natgillin/translations-raw huggingface dataset:
A total of 16 (1.5%, 95% CI 0.86% - 2.42%) events occurred in subjects in the edoxaban (N = 1067) group and 11 (1.0%, 95% CI 0.51% - 1.81%) events in the warfarin (N = 1082) group; OR 1.48 (95% CI 0.64 - 3.55); safety analysis set on-treatment period. 
Pri osebah v skupini z edoksabanom (N = 1067) je prišlo do skupno 16 dogodkov (1,5 %, 95-% IZ 0,86 %-2,42 %), pri osebah v skupini z varfarinom (N = 1082) pa do 11 dogodkov (1,0 %, 95-% IZ 0,51 %-1,81 %); razmerje obetov 1,48 (95-% IZ 0,64-3,55); analiza varnosti je zajemala obdobje zdravljenja.
(NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, 
Preprečevanje možganske kapi in sistemske embolije pri odraslih bolnikih z nevalvularno atrijsko fibrilacijo (NVAF - Non-Valvular Atrial Fibrillation) z enim ali več dejavniki tveganja, kot so kongestivno popuščanje srca, hipertenzija, starost ≥ 75 let, sladkorna bolezen, predhodna možganska kap ali prehodna možganska ishemija (TIA - Transient Ischaemic Attack).
All-cause mortality (adjudicated deaths) per renal subgroups (edoxaban vs. warfarin): CrCL 30 to ≤ 50 mL/min [HR (95% CI): 0.81 (0.68, 0.97)]; CrCL > 50 to < 80 mL/min [HR (95% CI): 0.87 (0.75, 1.02)]; CrCL ≥ 80 mL/min [HR (95% CI): 1.15 (0.95, 1.40)]. 
Smrtnost ne glede na vzrok (po strokovni presoji) po podkategorijah ledvične funkcije (edoksaban proti varfarinu): CrCL 30 do ≤ 50 ml/min [HR (95 % CI): 0,81 (0,68; 0,97)]; CrCL > 50 do < 80 ml/min [HR (95 % CI): 0,87 (0,75; 1,02)]; CrCL ≥ 80 ml/min [HR (95 % CI): 1,15 (0,95; 1,40)].
(e.g. stomach ulcer, injury or bleeding in the brain, or recent surgery of the brain or eyes) - if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, 
razjedo želodca, poškodbo ali krvavitev v možganihali nedavnikirurški poseg na možganih ali očeh), - če jemljete druga zdravilaza preprečevanje nastanka krvnih strdkov (n.pr.
PVC/Aluminium perforated unit dose blisters of 10 x 1 film-coated tablets. 
Enoodmerni perforirani pretisni omoti iz PVC/aluminija s po 10 x 1filmsko obloženo tableto.
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). 
Tveganje je bilo signifikantno zmanjšano v korist skupini, zdravljeni z edoksabanom 60 mg, v primerjavi s skupino z varfarinom pri veliki krvavitvi (2,75 % oziroma 3,43 % na leto) [HR (95 % CI): 0,80 (0,71, 0,91); p = 0,0009], intrakranialni krvavitvi (ICH) (0,39 % oziroma 0,85 % na leto) [HR (95 % CI): 0,47 (0,34, 0,63); p < 0,0001] in drugih vrstah krvavitev (preglednica 6).
Therefore Roteas is contraindicated during breast-feeding (see section 4.3). 
Uporaba zdravilaRoteasje med dojenjem kontraindicirana (glejte poglavje 4.3).
The primary efficacy endpoint was the composite of stroke and SEE. 
Primarni kriterij učinkovitosti je bil sestavljen iz dogodkov možganske kapi in SEE.
What Roteas contains - The active substance is edoxaban (as tosilate). 
Kaj vsebuje zdravilo Roteas - Zdravilna učinkovina jeedoksaban(v obliki edoksabanijevega tozilata).
Edoxaban 60 mg (N = 7,012) 
Edoksaban 60 mg (N = 7.012)
Safety and efficacy of edoxaban have not been established in breast-feeding women. 
Varnost in učinkovitost edoksabana pri doječih materah nista bili dokazani.
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. 
