natgillin/translations-raw huggingface dataset:
Clarithromycin (500 mg bid), for instance, considered as 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.
Klaritromicin (500 mg dvakrat na dan), ki močno zavira CYP3A4 in je zmeren zaviralec P- gp, je povzročil 1, 5- kratno zvečanje povprečne AUC rivaroksabana in 1, 4- kratno zvečanje Cmax.
Erythromycin (500 mg three times a day [tid]), which inhibits CYP3A4 and P-gp moderately, led to a 1.3 fold increase in mean rivaroxaban AUC and Cmax.
Eritromicin (500 mg trikrat na dan), ki zmerno zavira CYP3A4 in P- gp, je povzročil 1, 3- kratno povečanje povprečne AUC in Cmax.
Anticoagulants After combined administration of enoxaparin (40 mg single dose) with rivaroxaban (10 mg single dose) an additive effect on anti-Factor Xa activity was observed without any additional effects on clotting tests (PT, aPTT).
Antikoagulacijska zdravila Sočasna uporaba odmerkov enoksaparina (40 mg na posamezni odmerek) in rivaroksabana (10 mg na posamezni odmerek) povzroči aditivno zaviranje faktorja Xa, ne vpliva pa na teste strjevanja krvi (PČ, aPTČ).
Due to the increased bleeding risk care is to be taken if patients are treated concomitantly with any other anticoagulants (see section 4.4).
Zaradi večjega tveganja za krvavitev je pri bolnikih, ki sočasno prejemajo druga antikoagulacijska zdravila, potrebna previdnost (glejte poglavje 4. 4).
NSAIDs/ platelet aggregation inhibitors No clinically relevant prolongation of bleeding time was observed after concomitant administration of rivaroxaban and 500 mg naproxen.
NSAIDs/ zaviralci agregacije trombocitov Po sočasni uporabi rivaroksabana in 500 mg naproksena niso opazili klinično pomembnega podaljšanja časa krvavitve.
No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with 500 mg acetylsalicylic acid.
Med sočasno uporabo rivaroksabana in 500 mg acetilsalicilne kisline niso opazili klinično pomembnega farmakokinetičnega ali farmakodinamičnega medsebojnega delovanja.
Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction but a relevant increase in bleeding time was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/ IIIa receptor levels.
V podskupini bolnikov se je pomembno podaljšal čas krvavitve; sprememba ni bila povezana z agregacijo trombocitov, niti z ravnijo P- selektina ali receptorja GPIIb/ IIIa.
Care is to be taken if patients are treated concomitantly with NSAIDs (including acetylsalicylic acid) and platelet aggregation inhibitors because these medicinal products typically increase the bleeding risk (see section 4.4).
Med sočasno uporabo rivaroksabana in NSAIDs (tudi acetilsalicilne kisline) ali zaviralcev agregacije trombocitov je potrebna previdnost, ker ta zdravila povečajo tveganje za krvavitev (glejte poglavje 4. 4).
CYP3A4 inducers Co-administration of rivaroxaban with the strong CYP3A4 inducer rifampicin led to an approximate 50% decrease in mean rivaroxaban AUC, with parallel decreases in its pharmacodynamic effects.
Induktorji CYP3A4 Sočasna uporaba rivaroksabana in rifampicina, ki je močan induktor CYP3A4, zmanjša povprečno AUC rivaroksabana za približno 50%; obenem zmanjša njegove farmakodinamične učinke.
John’ s Wort) may also lead to reduced rivaroxaban plasma concentrations.
Koncentracijo rivaroksabana v plazmi lahko zmanjša tudi sočasna uporaba drugih močnih induktorjev CYP3A4 (npr. fenitoina, karbamazepina, fenobarbitala ali šentjanževke).
Strong CYP3A4 inducers should be co-administered with caution.
Pri sočasni uporabi močnih induktorjev CYP3A4 je potrebna previdnost.
Other concomitant therapies No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp) or atorvastatin (substrate of CYP3A4 and P-gp).
Druga sočasno uporabljena zdravila Med sočasno uporabo rivaroksabana in midazolama (substrat CYP3A4), digoksina (substrat P- gp) ali atorvastatina (substrat CYP3A4 in P- gp), niso ugotovili klinično pomembnega farmakokinetičnega ali farmakodinamičnega medsebojnega delovanja.
