natgillin/translations-raw huggingface dataset:
- The active substance is rivaroxaban.
- Učinkovina je rivaroksaban.
There were no clinically relevant differences in pharmacokinetics and pharmacodynamics between male and female patients.
Med bolniki in bolnicami ni bilo klinično pomembnih razlik v farmakokinetiki in farmakodinamiki.
Try to take the tablet(s) at the same time every day to help you to remember it.
Najbolje je, če tableto(-e) vzamete vsak dan ob istem času, da je (jih) ne boste pozabili vzeti.
However the incidence rates were balanced between Xarelto and placebo for the components of fatal bleeding events, hypotension requiring treatment with intravenous inotropic agents and surgical intervention for ongoing bleeding.
Vendar pa je bila incidenca posameznih komponent sestavljenega opazovanega dogodka med zdravilom Xarelto in placebom uravnotežena: krvavitev s smrtnim izidom, hipotenzija, ki jo je bilo treba zdraviti z intravenskimi inotropnimi učinkovinami in kirurški poseg zaradi trajajoče krvavitve.
Absorption of rivaroxaban is dependent on the site of its release in the gastrointestinal tract.
Absorpcija rivaroksabana je odvisna od mesta sproščanja v prebavilih.
Symptomatic PE and DVT 0
Simptomatska PE in GVT 0
Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery 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.
Preprečevanje VTE pri odraslih bolnikih po načrtovani kirurški zamenjavi kolka ali kolena Klinični program z rivaroksabanom je bil zasnovan tako, da dokaže učinkovitost rivaroksabana pri preprečevanju VTE, tj. proksimalne in distalne globoke venske tromboze (GVT) in pljučne embolije (PE), pri bolnikih z velikimi ortopedskimi kirurškimi posegi na spodnjih okončinah.
Take the tablet every day until your doctor tells you to stop.
Vsak dan zaužijte po eno tableto, dokler vam zdravnik ne bo svetoval, da zdravilo prenehate jemati.
This Xarelto 15 mg and 20 mg treatment initiation pack is only for the first 4 weeks of treatment.
To začetno pakiranje zdravila Xarelto 15 mg oziroma 20 mg je samo za prve 4 tedne zdravljenja.
Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
Zdravilo Xarelto, ki se jemlje sočasno z acetilsalicilno kislino, je indicirano za preprečevanje aterotrombotičnih dogodkov pri odraslih bolnikih s koronarno boleznijo (KB) ali simptomatsko periferno arterijsko boleznijo (PAB) z velikim tveganjem za ishemične dogodke.
a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome).
reakcija na zdravilo, ki povzroča izpuščaj, zvišano telesno temperaturo, vnetje notranjih organov, hematološke nepravilnosti in sistemsko bolezen (sindrom DRESS).
There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin in individuals receiving rivaroxaban.
Pri osebah, ki prejemajo rivaroksaban, je malo izkušenj s traneksamično kislino in ni izkušenj z aminokaprojsko kislino in aprotininom.
All-cause mortality a) Safety population, on treatment * Nominally significant
a) skupina preizkušancev za oceno varnosti zdravila, zdravljena * nominalno statistično značilno
Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is estimated to be low (see section 5.2).
Vstavitev ali odstranitev epiduralnega katetra ali lumbalno punkcijo je najbolje opraviti, kadar se oceni, da je antikoagulacijski učinek rivaroksabana majhen (glejte poglavje 5.2).
1.6% of patients
1,6 % bolnikov
93.2% of patients received ASA concomitantly plus thienopyridine treatment and 6.8% ASA only.
93,2 % bolnikov je sočasno prejemalo acetilsalicilno kislino in tienopiridin in 6,8 % bolnikov samo acetilsalicilno kislino.
CYP3A4 and P-gp inhibitors
Zaviralci CYP3A4 in P-gp
INR values were within the therapeutic range a mean of 63% of the time for the mean treatment duration of 215 days, and 57%, 62%, and 65% of the time in the 3-, 6-, and 12-month intended treatment duration groups, respectively.
