FrancophonIA/ELRC3.0 huggingface dataset:
English: • The guide for healthcare professionals to support counselling of the patient
Croatian: • Vodič za zdravstvene radnike koji služi kao pomoć pri savjetovanju bolesnika
English: The safety, efficacy and pharmacokinetics of baricitinib have not yet been established in a paediatric population (see section 4.2).
Croatian: Sigurnost, djelotvornost i farmakokinetika baricitiniba u pedijatrijskoj populaciji još nisu ustanovljene (vidjeti dio 4.2).
English: Improvements were seen as early as Week 1 and, in studies RA-BEGIN and RA-BEAM, this was maintained for up to 52 weeks.
Croatian: Poboljšanja su primijećena već u 1. tjednu, a u ispitivanjima RA-BEGIN i RA-BEAM održala su se do 52 tjedna.
English: The main objectives of the programme are to make the prescribers aware of the risks associated with the product's use, and to highlight specific risk minimisation measures to be performed before and during the treatment with Olumiant.
Croatian: Glavni ciljevi programa su ukazati liječnicima koji propisuju lijek na rizike povezane s primjenom ovog lijeka te istaknuti specifične mjere minimizacije rizika koje treba poduzeti prije i tijekom liječenja lijekom Olumiant.
English: • poly (vinyl alcohol)
Croatian: • poli(vinilni alkohol)
English: Administration with meals was not associated with a clinically relevant effect on exposure.
Croatian: Primjena uz obroke nije bila povezana s klinički značajnim učinkom na izloženost.
English: Haemoglobin (Hb)
Croatian: Hemoglobin (Hb)
English: Note: Proportions of responders at each time point based on those initially randomised to treatment (N).
Croatian: Napomena: Udjeli bolesnika s odgovorom u svakoj vremenskoj točki temeljili su se na onima prvotno randomiziranima za liječenje (N).
English: Rare cases of lymphoproliferative disorders have been reported.
Croatian: Prijavljeni su rijetki slučajevi limfoproliferativnih poremećaja.
English: • That Olumiant is contraindicated in pregnancy as pre-clinical data showed reduced foetal growth and malformations.
Croatian: • Upozorenje da je Olumiant kontraindiciran u trudnoći jer su neklinički podaci pokazali smanjen rast i malformacije ploda.
English: Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2.
Croatian: Baricitinib je selektivan i reverzibilan inhibitor Janus kinaze (JAK)1 i JAK2.
English: If you forget to take Olumiant - If you miss a dose, take it as soon as you remember.
Croatian: Ako propustite uzeti dozu, uzmite je čim se sjetite.
English: The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.
Croatian: Učinak tih povišenja vrijednosti lipidnih parametara na pobol i smrtnost od kardiovaskularnih bolesti još nije utvrđen.
English: A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections.
Croatian: Doza od 2 mg jedanput na dan prikladna je za bolesnike poput onih u dobi od ≥ 75 godina, a može biti prikladna i za bolesnike koji u anamnezi imaju kronične ili rekurentne infekcije.
English: If any serious allergic or anaphylactic reaction occurs, baricitinib should be discontinued immediately.
Croatian: U slučaju pojave bilo koje ozbiljne alergijske ili anafilaktičke reakcije potrebno je odmah obustaviti liječenje baricitinibom.
English: Of these, 2166 rheumatoid arthritis patients were exposed to Olumiant for at least one year.
Croatian: Među njima su 2166 bolesnika s reumatoidnim artritisom bila izložena lijeku Olumiant tijekom najmanje godinu dana.
English: Patients with evidence of active hepatitis B or C infection were excluded from clinical trials.
Croatian: Bolesnici s dokazima aktivnog hepatitisa B ili C nisu bili uključeni u klinička ispitivanja.
English: The rate of serious infections with Olumiant (1.1 %) was similar to placebo (1.2 %).
Croatian: Olumiant (1,1%) bila je slična onoj uz placebo (1,2%).
English: Inhibition of IL-6 induced STAT3 phosphorylation
Croatian: Inhibicija fosforilacije STAT3 inducirane djelovanjem IL-6
English: Mean volume of distribution following intravenous infusion administration was 76 L, indicating distribution of baricitinib into tissues.
Croatian: Srednja vrijednost volumena distribucije nakon primjene intravenskom infuzijom iznosila je 76 l, što ukazuje na to da se baricitinib raspodjeljuje u tkiva.
English: Analyses of erosion and joint space narrowing scores were consistent with the overall scores.
