FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal impairment had no evident effect on the relationship between apixaban plasma concentration and anti-FXa activity.
Maltese: Indeboliment renali ma kellu ebda effett evidenti fuq ir-relazzjoni bejn il-konċentrazzjoni talplasma ta' apixaban u attività anti-FXa.
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.
Maltese: Analiżi kkalibrata u kwantitattiva tal-attività kontra l-Fattur Xa jista' jkun utli f'sitwazzjonijiet eċċezzjonali (eż. doża eċċessiva u kirurġija ta' emerġenza(il-ħin ta' prothrombin (PT), proporzjon normalizzat internazzjonali (INR) u testijiet tal-koagulazzjoni tal-ħin parzjali ta' tromboplastin attivat (Aptt) mhumiex rakkomandati.
English: In the AVERROES study a total of 5,598 patients considered to be unsuitable for VKA by the investigators were randomised to treatment with apixaban 5 mg twice daily (or 2.5 mg twice daily in selected patients [6.4%], see section 4.2) or ASA.
Maltese: Fl-istudju AVERROES, total ta' 5,598 pazjent kkunsidrati mhux xierqa għal VKA mill-investigaturi kienu magħżula b'ordni addoċċ għat-trattament b'apixaban 5 mg darbtejn kuljum (jew 2.5 mg darbtejn kuljum f'pazjenti magħżula [6.4%], ara sezzjoni 4.2) jew ASA.
English: Take Eliquis regularly as instructed.
Maltese: Ħu Eliquis regolarment skond l-istruzzjoni.
English: For the prevention of stroke and systemic embolism in patients with NVAF, patients with severe renal impairment (creatinine clearance 15-29 mL/min), and patients with serum creatinine ≥ 1.5 mg/dL (133 micromole/L) associated with age ≥ 80 years or body weight ≤ 60 kg should receive the lower dose of apixaban 2.5 mg twice daily (see section 4.2);
Maltese: Għall-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'NVAF, pazjenti b'indeboliment sever tal-kliewi (bi tneħħija tal-krejatinina ta' 15-29 mL/min), u pazjenti 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, għandhom jirċievu d-doża aktar baxxa ta' apixaban 2.5 mg darbtejn kuljum (ara sezzjoni 4.2);
English: The safety endpoints of major bleeding, the composite of major and clinically relevant non-major (CRNM) bleeding, and all bleeding showed similar rates for patients treated with apixaban 2.5 mg compared with enoxaparin 40 mg (see Table 5).
Maltese: Il-punti ta' tmiem ta' sigurtà ta' fsada maġġuri, il-kompost ta' fsada maġġuri jew ta' fsada mhux maġġuri klinikament relevanti (CRNM), u l-fsadiet kollha urew rati simili għall-pazjenti kkurati b'apixaban 2.5 mg meta mqabbel ma' enoxaparin 40 mg (ara Tabella 5).
English: It is not recommended in patients with severe hepatic impairment (see sections 4.4. and 5.2).
Maltese: Mhuwiex rakkomandat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.4. u 5.2).
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.
Maltese: Clarithromycin (500 mg, darbtejn kuljum, inibitur ta' P-gp u inibitur qawwi ta' CYP3A4, wassal għal żieda ta' 1.6 drabi u ta' 1.3 drabi fl-AUC u fis-Cmax medji ta' apixaban rispettivament.
English: The pharmacodynamic effects of apixaban are reflective of the mechanism of action (FXa inhibition).
Maltese: L-effetti farmakodinamiċi ta' apixaban jirriflettu l-mekkaniżmu ta' azzjoni (inibizzjoni FXa).
English: Interaction with inhibitors of both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) The use of Eliquis is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir).
Maltese: L-użu ta' Eliquis mhuwiex rakkomandat 'f'pazjenti li jkunu qed jirċievu trattamentsistemiku 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).
English: Adjudicated ISTH major gastrointestinal bleeding occurred in 1 (0.1%) apixaban-treated patient at the 5 mg twice daily dose, no patients at the 2.5 mg twice daily dose, and 1 (0.1%) placebo-treated patient.
Maltese: Ħruġ ta' demm gastrointestinali maġġuri aġġudikat ISTH seħħ f'pazjent 1 (0.1%) ikkurat b'apixaban bid-doża ta' 5 mg darbtejn kuljum, fl-ebda pazjent fid-doża ta' 2.5 mg darbtejn kuljum, u f'pazjent 1 (0.1%) ikkurat bi plaċebo.
