FrancophonIA/ELRC3.0 huggingface dataset:
English: Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats and treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the vein of your legs and lungs A forgotten dose can still be taken up to 6 hours prior to the next due dose.
Croatian: Sprječavanje začepljenja krvnih žila mozga ili tijela stvaranjem krvnih ugrušaka koji se razvijaju nakon abnormalnih otkucaja srca i liječenje krvnih ugrušaka u venama nogu i pluća uključujući prevenciju ponovne pojave krvnih ugrušaka u venama nogu i pluća Propuštenu dozu se može još uvijek uzeti do 6 sati prije vremena sljedeće doze.
English: Dabigatran etexilate and dabigatran are not metabolised by the cytochrome P450 system and have no in vitro effects on human cytochrome P450 enzymes.
Croatian: Dabigatraneteksilat i dabigatran se ne metaboliziraju putem citokroma P450 te in vitro nemaju učinke na citokrom P450 enzime u ljudi.
English: • Renal function should be assessed during treatment with Pradaxa at least once a year or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).
Croatian: • Bubrežna funkcija se ocjenjuje tijekom liječenja Pradaxom najmanje jedanput godišnje ili češće, prema potrebi, u određenim kliničkim situacijama kada se sumnja na mogućnost smanjenja ili pogoršanja bubrežne funkcije (npr. hipovolemija, dehidracija, i u slučaju istodobne primjene određenih lijekova).
English: Since the patient populations treated in the three indications are not comparable and bleeding events are distributed over several System Organ Classes (SOC), a summary description of major and any bleeding are broken down by indication and provided in tables 12-16 below.
Croatian: S obzirom da skupine bolesnika, liječene u tri indikacije, nisu usporedive, a događaji krvarenja su raspoređeni u više skupina organskih sustava (SOC), pregledni opis velikih i svih krvarenja je prikazan prema indikaciji, te je naveden u tablicama 12-16 u nastavku teksta.
English: Breast-feeding should be discontinued during treatment with Pradaxa.
Croatian: Dojenje treba prekinuti tijekom liječenja Pradaxom.
English: •An instruction how to take Pradaxa
Croatian: •Upute kako uzimati Pradaxu
English: Pradaxa has no known effects on the ability to drive or use machines.
Croatian: Pradaxa nema poznatih učinakana sposobnost upravljanja vozilima i rada sa strojevima.
English: Substances influencing gastric pH
Croatian: Tvari koje utječu na želučani pH
English: After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma.
Croatian: Nakon peroralne primjene, dabigatraneteksilat brzo se i potpuno pretvara u dabigatran, aktivan oblik u plazmi.
English: The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).
Croatian: Preporučena doza je 220mg jedanput dnevno(uzeta u obliku 2 kapsule od 110mg).
English: • Congenital or acquired coagulation disorders
Croatian: • kongenitalni ili stečeni koagulacijski poremećaji
English: The RE-LY study demonstrated that dabigatran etexilate, at a dose of 110 mg twice daily, is non-inferior to warfarin in the prevention of stroke and systemic embolism in subjects with atrial fibrillation, with a reduced risk of ICH, total bleeding and major bleeding.
Croatian: RE-LY studija pokazala je da je dabigatraneteksilat, u dozama od 110 mg dvaput dnevno, neinferioran varfarinu u prevenciji moždanog udara i sistemske embolije u bolesnika s fibrilacijom atrija te da je rizik ICH, ukupnog krvarenja i velikog krvarenja niži.
English: In a study performed with 24 healthy subjects, when Pradaxa was co-administered with digoxin, no changes on digoxin and no clinically relevant changes on dabigatran exposure have been observed.
Croatian: U ispitivanju na 24 zdrava dobrovoljca, u kojem je Pradaxa primjenjivana istodobno s digoksinom, nisu primijećene promjene digoksina kao niti klinički značajne promjene u izloženosti dabigatranu.