Edoksaban 30 mg enkrat na dan se je uporabljal za preiskovance z enim ali več naslednjih kliničnih dejavnikov: zmerna okvara ledvic (CrCL 30 - 50 ml/min); telesna masa ≤ 60 kg; sočasno jemanje specifičnih inhibitorjev P-gp.
PHARMACEUTICAL FORM AND CONTENTS 10 film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 10 filmsko obloženih tablet 10 x 1 filmsko obložena tableta
- if you have an increased risk of bleeding, as could be the case if you have any of the following conditions: 
- če imate zvečano tveganje krvavitve, kar bi bilo možno, če imate katero od naslednjih bolezni: • končni stadij bolezni ledvic ali če ste na dializi,
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study (for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors), the event rate was: 2.29% per year for the primary endpoint, compared to the event rate of 2.66% per year for the matching subjects in the warfarin group [HR (95% CI): 0.86 (0.66, 1.13)]. 
V analizi podskupin za preiskovance v skupini, zdravljeni s 60 mg, ki jim je bil odmerek v študiji ENGAGE AF-TIMI 48 zmanjšan na 30 mg (zaradi telesne mase ≤ 60 kg, zmerne okvare ledvic ali sočasne uporabe inhibitorjev P-gp), je bila pogostnost dogodka 2,29 % na leto za primarni končni opazovani dogodek, v primerjavi s pogostnostjo dogodka 2,66 % na leto za preiskovance z enakimi demografskimi podatki v skupini z varfarinom [HR (95 % CI): 0,86 (0,66, 1,13)].
Naproxen had no effect on the Cmax and AUC of edoxaban. 
Naproksen ni vplival na Cmax in AUC edoksabana.
Discontinue subcutaneous anticoagulant and start Roteas at the time of the next scheduled subcutaneous anticoagulant dose. 
ukinite subkutani antikoagulant in začnite dajati zdravilo Roteas ob času naslednjega načrtovanega odmerka subkutanega antikoagulanta.
Edoxaban 60 mg (30 mg Dose Reduced) (N = 7,012) 
Edoksaban 60 mg (30 mg zmanjšani odmerek) (N = 7.012)
First Stroke/SEEa n Event Rate (%/yr)b 
Prva možganska kap/SEEa n pogostnost dogodka (%/leto)b
• Coagulation tests such as INR, prothrombin time (PT), or activated partial thromboplastin time 
• Koagulacijski testi, kot so INR, protrombinski čas (PT) ali aktivirani delni tromboplastinski čas (aPTT), niso uporabni za merjenje učinka zdravila Roteas.
In patients with end stage renal disease or on dialysis, Roteas is not recommended (see sections 4.2 and 5.2). 
Pri bolnikih z boleznijo ledvic v končnem stadiju ali na dializi zdravila Roteas ne priporočajo (glejte poglavji 4.2 in 5.2).
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. 
Večina bolnikov, zdravljenih z edoksabanom, je bila pripadnikov bele (69,6 %) in azijske rase
Roteas 30 mg once daily must be administered during concomitant use with the following P-gp inhibitors: 
Zdravilo Roteas 30 mg enkrat na dan moramo dajati med sočasno uporabo z naslednjimi inhibitorji
• Allergic reaction 
• alergijska reakcija, • koprivnica.
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 104 (3.05% per year) of edoxaban 30 mg dose reduced subjects and 166 (4.85% per year) of warfarin dose reduced subjects had a major bleeding event [HR (95% CI): 0.63 (0.50, 
V analizah podskupin za preiskovance v skupini, zdravljeni s 60 mg, ki so imeli v študiji ENGAGE AF-TIMI 48 odmerek zmanjšan na 30 mg zaradi telesne mase ≤ 60 kg, zmerne okvare ledvic ali sočasne uporabe inhibitorjev P-gp, so imeli 104 (3,05 % na leto) preiskovanci, zdravljeni z zmanjšanim odmerkom edoksabana 30 mg, in 166 (4,85 % na leto) preiskovancev z zmanjšanim odmerkom varfarina velik krvavitveni dogodek [HR (95 % CI): 0,63 (0,50, 0,81)].
In patients with severe hepatic impairment Roteas is not recommended (see sections 4.4 and 5.2). 
Pri bolnikih s hudo okvaro jeter zdravila Roteas ne priporočajo (glejte poglavji 4.4 in 5.2).