English: In the AMPLIFY-EXT study a total of 2,482 patients were randomised to treatment with apixaban 2.5 mg twice daily orally, apixaban 5 mg twice daily orally, or placebo for 12 months after completing 6 to 12 months of initial anticoagulant treatment.
Maltese: Fl-istudju AMPLIFY-EXT, total ta' 2,482 pazjent intgħażlu b'mod każwali għat-trattament b'apixaban 2.5 mg darbtejn kuljum mill-ħalq, apixaban 5 mg darbtejn kuljum mill-ħalq, jew plaċebo għal 12-il xahar wara li temmew trattament inizjali b'antikoagulanti li dam minn 6 sa 12-il xahar.
English: The overall incidence of adverse reactions related to bleeding with apixaban was 10% in the apixaban vs enoxaparin studies.
Maltese: L-inċidenza globali ta' reazzjonijiet avversi relatati ma' ħruġ ta' demm b'apixaban kienet ta' 10% fl-istudji dwar apixaban kontra enoxaparin.
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
Maltese: Dan jista' jinkludi ulċerazzjoni gastrointestinali kurrenti jew reċenti, ilpreżenza ta' neoplażmi malinni f'riskju għoli ta' fsada, korriment reċenti fil-moħħ jew fissinsla, kirurġija reċenti fil-moħħ, fis-sinsla jew kirurġija oftalmoloġika, emorraġija intrakranjali reċenti, variċi esofagali magħrufa jew issuspettati, malformazzjonijiet arterjovenużi, anewriżmi vaskulari jew anormalitajiet vaskulari maġġuri intraspinali jew intraċerebrali.
English: Coadministration of apixaban 10 mg with atenolol 100 mg did not have a clinically relevant effect on the pharmacokinetics of apixaban.
Maltese: L-għoti fl-istess ħin ta' apixaban 10 mg ma' atenolol 100 mg ma kellux effett klinikament relevanti fuq il-farmakokinetiċi ta' apixaban.
English: For the prevention of stroke and systemic embolism in patients with NVAF, patients with severe renal impairment (creatinine clearance 15-29 mL/min), and patients with serum creatinine ≥ 1.5 mg/dL (133 micromole/L) associated with age ≥ 80 years or body weight ≤ 60 kg should receive the lower dose of apixaban 2.5 mg twice daily (see section 4.2).
Maltese: Għall-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'NVAF, pazjenti b'indeboliment sever tal-kliewi (bi tneħħija tal-krejatinina ta' 15-29 mL/min), u pazjenti 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, għandhom jirċievu d-doża aktar baxxa ta' apixaban 2.5 mg darbtejn kuljum (ara sezzjoni 4.2).
English: Subjects received either apixaban 2.5 mg given orally twice daily (po bid) or enoxaparin 40 mg administered subcutaneously once daily (sc od).
Maltese: Suġġetti li rċevew jew apixaban 2.5 mg mogħti oralment darbtejn kuljum (po bid) jew enoxaparin 40 mg mogħti taħt il-ġilda darba kuljum (sc od).
English: Pink, oval tablets debossed with 894 on one side and 5 on the other side.
Maltese: Pillola miksija b'rita (pillola) Pilloli roża, ovali mnaqqxin b'894 fuq naħa waħda u b'5 fuq in-naħa l-oħra.
English: • Recommended dosages and guidance on the posology for different indications
Maltese: • Dożaġġi rrakkomandati u gwida fuq il-pożoloġija għall-indikazzjonijiet differenti
English: For example, diltiazem (360 mg once a day), considered a moderate CYP3A4 and a weak P-gp inhibitor, led to a 1.4-fold increase in mean apixaban AUC and a 1.3-fold increase in Cmax.
Maltese: Pereżempju, diltiazem (360 mg darba kuljum), meqjus bħala inibitur ta' CYP3A4 moderat u inibitur ta' P-gp dgħajjef, wassal għal żieda ta' 1.4 drabi fl-AUC medju ta' apixaban u żieda ta' 1.3 drabi fis-Cmax.
