FrancophonIA/ELRC3.0 huggingface dataset:
English: These active substances are strong inhibitors of both CYP3A4 and P-gp and therefore may increase rivaroxaban plasma concentrations to a clinically relevant degree (2.6 fold on average) which may lead to an increased bleeding risk (see section 4.5).
Croatian: Te djelatne tvari snažni su inhibitori CYP3A4 i P-gp-a i stoga mogu klinički značajno povećati koncentraciju rivaroksabana u plazmi (prosječno 2,6 puta) što može dovesti do povećanog rizika od krvarenja (vidjeti dio 4.5).
English: Patients with CAD/PAD a)
Croatian: Bolesnici s BKA-om/BPA-om a)
English: Prothrombin time (PT) is influenced by rivaroxaban in a dose dependent way with a close correlation to plasma concentrations (r value equals 0.98) if Neoplastin is used for the assay.
Croatian: Rivaroksaban utječe na protrombinsko vrijeme (PV) ovisno o dozi, pri čemu postoji bliska korelacija s njegovom koncentracijom u plazmi (r = 0,98) ako se u testu koristi Neoplastin.
English: Vascular pseudoaneurysmC
Croatian: Vaskularna pseudoaneurizmaC
English: Not known (frequency cannot be estimated from the available data) - kidney failure after a severe bleeding - increased pressure within muscles of the legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after a bleeding)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - zatajenje bubrega nakon teškog krvarenja - povećan tlak u mišićima nogu ili ruku nakon krvarenja, što uzrokuje bol, oticanje, promjenu osjeta, utrnulost ili paralizu (kompartment sindrom nakon krvarenja)
English: If you stop taking Xarelto
Croatian: Ako prestanete uzimati Xarelto
English: PP/Aluminium foil blisters in a wallet containing 49 film-coated tablets: 42 film-coated tablets Xarelto 15 mg and 7 film-coated tablets Xarelto 20 mg.
Croatian: PP/aluminij blisteri u kartonskom ovitku koji sadrži 49 filmom obloženih tableta: 42 filmom obložene tablete lijeka Xarelto 15 mg i 7 filmom obloženih tableta lijeka Xarelto 20 mg.
English: (PVC/PVDC/Aluminium foil blisters)
Croatian: (blisteri od PVC/PVDC/aluminijske folije)
English: 2,531 patients undergoing total knee replacement surgery
Croatian: 2531 bolesnik podvrgnut kirurškom zahvatu potpune zamjene koljena
English: The MAH shall also provide a Patient Alert Card in each medicine pack, the text of which is included in Annex III.
Croatian: Nositelj odobrenja osigurat će da Kartica s upozorenjima za bolesnika, čiji je tekst uključen u dodatak III, bude dostupna u svakom pakiranju lijeka.
English: Your doctor may decide to keep you under closer observation or change how you should be treated.
Croatian: Vaš liječnik može odlučiti hoćete li biti pod pažljivim nadzorom ili će promijeniti način
English: The volume of distribution is moderate with Vss being approximately 50 litres.
Croatian: Vss iznosi oko 50 litara.
English: Xarelto was non-inferior to warfarin for the primary composite endpoint of stroke and non-CNS systemic embolism.
Croatian: Xarelto nije bio inferioran u odnosu na varfarin za primarni kompozitni ishod moždanog udara i sistemske embolije koja nije vezana uz središnji živčani sustav.
English: Safety and efficacy of Xarelto have not been established in pregnant women.
Croatian: Sigurnost i djelotvornost lijeka Xarelto u trudnica nisu ustanovljene.
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations Xarelto is to be used with caution (see section 4.5).
Croatian: U bolesnika s umjereno oštećenom funkcijom bubrega (klirens kreatinina od 30 - 49 ml/min) koji istodobno primaju druge lijekove koji povećavaju koncentraciju rivaroksabana u plazmi Xarelto se mora primjenjivati s oprezom (vidjeti dio 4.5).
English: Fatal PE/death where PE cannot be ruled out
Croatian: PE sa smrtnim ishodom/Smrt za koju se ne može isključiti PE
English: If you have kidney problems, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Xarelto 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.