English: You should start treatment with Pradaxa within 1-4 hours after surgery finishes, taking a single capsule.
Croatian: Liječenje Pradaxom počinje unutar 1 - 4 sata nakon završetka kirurškog zahvata, s uzimanjem jedne kapsule.
English: No data aPTT [x-fold upper limit of normal] > 1.3 INR
Croatian: Nema podataka aPTV [x puta od gornje granice normale] > 1,3 INR
English: Since the patient populations treated in the three indications are not comparable and bleeding events are distributed over several System Organ Classes (SOC), a summary description of major and any bleeding are broken down by indication and are provided in tables 11-14 below.
Croatian: S obzirom da skupine bolesnika, liječene u tri indikacije, nisu usporedive, a događaji krvarenja su raspoređeni u više skupina organskih sustava (SOC), pregledni opis velikih i svih krvarenja je prikazan prema indikaciji, te je naveden u tablicama 11-14 u nastavku teksta.
English: Pradaxa treatment to parenteral anticoagulant:
Croatian: Prijelaz s liječenja Pradaxom na parenteralne antikoagulanse:
English: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Croatian: Primarna prevencija venskih tromboembolijskih događaja u odraslih bolesnika koji su podvrgnuti elektivnom kirurškom zahvatu ugradnje totalne endoproteze kuka ili koljena.
English: Table 12: Number (%) of patients experiencing the adverse reaction bleeding
Croatian: Tablica 12: Broj (%) bolesnika koji su imali krvarenje
English: A higher anti-FXa/FIIa activity was observed after dabigatran etexilate administration with enoxaparin pre-treatment compared to that after treatment with dabigatran etexilate alone.
Croatian: Veća anti-FXa/FIIa-aktivnost primijećena je uz primjenu dabigatraneteksilata nakon prethodnog liječenja enoksaparinom nego uz sam dabigatraneteksilat.
English: This exploratory study showed that dabigatran etexilate was associated with a significant reduction in MBE rate compared with INR-adjusted warfarin in the setting of ablation.
Croatian: Ovo eksplorativno ispitivanje pokazalo je da je dabigatraneteksilat bio povezan sa značajnim smanjenjem stope događaja velikih krvarenja kod ablacije u usporedbi s varfarinom prilagođenim INR-u.
English: Anaemia postoperative
Croatian: Postoperativna anemija rijetko
English: There are limited efficacy and safety data for Pradaxa available in these patients and therefore they should be treated with caution.
Croatian: Podaci o djelotvornosti i sigurnosti Pradaxe u spomenutih bolesnika su ograničeni te je stoga potreban oprez u njihovu liječenju.
English: 150 mg once daily N (%)
Croatian: 150 mg jedanput dnevno N (%)
English: In this situation Pradaxa and verapamil should be taken at the same time.
Croatian: U ovoj situaciji, Pradaxa i verapamil se uzimaju u isto vrijeme.
English: Test (trough value) dTT [ng/mL]
Croatian: Test (najniža vrijednost) dTV [ng/mL]
English: Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily.
Croatian: Ketokonazol je povećao ukupni AUC0-∞ i Cmax dabigatrana 2,38 puta odnosno 2,35 puta, nakon jednokratne peroralne doze od 400 mg, te 2,53 puta odnosno 2,49 puta nakon ponovljenih peroralnih doza 400 mg ketokonazola jedanput dnevno.
English: single capsule of 75 mg Pradaxa
Croatian: jedna kapsula Pradaxe od 75 mg
English: 4 days before
Croatian: 4 dana prije
English: The presence of lesions, conditions, procedures and/or pharmacological treatment (such as NSAIDs, antiplatelets, SSRIs and SNRIs, see section 4.5), which significantly increase the risk of major bleeding requires a careful benefit-risk assessment.
