FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Bolnikom, ki trenutno prejemajo 30-miligramski odmerek (zaradi enega ali več naslednjih kliničnih dejavnikov: zmerna do huda okvara ledvic (CrCL 15 - 50 ml/min), majhna telesna masa ali uporaba z določenimi inhibitorji P-gp), dajte 15-miligramski odmerek zdravila Lixiana enkrat na dan skupaj z ustreznim odmerkom VKA.
English: Table 4: Strokes and Systemic Embolic Events in the ENGAGE AF-TIMI 48 Study - mITT, on-treatment
Slovenian: Preglednica 4: Možganske kapi in sistemski embolični dogodki v študiji ENGAGE AF-TIMI 48 (mITT, med zdravljenjem)
English: There is a potential for inadequate anticoagulation during the transition from Lixiana to VKA.
Slovenian: Med prehodom z zdravila Lixiana na VKA obstaja možnost nezadostne antikoagulacije.
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.
Slovenian: Okrajšave:HR = razmerje tveganja proti varfarinu, CI = intervalzaupanja,n = število dogodkov, mITT = modificirana z namenom zdravljenja, N = število preiskovancev v populaciji mITT, SEE = sistemski embolični dogodek.
English: Therefore Lixiana should be used with caution in this population (see sections 4.4 and 5.2).
Slovenian: Zato je treba zdravilo Lixiana pri tej skupini bolnikov previdno uporabljati (glejte poglavji 4.4 in 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).
Slovenian: Zdravnik vam bo naročil, da zmanjšajte odmerek zdravila Lixiana na 30-miligramsko tableto enkrat na dan in jo jemljite skupaj z antagonistom vitamina K (n.pr.
English: INFORMATION IN BRAILLE Lixiana 60 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lixiana 60 mg
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].
Slovenian: V študiji Hokusai-VTE (preglednica 10) je bilo dokazano, da je edoksaban neinferioren varfarinu glede primarnega kriterija učinkovitosti, recidivnega VTE, ki se je pojavil pri 130 od 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].
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).
Slovenian: Plazemska AUC pri preiskovancih z blago (CrCL > 50 - 80 ml/min), zmerno (CrCL 30 - 50 ml/min) in hudo (CrCL < 30 ml/min, ki pa niso na dializi) okvaro ledvic je bila zvečana za 32 %, 74 % oziroma 72 %, v primerjavi s preiskovanci z normalno funkcijo ledvic (glejte poglavje 4.2 za zmanjšanje odmerkov).
English: Lixiana can be initiated or continued in patients who may require cardioversion.
Slovenian: Pri bolnikih, ki bi lahko potrebovali kardioverzijo, je mogoče uvesti zdravilo Lixiana ali nadaljevati z njegovo uporabo.
English: Periodic hepatic monitoring is recommended for patients on Lixiana treatment beyond 1 year.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Lixiana dalj od 1 leta, je priporočljivo spremljanje funkcije jeter v rednih presledkih.
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).
Slovenian: Sočasna uporaba zdravila Lixiana z inhibitorji P-glikoproteina (P-gp) Pri bolnikih, ki sočasno jemljejo zdravilo Lixiana in naslednje inhibitorje P-gp: ciklosporin, dronedaron, eritromicin ali ketokonazol, je priporočeni odmerek 30 mg zdravila Lixiana enkrat na dan (glejte poglavje 4.5).
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).
Slovenian: Pri sočasnem dajanju zdravila Lixiana in ASA pri starejših bolnikih moramo biti previdni zaradi možnega večjega tveganja krvavitve (glejte poglavje 4.5).
English: Subcutaneous anticoagulant (i.e.: LMWH, fondaparinux): Discontinue subcutaneous anticoagulant and start Lixiana at the time of the next scheduled subcutaneous anticoagulant dose.
Slovenian: : heparin z majhno molekulsko maso (LMWH), fondaparinuks): ukinite subkutani antikoagulant in začnite dajati zdravilo Lixiana ob času naslednjega načrtovanega odmerka subkutanega antikoagulanta.