Croatian: Ako imate problema s bubrezima, Vaš liječnik može odlučiti sniziti dozu lijeka nakon 3 tjedna na jednu tabletu lijeka Xarelto od 15 mg jedanput na dan ako je rizik od krvarenja veći nego rizik od dobivanja drugog krvnog ugruška.
English: Safety and efficacy of Xarelto 2.5 mg twice daily in combination with ASA plus clopidogrel/ticlopidine has only been studied in patients with recent ACS (see section 4.1).
Croatian: Sigurnost i djelotvornost lijeka Xarelto u dozi od 2,5 mg dvaput na dan u kombinaciji s ASK-om uz dodatak klopidogrela/tiklopidina ispitane su samo u bolesnika s nedavnim akutnim koronarnim sindromom (vidjeti dio 4.1).
English: 2,509 patients undergoing total hip replacement surgery
Croatian: 2509 bolesnika podvrgnutih kirurškom zahvatu potpune zamjene kuka
English: Direct acting Oral Anticoagulants (DOACs) including rivaroxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Croatian: Direktno djelujući oralni antikoagulansi (engl. direct acting oral anticoagulants, DOAC), uključujući rivaroksaban, ne preporučuju se bolesnicima koji u anamnezi imaju trombozu, a dijagnosticiran im je antifosfolipidni sindrom.
English: CYP3A4 and P-gp inhibitors
Croatian: Inhibitori CYP3A4 i P-gp-a
English: If a dose is missed during the 15 mg twice daily treatment phase (day 1 - 21), the patient should take Xarelto immediately to ensure intake of 30 mg Xarelto per day.
Croatian: Ako propusti dozu u razdoblju uzimanja lijeka u dozi od 15 mg dvaput na dan (od 1. do 21. dana), bolesnik mora uzeti Xarelto odmah kako bi osigurao unos od 30 mg lijeka Xarelto u tom danu.
English: No data are available for such patients with a history of stroke/ transient ischaemic attack (TIA).
Croatian: Nisu dostupni podaci za takve bolesnike s moždanim udarom / tranzitornom ishemijskom atakom (TIA) u povijesti bolesti.
English: The rivaroxaban clinical programme was designed to demonstrate the efficacy of Xarelto for the prevention of cardiovascular (CV) death, myocardial infarction (MI) or stroke in subjects with a recent ACS (ST-elevation myocardial infarction [STEMI], non- ST-elevation myocardial infarction [NSTEMI] or unstable angina [UA]).
Croatian: Klinički program za rivaroksaban osmišljen je da bi se pokazala djelotvornost lijeka Xarelto u sprječavanju kardiovaskularne (KV) smrti, infarkta miokarda (IM) ili moždanog udara u ispitanika s nedavnim akutnim koronarnim sindromom (infarkt miokarda s povišenjem ST spojnice [STEMI], infarkt miokarda bez povišenja ST-spojnice [NSTEMI] ili nestabilna angina pektoris).
English: - CV death 160 (1.7%) 2.19% 203 (2.2%) 2.88% 0.78 (0.64;0.96) p = 0.02053
Croatian: - kardiovask ularna smrt 160 (1,7%) 2,19% 203 (2,2%) 2,88% 0,78 (0,64; 0,96) p = 0,02053
English: Of the administered rivaroxaban dose, approximately 2/3 undergoes metabolic degradation, with half then being eliminated renally and the other half eliminated by the faecal route.
Croatian: Oko 2/3 primijenjene doze rivaroksabana metabolički se razgradi, od čega se oko polovina eliminira putem bubrega, a druga polovina putem crijeva.
English: After oral administration the elimination becomes absorption rate limited.
Croatian: Nakon peroralne primjene eliminacija postaje ograničena brzinom apsorpcije.
English: The effect of erythromycin is additive to that of renal impairment (see section 4.4).
Croatian: Učinak eritromicina aditivan je onom oštećenju funkcije bubrega (vidjeti dio 4.4).