English: - Name: - Birth Date: - Indication: - Dose : ........mg twice daily - Doctor's Name: - Doctor's telephone:
Maltese: - Doża: ........mg darbtejn kuljum - Isem tat-Tabib: - Telefon tat-tabib:
English: The following medicines may increase the effects of Eliquis and increase the chance for unwanted bleeding: - some medicines for fungal infections (e.g., ketoconazole, etc.) - some antiviral medicines for HIV / AIDS (e.g., ritonavir) - other medicines that are used to reduce blood clotting (e.g., enoxaparin, etc.) - anti-inflammatory or pain medicines (e.g., acetylsalicylic acid or naproxen).
Maltese: Il-mediċini li ġejjin jistgħu jżidu l-effetti ta' Eliquis u jżidu ċ-ċans ta' fsada mhux mixtieqa: xi mediċini għal infezzjonijiet fungali (eż. ketoconazole, eċċ.) xi mediċini antivirali għal HIV / AIDS (eż. ritonavir) mediċini oħrajn li jintużaw biex inaqqsu l-għaqid tad-demm (eż. enoxaparin, eċċ) mediċini anti-infjammatorji jew mediċini għal kontra l-uġigħ (eż. acetylsalicylic acid jew naproxen).
English: Efficacy across subgroups, including age, gender, body mass index (BMI), renal function, extent of index PE, location of DVT thrombus, and prior parenteral heparin use was generally consistent.
Maltese: Leffikaċja fost is-sottogruppi, li tinkludi l-età, is-sess tal-persuna, l-indiċi tal-piż tal-ġisem (BMI), ilfunzjoni tal-kliewi, il-grad ta' indiċi PE, il-post tal-embolu DVT, u l-użu fil-passat ta' heparin parenterali, kienet ġeneralment konsistenti.
English: Doctor's telephone:
Maltese: Sími:
English: Table 11: Bleeding Results in the AMPLIFY Study Apixaban N=2,676 n (%)
Maltese: Tabella 11: Riżultati tal-Ħruġ ta' Demm fl-Istudju AMPLIFY Apixaban N=2,676 n (%)
English: Mean half-life of apixaban decreased from 13.4 hours when apixaban was administered alone to 5.3 hours and 4.9 hours, respectively, when activated charcoal was administered 2 and 6 hours after apixaban.
Maltese: Il-half-life medja ta' apixaban naqset minn 13.4 sigħat meta apixaban kien amministrat waħdu, għal 5.3 sigħat u 4.9 sigħat, rispettivament, meta faħam attivat kien amministrat 2 u 6 sigħat wara apixaban.
English: The concomitant use of apixaban with other strong CYP3A4 and P-gp inducers (e.g., phenytoin, carbamazepine,
Maltese: L-użu konkomittanti ta' apixaban ma' indutturi b'saħħtihom oħrajn ta' CYP3A4 u P-gp (eż., phenytoin, carbamazepine, phenobarbital jew St.
English: Haemorrhage risk
Maltese: Riskju ta' emorraġija
English: In vitro apixaban studies showed no inhibitory effect on the activity of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 or CYP3A4 (IC50 > 45 µM) and weak inhibitory effect on the activity of CYP2C19 (IC50 > 20 µM) at concentrations that are significantly greater than peak plasma concentrations observed in patients.
Maltese: Apixaban jiġi metabolizzat prinċipalment permezz ta' CYP3A4/5 b'kontribuzzjonijiet minuri minn CYP1A2, 2C8, 2C9, 2C19, u 2J2. Apixaban mhux mibdul huwa lkomponent maġġuri relatat mal-mediċina fil-plasma tal-bniedem mingħajr ebda metabolit attiv li jiċċirkola preżenti.
English: Hepatobiliary disorders Liver function test abnormal, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased
Maltese: Test tal-funzjoni tal-fwied mhux normali, żieda fl-aspartate aminotransferase, żieda flalkaline phosphatase tad-demm, żieda fil-livell ta' bilirubin fiddemm
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.
Maltese: L-emodijaliżi naqqset l-AUC ta' apixaban b'14% f'suġġetti b'mard tal-kliewi fl-aħħar stadju (ESRD), meta ġiet amministrata doża waħda ta' apixaban 5 mg mill-ħalq.
English: Eliquis should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding.
Maltese: Eliquis għandu jitwaqqaf mill-inqas 24 siegħa qabel kirurġija elettiva jew proċeduri invażivi b'riskju baxx ta' fsada.
