scheme of nilotinib 230 mg/m twice daily
Croatian: Tablica 1 Prikaz pedijatrijskog doziranja nilotiniba 230 mg/m dva puta na dan
English: By 5 years
Croatian: Do 5. godine
English: Exposure to nilotinib in females at No-Observed-Adverse-Effect-Levels was generally less or equal to that in humans at 800 mg/day.
Croatian: Izloženost nilotinibu u ženki uz doze pri kojima se ne zamjećuje štetno djelovanje (No-Observed-Adverse-Effect-Level) u pravilu je niže ili jednako izloženosti u ljudi uz dozu od 800 mg/dan.
English: Efficacy was based on 321 CP patients and 137 AP patients enrolled.
Croatian: Djelotvornost će se određivati na 321 uključenom bolesniku u kroničnoj fazi i 137 uključenih bolesnika u ubrzanoj fazi.
English: Blood glucose levels should be assessed prior to initiating nilotinib therapy and monitored during treatment.
Croatian: Potrebno je ocijeniti razine glukoze u krvi prije početka liječenja nilotinibom te ih pratiti tijekom liječenja.
English: - if you develop chest pain or discomfort, numbness or weakness, problems with walking or with your speech, pain, discolouration or a cool feeling in a limb, tell your doctor immediately as this may be a sign of a cardiovascular event.
Croatian: - ako se kod Vas razvije bol ili nelagoda u prsnom košu, utrnulost ili slabost, problemi s hodom ili govorom, bol, promjena boje ili osjećaj hladnoće u udovima, odmah obavijestite o tome svog liječnika, jer bi to mogao biti znak srčanožilnog događaja.
English: Table 4 Adverse reactions in adult patients in the Tasigna Phase III study (<5% of all patients)
Croatian: Tablica 4 Nuspojave u odraslih bolesnika u fazi III kliničkih ispitivanja Tasigne (<5% svih bolesnika)
English: PA/Alu/PVC/Alu blisters
Croatian: PA/Al/PVC/Al blisteri
English: Among resistant or intolerant CML patients, the percentage of patients who achieved BCR-ABL/ABL ≤0.01% IS (MR4.0) by the cut-off date was 11.4%, while 4.5% of the patients achieved BCR-ABL/ABL ≤0.0032% IS (MR4.5).
Croatian: Među rezistentnim ili intolerantnim bolesnicima s KML-om, postotak bolesnika koji su postigli BCR-ABL/ABL ≤0,01% IS (MR4,0) do isključnog datuma bio je 11,4%, dok je 4,5% bolesnika postiglo BCR-ABL/ABL ≤0,0032% IS (MR4,5).
English: Hepatic impairment has a modest effect on the pharmacokinetics of nilotinib.
Croatian: Oštećenje jetre ima skroman učinak na farmakokinetiku nilotiniba.
English: How much Tasigna to take
Croatian: Koliko Tasigne uzeti