FrancophonIA/ELRC3.0 huggingface dataset:
English: - to prevent a blood clot from forming in the heart in patients with an irregular heart beat (atrial fibrillation) and at least one additional risk factor.
Slovenian: za preprečevanje nastanka krvnih strdkov v srcu pri bolnikih z nerednim srčnim utripom (atrijska fibrilacija), ki imajo vsaj še en dodaten dejavnik tveganja.
English: Anti-Xa Activity Max (IU/mL)
Slovenian: apiksaban največja aktivnost anti-Xa (i.e./ml)
English: Coadministration of a single dose of apixaban (10 mg) and atenolol (100 mg), a common beta-blocker, did not alter the pharmacokinetics of atenolol.
Slovenian: Pri sočasni uporabi enkratnega odmerka apiksabana (10 mg) in atenolola (100 mg), pogosto uporabljanega zaviralca adrenergičnih receptorjev beta, se farmakokinetika atenolola ni spremenila.
English: Alu PVC/PVdC perforated unit dose blisters of 60x1 and 100x1 film-coated tablets.
Slovenian: Perforirani enoodmerni pretisni omoti iz Alu-PVC/PVdC, ki vsebujejo 60 x 1 ali 100 x 1 filmsko obloženo tableto.
English: Alu-PVC/PVdC perforated unit dose blisters of 100x1 film coated tablets.
Slovenian: Perforirani enoodmerni pretisni omoti iz Alu-PVC/PVdC, ki vsebujejo 100 x 1 filmsko obloženo tableto.
English: - Bleeding: - in your lungs or your throat - into the space behind your abdominal cavity - into a muscle
Slovenian: krvavitve: v pljučih ali grlu v prostoru, ki se nahaja za trebušno votlino v mišicah
English: Coadministration of single doses of apixaban (10 mg) and naproxen (500 mg), a commonly used NSAID, did not have any effect on the naproxen AUC or Cmax.
Slovenian: Pri sočasni uporabi enkratnih odmerkov apiksabana (10 mg) in naproksena (500 mg), pogosto uporabljanega nesteroidnega protivnetnega zdravila, niso opazili nobenih učinkov na vrednosti AUC in Cmax naproksena.
English: Patient Alert Card: handling information
Slovenian: Opozorilna kartica za bolnika: navodila za uporabo
English: Patients with elevated liver enzymes ALT/AST > 2 x ULN or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Slovenian: Bolniki s povečanimi vrednostmi jetrnih encimov (vrednosti ALT/AST > 2-kratna zgornja meja normale) ali z vrednostmi skupnega bilirubina ≥ 1,5-kratne zgornje meje normale niso bili vključeni v klinična preskušanja.
English: Subjects received either apixaban 2.5 mg given orally twice daily (po bid) or enoxaparin 40 mg administered subcutaneously once daily (sc od).
Slovenian: Bolniki so prejemali bodisi apiksaban v odmerku 2,5 mg peroralno dvakrat na dan (p.o., dvakrat na dan) ali enoksaparin v odmerku 40 mg subkutano enkrat na dan (s.c., enkrat na dan).
English: Haemodialysis, started two hours after administration of a single dose of apixaban 5 mg, decreased apixaban AUC by 14% in these ESRD subjects, corresponding to an apixaban dialysis clearance of 18 mL/min.
Slovenian: Če se je pri preiskovancih s končno ledvično odpovedjo hemodializa začela dve uri po prejetju enkratnega 5-miligramskega odmerka apiksabana, se je vrednost AUC zmanjšala za 14 %, kar ustreza očistku apiksabana z dializo, 18 ml/min.
English: The recommended dose is one tablet twice a day, for example, one in the morning and one in the evening.
Slovenian: Priporočeni odmerek je ena tableta dvakrat na dan, na primer ena tableta zjutraj in ena tableta zvečer.
English: In patients with creatinine clearance < 15 mL/min, or in patients undergoing dialysis, there is no clinical experience therefore apixaban is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z očistkom kreatinina < 15 ml/min ali bolnikih na dializi kliničnih izkušenj ni, zato uporaba apiksabana ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: Therefore Eliquis should be used with caution in this population (see sections 4.4 and 5.2).
Slovenian: Pri tej skupini bolnikov je treba zdravilo Eliquis uporabljati previdno (glejte poglavji 4.4 in 5.2).
