FrancophonIA/ELRC3.0 huggingface dataset:
English: In the study, apixaban achieved statistically significant superiority in the primary endpoint of prevention of stroke (haemorrhagic, ischaemic or unspecified) or systemic embolism (see Table 8) compared to ASA.
Maltese: Fl-istudju, apixaban kiseb superjorità statistikament sinifikanti fil-punt tat-tmiem primarju talprevenzjoni ta' puplesija (emorraġika, iskemika jew mhux speċfika) u emboliżmu sistemiku (ara Tabella 8) meta mqabbel ma' ASA.
English: The major bleeding results for prespecified subgroups including CHADS2 score, age, body weight, gender, status of renal function, prior stroke or TIA and diabetes were consistent with the results for the overall population studied in the trial.
Maltese: Ir-riżultati tal-effikaċja għal sottogruppi speċifikati minn qabel, inkluż ir-riżultat CHADS2, età, piż talġisem, sess, stat tal-funzjoni tal-kliewi, puplesija jew TIA li ġraw qabel u dijabete kienu konsistenti mar-riżultati tal-effikaċja primarja tal popolazzjoni totali studjata fil-prova.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 2.5 mg (Symbol)
Maltese: FOLJA 2.5 mg (Simbolu)
English: Of the administered apixaban dose in humans, approximately 25% was recovered as metabolites, with the majority recovered in faeces.
Maltese: Mid-doża ta' apixaban mogħtija filbnedmin, madwar 25% ġiet irkuprata bħala metaboliti, bil-maġġoranza rkuprata fl-ippurgar.
English: Table 12: Efficacy Results in the AMPLIFY-EXT Study Apixaban Apixaban Placebo
Maltese: Tabella 12: Riżultati tal-Effikaċja fl-Istudju AMPLIFY-EXT Apixaban Apixaban Plaċebo
English: NAME OF THE MEDICINAL PRODUCT Eliquis 5 mg tablets apixaban
Maltese: Eliquis 5 mg pilloli apixaban
English: Activated charcoal Administration of activated charcoal reduces apixaban exposure (see section 4.9).
Maltese: Faħam attivat Amministrazzjoni ta' faħam attivat inaqqas l-esponiment ta' apixaban (ara sezzjoni 4.9).
English: Following administration of the two medicinal products together, mean apixaban AUC and Cmax were 15% and 18% lower than when administered alone.
Maltese: Wara l-għoti taż-żewġ prodotti mediċinali flimkien, l-AUC u l-Cmax medji ta' apixaban kienu 15% u 18% inqas milli meta ngħataw waħidhom.
English: The recommended dose is one tablet of Eliquis 2.5 mg twice a day if: - you have severely reduced kidney function - two or more of the following apply to you: - your blood test results suggest poor kidney function (value of serum creatinine is 1.5 mg/dL (133 micromole/L) or greater) - you are 80 years old or older - your weight is 60 kg or lower.
Maltese: Id-doża rrakomandata hija ta' pillola waħda ta' Eliquis 2.5 mg darbtejn kuljum.jekk: għandek tnaqqis b'mod sever fil-funzjoni tal-kliewi tnejn jew aktar minn dawn li ġejjin japplikaw għalik: - it-test tad-demm tiegħek ir-riżultati jissuġerixxu funzjoni tal-kliewi ħażina (valur tal kreatinina fis-serum huwa 1.5 mg/dL (133 mikromol/l) jew aktar) - għandek 80 sena jew aktar - il-piż tiegħek huwa 60 kg jew inqas.
English: Table 7: Secondary Endpoints in Patients with Atrial Fibrillation in the ARISTOTLE Study Apixaban N = 9,088 n (%/year)
Maltese: Punti tat-Tmiem Sekondarji f'Pazjenti b'Fibrillazzjoni fl-Atriju fl-Istudju ARISTOTLE Apixaban N = 9,088 n (%/sena)
English: Eye haemorrhage (including conjunctival haemorrhage)
Maltese: Disturbi fl-għajnejn Emorraġija fl-għajnejn (inkluż emorraġija konġuntivali)
English: EMANATE, an open-label, multi-center study, enrolled 1500 patients who were either oral anticoagulant naïve or pre-treated less than 48 hours, and scheduled for cardioversion for NVAF.
