FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 10 shows the adverse reactions identified studies and post-marketing data in the indications prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation, DVT/PE treatment and DVT/PE prevention.
Maltese: Tabella 10 turi r-reazzjonijiet avversi identifikati minn studji u data ta' wara t-tqegħid fis-suq flindikazzjonijiet għall-prevenzjoni ta' puplesija tromboembolika u emboliżmu sistemiku f'pazjenti b'fibrillazzjoni atrijali, kura għal DVT/PE u prevenzjoni ta' DVT/PE.
English: Traces of other metabolites were only detectable with highly sensitive analytical methods.
Maltese: Traċċi ta' metaboliti oħrajn instabu biss b'metodi analatiċi li kienu sensittivi ħafna.
English: • an ECT at trough (10-16 hours after the previous dose), elevated approximately 2.3-fold compared to baseline refers to the observed 90th percentile of ECT prolongation of 74 seconds,
Maltese: • ECT fil-livell minimu (10-16-il siegħa wara d-doża ta' qabel), ogħla b'madwar 2.3 darbiet meta mqabbel mal-linja bażi għan-90th percentile osservata tat-titwil ta' ECT ta' 74 sekonda,
English: As part of the descriptive analysis, TIMI (Thrombolysis In Myocardial Infarction) major bleeding events was lower in both dabigatran etexilate dual-therapy groups than in the warfarin triple-therapy group: 14 events (1.4%) in the dabigatran etexilate 110 mg dual-therapy group as compared with 37 events (3.8%) in the warfarin triple-therapy group (HR 0.37; 95% CI 0.20, 0.68; P=0.002) and 16 events (2.1%) in the dabigatran etexilate 150 mg dual-therapy group as compared with 30 events (3.9%) in the corresponding warfarin triple-therapy group (HR 0.51; 95% CI 0.28, 0.93; P=0.03).
Maltese: Bħala parti millanaliżi deskrittiva, avvenimenti maġġuri ta' fsada ta' TIMI (Trombolisi f'Infart Mijokardijaku [Trombolysis In Myocardial Infarction]) kienu aktar baxxi fiż-żewġ gruppi ta' terapija doppja b'dabigatran etexilate milli fil-grupp ta' terapija tripla b'warfarin: 14-il avveniment (1.4%) fil-grupp ta' terapija doppja b'dabigatran etexilate 110 mg meta mqabbel ma' 37 avveniment (3.8%) fil-grupp ta' terapija tripla b'warfarin (HR 0.37; CI ta' 95% 0.20, 0.68; P=0.002) u 16-il avveniment (2.1%) filgrupp ta' terapija doppja b'dabigatran etexilate 150 mg meta mqabbel ma' 30 avveniment (3.9%) filgrupp korrispondenti ta' terapija tripla b'warfarin (HR 0.51; CI ta' 95% 0.28, 0.93; P=0.03). Iż-żewġ gruppi ta' terapija doppja b'dabigatran etexilate kellhom rati aktar baxxi ta' emorraġija fil-kranju millgrupp korrispondenti ta' terapija tripla b'warfarin: 3 avvenimenti (0.3%) fil-grupp ta' terapija doppja b'110 mg dabigatran etexilate meta mqabbel ma' 10 avvenimenti (1.0%) fil-grupp ta' terapija tripla b'warfarin (HR 0.30; CI ta' 95% 0.08, 1.07; P=0.06) u avveniment wieħed (0.1%) fil-grupp ta' terapija doppja b'dabigatran etexilate 150 mg meta mqabbel ma' 8 avvenimenti (1.0%) fil-grupp korrispondenti ta' terapija tripla b'warfarin (HR 0.12; CI ta' 95% 0.02, 0.98; P=0.047).
English: These observations in real-world settings are consistent with the established safety and efficacy profile for dabigatran etexilate in the RE-LY study in this indication.
Maltese: Dawn l-osservazzjonijiet f'ambjenti reali huma konsistenti mal-profil tas-sigurtà u l-effikaċja stabbilit għal dabigatran etexilate fl-istudju RE-LY f'din l-indikazzjoni.