English: The recommended dose of apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL (133 micromole/L).
Maltese: Id-doża rakkomandata ta' apixaban hija 2.5 mg li tittieħed mill-ħalq darbtejn kuljum f'pazjenti b'NVAF u mill-inqas żewġ karatteristiċi milli ġejjin: età ≥ 80 sena, piż tal-ġisem ≤ 60 kg, jew kreatinina fis-serum ≥ 1.5 mg/dL (133 mikromol/L).
English: - for the prevention of VTE in elective hip or knee replacement surgery (VTEp), for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt), no dose adjustment is necessary (see section 5.2).
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), ma hemmx bżonn ta' ebda' aġġustament tad-doża (ara sezzjoni 5.2).
English: Table 4: Efficacy Outcomes in Patients with Atrial Fibrillation in the ARISTOTLE Study Apixaban N=9,120 n (%/yr)
Maltese: Tabella 4: Riżultati tal-Effikaċja f'Pazjenti b'Fibrillazzjoni fl-Atriju fl-Istudju ARISTOTLE Apixaban N=9,120 n (%/yr)
English: Hazard Ratio (95% CI)
Maltese: Proporzjon ta' riskju (95% CI)
English: For 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 5.2).
Maltese: Għat-trattament ta' DVT, 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: Limited clinical data indicate that apixaban plasma concentrations are increased in patients with severe renal impairment (creatinine clearance 15-29 mL/min) which may lead to an increased bleeding risk.
Maltese: Dejta klinika limitata tindika li l-konċentrazzjonijiet ta' apixaban fil-plażma jiżdiedu f'pazjenti b'indeboliment sever tal-kliewi (bi tneħħija tal-krejatinina ta' 15-29 mL/min) ) li jista' jwassal għal żieda fir-riskju ta' fsada.
English: s r.o.
Maltese: Ħu l-kartuna
English: The mean age was 69.1 years, the mean CHADS2 score was 2.1, 18.9 % of patients had prior stroke or TIA.
Maltese: L-età medja kienet 69.1 sena, r-riżultat medju ta' CHADS2 kien 2.1 u 18.9% tal-pazjenti kellhom qabel puplesija jew TIA.
English: Alternatively, Eliquis tablets may be crushed and suspended in 60 mL of water or D5W and immediately delivered through a nasogastric tube (see section 5.2).
Maltese: Inkella, il-pilloli ta' Eliquis jistgħu jitfarrku u jiġu sospiżi f'60 mL ta' ilma jew f'D5W u jingħataw immedjatament permezz ta' tubu nażogastriku (ara sezzjoni 5.2).
English: NAME OF THE MEDICINAL PRODUCT Eliquis 2.5 mg tablets apixaban
Maltese: Eliquis 2.5 mg pilloli apixaban
English: Table 6: Efficacy Outcomes in Patients with Atrial Fibrillation in the ARISTOTLE Study Apixaban N=9,120 n (%/yr)
Maltese: Tabella 6: Riżultati tal-Effikaċja f'Pazjenti b'Fibrillazzjoni fl-Atriju fl-Istudju ARISTOTLE Apixaban N=9,120 n (%/yr)
English: Nonfatal DVT
Maltese: DVT mhux fatali
English: - Bleeding: - in your brain or in your spinal column - in your mouth or blood in your spit when coughing - into your abdomen, or from the vagina - bright/red blood in the stools - bleeding occurring after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision (wound secretion) or injection site - from a haemorrhoid - tests showing blood in the stools or in the urine - Reduced number of platelets in your blood (which can affect clotting) - Blood tests may show: - abnormal liver function - an increase in some liver enzymes - an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes - Skin rash - Itching - Hair loss - Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing.
