FrancophonIA/ELRC3.0 huggingface dataset:
English: In case there is such need and based on the general PK characteristics of apixaban, a time interval of 20-30 hours (i.e., 2 x half-life) between the last dose of apixaban and catheter withdrawal should elapse, and at least one dose should be omitted before catheter withdrawal.
Slovenian: Na osnovi farmakokinetičnih podatkov mora pri takih bolnikih med uporabo zadnjega odmerka apiksabana in odstranitvijo katetra miniti od 20 do 30 ur (to je 2-kratna vrednost razpolovnega časa).
English: - Unit dose blisters in cartons of 60 x 1 and 100 x 1 film-coated tablets for delivery in hospitals are also available.
Slovenian: Za uporabo v bolnišnicah so na voljo tudi enoodmerni pretisni omoti v škatlah, ki vsebujejo 60x 1in 100 x 1filmsko obloženih tablet.
English: Gamma-glutamyltransferase increased
Slovenian: krvne preiskave lahko pokažejo: povečanje vrednosti gama-glutamiltransferaze (GGT)
English: INFORMATION IN BRAILLE Eliquis 2.5 mg
Slovenian: Eliquis 2,5 mg
English: Anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs and NSAIDs Due to an increased bleeding risk, concomitant treatment with any other anticoagulants is contraindicated except under specific circumstances of switching anticoagulant therapy, when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation (see section 4.3).
Slovenian: Zaradi povečanega tveganja za pojav krvavitev je sočasno zdravljenje s katerimkoli drugim antikoagulantom kontraindicirano, razen v posebnih primerih, ko gre za menjavo antikoagulantnega zdravljenja, kadar se nefrakcionirani heparin daje v odmerkih, ki so potrebni za vzdrževanje prehodnosti centralnega venskega ali arterijskega katetra, ali kadar se nefrakcionirani heparin daje med katetrsko ablacijo za atrijsko fibrilacijo (glejte poglavje 4.3).
English: - 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, apixaban should be used with caution;
Slovenian: - pri preprečevanju VTE pri načrtovani kirurški zamenjavi kolka ali kolena, preprečevanju možganske kapi ter sistemske embolije pri bolnikih z NVAF in preprečevanju ponovne GVT ter PE je treba apiksaban uporabljati previdno.
English: INFORMATION IN BRAILLE Eliquis 5 mg
Slovenian: Eliquis 5 mg
English: The film coated tablets are pink, oval and marked with “894” on one side and “5” on the other side.
Slovenian: Rožnate, ovalne, filmsko obložene tablete, označene z oznako “894” na eni in “5” na drugi strani.
English: Table 3: Predicted Apixaban Steady-state Exposure and Anti-Xa Activity
Slovenian: Preglednica 3: Predvidena izpostavljenost apiksabanu v stanju dinamičnega ravnovesja in aktivnost anti-Xa apiksaban Cmax (ng/ml)
English: Apix 2.5 mg vs.
Slovenian: PRETISNI OMOT 2,5 mg
English: Haemodialysis decreased apixaban AUC by 14% in subjects with end-stage renal disease (ESRD), when a single dose of apixaban 5 mg was administered orally.
Slovenian: Pri bolnikih s končno ledvično odpovedjo je hemodializa zmanjšala vrednost AUC apiksabana za 14 %, če so bolniki peroralno prejeli enkratni 5-miligramski odmerek apiksabana.
English: Major Major + CRNM Minor All
Slovenian: Večja + KPMK Manjša
English: A total of 8,464 patients were randomised in two pivotal, double-blind, multi-national studies, comparing apixaban 2.5 mg given orally twice daily (4,236 patients) or enoxaparin 40 mg once daily (4,228 patients).
Slovenian: V dve ključni, dvojno slepi, randomizirani, multinacionalni študiji, ki sta primerjali uporabo apiksabana v peroralnem odmerku 2,5 mg dvakrat na dan (4.236 bolnikov) in uporabo enoksaparina v odmerku 40 mg enkrat na dan (4.228 bolnikov), je bilo vključenih skupno 8.464 bolnikov.
English: Your doctor will decide how long you must continue treatment for.
