FrancophonIA/ELRC3.0 huggingface dataset:
English: Alopecia, muscle spasms, decreased appetite, arthralgia, abdominal pain, bone pain, peripheral oedema, asthenia, upper abdominal pain, dry skin, erythema and pain in extremity were observed less commonly (<10% and ≥5%) and have been of mild to moderate severity (Grade 1 or 2).
Croatian: Alopecija, grčevi u mišićima, anoreksija, artralgija, bol u abdomenu, bol u kostima, periferni edem, astenija, bol u gornjem dijelu abdomena, suha koža, eritem i bol u udovima manje često (<10% i ≥5%) su zapaženi i bili su blagi do umjereni s obzirom na težinu (1. ili 2. stupanj).
English: No episodes of torsade de pointes (transient or sustained) were observed.
Croatian: Nisu primijećene epizode torsade de pointes (prolazne ili trajne).
English: Metabolism of nilotinib is mainly hepatic.
Croatian: Metabolizam nilotiniba većim se dijelom odvija preko jetre.
English: Patients were randomised 1:1:1 to receive either nilotinib 300 mg twice daily (n=282), nilotinib 400 mg twice daily (n=281) or imatinib 400 mg once daily (n=283).
Croatian: Bolesnici su bili randomizirani u odnosu 1:1:1 za primjenu ili nilotiniba u dozi od 300 mg dva puta na dan (n=282), nilotiniba u dozi od 400 mg dva puta na dan (n=281) ili imatiniba u dozi od 400 mg jedanput na dan (n=283).
English: If clinically appropriate, re-escalation of the dose to 300 mg twice daily in adult patients or to 230 mg/m twice daily in paediatric patients should be considered.
Croatian: Ako je klinički primjereno, može se razmotriti ponovno povećanje doze na 300 mg dva puta na dan u odraslih bolesnika ili na 230 mg/m dva puta na dan u pedijatrijskih bolesnika.
English: Daily systemic exposure to nilotinib with 400 mg twice-daily dosing at steady state was 35% higher than with 800 mg once-daily dosing.
Croatian: Dnevna sistemska izloženost nilotinibu uz dozu od 400 mg dva puta na dan u stanju dinamičke ravnoteže bila je 35% viša nego uz dozu od 800 mg jedanput na dan.
English: If your doctor recommends that you discontinue treatment with Tasigna Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether you should continue to take this medicine.
Croatian: Vaš će liječnik redovito ocjenjivati Vaše liječenje specifičnim dijagnostičkim testom i odlučiti trebate li nastaviti uzimati ovaj lijek.
English: Progression to accelerated phase or blast crisis on treatment was observed in a total of 17 patients: 2 patients on nilotinib 300 mg twice daily, 3 patients on nilotinib 400 mg twice daily and 12 patients on imatinib 400 mg once daily.
Croatian: Progresija u ubrzanu fazu ili blastičnu krizu pri liječenju je zapažena u ukupno 17 bolesnika: u 2 bolesnika koja su primala 300 mg nilotiniba dva puta na dan, u 3 bolesnika koji su primali 400 mg nilotiniba dva puta na dan i u 12 bolesnika koji su primali 400 mg imatiniba jedanput na dan.
English: Posology for Philadelphia chromosome positive CML adult patients The recommended dose is: - 300 mg twice daily in newly diagnosed patients with CML in the chronic phase, - 400 mg twice daily in patients with chronic or accelerated phase CML with resistance or intolerance to prior therapy.
Croatian: Doziranje za odrasle bolesnike s KML-om s pozitivnim Philadelphia kromosomom Preporučena doza je: - 300 mg dva puta na dan u novodijagnosticiranih bolesnika s KML-om u kroničnoj fazi, - 400 mg dva puta na dan u bolesnika u kroničnoj ili ubrzanoj fazi KML-a s rezistencijom ili intolerancijom na prethodno liječenje.
English: CCyR rate by 24 months (includes patients who achieved CCyR at or before the 24 month time point as responders) was statistically higher for both the nilotinib 300 mg twice daily and 400 mg twice daily groups compared to the imatinib 400 mg once daily group.
Croatian: Stopa CCyR-a za 24 mjeseca (uključujući bolesnike koji su postigli CCyR u ili prije vremenske točke od 24 mjeseca kao oni s odgovorom) bila je statistički viša za skupine koje su primale 300 mg i 400 mg nilotiniba dva puta na dan u usporedbi sa skupinom koja je primala 400 mg imatinib jedanput na dan.