INR vrednosti so bile v terapevtskih mejah povprečno 63 % časa pri povprečnem trajanju zdravljenja 215 dni in 57 %, 62 % in 65 % časa pri 3-, 6-, in 12-mesecih načrtovanega trajanja zdravljenja v posamezni skupini.
Dual antiplatelet therapy has not been studied in combination with Xarelto 2.5 mg twice daily in patients with CAD/PAD (see sections 4.4 and 5.1).
Dvojnega antiagregacijskega zdravljenja v kombinaciji z zdravilom Xarelto 2,5 mg dvakrat na dan niso preučevali pri bolnikih s KB/PAB (glejte poglavji 4.4 in 5.1).
Treatment with Xarelto should be started as soon as possible after stabilisation of the ACS event (including revascularisation procedures); at the earliest 24 hours after admission to hospital and at the time when parenteral anticoagulation therapy would normally be discontinued.
Zdravljenje z zdravilom Xarelto je treba začeti takoj ko je mogoče po stabilizaciji AKS (vključno s postopkom revaskularizacije); najprej 24 ur po sprejemu v bolnišnico in nato takrat, ko se parenteralno antikoagulacijsko zdravilo običajno ukine.
Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE) and prevention of recurrence
Zdravljenje globoke venske tromboze (GVT) in pljučne embolije (PE) ter preprečevanje ponovne
Therapy with Xarelto should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding (see section 4.4).
Zdravljenje z zdravilom Xarelto je dolgotrajno, če koristi preprečevanja možganske kapi in sistemske embolije pretehtajo tveganje za krvavitve (glejte poglavje 4.4).
NSAIDs/platelet aggregation inhibitors
NSAID/zaviralci agregacije trombocitov
Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).
Zdravilo Xarelto, ki se jemlje sočasno samo z acetilsalicilno kislino ali z acetilsalicilno kislino in klopidogrelom ali tiklopidinom, je indicirano za preprečevanje aterotrombotičnih dogodkov pri odraslih bolnikih po akutnem koronarnem sindromu (AKS) s povišanimi vrednostmi srčnih biokemičnih označevalcev (glejte poglavja 4.3, 4.4 in 5.1).
Group 1 received rivaroxaban 15 mg once daily (10 mg once daily in patients with creatinine clearance 30 - 49 ml/min) plus P2Y12 inhibitor.
Skupina 1 je prejemala rivaroksaban 15 mg enkrat na dan (10 mg enkrat na dan bolniki z očistkom kreatinina 30 - 49 ml/min) in zaviralec P2Y12.
The duration of therapy and dose selection should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Trajanje zdravljenja in izbiro odmerka je treba individualno prilagoditi po skrbni oceni koristi zdravljenja in tveganja za krvavitve(glejte poglavje 4.4).
Clinical surveillance in line with anticoagulation practice is recommended throughout the treatment period.
Ves čas zdravljenja se priporoča klinično spremljanje v skladu s smernicami vodenja antikoagulacijskega zdravljenja.
Elderly population Increasing age may increase haemorrhagic risk (see sections 5.1 and 5.2).
Starejša populacija S starostjo se tveganje za krvavitve lahko poveča (glejte poglavji 5.1 in 5.2).
This exploratory study showed comparable efficacy and safety between rivaroxaban and VKA treatment groups in the setting of cardioversion.
Ta raziskava je pokazala primerljivo učinkovitost in varnost rivaroksabana z antagonisti vitamina K pri bolnikih med postopkom kardioverzije.
Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is estimated to be low.
Vstavitev ali odstranitev epiduralnega katetra ali lumbalno punkcijo je najbolje opraviti, kadar se oceni, da je antikoagulacijski učinek rivaroksabana majhen.
