FrancophonIA/ELRC3.0 huggingface dataset:
English: Most patients (85%) should be able to achieve an INR ≥ 2.0 within 14 days of concomitant administration of Lixiana and VKA.
Croatian: Kod većine bi se bolesnika (85%) trebao postići INR ≥ 2,0 unutar 14 dana od istovremene primjene Lixiane i AVK-a.
English: The safety and efficacy of Lixiana in children and adolescents less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost Lixiane u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: Phone no:
Croatian: Broj telefona:
English: If oral medicinal products cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant and then switch to oral once daily Lixiana (see section 4.2).
Croatian: Ako se tijekom ili nakon kirurške intervencije ne mogu uzimati oralni lijekovi, razmotrite primjenu parenteralnog antikoagulansa a zatim ga zamijenite Lixianom koja se uzima peroralno jedanput na dan (vidjeti dio 4.2).
English: You have been prescribed Lixiana, an anticoagulant medicine, which thins your blood and helps prevent you from suffering blood clots.
Croatian: Propisana Vam je Lixiana, antikoagulantni lijek, koji razrjeđuje krv i pomaže u sprječavanju nastanka krvnih ugrušaka.
English: Safety in patients with NVAF in ENGAGE AF-TIMI 48
Croatian: Sigurnost u bolesnika s NVAF-om u ispitivanju ENGAGE AF-TIMI 48
English: Lixiana, like other anticoagulants, is recommended to be used with caution in patients with increased risk of bleeding.
Croatian: Lixianu se, kao i druge antikoagulanse, preporučuje primjenjivati s oprezom u bolesnika s povećanim rizikom od krvarenja.
English: If a dose of Lixiana is missed, the dose should be taken immediately and then be continued the following day with the once-daily intake as recommended.
Croatian: Ako se propusti doza Lixiane, dozu je potrebno uzeti odmah i zatim nastaviti sljedećeg dana s uzimanjem jedanput na dan, kako je preporučeno.
English: • Coagulation tests such as INR, prothrombin time (PT), or activated partial thromboplastin time (aPTT) are not a useful measure of the effect of Lixiana.
Croatian: • Testovi koagulacije kao što su INR, protrombinsko vrijeme (PV) ili aktivirano parcijalno tromboplastinsko vrijeme (aPTV) nisu korisne mjere učinka Lixiane.
English: Due to the pharmacological mode of action, the use of Lixiana may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia.
Croatian: Zbog njegova načina farmakološkog djelovanja, primjena lijeka Lixiana može biti povezana s povećanim rizikom od prikrivenog (okultnog) ili vidljivog krvarenja iz bilo kojeg tkiva ili organa, što može rezultirati posthemoragijskom anemijom.
English: There is a potential for inadequate anticoagulation during the transition from Lixiana to VKA.
Croatian: Postoji mogućnost neodgovarajuće antikoagulacije tijekom prelaska s Lixiane na AVK.
English: If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, Lixiana should be stopped as soon as possible and preferably at least 24 hours before the procedure.
Croatian: Ako se antikoagulacija mora prekinuti da bi se smanjio rizik od krvarenja kod kirurških ili drugih postupaka, potrebno je čim prije prekinuti primjenu Lixiane, po mogućnosti najmanje 24 sata prije postupka.
English: For life-threatening bleeding that cannot be controlled with the measures such as transfusion or haemostasis, the administration of a 4-factor prothrombin complex concentrate (PCC) at 50 IU/kg has been shown to reverse the effects of Lixiana 30 minutes after completing the infusion.
Croatian: Kod životno opasnog krvarenja koje se ne može kontrolirati pomoću mjera kao što su transfuzija ili hemostaza, pokazalo se da primjena koncentrata protrombinskog kompleksa (PCC) s 4 faktora u dozi od 50 IU/kg poništava učinke Lixiane 30 minuta nakon završetka infuzije.
English: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
Croatian: Prevencija moždanog udara i sistemske embolije u odraslih bolesnika s nevalvularnom fibrilacijom atrija (NVAF) s jednim ili više čimbenika rizika, kao što su kongestivno zatajenje srca, hipertenzija, dob ≥ 75 godina, šećerna bolest, pretrpljeni moždani udar ili tranzitorna ishemijska ataka (TIA).
