FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is 20 mg once daily, which is also the recommended maximum dose.
Croatian: Preporučena doza je 20 mg jedanput na dan, što je također i maksimalna preporučena doza.
English: The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used (see section 4.5).
Croatian: INR nije odgovarajuća mjera antikoagulacijske aktivnosti lijeka Xarelto i stoga se ne smije koristiti (vidjeti dio 4.5).
English: Increased LDHA, increased lipaseA, increased amylaseA
Croatian: Povišeni LDHA, povišena lipazaA, povišena amilazaA
English: Depending on the different PT reagents used, the slope differed considerably.
Croatian: Ovisno o različitim reagensima korištenim za mjerenje PV-a, nagib pravca znatno se razlikovao.
English: Re-dosing of recombinant factor VIIa shall be considered and titrated depending on improvement of bleeding.
Croatian: Razmotrit će se ponovno doziranje rekombiniranog faktora VIIa i titriranje ovisno o poboljšanju krvarenja.
English: Elderly patients exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 1.5 fold higher, mainly due to reduced (apparent) total and renal clearance.
Croatian: Stariji bolesnici su bili izloženi većim plazmatskim koncentracijama nego mlađi, pri čemu je srednja vrijednost AUC bila oko 1,5 puta veća, uglavnom zbog smanjenog (vidljivog) ukupnog i renalnog klirensa.
English: Rivaroxaban is rapidly absorbed with maximum concentrations (Cmax) appearing 2 - 4 hours after tablet intake.
Croatian: Rivaroksaban se brzo apsorbira uz maksimalne koncentracije (Cmax) 2-4 sata nakon uzimanja tablete.
English: Transfusion of 4 or more units of blood over a 48 hour period a) safety population, on treatment b) vs. placebo; Log-Rank p-value * statistically significant
Croatian: Transfuzija 4 ili više jedinica krvi u razdoblju od 48 sati a) populacija za procjenu sigurnosti, na terapiji b) u odnosu na placebo; Log-rank p-vrijednost
English: Day 1-21
Croatian: 1.-21. dan
English: Pharmacokinetic data in patients
Croatian: Farmakokinetički podaci u bolesnika
English: In this case two 15 mg tablets may be taken at once.
Croatian: U tom slučaju mogu se odjednom uzeti dvije tablete od 15 mg.
English: To prevent blood clots in the brain (stroke) and other blood vessels in your body: If your heart beat needs to be restored to normal by a procedure called cardioversion, take Xarelto at the times your doctor tells you.
Croatian: Za sprječavanje krvnih ugrušaka u mozgu (moždani udar) i drugim krvnim žilama u Vašem tijelu: Ako Vaši srčani otkucaji trebaju biti vraćeni u normalu postupkom koji se zove kardioverzija, uzmite Xarelto u vrijeme koje Vam je rekao Vaš liječnik.
English: Take the tablet every day until your doctor tells you to stop.
Croatian: Tabletu uzimajte svaki dan, sve dok Vam liječnik ne kaže da prestanete.
English: Major intracranial bleeding p = 0.59858
Croatian: Veliko intrakranijalno krvarenje p = 0,59858
English: Rivaroxaban neither inhibits nor induces any major CYP isoforms like CYP3A4.
Croatian: Rivaroksaban ne inhibira niti inducira nijednu od glavnih CYP-izoformi, poput CYP3A4.
English: Elimination of rivaroxaban from plasma occurs with terminal half-lives of 5 to 9 hours in young individuals, and with terminal half-lives of 11 to 13 hours in the elderly.
Croatian: Eliminacija rivaroksabana iz plazme odvija se s poluvremenom od 5 do 9 sati kod mlađih pojedinaca, a 11 do 13 sati u starijih.
English: In contrast, the 3-factor PCC had a greater and more rapid overall effect on reversing changes in endogenous thrombin generation than the 4-factor PCC (see section 4.9).
Croatian: Suprotno tome, PCC koji sadrži 3 faktora imao je veći i brži ukupni učinak na poništavanje promjena u endogenom stvaranju trombina nego PCC koji sadrži 4 faktora (vidjeti dio 4.9).
