FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, it is not anticipated that the contraceptive efficacy of this combination will be compromised by co-administration of ruxolitinib.
Croatian: Stoga se ne očekuje da će istodobna primjena ruksolitiniba kompromitirati kontraceptivnu djelotvornost ove kombinacije.
English: - The recommended starting dose in myelofibrosis is 15 mg twice daily or 20 mg twice daily,
Croatian: - Preporučena početna doza kod mijelofibroze je 15 mg dvaput na dan ili 20 mg dvaput na dan,
English: At week 32, 49% and 64% of patients treated with ruxolitinib achieved a ≥50% reduction in TSS-14 and TSS-5, respectively, compared to only 5% and 11% of patients on BAT.
Croatian: U 32. tjednu 49% odnosno 64% bolesnika liječenih ruksolitinibom postiglo je smanjenje ≥50% u UZS-14 odnosno UZS-5, u usporedbi sa samo 5% odnosno 11% bolesnika na NDT-u.
English: Haematocrit control without phlebotomy
Croatian: Kontrola hematokrita bez flebotomije
English: Driving and using machines If you experience dizziness after taking Jakavi, do not drive or use machines.
Croatian: Ako osjetite omaglicu nakon uzimanja Jakavija, nemojte upravljati vozilom ili strojevima.
English: Of 301 patients, 111 (36.9%) had a baseline platelet count of between 100,000/mm and 200,000/mm and 190 (63.1%) had a baseline platelet count of
Croatian: Od 301 bolesnika, 111 (36,9%) imalo je početni broj trombocita između 100 000/mm i 200 000/mm
English: The three most frequent non-haematological laboratory abnormalities (any CTCAE grade) identified as adverse reactions were raised aspartate aminotransferase (26.1%), raised alanine aminotransferase (22.3%) and hypercholesterolaemia (20.7%).
Croatian: Tri najučestalije nehematološke laboratorijske abnormalnosti (bilo kojeg stupnja prema CTCAE-u) identificirane kao nuspojave bile su povišena aspartat aminotransferaza (26,1%), povišena alanin aminotransferaza (22,3%) i hiperkolesterolemija (20,7%).
English: In this arm, 83% of patients were still on treatment at the time of the week 80 data cut-off. Of patients who achieved a primary response at week 32, 80% maintained their response for at least 48 weeks after the initial response.
Croatian: Od bolesnika koji su postigli primarni odgovor u 32. tjednu, 80% ih je zadržalo odgovor najmanje 48 tjedana nakon početnog odgovora.
English: In patients with severe renal impairment (creatinine clearance less than 30 ml/min) the recommended starting dose based on platelet count for MF patients should be reduced by approximately 50% to be administered twice daily.
Croatian: U bolesnika s teškim oštećenjem bubrega (klirens kreatinina manji od 30 ml/min) preporučenu početnu dozu temeljenu na broju trombocita za bolesnike s MF-om treba smanjiti za otprilike 50% te je primjenjivati dvaput na dan.
English: A study in healthy subjects indicated that ruxolitinib did not inhibit the metabolism of the oral CYP3A4 substrate midazolam.
Croatian: Ispitivanje u zdravih ispitanika ukazalo je da ruksolitinib nije inhibirao metabolizam peroralnog midazolama, supstrata CYP3A4.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI
English: These metabolites have one half to one fifth of the parent JAK-related pharmacological activity.
Croatian: Ti metaboliti imaju polovicu do petinu farmakološke aktivnosti koju posjeduje početna tvar na JAK.
English: In the pups, decreased mean initial body weights and short period of decreased mean body weight gain were observed.
Croatian: Kod štenadi je bila uočena smanjena srednja početna tjelesna težina i kratko razdoblje smanjenog povećanja srednje tjelesne težine.
English: CYP3A4 inducers (such as, but not limited to, avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin (rifampicin), St.John's wort (Hypericum perforatum)) Patients should be closely monitored and the dose titrated based on safety and efficacy (see section 4.2).
Croatian: CYP3A4 induktori (kao što su, između ostalih, avasimib, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampin (rifampicin), gospina trava (Hypericum perforatum)) Bolesnike treba pažljivo pratiti te dozu titrirati na temelju sigurnosti i djelotvornosti (vidjeti dio 4.2).
