FrancophonIA/ELRC3.0 huggingface dataset:
English: The cumulative frequency of adverse events in these studies increased proportionally to the increase in the follow-up time.
Croatian: Kumulativna učestalost štetnih događaja u tim ispitivanjima proporcionalno je rasla do povećanja u vremenu praćenja.
English: Not all pack sizes or types may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine ili vrste pakiranja.
English: In case pregnancy should occur during treatment with Jakavi, a risk/benefit evaluation must be carried out on an individual basis with careful counselling regarding potential risks to the foetus (see section 5.3).
Croatian: U slučaju da dođe do trudnoće tijekom liječenja Jakavijem, treba obaviti procjenu rizika/koristi za svaki pojedinačni slučaj uz pažljivo savjetovanje o potencijalnim rizicima za fetus (vidjeti dio 5.3).
English: Jakavi must not be used during breast-feeding (see section 4.3) and breast-feeding should therefore be discontinued when treatment is started.
Croatian: Jakavi se ne smije koristiti tijekom dojenja (vidjeti dio 4.3), a dojenje stoga treba prekinuti kada se započne liječenje.
English: MF and PV are myeloproliferative neoplasms known to be associated with dysregulated JAK1 and JAK2 signalling.
Croatian: MF i PV su mijeloproliferativne neoplazme za koje se zna da su povezane s disreguliranom signalizacijom JAK1 i JAK2.
English: What Jakavi is and what it is used for What you need to know before you take Jakavi How to take Jakavi
Croatian: Što je Jakavi i za što se koristi Što morate znati prije nego počnete uzimati Jakavi
English: Your doctor will measure the amount of blood cells in your body and find the best dose for you, particularly if you have liver or kidney problems.
Croatian: Liječnik će Vam izmjeriti broj krvnih stanica u tijelu i naći najbolju dozu za Vas, osobito ako imate poteškoća s jetrom ili bubrezima.
English: Best available therapy
Croatian: Najbolja dostupna terapija
English: Teratogenicity was not observed in rats or rabbits.
Croatian: Teratogenost nije bila uočena u štakora i zečeva.
English: Raised aspartate aminotransferase b
Croatian: Povišena aspartat aminotransferaza b
English: Jakavi can help reduce the risk of serious blood or vascular complications.
Croatian: Jakavi može pomoći u smanjenju rizika od ozbiljnih komplikacija s krvlju ili žilama.
English: - Mibefradil or diltiazem, medicines to treat hypertension and chronic angina pectoris.
Croatian: - Mibefradil ili diltiazem, lijekovi za liječenje hipertenzije i kronične angine pectoris.
English: Unless abrupt discontinuation is required, gradual tapering of the dose of Jakavi may be considered, although the utility of the tapering is unproven.
Croatian: Osim ako nije potreban nagli prekid liječenja, može se razmotriti postupno smanjivanje doze Jakavija, iako korisnost takvog smanjivanja nije dokazana.
English: As a precautionary measure, the use of Jakavi during pregnancy is contraindicated (see section 4.3).
Croatian: Kao mjera predostrožnosti, primjena Jakavija tijekom trudnoće je kontraindicirana (vidjeti dio 4.3).
English: Following interruption or discontinuation of Jakavi, symptoms of MF may return over a period of approximately one week.
Croatian: Nakon privremenog ili trajnog prekida uzimanja Jakavija simptomi MF-a mogu se vratiti tijekom razdoblja od otprilike tjedan dana.
English: Progressive multifocal leukoencephalopathy (PML) has been reported with Jakavi treatment.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) zabilježena je uz liječenje Jakavijem.
English: If you experience certain side effects (e.g. blood disorders), your doctor might need to change the amount of Jakavi you have to take or tell you to stop taking Jakavi for a while.
Croatian: Ako primijetite određene nuspojave (npr. poremećaje krvi), liječnik će možda trebati promijeniti količinu Jakavija koju morate uzimati ili Vam reći da prestanete uzimati Jakavi na neko vrijeme.
