FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, phototoxicity, genotoxicity, carcinogenic potential and juvenile toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri posameznih odmerkih, fototoksičnosti, genotoksičnosti, kancerogenega potenciala in juvenilne toksičnosti ne kažejo posebnega tveganja za ljudi.
English: The crushed Xarelto tablet may also be given through gastric tubes after confirmation of the correct gastric placement of the tube.
Slovenian: Zdrobljeno tableto zdravila Xarelto se lahko daje tudi po želodčni sondi, ko je potrjeno, da je le-ta pravilno nameščena v želodcu.
English: PATIENT ALERT CARD Patient Alert Card
Slovenian: OPOZORILNA KARTICA ZA BOLNIKA
English: Among patients in the warfarin group, INR values were within the therapeutic range (2.0 to 3.0) a mean of 55% of the time (median, 58%; interquartile range, 43 to 71).
Slovenian: Med bolniki, ki so prejemali varfarin, je bil INR v terapevskih mejah (2,0 do 3,0) povprečno 55 % časa (srednja vrednost, 58 %; interkvartilni razmik, 43 do 71).
English: The most commonly reported bleedings were epistaxis (4.5 %) and gastrointestinal tract haemorrhage (3.8 %).
Slovenian: Krvavitve, o katerih so najpogosteje poročali, so bile epistaksa (4,5 %) in krvavitve v prebavilih (3,8 %).
English: The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water.
Slovenian: Zdrobljeno tableto je treba dati z majhno količino vode po želodčni sondi in jo nato prebrizgati z vodo.
English: Patients undergoing cardioversion
Slovenian: Bolniki z načrtovano kardioverzijo
English: Patients on treatment with Xarelto and ASA or with Xarelto and ASA plus clopidogrel/ticlopidine should only receive concomitant treatment with NSAIDs if the benefit outweighs the bleeding risk.
Slovenian: Bolniki, ki se zdravijo z zdravilom Xarelto in acetilsalicilno kislino ali z zdravilom Xarelto in acetilsalicilno kislino in klopidogrelom/tiklopidinom, smejo sočasno prejemati NSAID samo, če koristi pretehtajo možna tveganja za krvavitve.
English: The frequencies of adverse reactions reported with Xarelto are summarised in Table 3 below by system organ class (in MedDRA) and by frequency.
Slovenian: Pogostnosti neželenih učinkov, o katerih so poročali pri zdravljenju z zdravilom Xarelto, so povzete v preglednici 3 in prikazane po organskih sistemih (MedDRA) in pogostnosti.
English: What Xarelto looks like and contents of the pack
Slovenian: Izgled zdravila Xarelto in vsebina pakiranja
English: Major bleeding occurred in 2.1 per 100 patient years.
Slovenian: Pojavnost velikih krvavitev je bila 2,1 na 100 bolnikov-let.
English: Death due to bleeding*
Slovenian: Smrt zaradi krvavitve* 27
English: In both the Einstein DVT and the Einstein PE study, the comparator treatment regimen consisted of enoxaparin administered for at least 5 days in combination with vitamin K antagonist treatment until the PT/INR was in therapeutic range (≥ 2.0).
Slovenian: V obeh kliničnih preskušanjih, Einstein DVT in Einstein PE, so kot primerjalni režim zdravljenja uporabili kombinacijo enoksaparina, vsaj 5 dni, in antagonista vitamina K, dokler ni PČ/INR dosegel terapevtske vrednosti (≥ 2,0).
English: The rivaroxaban clinical programme was designed to demonstrate the efficacy of Xarelto for the prevention of cardiovascular (CV) death, myocardial infarction (MI) or stroke in subjects with a recent ACS (ST-elevation myocardial infarction [STEMI], non- ST-elevation myocardial infarction [NSTEMI] or unstable angina [UA]).
Slovenian: Klinični program rivaroksabana je bil zasnovan tako, da dokaže učinkovitost zdravila Xarelto pri preprečevanju kardiovaskularne (KV) smrti, miokardnega infarkta (MI) ali možganske kapi pri bolnikih z nedavnim AKS (miokardnega infarkta z elevacijo spojnice ST [STEMI], miokardnega infarkta brez elevacije spojnice ST [NSTEMI] ali nestabilno angino pektoris).
