FrancophonIA/ELRC3.0 huggingface dataset:
English: A post-authorisation study programme that addresses the safety of rivaroxaban in the secondary prevention of Acute Coronary Syndrome (ACS) outside the clinical trial setting, especially with regard to incidence, severity, management and outcome of bleeding events in all population and particularly in patients at increased risk of bleeding consisting of the following remaining studies:
Slovenian: Postavtorizacijski program študij o varnosti rivaroksabana v sekundarni preventivi akutnega koronarnega sindroma (AKS), izven kliničnih preskušanj, predvsem glede pogostnosti, resnosti, ukrepov obvladovanja in izidov krvavitev v celotni populaciji in posebno pri bolnikih s povečanim tveganjem za krvavitve, vključuje še naslednje študije:
English: 47 months
Slovenian: 47 mesecev
English: No specific studies with rivaroxaban in humans have been conducted to evaluate effects on fertility.
Slovenian: Posebnih študij o vplivu rivaroksabana na plodnost pri ljudeh niso izvedli.
English: ♦ Xarelto thins the blood, which prevents you from getting dangerous blood clots.
Slovenian: ♦ Zdravilo redči kri, kar preprečuje nastajanje nevarnih krvnih strdkov.
English: Rivaroxaban is metabolised via CYP3A4, CYP2J2 and CYP-independent mechanisms.
Slovenian: Rivaroksaban se presnovi s CYP3A4, CYP2J2 in z mehanizmi, ki niso odvisni od CYP.
English: As with other anticoagulants, patients taking Xarelto are to be carefully observed for signs of bleeding.
Slovenian: Kot pri uporabi drugih antikoagulantov, je treba bolnike, ki jemljejo zdravilo Xarelto, skrbno nadzorovati glede znakov krvavitve.
English: 6,785 patients with non-valvular atrial fibrillation were enrolled for prevention of stroke and non-central nervous system (CNS) systemic embolism in clinical practice.
Slovenian: V študijo je bilo vključenih 6.785 bolnikov z nevalvularno atrijsko fibrilacijo, ki so zdravilo prejemali za preprečevanje možganske kapi in sistemske embolije izven osrednjega živčevja (CNS) v klinični praksi.
English: Following removal of the catheter, at least 6 hours should elapse before the next rivaroxaban dose is administered.
Slovenian: Po odstranitvi katetra mora preteči vsaj 6 ur do naslednjega odmerka rivaroksabana.
English: Active substances strongly inhibiting only one of the rivaroxaban elimination pathways, either CYP3A4 or P-gp, are expected to increase rivaroxaban plasma concentrations to a lesser extent.
Slovenian: Učinkovine, ki močno zavrejo samo eno od poti izločanja rivaroksabana, bodisi CYP3A4 bodisi P-gp, lahko v manjši meri povečajo koncentracijo rivaroksabana v plazmi.
English: Swallow the tablet preferably with water.
Slovenian: Najbolje je, če tableto zaužijete z vodo.
English: Table 1: Number of patients studied, total daily dose and maximum treatment duration in phase III studies
Slovenian: Preglednica 1: Število preizkušanih bolnikov, skupni dnevni odmerek in najdaljši čas zdravljenja v kliničnih preskušanjih III. faze
English: Figure 2: Time to first occurrence of primary efficacy outcome (stroke, myocardial infarction, cardiovascular death) in COMPASS
Slovenian: Slika 2: Čas do prvega pojava primarnega končnega izida (možganska kap, miokardni infarkt ali kardiovaskularna smrt) v kliničnem preskušanju COMPASS
English: Xarelto can be taken with or without food.
Slovenian: Zdravilo Xarelto lahko jemljete s hrano ali brez nje.
English: 31 months
Slovenian: 31 mesecev
English: 5,142 patients with acute DVT were enrolled to investigate the long-term safety of rivaroxaban compared with standard-of-care anticoagulation therapy in clinical practice.
Slovenian: V študijo je bilo vključenih 5.142 bolnikov z akutno GVT, pri katerih so ocenjevali varnost dolgotrajnega zdravljenja z rivaroksabanom v primerjavi s standardnim antikoagulantnim zdravljenjem v klinični praksi.
