FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore Lixiana should be used with caution in this population (see sections 4.2 and 5.2).
Croatian: Stoga se Lixiana mora primjenjivati s oprezom u ove populacije (vidjeti dijelove 4.2 i 5.2).
English: Your doctor will tell you to reduce your dose of Lixiana to a 30 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 30 mg jedanput na dan i da je uzmete zajedno s antagonistom vitamina K (npr. varfarinom).
English: Lixiana administration should be discontinued if severe haemorrhage occurs (see sections 4.8 and 4.9).
Croatian: Primjena Lixiane mora se prekinuti u slučaju teškog krvarenja (vidjeti dijelove 4.8 i 4.9).
English: Therefore Lixiana should be used with caution in this population (see sections 4.4 and 5.2).
Croatian: Stoga se Lixiana mora primjenjivati s oprezom u ove populacije (vidjeti dijelove 4.4 i 5.2).
English: P-gp inducers
Croatian: Induktori P-gp-a
English: The use of Lixiana with other P-gp inhibitors including HIV protease inhibitors has not been studied.
Croatian: Primjena Lixiane s drugim inhibitorima P-gp-a uključujući inhibitore proteaze HIV-a nije ispitana.
English: The primary safety endpoint was clinically relevant bleeding (major or clinically relevant non-major).
Croatian: Primarni ishod sigurnosti primjene bilo je klinički značajno krvarenje (veliko krvarenje ili klinički značajno, ali ne veliko).
English: Overdose with edoxaban may lead to haemorrhage.
Croatian: Predoziranje edoksabanom može dovesti do krvarenja.
English: In clinical studies concomitant use of ASA (low dose ≤ 100 mg/day), other antiplatelet agents, and thienopyridines was permitted and resulted in approximately a 2-fold increase in major bleeding in comparison with no concomitant use, although to a similar extent in the edoxaban and warfarin groups (see section 4.4).
Croatian: U kliničkim je ispitivanjima bila dopuštena istovremena primjena ASK-a (u niskoj dozi ≤ 100 mg/dan), drugih antitrombotika i tienopiridina, što je rezultiralo približno dvostrukim povećanjem velikih krvarenja u usporedbi s neistovremenom primjenom, iako u sličnoj mjeri u skupinama koje su primale edoksaban i varfarin (vidjeti dio 4.4).
English: Hepatobiliary disorders Blood bilirubin increased
Croatian: Poremećaji jetre i žuči Povišen bilirubin u krvi
English: In patients with end stage renal disease (ESRD) (CrCL < 15 mL/min) or on dialysis, the use of Lixiana is not recommended (see sections 4.4 and 5.2).
Croatian: Za bolesnike u završnom stadiju bubrežne bolesti (ESRD) (CrCL < 15 ml/min) ili na dijalizi, primjena Lixiane se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
English: Concomitant use of Lixiana with P-glycoprotein (P-gp) inhibitors
Croatian: Istovremena primjena Lixiane s inhibitorima P-glikoproteina (P-gp)
English: In patients with mild renal impairment (CrCL > 50 - 80 mL/min), the recommended dose is 60 mg Lixiana once daily.
Croatian: Za bolesnike s blagim oštećenjem funkcije bubrega (CrCL > 50 - 80 ml/min), preporučena doza Lixiane je 60 mg jedanput na dan.
English: Common other adverse reactions for edoxaban were anaemia, rash and abnormal liver function tests.
Croatian: Druge česte nuspojave edoksabana bile su anemija, osip i poremećeni nalazi pretraga jetrene funkcije.
English: Known complications secondary to severe bleeding such as compartment syndrome and renal failure due to hypoperfusion have been reported for Lixiana.
Croatian: Kod primjene lijeka Lixiana prijavljene su poznate komplikacije kao sekundarna posljedica teškog krvarenja, kao što su sindrom odjeljka i zatajenje bubrega zbog hipoperfuzije.
English: Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.
Croatian: Interakcija s drugim lijekovima koji utječu na hemostazu Istovremena primjena lijekova koji utječu na hemostazu može povećati rizik od krvarenja.
English: For patients currently on a 30 mg dose (for one or more of the following clinical factors: moderate to severe renal impairment (CrCL 15 - 50 mL/min), low body weight, or use with certain P-gp inhibitors), administer a Lixiana dose of 15 mg once daily together with an appropriate VKA dose.
