FrancophonIA/ELRC3.0 huggingface dataset:
English: ASA was given at a once daily dose of 81 mg (64%), 162 (26.9%), 243 (2.1%), or 324 mg (6.6%) at the discretion of the investigator.
Maltese: ASA ngħata darba kuljum b'doża ta' 81 mg (64%), 162 (26.9%), 243 (2.1%), jew 324 mg (6.6%) bid-diskrezzjoni tal-investigatur.
English: CLINICAL PARTICULARS
Maltese: Klinikament Rilevanti
English: Gamma-glutamyltransferase increased
Maltese: Żieda fil-gamma-glutamyltransferase
English: The volume of distribution (Vss) is approximately 21 litres.
Maltese: Il-volum ta' distribuzzjoni (Vss) huwa madwar 21 litru.
English: Additional contributions from biliary and direct intestinal excretion were observed in clinical and nonclinical studies, respectively.
Maltese: Kontribuzzjonijiet addizzjonali mill-eskrezzjoni intestinali biljari u diretta ġew osservati fi studji kliniċi u mhux kliniċi, rispettivament.
English: Indication:
Maltese: Isem:
English: See section 2 "Eliquis contains lactose (a type of sugar) and sodium".
Maltese: Ara sezzjoni 2 “Eliquis fih lactose (tip ta' zokkor) u sodium”.
English: Inducers of CYP3A4 and P-gp
Maltese: Indutturi ta' CYP3A4 u P-gp
English: • The active substance is apixaban.
Maltese: Is-sustanza attiva hija apixaban.
English: Mouth haemorrhage
Maltese: Mhux Maġġuri
English: There were no strokes (0%) in the apixaban group (n= 753) and 6 (0.80%) strokes in the heparin and/or VKA group (n = 747; RR 0.00, 95% CI 0.00, 0.64).
Maltese: Ma kien hemm l-ebda puplesija (0%) fil-grupp ta' apixaban (n= 753) u 6 (0.80%) puplesiji fil-grupp tal-eparina u/jew VKA (n = 747; RR 0.00, 95% CI 0.00, 0.64).
English: Table 3: Predicted Apixaban Steady-state Exposure and Anti-Xa Activity
Maltese: Tabella 3: Esponiment fi Stat Fiss għal Apixaban u Attività Anti-Xa Mbassra
English: ASA N = 2,791 n (%/year)
Maltese: ASA N = 2,791 n (%/sena)
English: ASA N = 2,780 n (%/year)
Maltese: ASA N = 2,780 n (%/sena)
English: Surgery and invasive procedures
Maltese: Kirurġija u proċeduri invażivi
English: Total VTE/all-cause death Number of events/subjects Event Rate
Maltese: VTE maġġuri Numru ta' avvenimenti/suġġetti
English: Anti-Xa Activity Max (IU/mL)
Maltese: Anti-Xa Attività Massima (IU/mL)
English: Apixaban efficacy in initial treatment of VTE was consistent between patients who were treated for a PE [Relative Risk 0.9; 95% CI (0.5, 1.6)] or DVT [Relative Risk 0.8; 95% CI (0.5, 1.3)].
Maltese: [Riskju Relattiv 0.9; 95% CI (0.5, 1.6)] jew DVT [Riskju Relattiv 0.8; 95% CI (0.5, 1.3)].
English: Inhibitors of CYP3A4 and P-gp
Maltese: Inibituri ta' CYP3A4 u P-gp
English: No data are available.
Maltese: Ma hemm ebda dejta disponibbli.
English: In patients undergoing hip replacement surgery The recommended duration of treatment is 32 to 38 days.
Maltese: Pazjenti rikoverati li jkunu qegħdin jagħmlu kirurġija ta' sostituzzjoni tal-ġenbejn It-tul rakkomandat tat-trattament huwa ta' 32 sa 38 jum.
English: Musculoskeletal and connective tissue disorders Muscle haemorrhage
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Emorraġija fil-muskoli
English: Renal excretion of apixaban accounts for approximately 27% of total clearance.
Maltese: Leliminazzjoni renali ta' apixaban tammonta għal madwar 27% tal-eliminazzjoni totali.
English: † Secondary endpoint.
Maltese: Punt tat-tmiem sekondarju.
English: Warfarin N = 9,052 n (%/year)
Maltese: Warfarin N = 9,052 n (%/sena)
English: Eliquis can be given for three different medical conditions.