English: Overall list of possible side effects
Croatian: Ukupni popis mogućih nuspojava
English: All-cause death
Croatian: Smrtnost od svih uzroka
English: 23% of patients
Croatian: 23% bolesnika
English: Depending on local availability, a consultation with a coagulation expert should be considered in case of major bleedings (see section 5.1).
Croatian: Ovisno o lokalnoj dostupnosti, u slučaju većih krvarenja potrebno je razmotriti savjetovanje sa stručnjakom za koagulaciju (vidjeti dio 5.1).
English: Study data indicate that such patients may benefit less from treatment with rivaroxaban (see section 5.1).
Croatian: Podaci iz ispitivanja upućuju na to da takvi bolesnici mogu imati manje koristi od liječenja rivaroksabanom (vidjeti dio 5.1).
English: If you miss a dose, take your next dose at the usual time.
Croatian: Ako zaboravite uzeti dozu, uzmite sljedeću u uobičajeno vrijeme.
English: The risk of these events may be increased by the post-operative use of indwelling epidural catheters or the concomitant use of medicinal products affecting haemostasis.
Croatian: Rizik od tih događaja može se povećati postoperativnim korištenjem trajnih epiduralnih katetera ili istodobnom primjenom lijekova koji utječu na hemostazu.
English: breathlessness, chest pain or angina pectoris, which may be signs of bleeding.
Croatian: bol u prsnom košu ili anginu pektoris, koji mogu biti znakovi krvarenja.
English: If you forget to take a dose you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day.
Croatian: Ako zaboravite uzeti dozu, možete istovremeno uzeti dvije tablete od 15 mg kako biste došli do ukupno dvije tablete (30 mg) u jednom danu.
English: Therefore, Xarelto is to be used with caution in these patients.
Croatian: Stoga se Xarelto u tih bolesnika mora primjenjivati s oprezom.
English: Treatment duration median [interquartile range]
Croatian: Trajanje liječenja, medijan [interkvartilni raspon]
English: This is more marked in fasting state than in fed state.
Croatian: To je izraženije natašte nego u sitom stanju.
English: Given the predictable, dose-proportional pharmacokinetic profile of rivaroxaban, the bioavailability results from this study are likely applicable to lower rivaroxaban doses.
Croatian: S obzirom na predvidljiv farmakokinetički profil rivaroksabana proporcionalan dozi, rezultati ovog ispitivanja bioraspoloživosti vjerojatno su primjenjivi na niže doze rivaroksabana.
English: The overall combined treatment duration in all studies was up to 21 months.
Croatian: Ukupno kombinirano trajanje liječenja kroz sva ispitivanja bilo je do 21 mjesec.
English: In patients with mild and moderate heart failure the treatment effects for the COMPASS study subgroup were similar to those of the entire study population (see section CAD/PAD).
Croatian: U bolesnika s blagim i umjerenim zatajivanjem srca učinci liječenja za podskupine iz ispitivanja COMPASS bili su slični onima iz cjelokupne ispitivane populacije (vidjeti dio BKA/BPA).
English: 12.6% of patients 2.1% of patients
Croatian: 12,6% bolesnika 2,1% bolesnika
English: Treatment with Xarelto is not recommended for these patients.
Croatian: Liječenje lijekom Xarelto se ne preporučuje u tih bolesnika.
English: The most commonly reported bleedings were epistaxis (4.5 %) and gastrointestinal tract haemorrhage (3.8 %).
Croatian: Najčešće prijavljena krvarenja bila su epistaksa (4,5%) i krvarenje iz gastrointestinalnog trakta (3,8%).
English: Your doctor has prescribed you Xarelto 10 mg once a day.
Croatian: Liječnik Vam je propisao Xarelto 10 mg jedanput na dan.
English: - Without overnight stay p = 0.04983
Croatian: - Bez noćenja u bolnici p = 0,04983
English: Cardiovascular death
Croatian: Kardiovaskularna smrt
English: Extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited (see section 5.1).