English: Taking an anticoagulant medicine such as Lixiana can increase your risk of bleeding.
Croatian: Uzimanje antikoagulantnog lijeka kao što je Lixiana može Vam povećati rizik od krvarenja.
English: The majority of edoxaban treated patients were Caucasians (69.6%) and Asians (21.0%), 3.8% were Black, 5.3% were categorised as Other race.
Croatian: Bolesnici liječeni edoksabanom većinom su bili bijelci (69,6%) i azijati (21,0%), 3,8% bili su crnci, dok je njih 5,3% bilo kategorizirano kao „druge rase“.
English: Patients with elevated liver enzymes (ALT/AST > 2 x ULN) or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Croatian: Bolesnici s povišenim jetrenim enzimima (ALT/AST > 2 x GGN) ili ukupnim bilirubinom ≥ 1,5 x GGN bili su isključeni iz kliničkih ispitivanja.
English: For transoesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Lixiana treatment should be started at least 2 hours before cardioversion to ensure adequate anticoagulation (see sections 5.1 and 5.2).
Croatian: Kada je postupak kardioverzije vođen transezofagealnom ehokardiografijom (engl. transoesophageal echocardiogram, TEE) u bolesnika koji nisu prethodno liječeni antikoagulansima, liječenje Lixianom potrebno je početi najmanje 2 sata prije postupka kardioverzije kako bi se osigurala odgovarajuća antikoagulacija (vidjeti dijelove 5.1 i 5.2).
English: 2 Pre-dose is equivalent to Cmin
Croatian: 2 „Prije doze“ odgovara vrijednosti Cmin
English: Driving and using machines Lixiana has no or negligible effects on your ability to drive or use machines.
Croatian: Upravljanje vozilima i strojevima Lixiana ne utječe ili zanemarivo utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Lixiana has no or negligible influence on the ability to drive and use machines.
Croatian: Lixiana ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: *Dose reduction to 30 mg for low body weight ≤ 60 kg or specific concomitant P-glycoprotein (P-gp) inhibitors
Croatian: *Sniženje doze na 30 mg zbog niske tjelesne težine ≤ 60 kg ili određenih istovremeno primijenjenih inhibitora P-glikoproteina (P-gp)
English: Edoxaban increased the Cmax of concomitantly administered digoxin by 28%; however, the AUC was not affected.
Croatian: Edoksaban je povećao Cmax istovremeno primijenjenog digoksina za 28%; međutim, nije utjecao na njegov AUC.
English: 1 Post-dose is equivalent to Cmax (post-dose samples were drawn 1 - 3 hours after edoxaban administration)
Croatian: 1 „Nakon doze“ odgovara vrijednosti Cmax (uzorci nakon doze uzeti su 1 - 3 sata poslije primjene edoksabana)
English: After 14 days it is recommended that Lixiana is discontinued and the VKA continued to be titrated to achieve an INR between 2 and 3.
Croatian: Nakon 14 dana, preporučuje se prekinuti primjenu Lixiane i nastaviti titrirati AVK da bi se postigao INR između 2,0 i 3,0.
English: What you need to know before you take Lixiana
Croatian: Što morate znati prije nego počnete uzimati Lixianu
English: • Do not stop taking Lixiana without consulting your doctor as this can increase your risk of developing a blood clot.
Croatian: • Nemojte prestati uzimati Lixianu a da se prethodno niste posavjetovali s liječnikom jer Vam to može povećati rizik od nastanka krvnog ugruška.
English: Pharmocokinetic/pharmacodynamic relationship(s) PT, INR, aPTT and Anti-factor Xa correlate linearly with edoxaban concentrations.
Croatian: Farmakokinetički/farmakodinamički odnos(i) PT, INR, aPTT i anti-faktor Xa linearno koreliraju s koncentracijama edoksabana.
English: Periodic hepatic monitoring is recommended for patients on Lixiana treatment beyond 1 year.
Croatian: Povremeno praćenje jetrene funkcije preporučuje se u bolesnika koji se liječe Lixianom dulje od 1 godine.
English: Bleeding can occur at any site and may be severe and even fatal (see section 4.4).