Maltese: Eliquis jista' jingħata għal tliet kundizzjonijiet mediċi differenti.
English: Apixaban is a substrate of transport proteins, P-gp and breast cancer resistance protein (BCRP).
Maltese: Apixaban huwa substrat ta' proteini tat-trasport, P-gp u l-proteina ta' reżistenza ta' kanċer tas-sider (BCRP).
English: Immune system disorders Hypersensitivity, allergic oedema and Anaphylaxis
Maltese: Disturbi fis-sistema immuni Sensittività eċċessiva, edima allerġika u Anafilassi
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal xi eċċipjenti elenkati f'sezzjoni 6.1.
English: Patients with elevated liver enzymes alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2 x ULN or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Maltese: Pazjenti b'livelli ta' enżimi tal-fwied elevati alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2 x ULN jew total ta' bilirubin ≥1.5 x ULN ma kienux inklużi fil-provi kliniċi.
English: Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors, ATC code: B01AF02
Maltese: Aġenti antitrombotiċi, inibituri tal-fattur dirett Xa, Kodiċi ATC:
English: The pharmacokinetic /pharmacodynamic (PK/PD) relationship between apixaban plasma concentration and several PD endpoints (anti-FXa activity, INR, PT, aPTT) has been evaluated after administration of a wide range of doses (0.5 - 50 mg).
Maltese: Ir-relazzjoni farmakokinetika/farmakodinamika (PK/PD) bejn il-konċentrazzjoni tal-plasma ta' apixaban u l-bosta punti ta' tmiem PD (attività anti-FXa, INR, PT, aPTT) ġiet evalwata wara għoti ta' firxa wiesgħa ta' dożi (0.5 - 50 mg).
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) A total of 23,799 patients were randomised in the clinical program (ARISTOTLE: apixaban versus warfarin, AVERROES: apixaban versus ASA) including 11,927 randomised to apixaban.
Maltese: Total ta' 23799 pazjent kienu magħżula b'ordni addoċċ fi program kliniku (ARISTOTLE: apixaban versus warfarin, AVERROES: apixaban versus ASA) inkluż 11,927 magħżula b'ordni addoċċ għal apixaban.
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 11).
Maltese: Fl-istudju, apixaban kien statistikament superjuri għal enoxaparin/warfarin fil-punt aħħari tas-sigurtà primarja [Riskju Relattiv 0.31, 95% intervall ta' kunfidenza (0.17, 0.55), Valur p < 0.0001] (ara Tabella 9).
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.
Maltese: Mhux rakkomandat użu b'mod konkomitanti ta' prodotti mediċinali assoċjati ma' fsada serja ma' Eliquis, bħal: sustanzi trombolitiċi, antagonisti għar-riċetturi GPIIb/IIIa, thienopyridines (e.ż., clopidogrel), dipyridamole, dextran u sulfinpyrazone.
English: All treated n = 2,673
Maltese: Dawk kollha kkurati n = 2,673 n = 2,659
English: ADVANCE-3 (hip)
Maltese: ADVANCE-3 (ġenbejn)
English: Plasma protein binding in humans is approximately 87%.
Maltese: L-irbit tal-proteini tal-plasma fil-bnedmin huwa madwar 87%.
English: Other medicines and Eliquis
Maltese: Mediċini oħra u Eliquis
English: In a study comparing 8 subjects with mild hepatic impairment, Child-Pugh A score 5 (n = 6) and score 6 (n = 2), and 8 subjects with moderate hepatic impairment, Child-Pugh B score 7 (n = 6) and score 8 (n = 2), to 16 healthy control subjects, the single-dose pharmacokinetics and pharmacodynamics of apixaban 5 mg were not altered in subjects with hepatic impairment.
Maltese: Fi studju li jqabbel 8 suġġetti b'indeboliment tal-fwied ħafif, Child-Pugh A score 5 (n = 6) u score 6 (n = 2), u 8 suġġetti b'indeboliment tal-fwied moderat, Child Pugh B score 7 (n = 6) u score 8 (n = 2), ma' 16-il suġġett ta' kontroll b'saħħithom, il-farmakokinetiċi u l-farmakodinamiċi ta' doża waħdanija ta' apixaban 5 mg ma nbidlux f'suġġetti b'indeboliment tal-fwied.