Croatian: O produljenju liječenja preko 12 mjeseci mora se odlučiti za svakog bolesnika individualno jer je iskustvo primjene do 24 mjeseca ograničeno (vidjeti dio 5.1).
English: No clinically relevant interaction with food was observed (see section 4.2).
Croatian: Nisu uočene nikakve klinički relevantne interakcije s hranom (vidjeti dio 4.2).
English: The tablets can be taken with or without food (see sections 4.5 and 5.2).
Croatian: Tablete se mogu uzimati s hranom ili bez nje (vidjeti dijelove 4.5 i 5.2).
English: There is neither scientific rationale for benefit nor experience with the use of the systemic haemostatic desmopressin in individuals receiving rivaroxaban.
Croatian: Nema ni znanstvene osnove za korist ni iskustva s primjenom sistemskog hemostatika dezmopresina u osoba koje primaju rivaroksaban.
English: Table 1: Number of patients studied, total daily dose and maximum treatment duration in phase III studies
Croatian: Tablica 1: Broj ispitivanih bolesnika, ukupne dnevne doze i maksimalno trajanje liječenja u ispitivanjima faze III
English: At least 18 hours should elapse after the last administration of rivaroxaban before removal of an epidural catheter.
Croatian: Najmanje 18 sati mora proći od posljednje primjene rivaroksabana prije vađenja epiduralnog katetera.
English: If you have had a major hip operation you will usually take the tablets for 5 weeks.
Croatian: Ako ste imali veliku operaciju kuka, tablete je uobičajeno uzimati 5 tjedana.
English: The median time on treatment was 13 months and overall treatment duration was up to almost 3 years.
Croatian: Medijan trajanja liječenja iznosio je 13 mjeseci i ukupno trajanje liječenja iznosilo je do gotovo 3 godine.
English: Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.
Croatian: Rivaroksaban ne inhibira trombin (aktivirani faktor II), a nisu pokazani ni učinci na trombocite.
English: The tablet may be crushed and mixed with water or apple puree immediately before you take it.
Croatian: Tableta se može zdrobiti i pomiješati s vodom ili kašom od jabuke neposredno prije uzimanja.
English: Due to the increased bleeding risk care is to be taken if patients are treated concomitantly with any other anticoagulants (see sections 4.3 and 4.4).
Croatian: Zbog povećanog rizika od krvarenja, nužan je oprez ako su bolesnici istodobno liječeni bilo kojim drugim antikoagulansom (vidjeti dijelove 4.3 i 4.4).
English: If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.
Croatian: Ako liječnik smatra da kod Vas postoji povećan rizik za razvoj ulkusa (čira) želuca ili crijeva, može Vam dati preventivnu terapiju protiv ulkusa (čira).
English: Bleeding is the most common side effect.
Croatian: Krvarenje je najčešća nuspojava.
English: These results in clinical practice are consistent with the established safety profile in this indication.
Croatian: Ovi rezultati u kliničkoj praksi u skladu su s ustanovljenim sigurnosnim profilom u ovoj indikaciji.
English: What should I know about Xarelto?
Croatian: Što trebam znati o lijeku Xarelto?
English: In rats, no effects on male or female fertility were seen.
Croatian: U štakora nisu primijećeni nikakvi učinci na plodnost mužjaka ili ženki.
English: Dry mouth
Croatian: - suha usta
English: Rivaroxaban is metabolised via CYP3A4, CYP2J2 and CYP-independent mechanisms.
Croatian: Rivaroksaban se metabolizira s pomoću CYP3A4, CYP2J2 i mehanizmima neovisnima o CYPizoformama.
English: - you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms.
Croatian: - zato što su Vam dijagnosticirali visok rizik od nastanka krvnog ugruška zbog bolesti koronarnih arterija ili bolesti perifernih arterija koja uzrokuje simptome.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.
Croatian: Mora se donijeti odluka hoće li se prekinuti dojenje ili prekinuti uzimanje lijeka.
English: Patients were randomly assigned in a 1:1:1 fashion for an overall 12-month-therapy.