Maltese: - Fsada: - fsada fil-moħħ jew fis-sinsla tad-dahar tiegħek - fsada mill-ħalq tiegħek jew demm fil-bżieq tiegħek meta tisgħol - fsada fl-addome tiegħek, jew fsada vaġinali - demm aħmar/aħmar jgħajjat fl-ippurgar - fsada li sseħħ wara l-operazzjoni tiegħek inkluż tbenġil u nefħa, tnixxija ta' demm jew likwidu mill-ferita/inċiżjoni kirurġika (sekrezzjoni mill-ferita) jew mis-sit tal-injezzjoni - mill-murliti - testijiet li juru demm fl-ippurgar jew fl-awrina - Għadd ta' plejtlits imnaqqas fid-demm tiegħek (li jista' jaffettwa l-għaqid tad-demm) - Testijiet tad-demm jistgħu juru: - funzjoni tal-fwied mhux normali - żieda f'xi enzimi tal-fwied - żieda fil-bilirubina, prodott ta' tkissir ta' ċelloli tad-demm ħomor, li jista' jikkawża sfurija talġilda u tal-għajnejn Raxx tal-ġilda - Ħakk Telf tax-xagħar Reazzjonijiet allerġiċi (sensittività eċċessiva) li jistgħu jikkawżaw: nefħa fil-wiċċ, xofftejn, ħalq, ilsien u/jew gerżuma u diffikultà fit-teħid tan-nifs.
English: Uncommon
Maltese: Mhux komun
English: Table 10: Efficacy Results in the AMPLIFY Study Apixaban N=2,609 n (%)
Maltese: Riżultati tal-Effikaċja fl-Istudju AMPLIFY Apixaban N=2,609 n (%)
English: Temporary discontinuation
Maltese: Disturbi fis-sistema immuni
English: Compared to apixaban exposure in subjects with body weight of 65 to 85 kg, body weight > 120 kg was associated with approximately 30% lower exposure and body weight < 50 kg was associated with approximately 30% higher exposure.
Maltese: Meta mqabbel ma' espożizzjoni ta' apixaban f'suġġetti b'piż tal-ġisem ta' 65 sa 85 kg, piż tal-ġisem > 120 kg kien assoċjat ma' bejn wieħed u ieħor 30% espożizzjoni aktar baxxa u piż tal-ġisem < 50 kg kien assoċjat ma' bejn wieħed u ieħor 30% espożizzjoni ogħla.
English: Switching from Eliquis to VKA therapy
Maltese: Tibdil minn Eliquis għal terapija b'VKA
English: Eliquis (apixaban) is an oral anticoagulant acting by direct selective inhibition of factor Xa.
Maltese: Eliquis(apixaban) huwa antikoagulant orali li jagħmel inibizzjoniselettivadirettata' fattur Xa.
English: Table 9: Bleeding Events in Patients with Atrial Fibrillation in the AVERROES Study Apixaban N = 2,798 n(%/year)
Maltese: Tabella 9: Avvenimenti ta' Fsada f'Pazjenti b'Fibrillazzjoni fl-Atriju fl-Istudju AVERROES Apixaban N = 2,798 n(%/sena)
English: In subjects with end-stage renal disease (ESRD), the AUC of apixaban was increased by 36% when a single dose of apixaban 5 mg was administered immediately after haemodialysis, compared to that seen in subjects with normal renal function.
Maltese: F'suġġetti b'mard tal-kliewi fl-aħħar stadju (ESRD), l-AUC ta' apixaban żdiedet b'36% meta ngħatat doża waħda ta' apixaban 5 mg eżatt wara l-emodijaliżi, meta mqabbla ma' dik osservata f'suġġetti b'funzjoni normali tal-kliewi.
English: Major + CRNM 96 (3.6%) All
Maltese: Maġġuri + CRNM 115 (4
English: All-cause death occurred in 2 patients (0.27%) in the apixaban group and 1 patient (0.13%) in the heparin and/or VKA group.
Maltese: Mewt minn kull kawża seħħet f'2 pazjenti (0.27%) fil-grupp ta' apixaban u f'pazjent 1 (0.13%) fil-grupp tal-eparina u/jew VKA.
English: The administration of apixaban 10 mg with famotidine 40 mg had no effect on apixaban AUC or Cmax.
Maltese: L-għoti ta' apixaban 10 mg ma' famotidine 40 mg ma kellu ebda effett fuq l-AUC jew l-Cmax ta' apixaban.
English: Apixaban also demonstrates anti-FXa activity as evident by reduction in Factor Xa enzyme activity in multiple commercial anti-FXa kits, however results differ across kits.
Maltese: Apixaban juri wkoll attività anti-FXa kif inhu evidenti fl-attività tal-enzim tal-Fattur Xa f'kits anti-Fxa kummerċjali multipli, madankollu, ir-riżultati huma differenti bejn kit u ieħor.
