FrancophonIA/ELRC3.0 huggingface dataset:
English: At clinically relevant concentrations, ruxolitinib does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 and is not a potent inducer of CYP1A2, CYP2B6 or CYP3A4 based on in vitro studies.
Croatian: Pri klinički relevantnim koncentracijama, ruksolitinib ne inhibira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili CYP3A4 i nije snažan CYP1A2, CYP2B6 ili CYP3A4 induktor na temelju in vitro ispitivanja.
English: In a thorough QT study in healthy subjects, there was no indication of a QT/QTc prolonging effect of ruxolitinib in single doses up to a supratherapeutic dose of 200 mg, indicating that ruxolitinib has no effect on cardiac repolarisation.
Croatian: U osnovnom ispitivanju QT intervala u zdravih ispitanika nije bilo naznaka učinka ruksolitiniba u obliku produljenja QT/QTc intervala pri jednostrukim dozama do supraterapijske doze od 200 mg, što upućuje na to da ruksolitinib nema učinak na srčanu repolarizaciju.
English: Discontinuation due to adverse events, regardless of causality, was observed in 2.2% of patients.
Croatian: Prekid uzrokovan štetnim događajima, bez obzira na uzročno-posljedičnu vezu, bio je uočen u 2,2% bolesnika.
English: No intracranial bleeding or gastrointestinal haemorrhage events were reported in patients receiving ruxolitinib.
Croatian: Nisu bili zabilježeni događaji intrakranijalnog krvarenja ili gastrointestinalnog krvarenja u bolesnika koji su primali ruksolitinib.
English: Patients diagnosed with hepatic impairment while receiving ruxolitinib should have complete blood counts, including a white blood cell count differential, monitored at least every one to two weeks for the first 6 weeks after initiation of therapy with ruxolitinib and as clinically indicated thereafter once their liver function and blood counts have been stabilised.
Croatian: Bolesnicima kojima je dijagnosticirano oštećenje jetre dok uzimaju ruksolitinib treba pratiti kompletnu krvnu sliku, uključujući i diferencijalnu krvnu sliku leukocita, najmanje svakih tjedan do dva tijekom prvih 6 tjedana od uvođenja terapije ruksolitinibom te u skladu s kliničkim indikacijama nakon što im se funkcija jetre i krvna slika stabiliziraju.
English: Ruxolitinib is eliminated through metabolism catalysed by CYP3A4 and CYP2C9.
Croatian: Ruksolitinib se eliminira kroz metabolizam kataliziran pomoću CYP3A4 i CYP2C9.
English: In PV, dose reductions should also be considered if haemoglobin decreases below 12 g/dl and is recommended if it decreases below 10 g/dl.
Croatian: Kod PV-a, smanjivanje doze treba razmotriti i ako se hemoglobin smanji ispod 12 g/dl te se preporučuje ako se smanji ispod 10 g/dl.
English: P value: < .0001 Odds ratio (ruxolitinib/BAT) and 95% CI:
Croatian: P-vrijednost: < 0,0001 Omjer izgleda (ruksolitinib/NDT) i 95% CI:
English: The basis for the dysregulation is believed to include high levels of circulating cytokines that activate the JAK-STAT pathway, gain-of-function mutations such as JAK2V617F, and silencing of negative regulatory mechanisms.
Croatian: Vjeruje se da temelj za disregulaciju uključuje visoke razine cirkulirajućih citokina koje aktiviraju put JAK-STAT, mutacije dobivanja nove funkcije (engl. gain-offunction) kao što su JAK2V617F, te zatomljavanje negativnih regulatornih mehanizama.
English: It is not known whether the Janus Associated Kinase (JAK) inhibition by ruxolitinib reduces the efficacy of the haematopoietic growth factors or whether the haematopoietic growth factors affect the efficacy of ruxolitinib (see section 4.4).
Croatian: Nije poznato smanjuje li inhibicija Janus kinaze (JAK) koju vrši ruksolitinib djelotvornost hematopoetskih čimbenika rasta ili utječu li hematopoetski čimbenici rasta na djelotvornost ruksolitiniba (vidjeti dio 4.4).