Maltese: EMANATE, studju open-label, multiċentriku, irreġistra 1500 pazjent li jew qatt ma ħadu antikoagulanti orali jew li ġe ittrattati minn qabel f'inqas minn 48 siegħa, u li ġew skedati għal kardjoverżjoni għal NVAF.
English: Apixaban efficacy for prevention of a recurrence of a VTE was maintained across subgroups, including age, gender, BMI, and renal function.
Maltese: L-effikaċja ta' apixaban għal prevenzjoni ta' rikorrenza ta' VTE inżammet fis-sottogruppi kolha, li jinkludu l-età, is-sess tal-persuna, il-BMI, u l-funzjoni tal-kliewi.
English: Cartons of 10, 20, 60, 168 and 200 film-coated tablets.
Maltese: Jiġu f'folji f'kartun ta' 10, 20, 60, 168 u 200 pillola miksijin b'rita.
English: In rat milk, a high milk to maternal plasma ratio (Cmax about 8, AUC about 30) was found, possibly due to active transport into the milk.
Maltese: Fil-ħalib tal-firien, instab proporzjon għoli ta' ħalib għal plasma materna (Cmax ta' madwar 8, AUC ta' madwar 30), possibbilment minħabba trasport attiv fil-ħalib.
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.
Maltese: L-għoti fl-istess ħin ta' dożi singoli ta' apixaban (10 mg) u naproxen (500 mg), NSAID użat b'mod komuni, ma kellu ebda effett fuq l-AUC jew Cmax ta' naproxen.
English: Switching from vitamin K antagonist (VKA) therapy to Eliquis When converting patients from vitamin K antagonist (VKA) therapy to Eliquis, warfarin or other VKA therapy should be discontinued and Eliquis started when the international normalised ratio (INR) is < 2.
Maltese: Tibdil minn terapija b'antagonist ta' vitamina K (VKA) għal Eliquis Meta fil-pazjenti t-terapija b'antagonist ta' vitamina K (VKA) tinbidel għal Eliquis, il-warfarin jew terapija b'VKA oħra għandhom jitwaqqfu u Eliquis għandu jinbeda meta l-proporzjoni normalizzat internazzjonali (INR) huwa < 2.
English: If you have had a major hip operation you will usually take the tablets for 32 to38 days If you have had a major knee operation you will usually take the tablets for 10 to 14 days
Maltese: Jekk kellek operazzjoni maġġuri tal-ġenbejn normalment tieħu l-pilloli għal 32 sa 38 jum.
English: Table 6: Key Efficacy Outcomes in Patients with Atrial Fibrillation in the AVERROES Study Apixaban N = 2,807 n (%/year)
Maltese: Tabella 6: Riżultati Ewlenin tal-Effikaċja f'Pazjenti b'Fibrillazzjoni fl-Atriju fl-Istudju AVERROES Apixaban N = 2,807 n (%/sena)
English: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).
Maltese: Il-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'fibrillazzjoni tal-atriju mhux valvulari (NVAF) u b'fattur ta' riskju wieħed jew aktar bħal puplesija jew attakk iskemiku għal żmien qasir (TIA) li jkunu ġraw qabel; età ≥ 75 sena; pressjoni għolja; dijabete mellitus; insuffiċjenza sintomatika tal-qalb (NYHA Klassi ≥ II).
English: Table 8: Key Efficacy Outcomes in Patients with Atrial Fibrillation in the AVERROES Study Apixaban N = 2,807 n (%/year)
Maltese: Tabella 8: Riżultati Ewlenin tal-Effikaċja f'Pazjenti b'Fibrillazzjoni fl-Atriju fl-Istudju AVERROES Apixaban N = 2,807 n (%/sena)
English: In non-valvular atrial fibrillation patients taking apixaban for the prevention of stroke and systemic embolism, the results demonstrate a less than 1.7-fold fluctuation in peak-to-trough levels.
Maltese: F'pazjenti b'fibrillazzjoni tal-atriju mhux valvulari li qed jieħdu apixaban għall-prevenzjoni ta' puplesija u emboliżmu sistemiku, ir-riżultati juru varjazzjoni inqas minn 1.7 darbiet fil-livelli ta peak-to trough.