Slovenian: Trajanje zdravljenja bo določil zdravnik.
English: The film-coated tablets are yellow, round and marked with “893” on one side and “2½” on the other side.
Slovenian: Rumene, okrogle, filmsko obložene tablete, označene z oznako “893” na eni in “2½” na drugi strani.
English: ASA N = 2,780 n (%/year)
Slovenian: acetilsalicilna kislina n = 2.780 n (% na leto)
English: The recommended dose is one tablet of Eliquis 2.5 mg twice a day for example, one in the morning and one in the evening.
Slovenian: Priporočeni odmerek je ena tableta zdravila Eliquis 2,5 mg dvakrat na dan, na primer ena tableta zjutraj in ena zvečer.
English: Cartons of 14, 20, 28, 56, 60, 168 and 200 film-coated tablets.
Slovenian: Škatle vsebujejo 14, 20, 28, 56, 60, 168 ali 200 filmsko obloženih tablet.
English: - for the prevention of stroke and systemic embolism in patients with NVAF and for the prevention of recurrent DVT and PE, apixaban should be used with caution;
Slovenian: - pri preprečevanju možganske kapi ter sistemske embolije pri bolnikih z NVAF in preprečevanju ponovne GVT ter PE je treba apiksaban uporabljati previdno.
English: Table 11: Bleeding Results in the AMPLIFY Study Apixaban N=2,676 n (%)
Slovenian: Preglednica 11: Rezultati spremljanja krvavitev v študiji AMPLIFY apiksaban n = 2.676 n (%)
English: Table 10: Efficacy Results in the AMPLIFY Study Apixaban N=2,609 n (%)
Slovenian: Preglednica 10: Rezultati učinkovitosti v študiji AMPLIFY apiksaban n = 2.609 n (%)
English: Eliquis helps to thin your blood.
Slovenian: Zdravilo pomaga redčiti kri.
English: Table 8: Efficacy Results in the AMPLIFY Study Apixaban N=2,609 n (%)
Slovenian: Preglednica 8: Rezultati učinkovitosti v študiji AMPLIFY apiksaban n = 2.609 n (%)
English: Enoxaparin 40 mg sc once daily 12 ± 2 d p-value
Slovenian: 40 mg s.c. enkrat na dan 12 ± 2 dni vrednost p
English: Dosing schedule
Slovenian: Shema odmerjanja
English: Coadministration of apixaban with ketoconazole (400 mg once a day), a strong inhibitor of both CYP3A4 and P-gp, led to a 2-fold increase in mean apixaban AUC and a 1.6-fold increase in mean apixaban Cmax.
Slovenian: Pri sočasni uporabi apiksabana in ketokonazola (400 mg enkrat na dan), ki je močan zaviralec obeh, CYP3A4 in P-gp, se je povprečna vrednost AUC apiksabana povečala za 2-krat, Cmax pa za 1,6-krat.
English: ASA N = 2,791 n (%/year)
Slovenian: acetilsalicilna kislina n = 2.791 n (% na leto)
English: - Unit dose blisters in cartons of 100 x 1 film-coated tablets for delivery in hospitals are also available.
Slovenian: Za uporabo v bolnišnicah so na voljo tudi enoodmerni pretisni omoti v škatlah, ki vsebujejo 100 x 1 filmsko obloženih tablet.
English: Switching from Eliquis to VKA therapy
Slovenian: Prehod z zdravila Eliquis na zdravljenje z AVK
English: Myocardial infarction Vascular Death All-cause death
Slovenian: Izidi krvavitev Večje* Smrtne Intrakranialne Večje + KPMK Vse Drugi opazovani dogodki Vsi vzroki smrti
English: There is no clinical experience with the use of apixaban with indwelling intrathecal or epidural catheters.
Slovenian: Pri bolnikih, ki imajo vstavljen intratekalni ali epiduralni kateter, ni kliničnih izkušenj z uporabo apiksabana.
English: Prevention of VTE (VTEp): elective hip or knee replacement surgery The recommended dose of apixaban is 2.5 mg taken orally twice daily.