English: These include medicines used to treat fungal diseases (such as ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole), medicines used to treat certain types of bacterial infections (antibiotics such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin), medicines to treat viral infections, including HIV infection/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), medicines to treat hepatitis C (boceprevir, telaprevir).
Croatian: Oni uključuju lijekove za liječenje gljivičnih bolesti (kao što su ketokonazol, itrakonazol, posakonazol, flukonazol i vorikonazol), lijekove koji se primjenjuju za liječenje određenih vrsta bakterijskih infekcija (antibiotici kao što su klaritromicin, telitromicin, ciprofloksacin, ili eritromicin), lijekove za liječenje virusnih infekcija, uključujući infekciju HIV-om/AIDS (kao što su amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, sakvinavir), lijekove za liječenje hepatitisa C (boceprevir, telaprevir).
English: Anaemia, thrombocytopenia and neutropenia are dose-related effects.
Croatian: Anemija, trombocitopenija i neutropenija su nuspojave povezane s dozom.
English: Significantly more patients treated with Jakavi (23%) achieved a primary response (p<0.0001) compared to BAT (0.9%).
Croatian: Značajno više bolesnika liječenih Jakavijem (23%) postiglo je primarni odgovor (p<0,0001) u usporedbi s NDT-om (0,9%).
English: What Jakavi contains - The active substance of Jakavi is ruxolitinib.
Croatian: Što Jakavi sadrži - Djelatna tvar Jakavija je ruksolitinib.
English: The margins (based on unbound Cmax) at the non-adverse level in the dog and rat studies were 15.7-fold and 10.4-fold greater, respectively, than the maximum human recommended dose of 25 mg twice daily.
Croatian: Granice (na temelju nevezanog Cmax) pri razinama koje nisu štetne u ispitivanjima na psima i štakorima bila su 15,7 odnosno 10,4-puta veća od najveće preporučene doze u ljudi od 25 mg dvaput na dan.
English: There was no clinically relevant change in the pharmacokinetics of ruxolitinib upon administration with a high-fat meal.
Croatian: Nije bilo klinički relevantne promjene u farmakokinetici ruksolitiniba po primjeni obroka s visokim udjelom masnoća.
English: The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
Croatian: Najveća preporučena početna doza u tih bolesnika iznosi 5 mg dvaput na dan, pri čemu dozu kod tih bolesnika treba oprezno titrirati.
English: A significantly higher proportion of patients in the Jakavi group achieved ≥35% reduction from baseline in spleen volume (Table 2) regardless of the presence or absence of the JAK2V617F mutation or the disease subtype (primary MF, post-polycythaemia vera MF, post-essential thrombocythaemia MF).
Croatian: Značajno viši udio bolesnika u skupini koja je primala Jakavi postigao je smanjenje volumena slezene ≥35% u odnosu na početnu vrijednosti (Tablica 2) bez obzira na prisutnost ili odsutnost JAK2V617F mutacije ili podtipa bolesti (primarni MF, MF kao posljedica policitemije vere, MF kao posljedica esencijalne trombocitopenije).
English: Table 2 Percentage of patients with ≥35% reduction from baseline in spleen volume at week 24 in COMFORT-I and at week 48 in COMFORT-II (ITT)
Croatian: Tablica 2 Postotak bolesnika sa smanjenjem u volumenu slezene ≥35% od početne vrijednosti u 24. tjednu u COMFORT-I, te u 48. tjednu u COMFORT-II (ITT)
English: Target organs associated with the pharmacological action of ruxolitinib in repeated dose studies include bone marrow, peripheral blood and lymphoid tissues.
Croatian: Ciljni organi povezani s farmakološkim djelovanjem ruksolitiniba u ispitivanjima ponovljenih doza uključuju koštanu srž, perifernu krvi i limfoidna tkiva.
English: Further dose modifications should be based on the safety and efficacy of the medicinal product (see sections 4.2 and 5.2).
Croatian: Daljnje promjene doze trebaju se temeljiti na sigurnosti i djelotvornosti lijeka (vidjeti dijelove 4.2 i 5.2).
English: MF patients exhibit dysregulated JAK signalling regardless of JAK2V617F mutation status.
Croatian: MF-om pokazuju disreguliranu JAK signalizaciju bez obzira na status mutacije JAK2V617F.
English: When you stop taking Jakavi, the myelofibrosis symptoms may come back.