Croatian: Analize rezultata za eroziju i suženje zglobnog prostora bile su u skladu s ukupnim rezultatima.
English: Olumiant treatment should not be resumed until the infection resolves.
Croatian: Liječenje lijekom Olumiant ne smije se nastaviti dok se infekcija ne povuče.
English: • Low disease activity and remission (SDAI)
Croatian: • Niska aktivnost bolesti i remisija (SDAI)
English: • That Olumiant should not be taken while pregnant and that women should inform their doctor should they become (or wish to become) pregnant
Croatian: • Upozorenje da se Olumiant ne smije uzimati tijekom trudnoće i da žene moraju obavijestiti svog liječnika ako zatrudne (ili žele zatrudnjeti).
English: There was no clear relationship between decreases in neutrophil counts and the occurrence of serious infections.
Croatian: Nije postojala jasna povezanost između pada broja neutrofila i razvoja ozbiljnih infekcija.
English: Patients who develop adverse reactions should receive appropriate treatment.
Croatian: Bolesnici u kojih se jave nuspojave trebaju primiti odgovarajuće liječenje.
English: Patients should be instructed to seek immediate medical attention, if signs or symptoms suggesting infection appear.
Croatian: Bolesnike treba uputiti da odmah zatraže liječničku pomoć ako se pojave znakovi ili simptomi koji ukazuju na infekciju.
English: Before treatment initiation and thereafter according to routine patient management
Croatian: Prije početka liječenja, a zatim u skladu s rutinskim mjerama skrbi
English: Combination with biologic DMARDs or other JAK inhibitors has not been studied.
Croatian: Kombinacija s biološkim DMARD-ovima ili drugim JAK inhibitorima nije se ispitivala.
English: • magnesium stearate
Croatian: • magnezijev stearat
English: No relevant differences regarding efficacy and safety were observed in subgroups defined by types of concomitant DMARDs used in combination with baricitinib.
Croatian: Nisu primijećene značajne razlike s obzirom na djelotvornost i sigurnost između podskupina definiranih prema vrsti DMARD-ova koji su se primjenjivali u kombinaciji s baricitinibom.
English: • cellulose, microcrystalline
Croatian: • celuloza, mikrokristalična
English: < 1 x 109 cells/L.
Croatian: < 1 x 109 stanica/l.
English: It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation.
Croatian: Pripada skupini lijekova koji se zovu inhibitori Janus kinaze, a pomažu ublažiti upalu.
English: Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90 % of the administered dose is expected to be eliminated within 24 hours.
Croatian: Na temelju farmakokinetičkih podataka prikupljenih nakon primjene jednokratne doze od 40 mg u zdravih dobrovoljaca, očekuje se da će se više od 90% primijenjene doze eliminirati unutar 24 sata.
English: Please remove this portion of the patient leaflet and keep it with you.
Croatian: Molimo, odvojite ovaj dio upute o lijeku i nosite ga sa sobom.
English: If a patient becomes pregnant while taking Olumiant the parents should be informed of the potential risk to the foetus.
Croatian: Ako bolesnica zatrudni dok uzima Olumiant, roditelje treba upozoriti na mogući rizik za plod.
English: • Do not take Olumiant if you are pregnant or suspect you may be pregnant.
Croatian: • Nemojte uzimati Olumiant ako ste trudni ili mislite da biste mogli biti trudni.
English: You should not use Olumiant while breast-feeding as it is not known if this medicine passes into milk.
Croatian: Ne smijete uzimati Olumiant dok dojite jer nije poznato prolazi li ovaj lijek u majčino mlijeko.
English: Do not take Olumiant: - if you are allergic to baricitinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na baricitinib ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.)
English: Treatment should be temporarily interrupted if drug-induced liver injury is suspected
Croatian: Liječenje treba privremeno prekinuti ako se sumnja na oštećenje jetre izazvano lijekom
English: Treatment with Olumiant 4 mg resulted in a statistically significant inhibition of progression of structural joint damage (Table 5).
Croatian: Liječenje lijekom Olumiant u dozi od 4 mg dovelo je do statistički značajne inhibicije progresije strukturnog oštećenja zglobova (Tablica 5).
English: In isolated enzyme assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 values of 5.9, 5.7, 53 and > 400 nM, respectively.
Croatian: U izoliranim enzimskim testovima, baricitinib je inhibirao aktivnost kinaza JAK1, JAK2, tirozin kinaze 2 i kinaze JAK3, uz vrijednosti IC50 od 5,9; 5,7; 53 odnosno > 400 nM.