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation The Xarelto clinical programme was designed to demonstrate the efficacy of Xarelto for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Preprečevanje možganske kapi in sistemske embolije pri bolnikih z nevalvularno atrijsko fibrilacijo Klinični program zdravila Xarelto je bil zasnovan tako, da dokaže učinkovitost zdravila Xarelto pri preprečevanju možganske kapi in sistemske embolije pri bolnikih z nevalvularno atrijsko fibrilacijo.
In Table 5 the efficacy results of patients undergoing percutaneous coronary intervention (PCI) are presented.
V preglednici 5 so prikazani izsledki glede učinkovitosti pri bolnikih po perkutanem koronarnem posegu.
In patients at high risk of ischaemic events with CAD/PAD, efficacy and safety of Xarelto 2.5 mg have only been investigated in combination with ASA.
Pri bolnikih s KB/PAB in visokim tveganjem za ishemične dogodke so učinkovitost in varnost zdravila Xarelto 2,5 mg preučevali samo v kombinaciji z acetilsalicilno kislino.
If a patient is to undergo elective surgery and anti-platelet effect is not desired, platelet aggregation inhibitors should be discontinued as directed by the manufacturer's prescribing information.
Če je pri bolniku načrtovan kirurški poseg in učinek na trombocite ni zaželen, je treba prenehati z uporabo zaviralcev agregacije trombocitov, kot je priporočeno v navodilih za uporabo teh zdravil.
No dose adjustment is necessary.
Odmerka ni treba prilagajati.
♦ Keep this card with you at all times ♦ Present this card to every physician or dentist prior to treatment
♦ Preden začnete katero koli zdravljenje pokažite kartico vsakemu zdravniku ali zobozdravniku.
If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention - PCI with an insertion of a stent), there is limited evidence to reduce the dose to one tablet Xarelto 15 mg once a day (or to one tablet Xarelto 10 mg once a day in case your kidneys are not working properly) in addition to an antiplatelet medicinal product such as clopidogrel.
Če je pri vas potreben poseg za odpravo zapore krvne žile v srcu (t.i. perkutana koronarna intervencija - PCI z vstavitvijo žilne opornice), so podatki o zmanjšanju odmerka na eno tableto zdravila Xarelto 15 mg enkrat na dan (ali na eno tableto zdravila Xarelto 10 mg enkrat na dan v primeru, da vaše ledvice ne delujejo pravilno) skupaj z antitrombotikom, kot je klopidogrel,
For the removal of an epidural catheter and based on the general PK characteristics at least 2x halflife, i.e. at least 18 hours in young patients and 26 hours in elderly patients should elapse after the last administration of rivaroxaban (see section 5.2).
Za odstranitev epiduralnega katetra in glede na splošne farmakokinetične lastnosti mora po zadnji uporabi rivaroksabana preteči vsaj 2-kratni razpolovni čas tj. najmanj 18 ur pri mlajših bolnikih in 26 ur pri starejših bolnikih (glejte poglavje 5.2).
• The Summary of Product Characteristics
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
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.
Sočasna uporaba rivaroksabana in rifampicina, ki je močan induktor CYP3A4, zmanjša povprečno AUC rivaroksabana za približno 50 %, hkrati zmanjša njegove farmakodinamične učinke.
Xarelto is to be used with caution in patients with creatinine clearance 15 - 29 ml/min (see section 4.4).
Zdravilo Xarelto je treba uporabljati previdno pri bolnikih z očistkom kreatinina med 15 - 29 ml/min (glejte poglavje 4.4).
To support the dose switch from 15 mg to 20 mg after Day 21 a first 4 weeks treatment initiation pack of Xarelto for treatment of DVT/PE is available.
Za lažji prehod z odmerjanja po 15 mg na 20 mg po 21. dnevu, je za prve 4 tedne na voljo začetno pakiranje zdravila Xarelto za zdravljenje GVT/PE.
There is no clinical experience with the use of 15 mg rivaroxaban in these situations.
Kliničnih izkušenj z uporabo 15 mg rivaroksabana v teh stanjih ni.
There is no clinical experience with the use of 20 mg rivaroxaban in these situations.