Croatian: Krvarenje može nastati na bilo kojem mjestu, može biti teško pa čak imati i smrtni ishod (vidjeti dio
English: 1.23 × (140-age [years]) × weight [kg] (× 0.85 if female) serum creatinine [µmol/L]
Croatian: 1,23 × (140-dob [godine]) × tjelesna težina [kg] (× 0,85 kod žena) kreatinin u serumu [µmol/l]
English: A 4 hour haemodialysis session reduced total edoxaban exposures by less than 9%.
Croatian: Hemodijaliza Četverosatna hemodijaliza smanjila je ukupnu izloženost edoksabanu za manje od 9%.
English: Concomitant Lixiana and VKA can increase the INR post Lixiana dose by up to 46%.
Croatian: Istovremeno primijenjeni Lixiana i AVK mogu povećati INR nakon primjene doze Lixiane i do 46%.
English: Your doctor will determine when to restart Lixiana.
Croatian: Liječnik će odrediti kada ćete ponovno početi uzimati Lixianu.
English: If you stop taking Lixiana
Croatian: Ako prestanete uzimati Lixianu
English: • Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone,
Croatian: • istovremena primjena sljedećih inhibitora P-glikoproteina (P-gp): ciklosporina, dronedarona,
English: Lixiana Discontinue the VKA and start Lixiana when the international normalised ratio (INR) is ≤ 2.5.
Croatian: Prekinite primjenu AVK-a i započnite s primjenom Lixiane kad međunarodni normalizirani omjer (INR) bude ≤ 2,5.
English: Therefore Lixiana is contraindicated during breast-feeding (see section 4.3).
Croatian: Stoga je Lixiana kontraindicirana tijekom dojenja (vidjeti dio 4.3).
English: • Renal function should be assessed in all patients by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Lixiana to exclude patients with end stage renal disease (i.e. CrCL < 15 mL/min), to use the correct Lixiana dose in patients with CrCL 15 - 50 mL/min (30 mg once daily), in patients with CrCL > 50 mL/min (60 mg once daily) and when deciding on the use of Lixiana in patients with increased creatinine clearance (see section 4.4).
Croatian: • Funkciju bubrega treba procijeniti u svih bolesnika izračunavanjem klirensa kreatinina (CrCL) prije početka liječenja Lixianom kako bi se isključili bolesnici u završnom stadiju bubrežne bolesti (tj. CrCL < 15 ml/min) i primijenila ispravna doza Lixiane u bolesnika s CrCL 15 - 50 ml/min (30 mg jedanput na dan), u bolesnika s CrCL > 50 ml/min (60 mg jedanput na dan) te kad se odlučuje o primjeni Lixiane u bolesnika s povećanim klirensom kreatinina (vidjeti dio 4.4).
English: HR (95% CI) All Bleeding n
Croatian: HR (95% CI) Sva krvarenja n
English: A QR Code and the following text may be printed on the inner lid of the carton: Lixiana should be taken once daily and ideally at the same time every day
Croatian: QR kod i tekst u nastavku mogu se otisnuti na unutrašnjoj strani poklopca kutije: Lixiana se uzima jedanput na dan, po mogućnosti u isto vrijeme svakoga dana.
English: In clinical studies, co-administration of NSAIDs resulted in increased clinically relevant bleeding.
Croatian: U kliničkim je ispitivanjima istovremena primjena NSAR-ova rezultirala povećanim klinički značajnim krvarenjem.
English: Co-administration of edoxaban with the P-gp inducer rifampicin led to a decrease in mean edoxaban AUC and a shortened half-life, with possible decreases in its pharmacodynamic effects.
Croatian: Istodobna primjena edoksabana s induktorom P-gp-a rifampicinom dovela je do smanjenja srednje vrijednosti AUC-a i skraćenog poluvijeka edoksabana, uz moguće slabljenje njegovih farmakodinamičkih učinaka.
English: • Moderate or severe renal impairment (creatinine clearance (CrCL) 15 - 50 mL/min)
Croatian: • umjereno ili teško oštećenje funkcije bubrega (klirens kreatinina (CrCL) 15 - 50 ml/min)
English: The recommended dose is 60 mg edoxaban once daily.
Croatian: Preporučena doza je 60 mg edoksabana jedanput na dan.
English: They come in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets.
Croatian: Dolaze u blisterima u kutijama s 10, 14, 28, 30, 56, 60, 84, 90, 98 ili 100 filmom obloženih tableta ili blisterima s jediničnim dozama u kutijama s 10 x 1, 50 x 1 ili 100 x 1 filmom obloženom tabletom.