Croatian: Bolesnici su bili randomizirani u omjeru 1:1:1 u ukupnom trajanju terapije 12 mjeseci.
English: Prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS)
Croatian: Prevencija aterotrombotskih događaja u bolesnika nakon akutnog koronarnog sindroma (ACS)
English: (For patients with renal impairment: see section 4.4).
Croatian: (Za bolesnike s oštećenjem funkcije bubrega: vidjeti dio 4.4).
English: Management should be individualised according to the severity and location of the haemorrhage.
Croatian: Zbrinjavanje mora biti individualno, prema težini i lokaciji krvarenja.
English: No dose adjustment (see sections 4.4 and 5.2) The risk of bleeding increases with increasing age (see section 4.4).
Croatian: Dozu ne treba prilagođavati (vidjeti dijelove 4.4 i 5.2) Rizik od krvarenja povećava se s povećanjem dobi (vidjeti dio 4.4).
English: Possible side effects which may be a sign of severe skin reaction
Croatian: Moguće nuspojave koje mogu biti znak teške kožne reakcije
English: Patients experiencing these adverse reactions should not drive or use machines.
Croatian: Bolesnici u kojih se jave te nuspojave ne smiju upravljati vozilima niti raditi sa strojevima.
English: Kaiser-Wilhelm-Allee
Croatian: Bayer AG Kaiser-Wilhelm-Allee
English: If you have had a major knee operation you will usually take the tablets for 2 weeks.
Croatian: Ako ste imali veliku operaciju koljena, tablete je uobičajeno uzimati 2 tjedna.
English: • Final Study Reports submitted by Q4 2020
Croatian: • Završna izvješća o ispitivanju dostaviti do četvrtog kvartala 2020.
English: Should a bleeding complication arise in a patient receiving rivaroxaban, the next rivaroxaban administration should be delayed or treatment should be discontinued as appropriate.
Croatian: Ako dođe do komplikacija krvarenja u bolesnika koji uzimaju rivaroksaban, sljedeća primjena rivaroksabana se mora odgoditi ili se liječenje mora prekinuti na odgovarajući način.
English: Like all medicines, Xarelto can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Xarelto može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Inter-ethnic differences
Croatian: Međurasne razlike
English: Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-factor Xa assay may be useful in exceptional situations where knowledge of rivaroxaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery (see sections 5.1 and 5.2).
Croatian: Iako liječenje rivaroksabanom ne zahtijeva rutinsko praćenje izloženosti, mjerenje razine rivaroksabana kalibriranim kvantitativnim anti-faktor Xa testom može biti korisno u iznimnim situacijama gdje poznavanje izloženosti rivaroksabanu može pomoći kao informacija u kliničkim odlukama, npr. predoziranje ili hitna operacija (vidjeti dijelove 5.1 i 5.2).
English: A pre-specified propensity score stratified analysis was used to adjust for measured baseline differences but residual confounding may, in spite of this, influence the results.
Croatian: Koristila se unaprijed određena stratificirana analiza prema vjerojatnosti sklonosti (engl. propensity score) kako bi se prilagodile izmjerene početne razlike, ali ostatni ometajući čimbenici (engl. residual confounding) mogu, usprkos tome, utjecati na rezultate.
English: In a study on male and female fertility in rats no effects were seen (see section 5.3).
Croatian: U ispitivanjima učinaka na plodnost mužjaka i ženki štakora, nisu uočeni učinci (vidjeti dio 5.3).
English: Take the tablet(s) every day until your doctor tells you to stop.
Croatian: Uzimajte tabletu (tablete) svaki dan dok Vam liječnik ne kaže da prestanete.
English: Patients are to be frequently monitored for signs and symptoms of neurological impairment (e.g. numbness or weakness of the legs, bowel or bladder dysfunction).
Croatian: U bolesnika treba često pratiti pojavu znakova i simptoma neurološkog oštećenja (npr. utrnulost ili slabost u nogama, disfunkcija crijeva ili mokraćnog mjehura).
English: If you have missed a dose, take it as soon as you remember.
