FrancophonIA/ELRC3.0 huggingface dataset:
English: Figure 2 Cumulative incidence of molecular response of ≤0.01% (4-log reduction)
Croatian: Slika 2 Kumulativna incidencija molekularnog odgovora ≤0,01% (4 log sniženje)
English: In 22 CP patients evaluated for efficacy nilotinib induced a 32% MCyR rate and a 50% CHR rate.
Croatian: U 22 bolesnika u kroničnoj fazi u kojih je procijenjena djelotvornost, nilotinib je rezultirao stopom MCyR-a od 32%, te stopom CHR-a od 50%.
English: 28 hard capsules 40 hard capsules
Croatian: 28 tvrdih kapsula 40 tvrdih kapsula
English: Special monitoring of adult Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response
Croatian: Posebno praćenje odraslih bolesnika s Ph+ KML-om u kroničnoj fazi koji su postigli održani duboki molekularni odgovor
English: In a Phase III study in newly diagnosed CML patients, 1.1% of the patients treated with 400 mg nilotinib twice daily showed a Grade 3-4 elevation in total cholesterol; no Grade 3-4 elevations were however observed in the 300 mg twice daily dose group (see section 4.8).
Croatian: U ispitivanju faze III u bolesnika s novodijagnosticiranim KML-om 1,1% bolesnika liječenih s 400 mg nilotiniba dva puta na dan imalo je povišenja ukupnog kolesterola 3.- 4. stupnja; međutim, povišenja 3.- 4. stupnja nisu bila zabilježena u skupini koja je primala dozu od 300 mg dva puta na dan (vidjeti dio 4.8).
English: Leukopenia, eosinophilia, febrile neutropenia, pancytopenia, lymphopenia
Croatian: Leukopenija, eozinofilija, febrilna neutropenija, pancitopenija, limfopenija
English: Treatment must be resumed within 2 weeks at prior dose if ANC >1.0 x 9/l and/or platelets >20 x 10
Croatian: Liječenje se mora nastaviti unutar 2 tjedna s prijašnjom dozom ako je ABN >1,5 x 109/l i/ili trombociti >75 x 109/l.
English: Cholestasis, hepatomegaly Skin and subcutaneous tissue disorders Common:
Croatian: Kolelitijaza, hepatomegalija Poremećaji kože i potkožnog tkiva Često:
English: INTERMEDIATE WALLET OF MULTIPACK (WITHOUT BLUE BOX) INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Croatian: SREDNJE DŽEPNO PAKIRANJE VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Caution is recommended in patients with previous history of pancreatitis.
Croatian: Oprez je potreban u bolesnika s pankreatitisom u anamnezi.
English: Based on the Kaplan-Meier analysis of time to first MMR the probability of achieving MMR at different time points was higher for both nilotinib at 300 mg and 400 mg twice daily compared to imatinib 400 mg once daily (HR=2.17 and stratified log-rank p<0.0001 between nilotinib 300 mg twice daily and imatinib 400 mg once daily, HR=1.88 and stratified log-rank p<0.0001 between nilotinib 400 mg twice daily and imatinib 400 mg once daily).
Croatian: Na temelju Kaplan-Meierove analize vremena do prvog MMR-a vjerojatnost postizanja MMR-a u različitim vremenskim točkama bila je viša za nilotinib kako u dozi od 300 mg tako i u dozi od 400 mg dva puta na dan u usporedbi s imatinibom u dozi od 400 mg jedanput na dan (HR=2,17 i stratificirani log-rang p<0,0001 između 300 mg nilotiniba dva puta na dan i 400 mg imatiniba jedanput na dan, HR=1,88 i stratificirani log-rang p<0,0001 između 400 mg nilotiniba dva puta na dan i 400 mg imatiniba jedanput na dan).
English: Pleural and pericardial effusions, regardless of causality, occurred in 2% and <1% of patients, respectively, receiving nilotinib 300 mg twice daily.
Croatian: Pleuralni, odnosno perikardijalni izljevi, neovisno o uzroku, pojavili su se u 2%, odnosno <1% bolesnika liječenih nilotinibom 300 mg dva puta na dan.
English: Prior hydroxyurea
Croatian: Prethodno hidroksiureja
English: The most frequent (≥10%) non-haematological drug-related adverse events were rash, pruritus, nausea, fatigue, headache, vomiting, myalgia, constipation and diarrhoea.