English: ITT analyses of efficacy in patients with non-valvular atrial fibrillation
Croatian: ITT analize djelotvornosti u bolesnika s nevalvularnom fibrilacijom atrijaa
English: In individuals with mild (creatinine clearance 50 - 80 ml/min), moderate (creatinine clearance 30 - 49 ml/min) and severe (creatinine clearance 15 - 29 ml/min) renal impairment, rivaroxaban plasma concentrations (AUC) were increased 1.4, 1.5 and 1.6 fold respectively.
Croatian: U osoba s blago (klirens kreatinina 50 - 80 ml/min), umjereno (klirens kreatinina 30 - 49 ml/min) i teško (klirens kreatinina 15 - 29 ml/min) oštećenom funkcijom bubrega, koncentracije rivaroksabana u plazmi (AUC) povećale su se, redom, 1,4, 1,5 i 1,6 puta.
English: Once Xarelto is discontinued INR testing may be done reliably at least 24 hours after the last dose (see sections 4.5 and 5.2).
Croatian: Nakon što se Xarelto ukine INR se može pouzdano izmjeriti najmanje 24 sata nakon zadnje doze (vidjeti dijelove 4.5 i 5.2).
English: Xarelto 2.5 mg (tick box to tick the prescribed dose) Xarelto 10 mg (tick box to tick the prescribed dose) Xarelto 15 mg (tick box to tick the prescribed dose) Xarelto 20 mg (tick box to tick the prescribed dose)
Croatian: Xarelto 2,5 mg (kućica za označavanje propisane doze kvačicom ) Xarelto 10 mg (kućica za označavanje propisane doze kvačicom ) Xarelto 15 mg (kućica za označavanje propisane doze kvačicom ) Xarelto 20 mg (kućica za označavanje propisane doze kvačicom )
English: Treatment with Xarelto after an acute coronary syndrome should be started as soon as possible after stabilisation of the acute coronary syndrome, at the earliest 24 hours after admission to hospital and at the time when parenteral (via injection) anticoagulation therapy would normally be stopped.
Croatian: Liječenje lijekom Xarelto nakon akutnog koronarnog sindroma mora se započeti čim to bude moguće nakon stabilizacije akutnog koronarnog sindroma, najranije 24 sata nakon prijema u bolnicu i u vrijeme kad bi se uobičajeno prekinula parenteralna (putem injekcije) antikoagulacijska terapija.
English: There is limited experience of a reduced dose of 15 mg Xarelto once daily (or 10 mg Xarelto once daily for patients with moderate renal impairment [creatinine clearance 30 - 49 ml/min]) in addition to a P2Y12 inhibitor for a maximum of 12 months in patients with non-valvular atrial fibrillation who require oral anticoagulation and undergo PCI with stent placement (see sections 4.4 and 5.1).
Croatian: Postoji ograničeno iskustvo sa smanjenom dozom lijeka Xarelto 15 mg jedanput na dan (ili Xarelto 10 mg jedanput na dan za bolesnike s umjereno oštećenom funkcijom bubrega [klirens kreatinina 30-49 ml/min]), dodatno uz inhibitor receptora P2Y12 tijekom najdulje 12 mjeseci u bolesnika s nevalvularnom fibrilacijom atrija kojima je potrebna terapija peroralnim antikoagulansom, i koji se podvrgavaju PCI-u s postavljanjem stenta (vidjeti dijelove 4.4 i 5.1).
English: Xarelto administration should be discontinued if severe haemorrhage occurs (see section 4.9).
Croatian: Primjena lijeka Xarelto mora se prekinuti ako se pojavi teško krvarenje (vidjeti dio 4.9).
English: CAD/PAD patients with previous haemorrhagic or lacunar stroke, or an ischaemic, non-lacunar stroke with in the previous month were not studied (see section 4.3).
Croatian: Bolesnici s BKA-om/BPA-om koji su prethodno imali hemoragijski ili lakunarni moždani udar, ili ishemijski, nelakunarni moždani udar unutar prethodnih mjesec dana nisu ispitani (vidjeti dio 4.3).
English: Oral absorption of rivaroxaban is almost complete and oral bioavailability is high (80 - 100%) for the 2.5 mg and 10 mg tablet dose, irrespective of fasting/fed conditions.
