FrancophonIA/ELRC3.0 huggingface dataset:
English: The COMMANDER HF study included 5,022 patients with heart failure and significant coronary artery disease (CAD) following a hospitalization of decompensated heart failure (HF) which were randomly assigned into one of the two treatment groups: rivaroxaban 2.5 mg twice daily (N=2,507) or matching placebo (N=2,515), respectively.
Slovenian: Naključno so bili razvrščeni v eno od dveh zdravljenih skupin bolnikov: skupino, ki je bila zdravljena z rivaroksabanom 2,5 mg dvakrat na dan (n = 2.507) oziroma skupino, ki je prejemala placebo (n = 2.515).
English: Talk to your doctor or pharmacist before taking Xarelto.
Slovenian: Pred začetkom jemanja zdravila Xarelto se posvetujte z zdravnikom ali farmacevtom.
English: For modified ISTH major bleeding, the observed risk increase was HR=2.12 (95% CI 1.5-3.0) in patients ≥75 years (5.2% vs 2.5%) and HR=1.53 (95% CI 1.2-1.9) in patients <75 years (2.6% vs
Slovenian: Za velike krvavitve po prirejenih merilih združenja ISTH je bilo opaženo povečanje razmerja tveganja 2,12 (95 % IZ 1,5 - 3,0) pri bolnikih ≥ 75 let
English: Body weight No dose adjustment (see section 5.2)
Slovenian: Telesna masa Odmerka ni treba prilagajati (glejte poglavje 5.2)
English: • The need for intake of the 15 mg and 20 mg tablets with food
Slovenian: • navodila glede zamenjave z drugim zdravilom ali prehod na zdravljenje z rivaroksabanom • pomembnost jemanja tablet po 15 mg oziroma 20 mg skupaj s hrano
English: See section 2 “Xarelto contains lactose and sodium”.
Slovenian: Zdravilo Xarelto vsebuje laktozo in natrij.
English: Dose-dependent inhibition of factor Xa activity was observed in humans.
Slovenian: Pri ljudeh je zaviranje faktorja Xa odvisno od odmerka.
English: Muscle haemorrhage
Slovenian: vaskularna psevdoanevrizmaC
English: Treatment dose
Slovenian: Nadaljevanje zdravljenja
English: EU/1/08/472/033 100 x 1 film-coated tablets (PP/Aluminium foil blisters) EU/1/08/472/035 30 film-coated tablets
Slovenian: EU/1/08/472/033 100 x 1 filmsko obložena tableta (pretisni omot iz PP/aluminija) EU/1/08/472/035 30 filmsko obloženih tablet
English: Increase in transaminases
Slovenian: povečane vrednosti amilazeA
English: Your doctor will tell you when to start treatment with Xarelto if you have been diagnosed with coronary artery disease or peripheral artery disease.
Slovenian: Če imate diagnozo koronarne bolezni ali periferne arterijske bolezni, vam bo zdravnik svetoval, kdaj začnite zdravljenje z zdravilom Xarelto.
English: Table 8: Efficacy and safety results from phase III Einstein Extension Study population
Slovenian: Preglednica 8: Izsledki učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein Extension
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF TREATMENT INITIATION PACK IN WALLET (42 FILM-COATED TABLETS OF 15 MG AND 7 FILM-COATED TABLETS OF 20 MG)
Slovenian: PRETISNI OMOT ZA ZAČETNO PAKIRANJE (ZAČETEK ZDRAVLJENJA) V OVITKU (42 FILMSKO OBLOŽENIH TABLET PO 15 MG IN 7 FILMSKO OBLOŽENIH TABLET PO
English: In patients receiving rivaroxaban for treatment of DVT and PE and prevention of recurrence, the 5/95 percentiles for PT (Neoplastin) 2 - 4 hours after tablet intake (i.e. at the time of maximum effect) for 15 mg rivaroxaban twice daily ranged from 17 to 32 s and for 20 mg rivaroxaban once daily from 15 to 30 s. At trough (8 - 16 h after tablet intake) the 5/95 percentiles for 15 mg twice daily ranged from 14 to 24 s and for 20 mg once daily (18 - 30 h after tablet intake) from 13 to 20 s. In patients with non-valvular atrial fibrillation receiving rivaroxaban for the prevention of stroke and systemic embolism, the 5/95 percentiles for PT (Neoplastin) 1 - 4 hours after tablet intake (i.e. at the time of maximum effect) in patients treated with 20 mg once daily ranged from 14 to 40 s and in patients with moderate renal impairment treated with 15 mg once daily from 10 to 50 s. At trough (16 - 36 h after tablet intake) the 5/95 percentiles in patients treated with 20 mg once daily ranged from 12 to 26 s and in patients with moderate renal impairment treated with 15 mg once daily from 12 to 26 s.