Rivaroxaban neither inhibits nor induces any major CYP isoforms like CYP3A4.
CYP3A4.
No clinically relevant interaction with food was observed (see section 4.2).
Klinično pomembnih interakcij s hrano niso ugotovili (glejte poglavje 4. 2).
Laboratory parameters Clotting parameters (e. g.
5 Laboratorijske vrednosti Rivaroksaban vpliva na teste strjevanja krvi (npr.
PT, aPTT, HepTest) are affected as expected by the mode of action of rivaroxaban (see section 5.1).
PČ, aPTČ, HepTest), kar je pričakovano glede na njegov način delovanja (glejte poglavje 5. 1).
Pregnancy There are no adequate data from the use of rivaroxaban in pregnant women.
Nosečnost Ustreznih podatkov o uporabi rivaroksabana pri nosečnicah ni na voljo.
Due to the potential reproductive toxicity, the intrinsic
Študije na živalih kažejo vplive na sposobnost razmnoževanja (glejte poglavje 5. 3).
5 risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy (see section 4.3).
Zaradi možnega vpliva na sposobnost razmnoževanja, tveganja za krvavitve in dokazov, da rivaroksaban prehaja skozi placento, je uporaba zdravila Xarelto med nosečnostjo kontraindicirana (glejte poglavje 4. 3).
Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
Ženske v rodni dobi se morajo med zdravljenjem z zdravilom Xarelto izogibati zanositvi.
Lactation No data on the use of rivaroxaban in breast-feeding women are available.
Dojenje Podatkov o uporabi rivaroksabana pri doječih materah ni.
Data from animals indicate that rivaroxaban is secreted into milk.
Podatki pri živalih kažejo, da se rivaroksaban izloča z mlekom.
Therefore Xarelto is contraindicated during breast-feeding (see section 4.3).
Uporaba zdravila Xarelto je med dojenjem kontraindicirana (glejte poglavje 4. 3).
A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from therapy.
Odločiti se je treba ali prenehati z dojenjem ali prenehati oz. vzdržati se zdravljenja.
Syncope and dizziness have been reported in the post-operative setting and may affect the ability to drive and use machines, these adverse reactions have been reported to be uncommon (see section 4.8).
Po kirurških posegih so občasno poročali o pojavu sinkope in omotice, ki lahko vplivata na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4. 8).
Patients experiencing these adverse reactions should not drive or use machines.
Bolniki, pri katerih se pojavijo ti neželeni učinki ne smejo voziti ali upravljati s stroji.
The safety of rivaroxaban 10 mg has been evaluated in three phase III studies including 4,571 patients exposed to rivaroxaban undergoing major orthopaedic surgery of the lower limbs (total hip replacement or total knee replacement) treated for up to 39 days.
Bolniki so prejemali rivaroksaban do 39 dni.
In total, about 14% of the treated patients experienced adverse reactions.
Skupno 14% zdravljenih bolnikov je imelo neželene učinke.
Bleedings or anaemia occurred in approximately 3.3% and 1% of patients, respectively.
1% bolnikov.
Other common adverse reactions were nausea, increased GGT and an increase in transaminases.
Drugi pogosti neželeni učinki so bili navzea, zvečane vrednosti GGT in transaminaz.
The adverse reactions should be interpreted within the surgical setting.
Podani so neželeni učinki v okviru kirurških posegov.
Due to the pharmacological mode of action, the use of Xarelto may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in posthaemorrhagic anaemia.
Zaradi farmakološkega načina delovanja lahko uporabo zdravila Xarelto spremlja večje tveganje za prikrite ali očitne krvavitve iz tkiv ali organov, ki lahko povzročijo pohemoragično anemijo.
The signs, symptoms, and severity (including possibly fatal outcome) will vary according to the location and degree or extent of the bleeding.
Znaki, simptomi in njihova izrazitost (vključno smrt) so odvisni od mesta in obsežnosti krvavitve.
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 with other medicinal products affecting haemostasis (see Haemorrhagic risk in section 4.4).
Tveganje za krvavitev je lahko večje v določenih skupinah bolnikov, npr. bolniki z nenadzorovano hudo arterijsko hipertenzijo in/ ali sočasno uporabo drugih zdravil, ki vplivajo na hemostazo (glejte Tveganje za krvavitev v poglavju 4. 4).
