FrancophonIA/ELRC3.0 huggingface dataset:
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+49 (0)89 121 42 350)
Maltese: KGaA Tel: 0800 0752002 (+49 (0)89 121 42 350)
English: Alu-PVC/PVdC perforated unit dose blisters of 100x1 film coated tablets.
Maltese: Folji ta' doża waħda mtaqqbin tal-Alu-PVC/PVdC ta' 100x1 pillola miksija b'rita.
English: * There were no occurrences of generalized pruritus in CV185057 (long term prevention of VTE) † The term “Brain haemorrhage” encompasses all intracranial or intraspinal haemorrhages (ie., haemorrhagic stroke or putamen, cerebellar, intraventricular, or subdural haemorrhages).
Maltese: * Ma kienx hemm okkorrenzi ta' ħakk ġeneralizzat f'CV185057 (prevenzjoni fit-tul ta' VTE) It-terminu “Emorraġija fil-moħħ” jiġbor fih l-emorraġiji intrakranjali u intraspinali kollha (jiġifieri, puplesija emorraġika jew emorraġiji putameni, ċerebellari, intraventrikulari, jew subdurali).
English: Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
Maltese: Il-prevenzjoni ta' avvenimenti tromboemboliċi venużi (VTE) f'pazjenti adulti li jkunu għamlu kirurġija ta' sostituzzjoni elettiva tal-ġenbejn jew tal-irkoppa.
English: As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR and activated partial thromboplastin time (aPTT).
Maltese: B'konsegwenza tal-inibizzjoni ta' FXa, apixaban itawwal it-testijiet tal-għaqid bħall-ħin protrombin (PT), INR u ħin tromboplastin parzjali attivat (activated partial thromboplastin time - aPTT).
English: Relative Risk 95% CI
Maltese: Rata tal-avveniment Riskju Relattiv 95% CI
English: Nonfatal PE†
Maltese: Mekkaniżmu ta' azzjoni
English: Reproductive system and breast disorders Abnormal vaginal haemorrhage, urogenital haemorrhage
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Emorraġija mhux normali fil-vaġina, emorraġija uroġenitali
English: In the study, apixaban was statistically superior to enoxaparin/warfarin in the primary safety endpoint [Relative Risk 0.31, 95% confidence interval (0.17, 0.55), P-value < 0.0001] (see Table 9).
Maltese: Fl-istudju, apixaban kien statistikament superjuri għal enoxaparin/warfarin fil-punt ta'l-aħħar tas-sigurtà primarja [Riskju Relattiv 0.31, 95% intervall ta' kunfidenza (0.17, 0.55), Valur p <0.
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) The clinical program (AMPLIFY: apixaban versus enoxaparin/warfarin, AMPLIFY-EXT: apixaban versus placebo) was designed to demonstrate the efficacy and safety of apixaban for the treatment of DVT and/or PE (AMPLIFY), and extended therapy for the prevention of recurrent DVT and/or PE following 6 to 12 months of anticoagulant treatment for DVT and/or PE (AMPLIFY-EXT).
Maltese: Trattament ta' DVT, trattament ta' PE u prevenzjoni ta' DVT u PE rikorrenti (VTEt)Il-programm kliniku (AMPLIFY: apixaban kontra enoxaparin/warfarin, AMPLIFY-EXT: apixaban kontra plaċebo) kien maħsub biex juri l-effikaċja u s-sigurtà ta' apixaban għat-trattament ta' DVT u/jew PE (AMPLIFY), u terapija estiża għall-prevenzjoni ta' DVT u/jew PE rikorrenti wara minn 6 sa 12-il xahar ta' trattamentb'antikoagulanti għal DVT u/jew PE (AMPLIFY-EXT).
English: Naproxen (500 mg), an inhibitor of P-gp, led to a 1.5-fold and 1.6-fold increase in mean apixaban AUC and Cmax, respectively.
Maltese: Naproxen (500 mg), inibitur ta' P-gp, wassal għal żieda ta' 1.5 u 1.6 drabi l-AUC u Cmax medji ta' apixaban rispettivament.
English: 10 mg
Maltese: 10 mg darbtejn kuljum
English: Apixaban exposure parameters exhibit low to moderate variability reflected by a within-subject and inter-subject variability of ~20% CV and ~30% CV, respectively.