English: Other than bone development, the effects of ruxolitinib in juvenile rats were similar to those in adult rats.
Croatian: Osim na razvoj kostiju, učinci ruksolitiniba u mladih štakora bili su slični onima u odraslih štakora.
English: ≥35% reduction in spleen volume
Croatian: Smanjenje ≥35% u volumenu slezene
English: While you are taking Jakavi you should never start a new medicine without checking first with the doctor who prescribed Jakavi.
Croatian: Dok uzimate Jakavi ne smijete početi uzimati novi lijek ako to prethodno ne provjerite s liječnikom koji Vam je propisao Jakavi.
English: In lactating rats, ruxolitinib and/or its metabolites were excreted into the milk with a concentration that was 13-fold higher than the maternal plasma concentration.
Croatian: U štakora u laktaciji, ruksolitinib i/ili njegovi metaboliti izlučivali su se u mlijeku s koncentracijom koja je bila 13-puta viša od koncentracije u majčinoj plazmi.
English: Do not breast-feed while taking Jakavi.
Croatian: Nemojte dojiti dok uzimate Jakavi.
English: .RUX .BAT
Croatian: .RUX .NDT
English: The effects were generally more severe when administration was initiated earlier in the postnatal period.
Croatian: Učinci su općenito bili teži kada je primjena lijeka započela ranije u postnatalnom razdoblju.
English: Women of childbearing potential/Contraception
Croatian: Žene u reproduktivnoj dobi/Kontracepcija
English: Bleeding (any bleeding including intracranial, and gastrointestinal bleeding, bruising and other bleeding)
Croatian: Krvarenje (bilo koje krvarenje uključujući intrakranijalno, gastrointestinalno, modrice i druga krvarenja)
English: The exposure of ruxolitinib active metabolites was unchanged.
Croatian: Izloženost aktivnim metabolitima ruksolitiniba bila je nepromijenjena.
English: Overall, the ruxolitinib pharmacodynamic activity was similar, suggesting the CYP3A4 induction resulted in minimal effect on the pharmacodynamics.
Croatian: Općenito je farmakodinamička aktivnost ruksolitiniba bila slična, što upućuje na to da je CYP3A4 indukcija rezultirala minimalnim učinkom na farmakodinamiku.
English: The safety assessment was based on a total of 982 patients (with MF or PV) receiving Jakavi in phase 2 and 3 studies.
Croatian: Procjena sigurnosti temeljila se na ukupno 982 bolesnika (s MF-om ili PV-om) koji su primali Jakavi u ispitivanjima faze 2 i 3.
English: Adverse decreases in blood pressure along with increases in heart rate were noted in a dog telemetry study, and an adverse decrease in minute volume was noted in a respiratory study in rats.
Croatian: Štetna smanjenja krvnog tlaka zajedno s povišenjima srčane frekvencije bila su uočena u telemetrijskom ispitivanju u pasa, a štetno smanjenje u minutnom volumenu bilo je uočeno u respiratornom ispitivanju u štakora.
English: Table 1 Frequency category of adverse drug reactions reported in the phase 3 studies (COMFORT-I, COMFORT-II, RESPONSE, RESPONSE 2)
Croatian: Tablica 1 Kategorija učestalosti nuspojava na lijek prijavljenih u ispitivanjima faze 3 (COMFORT-I, COMFORT-II, RESPONSE, RESPONSE 2)
English: The study met its primary objective and a higher proportion of patients in the Jakavi group achieved the primary composite endpoint and each of its individual components.
Croatian: Ispitivanje je ispunilo svoj primarni cilj i veći udio bolesnika u skupini koja je primala Jakavi postigao je mjeru primarnog kompozitnog ishoda i svaku od njegovih pojedinačnih komponenti.
English: However, the exposure margins compared to the highest clinical dose were low and the results are therefore of limited relevance for humans (see section 5.3).
