FrancophonIA/ELRC3.0 huggingface dataset:
English: As a result of FXa inhibition, edoxaban also prolongs clotting time in tests such as prothrombin time (PT), and activated partial thromboplastin time (aPTT).
Slovenian: Zaradi inhibicije FXa edoksaban tudi podaljšuje čas strjevanja v testih, kakršna sta na primer protrombinski čas (PT) in aktivirani delni tromboplastinski čas (aPTT).
English: Adverse reactions were experienced by 2,256 (32.2%) of the patients treated with edoxaban 60 mg (30 mg dose reduced) in the ENGAGE AF-TIMI 48 study and 1,249 (30.3%) in the Hokusai-VTE study.
Slovenian: Neželene učinke je opazilo 2.256 (32,2 %) bolnikov, zdravljenih z edoksabanom 60 mg (zmanjšani odmerek 30 mg) v študiji ENGAGE AF-TIMI 48 in 1.249 (30,3 %) v študiji Hokusai-VTE.
English: Roteas 60 mg once daily is recommended during concomitant use with the following P-gp inhibitors:
Slovenian: Zdravilo Roteas 60 mg enkrat na dan priporočajo med sočasno uporabo naslednjih inhibitorjev P-gp:
English: Edoxaban Anti-FXa activity post-dose (IU/mL)1
Slovenian: Aktivnost edoksabana proti faktorju Xa po odmerku (IE/ml)1
English: Discontinue dabigatran, rivaroxaban or apixaban and start Roteas at the time of the next dose of the oral anticoagulant (see section 5.1).
Slovenian: Ukinite dabigatran, rivaroksaban ali apiksaban in začnite z zdravilom Roteas ob času naslednjega odmerka peroralnega antikoagulanta (glejte poglavje 5.1).
English: b The HR, two-sided CI are based on the Cox proportional hazards regression model including treatment and the following randomisation stratification factors as covariates: presenting diagnosis (PE with or without DVT, DVT only), baseline risk factors (temporary factors, all others), and the need for 30 mg edoxaban/edoxaban placebo dose at randomisation (yes/no).
Slovenian: b HR, dvostranski CI temeljita na Coxovem regresijskem modelu proporcionalnih tveganj, vključno z zdravljenjem in naslednjimi randomizacijskimi stratifikacijskimi dejavniki kot sospremenljivkami: diagnoza ob prvem pregledu (PE z GVT ali brez nje, samo GVT), izhodiščni dejavniki tveganja (začasni dejavniki, vsi drugi) in potreba po odmerku edoksabana
English: The Hazard Ratio (Edoxaban 60 mg vs. warfarin) for the primary endpoint in the centres with a lower average time of INR in the target range (INR TTR) for warfarin was 0.73 - 0.80 for the lowest 3 quartiles (INR TTR ≤ 57.7% to ≤ 73.9%).
Slovenian: Razmerje tveganja (edoksaban 60 mg proti varfarinu) za primarni končni opazovani dogodek v centrih s krajšim povprečnim časom INR v ciljnem območju (INR TTR) za varfarin je bilo 0,73 -0,80 za najnižje 3 kvartile (INR TTR ≤ 57,7 % do ≤ 73,9 %).
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.
Slovenian: V obeh študijah so najpogostejši neželeni učinki v zvezi s krvavitvami z edoksabanom 60 mg po strokovni presoji vključevali krvavitve v mehkih tkivih kože (do 5,9 %) in epistakso (do 4,7 %), medtem ko je bila vaginalna krvavitev(9,0 %) najpogostejši s krvavitvijo povezan neželeni učinek samo v študiji Hokusai-VTE.
English: Once an INR ≥ 2.0 is achieved, Roteas should be discontinued.
Slovenian: Ko se doseže stabilen INR ≥ 2,0, zdravilo Roteas ukinite.
English: • The Summary of Product Characteristics
Slovenian: • povzetek glavnih značilnosti zdravila;
English: a The event rate (%/yr) is calculated as number of events/subject-year exposure.