Croatian: Najčešće (≥10%) nehematološke nuspojave povezane s primjenom lijeka bile su osip, svrbež, mučnina, umor, glavobolja, povraćanje, mijalgija, konstipacija i proljev.
English: A red imprint is stamped on each hard capsule (“NVR/TKI”).
Croatian: Crvena oznaka je otisnuta na svakoj tvrdoj kapsuli („NVR/TKI“).
English: Patients who re-initiate nilotinib therapy should have their BCR-ABL transcript levels monitored monthly until previous major molecular response or MR4 level is re-established and every 12 weeks thereafter (see section 4.4).
Croatian: Kod bolesnika koji ponovo započnu terapiju nilotinibom potrebno je mjesečno pratiti razine BCR-ABL transkripcija dok se ponovo ne uspostavi prijašnji veliki molekularni odgovor ili razina MR4 te svakih 12 tjedana nakon toga (vidjeti dio 4.4).
English: Gastrointestinal haemorrhage, regardless of causality, was reported in 3% of these patients.
Croatian: Gastrointestinalno krvarenje prijavljeno je u 3% bolesnika.
English: Breast pain, gynaecomastia, erectile dysfunction
Croatian: Bol u dojkama, ginekomastija, erektilna disfunkcija
English: Use in adults - Patients newly diagnosed with CML: The recommended dose is 600 mg per day.
Croatian: Primjena u odraslih - Bolesnici s novodijagnosticiranim KML-om: Preporučena doza je 600 mg na dan.
English: A black imprint is stamped on each hard capsule (“NVR/ABL”).
Croatian: Crna oznaka je otisnuta na svakoj tvrdoj kapsuli („NVR/ABL“).
English: CARTON OF MULTIPACK (WALLET) (INCLUDING BLUE BOX) CARTON OF MULTIPACK (CARTON) (INCLUDING BLUE BOX)
Croatian: VIŠESTRUKO PAKIRANJE (DŽEPNO PAKIRANJE) (UKLJUČUJUĆI PLAVI OKVIR) KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: Pyrexia, chest pain (including non-cardiac chest pain), chest discomfort
Croatian: Pireksija, bol u prsištu (uključujući nekardiološku bol u prsištu), nelagoda u prsištu
English: Treatment with nilotininb must be interrupted and blood count monitored.
Croatian: Liječenje nilotinibom se mora prekinuti i pratiti broj krvnih stanica.
English: The average nilotinib trough and peak concentrations over 12 months were approximately 15.7% and 14.8% higher following 400 mg twice daily dosing compared to 300 mg twice daily.
Croatian: Prosječne najniže i vršne koncentracije nilotiniba nakon 12 mjeseci bile su približno 15,7% više nakon 400 mg dva puta na dan u usporedbi s 14,8% nakon 300 mg dva puta na dan.
English: Ischaemic stroke, cerebral infarction, migraine, paraestheisa
Croatian: Ishemijski moždani udar, cerebralni infarkt, migrena, parestezija
English: Leukopenia, eosinophilia, lymphopenia
Croatian: Leukopenija, eozinofilija, limfopenija
English: Substances that may decrease nilotinib serum concentrations
Croatian: Tvari koje mogu smanjiti koncentraciju nilotiniba u serumu
English: Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients treated with 300 mg of nilotinib twice daily in the randomised Phase III study are shown in Table 3.
Croatian: Najčešće prijavljene nuspojave u kliničkim ispitivanjima s Tasignom Nehematološke nuspojave (isključujući abnormalne vrijednosti laboratorijskih nalaza) koje su prijavljene u najmanje 5% odraslih bolesnika liječenih dozom od 300 mg nilotiniba dva puta na dan u randomiziranom ispitivanju faze III prikazane su u Tablici 3.
English: In a Phase II clinical study with newly diagnosed adult patients with Ph+ CML in chronic phase (N=190), musculoskeletal symptoms were reported within a year of Tasigna discontinuation in 24.7% versus 16.3% within the previous year on nilotinib treatment.
Croatian: U kliničkom ispitivanju faze II s novodijagnosticiranim odraslim bolesnicima s Ph+ KML-om u kroničnoj fazi (N=190), mišićno-koštani simptomi bili su prijavljeni u 24,7% bolesnika tijekom godine dana od prekida terapije Tasignom u usporedbi s 16,3% tijekom prethodne godine na terapiji nilotinibom.