English: Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg is appropriate.
Croatian: Budući da je kliničko iskustvo s primjenom u bolesnika u dobi od ≥ 75 godina vrlo ograničeno, za te je bolesnike prikladna početna doza od 2 mg.
English: Food intake led to a decreased exposure by up to 14 %, a decrease in Cmax by up to 18 % and delayed tmax by 0.5 hours.
Croatian: Unos hrane smanjio je izloženost za do 14% i Cmax za do 18% te je produljio tmax za 0,5 sati.
English: In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
Croatian: U slučaju predoziranja, preporučuje se nadzirati bolesnika zbog mogućih znakova i simptoma nuspojava.
English: By reducing the activity of this enzyme, Olumiant helps to reduce pain, stiffness and swelling in your joints, tiredness, and helps to slow damage to the bone and cartilage in the joints.
Croatian: Smanjenjem aktivnosti tog enzima Olumiant pomaže ublažiti bol, ukočenost i oticanje zglobova i umor te pomaže usporiti oštećenje kostiju i hrskavice u zglobovima.
English: Since there were no effects on spermatogenesis (as assessed by histopathology) or semen/sperm endpoints in male rats, the decreased overall mating performance was likely the result of these female effects.
Croatian: Budući da u mužjaka štakora nije bilo učinaka na spermatogenezu (što je utvrđeno histopatološki) niti na mjere ishoda koje su se odnosile na sjeme/spermu, smanjena sveukupna uspješnost parenja vjerojatno je bila posljedica navedenih učinaka u ženki.
English: Most cases of hepatic transaminase elevations were asymptomatic and transient.
Croatian: Većina slučajeva porasta vrijednosti jetrenih transaminaza bila je asimptomatske i prolazne prirode.
English: Baricitinib modulates these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing the phosphorylation and activation of STATs.
Croatian: Baricitinib modulira te putove signalizacije tako što djelomično inhibira enzimsku aktivnost kinaza JAK1 i JAK2 te na taj način smanjuje fosforilaciju i aktivaciju STAT-ova.
English: Baricitinib was detected in the milk of lactating rats.
Croatian: Baricitinib je pronađen u mlijeku ženki štakora u laktaciji.
English: Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma.
Croatian: Imunomodulacijski lijekovi mogu povećati rizik od zloćudnih bolesti, uključujući limfom.
English: Baricitinib was teratogenic in rats and rabbits.
Croatian: Baricitinib se pokazao teratogenim u štakora i kunića.
English: • That Olumiant use should be stopped in case of herpes zoster or any other infection that doesn't respond to standard treatment until the event resolves.
Croatian: • Upozorenje da se primjena lijeka Olumiant mora prekinuti u slučaju herpesa zoster ili bilo koje druge infekcije koja ne odgovara na standardno liječenje, sve dok se taj događaj ne povuče.
English: If you stop taking Olumiant Do not stop taking Olumiant unless your doctor tells you to stop taking it.
Croatian: Nemojte prestati uzimati Olumiant, osim ako Vam to ne kaže liječnik.
English: Studies in animals suggest that treatment with baricitinib has the potential to decrease female fertility while on treatment, but there was no effect on male spermatogenesis (see section 5.3).
Croatian: Ispitivanja na životinjama upućuju na to da bi baricitinib mogao smanjiti plodnost žena tijekom liječenja, dok učinka na spermatogenezu nije bilo (vidjeti dio 5.3).
English: • iron oxide red (E172)
Croatian: • željezov oksid, crveni (E172)
English: Infections reported with Olumiant treatment included Herpes zoster.
Croatian: Infekcije prijavljene kod liječenja lijekom Olumiant uključivale su herpes zoster.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Olumiant in one or more subsets of the paediatric population in chronic idiopathic arthritis (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Olumiant u jednoj ili više podskupina pedijatrijske populacije za liječenje kroničnog idiopatskog artritisa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: From the 316 events included for review from post-marketing reports, rash (n=95) was the most frequently reported event.
Croatian: Među 316 događaja prijavljenih nakon stavljanja lijeka u promet i uključenih u ocjenu, najčešće prijavljen događaj bio je osip (n=95).
English: The effect of Olumiant on progression of structural joint damage was evaluated radiographically in studies RA-BEGIN, RA-BEAM and RA-BUILD and assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Croatian: Učinak lijeka Olumiant na progresiju strukturnog oštećenja zglobova procjenjivao se radiografski u ispitivanjima RA-BEGIN, RA-BEAM i RA-BUILD i ocjenjivao na temelju ukupnog rezultata prema modificiranoj Sharpovoj ljestvici (mTSS) i njegovim sastavnicama, rezultatu za eroziju i rezultatu za suženje zglobnog prostora.