English: If it is desired to test the pharmacodynamic effects of warfarin during the conversion period, INR measurement can be used at the Ctrough of rivaroxaban (24 hours after the previous intake of rivaroxaban) as this test is minimally affected by rivaroxaban at this time point.
Slovenian: Za preiskavo farmakodinamičnih učinkov varfarina v prehodnem obdobju se lahko izmeri vrednosti INR pri najnižji koncentraciji rivaroksabana (24 ur po predhodnem odmerku rivaroksabana), saj v tem času rivaroksaban le malo vpliva na to preiskavo.
English: Treatment initiation pack for the first 4 weeks of treatment:
Slovenian: Začetno pakiranje za prve 4 tedene zdravljenja:
English: Jaundice, Bilirubin conjugated increased (with or without concomitant increase of ALT), Cholestasis, Hepatitis (incl.
Slovenian: zlatenica, povečane vrednosti konjugiranega bilirubina (z ali brez sočasnega povečanja vrednosti ALT), holestaza, hepatitis (vključno s hepatocelularno poškodbo)
English: The mean CHADS2 and HAS-BLED scores were both 2.0 in XANTUS, compared to a mean CHADS2 and HAS-BLED score of 3.5 and 2.8 in ROCKET AF, respectively.
Slovenian: Povprečna vrednost CHADS2 in ocena HAS-BLED sta bili v študiji XANTUS obe 2,0, v primerjavi s povprečno vrednostjo CHADS2 in oceno HAS-BLED, ki sta bili v študiji ROCKET AF 3,5 oz. 2,8.
English: In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with Xarelto 10 mg once daily, a dose of Xarelto 20 mg once daily should be considered.
Slovenian: Pri bolnikih, pri katerih je tveganje za ponovno GVT ali PE veliko, na primer pri tistih z zapletenimi sočasnimi boleznimi, ali pri tistih, ki so imeli ponovno GVT ali PE pri podaljšanem preventivnem zdravljenju z zdravilom Xarelto 10 mg enkrat na dan, je treba razmisliti o uporabi zdravila Xarelto 20 mg enkrat na dan.
English: Xarelto should not be used in combination with certain other medicines which reduce blood clotting such as prasugrel or ticagrelor other than acetylsalicylic acid and clopidogrel/ticlopidine.
Slovenian: Zdravila Xarelto se ne sme uporabljati skupaj z nekaterimi drugimi zdravili, ki preprečujejo nastajanje krvnih strdkov, kot so npr. prasugrel ali tikagrelor, izjemi sta acetilsalicilna kislina in klopidogrel/tiklopidin.
English: Safety and efficacy of Xarelto have not been established in pregnant women.
Slovenian: Varnost in učinkovitost zdravila Xarelto pri nosečnicah nista bili dokazani.
English: • bronchiectasis or history of pulmonary bleeding
Slovenian: • bronhiektazije ali v anamnezi krvavitev v pljučih.
English: The frequency of this side effect is very rare (up to 1 in 10,000).
Slovenian: Ta neželeni učinek je zelo redek (pri največ 1 od 10.000 bolnikov).
English: What Xarelto is and what it is used for What you need to know before you take Xarelto How to take Xarelto
Slovenian: Kaj je zdravilo Xarelto in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xarelto Kako jemati zdravilo Xarelto Možni neželeni učinki
English: Therefore, Xarelto is not recommended for use in children below 18 years of age.
Slovenian: Uporabe zdravila Xarelto se ne priporoča pri osebah, mlajših od 18 let.
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations Xarelto is to be used with caution (see section 4.5).
Slovenian: Pri bolnikih z zmerno okvaro ledvic (očistek kreatinina 30 - 49 ml/min), ki sočasno prejemajo druga zdravila, ki povečajo plazemsko koncentracijo rivaroksabana, je treba zdravilo Xarelto uporabljati previdno (glejte poglavje 4.5).