Maltese: Il-parametri ta' espożizzjoni ta' Apixaban juru varjabbiltà baxxa għal moderata riflessa minn varjabbiltà fi ħdan is-suġġett u bejn is-suġġetti ta' ~20% CV u ~30% CV, rispettivament.
English: In a clinical trial of patients with atrial fibrillation, concomitant use of ASA increased the major bleeding risk on apixaban from 1.8% per year to 3.4% per year and increased the bleeding risk on warfarin from 2.7% per year to 4.6% per year.
Maltese: Fi prova klinika f'pazjenti b'fibrillazzjoni tal-atriju, l-użu flimkien ma' ASA żied ir-riskju ta' fsada b'apixaban minn 1.8% fis-sena għal 3.4% fis-sena, u żieda fir-riskju ta' fsada bil-warfarin minn 2.7% fis-sena għal 4.6% fis-sena.
English: The incidence of ISTH major gastrointestinal bleeds (including upper GI, lower GI, and rectal bleeding) was 0.76%/year with apixaban and 0.86%/year with warfarin.
Maltese: L-inċidenza ta' fsada maġġuri tal-ISTH gastrointestinali (inkluż il-parti ta' fuq tal-GI, il-parti t'isfel tal-GI, u fsada fir-rektum) kienet 0.76%/sena b'apixaban u 0.86%/sena b'warfarin.
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).
Maltese: Antikoagulanti, inibituri ta' aggregazzjoni tal-plejtlits, SSRIs/SNRIs u NSAIDs Minħabba riskju miżjud ta' fsada, għandha tingħata attenzjoni jekk il-pazjenti jiġu kkurati fl-istess ħin b' xi antikoagulanti oħrajn ħlief taħt ċirkostanzi speċifiċi ta' qlib ta' terapija antikoagulanti, meta UFH tingħata f'dożi meħtieġa biex jinżamm miftuħ kateter venuż ċentrali jew arterjali jew meta UFH tingħata waqt ablazzjoni tal-kateter għal fibrillazzjoni atrijali (ara sezzjoni 4.3).
English: The overall discontinuation rate due to adverse reactions was 1.8% for apixaban and 2.6% for warfarin in the ARISTOTLE study.
Maltese: Ir-rata totali tat-twaqqif minħabba reazzjonijiet avversi kienet 1.8% għal apixaban u 2.6% għal warfarin fl-istudju ARISTOTLE.
English: Direct acting Oral Anticoagulants (DOACs) including apixaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Maltese: Orali b'azzjoni diretta (DOACs) inkluż apixaban mhumiex rakkomandati għal pazjenti bi storja ta' trombożi li huma dijanjostikati bis-sindrome antifosfolipid.
English: In a clinical trial of high-risk post acute coronary syndrome patients, characterised by multiple cardiac and non-cardiac comorbidities, who received ASA or the combination of ASA and clopidogrel, a significant increase in risk of ISTH (International Society on Thrombosis and Haemostasis) major bleeding was reported for apixaban (5.13% per year) compared to placebo (2.04% per year).
Maltese: Fi prova klinika f'pazjenti b'riskju ogħli wara sindromu koronarju akut, ikkaratterizzat minn komorbożitajiet kardijaċi multipli jew mhux kardijaċi, li rċivew ASA jew kombinazzjoni ta' ASA flimkien ma' clopidogrel, kienet irrapurtata żieda sinifikanti fir-riskju ta' fsada maġġuri tal-ISTH (Soċjetà Internazzjonali fuq Trombożi u Emostasi) b'apixaban (5.13% fis-sena) meta mqabbla malplaċebo (2.04% fis-sena).
English: Data from clinical trials are only available for the Rotachrom® Heparin chromogenic assay.
Maltese: Dejta minn provi kliniċi hija disponibbli biss għall-eżami kromoġeniku ta' Rotachrom
English: Table 8: Efficacy Results in the AMPLIFY Study Apixaban N=2,609 n (%)
Maltese: Tabella 8: Riżultati tal-Effikaċja fl-Istudju AMPLIFY Apixaban N=2,609 n (%)
English: Eliquis should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of bleeding.
