FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders
Slovenian: krvavitve v koži in podkožju urtikarija
English: Patients with non-valvular atrial fibrillation who undergo PCI with stent placement Clinical data are available from an interventional study with the primary objective to assess safety in patients with non-valvular atrial fibrillation who undergo PCI with stent placement.
Slovenian: Na voljo so klinični podatki iz intervencijske študije s primarnim ciljem oceniti varnost pri bolnikih z nevalvularno atrijsko fibrilacijo, pri katerih je bila narejena perkutana koronarna intervencija z vstavitvijo žilne opornice.
English: If you are taking one 20 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 enkrat na dan in ste pozabili vzeti odmerek, ga vzemite takoj ko se spomnite.
English: Re-dosing of recombinant factor VIIa shall be considered and titrated depending on improvement of bleeding.
Slovenian: Razmisliti je treba o spremembi odmerka rekombinantnega faktorja VIIa; odmerek je odvisen od izboljšanja kazalcev koagulacije.
English: In individuals with mild (creatinine clearance 50 - 80 ml/min), moderate (creatinine clearance 30 - 49 ml/min) and severe (creatinine clearance 15 - 29 ml/min) renal impairment, rivaroxaban plasma concentrations (AUC) were increased 1.4, 1.5 and 1.6 fold respectively.
Slovenian: Pri bolnikih z blago okvaro ledvic (očistek kreatinina 5080 ml/min) so ugotovili 1,4-kratno povečanje koncentracije rivaroksabana v plazmi (AUC), pri bolnikih z zmerno okvaro (očistek kreatinina 30 - 49 ml/min) 1,5-kratno in pri bolnikih s hudo okvaro (očistek kreatinina < 15 - 29 ml/min) 1,6-kratno povečanje.
English: From Day 22: One 20 mg tablet once a day (taken at same time each day) together with food.
Slovenian: od 22. dneva: ena tableta po 20 mg enkrat na dan (vzeta vsak dan ob istem času) skupaj s hrano.
English: In the Einstein Extension study (see Table 8) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Slovenian: V kliničnem preskušanju Einstein Extension (glejte preglednico 8) je bil rivaroksaban boljši od placeba glede na primarni in sekundarni izid učinkovitosti.
English: Symptomatic recurrent PE
Slovenian: Simptomatska ponovna PE
English: 5 film-coated tablets
Slovenian: 5 filmsko obloženih tablet
English: The concomitant use of rivaroxaban with other strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbital or St. John's Wort (Hypericum perforatum)) may also lead to reduced rivaroxaban plasma concentrations.
Slovenian: Koncentracija rivaroksabana v plazmi se lahko zmanjša tudi pri sočasni uporabi drugih močnih induktorjev CYP3A4 (npr. fenitoina, karbamazepina, fenobarbitala ali šentjanževke (Hypericum perforatum)).
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: (For patients with renal impairment: see section 4.4).
Slovenian: (glejte poglavje 4.4).
English: Xarelto 15 mg film-coated tablets
Slovenian: Xarelto 15 mg filmsko obložene tablete
English: Xarelto 15 mg tablets Xarelto 20 mg tablets rivaroxaban
Slovenian: Xarelto 15 mg tablete Xarelto 20 mg tablete rivaroksaban
English: The main safety endpoint, major bleeding, showed comparable rates for patients treated with rivaroxaban 10 mg compared to enoxaparin 40 mg.
Slovenian: Delež bolnikov z velikimi krvavitvami, ki so predstavljale glavni varnostni izid, je bil med bolniki, ki so prejemali 10 mg rivaroksabana oz. 40 mg enoksaparina primerljiv.
English: In subjects with mild renal impairment erythromycin (500 mg three times a day) led to a 1.8 fold increase in mean rivaroxaban AUC and 1.6 fold increase in CRmax when compared to subjects with normal renal function.
Slovenian: Eritromicin (500 mg trikrat na dan) je povzročil 1,8-kratno povečanje povprečne AUC za rivaroksaban in 1,6-kratno povečanje Cmax pri bolnikih z blago okvaro ledvic v primerjavi z bolniki z normalnim delovanjem ledvic.