Croatian: Međutim, granice izloženosti u usporedbi s najvišom kliničkom dozom bile su niske i rezultati su stoga od ograničene važnosti za ljude (vidjeti dio 5.3).
English: During the treatment your doctor may recommend a lower or higher dose to you if the results of blood tests show that this is necessary, if you have problems with your liver or kidneys, or if you also need treatment with certain other medicines.
Croatian: Tijekom liječenja liječnik će Vam možda preporučiti nižu ili višu dozu ako rezultati krvnih pretraga pokažu da je to potrebno, ako imate poteškoća s jetrom ili bubrezima ili ako trebate liječenje i nekim drugim lijekovima.
English: The half-life was prolonged from 3.7 to 6.0 hours with concurrent ketoconazole administration.
Croatian: Poluvijek je bio produljen s 3,7 na 6,0 sati uz istodobnu primjenu ketokonazola.
English: Myelofibrosis (MF)
Croatian: Mijelofibroza (MF)
English: - Nefazodone, a medicine to treat depression.
Croatian: - Nefazodon, lijek za liječenje depresije.
English: Polycythaemia vera (PV)
Croatian: Policitemija vera (PV)
English: Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Croatian: Bolesnike s kroničnom HBV infekcijom treba liječiti i pratiti u skladu s kliničkim smjernicama.
English: Your doctor may need to prescribe a different dose of Jakavi.
Croatian: Liječnik će Vam možda trebati propisati drugačiju dozu Jakavija.
English: Talk to your doctor about how to take appropriate measures to avoid becoming pregnant during your treatment with Jakavi.
Croatian: Razgovarajte sa svojim liječnikom o odgovarajućim mjerama izbjegavanja trudnoće tijekom liječenja Jakavijem.
English: Increased systolic blood pressure
Croatian: Povišeni sistolički krvni tlak
English: Neutropenia b
Croatian: Neutropenija b
English: Enlargement of the spleen is one of the characteristics of myelofibrosis.
Croatian: Povećanje slezene jedna je od karakteristika mijelofibroze.
English: Ruxolitinib was not carcinogenic in the Tg.rasH2 transgenic mouse model.
Croatian: Ruksolitinib nije bio kancerogen u modelu Tg.rasH2 transgeničnih miševa.
English: Number (%) of subjects with spleen volume reduced by ≥35% 95% confidence intervals p-value
Croatian: Broj (%) ispitanika kod kojih se volumen slezene smanjio za ≥35% 95%-tni intervali pouzdanosti p-vrijednost
English: It is possible that in the individual patient, an increase of the ruxolitinib dose is needed when initiating treatment with a strong enzyme inducer.
Croatian: Moguće je da je kod pojedinačnih bolesnika potrebno povećanje doze ruksolitiniba kada se započinje liječenje snažnim induktorom enzima.
English: You will need to have further blood tests during treatment so that your doctor can monitor the amount of blood cells (white cells, red cells and platelets) in your body and assess how you are responding to the treatment and whether Jakavi is having an unwanted effect on these cells.
Croatian: Trebat ćete obaviti dodatne krvne pretrage tijekom liječenja kako bi Vam liječnik mogao pratiti količinu krvnih stanica (leukocita, eritrocita i trombocita) u tijelu i procijeniti kako odgovarate na liječenje te ima li Jakavi neželjeni učinak na te stanice.
English: In PV, treatment should also be interrupted when haemoglobin is below 8 g/dl.
Croatian: PV-a, liječenje također treba prekinuti kada je hemoglobin ispod 8 g/dl.
English: The median time to recovery of platelet counts above 50,000/mm was 14 days.
Croatian: Medijan vremena do povratka razina trombocita na iznad 50 000/mm bio je 14 dana.
English: The safety and effectiveness of Jakavi in paediatric patients have not been established (see section 5.1, “Paediatric population”).