Croatian: Prisustvo lezija, stanja, postupaka, i/ili farmakološkog liječenja (kao što su NSAIL-i, antitrombotici, SSRI-i i SNRI-i, vidjeti dio 4.5), koji značajno povećavaju rizik od velikog krvarenja zahtijeva pažljivu ocjenu omjera koristi i rizika.
English: In the clinical studies mucosal bleedings (e.g. gastrointestinal, genitourinary) were seen more frequently during long term Pradaxa treatment compared with VKA treatment.
Croatian: U kliničkim ispitivanjima češće su bila opažena krvarenja iz sluznica (npr, gastrointestinalno, urogenitalno) tijekom dugotrajnog liječenja Pradaxom u usporedbi s liječenjem antagonistima vitamina K (VKA).
English: In a clinical trial the rate of heart attacks with Pradaxa was numerically higher than with warfarin.
Croatian: U kliničkom ispitivanju, stopa srčanih udara uz Pradaxu bila je brojčano viša nego uz varfarin.
English: The table 9 shows the number (%) of patients experiencing the adverse reaction bleeding during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.
Croatian: Tablica 9 pokazuje broj (%) bolesnika koji su imali krvarenje tijekom razdoblja liječenja u prevenciji VTE-a u dva ključna klinička ispitivanja, prema dozi.
English: Dabigatran etexilate is a substrate for the efflux transporter P-gp.
Croatian: Dabigatraneteksilat je supstrat efluksnog prijenosnika P-gp.
English: There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Pradaxa: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparins (LMWH), and heparin derivatives (fondaparinux, desirudin), thrombolytic medicinal products, and vitamin K antagonists, rivaroxaban or other oral anticoagulants (see section 4.3), and antiplatelet aggregation medicinal products such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinpyrazone (see section 4.4).
Croatian: Ne postoji ili postoji samo ograničeno iskustvo sa sljedećim lijekovima koji mogu povećati rizik od krvarenja kada se primjenjuju istodobno s Pradaxom: antikoagulansi poput nefrakcioniranog heparina (UFH), niskomolekularni heparini (LMWH) i derivati heparina (fondaparinuks, desirudin), trombolitici, te antagonisti vitamina K, rivaroksaban, ili drugi oralni antikoagulansi (vidjeti dio 4.3), i inhibitori agregacije trombocita kao što su antagonisti GPIIb/IIIa receptora, tiklopidin, prasugrel, tikagrelor, dekstran i sulfinpirazon (vidjeti dio 4.4).
English: • Renal function should also be assessed when a decline in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products ).
Croatian: • Bubrežna funkcija se također treba procijeniti kada se sumnja na smanjenje bubrežne funkcije tijekom liječenja (npr. hipovolemija, dehidracija, i u slučaju istodobne primjene određenih lijekova).
English: Major or severe bleeding may occur, these constitute the most serious side effects and, regardless of location, may become disabling, life-threatening or even lead to death.
Croatian: Može doći do pojave velikih ili teških krvarenja, koja predstavljaju najozbiljnije nuspojave te, bez obzira na mjesto, ona mogu biti onesposobljavajuća, opasna po život ili čak dovesti do smrti.
English: Composite of total VTE (including PE, proximal and distal DVT, whatever symptomatic or asymptomatic detected by routine venography) and all-cause mortality constituted the primary end-point for both studies.
Croatian: Ukupni broj svih VTE-a (uključujući plućnu emboliju (PE), proksimalnu i distalnu duboku vensku trombozu (DVT), bez obzira jesu li bile simptomatske ili asimptomatske, otkrivene rutinskom venografijom) te smrt bilo kojeg uzroka činili su primarni kompozitni ishod u obje studije.
English: ® thins the blood, which prevents you from getting dangerous bood clots.
Croatian: ® razrjeđuje krv, što sprječava stvaranje opasnih krvnih ugrušaka.
English: In the trial program the rate of heart attacks with Pradaxa was higher than with warfarin.
Croatian: U istraživačkom programu, stopa srčanih udara uz Pradaxu bila je viša nego uz varfarin.