English: There are no human data on the effect of ruxolitinib on fertility.
Croatian: Nema podataka za ljude o učinku ruksolitiniba na plodnost.
English: Anaemia or thrombocytopenia CTCAE grade 3 and 4 were reported in respectively 1.1% or 3.3%.
Croatian: Anemija ili trombocitopenija stupnja 3 ili 4 prema CTCAE-u bile su prijavljene u 1,1%, odnosno 3,3%.
English: Mild or moderate CYP3A4 inhibitors (such as, but not limited to, ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine)
Croatian: Blagi ili umjereni CYP3A4 inhibitori (kao što su, između ostalih, ciprofloksacin, eritromicin, amprenavir, atazanavir, diltiazem, cimetidin)
English: The recommended starting dose for PV patients with severe renal impairment is 5 mg twice daily.
Croatian: Preporučena početna doza za bolesnike s PV-om s teškim oštećenjem bubrega je 5 mg dvaput na dan.
English: Another study in healthy subjects indicated that ruxolitinib does not affect the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel.
Croatian: Drugo ispitivanje u zdravih ispitanika ukazalo je da ruksolitinib ne utječe na farmakokinetiku oralnog kontraceptiva koji sadrži etinilestradiol i levonorgestrel.
English: Ruxolitinib inhibits cytokine-induced STAT3 phosphorylation in whole blood from healthy subjects, MF patients and PV patients.
Croatian: Ruksolitinib inhibira fosforilaciju STAT3 potaknutu citokinima u punoj krvi zdravih ispitanika, bolesnika s MF-om i bolesnika s PV-om.
English: Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 (IC50 values of 3.3 nM and 2.8 nM for JAK1 and JAK2 enzymes, respectively).
Croatian: Janus Associated Kinases) JAK1 i JAK2 (IC50 vrijednost od 3,3 nM za enzim JAK1, odnosno 2,8 nM za JAK2).
English: An extended follow-up of patients treated with ruxolitinib showed no trends towards an increase in the rate of sepsis over time.
Croatian: Produženo praćenje bolesnika liječenih ruksolitinibom nije pokazalo trend povećanja stope sepse tijekom vremena.
English: Figure 1 Patients achieving the primary endpoint and components of the primary endpoint at week 32
Croatian: Slika 1 Bolesnici koji su postigli mjeru primarnog ishoda i komponente mjere primarnog ishoda u 32. tjednu
English: More frequent monitoring of haematology parameters and of clinical signs and symptoms of Jakavi-related adverse drug reactions is recommended for patients with baseline haemoglobin below 10.0 g/dl.
Croatian: Preporučuje se učestalije praćenje hematoloških parametara i kliničkih znakova i simptoma nuspojava na lijek povezanih s Jakavijem za bolesnike s početnom razinom hemoglobina ispod 10,0 g/dl.
English: Dose reductions should be considered if the platelet count decreases below 100,000/mm
Croatian: Treba razmotriti smanjivanje doze ako se razina trombocita snizi na manje od 100 000/mm
English: How Jakavi works
Croatian: Kako Jakavi djeluje
English: In the phase 3 pivotal clinical studies in MF an increase in systolic blood pressure of 20 mmHg or more from baseline was recorded in 31.5% of patients on at least one visit compared with 19.5% of the control-treated patients.
Croatian: U ključnim kliničkim ispitivanjima MF-a faze 3 zabilježeno je povišenje sistoličkog krvnog tlaka od 20 mmHg ili više u odnosu na početnu vrijednost u 31,5% bolesnika tijekom barem jednog posjeta u usporedbi s 19,5% bolesnika koji su primali kontrolnu terapiju.
English: - The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate, povidone, hydroxypropylcellulose, lactose monohydrate.
Croatian: - Drugi sastojci su: mikrokristalična celuloza, magnezijev stearat, koloidni bezvodni silicijev dioksid, natrijev škroboglikolat, povidon, hidroksipropilceluloza, laktoza hidrat.
English: - The maximum dose is 25 mg twice daily.
Croatian: - Najveća doza je 25 mg dvaput na dan.