• Amiodarone: Co-administration of amiodarone 400 mg once daily with edoxaban 60 mg once daily increased AUC by 40% and Cmax by 66%. 
• Amiodaron: sočasno dajanjeamiodarona 400 mg enkrat na dan z edoksabanom 60 mg enkrat na dan je zvečalo AUC za 40 % in Cmax za 66 %.
For the subjects who were dose reduced to 30 mg (predominantly low body weight or renal function) 15 (2.1%) edoxaban and 22 (3.1%) of warfarin subjects had a recurrent VTE [HR (95% CI): 0.69 
Od preiskovancev, ki jim je bil odmerek zmanjšan na 30 mg (prevladujoča razloga sta bila majhna telesna masa ali funkcija ledvic), je imelo 15 (2,1 %) preiskovancev z edoksabanom in 22 (3,1 %) preiskovancev z varfarinom recidivne VTE [HR (95 % CI): 0,69 (0,36, 1,34)].
Table 4: Strokes and Systemic Embolic Events in the ENGAGE AF-TIMI 48 Study - mITT, on-treatment 
Preglednica 4: Možganske kapi in sistemski embolični dogodki v študiji ENGAGE AF-TIMI 48
Pharmocokinetic/pharmacodynamic relationship(s) PT, INR, aPTT and Anti-factor Xa correlate linearly with edoxaban concentrations. 
PT, INR, aPTT in anti-faktor Xa so v linearni korelaciji s koncentracijami edoksabana.
Changing from vitamin K antagonists (e.g. warfarin) to Roteas Stop taking the vitamin K antagonist (e.g. warfarin). 
varfarina)na zdravilo Roteas Prenehajte jemati antagonist vitamina K (n.pr.
• Ketoconazole: Ketoconazole 400 mg once daily for 7 days with a single concomitant dose of edoxaban 60 mg on Day 4, increased edoxaban AUC and Cmax by 87% and 89%, respectively. 
• Ketokonazol: ketokonazol 400 mg enkrat na dan 7 dni z enkratnim sočasnim odmerkom edoksabana 60 mg 4. dne je zvečal AUC in Cmax edoksabana za 87 % oziroma 89 %.
a The primary efficacy endpoint is adjudicated symptomatic recurrent VTE (i.e., the composite endpoint of DVT, non-fatal PE, and fatal PE). 
končno stanje, sestavljeno iz GVT, ne-fatalne PE in fatalne PE).
Edoxaban has not been studied in patients with severe hepatic impairment (see section 4.2). 
Pri bolnikih s hudo okvaro jeter edoksabana niso raziskovali (glejte poglavje 4.2).
How to store Roteas 
Shranjevanje zdravila Roteas
Abbreviations: CI = Confidence Interval; DVT = deep vein thrombosis; mITT = modified intent-totreat; HR = Hazard Ratio vs. warfarin; n = number of subjects with events; N = number of subjects in mITT population; PE = pulmonary embolism; VTE = venous thromboembolic events. 
Okrajšave: CI = interval zaupanja; GVT = globoka venska tromboza; mITT = modificirana z namenom zdravljenja; HR = razmerje tveganja proti varfarinu; n = število preiskovancev z dogodki;
• Tar-coloured stools 
• blato barve katrana,
Due to the high plasma protein binding edoxaban is not expected to be dialysable. 
Edoksaban se veže na beljakovine v plazmi, zato ni verjetno, da bi se dializiral.
Anticoagulants, antiplatelets, NSAIDs and SSRIs/SNRIs Anticoagulants: Co-administration of edoxaban with other anticoagulants is contraindicated due to increased risk of bleeding (see section 4.3). 
Antikoagulanti: sočasna uporaba edoksabana z drugimi antikoagulanti je kontraindicirana zaradi zvečane nevarnosti krvavitve (glejte poglavje 4.3).
In patients with mild to moderate hepatic impairment the recommended dose is 60 mg Roteas once daily (see section 5.2). 
Pri bolnikih z blago do zmerno okvaro jeter je priporočeni odmerek 60 mg zdravila Roteas enkrat na dan (glejte poglavje 5.2).
Tell your doctor immediately if you have taken too many Roteas tablets. 
Če ste vzeli večji odmerek zdravila Roteas, kot bi smeli Če ste vzeli preveč tablet zdravila Roteas, to takoj povejte zdravniku.