English: Patients should be instructed to contact the treating physician if they develop gastrointestinal symptoms such as dyspepsia (see section
Croatian: Bolesnicima treba savjetovati da se obrate nadležnom liječniku ako razviju gastrointestinalne simptome, kao što je dispepsija (vidjeti dio 4.8).
English: This has been confirmed by in vivo studies with healthy volunteers, who did not show any interaction between this treatment and the following active substances: atorvastatin (CYP3A4), digoxin (P-gp transporter interaction) and diclofenac (CYP2C9).
Croatian: Ovo je potvrđeno in vivo ispitivanjima na zdravim dobrovoljcima, u kojih nisu uočene interakcije dabigatrana i sljedećih djelatnih tvari: atorvastatina (CYP3A4), digoksina (interakcija P-gp prijenosnika) i diklofenaka (CYP2C9).
English: Recovery of the total radioactivity ranged from 88-94 % of the administered dose by 168 hours post dose.
Croatian: Tijekom 168 sati, nakon doze, ukupno je izlučeno 88 - 94 % primijenjene radioaktivnosti.
English: Interactions linked to dabigatran etexilate and dabigatran metabolic profile
Croatian: Interakcije povezane s dabigatraneteksilatom i metaboličkim profilom dabigatrana
English: In the pooled studies the primary safety endpoints of major bleeding, major or clinically relevant bleeding and any bleeding were significantly lower than warfarin at a nominal alpha level of 5 %.
Croatian: U združenim ispitivanjima primarni ishodi za procjenu sigurnosti: veliko krvarenje, veliko ili klinički značajno krvarenje, te svako krvarenje bili su značajno manji nego uz varfarin na nominalnoj alfarazini od 5 %.
English: There is no data on the use of Pradaxa in patients undergoing hip fracture surgery.
Croatian: Ne postoje podaci o primjeni Pradaxe kod bolesnika podvrgnutih kirurškom zahvatu zbog prijeloma kuka.
English: An effect on female fertility was observed in the form of a decrease in implantations and an increase in pre-implantation loss at 70 mg/kg (5-fold the plasma exposure level in patients).
Croatian: Učinak na žensku plodnost primijećen je u obliku smanjenja implantacija te porasta predimplantacijskih gubitaka pri 70 mg/kg (5-struko veća izloženost nego u bolesnika).
English: • One individual blister should be teared off from the blister card along the perforated line.
Croatian: • Pojedini blister je po perforaciji potrebno otkinuti od blister pločice.
English: Parenteral anticoagulants to Pradaxa:
Croatian: Prijelaz s parenteralnih antikoagulansa na Pradaxu:
English: Pradaxa can be taken with or without food.
Croatian: Pradaxa se može uzimati sa ili bez hrane.
English: Pradaxa is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults.
Croatian: Pradaxa se primjenjuje u sprječavanju stvaranja krvnih ugrušaka u venama nakon kirurškog zahvata ugradnje endoproteze koljena ili kuka kod odraslih osoba.
English: Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient (see table 1 above).
Croatian: O prilagođavanju doze odlučuje liječnik, na osnovu ocjene potencijalnih pozitivnih učinaka i rizika za pojedinog bolesnika (vidjeti tablicu 1 iznad).
English: The table 12 shows the number (%) of patients experiencing the adverse reaction bleeding during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.
Croatian: Tablica 12 pokazuje broj (%) bolesnika koji su imali krvarenje tijekom razdoblja liječenja u prevenciji VTE-a u dva ključna klinička ispitivanja, prema dozi.
English: Your doctor has initiated treatment with Pradaxa
Croatian: Poštovani bolesniče, Vaš liječnik počeo je liječenje Pradaxom
English: A forgotten dose can still be taken up to 6 hours prior to the next due dose.
Croatian: Propuštenu dozu se može još uvijek uzeti do 6 sati prije vremena sljedeće doze.