Maltese: Eliquis għandu jitwaqqaf mill-inqas 48 siegħa qabel kirurġija elettiva jew proċeduri invażivi b'riskju moderat jew ogħli ta' fsada.
English: Apix 2.5 mg vs.
Maltese: KARTUNA 2.5 mg
English: Enoxaparin 40 mg sc once daily 12 ± 2 d
Maltese: Enoxaparin 40 mg sc darba kuljum 12 ± 2 d
English: Eliquis contains the active substance apixaban and belongs to a group of medicines called anticoagulants.
Maltese: Eliquis fih is-sustanza attiva apixaban u jappartjeni għal grupp ta' mediċini msejħin antikoagulanti.
English: Thrombocytopenia
Maltese: Doża maqbuża
English: Respiratory tract haemorrhage
Maltese: Emorraġija fit-tratt respiratorju
English: 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets 60 film-coated tablets 100x 1 film-coated tablets 168 film-coated tablets 200 film-coated tablets
Maltese: 10 pilloli miksijin b'rita 20 pillola miksija b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 100 x 1 pillola miksija b'rita 168 pillola miksija b'rita 200 pillola miksija b'rita
English: In controlled clinical trials, orally-administered apixaban in healthy subjects at doses up to 50 mg daily for 3 to 7 days (25 mg twice daily (bid) for 7 days or 50 mg once daily (od) for 3 days) had no clinically relevant adverse effects.
Maltese: Fi provi kliniċi kkontrollati, apixaban mogħti mill-ħalq f'suġġetti b'saħħithom f'dożi sa 50 mg kuljum għal 3 sa 7 ijiem (25 mg darbtejn kuljum (bid) għal 7 ijiem jew 50 mg darba kuljum (od) għal 3 ijiem) ma kellu ebda effett avvers klinikament relevanti.
English: PFIZER ΕΛΛΑΣ Α.Ε.
Maltese: PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)
English: Following oral administration of 10 mg of apixaban as 2 crushed 5 mg tablets with 30 g of apple puree, the Cmax and AUC were 21% and 16% lower, respectively, when compared to administration of 2 whole 5 mg tablets.
Maltese: Wara l-għoti mill-ħalq ta' 10 mg ta' apixaban bħala 2 pilloli mfarrkin ta' 5 mg ma' 30 g polpa tattuffieħ, is-Cmax u l-AUC kienu 21% u 16% aktar baxxi, rispettivament, meta mqabbel mal-għoti ta' 2 pilloli sħaħ ta' 5 mg.
English: Enoxaparin 40 mg sc once daily 12 ± 2 d p-value
Maltese: Enoxaparin 40 mg sc darba kuljum 12 ± 2 d valur p
English: - Changing from treatment with anticoagulant containing vitamin K antagonist (e.g., warfarin) to Eliquis
Maltese: Tibdil minn trattament kontra l-koagulazzjoni li fih antagonist ta' vitamina K (e.ż., warfarin) għal Eliquis
English: Apixaban has a total clearance of about 3.3 L/h and a half-life of approximately 12 hours.
Maltese: Apixaban għandu eliminazzjoni totali ta' madwar 3.3 L/h u half-life ta' madwar 12-il siegħa.
English: The mean age was 69.9 years, the mean CHADS2 score was 2.0 and 13.6% of patients had prior stroke or TIA.
Maltese: L-età medja kienet 69.9 sena, rriżultat medju CHADS2 kien 2.0 u 13.6% tal-pazjenti kellhom puplesija jew TIA qabel.
English: Apixaban showed a reduction of stroke and systemic embolism compared to warfarin across the different levels of center TTR; within the highest quartile of TTR according to center, the hazard ratio for apixaban vs warfarin was 0.73 (95% CI, 0.38, 1.40).
Maltese: Apixaban wera tnaqqis ta' puplesija u emboliżmu sistemiku meta mqabbel ma' warfarin fil-livelli differenti tat-TTR ċentrali; fl-ogħla kwartili tat-TTR skont iċ-ċentru, il-proporzjon ta' riskju għal apixaban vs warfarin kien 0.73 (95% CI, 0.38, 1.40).
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.
Maltese: Naproxen (500 mg, doża singola), inibitur ta' P-gp iżda mhux inibitur ta' CYP3A4, wassal għal żieda ta' 1.5 u ta' 1.6 fl-AUC u fis-Cmax medju ta' apixaban, rispettivament.
