FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients receiving rivaroxaban 2.5 mg twice daily for the prevention of atherothrombotic events in patients with ACS the geometric mean concentration (90% prediction interval) 2 - 4 h and about 12 h after dose (roughly representing maximum and minimum concentrations during the dose interval) was 47 (13 - 123) and 9.2 (4.4 - 18) mcg/l, respectively.
Slovenian: Pri bolnikih, ki so prejemali rivaroksaban 2,5 mg dvakrat na dan za preprečevanje aterotrombotičnih dogodkov pri bolnikih z AKS, je bila geometrična povprečna koncentracija (90 % napovedanega intervala odmerjanja) 2 do 4 ure oziroma približno 12 ur po odmerku (v grobem predstavlja največje in najmanjše koncentracije med odmerki) 47 (13 - 123) oziroma 9,2 (4,4 - 18) mikrogramov/l.
English: In patients receiving rivaroxaban for treatment of acute DVT 20 mg once daily the geometric mean concentration (90% prediction interval) 2 - 4 h and about 24 h after dose (roughly representing maximum and minimum concentrations during the dose interval) was 215 (22 - 535) and 32 (6239) mcg/l, respectively.
Slovenian: Pri bolnikih, ki so prejemali rivaroksaban za zdravljenje akutne globoke venske tromboze (GVT) v odmerku 20 mg enkrat na dan, je bila geometrična povprečna koncentracija (90 % napovedanega intervala odmerjanja) 2 do 4 ure oziroma približno 24 ur po odmerku (v grobem predstavlja največje in najmanjše koncentracije med odmerki) 215 (22 - 535) oziroma 32 (6 - 239) mikrogramov/l.
English: Each tablet contains 2.5 mg of rivaroxaban.
Slovenian: Ena tableta vsebuje 2,5 mg rivaroksabana.
English: Short duration of therapy (at least 3 months) should be considered in patients with DVT or PE provoked by major transient risk factors (i.e. recent major surgery or trauma).
Slovenian: Pri bolnikih z GVT ali PE, izzvano s pomembnimi prehodnimi dejavniki tveganja (tj. nedavni večji kirurški poseg ali poškodba) je treba razmisliti o kratkotrajnem zdravljenju (vsaj 3-mesečnem).
English: The recommended dose is 20 mg once daily, which is also the recommended maximum dose.
Slovenian: Preprečevanje možganske kapi in sistemske embolije Priporočeni odmerek je 20 mg enkrat na dan, kar je tudi priporočeni največji odmerek.
English: 5 mg coadministered with ASA or 10 mg alone
Slovenian: 5 mg sočasno z acetilsalicilno kislino ali samo 10 mg
English: Symptomatic recurrent DVT 18
Slovenian: Simptomatska ponovna VTE* Simptomatska ponovna PE Simptomatska ponovna GVT 18
English: Furthermore, in all three studies the rate of symptomatic VTE (symptomatic DVT, nonfatal PE, VTE-related death) was lower in rivaroxaban treated patients compared to patients treated with enoxaparin.
Slovenian: (simptomatske GVT, neusodne PE, smrti povezane z VTE) je bil v vseh treh kliničnih preskušanjih manjši pri bolnikih, ki so prejemali rivaroksaban v primerjavi z bolniki, ki so prejemali enoksaparin.
English: Exclusion criteria included the need for dual antiplatelet or other non-ASA antiplatelet or oral anticoagulant therapy and patients with high bleeding risk, or heart failure with ejection fraction < 30% or New York Heart Association class III or IV, or any ischaemic, non-lacunar stroke within 1 month or any history of haemorrhagic or lacunar stroke.
Slovenian: Med izključitvenimi kriteriji so bili potreba po dvojnem antiagregacijskem zdravljenju ali drugem antagregacijskem ali peroralnem antikoagulantnem zdravljenju brez acetilsalicilne kisline, visoko tveganje za krvavitve, srčno popuščanje z iztisnim deležem < 30 %, III .
English: If you need to have an operation it is very important to take Xarelto before and after the operation exactly at the times you have been told by your doctor.
Slovenian: Če je pri vas potreben kirurški poseg - Zelo pomembno je, da zdravilo Xarelto pred kirurškim posegom in po njem jemljete natančno ob predpisanem času, kot vam ga je svetoval zdravnik.
