FrancophonIA/ELRC3.0 huggingface dataset:
English: common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) rare (≥ 1/10,000 to < 1/1,000) very rare ( < 1/10,000) not known (cannot be estimated from the available data)
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10) često (≥ 1/100 do < 1/10) manje često (≥ 1/1000 do < 1/100) rijetko (≥ 1/10 000 do < 1/1000) vrlo rijetko (< 1/10 000) nepoznato (ne može se procijeniti iz dostupnih podataka)
English: • acetylsalicylic acid or
Croatian: • acetilsalicilatnu kiselinu ili
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 (see section 5.2).
Croatian: Zdrobljenu tabletu treba primijeniti u maloj količini vode putem želučane sonde nakon čega je treba isprati vodom (vidjeti dio 5.2).
English: When Xarelto 20 mg tablets are taken together with food increases in mean AUC by 39% were observed when compared to tablet intake under fasting conditions, indicating almost complete absorption and high oral bioavailability.
Croatian: Kada se Xarelto tablete od 20 mg uzmu zajedno s hranom, primjećuje se povećanje srednje vrijednosti područja ispod krivulje za 39% u usporedbi s uzimanjem tablete na prazan želudac, što indicira gotovo potpunu apsorpciju i visoku peroralnu bioraspoloživost.
English: DAY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
Croatian: 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. dan simbol sunca simbol mjeseca
English: Treatment initiation pack for the first 4 weeks of treatment:
Croatian: Pakiranje za početak liječenja za prva 4 tjedna liječenja:
English: Xarelto 2.5mg bid + ASA 100mg od: 5.2 (4.7 - 5.8)
Croatian: Xarelto 2,5mg bid+ ASK 100 mg od: 5,2 (4,7 - 5,8)
English: Due to a reduced extent of absorption an oral bioavailability of 66% was determined for the 20 mg tablet under fasting conditions.
Croatian: Zbog smanjenog opsega apsorpcije utvrđena je peroralna bioraspoloživost od 66% za tablete od 20 mg na prazan želudac.
English: The tablets are to be taken with food (see section 5.2).
Croatian: Tablete se moraju uzeti s hranom (vidjeti dio 5.2).
English: At baseline, the median ejection fraction was 34% (IQR: 28%-38%) and 53% of subjects were NYHA Class III or IV.
Croatian: Medijan početnih vrijednosti ejekcijske frakcije bio je 34% (interkvartilni raspon 28% - 38%) ,a 53% ispitanika bili su kategorije III ili IV,
English: 93.2% of patients received ASA concomitantly plus thienopyridine treatment and 6.8% ASA only.
Croatian: 93,2 % bolesnika istodobno je primalo ASK uz dodatak tienopiridina, a 6,8 % samo ASK.
English: 47 months
Croatian: 47 mjeseci
English: Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%, apart from on the day of surgery and the following day when variability in exposure is high (70%).
Croatian: Varijabilnost farmakokinetike rivaroksabana umjerena je s interindividualnom varijabilnošću (CV %) u rasponu od 30 do 40 %, osim na dan kirurškog zahvata i dan kasnije, kada je varijabilnost u izloženosti lijeku velika (70 %).
English: Rivaroxaban should be discontinued at the first appearance of a severe skin rash (e.g. spreading, intense and/or blistering), or any other sign of hypersensitivity in conjunction with mucosal lesions.
Croatian: Potrebno je prekinuti primjenu rivaroksabana pri prvoj pojavi teškog kožnog osipa (npr. koji se širi, intenzivan je i/ili praćen stvaranjem mjehurića) ili na bilo koji drugi znak preosjetljivosti povezan s lezijama sluznice.
English: If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention - PCI with an insertion of a stent), there is limited evidence to reduce the dose to one tablet Xarelto 15 mg once a day (or to one tablet Xarelto 10 mg once a day in case your kidneys are not working properly) in addition to an antiplatelet medicinal product such as clopidogrel.