English: Safety and efficacy of Xarelto 2.5 mg twice daily in combination with ASA plus clopidogrel/ticlopidine has only been studied in patients with recent ACS (see section 4.1).
Slovenian: Varnost in učinkovitost uporabe zdravila Xarelto 2,5 mg dvakrat na dan v kombinaciji z acetilsalicilno kislino in klopidogrelom/tiklopidinom so preučevali le pri bolnikih z nedavnim AKS (glejte poglavje 4.1).
English: Each of the rivaroxaban regimens showed a significant reduction in clinically significant bleeding events compared to the VKA regimen in patients with non-valvular atrial fibrillation who underwent a PCI with stent placement.
Slovenian: Vsak od režimov zdravljenja z rivaroksabanom je pokazal pomembno zmanjšanje klinično pomembnih krvavitev v primerjavi z zdravljenjem z antagonisti vitamina K pri bolnikih z nevalvularno atrijsko fibrilacijo, pri katerih je bila narejena perkutana koronarna intervencija z vstavitvijo žilne opornice.
English: The results of this patient population were also consistent with the overall efficacy and safety results.
Slovenian: Izvidi pri tej populaciji so v skladu s splošno učinkovitostjo in izsledki glede varnosti.
English: Treatment with Xarelto after an acute coronary syndrome should be started as soon as possible after stabilisation of the acute coronary syndrome, at the earliest 24 hours after admission to hospital and at the time when parenteral (via injection) anticoagulation therapy would normally be stopped.
Slovenian: Zdravljenje z zdravilom Xarelto po akutnem koronarnem sindromu morate začeti čimprej po stabilizaciji akutnega koronarnega sindroma, najprej 24 ur po sprejemu v bolnišnico in takrat, ko se parenteralno antikoagulacijsko zdravljenje (z injekcijami) običajno ukine.
English: Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.
Slovenian: Pri odločitvi glede uvedbe in trajanja zdravljenja pri bolnikih z načrtovano kardioverzijo je treba upoštevati uveljavljene smernice/priporočila za antikoagulacijsko zdravljenje.
English: How much to take
Slovenian: Kolikšen odmerek zdravila morate vzeti
English: 6.8% of patients
Slovenian: 6,8 % bolnikov
English: 0.15 per 100 patient years** * For all rivaroxaban studies all bleeding events are collected, reported and adjudicated.
Slovenian: 0,15 na 100 bolnikovlet** * Zbrali, poročali in presojali so o vseh krvavitvah iz vseh študij z rivaroksabanom.
English: Do not use this medicine after the expiry date which is stated on the carton and on each blister or bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na vsakem pretisnem omotu ali plastenki poleg oznake EXP.
English: In addition to the phase III EINSTEIN programme, a prospective, non-interventional, open-label cohort study (XALIA) with central outcome adjudication including recurrent VTE, major bleeding and death has been conducted.
Slovenian: Poleg III. faze programa EINSTEIN je bila izvedena prospektivna, neintervencijska, odprta kohortna študija (XALIA) z osrednjo obravnavo izidov ponovnih VTE, velikih krvavitev in smrti.
English: After at least 6 months: 10 mg or 20 mg
Slovenian: 20 mg po vsaj 6 mesecih: 10 mg ali 20 mg
English: CAD patients had multivessel CAD and/or prior MI. For patients < 65 years of age atherosclerosis involving at least two vascular beds or at least two additional cardiovascular risk factors were required.
Slovenian: Bolniki, mlajši od 65 let so imeli aterosklerozo na vsaj dveh žilnih povirjih ali vsaj dva dodatna dejavnika tveganja za kardiovaskularno bolezen.
English: Converting patients from the vitamin K antagonist warfarin (INR 2.0 to 3.0) to rivaroxaban (20 mg) or from rivaroxaban (20 mg) to warfarin (INR 2.0 to 3.0) increased prothrombin time/INR (Neoplastin) more than additively (individual INR values up to 12 may be observed), whereas effects on aPTT, inhibition of factor Xa activity and endogenous thrombin potential were additive.