Slovenian: Preprečevanje VTE: načrtovana kirurška zamenjava kolka ali kolena (VTEp - VTE prevention) Priporočeni odmerek apiksabana je 2,5 mg peroralno dvakrat na dan. Bolnik mora začetni odmerek vzeti od 12 do 24 ur po operaciji.
English: - bruising and swelling - Nausea (feeling sick)
Slovenian: z modricami in oteklinami navzea (siljenje na bruhanje)
English: There was no statistically significant difference in the incidence of major + CRNM, minor, and all bleeding between the apixaban 2.5 mg twice daily and placebo treatment groups (see Table 11).
Slovenian: Pri pojavnosti večjih krvavitev + klinično pomembnih manjših krvavitev (KPMK), manjših krvavitev in vseh krvavitev med skupino z apiksabanom 2,5 mg dvakrat na dan in skupino s placebom (glejte Preglednico 11) ni bilo statistično pomembne razlike.
English: Table 9: Bleeding Results in the AMPLIFY Study Apixaban N=2,676 n (%)
Slovenian: Preglednica 9: Rezultati spremljanja krvavitev v študiji AMPLIFY apiksaban n = 2.676 n (%)
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) apixaban is to be used with caution;
Slovenian: - pri preprečevanju VTE pri načrtovani kirurški zamenjavi kolka ali kolena (VTEp), zdravljenju GVT, zdravljenju PE ter preprečevanju ponovne GVT in PE (VTEt) je treba apiksaban uporabljati previdno;
English: Bleeding: - in your brain or in your spinal column - in your lungs
Slovenian: krvavitve: v možganihali hrbtenjači v pljučih
English: 5 mg twice daily
Slovenian: 2,5 mg dvakrat na dan
English: 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) (see section 4.4).
Slovenian: Pri bolnikih, ki se sočasno 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 (glejte poglavje 4.4).
English: Apixaban 2.5 mg po twice daily 35 ± 3 d
Slovenian: 2,5 mg p.o. dvakrat na dan 35 ± 3 dni enoksaparin
English: A significant increase in bleeding risk was reported with the triple combination of apixaban, ASA and clopidogrel in a clinical study in patients with acute coronary syndrome (see section 4.4).
Slovenian: V klinični študiji so pri bolnikih z akutnim koronarnim sindromom pri sočasni uporabi apiksabana, acetilsalicilne kisline in klopidogrela poročali o pomembnem povečanju tveganja za pojav krvavitev (glejte poglavje 4.4.
English: There was no statistically significant difference in the incidence of major + CRNM, minor, and all bleeding between the apixaban 2.5 mg twice daily and placebo treatment groups (see Table 13).
Slovenian: Pri pojavnosti večjih krvavitev + klinično pomembnih manjših krvavitev (KPMK), manjših krvavitev in vseh krvavitev med skupino z apiksabanom 2,5 mg dvakrat na dan in skupino s placebom (glejte Preglednico 13) ni bilo statistično pomembne razlike.
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when apixaban was coadministered with atenolol or famotidine.
Slovenian: Pri sočasni uporabi apiksabana in atenolola ali famotidina niso poročali o klinično pomembnih farmakokinetičnih ali farmakodinamičnih interakcijah.
English: After 7 days the recommended dose is one tablet of Eliquis 5 mg twice a day, for example, one in the morning and one in the evening.
Slovenian: Po 7 dneh je priporočeni odmerek ena tableta zdravila Eliquis 5 mg dvakrat na dan, na primer ena tableta zjutraj in ena tableta zvečer.
English: Naproxen (500 mg, single dose) an inhibitor of P-gp but not an inhibitor of CYP3A4, led to a 1.5-fold and 1.6-fold increase in mean apixaban AUC and Cmax, respectively.
Slovenian: Naproksen (enkratni 500 mg odmerek), ki je zaviralec P-gp, ni pa zaviralec CYP3A4, je srednjo vrednost AUC apiksabana povečal za 1,5-krat, srednjo vrednost Cmax pa za 1,6-krat.
English: In the knee replacement surgery study during the intended treatment period, in the apixaban arm 4 cases of PE were diagnosed against no cases in the enoxaparin arm. No explanation can be given to this higher number of PE.