English: Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors (NVAF)
Maltese: Prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'NVAF, b'fattur ta' riskju wieħed jew aktar (NVAF)
English: Haematochezia
Maltese: Ematokeżija
English: Hip fracture surgery
Maltese: Perjodu ta' trattament wara l-kirurġija
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffetwaw sa 1 minn 1,000 persuna)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, id-defiċjenza ta' Lapp lactase jew l-assorbiment ħażin ta' glucose-galactose ma għandhomx jieħdu dan il-prodott mediċinali.
English: Intracranial, n Major + CRNM† All
Maltese: Ġol-kranju, n Maġġuri + CRNM Kollha
English: In the AMPLIFY study a total of 5,395 patients were randomised to treatment with apixaban 10 mg twice daily orally for 7 days followed by apixaban 5 mg twice daily orally for 6 months, or enoxaparin 1 mg/kg twice daily subcutaneously for at least 5 days (until INR≥ 2) and warfarin (target INR range 2.0-3.0) orally for 6 months.
Maltese: Fl-istudju AMPLIFY, total ta' 5,395 pazjent intgħażlu b'mod każwali għat-trattamentb'apixaban 10 mg darbtejn kuljum mill-ħalq għal 7 ijiem segwit minn apixaban 5 mg darbtejn kuljum mill-ħalq għal 6 xhur, jew enoxaparin 1 mg/kg darbtejn kuljum taħt il-ġilda għal mill-inqas 5 ijiem (sa INR 2) u warfarin (medda ta' mira INR ta' 2.0-3.0) mill-ħalq għal 6 xhur.
English: Placebo n (%)
Maltese: Apix 5.0 mg kontra Plaċebo n (%)
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
Maltese: Għall-prevenzjoni ta' VTE f'operazzjoni mhux obbligatorja tas-sostituzzjoni tal-ġenbejn u tal-irkoppa (VTEp), it-trattament ta' DVT, it-trattament ta' PE u prevenzjoni ta' DVT u PE rikorrenti (VTEt), apixaban għandu jintuża b'kawtela f'pazjenti b'indeboliment sever tal-kliewi (bi tneħħija tal-krejatinina ta' 15-29 mL/min) (ara sezzjonijiet 4.2 u 5.2).
English: *Major bleeding defined per International Society on Thrombosis ad Haemostasis (ISTH) criteria.
Maltese: * Fsada maġġuri definita skont il-kriterji tas-Soċjetà Internazzjonali tat-Trombożi u Emostasti (ISTH). †
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.
Maltese: L-għoti fl-istess ħin ta' apixaban (20 mg darba kuljum) u digoxin (0.25 mg darba kuljum), substrat ta' P-gp, ma affettwax l-AUC jew is-Cmax ta' digoxin.
English: In the NVAF studies, the overall incidence of adverse reactions related to bleeding with apixaban was 24.3% in the apixaban vs warfarin study and 9.6% in the apixaban vs acetylsalicylic acid study.
Maltese: Fl-istudji dwar NVAF, l-inċidenza globali ta' reazzjonijiet avversi relatati ma' ħruġ ta' demm b'apixaban kienet ta' 24.3% fl-istudji dwar apixaban kontra warfarin u ta' 9.6% fl-istudju dwar apixaban kontra l-aspirina.
English: The initial dose should be taken 12 to 24 hours after surgery.
Maltese: Id-doża inizjali għandha tittieħed 12 sa 24 siegħa wara l-kirurġija.
English: * Dose adjusted population based on 2 of 3 dose reduction criteria in the ARISTOTLE study.
Maltese: * Popolazzjoni aġġustata skont id-doża fuq bażi ta' żewġ kriterji ta' tnaqqis fid-doża minn 3 fl-istudju ARISTOTLE.
English: Cartons of 14, 20, 28, 56, 60, 168 and 200 film-coated tablets.
Maltese: Jiġu f'folji f'kartun ta' 14, 20, 28, 56, 60, 168 u 200 pillola miksijin b'rita.
English: Apixaban coadministered with clopidogrel (75 mg once a day) or with the combination of clopidogrel 75 mg and ASA 162 mg once daily, or with prasugrel (60 mg followed by 10 mg once daily) in Phase I studies did not show a relevant increase in template bleeding time, or further inhibition of platelet aggregation, compared to administration of the antiplatelet agents without apixaban.