English: Ruxolitinib is a Biopharmaceutical Classification System (BCS) class 1 compound, with high permeability, high solubility and rapid dissolution characteristics.
Croatian: Biopharmaceutical Classification System, BCS), visoke permeabilnosti, visoke topivosti i brzog otapanja.
English: The concomitant use of cytoreductive therapies or haematopoietic growth factors with Jakavi has not been studied.
Croatian: Istodobna primjena citoreduktivnih terapija ili hematopoetskih čimbenika rasta s Jakavijem nije do sada ispitivana.
English: Treatment benefit perception was measured by the Patient Global Impression of Change (PGIC) questionnaire.
Croatian: Patient Global Impression of Change, PGIC).
English: Following a single ruxolitinib dose of 25 mg, the exposure of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function.
Croatian: Nakon jednokratne doze ruksolitiniba od 25 mg, izloženost ruksolitinibu bila je slična u ispitanika s različitim stupnjevima oštećenja bubrega te u onih s normalnom funkcijom bubrega.
English: A single dose of 15 mg is recommended for MF patients with platelet count between 100,000/mm and 200,000/mm
Croatian: Jednokratna doza od 15 mg se preporučuje za bolesnike s MF-om s brojem trombocita između 100 000/mm i 200 000/mm
English: In COMFORT-I, 45.9% subjects in the Jakavi group achieved a ≥50% improvement from baseline in the week 24 total symptom score (measured using MFSAF diary v2.0), as compared to 5.3% in the placebo group (p<0.0001 using chi-square test).
Croatian: U ispitivanju COMFORT-I, 45,9% ispitanika u skupini koja je primala Jakavi postiglo je poboljšanje ≥50% u odnosu na početnu vrijednosti u ukupnom zbroju simptoma u 24. tjednu (mjereno pomoću dnevnika MFSAF v2.0), u usporedbi s 5,3% u placebo skupini (p<0,0001 koristeći hi-kvadrat test).
English: It is unknown whether ruxolitinib and/or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se ruksolitinib i/ili metaboliti u majčino mlijeko u ljudi.
English: Complete blood counts should be monitored as clinically indicated and dose adjusted as required (see sections 4.2 and 4.8).
Croatian: Kompletnu krvnu sliku treba pratiti sukladno kliničkim indikacijama te prema potrebi prilagoditi dozu (vidjeti dijelove 4.2 i 4.8).
English: Therapeutic drug monitoring (TDM) or clinical monitoring of the affected substance is advised.
Croatian: Savjetuje se terapijsko praćenje koncentracije lijeka ili kliničko praćenje tvari na koje to utječe.
English: Patients with a platelet count of 100,000/mm to 200,000/mm before starting ruxolitinib had a higher frequency of grade 3 or 4 thrombocytopenia compared to patients with platelet count >200,000/mm
Croatian: Bolesnici s brojem trombocita od 100 000/mm do 200 000/mm prije početka liječenja ruksolitinibom imali su veću učestalost trombocitopenije stupnja 3 ili 4 u usporedbi s bolesnicima s razinom trombocita >200 000/mm
English: In juvenile rat studies, administration of ruxolitinib resulted in effects on growth and bone measures.
Croatian: U ispitivanjima na mladim štakorima primjena ruksolitiniba rezultirala je učincima na rast i dimenziju kostiju.
English: In the randomised, placebo-controlled study COMFORT-I 60.6% of Jakavi-treated MF patients and 37.7% of placebo-treated MF patients received red blood cell transfusions during randomised treatment.
Croatian: U randomiziranom, placebom kontroliranom ispitivanju COMFORT-I 60,6% bolesnika s MF-om liječenih Jakavijem i 37,7% bolesnika s MF-om koji su primali placebo primilo je transfuziju eritrocita tijekom randomiziranog liječenja.
English: The three most frequent non-haematological adverse drug reactions were bruising (21.3%), dizziness (15.3%) and headache (14.0%).
Croatian: Tri najučestalije nehematološke nuspojave na lijek bile su modrice (21,3%), omaglica (15,3%) i glavobolja (14,0%).
English: The three most frequent non-haematological laboratory abnormalities were raised alanine aminotransferase (27.2%), raised aspartate aminotransferase (19.9%) and hypercholesterolaemia (16.9%).