English: CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Croatian: KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: For patients who are unable to swallow hard capsules, the content of each hard capsule may be dispersed in one teaspoon of apple sauce and should be taken immediately.
Croatian: Bolesnici koji ne mogu progutati tvrde kapsule mogu pomiješati sadržaj svake tvrde kapsule u jednoj čajnoj žličici kaše od jabuke i odmah ju uzeti.
English: System organ class/
Croatian: Klasifikacija organskih sustava/ Nuspojave
English: There are no steady-state data.
Croatian: Nema podataka u stanju dinamičke ravnoteže.
English: Table 2 Dose adjustments for neutropenia and thrombocytopenia
Croatian: Tablica 2 Prilagođavanje doze zbog neutropenije i trombocitopenije
English: Adverse reactions that were reported in adult patients in the Tasigna clinical studies which serve as a basis for the approved indications at a frequency of less than 5% are shown in Table 4.
Croatian: Nuspojave koje su prijavljene u odraslih bolesnika u kliničkim ispitivanjima s Tasignom koja služe kao osnova za odobrene indikacije s učestalošću manjom od 5% prikazane su u Tablici
English: For patients who are unable to swallow hard capsules, the content of each hard capsule may be dispersed in one teaspoon of apple sauce (puréed apple) and should be taken immediately.
Croatian: Bolesnici koji ne mogu progutati tvrde kapsule mogu pomiješati sadržaj svake tvrde kapsule u jednoj čajnoj žličici kaše od jabuke (jabučnog pirea) i odmah ju uzeti.
English: <1 Common
Croatian: <1 Često
English: By 4 years
Croatian: Do 4. godine
English: Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients in Tasigna clinical studies that serve as the basis for the approved indications are shown in Table 3.
Croatian: Najčešće prijavljene nuspojave u kliničkim ispitivanjima s Tasignom Nehematološke nuspojave (isključujući abnormalne vrijednosti laboratorijskih nalaza) koje su prijavljene u najmanje 5% odraslih bolesnika u kliničkim ispitivanjima s Tasignom koja služe kao osnova za odobrene indikacije prikazane su u Tablici 3.
English: A black imprint is stamped on each hard capsule (“NVR/BCR”).
Croatian: Crna oznaka je otisnuta na svakoj tvrdoj kapsuli („NVR/BCR“).
English: Sepsis, subcutaneous abscess, anal abscess, furuncle, tinea pedis, hepatitis B reactivation Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Croatian: Sepsa, supkutani apsces, analni apsces, furunkul, tinea pedis, ponovna aktivacija hepatitisa B Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Često:
English: Ventricular dysfunction, pericarditis, ejection fraction decreased
Croatian: Disfunkcija ventrikula, perikarditis, smanjenje ejekcijske frakcije Krvožilni poremećaji
English: The rate of MMR at 12 months, was also statistically significantly higher for nilotinib 400 mg twice daily compared to imatinib 400 mg once daily (42.7% versus 22.3%, p<0.0001).
Croatian: Stopa MMR-a u 12. mjesecu je također bila statistički značajno viša za 400 mg nilotiniba dva puta na dan u usporedbi s 400 mg imatiniba jedanput na dan (42,7% u odnosu na 22,3%, p<0,0001).
English: Following administration of nilotinib in paediatric patients at 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg), steady-state exposure and clearance of nilotinib were found to be similar (within 2-fold) to adult patients treated with 400 mg twice daily.
Croatian: Nakon primjene nilotiniba u pedijatrijskih bolesnika u dozi od 230 mg/m dva puta na dan, zaokruženo na najbližu dozu od 50 mg (do najveće pojedinačne doze od 400 mg), otkriveno je da su izloženost u stanju dinamičke ravnoteže i klirens nilotiniba slični (unutar dvostruke vrijednosti) onima u odraslih bolesnika liječenih s 400 mg dva puta na dan.
English: Musculoskeletal chest pain, musculoskeletal pain, back pain, flank pain, neck pain, muscular weakness
Croatian: Mišićno koštana bol u prsištu, mišićno koštana bol, bol u leđima, bol u slabinama, bol u vratu, slabost mišića
English: White to yellowish powder in hard gelatin capsule with red opaque cap and light yellow opaque body, size 4 with black radial imprint “NVR/ABL” on cap.