English: EU/1/08/442/005 10 x 1 capsules EU/1/08/442/006 30 x 1 capsules EU/1/08/442/007 60 x 1 capsules EU/1/08/442/018 60 x 1 capsules
Maltese: EU/1/08/442/005 10 x 1 kapsula EU/1/08/442/006 30 x 1 kapsula EU/1/08/442/007 60 x 1 kapsula EU/1/08/442/018 60 x 1 kapsula
English: In patients treated for DVT and PE with 150 mg dabigatran etexilate twice daily, the dabigatran geometric mean trough concentration, measured within 10−16 hours after dose, at the end of the dosing interval (i.e. 12 hours after the 150 mg dabigatran evening dose), was 59.7 ng/ml, with a range of 38.6 - 94.5 ng/ml (25th-75th percentile range).
Maltese: F'pazjenti kkurati għal DVT u PE b'150 mg ta' dabigatran etexilate darbtejn kuljum, il-medja ġeometrika tal-konċentrazzjoni minima ta' dabigatran, imkejla fi żmien 10−16-il siegħa wara doża, fittmiem tal-intervall tad-dożaġġ (i.e. 12-il siegħa wara d-doża ta' filgħaxija ta' 150 mg dabigatran), kienet ta' 59.7 ng/ml, b'medda ta' 38.6 - 94.5 ng/ml (medda tat-25th-75th percentile).
English: All patients underwent a Trans-oesophageal Echocardiography (TEE) prior to catheter ablation.
Maltese: Il-pazjenti kollha kellhom Ekokardjografija Transesofagali (TEE - Trans-oesophageal Echocardiography) qabel l-asportazzjoni tal-kateter.
English: EU/1/08/442/001 10 x 1 capsules EU/1/08/442/002 30 x 1 capsules EU/1/08/442/003 60 x 1 capsules EU/1/08/442/017 60 x 1 capsules
Maltese: EU/1/08/442/001 10 x 1 kapsula EU/1/08/442/002 30 x 1 kapsula EU/1/08/442/003 60 x 1 kapsula EU/1/08/442/017 60 x 1 kapsula
English: Pantoprazole When Pradaxa was co-administered with pantoprazole, a decrease in the dabigatran AUC of approximately 30 % was observed.
Maltese: Pantoprazole Meta Pradaxa ngħata flimkien ma' pantoprazole, kien osservat tnaqqis fl-AUC ta' dabigatran ta' madwar 30%.
English: 300 mg Pradaxa taken as one 150 mg capsule twice daily following treatment with a parenteral anticoagulant for at least 5 days
Maltese: 300 mg Pradaxa meħuda bħala kapsula waħda ta' 150 mg darbtejn kuljum wara trattament b'mediċina parenterali kontra l-koagulazzjoni tad-demm għal millinqas 5 ijiem
English: Patients with an increased bleeding risk (see sections 4.4, 4.5, 5.1 and 5.2) should be closely monitored clinically (looking for signs of bleeding or anaemia).
Maltese: Pazjenti b'żieda fir-riskju ta' ħruġ ta' demm (ara sezzjonijiet 4.4, 4.5, 5.1 u 5.2) għandhom jiġu mmonitorjati mill-qrib klinikament (tingħata attenzjoni għal sinjali ta' ħruġ ta' demm jew anemija).
English: In patients treated for prevention of VTEs after hip or knee replacement surgery with 220 mg dabigatran etexilate once daily,
Maltese: F'pazjenti kkurati għal prevenzjoni ta' VTEs wara operazzjoni tas-sostituzzjoni tal-ġenbejn jew talirkoppa b'220 mg ta' dabigatran etexilate darba kuljum,
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Artical 107c(7) of Directive 1002/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Results of both studies showed that the antithrombotic effect of Pradaxa 220 mg and 150 mg were statistically non-inferior to that of enoxaparin on total VTE and all-cause mortality.