English: Due dates
Slovenian: DRUGI PODATKI
English: Initial treatment Xarelto 15 mg twice a day First 3 weeks Continuous treatment Xarelto 20 mg once a day Week 4 onwards Visit your doctor to ensure continued treatment.
Slovenian: Xarelto 20 mg enkrat na dan od 4. tedna dalje Glede nadaljevanja zdravljenja se posvetujte z zdravnikom.
English: Cerebral and intracranial haemorrhage, syncope
Slovenian: Bolezni živčevja omotica, glavobol cerebralna in intrakranialna krvavitev, sinkopa
English: Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C (see section 5.2).
Slovenian: Bolezen jeter, povezana z motnjami koagulacije in klinično pomembnim tveganjem za krvavitve, vključno z jetrno cirozo razreda Child-Pugh B in C (glejte poglavje 5.2).
English: Xarelto 15 mg film-coated tablets Xarelto 20 mg film-coated tablets
Slovenian: Xarelto 15 mg filmsko obložene tablete Xarelto 20 mg filmsko obložene tablete
English: bid: twice daily; CI: confidence interval; KM %: Kaplan-Meier estimates of cumulative incidence risk calculated at 900 days; CV: cardiovascular; MI: myocardial infarction; od: once daily
Slovenian: % KM: ocena kumulativnega tveganja po metodi Kaplan-Meier, izračunana na 900 dni
English: Xarelto 2.5 mg, twice daily, N=5,114 n (%)
Slovenian: Odmerek zdravila zdravilo Xarelto 2,5 mg dvakrat na dan, n = 5.114 n (%)
English: Xarelto may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4 ”Possible side effects”).
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Xarelto lahko povzroči omotico (pogost neželeni učinek) ali omedlevico (občasen neželeni učinek) (glejte poglavje 4.
English: Among all randomised patients analysed according to ITT, primary events occurred in 269 on rivaroxaban (2.12% per year) and 306 on warfarin (2.42% per year) (HR 0.88; 95% CI, 0.74 - 1.03; P<0.001 for non-inferiority; P=0.117 for superiority).
Slovenian: Glede na statistično analizo ITT (intention to treat) vseh randomiziranih bolnikov, se je primarni dogodek pojavil pri 269 bolnikih, ki so prejemali rivaroksaban (2,12 % na leto) in 306 bolnikih, ki so prejemali varfarin (2,42 % na leto) (razmerje tveganja 0,88; 95 % IZ 0,74 - 1,03; p < 0,001 za neinferiornost; p =
English: Enoxaparin/VKAb) 3, 6 or 12 months N=1,718
Slovenian: enoksaparin/AVKb) 3, 6 ali 12 mesecev n = 1.718
English: Oxidative degradation of the morpholinone moiety and hydrolysis of the amide bonds are the major sites of biotransformation.
Slovenian: Biotransformacija poteka v glavnem preko oksidativne razgradnje morfolinonske skupine in hidrolize amidnih vezi.
English: Each tablet contains 10 mg of rivaroxaban.
Slovenian: Ena tableta vsebuje 10 mg rivaroksabana.
English: If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction): it is very important to take Xarelto before and after the injection or removal of the catheter exactly at the times you have been told by your doctor tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.
Slovenian: je zelo pomembno, da vzamete zdravilo Xarelto pred ali po injekciji ali odstranitvi katetra natančno takrat, kot vam je svetoval zdravnik takoj obvestite zdravnika, če občutite mravljinčenje ali šibkost v nogah ali imate po anesteziji težave z odvajanjem blata ali vode, ker je potrebna nujna medicinska pomoč.
English: Treatment of DVT, PE and prevention of recurrence
Slovenian: Zdravljenje GVT, zdravljenje PE ter preprečevanje ponovne GVT in PE
English: • Prescriber Guide
Slovenian: Kaj vsebuje navodilo
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v udih
English: Bayer plc Tel: +44-(0) 118 206 3000
Slovenian: Tel: +44-(0)118 206 3000
English: N=9152
Slovenian: INR 2,5
English: Table 4: Efficacy results from phase III ROCKET AF Study population
Slovenian: Preglednica 4: Izsledki glede učinkovitosti iz III. faze kliničnega preskušanja ROCKET AF
English: Day 1 to 21: One 15 mg tablet twice a day (one 15 mg tablet in the morning and one in the evening) together with food.
