FrancophonIA/ELRC3.0 huggingface dataset:
English: For transesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Xarelto treatment should be started at least 4 hours before cardioversion to ensure adequate anticoagulation (see sections 5.1 and 5.2).
Croatian: Za kardioverziju vođenu transezofagealnim ehokardiogramom (TEE) u bolesnika koji prethodno nisu bili liječeni antikoagulansima, liječenje lijekom Xarelto treba započeti najmanje 4 sata prije kardioverzije da bi se osigurala odgovarajuća antikoagulacija (vidjeti dijelove 5.1 i 5.2).
English: Due to limited absorption a ceiling effect with no further increase in average plasma exposure is expected at supratherapeutic doses of 50 mg rivaroxaban or above.
Croatian: Zbog ograničene apsorpcije vršni učinak bez daljnjeg povećanja prosječne izloženosti plazme očekuje se kod doza koje su veće od terapijskih, a to je 50 mg rivaroksabana ili više.
English: A 29% and 56% decrease in AUC and Cmax compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine.
Croatian: Zabilježeno je smanjenje AUC za 29% i Cmax za 56% u usporedbi s tabletom kad se rivaroksaban iz granulata oslobađa u proksimalnom tankom crijevu.
English: • bronchiectasis or history of pulmonary bleeding
Croatian: • s bronhiektazijama ili anamnezom plućnog krvarenja
English: There are no data in patients with severe hepatic impairment.
Croatian: Nema podataka za bolesnike s teško oštećenom funkcijom jetre.
English: As with other antithrombotics, rivaroxaban is not recommended in patients with an increased bleeding risk such as:
Croatian: Kao i s drugim antitromboticima, ne preporučuje se primjena rivaroksabana u bolesnika s povećanim rizikom od krvarenja, kao što su bolesnici:
English: Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi.
Croatian: Inhibicijom faktora Xa prekida se unutarnji i vanjski put kaskade zgrušavanja krvi, čime se inhibira stvaranje trombina i razvoj tromba.
English: risk %)
Croatian: n (kum. rizik %)
English: Xarelto is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of Xarelto have not been established in these clinical situations.
Croatian: Xarelto se ne preporučuje kao alternativa nefrakcioniranom heparinu u bolesnika s plućnom embolijom koji su hemodinamički nestabilni ili bi mogli dobiti trombolizu ili plućnu embolektomiju jer sigurnost i djelotvornost lijeka Xarelto u tim kliničkim situacijama nisu potvrđene.
English: NSAIDs/platelet aggregation inhibitors
Croatian: NSAIL/inhibitori agregacije trombocita
English: Possible side effects which may be a sign of bleeding
Croatian: Moguće nuspojave koje mogu biti znak krvarenja
English: The frequencies of these side effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people).
Croatian: Učestalosti ovih nuspojava su vrlo rijetke (anafilaktičke reakcije, uključujući anafilaktički šok; mogu se javiti u do 1 na 10 000 osoba) i manje česte (angioedem i alergijski edem; mogu se javiti u do 1 na 100 osoba).
English: Patients with elevated biomarkers (troponin or CK-MB) and without a prior stroke/TIA constituted 80% of the study population.
Croatian: Bolesnici s povišenim biomarkerima (troponin ili CK-MB) koji prethodno nisu imali moždani udar/TIA činili su 80% populacije uključene u ispitivanje.
English: Major bleeding occurred in 2.1 per 100 patient years.
Croatian: Veće krvarenje javilo se u 2,1 na 100 bolesnik-godina.
English: The treatment duration was for an additional 6 or 12 months in patients who had completed 6 to 12 months of treatment for venous thromboembolism depending on the clinical judgment of the investigator.
Croatian: Liječenje je trajalo dodatnih 6 ili 12 mjeseci, u bolesnika koji su završili 6 do 12 mjeseci liječenja radi venske tromboembolije, ovisno o kliničkoj procjeni ispitivača.
English: This exploratory study showed comparable efficacy and safety between rivaroxaban and VKA treatment groups in the setting of cardioversion.
Croatian: Ovo eksploracijsko ispitivanje pokazalo je usporedive rezultate djelotvornosti i sigurnosti između skupina liječenih rivaroksabanom i VKA u slučaju kardioverzije.
English: Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors, ATC code: B01AF01 Mechanism of action
Croatian: Farmakoterapijska skupina: antitrombotici, direktni inhibitori faktora Xa, ATK oznaka: B01AF01 Mehanizam djelovanja
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR).