English: Tell your doctor immediately if you experience any of the following side effects: - swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.
Slovenian: Možni neželeni učinki, ki so lahko znak hude alergijske reakcije Takoj obvestite zdravnika, če se vam pojavi kateri od naslednjih neželenih učinkov: oteklost obraza, ustnic, ust, jezika ali žrela; težave pri požiranju; koprivnica in težave z dihanjem; nenadno znižanje krvnega tlaka.
English: Patients with non-valvular atrial fibrillationa)
Slovenian: Preizkušana populacija Bolniki z nevalvularno atrijsko fibrilacijoa)
English: There is neither scientific rationale for benefit nor experience with the use of the systemic haemostatic desmopressin in individuals receiving rivaroxaban.
Slovenian: Koristi uporabe sistemskega hemostatika dezmopresina pri osebah, ki prejemajo rivaroksaban, niso strokovno utemeljene, prav tako ni izkušenj z njegovo uporabo.
English: 2.5 per 100 patient years
Slovenian: 2,5 na 100 bolnikov-let
English: Figure 1: Time to first occurrence of primary efficacy endpoint (CV death, MI or stroke)
Slovenian: Slika 1: Čas do prvega pojava primarnega končnega izida (kardiovaskularna smrt, miokardni infarkt ali možganska kap)
English: Erythromycin (500 mg three times a day), which inhibits CYP3A4 and P-gp moderately, led to a 1.3 fold increase in mean rivaroxaban AUC and Cmax.
Slovenian: Eritromicin (500 mg trikrat na dan), ki zmerno zavira CYP3A4 in P-gp, je povzročil 1,3-kratno povečanje povprečne AUC in Cmax rivaroksabana.
English: Xarelto should be restarted as soon as possible after the invasive procedure or surgical intervention provided the clinical situation allows and adequate haemostasis has been established as determined by the treating physician (see section 5.2).
Slovenian: Po invazivnem postopku ali kirurškem posegu je treba zdravilo Xarelto ponovno uvesti takoj ko je mogoče glede na klinično sliko in ko je po presoji lečečega zdravnika vzpostavljena ustrezna hemostaza (glejte poglavje 5.2).
English: Tablet film coat: macrogol 3350, hypromellose 2910, titanium dioxide (E 171), iron oxide yellow (E 172).
Slovenian: Filmska obloga tablete: makrogol 3350, hipromeloza 2910, titanov dioksid (E 171), rumeni železov oksid (E 172).
English: Τηλ: +30-210-618 75 00
Slovenian: Bayer Ελλάς ΑΒΕΕ Τηλ: +30-210-618 75 00
English: 40 mg od 35 ± 4 days p Rivaroxaban 10 mg od 35 ± 4 days
Slovenian: 35 ± 4 dni p rivaroksaban 10 mg enkrat na dan
English: Safety and efficacy of Xarelto have not been established in breast-feeding women.
Slovenian: Varnost in učinkovitost zdravila Xarelto pri doječih materah nista bili dokazani.
English: No data are available for such patients with a history of stroke/TIA.
Slovenian: Podatkov za te bolnike, ki imajo v anamnezi tudi možgansko kap/TIA, ni na voljo.
English: From Day 22: One 20 mg tablet once a day (taken at same time each day).
Slovenian: od 22. dneva: ena tableta po 20 mg enkrat na dan (vzeta vsak dan ob istem času).
English: If you are taking one 20 mg tablet or one 15 mg tablet once a day and have missed a dose, take it as soon as you remember.
Slovenian: - Če jemljete eno tableto po 20 mg ali eno tableto po 15 mg enkrat na dan in ste pozabili vzeti odmerek, ga vzemite takoj ko se spomnite.
English: Fluconazole (400 mg once daily), considered as a moderate CYP3A4 inhibitor, led to a 1.4 fold increase in mean rivaroxaban AUC and a 1.3 fold increase in mean Cmax.
Slovenian: Flukonazol (400 mg enkrat na dan), ki zmerno zavira CYP3A4, je povzročil 1,4-kratno povečanje povprečne AUC in 1,3-kratno povečanje povprečne Cmax rivaroksabana.
English: Rivaroxaban has not been studied in interventional clinical studies in patients undergoing hip fracture surgery to evaluate efficacy and safety.