Croatian: Bijeli do žućkasti prašak u tvrdoj želatinskoj kapsuli s crvenom neprozirnom kapicom i svijetložutim neprozirnim tijelom, veličine 4 s crnom radijalnom oznakom „NVR/ABL“ na kapici.
English: Occurrence is more frequent in patients with imatinib-resistant or intolerant CML, in particular in patients with accelerated-phase CML.
Croatian: Učestalost pojavljivanja je veća u bolesnika s KML-om s rezistencijom ili intolerancijom na imatinib, posebno u bolesnika s KML-om u ubrzanoj fazi.
English: If the prior dose was 230 mg/m once daily, treatment should be discontinued.
Croatian: Ako je prijašnja doza bila 230 mg/m jedanput na dan, liječenje treba trajno obustaviti.
English: Posology for Philadelphia chromosome positive CML adult patients The recommended dose is 300 mg twice daily.
Croatian: Doziranje za odrasle bolesnike s KML-om s pozitivnim Philadelphia kromosomom Preporučena doza je 300 mg dva puta na dan.
English: QTcF exceeding 500 msec was observed in <1% of patients.
Croatian: Produženje QTcF veće od 500 msek opaženo je u <1% bolesnika.
English: In murine models of CML, as a single agent nilotinib reduces tumour burden and prolongs survival following oral administration.
Croatian: U mišjim modelima KML-a, nilotinib primijenjen peroralno kao samostalni agens smanjuje tumorsku masu i produžuje vrijeme preživljavanja.
English: Steady-state nilotinib exposure was dose-dependent, with less than dose-proportional increases in systemic exposure at dose levels higher than 400 mg given as once-daily dosing.
Croatian: Izloženost nilotinibu u stanju dinamičke ravnoteže ovisna je o dozi, dok su povećanja sistemske izloženosti u dozama višim od 400 mg primijenjenim jedanput na dan manje proporcionalna dozi.
English: By 2 years
Croatian: Do 2. godine
English: Diabetes mellitus, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hyperglycaemia, decreased appetite, hypocalcaemia, hypokalaemia
Croatian: Dijabetes mellitus, hiperkolesterolemija, hiperlipidemija, hipertrigliceridemija, hiperglikemija, smanjen apetit, hipokalcijemija, hipokalijemija
English: A total of 55 patients died during treatment or during the follow-up after discontinuation of treatment (21 in the nilotinib 300 mg twice daily group, 11 in the nilotinib 400 mg twice daily group and 23 in the imatinib 400 mg once daily group).
Croatian: Ukupno je 55 bolesnika umrlo tijekom liječenja ili tijekom praćenja nakon prekida liječenja (21 u skupini na nilotinibu 300 mg dva puta na dan, 11 u skupini na nilotinibu 400 mg dva puta na dan i 23 u skupini na imatinibu 400 mg jedanput na dan).
English: In this clinical study with a median on-therapy time of 60.5 months, Grade 3-4 cardiovascular events included peripheral arterial occlusive disease (1.4% and 1.1% at 300 mg and 400 mg nilotinib twice daily, respectively), ischaemic heart disease (2.2% and 6.1% at 300 mg and 400 mg nilotinib twice daily, respectively) and ischaemic cerebrovascular events (1.1% and 2.2% at 300 mg and 400 mg nilotinib twice daily, respectively).
Croatian: U ovom kliničkom ispitivanju s medijanom vremena na terapiji od 60,5 mjeseci, kardiovaskularni događaji 3.-4. stupnja uključivali su okluzivnu bolest perifernih arterija (1,4% uz 300 mg i 1,1% uz 400 mg nilotiniba dvaput na dan), ishemijsku bolest srca (2,2% uz 300 mg i 6,1% uz 400 mg nilotiniba dvaput na dan) te ishemijske cerebrovaskularne događaje (1,1% uz 300 mg i 2,2% uz 400 mg nilotiniba dvaput na dan).
English: Figure 3 Cumulative incidence of molecular response of ≤0.0032% (4.5 log reduction)
Croatian: Slika 3 Kumulativna incidencija molekularnog odgovora ≤0,0032% (4,5 log sniženje)
English: Alternative concomitant medicinal products with no or minimal CYP3A4 inhibition should be considered.
Croatian: Potrebno je razmotriti istodobnu primjenu lijekova koji ne inhibiraju CYP3A4 ili ga minimalno inhibiraju.