Slovenian: V študiji pri bolnikih s kirurško zamenjavo kolena so med obdobjem zdravljenja v skupini, ki je prejemala apiksaban, poročali o 4 primerih pljučne embolije.
English: Cartons of 10, 20, 60, 168 and 200 film-coated tablets.
Slovenian: Škatle vsebujejo 10, 20, 60, 168 ali 200 filmsko obloženih tablet.
English: • Management of overdose situations and haemorrhage
Slovenian: • ukrepe pri prevelikem odmerjanju ali krvavitvah
English: Gastrointestinal haemorrhage
Slovenian: ® Heparin kromogeni test.
English: Apixaban demonstrated a statistically superior reduction in the primary endpoint, a composite of all VTE/all cause death, and in the Major VTE endpoint, a composite of proximal DVT, non-fatal PE, and VTE-related death, compared to enoxaparin in both elective hip or knee replacement surgery (see Table 4).
Slovenian: Apiksaban se je tako pri načrtovani kirurški zamenjavi kolka kot kolena izkazal za statistično boljšega od enoksaparina pri primarnem opazovanem dogodku (sestavljen iz vseh venskih trombemboličnih dogodkov (VTE)/vseh vzrokov smrti) in glavnem VTE opazovanem dogodku (sestavljen iz proksimalne globoke venske tromboze (DVT), pljučne embolije (PE) brez smrtnega izida in z VTE povezanih smrtnih primerov) (glejte Preglednico 4).
English: A calibrated quantitative anti-Factor Xa assay may be useful in exceptional situations, e.g., overdose and emergency surgery (prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) clotting tests are not recommended) - see SmPC.
Slovenian: Uporaba kalibriranega kvantitativnega testa aktivnosti anti-FXa je lahko koristnav izjemnih okoliščinah, npr. v primeru prevelikega odmerjanja ali nujnega kirurškega posega (PČ, INR in aPTČ testi strjevanja krvi niso primerni) -glejte povzetek glavnih značilnostizdravila.
English: How to store Eliquis
Slovenian: Shranjevanje zdravila Eliquis
English: Apixaban 2.5 mg po twice daily 12 ± 2 d
Slovenian: 2,5 mg p.o. dvakrat na dan 12 ± 2 dni enoksaparin
English: It should be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter (stopnja A ali B po Child-Pugh-u) je treba zdravilo Eliquis uporabljati previdno.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 2.5 mg (Symbol)
Slovenian: PRETISNI OMOT 2,5 mg (s simboli)
English: Clarithromycin (500 mg, twice a day), an inhibitor of Pgp and a strong inhibitor of CYP3A4, led to a 1.6-fold and 1.3-fold increase in mean apixaban AUC and Cmax respectively.
Slovenian: Klaritromicin (500 mg dvakrat na dan), ki je zaviralec P-gp in močan zaviralec CYP3A4, je srednjo vrednost AUC apiksabana povečal za 1,6-krat, srednjo vrednost Cmax pa za 1,3-krat.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin
Slovenian: Filmska obloga: laktoza monohidrat hipromeloza (E464) titanov dioksid (E171)
English: Blood and lymphatic system disorders Anaemia
Slovenian: Bolezni krvi in limfatičnega sistema anemija pogosti pogosti trombocitopenija občasni pogosti
English: The following medicines may reduce the ability of Eliquis to help prevent blood clots from forming: - medicines to prevent epilepsy or seizures (e.g., phenytoin, etc.) - St John's Wort (a herbal supplement used for depression) - medicines to treat tuberculosis or other infections (e.g., rifampicin)
Slovenian: zdravila za preprečevanje epileptičnih napadov ali krčev (npr. fenitoin ipd.) šentjanževka (zdravilo rastlinskega izvora za zdravljenje depresije) zdravila za zdravljenje tuberkuloze ali drugih okužb (npr. rifampicin)
English: It is not recommended in patients with severe hepatic impairment (see sections 4.4. and 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter uporaba zdravila Eliquis ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: Table 11: Bleeding Results in the AMPLIFY-EXT Study Apixaban Apixaban Placebo
Slovenian: Preglednica 11: Rezultati spremljanja krvavitev v študiji AMPLIFY-EXT apiksaban apiksaban placebo relativno tveganje (95 % IZ)
English: Table 5: Secondary Endpoints in Patients with Atrial Fibrillation in the ARISTOTLE Study Apixaban N = 9,088 n (%/year)
Slovenian: Preglednica 5: Sekundarni opazovani dogodki pri bolnikih z atrijsko fibrilacijo v študiji ARISTOTLE apiksaban n = 9.088 n (% na leto)
English: Elderly VTEp and VTEt - No dose adjustment required (see sections 4.4 and 5.2).