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).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic (CrCL 15 - 50 ml/min) je priporočeni odmerek 30 mg zdravila Lixiana enkrat na dan (glejte poglavje 5.2).
English: Edoxaban Anti-FXa activity pre-dose (IU/mL)2
Slovenian: Aktivnost edoksabana proti faktorju Xa pred odmerkom (IE/ml)2
English: INFORMATION IN BRAILLE Lixiana 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lixiana 15 mg
English: INFORMATION IN BRAILLE Lixiana 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lixiana 30 mg
English: Parenteral option: Discontinue Lixiana and administer a parenteral anticoagulant and VKA at the time of the next scheduled Lixiana dose.
Slovenian: Parenteralna opcija: ukinite zdravilo Lixiana in bolniku dajte parenteralni antikoagulant in VKA ob času naslednjega načrtovanega odmerka zdravila Lixiana.
English: Lixiana should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4).
Slovenian: Zdravilo Lixiana je treba pri bolnikih z blago do zmerno okvaro jeter previdno uporabljati (glejte poglavje 4.4).
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.
Slovenian: • Koagulacijski testi, kot so INR, protrombinski čas (PT) ali aktivirani delni tromboplastinski čas
English: 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.
Slovenian: Pri osebah v skupini z edoksabanom (N = 1067) je prišlo do skupno16 dogodkov (1,5 %, 95-% IZ 0,86 %-2,42 %), pri osebah v skupini z varfarinom (N = 1082) pa do11 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.
English: Primary endpointa
Slovenian: Primarno končno stanjea
English: PVC/Aluminium perforated unit dose blisters of 10 x 1 film-coated tablets.
Slovenian: Enoodmerni perforirani pretisni omoti iz PVC/aluminija s po 10 x 1 filmsko obloženo tableto.
English: Table 2: Switching
Slovenian: Preglednica 2: Zamenjava zdravil
English: In patients with severe hepatic impairment Lixiana is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter zdravila Lixiana ne priporočajo (glejte poglavji 4.4 in 5.2).
English: What Lixiana contains - The active substance is edoxaban (as tosilate).
Slovenian: Kaj vsebuje zdravilo Lixiana - Zdravilna učinkovina jeedoksaban(v obliki edoksabanijevega tozilata).
English: • problems with the blood vessels in your brain or spinal column if you have a mechanical heart valve
Slovenian: • težave s krvnimi žilami v vaših možganih ali hrbtenjači.
English: Talk to your doctor or pharmacist before taking Lixiana,
Slovenian: Pred začetkom jemanja zdravila Lixiana se posvetujte z zdravnikom ali farmacevtom,
English: 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.
Slovenian: Okrajšave: CI = interval zaupanja; GVT = globoka venska tromboza; mITT = modificirana z namenom zdravljenja; HR = razmerje tveganja proti varfarinu; n = število preiskovancev z dogodki; N = število preiskovancev v populaciji mITT; PE = pljučna embolija; VTE = venski trombembolični dogodki a Primarno končno stanje učinkovitosti je simptomatski recidivni VTE po strokovni presoji (t.j.
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.
Slovenian: Zdravljenje GVT, zdravljenje PE in preprečevanje recidivnih GVT in PE (VTE) Klinični program edoksabana za vensko trombembolijo (VTE) je bil zasnovan tako, da bi prikazal učinkovitost in varnost edoksabana za zdravljenje GVT in PE in za preprečevanje recidivnih GVT in PE.
English: Edoxaban should be used with caution when co-administered with P-gp inducers.
Slovenian: Pri sočasni uporabi s spodbujevalci P-gp je treba edoksaban previdno uporabljati.
English: For patients with body weight ≤ 60 kg, the recommended dose is 30 mg Lixiana once daily (see section 5.2).
Slovenian: Pri bolnikih s telesno maso ≤ 60 kg je priporočeni odmerek 30 mg zdravila Lixiana enkrat na dan (glejte poglavje 5.2).
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
Slovenian: EU/1/15/993/025100 filmsko obloženih tablet EU/1/15/993/02610 x 1 filmsko obložena tableta EU/1/15/993/02750 x 1 filmsko obložena tableta EU/1/15/993/028100 x 1 filmsko obložena tableta
English: Therefore Lixiana is contraindicated during breast-feeding (see section 4.3).