English: LIST OF EXCIPIENTS Contains lactose.
Slovenian: Zdravilo vsebuje laktozo.
English: Coadministration of apixaban with rifampicin, a strong inducer of both CYP3A4 and P-gp, led to an approximate 54% and 42% decrease in mean apixaban AUC and Cmax, respectively.
Slovenian: Pri sočasni uporabi apiksabana in rifampicina, ki je močan induktor obeh, CYP3A4 in P-gp, se je srednja vrednost AUC apiksabana zmanjšala za približno 54 %, Cmax pa za približno 42 %.
English: Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp, (e.g., diltiazem, naproxen, clarithromycin, amiodarone, verapamil, quinidine) are expected to increase apixaban plasma concentration to a lesser extent.
Slovenian: Za učinkovine, ki ne sodijo med močne zaviralce tako CYP3A4 kot P-gp (npr. diltiazem, naproksen, klaritromicin, amiodaron, verapamil, kinidin), se pričakuje, da bodo plazemske koncentracije apiksabana povečale v manjšem obsegu.
English: - you are taking medicines to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open, or if a tube is inserted into your blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).
Slovenian: jemljete zdravila za preprečevanje strjevanja krvi (npr. varfarin, rivaroksaban, dabigatran ali heparin), razen če ravno menjate antikoagulantno zdravljenje, če imate vstavljen venski ali arterijski kateter in skozi njega prejemate heparin, da kateter ostane odprt, ali če so vam v žilo vstavili cevko (katetrska ablacija)za zdravljenje nerednega srčnega utripa (aritmija).
English: Enoxaparin 40 mg sc once daily 35 ± 3 d p-value Apixaban 2.5 mg po twice daily 12 ± 2 d
Slovenian: apiksaban 2,5 mg p.o. dvakrat na dan 35 ± 3 dni enoksaparin 40 mg s.c. enkrat na dan 35 ± 3 dni apiksaban 2,5 mg p.o. dvakrat na dan 12 ± 2 dni enoksaparin 40 mg s.c. enkrat na dan 12 ± 2 dni
English: Coadministration of apixaban (20 mg once a day) and digoxin (0.25 mg once a day), a P-gp substrate, did not affect digoxin AUC or Cmax.
Slovenian: Pri sočasni uporabi apiksabana (20 mg enkrat na dan) in digoksina (0,25 mg enkrat na dan), ki je substrat za P-gp, niso opazili vplivov na vrednosti AUC in Cmax digoksina, kar kaže, da apiksaban ne zavira s P-gp posredovanega transporta substratov.
English: Total VTE/all-cause death Number of events/subjects Event Rate
Slovenian: Vsi VTE/vsi vzroki smrti Število dogodkov/oseb Delež dogodkov Relativno tveganje 95 % interval zaupanja Glavni VTE
English: The overall discontinuation rate due to adverse reactions was 1.5% for apixaban and 1.3% for ASA in the AVERROES study.
Slovenian: Skupni delež prekinitev zdravljenja zaradi neželenih učinkov je v študiji AVERROES znašal 1,5 % pri apiksabanu in 1,3 % pri acetilsalicilni kislini.
English: The administration of apixaban 10 mg with famotidine 40 mg had no effect on apixaban AUC or Cmax.
Slovenian: Pri sočasni uporabi apiksabana v odmerku 10 mg in famotidina v odmerku 40 mg učinkov na vrednosti AUC ali Cmax apiksabana niso opazili.
English: The recommended dose is one tablet of Eliquis 5 mg twice a day.
Slovenian: Priporočeni odmerek je ena tableta zdravila Eliquis 5 mg dvakrat na dan.
English: No dose adjustment for apixaban is required during concomitant therapy with such medicinal products, however in patients receiving concomitant systemic treatment with strong inducers of both CYP3A4 and P-gp apixaban should be used with caution for the prevention of VTE in elective hip or knee replacement surgery, for the prevention of stroke and systemic embolism in patients with NVAF and for the prevention of recurrent DVT and PE.