Slovenian: Pri prehodu bolnikov z varfarina, antagonista vitamina K, (INR 2,0 do 3,0) na rivaroksaban (20 mg) ali z rivaroksabana (20 mg) na varfarin (INR 2,0 do 3,0) je bilo podaljšanje protrombinskega časa/INR (Neoplastin) več kot aditivno (pri posameznikih je mogoče opaziti vrednosti INR do 12), medtem ko so bili učinki na aPTČ, zaviranje aktivnosti faktorja Xa in endogeni potencial trombina aditivni.
English: Once Xarelto is discontinued INR testing may be done reliably at least 24 hours after the last dose (see sections 4.5 and 5.2).
Slovenian: Ko se zdravilo Xarelto preneha uporabljati, se vrednosti INR lahko zanesljivo določijo šele 24 ur po zadnjem odmerku zdravila Xarelto (glejte poglavji 4.5 in 5.2).
English: Xarelto should be used with caution in patients with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations (see section 4.5).
Slovenian: Zdravilo Xarelto je treba uporabljati previdno pri bolnikih z okvaro ledvic, ki sočasno prejemajo druga zdravila, ki povečajo plazemsko koncentracijo rivaroksabana (glejte poglavje 4.5).
English: Fatal haemorrhage was reported in 0.2 per 100 patient years and intracranial haemorrhage in 0.4 per 100 patient years.
Slovenian: Pojavnost krvavitev s smrtnim izidom je bila 0,2 na 100 bolnikov-let in intrakranialnih krvavitev 0,4 na 100 bolnikov-let.
English: If necessary, your doctor may also give you the crushed Xarelto tablet through a stomach tube.
Slovenian: Po potrebi boste prejeli zdrobljeno tableto zdravila Xarelto tudi po želodčni sondi.
English: Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA) (see section 4.4).
Slovenian: Sočasno zdravljenje AKS z antitrombotiki pri bolnikih s predhodno možgansko kapjo ali prehodnim ishemičnim napadom (TIA - Transient Ischaemic Attack) (glejte poglavje 4.4).
English: Patients with non-valvular atrial fibrillation who undergo PCI (percutaneous coronary intervention) with stent placement
Slovenian: Bolniki z nevalvularno atrijsko fibrilacijo, pri katerih je bila narejena perkutana koronarna intervencija (PCI - Percutaneous Coronary Intervention) z vstavitvijo žilne opornice
English: Treatment of DVT, PE and prevention of recurrent DVT and PE The Xarelto clinical programme was designed to demonstrate the efficacy of Xarelto in the initial and continued treatment of acute DVT and PE and prevention of recurrence.
Slovenian: Zdravljenje GVT, PE in preprečevanje ponovne GVT in PE Klinični program za zdravilo Xarelto je bil zasnovan tako, da dokaže učinkovitost zdravila Xarelto v začetnem in nadaljevalnem zdravljenju akutne GVT in PE ter pri preprečevanju ponovne GVT in PE.
English: HDPE bottles with a PP screw cap containing 100 film-coated tablets.
Slovenian: HDPE vsebnik s PP navojno zaporko, po 100 filmsko obloženih tablet.
English: After at least 6 months blood clot treatment your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.
Slovenian: 6 mesecih zdravljenja krvnih strdkov se lahko zdravnik odloči, da se zdravljenje nadaljuje z eno tableto po 10 mg enkrat na dan ali z eno tableto po 20 mg enkrat na dan.
English: Take the tablet(s) every day until your doctor tells you to stop.
Slovenian: Tableto(-e) vzemite vsak dan, dokler vam zdravnik ne bo svetoval, da zdravilo prenehate jemati.
English: Your doctor will also tell you to take acetylsalicylic acid.
Slovenian: Zdravnik vam bo naročil, da poleg zdravila Xarelto jemljete tudi acetilsalicilno kislino.
English: The interaction with erythromycin is likely not clinically relevant in most patients but can be potentially significant in high-risk patients.
Slovenian: Medsebojno delovanje z eritromicinom pri večini bolnikov najverjetneje ni klinično pomembno, vendar je lahko potencialno pomembno pri bolnikih z visokim tveganjem.