Croatian: Ako trebate postupak liječenja začepljenih krvnih žila u Vašem srcu (koji se naziva perkutana koronarna intervencija - PCI s postavljanjem potpornice (stenta)), postoje ograničeni dokazi za smanjenje doze na jednu tabletu lijeka Xarelto 15 mg jedanput na dan (ili jednu tabletu lijeka Xarelto 10 mg jedanput na dan ako imate problema s bubrezima) dodatno uz antiagregacijski lijek kao što je klopidogrel.
English: Patients with an ACS under the age of 55 had to have either diabetes mellitus or a previous MI.
Croatian: Bolesnici s akutnim koronarnim sindromom, mlađi od 55 godina, morali su imati diabetes mellitus ili prethodni infarkt miokarda.
English: Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
Croatian: Žene reproduktivne dobi moraju izbjegavati trudnoću tijekom liječenja rivaroksabanom.
English: However the incidence rates were balanced between Xarelto and placebo for the components of fatal bleeding events, hypotension requiring treatment with intravenous inotropic agents and surgical intervention for ongoing bleeding.
Croatian: Međutim, stope incidencije bile su slične kod lijeka Xarelto i placebo za komponente krvarenja sa smrtnim ishodom, hipotenzije koja je zahtijevala liječenje intravenskim inotropnim sredstvima i kirurških zahvata zbog krvarenja koje ne prestaje.
English: On the fourth day after the last dose of warfarin, all tests (including PT, aPTT, inhibition of factor Xa activity and ETP) reflected only the effect of rivaroxaban.
Croatian: Četvrtoga dana nakon zadnje doze varfarina svi testovi (uključujući PV, aPTV, inhibiciju aktivnosti faktora Xa i ETP) odražavali su samo učinak rivaroksabana.
English: Treatment dose and duration
Croatian: Terapijska doza i trajanje liječenja
English: If bleeding cannot be controlled by the above measures, either the administration of a specific factor Xa inhibitor reversal agent (andexanet alfa), which antagonises the pharmacodynamic effect of rivaroxaban, or a specific procoagulant reversal agent, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (r-FVIIa), should be considered.
Croatian: Ako se krvarenje ne može kontrolirati navedenim mjerama, mora se razmotriti primjena ili specifičnog agensa za reverziju inhibitora faktora Xa (andeksanet alfa), koji antagonizira farmakodinamički učinak rivaroksabana, ili specifičnog agensa za poticanje zgrušnjavanja poput koncentrata protrombinskog kompleksa (PCC), aktiviranog koncentrata protrombinskog kompleksa (APCC) ili rekombinantnog faktora VIIa (r-FVIIa).
English: Among patients receiving dual antiplatelets therapy 98.8% received clopidogrel, 0.9% received ticlopidine and 0.3% received prasugrel.
Croatian: Među bolesnicima koji su primali dvostruku antitrombocitnu terapiju, 98,8 % primalo je klopidogrel, 0,9 % primalo je tiklopidin, a 0,3 % primalo je prasugrel.
English: Different weight categories
Croatian: Različite kategorije s obzirom na tjelesnu težinu
English: There is no clinical experience with the use of Xarelto 2.5 mg with ASA alone or with ASA plus clopidogrel or ticlopidine in these situations.
Croatian: Nema kliničkog iskustva s primjenom lijeka Xarelto u dozi od 2,5 mg samo s ASKom ili s ASK-om uz klopidogrel ili tiklopidin u ovakvim situacijama.
English: TEE- guided (1 - 5 days of pretreatment) or conventional cardioversion (at least three weeks of pre-treatment) strategies were employed.
Croatian: Korištene su strategije kardioverzije vođene transezofagealnim ehokardiogramom (s prethodnim liječenjem 1 - 5 dana) ili konvencionalne kardioverzije (s prethodnim liječenjem najmanje 3 tjedna).
English: In patients at high risk of ischaemic events with CAD/PAD, efficacy and safety of Xarelto 2.5 mg have only been investigated in combination with ASA.
Croatian: U bolesnika s BKA-om/BPA-om s visokim rizikom od ishemijskih događaja, djelotvornost i sigurnost lijeka Xarelto u dozi od 2,5 mg ispitane su samo u kombinaciji s ASK-om.