Slovenian: Pri sočasni uporabi tovrstnih zdravil odmerka apiksabana ni treba prilagajati, vendar je treba pri bolnikih, ki prejemajo sočasno sistemsko zdravljenje z močnimi induktorji tako CYP3A4 kot P-gp, apiksaban za preprečevanje VTE pri načrtovani kirurški zamenjavi kolka ali kolena, preprečevanje možganske kapi ter sistemske embolije pri bolnikih z NVAF in preprečevanje ponovne GVT ter PE uporabljati previdno.
English: Haemorrhage risk
Slovenian: Tveganje za krvavitve
English: To prevent a blood clot from forming in the heart in patients with an irregular heart beat and at least one additional risk factor.
Slovenian: Za preprečevanje nastanka krvnih strdkov v srcu pri bolnikih z nerednim srčnim utripom, ki imajo vsaj še en dodaten dejavnik tveganja.
English: 5.0 mg (N=813)
Slovenian: 5,0 mg (n = 813) (n = 829)
English: ¥ p-value < 0.0001 * For patients with more than one event contributing to the composite endpoint, only the first event was reported (e.g., if a subject experienced both a DVT and then a PE, only the DVT was reported) † Individual subjects could experience more than one event and be represented in both classifications
Slovenian: Pri bolnikih z več kot enim dogodkom, ki je prispeval k sestavljenemu opazovanemu dogodku, so poročali samo o prvem dogodku (npr. če je imel bolnik GVT in potem PE, so poročali samo o GVT).
English: Medicinal products associated with serious bleeding are not recommended concomitantly with Eliquis, such as: thrombolytic agents, GPIIb/IIIa receptor antagonists, thienopyridines (e.g., clopidogrel), dipyridamole, dextran and sulfinpyrazone.
Slovenian: Take učinkovine so: trombolitične učinkovine, antagonisti receptorjev GPIIb/IIIa, tienopiridini (npr. klopidogrel), dipiridamol, dekstran in sulfinpirazon.
English: In patients with creatinine clearance < 15 mL/min, or in patients undergoing dialysis, there is no clinical experience therefore apixaban is not recommended (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z očistkom kreatinina < 15 ml/min ali bolnikih na dializi ni kliničnih izkušenj, zato uporaba apiksabana ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: The safety of apixaban has been investigated in 4 Phase III clinical studies including more than 15,000 patients: more than 11,000 patients in NVAF studies and more than 4,000 patients in the VTE treatment (VTEt) studies, for an average total exposure of 1.7 years and 221 days respectively (see section 5.1).
Slovenian: Varnost apiksabana so ocenili v 4 kliničnih študijah III. faze, ki so vključile več kot 15.000 bolnikov: več kot 11.000 bolnikov v študijah NVAF in več kot 4.000 bolnikov v študijah zdravljenja VTE (VTEt).
English: Major + CRNM
Slovenian: Večje + KPMK
English: 10 mg twice daily 251 [111, 572]
Slovenian: 5 mg dvakrat na dan 171 [91, 321]
English: The incidence of ISTH major intraocular bleeding with apixaban was 0.18%/year.
Slovenian: Pojavnost večjih očesnih krvavitev po merilih ISTH je pri apiksabanu znašala 0,18 % na leto.
English: To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs
Slovenian: Za zdravljenje krvnih strdkov v venah nog in krvnih strdkov v žilah v pljučih.
English: Duration of treatment
Slovenian: Obdobje zdravljenja Večje
English: - Bleeding: - in your brain or in your spinal column, - in your lungs or your throat - in your mouth - into your abdomen or space behind your abdominal cavity - from a haemorrhoid - tests showing blood in the stools or in the urine - Skin rash
Slovenian: krvavitve: v možganih ali hrbtenjači v pljučih ali grlu v ustih v trebuhu ali prostoru, ki se nahaja za trebušno votlino iz hemoroida (zlate žile) preiskave, ki kažejo na kri v blatu ali urinu kožni izpuščaj
English: Major
Slovenian: Večja
English: The recommended dose is two tablets of Eliquis 5 mg twice a day for the first 7 days, for example, two in the morning and two in the evening.
Slovenian: Priporočeni odmerek je dve tableti zdravila Eliquis 5 mg dvakrat na dan prvih 7 dni, na primer dve tableti zjutraj in dve zvečer.