Croatian: Kad prestanete uzimati Jakavi, simptomi mijelofibroze mogli bi se vratiti.
English: Ruxolitinib resulted in maximal inhibition of STAT3 phosphorylation 2 hours after dosing which returned to near baseline by 8 hours in both healthy subjects and MF patients, indicating no accumulation of either parent or active metabolites.
Croatian: Ruksolitinib je rezultirao maksimalnom inhibicijom STAT3 fosforilacije 2 sata nakon doze koja se vratila na vrijednost blizu početne nakon 8 sati kod zdravih ispitanika i kod bolesnika s MF-om, što upućuje na to nema nakupljanja ni osnovne tvari ni aktivnih metabolita.
English: During the randomised period, dose holding or reductions due to neutropenia were reported in 1.0% of patients, and 0.3% of patients discontinued treatment because of neutropenia.
Croatian: Tijekom razdoblja randomizacije, zadržavanje iste doze ili smanjenja doze zbog neutropenije bila su prijavljena u 1,0% bolesnika, a 0,3% bolesnika prekinulo je terapiju zbog neutropenije.
English: If you forget to take Jakavi
Croatian: Ako ste zaboravili uzeti Jakavi
English: Table 3 Percentage of patients with ≥35% reduction from baseline in spleen volume by JAK mutation status (safety set)
Croatian: Tablica 3 Postotak bolesnika sa smanjenjem volumena slezene ≥35% u odnosu na početnu vrijednost prema statusu JAK mutacije (sigurnosna skupina)
English: In phase 3 clinical studies in MF, neither CTCAE grade 3 or 4 hypercholesterolaemia, raised aspartate aminotransferase nor CTCAE grade 4 raised alanine aminotransferase were observed.
Croatian: U kliničkim ispitivanjima MF-a faze 3 nisu bili uočeni ni hiperkolesterolemija stupnja 3 ili 4 prema CTCAE-u, ni povišenje aspartat aminotransferaze, ni povišenje alanin aminotransferaze stupnja 4 prema CTCAE-u.
English: Patients were randomised 2:1 to ruxolitinib versus best available therapy.
Croatian: Bolesnici su bili randomizirani u omjeru 2:1 na ruksolitinib u odnosu na najbolju dostupnu terapiju.
English: Reduced bone growth was observed at doses ≥5 mg/kg/day when treatment started on postnatal day 7 (comparable to human newborn) and at ≥15 mg/kg/day when treatment started on postnatal days 14 or 21 (comparable to human infant, 1-3 years).
Croatian: Smanjeni rast kostiju bio je uočen pri dozama ≥5 mg/kg/dan kada je liječenje započelo 7. postnatalnog dana (usporedivo s ljudskim novorođenčem) i pri dozama ≥15 mg/kg/dan kada je liječenje započelo 14. ili 21. postnatalnog dana (usporedivo s ljudskim dojenčem u dobi od 1. do 3. godine).
English: However, plasma AUC values of ruxolitinib metabolites tended to increase with increasing severity of renal impairment, and were most markedly increased in the subjects with severe renal impairment.
Croatian: Međutim, AUC vrijednosti metabolita ruksolitiniba u plazmi bile su sklone povećavanju uz povećanu težinu oštećenja bubrega te su bile najizraženije povećane u ispitanika s teškim oštećenjem bubrega.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svake klasifikacije organskog sustava, nuspojave na lijek su poredane po učestalosti, pri čemu su najučestalije nuspojave navedene prve.
English: Patients with a haemoglobin level below 10.0 g/dl at the beginning of the treatment have a higher risk of developing a haemoglobin level below 8.0 g/dl during treatment compared to patients with a higher baseline haemoglobin level (79.3% versus 30.1%).
Croatian: U bolesnika s razinom hemoglobina ispod 10,0 g/dl na početku liječenja veći je rizik od pada razine hemoglobina ispod 8,0 g/dl tijekom liječenja u usporedbi s bolesnicima s višom početnom razinom hemoglobina (79,3% u odnosu na 30,1%).
English: Treatment with Jakavi has been associated with increases in lipid parameters including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.