English: Apixaban 2.5 mg po twice daily 12 ± 2 d
Maltese: Apixaban 2.5 mg po darbtejn kuljum 12 ± 2 d
English: ADVANCE-2 (knee)
Maltese: ADVANCE-2 (irkoppa)
English: Included in this total were 1,262 patients (618 in the apixaban group) of age 75 or older, 1,004 patients (499 in the apixaban group) with low body weight (≤ 60 kg), 1,495 patients (743 in the apixaban group) with BMI ≥ 33 kg/m2, and 415 patients (203 in the apixaban group) with moderate renal impairment.
Maltese: Inklużi f'dan it-total kien hemm 1262 pazjent (618 fil-grupp ta' apixaban) ta' età ta' 75 jew iktar, 1004 pazjenti (499 fil-grupp ta' apixaban) b'piż baxx tal-ġisem (≤ 60 kg), 1495 pazjent (743 fil-grupp ta' apixaban) b'BMI ≥ 33 kg/m2, u 415-il pazjent (203 fil-grupp ta' apixaban) b'indeboliment renali moderat.
English: AMPLIFY-EXT STUDY
Maltese: L-ISTUDJU AMPLIFY-EXT
English: O-demethylation and hydroxylation at the 3-oxopiperidinyl moiety are the major sites of biotransformation.
Maltese: O-demethylation u hydroxylation fil-moiety ta' 3-oxopiperidinyl huma s-siti maġġuri ta' bijotrasformazzjoni.
English: Eliquis contains lactose (a type of sugar) and sodium
Maltese: Eliquis fih lactose (tip ta' zokkor) u sodium.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 May 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Mejju 2011
English: Intracranial, n
Maltese: Ġol-kranju, n
English: Enoxaparin 40 mg sc once daily 35 ± 3 d p-value Apixaban 2.5 mg po twice daily 12 ± 2 d
Maltese: Enoxaparin 40 mg sc darba kuljum 35 ± 3 d valur p Apixaban 2.5 mg po darbtejn kuljum 12 ± 2 d
English: Alu PVC/PVdC perforated unit dose blisters of 60x1 and 100x1 film-coated tablets.
Maltese: Folji ta' doża waħda mtaqqbin tal-Alu-PVC/PVdC ta' 60x1 u 100x1 pillola miksija b'rita.
English: Eliquis contains lactose.
Maltese: Eliquis fih lactose.
English: Based on patient medical history in the studied population of ADVANCE-3 and ADVANCE-2 (8,464 patients), 46% had hypertension, 10% had hyperlipidemia, 9% had diabetes, and 8% had coronary artery disease.
Maltese: Fuq il-bażi tal-istorja medika tal-pazjent fil-popolazzjoni studjata ta' ADVANCE-3 u ADVANCE-2 (8464 pazjent), 46% kellhom pressjoni għolja, 10% kellhom iperlipidemija, 9% kellhom id-dijabete, u 8% kellhom mard fl-arterja koronarja.
English: The ADVANCE-3 study included 5,407 patients undergoing elective hip replacement, and the ADVANCE-2 study included 3,057 patients undergoing elective knee replacement.
Maltese: L-istudju ADVANCE-3 inkluda 5407 pazjenti li kienu qegħdin jagħmlu sostituzzjoni elettiva talġenbejn, u l-istudju ADVANCE-2 inkluda 3057 pazjent li kienu qegħdin jagħmlu sostituzzjoni elettiva tal-irkoppa.
English: Spinal/epidural anaesthesia or puncture
Maltese: Anesteżija spinali/epidurali jew titqib
English: Apixaban 2.5 mg po twice daily 35 ± 3 d
Maltese: Apixaban 2.5 mg po darbtejn kuljum 35 ± 3 d
English: Major bleeding and CRNM bleeding events occurred in 3 (0.41%) and 11 (1.50%) patients, respectively, in the apixaban group, compared to 6 (0.83%) and 13 (1.80%) patients in the heparin and/or VKA group.
Maltese: 41%) u 11 (1.50%)-il pazjent, rispettivament, fil-grupp ta' apixaban, meta mqabbel ma' 6 (0.83%) u 13 (1.80%)-il pazjent fil-grupp tal-eparina u/jew VKA.
English: After combined administration of enoxaparin (40 mg single dose) with apixaban (5 mg single dose), an additive effect on anti-Factor Xa activity was observed.
Maltese: Wara għoti kkombinat ta' enoxaparin (doża waħda ta' 40 mg) ma' apixaban (doża waħda ta' 5 mg), ġie osservat effett addittiv fuq l-attività ta'anti-Factor Xa.