Slovenian: 1. do 21. dan: ena tableta po 15 mg dvakrat na dan (ena tableta po 15 mg zjutraj in ena zvečer) skupaj s hrano.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 2.5 MG
Slovenian: PRETISNI OMOT ZA ENKRATNI ODMEREK (10 x 1 TABLETA) PO 2,5 MG
English: Symptomatic recurrent VTE or major bleeding (net clinical benefit) * p<0.001(superiority) Xarelto 20 mg od vs ASA 100 mg od; HR=0.34 (0.20-0.59) ** p<0.001 (superiority) Xarelto 10 mg od vs ASA 100 mg od; HR=0.26 (0.14-0.47) + Xarelto 20 mg od vs. ASA 100 mg od; HR=0.44 (0.27-0.71), p=0.0009 (nominal) ++ Xarelto 10 mg od vs. ASA 100 mg od; HR=0.32 (0.18-0.55), p<0.0001 (nominal)
Slovenian: * p < 0,001(superiornost) zdravila Xarelto 20 mg enkrat na dan v primerjavi z acetilsalicilno kislino 100 mg enkrat na dan; razmerje tveganja = 0,34 (0,20-0,59) ** p < 0,001 (superiornost) zdravila Xarelto 10 mg enkrat na dan v primerjavi z acetilsalicilno kislino 100 mg enkrat na dan; razmerje tveganja = 0,26 (0,14-0,47) + Zdravilo Xarelto 20 mg enkrat na dan v primerjavi z acetilsalicilno kislino 100 mg enkrat na dan;
English: The results of the PK/PD analyses in Phase II and III were consistent with the data established in healthy subjects.
Slovenian: in III. faze so skladni z izsledki, ki so jih ugotovili pri zdravih osebah.
English: There are no data in patients with creatinine clearance < 15 ml/min.
Slovenian: Podatkov o bolnikih z ledvičnim očistkom <15 ml/min ni na voljo.
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 10 MG
Slovenian: ŠKATLA IN NALEPKA ZA HDPE PLASTENKE ZA TABLETE PO 10 MG
English: The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a HR of 0.849 ((95% CI: 0.633 - 1.139), nominal p value p= 0.275).
Slovenian: O predhodno opredeljeni čisti klinični koristi (izid primarne učinkovitosti in velike krvavitve) so poročali z razmerjem tveganja 0,849 ((95 % IZ: 0,633 - 1,139), nominalna vrednost p = 0,275).
English: Package leaflet: Information for the user Xarelto 2.5 mg film-coated tablets rivaroxaban This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Xarelto 2,5 mg filmsko obložene tablete rivaroksaban Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Xareltoa) 6 or 12 months N=602
Slovenian: Odmerek in trajanje zdravljenja zdravilo Xareltoa) 6 ali 12 mesecev n = 602
English: No data are available for such patients with a history of stroke/ transient ischaemic attack (TIA).
Slovenian: Podatkov za te bolnike, ki imajo v anamnezi tudi možgansko kap/prehodni ishemični napad
English: Nervous system disorders
Slovenian: Sistemska embolija izven osrednjega živčevja
English: Therefore, the use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics such as ketoconazole, itraconazole, voriconazole and posaconazole or HIV protease inhibitors.
Slovenian: Uporabe zdravila Xarelto se ne priporoča pri bolnikih, ki sočasno jemljejo tudi azolne antimikotike za sistemsko zdravljenje (npr. ketokonazol, itrakonazol, vorikonazol in posakonazol) ali zaviralce proteaz
English: ASA 100 mg od N=1,131
Slovenian: acetilsalicilna kislina 100 mg enkrat na dan n = 1.131
English: Direct acting Oral Anticoagulants (DOACs) including rivaroxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Slovenian: Uporaba peroralnih antikoagulantov z neposrednim delovanjem, vključno z rivaroksabanom/apiksabanom/edoksabanom/dabigatran eteksilatom, pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ni priporočljiva.
English: platelet count increased)A, Thrombocytopenia
Slovenian: (vključno s povečanim številom trombocitov)A, trombocitopenija
English: Day 1 to 21: 15 mg 1 tablet twice a day (one 15 mg tablet in the morning and one in the evening) together with food.