Croatian: Liječenje Jakavijem je povezano s povišenjima u lipidnim parametrima, uključujući ukupni kolesterol, kolesterol vezan na lipoproteine visoke gustoće (HDL), kolesterol vezan na lipoproteine niske gustoće (LDL) i trigliceride.
English: Adverse drug reactions from clinical studies (Table 1) are listed by MedDRA system organ class.
Croatian: Nuspojave na lijek iz kliničkih ispitivanja (Tablica 1) navedene su prema klasifikaciji organskih sustava po MedDRA-i.
English: Dose modifications
Croatian: Promjene doze
English: Most of these patients had histories of extended treatment with hydroxyurea and prior NMSC or pre-malignant skin lesions.
Croatian: Većina tih bolesnika imala je u anamnezi produljeno liječenje hidroksiurejom i prethodni nemelanomski rak kože ili premaligne kožne lezije.
English: 14 tablets
Croatian: 14 tableta
English: Thrombocytopenia was generally reversible with dose reduction or dose interruption.
Croatian: Trombocitopenija je općenito bila reverzibilna uz smanjenje doze ili prekid uzimanja doze.
English: In a pre- and post-natal development study, a slightly prolonged gestation period, reduced number of implantation sites, and reduced number of pups delivered were observed.
Croatian: U ispitivanju pred- i postnatalnog razvoja bilo je uočeno blago produženo razdoblje gestacije, smanjeni broj mjesta implantacije te smanjeni broj štenadi u okotu.
English: In the randomised period of the pivotal studies, anaemia was less frequent in PV patients than in MF patients (40.8% versus 82.4%).
Croatian: U razdoblju randomizacije ključnih ispitivanja, anemija je bila manje učestala u bolesnika s PV-om nego u bolesnika s MF-om (40,8% naspram 82,4%).
English: These ADRs are discussed in the text.
Croatian: Ove su nuspojave na lijek opisane u tekstu.
English: With these updated data, therapy discontinuation due to adverse events was observed in 27.4% of patients treated with ruxolitinib.
Croatian: S tim ažuriranim podacima, prekid terapije zbog štetnih događaja uočen je u 27,4% bolesnika liječenih ruksolitinibom.
English: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5-200 mg.
Croatian: Srednji Cmax i ukupna izloženost (AUC) ruksolitinibu razmjerno su se povećali u rasponu jednostruke doze od 5 do 200 mg.
English: 110 patients were randomised to the ruxolitinib arm and 112 patients to the BAT arm.
Croatian: 110 bolesnika bilo je randomizirano u skupinu koja je primala ruksolitinib, a 112 bolesnika u skupinu koja je primala NDT.
English: Bruising events were more frequently reported in patients taking ruxolitinib compared with the reference treatments (21.3% versus 11.6%).
Croatian: Modrice su bile češće prijavljivane u bolesnika koji su uzimali ruksolitinib u usporedbi s referentnim terapijama (21,3% u odnosu na 11,6%).
English: Following a single ruxolitinib dose of 25 mg in patients with varying degrees of hepatic impairment, the mean AUC for ruxolitinib was increased in patients with mild, moderate and severe hepatic impairment by 87%, 28% and 65%, respectively, compared to patients with normal hepatic function.
Croatian: Nakon jednokratne doze ruksolitiniba od 25 mg u bolesnika s različitim stupnjevima oštećenja jetre, srednji AUC za ruksolitinib bio je povećan u bolesnika s blagim, umjerenim i teškim oštećenjem jetre za 87%, 28% odnosno 65%, u usporedbi s bolesnicima s normalnom funkcijom jetre.
English: There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm and <100,000/mm 3.
Croatian: Postoje ograničene informacije o preporučenoj početnoj dozi za bolesnike s brojem trombocita između 50 000/mm i <100 000/mm
English: For patients with end-stage renal disease on haemodialysis the starting dose for MF patients should be based on platelet counts (see section 4.2).
Croatian: Za bolesnike s terminalni bubrežnim zatajenjem koji su na hemodijalizi, početna se doza za bolesnike s MF-om treba temeljiti na razinama trombocita (vidjeti dio 4.2).
English: Cytoreductive therapies
Croatian: Citoreduktivne terapije
English: Fractures and early termination of rats were observed at doses ≥30 mg/kg/day when treatment was started on postnatal day 7.