Haemorrhagic complications may present as weakness, asthenia, paleness, dizziness, headache or unexplained swelling.
Krvavitev se lahko kaže z oslabelostjo, astenijo, bledico, omotico, glavobolom ali nepojasnjenim otekanjem.
Adverse reactions in the three phase III studies are listed in table 1 below by system organ class (in MedDRA) and by frequency.
Neželeni učinki v treh študijah III. faze so našteti v preglednici 1 (spodaj) po organskih sistemih (MedDRA) in pogostnosti.
Frequencies are defined as:
Neznana:
Common: ≥ 1/ 100 to < 1/ 10 Uncommon: ≥ 1/ 1,000 to < 1/ 100 Rare: ≥ 1/ 10,000 to < 1/ 1,000 Very rare: < 1/ 10,000 Not known: cannot be estimated from the available data.
≥ 1/ 100 do < 1/ 10 ≥ 1/ 1. 000 do < 1/ 100 ≥ 1/ 10. 000 do < 1/ 1. 000 < 1/ 10. 000 ni mogoče oceniti iz razpoložljivih podatkov
Table 1:
6 Preglednica 1:
Treatment-emergent adverse reactions
Neželeni učinki pri katerih je bilo potrebno takojšnje ukrepanje
Not known*
Neznana *
LDH, increased alkaline phosphatase ALT increase, AST increase)
zvečane vrednosti GGT, transaminaz (vključno z zvečanjem vrednosti ALT in AST) Srčne bolezni
increased (with or without concomitant increase of ALT)
zvečane vrednosti lipaze, amilaze, bilirubina v krvi, LDH, alkalne fosfataze tahikardija
Cardiac disorders Tachycardia Blood and lymphatic system disorders
zvečane vrednosti konjugiranega bilirubina (z ali brez sočasnega zvečanja vrednosti ALT)
Anaemia (incl. respective laboratory parameter)
Bolezni krvi in limfatičnega sistema
Thrombocythaemia (incl. platelet count increased)
anemija (tudi ustrezni laboratorijski parametri) Bolezni živčevja Bolezni prebavil
Nervous system disorders Syncope (incl. loss of consciousness), dizziness, headache Gastrointestinal disorders
trombocitemija (vključno s povečanim številom trombocitov) sinkopa (tudi izguba zavesti), omotica, glavobol
Nausea
navzea Bolezni sečil
Constipation, diarrhoea, abdominal and gastrointestinal pain (incl. upper abdominal pain, stomach discomfort), dyspepsia (incl. epigastric discomfort), dry mouth, vomiting
zaprtje, driska, bolečine v trebuhu in prebavilih (vključno z bolečinami v zgornjem delu trebuha, neprijetnim občutkom v želodcu), dispepsija (vključno z bolečino v epigastriju), suha usta, bruhanje okvara ledvic (vključno z zvišanjem kreatinina in sečnine v krvi)
Renal and urinary disorders Renal impairment (incl. blood creatinine increased, blood urea increased) Skin and subcutaneous tissue disorders Pruritus (incl. rare cases of generalised pruritus), rash, urticaria (incl. rare cases of generalised urticaria), contusion Musculoskeletal and connective tissue disorders Pain in extremity Injury, poisoning and procedural complications Wound secretion Vascular disorders
Bolezni kože in podkožja srbenje (vključno z redkimi primeri generaliziranega srbenja), osip, urtikarija (vključno z redkimi primeri generalizirane urtikarije), kontuzija Bolezni mišično- skeletnega sistema in vezivnega tkiva bolečine v udih Poškodbe in zastrupitve in zapleti pri posegih sekrecija iz rane Žilne bolezni
Post-procedural
krvavitve po
Haemorrhage (incl. haematoma and rare
krvavitev (vključno s hematomi in
Bleeding into a
krvavitve v
haemorrhage (incl. cases of muscle haemorrhage), post-operative gastrointestinal tract haemorrhage (incl. anaemia, and gingival bleeding, rectal haemorrhage, wound haememesis), haematuria (incl. blood haemorrhage) urine present), genital tract haemorrhage (incl. menorrhagia), hypotension (incl. blood pressure decreased, procedural hypotension), nose bleed General disorders and administration site conditions Localised oedema, peripheral oedema, feeling unwell (incl. fatigue, asthenia), fever Immune system disorders
posegih (vključno z redkimi primeri krvavitev v mišice), anemijo po krvavitev v prebavilih (vključno s kirurškem posegu krvavitvijo iz dlesni, krvavitvijo iz in krvavitev iz danke, hematemezo), hematurija (tudi kri rane) v seču), krvavitev iz spolovil (vključno z menoragijo), hipotenzija (tudi znižanje krvnega tlaka, hipotenzija pri posegu), krvavitev iz nosu Splošne težave in spremembe na mestu aplikacije lokalizirani edemi, periferni edemi, slabo počutje (vključno z utrujenostjo, astenijo), zvišana telesna temperatura
critical organ (e. g. brain), adrenal haemorrhage, conjunctival haemorrhage, haemoptysis
kritične organe (npr. možgane), krvavitev v nadledvično žlezo, krvavitev v očesno veznico, hemoptiza
7 4.9 Overdose
7
Overdose following administration of rivaroxaban may lead to haemorrhagic complications due to its pharmacodynamic properties.