Slovenian: Preprečevanje in zdravljenje VTE - prilagajanje odmerka ni potrebno (glejte poglavji 4.4 in 5.2).
English: - Bleeding including: - from your nose - from your gums - blood in the urine - bruising and swelling - in your stomach, your bowel, from your rectum - in your mouth - from the vagina - Anaemia which may cause tiredness or paleness - Reduced number of platelets in your blood (which can affect clotting) - Nausea (feeling sick) - Skin rash - Blood tests may show: - an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT)
Slovenian: krvavitve, vključno: iz nosu iz dlesni s krvjo v urinu z modricami in oteklinami v želodcu, črevesjuali izdanke v ustih iz nožnice anemija, ki lahko povzročiutrujenost ali bledico zmanjšanje števila trombocitov v krvi (kar lahko vpliva na strjevanje krvi) navzea (siljenje na bruhanje) kožni izpuščaj krvne preiskave lahko pokažejo: povečanje vrednosti gama-glutamiltransferaze (GGT) ali alanin-aminotransferaze(ALT)
English: Table 7: Secondary Endpoints in Patients with Atrial Fibrillation in the ARISTOTLE Study Apixaban N = 9,088 n (%/year)
Slovenian: Preglednica 7: Sekundarni opazovani dogodki pri bolnikih z atrijsko fibrilacijo v študiji ARISTOTLE apiksaban n = 9.088 n (% na leto)
English: Immune system disorders Hypersensitivity, allergic oedema and Anaphylaxis
Slovenian: Bolezni imunskega sistema preobčutljivost, alergijski edem in anafilaksija občasni občasni pruritus občasni občasni*
English: It does not require antithrombin III for antithrombotic activity.
Slovenian: Za antitrombotično delovanje ne potrebuje antitrombina III. Apiksaban zavira prosti in na strdek vezani faktor Xa ter aktivnost protrombinaze.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg apixaban.
Slovenian: Ena filmsko obložena tableta vsebuje 2,5 mg apiksabana.
English: Yellow, round tablets debossed with 893 on one side and 2½ on the other side.
Slovenian: filmsko obložena tableta (tableta) rumene, okrogle tablete, označene z oznako 893 na eni in 2½ na drugi strani
English: Table 13: Bleeding Results in the AMPLIFY-EXT Study Apixaban Apixaban Placebo
Slovenian: Preglednica 13: Rezultati spremljanja krvavitev v študiji AMPLIFY-EXT apiksaban apiksaban placebo relativno tveganje (95 % IZ)
English: Pruritus
Slovenian: Naproksen
English: Table 6: Key Efficacy Outcomes in Patients with Atrial Fibrillation in the AVERROES Study Apixaban N = 2,807 n (%/year)
Slovenian: Preglednica 6: Ključni rezultati učinkovitosti pri bolnikih z atrijsko fibrilacijo v študiji AVERROES apiksaban n = 2.807 n (% na leto)
English: Eliquis is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 4.3).
Slovenian: Pri bolnikih z boleznijo jeter, ki je povezana z motnjami strjevanja krvi in klinično pomembnim tveganjem za krvavitve, je uporaba zdravila Eliquis kontraindicirana (glejte poglavje 4.3).
English: It is not recommended in patients with severe hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter uporaba zdravila Eliquis ni priporočljiva (glejte poglavje 5.2).
English: Thus, administration of activated charcoal may be useful in the management of apixaban overdose or accidental ingestion.
Slovenian: Torej bi pri obvladovanju prevelikega odmerjanja apiksabana ali pri nenamernem zaužitju zdravila lahko bilo dajanje aktivnega oglja koristno.