English: If you have kidney problems, the dose may be reduced to one tablet Xarelto 15 mg once a day.
Slovenian: Če imate težave z ledvicami, se lahko odmerek zmanjša na eno tableto zdravila Xarelto po 15 mg enkrat na dan.
English: Rivaroxaban 2.5 mg and 10 mg tablets can be taken with or without food.
Slovenian: Tablete po 2,5 mg in 10 mg rivaroksabana se lahko jemljejo skupaj s hrano ali brez nje.
English: (PVC/PVDC/Aluminium foil blisters)
Slovenian: (pretisni omot iz PVC/PVDC/aluminija)
English: The 4-week treatment initiation pack of Xarelto is dedicated to patients who will transition from 15 mg twice daily to 20 mg once daily from Day 22 onwards (see section 6.5).
Slovenian: 4-tedensko začetno pakiranje zdravila Xarelto je namenjeno bolnikom, ki bodo od 22. dne dalje prešli z odmerjanja 15 mg dvakrat na dan na odmerjanje 20 mg enkrat na dan (glejte poglavje 6.5).
English: Placebo 6 or 12 months N=594
Slovenian: placebo 6 ali 12 mesecev n = 594
English: Rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR).
Slovenian: Bolniki z umetnimi zaklopkami Rivaroksaban se ne sme uporabljati za tromboprofilakso pri bolnikih, ki so pred kratkim prestali transkatetrsko zamenjavo aortne zaklopke (TAVR- transcatheter aortic valve replacement).
English: ITT analyses of efficacy in patients with non-valvular atrial fibrillation
Slovenian: ITT analiza učinkovitosti pri bolnikih z nevalvularno atrijsko fibrilacijo
English: Xarelto belongs to a group of medicines called antithrombotic agents.
Slovenian: Zdravilo Xarelto spada v skupino zdravil, imenovanih antitrombotiki.
English: The benefit was driven by a reduction in CV death and MI and appeared early with a constant treatment effect over the entire treatment period (see Table 4 and Figure 1).
Slovenian: Učinek se je pojavil kmalu in je bil konstanten v celotnem obdobju zdravljenja (glejte preglednico 4 in sliko 1).
English: Safety and efficacy of Xarelto have not been studied in patients with prosthetic heart valves; therefore, there are no data to support that Xarelto provides adequate anticoagulation in this patient population.
Slovenian: Varnosti in učinkovitosti zdravila Xarelto niso preučevali pri bolnikih z umetnimi srčnimi zaklopkami, zato ni podatkov, ki bi potrdili da uporaba zdravila Xarelto zagotavlja ustrezno antikoagulacijo pri tej populaciji bolnikov.
English: The risk of bleedings may be increased in certain patient groups, e.g. those patients with uncontrolled severe arterial hypertension and/or on concomitant treatment affecting haemostasis (see section 4.4 “Haemorrhagic risk”).
Slovenian: Tveganje za krvavitve je lahko večje v določenih skupinah bolnikov, npr. pri bolnikih z nenadzorovano hudo arterijsko hipertenzijo in/ali sočasnim zdravljenjem, ki vpliva na hemostazo (glejte poglavje 4.4 Tveganje za krvavitve).
English: 34.9% of patients were treated with acetylsalicylic acid and 11.4% were treated with class III antiarrhythmic including amiodarone.
Slovenian: 34,9 % bolnikov je prejemalo acetilsalicilno kislino in 11,4 % je bilo zdravljenih z antiaritmiki
English: Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of rivaroxaban.
Slovenian: Učinki, ki so jih opazili v študijah toksičnosti ponavljajočih odmerkov so se pojavili večinoma zaradi povečanega farmakodinamičnega delovanja rivaroksabana.
English: PAD patients had previous interventions such as bypass surgery or percutaneous transluminal angioplasty or limb or foot amputation for arterial vascular disease or intermittent claudication with ankle/arm blood pressure ratio < 0.90 and/ or significant peripheral artery stenosis or previous carotid revascularization or asymptomatic carotid artery stenosis ≥ 50%.