Croatian: Prijelomi i rana smrt štakora uočeni su pri dozama ≥30 mg/kg/dan kada je liječenje započelo 7. postnatalnog dana.
English: Jakavi tablets are supplied in blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets
Croatian: Jakavi tablete su dostupne u blister pakiranjima koja sadrže 14 ili 56 tableta ili višestrukim pakiranjima koja sadrže 168 (3 pakiranja od 56) tableta.
English: Very common a
Croatian: Vrlo često a
English: 3, with the goal of avoiding dose interruptions for thrombocytopenia.
Croatian: 3, kako bi se izbjegao prekid u doziranju zbog trombocitopenije.
English: Additional dose modifications should be made with careful monitoring of safety and efficacy (see sections 4.2 and 5.2).
Croatian: Dodatne modifikacije doze trebaju se vršiti uz pažljivo praćenje sigurnosti i djelotvornosti (vidjeti dijelove 4.2 i 5.2).
English: The frequency of severe (i.e. CTCAE grade 3 and 4) thrombocytopenia was lower in PV (2.7%) than in MF (11.6%) patients.
Croatian: Učestalost teške (tj. stupnja 3 i 4 prema CTCAE-u) trombocitopenije bila je niža u bolesnika s PV-om (2,7%) nego u onih s MF-om (11,6%).
English: Two randomised phase 3 studies (COMFORT-I and COMFORT-II) were conducted in patients with MF (primary MF, post-polycythaemia vera MF or post-essential thrombocythaemia MF).
Croatian: Dva randomizirana ispitivanja faze 3 (COMFORT-I i COMFORT-II) bila su provedena u bolesnika s MF-om (primarni MF, MF kao posljedica policitemije vere ili MF kao posljedica esencijalne trombocitopenije).
English: The safety and efficacy of this co-administration is not known (see section 4.4).
Croatian: Sigurnost i djelotvornost ove istodobne primjene nisu poznate (vidjeti dio 4.4).
English: No effects were noted on fertility.
Croatian: Nisu bili uočeni učinci na plodnost.
English: Tabulated list of adverse drug reactions from clinical studies
Croatian: Tablični popis nuspojava na lijek iz kliničkih ispitivanja
English: Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anaemia and thrombocytopenia.
Croatian: Opetovane doze više od preporučenih povezane su s povećanom mijelosupresijom koja uključuje leukopeniju, anemiju i trombocitopeniju.
English: 50% dose reduction should be considered when using medicinal products which are dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole).
Croatian: Treba razmotriti smanjenje doze za 50% kada se primjenjuju lijekovi koji su dvostruki inhibitori enzima CYP2C9 i CYP3A4 (npr. flukonazol).
English: Key secondary endpoints included the proportion of patients who achieved the primary endpoint and remained free from progression at week 48, as well as the proportion of patients achieving complete haematological remission at week 32.
Croatian: Ključne mjere sekundarnih ishoda uključivali su udio bolesnika koji su postigli mjeru primarnog ishoda i nisu imali progresiju do 48. tjedna, kao i udio bolesnika koji su postigli potpunu hematološku remisiju do 32. tjedna.
English: In these clinical studies, discontinuation due to adverse events, regardless of causality, was observed in 11.3% of patients.
Croatian: U tim kliničkim ispitivanjima prekidi terapije uzrokovani štetnim događajima, bez obzira na uzročnoposljedičnu vezu, uočeni su u 11,3% bolesnika.
English: Polycythaemia vera
Croatian: Policitemija vera
English: In both studies, the lower death rates noted in the ruxolitinib arm were predominantly driven by the results obtained in the post polycythaemia vera and post essential thrombocythaemia subgroups.
Croatian: U oba ispitivanja niže stope smrtnosti zabilježene u ruksolitinib skupini bile su uglavnom uzrokovane rezultatima dobivenima u podskupinama s mijelofibrozom nakon policitemije vere i mijelofibrozom nakon esencijalne trombocitemije.
English: Thrombocytopenia is generally reversible and is usually managed by reducing the dose or temporarily withholding Jakavi (see sections 4.2 and 4.8).
Croatian: Trombocitopenija je općenito reverzibilna i obično se kontrolira smanjenjem doze ili privremenim prekidom primjene Jakavija (vidjeti dijelove 4.2 i 4.8).