English: VTEt - No dose adjustment required (see sections 4.4 and 5.2).
Maltese: VTEt - Ma huwa meħtieġ ebda aġġustament tad-doża (ara sezzjonijiet 4.4 u 5.2).
English: Switching
Maltese: Manufattur
English: DVT*
Maltese: Maġġuri*
English: Each tablet contains 5 mg of apixaban.
Maltese: Kull pillola fiha 5 mg ta' apixaban.
English: There was no statistically significant difference in the incidence of major bleeding between apixaban and ASA (see Table 7).
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti fl-inċdenza ta' fsada maġġuri bejn apixaban u ASA (ara Tabella 7).
English: - Changing from Eliquis to anticoagulant treatment containing vitamin K antagonist (e.g., warfarin).
Maltese: Tibdil minn Eliquis għal kontra l-koagulazzjoni li fih antagonist ta' vitamina K (e.ż., warfarin)
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)
Maltese: - Ħruġ ta' demm li jinkludi: - minn imnieħrek - mill-ħanek - demm fl-awrina - tbenġil u nefħa - fl-istonku, fl-imsaren, mir-rektum tiegħek - f'ħalqek - mill-vaġina - Anemija li tista' tikkawża għeja jew sfurija tal-ġilda - Għadd ta' plejtlits imnaqqas fid-demm tiegħek (li jista' jaffettwa l-għaqid tad-demm) - Dardir (tħossok se tirremetti) - Raxx tal-ġilda - Testijiet tad-demm jistgħu juru: - żieda fil-gamma-glutamyltransferase (GGT) jew fl-alanine aminotransferase (ALT)
English: There was no statistically significant difference in the incidence of major bleeding between apixaban and ASA (see Table 9).
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti fl-inċdenza ta' fsada maġġuri bejn apixaban u ASA (ara Tabella 9).
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.
Maltese: Interazzjoni ma' indutturi kemm ta' CYP3A4 kif ukoll ta' P-gp L-użu konkomittanti ta' Eliquis ma' indutturi CYP3A4 u P-gp b'saħħithom (eż., rifampicin, phenytoin, carbamazepine, phenobarbital jew St.
English: The program was designed to demonstrate the efficacy and safety of apixaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and one or more additional risk factors, such as:
Maltese: Il-programm huwa ddisinjat biex juri l-effikaċja u s-sigurtà ta' apixaban għal prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'fibrillazzjoni tal-atriju mhux valvulari (NVAF) u li għandhom wieħed jew aktar fatturi ta' riskju addizzjonali, bħal:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg apixaban.
Maltese: Kull pillola miksija b'rita fiha 2.5 mg apixaban.
English: Both studies were randomised, parallel-group, double-blind, multinational trials in patients with symptomatic proximal DVT or symptomatic PE. All the key safety and efficacy endpoints were adjudicated by an independent blinded committee.
Maltese: Iż-żewġ studji kienu tattip fejn il-parteċipanti ntgħażlu b'mod każwali, grupp parallel, double-blind, provi multinazzjonali f'pazjenti b'DVT prossimali sintomatika jew PE sintomatika.
English: In the study, apixaban was shown to be non-inferior to enoxaparin/warfarin in the combined primary endpoint of adjudicated recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death (see Table 10).
Maltese: Fl-istudju, intwera li apixaban kien mhux inferjuri għal enoxaparin/warfarin fil-punt ta' tmiem primarju kombinat ta' VTE sintomatika rikorrenti aġġudikata (DVT mhux fatali jew PE mhux fatali) jew mewt relatata ma' VTE (ara Tabella 10).
English: Administration of prothrombin complex concentrates (PCCs) or recombinant factor VIIa may also be considered.
Maltese: Tista' wkoll tiġi kkunsidrata amministrazzjoni ta' konċentrati kumplessi talprothrombin (PCCs) fattur VIIa rikombinanti.
English: Fertility Studies in animals dosed with apixaban have shown no effect on fertility (see section 5.3).
Maltese: Fertilità Studji fl-annimali ddożati b'apixaban ma urew ebda effett fuq il-fertilità (ara sezzjoni 5.3).
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.