Slovenian: Uporaba zdravilaLixianaje med dojenjem kontraindicirana (glejte poglavje 4.3).
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
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/993/00110 filmsko obloženih tablet EU/1/15/993/01610 x 1 filmsko obložena tableta
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
Slovenian: 30-miligramske filmsko obložene tablete: EU/1/15/993/002, EU/1/15/993/004-015 60-miligramske filmsko obložene tablete: EU/1/15/993/003, EU/1/15/993/017-028
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
Slovenian: EU/1/15/993/012100 filmsko obloženih tablet EU/1/15/993/01310 x 1 filmsko obložena tableta EU/1/15/993/01450 x 1 filmsko obložena tableta EU/1/15/993/015100 x 1 filmsko obložena tableta
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).
Slovenian: Zdravnik vam bo naročil, da zmanjšajteodmerek zdravila Lixiana na 15-miligramsko tabletoenkrat na danin jo jemljite skupaj z antagonistom vitamina K (n.pr.
English: • 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.
Slovenian: • 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 Cmax za 85 %.
English: 2 Pre-dose is equivalent to Cmin
Slovenian: 2Pred odmerkom ustreza Cmin.
English: In subgroup analyses, for subjects who were dose reduced to 30 mg in the Hokusai-VTE study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 58 (7.9%) of edoxaban 30 mg dose reduced subjects and 92 (12.8%) of warfarin subjects had a major bleeding or CRNM event [HR (95%): 0.62 (0.44, 0.86)].
Slovenian: V analizi podskupin preiskovancev, ki so imeli v študiji Hokusai-VTE odmerek zmanjšan na 30 mg zaradi telesne mase ≤ 60 kg, zmerne okvare ledvic ali sočasne uporabe inhibitorjev P-gp, je imelo 58 (7,9 %) preiskovancev, ki so prejemali zmanjšan odmerek edoksabana 30 mg, in 92 (12,8 %) preiskovancev, ki so prejemali varfarin, veliko krvavitev ali CRNM dogodek [HR (95 %): 0,62
English: • Bleeding in the bowel
Slovenian: • krvavitev v črevesu,
English: Continued anticoagulant therapy is important in patients with NVAF and VTE.
Slovenian: Zamenjava zdravila Lixiana z drugim zdravilom in obratno Pri bolnikih z NVAF in VTE je pomembna neprekinjena antikoagulantna terapija.
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.
Slovenian: Osebe v skupini zdravljenja z edoksabanom so prejele odmerek 30 mg enkrat na dan, če je bil prisoten vsaj eden od naslednjih kliničnih dejavnikov: zmerna okvara ledvic (CrCL 30-50 ml/min), nizka telesna masa (≤ 60 kg) ali sočasna uporaba specifičnih zaviralcev P-gp.
English: Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Lixiana at the time of the next scheduled dose.
Slovenian: dabigatran, rivaroksaban ali apiksaban)in začnite jemati zdravilo Lixiana ob času naslednjega načrtovanega odmerka.
English: How to take Lixiana).
Slovenian: Kako jemati zdravilo Lixiana 4.
English: • bleeding disorders
Slovenian: • motnje strjevanja krvi,
English: In patients with mild to moderate hepatic impairment the recommended dose is 60 mg Lixiana once daily (see section 5.2).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter je priporočeni odmerek 60 mg zdravila Lixiana enkrat na dan (glejte poglavje 5.2).
English: Discontinue Lixiana and start the non-VKA anticoagulant at the time of the next scheduled dose of Lixiana.
Slovenian: Ukinite zdravilo Lixiana in začnite z antikoagulantom, ki ni VKA, ob času naslednjega načrtovanega odmerka zdravila Lixiana.
English: Macroscopic haematuria/urethral haemorrhage
Slovenian: Bolezni sečil makroskopska hematurija/uretralna krvavitev pogosti
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).