Croatian: Rivaroksaban se ne smije primjenjivati za tromboprofilaksu u bolesnika koji su nedavno podvrgnuti transkateterskoj zamjeni aortnog zaliska (engl. transcatheter aortic valve replacement, TAVR).
English: - Symptomatic bleeding in critical organ (non-fatal)
Croatian: - Simptomatsko krvarenje u kritični organ (bez smrtnog ishoda)
English: Fatal haemorrhage was reported in 0.2 per 100 patient years and intracranial haemorrhage in 0.4 per 100 patient years.
Croatian: Smrtonosno krvarenje prijavljeno je u 0,2 na 100 bolesnik-godina, a intrakranijalno krvarenje u 0,4 na 100 bolesnik-godina.
English: Bayer Hungária KFT Tel: +36-1-487 4100
Croatian: Magyarország Bayer Hungária KFT Tel: +36-1-487 4100
English: The safety results in this subgroup of patients undergoing PCI were comparable to the overall safety results.
Croatian: Rezultati sigurnosti u ovoj podskupini bolesnika koji su podvrgnuti perkutanoj koronarnoj intervenciji bili su usporedivi s ukupnim rezultatima sigurnosti.
English: Therefore Xarelto is contraindicated during breastfeeding (see section 4.3).
Croatian: Stoga je Xarelto kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: See section 2 “Xarelto contains lactose and sodium”.
Croatian: Vidjeti dio 2 „Xarelto sadrži laktozu i natrij“.
English: This treatment initiation pack is only for the first 4 weeks of treatment.
Croatian: Ovo pakiranje za početak liječenja je samo za prva četiri tjedna liječenja.
English: As with other anticoagulants the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs due to their reported effect on platelets.
Croatian: Kao i s drugim antikoagulansima, može postojati mogućnost povećanog rizika od krvarenja u bolesnika u slučaju istodobne primjene sa SSRI-jevima i SNRI-jevima zbog njihovog zabilježenog učinka na trombocite.
English: Enoxaparin did not affect the pharmacokinetics of rivaroxaban.
Croatian: Enoksaparin nije utjecao na farmakokinetiku rivaroksabana.
English: Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of rivaroxaban.
Croatian: Učinci primijećeni u ispitivanjima toksičnosti ponovljene doze uglavnom su posljedica pojačanog farmakodinamičkog djelovanja rivaroksabana.
English: Platelet aggregation inhibitors should be discontinued as suggested by the manufacturer's prescribing information.
Croatian: Inhibitori agregacije trombocita moraju se prestati koristiti kao što se preporučuje u uputama proizvođača.
English: Animal studies have shown reproductive toxicity related to the pharmacological mode of action of rivaroxaban (e.g. haemorrhagic complications).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost vezanu uz farmakološki način djelovanja rivaroksabana (npr. hemoragijske komplikacije).
English: Unbound AUC was increased 2.6 fold.
Croatian: AUC nevezanog rivaroksabana povećao se 2,6 puta.
English: The recommendation for the use of 15 mg is based on PK modelling and has not been studied in this clinical setting (see sections 4.4, 5.1 and 5.2).
Croatian: Preporuka za uzimanje 15 mg temelji se na farmakokinetičkom modelu i nije ispitivana u ovim kliničkim uvjetima (vidjeti dijelove 4.4, 5.1 i 5.2).
English: Also the first secondary endpoint (all-cause death, MI or stroke) was reduced significantly.
Croatian: Prvi sekundarni ishod (svi uzroci smrti, infarkt miokarda ili moždani udar) također je bio značajno smanjen.
English: The median time on treatment was 19 months and overall treatment duration was up to 41 months.
Croatian: Medijan vremena liječenja iznosio je 19 mjeseci, a ukupno trajanje liječenja iznosilo je najviše 41 mjesec.
English: PVC/PVDC/Aluminium foil blisters in cartons of 14 film-coated tablets.
Croatian: Blisteri od PVC/PVDC/aluminijske folije u kutijama s po 14 filmom obloženih tableta.
English: The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water.
Croatian: Zdrobljenu tabletu treba primijeniti u maloj količini vode putem želučane sonde nakon čega je treba isprati vodom.
English: If it is desired to test the pharmacodynamic effects of warfarin during the conversion period, INR measurement can be used at the Ctrough of rivaroxaban (24 hours after the previous intake of rivaroxaban) as this test is minimally affected by rivaroxaban at this time point.
Croatian: Ako se žele ispitati farmakodinamički učinci varfarina tijekom prijelaznog razdoblja, može se koristiti mjerenje INR-a kod Cmin rivaroksabana (24 sata nakon prethodnog uzimanja rivaroksabana) jer rivaroksaban minimalno utječe na ovaj test u to vrijeme.