English: Including clonal evolution as a criterion for progression, a total of 25 patients progressed to accelerated phase or blast crisis on treatment by the cut-off date (3 in the nilotinib 300 mg twice daily group, 5 in the nilotinib 400 mg twice daily group and 17 in the imatinib 400 mg once daily group).
Croatian: Uključujući klonalnu evoluciju kao kriterij progresije, ukupno je 25 bolesnika imalo progresiju do ubrzane faze ili blastične krize pri terapiji do zaključnog dana (3 u skupini koja je primala nilotinib 300 mg dva puta na dan, 5 u skupini koja je primala 400 mg nilotiniba dva puta na dan te 17 u skupini koja je primala 400 mg imatiniba jedanput na dan).
English: The Kaplan-Meier (KM) estimated median time on nilotinib treatment to regain MMR and MR4.5 was 7.9 weeks (95% CI: 5.1, 8.0) and 13.1 weeks (95% CI: 12.3, 15.7), respectively.
Croatian: Kaplan-Meierova (KM) procjena medijana vremena na terapiji nilotinibom do ponovnog postizanja MMR-a, odnosno MR4,5, bila je 7,9 tjedana (95% CI: 5,1; 8,0), odnosno 13,1 tjedan (95% CI: 12,3; 15,7).
English: Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Croatian: Podaci o djelotvornosti u bolesnika s KML-om u blastičnoj krizi nisu dostupni, - pedijatrijskih bolesnika u kroničnoj fazi KML-a s pozitivnim Philadelphia kromosomom s rezistencijom ili intolerancijom na prethodno liječenje, uključujući imatinib.
English: In a Phase II clinical study with adult patients with Ph+ CML in chronic phase on nilotinib treatment and previously treated with imatinib (N=126), musculoskeletal symptoms were reported within a year of discontinuation in 42.1% versus 14.3% within the previous year on nilotinib treatment.
Croatian: U kliničkom ispitivanju faze II s odraslim bolesnicima s Ph+ KML-om u kroničnoj fazi na terapiji nilotinibom koji su se prethodno liječili imatinibom (N=126), mišićno-koštani simptomi bili su prijavljeni u 42,1% bolesnika tijekom godine dana od prekida terapije u usporedbi s 14,3% tijekom prethodne godine na terapiji nilotinibom.
English: Abdominal distension, abdomnial discomfort, dysgeusia, flatulence
Croatian: Distenzija abdomena, nelagoda u abdomenu, disgeuzija, flatulencija
English: Of the patients who achieved HR, 53% (95% CI: 39% - 67%) were maintaining response at 24 months.
Croatian: Od bolesnika koji su postigli HR, njih 53% (95% CI: 39% - 67%) su zadržali odgovor u 24. mjesecu.
English: Treatment with nilotinib is associated with (National Cancer Institute Common Toxicity Criteria grade 3-4) thrombocytopenia, neutropenia and anaemia.
Croatian: Liječenje nilotinibom je povezano s trombocitopenijom, neutropenijom i anemijom (Opći kriteriji toksičnosti 3.-4. stupnja Nacionalnog instituta za rak - National Cancer Institute).
English: Herpes virus infection, oral candidiasis, subcutaneous abscess, anal abscess, tinea pedis, hepatitis B reactivation Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Croatian: Infekcija s virusom herpesa, oralna kandidijaza, supkutani apsces, analni apsces, tinea pedis, ponovna aktivacija hepatitisa B Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Često:
English: Tasigna is used in adult and paediatric patients with newly diagnosed CML or in patients with CML who are no longer benefiting from previous treatment including imatinib.
Croatian: Tasigna se primjenjuje u odraslih i pedijatrijskih bolesnika s novodijagnosticiranim KML-om ili u bolesnika s KML-om u kojih je prethodno liječenje, uključujući imatinib, bezuspješno.
English: • Unit packs containing 28 hard capsules (7 daily blisters, each containing 4 hard capsules) or
Croatian: • jedinična pakiranja koja sadrže 28 tvrdih kapsula (7 dnevnih blistera, svaki sadrži 4 tvrde kapsule) ili 40 tvrdih kapsula (5 blistera, svaki sadrži 8 tvrdih kapsula).
English: Component of a multipack comprising 14 cartons.
Croatian: Sastavni dio višestrukog pakiranja kojeg čini 14 kutija.