Slovenian: Bolniki s PAB so imeli predhodno posege, kot je obvodna operacija ali perkutana transluminalna angioplastika ali amputacija okončine ali stopala zaradi arterijske vaskularne bolezni ali intermitentne klavdikacije z gleženjskim indeksom < 0,90 in/ali pomembne stenoze periferne arterije ali predhodne karotidne revaskularizacije ali asimptomatske stenoze karotidne arterije ≥ 50 %.
English: The final 1/3 of the administered dose undergoes direct renal excretion as unchanged active substance in the urine, mainly via active renal secretion.
Slovenian: Ena tretjina uporabljenega odmerka se kot nespremenjena učinkovina izloči v seču, v glavnem z aktivno ledvično sekrecijo.
English: Bayer Hungária KFT Tel: +36-1-487 4100
Slovenian: Magyarország Bayer Hungária KFT Tel: +36-1-487 4100
English: As with other antithrombotics, rivaroxaban is not recommended in patients with an increased bleeding risk such as:
Slovenian: Tako kot pri drugih antitrombotikih, se uporabe rivaroksabana ne priporoča pri bolnikih s povečanim tveganjem za krvavitve, če imajo/so imeli:
English: What you need to know before you take Xarelto Do not take Xarelto
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xarelto Ne jemljite zdravila Xarelto
English: Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%.
Slovenian: Variabilnost farmakokinetike rivaroksabana je zmerna; interindividualna variabilnost (koeficient variacije %) je od 30 % do 40 %.
English: Exposure is further reduced when rivaroxaban is released in the distal small intestine, or ascending colon.
Slovenian: Izpostavljenost se dodatno zmanjša, če se rivaroksaban sprosti v spodnjem delu tankega črevesa ali v ascendentnem delu debelega črevesa.
English: When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/(100 mcg/l).
Slovenian: Kadar je bil uporabljen Neoplastin, je bil izhodiščni PČ približno 13 sekund in naklon krivulje približno 3 do 4 s/(100 mikrogramov/l).
English: Platelet aggregation inhibitors should be discontinued as suggested by the manufacturer's prescribing information.
Slovenian: Z uporabo zaviralcev agregacije trombocitov je treba prenehati v skladu s priporočili proizvajalca v navodilih za uporabo.
English: Rivaroxaban neither inhibits nor induces any major CYP isoforms like CYP3A4.
Slovenian: Rivaroksaban niti ne zavira niti ne inducira nobene pomembne izooblike CYP, npr. CYP3A4.
English: These active substances are strong inhibitors of both CYP3A4 and P-gp (see section 4.4).
Slovenian: Te učinkovine močno zavirajo CYP3A4 in P-gp (glejte poglavje 4.4).
English: - For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, the recommended dose is 15 mg once daily (see section 5.2).
Slovenian: - Za preprečevanje možganske kapi ali sistemske embolije pri bolnikih z nevalvularno atrijsko fibrilacijo je priporočeni odmerek 15 mg enkrat na dan (glejte poglavje 5.2).
English: Limited clinical data for patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased.
Slovenian: Omejeni klinični podatki pri bolnikih s hudo okvaro ledvic (očistek kreatinina 15 - 29 ml/min) kažejo, da je koncentracija rivaroksabana v plazmi pomembno povečana.
English: The incidence rates for the principal safety outcome (non-coronary artery bypass graft (CABG) TIMI major bleeding events) were higher in patients treated with Xarelto than in patients who received placebo (see Table 6).
Slovenian: Incidenca glavnega varnostnega izida (velika krvavitev po TIMI, ki ni v povezavi z operacijo aortokoronarnih obvodov (CABG - Coronary Artery Bypass Graft)) je bila višja pri bolnikih, zdravljenih z zdravilom Xarelto, kot pri bolnikih, ki so prejemali placebo (glejte preglednico 6).
English: A specific reversal agent (andexanet alfa) antagonising the pharmacodynamic effect of rivaroxaban is available (refer to the Summary of Product Characteristics of andexanet alfa).