English: - for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) apixaban is to be used with caution;
Slovenian: - pri zdravljenju GVT, zdravljenju PE ter preprečevanju ponovne GVT in PE (VTEt) je treba apiksaban uporabljati previdno;
English: There was no statistically significant difference in the incidence of major bleeding between apixaban and ASA (see Table 9).
Slovenian: Kar se tiče pojavnosti večjih krvavitev, ni bilo nobene statistično pomembne razlike med apiksabanom in acetilsalicilno kislino (glejte Preglednico 9).
English: General disorders and administration site conditions Application site bleeding
Slovenian: Splošne težave in spremembe na mestu aplikacije krvavitve na mestu aplikacije občasni občasni
English: 10 mg twice daily for the first 7 days 20 mg followed by 5 mg twice daily
Slovenian: 10 mg dvakrat na dan prvih 7 dni
English: They will advise you to either stop breastfeeding or to stop/not start taking Eliquis.
Slovenian: Morda boste morali prekiniti z dojenjem ali pa prenehati jemati zdravilo Eliquis oziroma zdravila ne boste smeli začeti jemati.
English: It should be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B) (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter (stopnja A ali B po Child-Pugh-u) je treba zdravilo Eliquis uporabljati previdno (glejte poglavji 4.2 in 5.2).
English: Stroke or systemic embolism* 51 (1.62) Stroke Ischaemic or unspecified Haemorrhagic Systemic embolism Stroke, systemic embolism,
Slovenian: Možganska kap ali sistemska embolija* 51 (1,62) Možganska kap Ishemična ali neopredeljena Hemoragična Sistemska embolija Možganska kap, sistemska embolija, MI, ali žilna smrt* Miokardni infarkt Žilna smrt Vsi vzroki smrti
English: Each tablet contains 5 mg of apixaban.
Slovenian: Ena tableta vsebuje 5 mg apiksabana.
English: There was no impact of impaired renal function on peak concentration of apixaban.
Slovenian: Okvara delovanja ledvic ne vpliva na največje koncentracije apiksabana.
English: Start treatment with the anticoagulant medicines (for example heparin) at the time you would have taken the next tablet.
Slovenian: Ko pride čas, ko bi morali vzeti naslednjo tableto, začnite z zdravljenjem z antikoagulantnimi zdravili (npr. s heparinom).
English: Reproductive system and breast disorders Abnormal vaginal haemorrhage, urogenital haemorrhage
Slovenian: Motnje reprodukcije in dojk nenormalne vaginalne krvavitve, urogenitalne krvavitve občasni pogosti
English: Investigations Occult blood positive
Slovenian: Preiskave pozitiven izid pri preverjanju prisotnosti prikrite krvi občasni občasni
English: Table 3 below shows the predicted steady state exposure and anti-Factor Xa activity.
Slovenian: Spodnja Preglednica 3 prikazuje predvideno izpostavljenost v stanju dinamičnega ravnovesja in aktivnost anti-FXa.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb/Pfizer EEIG
Slovenian: Bristol-Myers Squibb/Pfizer EEIG
English: What Eliquis contains
Slovenian: Kaj vsebuje zdravilo Eliquis
English: Stroke or systemic embolism 212 (1.27) 265 (1.60) 0.79 (0.66, 0.95) Stroke Ischaemic or unspecified 162 (0.97) 175 (1.05) 0.92 (0.74, 1.13) Haemorrhagic Systemic embolism 15 (0.09) 17 (0.10) 0.87 (0.44, 1.75)
Slovenian: Možganska kap ali sistemska embolija 212 (1,27) 265 (1,60) 0,79 (0,66; 0,95) Možganska kap Ishemična ali neopredeljena Hemoragična Sistemska embolija
English: Warfarin N=9,081 n (%/yr)
Slovenian: varfarin n = 9.081 (% na leto)
English: Eliquis administration should be discontinued if severe haemorrhage occurs (see sections 4.8 and 4.9).
Slovenian: V primeru pojava hude krvavitve je treba zdravljenje z zdravilom Eliquis prekiniti (glejte poglavji 4.8 in 4.9).
English: Musculoskeletal and connective tissue disorders Muscle haemorrhage
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva krvavitve v mišicah redki občasni
English: In the apixaban vs warfarin study the incidence of ISTH major gastrointestinal bleeds (including upper GI, lower GI, and rectal bleeding) with apixaban was 0.76%/year.
