FrancophonIA/ELRC3.0 huggingface dataset:
English: The activated partial thromboplastin time (aPTT) and HepTest are also prolonged dose-dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban.
Croatian: Aktivirano parcijalno tromboplastinsko vrijeme (aPTV) i vrijeme izmjereno Heptestom također se produljuju ovisno o dozi, no ti se pokazatelji ne preporučuju za procjenu farmakodinamičkih učinaka rivaroksabana.
English: B: observed in treatment of DVT, PE and prevention of recurrence as very common in women < 55 years
Croatian: B: uočeno kod liječenja duboke venske tromboze, plućne embolije i prevencije ponovnog javljanja kao vrlo često kod žena < 55 godina
English: When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis.
Croatian: Pri izvođenju neuroaksijalne anestezije (spinalna/epiduralna anestezija) ili spinalne/epiduralne punkcije, bolesnici koji primaju antitrombotike za prevenciju tromboembolijskih komplikacija izloženi su riziku od razvoja epiduralnog ili spinalnog hematoma, koji mogu rezultirati dugotrajnom ili trajnom paralizom.
English: Renal failure/acute renal failure secondary to a bleeding sufficient to cause hypoperfusion
Croatian: Zatajivanje bubrega/akutno zatajivanje bubrega kao posljedica krvarenja dostatnog da uzrokuje hipoperfuziju
English: 8,281 patients with an acute symptomatic DVT or PE
Croatian: Populacija uključena u ispitivanje 8281 bolesnik s akutnom simptomatskom dubokom venskom trombozom ili plućnom embolijom
English: The 2.5 mg twice daily regimen reduced mortality, and there is evidence that the lower dose had lower bleeding risks, therefore rivaroxaban 2.5 mg twice daily co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine is recommended for the prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers.
Croatian: Režim od 2,5 mg dvaput na dan smanjio je smrtnost, a dokazi pokazuju da je niža doza imala manji rizik od krvarenja pa se stoga rivaroksaban od 2,5 mg dvaput na dan primijenjen istodobno samo s acetilsalicilatnom kiselinom (ASK) ili s ASK-om uz dodatak klopidogrela ili tiklopidina preporučuje za prevenciju aterotrombotskih događaja u odraslih bolesnika nakon akutnog koronarnog sindroma s povišenim srčanim biomarkerima.
English: Like other similar medicines (antithrombotic agents), Xarelto may cause bleeding which may potentially be life threatening.
Croatian: Kao i drugi slični lijekovi (antitrombotici), Xarelto može prouzročiti krvarenje, koje može biti potencijalno opasno po život.
English: For patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered (see section 4.5).
Croatian: U bolesnika koji imaju rizik za razvoj ulcerozne gastrointestinalne bolesti, može se razmotriti prikladno profilaktično liječenje (vidjeti dio 4.5).
English: In a clinical pharmacology study on the reversal of rivaroxaban pharmacodynamics in healthy adult subjects (n=22), the effects of single doses (50 IU/kg) of two different types of PCCs, a 3-factor PCC (Factors II, IX and X) and a 4-factor PCC (Factors II, VII, IX and X) were assessed.
Croatian: U kliničkom farmakološkom ispitivanju poništavanja farmakodinamičkog učinka rivaroksabana u zdravih odraslih osoba (n=22), ocijenjeni su učinci pojedinačne doze (50 IU/kg) dva različita tipa koncentrata protrombinskog kompleksa (PCC), PCC-a koji sadrži 3 faktora (faktor II, IX i X) te PCCa koji sadrži 4 faktora (faktor II, VII, IX i X).
English: Patients on treatment with Xarelto and ASA or with Xarelto and ASA plus clopidogrel/ticlopidine should only receive concomitant treatment with NSAIDs if the benefit outweighs the bleeding risk.
Croatian: Bolesnici koji se liječe lijekom Xarelto i ASK-om ili lijekom Xarelto i ASK-om uz dodatak klopidogrela/tiklopidina smiju biti istodobno liječeni nestereoidnim protuupalnim lijekovima samo ako je korist veća od rizika od krvarenja.