English: In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Slovenian: Zlasti pri trojno pozitivnih bolnikih (za lupusni antikoagulant, protitelesa proti kardiolipinu in protitelesa proti beta 2glikoproteinu I) je zdravljenje s peroralnimi antikoagulanti z neposrednim delovanjem v primerjavi z zdravljenjem z antagonisti vitamina K lahko povezano s povečano pogostnostjo ponavljajočih se trombotičnih dogodkov.
English: Event rate (100 pt-yr)
Slovenian: pojavnost dogodkov (100 bolnikov-let)
English: However, if clinically indicated, rivaroxaban levels can be measured by calibrated quantitative antifactor-Xa tests (see section 5.2).
Slovenian: Če je klinično indicirano, se lahko vrednosti rivaroksabana določi s kalibriranim kvantitativnim merjenjem aktivnosti anti-FXa (glejte poglavje 5.2).
English: HR (95% CI) p-value, test for superiority
Slovenian: razmerje tveganja (95-odstotni interval zaupanja) vrednost p, test za superiornost
English: Xarelto reduces the risk in adults of getting blot clots (atherothrombotic events).
Slovenian: Zdravilo Xarelto zmanjša tveganje nastanka krvnih strdkov pri odraslih (aterotrombotični dogodki).
English: In patients receiving Xarelto for VTE prevention following elective hip or knee replacement surgery, this may be done by regular physical examination of the patients, close observation of the surgical wound drainage and periodic measurements of haemoglobin.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Xarelto za preprečevanje VTE po načrtovani kirurški zamenjavi kolka ali kolena, je to mogoče doseči z rednimi kliničnimi pregledi bolnikov, natančnim opazovanjem sekrecije iz kirurške rane in občasnimi meritvami hemoglobina.
English: Xarelto 20 mg once daily was compared with placebo.
Slovenian: Zdravilo Xarelto v odmerku 20 mg enkrat na dan so primerjali s placebom.
English: Like all medicines, Xarelto can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Xarelto neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability.
Slovenian: Rivaroksaban je zelo selektiven direkten peroralno učinkovit zaviralec faktorja Xa.
English: The recommended dose is one tablet Xarelto 15 mg twice a day for the first 3 weeks.
Slovenian: Priporočeni odmerek je ena tableta zdravila Xarelto po 15 mg dvakrat na dan prve 3 tedne.
English: These active substances are strong inhibitors of both CYP3A4 and P-gp and therefore may increase rivaroxaban plasma concentrations to a clinically relevant degree (2.6 fold on average) which may lead to an increased bleeding risk (see section 4.5).
Slovenian: Te učinkovine močno zavirajo CYP3A4 in P-gp ter lahko klinično pomembno (2,6-kratna povprečna vrednost) povečajo plazemske koncentracije rivaroksabana, kar lahko poveča tveganje za krvavitve (glejte poglavje 4.5).
English: PC (only applicable for outer carton, not applicable for bottle label) SN (only applicable for outer carton, not applicable for bottle label) NN (only applicable for outer carton, not applicable for bottle label)
Slovenian: PC (samo za škatlo, ne za nalepko za plastenko) SN (samo za škatlo, ne za nalepko za plastenko) NN (samo za škatlo, ne za nalepko za plastenko)
English: hepatocellular injury)
Slovenian: (vključno s hepatocelularno poškodbo)
English: - The active substance is rivaroxaban.
Slovenian: - Učinkovina je rivaroksaban.
English: There were no clinically relevant differences in pharmacokinetics and pharmacodynamics between male and female patients.
Slovenian: Med bolniki in bolnicami ni bilo klinično pomembnih razlik v farmakokinetiki in farmakodinamiki.
English: Try to take the tablet(s) at the same time every day to help you to remember it.
Slovenian: Najbolje je, če tableto(-e) vzamete vsak dan ob istem času, da je (jih) ne boste pozabili vzeti.
English: However the incidence rates were balanced between Xarelto and placebo for the components of fatal bleeding events, hypotension requiring treatment with intravenous inotropic agents and surgical intervention for ongoing bleeding.