Slovenian: a Pogostnost dogodka (%/leto) je izračunana kot število dogodkov/izpostavljenost preiskovanskega leta.
English: Increased post-implantation pregnancy losses occurred in rats at 300 mg/kg/day (approximately 49 times the MRHD) and in rabbits at 200 mg/kg/day (approximately 65 times the MRHD) respectively.
Slovenian: Zvečane izgube zarodkov po implantaciji so se pojavljale pri podganah pri odmerku 300 mg/kg/dan (približno 49-kratnik MRHD) in pri kuncih pri 200 mg/kg/dan (približno 65-kratnik MRHD).
English: • antibiotic medicines (e.g. erythromycin)
Slovenian: • antibiotična zdravila (n.pr.
English: The median subject-year exposure was 15,471, and 15,840 for the 60 mg and 30 mg treatment groups, respectively; and the median subject-year follow-up was 19,191 and 19,216 for the 60 mg and 30 mg treatment groups, respectively.
Slovenian: Mediana izpostavljenost preiskovanec-leto je bila 15.471 in 15.840 za skupini, zdravljeni s 60 mg oziroma 30 mg; in mediano spremljanje preiskovanecleto je bilo 19.191 in 19.216 za skupini, zdravljeni s 60 mg oziroma 30 mg.
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 Roteas (see section 4.2).
Slovenian: Če bolnik med kirurškim posegom ali po njem ne more jemati peroralnih zdravil, pride v poštev uporaba parenteralnega antikoagulanta, nato pa prehod na zdravilo Roteas enkrat na dan (glejte poglavje 4.2).
English: *Dose reduction to 30 mg for low body weight ≤ 60 kg or specific concomitant P-glycoprotein (P-gp)
Slovenian: *Zmanjšanje odmerka na 30 mg ob majhni telesni masi ≤ 60 kg ali specifičnih sočasno uporabljenih inhibitorjih P-glikoproteina (P-gp).
English: The edoxaban clinical programme for atrial fibrillation was designed to demonstrate the efficacy and safety of two dose groups of edoxaban compared to warfarin for the prevention of stroke and systemic embolism in subjects with nonvalvular atrial fibrillation and at moderate to high risk of stroke and systemic embolic events (SEE).
Slovenian: Preprečevanje možganske kapi in sistemskih embolij Klinični program za edoksaban pri atrijski fibrilaciji je bil zasnovan, da bi prikazal učinkovitost in varnost dveh skupin odmerkov edoksabana v primerjavi z varfarinom za preprečevanje možganske kapi in sistemskih embolij pri preiskovancih z nevalvularno atrijsko fibrilacijo in ob zmernem do velikem tveganju možganske kapi in sistemskih emboličnih dogodkov (SEE).
English: The recommended dose is one 60 mg tablet once daily.
Slovenian: Priporočeni odmerek je ena60-miligramska tabletaenkrat na dan.
English: Reproductive system and breast disorders Vaginal haemorrhage1
Slovenian: Motnje reprodukcije in dojk vaginalna krvavitev1
English: There is no clinically relevant accumulation of edoxaban (accumulation ratio 1.14) with once daily dosing.
Slovenian: Pri odmerjanju enkrat na dan ni klinično pomembnega kopičenja edoksabana (kvocient kopičenja 1,14).
English: In the warfarin group, the median TTR (time in therapeutic range, INR 2.0 to 3.0) was 65.6%.
Slovenian: V skupini z varfarinom je bil mediani TTR (čas v terapevtskem območju, INR 2,0 do 3,0) 65,6 %.
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.
Slovenian: Digoksin:edoksaban 60 mg enkrat na dan od 1. do 14. dne s sočasno uporabo večkratnih dnevnih odmerkov digoksina 0,25 mg dvakrat na dan (8. in 9. dne) in 0,25 mg enkrat na dan (10. do 14. dne) je zvečal Cmax edoksabana za 17 % brez pomembnega vpliva na AUC ali ledvični očistek v stanju ravnovesja.
English: - If you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor.
Slovenian: - Če imate okvaro delovanja ledvic, vam bo mogoče zdravnik zmanjšal odmerek na eno30-miligramsko tableto enkrat na dan.