English: Each of the rivaroxaban regimens showed a significant reduction in clinically significant bleeding events compared to the VKA regimen in patients with non-valvular atrial fibrillation who underwent a PCI with stent placement.
Croatian: Svaki od režima s rivaroksabanom pokazao je značajno smanjenje klinički značajnih krvarenja u usporedbi s VKA režimom u bolesnika s nevalvularnom fibrilacijom atrija koji su se podvrgnuli PCI-u s postavljanjem stenta.
English: Due to the pharmacological mode of action, the use of Xarelto may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia.
Croatian: Zbog njegova načina farmakološkog djelovanja, primjena lijeka Xarelto može biti povezana s povećanim rizikom od prikrivenog (okultnog) ili vidljivog krvarenja iz bilo kojeg tkiva ili organa, što može rezultirati posthemoragijskom anemijom.
English: Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.
Croatian: S obzirom na to da su dostupni klinički podaci s dronedaronom ograničeni, istodobna primjena s rivaroksabanom mora se izbjegavati.
English: 5,142 patients with acute DVT were enrolled to investigate the long-term safety of rivaroxaban compared with standard-of-care anticoagulation therapy in clinical practice.
Croatian: Bilo je uključeno 5142 bolesnika s akutnom dubokom venskom trombozom kako bi se ispitala dugotrajna sigurnost primjene rivaroksabana u odnosu na standardnu antikoagulacijsku terapiju u kliničkoj praksi.
English: ♦ INR values should not be used as they are not a dependable measure of the anticoagulant activity of Xarelto.
Croatian: Obavijest za liječnike: ♦ INR vrijednosti se ne bi smjele koristiti jer nisu pouzdana mjera antikoagulacijske aktivnosti lijeka Xarelto.
English: • Guidance regarding switching from or to rivaroxaban treatment
Croatian: • Smjernice u pogledu prebacivanja s liječenja i na liječenje rivaroksabanom
English: No specific studies with rivaroxaban in humans have been conducted to evaluate effects on fertility.
Croatian: Specifična ispitivanja s rivaroksabanom u ljudi radi procjene učinaka na plodnost nisu provedena.
English: No pharmacokinetic interaction was observed between warfarin and rivaroxaban.
Croatian: Nije uočena farmakokinetička interakcija između varfarina i rivaroksabana.
English: In some cases as a consequence of anaemia, symptoms of cardiac ischaemia like chest pain or angina pectoris have been observed.
Croatian: U nekim slučajevima kao posljedica anemije, uočeni su simptomi srčane ishemije poput boli u prsištu ili angine pektoris.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xarelto in one or more subsets of the paediatric population in the treatment of thromboembolic events.
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Xarelto u jednoj ili više podskupina pedijatrijske populacije u liječenju tromboembolijskih događaja.
English: Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding and quantify the clinical relevance of overt bleeding, as judged to be appropriate.
Croatian: Stoga, osim adekvatnog kliničkog praćenja, laboratorijsko određivanje hemoglobina/hematokrita može biti vrijedno za otkrivanje okultnog krvarenja i određivanje kliničkog značaja vidljivog krvarenja, prema procjeni.
English: No dose adjustment is necessary.
Croatian: Dozu ne treba prilagođavati.
English: - For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, the recommended dose is 15 mg once daily (see section 5.2).
Croatian: Za prevenciju moždanog udara i sistemske embolije u bolesnika s nevalvularnom fibrilacijom atrija, preporučena doza je 15 mg jedanput na dan (vidjeti dio 5.2).
English: Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks.
Croatian: Liječenje treba redovito procjenjivati za svakog pojedinog bolesnika važući rizik od ishemijskih događaja nasuprot riziku od krvarenja.
English: Take the next tablet on the following day and then carry on taking one tablet once a day.
Croatian: Iduću tabletu uzmite sljedeći dan, a potom nastavite uzimati jednu tabletu jedanput na dan.
English: For patients with moderate or severe renal impairment where the decision has been taken for 15 mg once daily from Day 22 onwards, other pack sizes only containing 15 mg film-coated tablets are available (see dosing instructions in section “Special populations” below).
Croatian: Za bolesnike s umjerenim ili teškim oštećenjem funkcije bubrega za koje je odlučeno da uzimaju dozu od 15 mg jedanput na dan od 22. dana nadalje, dostupna su druga pakiranja koja sadrže samo 15 mg filmom obložene tablete (vidjeti upute za doziranje u dijelu Posebne populacije ispod).