Maltese: - għall-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'NVAF u bi krejatinina fis-serum ta' ≥ 1.5 mg/dL (133 mikromol/L) assoċjata ma' età ta' ≥ 80 sena jew piż tal-ġisem ta' ≤ 60 kg tnaqqis fid-doża hija meħtieġa u deskritta aktar ‘il fuq.
English: * Noninferior compared to enoxaparin/warfarin (p-value < 0.0001)
Maltese: VTE, mewt relatata ma' VTE, jew ħruġ ta' demm maġġuri * Mhux inferjuri meta mqabbel ma' enoxaparin/warfarin (valur p < 0.0001)
English: Treatment of DVT and PE, and prevention of recurrent DVT and PE (VTEt)
Maltese: Trattament ta' DVT, trattament ta' PE u prevenzjoni ta' DVT rikkorenti u PE (VTEt)
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 stroke and systemic embolism in patients with NVAF and for the prevention of recurrent DVT and PE. Apixaban is not recommended for the treatment of DVT and PE in patients receiving concomitant systemic treatment with strong inducers of both CYP3A4 and P-gp since efficacy may be compromised (see section 4.4).
Maltese: Ebda aġġustament tad-doża għal apixaban ma huwa meħtieġ matul trattament flistess ħin ma' prodotti mediċinali bħal dawn, madankollu f'pazjenti li jkunu qed jirċievu trattament sistemiku fl-istess ħin b'indutturi qawwijin kemm ta' CYP3A4 kif ukoll ta' P-gp, apixaban għandu jintuża b'kawtela għall-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'NVAF u għallprevenzjoni ta' DVT u PE rikorrenti.
English: AMPLIFY STUDY
Maltese: L-ISTUDJU AMPLIFY
English: In healthy subjects, administration of activated charcoal 2 and 6 hours after ingestion of a 20 mg dose of apixaban reduced mean apixaban AUC by 50% and 27%, respectively, and had no impact on Cmax.
Maltese: F'suġġetti b'saħħithom, amministrazzjoni ta' faħam attivat 2 u 6 sigħat wara l-inġestjoni ta' doża ta' 20 mg ta' apixaban naqqas il-medja tal-AUC ta' apixaban b'50% u 27% rispettivament, u ma kellu lebda impatt fuq is-Cmax.
English: Use of thrombolytic agents for the treatment of acute ischemic stroke There is very limited experience with the use of thrombolytic agents for the treatment of acute ischemic stroke in patients administered apixaban.
Maltese: Użu ta' aġenti trombolitiċi għat-trattament ta' puplesija iskemika akuta Hemm esperjenza limitata ħafna fuq l-uż ta' aġenti trombolitiċi għat-trattament ta' puplesija iskemika akuta f'pazjenti li kienu amministrati apixaban.
English: Prevention of VTE: elective hip or knee replacement surgery 2.5 mg twice daily 77 [41, 146]
Maltese: Prevenzjoni ta' VTE: kirurġija elettiva ta' sostituzzjoni tal-ġenbejn jew tal-irkoppa 2.5 mg darbtejn kuljum
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).
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti fl-inċidenza ta' ħruġ ta' demm maġġuri + CRNM, minuri, u l-ħruġ ta' demm kollu bejn il-gruppi ta' trattamentta' apixaban 2.5 mg darbtejn kuljum u tal-plaċebo (ara Tabella 11).
English: Nervous system disorders Brain haemorrhage†
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: Table 9: Bleeding Results in the AMPLIFY Study Apixaban N=2,676 n (%)
Maltese: Riżultati tal-Ħruġ ta' Demm fl-Istudju AMPLIFY Apixaban N=2,676 n (%)
English: Table 4: Efficacy Results from Pivotal Phase III Studies Study
Maltese: Tabella 4: Riżultati tal-Effikaċja minn Studji Pivotali ta' Fażi
English: When prevention of recurrent DVT and PE is indicated, the 2.5 mg twice daily dose should be initiated following completion of 6 months of treatment with apixaban 5 mg twice daily or with another anticoagulant, as indicated in Table 1 below (see also section 5.1)
Maltese: Meta l-prevenzjoni ta' DVT u PE rikorrenti tkun indikata, id-doża ta' 2.5 mg darbtejn kuljum għandha tinbeda wara t-tlestija ta' 6 xhur ta' trattament b'apixaban 5 mg darbtejn kuljum jew b'antikoagulant ieħor, kif indikat f'Tabella 1 hawn taħt (ara wkoll sezzjoni 5.1).