Croatian: Ako ste propustili uzeti dozu, uzmite je čim se sjetite.
English: Therefore, the use of Xarelto in combination with dual antiplatelet therapy in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events.
Croatian: Stoga primjenu lijeka Xarelto u kombinaciji s dvojnom antitrombocitnom terapijom u bolesnika za koje se zna da imaju povećani rizik od krvarenja treba uravnotežiti u odnosu na korist za sprječavanje aterotrombotskih događaja.
English: Talk to your doctor or pharmacist before taking Xarelto.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Xarelto.
English: When the recommended dose is 10 mg once daily, no dose adjustment from the recommended dose is necessary.
Croatian: Kad je preporučena doza 10 mg jedanput na dan, nije potrebna prilagodba preporučene doze.
English: If you need to have an operation it is very important to take Xarelto before and after the operation exactly at the times you have been told by your doctor.
Croatian: Ako se trebate podvrgnuti operaciji: - vrlo je važno da uzmete Xarelto prije i poslije operacije točno u vrijeme koje Vam je odredio liječnik.
English: These observations in clinical practice are consistent with the established safety profile in this indication.
Croatian: Ova opažanja u kliničkoj praksi u su skladu s ustanovljenim sigurnosnim profilom u ovoj indikaciji.
English: • other gastrointestinal disease without active ulceration that can potentially lead to bleeding complications (e.g. inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease)
Croatian: • s drugom gastrointestinalnom bolesti bez aktivnog ulkusa koja može dovesti do komplikacija s krvarenjem (npr. upalna bolest crijeva, ezofagitis, gastritis i gastroezofagealna refluksna bolest)
English: If you stop taking this medicine, it may increase your risk of having another heart attack or stroke or dying from a disease related to your heart or your blood vessels.
Croatian: Ako prestanete uzimati ovaj lijek, to Vam može povećati rizik od drugog srčanog ili moždanog udara ili Vam se može povisiti rizik od umiranja od bolesti povezane sa srcem ili krvnim žilama.
English: Figure 2: Time to first occurrence of primary efficacy outcome (stroke, myocardial infarction, cardiovascular death) in COMPASS
Croatian: Slika 2: Vrijeme do prve pojave primarnog ishoda djelotvornosti (moždani udar, infarkt miokarda, kardiovaskularna smrt) u ispitivanju COMPASS
English: Active clinically significant bleeding.
Croatian: Aktivno klinički značajno krvarenje.
English: What Xarelto is and what it is used for What you need to know before you take Xarelto How to take Xarelto
Croatian: Što se nalazi u ovoj uputi Što je Xarelto i za što se koristi Što morate znati prije nego počnete uzimati Xarelto
English: Stroke or non-CNS systemic embolism was recorded in 0.8 per 100 patient years.
Croatian: Moždani udar ili sistemska embolija koja nije povezana sa SŽS zabilježeni su u 0,8 na 100 bolesnik-godina.
English: • Drug Utilisation and Outcome Studies in the UK, Germany, The Netherlands and Sweden
Croatian: • Ispitivanja potrošnje lijeka i ishoda liječenja u Ujedinjenom Kraljevstvu, Njemačkoj,
English: Table 3: All adverse reactions reported in patients in phase III clinical trials or through postmarketing use*
Croatian: Tablica 3: Sve nuspojave prijavljene u bolesnika u ispitivanjima faze III ili nakon stavljanja lijeka u promet*
English: When concomitantly used in the rivaroxaban clinical programme, numerically higher rates of major or nonmajor clinically relevant bleeding were observed in all treatment groups.
Croatian: Kad su se istodobno primjenjivali u kliničkom programu rivaroksabana, bile su opažene brojčano više stope većih i manjih klinički značajnih krvarenja u svim liječenim skupinama.
English: SSRIs/SNRIs
Croatian: SSRI-jevi/SNRI-jevi
English: There were differences in patient baseline characteristics including age, cancer and renal impairment.
Croatian: Bilo je razlika u početnim karakteristikama bolesnika, uključujući dob, rak i poremećaj funkcije bubrega.