English: For laboratory abnormalities, very common adverse reactions not included in Table 3 are also reported.
Croatian: 4. Za abnormalne vrijednosti laboratorijskih nalaza, prijavljene su vrlo česte nuspojave koje nisu uključene u Tablicu
English: Excipient with known effect One hard capsule contains 156.11 mg lactose monohydrate.
Croatian: Jedna tvrda kapsula sadrži 156,11 mg laktoze hidrata.
English: 126 of 163 patients (77.3%) entered the TFR phase after achieving a sustained deep molecular response during the consolidation phase, defined by the following criterion: - The 4 last quarterly assessments (taken every 12 weeks) showed no confirmed loss of MR4.5
Croatian: 126 od 163 bolesnika (77,3%) ušlo je u TFR fazu nakon što su postigli održani duboki molekularni odgovor tijekom faze konsolidacije, definiran prema sljedećem kriteriju: - 4 zadnje tromjesečne procjene (napravljene svakih 12 tjedana) pokazale su da nema potvrđenog gubitka MR4,5 (BCR-ABL/ABL ≤0,0032% IS) tijekom jedne godine.
English: 149 to 517 mg/m2/day), and the median relative dose intensity was 94.7% (range: 32 to 112%).
Croatian: U objedinjenoj populaciji bolesnika s KML-om, medijan stvarnog intenziteta doze bio je 435,5 mg/m2/dan (raspon: 149 do 517 mg/m2/dan), a medijan relativnog intenziteta doze bio je 94,7% (raspon: 32 do 112%).
English: Bone pain, back pain, muscular weakness
Croatian: Bol u kostima, bol u leđima, slabost mišića
English: Cumulative incidence of MR4 (BCR-ABL ≤0.01% on the international scale), %
Croatian: Kumulativna incidencija molekularnog odgovora4 (BCR-ABL ≤0,01% na internacionalnoj skali), %
English: Based on Kaplan-Meier estimates, the proportions of patients who were maintaining response for 72 months among patients who achieved CCyR were 99.1% (95% CI: 97.9-100%) in the nilotinib 300 mg twice daily group, 98.7% (95% CI: 97.1-100%) in the nilotinib 400 mg twice daily group and 97.0% (95% CI: 94.7-99.4%) in the imatinib 400 mg once daily group.
Croatian: Na temelju Kaplan-Meierovih procjena, udjeli bolesnika koji su održavali odgovor tijekom 72 mjeseca među bolesnicima koji su postigli CCyR bili su 99,1% (95% CI: 97,9-100%) u skupini koja je primala 300 mg nilotiniba dva puta na dan, 98,7% (95% CI: 97,1-100%) u skupini koja je primala 400 mg nilotiniba dva puta na dan te 97,0% (95% CI: 94,7-99,4%) u skupini koja je primala 400 mg imatiniba jedanput na dan.
English: 120 hard capsules
Croatian: 120 tvrdih kapsula
English: Thrombocythaemia, leukocytosis Immune system disorders Not known:
Croatian: Trombocitemija, leukocitoza Poremećaji imunološkog sustava Nepoznato:
English: No food should be consumed for 2 hours before the dose is taken and for at least one hour after.
Croatian: Hrana se ne smije uzimati 2 sata prije uzimanja doze i najmanje jedan sat nakon uzimanja doze.
English: The data described below reflect exposure to nilotinib in a total of 737 adult patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated at the recommended dose of 300 mg twice daily (n=279) and from an open-label multicentre Phase II study in adult patients with imatinib-resistant or intolerant CML in chronic phase (n=321) and accelerated phase (n=137) treated at the recommended dose of 400 mg twice daily.
Croatian: Podaci navedeni u nastavku prikazuju izloženost nilotinibu u ukupno 737 odraslih bolesnika iz randomiziranog ispitivanja faze III u novodijagnosticiranih bolesnika s KML-om u kroničnoj fazi liječenih preporučenom dozom od 300 mg dva puta na dan (n=279) i iz otvorenog multicentričnog ispitivanja faze II u odraslih bolesnika s KML-om u kroničnoj (n=321) i ubrzanoj fazi (n=137) s rezistencijom ili intolerancijom na imatinib, a koji su liječeni preporučenom dozom od 400 mg dva puta na dan.
English: White to yellowish powder in red opaque hard gelatin capsules, size 1 with black axial imprint “NVR/BCR”.