English: Take the medicine pack with you, even if there are no tablets left.
Maltese: Ħu l-pakkett talmediċina miegħek, anki jekk ma jkun għad fadal ebda pillola.
English: Bristol-Myers Squibb S.r.l Loc. Fontana del Ceraso 03012 Anagni (FR) Italy
Maltese: Fontana del Ceraso 03012 Anagni (FR) L-Italja
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).
Maltese: Żieda sinifikanti fir-riskju ta' fsada ġiet irrapportata bilkombinazzjoni tripla ta' apixaban, ASA u clopidogrel fi studju kliniku f'pazjenti b'sindromu koronarju akut (ara sezzjoni 4.4).
English: • The other ingredients are: - Tablet core: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, sodium laurilsulfate, magnesium stearate (E470b).
Maltese: - Qalba tal-pillola: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, sodium laurilsulfate, magnesium stearate (E470b).
English: Adjudicated ISTH major gastrointestinal bleeding occurred in 6 (0.2%) apixaban-treated patients and 17 (0.6%) enoxaparin/warfarin-treated patients.
Maltese: Ħruġ ta' demm gastrointestinali maġġuri aġġudikat ISTH seħħ f'6 (0.2%) pazjenti kkurati b'apixaban u fi 17-il (0.6%) pazjent kkurati b'enoxaparin/warfarin.
English: - Film coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).
Maltese: - Kisja tar-rita tal-pillola: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).
English: The overall discontinuation rate due to adverse reactions was 1.5% for apixaban and 1.3% for ASA in the AVERROES study.
Maltese: Ir-rata totali tat-twaqqif minħabba reazzjonijiet avversi kienet 1.5% għal apixaban u 1.3% għal ASA fl-istudju AVERROES.
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).
Maltese: Total ta' 8464 pazjent ġew randomizzati f'żewġ studji pivotali, double-blind, multinazzjonali, li qabblu apixaban 2.5 mg mogħti mill-ħalq darbtejn klujum (4236 pazjent) jew enoxaparin
English: Table 2 shows the adverse reactions ranked under headings of system organ class and frequency using the following convention: very common (≥ 1/10); 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) for VTEp, NVAF, and VTEt respectively.
Maltese: Tabella 2 turi r-reazzjonijiet avversi elenkati skont is-sistema tal-klassifika tal-organi u skont ilfrekwenza bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma setgħetx tittieħed stima mid-dejta disponnibli) għal VTEp, NVAF, u VTEt rispettivament.
English: • Guidance regarding surgery or invasive procedure, and temporary discontinuation
Maltese: • Gwida fuq il-kirurġija u proċeduri invażivi, u twaqqif temporanju
English: Fatal
Maltese: Fatali
English: Discontinuing anticoagulants, including Eliquis, for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of thrombosis.
Maltese: Twaqqif ta' antikoagulanti, inkluż Eliquis, għal fsada attiva, kirurġija elettiva, jew proċeduri invażivi jista' jżid ir-riskju ta' trombożi fil-pazjenti.
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
Maltese: It-trattamentta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE), u l-prevenzjoni ta' DVT u PE rikorrenti fl-adulti (ara sezzjoni 4.4 għal pazjenti b'PE emodinamikament instabbli).
English: Of these, 836 patients (33.7%) participated in the AMPLIFY study prior to enrollment in the AMPLIFY-EXT study.
Maltese: Minn dawn, 836 pazjent (33.7%) ipparteċipaw fl-istudju AMPLIFY qabel ma rreġistraw fl-istudju AMPLIFY-EXT.
English: In this clinical trial, there was limited (2.1%) use of concomitant dual antiplatelet therapy.
Maltese: F'din il-prova klinika, kien hemm użu limitat (2.1%) ta' użu flimkien ma' żewġ terapiji kontra l-plejtlits.
English: Median [5th, 95th Percentile]
Maltese: Medjan [il-5 u l-95 perċentil]
English: INFORMATION IN BRAILLE Eliquis 5 mg
Maltese: Eliquis 5 mg
English: Common adverse reactions were haemorrhage, contusion, epistaxis, and haematoma (see Table 2 for adverse reaction profile and frequencies by indication).
Maltese: Reazzjonijiet avversi komuni kienu emorraġija, kontużjoni, epistassi, u ematoma (ara Tabella 2 għallprofil u l-frekwenzi tar-reazzjonijiet avversi skont l-indikazzjoni).