English: • acetylsalicylic acid plus clopidogrel or ticlopidine.
Croatian: • acetilsalicilatnu kiselinu uz dodatak klopidogrela ili tiklopidina.
English: Results for secondary endpoints as tested in hierarchical order in the ITT analysis are displayed in Table 4.
Croatian: Rezultati za sekundarni ishod, hijerarhijski poredanih u analizama prema namjeri liječenja, prikazani su u tablici 4.
English: Patients undergoing cardioversion
Croatian: Bolesnici koji se podvrgavaju kardioverziji
English: Few ACS patients with a prior stroke or TIA have been studied but the limited efficacy data available indicate that these patients do not benefit from treatment.
Croatian: Ispitana je nekolicina bolesnika s akutnim koronarnim sindromom koji su imali moždani udar ili TIA-u, ali ograničeni podaci o djelotvornosti koji su dostupni pokazuju da ovi bolesnici nemaju koristi od ovog liječenja.
English: Patients must have had symptomatic HF for at least 3 months and left ventricular ejection fraction (LVEF) of ≤40% within one year of enrollment.
Croatian: Bolesnici su morali imati simptomatsko zatajivanje srca najmanje 3 mjeseca i ejekcijsku frakciju lijeve klijetke (engl. left ventricular ejection fraction, LVEF) ≤40% unutar jedne godine od uključenja.
English: The 3-factor PCC reduced mean Neoplastin PT values by approximately 1.0 second within 30 minutes, compared to reductions of approximately 3.5 seconds observed with the 4-factor PCC.
Croatian: PCC koji sadrži 3 faktora smanjio je srednju vrijednost PV-a, koristeći Neoplastin reagens, za otprilike 1,0 sekundu unutar 30 minuta u usporedbi sa smanjenjem od otprilike 3,5 sekunde zabilježeno PCC-om koji sadrži 4 faktora.
English: Taking too much Xarelto increases the risk of bleeding.
Croatian: Uzimanje previše tableta Xarelto povećava rizik od krvarenja.
English: In both the Einstein DVT and the Einstein PE study, the comparator treatment regimen consisted of enoxaparin administered for at least 5 days in combination with vitamin K antagonist treatment until the PT/INR was in therapeutic range (≥ 2.0).
Croatian: U oba ispitivanja Einstein DVT i Einstein PE, režim komparativnog liječenja sadržavao je enoksaparin primjenjivan najmanje 5 dana u kombinaciji s liječenjem antagonistom vitamina K sve dok PV/INR nije bio u terapijskom rasponu (≥2,0).
English: If traumatic puncture occurs the administration of rivaroxaban is to be delayed for 24 hours.
Croatian: Dogodi li se traumatska punkcija, primjena rivaroksabana mora se odgoditi za 24 sata.
English: Total daily dose Maximum treatment duration
Croatian: Ukupna dnevna doza Maksimalno trajanje liječenja
English: Table 2: Bleeding* and anaemia events rates in patients exposed to rivaroxaban across the completed phase III studies
Croatian: Tablica 2: Stope događaja krvarenja* i anemije u bolesnika izloženih rivaroksabanu u završenim kliničkim ispitivanjima faze III
English: Einstein DVT, PE and Extension used the same pre-defined primary and secondary efficacy outcomes.
Croatian: U ispitivanjima Einstein DVT, PE i Extension koristili su se isti unaprijed određeni primarni i sekundarni ishodi djelotvornosti.
English: The relationship between rivaroxaban concentration and factor-Xa activity was best described by an Emax model.
Croatian: Odnos između koncentracije rivaroksabana i aktivnosti faktora Xa najbolje se može opisati modelom Emax.
English: 6,785 patients with non-valvular atrial fibrillation were enrolled for prevention of stroke and non-central nervous system (CNS) systemic embolism in clinical practice.
Croatian: Bilo je uključeno 6785 bolesnika s nevalvularnom fibrilacijom atrija u svrhu prevencije moždanog udara i sistemske embolije koja nije povezana sa središnjim živčanim sustavom (SŽS) u kliničkoj praksi.