English: Table 7: Bleeding Events in Patients with Atrial Fibrillation in the AVERROES Study Apixaban N = 2,798 n(%/year)
Maltese: Tabella 7: Avvenimenti ta' Fsada f'Pazjenti b'Fibrillazzjoni fl-Atriju fl-Istudju AVERROES Apixaban N = 2,798 n(%/sena)
English: Following surgery, other platelet aggregation inhibitors are not recommended concomitantly with Eliquis (see section 4.5).
Maltese: Wara operazzjoni, mhux rakkomandat li inibituri oħra tal-aggregazzjoni tal-plejtlits jingħataw flimkien ma' Eliquis (ara sezzjoni 4.5).
English: Major
Maltese: max
English: - for the prevention of stroke and systemic embolism in patients with NVAF, patients should receive the lower dose of apixaban 2.5 mg twice daily.
Maltese: - għall-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'NVAF, il-pazjenti għandhom jirċievu d-doża aktar baxxa ta' apixaban 2.5 mg darbtejn kuljum.
English: In the thrombin generation assay, apixaban reduced endogenous thrombin potential, a measure of thrombin generation in human plasma.
Maltese: Fleżami tal-ġenerazzjoni tat-trombina, apixaban naqqas il-potenzjal tat-trombina endoġena, kejl talġenerazzjoni tat-trombina fil-plażma tal-bniedem.
English: How to store Eliquis
Maltese: X'fih Eliquis
English: Apixaban demonstrates linear pharmacokinetics with dose proportional increases in exposure for oral doses up to 10 mg. At doses ≥ 25 mg apixaban displays dissolution limited absorption with decreased bioavailability.
Maltese: Apixaban juri farmakokinetiċi lineari b'żidiet proporzjonali tad-doża fl-espożizzjoni għal dożi orali ta mhux aktar minn 10 mg.
English: Body weight VTEp and VTEt - No dose adjustment required (see sections 4.4 and 5.2).
Maltese: Piż tal-ġisem VTEp u VTEt - Ma huwa meħtieġ ebda aġġustament tad-doża (ara sezzjonijiet 4.4 u 5.2).
English: The incidence of ISTH major intraocular bleeding with apixaban was 0.18%/year.
Maltese: ISTH b'apixaban kienet ta' 0.18%/sena.
English: In the VTEp studies, in total, 11% of the patients treated with apixaban 2.5 mg twice daily experienced adverse reactions.
Maltese: Fl-istudji dwar VTEp, b'kollox, 11% tal-pazjenti ikkurati b'apixaban 2.5 mg darbtejn kuljum kellhom reazzjonijiet avversi.
English: Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery (VTEp)
Maltese: Prevenzjoni ta' VTE (VTEp): kirurġija ta' sostituzzjoni elettiva tal-ġenbejn jew tal-irkoppa
English: Prevention of VTE (VTEp): elective hip or knee replacement surgery The apixaban clinical program was designed to demonstrate the efficacy and safety of apixaban for the prevention of VTE in a broad range of adult patients undergoing elective hip or knee replacement.
Maltese: Il-programm kliniku apixaban tfassal sabiex juri l-effikaċja u s-sigurtà ta' apixaban għall-prevenzjoni ta' VTE f'firxa wiesgħa ta' pazjenti adulti li jkunu qegħdin jagħmlu sostituzzjoni elettiva tal-ġenbejn jew tal-irkoppa.
English: Increases in clotting tests (PT, INR, and aPTT) were consistent with the effects of apixaban alone.
Maltese: Żidiet fit-testijiet ta' għaqid tad-demm (PT, INR, u aPTT) kienu konsistenti maleffetti ta' apixaban waħdu.
English: - Film coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172) See section 2 "Eliquis contains lactose (a type of sugar) and sodium".
Maltese: Kisja tar-rita tal-pillola: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172).
English: Body weight Low body weight (< 60 kg) may increase haemorrhagic risk (see section 5.2).
Maltese: Piż tal-ġisem Piż tal-ġisem baxx (< 60 kg) jista'jżid riskju emorraġiku (ara sezzjoni 5.2).
English: You should take the first tablet 12 to 24 hours after your operation.
Maltese: Għandek tieħu l-ewwel pillola minn 12 sa 24 siegħa wara l-operazzjoni tiegħek.