English: In both studies, the most common adverse reactions related to bleeding with edoxaban 60 mg based on adjudicated terms included cutaneous soft tissue haemorrhage (up to 5.9%) and epistaxis (up to 4.7%), while vaginal haemorrhage (9.0%) was the most common bleeding-related adverse reaction in Hokusai-VTE only.
Croatian: U oba ispitivanja, najčešće nuspojave povezane s krvarenjem kod primjene edoksabana u dozi od 60 mg na temelju prosudbe bile su krvarenje u meko tkivo kože (do 5,9%) i epistaksa (do 4,7%), dok je vaginalno krvarenje (9,0%) bila najčešća nuspojava povezana s krvarenjem samo u ispitivanju Hokusai-VTE.
English: Secondary efficacy endpoints included: Composite of stroke, SEE, and cardiovascular (CV) mortality; major adverse cardiovascular event (MACE), which is the composite of non-fatal MI, non-fatal stroke, non-fatal SEE, and death due to CV cause or bleeding; composite of stroke, SEE, and all-cause mortality.
Croatian: Sekundarni ishodi djelotvornosti uključivali su: kompozitnu mjeru sastavljenu od moždanog udara, SED-a i kardiovaskularnog (KV) mortaliteta; veliki štetni kardiovaskularni događaj (MACE), koji je kompozitna mjera sastavljena od infarkta miokarda bez smrtnog ishoda, moždanog udara bez smrtnog ishoda, SED-a bez smrtnog ishoda i smrti zbog KV uzroka ili krvarenja; kompozitnu mjeru sastavljenu od moždanog udara, SED-a i mortaliteta bilo kojeg uzroka.
English: Event Rate (%/yr)b
Croatian: Stopa događaja (%/god)b
English: Lixiana is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 4.3).
Croatian: Lixiana je kontraindicirana u bolesnika s bolešću jetre povezanom s koagulopatijom i klinički značajnim rizikom od krvarenja (vidjeti dio 4.3).
English: Major Bleeding n Event rate (%/yr)a HR (95% CI) p-value ICHb n Event rate (%/yr)a HR (95% CI) Fatal Bleeding n Event rate (%/yr)a HR (95% CI) CRNM Bleeding n Event rate (%/yr)a HR (95% CI) Any Confirmed Bleedingc n Event rate (%/yr)a HR (95% CI) Abbreviations: ICH = Intracranial Haemorrhage, HR = Hazard Ratio versus warfarin, CI = Confidence Interval, CRNM = Clinically Relevant Non-Major, n = number of subjects with events, N = number of subjects in Safety population, yr = year.
Croatian: Veliko krvarenje n Stopa događaja (%/god)a HR (95% CI) p-vrijednost ICHb n Stopa događaja (%/god)a HR (95% CI) Krvarenje sa smrtnim ishodom n Stopa događaja (%/god)a HR (95% CI) CRNM krvarenje n Stopa događaja (%/god)a HR (95% CI) Bilo koje potvrđeno krvarenjec n Stopa događaja (%/god)a HR (95% CI) Kratice: ICH = intrakranijalno krvarenje, HR = omjer hazarda naspram varfarinu, CI = interval pouzdanosti, CRNM = klinički značajno, ali ne veliko, n = broj ispitanika s događajima, N = broj ispitanika u populaciji za procjenu sigurnosti primjene, god = godina.
English: HR (95% CI) First SEE n (%/yr)a
Croatian: HR (95% CI) Prvi SED n (%/god)a
English: - If you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor.
Croatian: Ako imate oštećenu funkciju bubrega, liječnik Vam može sniziti dozu na jednu tabletu od 30 mg jedanput na dan.
English: Immune system disorders Hypersensitivity
Croatian: Poremećaji imunološkog sustava Preosjetljivost
English: • When an invasive procedure is required, Lixiana should be stopped at least 24 hours beforehand,
Croatian: • Kad je potreban invazivni postupak, primjenu Lixiane treba prekinuti najmanje 24 sata prije i primijeniti odgovarajući oprez.
English: Discontinue dabigatran, rivaroxaban or apixaban and start Lixiana at the time of the next dose of the oral anticoagulant (see section 5.1).