English: • Bleeding following a surgical procedure
Slovenian: • krvavitev po kirurškem postopku.
English: What Roteas is and what it is used for
Slovenian: Kaj je zdraviloRoteasin za kaj ga uporabljamo
English: In a study on male and female fertility in rats no effects were seen (see section 5.3).
Slovenian: V študiji na samcih in samicahpodgan niso opazili vpliva na plodnost (glejte poglavje 5.3).
English: Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotupoleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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).
Slovenian: V kliničnih študijah je bila sočasna uporaba ASA (majhen odmerek ≤ 100 mg/dan), drugih antiagregacijskih zdravil in tienopiridinov dovoljena in je povzročila približno 2-kratno zvečanje velikih krvavitev v primerjavi z uporabo enega samega zdravila, čeprav v podobnem obsegu v skupini z edoksabanom in v skupini z varfarinom (glejte poglavje 4.4).
English: Roteas contains the active substance edoxaban and belongs to a group of medicines called anticoagulants.
Slovenian: Zdravilna učinkovina zdravilaRoteasje edoksaban,ki sodi v skupino zdravil, imenovano antikoagulanti.
English: There is very limited experience on the use of edoxaban with dual antiplatelet therapy or fibrinolytic agents.
Slovenian: Izkušenj z uporabo edoksabana skupaj z dvojno antitrombocitno terapijo ali fibrinolitičnimi sredstvi je zelo malo.
English: If you are taking any of the following:
Slovenian: Če jemljete:
English: inhibitors 1 Post-dose is equivalent to Cmax (post-dose samples were drawn 1 - 3 hours after edoxaban administration) 2 Pre-dose is equivalent to Cmin
Slovenian: 1Po odmerku ustreza Cmax (vzorci po odmerku so bili odvzeti 1-3 ure po dajanju edoksabana).
English: Edoxaban showed vaginal haemorrhage at higher doses in rats and rabbits but had no effects in the reproductive performance of parent rats.
Slovenian: Toksičen vpliv na sposobnost razmnoževanja Edoksaban je v večjih odmerkih pri podganah in kuncih kazal krvavitve v nožnico, ni pa vplival na reproduktivno funkcijo roditeljske generacije podgan.
English: Management should be individualised according to the severity and location of the haemorrhage.
Slovenian: Ukrepi pri krvavitvah morajo biti prilagojeni posamezniku glede na resnost in mesto krvavitve.
English: Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant.
Slovenian: Med prehajanjem na alternativen antikoagulant morate zagotoviti neprekinjeno zadostno antikoagulacijo.
English: Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Slovenian: Krvavitev se lahko kaže z oslabelostjo, bledico, omotico, glavobolom ali otekanjem iz nepojasnjenega vzroka, dispnejo in šokom iz nepojasnjenega vzroka.
English: • Nose bleeds or cuts that take a long time to stop bleeding
Slovenian: • krvavitve iz nosu ali iz ureznin, ki dolgo ne prenehajo krvaveti,
English: Table 3: List of adverse reactions for NVAF and VTE System Organ Class
Slovenian: Preglednica 3: Seznam neželenih učinkov za NVAF in VTE
English: A trend towards decreasing efficacy with increasing creatinine clearance was observed for edoxaban compared to well-managed warfarin (see section 5.1).
Slovenian: Pri edoksabanu so v primerjavi z dobro vodenim zdravljenjem z varfarinom opazili trend v smeri zmanjševanja učinkovitosti ob zviševanju očistka kreatinina (glejte poglavje 5.1).
English: • Moderate or severe renal impairment (creatinine clearance (CrCL) 15 - 50 mL/min)
Slovenian: • zmerna ali huda okvara ledvic (očistek kreatinina (CrCL)15-50 ml/min),
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.
Slovenian: Sočasna uporaba edoksabana in spodbujevalca P-gp rifampicina zmanjša povprečno AUC edoksabana in skrajša njegov razpolovni čas ter hkrati lahko zmanjša njegove farmakodinamične učinke.