English: The efficacy and safety have not been established for DVT/PE patients with active cancer.
Croatian: Učinkovitost i sigurnost još nisu utvrđene za bolesnike s rakom u aktivnoj fazi bolesti.
English: Pradaxa treatment (150 mg twice daily) does not need to be interrupted in patients undergoing catheter ablation for atrial fibrillation (see section
Croatian: Liječenje Pradaxom (150 mg dvaput dnevno) ne mora se prekinuti u bolesnika podvrgnutih kateterskoj ablaciji radi fibrilacije atrija (vidjeti dio 4.2).
English: 18 months (%)
Croatian: Kumulativni rizik nakon 18 mjeseci (%)
English: If you are taking amiodarone, quinidine or verapamil containing medicines, your doctor may tell you to use a reduced dose of Pradaxa depending on the condition for which Pradaxa is prescribed to you.
Croatian: Ako uzimate lijekove koji sadrže amiodaron, kinidin ili verapamil, liječnik Vam može savjetovati da uzimate sniženu dozu Pradaxe ovisno o stanju zbog kojeg Vam je Pradaxa propisana.
English: Use of platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux increase the risk of GI bleeding.
Croatian: Primjena inhibitora agregacije trombocita poput klopidogrela i acetilsalicilatne kiseline (ASA) ili nesteroidnih protuupalnih lijekova (NSAIL), kao i prisustvo ezofagitisa, gastritisa ili gastroezofagealnog refluksa povećavaju rizik od gastrointestinalnog krvarenja.
English: The dose of 150 mg twice daily reduces significantly the risk of ischemic and haemorrhagic stroke, vascular death, ICH and total bleeding compared to warfarin.
Croatian: Doza od 150 mg dvaput dnevno značajno smanjuje rizik od ishemijskog i hemoragijskog moždanog udara, vaskularne smrti, ICH i ukupnog krvarenja u usporedbi s varfarinom.
English: RE-NOVATE (hip)
Croatian: RE-NOVATE (kuk) Br.
English: The objective of the RE-SONATE study was to evaluate superiority of dabigatran etexilate versus placebo for the prevention of recurrent symptomatic DVT and/or PE in patients who had already completed 6 to 18 months of treatment with VKA.
Croatian: Cilj ispitivanja RE-SONATE bio je ocijeniti superiornost dabigatraneteksilata u odnosu na placebo radi prevencije rekurentnog simptomatskog DVT-a i/ili PE-a kod bolesnika koji su već završili 6-18 mjeseci liječenja VKA-om.
English: Table 9: Number (%) of patients experiencing the adverse reaction bleeding
Croatian: Tablica 9: Broj (%) bolesnika koji su imali krvarenje
English: Primary prevention of Venous Thromboembolism in Orthopaedic Surgery The recommended doses of Pradaxa and the duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery are shown in table 1.
Croatian: Primarna prevencija venske tromboembolije u ortopedskoj kirurgiji Preporučene doze Pradaxe i trajanje terapije kod primarne prevencije venske tromboembolije u ortopedskoj kirurgiji prikazani su u tablici 1.
English: Patients with elevated liver enzymes > 2 ULN were excluded in the main trials.
Croatian: Bolesnici s povišenim vrijednostima jetrenih enzima 2 vrijednosti gornje granice normalne bili su isključeni iz glavnih ispitivanja.
English: 95 % confidence interval VTE-related deaths 95 % confidence interval All-cause deaths
Croatian: Interval pouzdanosti 95 % Smrti povezane s VTE-om Interval pouzdanosti 95 % Smrti svih uzroka
English: Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient (see table 2 above).
Croatian: O prilagođavanju doze odlučuje liječnik, na osnovu ocjene potencijalnih pozitivnih učinaka i rizika za pojedinog bolesnika (vidjeti tablicu 2 iznad).