Croatian: Apsorpcija rivaroksabana nakon peroralne primjene gotovo je potpuna, a bioraspoloživost nakon peroralne primjene je visoka (80-100%) za dozu tablete od 2,5 mg i 10 mg, bez obzira na prazan/pun želudac.
English: With a systemic clearance of about 10 l/h, rivaroxaban can be classified as a low-clearance substance.
Croatian: Budući da mu sistemski klirens iznosi oko 10 l/h, rivaroksaban se može svrstati među lijekove s niskim klirensom.
English: In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Croatian: Posebice se ne preporučuju u bolesnika koji su trostruko pozitivni (na lupus antikoagulans, antikardiolipinska antitijela i anti-beta2-glikoprotein-I antitijela), u kojih bi liječenje direktno djelujućim oralnim antikoagulansima moglo biti povezano s povećanom stopom rekurentnih trombotskih događaja u usporedbi s terapijom antagonistima vitamina K.
English: Xarelto 2.5 mg twice daily in combination with ASA 100 mg once daily was superior to ASA 100 mg, in the reduction of the primary composite outcome of CV death, MI, stroke (see Table 7 and Figure 2).
Croatian: Xarelto u dozi od 2,5 mg dvaput na dan u kombinaciji s ASK-om u dozi od 100 mg jedanput na dan bio je superioran ASK-u u dozi od 100 mg u pogledu smanjenja primarnog kompozitnog ishoda koji se sastojao od kardiovaskularne smrti, infarkta miokarda i moždanog udara (vidjeti tablicu 7 i sliku 2).
English: When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/(100 mcg/l).
Croatian: Kad se za mjerenje PV-a koristio Neoplastin, početni PV iznosio je oko 13 s, a nagib pravca bio je oko 3 do 4 s/(100 mikrograma/l).
English: Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction with rivaroxaban (15 mg) but a relevant increase in bleeding time was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/IIIa receptor levels.
Croatian: Klopidogrel (početna doza od 300 mg, potom doza održavanja od 75 mg) nije pokazao farmakokinetičku interakciju s rivaroksabanom (15 mg), ali je uočeno značajno produljenje vremena krvarenja u podskupini bolesnika, koje nije bilo u korelaciji s agregacijom trombocita, s razinama Pselektina ili GPIIb/IIIa-receptora.
English: Elderly population Increasing age may increase haemorrhagic risk (see sections 5.1 and 5.2).
Croatian: S porastom dobi može biti povećan rizik od krvarenja (vidjeti dijelove 5.1 i 5.2).
English: Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA) (see section 4.4).
Croatian: Istodobno liječenje akutnog koronarnog sindroma s antitrombocitnom terapijom u bolesnika s prethodnim moždanim udarom ili tranzitornom ishemijskom atakom (TIA) (vidjeti dio 4.4).
English: The recommended dose is one 2.5 mg tablet twice a day.
Croatian: Preporučena doza je jedna tableta od 2,5 mg dvaput na dan.
English: The risk of bleedings may be increased in certain patient groups, e.g. those patients with uncontrolled severe arterial hypertension and/or on concomitant treatment affecting haemostasis (see section 4.4 “Haemorrhagic risk”).
Croatian: Rizik od krvarenja može u određenih skupina bolesnika biti povećan, npr. u bolesnika s jakom, nekontroliranom arterijskom hipertenzijom i/ili u onih koji istodobno primaju druge lijekove koji utječu na hemostazu (vidjeti dio 4.4 „Rizik od krvarenja“).
English: Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.
Croatian: Vaš liječnik će odlučiti smijete li biti liječeni lijekom Xarelto i morate li biti pod pažljivim nadzorom.
English: • congenital or acquired bleeding disorders
Croatian: • s prirođenim ili stečenim poremećajima krvarenja
English: Xarelto contains lactose and sodium
Croatian: Xarelto sadrži laktozu i natrij
English: Xarelto is to be used with caution in patients with creatinine clearance 15 - 29 ml/min (see section 4.4).
Croatian: Xarelto se mora primjenjivati s oprezom u bolesnika s klirensom kreatinina 15 - 29 ml/min (vidjeti dio 4.4).