Your doctor will tell you to reduce your dose of Roteas to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). 
Zdravnik vam bo naročil, da zmanjšajteodmerek zdravila Roteasna 15-miligramsko tabletoenkrat na danin jo jemljite skupaj z antagonistom vitamina K (n.pr.
Respiratory, thoracic and mediastinal disorders Epistaxis 
Bolezni dihal, prsnega koša in mediastinalnega prostora Epistaksa pogosti hemoptiza občasni
• Importance of treatment compliance 
• o pomembnostijemanja zdravila po zdravnikovih navodilih;
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 
Sekundarni sestavljeni kriterij, ki sta ga sestavljala recidivni VTE in smrtnost ne glede na vzrok, so ugotovili pri 138 preiskovancih (3,4 %) v skupini z edoksabanom in 158 preiskovancih (3,9 %) v skupini z varfarinom [HR (95 % CI): 0,87 (0,70, 1,10)].
In the clinical studies mucosal bleedings (e.g. epistaxis, gastrointestinal, genitourinary) and anaemia were seen more frequently during long term edoxaban treatment compared with VKA treatment. 
V kliničnih preskušanjih so med dolgotrajnim zdravljenjem z edoksabanompogosteje opazili krvavitve iz sluznic (tj. iz nosu, prebavil, rodil in sečil) in slabokrvnost kot pri zdravljenju z VKA.
Rare 
pogosti
How to take Roteas 
Kako jemati zdraviloRoteas
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. 
Okrajšave:HR = razmerje tveganja proti varfarinu, CI = intervalzaupanja,n = število dogodkov, mITT = modificirana z namenom zdravljenja, N = število preiskovancev v populaciji mITT,
• Erythromycin: Erythromycin 500 mg four times daily for 8 days with a single concomitant dose of edoxaban 60 mg on Day 7 increased the edoxaban AUC and Cmax by 85% and 68%, respectively. 
• Eritromicin: eritromicin 500 mg štirikrat na dan 8 dni z enkratnim sočasnim odmerkom edoksabana 60 mg 7. dne je zvečal AUC in Cmax edoksabana za 85 % oziroma 68 %.
P-gp inducers 
Spodbujevalci P-gp
• 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. 
• Ciklosporin: sočasno dajanje enkratnega odmerka ciklosporina 500 mg z enkratnim odmerkom edoksabana 60 mg je zvečalo AUC in Cmax edoksabana za 73 % oziroma 74 %.
• Bleeding in the brain 
• krvavitev v možganih,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 60 MG 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (KARTONSKA ŠKATLA) ZA 60 MG
> 50 to ≤ 70 2,093 148 3.31 2,106 171 3.77 0.88 (0.71, 1.10) > 70 to ≤ 90 1,661 108 2.88 1,703 119 3.08 0.93 (0.72, 1.21) > 90 to ≤ 110 927 29 
> 50 do ≤ 70 2093 148 3,31 2106 171 3,77 0,88 (0,71; 1,10) > 70 do ≤ 90 1661 108 2,88 1703 119 3,08 0,93 (0,72; 1,21) > 90 do ≤ 110 927 29
Concomitant administration of higher doses than 100 mg ASA should only be performed under medical supervision. 
Sočasna kronična uporaba ASA v velikih odmerkih (325 mg) z edoksabanom ni priporočljiva.Sočasna uporaba odmerkov ASA, večjih od 100 mg, je dovoljena samo pod medicinskih nadzorom.
Oral/Pharyngeal haemorrhage 
Farmakokinetično/farmakodinamično razmerje
• Dronedarone: Dronedarone 400 mg twice daily for 7 days with a single concomitant dose of edoxaban 60 mg on Day 5 increased edoxaban AUC and Cmax by 85% and 46%, respectively. 
• Dronedaron: dronedaron 400 mg dvakrat na dan 7 dni z enkratnim sočasnim odmerkom edoksabana 60 mg 5. dne je zvečal AUC in Cmax edoksabana za 85 % oziroma 46 %.
Edoxaban should be used with caution when co-administered with P-gp inducers. 
P-gp je treba edoksaban previdno uporabljati.