English: INFORMATION IN BRAILLE Eliquis 2.5 mg
Maltese: Eliquis 2.5 mg
English: Τηλ: +30 210 67 85 800
Maltese: PFIZER ΕΛΛΑΣ Α.Ε. Τηλ: +30 210 67 85 800
English: Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Maltese: Għandha tingħata attenzjoni jekk pazjenti jiġu kkurati b'mod konkomittanti b'inibituri selettivi ta' assorbiment mill-ġdid ta' serotonina (SSRIs, selective serotonin reuptake inhibitors) jew inibituri ta' assorbiment mill-ġdid ta' serotonina norepinefrina (SNRIs, serotonin norepinephrine reuptake inhibitors), jew mediċini anti-infjammatorji mhux sterojdali (NSAIDs) inkluż acetylsalicylic acid.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin
Maltese: Kisja tar-rita tal-pillola: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin
English: Bristol-Myers Squibb S.r.l Loc. Fontana del Ceraso 03012 Anagni (FR)
Maltese: Fontana del Ceraso 03012 Anagni (FR)
English: Each 2.5 mg film-coated tablet contains 51.43 mg lactose (see section 4.4).
Maltese: Eċċipjenti bl-effett magħruf Kull pillola ta' 2.5mg miksija b'rita fiha 51.43 mg ta' lactose (ara sezzjoni 4.4).
English: AVERROES was stopped early based on a recommendation by the independent Data Monitoring Committee due to clear evidence of reduction of stroke and systemic embolism with an acceptable safety profile.
Maltese: AVERROES kien imwaqqaf kmieni fuq bażi tar-rakkomandazzjoni tal-Kumitat tal-Monitoraġġ tadDejta indipendenti minħabba evidenza ċara ta' tnaqqis ta' puplesija u emboliżmu sistemiku bil-profil ta' sigurtà aċċettabbli.
English: Each 5 mg film-coated tablet contains 102.86 mg lactose (see section 4.4).
Maltese: Eċċipjenti bl-effett magħruf Kull pillola miksija b'rita ta' 5 mg fiha 102.86 mg ta' lactose (ara sezzjoni 4.4).
English: Pharmacokinetic or pharmacodynamic interactions were not evident when apixaban was coadministered with ASA 325 mg once a day.
Maltese: Interazzjonijiet farmakokinetiċi jew farmakodinamiċi ma kinux evidenti meta apixaban ingħata flistess ħin ma' ASA 325 mg darba kuljum.
English: Table 2 shows the adverse reactions ranked under headings of system organ class and frequency using the following convention: very common (≥ 1/10) 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) for NVAF and VTEt respectively.
Maltese: Tabella 2 turi r-reazzjonijiet avversi elenkati skont is-sistema tal-klassifika tal-organi u skont ilfrekwenza bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma setgħetx tittieħed stima mid-dejta disponnibli) għal NVAF u VTEt rispettivament.
English: Major + CRNM 613 (4.07) All
Maltese: Maġġuri + CRNM† 140 (4.46)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb/Pfizer EEIG
Maltese: Bristol-Myers Squibb/Pfizer EEIG
English: Elderly patients Increasing age may increase haemorrhagic risk (see section 5.2).
Maltese: Iż-żieda fl-età tista' żżid riskju emorraġiku (ara sezzjoni 5.2).
English: In the VTEt studies, the overall incidence of adverse reactions related to bleeding with apixaban was 15.6% in the apixaban vs enoxaparin/warfarin study and 13.3% in the apixaban vs placebo study (see section 5.1).
Maltese: 6% fl-istudju dwar apixaban kontra enoxaparin/warfarin u ta' 13.3% flistudju dwar apixaban kontra plaċebo (ara sezzjoni 5.1).
English: Major + CRNM
Maltese: Maġġuri + CRNM Minuri
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodiumfree".
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) f'kull pillola, jiġifieri essenzjalment “ħielsa mis-sodium”.
English: The mean age was 56.9 years and 89.8% of randomised patients had unprovoked VTE events.
Maltese: L-età medja kienet ta' 56.9 snin u 89.8% tal-pazjenti li ntgħażlu b'mod każwali kellhom avvenimenti
English: The mean age was 56.7 years and 91.7% of randomised patients had unprovoked VTE events.