Maltese: Apixaban meta mogħti fl-istess ħin ma' clopidogrel (75 mg darba kuljum) jew bil-kombinazzjoni ta' clopidogrel 75 mg u ASA 162 mg darba kuljum, jew ma' prasugrel (60 mg segwit minn 10 mg darba kuljum) fl-istudji ta' Fażi I, ma weriex żieda relevanti fil-ħin ta' fsada tat-template, jew aktar inibizzjoni tal-aggregazzjoni tal-plejtlits, meta mqabbel ma' amministrazzjoni tas-sustanzi antiplejtlits mingħajr apixaban.
English: The safety of apixaban has been investigated in 7 Phase III clinical studies including more than 21,000 patients: more than 5,000 patients in VTEp studies, 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 20 days, 1.7 years and 221 days respectively (see section 5.1).
Maltese: III li kienu jinkludu iktar minn 21,000 pazjent: iktar minn 5,000 pazjent fi studji dwar VTEp, iktar minn 11,000 pazjent fi studji dwar NVAF u iktar minn 4,000 pazjent fi studji dwar it-trattament ta' VTE (VTEt), għal medja ta' esponiment totali ta' 20 jum, 1.7 snin u 221 jum rispettivament (ara sezzjoni 5.1).
English: They are not recommended to assess the pharmacodynamic effects of apixaban.
Maltese: Mhumiex rakkomandati biex jivvalutaw l-effetti farmakodinamiċi ta' apixaban.
English: In the apixaban group, 342 patients received a loading dose (331 patients received the 10 mg dose and 11 patients received the 5 mg dose).
Maltese: Fil-grupp ta' apixaban, 342 pazjent irċvew doża qawwija tal-bidu (331 pazjent irċivew id-doża ta' 10 mg u 11-il pazjent irċivew id-doża ta' 5 mg).
English: Prevention of stroke and systemic embolism: NVAF 2.5 mg twice daily*
Maltese: NVAF 2.5 mg darbtejn kuljum*
English: MI, or vascular death*†
Maltese: Riżultati ta' Fsada Maġġuri*
English: * Noninferior compared to enoxaparin/warfarin (p-value <0.0001)
Maltese: * Mhux inferjuri meta mqabbel ma' enoxaparin/warfarin (valur p <0.
English: • Concomitant treatment with any other anticoagulant agent e.g., unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy (see section 4.2), 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 sections 4.4 and 4.5).
Maltese: • It-trattament fl-istess ħin bi kwalunkwe mediċina li traqqaq id-demm, eż., eparina mhux frazzjonata (UFH), eparini b'piż molekulari baxx (enoxaparin, dalteparin, eċċ.), derivattivi taleparina (fondaparinux, eċċ.), mediċini orali kontra l-koagulazzjoni tad-demm (warfarin, rivaroxaban, dabigatran eċċ.) ħlief f'ċirkustanzi speċifiċi meta tinqaleb it-terapija blantikoagulanti (ara sezzjoni 4.2), meta UFH tingħata f'dożi meħtieġa biex iżżomm kateter venuż ċentrali jew arterjali miftuħ jew meta UFH tingħata waqt ablazzjoni tal-kateter għal fibrillazzjoni atrijali (ara sezzjonijiet 4.4 u 4.5).
English: In the ARISTOTLE study a total of 18,201 patients were randomised to double-blind treatment with apixaban 5 mg twice daily (or 2.5 mg twice daily in selected patients [4.7%], see section 4.2) or warfarin (target INR range 2.0-3.0), patients were exposed to study drug for a mean of 20 months.
Maltese: Fl-istudju ARISTOTLE, total ta' 18,201 pazjent kienu magħżula b'ordni addoċċ għal trattament double-blind b'apixaban 5 mg darbtejn kuljum (jew 2.5 mg darbtejn kuljum f'pazjenti magħżula [4.7%], ara sezzjoni 4.2) jew warfarin (medda ta' INR fil-mira 2.0-3.0).
English: Stop taking the medicine containing a vitamin K antagonist.
Maltese: Tibqax tieħu l-mediċina li fiha l-antagonist ta' vitamina K.