Slovenian: 1. do 21. dan: 15 mg, 1 tableta dvakrat na dan (ena tableta po 15 mg zjutraj in ena zvečer) skupaj s hrano.
English: Batch
Slovenian: GGT
English: Take the next tablet on the following day and then carry on taking a tablet once a day as normal.
Slovenian: potem pa nadaljujte z jemanjem ene tablete enkrat na dan kot običajno.
English: MI
Slovenian: O
English: Xarelto 2.5 mg (only applicable for outer carton, not applicable for bottle label)
Slovenian: Xarelto 2,5 mg (samo za škatlo, ne za nalepko za plastenko)
English: In Einstein PE, 4,832 patients with acute PE were studied for the treatment of PE and the prevention of recurrent DVT and PE.
Slovenian: V kliničnem preskušanju Einstein PE so preučevali 4.832 bolnikov z akutno PE pri zdravljenju PE in preprečevanju ponovne GVT in PE. Zdravljenje je trajalo 3, 6 ali 12 mesecev, odvisno od klinične presoje raziskovalca.
English: Possible side effects
Slovenian: Možni neželeni učinki).
English: Group 2 received rivaroxaban 2.5 mg twice daily plus DAPT (dual antiplatelet therapy i.e. clopidogrel 75 mg [or alternate P2Y12 inhibitor] plus low-dose acetylsalicylic acid [ASA]) for 1, 6 or 12 months followed by rivaroxaban 15 mg (or 10 mg for subjects with creatinine clearance 30 - 49 ml/min) once daily plus low-dose ASA.
Slovenian: P2Y12] in nizek odmerek acetilsalicilne kisline) 1, 6 ali 12 mesecev, ki mu je sledilo zdravljenje z rivaroksabanom 15 mg (ali 10 mg pri bolnikih z očistkom kreatinina 30 - 49 ml/min) enkrat na dan in nizek odmerek acetilsalicilne kisline.
English: The secondary efficacy outcome was defined as the composite of recurrent DVT, non-fatal PE and all-cause mortality.
Slovenian: Primarni izid učinkovitosti je bila ponovna simptomatska VTE, sestavljena iz ponovne GVT ali smrtne ali nesmrtne PE. Sekundarni izid učinkovitosti je bil sestavljen iz ponovne GVT, nesmrtne PE in smrti zaradi vseh vzrokov.
English: In ACS patients, efficacy and safety of Xarelto 2.5 mg have been investigated in combination with the antiplatelet agents ASA alone or ASA plus clopidogrel/ticlopidine.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Pri bolnikih z AKS so učinkovitost in varnost zdravila Xarelto 2,5 mg preučevali v kombinaciji z antitrombotiki, kot so samo acetilsalicilna kislina ali acetilsalicilna kislina in klopidogrel oz.
English: Тел: +359-(0)2-424 72 80
Slovenian: Байер България ЕООД Тел: +359-(0)2-424 72 80
English: (HDPE Bottle)
Slovenian: [interkvartilni razpon]
English: Table 4: Efficacy and safety results from phase III clinical studies
Slovenian: Preglednica 4: Izsledki glede učinkovitosti in varnosti v kliničnih preskušanjih III. faze
English: Package leaflet: Information for the user Xarelto 10 mg film-coated tablets rivaroxaban This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Xarelto 10 mg filmsko obložene tablete rivaroksaban Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Within the highest quartile according to centre, the Hazard Ratio (HR) with rivaroxaban versus warfarin was 0.74 (95% CI, 0.49 - 1.12).
Slovenian: V najvišji kvartili glede na sredino je bilo razmerje tveganja z rivaroksabanom v primerjavi z varfarinom 0,74 (95 % IZ 0,49 do 1,12).
English: fatigue and asthenia)
Slovenian: (tudi utrujenost,
English: At higher doses rivaroxaban displays dissolution limited absorption with decreased bioavailability and decreased absorption rate with increased dose.
Slovenian: Z večanjem odmerka se biološka uporabnost in hitrost absorpcije zmanjšujeta.
English: In patients converting from Xarelto to VKA, VKA should be given concurrently until the INR is ≥ 2.0.