Bolezni jeter, žolčnika in žolčevodov
A specific antidote antagonising the pharmacodynamic effect of rivaroxaban is not available.
* O neželenih učinkih so pri bolnikih z velikimi ortopedskimi kirurškimi posegi na spodnjih okončinah poročali razen v študijah III. faze tudi v drugih kliničnih študijah.
The use of activated charcoal to reduce absorption in case of rivaroxaban overdose may be considered.
Specifičnega antidota, ki bi odpravil farmakodinamične učinke rivaroksabana, ni na voljo.
Should bleeding occur, management of the haemorrhage may include the following steps: • delay of next rivaroxaban administration or discontinuation of treatment as appropriate.
Pri prevelikem odmerjanju rivaroksabana je možna uporaba aktivnega oglja.
Rivaroxaban has mean terminal half-lives between 7 and 11 hours (see section 5.2). • appropriate symptomatic treatment, e. g. mechanical compression, surgical interventions, fluid replacement and haemodynamic support, blood product or component transfusion should be considered.
Če se pojavi krvavitev, pridejo v poštev naslednji ukrepi: • odložitev naslednjega odmerka rivaroksabana ali prekinitev zdravljenja; povprečni razpolovni časi rivaroksabana so od 7 do 11 ur (glejte poglavje 5. 2) • simptomatsko zdravljenje npr. mehanska kompresija, kirurški posegi, nadomeščanje tekočine in hemodinamska podpora ter transfuzija krvnih pripravkov ali sestavin.
If life-threatening bleeding cannot be controlled by the above measures, administration of recombinant factor VIIa may be considered.
Če življenjsko ogrožujoče krvavitve ni mogoče obvladati z naštetimi ukrepi, se lahko uporabi rekombinantni faktor VIIa.
However, there is currently no experience with the use of recombinant factor VIIa in individuals receiving rivaroxaban.
Do sedaj ni izkušenj z uporabo rekombinantnega faktorja VIIa pri bolnikih, ki prejemajo rivaroksaban.
The recommendation is based on limited non-clinical data.
Priporočila temeljijo glede na omejeno število predkliničnih podatkov.
Re-dosing of recombinant factor VIIa shall be considered and titrated depending on improvement of bleeding.
Razmisliti je treba o spremembi odmerka rekombinantnega faktorja VIIa; odmerek je odvisen od izboljšanja parametrov krvavitve.
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban.
Protaminijev sulfat in vitamin K ne vplivata na antikoagulacijski učinek rivaroksabana.
There is neither scientific rationale for benefit nor experience with the use of systemic haemostatics (e. g. desmopressin, aprotinin, tranexamic acid, aminocaproic acid) in individuals receiving rivaroxaban.
Uporaba sistemskih hemostatikov (npr. dezmopresina, aprotinina, traneksamične kisline, aminokaprojske kisline) pri osebah, ki dobivajo rivaroksaban, ni preizkušena.
Other antithrombotic agents, ATC code:
Farmakoterapevtska skupina: drugi antitrombotiki, oznaka ATC:
Mechanism of Action Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability.