English: The starting dose of Jakavi was 10 mg twice daily.
Croatian: Početna doza Jakavija bila je 10 mg dvaput na dan.
English: If you stop taking Jakavi
Croatian: Ako prestanete uzimati Jakavi
English: 56 tablets.
Croatian: 56 tableta.
English: - St. John's wort (Hypericum perforatum), a herbal product used to treat depression.
Croatian: - Gospina trava (Hypericum perforatum), biljni lijek koji se primjenjuje za liječenje depresije.
English: Not all packs may be marketed in your country.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: The starting dose of Jakavi should be reduced in patients with severe renal impairment.
Croatian: Početnu dozu Jakavija treba smanjiti u bolesnika s teškim oštećenjem bubrega.
English: Treatment with Jakavi can cause haematological adverse drug reactions, including thrombocytopenia, anaemia and neutropenia.
Croatian: Liječenje Jakavijem može uzrokovati hematološke nuspojave na lijek, koje uključuju trombocitopeniju, anemiju i neutropeniju.
English: The most frequently reported adverse drug reactions were thrombocytopenia and anaemia.
Croatian: Najčešće prijavljene nuspojave na lijek bile su trombocitopenija i anemija.
English: There are limited data to determine the best dosing options for patients with end-stage renal disease (ESRD) on haemodialysis.
Croatian: Postoje ograničeni podaci za određivanje najbolje doze u bolesnika s terminalnim bubrežnim zatajenjem koji su na hemodijalizi.
English: Description of selected adverse drug reactions
Croatian: Opis odabranih nuspojava uz lijek
English: Time points
Croatian: Vremenske točke
English: Based on unbound AUC, the exposure at the NOAEL (no observed adverse effect level) in juvenile rats treated as early as postnatal day 7 was 0.3-fold that of adult patients at 25 mg twice daily, while reduced bone growth and fractures occurred at exposures that were 1.5- and 13-fold that of adult patients at 25 mg twice daily, respectively.
Croatian: Na temelju nevezanog AUC-a, izloženost pri razini na kojoj nije uočen nikakav štetan učinak (no observed adverse effect level, NOAEL) u mladih štakora liječenih već od 7. postnatalnog dana iznosila je 0,3 puta one u odraslih bolesnika pri dozi od 25 mg dvaput dnevno, dok su se smanjeni rast kostiju i prijelomi javili pri izloženostima koje su bile 1,5 odnosno 13 puta veće od one u odraslih bolesnika pri dozi do 25 mg dvaput dnevno.
English: c grade 3 (> 5x - 20 x ULN)
Croatian: c stupanj 3 (> 5x - 20 x GGN)
English: Myelofibrosis
Croatian: Mijelofibroza
English: Very common (may affect more than 1 in 10 people): - high level of cholesterol or fat in the blood (hypertriglyceridaemia) - abnormal liver function test results - dizziness - headache - urinary tract infections - weight gain
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 ljudi): - visoka razina kolesterola ili masnoća u krvi (hipertrigliceridemija) - poremećeni rezultati ispitivanja jetrene funkcije - omaglica - glavobolja - infekcije mokraćnog sustava - porast tjelesne težine
English: Ruxolitinib inhibits JAK-STAT signalling and cell proliferation of cytokine-dependent cellular models of haematological malignancies, as well as of Ba/F3 cells rendered cytokine-independent by expressing the JAK2V617F mutated protein, with IC50 ranging from 80-320 nM.
Croatian: Ruksolitinib inhibira JAK-STAT signalizaciju i proliferaciju stanica u celularnim modelima o citokinu ovisnih hematoloških malignosti, kao i onu Ba/F3 stanica koje je ekspresija JAK2V617F mutiranog proteina učinila neovisnim o citokinima, uz IC50 u rasponu od 80-320 nM.
English: Physicians should carefully observe patients receiving Jakavi for signs and symptoms of infections and initiate appropriate treatment promptly.
Croatian: Liječnici trebaju u bolesnika koji primaju Jakavi pažljivo pratiti pojavu znakova i simptoma infekcija te pravovremeno započeti odgovarajuće liječenje.
English: Gastrointestinal bleeding
Croatian: Gastrointestinalno krvarenje