Kliničnih izkušenj z uporabo 20 mg rivaroksabana v teh stanjih ni.
Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE.
Zdravljenje GVT, zdravljenje PE ter preprečevanje ponovne GVT in PE Priporočeni odmerek za začetno zdravljenje akutne GVT ali PE je prve tri tedne 15 mg dvakrat na dan, nato pa 20 mg enkrat na dan kot nadaljevanje zdravljenja in preprečevanje ponovne GVT in PE.
10 mg or 20 mg
10 mg ali 20 mg
Of the administered rivaroxaban dose, approximately 2/3 undergoes metabolic degradation, with half then being eliminated renally and the other half eliminated by the faecal route.
Približno dve tretjini uporabljenega odmerka se presnovi; od tega se polovica izloči skozi ledvice in druga polovica z blatom.
In the pivotal double-blind ATLAS ACS 2 TIMI 51 study, 15,526 patients were randomly assigned in a 1:1:1 fashion to one of three treatment groups: Xarelto 2.5 mg orally twice daily, 5 mg orally twice daily or to placebo twice daily co-administered with ASA alone or with ASA plus a thienopyridine (clopidogrel or ticlopidine).
V ključni dvojno slepi študiji ATLAS ACS 2 TIMI 51 so 15.526 bolnikov naključno razdelili po shemi 1:1:1 v eno od treh skupin zdravljenja: zdravljenje z zdravilom Xarelto 2,5 mg peroralno dvakrat na dan, 5 mg peroralno dvakrat na dan ali skupino, ki je prejemala placebo dvakrat na dan sočasno samo z acetilsalicilno kislino ali z acetilsalicilno kislino in tienopiridinom (klopidogrel ali tiklopidin).
Acute limb ischaemia a) intention to treat analysis set, primary analyses b) vs. ASA 100 mg; Log-Rank p-value * The reduction in the primary efficacy outcome was statistically superior.
Akutna ishemija uda a) analiza z namenom zdravljenja, primarne analize b) v primerjavi s 100 mg acetilsalicilne kisline; p-vrednost Log-Rank
Study population
Preizkušana populacija
This mixture should be immediately followed by food.
Takoj po zaužitju te mešanice pojejte še nekaj hrane.
Stroke or non-CNS systemic embolism was recorded in 0.8 per 100 patient years.
Pojavnost možganske kapi ali sistemske embolije izven osrednjega živčevja je bila 0,8 na 100 bolnikov-let.
Serious skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and DRESS syndrome, have been reported during post-marketing surveillance in association with the use of rivaroxaban (see section 4.8).
V obdobju trženja so poročali o hudih kožnih reakcijah, tudi Stevens-Johnsonovem sindromu / toksični epidermalni nekrolizi in sindromu DRESS, ki so bile povezane z uporabo rivaroksabana (glejte poglavje 4.8).
10 mg once daily or 20 mg once daily
10 mg enkrat na dan ali 20 mg enkrat na dan
Warfarin titrated to a target INR of 2.5 (therapeutic range 2.0 to 3.0)
varfarin, titriran na ciljni INR 2,5 (terapevtske meje 2,0 do 3,0)
B: observed in treatment of DVT, PE and prevention of recurrence as very common in women < 55 years
B: opazili zelo pogosto pri ženskah < 55 let pri zdravljenju GVT, PE ali preprečevanju ponovne
Xarelto administration should be discontinued if severe haemorrhage occurs (see section 4.9).
Zdravljenje z zdravilom Xarelto je treba prenehati, če se pojavijo hude krvavitve (glejte poglavje 4.9).
The effect of rivaroxaban did not differ across the level of centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized quartiles (P=0.74 for interaction).
Učinek rivaroksabana se ni razlikoval od stopnje urejenosti TTR (Time in Target INR v mejah od 2,0 do 3,0) v enakomerno velikih kvartilih (p = 0,74 za interakcije).