English: C: observed as uncommon in prevention of atherothrombotic events in patients after an ACS (following percutaneous coronary intervention) * A pre-specified selective approach to adverse event collection was applied.
Croatian: C: uočeno kao manje često kod prevencije aterotrombotskih događaja u bolesnika nakon akutnog koronarnog sindroma (nakon perkutane koronarne intervencije) * Primijenjen je unaprijed određen selektivni pristup u prikupljanju prijava štetnih događaja.
English: Placebo 6 or 12 months N=594
Croatian: Placebo 6 ili 12 mjeseci N=594
English: ♦ Tell your health care provider that you are taking Xarelto before any surgery or invasive procedure.
Croatian: ♦ Obavijestite liječnika da uzimate lijek Xarelto prije bilo kakve operacije ili invazivnog postupka.
English: Due to the high plasma protein binding rivaroxaban is not expected to be dialysable.
Croatian: Zbog visokog stupnja vezanja na proteine plazme, ne očekuje se da bi se rivaroksaban mogao iz organizma uklanjati dijalizom.
English: The incidence rates for the primary safety outcome (major or clinically relevant non-major bleeding events) as well as the secondary safety outcome (major bleeding events) were similar for both treatment groups.
Croatian: Stope incidencije za primarni ishod sigurnosti (veća ili klinički značajna manja krvarenja) kao i za sekundarni ishod sigurnosti (veća krvarenja) bile su slične u obje liječene skupine.
English: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Croatian: Prevencija moždanog udara i sistemske embolije u odraslih bolesnika s nevalvularnom fibrilacijom atrija koji imaju jedan ili više čimbenika rizika poput kongestivnog zatajivanja srca, hipertenzije, dobi ≥ 75 godina, šećerne bolesti, pretrpljenog moždanog udara ili tranzitorne ishemijske atake.
English: Xarelto is for oral use.
Croatian: Xarelto je namijenjen za peroralnu primjenu.
English: Bioavailability (AUC and Cmax) was comparable for 20 mg rivaroxaban administered orally as a crushed tablet mixed in apple puree, or suspended in water and administered via a gastric tube followed by a liquid meal, compared to a whole tablet.
Croatian: Bioraspoloživost (AUC i Cmax) je bila usporediva za 20 mg rivaroksabana primijenjenog peroralno u obliku zdrobljene tablete umiješane u kašu od jabuke ili suspendirane u vodi i primijenjene putem želučane sonde nakon čega je uslijedio tekući obrok, u usporedbi s cijelom tabletom.
English: These active substances are strong inhibitors of both CYP3A4 and P-gp (see section 4.4).
Croatian: Te su djelatne tvari snažni inhibitori CYP3A4 i P-gp-a (vidjeti dio 4.4).
English: Swallow the tablet(s) preferably with water.
Croatian: Progutajte tabletu (tablete), po mogućnosti s vodom.
English: Safety and efficacy of Xarelto have not been studied in patients with prosthetic heart valves; therefore, there are no data to support that Xarelto provides adequate anticoagulation in this patient population.
Croatian: Sigurnost i djelotvornost lijeka Xarelto nisu ispitivane u bolesnika s umjetnim srčanim zaliscima, stoga nema podataka u prilog tomu da Xarelto osigurava adekvatnu antikoagulaciju u toj skupini bolesnika.
English: Upon completion of this pack, treatment will continue on Xarelto 20 mg once daily as your doctor has told you.
Croatian: Nakon što potrošite sve tablete iz ovog pakiranja liječenje će se nastaviti s lijekom Xarelto 20 mg jedanput na dan, kako Vam je rekao Vaš liječnik.
English: As with other anticoagulants, patients taking Xarelto are to be carefully observed for signs of bleeding.
Croatian: Kao i s drugim antikoagulansima, u bolesnika koji uzimaju Xarelto mora se paziti na znakove krvarenja.
English: KM % Patients with events
Croatian: KM% Bolesnici s događajim a
English: Over 12,800 patients were studied in four randomised controlled phase III clinical studies (Einstein DVT, Einstein PE, Einstein Extension and Einstein Choice) and additionally a predefined pooled analysis of the Einstein DVT and Einstein PE studies was conducted.
Croatian: Ispitano je preko 12 800 bolesnika u četiri randomizirana kontrolirana klinička ispitivanja faze III (Einstein DVT, Einstein PE, Einstein Extension i Einstein Choice), te je dodatno provedena unaprijed definirana objedinjena analiza ispitivanja Einstein DVT i Einstein PE.