Croatian: Sigurnost primjene i djelotvornost Jakavija u pedijatrijskih bolesnika nisu ustanovljene (vidjeti dio 5.1, „Pedijatrijska populacija“).
English: This can include medical history, possible previous contact with tuberculosis, and/or appropriate screening such as lung x-ray, tuberculin test and/or interferon-gamma release assay, as applicable.
Croatian: To može uključivati anamnezu, mogući prethodni kontakt s tuberkulozom i/ili odgovarajuću pretragu, kao što je rendgen pluća, tuberkulinski test i/ili test otpuštanja interferona gama, prema potrebi.
English: The mean Cmax was moderately decreased (24%) while the mean AUC was nearly unchanged (4% increase) on dosing with a high-fat meal.
Croatian: Srednji Cmax bio je umjereno smanjen (24%), dok je srednji AUC bio gotovo nepromijenjen (povećanje od 4%) po uzimanju doze uz obrok s visokim udjelom masnoće.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: If either of the above applies to you, tell your doctor who will then decide whether you should start treatment with Jakavi.
Croatian: Ako ste išta od gore navedenoga odnosi na Vas, obratite se svom liječniku koji će zatim odlučiti trebate li započeti liječenje Jakavijem.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of ruxolitinib and its metabolites in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se ruksolitinib i njegovi metaboliti izlučuju u mlijeko (vidjeti dio 5.3).
English: Parent compound is the predominant entity in human plasma, representing approximately 60% of the drug-related material in circulation.
Croatian: Nepromijenjeni spoj je dominantni entitet u ljudskoj plazmi, koji predstavlja otprilike 60% materijala povezanog s lijekom u cirkulaciji.
English: COMFORT-II was an open-label, randomised study in 219 patients.
Croatian: COMFORT-II bilo je otvoreno, randomizirano ispitivanje s 219 bolesnika.
English: The mean elimination half-life of ruxolitinib is approximately 3 hours.
Croatian: Srednje poluvrijeme eliminacije ruksolitiniba je otprilike 3 sata.
English: Subsequent doses should be adjusted based on careful monitoring of safety and efficacy.
Croatian: Naknadne doze treba prilagoditi na temelju pažljivog praćenja sigurnosti i djelotvornosti.
English: Intracranial bleeding
Croatian: Intrakranijalno krvarenje
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE18
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE18
English: Ruxolitinib decreased foetal weight and increased post-implantation loss in animal studies.
Croatian: Ruksolitinib je smanjio težinu fetusa i povećao gubitak nakon implantacije u ispitivanja na životinjama.
English: Women of child-bearing potential should use effective contraception during the treatment with Jakavi.
Croatian: Žene u reproduktivnoj dobi moraju upotrebljavati učinkovitu kontracepciju tijekom liječenja Jakavijem.
English: Interactions resulting in dose reduction of ruxolitinib
Croatian: Interakcije koje rezultiraju smanjenjem doze ruksolitiniba
English: These dose recommendations are based on simulations and any dose modification in ESRD should be followed by careful monitoring of safety and efficacy in individual patients.
Croatian: Te preporuke doze se temelje na simulaciji i nakon bilo koje promjene doze u terminalnom bubrežnom zatajenju treba uslijediti pažljivo praćenje sigurnosti i djelotvornosti u pojedinačnih bolesnika.
English: Doses may be titrated based on safety and efficacy.
Croatian: Doze se mogu titrirati na temelju sigurnosti primjene i djelotvornosti.
English: The mean volume of distribution at steady state is approximately 75 litres in MF and PV patients.
Croatian: Srednji volumen distribucije u stanju dinamičke ravnoteže je približno 75 litara u bolesnika s MF-om i PV-om.
English: Other medicines and Jakavi
Croatian: Drugi lijekovi i Jakavi
English: c grade
Croatian: c stupanj
English: Withdrawal effects
Croatian: Učinci povlačenja
English: Effects of ruxolitinib on other medicinal products
Croatian: Učinci ruksolitiniba na druge lijekove
English: Lipid abnormalities/elevations
Croatian: Abnormalnosti/povišenja lipida
English: Patients should be monitored for any of these new or worsening symptoms or signs, and if such symptoms/signs occur, referral to a neurologist and appropriate diagnostic measures for PML should be considered.