Croatian: U bolesnika koji trenutno uzimaju dozu od 30 mg (zbog jednog ili više sljedećih kliničkih čimbenika: umjereno do teško oštećenje funkcije bubrega (CrCL 15 - 50 ml/min), niska tjelesna težina ili primjena određenih inhibitora P-gp-a) primijenite Lixianu u dozi od 15 mg jedanput na dan zajedno s odgovarajućom dozom AVK-a.
English: The primary efficacy outcome occurred in 14 (3.1%) and 30 (6.2%) of edoxaban and warfarin subjects, respectively [HR (95% CI): 0.50 (0.26, 0.94)].
Croatian: Primarni ishod djelotvornosti pojavio se u 14 (3,1%) ispitanika liječenih edoksabanom i 30 (6,2%) ispitanika liječenih varfarinom [HR (95% CI): 0,50 (0,26, 0,94)].
English: The co-administration of Lixiana with ASA in elderly patients should be used cautiously because of a potentially higher bleeding risk (see section 4.5).
Croatian: Istovremena primjena Lixiane i ASK-e u starijih bolesnika mora se provesti s oprezom zbog potencijalno višeg rizika od krvarenja (vidjeti dio 4.5).
English: Edoxaban has not been studied in patients with mechanical heart valves, in patients during the first 3 months after implantation of a bioprosthetic heart valve, with or without atrial fibrillation, or in patients with moderate to severe mitral stenosis.
Croatian: Prostetički srčani zalisci i umjerena do teška mitralna stenoza Edoksaban nije ispitan u bolesnika s mehaničkim srčanim zaliscima, bolesnika tijekom prva 3 mjeseca nakon implantacije bioprostetičkog srčanog zaliska, s atrijskom fibrilacijom ili bez nje ili u bolesnika s umjerenom do teškom mitralnom stenozom.
English: The plasma AUC for subjects with mild (CrCL > 50 - 80 mL/min), moderate (CrCL 30 - 50 mL/min) and severe (CrCL < 30 mL/min but not undergoing dialysis) renal impairment was increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function (see section 4.2 for dose reduction).
Croatian: AUC u plazmi ispitanika s blagim (CrCL > 50 - 80 ml/min), umjerenim (CrCL 30 - 50 ml/min) i teškim (CrCL < 30 ml/min, ali ne na dijalizi) oštećenjem funkcije bubrega bio je povećan 32%, 74% odnosno 72% u odnosu na ispitanike s normalnom funkcijom bubrega (vidjeti dio 4.2 za sniženje doze).
English: The plasma AUCs for subjects with mild (CrCL > 50 - 80 mL/min), moderate (CrCL 30 - 50 mL/min) and severe (CrCL < 30 mL/min but not undergoing dialysis) renal impairment were increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function.
Croatian: AUC u plazmi u ispitanika s blagim (CrCL > 50 - 80 ml/min), umjerenim (CrCL 30 - 50 ml/min) i teškim (CrCL < 30 ml/min ali ne na dijalizi) oštećenjem funkcije bubrega bio je povećan za 32%, 74% odnosno 72% u odnosu na onaj kod ispitanika s normalnom funkcijom bubrega.
English: For patients with body weight ≤ 60 kg, the recommended dose is 30 mg Lixiana once daily (see section 5.2).
Croatian: Za bolesnike s tjelesnom težinom ≤ 60 kg, preporučena doza Lixiane je 30 mg jedanput na dan (vidjeti dio 5.2).
English: Table 5 shows ischaemic strokes/SEE by creatinine clearance category in NVAF patients in ENGAGE AF-TIMI 48.
Croatian: Tablica 5 pokazuje ishemijske moždane udare/SED prema kategoriji klirensa kreatinina u bolesnika s NVAF-om u ispitivanju ENGAGE AF-TIMI 48.
English: Compared to warfarin-treated subjects, the HR in the edoxaban 60 mg group was 0.87 (99% CI: 0.71, 1.07, p = 0.08 for superiority).
Croatian: U usporedbi s ispitanicima liječenima varfarinom, HR u skupini liječenoj edoksabanom od 60 mg iznosio je 0,87 (99% CI: 0,71, 1,07; p = 0,08 za superiornost).