Croatian: Bijeli do žućkasti prašak u crvenoj neprozirnoj tvrdoj želatinskoj kapsuli, veličine 1 s crnom aksijalnom oznakom „NVR/BCR“.
English: Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Croatian: Tasigna je indicirana za liječenje: - odraslih i pedijatrijskih bolesnika s novodijagnosticiranom kroničnom mijeloičnom leukemijom (KML) s pozitivnim Philadelphia kromosomom u kroničnoj fazi, - odraslih bolesnika u kroničnoj i ubrzanoj fazi KML-a s pozitivnim Philadelphia kromosomom s rezistencijom ili intolerancijom na prethodno liječenje, uključujući imatinib.
English: If the prior dose was 300 mg twice daily in adult newly diagnosed patients with CML in the chronic phase, or 400 mg twice daily in adult patients with imatinib-resistant or intolerant CML in chronic or accelerated phase, or 230 mg/m twice daily in paediatric patients, dosing may be resumed at 400 mg once daily in adult patients and at 230 mg/m once daily in paediatric patients once the toxicity has resolved.
Croatian: Ako je prijašnja doza bila 300 mg dva puta na dan u odraslih novodijagnosticiranih bolesnika s KML-om u kroničnoj fazi, ili 400 mg dva puta na dan u odraslih bolesnika s KML-om u kroničnoj ili ubrzanoj fazi s rezistencijom ili intolerancijom na imatinib, ili 230 mg/m dva puta na dan u pedijatrijskih bolesnika, doziranje se može nastaviti u dozi od 400 mg jedanput na dan u odraslih bolesnika i 230 mg/m jedanput na dan u pedijatrijskih bolesnika nakon nestanka toksičnosti.
English: Endocrine disorders Not known:
Croatian: Preosjetljivost Endokrini poremećaji Nepoznato:
English: ≤0.01% IS), and maintained for one year - the last assessment being MR4.5 (BCR-ABL/ABL ≤0.0032% IS) - no more than two assessments falling between MR4.0 and MR4.5
Croatian: (BCR-ABL/ABL ≤0,01% IS), i održale su se tijekom jedne godine - zadnja je ocjena bila MR4,5 (BCR-ABL/ABL ≤0,0032% IS) - najviše dvije ocjene bile su između MR4.0 i MR4,5 (0,0032% IS < BCR-ABL/ABL
English: Chronic phase n=321
Croatian: Kronična faza n=321
English: The KM estimated MR4.0 and MR4.5 rates at 48 weeks of re-initiation were 100.0% (95% CI: not estimated) and 94.8% (95% CI: 85.1, 99.0), respectively.
Croatian: KM procjene stope MR4,0, odnosno MR4,5, u 48. tjednu nakon ponovnog početka terapije bile su 100,0% (95% CI: nije procijenjen), odnosno 94,8% (95% CI: 85,1; 99,0).
English: 190 of 215 patients (88.4%) entered the TFR phase after achieving a sustained deep molecular response during the consolidation phase, defined by the following criteria: - the 4 last quarterly assessments (taken every 12 weeks) were at least MR4.0 (BCR-ABL/ABL
Croatian: 190 od 215 bolesnika (88,4%) ušlo je u fazu remisije bez liječenja (TFR) nakon što su postigli održani duboki molekularni odgovor tijekom faze konsolidacije, definiran prema sljedećim kriterijima: - 4 zadnje tromjesečne ocjene (napravljene svakih 12 tjedana) bile su najmanje MR4.0
English: Adverse reactions that were reported in adult patients in the Tasigna Phase III study at a frequency of less than 5% are shown in Table 4.
Croatian: Nuspojave koje su prijavljene u odraslih bolesnika u ispitivanju faze III s Tasignom s učestalošću manjom od 5% prikazane su u Tablici
English: Febrile neutropenia Immune system disorders Not known:
Croatian: Poremećaji imunološkog sustava Nepoznato:
English: In a study in the CML paediatric population, growth retardation has been documented in patients treated with nilotinib (see section 4.8).
Croatian: U ispitivanju u pedijatrijskih bolesnika s KML-om, u bolesnika liječenih nilotinibom bio je zabilježen zastoj u rastu (vidjeti dio 4.8).
English: The administration of Tasigna with agents that are strong CYP3A4 inhibitors (including, but not limited to, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir) should be avoided.