Croatian: Tri najučestalije nehematološke laboratorijske patološke vrijednosti bile su povišena alanin aminotransferaza (27,2%), povišena aspartat aminotransferaza (19,9%) i hiperkolesterolemija (16,9%).
English: Hypercholesterolaemia b
Croatian: Hiperkolesterolemija b
English: In the phase 3 pivotal studies in MF, grade 3 or 4 urinary tract infection was reported in 1.0% of patients, herpes zoster in 4.3% and tuberculosis in 1.0%.
Croatian: U ključnim ispitivanjima MF-a faze 3 infekcije mokraćnog sustava stupnja 3 ili 4 bile su prijavljene u 1,0% bolesnika, herpes zoster u 4,3% te tuberkuloza u 1,0%.
English: Other bleeding events (including events such as epistaxis, post-procedural haemorrhage and haematuria) were reported in 13.3% of patients treated with ruxolitinib and 10.3% treated with reference treatments.
Croatian: Ostali događaji krvarenja (uključujući događaje kao što je epistaksa, postproceduralno krvarenje i hematurija) bili su prijavljeni u 13,3% bolesnika liječenih ruksolitinibom te u 10,3% liječenih referentnim terapijama.
English: Gastrointestinal bleeding was reported in 5.0% of patients exposed to ruxolitinib compared to 3.1% exposed to reference treatments.
Croatian: Gastrointestinalno krvarenje bilo je prijavljeno u 5,0% bolesnika izloženih ruksolitinibu u usporedbi s 3,1% bolesnika izloženih referentnim terapijama.
English: Novartis Farmacéutica S.A. Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
Croatian: 08210 Barberà del Vallès, Barcelona Španjolska
English: Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
Croatian: Jakavi je indiciran za liječenje splenomegalije povezane s bolesti ili simptoma u odraslih bolesnika s primarnom mijelofibrozom (koja se naziva i kroničnom idiopatskom mijelofibrozom), mijelofibrozom nakon policitemije vere ili mijelofibrozom nakon esencijalne trombocitemije.
English: No effects were noted in an evaluation of the neuropharmacological effects of ruxolitinib.
Croatian: Nisu bili uočeni nikakvi učinci u procjenjivanju neurofarmakoloških učinaka ruksolitiniba.
English: A causal relationship to ruxolitinib has not been established.
Croatian: Uzročno-posljedična veza s ruksolitinibom nije utvrđena.
English: In phase 3 clinical studies in MF, median time to onset of first CTCAE grade 2 or higher anaemia was 1.5 months.
Croatian: U kliničkim ispitivanjima MF-a faze 3, medijan vremena do prve anemije stupnja 2 ili višeg prema CTCAE-u bio je 1,5 mjesec.
English: Ruxolitinib dose can be titrated to reduce the risk of cytopenia.
Croatian: Doza ruksolitiniba može se titrirati da bi se smanjio rizik od citopenije.
English: In the randomised period of the pivotal studies, the rate of patients experiencing thrombocytopenia was lower in PV (16.8%) patients compared to MF (69.8%) patients.
Croatian: U razdoblju randomizacije ključnih ispitivanja, stopa bolesnika u kojih se pojavila trombocitopenija bila je niža kod bolesnika s PV-om (16,8%) u usporedbi s bolesnicima s MF-om (69,8%).
English: INTERMEDIATE CARTON OF MULTIPACK
Croatian: SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA
English: More frequent monitoring (e.g. twice a week) of haematology parameters and of clinical signs and symptoms of ruxolitinib-related adverse drug reactions is recommended while on strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes.
Croatian: Preporučuje se učestalije praćenje (npr. dvaput tjedno) hematoloških parametara te kliničkih znakova i simptoma nuspojava na lijek povezanih s ruksolitinibom tijekom primjene snažnih CYP3A4 inhibitora ili dvostrukih inhibitora enzima CYP2C9 i CYP3A4.
English: Haematological adverse reactions (any CTCAE grade) included anaemia (40.8%) and thrombocytopenia (16.8%).
Croatian: Hematološke nuspojave (bilo kojeg stupnja prema CTCAE-u) uključivale su anemiju (40,8%) i trombocitopeniju (16,8%).