English: Active substances strongly inhibiting only one of the rivaroxaban elimination pathways, either CYP3A4 or P-gp, are expected to increase rivaroxaban plasma concentrations to a lesser extent.
Croatian: Očekuje se da djelatne tvari koje snažno inhibiraju samo jedan od putova eliminacije rivaroksabana, bilo CYP3A4 bilo P-gp, u manjoj mjeri povećavaju koncentraciju rivaroksabana u plazmi.
English: Xarelto should not be used in combination with certain other medicines which reduce blood clotting such as prasugrel or ticagrelor other than acetylsalicylic acid and clopidogrel/ticlopidine.
Croatian: Xarelto se ne smije uzimati u kombinaciji s određenim drugim lijekovima koji smanjuju zgrušavanje krvi kao što su prasugrel ili tikagrelor, osim s acetilsalicilatnom kiselinom i klopidogrelom/tiklopidinom.
English: However, if clinically indicated, rivaroxaban levels can be measured by calibrated quantitative antifactor-Xa tests (see section 5.2).
Croatian: Međutim, ako je klinički indicirano, razina rivaroksabana može se mjeriti kalibriranim kvantitativnim anti-faktor Xa testovima (vidjeti dio 5.2).
English: To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban.
Croatian: Da bi se smanjio potencijalni rizik od krvarenja povezan s istodobnom primjenom rivaroksabana i neuroaksijalne (epiduralne/spinalne) anestezije ili spinalne punkcije, mora se uzeti u obzir farmakokinetički profil rivaroksabana.
English: There were no clinically relevant differences in pharmacokinetics and pharmacodynamics between male and female patients.
Croatian: Nisu uočene klinički značajne razlike u farmakokinetici ni u farmakodinamici između bolesnika i bolesnica.
English: Therefore, Xarelto is not recommended for use in children below 18 years of age.
Croatian: Stoga se primjena lijeka Xarelto ne preporučuje u djece mlađe od 18 godina.
English: Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%.
Croatian: Varijabilnost farmakokinetike rivaroksabana umjerena je s interindividualnom varijabilnošću (CV%) u rasponu od 30 % do 40 %.
English: The phase III COMPASS study (27,395 patients, 78.0% male, 22.0% female) demonstrated the efficacy and safety of Xarelto for the prevention of a composite of CV death, MI, stroke in patients with CAD or symptomatic PAD at high risk of ischaemic events.
Croatian: Ispitivanje faze III pod nazivom COMPASS (27 395 bolesnika, 78,0% muškaraca, 22,0% žena) pokazalo je djelotvornost i sigurnost lijeka Xarelto u prevenciji kompozitnog ishoda koji se sastojao od kardiovaskularne smrti, infarkta miokarda, moždanog udara u bolesnika s BKA-om ili simptomatskim BPA-om s visokim rizikom od ishemijskih događaja.
English: This Xarelto 15 mg and 20 mg treatment initiation pack is only for the first 4 weeks of treatment.
Croatian: Ovo pakiranje lijeka Xarelto 15 mg i 20 mg za početno liječenje namijenjeno je samo za prva četiri tjedna liječenja.
English: For the removal of an epidural catheter and based on the general PK characteristics at least 2x halflife, i.e. at least 18 hours in young patients and 26 hours in elderly patients should elapse after the last administration of rivaroxaban (see section 5.2).
Croatian: Za vađenje epiduralnog katetera i na temelju općih farmakokinetičkih karakteristika, mora proći najmanje dvostruko poluvrijeme, odnosno najmanje 18 sati u mlađih bolesnika te 26 sati u starijih bolesnika od posljednje primjene rivaroksabana (vidjeti dio 5.2).
English: The MAH shall provide an educational pack prior to launch, targeting all physicians who are expected to prescribe/use Xarelto.
Croatian: Nositelj odobrenja će, prije stavljanja lijeka u promet, dostaviti edukacijski paket svim liječnicima za koje se očekuje da bi mogli propisivati/primjenjivati Xarelto.
English: ♦ Xarelto must be taken exactly as prescribed by your doctor.
Croatian: ♦ Xarelto morate uzimati točno prema uputama liječnika.