Slovenian: Na voljo je specifična protiučinkovina (andeksanet alfa), ki izniči farmakodinamične učinke rivaroksabana (glejte povzetek glavnih značilnosti zdravila za andeksanet alfa).
English: For patients who are unable to swallow whole tablets, Xarelto tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally.
Slovenian: Pri bolnikih, ki cele tablete ne morejo pogoltniti, se lahko tableto zdravila Xarelto tik pred peroralno uporabo zdrobi in zmeša z vodo ali jabolčno čežano.
English: To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring After at least 6 months blood clot treatment, the recommended dose is either one 10 mg tablet once a day or one 20 mg tablet once a day.
Slovenian: Za zdravljenje krvnih strdkov v venah vaših nog in krvnih strdkov v krvnih žilah vaših pljuč ter za preprečevanje ponovnega nastanka krvnih strdkov Po vsaj 6 mesecih zdravljenja krvnih strdkov je priporočeni odmerek ena tableta po 10 mg enkrat na dan ali ena tableta po 20 mg enkrat na dan.
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min) rivaroxaban plasma levels may be significantly increased (1.6 fold on average) which may lead to an increased bleeding risk.
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) so lahko vrednosti rivaroksabana v plazmi pomembno povečane (1,6-kratna povprečna vrednost), kar lahko poveča tveganje za krvavitve.
English: Elderly patients exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 1.5 fold higher, mainly due to reduced (apparent) total and renal clearance.
Slovenian: Pri starejših je bila povprečna AUC približno 1,5-krat večja, predvsem zaradi manjšega (navideznega) celotnega in ledvičnega očistka.
English: Patients received the first dose of Xarelto at a minimum of 24 hours and up to 7 days (mean 4.7 days) after admission to the hospital, but as soon as possible after stabilisation of the ACS event, including revascularisation procedures and when parenteral anticoagulation therapy would normally be discontinued.
Slovenian: Bolniki so prvi odmerek zdravila Xarelto prejeli vsaj po 24 urah in do 7. dne (povprečje 4,7 dni) po sprejemu v bolnišnico, vendar takoj, ko je bilo mogoče po stabilizaciji AKS, vključno s postopkom revaskularizacije in ko se parenteralno antikogulacijsko zdravljenje običajno ukine.
English: Sodium laurilsulphate Magnesium stearate
Slovenian: natrijev lavrilsulfat magnezijev stearat
English: 168 film-coated tablets 196 film-coated tablets 10 x 1 film-coated tablets 100 x 1 film-coated tablets 30 film-coated tablets
Slovenian: 168 filmsko obloženih tablet 196 filmsko obloženih tablet 10 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta 30 filmsko obloženih tablet
English: Day 1 - 21: 30 mg Day 22 and onwards: 20 mg After at least 6 months: 10 mg or 20 mg
Slovenian: - 21. dan: 30 mg 22. dan in naprej: 20 mg po vsaj 6 mesecih: 10 mg ali 20 mg
English: 3,396 patients continued prevention of recurrent venous thromboembolism
Slovenian: Preizkušana populacija 3.396 bolnikov z nadaljevalnim preprečevanjem ponovne venske trombembolije
English: The activated partial thromboplastin time (aPTT) and HepTest are also prolonged dose-dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban.
Slovenian: Podaljšanje aktiviranega parcialnega tromboplastinskega časa (aPTČ) in HepTest sta prav tako odvisna od odmerka; preiskavi nista priporočljivi za ocenjevanje farmakodinamičnega učinka rivaroksabana.
English: 349 [189-362] days 353 [190-362] days 350 [186-362] days
Slovenian: 349 [189-362] dni
English: • If the first and second characters are IT, the manufacturer is Bayer HealthCare Manufacturing Srl.
Slovenian: • Če sta prvi in drugi znak »IT« je proizvajalec Bayer HealthCare Manufacturing Srl.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVIL
English: Xarelto 15 mg and 20 mg are to be taken with food (see section 4.2).
Slovenian: Zdravilo Xarelto 15 mg oziroma 20 mg je treba jemati s hrano (glejte poglavje 4.2).