English: Therefore, administration of rivaroxaban distal to the stomach should be avoided since this can result in reduced absorption and related rivaroxaban exposure.
Croatian: Stoga treba izbjegavati primjenu rivaroksabana distalno od želuca budući da to može rezultirati smanjenom apsorpcijom i s time povezanom izloženosti rivaroksabanu.
English: Treatment in combination with other antiplatelet agents, e.g. prasugrel or ticagrelor, has not been studied and is not recommended.
Croatian: Liječenje u kombinaciji s drugim antitrombocitnim lijekovima npr. prasugrelom ili tikagrelorom nije ispitivano te se ne preporučuje.
English: Patients with moderate hepatic impairment were more sensitive to rivaroxaban resulting in a steeper PK/PD relationship between concentration and PT.
Croatian: Bolesnici s umjereno oštećenom funkcijom jetre bili su osjetljiviji na rivaroksaban, što je rezultiralo većim nagibom krivulje odnosa FK/FD između koncentracije i PV-a.
English: Xarelto reduces the risk in adults of getting blot clots (atherothrombotic events).
Croatian: Xarelto smanjuje rizik nastanka krvnih ugrušaka u odraslih (aterotrombotski događaji).
English: Among patients in the warfarin group, INR values were within the therapeutic range (2.0 to 3.0) a mean of 55% of the time (median, 58%; interquartile range, 43 to 71).
Croatian: Među bolesnicima u skupini s varfarinom, INR vrijednosti bile su u terapijskom rasponu (2,0 do 3,0)srednja vrijednost od 55% vremena (medijan, 58%; raspon među kvartilima, 43 do 71).
English: Therapy with Xarelto should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding (see section 4.4).
Croatian: Liječenje lijekom Xarelto mora se nastaviti dugotrajno ako je korist prevencije moždanog udara i sistemske embolije veća od rizika od krvarenja (vidjeti dio 4.4).
English: Xarelto reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels.
Croatian: Xarelto smanjuje rizik od sljedećeg srčanog udara ili smanjuje rizik od umiranja od bolesti povezane sa srcem ili krvnim žilama u odraslih.
English: Jaundice, Bilirubin conjugated increased (with or without concomitant increase of ALT), Cholestasis, Hepatitis (incl.
Croatian: Žutica, povišeni konjugirani bilirubin (sa ili bez istodobnog porasta ALT-a), kolestaza, hepatitis (uključujući hepatocelularno oštećenje)
English: Hepatic impairment, Increased bilirubin, increased blood alkaline phosphataseA, increased GGTA
Croatian: Oštećenje funkcije jetre, povišeni bilirubin, povišena alkalna fosfataza u krviA, povišen GGTA
English: However, there is currently very limited clinical experience with the use of these medicinal products in individuals receiving rivaroxaban.
Croatian: Međutim, trenutno je kliničko iskustvo primjene ovih lijekova u bolesnika koji primaju rivaroksaban vrlo ograničeno.
English: Start date
Croatian: Datum početka
English: 5.9% of patients
Croatian: 5,9% bolesnika
English: Short duration of therapy (at least 3 months) should be considered in patients with DVT or PE provoked by major transient risk factors (i.e. recent major surgery or trauma).
Croatian: Potrebno je razmotriti kratko trajanje liječenja (najmanje 3 mjeseca) u bolesnika s dubokom venskom trombozom i plućnom embolijom provociranima glavnim prolaznim čimbenicima rizika (tj. nedavnim velikim kirurškim zahvatom ili traumom).
English: The 4-week treatment initiation pack of Xarelto is dedicated to patients who will transition from 15 mg twice daily to 20 mg once daily from Day 22 onwards (see section 6.5).
Croatian: Pakiranje lijeka Xarelto za prva 4 tjedna početnog liječenja namijenjeno je bolesnicima koji će preći s 15 mg dvaput na dan na 20 mg jedanput na dan od 22. dana nadalje (vidjeti dio 6.5).
English: Try to take the tablet at the same time every day to help you to remember it.
Croatian: Nastojte tabletu uzeti svakog dana u isto vrijeme, kako bi Vam to pomoglo da ih ne zaboravite uzeti.
English: Do not take more than one tablet in a single day to make up for a forgotten dose.
Croatian: Nemojte uzeti više od jedne tablete u jednom danu kako biste nadoknadili zaboravljenu dozu.
English: 3,396 patients continued prevention of recurrent venous thromboembolism
Croatian: 3396 bolesnika nastavilo je s prevencijom ponavljajuće venske tromboembolije