English: Olumiant 2 mg film-coated tablets EU/1/16/1170/001
Croatian: Olumiant 2 mg filmom obložene tablete EU/1/16/1170/001
English: There are no adequate data from the use of baricitinib in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni baricitiniba u trudnica.
English: b Combined term (eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes).
Croatian: b Objedinjen pojam (herpesni ekcem, herpes simpleks, oftalmički herpes simpleks, oralni herpes).
English: Most infections were mild to moderate in severity.
Croatian: Većina infekcija bila je blage do umjerene težine.
English: • That the patient may need to have their cholesterol level checked during treatment
Croatian: • Napomenu da će bolesnik možda morati kontrolirati razine kolesterola tijekom liječenja.
English: Weight increased Creatine phosphokinase increased >5 x ULNc a Combined term (acute sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection).
Croatian: Pretrage povećanje tjelesne težine povišene vrijednosti kreatin fosfokinaze > 5 x GGNc a Objedinjen pojam (akutni sinusitis, epiglotitis, laringitis, nazofaringitis, orofaringealna bol, faringitis, faringotonzilitis, rinitis, sinusitis, tonzilitis, traheitis, infekcija gornjih dišnih putova).
English: Baricitinib treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol.
Croatian: Liječenje baricitinibom bilo je povezano s o dozi ovisnim porastom vrijednosti lipidnih parametara, uključujući ukupni kolesterol, trigliceride, LDL-kolesterol i HDL-kolesterol.
English: A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering (see section 5.1).
Croatian: Doza od 2 mg jedanput na dan može se razmotriti i u bolesnika koji su dozom od 4 mg jedanput na dan postigli održanu kontrolu aktivnosti bolesti i koji su kandidati za postupno smanjivanje doze (vidjeti dio 5.1).
English: • Morning Joint Stiffness
Croatian: • Jutarnja ukočenost zglobova
English: 12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia
Croatian: 12 tjedana nakon početka liječenja, a zatim u skladu s međunarodnim kliničkim smjernicama za hiperlipidemiju
English: If a planned pregnancy is considered, Olumiant treatment should be stopped.
Croatian: Ako se razmatra planirana trudnoća, liječenje lijekom Olumiant mora se prekinuti.
English: 14 film-coated tablets 28 film-coated tablets 35 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 28 x 1 film-coated tablets 84 x 1 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 35 filmom obloženih tableta 56 filmom obloženih tableta 84 filmom obložene tablete 98 filmom obloženih tableta 28 x 1 filmom obložena tableta 84 x 1 filmom obložena tableta
English: Blood fat:
Croatian: Masnoće u krvi:
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Infekcije
English: In female rats there were decreased numbers of corpora lutea and implantation sites, increased pre-implantation loss, and/or adverse effects on intrauterine survival of the embryos.
Croatian: U ženki štakora zabilježen je smanjen broj žutih tijela i mjesta implantacije, povećan broj gubitaka prije implantacije i/ili štetni učinci na intrauterino preživljenje embrija.
English: How to take Olumiant
Croatian: Kako uzimati Olumiant
English: Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase', which is involved in inflammation.
Croatian: Olumiant djeluje tako da smanjuje aktivnost enzima u tijelu koji se zove 'Janus kinaza' i koji sudjeluje u upalnom procesu.
English: Olumiant can reduce your body's ability to fight infections and may make an existing infection worse or increase the chance of you getting a new infection - have, or have previously had, tuberculosis.
Croatian: Olumiant može smanjiti sposobnost tijela da se bori protiv infekcija i tako pogoršati postojeću infekciju ili povećati vjerojatnost razvoja nove infekcije. - ako imate ili ste nekada imali tuberkulozu.
English: No association was observed between increased platelet counts and adverse events of a thrombotic nature.
Croatian: Nije primijećena povezanost između povećanog broja trombocita i štetnih događaja trombotske prirode.
English: In particular, tell your doctor or pharmacist before taking Olumiant if you are taking: - probenecid (for gout), since this medicine may increase the levels of Olumiant in your blood.
Croatian: Osobito je važno da prije uzimanja lijeka Olumiant obavijestite svog liječnika ili ljekarnika ako uzimate: - probenecid (za giht), jer on može povisiti razine lijeka Olumiant u krvi.