Slovenian: Kirurški poseg pri zlomu kolka Intervencijskih kliničnih študij o učinkovitosti in varnosti rivaroksabana pri bolnikih s kirurškim posegom zaradi zloma kolka niso izvedli.
English: Each tablet contains 15 mg or 20 mg of rivaroxaban.
Slovenian: Ena tableta vsebuje 15 mg ali 20 mg rivaroksabana.
English: Major bleeding occurred in 35 (0.4%) and 29 (0.3%) of patients in the rivaroxaban and standard-of-care groups (HR 1.10; 95% CI 0.67-1.80).
Slovenian: Velike krvavitve so se pojavile pri 35 (0,4 %) bolnikih v skupini, ki je prejemala rivaroksaban in pri 29 (0,3 %) bolnikih v skupini s standardno oskrbo (razmerje tveganja 1,10; 95 % interval zaupanja 0,67 - 1,80).
English: Patients with a history of stroke or TIA were excluded.
Slovenian: Bolniki z anamnezo možganske kapi/TIA so bili izključeni.
English: Rivaroxaban 10 mg once daily (od) started no sooner than 6 hours post-operatively was compared with enoxaparin 40 mg once daily started 12 hours pre-operatively.
Slovenian: Primerjali so delovanje rivaroksabana v odmerku 10 mg enkrat na dan in enoksaparina v odmerku 40 mg enkrat na dan. Bolniki niso prejeli prvega odmerka rivaroksabana prej kot 6 ur po kirurškem posegu.
English: On the fourth day after the last dose of warfarin, all tests (including PT, aPTT, inhibition of factor Xa activity and ETP) reflected only the effect of rivaroxaban.
Slovenian: Četrti dan po zadnjem odmerku varfarina so vsi izvidi (vključno s PČ, aPTČ,
English: - With overnight stay p < 0.00001
Slovenian: Prenočitev p < 0,00001
English: Do not start taking Xarelto if you know you are at risk of bleeding, without first discussing this with your doctor.
Slovenian: Če veste, da pri vas obstaja tveganje za krvavitve, ne začnite z jemanjem zdravila Xarelto, dokler se ne posvetujete z zdravnikom.
English: Within the highest tertile according to centre, the HR with rivaroxaban versus warfarin was 0.642 (95% CI: 0.277 - 1.484).
Slovenian: V najvišji tercili glede na sredino je bilo razmerje tveganja z rivaroksabanom v primerjavi z varfarinom 0,642 (95 % IZ: 0,277 - 1,484).
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp), atorvastatin (substrate of CYP3A4 and P-gp) or omeprazole (proton pump inhibitor).
Slovenian: Med sočasno uporabo rivaroksabana in midazolama (substrat CYP3A4), digoksina (substrat P-gp), atorvastatina (substrat CYP3A4 in P-gp) ali omeprazola (zaviralec protonske črpalke) niso ugotovili klinično pomembnega farmakokinetičnega ali farmakodinamičnega medsebojnega delovanja.
English: Xarelto 10 mg od N=1,127
Slovenian: zdravilo Xarelto 10 mg enkrat na dan n = 1.127
English: For PT, the linear intercept model generally described the data better.
Slovenian: Za PČ, je bolj primeren linearni model.
English: Day 1 to 21: One 15 mg tablet twice a day (one 15 mg tablet in the morning and one in the evening).
Slovenian: 1. do 21. dan: ena tableta po 15 mg dvakrat na dan (ena tableta po 15 mg zjutraj in ena zvečer).
English: Posology The recommended dose is 2.5 mg twice daily.
Slovenian: Priporočeni odmerek je 2,5 mg dvakrat na dan.
English: Gender No dose adjustment (see section 5.2)
Slovenian: Spol Odmerka ni treba prilagajati (glejte poglavje 5.2)
English: How to take Xarelto
Slovenian: Kako jemati zdravilo Xarelto
English: Converting from Vitamin K Antagonists (VKA) to Xarelto When converting patients from VKAs to Xarelto, International Normalised Ratio (INR) values could be falsely elevated after the intake of Xarelto.