English: Care is to be taken if patients are treated concomitantly with NSAIDs (including acetylsalicylic acid) and platelet aggregation inhibitors because these medicinal products typically increase the bleeding risk (see section 4.4).
Croatian: Nužan je oprez ako su bolesnici istodobno liječeni NSAIL-ima (uključujući acetilsalicilatnu kiselinu) i inhibitorima agregacije trombocita, jer ti lijekovi tipično povećavaju rizik od krvarenja (vidjeti dio 4.4).
English: In addition to the phase III RECORD programme, a post-authorization, non-interventional, open-label cohort study (XAMOS) has been conducted in 17,413 patients undergoing major orthopaedic surgery of the hip or knee, to compare rivaroxaban with other pharmacological thromboprophylaxis (standardof-care) under real-life setting.
Croatian: Kao dodatak RECORD programu faze III, nakon stavljanja lijeka na tržište, provedeno je neintervencijsko, otvoreno ispitivanje kohorte (XAMOS) u 17413 bolesnika podvrgnutih velikom ortopedskom kirurškom zahvatu kuka ili koljena, da bi se rivaroksaban usporedio s drugom farmakološkom tromboprofilaksom (standardna terapija) u uvjetima stvarnog života.
English: - Bleeding into the surgical site requiring reoperation (nonfatal, not in critical organ)
Croatian: - Krvarenje na mjestu kirurškog zahvata koje je zahtijevalo ponovnu operaciju (bez smrtnog ishoda, ne u kritični organ)
English: In Table 5 the efficacy results of patients undergoing percutaneous coronary intervention (PCI) are presented.
Croatian: U tablici 5 prikazani su rezultati djelotvornosti u bolesnika koji su podvrgnuti perkutanoj koronarnoj intervenciji.
English: Multipack: 100 (10 packs of 10 x 1) film-coated tablets.
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 100 (10 pakiranja od 10 x 1) filmom obloženih tableta.
English: The incidence rates for the principal safety outcome (major and non-major clinically relevant bleeding events) were similar for both treatment groups (see Table 5).
Croatian: Stopa incidencije za glavni ishod sigurnosti (veća i manja klinički značajna krvarenja) bila je slična za obje skupine bolesnika (vidjeti tablicu 5).
English: When taking a blood thinner such as Xarelto it is important to be aware of its possible side effects.
Croatian: Prilikom uzimanja antikoagulacijskih lijekova kao što je Xarelto, važno je biti svjestan mogućih nuspojava.
English: The crushed Xarelto tablet may also be given through gastric tubes after confirmation of the correct gastric placement of the tube.
Croatian: Zdrobljena Xarelto tableta može se dati kroz želučanu sondu nakon potvrde da je sonda ispravno postavljena u želudac.
English: Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy
Croatian: Hemodinamički nestabilni bolesnici s plućnom embolijom ili bolesnici koji trebaju trombolizu ili plućnu embolektomiju
English: It is recommended to be used with caution in conditions with increased risk of haemorrhage.
Croatian: Preporučuje se njegova pažljiva primjena u stanjima s povišenim rizikom od krvarenja.
English: The incidence rates for the primary safety outcome (major or clinically relevant non-major bleeding events) were slightly lower in the rivaroxaban treatment group (10.3% (249/2412)) than in the enoxaparin/VKA treatment group (11.4% (274/2405)).
Croatian: Stope incidencije za primarni ishod sigurnosti (veća ili klinički značajna manja krvarenja) bile su nešto niže u skupini liječenoj rivaroksabanom (10,3% (249/2412)) nego u skupini liječenoj enoksaparinom/ antagonistom vitamina K (11,4% (274/2405)).
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min) rivaroxaban plasma levels may be significantly increased (1.6 fold on average) which may lead to an increased bleeding risk.