English: Musculoskeletal and connective tissue disorders Intramuscular haemorrhage (no compartment syndrome)
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva intramuskularna krvavitev (brez utesnitvenega sindroma)
English: Investigations Liver function test abnormal
Slovenian: Preiskave abnormalni testi delovanja jeter pogosti
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.
Slovenian: Preglednice 7, 8 in 9 kažejo velike, smrtne oziroma intrakranialne krvavitve po kategorijah očistka kreatinina pri bolnikih z NVAF v študiji ENGAGE AF-TIMI 48.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or phototoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potencialaali fototoksičnosti ne kažejo posebnega tveganja za človeka.
English: Co-administration of protonpump inhibitors had no relevant impact on edoxaban exposure.
Slovenian: Sočasno dajanje inhibitorjev protonske črpalke ni pomembno vplivalo na izpostavljenost edoksabanu.
English: Co-administration of low dose ASA (≤ 100 mg) did not affect the peak or total exposure of edoxaban either after single dose or at steady-state.
Slovenian: Sočasna uporaba ASA v majhnem odmerku (≤ 100 mg) ni vplivala na vrh ali na celotno izpostavljenost edoksabanu bodisi po enkratnem odmerku ali v stanju ravnovesja.
English: Effects of coagulation markers when switching from rivaroxaban, dabigatran, or apixaban to edoxaban
Slovenian: Učinki koagulacijskih markerjev pri prehodu z rivaroksabana, dabigatrana ali apiksabana na edoksaban
English: Edoxaban was administered with or without food in the ENGAGE AF-TIMI 48 and the Hokusai-VTE studies.
Slovenian: Edoksaban so v študijah ENGAGE AF-TIMI 48 in Hokusai-VTE dajali s hrano ali brez hrane.
English: Edoxaban displays approximately dose-proportional pharmacokinetics for doses of 15 mg to 60 mg in healthy subjects.
Slovenian: Edoksaban kaže pri zdravih osebah za odmerke od 15 mg do 60 mg farmakokinetiko, ki je približno proporcionalna odmerku.
English: Safety and efficacy of edoxaban have not been established in pregnant women.
Slovenian: Nosečnost Varnost in učinkovitost edoksabana pri nosečnicah nista bili dokazani.
English: In the warfarin group, the median TTR (time in therapeutic range, INR 2.0 to 3.0) was 68.4%.
Slovenian: V skupini z varfarinom je bil mediani TRR (čas v terapevtskem območju, INR 2,0 do 3,0) 68,4 %.
English: If a dose of Roteas is missed, the dose should be taken immediately and then be continued the following day with the once-daily intake as recommended.
Slovenian: Pozabljeni odmerek Če bolnik pozabi vzeti odmerek zdravila Roteas, naj ga nemudoma vzame, potem pa naslednjega dne nadaljuje z jemanjem enkrat na dan, kot je priporočeno.
English: In clinical pharmacology studies, healthy subjects received rivaroxaban 20 mg once daily, dabigatran 150 mg twice daily, or apixaban 5 mg twice daily, followed by a single dose of edoxaban 60 mg on Day 4.
Slovenian: V kliničnofarmakoloških študijah so zdravipreiskovanci prejemali rivaroksaban 20 mg enkrat na dan, dabigatran 150 mg dvakrat na dan ali apiksaban 5 mg dvakrat na dan, ki mu je 4. dne sledil enkraten odmerek edoksabana 60 mg.
English: These include acetylsalicylic acid (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and chronic nonsteroidal anti-inflammatory drugs (NSAIDs) (see section 4.5).
Slovenian: Ta zdravila vključujejo acetilsalicilno kislino (ASA), inhibitorje trombocitov P2Y12, druga antitrombotična sredstva, fibrinolitično terapijo, selektivne zaviralce privzema serotonina (SSRI) ali zaviralce privzema serotonina in noradrenalina (SNRI) in kronična nesteroidna protivnetna zdravila (NSAID)
English: NSAIDs: Co-administration of naproxen and edoxaban increased bleeding time relative to either medicine alone.