Roteas is used in adults to: 
Roteas, prejeli naslednje izobraževalne materiale:
Discontinue Roteas and start the non-VKA anticoagulant at the time of the next scheduled dose of Roteas. 
Ukinite zdravilo Roteas in začnite z antikoagulantom, ki ni VKA, ob času naslednjega načrtovanega odmerka zdravila Roteas.
Intracranial haemorrhage (ICH) 
Bolezni živčevja omotica pogosti glavobol pogosti intrakranialna krvavitev (ICH)
• Quinidine: Quinidine 300 mg once daily on Days 1 and 4 and three times daily on Days 2 and 3, with a single concomitant dose of edoxaban 60 mg on Day 3, increased edoxaban AUC over 24 hours by 77% and Cmax by 85%, respectively. 
• Kinidin: kinidin 300 mg enkrat na dan 1. in 4. dne in trikrat na dan 2. in 3. dne z enkratnim sočasnim odmerkom edoksabana 60 mg 3. dne je zvečal AUC edoksabana v 24 urah za 77 % in
In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitors: ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, or verapamil resulted in increased plasma concentrations of edoxaban. 
V farmakokinetičnih (PK) študijah je sočasna uporaba edoksabana skupaj z inhibitorji P-gp ciklosporinom, dronedaronom, eritromicinom,
- treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels in the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels in the legs and/or lungs. 
- za zdravljenje krvnih strdkov v venah nog(globoka venska tromboza) in v žilah v pljučih
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]. 
4.118 preiskovancev (3,2 %) v skupini z edoksabanom proti 146 od 4.122 preiskovancev (3,5 %) v skupini z varfarinom [HR (95 % CI): 0,89 (0,70, 1,13); p < 0,0001 za neinferiornost].
Safety in patients with NVAF in ENGAGE AF-TIMI 48 The primary safety endpoint was major bleeding. 
Varnost pri bolnikih z NVAF v študiji ENGAGE AF-TIMI 48
• Renal function should be assessed in all patients by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Roteas to exclude patients with end stage renal disease (i.e. CrCL < 15 mL/min), to use the correct Roteas 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 Roteas in patients with increased creatinine clearance (see section 4.4). 
(t. j. CrCL < 15 ml/min) in da uporabite pravilen odmerek zdravila Roteas pri bolnikih s CrCL 15 - 50 ml/min (30 mg enkrat na dan) in pri bolnikih s CrCL > 50 ml/min (60 mg enkrat na dan),
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 30 MG 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (KARTONSKA ŠKATLA) ZA 30 MG
Roteas 15 mg: Each tablet contains 15 mg edoxaban (as tosilate). 
Roteas 15 mg: ena tableta vsebuje 15 mg edoksabana (v obliki edoksabanijevega tozilata).
There is neither scientific rationale for benefit nor experience with the use of systemic haemostatics (desmopressin, aprotinin) in individuals receiving edoxaban. 
Koristi uporabe sistemskih hemostatikov (npr. dezmopresina, aprotinina) pri osebah, ki prejemajo edoksaban, niso strokovno utemeljene, prav tako pa ni izkušenj.
In a pre-specified subgroup analysis of PE subjects 447 (30.6%) and 483 (32.2%) of edoxaban and warfarin treated subjects, respectively, were identified as having PE and NT-proBNP ≥ 500 pg/mL. 
V vnaprej določeni analizi podskupin preiskovancev s PE so za 447 (30,6 %) oziroma 483 (32,2 %)
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. 
2,5 leta pri 7.012 bolnikih v študiji ENGAGE AF-TIMI 48 in 251 dni pri 4.118 bolnikih v študiji Hokusai-VTE.
Posology 
PRILOGAI
• Verapamil: Verapamil 240 mg once daily for 11 days with a single concomitant dose of edoxaban 60 mg on Day 10 increased the edoxaban AUC and Cmax by approximately 53%. 
• Verapamil: verapamil 240 mg enkrat na dan 11 dni z enkratnim sočasnim odmerkom edoksabana 60 mg 10. dne je zvečal AUC in Cmax edoksabana za približno 53 %.
• Prescriber Guide for healthcare professionals 
• smernice za predpisovanje za zdravstvene delavce; • kartico z opozorili za bolnika.
• Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole. 