Slovenian: Pri bolnikih z nevalvularno atrijsko fibrilacijo, ki so prejemali rivaroksaban za preprečevanje možganske kapi in sistemske embolije, je bil 5/95 percentil za PČ (Neoplastin) 1 do 4 ure po zaužitju tablete (tj. v času največjega učinka) pri bolnikih zdravljenih z odmerkom 20 mg enkrat na dan od 14 do 40 sekund in pri bolnikih z zmerno okvaro ledvic, zdravljenih z odmerkom po 15 mg enkrat na dan od 10 do 50 sekund.
English: Stroke, non-CNS systemic embolism and vascular death
Slovenian: Možganska kap in sistemska embolija izven osrednjega živčevja Možganska kap in sistemska embolija izven osrednjega živčevja in vaskularna smrt
English: - if you have an increased risk of bleeding, as could be the case in situations such as: moderate or severe kidney disease, since your kidney function may affect the amount of medicine that works in your body if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see section “Other medicines and Xarelto”) bleeding disorders very high blood pressure, not controlled by medical treatment diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus) a problem with the blood vessels in the back of your eyes (retinopathy) a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung - if you have a prosthetic heart valve - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Slovenian: motnje strjevanja krvi zelo visok krvni tlak, ki ni urejen z zdravili bolezen želodca ali črevesja, ki lahko povzroči krvavitve, npr. vnetje črevesne ali želodčne sluznice, vnetje požiralnika (ezofagusa) zaradi npr. gastroezofagealne refluksne bolezni (bolezni, pri kateri se vsebina želodca vrača nazaj v požiralnik) težave z ožiljem na očesnem ozadju (retinopatija) bolezen pljuč, pri kateri so bronhiji razširjeni in napolnjeni z gnojnim izmečkom (bronhiektazije) ali predhodne krvavitve v pljučih - če imate umetno srčno zaklopko - če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika,
English: When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto.
Slovenian: Vrednosti INR so pri bolnikih, ki prehajajo z zdravljenja z antagonisti vitamina K na zdravljenje z zdravilom Xarelto, lažno povišane po jemanju zdravila Xarelto.
English: EU/1/08/472/027 56 film-coated tablets
Slovenian: EU/1/08/472/027 56 filmsko obloženih tablet
English: Table 9: Efficacy and safety results from phase III Einstein Extension Study population
Slovenian: Preglednica 9: Izsledki učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein Extension
English: PP/Aluminium foil blisters in cartons of 14, 20, 28, 30, 56, 60, 98, 168 or 196 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1 or 100 x 1 or in multipacks containing 100 (10 packs of 10 x 1) film-coated tablets.
Slovenian: Škatla po 14, 20, 28, 30, 56, 60, 98, 168 ali 196 filmsko obloženih tablet v pretisnih omotih iz PP/aluminija ali škatla po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnih pakiranjih, ki vsebujejo 100 (10 enot po 10 x 1) filmsko obloženih tablet.
English: very common (≥ 1/10)
Slovenian: Po pogostnosti so neželeni učinki opredeljeni kot sledi: zelo pogosti (≥ 1/10)
English: Epistaxis, haemoptysis
Slovenian: holestaza, hepatitis
English: ▪ some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital) ▪ St John's Wort (Hypericum perforatum), a herbal product used for depression ▪ rifampicin, an antibiotic
Slovenian: šentjanževko (Hypericum perforatum), zdravilo rastlinskega izvora, ki se uporablja pri depresiji, antibiotik rifampicin.