Mehanizem delovanja Rivaroksaban je zelo selektiven direkten peroralno učinkovit zaviralec faktorja Xa.
Inhibition of Factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi.
Zaviranje faktorja Xa poteka po intrinzični in ekstrinzični poti koagulacije krvi in zavira nastanek trombina in strdka.
Rivaroxaban does not inhibit thrombin (activated Factor II) and no effects on platelets have been demonstrated.
Rivaroksaban ne zavira delovanje trombina (aktivirani faktor II) in ne deluje na trombocite.
Pharmacodynamic effects Dose-dependent inhibition of Factor Xa activity was observed in humans.
Farmakodinamični učinki Pri ljudeh je zaviranje faktorja Xa odvisno od odmerka.
Prothrombin time (PT) is influenced by rivaroxaban in a dose dependent way with a close correlation to plasma concentrations (r value equals 0.98) if Neoplastin is used for the assay.
Vpliv rivaroksabana na protrombinski čas (PČ) je odvisen od odmerka in je sorazmeren s koncentracijo v plazmi (r = 0, 98).
Other reagents would provide different results.
Podatek velja za meritve z Neoplastin- om, ne pa za druge reagente, ki bi lahko dali drugačne rezultate.
The readout for PT is to be done in seconds, because the INR (International Normalized Ratio) is only calibrated and validated for coumarins and cannot be used for any other anticoagulant.
Protrombinski čas je treba odčitati v nekaj sekundah, kajti INR (International Normalised Ratio – mednarodno umerjeno razmerje) je kalibriran in validiran samo za kumarine in ni uporaben za meritev učinka drugih antikoagulacijskih zdravil.
In patients undergoing major orthopaedic surgery, the 5/ 95 percentiles for PT (Neoplastin) 2 - 4 hours after tablet intake (i. e. at the time of maximum effect) ranged from 13 to 25 s (baseline values before surgery 12 to 15s).
Pri bolnikih z velikimi ortopedskimi kirurškimi posegi je znašal PČ izmerjen z Neoplastin- om v času največjega učinka zdravila (2 do 4 ure po zaužitju tablete t. j. v času največjega učinka) od 13 do 25 sekund (razpon od 5 do 95 percentila) (izhodiščne vrednosti pred kirurškim posegom so 12 do 15 sekund).
The activated partial thomboplastin time (aPTT) and HepTest are also prolonged dose-dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban.
8 Podaljšanje aktiviranega parcialnega tromboplastinskega časa (aPTČ) in HepTest sta prav tako odvisna od odmerka; testa nista priporočljiva za ocenjevanje farmakodinamičnega učinka rivaroksabana.
Anti- Factor Xa activity is also influenced by rivaroxaban; however, no standard for calibration is available.
Rivaroksaban vpliva tudi na anti Xa aktivnost, vendar standardne kalibracije ni na voljo.
There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine.
V vsakdanji praksi med zdravljenjem z rivaroksabanom ni potrebna kontrola koagulacijskih testov.
Clinical efficacy and safety The rivaroxaban clinical programme was designed to demonstrate the efficacy of rivaroxaban for the prevention of VTE, i. e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs.
Klinična učinkovitost in varnost Cilj kliničnega programa z rivaroksabanom je bila ocena njegove učinkovitosti pri preprečevanju VTE, tj. proksimalne in distalne venske tromboze (VT) udov in pljučne embolije (PE), pri bolnikih z velikimi ortopedskimi kirurškimi posegi na spodnjih okončinah.
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.
V kontrolirane, randomizirane dvojno slepe klinične študije III. faze (program RECORD) je bilo vključenih več kot 9500 bolnikov (7050 z zamenjavo kolka in 2531 z zamenjavo kolena).
8 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.
Bolniki niso prejeli prvega odmerka rivaroksabana prej kot 6 ur po kirurškem posegu.
In all three phase III studies (see table 2), 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.
V vseh treh študijah III. faze (glejte preglednico 2) je rivaroksaban značilno zmanjšal delež vseh VTE (venografsko potrjene ali simptomatske VT, neusodne PE in smrti), kakor tudi težjih oblik VTE (proksimalne VT, neusodne PE in smrti, povezane z VTE), kar so bile vnaprej določene primarne in pomembne sekundarne končne točke študij.