Maltese: Ir-riżultati taż-żewġ studji wrew li l-effett antitrombotiku ta' Pradaxa 220 mg u 150 mg kien statistikament mhux inferjuri għal dak ta' enoxaparin fuq il-VTE totali u l-mortalità mill-kawżi kollha.
English: - Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine) - A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C) - Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac) - St. John´s wort, a herbal medicine for depression - Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin norepinephrine re-uptake inhibitors - Rifampicin or clarithromycin (two antibiotics) - Anti-viral medicines for AIDS (e.g. ritonavir) - Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)
Maltese: John´s wort, mediċina miksuba mill-ħxejjex li tintuża biex tikkura d-dipressjoni - Mediċini kontra d-dipressjoni msejħa inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin jew inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin-norepinephrine - Rifampicin jew clarithromycin (żewġ antibijotiċi) - Mediċini antivirali għall-AIDS (eż. ritonavir) - Ċerti mediċini għall-kura ta' epilessija (eż. carbamazepine, phenytoin).
English: In a dedicated study exclusively in patients with moderate renal impairment (creatinine clearance, CrCL 30-50 mL/min) treated with dabigatran etexilate 150 mg QD, the dabigatran geometric mean trough concentration, measured at the end of the dosing interval, was on average 47.5 ng/mL, with a range of 29.6 - 72.2 ng/mL (25
Maltese: Fi studju ddedikat esklussivament f'pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal-kreatinina, CrCL 30-50 mL/min) ikkurati b'dabigatran etexilate 150 mg QD, il-medja ġeometrika tal konċentrazzjoni minima ta' dabigatran, imkejla fit-tmiem tal-intervall tad-dożaġġ, kienet bħala medjata' 47.
English: 24 hours before
Maltese: Tabella 24:
English: Multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in perforated aluminium unit dose blisters.
Maltese: Pakkett multiplu li jkun fih 2 pakketti ta' 50 x 1 kapsuli ibsin (100 kapsula iebsa) f'folji tad-doża ta' lunità ta' l-aluminju.
English: In total, about 9 % of patients treated for elective hip or knee surgery (short-term treatment for up to 42 days), 22 % of patients with atrial fibrillation treated for the prevention of stroke and systemic embolism (long-term treatment for up to 3 years), 14 % of patients treated for DVT/PE and 15 % of patients treated for DVT/PE prevention experienced adverse reactions.
Maltese: B'kollox, madwar 9% tal-pazjenti kkurati għal operazzjoni mhux obbligatorja tas-sostituzzjoni tal-ġenbejn jew tal-irkoppa (kura għal żmien qasir għal sa 42 jum), 22% tal-pazjenti b'fibrillazzjoni atrijali kkurati għal prevenzjoni ta' puplesija u emboliżmu sistemiku (kura fit-tul għal 3 snin), 14% talpazjenti kkurati għal DVT/PE u 15% tal-pazjenti kkurati għal prevenzjoni ta' DVT/PE kellhom reazzjonijiet avversi.
English: Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors (SPAF)
Maltese: Prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'NVAF b'fattur ta' riskju wieħed jew aktar (SPAF)
English: The point estimate for incidence of Major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 17).
Maltese: Il-point estimate għall-inċidenza ta' VTE maġġuri u mortalità marbuta ma' VTE għad-doża ta' 150 mg kien ftit agħar minn dak ta' enoxaparin (Tabella 17).
English: This study demonstrated that dual-therapy with dabigatran etexilate and a P2Y12 antagonist significantly reduced the risk of bleeding vs. warfarin triple-therapy with non-inferiority for composite of thromboembolic events in patients with atrial fibrillation who underwent a PCI with stenting.
Maltese: Dan l-istudju wera li terapija doppja, b'dabigatran etexilate u antagonist ta' P2Y12, naqqset b'mod sinifikanti r-riskju ta' fsada kontra terapija tripla b'warfarin, b'nuqqas ta' inferjorità għall-kompost ta' avvenimenti tromboemboliċi f'pazjenti b'fibrillazzjoni atrijali li għaddew minn PCI bi stent.