English: P-gp Inhibitors
Croatian: Inhibitori P-gp-a
English: INFORMATION IN BRAILLE Lixiana 60 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lixiana 60 mg
English: Take special care with Lixiana
Croatian: Budite posebno oprezni s lijekom Lixiana
English: In the Hokusai-VTE study (Table 10) edoxaban was demonstrated to be non-inferior to warfarin for the primary efficacy outcome, recurrent VTE, which occurred in 130 of 4,118 subjects (3.2%) in the edoxaban group versus 146 of 4,122 subjects (3.5%) in the warfarin group [HR (95% CI): 0.89 (0.70, 1.13); p < 0.0001 for non-inferiority].
Croatian: U ispitivanju Hokusai-VTE (tablica 10), edoksaban se pokazao neinferiornim varfarinu u primarnom ishodu djelotvornosti, recidivirajućem VTE-u, koji je nastao u 130 od 4118 ispitanika (3,2%) u skupini liječenoj edoksabanom naspram 146 od 4122 ispitanika (3,5%) u skupini liječenoj varfarinom [HR (95% CI): 0,89 (0,70, 1,13); p < 0,0001 za neinferiornost].
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje često (mogu se javiti u najviše 1 na 100 osoba):
English: Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Lixiana at the time of the next scheduled dose.
Croatian: Prestanite uzimati prethodne lijekove (npr. dabigatran, rivaroksaban ili apiksaban) i počnite uzimati Lixianu u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu.
English: Lixiana is not recommended in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Croatian: Lixiana se ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 5.2).
English: Gastrointestinal disorders Abdominal pain
Croatian: Poremećaji probavnog sustava Bol u abdomenu
English: Stop taking Lixiana and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Lixiana.
Croatian: Prestanite uzimati Lixianu i počnite uzimati antikoagulans koji nije antagonist vitamina K (npr. dabigatran, rivaroksaban ili apiksaban) u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu Lixiane.
English: The primary safety outcome was a composite of major and CRNM bleeding.
Croatian: Primarni ishod sigurnosti bio je kompozitni ishod koji su činila velika i klinički značajna, ali ne velika (CRNM) krvarenja.
English: Stroke and SEE occurred in fewer subjects in the edoxaban 60 mg treatment group than in the warfarin group (1.57% and 1.80% per year, respectively), with a HR of 0.87 (99% CI: 0.71, 1.07, p = 0.0807 for superiority).
Croatian: Moždani udar i SED nastali su u manjeg broja ispitanika u skupini liječenoj edoksabanom u dozi od 60 mg nego u skupini liječenoj varfarinom (1,57% odnosno 1,80% godišnje), uz HR od 0,87 (99% CI: 0,71, 1,07, p = 0,0807 za superiornost).
English: INFORMATION IN BRAILLE Lixiana 30 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lixiana 30 mg
English: Safety and efficacy of edoxaban have not been established in breast-feeding women.
Croatian: Sigurnost i djelotvornost edoksabana u dojilja nisu ustanovljene.
English: Cardiac disorders Pericardial haemorrhage
Croatian: Srčani poremećaji Perikardijalno krvarenje
English: How to take Lixiana
Croatian: Kako uzimati Lixianu
English: First Ischaemic Stroke n
Croatian: Prvi ishemijski moždani udar n
English: The reduction in fatal bleeds was also significant for the edoxaban 60 mg treatment group compared with the warfarin group (0.21%, and 0.38%) [HR (95% CI): 0.55 (0.36, 0.84); p = 0.0059 for superiority], primarily because of the reduction in fatal ICH bleeds [HR (95% CI): 0.58 (0.35, 0.95); p = 0.0312].
Croatian: Krvarenje sa smrtnim ishodom također je bilo značajno smanjeno u terapijskoj skupini liječenoj edoksabanom u dozi od 60 mg u usporedbi sa skupinom liječenom varfarinom (0,21% odnosno 0,38%) [HR (95% CI): 0,55 (0,36, 0,84); p = 0,0059 za superiornost], prvenstveno zbog smanjenja intrakranijalnih krvarenja sa smrtnim ishodom [HR (95% CI): 0,58 (0,35, 0,95); p = 0,0312].
English: In patients with end stage renal disease or on dialysis, Lixiana is not recommended (see sections 4.2 and 5.2).