Croatian: Prekinite primjenu dabigatrana, rivaroksabana ili apiksabana i započnite s primjenom Lixiane u vrijeme sljedeće doze oralnog antikoagulansa (vidjeti dio 5.1).
English: Lixiana should be restarted after the surgical or other procedures as soon as adequate haemostasis has been established, noting that the time to onset of the edoxaban anticoagulant therapeutic effect is 12 hours.
Croatian: Nakon kirurških ili drugih postupaka, s primjenom Lixiane treba ponovno započeti čim se uspostavi odgovarajuća hemostaza, uzimajući u obzir da antikoagulacijski terapijski učinak edoksabana nastupa nakon 1 - 2 sata.
English: In the pivotal Hokusai-VTE study, 8,292 subjects were randomised to receive initial heparin therapy (enoxaparin or unfractionated heparin) followed by edoxaban 60 mg once daily or the comparator.
Croatian: U glavnom ispitivanju Hokusai-VTE, 8292 ispitanika bilo je randomizirano u skupinu koja je primala početnu terapiju heparinom (enoksaparin ili nefrakcionirani heparin) a zatim edoksaban u dozi od 60 mg jedanput na dan ili komparator.
English: If you forget to take Lixiana
Croatian: Ako ste zaboravili uzeti Lixianu
English: Your doctor will need to do blood measurements and will instruct you when to stop taking Lixiana.
Croatian: Liječnik će morati napraviti krvne pretrage i onda će Vam dati uputu kada da prestanete uzimati Lixianu.
English: Lixiana 15 mg is only to be used when changing from Lixiana 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3.
Croatian: Lixiana 15 mg smije se primjenjivati samo kad se Lixiana 30 mg zamjenjuje antagonistom vitamina K (npr. varfarinom) (vidjeti dio 3.
English: Common (may affect up to 1 in 10 people):
Croatian: Često (mogu se javiti u najviše 1 na 10 osoba):
English: If you currently take 30 mg (dose reduced) Lixiana:
Croatian: Ako trenutno uzimate Lixianu u dozi od 30 mg (sniženu dozu):
English: In Phase 3 clinical studies (both NVAF and VTE indications) patients with body weight ≤ 60 kg had a 50% edoxaban dose reduction and had similar efficacy and less bleeding when compared to warfarin.
Croatian: U kliničkim ispitivanjima faze 3 (u indikacijama NVAF i VTE), bolesnicima s tjelesnom težinom ≤ 60 kg doza edoksabana bila je snižena za 50% i imala je sličnu djelotvornost, a bilo je i manje krvarenja u usporedbi s varfarinom.
English: Your doctor will need to do blood measurements and will instruct you when to start taking Lixiana.
Croatian: Liječnik će Vam morati napraviti krvne pretrage i onda će Vam dati uputu kada da počnete uzimati Lixianu.
English: The duration of therapy for treatment of DVT and PE (venous thromboembolism, VTE), and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Croatian: Trajanje terapije za liječenje DVT-a i PE-a (venske tromboembolije, VTE) te prevencije ponavljajućeg VTE-a treba biti prilagođeno pojedinom bolesniku nakon pažljive procjene koristi od liječenja u odnosu na rizik od krvarenja (vidjeti dio 4.4).
English: Skin and subcutaneous tissue disorders Cutaneous soft tissue haemorrhage
Croatian: Poremećaji kože i potkožnog tkiva Krvarenje u meko tkivo kože
English: It is only indicated in the process of switching from Lixiana 30 mg (patients with one or more clinical factors for increased exposure; see table 1) to VKA, together with an appropriate VKA dose (see table 2, section 4.2).
Croatian: Ova je doza indicirana samo u postupku zamjene Lixiane 30 mg AVK-om (bolesnici s jednim ili više kliničkih čimbenika za povećanu izloženost, vidjeti tablicu 1), zajedno s odgovarajućom dozom AVKa (vidjeti tablicu 2, dio 4.2).
English: □ Either in the morning □ Or at noon □ Or in the evening For more information please visit: www.dspatient.eu
Croatian: Ili ujutro □ ili u podne □ ili navečer Za više informacija posjetite internetsku stranicu:
English: Reproductive system and breast disorders Vaginal haemorrhage1
Croatian: Poremećaji reproduktivnog sustava i dojki Vaginalno krvarenje1
English: Digoxin: Edoxaban 60 mg once daily on days 1 to 14 with coadministration of multiple daily doses of digoxin 0.25 mg twice daily (days 8 and 9) and 0.25 mg once daily (days 10 to 14) increased the Cmax of edoxaban by 17%, with no significant effect on AUC or renal clearance at steady state.