Slovenian: Vendar pa je bila incidenca posameznih komponent sestavljenega opazovanega dogodka med zdravilom Xarelto in placebom uravnotežena: krvavitev s smrtnim izidom, hipotenzija, ki jo je bilo treba zdraviti z intravenskimi inotropnimi učinkovinami in kirurški poseg zaradi trajajoče krvavitve.
English: Absorption of rivaroxaban is dependent on the site of its release in the gastrointestinal tract.
Slovenian: Absorpcija rivaroksabana je odvisna od mesta sproščanja v prebavilih.
English: Symptomatic PE and DVT 0
Slovenian: Simptomatska PE in GVT 0
English: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery The rivaroxaban clinical programme was designed to demonstrate the efficacy of rivaroxaban for the prevention of VTE, i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs.
Slovenian: Preprečevanje VTE pri odraslih bolnikih po načrtovani kirurški zamenjavi kolka ali kolena Klinični program z rivaroksabanom je bil zasnovan tako, da dokaže učinkovitost rivaroksabana pri preprečevanju VTE, tj. proksimalne in distalne globoke venske tromboze (GVT) in pljučne embolije (PE), pri bolnikih z velikimi ortopedskimi kirurškimi posegi na spodnjih okončinah.
English: Take the tablet every day until your doctor tells you to stop.
Slovenian: Vsak dan zaužijte po eno tableto, dokler vam zdravnik ne bo svetoval, da zdravilo prenehate jemati.
English: This Xarelto 15 mg and 20 mg treatment initiation pack is only for the first 4 weeks of treatment.
Slovenian: To začetno pakiranje zdravila Xarelto 15 mg oziroma 20 mg je samo za prve 4 tedne zdravljenja.
English: Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
Slovenian: Zdravilo Xarelto, ki se jemlje sočasno z acetilsalicilno kislino, je indicirano za preprečevanje aterotrombotičnih dogodkov pri odraslih bolnikih s koronarno boleznijo (KB) ali simptomatsko periferno arterijsko boleznijo (PAB) z velikim tveganjem za ishemične dogodke.
English: a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome).
Slovenian: reakcija na zdravilo, ki povzroča izpuščaj, zvišano telesno temperaturo, vnetje notranjih organov, hematološke nepravilnosti in sistemsko bolezen (sindrom DRESS).
English: There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin in individuals receiving rivaroxaban.
Slovenian: Pri osebah, ki prejemajo rivaroksaban, je malo izkušenj s traneksamično kislino in ni izkušenj z aminokaprojsko kislino in aprotininom.
English: All-cause mortality a) Safety population, on treatment * Nominally significant
Slovenian: a) skupina preizkušancev za oceno varnosti zdravila, zdravljena * nominalno statistično značilno
English: Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is estimated to be low (see section 5.2).
Slovenian: Vstavitev ali odstranitev epiduralnega katetra ali lumbalno punkcijo je najbolje opraviti, kadar se oceni, da je antikoagulacijski učinek rivaroksabana majhen (glejte poglavje 5.2).
English: 1.6% of patients
Slovenian: 1,6 % bolnikov
English: 93.2% of patients received ASA concomitantly plus thienopyridine treatment and 6.8% ASA only.
Slovenian: 93,2 % bolnikov je sočasno prejemalo acetilsalicilno kislino in tienopiridin in 6,8 % bolnikov samo acetilsalicilno kislino.
English: CYP3A4 and P-gp inhibitors
Slovenian: Zaviralci CYP3A4 in P-gp
English: INR values were within the therapeutic range a mean of 63% of the time for the mean treatment duration of 215 days, and 57%, 62%, and 65% of the time in the 3-, 6-, and 12-month intended treatment duration groups, respectively.
Slovenian: INR vrednosti so bile v terapevtskih mejah povprečno 63 % časa pri povprečnem trajanju zdravljenja 215 dni in 57 %, 62 % in 65 % časa pri 3-, 6-, in 12-mesecih načrtovanega trajanja zdravljenja v posamezni skupini.