Croatian: U bolesnika s teško oštećenom funkcijom bubrega (klirens kreatinina < 30 ml/min) mogu se značajno povisiti razine rivaroksabana u plazmi (prosječno 1,6 puta), što može dovesti do povećanog rizika od krvarenja.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodiumfree”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti tj. zanemarive količine natrija.
English: Each red film-coated tablet for week 1, 2 and 3 contains 15 mg rivaroxaban.
Croatian: Jedna crvena filmom obložena tableta za 1., 2. i 3. tjedan sadrži 15 mg rivaroksabana.
English: Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).
Croatian: Xarelto, primijenjen istodobno samo s acetilsalicilatnom kiselinom (ASK) ili s ASK-om uz klopidogrel ili tiklopidin, je indiciran za prevenciju aterotrombotskih događaja u odraslih bolesnika nakon akutnog koronarnog sindroma s povišenim srčanim biomarkerima (vidjeti dijelove 4.3, 4.4 i
English: Patients received the first dose of Xarelto at a minimum of 24 hours and up to 7 days (mean 4.7 days) after admission to the hospital, but as soon as possible after stabilisation of the ACS event, including revascularisation procedures and when parenteral anticoagulation therapy would normally be discontinued.
Croatian: Bolesnici su primili prvu dozu lijeka Xarelto najmanje 24 sata i najviše 7 dana (srednja vrijednost 4,7 dana) nakon prijema u bolnicu, ali čim je to bilo moguće nakon stabilizacije akutnog koronarnog sindroma, uključujući postupke revaskularizacije i kada bi se obično prekinula antikoagulacijska terapija.
English: Paediatric population Safety and efficacy have not been established for children and adolescents up to 18 years.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: Do not use this medicine after the expiry date which is stated on the carton and on each blister or bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na svakom blisteru ili boci iza oznake EXP.
English: Risk: Cumulative incidence risk (Kaplan-Meier estimates) at 30 months; ISTH: International Society on Thrombosis and Haemostasis; od:
Croatian: CI: raspon pouzdanosti; kum. rizik: rizik kumulativne incidencije (Kaplan-Meierova procjena) nakon 30 mjeseci; ISTH: Međunarodno društvo za trombozu i hemostazu (engl.
English: What you need to know before you take Xarelto Do not take Xarelto
Croatian: Što morate znati prije nego počnete uzimati Xarelto
English: Dual antiplatelet therapy has not been studied in combination with Xarelto 2.5 mg twice daily in patients with CAD/PAD (see sections 4.4 and 5.1).
Croatian: Dvojna antitrombocitna terapija nije ispitana u kombinaciji s lijekom Xarelto u dozi od 2,5 mg dvaput na dan u bolesnika s BKA-om/BPA-om (vidjeti dijelove 4.4 i 5.1).
English: Both the 2.5 mg twice daily and the 5 mg twice daily regimens of rivaroxaban were effective in further reducing the incidence of CV events on a background of standard antiplatelet care.
Croatian: Oba režima primjene rivaroksabana, 2,5 mg dvaput na dan i 5 mg dvaput na dan, bila su djelotvorna u daljnjem smanjivanju incidencije kardiovaskularnih događaja u odnosu na standardno antitrombocitno liječenje.
English: In patients with an acute thrombotic event or vascular procedure and a need for dual antiplatelet therapy, the continuation of Xarelto 2.5 mg twice daily should be evaluated depending on the type of event or procedure and antiplatelet regimen.
Croatian: U bolesnika s akutnim trombotskim događajem ili zahvatom na krvnim žilama kojima je potrebna dvojna antitrombocitna terapija, nastavak primjene lijeka Xarelto u dozi od 2,5 mg dvaput na dan treba procijeniti ovisno o vrsti događaja ili zahvata te antitrombocitnoj terapiji.
English: A specific reversal agent (andexanet alfa) antagonising the pharmacodynamic effect of rivaroxaban is available (refer to the Summary of Product Characteristics of andexanet alfa).