English: Symptomatic recurrent VTE*
Slovenian: Simptomatska ponovna VTE*
English: Other medicines and Xarelto
Slovenian: Druga zdravila in zdravilo Xarelto
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
Slovenian: To lahko vključuje aktivno ali nedavno razjedo v prebavilih, prisotne maligne neoplazme z visokim tveganjem za krvavitve, nedavno poškodbo možganov ali hrbtenice, nedavni kirurški poseg na možganih, hrbtenici ali očeh, nedavno intrakranialno krvavitev, prisotnost varic požiralnika ali sum nanje, arteriovenske nepravilnosti, žilne anevrizme ali velike intraspinalne ali intracerebralne žilne nepravilnosti.
English: Your doctor will tell you how much of these to take (usually between 75 to 100 mg acetylsalicylic acid daily or a daily dose of 75 to 100 mg acetylsalicylic acid plus a daily dose of either 75 mg clopidogrel or a standard daily dose of ticlopidine).
Slovenian: Zdravnik vam bo svetoval, koliko zdravila morate vzeti (običajno med 75 do 100 mg acetilsalicilne kisline na dan ali dnevni odmerek 75 do 100 mg acetilsalicilne kisline in dnevni odmerek 75 mg klopidogrela ali standardni dnevni odmerek tiklopidina).
English: There were differences in patient baseline characteristics including age, cancer and renal impairment.
Slovenian: Bolniki so se razlikovali v osnovnih značilnostih, kot so na primer starost, rakava obolenja ali okvara ledvic.
English: In Einstein DVT 3,449 patients with acute DVT were studied for the treatment of DVT and the prevention of recurrent DVT and PE (patients who presented with symptomatic PE were excluded from this study).
Slovenian: V kliničnem preskušanju Einstein DVT so preučevali 3.449 bolnikov z akutno GVT pri zdravljenju GVT in preprečevanju ponovne GVT in PE (bolniki, ki so imeli simptomatsko PE, so bili izključeni iz tega preskušanja).
English: In all three phase III studies (see table 4), rivaroxaban significantly reduced the rate of total VTE (any venographically detected or symptomatic DVT, non-fatal PE and death) and major VTE (proximal DVT, non-fatal PE and VTE-related death), the pre-specified primary and major secondary efficacy endpoints.
Slovenian: V vseh treh kliničnih preskušanjih III. faze (glejte preglednico 4) je rivaroksaban značilno zmanjšal delež vseh VTE (z venografijo potrjene ali simptomatske GVT, neusodne PE in smrti), kakor tudi težjih oblik VTE (proksimalne GVT, neusodne PE in smrti, povezane z VTE), kar so bili vnaprej določeni primarni in pomembni sekundarni cilji preskušanja.
English: In patients with an acute thrombotic event or vascular procedure and a need for dual antiplatelet therapy, the continuation of Xarelto 2.5 mg twice daily should be evaluated depending on the type of event or procedure and antiplatelet regimen.
Slovenian: Pri bolnikih z akutnim trombotičnim dogodkom ali posegom na žilah, pri katerih je potrebno dvojno antiagregacijsko zdravljenje je treba nadaljevanje zdravljenja z zdravilom Xarelto 2,5 mg dvakrat na dan oceniti glede na vrsto dogodka ali posega in režima odmerjanja antitrombotikov.
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 (see section 5.2).
Slovenian: Zdrobljeno tableto je treba dati z majhno količino vode po želodčni sondi in jo nato prebrizgati z vodo (glejte poglavje 5.2).
English: Due to the increased bleeding risk care is to be taken if patients are treated concomitantly with any other anticoagulants (see sections 4.3 and 4.4).
Slovenian: Zaradi večjega tveganja za krvavitve je pri bolnikih, ki sočasno prejemajo druga antikoagulacijska zdravila, potrebna previdnost (glejte poglavji 4.3 in 4.4).
English: On the following day you should carry on taking one 15 mg tablet twice a day.
Slovenian: Naslednji dan nadaljujte z jemanjem ene tablete po 15 mg dvakrat na dan.