Croatian: Treba izbjegavati primjenu Tasigne sa snažnim inhibitorima CYP3A4 (kao što su između ostalih ketokonazol, itrakonazol, vorikonazol, klaritromicin, telitromicin, ritonavir).
English: Haemoglobin decreased, blood amylase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, blood creatinine phosphokinase increased, weight decreased, weight increased, blood insulin increased, globulins decreased
Croatian: Sniženje hemoglobina, povišenje amilaza u krvi, povišenje alkalne fosfataze u krvi, povišenje gama glutamiltransferaze, povišenje kreatinin fosfokinaze u krvi, pad tjelesne težine, porast tjelesne težine, povišenje inzulina u krvi, sniženje globulina
English: INTERMEDIATE CARTON
Croatian: SREDNJA KUTIJA
English: How to take Tasigna
Croatian: Kako uzimati Tasignu
English: Cerebrovascular accident, basilar artery stenosis, syncope, tremor, lethargy, dysaesthesia, restless legs syndrome, hyperaesthesia
Croatian: Cerebrovaskularni inzult, stenoza bazilarne arterije, sinkopa, tremor, letargija, disestezija, sindrom nemirnih nogu, hiperestezija
English: However, patients with hepatic impairment should be treated with caution (see section 4.4).
Croatian: Međutim potreban je oprez pri liječenju bolesnika s oštećenjem jetre (vidjeti dio 4.4).
English: Chest pain (including non-cardiac chest pain), pain, pyrexia, chest discomfort, malaise
Croatian: Bol u prsištu (uključujući nekardiološku bol u prsištu), bol, vrućica, nelagoda u prsištu, malaksalost
English: Newly diagnosed CML-CP 300 mg twice daily n=279
Croatian: Novodijagnosticirani KML u kroničnoj fazi 300 mg dva puta na dan n=279
English: Fluid retention and oedema
Croatian: Zadržavanje tekućine i edem
English: White to yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “NVR/TKI”.
Croatian: Bijeli do žućkasti prašak u svijetložutoj neprozirnoj tvrdoj želatinskoj kapsuli, veličine 0 s crvenom aksijalnom oznakom „NVR/TKI“.
English: Nilotinib 300 mg twice daily n=282
Croatian: Nilotinib 300 mg dva puta na dan n=282
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172)
English: Dyspnoea, dyspnoea exertional, epistaxis, cough, dysphonia
Croatian: Dispneja, dispneja u naporu, epistaksa, kašalj, disfonija
English: Adult patients with newly diagnosed chronic phase CML at 300 mg twice daily
Croatian: Odrasli bolesnici s novodijagnosticiranim KML-om u kroničnoj fazi uz primjenu 300 mg dva puta na dan
English: Increases in total serum cholesterol levels have been reported with nilotinib therapy (see section 4.4).
Croatian: Uz liječenje nilotinibom zabilježene su povišene razine ukupnog kolesterola u serumu (vidjeti dio 4.4).
English: Concomitant use of nilotinib with medicinal products that are potent inducers of CYP3A4 (e.g., phenytoin, rifampicin, carbamazepine, phenobarbital and St. John's Wort) is likely to reduce exposure to nilotinib to a clinically relevant extent.
Croatian: Istodobna primjena nilotiniba s lijekovima koji snažno induciraju CYP3A4 (npr. fenitoin, rifampicin, karbamazepin, fenobarbital i gospina trava) može smanjiti izloženost nilotinibu do klinički značajnih razmjera.
English: Pancreatitis, abdominal discomfort, abdominal distension, dysgeusia, flatulence
Croatian: Pankreatitis, nelagoda u abdomenu, distenzija abdomena, disgeuzija, flatulencija
English: Gastrointestinal haemorrhage, melaena, mouth ulceration, gastroesophageal reflux, stomatitis, oesophageal pain, dry mouth, gastritis, sensitivity of teeth
Croatian: Krvarenje u probavnom sustavu, melena, ulceracije u ustima, gastroezofagealni refluks, stomatitis, bol u jednjaku, suha usta, gastritis, osjetljivost zuba
English: 40 hard capsules.
Croatian: 40 tvrdih kapsula.
English: Component of a multipack comprising 3 cartons.
Croatian: Sastavni dio višestrukog pakiranja kojeg čine 3 kutije.
English: Pulmonary oedema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain, throat irritation
Croatian: Edem pluća, pleuralni izljev, intersticijska plućna bolest, pleuralna bol, pleuritis, bol u ždrijelu i laringsu, iritacija grla
English: Tasigna with food and drink Do not take Tasigna with food.