Slovenian: Zamenjava antagonistov vitamina K (AVK) z zdravilom Xarelto Vrednosti mednarodnega umerjenega razmerja (INR - International Normalized Ratio) so pri bolnikih, ki prehajajo z zdravljenja z antagonisti vitamina K na zdravljenje z zdravilom Xarelto, lahko lažno povišane po jemanju zdravila Xarelto.
English: Intake with food does not affect rivaroxaban AUC or Cmax at the 2.5 mg and 10 mg dose.
Slovenian: Pri 2,5 mg in 10 mg odmerku hrana ne vpliva na AUC ali Cmax rivaroksabana.
English: Rare (may affect up to 1 in 1,000 people) - bleeding into a muscle - cholestasis (decreased bile flow), hepatitis incl.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - krvavitev v mišico
English: If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of
Slovenian: Če se kar koli od naštetega nanaša na vas, se posvetujte z zdravnikom, preden boste začeli jemati zdravilo Xarelto, ker se učinek zdravila Xarelto lahko poveča.
English: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Slovenian: Preprečevanje venske trombembolije (VTE) pri odraslih bolnikih po načrtovani kirurški zamenjavi kolka ali kolena.
English: From Day 22: 20 mg 1 tablet once a day (taken at same time each day) together with food.
Slovenian: od 22. dneva: 20 mg, 1 tableta enkrat na dan (vzeta vsak dan ob istem času) skupaj s hrano.
English: Prevention of atherothrombotic events in patients after an ACS
Slovenian: Preprečevanje aterotrombotičnih dogodkov pri bolnikih po akutnem
English: Thereafter, when the recommended dose is 20 mg once daily, a reduction of the dose from 20 mg once daily to 15 mg once daily should be considered if the patient's assessed risk for bleeding outweighs the risk for recurrent DVT and PE.
Slovenian: 3 tedne prejemati odmerek 15 mg dvakrat na dan. Nato, ko je priporočeni odmerek 20 mg enkrat na dan, je je smiselno razmisliti o zmanjšanju odmerka z 20 mg enkrat na dan na 15 mg enkrat na dan, če je pri bolniku ocenjeno tveganje za krvavitve večje od tveganja za ponovno GVT in PE.
English: Bayer AB Tel: +46-(0)8-580 223 00
Slovenian: Tel: +46-(0)8-580 223 00
English: (only applicable for outer carton, not applicable for bottle label)
Slovenian: (samo za škatlo, ne za nalepko za plastenko)
English: Luxembourg / Luxemburg
Slovenian: Luxembourg / Luxemburg Bayer SA-NV
English: ASA 100 mg od N=9126
Slovenian: 100 mg enkrat na dan n = 9.126
English: The dose should not be doubled to make up for a missed dose.
Slovenian: Bolnik naj ne vzame dvojnega odmerka, da bi nadomestil izpuščeni odmerek.
English: Do not use this medicine after the expiry date which is stated on the carton and on each wallet after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na vsakem ovitku poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: liver injury) - yellowing of the skin and eye (jaundice) localised swelling - collection of blood (haematoma) in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery (pseudoaneurysm)
Slovenian: - lokalizirana oteklina - nabiranje krvi (hematom) v dimljah kot zaplet po posegu na srcu s katetrom, ki je vstavljen v vašo stegensko arterijo (psevdoanevrizma)
English: Patients with non-valvular atrial fibrillation who undergo PCI with stent placement A randomised, open-label, multicentre study (PIONEER AF-PCI) was conducted in 2,124 patients with non-valvular atrial fibrillation who underwent PCI with stent placement for primary atherosclerotic disease to compare safety of two rivaroxaban regimens and one VKA regimen.
Slovenian: V randomizirani, odprti, multicentrični študiji (PIONEER AF-PCI), izvedeni pri 2.124 bolnikih z nevalvularno atrijsko fibrilacijo, pri katerih je bila narejena perkutana koronarna intervencija z vstavitvijo žilne opornice zaradi primarne aterosklerotične bolezni, so primerjali varnost dveh režimov zdravljenja z rivaroksabanom in enim režimom zdravljenja z antagonistom vitamina K. Bolnike so naključno razdelili po shemi 1:1:1 za skupno 12 mesecev zdravljenja.