English: TEE- guided (1 - 5 days of pretreatment) or conventional cardioversion (at least three weeks of pre-treatment) strategies were employed.
Slovenian: Uporabljali so s transezofagealnim ehokardiogramom vodeno (1 - 5 dni predhodnega zdravljenja) ali konvencionalno kardioverzijo (pri najmanj tri tedenskem predhodnem zdravljenju).
English: 41 months
Slovenian: 41 mesecev
English: Interaction with other medicinal products
Slovenian: Interakcije z drugimi zdravili
English: Appropriate symptomatic treatment could be used as needed, such as mechanical compression (e.g. for severe epistaxis), surgical haemostasis with bleeding control procedures, fluid replacement and haemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anaemia or coagulopathy) or platelets.
Slovenian: Po potrebi se lahko uvede ustrezno simptomatsko zdravljenje, kot je mehanska kompresija (npr. v primeru hude epistakse), kirurška hemostaza s postopki za nadzor krvavitev, nadomeščanje tekočine in hemodinamska podpora, dajanje krvnih pripravkov (koncentrirani eritrociti ali sveža zamrznjena plazma, odvisno od prisotnosti anemije ali koagulopatije) ali trombocitov.
English: When concomitantly used in the rivaroxaban clinical programme, numerically higher rates of major or nonmajor clinically relevant bleeding were observed in all treatment groups.
Slovenian: Kadar so jih v kliničnem programu z rivaroksabanom uporabljali sočasno, so pri vseh skupinah bolnikov opazili pogostejše velike ali klinično pomembne majhne krvavitve.
English: 5.9% of patients
Slovenian: 5,9 % bolnikov
English: Rivaroxaban should be discontinued at the first appearance of a severe skin rash (e.g. spreading, intense and/or blistering), or any other sign of hypersensitivity in conjunction with mucosal lesions.
Slovenian: Zdravljenje z rivaroksabanom je treba prekiniti ob prvem pojavu hudega kožnega izpuščaja (tj. obsežen, intenziven in/ali mehurjast izpuščaj) ali katerega koli znaka probčutljivosti, ki se pojavi hkrati s spremembami na sluznicah.
English: * Patients exposed to at least one dose of rivaroxaban The most commonly reported adverse reactions in patients receiving rivaroxaban were bleedings (see section 4.4. and ‘Description of selected adverse reactions' below) (Table 2).
Slovenian: * bolniki, ki so prejeli vsaj en odmerek rivaroksabana Najpogostejši neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali rivaroksaban, so bile krvavitve (preglednica 2) (glejte tudi poglavje 4.4 in "Opis izbranih neželenih učinkov" spodaj).
English: Xarelto contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents.
Slovenian: Zdravilo Xarelto vsebuje učinkovino rivaroksaban in spada v skupino zdravil, imenovanih antitrombotiki.
English: The incidence rates for the primary safety outcome (major or clinically relevant non-major bleeding events) as well as the secondary safety outcome (major bleeding events) were similar for both treatment groups.
Slovenian: Incidence za primarni (velike ali klinično pomembne majhne krvavitve) in sekundarni varnostni izid (velike krvavitve) so bile v obeh zdravljenih skupinah podobne.
English: 59 patients were randomized to rivaroxaban 20 mg (15 mg for patients with creatinine clearance (CrCl) <50 mL/min) and 61 to warfarin (INR 2.0-3.0).
Slovenian: 59 bolnikov so randomizirali na rivaroksaban v jakosti 20 mg (15 mg pri bolnikih z očistkom kreatinina (CrCl) < 50 ml/min), 61 pa na varfarin (INR 2,0-3,0).
English: Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily.
Slovenian: Farmakokinetika rivaroksabana je skoraj linearna do odmerka približno 15 mg enkrat na dan.
English: The primary efficacy outcome was symptomatic recurrent VTE defined as the composite of recurrent DVT or fatal or non-fatal PE.
Slovenian: Primarni izid učinkovitosti je bila ponovna simptomatska VTE, sestavljena iz ponovne GVT ali smrtne ali nesmrtne PE.