Slovenian: NSAID: sočasna uporaba naproksena in edoksabana je bolj podaljšala čas krvavitve kot vsako posamezno zdravilo.
English: Unchanged edoxaban is the predominant form in plasma.
Slovenian: Prevladujoča oblika v plazmi je nespremenjeni edoksaban.
English: ≥ 30 to ≤ 50 1,302 96
Slovenian: ≥ 30 do ≤ 50 1302 96
English: During the overall study period in the ITT population (analysis set to show superiority), adjudicated stroke or SEE occurred in 296 subjects in the edoxaban 60 mg group (1.57% per year), and 337 subjects in the warfarin group (1.80% per year).
Slovenian: Med celotnim obdobjem študije se je v populaciji ITT (analiza z namenom prikaza superiornosti) možganska kap ali SEE po strokovni presoji pojavila pri 296 preiskovancih v skupini z edoksabanom 60 mg (1,57 % na leto)in pri 337 preiskovancih v skupini z varfarinom(1,80 % na leto).
English: PATIENT ALERT CARD
Slovenian: KARTICA Z OPOZORILI ZA BOLNIKA
English: Taking an anticoagulant medicine such as Roteas can increase your risk of bleeding.
Slovenian: Jemanje zdravil proti strjevanju krvi, kot je zdravilo Roteas, lahko zveča vaše tveganje za krvavitev.
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.
Slovenian: Na voljo so v pretisnih omotih v kartonskih škatlah s po 10, 14, 28, 30, 56, 60, 84, 90, 98 ali 100 filmsko obloženimi tabletami ali v enoodmernih pretisnih omotih v kartonskih škatlah s po 10 x 1, 50 x 1 ali 100 x 1 filmsko obloženo tableto.
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) 30 mg QD ≥ 30 to ≤ 50
Slovenian: ZdravljenjeGVT, zdravljenje PE ter preprečevanje ponovljeneGVT in PE (VTE) 30 mg enkrat na dan
English: There is a decreasing event rate at increasing CrCL in both treatment groups.
Slovenian: Z rastjo CrCL se pogostnost dogodka v skupinah z obema terapijama zmanjšuje.
English: Edoxaban prolongs standard clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT) as a result of FXa inhibition.
Slovenian: Edoksaban podaljšuje standardne koagulacijske teste, na primer protrombinski čas (PT), INR in aktivirani delni tromboplastinski čas (aPTT) zaradi inhibicije FXa.
English: Roteas is not recommended in children and adolescents under 18 years of age.
Slovenian: Uporaba zdravila Roteasse ne priporoča pri otrocih in mladostnikih, mlajših od 18 let.Na voljo ni podatkov o uporabi zdravila pri otrocih in mladostnikih.
English: and appropriate caution exercised.
Slovenian: med posegom pa je potrebna ustrezna mera previdnosti.
English: Direct acting Oral Anticoagulants (DOACs) including edoxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Slovenian: Uporaba peroralnih antikoagulantov z neposrednim delovanjem, vključno z edoksabanom, pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ni priporočljiva.
English: There is a potential for inadequate anticoagulation during the transition from Roteas to VKA.
Slovenian: Med prehodom z zdravila Roteas na VKA obstaja možnost nezadostne antikoagulacije.
English: The median study drug exposure for both the edoxaban 60 mg and 30 mg treatment groups was 2.5 years.
Slovenian: Mediana izpostavljenost zdravilu v študiji za skupini, zdravljeni tako z edoksabanom 60 mg kot edoksabanom 30 mg, je bila 2,5 leta.
English: Woman of childbearing potential Women of childbearing potential should avoid becoming pregnant during treatment with edoxaban.
Slovenian: Ženske v rodni dobi Ženske v rodni dobi med zdravljenjem z edoksabanom ne smejo zanositi.
English: Roteas 15 mg is only to be used when changing from Roteas 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3.
Slovenian: Zdravilo Roteas 15 mg se uporablja samo, kadar bolnik prehaja z zdravljenja z zdravilom Roteas 30 mg na zdravljenje z antagonistom vitamina K (npr. varfarin) (glejte poglavje 3: Kako jemati zdravilo Roteas).