Croatian: Tasigna s hranom i pićem
English: Blood parathyroid hormone increased, blood insulin decreased, insulin C-peptide decreased, weight decreased
Croatian: Povišenje paratireoidnog hormona u krvi, sniženje inzulina u krvi, sniženje inzulin C peptida, smanjenje tjelesne težine
English: By 6 years
Croatian: Do 6. godine
English: In the Phase II study in imatinib-resistant and intolerant CML patients in chronic and accelerated phase receiving 400 mg nilotinib twice daily, the change from baseline in mean time-averaged QTcF interval at steady state was 5 and 8 msec, respectively.
Croatian: U ispitivanju faze II u bolesnika s KML-om u kroničnoj i ubrzanoj fazi s rezistencijom ili intolerancijom na imatinib, a koji su primali 400 mg nilotiniba dva puta na dan, promjene u srednjem prosječnom vremenu QTcF intervala u stanju dinamičke ravnoteže bile su 5, odnosno 8 msek u odnosu na početne vrijednosti.
English: Musculoskeletal and connective tissue disorders Myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Mijalgija
English: The estimated 24-month overall survival rate in CML-AP patients was 70%.
Croatian: Procijenjena stopa 24-mjesečnog sveukupnog preživljavanja bila je 70% u bolesnika s KML-om u ubrzanoj fazi.
English: Tasigna should be used with caution in patients who have or who are at significant risk of developing prolongation of QTc, such as those: - with congenital long QT prolongation - with uncontrolled or significant cardiac disease including recent myocardial infarction,
Croatian: Tasigna se treba primjenjivati s oprezom u bolesnika s produženim QT intervalom ili sa značajnim rizikom od njegova razvoja, kao što su oni: - s prirođenim sindromom produženog QT intervala.
English: The estimated 24-month overall survival rate in CML-CP patients was 87%.
Croatian: Procijenjena stopa 24-mjesečnog sveukupnog preživljavanja bila je 87% u bolesnika s KML-a u kroničnoj fazi.
English: Visual impairment, vision blurred, conjunctival haemorrhage, visual acuity reduced, eyelid oedema, photopsia, hyperaemia (scleral, conjunctival, ocular), eye irritation
Croatian: Oštećenje vida, zamagljen vid, krvarenje konjunktive, smanjena vidna oštrina, edem kapka, fotopsija, hiperemija (bjeloočnice, konjunktive, oka), iritacija oka
English: The Kaplan-Meier (KM) estimated median time on nilotinib to regain MR4.0 and MR4.5 was 12.0 weeks (95% CI: 8.3, 12.7) and 13.1 weeks (95% CI: 12.4, 16.1), respectively.
Croatian: Kaplan-Meierova (KM) procjena medijana vremena na nilotinibu do ponovnog postizanja MR4,0, odnosno MR4,5, bila je 12,0 tjedana (95% CI: 8,3; 12,7), odnosno 13,1 tjedan (95% CI: 12,4; 16,1).
English: The hard capsules are light yellow.
Croatian: Tvrde kapsule su svijetložute boje.
English: At 12 months At 24 months At 36 months At 48 months At 60 months At 72 months
Croatian: U 12. mjesecu 11,7 U 24. mjesecu 24,5 U 36. mjesecu 29,4 U 48. mjesecu 33,3
English: Tasigna 50 mg hard capsules Tasigna 200 mg hard capsules
Croatian: Tasigna 50 mg tvrde kapsule Tasigna 200 mg tvrde kapsule
English: Troponin increased, blood bilirubin unconjugated increased, blood insulin decreased, insulin C-peptide decreased, blood parathyroid hormone increased
Croatian: Povišenje troponina, povišenje nekonjugiranog bilirubina u krvi, sniženje inzulina u krvi, sniženje inzulin C peptida, povišenje paratireoidnog hormona u krvi
English: Of the patients who achieved MCyR, 63% (95% CI: 45% - 80%) were maintaining response at 24 months.
Croatian: Od bolesnika koji su postigli MCyR, njih 63% (95% CI: 45% - 80%) su zadržali odgovor u 24. mjesecu.
English: PVC/PVDC/Alu [in carton] 392 hard capsules
Croatian: PVC/PVDC/Al [u kutiji] 392 tvrde kapsule
English: Upper abdominal pain
Croatian: Bol u gornjem dijelu abdomena