English: Haemorrhoidal haemorrhage
Maltese: Klinikament Rilevanti Mhux Maġġuri
English: Treatment with Eliquis does not require routine monitoring of exposure.
Maltese: It-trattament Eliquis ma jeħtieġ monitoraġġ ta' rutina tal-esponiment.
English: For patients undergoing catheter ablation for atrial fibrillation, Eliquis treatment does not need to be interrupted (see sections 4.2, 4.3 and 4.5).
Maltese: Għal pazjenti li tkun qed issirilhom ablazzjoni tal-kateter għal fibrillazzjoni atrijali, m'hemmx bżonn li l-kura b'Eliquis tiġi interrotta (ara sezzjonijiet 4.2, 4.3 u 4.5).
English: Patient Alert Card: handling information
Maltese: Kartuna ta' Twissija tal-Pazjent: informazzjoni dar l-immaniġġjar
English: In the study, apixaban achieved statistically significant superiority in the primary endpoint of prevention of stroke (haemorrhagic or ischaemic) and systemic embolism (see Table 6) compared with warfarin.
Maltese: Fl-istudju, apixaban kiseb superjorità statistikament sinifikanti fil-punt tat-tmiem primarju talprevenzjoni ta' puplesija (emorraġika jew iskemika) u emboliżmu sistemiku (ara Tabella 6) meta mqabbel ma' warfarin.
English: Patients undergoing catheter ablation (NVAF) Patients can continue apixaban use while undergoing catheter ablation (see sections 4.3, 4.4 and 4.5).
Maltese: Il-pazjenti jistgħu jkomplu l-użu ta' apixaban waqt li tkun qed issirilhom ablazzjoni tal-kateter (ara sezzjonijiet 4.3, 4.4 u 4.5).
English: In the study, apixaban achieved statistically significant superiority in the primary endpoint of prevention of stroke (haemorrhagic, ischaemic or unspecified) or systemic embolism (see Table 6) compared to ASA.
Maltese: Fl-istudju, apixaban kiseb superjorità statistikament sinifikanti fil-punt tat-tmiem primarju talprevenzjoni ta' puplesija (emorraġika, iskemika jew mhux speċfika) u emboliżmu sistemiku (ara Tabella 6) meta mqabbel ma' ASA.
English: Corresponding increases in clotting tests were observed for apixaban.
Maltese: Żidiet korrespondenti fit-testijiet ta' għaqid ġew osservati għal apixaban.
English: The dosing regimen should be reduced to 2.5 mg apixaban given twice daily for at least 2.5 days (5 single doses) if the patient meets the criteria for dose reduction (see above sections Dose reduction and Renal impairment).
Maltese: Il-kors tad-dożaġġ għandu jitnaqqas għal 2.5 mg apixaban li tingħata darbtejn kuljum għal tal-inqas 2.5 jiem (5 dożi waħdanin) jekk il-pazjent jissodisfa l-kriterji għal tnaqqis fid-doża (ara sezzjonijiet ta' hawn fuq Tnaqqis fid-doża u Indeboliment tal-kliewi).
English: - 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).
Maltese: - għat-trattament ta' DVT, trattament ta' PE u prevenzjoni ta' DVT u PE rikorrenti (VTEt), ma hemmx bżonn ta' ebda' aġġustament tad-doża (ara sezzjoni 5.2).
English: There was an increase in apixaban exposure correlated to decrease in renal function, as assessed via measured creatinine clearance.
Maltese: Kien hemm żieda fl-espożizzjoni ta' apixaban korrelatata ma' tnaqqis fil-funzjoni renali, kif ivvalutat permezz tal-eliminazzjoni tal-kreatinina mkejla.
English: The recommended dose is one tablet of Eliquis 2.5 mg twice a day if:
Maltese: Id-doża rrakomandata hija ta' pillola waħda ta' Eliquis 2.5 mg darbtejn kuljum jekk:
English: Interaction with other medicinal products affecting haemostasis Due to an increased bleeding risk, concomitant treatment with any other anticoagulants is contraindicated (see section 4.3).