English: When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis.
Maltese: Meta tintuża anesteżija newrassjali (anesteżija spinali/epidurali) jew ikun hemm titqib spinali/epidurali, pazjenti kkurati b'sustanzi antitrombotiċi għall-prevenzjoni ta' kumplikazzjonijiet tromboemboliċi huma f'riskju li jiżviluppaw ematoma epidurali jew spinali li tista' twassal għal paraliżi fit-tul jew permanenti.
English: The results across phase I studies showed no discernible difference in apixaban pharmacokinetics between White/Caucasian, Asian and Black/African American subjects.
Maltese: Ir-riżultati tul l-istudji ta' fażi I ma urew ebda differenza li tintgħaraf fil-farmakokinetiċi ta' apixaban bejn suġġetti Bojod/Kawkażi, Asjatiċi u Suwed/Afrikani Amerikani.
English: The major observed effects in the repeated dose toxicity studies were those related to the pharmacodynamic action of apixaban on blood coagulation parameters.
Maltese: L-akbar effetti osservati fl-istudji ta' tossiċità ripetuta kienu dawk relatati mal-azzjoni farmakodinamika ta' apixaban fuq il-paramteri ta' koagulazzjoni tad-demm.
English: The reduction in exposure is not considered clinically relevant.
Maltese: It-tnaqqis fl-espożizzjoni mhuwiex ikkunsidrat klinikament rilevanti.
English: Post procedural haemorrhage (including post procedural haematoma, wound haemorrhage, vessel puncture site haematoma and catheter site haemorrhage), wound secretion, incision site haemorrhage (including incision site haematoma), operative haemorrhage
Maltese: Emorraġija ta' wara l-proċedura (inkluż ematoma ta' wara lproċedura, emorraġija tal-ferita, ematoma fis-sit tat-titqib talvina/arterja u emorraġija fis-sit tal-katiter), tnixxija minn ferita, emorraġija fis-sit tal-inċiżjoni (inkluż ematoma fis-sit talinċiżjoni), emorraġija operattiva
English: A stroke can be life-threatening and requires immediate medical attention.
Maltese: Jekk il-fsada ma' tieqafx waħedha, fittex attenzjoni medika immedjatament.
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.
Maltese: L-għoti fl-istess ħin ta' doża singola ta' apixaban (10 mg) u atenolol (100 mg), beta-imblokkatur komuni, ma bidilx il-farmakokinetiċi ta' atenolol.
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).
Maltese: Apixaban wera tnaqqis li huwa statistikament superjuri fil-punt ta' tmiem primarju, kompost tal-VTE kollha/mewta b'kull kawża, u fil-punt ta' tmiem tal-VTE Maġġuri, kompost ta' DVT prossimali, PE mhux fatali u mewta relatata mal-VTE, meta mqabbel ma' enoxaparin kemm f'kirurġija ta' sostituzzjoni selettiva tal-ġenbejn kif ukoll f'dik tal-irkoppa (ara Tabella 4).
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).
Maltese: III li kienu jinkludu iktar minn 15,000 pazjent: iktar minn 11,000 pazjent fi studji dwar NVAF u iktar minn 4,000 pazjent fi studji dwar it-trattament ta' VTE (VTEt), għal medja ta' esponiment totali ta' 1.7 snin u 221 jum rispettivament (ara sezzjoni 5.1).
English: For patients randomised to warfarin, the mean percentage of time in therapeutic range (INR 2.0-3.0) was 60.9.
Maltese: Għal pazjenti li ntgħażlu b'mod każwali għal warfarin, il-perċentwali medja taż-żmien fil-medda terapewtika (INR 2.0-3.0) kien ta' 60.9%.
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).
Maltese: L-użu ta' Eliquis mhuwiex rakkomandat f'pazjenti li jkunu qegħdin jirċievu trattament sistemiku konkomittanti b'inibituri b'saħħithom kemm ta' CYP3A4 kif ukoll ta' P-gp, bħal azole-antimycotics (eż., ketoconazole, itraconazole, voriconazole u posaconazole) u inibituri tal-protease tal-HIV (eż., ritonavir) (ara sezzjoni 4.4).
English: Gastrointestinal haemorrhage
Maltese: Emorraġija gastro-intestinali