Furthermore, in all three studies the rate of symptomatic VTE (symptomatic DVT, non- fatal PE, VTE-related death) was lower in rivaroxaban treated patients compared to patients treated with enoxaparin.
Delež simptomatskih VTE (simptomatske VT, neusodne PE, smrti povezane z VTE) je bil v vseh treh študijah manjši pri bolnikih, ki so prejemali rivaroksaban v primerjavi z bolniki, ki so prejemali enoksaparin.
The main safety endpoint, major bleeding, showed comparable rates for patients treated with rivaroxaban 10 mg compared to enoxaparin 40 mg.
40 mg enoksaparina primerljiv.
Efficacy and safety results from phase III clinical studies
Rezultati učinkovitosti in varnosti v kliničnih študijah III. faze
RECORD 2
RECORD 2 RECORD 3
RECORD 3
raziskovana populacija
Study Population
4. 541 bolnikov
4,541 patients undergoing total hip replacement surgery
z zamenjavo kolka 2. 509 bolnikov z zamenjavo kolka 2. 531 bolnikov z zamenjavo kolena enoksaparin p p rivaroksaba enoksapari p rivaroksaba
2,509 patients undergoing total hip replacement surgery
enoksapari rivaroksaba odmerek 40 mg n n n n n zdravila in enkrat na 10 mg 40 mg 10 mg 40 mg 10 mg trajanje dan enkrat na enkrat na enkrat na enkrat na enkrat na prejemanja 12 ± 2 dni dan dan dan dan dan po 12 ± 2 dni 12 ± 2 dni 35 ± 4 dni 35 ± 4 dni 35 ± 4 dni kirurškem posegu vse VTE
2,531 patients undergoing total replacement surgery
58 (3, 7%)
knee
< 0, 001
Treatment dose and duration after surgery
17 (2, 0%)
Rivaroxaban Enoxaparin p 10 mg od 40 mg od 35 ± 4 days 35 ± 4 days
81 (9, 3%) < 0, 001
Rivaroxaban Enoxaparin p 10 mg od 40 mg od 35 ± 4 days 12 ± 2 days
79 (9, 6%)
Rivaroxaban Enoxaparin 10 mg od 40 mg od 12 ± 2 days 12 ± 2 days
166 (18, 9%)
p
< 0, 001
Total VTE Major VTE
težje oblike VTE
18 (1.1%) 4 (0.2%)
4 (0, 2%)
58 (3.7%) 33 (2.0%)
33 (2, 0%)
17 (2.0%) 6 (0.6%)
6 (0, 6%)
81 (9.3%) < 0.001 49 (5.1%) < 0.001
49 (5, 1%) < 0, 001
79 (9.6%) 9 (1.0%)
9 (1, 0%)
166 (18.9%) < 0.001 24 (2.6%) 0.01
24 (2, 6%)
Sympto- matic VTE
simptomatske VTE
1 (0.1%)
2 (0, 1%)
1 (0.1%)
1 (0, 1%) 1 (0, 1%)
The analysis of the pooled results of the phase III trials corroborated the data obtained in the individual studies regarding reduction of total VTE, major VTE and symptomatic VTE with rivaroxaban 10 mg once daily compared to enoxaparin 40 mg once daily.
Skupna analiza rezultatov iz vseh preskušanj III. faze je potrdila podatke posameznih študij o zmanjšanju vseh VTE, težjih oblik VTE in simptomatskih VTE z rivaroksabanom 10 mg enkrat na dan v primerjavi z enoksaparinom 40 mg enkrat na dan.
Absorption The absolute bioavailability of rivaroxaban is high (80% - 100%) for the 10 mg dose.
Absorpcija Absolutna biološka uporabnost rivaroksabana v odmerku 10 mg je visoka (80 – 100%).
Intake with food does not affect rivaroxaban AUC or Cmax at the 10 mg dose.
Pri 10 - miligramskem odmerku hrana ne vpliva na AUC ali Cmax rivaroksabana.
Rivaroxaban 10 mg dose can be taken with or without food.
Odmerek 10 mg rivaroksabana lahko bolnik vzame s hrano ali brez nje.
Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily.
9 odmerka približno15 mg enkrat na dan.