English: The safety and efficacy of Xarelto in children aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Xarelto u djece u dobi od 0 do 18 godina nisu ustanovljene.
English: There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin in individuals receiving rivaroxaban.
Croatian: Iskustvo s primjenom traneksamatne kiseline je ograničeno te nema iskustva s primjenom aminokaproatne kiseline i aprotinina u bolesnika koji primaju rivaroksaban.
English: The frequencies of adverse reactions reported with Xarelto are summarised in Table 3 below by system organ class (in MedDRA) and by frequency.
Croatian: Nuspojave prijavljene uz Xarelto navedene su niže u tablici 3, prema klasifikaciji organskih sustava (prema MedDRA-i) i prema učestalosti.
English: If a patient is to undergo elective surgery and anti-platelet effect is not desired, platelet aggregation inhibitors should be discontinued as directed by the manufacturer's prescribing information.
Croatian: Ako se u bolesnika planira elektivni kirurški zahvat i antitrombocitni učinak nije poželjan, potrebno je prekinuti primjenu inhibitora agregacije trombocita sukladno uputama proizvođača.
English: The use of pantoprazole 40 mg once daily in addition to antithrombotic study medication in patients with no clinical need for a proton pump inhibitor showed no benefit in the prevention of upper gastrointestinal events (i.e. composite of upper gastrointestinal bleeding, upper gastrointestinal ulceration, or upper gastrointestinal obstruction or perforation); the incidence rate of upper gastrointestinal events was 0.39/100 patient-years in the pantoprazole 40 mg once daily group and 0.44/100 patient-years in the placebo once daily group.
Croatian: Primjena pantoprazola u dozi od 40 mg jedanput na dan kao dodatka liječenju ispitivanim antitrombotikom u bolesnika bez kliničke potrebe za inhibitorima protonske pumpe nije pokazala korist u prevenciji događaja vezanih uz gornji dio gastrointestinalnog sustava (tj. kompozita krvarenja u gornjem dijelu gastrointestinalnog sustava, ulceracije gornjeg dijela gastrointestinalnog sustava ili opstrukcije ili perforacije gornjeg dijela gastrointestinalnog sustava); stopa incidencije događaja vezanih uz gornji dio gastrointestinalnog sustava bila je 0,39/100 bolesnik-godina u skupini koja je primala pantoprazol 40 mg jedanput na dan te 0,44/100 bolesnik-godina u skupini koja je primala placebo jedanput na dan.
English: If you have kidney problems, the dose may be reduced to one tablet Xarelto 15 mg once a day.
Croatian: Ako imate probleme s bubrezima, doza se može sniziti na jednu tabletu lijeka Xarelto od 15 mg jedanput na dan.
English: Swallow the tablet preferably with water.
Croatian: Tabletu progutajte, po mogućnosti s vodom.
English: There was an increase in rivaroxaban exposure correlated to decrease in renal function, as assessed via creatinine clearance measurements.
Croatian: Postojalo je povećanje u izloženosti rivaroksabanu u korelaciji sa slabljenjem funkcije bubrega, sudeći prema izmjerenim vrijednostima klirensa kreatinina.
English: Warfarin titrated to a target INR of 2.5 (therapeutic range 2.0 to 3.0)
Croatian: Varfarin titriran do ciljnog INR-a od 2,5 (terapijski raspon od 2,0 do 3,0)
English: 6.8% of patients
Croatian: 6,8% bolesnika
English: Symptomatic recurrent PE 43
Croatian: Simptomatski ponavljajući PE 43
English: Xarelto should be restarted as soon as possible after the invasive procedure or surgical intervention provided the clinical situation allows and adequate haemostasis has been established as determined by the treating physician (see section 5.2).
Croatian: Primjena lijeka Xarelto mora se nastaviti čim prije nakon invazivnog postupka ili kirurškog zahvata pod uvjetom da to dopušta klinička situacija i da je uspostavljena odgovarajuća hemostaza prema ocjeni nadležnog liječnika (vidjeti dio 5.2).
English: Xarelto contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents.
Croatian: Xarelto sadrži djelatnu tvar rivaroksaban i pripada skupini lijekova koji se nazivaju antitromboticima.