English: Accelerated phase n=137
Croatian: Ubrzana faza n=137
English: Amnesia, dysphoria Nervous system disorders Common:
Croatian: Amnezija, disforija Poremećaji živčanog sustava Često:
English: Close monitoring of growth in paediatric patients under nilotinib treatment is recommended.
Croatian: Preporučuje se pažljivo praćenje rasta u pedijatrijskih bolesnika koji se liječe nilotinibom.
English: Hyperparathyroidism secondary, thyroiditis Metabolism and nutrition disorders Very common:
Croatian: Sekundarni hiperparatireoidizam, tireoiditis Poremećaji metabolizma i prehrane Vrlo često:
English: If blood counts remain low, a dose reduction to 230 mg/m once daily may be required.
Croatian: 3. Ako je broj krvnih stanica i dalje nizak, može biti potrebno smanjiti dozu na 230 mg/m2 jedanput na dan.
English: Uncommon cases (0.1 to 1%) of sudden deaths have been reported in patients with imatinib-resistant or intolerant CML in chronic phase or accelerated phase with a past medical history of cardiac disease or significant cardiac risk factors.
Croatian: Rijetki slučajevi (0,1 do 1%) iznenadnih smrti bili su prijavljeni u bolesnika s KML-om u kroničnoj ili ubrzanoj fazi u kojih se razvila rezistencija ili intolerancija na imatinib koji su u povijesti bolesti imali srčanu bolest ili značajne srčane čimbenike rizika.
English: Table 11 CML disease history characteristics
Croatian: Tablica 11 Karakteristike KML-a u anamnezi
English: Hypertensive crisis, peripheral arterial occlusive disease, intermittent claudication, arterial stenosis limb, haematoma, arteriosclerosis
Croatian: Hipertenzivna kriza, okluzivna bolest perifernih arterija, intermitentna klaudikacija, stenoza arterije u ekstremitetu, hematom, arterioskleroza
English: In a Phase III study in newly diagnosed CML patients, 6.9% and 7.2% of the patients treated with 400 mg nilotinib and 300 mg nilotinib twice daily, respectively, showed a Grade 3-4 elevation in blood glucose.
Croatian: U ispitivanju faze III u bolesnika s novodijagnosticiranim KML-om 6,9% bolesnika liječenih s 400 mg nilotiniba dva puta na dan, odnosno 7,2% bolesnika liječenih s 300 mg nilotiniba dva puta na dan imalo je povišenja glukoze u krvi 3.- 4. stupnja.
English: Unchanged nilotinib accounted for 69% of the dose.
Croatian: Na nepromijenjeni dio lijeka otpada 69% doze.
English: Frequency rare: Cases of tumour lysis syndrome have been reported in patients treated with nilotinib.
Croatian: Rijetka učestalost: slučajevi sindroma lize tumora bili su prijavljeni u bolesnika koji su primali terapiju nilotinibom.
English: The MMR rate at 12 months was statistically significantly higher for nilotinib 300 mg twice daily compared to imatinib 400 mg once daily (44.3% versus 22.3%, p<0.0001).
Croatian: Stopa MMR-a u 12. mjesecu je bila statistički značajno viša za 300 mg nilotiniba dva puta na dan u usporedbi s 400 mg imatiniba jedanput na dan (44,3% u odnosu na 22,3%, p<0,0001).
English: Some side effects are uncommon (may affect up to 1 in 100 people) - generally feeling unwell - painful and swollen joints (gout) - inability to achieve or maintain an erection - feeling body temperature change (including feeling hot, feeling cold) - sensitive teeth
Croatian: Neke nuspojave su manje česte (mogu se javiti u manje od 1 na 100 ljudi) - opće loše stanje - bolni i otečeni zglobovi (giht) - nemogućnost postizanja ili održavanja erekcije - osjećaj promjene tjelesne temperature (uključujući osjećaj vrućine i osjećaj hladnoće) - osjetljivi zubi
English: Patients who re-initiate nilotinib therapy should have their BCR-ABL transcript levels monitored monthly until MMR is re-established and every 12 weeks thereafter (see section 4.4).
Croatian: Kod bolesnika koji ponovo započnu terapiju nilotinibom potrebno je mjesečno pratiti razine BCR-ABL transkripcija dok se ponovo ne uspostavi MMR te svakih 12 tjedana nakon toga (vidjeti dio 4.4).