Maltese: Interazzjoni ma' prodotti mediċinali oħra li jaffetwaw l-emostasi Minħabba żieda fir-riskju ta' fsada, trattament flimkien ma' kwalunkwe antikoagulanti oħra huwa kontaindikat (ara sezzjoni 4.3).
English: Table 11: Bleeding Results in the AMPLIFY-EXT Study Apixaban Apixaban Placebo
Maltese: Riżultati tal-Effikaċja fl-Istudju AMPLIFY-EXT Apixaban Apixaban Placebo
English: - Unit dose blisters in cartons of 60 x 1 and 100 x 1 film-coated tablets for delivery in hospitals are also available.
Maltese: Folji ta' doża waħda f'kartun ta' 60 x 1 u 100 x 1 pillola miksijin b'rita għal kunsinna flisptarijiet huma disponibbli wkoll.
English: Study treatment Dose
Maltese: TAL-PRODOTT MEDIĊINALI
English: If cardioversion is required before 5 doses of apixaban can be administered, a 10 mg loading dose should be given, followed by 5 mg twice daily.
Maltese: Il-bijodisponibbiltà assoluta ta' apixaban hija ta' madwar 50% għal dożi sa 10 mg.
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;
Maltese: - għall-prevenzjoni ta' VTE f'operazzjoni mhux obbligatorja tas-sostituzzjoni tal-ġenbejn u tal-irkoppa (VTEp), it-trattament ta' DVT, trattament ta' PE u prevenzjoni ta' DVT u PE rikorrenti (VTEt), apixaban għandu jintuża b'kawtela;
English: Apixaban has no direct effects on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin.
Maltese: Apixaban ma għandu ebda effett dirett fuq l-aggregazzjoni talplejtlits, iżda jinibixxi indirettament l-aggregazzjoni tal-plejtlits indotta minn thrombin.
English: Traumatic haemorrhage
Maltese: Emorraġija trawmatika
English: Missed dose
Maltese: Tnaqqis fid-doża
English: Recurrent VTE or VTErelated death
Maltese: KONDIZZJONIJIET OĦRA TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: VTE or CV-related death
Maltese: VTE rikorrenti jew mewt relatata ma' CV
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.
Maltese: Ebda aġġustament tad-doża għal apixaban ma huwa meħtieġ matul trattament flistess ħin ma' prodotti mediċinali bħal dawn, madankollu f'pazjenti li jkunu qed jirċievu trattament sistemiku fl-istess ħin b'indutturi qawwijin kemm ta' CYP3A4 kif ukoll ta' P-gp, apixaban għandu jintuża b'kawtela għall-prevenzjoni ta' VTE f'operazzjoni mhux obbligatorja tas-sostituzzjoni talġenbejn u tal-irkoppa, għall-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'NVAF u għall-prevenzjoni ta' DVT u PE rikorrenti.
English: This exploratory study showed comparable efficacy and safety between apixaban and heparin and/or VKA treatment groups in the setting of cardioversion.
Maltese: Dan l-istudju esploratorju wera effikaċja u sigurtà komparabbli bejn il-gruppi ta' kura b'apixaban u eparina u/jew VKA fl-ambjent tal-kardjoverżjoni.
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).
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti fl-inċidenza ta' ħruġ ta' demm maġġuri + CRNM, minuri, u l-ħruġ ta' demm kollu bejn il-gruppi ta' trattament ta' apixaban 2.5 mg darbtejn kuljum u tal-plaċebo (ara Tabella 13).
English: What Eliquis looks like and contents of the pack
Maltese: Id-dehra ta' Eliquis u l-kontenuti tal-pakkett
English: For patients who are unable to swallow whole tablets, Eliquis tablets may be crushed and suspended in water, or 5% dextrose in water (D5W), or apple juice or mixed with apple puree and immediately administered orally (see section 5.2).
Maltese: Għal pazjenti li ma jistgħux jibilgħu pilloli sħaħ, il-pilloli ta' Eliquis jistgħu jitfarrku jew jiġu sospiżi fl-ilma, jew f'5% dextrose fl-ilma (D5W), jew fil-meraq tat-tuffieħ jew jitħalltu mal-polpa tat-tuffieħ u jingħataw mill-ħalq immedjatament (ara sezzjoni 5.2).