English: Xarelto contains lactose.
Croatian: Xarelto sadrži laktozu.
English: Xarelto belongs to a group of medicines called antithrombotic agents.
Croatian: Xarelto pripada skupini lijekova koji se nazivaju antitromboticima.
English: The incidence rates for the principal safety outcome (non-coronary artery bypass graft (CABG) TIMI major bleeding events) were higher in patients treated with Xarelto than in patients who received placebo (see Table 6).
Croatian: Stope incidencije glavnog ishoda sigurnosti (nekoronarna arterijska premosnica (CABG) TIMI veća krvarenja) bile su više u bolesnika liječenih lijekom Xarelto nego u bolesnika koji su primali placebo (vidjeti tablicu 6).
English: Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is estimated to be low.
Croatian: Postavljanje ili vađenje epiduralnog katetera ili lumbalna punkcija najbolje se provode kad je antikoagulacijski učinak rivaroksabana procijenjen kao nizak.
English: 31 months
Croatian: 31 mjesec
English: Co-administration of rivaroxaban with the strong CYP3A4 inducer rifampicin led to an approximate 50% decrease in mean rivaroxaban AUC, with parallel decreases in its pharmacodynamic effects.
Croatian: Istodobna primjena rivaroksabana s jakim induktorom CYP3A4 rifampicinom dovela je do smanjenja srednje vrijednosti AUC rivaroksabana za oko 50 %, uz istodobno slabljenje njegovih farmakodinamičkih učinaka.
English: Duration of treatment should be determined for each individual patient based on regular evaluations and should consider the risk for thrombotic events versus the bleeding risks.
Croatian: Trajanje liječenja u svakog pojedinog bolesnika treba odrediti na temelju redovitih kontrola, te je potrebno uzeti u obzir rizik od trombotskih događaja naspram rizika od krvarenja.
English: • with lower body weight (< 60 kg) if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine.
Croatian: • manje tjelesne težine (< 60 kg) ako se primjenjuje istodobno samo s ASK-om ili s ASK-om uz dodatak klopidogrela ili tiklopidina.
English: 10 mg or 20 mg
Croatian: 10 mg ili 20 mg
English: After at least 6 months blood clot treatment your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.
Croatian: Nakon najmanje 6 mjeseci liječenja krvnih ugrušaka, liječnik može odlučiti da Vas nastavi liječiti ili jednom tabletom od 10 mg jedanput na dan ili jednom tabletom od 20 mg jedanput na dan.
English: • vascular retinopathy
Croatian: • s vaskularnom retinopatijom
English: PAD patients had previous interventions such as bypass surgery or percutaneous transluminal angioplasty or limb or foot amputation for arterial vascular disease or intermittent claudication with ankle/arm blood pressure ratio < 0.90 and/ or significant peripheral artery stenosis or previous carotid revascularization or asymptomatic carotid artery stenosis ≥ 50%.
Croatian: Bolesnici s BPA-om imali su prethodne intervencije kao što je ugradnja premosnice ili perkutana transluminalna angioplastika ili amputacija uda ili stopala zbog bolesti arterija ili intermitentne klaudikacije s omjerom krvnog tlaka na gležnju i nadlaktici < 0,90 i/ili značajnu stenozu periferne arterije ili prethodnu revaskularizaciju karotidne arterije ili asimptomatsku stenozu karotidne arterije
English: Your doctor will tell you how much of these to take (usually between 75 to 100 mg acetylsalicylic acid daily or a daily dose of 75 to 100 mg acetylsalicylic acid plus a daily dose of either 75 mg clopidogrel or a standard daily dose of ticlopidine).
Croatian: Liječnik će Vam reći koliko tableta da uzimate (obično od 75 do 100 mg acetilsalicilatne kiseline na dan ili dnevnu dozu od 75 do 100 mg acetilsalicilatne kiseline uz dodatak dnevne doze od 75 mg klopidogrela ili uobičajenu dnevnu dozu tiklopidina).
English: 1.6% of patients
Croatian: 1,6% bolesnika
English: • If the first and second characters are IT, the manufacturer is Bayer HealthCare Manufacturing Srl.