English: Table 7: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Slovenian: Preglednica 7: Izsledki glede učinkovitosti in varnosti iz analize zbranih podatkov iz III. faze kliničnih preskušanj Einstein DVT in Einstein PE
English: Bayer OÜ Tel: +372-655 85 65
Slovenian: Tel: +372-655 85 65
English: Tell your doctor immediately, if you experience any of the following side effects: - long or excessive bleeding - exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling,
Slovenian: Takoj obvestite zdravnika, če imate znake ali simptome krvavitve, kot so: ♦ bolečina ♦ oteklina ali neprijeten občutek
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 10 MG
Slovenian: VMESNI KARTON PRI VEČKRATNEM PAKIRANJU ZA TABLETE PO 10 MG (BREZ PODATKOV ZA 'BLUE BOX')
English: Table 10: Efficacy and safety results from phase III Einstein Choice Study population
Slovenian: Preglednica 10: Izsledki učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein Choice
English: Treatment and prevention of recurrent DVT and PE
Slovenian: Zdravljenje GVT, PE in preprečevanje ponovne GVT in PE
English: Table 6: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Slovenian: Preglednica 6: Izsledki glede učinkovitosti in varnosti iz analize zbranih podatkov iz III. faze kliničnih preskušanj Einstein DVT in Einstein PE
English: 20 mg once a day taken at same time each day
Slovenian: Xarelto 20 mg 20 mg enkrat na dan vzeto vsak dan ob istem času dan spremembe zdravljenja 4. teden
English: CAD with heart failure
Slovenian: Koronarna bolezen s srčnim popuščanjem
English: If a dose is missed the patient should take Xarelto immediately and continue on the following day with the once daily intake as recommended.
Slovenian: Izpuščeni odmerek zdravila Xarelto naj bolnik vzame takoj ko se spomni in naslednji dan nadaljuje z jemanjem enkrat na dan, kot je priporočeno.
English: In the clinical studies mucosal bleedings (i.e. epistaxis, gingival, gastrointestinal, genito urinary including abnormal vaginal or increased menstrual bleeding) and anaemia were seen more frequently during long term rivaroxaban treatment on top of single or dual anti-platelet therapy.
Slovenian: V kliničnih preskušanjih so med dolgotrajnim zdravljenjem z rivaroksabanom poleg enojnega ali dvojnega antiagregacijskega zdravljenja pogosteje opazili krvavitve iz sluznic (tj. iz nosu, dlesni, prebavil, rodil in sečil, vključno z nenormalnimi krvavitvami iz nožnice ali močnejšimi menstrualnimi krvavitvami) in anemijo.
English: other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol) anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid) dronedarone, a medicine to treat abnormal heart beat some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))
Slovenian: protivnetna zdravila in zdravila za lajšanje bolečin (npr. naproksen ali acetilsalicilno kislino), dronedaron, zdravilo za zdravljenje motenj srčnega ritma, nekatera zdravila za zdravljenje depresije (selektivne zaviralce ponovnega privzema serotonina (SSRI - Selective Serotonin Reuptake Inhibitors) ali zaviralce ponovnega privzema serotonina in noradrenalina (SNRI - Serotonin Norepinephrine Reuptake Inhibitors)).
English: EU/1/08/472/013 42 film-coated tablets
Slovenian: EU/1/08/472/013 42 filmsko obloženih tablet
English: Table 7: Efficacy and safety results from phase III Einstein Extension Study population
Slovenian: Preglednica 7: Izsledki učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein Extension
English: PVC/PVDC/Aluminium foil blisters in cartons of 5, 10 or 30 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1 or 100 x 1 film-coated tablets.
Slovenian: Škatla po 5, 10 ali 30 filmsko obloženih tablet v pretisnih omotih iz PVC/PVDC/aluminija ali škatla po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek, HDPE vsebnik s PP navojno zaporko, po 100 filmsko obloženih tablet.