Slovenian: Pri bolnikih, ki prehajajo z zdravila Xarelto na antagoniste vitamina K, je treba zdravilo Xarelto in antagoniste vitamina K jemati sočasno, dokler niso vrednosti INR ≥ 2,0.
English: 12.6% of patients 2.1% of patients
Slovenian: 12,6 % bolnikov
English: Xarelto therapy should be initiated once the INR is ≤ 2.5.
Slovenian: Xarelto, ko je mednarodno umerjeno razmerje (INR - International Normalized Ratio) ≤ 2,5.
English: In the enoxaparin/VKA group, there was no clear relation between the level of mean centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized tertiles and the incidence of the recurrent VTE (P=0.932 for interaction).
Slovenian: V skupini, ki je prejemala enoksaparin/antagoniste vitamina K, ni bilo jasnega razmerja med povprečno vrednostjo TTR (Time in Target INR v mejah od 2,0 do 3,0) pri enako velikih tercilih in incidenco ponovne VTE (p = 0,932 za interakcije).
English: Enoxaparin
Slovenian: sinkopa
English: HR (95% CI) p-value b)
Slovenian: (95-odstotni interval zaupanja) vrednost p b)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WALLET OF TREATMENT INITIATION PACK (42 FILM-COATED TABLETS OF 15 MG AND 7 FILM-COATED TABLETS OF 20 MG) (WITHOUT BLUE BOX)
Slovenian: ŠKATLA ZA ZAČETNO PAKIRANJE (ZAČETEK ZDRAVLJENJA) (42 FILMSKO OBLOŽENIH TABLET PO 15 MG IN 7 FILMSKO OBLOŽENIH TABLET PO 20 MG) (S PODATKI ZA 'BLUE BOX')
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) - blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets - fainting - feeling unwell - faster heartbeat - dry mouth - hives
Slovenian: - 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) - izvidi krvnih preiskav lahko pokažejo povečane vrednosti bilirubina, nekaterih encimov trebušne slinavke ali jetrnih encimov ali povečano število trombocitov
English: In the enoxaparin/VKA group, there was no clear relation between the level of mean centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized tertiles and the incidence of the recurrent VTE (p=0.082 for interaction).
Slovenian: V skupini, ki je prejemala enoksaparin/antagoniste vitamina K ni bilo jasnega razmerja med povprečno vrednostjo TTR (Time in Target INR v mejah 2,0 do 3,0) pri enako velikih tercilih in incidenci ponovne VTE (p = 0,082 za interakcije).
English: If a dose is missed during the once daily treatment phase, the patient should take Xarelto immediately, and continue on the following day with the once daily intake as recommended.
Slovenian: Če bolnik pozabi vzeti zdravilo Xarelto v času zdravljenja z enkratnim odmerkom na dan, ga mora vzeti takoj ko se spomni in nadaljevati naslednji dan z jemanjem enkrat na dan, kot je priporočeno.
English: Hazard Ratio (HR) (95% CI) pvalue b)
Slovenian: razmerje tveganja (95-odstotni interval zaupanja) vrednost p b)
English: Xarelto 2.5 mg tablets rivaroxaban
Slovenian: Xarelto 2,5 mg tablete rivaroksaban
English: Anaphylactic reactions including anaphylactic shock
Slovenian: - alergijske reakcije, vključno z alergijskimi kožnimi reakcijami
English: The primary efficacy analysis (i.e. composite of all-cause mortality, MI, or stroke) showed no statistically significant difference between the rivaroxaban 2.5 mg bid group and the placebo group with a HR=0.94 (95% CI 0.84 - 1.05), p=0.270.
Slovenian: smrt zaradi vseh vzrokov, miokardni infarkt ali možganska kap) so pokazale, da ni statistično pomembne razlike med skupino bolnikov zdravljenih z rivaroksabanom 2,5 mg dvakrat na dan in skupino bolnikov, ki je prejemala placebo z HR = 0,94 (95 % IZ 0,84
English: Hazard Ratio (95 % CI)
Slovenian: razmerje tveganja (95-odstotni interval zaupanja)
English: Patients were followed for a median of 23 months and maximum of 3.9 years.