Croatian: • Ako su prva dva slova IT, proizvođač je: Bayer HealthCare Manufacturing Srl.
English: In case of emergency, please notify:
Croatian: U hitnom slučaju molim obavijestite: Ime i prezime liječnika:
English: • The need for intake of the 15 mg and 20 mg tablets with food
Croatian: • Potrebu da se tablete od 15 mg i 20 mg uzimaju s hranom
English: 41 months
Croatian: 41 mjesec
English: Rivaroxaban 10 mg once daily (od) started no sooner than 6 hours post-operatively was compared with enoxaparin 40 mg once daily started 12 hours pre-operatively.
Croatian: Primjena rivaroksabana u dozi od 10 mg jedanput na dan, koja je počela najranije 6 sati nakon operacije, uspoređena je s primjenom enoksaparina u dozi od 40 mg jedanput na dan, koja je započela 12 sati prije operacije.
English: Subjects without a continuous need for treatment with a proton pump inhibitor were randomized to pantoprazole or placebo.
Croatian: Ispitanici kojima nije neprekidno bilo potrebno liječenje inhibitorom protonske pumpe bili su randomizirani u skupinu koja je primala pantoprazol i skupinu koja je primala placebo.
English: The benefit-risk of the treatment should be individually assessed on a regular basis.
Croatian: Omjer koristi i rizika liječenja treba redovito procjenjivati u svakog pojedinog bolesnika.
English: • CAD patients with severe symptomatic heart failure.
Croatian: • Bolesnici s BKA-om koji imaju teško simptomatsko zatajivanje srca.
English: 21 months
Croatian: 21 mjesec
English: Based on in vitro investigations rivaroxaban is a substrate of the transporter proteins P-gp (P-glycoprotein) and Bcrp (breast cancer resistance protein).
Croatian: Istraživanja in vitro pokazala su da je rivaroksaban supstrat transportnih proteina P-gp-a (engl, P-glycoprotein) i BCRP-a (engl. breast cancer resistance protein).
English: The concomitant use of rivaroxaban with other strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbital or St. John's Wort (Hypericum perforatum)) may also lead to reduced rivaroxaban plasma concentrations.
Croatian: Istodobna primjena rivaroksabana s drugim jakim induktorima CYP3A4 (npr. fenitoinom, karbamazepinom, fenobarbitalom ili gospinom travom (Hypericum perforatum)) također može dovesti do smanjene koncentracije rivaroksabana u plazmi.
English: PC (only applicable for outer carton, not applicable for bottle label) SN (only applicable for outer carton, not applicable for bottle label) NN (only applicable for outer carton, not applicable for bottle label)
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC (primjenjivo samo za vanjsku kutiju, nije primjenjivo za naljepnicu za bocu) SN (primjenjivo samo za vanjsku kutiju, nije primjenjivo za naljepnicu za bocu) NN (primjenjivo samo za vanjsku kutiju, nije primjenjivo za naljepnicu za bocu)
English: Following removal of the catheter, at least 6 hours should elapse before the next rivaroxaban dose is administered.
Croatian: Nakon vađenja katetera, mora proći najmanje 6 sati prije primjene iduće doze rivaroksabana.
English: Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
Croatian: Xarelto, primijenjen istodobno s acetilsalicilatnom kiselinom (ASK), indiciran je za prevenciju aterotrombotskih događaja u odraslih bolesnika koji imaju bolest koronarnih arterija (BKA) ili simptomatsku bolest perifernih arterija (BPA) s visokim rizikom od ishemijskih događaja.
English: Clotting parameters (e.g. PT, aPTT, HepTest) are affected as expected by the mode of action of rivaroxaban (see section 5.1).
Croatian: Uočen je utjecaj na parametre zgrušavanja (npr. na PV, aPTV, Heptest), kao što se i očekivalo s obzirom na način djelovanja rivaroksabana (vidjeti dio 5.1).
English: 1,197 patients continued treatment and prevention of recurrent venous thromboembolism
Croatian: 1197 bolesnika koji su nastavili liječenje i prevenciju ponavljajuće venske tromboembolije