English: Xarelto 15 mg film-coated tablets are red, round, biconvex and marked with the BAYER-cross on one side and “15” and a triangle on the other side.
Slovenian: Zdravilo Xarelto 15 mg filmsko obložene tablete so rdeče, okrogle, bikonveksne in na eni strani označene z oznako BAYER (križ) in na drugi s številko »15« in trikotnikom.
English: Table 8: Efficacy and safety results from phase III Einstein Choice Study population
Slovenian: Preglednica 8: Izsledki učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein Choice
English: EU/1/08/472/020 10 x 1 film-coated tablets
Slovenian: EU/1/08/472/020 10 x 1 filmsko obložena tableta
English: EU/1/08/472/021 100 x 1 film-coated tablets (PP/Aluminium foil blisters) EU/1/08/472/039 10 film-coated tablets
Slovenian: EU/1/08/472/021 100 x 1 filmsko obložena tableta (pretisni omot iz PP/aluminija) EU/1/08/472/039 10 filmsko obloženih tablet
English: EU/1/08/472/041 20 film-coated tablets
Slovenian: EU/1/08/472/041 20 filmsko obloženih tablet
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 15 MG
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN NALEPKA ZA HDPE PLASTENKE ZA TABLETE PO 15 MG
English: Other haemorrhagic risk factors
Slovenian: Drugi dejavniki tveganja za krvavitve
English: Each film-coated tablet contains 2.5 mg rivaroxaban.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 2,5 mg rivaroksabana.
English: ♦ Tell your health care provider that you are taking Xarelto before any surgery or invasive procedure.
Slovenian: ♦ Pred katerim koli kirurškim posegom ali invazivnim postopkom obvestite zdravnika, da jemljete zdravilo Xarelto.
English: In the Einstein DVT study (see Table 6) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p < 0.0001 (test for non-inferiority); HR: 0.680 (0.443 - 1.042), p=0.076 (test for superiority)).
Slovenian: V kliničnem preskušanju Einstein DVT (glejte preglednico 6) se je v primarnem izidu učinkovitosti pokazalo, da je rivaroksaban neinferioren zdravljenju z enoksaparinom/antagonisti vitamina K (p < 0,0001 (test neinferiornosti); razmerje tveganja: 0,680 (0,443 - 1,042), p = 0,076 (test superiornosti)).
English: Dosing recommendations before and after invasive procedures and surgical intervention If an invasive procedure or surgical intervention is required, Xarelto 2.5 mg should be stopped at least 12 hours before the intervention, if possible and based on the clinical judgement of the physician.
Slovenian: Priporočila za odmerjanje pred invazivnimi postopki in kirurškimi posegi in po njih Če je potreben invazivni postopek ali kirurški poseg, je treba, če je mogoče, in glede na klinično presojo zdravnika, zdravljenje z zdravilom Xarelto 2,5 mg prenehati vsaj 12 ur pred posegom.