Slovenian: Mediana dolžine spremljanja bolnikov je bila 23 mesecev, največ pa
English: Contact your doctor immediately if you have taken too many Xarelto tablets.
Slovenian: Če ste vzeli večji odmerek zdravila Xarelto, kot bi smeli Če ste vzeli preveč tablet zdravila Xarelto, se takoj posvetujte z zdravnikom.
English: The 2.5 mg twice daily regimen reduced mortality, and there is evidence that the lower dose had lower bleeding risks, therefore rivaroxaban 2.5 mg twice daily co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine is recommended for the prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers.
Slovenian: zato se za preprečevanje aterotrombotičnih dogodkov pri odraslih bolnikih z AKS zvišanimi vrednostmi srčnih biokemičnih označevalcev priporoča rivaroksaban 2,5 mg dvakrat na dan sočasno samo z acetilsalicilno kislino ali z acetilsalicilno kislino in tienopiridinom (klopidogrel ali tiklopidin).
English: Fatal bleeding event
Slovenian: Krvavitev s smrtnim izidom
English: • acetylsalicylic acid plus clopidogrel or ticlopidine.
Slovenian: sočasno z acetilsalicilno kislino ali kombinacijo acetilsalicilne kisline in klopidogrela ali tiklopidina
English: Xareltoa) 3, 6 or 12 months N=4,150
Slovenian: Odmerek in trajanje zdravljenja zdravilo Xareltoa) 3, 6 ali 12 mesecev n = 4,150
English: No clinically relevant prolongation of bleeding time was observed after concomitant administration of rivaroxaban (15 mg) and 500 mg naproxen.
Slovenian: Po sočasni uporabi rivaroksabana (15 mg) in naproksena (500 mg) niso opazili klinično pomembnega podaljšanja časa krvavitve.
English: For the initial 3 week treatment of acute DVT 15 mg rivaroxaban was administered twice daily.
Slovenian: Prve 3 tedne zdravljenja akutne GVT so bolniki prejemali 15 mg rivaroksabana dvakrat na dan, nato pa nadaljevali z odmerkom po 20 mg rivaroksabana enkrat na dan.
English: When to take Xarelto
Slovenian: Kdaj morate vzeti zdravilo Xarelto
English: 6.7 per 100 patient years
Slovenian: 6,7 na 100 bolnikov-let
English: If you have missed a dose, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo Xarelto Če pozabite vzeti odmerek, ga vzemite takoj ko se spomnite.
English: If you have kidney problems and take one tablet Xarelto 20 mg once a day, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Xarelto 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.
Slovenian: Če imate težave z ledvicami in jemljete po eno tableto zdravila Xarelto 20 mg enkrat na dan, se po 3 tednih zdravnik lahko odloči za zdravljenje z manjšim odmerkom - eno tableto zdravila
English: Xarelto 15 mg tablets rivaroxaban
Slovenian: Xarelto 15 mg tablete rivaroksaban
English: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery
Slovenian: Preprečevanje VTE pri odraslih bolnikih po načrtovani kirurški zamenjavi kolka ali kolena
English: Bayer d. o. o. Tel: +386-(0)1-58 14 400
Slovenian: Tel: +386-(0)1-58 14 400
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 2.5 MG
Slovenian: VMESNI KARTON PRI VEČKRATNEM PAKIRANJU ZA TABLETE PO 2,5 MG (BREZ PODATKOV ZA 'BLUE BOX')
English: Anticoagulants
Slovenian: Antikoagulacijska zdravila
English: Each film-coated tablet contains 10 mg rivaroxaban.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg rivaroksabana.
English: EU/1/08/472/031 196 film-coated tablets
Slovenian: EU/1/08/472/031 196 filmsko obloženih tablet
English: Enoxaparin/VKAb) 3, 6 or 12 months N=4,131
Slovenian: Enoksaparin/AVKb) 3, 6 ali 12 mesecev n = 4.131
English: Each film-coated tablet contains 20 mg rivaroxaban.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg rivaroksabana.
English: Xarelto 15 mg Xarelto 20 mg film-coated tablets rivaroxaban
Slovenian: Xarelto 15 mg Xarelto 20 mg filmsko obložene tablete rivaroksaban