Croatian: Dostupan je specifični agens za reverziju (andeksanet alfa) koji antagonizira farmakodinamički učinak rivaroksabana (vidjeti sažetak opisa svojstava lijeka za andeksanet alfa).
English: Relative to placebo, Xarelto significantly reduced the primary composite endpoint of CV death, MI or stroke.
Croatian: U odnosu na placebo, Xarelto je značajno smanjio primarni kompozitni ishod kardiovaskularne smrti, infarkta miokarda ili moždanog udara.
English: Do not stop taking Xarelto without talking to your doctor first, because Xarelto treats and prevents serious conditions.
Croatian: Nemojte prestati uzimati Xarelto a da najprije ne porazgovarate s liječnikom jer Xarelto liječi i sprječava ozbiljna stanja.
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 (see section 5.2).
Croatian: Postavljanje ili vađenje epiduralnog katetera ili lumbalna punkcija najbolje se provode kad je antikoagulacijski učinak rivaroksabana procijenjen kao nizak (vidjeti dio 5.2).
English: Do not stop taking Xarelto without talking to your doctor first, because Xarelto prevents the development of a serious condition.
Croatian: Nemojte prestati uzimati Xarelto a da prije toga ne razgovarate sa svojim liječnikom jer Xarelto sprječava razvoj ozbiljnog stanja.
English: After combined administration of enoxaparin (40 mg single dose) with rivaroxaban (10 mg single dose) an additive effect on anti-factor Xa activity was observed without any additional effects on clotting tests (PT, aPTT).
Croatian: Nakon kombinirane primjene enoksaparina (40 mg u jednokratnoj dozi) i rivaroksabana (10 mg u jednokratnoj dozi) uočen je aditivni učinak na potiskivanje aktivnosti faktora Xa, bez ikakvih dodatnih učinaka na rezultate testova zgrušavanja (PV, aPTV).
English: After at least 6 months: 10 mg or 20 mg
Croatian: 6 mjeseci: 10 mg ili 20 mg
English: Tell your doctor immediately if you experience skin reactions such as: spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (StevensJohnson syndrome/toxic epidermal necrolysis).
Croatian: Odmah se obratite liječniku ako primijetite kožne reakcije kao što su: - intenzivni kožni osip koji se širi, stvaranje mjehurića ili lezije sluznice, npr. u ustima ili očima (Stevens-Johnsonov sindrom / toksična epidermalna nekroliza).
English: The COMMANDER HF study included 5,022 patients with heart failure and significant coronary artery disease (CAD) following a hospitalization of decompensated heart failure (HF) which were randomly assigned into one of the two treatment groups: rivaroxaban 2.5 mg twice daily (N=2,507) or matching placebo (N=2,515), respectively.
Croatian: COMMANDER HF ispitivanje uključilo je 5022 bolesnika sa zatajivanjem srca i značajnom bolesti koronarnih arterija (BKA) nakon hospitalizacije radi dekompenzacije srčanog zatajivanja, koji su randomizirani u jednu od dvije skupine: rivaroksaban 2,5 mg dvaput na dan (N=2507) ili placebo (N=2515).
English: Dosing recommendations before and after invasive procedures and surgical intervention other than elective hip or knee replacement surgery
Croatian: Preporuke za doziranje prije i nakon invazivnih postupaka i kirurškog zahvata koji nije elektivna operacija zamjene kuka ili koljena
English: 40 mg od 12 ± 2 days p
Croatian: 12 ± 2 dana p
English: Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability.
Croatian: Rivaroksaban je visokoselektivni, direktni inhibitor faktora Xa, bioraspoloživ nakon peroralne primjene.
English: The recommended dose is one tablet Xarelto 15 mg twice a day for the first 3 weeks.
Croatian: Preporučena doza je jedna tableta lijeka Xarelto od 15 mg dvaput na dan kroz prva 3 tjedna.
English: For patients who are unable to swallow whole tablets, Xarelto tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally.