English: If you have kidney problems and take one tablet Xarelto 20 mg once a day, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Xarelto 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.
Croatian: Ako imate problema s bubrezima i uzimate jednu tabletu lijeka Xarelto od 20 mg jedanput na dan, Vaš liječnik može odlučiti sniziti dozu lijeka nakon 3 tjedna na jednu tabletu lijeka Xarelto od 15 mg jedanput na dan ako je rizik od krvarenja veći nego rizik od dobivanja drugog krvnog ugruška.
English: Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.
Croatian: Vaš liječnik će odlučiti smijete li biti liječeni ovim lijekom i morate li biti pod pažljivim nadzorom.
English: These patients also had reduced renal elimination of rivaroxaban, similar to patients with moderate renal impairment.
Croatian: U tih se bolesnika smanjila i eliminacija rivaroksabana putem bubrega, slično kao i u bolesnika s umjereno oštećenom funkcijom bubrega.
English: Rivaroxaban has not been studied in interventional clinical studies in patients undergoing hip fracture surgery to evaluate efficacy and safety.
Croatian: Nisu provedena intervencijska klinička ispitivanja s rivaroksabanom u bolesnika podvrgnutih kirurškom zahvatu zbog prijeloma kuka, kojima bi se procijenila djelotvornost i sigurnost lijeka.
English: Dosing schedule
Croatian: Raspored doziranja
English: Symptomatic recurrent PE 20
Croatian: Simptomatski ponavljajući PE 20
English: Exposure is further reduced when rivaroxaban is released in the distal small intestine, or ascending colon.
Croatian: Izloženost se dodatno smanji kad se rivaroksaban oslobađa u distalnom tankom crijevu ili uzlaznom debelom crijevu.
English: Symptomatic recurrent PE 2
Croatian: Simptomatski ponavljajući PE 2
English: Dose-dependent inhibition of factor Xa activity was observed in humans.
Croatian: U ljudi je uočena o dozi ovisna inhibicija aktivnosti faktora Xa.
English: INR values were within the therapeutic range a mean of 63% of the time for the mean treatment duration of 215 days, and 57%, 62%, and 65% of the time in the 3-, 6-, and 12-month intended treatment duration groups, respectively.
Croatian: INR vrijednosti bile su unutar terapijskog rasponasrednja vrijednost od 63% vremena u slučaju srednjeg trajanja liječenja od 215 dana, te 57%, 62% i 65% vremena kod skupina s planiranim trajanjem liječenja od 3, 6 i 12 mjeseci.
English: Under fed conditions Xarelto 10 mg, 15 mg and 20 mg tablets demonstrated dose-proportionality.
Croatian: Xarelto tablete od 10 mg, 15 mg i 20 mg na pun želudac pokazuju proporcionalnost s dozom.
English: Symptomatic intracranial haemorrhage
Croatian: Simptomatsko intrakranijalno krvarenje
English: Limited clinical data for patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased.
Croatian: Ograničeni klinički podaci za bolesnike s teško oštećenom funkcijom bubrega (klirens kreatinina 1529 ml/min) upućuju da su koncentracije rivaroksabana u plazmi značajno povišene.
English: Take the next tablet on the following day and then carry on taking a tablet once a day as normal.
Croatian: Iduću tabletu uzmite sljedeći dan, a potom nastavite uzimati tabletu jedanput na dan, kao i inače.
English: Surgical intervention for ongoing bleeding
Croatian: Kirurški zahvat zbog krvarenja koje ne prestaje
English: Compartment syndrome secondary to a bleeding
Croatian: Kompartment sindrom kao posljedica krvarenja
English: Table 4: Efficacy and safety results from phase III clinical studies
Croatian: Tablica 4: Rezultati djelotvornosti i sigurnosti u kliničkim ispitivanjima faze III
English: Concomitant treatment with any other anticoagulants, e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumstances of switching anticoagulant therapy (see section 4.2) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5).