Slovenian: V študiji, v kateri so apiksaban primerjali z varfarinom, je pojavnost večjih krvavitev v prebavilih po merilih ISTH (vključno s krvavitvami v zgornjem delu prebavnega trakta, spodnjem delu prebavnega trakta in krvavitvami v rektumu) pri apiksabanu znašala 0,76 % na leto.
English: Mouth haemorrhage
Slovenian: Okvara ledvic
English: Prevention of VTE (VTEp): elective hip or knee replacement surgery The apixaban clinical program was designed to demonstrate the efficacy and safety of apixaban for the prevention of VTE in a broad range of adult patients undergoing elective hip or knee replacement.
Slovenian: Klinični program apiksabana je bil zasnovan za dokaz učinkovitosti in varnosti uporabe apiksabana pri preprečevanju venskih trombemboličnih dogodkov pri širokem spektru odraslih bolnikov po kirurški zamenjavi kolka ali kolena.
English: Eliquis is not recommended in children and adolescents under 18 years of age.
Slovenian: Pri otrocih in mladostnikih, mlajših od 18 let, uporaba zdravila Eliquis ni priporočljiva.
English: There was no statistically significant difference in the incidence of major bleeding between apixaban and ASA (see Table 7).
Slovenian: Kar se tiče pojavnosti večjih krvavitev, ni bilo nobene statistično pomembne razlike med apiksabanom in acetilsalicilno kislino (glejte Preglednico 7).
English: Interaction with inhibitors of both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) The use of Eliquis is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir).
Slovenian: Interakcije z zdravili, ki so zaviralci tako citokroma P450 3A4 (CYP3A4) kot P-glikoproteina (P-gp) Pri bolnikih, ki se sistemsko zdravijo z zdravili, ki so močni zaviralci obeh, tako CYP3A4 kot P-gp, kot so azolni antimikotiki (npr. ketokonazol, itrakonazol, vorikonazol in posakonazol) ter zaviralci proteaze virusa HIV (npr. ritonavir), uporaba zdravila Eliquis ni priporočljiva.
English: - for the prevention of stroke and systemic embolism in patients with NVAF and serum creatinine ≥ 1.5 mg/dL (133 micromole/L) associated with age ≥ 80 years or body weight ≤ 60 kg, a dose reduction is necessary and described above.
Slovenian: - pri preprečevanju možganske kapi in sistemske embolije pri bolnikih z NVAF in serumsko koncentracijo kreatinina ≥ 1,5 mg/dl (133 mikromolov/l) ter s starostjo ≥ 80 let ali telesno maso ≤ 60 kg je treba zmanjšati odmerek, kot je opisano zgoraj.
English: Each tablet contains 2.5 mg of apixaban.
Slovenian: Ena tableta vsebuje 2,5 mg apiksabana.
English: Fatal
Slovenian: Smrtne
English: - for the prevention of VTE in elective hip or knee replacement surgery (VTEp), for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt), no dose adjustment is necessary (see section 5.2).
Slovenian: - pri preprečevanju VTE pri načrtovani kirurški zamenjavi kolka ali kolena (VTEp), zdravljenju GVT, zdravljenju PE ter preprečevanju ponovne GVT in PE (VTEt) prilagajanje odmerka ni potrebno (glejte poglavje 5.2);
English: Bleeding Outcomes Major* Fatal Intracranial
Slovenian: Izidi krvavitev Večje*
English: Eye haemorrhage (including conjunctival haemorrhage)
Slovenian: Očesne bolezni očesne krvavitve (vključno s krvavitvami v očesni veznici)
English: Interaction with inducers of both CYP3A4 and P-gp The concomitant use of Eliquis with strong CYP3A4 and P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to a ~50% reduction in apixaban exposure.
Slovenian: Interakcije z zdravili, ki so induktorji tako CYP3A4 kot P-gp Pri sočasni uporabi zdravila Eliquis in močnih induktorjev CYP3A4 in P-gp (npr. rifampicin, fenitoin, karbamazepin, fenobarbital ali šentjanževka) se lahko izpostavljenost apiksabanu zmanjša za približno 50 %.
English: Elderly patients (above 65 years) exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 32% higher and no difference in Cmax.
Slovenian: Pri starejših bolnikih (starejših od 65 let) so bile plazemske koncentracije večje kot pri mlajših bolnikih.