Croatian: Za bolesnike koji ne mogu progutati cijelu tabletu, Xarelto tableta može se zdrobiti i pomiješati s vodom ili kašom od jabuke, neposredno prije uzimanja te primijeniti peroralno.
English: Symptomatic PE and DVT
Croatian: Simptomatski PE i DVT
English: • Prescriber Guide
Croatian: • Upute za propisivača
English: 4,541 patients undergoing total hip replacement surgery
Croatian: 4541 bolesnik podvrgnut kirurškom zahvatu potpune zamjene kuka
English: Event rate (100 pt-yr)
Croatian: Stopa događaja (100 bolesnik-godina)
English: Body weight No dose adjustment (see sections 4.4 and 5.2)
Croatian: Tjelesna težina Dozu ne treba prilagođavati (vidjeti dijelove 4.4 i 5.2)
English: * Patients exposed to at least one dose of rivaroxaban The most commonly reported adverse reactions in patients receiving rivaroxaban were bleedings (see section 4.4. and ‘Description of selected adverse reactions' below) (Table 2).
Croatian: Najčešće prijavljene nuspojave u bolesnika koji su primali rivaroksaban bile su krvarenja (vidjeti također dio 4.4 i „Opis odabranih nuspojava“ niže) (tablica 2).
English: In the pivotal double-blind ATLAS ACS 2 TIMI 51 study, 15,526 patients were randomly assigned in a 1:1:1 fashion to one of three treatment groups: Xarelto 2.5 mg orally twice daily, 5 mg orally twice daily or to placebo twice daily co-administered with ASA alone or with ASA plus a thienopyridine (clopidogrel or ticlopidine).
Croatian: U osnovnom dvostruko slijepom ispitivanju ATLAS ACS 2 TIMI 51, 15 526 bolesnika bilo je nasumično raspodijeljeno u omjeru 1:1:1 u jednu od tri terapijske skupine: Xarelto 2,5 mg peroralno dvaput na dan, 5 mg peroralno dvaput na dan ili placebo dvaput na dan primijenjen istodobno s ASK-om samim ili s ASK-om uz dodatak tienopiridina (klopidogrel ili tiklopidin).
English: On the following day you should carry on taking one 15 mg tablet twice a day.
Croatian: Idućeg dana trebate nastaviti s uzimanjem jedne tablete od 15 mg dvaput na dan.
English: The duration of therapy and dose selection should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Croatian: Trajanje liječenja i odabir doze treba prilagoditi pojedinom bolesniku nakon pažljive procjene omjera koristi od liječenja i rizika od krvarenja (vidjeti dio 4.4).
English: Doctor's phone: Doctor's stamp:
Croatian: Broj telefona liječnika:
English: - With overnight stay p < 0.00001
Croatian: Uz noćenje u bolnici p < 0,00001
English: Group 1 received rivaroxaban 15 mg once daily (10 mg once daily in patients with creatinine clearance 30 - 49 ml/min) plus P2Y12 inhibitor.
Croatian: Skupina 1 primala je 15 mg rivaroksabana jedanput na dan (10 mg jedanput na dan u bolesnika s klirensom kreatinina 30 - 49 ml/min) uz P2Y12 inhibitor.
English: • ≥ 75 years of age if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine.
Croatian: • u dobi od ≥ 75 godina ako se primjenjuje istodobno samo s ASK-om ili s ASK-om uz dodatak klopidogrela ili tiklopidina.
English: Xarelto 15 mg and 20 mg are to be taken with food (see section 4.2).
Croatian: Xarelto tablete od 15 i 20 mg moraju se uzimati s hranom (vidjeti dio 4.2).
English: The analysis of the pooled results of the phase III studies corroborated the data obtained in the individual studies regarding reduction of total VTE, major VTE and symptomatic VTE with rivaroxaban 10 mg once daily compared to enoxaparin 40 mg once daily.