English: 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.
Slovenian: V kliničnih študijah faze 3 (obe indikaciji, NVAF in VTE) so imeli bolniki s telesno maso ≤ 60 kg 50-odstotno zmanjšanje odmerka edoksabana in so imeli v primerjavi z varfarinom podobno učinkovitost in manj krvavitev.
English: 15 mg and 60 mg film-coated tablets: Iron oxide yellow (E172) 15 mg and 30 mg film-coated tablets: Iron oxide red (E172)
Slovenian: 15 miligramske in 60-miligramske filmsko obložene tablete: rumeni železov oksid (E172) 15 miligramske in 30-miligramske filmsko obložene tablete: rdeči železov oksid (E172)
English: A multicentre, prospective, randomised, open-label study with blinded endpoint evaluation (ENSUREAF) was conducted which randomised 2199 subjects (oral anticoagulant naïve and pre-treated) with non-valvular atrial fibrillation scheduled for cardioversion, to compare edoxaban 60 mg once daily with enoxaparin/warfarin to maintain a therapeutic INR of 2.0 to 3.0 (randomised 1:1), mean TTR on warfarin was 70.8%.
Slovenian: Izvedena je bila multicentrična, prospektivna, randomizirana odprta študija s slepo evalvacijo opazovanih dogodkov (ENSURE-AF), pri kateri so randomizirali 2199 oseb (takih, ki še niso bile zdravljene s peroralnimi antikoagulanti, in takih, ki so že bile) z nevalvularno atrijsko fibrilacijo, pri katerih je bila načrtovana kardioverzija, z namenom primerjave edoksabana 60 mg enkrat na dan in enoksaparina/varfarina pri vzdrževanju terapevtskega INR 2,0-3,0 (randomizacija v razmerju 1 : 1); povprečni TTR pri varfarinu je bil 70,8 %.
English: • Blood in the spit when coughing
Slovenian: • kri v izpljunku pri kašljanju,
English: PVC/Aluminium perforated unit dose blisters of 10 x 1, 50 x 1 and 100 x 1 film-coated tablets.
Slovenian: Enoodmerni perforirani pretisni omoti iz PVC/aluminija s po 10 x 1, 50 x 1 in 100 x 1 filmsko obloženo tableto.
English: It was 1.07 in centres with the best control of warfarin therapy (4th quartile with > 73.9% of INR values in the therapeutic range).
Slovenian: V centrih z najboljšo kontrolo varfarinske terapije (4. kvartil z> 73,9 % vrednosti INR v terapevtskem območju) je bilo 1,07.
English: • Recommendations for dose adjustment in at risk populations, including patients with renal or hepatic impairment, low body weight and concomitant use of some P-gp inhibitors
Slovenian: • priporočila za prilaganje odmerjanja pri skupinah bolnikov z zvečanim tveganjem, vključno z bolniki z okvaro ledvic ali jeter, majhno telesno maso in s tistimi, ki sočasno uporabljajo nekatere inhibitorje P-gp; • smernice za prehajanje z zdravljenja in na zdravljenje z zdravilom Roteas;
English: Ciclosporin, dronedarone, erythromycin, ketoconazole
Slovenian: dronedaron, eritromicin ali ketokonazol.
English: • Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban etc.) except under specific circumstances of switching oral anticoagulant therapy (see section 4.2) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5).
Slovenian: nizkomolekularnimi heparini (enoksaparin, dalteparin in drugi), derivati heparina (fondaparinuks in drugi), peroralnimi antikoagulanti (varfarin, dabigatran eteksilat, rivaroksaban, apiksaban in drugi) razen v posebnih primerih zamenjave peroralnega antikoagulacijskega zdravljenja (glejte poglavje 4.2) ali kadar se nefrakcionirani heparini uporabljajo v odmerkih, ki so potrebni za vzdrževanje prehodnosti centralnega venskega ali arterijskega katetra (glejte poglavje 4.5).