English: Table 9: Efficacy and safety results from phase III Einstein Choice Study population
Slovenian: Preglednica 9: Izsledki učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein Choice
English: EU/1/08/472/043 28 film-coated tablets
Slovenian: EU/1/08/472/043 28 filmsko obloženih tablet
English: Table 5: Efficacy and safety results from phase III Einstein DVT Study population
Slovenian: Preglednica 5: Izsledki glede učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein DVT
English: 20 mg once a day (15 mg once a day in patients with moderate renal impairment) Event rate (100 pt-yr)
Slovenian: Odmerek zdravila zdravilo Xarelto 20 mg enkrat na dan (15 mg enkrat na dan pri bolnikih z zmerno okvaro ledvic)
English: EU/1/08/472/006 10 film-coated tablets
Slovenian: EU/1/08/472/006 10 filmsko obloženih tablet
English: Table 7: Efficacy results from phase III COMPASS Study
Slovenian: Preglednica 7: Izsledki glede učinkovitosti v kliničnem preskušanju III.faze COMPASS Preizkušana populacija
English: EU/1/08/472/018 28 film-coated tablets
Slovenian: EU/1/08/472/018 28 filmsko obloženih tablet
English: Xarelto 2.5 mg, twice daily, N=3114 n (%)
Slovenian: Odmerek zdravila zdravilo Xarelto 2,5 mg, dvakrat na dan, n = 3.114
English: rectal haemorrhage), gastrointestinal and abdominal pains, dyspepsia, nausea, constipationA, diarrhoea, vomitingA
Slovenian: bolečine v prebavilih in trebuhu, dispepsija,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 15 MG
Slovenian: VMESNI KARTON PRI VEČKRATNEM PAKIRANJU ZA TABLETE PO 15 MG (BREZ PODATKOV ZA 'BLUE BOX'
English: Converting from Vitamin K Antagonists (VKA) to Xarelto For patients treated for prevention of stroke and systemic embolism, VKA treatment should be stopped and Xarelto therapy should be initiated when the International Normalised Ratio (INR) is
Slovenian: Pri bolnikih, ki za preprečevanje možganske kapi in sistemske embolije jemljejo antagoniste vitamina K, je treba zdravljenje z antagonisti vitamina K prenehati in uvesti zdravljenje z zdravilom
English: EU/1/08/472/007 30 film-coated tablets
Slovenian: EU/1/08/472/007 30 filmsko obloženih tablet
English: If an invasive procedure or surgical intervention is required, Xarelto 10 mg should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
Slovenian: Če je potreben invazivni postopek ali kirurški poseg, je treba, če je mogoče, in glede na klinično presojo zdravnika, zdravljenje z zdravilom Xarelto 10 mg prenehati vsaj 24 ur pred posegom.
English: They come - in blisters in cartons of 14, 20, 28, 30, 56, 60, 98, 168 or 196 film-coated tablets or - in unit dose blisters in cartons of 10 x 1 or 100 x 1 or - in multipacks comprising 10 cartons, each containing 10 x 1 film-coated tablets or - in bottles of 100 film-coated tablets.
Slovenian: v škatlah po 14, 20, 28, 30, 56, 60, 98, 168 ali 196 filmsko obloženih tablet v pretisnih omotih ali v škatlah po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnem pakiranju po 10 enot, ena enota vsebuje 10 x 1 filmsko obloženo tableto ali v plastenkah po 100 filmsko obloženih tablet.
English: Hepatic impairment
Slovenian: - lokalizirana oteklina
English: Each film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4.
Slovenian: Ena filmsko obložena tableta vsebuje 24,13 mg laktoze (v obliki laktoze monohidrata), glejte poglavje 4.4.
English: Eye haemorrhage (incl.
Slovenian: - porumenelost kože in oči (zlatenica)
English: Symptomatic PE and DVT 1
Slovenian: Simptomatska ponovna VTE* Simptomatska ponovna PE 20 Simptomatska ponovna GVT 14 Simptomatska PE in GVT 1
English: In addition to the phase III RECORD programme, a post-authorization, non-interventional, open-label cohort study (XAMOS) has been conducted in 17,413 patients undergoing major orthopaedic surgery of the hip or knee, to compare rivaroxaban with other pharmacological thromboprophylaxis (standardof-care) under real-life setting.
Slovenian: 17.413 bolnikih, ki so imeli velik ortopedski kirurški poseg na kolku ali kolenu, izvedena neintervencijska, odprta kohortna študija (XAMOS).