Slovenian: Zdravljenje GVT, zdravljenje PE ter preprečevanje ponovne GVT in PE (VTE) Priporočeni odmerek je 60 mg edoksabana enkrat na dan po začetni vsaj 5-dnevni uporabi parenteralnega antikoagulanta (glejte poglavje 5.1).Edoksabana in začetnega parenteralnega antikoagulanta ne smete dajati sočasno.
English: Lixiana 15 mg: Each tablet contains 15 mg edoxaban (as tosilate).
Slovenian: Lixiana 15 mg: ena tableta vsebuje 15 mg edoksabana (v obliki edoksabanijevega tozilata).
English: In patients with end stage renal disease or on dialysis, Lixiana is not recommended (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z boleznijo ledvic v končnem stadiju ali na dializi zdravila Lixiana ne priporočajo (glejte poglavji 4.2 in 5.2).
English: Changing from Lixiana to parenteral anticoagulants (e.g. heparin)
Slovenian: Prehod z zdravila Lixiana na parenteralne antikoagulante (n.pr.
English: Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Lixiana
Slovenian: Prehod s peroralnih antikoagulantov, ki niso antagonisti vitamina K (dabigatran, rivaroksabanali apiksaban)na zdravilo Lixiana
English: Lixiana 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
Slovenian: Lixiana 30 mg filmsko obložene tablete so rožnate, okrogle,premera 8,5 mm, z vtisnjenim napisom “DSC L30”na eni strani.
English: Lixiana 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).
Slovenian: Lixiana 60 mg: ena tableta vsebuje 60 mg edoksabana (v obliki edoksabanijevega tozilata).
English: Lixiana 30 mg: Each tablet contains 30 mg edoxaban (as tosilate).
Slovenian: Lixiana 30 mg: ena tableta vsebuje 30 mg edoksabana (v obliki edoksabanijevega tozilata).
English: Lixiana 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side.
Slovenian: Lixiana 60 mg filmsko obložene tablete so rumene, okrogle,premera 10,5 mm,z vtisnjenim napisom “DSC L60”na eni strani.
English: Reproductive toxicology
Slovenian: Shranjevanje zdravilaLixiana
English: Tell your doctor immediately if you have taken too many Lixiana tablets.
Slovenian: Če ste vzeli večji odmerek zdravila Lixiana, kot bi smeli Če ste vzeli preveč tablet zdravila Lixiana, to takoj povejte zdravniku.
English: Lixiana 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Slovenian: Lixiana 15 mg:hipromeloza (E464), makrogol 8000, titanov dioksid (E171), smukec, karnauba vosek, rdeči železov oksid (E172), rumeni železov oksid (E172);
English: 15 mg film-coated tablet: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”.
Slovenian: Oranžne, okrogle filmsko obložene tablete, premera 6,7 mm, z vtisnjenim napisom “DSC L15”.
English: • Patient alert card
Slovenian: • kartico z opozorili za bolnika.
English: Lixiana 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172).
Slovenian: Lixiana 30 mg:hipromeloza (E464), makrogol 8000, titanov dioksid (E171), smukec, karnauba vosek, rdeči železov oksid (E172);
English: • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
Slovenian: • protivnetna zdravila in zdravila za lajšanje bolečin (n.pr.
English: It is very important to take Lixiana before and after the operation exactly at the times you have been told by your doctor.
Slovenian: Zelo pomembno je, da zdravilo Lixiana pred kirurškim posegom in po njem jemljete natančno ob predpisanem času, kot vam je svetoval zdravnik.Če je mogoče, nehajte jemati zdravilo Lixiana vsaj 24 ur pred operacijo.
English: Lixiana 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172).
Slovenian: Lixiana 60 mg:hipromeloza (E464), makrogol 8000, titanov dioksid (E171), smukec, karnauba vosek, rumeni železov oksid (E172).