Co-administration of rivaroxaban with ketoconazole (400 mg once a day) or ritonavir (600 mg twice a day) led to a 2.6 fold / 2.5 fold increase in mean rivaroxaban AUC and a 1.7 fold / 1.6 fold increase in mean rivaroxaban Cmax, with significant increases in pharmacodynamic effects which may lead to an increased bleeding risk.
Sočasna uporaba rivaroksabana in ketokonazola (400 mg enkrat na dan) oz. ritonavira (600 mg dvakrat na dan) je povzročila 2,6- oz. 2,5-kratno povečanje povprečne AUC rivaroksabana ter 1,7- oz. 1,6-kratno povečanje povprečne Cmax rivaroksabana, kar pomembno poveča farmakodinamične učinke, in tako lahko poveča tveganje za krvavitve.
The pharmacokinetic/pharmacodynamic (PK/PD) relationship between rivaroxaban plasma concentration and several PD endpoints (factor-Xa inhibition, PT, aPTT, Heptest) has been evaluated after administration of a wide range of doses (5 - 30 mg twice a day).
Farmakokinetično/farmakodinamsko razmerje (PK/PD) med plazemsko koncentracijo rivaroksabana in posameznimi farmakodinamičnimi končnimi točkami (zavrtje faktorja Xa, PČ, aPTČ, HepTest) so ocenjevali po uporabi več odmerkov (5 - 30 mg dvakrat na dan).
Prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS)
Preprečevanje aterotrombotičnih dogodkov pri bolnikih po akutnem koronarnem sindromu
Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding and quantify the clinical relevance of overt bleeding, as judged to be appropriate.
Poleg ustreznega kliničnega spremljanja se za odkrivanje prikritih krvavitev in ovrednotenje kliničnega pomena očitnih krvavitev lahko laboratorijsko določijo vrednosti hemoglobina/hematokrita, če se to presodi kot potrebno.
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)
zelo pogosti (≥ 1/10) pogosti (≥ 1/100 do < 1/10) občasni (≥ 1/1.000 do < 1/100) redki (≥ 1/10.000 do < 1/1.000) zelo redki (< 1/10.000)
10 x 1 film-coated tablets 100 x 1 film-coated tablets
10 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta
If a dose is missed during the 15 mg twice daily treatment phase (day 1 - 21), the patient should take Xarelto immediately to ensure intake of 30 mg Xarelto per day.
Če bolnik pozabi vzeti zdravilo Xarelto v obdobju, ko jemlje tablete po 15 mg dvakrat na dan (1. do 21. dan), ga mora vzeti takoj ko se spomni, da je zagotovljen odmerek 30 mg zdravila Xarelto na dan.
First 4 weeks treatment initiation pack: each pack of 49 film-coated tablets for the first 4 weeks of treatment contains:
Začetno pakiranje za prve 4 tedne zdravljenja: eno pakiranje po 49 fimsko obloženih tablet za prve
• For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.
• Po velikem kirurškem posegu na kolenu se priporoča 2-tedenska zaščita.
The incidence rates for the principal safety outcome (major and non-major clinically relevant bleeding events) were similar for both treatment groups (see Table 5).
Pojavnost glavnega varnostnega izida (velike in klinično pomembne majhne krvavitve) je bila podobna v obeh skupinah bolnikov (glejte preglednico 5).
The MAH shall provide an educational pack prior to launch, targeting all physicians who are expected to prescribe/use Xarelto.
Pred prihodom zdravila na trg, mora imetnik dovoljenja za promet z zdravilom pripraviti izobraževalno gradivo za vse zdravnike, ki bodo predvidoma predpisovali/uporabljali zdravilo Xarelto.
Adjusted HRs comparing rivaroxaban and standard-of-care for major bleeding, recurrent VTE and all-cause mortality were 0.77 (95% CI 0.40 - 1.50), 0.91 (95% CI 0.54 - 1.54) and 0.51 (95% CI 0.24 - 1.07), respectively.