English: There is no relevant use of Pradaxa in the paediatric population for the indication of primary prevention of venous thromboembolic events in patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Croatian: Nije opravdana primjena Pradaxe u pedijatrijskoj populaciji za indikaciju primarne prevencije venskih tromboembolijskih događaja u bolesnika koji su bili podvrgnuti elektivnom kirurškom zahvatu ugradnje endoproteze kuka ili koljena.
English: A study evaluating post-operative absorption of dabigatran etexilate, 1-3 hours following surgery, demonstrated relatively slow absorption compared with that in healthy volunteers, showing a smooth plasma concentration-time profile without high peak plasma concentrations.
Croatian: Ispitivanje postoperativne apsorpcije dabigatraneteksilata, 1-3 sata nakon zahvata, pokazalo je relativno sporu apsorpciju u usporedbi s onom u zdravih dobrovoljaca, s uravnoteženim profilom koncentracija-vrijeme, bez visokih vršnih koncentracija u plazmi.
English: Pradaxa is for oral use.
Croatian: Pradaxa je namijenjena za peroralnu primjenu.
English: 220 mg once daily N (%)
Croatian: 220 mg jedanput dnevno N (%)
English: Once the bottle is opened, the medicinal product must be used within 4 months.
Croatian: Nakon prvog otvaranja boce, lijek se mora upotrijebiti u roku 4 mjeseca.
English: When a single dose of 75 mg dabigatran etexilate was coadministered simultaneously with a loading dose of 180 mg ticagrelor, the dabigatran AUC and Cmax were increased by 1.73-fold and 1.95-fold, respectively.
Croatian: Kada je jednokratna doza dabigatraneteksilata od 75 mg istodobno primijenjena s udarnom dozom od 180 mg tikagrelora, AUC i Cmax dabigatrana povećali su se za 1,73 odnosno 1,95 puta.
English: Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg.
Croatian: Kada su dabigatraneteksilat i dronedaron primjenjivani u isto vrijeme, ukupne AUC0-oo i Cmax vrijednosti za dabigatran su se povećale za oko 2,4, odnosno 2,3 puta nakon ponovljenih doza 400 mg dronedarona dvaput dnevno, te oko 2,1, odnosno 1,9 puta nakon jednokratnog doziranja 400 mg.
English: Data for the total VTE and all cause mortality endpoint are shown in table 18.
Croatian: Podaci za ukupne VTE i sve uzroke mortaliteta (primarni ishod) prikazani su u tablici 18.
English: Treated
Croatian: Liječeni
English: In patients with moderate renal impairment and concomitantly treated with verapamil, a dose reduction of Pradaxa to 75 mg daily should be considered (see sections 4.4 and 4.5).
Croatian: Za bolesnike s umjerenim oštećenjem bubrega koji se istovremeno liječe verapamilom potrebno je razmotriti snižavanje doze Pradaxe na 75 mg dnevno (vidjeti dijelove 4.4 i 4.5).
English: See section 3.
Croatian: PRILOG III.
English: ® without talking to your doctor, if you experience heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.
Croatian: ® bez savjetovanja s liječnikom ako osjetite žgaravicu, mučninu, povraćate, osjećate nelagodu u trbuhu, nadutost ili bol u gornjem dijelu trbuha.
English: Concomitant use of Pradaxa with mild to moderate P-glycoprotein (P-gp) inhibitors, i.e. amiodarone, quinidine or verapamil
Croatian: Istodobna primjena Pradaxe i blagih do umjerenih inhibitora P-glikoproteina (P-gp), tj. amiodarona, kinidina, ili verapamila
English: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
Croatian: Prevencija moždanog udara i sistemske embolije u odraslih osoba s nevalvularnom fibrilacijom atrija (engl. non-valvular atrial fibrillation, NVAF), s jednim ili više čimbenika rizika kao što je prethodni moždani udar ili tranzitorna ishemična ataka (TIA); dob ≥ 75 godina; zatajenje srca (NYHA - stupanj ≥ II); dijabetes melitus; hipertenzija.