Croatian: Potrebno je pratiti stanje bolesnika zbog moguće pojave ili pogoršanja bilo kojeg od tih simptoma ili znakova, a ako se takvi simptomi/znakovi pojave, potrebno je razmotriti upućivanje neurologu ili odgovarajuće dijagnostičke mjere za PML.
English: However, the exposure margins compared to the highest clinical dose were low and the results are therefore of limited relevance for humans.
Croatian: Međutim, granice izloženosti u usporedbi s najvišim kliničkim dozama bile su niske i stoga od ograničene relevantnosti za ljude.
English: At clinically relevant concentrations of ruxolitinib, binding to plasma proteins in vitro is approximately 97%, mostly to albumin.
Croatian: Pri klinički relevantnim koncentracijama ruksolitiniba, in vitro vezanje na proteine plazme iznosi otprilike 97%, većinom na albumin.
English: Ruxolitinib was not mutagenic or clastogenic.
Croatian: Ruksolitinib nije bio mutagen ili klastogen.
English: The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours).
Croatian: Terminalno poluvrijeme eliminacije bilo je produljeno u bolesnika s oštećenjem jetre u usporedbi sa zdravim kontrolnim ispitanicima (4,1-5,0 sati u odnosu na 2,8 sati).
English: There was no clear relationship between AUC and the degree of hepatic impairment based on Child-Pugh scores.
Croatian: Nije bilo jasne povezanosti između AUC-a i stupnja oštećenja jetre na temelju Child-Pugh rezultata.
English: If you receive dialysis, take either one single dose or two separate doses of Jakavi only on dialysis days, after the dialysis has been completed.
Croatian: Ako primate dijalizu, uzmite ili jednu jednokratnu dozu ili dvije odvojene doze Jakavija samo u dane dijalize, nakon što je dijaliza završena.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Jakavi in all subsets of the paediatric population for the treatment of MF and PV (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Jakavi u svim podskupinama pedijatrijske populacije za liječenje MF-a i PV-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: This may result in increased sytemic exposure of substrates of these transporters, such as dabigatran etexilate, ciclosporin, rosuvastatin and potentially digoxin.
Croatian: To može rezultirati povećanom sistemskom izloženošću supstrata tih transportera, kao što su dabigatraneteksilat, ciklosporin, rosuvastatin i potencijalno digoksin.
English: - if you develop painful skin rash with blisters (these are signs of shingles).
Croatian: - ako se kod Vas razvije bolni kožni osip s mjehurićima (to su znakovi herpesa zoster).
English: The effect of Jakavi on viral replication in patients with chronic HBV infection is unknown.
Croatian: Učinak Jakavija na replikaciju virusa u bolesnika s kroničnom HBV infekcijom nije poznat.
English: Ruxolitinib is mainly eliminated through metabolism.
Croatian: Ruksolitinib se uglavnom eliminira putem metabolizma.
English: However, patients who experience dizziness after the intake of Jakavi should refrain from driving or using machines.
Croatian: Međutim, bolesnici koji osjete omaglicu nakon uzimanja Jakavija moraju se suzdržati od upravljanja vozilima ili rada sa strojevima.
English: If efficacy is considered insufficient and blood counts are adequate, doses may be increased by a maximum of 5 mg twice daily, up to the maximum dose of 25 mg twice daily.
Croatian: Ako se djelotvornost smatra nedostatnom, a krvna slika je primjerena, doze se mogu povećavati za najviše 5 mg dvaput na dan, do najveće doze od 25 mg dvaput na dan.
English: Number (%) of subjects with spleen volume reduced by
Croatian: Broj (%) ispitanika kod kojih se volumen slezene smanjio za
English: Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji ili blisteru iza oznake „Rok valjanosti”/„EXP”.