English: Your doctor will also tell you to take either:
Slovenian: Zdravnik vam bo svetoval, da poleg zdravila Xarelto jemljete tudi:
English: Major gastrointestinal bleeding p < 0.00001
Slovenian: Velika krvavitev v prebavilih p < 0,00001
English: 20 mg once daily
Slovenian: 20 mg enkrat na dan 20 mg
English: For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing, as guided by INR testing.
Slovenian: Prva dva dni po uvedbi antagonista vitamina K je treba uporabiti standardni začetni odmerek antagonista vitamina K, nato pa nadaljevati z odmerjanjem antagonista vitamina K glede na vrednosti INR.
English: FeverA, peripheral oedema, decreased general strength and energy (incl.
Slovenian: periferni edem, splošna oslabelost in pomanjkanje energije (tudi utrujenost, astenija)
English: Table 5: Safety results from phase III ROCKET AF Study population
Slovenian: Preglednica 5: Izsledki glede varnosti iz III. faze kliničnega preskušanja ROCKET AF
English: Multipack: 100 (10 packs of 10 x 1) film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 100 filmsko obloženih tablet (10 enot po 10 x 1 filmsko obložena tableta)
English: (only applicable for bottle label, not applicable for outer carton)
Slovenian: (samo za nalepko za plastenko, ne za škatlo)
English: In the Einstein Extension study (see Table 9) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Slovenian: V kliničnem preskušanju Einstein Extension (glejte preglednico 9) je bil rivaroksaban boljši od placeba glede na primarni in sekundarni izid učinkovitosti.
English: - Bleeding into the surgical site requiring reoperation (nonfatal, not in critical organ)
Slovenian: - Krvavitev na mestu kirurškega posega, ki zahteva ponovni kirurški poseg (brez smrnega izida,
English: For the primary safety outcome (major bleeding events) there was a non-significant numerically higher incidence rate for patients treated with rivaroxaban 20 mg once daily compared to placebo.
Slovenian: Primarni varnostni izid (velike krvavitve) je bil neznačilno pogostejši pri bolnikih, zdravljenih z rivaroksabanom 20 mg enkrat na dan v primerjavi s placebom.
English: Each brown-red film-coated tablet for week 4 contains 20 mg rivaroxaban.
Slovenian: Ena rjavordeča filmsko obložena tableta za 4. teden vsebuje 20 mg rivaroksabana.
English: 42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban in a wallet.
Slovenian: 42 filmsko obloženih tablet po 15 mg rivaroksabana in 7 filmsko obloženih tablet po 20 mg rivaroksabana v ovitku.
English: For all-cause mortality, there was no difference between rivaroxaban and placebo in the number of events (event rate per 100 patient-years; 11.41 vs. 11.63, HR: 0.98; 95% CI: 0.87 to 1.10; p=0.743).
Slovenian: Pri smrti zaradi vseh vzrokov ni bilo razlike med rivaroksabanom in placebom glede števila dogodkov (pogostnost dogodkov na 100 bolnikov-let; 11,41 v primerjavi z 11,63, HR: 0,98; 95
English: a) Rivaroxaban 20 mg once daily * p < 0.0001 (superiority), HR: 0.185 (0.087 - 0.393)
Slovenian: * p < 0,0001 (superiornost); razmerje tveganja: 0,185 (0,087 - 0,393)
English: In the Einstein Extension study (see Table 7) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Slovenian: V kliničnem preskušanju Einstein Extension (glejte preglednico 7) je bil rivaroksaban boljši od placeba glede na primarni in sekundarni izid učinkovitosti.
English: • acetylsalicylic acid or
Slovenian: acetilsalicilna kislina
English: A: observed in prevention of VTE in adult patients undergoing elective hip or knee replacement surgery
Slovenian: A: opazili pri preprečevanju VTE po načrtovani kirurški zamenjavi kolka ali kolena pri odraslih bolnikih
English: Within the highest tertile according to centre, the HR with rivaroxaban versus warfarin was 0.69 (95% CI: 0.35 - 1.35).
Slovenian: V najvišji tercili glede na sredino je bilo razmerje tveganja z rivaroksabanom v primerjavi z varfarinom 0,69 (95 % IZ: 0,35 do 1,35).