Croatian: U bolesnika u završnom stadiju bubrežne bolesti ili bolesnika na dijalizi, Lixiana se ne preporučuje (vidjeti dijelove 4.2 i 5.2).
English: Abbreviations: HR = Hazard Ratio versus warfarin, CI = Confidence Interval, n = number of events, mITT = modified Intent To Treat, N = number of subjects in mITT population, SEE = Systemic Embolic Event, yr = year.
Croatian: Kratice: HR = omjer hazarda naspram varfarinu, CI = interval pouzdanosti, n = broj događaja, mITT = modificirano planirano liječenje, N = broj ispitanika u mITT populaciji, SED = sistemski embolijski događaj, god = godina a Jedan ispitanik može biti prikazan u većem broju redova.
English: INFORMATION IN BRAILLE Lixiana 15 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lixiana 15 mg
English: The secondary composite endpoint of recurrent VTE and all-cause mortality occurred in 138 subjects (3.4%) in the edoxaban group and 158 subjects (3.9%) in the warfarin group [HR (95% CI): 0.87
Croatian: Sekundarni kompozitni ishod recidivirajućeg VTE-a i mortaliteta bilo kojeg uzroka nastao je u 138 ispitanika (3,4%) u skupini liječenoj edoksabanom i 158 ispitanika (3,9%) u skupini liječenoj varfarinom [HR (95% CI): 0,87 (0,70, 1,10)].
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Epistaksa
English: In patients with moderate or severe renal impairment (CrCL 15 - 50 mL/min), the recommended dose is 30 mg Lixiana once daily (see section 5.2).
Croatian: Za bolesnike s umjerenim ili teškim oštećenjem funkcije bubrega (CrCL 15 - 50 ml/min), preporučena doza Lixiane je 30 mg jedanput na dan (vidjeti dio 5.2).
English: There was a significant risk reduction in favour of the edoxaban 60 mg treatment group compared with the warfarin group in major bleeding (2.75%, and 3.43% per year, respectively) [HR (95% CI): 0.80 (0.71, 0.91); p = 0.0009], ICH (0.39%, and 0.85% per year, respectively) [HR (95% CI): 0.47 (0.34, 0.63); p < 0.0001], and other types of bleeding (Table 6).
Croatian: U skupini liječenoj edoksabanom u dozi od 60 mg u usporedbi sa skupinom liječenom varfarinom opaženo je značajno sniženje rizika od velikog krvarenja (2,75% odnosno 3,43% godišnje) [HR (95% CI): 0,80 (0,71, 0,91); p = 0,0009], intrakranijalno krvarenje (0,39% odnosno 0,85% godišnje) [HR (95% CI): 0,47 (0,34, 0,63); p < 0,0001] i drugih vrsta krvarenja (tablica 6).
English: • bleeding disorders
Croatian: • poremećaj krvarenja
English: • problems with the blood vessels in your brain or spinal column if you have a mechanical heart valve
Croatian: • tegobe s krvnim žilama u mozgu ili kralježnici
English: Nervous system disorders Dizziness
Croatian: Poremećaji živčanog sustava Omaglica
English: MARKETING AUTHORISATION NUMBER(S) 15 mg film-coated tablets: EU/1/15/993/001, EU/1/15/993/016 30 mg film-coated tablets: EU/1/15/993/002, EU/1/15/993/004-015 60 mg film-coated tablets: EU/1/15/993/003, EU/1/15/993/017-028
Croatian: 30 mg filmom obložene tablete: EU/1/15/993/002, EU/1/15/993/004-015 60 mg filmom obložene tablete: EU/1/15/993/003, EU/1/15/993/017-028
English: Table 12 below shows the edoxaban anti-Factor Xa activity by CrCL category for each indication.
Croatian: Inhibicijsko djelovanje na faktor Xa prema kategoriji CrCL Tablica 12 niže pokazuje inhibicijsko djelovanje edoksabana na faktor Xa prema kategoriji CrCL u pojedinoj indikaciji.
English: Edoxaban Anti-FXa activity pre-dose (IU/mL)2
Croatian: Inhibicijsko djelovanje edoksabana na faktor Xa prije doze (IU/ml)2
English: Parenteral option: Discontinue Lixiana and administer a parenteral anticoagulant and VKA at the time of the next scheduled Lixiana dose.