English: Monitoring of patients who have discontinued therapy Frequent monitoring of BCR-ABL transcript levels in patients eligible for treatment discontinuation must be performed with a quantitative diagnostic test validated to measure molecular response levels with a sensitivity of at least MR4.5 (BCR-ABL/ABL ≤0.0032% IS).
Croatian: Učestalo praćenje razina BCR-ABL transkripcija u bolesnika podobnih za prekid liječenja mora se obaviti kvantitativnim dijagnostičkim testom validiranim za mjerenje razina molekularnog odgovora s osjetljivošću od najmanje MR4,5 (BCR-ABL/ABL ≤0,0032% IS).
English: Angina pectoris, arrhythmia (including atroventricular block, cardiac flutter, extrasystoles, tachycardia, atrial fibrillation, bradycardia), palpitations, electrocardiogram QT prolonged
Croatian: Angina pektoris, aritmija (uključujući atrioventrikularni blok, treperenje srca, ekstrasistole, tahikardiju, fibrilaciju atrija, bradikardiju), palpitacije, produžen QT interval u elektrokardiogramu
English: Cardiac failure, myocardial infarction, coronary artery disease, cardiac murmur, pericardial effusion, cyanosis
Croatian: Zatajenje srca, infarkt miokarda, bolest koronarnih arterija, šum na srcu, perikardijalni izljev, cijanoza
English: Median age was 47 years in both nilotinib arms and 46 years in the imatinib arm, with 12.8%, 10.0% and 12.4% of patients were ≥65 years of age in the nilotinib 300 mg twice daily, nilotinib 400 mg twice daily and imatinib 400 mg once daily treatment arms, respectively.
Croatian: Medijan dobi bio je 47 godina u obje skupine koje su primale nilotinib i 46 godina u skupini koja je primala imatinib, uz 12,8%, 10,0% i 12,4% bolesnika koji su imali ≥65 godina u skupini koja je primala 300 mg nilotiniba dva puta na dan, 400 mg nilotiniba dva puta na dan, odnosno 400 mg imatiniba jedanput na dan.
English: ANC* <1.0 x 10 9/l and/or platelet counts <50 x 10 9/l
Croatian: ABN* <1,0 x 10 9/l i/ili broj trombocita <50 x 10 9/l
English: Intoleran t (n=27)
Croatian: Nepodnoš -ljivost (n=27)
English: Dysuria, polliakiuria, chromaturia Reproductive system and breast disorders Uncommon:
Croatian: Dizurija, polakizurija, kromaturija Poremećaji reproduktivnog sustava i dojki Manje često:
English: Excipient with known effect One hard capsule contains 39.03 mg lactose monohydrate.
Croatian: Jedna tvrda kapsula sadrži 39,03 mg laktoze hidrata.
English: Angina pectoris, arrhythmia (including atroventricular block, tachycardia, atrial fibrillation, ventricular extrasystoles, bradycardia), electrocardiogram QT prolonged, palpitations, myocardial infarction
Croatian: Angina pektoris, aritmija (uključujući atrioventrikularni blok, tahikardiju, fibrilaciju atrija, ventrikularne ekstrasistole, bradikardiju), produžen QT interval u elektrokardiogramu, palpitacije, infarkt miokarda
English: Localised oedema
Croatian: Lokalizirani edem
English: No new events of progression to AP/BC were reported on-treatment since the 2-year analysis.
Croatian: Nije bilo zabilježenih novih događaja progresije do ubrzane faze/blastične krize tijekom liječenja od vremena analize provedene nakon 2 godine.
English: QTcF increase from baseline exceeding 60 msec was observed in <1% of patients while on the study medicinal product.
Croatian: Produženje QTcF veće od 60 msek u odnosu na početnu vrijednost opaženo je u <1% bolesnika tijekom primjene ispitivanog lijeka.
English: No food should be consumed for 2 hours before the dose is taken and no food should be consumed for at least one hour after the dose is taken.
Croatian: Hrana se ne smije uzimati 2 sata prije uzimanja doze te se ne smije uzimati najmanje jedan sat nakon uzimanja doze.
English: The most frequent (≥10%) non-haematological adverse reactions were rash, pruritus, headache, nausea, fatigue, alopecia, myalgia and upper abdominal pain.
Croatian: Najčešće (≥10%) nehematološke nuspojave bile su osip, svrbež, glavobolja, mučnina, umor, alopecija, mijalgija i bol u gornjem dijelu abdomena.