English: EU/1/08/472/044 98 film-coated tablets
Slovenian: EU/1/08/472/044 98 filmsko obloženih tablet
English: Titanium dioxide (E 171) Iron oxide red (E 172)
Slovenian: rdeči železov oksid (E 172) 6.2 Inkompatibilnosti
English: Relationship:
Slovenian: Telefon: Sorodstveno razmerje:
English: EU/1/08/472/003 30 film-coated tablets
Slovenian: EU/1/08/472/003 30 filmsko obloženih tablet
English: Xarelto 10 mg film-coated tablets
Slovenian: IME ZDRAVILA Xarelto 10 mg filmsko obložene tablete
English: Absorption
Slovenian: Extension
English: EU/1/08/472/049 14 film-coated tablets
Slovenian: EU/1/08/472/049 14 filmsko obloženih tablet
English: Xarelto 10 mg film-coated tablets rivaroxaban
Slovenian: IME ZDRAVILA Xarelto 10 mg filmsko obložene tablete rivaroksaban
English: Date of dose change
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Compartment syndrome secondary to a bleeding
Slovenian: sekundarno po krvavitvi
English: PP/Aluminium foil blisters in cartons of 5, 10, 14, 28, 30 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1, 100 x 1, or in multipacks containing 100 (10 packs of 10 x 1) filmcoated tablets.
Slovenian: 6.5 Vrsta ovojnine in vsebina Škatla po 5, 10, 14, 28, 30 ali 98 filmsko obloženih tablet v pretisnih omotih iz PP/aluminija ali škatla po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnih pakiranjih, ki vsebujejo 100 (10 enot po 10 x 1) filmsko obloženih tablet.
English: Table 4: Efficacy and safety results from phase III Einstein DVT Study population
Slovenian: Preglednica 4: Izsledki glede učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein DVT
English: Xarelto 20 mg film-coated tablets
Slovenian: IME ZDRAVILA Xarelto 20 mg filmsko obložene tablete
English: Table 6: Efficacy and safety results from phase III Einstein DVT Study population
Slovenian: Preglednica 6: Izsledki glede učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein DVT
English: Non-major clinically relevant bleeding events
Slovenian: Klinično pomembne majhne krvavitve
English: In the Einstein PE study (see Table 5) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p=0.0026 (test for non-inferiority); HR: 1.123 (0.749 - 1.684)).
Slovenian: V kliničnem preskušanju Einstein PE (glejte preglednico 5) je bilo prikazano, da je rivaroksaban neinferioren v primerjavi z zdravljenjem z enoksaparinom/antagonisti vitamina K za primarni izid učinkovitosti (p = 0.0026 (test za neinferiornost); razmerje tveganja: 1,123 (0,749 - 1,684)).
English: EU/1/08/472/002 10 film-coated tablets
Slovenian: EU/1/08/472/002 10 filmsko obloženih tablet
English: EU/1/08/472/048 14 film-coated tablets
Slovenian: EU/1/08/472/048 14 filmsko obloženih tablet
English: They come in blisters in cartons of 5, 10, 14, 28, 30 or 98 film-coated tablets or in unit dose blisters in cartons of 10 x 1 or 100 x 1 or in multipacks comprising 10 cartons, each containing 10 x 1 film-coated tablets or in bottles of 100 film-coated tablets.
Slovenian: Na voljo so: v škatlah po 5, 10, 14, 28, 30 ali 98 filmsko obloženih tablet v pretisnih omotih ali v škatlah po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnem pakiranju po 10 enot; ena enota vsebuje 10 x 1 filmsko obloženo tableto ali v plastenkah po 100 filmsko obloženih tablet.
English: Dosing recommendations before and after invasive procedures and surgical intervention If an invasive procedure or surgical intervention is required, Xarelto 15 mg/ Xarelto 20 mg should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
Slovenian: Priporočila za odmerjanje pred invazivnimi postopki in kirurškimi posegi in po njih Če je potreben invazivni postopek ali kirurški poseg, je treba, če je mogoče, in glede na klinično presojo zdravnika, zdravljenje z zdravilom Xarelto 15 mg/ Xarelto 20 mg prenehati vsaj 24 ur pred posegom.
English: Each 15 mg film-coated tablet contains 15 mg rivaroxaban.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 15 mg rivaroksabana.
English: Take Xarelto on a regular basis and for as long as your doctor keeps prescribing it. Do not stop taking Xarelto without talking to your doctor first.
Slovenian: Zdravilo Xarelto jemljite redno in dokler vam ga zdravnik predpisuje.