Croatian: Mogućnost parenteralne primjene: Prekinite primjenu Lixiane i primijenite parenteralni antikoagulans i AVK kad bi prema rasporedu bilo vrijeme za sljedeću dozu Lixiane.
English: EU/1/15/993/025 100 film-coated tablets EU/1/15/993/026 10 x 1 film-coated tablets EU/1/15/993/027 50 x 1 film-coated tablets EU/1/15/993/028 100 x1 film-coated tablets
Croatian: EU/1/15/993/025 100 filmom obloženih tableta EU/1/15/993/026 10 x 1 filmom obložena tableta EU/1/15/993/027 50 x 1 filmom obložena tableta EU/1/15/993/028 100 x 1 filmom obložena tableta
English: Stop taking the vitamin K antagonist (e.g. warfarin).
Croatian: Zamjena antagonista vitamina K (npr. varfarina) lijekom Lixiana Prestanite uzimati antagonist vitamina K (npr. varfarin).
English: In patients with severe hepatic impairment Lixiana is not recommended (see sections 4.4 and 5.2).
Croatian: Za bolesnike s teškim oštećenjem funkcije jetre, Lixiana se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
English: • Ciclosporin: Concurrent administration of a single dose of ciclosporin 500 mg with a single dose of edoxaban 60 mg increased edoxaban AUC and Cmax by 73% and 74%, respectively.
Croatian: • Ciklosporin: Istovremena primjena jedne doze ciklosporina od 500 mg s jednom dozom edoksabana od 60 mg povećala je AUC edoksabana za 73%, a Cmax za 74%.
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: +421 (2) 58282010
Croatian: Česká republika Merck Sharp & Dohme s.r.o. Tel: +420 233 010 111
English: The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section 5.1).
Croatian: Liječenje DVT-a, liječenje PE-a i prevencija ponavljajućih DVT-a i PE-a (VTE) Preporučena doza je 60 mg edoksabana jedanput na dan nakon početne primjene parenteralnog antikoagulansa tijekom najmanje 5 dana (vidjeti dio 5.1).
English: QR code to be included
Croatian: umetnuti QR kod
English: The edoxaban clinical programme for VTE was designed to demonstrate the efficacy and safety of edoxaban in the treatment of DVT and PE, and the prevention of recurrent DVT and PE.
Croatian: Liječenje DVT-a, liječenje PE-a i prevencija ponavljajućih DVT-a i PE-a (VTE) Klinički program ispitivanja edoksabana u liječenju venske tromboembolije (VTE) bio je ustrojen tako da se pokaže djelotvornost i sigurnost edoksabana u liječenju DVT-a i PE-a te prevenciji ponavljajućih DVT-a i PE-a.
English: In patients with mild to moderate hepatic impairment the recommended dose is 60 mg Lixiana once daily (see section 5.2).
Croatian: Za bolesnike s blagim do umjerenim oštećenjem funkcije jetre, preporučena doza Lixiane je 60 mg jedanput na dan (vidjeti dio 5.2).
English: Subjects in the edoxaban treatment group received 30 mg once daily if one or more of the following clinical factors were present: moderate renal impairment (CrCL 3050 mL/min), low body weight (≤ 60 kg) or concomitant use of specific P-gp inhibitors.
Croatian: Ispitanici u skupini koja je liječena edoksabanom primali su 30 mg jednom dnevno ako je bio prisutan jedan ili više sljedećih kliničkih faktora: umjereno oštećenje funkcije bubrega (CrCL 30 - 50 ml/min), mala tjelesna težina (≤ 60 kg) ili istovremena primjena specifičnih inhibitora P-gp-a.
English: EU/1/15/993/012 100 film-coated tablets EU/1/15/993/013 10 x 1 film-coated tablets EU/1/15/993/014 50 x 1 film-coated tablets EU/1/15/993/015 100 x1 film-coated tablets
Croatian: EU/1/15/993/013 100 filmom obloženih tableta EU/1/15/993/014 10 x 1 filmom obložena tableta EU/1/15/993/004 50 x 1 filmom obložena tableta EU/1/15/993/015 100 x 1 filmom obložena tableta
English: Lixiana should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4).
Croatian: Lixiana se mora primjenjivati s oprezom u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (vidjeti dio 4.4).
English: Edoxaban 30 mg once daily was used for subjects with one or more of the following clinical factors: moderate renal impairment (CrCL 30 - 50 mL/min); body weight ≤ 60 kg; concomitant use of specific P-gp inhibitors.