Croatian: Digoksin: Edoksaban u dozi od 60 mg jedanput na dan od 1. do 14. dana uz istovremenu primjenu višestrukih dnevnih doza digoksina od 0,25 mg dvaput na dan (8. i 9. dana) i 0,25 mg jedanput na dan (od 10. do 14. dana) povećao je Cmax edoksabana za 17%, bez značajnog utjecaja na AUC ili bubrežni klirens u stanju dinamičke ravnoteže.
English: Your doctor will decide, if you should be treated with Lixiana and if you should be kept under observation.
Croatian: Vaš će liječnik odlučiti smijete li se liječiti Lixianom i trebate li biti pod nadzorom.
English: Edoxaban 60 mg was non-inferior to warfarin for the primary efficacy endpoint of stroke or SEE (upper limit of the 97.5% CI of the HR was below the prespecified non-inferiority margin of 1.38) (Table 4).
Croatian: Edoksaban od 60 mg bio je neinferioran varfarinu u primarnom ishodu djelotvornosti, što je bio moždani udar ili SED (gornja granica 97,5% CI HR-a bila je ispod unaprijed određene margine neinferiornosti od 1,38) (tablica 4).
English: How to take Lixiana).
Croatian: Kako uzimati Lixianu).
English: The average exposure to edoxaban 60 mg (including 30 mg dose reduced) was 2.5 years among 7,012 patients in ENGAGE AF-TIMI 48 and 251 days among 4,118 patients in Hokusai-VTE.
Croatian: Prosječna izloženost edoksabanu u dozi od 60 mg (uključujući dozu sniženu na 30 mg) iznosila je 2,5 godina kod 7012 bolesnika u ispitivanju ENGAGE AF-TIMI 48 i 251 dan kod 4118 bolesnika u ispitivanju Hokusai-VTE.
English: In patients concomitantly taking Lixiana and the following P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is 30 mg Lixiana once daily (see section 4.5).
Croatian: U bolesnika koji istovremeno uzimaju Lixianu i sljedeće inhibitore P-gp-a: ciklosporin, dronedaron, eritromicin ili ketokonazol, preporučena doza Lixiane je 30 mg jedanput na dan (vidjeti dio 4.5).
English: Tables 7, 8 and 9 show major, fatal and intracranial bleedings, respectively, by creatinine clearance category in NVAF patients in ENGAGE AF-TIMI 48.
Croatian: Tablice 7, 8 i 9 pokazuju velika krvarenja, krvarenja sa smrtnim ishodom odnosno intrakranijalna krvarenja prema kategoriji klirensa kreatinina u bolesnika s NVAF-om u ispitivanju ENGAGE AFTIMI 48.
English: The concomitant use of edoxaban with other P-gp inducers (e.g. phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to reduced edoxaban plasma concentrations.
Croatian: Istodobna primjena edoksabana s drugim induktorima P-gp-a (npr. fenitoinom, karbamazepinom, fenobarbitalom ili gospinom travom) može dovesti do smanjene koncentracije edoksabana u plazmi.
English: Tablet core:
Croatian: Procjena funkcije bubrega:
English: Oral option: For patients currently on a 60 mg dose, administer a Lixiana dose of 30 mg once daily together with an appropriate VKA dose.
Croatian: Mogućnost oralne primjene: U bolesnika koji trenutno uzimaju dozu od 60 mg primijenite Lixianu u dozi od 30 mg jedanput na dan zajedno s odgovarajućom dozom AVK-a.
English: First Stroke/SEEa n Event Rate (%/yr)b
Croatian: Prvi moždani udar/SEDa n Stopa događaja (%/god)b
English: Eye disorders Conjunctival/Scleral haemorrhage
Croatian: Poremećaji oka Konjunktivalno/skleralno krvarenje
English: Your doctor will tell you to reduce your dose of Lixiana to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin).
Croatian: Liječnik će Vam reći da snizite dozu Lixiane na 15 mg jedanput na dan i da je uzmete zajedno s antagonistom vitamina K (npr. varfarin).