English: Doses were then adjusted in individual patients based on tolerability and efficacy with a maximum dose of 25 mg twice daily.
Croatian: Doze su zatim bile prilagođene u pojedinačnih bolesnika na temelju podnošljivosti i djelotvornosti uz najveću dozu od 25 mg dvaput na dan.
English: Blood and lymphatic system disorders b,d
Croatian: Poremećaji krvi i limfnog sustava b,d
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencija za lijekove: : http://www.ema.europa.eu.
English: Frequency is based on adverse event data.
Croatian: Učestalost se temelji na podacima o štetnim događajima.
English: It has been observed that patients with low platelet counts (<200,000/mm 3) at the start of therapy are more likely to develop thrombocytopenia during treatment.
Croatian: Uočeno je da kod bolesnika s niskim razinama trombocita (<200 000/mm 3) na početku liječenja postoji veća vjerojatnost da će razviti trombocitopeniju tijekom liječenja.
English: Symptom burden was assessed using the MPN-SAF total symptom score (TSS) electronic patient diary, which consisted of 14 questions.
Croatian: Opterećenje simptomima bilo je procijenjeno pomoću ukupnog zbroja simptoma (UZS) u elektroničkom dnevniku za bolesnike MPN-SAF koji se sastojao od 14 pitanja.
English: Therefore, no increase in exposure of CYP3A4 substrates is anticipated when combining them with ruxolitinib.
Croatian: Stoga se ne očekuje povećana izloženost CYP3A4 supstratima kada se kombiniraju s ruksolitinibom.
English: These mediate the signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function.
Croatian: One su posrednici kod signalizacije niza citokina i čimbenika rasta koji su važni za hematopoezu i imunološku funkciju.
English: Dose modifications or interruption for patients developing anaemia may also be considered.
Croatian: Mogu se razmotriti i modifikacije doze ili prekid doziranja u bolesnika kod kojih se razvije anemija.
English: 66% of patients treated with ruxolitinib compared to 19% treated with BAT reported an improvement as early as four weeks after beginning treatment.
Croatian: 66% bolesnika liječenih ruksolitinibom u usporedbi s 19% liječenih NDT-om prijavilo je poboljšanje već četiri tjedna nakon početka liječenja.
English: Jakavi is to be taken orally, with or without food.
Croatian: Jakavi se uzima peroralno, uz obrok ili bez obroka.
English: Ruxolitinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity and reproductive toxicity studies and in a carcinogenicity study.
Croatian: Ruksolitinib je bio procjenjivan u ispitivanjima sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i reproduktivne toksičnosti te u ispitivanju kancerogenosti.
English: - if you have ever had skin cancer.
Croatian: - ako ste ikada imali tuberkulozu. - ako ste ikada imali rak kože.
English: The probability of maintaining spleen response (≥35% reduction) on Jakavi for at least 24 weeks was 89% in COMFORT-I and 87% in COMFORT-II; 52% maintained spleen responses for at least 48 weeks in COMFORT-II.
Croatian: Vjerojatnost održavanja odgovora slezene (smanjenje ≥35%) uz Jakavi tijekom najmanje 24 tjedna bila je 89% u COMFORT-I te 87% u COMFORT-II; 52% je održalo odgovore slezene tijekom najmanje 48 tjedana u COMFORT-II ispitivanju.
English: COMFORT-I was a double-blind, randomised, placebo-controlled study in 309 patients who were refractory to or were not candidates for available therapy.
Croatian: COMFORT-I bilo je dvostruko slijepo, randomizirano, placebom kontrolirano ispitivanje u 309 bolesnika koji su bili refraktorni na dostupnu terapiju ili nisu bili kandidati za nju.
English: However, platelet transfusions may be required as clinically indicated.
Croatian: Međutim, mogle bi biti potrebne transfuzije trombocita ako je to klinički indicirano.