Croatian: Edoksaban u dozi od 30 mg jedanput na dan primjenjivao se u ispitanika s jednim ili više od sljedećih kliničkih čimbenika: umjereno oštećenje funkcije bubrega (CrCL 30 - 50 ml/min); tjelesna težina ≤ 60 kg; istovremena primjena inhibitora P-gp-a.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/993/001 10 film-coated tablets EU/1/15/993/016 10 x 1 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/993/001 10 filmom obloženih tableta EU/1/15/993/016 10 x 1 filmom obložena tableta
English: NAME OF THE MEDICINAL PRODUCT Lixiana 60 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Croatian: NAZIV LIJEKA Lixiana 60 mg filmom obložene tablete edoksaban NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Daiichi-Sankyo (logo) ROK VALJANOSTI
English: 60 mg once daily Dose recommendation for patients with one or more of the following clinical factors: Renal Impairment
Croatian: 60 mg jedanput na dan Preporučena doza za bolesnike s jednim ili više od sljedećih kliničkih čimbenika: Oštećenje funkcije bubrega umjereno ili teško (CrCL 15 - 50 ml/min)
English: NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Croatian: NAZIV LIJEKA Lixiana 15 mg filmom obložene tablete edoksaban NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Daiichi-Sankyo (logo) ROK VALJANOSTI
English: Primary endpointa
Croatian: Primarni ishoda
English: Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Lixiana
Croatian: Zamjena oralnih antikoagulansa koji nisu antagonisti vitamina K (dabigatran, rivaroksaban ili apiksaban) lijekom Lixiana
English: NAME OF THE MEDICINAL PRODUCT Lixiana 30 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Croatian: NAZIV LIJEKA Lixiana 30 mg filmom obložene tablete edoksaban NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Daiichi-Sankyo (logo) ROK VALJANOSTI
English: Discontinue Lixiana and start the parenteral anticoagulant at the time of the next scheduled dose of Lixiana.
Croatian: Prekinite primjenu Lixiane i započnite s primjenom parenteralnog antikoagulansa kad bi prema rasporedu bilo vrijeme za sljedeću dozu Lixiane.
English: Lixiana 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Croatian: Lixiana 15 mg: hipromeloza (E464), makrogol 8000, titanijev dioksid (E171), talk, karnauba vosak, željezov oksid crveni (E172), željezov oksid žuti (E172).
English: Lixiana should be used with caution in patients with mild or moderate hepatic impairment (see section
Croatian: Lixiana se mora primjenjivati s oprezom u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (vidjeti dio 4.2).
English: Lixiana 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
Croatian: Lixiana 30 mg filmom obložene tablete su ružičaste i okrugle (8,5 mm u promjeru) s utisnutom oznakom „DSC L30“ na jednoj strani.
English: Lixiana 15 mg: Each tablet contains 15 mg edoxaban (as tosilate).
Croatian: Lixiana 15 mg: Jedna tableta sadrži 15 mg edoksabantosilata.
English: Anticoagulants: Co-administration of edoxaban with other anticoagulants is contraindicated due to increased risk of bleeding (see section 4.3).
Croatian: Antikoagulansi, antitrombotici, NSAR-ovi i SSRI-jevi/SNRI-jevi Antikoagulansi: Istovremena primjena edoksabana s drugim antikoagulansima kontraindicirana je zbog povećanog rizika od krvarenja (vidjeti dio 4.3).
English: Event rate (%/year)
Croatian: Stopa događaja godina)
English: EU/1/15/993/020 56 film-coated tablets
Croatian: EU/1/15/993/020 56 filmom obloženih tableta
English: Lixiana 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side.
Croatian: Lixiana 60 mg filmom obložene tablete su žute i okrugle (10,5 mm u promjeru) s utisnutom oznakom „DSC L60“ na jednoj strani.
English: Changing from Lixiana to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban)
Croatian: Zamjena lijeka Lixiana oralnim antikoagulansima koji nisu antagonisti vitamina K (dabigatran, rivaroksaban ili apiksaban)
English: How to store Lixiana
Croatian: Kako čuvati Lixiana
English: What Lixiana contains - The active substance is edoxaban (as tosilate).
Croatian: - Djelatna tvar je edoksaban (u obliku tosilata).