Croatian: Istodobno liječenje s bilo koji drugim antikoagulansom npr. nefrakcioniranim heparinom, niskomolekularnim heparinima (enoksaparin, dalteparin i drugi), derivatima heparina (fondaparinuks i drugi), oralnim antikoagulansima (varfarin, dabigatran eteksilat, apiksaban i drugi) osim u specifičnim situacijama kad se mijenja antikoagulacijska terapija (vidjeti dio 4.2) ili kad se nefrakcionirani heparin daje u dozama potrebnim za održavanje otvorenog centralnog venskog ili arterijskog katetera (vidjeti dio 4.5).
English: Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose 2910, sodium laurilsulphate, magnesium stearate.
Croatian: Jezgra tablete: mikrokristalična celuloza, umrežena karmelozanatrij, laktoza hidrat, hipromeloza 2910, natrijev laurilsulfat, magnezijev stearat.
English: Exclusion criteria included the need for dual antiplatelet or other non-ASA antiplatelet or oral anticoagulant therapy and patients with high bleeding risk, or heart failure with ejection fraction < 30% or New York Heart Association class III or IV, or any ischaemic, non-lacunar stroke within 1 month or any history of haemorrhagic or lacunar stroke.
Croatian: Kriteriji isključenja uključivali su potrebu za dvojnom antitrombocitnom ili drugom antitrombocitnom terapijom koja nije ASK ili peroralnom antikoagulantnom terapijom i bolesnike s velikim rizikom od krvarenja ili zatajivanjem srca s ejekcijskom frakcijom < 30 % ili kategorije III ili IV prema NYHA (engl.
English: (only applicable for outer carton, not applicable for bottle label)
Croatian: (primjenjivo samo za vanjsku kutiju, nije primjenivo za naljepnicu za bocu)
English: Transfusion of 2 or more units of packed red blood cells or whole blood*
Croatian: Pad hemoglobina* Transfuzija 2 ili više jedinica koncentrata eritrocita ili pune krvi*
English: There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine.
Croatian: Tijekom liječenja rivaroksabanom nema potrebe za kliničkim rutinskim praćenjem koagulacijskih parametara.
English: (only applicable for bottle label, not applicable for outer carton)
Croatian: (primjenjivo samo za naljepnicu za bocu, nije primjenivo za vanjsku kutiju)
English: • If the first and second characters are BX, the manufacturer is Bayer AG
Croatian: • Ako su prva dva slova BX, proizvođač je:
English: Converting from parenteral anticoagulants to Xarelto For patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start Xarelto 0 to 2 hours before the time that the next scheduled administration of the parenteral medicinal product (e.g. low molecular weight heparins) would be due or at the time of discontinuation of a continuously administered parenteral medicinal product (e.g. intravenous unfractionated heparin).
Croatian: U bolesnika koji trenutno primaju parenteralni antikoagulans, mora se prekinuti primjena parenteralnog antikoagulansa i početi primjena lijeka Xarelto od 0 do 2 sata prije nego bi bila sljedeća planirana primjena parenteralnog lijeka (npr. niskomolekularni heparin) ili u vrijeme ukidanja kontinuirano primjenjivanog parenteralnog lijeka (npr. intravenski nefrakcionirani heparin).
English: For all-cause mortality, there was no difference between rivaroxaban and placebo in the number of events (event rate per 100 patient-years; 11.41 vs. 11.63, HR: 0.98; 95% CI: 0.87 to 1.10; p=0.743).
Croatian: Za smrtnost od svih uzroka, nije bilo razlike između rivaroksabana i placeba u broju događaja (stopa događaja na 100 bolesnik-godina; 11,41 naspram 11,63, HR: 0,98; 95% CI: 0,871,10; p=0,743).
English: 5 film-coated tablets
Croatian: 5 filmom obloženih tableta
English: Patients taking Xarelto 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA or a daily dose of 75 - 100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
Croatian: Bolesnici koji uzimaju Xarelto u dozi od 2,5 mg dvaput na dan također moraju svakodnevno uzimati dozu od 75-100 mg ASK-a ili dnevnu dozu od 75-100 mg ASK-a uz dodatak dnevne doze od 75 mg klopidogrela ili uobičajene dnevne doze tiklopidina.