English: Uncommon (may affect up to 1 in 100 people) - bleeding into the brain or inside the skull - bleeding into a joint causing pain and swelling - thrombocytopenia (low number of platelets, which are cells that help blood to clot) - allergic reactions, including allergic skin reactions - impaired function of the liver (may be seen in tests performed by your doctor)
Slovenian: - krvavitev v možganih ali znotrajlobanjske krvavitve - krvavitev v sklep, kar povzroča bolečino in oteklost - trombocitopenija (majhno število trombocitov, tj. celic, ki sodelujejo pri strjevanju krvi) - alergijske reakcije, vključno z alergijskimi kožnimi reakcijami - moteno delovanje jeter (kar se lahko ugotovi s preiskavami, ki jih opravi zdravnik)
English: If you are taking one 15 mg tablet twice a day and have missed a dose, take it as soon as you remember.
Slovenian: Če jemljete eno tableto po 15 mg dvakrat na dan in ste pozabili vzeti odmerek, ga vzemite takoj ko se spomnite.
English: Xarelto 20 mg od N=1,107
Slovenian: Odmerek zdravilo Xarelto 20 mg enkrat na dan n = 1.107
English: • CAD/PAD Patients taking Xarelto 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA.
Slovenian: Bolniki, ki jemljejo zdravilo Xarelto 2,5 mg dvakrat na dan, naj jemljejo tudi dnevni odmerek 75
English: Clarithromycin (500 mg twice a day), for instance, considered as a strong CYP3A4 inhibitor and moderate P-gp inhibitor, led to a 1.5 fold increase in mean rivaroxaban AUC and a 1.4 fold increase in Cmax.
Slovenian: Klaritromicin (500 mg dvakrat na dan), ki močno zavira CYP3A4 in je zmeren zaviralec P-gp, je povzročil 1,5-kratno povečanje povprečne AUC rivaroksabana in 1,4-kratno povečanje Cmax.
English: The inhibition of factor Xa activity was increased by a factor of 2.6 in patients with moderate hepatic impairment as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 2.1.
Slovenian: Zavrtje aktivnosti faktorja Xa je bilo pri bolnikih z zmerno okvaro jeter 2,6-krat večje kot pri zdravih prostovoljcih.
English: Treatment Initiation Pack rivaroxaban This medicine is subject to additional monitoring.
Slovenian: rivaroksaban Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Over 9,500 patients (7,050 in total hip replacement surgery and 2,531 in total knee replacement surgery) were studied in controlled randomised double-blind phase III clinical studies, the RECORD-programme.
Slovenian: V kontrolirana, randomizirana dvojno slepa klinična preskušanja III. faze (program RECORD) je bilo vključenih več kot 9500 bolnikov (7050 z zamenjavo kolka in 2531 z zamenjavo kolena).
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Slovenian: Zdravljenje globoke venske tromboze (GVT), pljučne embolije (PE) in preprečevanje ponovne GVT in PE
English: Localised oedemaA
Slovenian: lokaliziran edemA
English: Converting from Vitamin K Antagonists (VKA) to Xarelto For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Xarelto therapy should be initiated once the INR is ≤ 2.5.
Slovenian: Pri bolnikih, ki za zdravljenje GVT, PE in preprečevanje ponovne GVT in PE jemljejo antagoniste vitamina K, je treba zdravljenje z antagonisti vitamina K prenehati in uvesti zdravljenje z zdravilom Xarelto, ko je INR ≤ 2,5.
English: 42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban (treatment initiation pack)
Slovenian: 42 filmsko obloženih tablet po 15 mg rivaroksabana 7 filmsko obloženih tablet po 20 mg rivaroksabana (začetno pakiranje)
English: Overall list of possible side effects
Slovenian: Pregled možnih neželenih učinkov
English: - For the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery, no dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) or moderate renal impairment (creatinine clearance 30- 49 ml/min) (see section 5.2).
Slovenian: - Za preprečevanje VTE pri odraslih bolnikih po načrtovani kirurški zamenjavi kolka ali kolena bolnikom z blago (očistek kreatinina 50 - 80 ml/min) ali zmerno (očistek kreatinina 30
English: When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis.
Slovenian: Pri bolnikih, ki za preprečevanje trombemboličnih zapletov prejemajo antitrombotike, med nevraksialno (spinalno/epiduralno) anestezijo ali spinalno/epiduralno punkcijo obstaja tveganje za nastanek epiduralnega ali spinalnega hematoma.