English: - antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin norepinephrine re-uptake inhibitors
Slovenian: Antikoagulanti, zaviralci agregacije trombocitov, selektivni zaviralci privzema serotonina (SSRI)/zaviralci privzema serotonina in noradrenalina (SNRI) in nesteroidna protivnetna zdravila (NSAID)
English: Intra-abdominal haemorrhage
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: - They come in blisters in cartons of 14, 20, 28, 56, 60, 168 and 200 film-coated tablets.
Slovenian: Tablete so na voljo v pretisnih omotih v škatlah, ki vsebujejo 14, 20, 28, 56, 60, 168 in 200 filmsko obloženih tablet.
English: NAME OF THE MEDICINAL PRODUCT Eliquis 2.5 mg film-coated tablets
Slovenian: Eliquis 2,5 mg filmsko obložene tablete
English: The following side effects are known if you take Eliquis to prevent blood clots from forming after hip or knee replacement operations.
Slovenian: Pri jemanju zdravila Eliquis za preprečevanje nastanka krvnih strdkov po kirurški zamenjavi kolka ali kolena so opazili naslednje neželene učinke:
English: For the prevention of VTE in elective hip or knee replacement surgery (VTEp), the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt), apixaban is to be used with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min) (see sections 4.2 and
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina 15-29 ml/min) je za preprečevanje VTE pri načrtovani kirurški zamenjavi kolka ali kolena (VTEp), zdravljenje GVT, zdravljenje PE ter preprečevanje ponovne GVT in PE (VTEt) treba apiksaban uporabljati previdno (glejte poglavji 4.2 in 5.2).
English: Hip fracture surgery
Slovenian: Kirurški poseg pri zlomu kolka
English: • Patient Alert Cards
Slovenian: • opozorilne kartice za bolnika
English: Table 8: Key Efficacy Outcomes in Patients with Atrial Fibrillation in the AVERROES Study Apixaban N = 2,807 n (%/year)
Slovenian: Preglednica 8: Ključni rezultati učinkovitosti pri bolnikih z atrijsko fibrilacijo v študiji AVERROES apiksaban n = 2.807 n (% na leto)
English: NAME OF THE MEDICINAL PRODUCT Eliquis 5 mg film-coated tablets
Slovenian: Eliquis 5 mg filmsko obložene tablete
English: In the study, both doses of apixaban were statistically superior to placebo in the primary endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death (see Table 12).
Slovenian: V študiji sta bila oba odmerka apiksabana pri primarnem opazovanem dogodku - ponovna simptomatska VTE (GVT brez smrtnega izida ali PE brez smrtnega izida) ali smrt iz vseh vzrokovstatistično superiorna v primerjavi s placebom (glejte Preglednico 12).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateregakoli izmed neželenih učinkov,seposvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: - Bleeding including: - in your eyes - in your stomach or bowel - from your rectum - blood in the urine - from your nose - from your gums - bruising and swelling - Anaemia which may cause tiredness or paleness - Low blood pressure which may make you feel faint or have a quickened heartbeat - Nausea (feeling sick) - Blood tests may show: - an increase in gamma-glutamyltransferase (GGT)
Slovenian: krvavitve, vključno: v očeh v želodcualičrevesju iz danke s krvjo v urinu iz nosu iz dlesni z modricamiin oteklinami anemija,ki lahko povzroči utrujenost ali bledico nizek krvni tlak, kar lahko povzroči omedlevico ali hiter srčni utrip navzea (siljenje na bruhanje) krvne preiskave lahko pokažejo: povečanje vrednosti gama-glutamiltransferaze (GGT)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg apixaban.
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg apiksabana.
English: The known side effects and how frequently they occur for each of these medical conditions may differ and are listed separately below.For these conditions, the most common general side effect of Eliquis is bleeding which may be potentially life threatening and require immediate medical attention.
Slovenian: Opaženi neželeni učinki in njihova pogostnost pojavljanja pri vsakem izmed zdravstvenih stanj se lahko razlikujejo in so spodaj navedeni ločeno.
English: Bleeding: - into your abdomen or the space behind your abdominal cavity
Slovenian: krvavitve: v trebuhu ali prostoru, ki se nahaja za trebušno votlino