• sočasna uporaba katerega od naslednjih inhibitorjev P-glikoproteina (P-gp): ciklosporin,
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 pre-specified non-inferiority margin of 1.38) (Table 4). 
(zgornja meja 97,5-odstotnegaCI(intervala zaupanja) HR (razmerja tveganja) je bila pod vnaprej določeno mejo neinferiornosti, ki je bila 1,38) (preglednica 4).
Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate). 
Ena 15 mg filmsko obložena tableta vsebuje 15 mg edoksabana (v obliki edoksabanijevega tozilata).
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. 
Koncentracija edoksabana v plazmi se lahko zmanjša tudi pri sočasni uporabi drugih induktorjev P-gp (npr. fenitoina, karbamazepina, fenobarbitala ali šentjanževke).
Continued anticoagulant therapy is important in patients with NVAF and VTE. 
Zamenjava zdravila Roteas z drugim zdravilom in obratno Pri bolnikih z NVAF in VTE je pomembna neprekinjena antikoagulantna terapija.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 15 MG 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (KARTONSKA ŠKATLA) ZA15 MG
Platelet inhibitors: In ENGAGE AF-TIMI 48 concomitant use of thienopyridines (e.g. clopidogrel) monotherapy was permitted and resulted in increased clinically relevant bleeding although with a lower risk of bleeding on edoxaban compared to warfarin (see section 4.4). 
klopidogrelom) dovoljena in je povzročila zvečano klinično pomembno krvavitev, čeprav z manjšim tveganjem krvavitve pri edoksabanu kot pri varfarinu (glejte poglavje 4.4).
Roteas 60 mg: Each tablet contains 60 mg edoxaban (as tosilate). 
Roteas 60 mg: ena tableta vsebuje 60 mg edoksabana (v obliki edoksabanijevega tozilata).
In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study in NVAF, Cmax and AUC in patients with median low body weight (55 kg) were increased by 40% and 13%, respectively, as compared with patients with median high body weight (84 kg). 
pri bolnikih z mediano majhno telesno maso (55 kg) zvečani za 40 % oziroma 13 % v primerjavi z bolniki z mediano veliko telesno maso (84 kg).
Roteas 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side. 
Roteas 15 mg filmsko obložene tablete so oranžne, okrogle,premera 6,7 mm,z vtisnjenim napisom “DSC L15”na eni strani.
• other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban) 
varfarin, acenokumarol, fenprokumon ali dabigatran, rivaroksaban, apiksaban),
Roteas 30 mg: Each tablet contains 30 mg edoxaban (as tosilate). 
Roteas 30 mg: ena tableta vsebuje 30 mg edoksabana (v obliki edoksabanijevega tozilata).
Table 5: Number of Ischaemic Strokes/SEE by creatinine clearance category in ENGAGE AFTIMI 48, mITT Analysis Set Overall Study CrCL subgroup (mL/min) 
Preglednica 5: Število ishemičnih možganskih kapi/SEE po kategorijah očistka kreatinina v študiji ENGAGE AF-TIMI 48, mITT celotno obdobje študije
INFORMATION FOR HEALTHCARE PROFESSIONALS 
INFORMACIJE O PREDPISOVALCU
Therapy with edoxaban in NVAF patients should be continued long term. 
Priporočeni odmerek je 60 mg edoksabanaenkrat na dan. Zdravljenje bolnikov z NVAFz edoksabanomje treba nadaljevati dolgo časa.
• Bleeding from the nose 
• krvavitev iz nosu, • krvavitev iz nožnice,
Co-administration of high dose ASA (325 mg) increased the steady state Cmax and AUC of edoxaban by 35% and 32%, respectively. 
je zvečala Cmax in AUC edoksabana v stanju ravnovesja za 35 % oziroma 32 %.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 60 MG 
ENOODMERNI PRETISNI OMOT (10 x 1 TABLETA) ZA 60 MG
First Ischaemic Stroke n Event Rate (%/yr)b 
Prva ishemična možganska kap n pogostnost dogodka (%/leto)b
Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate). 
Ena 60 mg filmsko obložena tableta vsebuje 60 mg edoksabana (v obliki edoksabanijevega tozilata).
Roteas 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side. 
Roteas 30 mg filmsko obložene tablete so rožnate, okrogle,premera 8,5 mm, z vtisnjenim napisom “DSC L30”na eni strani.