Prilagojeno razmerje tveganja rivaroksabana v primerjavi s standardnim zdravljenjem za velike krvavitve, ponovno VTE in smrt zaradi vseh vzrokov je bilo 0,77 (95 % IZ 0,40 - 1,50), 0,91 (95 % IZ 0,54 - 1,54) oziroma 0,51 (95 % IZ 0,24 - 1,07).
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 aktivacijo trombina in s tem nastanek krvnega strdka.
- treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.
- zdravljenje krvnih strdkov v venah vaših nog (globoka venska tromboza) in v krvnih žilah vaših pljuč (pljučna embolija) ter za preprečevanje ponovnega nastanka krvnih strdkov v krvnih žilah vaših nog in/ali pljučih (pljučna embolija).
Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-factor Xa assay may be useful in exceptional situations where knowledge of rivaroxaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery (see sections 5.1 and 5.2).
Čeprav pri zdravljenju z rivaroksabanom ni potrebno rutinsko spremljanje koncentracije rivaroksabana v krvi, je lahko v izjemnih primerih, ko bi lahko podatki o koncentraciji rivaroksabana v krvi pomagali pri klinični odločitvi (npr. pri prekomernem odmerjanju in nujnem kirurškem posegu), v pomoč določanje vrednosti rivaroksabana s kalibriranim kvantitativnim merjenjem aktivnosti anti-FXa (glejte poglavji 5.1 in 5.2).
The tablet may be crushed and mixed with water or apple puree immediately before you take it.
Tableto lahko tik pred jemanjem zdrobite in zmešate z vodo ali jabolčno čežano.
Day 1-21
- 21. dan
Prevention of atherothrombotic events in patients with CAD/PAD
Preprečevanje aterotrombotičnih dogodkov pri bolnikih s KB/PAB
♦ To ensure optimal protection, Xarelto - 2.5 mg can be taken with or without food - 10 mg can be taken with or without food - 15 mg must be taken with food - 20 mg must be taken with food
♦ Za zagotovitev ustrezne zaščite lahko zdravilo Xarelto 2,5 mg jemljete s hrano ali brez nje lahko zdravilo Xarelto 10 mg jemljete s hrano ali brez nje morate zdravilo Xarelto 15 mg jemati skupaj s hrano morate zdravilo Xarelto 20 mg jemati skupaj s hrano
Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
Ženske v rodni dobi naj se med zdravljenjem z rivaroksabanom izogibajo zanositvi.
Patients taking Xarelto 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA or a daily dose of 75 - 100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
Bolniki, ki jemljejo zdravilo Xarelto 2,5 mg dvakrat na dan, naj jemljejo tudi dnevni odmerek 75100 mg acetilsalicilne kisline ali dnevni odmerek 75 - 100 mg acetilsalicilne kisline poleg dnevnega odmerka 75 mg klopidogrela ali standardnega dnevnega odmerka tiklopidina.
Xarelto 20 mg once daily and Xarelto 10 mg once daily were compared with 100 mg acetylsalicylic acid once daily.
Zdravilo Xarelto 20 mg enkrat na dan in zdravilo Xarelto 10 mg enkrat na dan so primerjali s 100 mg acetilsalicilne kisline enkrat na dan.
• with lower body weight (< 60 kg) if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine.
• imajo nižjo telesno maso (< 60 kg), če sočasno prejemajo samo acetilsalicilno kislino ali acetilsalicilno kislino in klopidogrel oz. tiklopidin.
The principal safety outcome (major bleeding events) was similar for patients treated with Xarelto 20 mg and 10 mg once daily compared to 100 mg acetylsalicylic acid.
Glavni varnostni izid (velike krvavitve) je bil podoben za bolnike, zdravljene z zdravili Xarelto 20 mg in 10 mg enkrat na dan v primerjavi s 100 mg acetilsalicilne kisline.
In rats, increased IgG and IgA plasma levels were seen at clinically relevant exposure levels.
Pri podganah so pri klinično pomembnih odmerkih opažali večje plazemske koncentracije IgG in IgA.