Croatian: Analiza objedinjenih rezultata ispitivanja faze III potvrdila je podatke dobivene pojedinačnim ispitivanjima, o smanjenju pojavnosti ukupne venske tromboembolije, teške venske tromboembolije i simptomatske venske tromboembolije pri uzimanju rivaroksabana 10 mg jedanput na dan u usporedbi s uzimanjem enoksaparina 40 mg jedanput na dan.
English: Very rare
Croatian: Vrlo rijetko Nepoznato
English: Appropriate symptomatic treatment could be used as needed, such as mechanical compression (e.g. for severe epistaxis), surgical haemostasis with bleeding control procedures, fluid replacement and haemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anaemia or coagulopathy) or platelets.
Croatian: Prema potrebi može se primijeniti primjereno simptomatsko liječenje, poput mehaničke kompresije (npr. za tešku epistaksu), kirurške hemostaze s postupcima kontrole krvarenja, nadoknade tekućine i hemodinamičke potpore, krvnih pripravaka (koncentrat eritrocita ili svježe smrznuta plazma, ovisno o povezanoj anemiji ili koagulopatiji) ili trombocita.
English: These patients are to be carefully monitored for signs and symptoms of bleeding complications and anaemia after initiation of treatment (see section 4.8).
Croatian: U tih bolesnika mora se pozorno pratiti pojava znakova i simptoma komplikacija zbog krvarenja i anemije nakon početka liječenja (vidjeti dio 4.8).
English: I am under anticoagulation treatment with Xarelto (rivaroxaban)
Croatian: Ja sam na antikoagulacijskoj terapiji lijekom Xarelto (rivaroksaban) Ime i prezime:
English: Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea and unexplained shock.
Croatian: Komplikacije zbog krvarenja mogu se očitovati kao slabost, bljedilo, omaglica, glavobolja ili neobjašnjivo oticanje, dispneja i neobjašnjeni šok.
English: Major gastrointestinal bleeding p < 0.00001
Croatian: Veliko gastrointestinalno krvarenje p < 0,00001
English: Xarelto should be used with caution in patients with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations (see section 4.5).
Croatian: Xarelto se mora primjenjivati s oprezom u bolesnika s oštećenom funkcijom bubrega koji istodobno primaju druge lijekove koji povećavaju koncentracije rivaroksabana u plazmi (vidjeti dio 4.5).
English: You have been given Xarelto because - you have been diagnosed with an acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests.
Croatian: Što je Xarelto i za što se koristi Dobivate Xarelto: - zato što su Vam dijagnosticirali akutni koronarni sindrom (skupinu stanja koja uključuju srčani udar i nestabilnu anginu pektoris, vrstu jake boli u prsnom košu) i dokazano je da su Vam povišene vrijednosti određenih krvnih testova za bolesti srca.
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
Croatian: To može uključivati postojeći ili nedavni gastrointestinalni ulkus, prisutnost zloćudne novotvorine s visokim rizikom od krvarenja, nedavnu ozljedu mozga ili kralježnične moždine, nedavni kirurški zahvat na mozgu, kralježničnoj moždini ili oku, nedavno intrakranijalno krvarenje, potvrđene ili suspektne varikozitete jednjaka, arteriovenske malformacije, vaskularne aneurizme ili velike intraspinalne i intracerebralne vaskularne abnormalnosti.
English: In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with Xarelto 10 mg once daily, a dose of Xarelto 20 mg once daily should be considered.
Croatian: U bolesnika u kojih se smatra da je rizik ponavljajuće duboke venske tromboze ili plućne embolije visok, kao što su oni s kompliciranim komorbiditetima ili u kojih je ponavljajuća duboka venska tromboza ili plućna embolija nastala tijekom produljene prevencije s lijekom Xarelto 10 mg jedanput na dan, potrebno je razmotriti Xarelto u dozi od 20 mg jedanput na dan.
English: There are no data in patients with creatinine clearance < 15 ml/min.
Croatian: Nema podataka za bolesnike s klirensom kreatinina < 15 ml/min.