Maltese: L-età medja kienet ta' 56.7 snin u 91.7% tal-pazjenti li ntgħażlu b'mod każwali kellhom avvenimenti
English: Patients with elevated liver enzymes ALT/AST > 2 x ULN or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Maltese: Pazjenti b'enzimi tal-fwied għoljin ALT/AST > 2 x ULN jew bilirubin totali ≥ 1.5 x ULN ġew esklużi mill-provi kliniċi.
English: Both apixaban and enoxaparin were given for 32-38 days in the ADVANCE-3 study and for 10-14 days in the ADVANCE-2 study.
Maltese: Kemm apixaban kif ukoll enoxaparin ingħataw għal 32-38 jum fl-istudju ADVANCE-3 u għal 10-14-il jum fl-istudju ADVANCE-2.
English: 10 mg twice daily for the first 7 days 20 mg followed by 5 mg twice daily
Maltese: 10 mg darbtejn kuljum għall-ewwel 7 ijiem20 mg segwita minn 5 mg darbtejn kuljum 10 mg
English: In individuals with mild (creatinine clearance 51-80 mL/min), moderate (creatinine clearance 30-50 mL/min) and severe (creatinine clearance 15-29 mL/min) renal impairment, apixaban plasma concentrations (AUC) were increased 16, 29, and 44% respectively, compared to individuals with normal creatinine clearance.
Maltese: F'individwi b'indeboliment renali ħafif (eliminazzjoni tal-kreatinina 51 - 80 ml/min), moderat (eliminazzjoni tal-kreatinina 30 - 50 ml/min) u sever (eliminazzjoni tal-kreatinina15 - 29 ml/min), il-konċentrazzjoni tal-plasma ta' apixaban (AUC) żdiedet b'16, 29, u 44% rispettivament, meta mqabbel ma' individwi b'eliminazzjoni tal-kreatinina normali.
English: Enoxaparin 40 mg sc once daily 35 ± 3 d
Maltese: Enoxaparin 40 mg sc darba kuljum 35 ± 3 d
English: Eliquis may increase the risk of bleeding.
Maltese: Eliquis jista' jżid ir-riskju ta' fsada.
English: Apixaban showed a reduction in recurrent symptomatic VTE or VTE- related death across the different levels of center TTR; within the highest quartile of TTR according to center, the relative risk for apixaban vs enoxaparin/warfarin was 0.79 (95% CI, 0.39, 1.61).
Maltese: sintomatika rikorrenti jew VTE fuq il-livelli kollha differenti ta' center TTR; fl-ogħla quartile ta' TTR skont center, ir-riskju relattiv għal apixaban kontra enoxaparin/warfarin kien ta' 0.79 (95% CI, 0.39,
English: 10 film-coated tablets 20 film-coated tablets 60 film-coated tablets 60 x 1 film-coated tablets 100 x 1 film-coated tablets 168 film-coated tablets 200 film-coated tablets
Maltese: 10 pilloli miksijin b'rita 20 pillola miksija b'rita 60 pillola miksija b'rita 60 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita 168 pillola miksija b'rita 200 pillola miksija b'rita
English: Vascular disorders Haemorrhage, haematoma
Maltese: Disturbi vaskulari Emorraġija, ematoma
English: The first dose of apixaban was given 12 to 24 hours post-surgery, whereas enoxaparin was started 9 to 15 hours prior to surgery.
Maltese: L-ewwel doża ta' apixaban ingħatat 12 sa 24 siegħa wara l-kirurġija, filwaqt li enoxaparin inbeda 9 sa 15-il siegħa qabel il-kirurġija.
English: Common reasons for unsuitability for VKA therapy in the AVERROES study included unable/unlikely to obtain INRs at requested intervals (42.6%), patient refused treatment with VKA (37.4%), CHADS2 score = 1 and physician did not recommend VKA (21.3%), patient could not be relied on to adhere to VKA medicinal product instruction (15.0%), and difficulty/expected difficulty in contacting patient in case of urgent dose change (11.7%).
Maltese: Raġunijiet komuni għaliex il-pazjenti ma kienux xierqa għat-terapija VKA fl-istudju AVERROES jinkludu jekk ma setgħux/kien improbbabli li jinkisbu l-INRs fl-intervalli mitluba (42.6%), il-pazjent rrifjuta t-trattament b'VKA (37.4%), ir-riżultat CHADS2 =1 u t-tabib ma rrikomandax VKA (21.3%), il-pazjent ma setgħax jkun fdat li jimxi mal-istruzzjonijiet tal-prodott mediċinali VKA (15.