English: In the randomised period of the pivotal study in PV patients, neutropenia was reported in three patients (1.6%) of which one patient developed CTCAE grade 4 neutropenia.
Croatian: U razdoblju randomizacije ključnog ispitivanja u bolesnika s PV-om neutropenija je bila prijavljena u tri bolesnika (1,6%), od čega se u jednoga bolesnika razvila neutropenija stupnja 4 prema CTCAE-u.
English: The dose of Jakavi depends on the patient's blood cell count.
Croatian: Doza Jakavija ovisi o bolesnikovoj krvnoj slici.
English: In COMFORT-II, after a median follow-up of 55.9 months, the death rate in patients randomised to the ruxolitinib arm was 40.4% (59 of 146 patients) versus 47.9% (35 of 73 patients) in patients randomized to best available therapy (BAT).
Croatian: U ispitivanju COMFORT-II, nakon medijana praćenja od 55,9 mjeseci, stopa smrtnosti u bolesnika randomiziranih na ruksolitinib bila je 40,4% (59 od 146 bolesnika) naspram 47,9% (35 od 73 bolesnika) u bolesnika randomiziranih na najbolju dostupnu terapiju (NDT).
English: - if you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty thinking, loss of balance or difficulty walking, clumsiness, difficulty speaking, decreased strength or weakness on one side of your body, blurred and/or loss of vision.
Croatian: - ako osjetite vrućicu, zimicu ili druge simptome infekcija. - ako imate kroničan kašalj s krvavo obojenim iskašljajem, vrućicu, noćno znojenje i gubitak tjelesne težine (to mogu biti znakovi tuberkuloze). - ako imate bilo koji od sljedećih simptoma ili ako netko blizu Vas primijeti da imate bilo koji od ovih simptoma: smetenost ili poteškoće u razmišljanju, gubitak ravnoteže ili poteškoće u hodanju, nespretnost, poteškoće s govorom, smanjena snaga ili slabost na jednoj strani tijela, zamućeni vid i/ili gubitak vida.
English: Stopping Jakavi
Croatian: Prekid uzimanja Jakavija
English: No dose adjustment is recommended when ruxolitinib is co-administered with mild or moderate CYP3A4 inhibitors (e.g. erythromycin).
Croatian: Ne preporučuje se prilagođavanje doze kada se ruksolitinib primjenjuje istodobno s blagim ili umjerenim CYP3A4 inhibitorima (npr. eritromicinom).
English: c grade 3 (50,000 - 25,000/mm
Croatian: c stupanj 3 (50 000 - 25 000/mm
English: Percentage e of patients
Croatian: Postotak bolesnika
English: Haematocrit control was achieved in 60% of patients in the Jakavi arm compared to 18.8% in the BAT arm and a ≥35% reduction in spleen volume was achieved in 40% of patients in the Jakavi arm compared to 0.9% in the BAT arm (Figure 1).
Croatian: Kontrola hematokrita bila je postignuta u 60% bolesnika u Jakavi skupini u usporedbi s 18,8% u NDT skupini, a smanjenje ≥35% u volumenu slezene postignuto je u 40% bolesnika u Jakavi skupini u usporedbi s 0,9% u NDT skupini (Slika 1).
English: Haematological adverse drug reactions (any Common Terminology Criteria for Adverse Events [CTCAE] grade) included anaemia (82.4%), thrombocytopenia (69.8%) and neutropenia (16.6%).
Croatian: Common Terminology Criteria for Adverse Events, CTCAE)) uključivale su anemiju (82,4%), trombocitopeniju (69,8%) i neutropeniju (16,6%).
English: In the COMFORT-II study the rate of packed red blood cell transfusions was 53.4% in the Jakavi arm and 41.1% in the best available therapy arm.
Croatian: U ispitivanju COMFORT-II stopa transfuzija koncentrata eritrocita bila je 53,4% u Jakavi kraku te 41,1% u kraku s najboljom dostupnom terapijom.