English: Cytochrome P450 enzymes
Croatian: Enzimi citokroma P450
English: A risk to newborns/infants cannot be excluded and Olumiant should not be used during breast-feeding.
Croatian: Ne može se isključiti rizik za novorođenčad/dojenčad i stoga se Olumiant ne smije uzimati tijekom dojenja.
English: The prodrug leflunomide rapidly converts to teriflunomide which is a weak OAT3 inhibitor and therefore may lead to an increase in baricitinib exposure.
Croatian: Predlijek leflunomid brzo se pretvara u teriflunomid, koji je slab inhibitor OAT3, pa može povećati izloženost baricitinibu.
English: The mean effects of intrinsic factors on PK parameters (AUC and Cmax) were generally within the inter-subject PK variability of baricitinib.
Croatian: Srednje vrijednosti učinaka intrinzičnih faktora na farmakokinetičke parametre (AUC i Cmax) općenito su bile unutar raspona interindividualne farmakokinetičke varijabilnosti baricitiniba.
English: Since dedicated interaction studies have not been conducted, caution should be used when leflunomide or teriflunomide are given concomitantly with baricitinib.
Croatian: Budući da nisu provedena posebna ispitivanja interakcija, potreban je oprez kada se leflunomid ili teriflunomid primjenjuju istodobno s baricitinibom.
English: Olumiant should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisation.
Croatian: Olumiant treba primjenjivati uz oprez u bolesnika s faktorima rizika za DVT/PE, kao što su starija dob, pretilost, DVT/PE u povijesti bolesti, te u bolesnika u kirurškoj obradi i imobilizaciji.
English: The overall incidence rate of serious infections in the clinical trial programme was 3.2 per 100 patient-years.
Croatian: Ukupna incidencija ozbiljnih infekcija u programu kliničkih ispitivanja iznosila je 3,2 na
English: Laboratory measures and monitoring guidance
Croatian: Laboratorijska mjerila i smjernice za praćenje
English: In treatment-naïve patients, the combination of Olumiant with potentially hepatotoxic medicinal products, such as methotrexate, resulted in increased frequency of these elevations.
Croatian: U prethodno neliječenih bolesnika, kombinacija lijeka Olumiant i potencijalno hepatotoksičnih lijekova, poput metotreksata, povećala je učestalost tih porasta vrijednosti.
English: Consequently, estimates of the glomerular filtration rate based on serum creatinine may be slightly reduced, without actual loss of renal function or the occurrence of renal adverse events.
Croatian: Zbog toga procjene brzine glomerularne filtracije utemeljene na serumskoj razini kreatinina mogu biti blago snižene, a da nema stvarnog gubitka bubrežne funkcije ili nastupa bubrežnih nuspojava.
English: No data are available on the response to vaccination with live vaccines in patients receiving baricitinib.
Croatian: Nema dostupnih podataka o odgovoru na cijepljenje živim cjepivima u bolesnika koji uzimaju baricitinib.
English: Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell.
Croatian: U sklopu unutarstanične signalizacije, Janus kinaze fosforiliraju i aktiviraju prijenosnike signala i aktivatore transkripcije (engl. signal transducers and activators of transcription, STAT), koji aktiviraju gensku ekspresiju unutar stanice.
English: RA-BEGIN (52 weeks)
Croatian: RA-BEGIN (52 tjedna)
English: In a clinical pharmacology study, approximately 75 % of the administered dose was eliminated in the urine, while about 20 % of the dose was eliminated in the faeces.
Croatian: U kliničkom farmakološkom ispitivanju, približno 75% primijenjene doze izlučilo se kroz mokraću, dok se približno 20% doze izlučilo kroz feces.
English: • That Olumiant use is associated with hyperlipidaemia; prescribers should monitor the patient's lipid parameters and manage the hyperlipidaemia, if detected.
Croatian: • Upozorenje da je primjena lijeka Olumiant povezana s hiperlipidemijom; liječnici koji propisuju lijek moraju pratiti bolesnikove lipidne parametre i liječiti hiperlipidemiju ako se ona utvrdi.
English: These could be symptoms of tuberculosis (an infectious disease of the lungs).
Croatian: To bi mogli biti simptomi tuberkuloze (zarazne bolesti pluća) • bolan kožni osip praćen mjehurićima.
English: No clinical pharmacology study has been conducted with OAT3 inhibitors with less inhibition potential.
Croatian: Nisu provedena farmakološka ispitivanja s inhibitorima OAT3 slabijeg inhibicijskog potencijala.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake 'Rok valjanosti' ili 'EXP'.