English: EU/1/15/993/017 14 film-coated tablets
Slovenian: EU/1/15/993/01714 filmsko obloženih tablet
English: Lixiana 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Slovenian: Lixiana 60 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
English: EU/1/15/993/020 56 film-coated tablets
Slovenian: EU/1/15/993/02056 filmsko obloženih tablet
English: 60 mg once daily Dose recommendation for patients with one or more of the following clinical factors: Renal Impairment
Slovenian: 60 mg enkrat na dan Priporočila za odmerjanje za bolnike z enim ali več naslednjih kliničnih dejavnikov: okvara ledvic zmerna ali huda (CrCL 15 - 50 ml/min)
English: Lixiana 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Slovenian: Lixiana 15 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b);
English: EU/1/15/993/005 28 film-coated tablets
Slovenian: EU/1/15/993/00528 filmsko obloženih tablet
English: Lixiana 60 mg film-coated tablets
Slovenian: Lixiana 60 mg filmsko obložene tablete edoksaban
English: Median [2.5 - 97.5% range] Prevention of stroke and systemic embolism: NVAF 30 mg QD ≥ 30 to ≤ 50
Slovenian: Preprečevanje možganske kapi in sistemske embolije: NVAF 30 mg enkrat na dan
English: HR (95% CI) First SEE n (%/yr)a
Slovenian: Prvi SEE n (%/leto)a
English: Lixiana 30 mg film-coated tablets
Slovenian: Lixiana 30 mg filmsko obložene tablete edoksaban
English: EU/1/15/993/010 90 film-coated tablets
Slovenian: EU/1/15/993/01090 filmsko obloženih tablet
English: Lixiana 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Slovenian: Lixiana 30 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b);
English: EU/1/15/993/006 30 film-coated tablets
Slovenian: EU/1/15/993/00630 filmsko obloženih tablet
English: EU/1/15/993/007 56 film-coated tablets
Slovenian: EU/1/15/993/00756 filmsko obloženih tablet
English: EU/1/15/993/004 14 film-coated tablets
Slovenian: EU/1/15/993/00414 filmsko obloženih tablet
English: NAME OF THE MEDICINAL PRODUCT Lixiana 60 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Slovenian: IME ZDRAVILA Lixiana 60 mg filmsko obložene tablete edoksaban IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Daiichi-Sankyo (logotip) DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: No dose reduction is required for concomitant use of amiodarone, quinidine or verapamil (see section
Slovenian: Pri sočasni uporabi amiodarona, kinidina ali verapamila ni potrebno nikakršno zmanjševanje odmerka (glejte poglavje 4.5).
English: NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Slovenian: IME ZDRAVILA Lixiana 15 mg filmsko obložene tablete edoksaban IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Daiichi-Sankyo (logotip) DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: EU/1/15/993/018 28 film-coated tablets
Slovenian: EU/1/15/993/01828 filmsko obloženih tablet
English: EU/1/15/993/008 60 film-coated tablets
Slovenian: EU/1/15/993/00860 filmsko obloženih tablet
English: EU/1/15/993/019 30 film-coated tablets
Slovenian: EU/1/15/993/01930 filmsko obloženih tablet
English: EU/1/15/993/023 90 film-coated tablets
Slovenian: EU/1/15/993/02390 filmsko obloženih tablet
English: Changing from Lixiana to vitamin K antagonists (e.g. warfarin)
Slovenian: Prehod z zdravila Lixiana na antagoniste vitamina K (n.pr.
English: Daiichi Sankyo Portugal, Unip.
Slovenian: Daiichi Sankyo Italia S.p.A.
English: NAME OF THE MEDICINAL PRODUCT Lixiana 30 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Slovenian: IME ZDRAVILA Lixiana 30 mg filmsko obložene tablete edoksaban IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Daiichi-Sankyo (logotip) DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets edoxaban
Slovenian: Lixiana 15 mg filmsko obložene tablete edoksaban
English: What Lixiana looks like and contents of the pack Lixiana 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.
Slovenian: Lixiana 15 mg filmsko obložene tablete so oranžne, okrogle,premera 6,7 mm,z vtisnjenim napisom “DSC L15”na eni strani.
English: EU/1/15/993/009 84 film-coated tablets
Slovenian: EU/1/15/993/00984 filmsko obloženih tablet
English: How to take Lixiana
Slovenian: Kako jemati zdraviloLixiana