English: Treatment should be discontinued for platelet counts less than 50,000/mm or absolute neutrophil counts less than 500/mm
Croatian: Liječenje treba prekinuti ako je broj trombocita manji od 50 000/mm ili ako je apsolutni broj neutrofila manji od 500/mm
English: c grade 3 (<8.0 - 6.5g/dl)
Croatian: c stupanj 3 (<8,0 - 6,5 g/dl)
English: How to take Jakavi
Croatian: Kako uzimati Jakavi
English: During the randomised period, platelet transfusions were administered to 4.7% of patients receiving ruxolitinib and to 4.0% of patients receiving control regimens.
Croatian: Tijekom razdoblja randomizacije, transfuzije trombocita bile su primijenjene kod 4,7% bolesnika koji su primali ruksolitinib te kod 4,0% bolesnika koji su primali kontrolne režime.
English: The key secondary endpoint defined as the proportion of patients achieving complete haematological remission at week 28 was also met (23.0% in the Jakavi arm versus 5.3% in the BAT arm).
Croatian: Ključna mjera sekundarnog ishoda definirana kao udio bolesnika koji su postigli kompletnu hematološku remisiju u 28. tjednu je također postignuta (23,0% u Jakavi skupini u odnosu na 5,3% u skupini s najboljom dostupnom terapijom).
English: Hepatobiliary disorders Raised alanine aminotransferase b
Croatian: Poremećaji jetre i žuči Povišena alanin aminotransferaza b
English: Intracranial bleeding was reported in 1% of patients exposed to ruxolitinib and 0.9% exposed to reference treatments.
Croatian: Intrakranijalno krvarenje bilo je prijavljeno u 1% bolesnika izloženih ruksolitinibu te u 0,9% bolesnika izloženih referentnim terapijama.
English: In patients with any hepatic impairment the recommended starting dose based on platelet count should be reduced by approximately 50% to be administered twice daily.
Croatian: U bolesnika s bilo kakvim oštećenjem jetre preporučenu početnu dozu temeljenu na broju trombocita treba smanjiti za otprilike 50% te primjenjivati dvaput na dan.
English: Long term safety data from two pivotal phase 3 studies assessed 457 patients with MF who were treated with ruxolitinib, including patients initially randomised to ruxolitinib (n=301; exposure 0.368.1 months, median exposure 33.4 months) and patients who received ruxolitinib after crossing over from control treatments (n=156; exposure: 0.5-59.8 months, median exposure 25.0 months).
Croatian: Podaci dugoročne sigurnosti iz dva ključna ispitivanja faze 3 procjenjivali su 457 bolesnika s MF-om liječenih ruksolitinibom, uključujući bolesnike inicijalno randomizirane na ruksolitinib (n=301; izloženost 0,3-68,1 mjeseci, medijan izloženosti 33,4 mjeseca) i bolesnike koji su primali ruksolitinib nakon prelaska iz kontrolnih skupina (n=156; izloženost 0,5-59,8 mjeseci, medijan izloženosti 25,0 mjeseca).
English: The primary endpoint defined as the proportion of patients achieving HCT control (absence of phlebotomy eligibility) at week 28 was met (62.2% in the Jakavi arm versus 18.7% in the BAT arm).
Croatian: Mjera primarnog ishoda definirana kao udio bolesnika koji su postigli kontrolu hematokrita (odsutnost prikladnosti za flebotomiju) u 28. tjednu je postignuta (62,2% u Jakavi skupini u odnosu na 18,7% u skupini s najboljom dostupnom terapijom).
English: Other bleeding (including epistaxis, post-procedural haemorrhage and haematuria)
Croatian: Druga krvarenja (uključujući epistaksu, postproceduralno krvarenje i hematuriju)
English: The primary efficacy endpoint was proportion of subjects achieving ≥35% reduction from baseline in spleen volume at week 24 as measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Croatian: Mjera primarnog ishoda djelotvornosti bio je udio ispitanika koji su postigli smanjenje ≥35% od početne vrijednosti u volumenu slezene u 24. tjednu mjereno magnetskom rezonancijom (MR) ili kompjuteriziranom tomografijom (CT).
English: Jakavi is also used to treat patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Croatian: Jakavi se primjenjuje i za liječenje bolesnika s policitemijom verom koji su otporni na ili ne podnose hidroksiureju.