English: Anti-FXa activity exhibits a close direct linear relationship with apixaban plasma concentration, reaching maximum values at the time of apixaban peak plasma concentrations.
Slovenian: Aktivnost anti-FXa kaže tesno neposredno linearno povezavo s koncentracijami apiksabana v plazmi.
English: For the prevention of stroke and systemic embolism in patients with NVAF, patients with severe renal impairment (creatinine clearance 15-29 mL/min), and patients with serum creatinine ≥ 1.5 mg/dL (133 micromole/L) associated with age ≥ 80 years or body weight ≤ 60 kg should receive the lower dose of apixaban 2.5 mg twice daily (see section 4.2).
Slovenian: Pri preprečevanju možganske kapi in sistemske embolije pri bolnikih z NVAF morajo bolniki s hudo okvaro ledvic (očistek kreatinina 15-29 ml/min) in bolniki s serumsko koncentracijo kreatinina ≥ 1,5 mg/dl (133 mikromolov/l) ter s starostjo ≥ 80 let ali telesno maso ≤ 60 kg prejemati manjši odmerek apiksabana, in sicer 2,5 mg dvakrat na dan (glejte poglavje 4.2).
English: Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window.
Slovenian: Pri odločanju o času uporabe zdravila v tem časovnem okviru mora zdravnik upoštevati tako možne koristi zgodnejše antikoagulacije za preprečevanje venskih trombemboličnih dogodkov kot tudi tveganja za pojav krvavitev po operaciji.
English: - Bleeding:
Slovenian: Odmerek:
English: For example, diltiazem (360 mg once a day), considered a moderate CYP3A4 and a weak P-gp inhibitor, led to a 1.4-fold increase in mean apixaban AUC and a 1.3-fold increase in Cmax.
Slovenian: Na primer diltiazem (360 mg enkrat na dan), ki je zmeren zaviralec CYP3A4 in šibek zaviralec P-gp, je srednjo vrednost AUC apiksabana povečal za 1,4-krat, srednjo vrednost Cmax pa za 1,3-krat.
English: The concomitant use of apixaban with other strong CYP3A4 and P-gp inducers (e.g., phenytoin, carbamazepine,
Slovenian: Koncentracije apiksabana v plazmi se lahko zmanjšajo tudi pri sočasni uporabi drugih močnih induktorjev CYP3A4 in P-gp (npr. fenitoin, karbamazepin, fenobarbital ali šentjanževka).
English: - Film coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).
Slovenian: Filmska obloga: laktoza monohidrat, hipromeloza (E464), titanov dioksid (E171), triacetin, rdeči železov oksid (E172).
English: Following administration of the two medicinal products together, mean apixaban AUC and Cmax were 15% and 18% lower than when administered alone.
Slovenian: Pri sočasni uporabi obeh zdravil je bila povprečna vrednost AUC apiksabana za 15 %, povprečna vrednost Cmax apiksabana pa za 18 % manjša kot pri uporabi apiksabana samega.
English: Pharmacokinetic or pharmacodynamic interactions were not evident when apixaban was coadministered with ASA 325 mg once a day.
Slovenian: Pri sočasni uporabi apiksabana in acetilsalicilne kisline v odmerku 325 mg enkrat na dan farmakokinetičnih ali farmakodinamičnih interakcij niso zasledili.
English: Compared to apixaban exposure in subjects with body weight of 65 to 85 kg, body weight > 120 kg was associated with approximately 30% lower exposure and body weight < 50 kg was associated with approximately 30% higher exposure.
Slovenian: Pri osebah s telesno maso, večjo od 120 kg, je bila izpostavljenost za približno 30 % manjša, pri osebah s telesno maso, manjšo od 50 kg, pa za približno 30 % večja kot pri osebah s telesno maso od 65 do 85 kg.
English: The following side effects are known if you take Eliquis to treat or prevent re-occurrence of blood clots in the veins of your legs and blood clots in the blood vessels of your lungs.
Slovenian: Pri jemanju zdravila Eliquis za zdravljenje ali preprečevanje ponovitve krvnih strdkov v venah nog in krvnih strdkov v žilah v pljučih so opazili naslednje neželene učinke:
English: Table 1:
Slovenian: Preglednica 1