English: Pradaxa 110 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Maltese: Pradaxa 110 mg kapsuli ibsin huma disponibbli wkoll fi fliexken tal-polypropylene (plastik) b'60 kapsula ibsin.
English: When a loading dose of 180 mg ticagrelor was given 2 hours after 110 mg dabigatran etexilate (in steady state), the increase of dabigatran AUCτ,ss and Cmax,ss was reduced to 1.27-fold and 1.23-fold, respectively, compared with dabigatran etexilate given alone.
Maltese: Meta doża għolja tal-bidu ta' 180 mg ta' ticagrelor ingħatat sagħtejn wara 110 mg ta' dabigatran etexilate (fi stat fiss), iż-żieda tal-AUCτ,ss u s-Cmax,ss ta' dabigatran naqset għal 1.27 darba u 1.23 darba, rispettivament, meta mqabbla ma' dabigatran etexilate mogħti waħdu.
English: Better results were seen with the 220 mg dose where the point estimate of Major VTE was slightly better than enoxaparin (table 10).
Maltese: Riżultati aħjar kienu osservati bid-doża ta' 220 mg fejn il-point estimate ta' VTE maġġuri kien ftit aħjar minn dak ta' enoxaparin (Tabella 10).
English: ® is mainly eliminated by the kidneys; adequate diuresis must be maintained.
Maltese: ® huwa eliminat mill-kliewi; dijuresi xierqa għandha tiġi mantenuta.
English: 300 mg Pradaxa taken as one 150 mg capsule twice daily
Maltese: 300 mg Pradaxa meħuda bħala kapsula waħda ta' 150 mg darbtejn kuljum
English: Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
Maltese: Kull kapsula iebsa fiha 150 mg ta' dabigatran etexilate (bħala mesilate).
English: Prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults (DVT/PE prevention)
Maltese: Il-prevenzjoni trombożi tal-vini profondi (DVT) rikorrenti u emboliżmu pulmonari (PE) fl-adulti (prevenzjoni ta' DVT/PE)
English: Table 11: Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation
Maltese: Tabella 11: Każijiet ta' ħruġ ta' demm fi studju li ttestja l-prevenzjoni ta' puplesija tromboembolika u emboliżmu sistemiku f'pazjenti b'fibrillazzjoni atrijali
English: Table 13: Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation
Maltese: Tabella 13: Każijiet ta' ħruġ ta' demm fi studju li ttestja l-prevenzjoni ta' puplesija tromboembolika u emboliżmu sistemiku f'pazjenti b'fibrillazzjoni atrijali
English: Carton containing 6 blister strips (60 x 1) in perforated aluminium unit dose white blisters.
Maltese: Kaxxa tal-kartun li fiha 6 strixxi tal-folji (60 x 1) fi strixxi bojod tad-doża ta' l-unità ta' l-aluminju perforati.
English: Better results were seen with the 220 mg dose where the point estimate of Major VTE was slightly better than enoxaparin (table 17).
Maltese: Riżultati aħjar kienu osservati bid-doża ta' 220 mg fejn il-point estimate ta' VTE maġġuri kien ftit aħjar minn dak ta' enoxaparin (Tabella 17).
English: If you are taking amiodarone, quinidine or verapamil containing medicines the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).
Maltese: Jekk qed tieħu mediċini li fihom amiodarone, quinidine jew verapamil, id-doża rakkomandata hija ta' 150 mg darba kuljum (li tittieħed bħala 2 kapsuli ta' 75 mg).
English: • Make sure to use the latest version
Maltese: • Immaniġġjar ta' sitwazzjonijiet ta' doża eċċessiva
English: Primary prevention of Venous Thromboembolism in Orthopaedic Surgery The recommended doses of Pradaxa and the duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery are shown in table 1.
Maltese: Id-dożi rakkomandati ta' Pradaxa u t-tul tat-terapija għall-prevenzjoni primarja ta' tromboemboliżmu venuż f'operazzjoni ortopedika huma murija fit-tabella 1.
English: The calibrated quantitative diluted TT (dTT) test provides an estimation of dabigatran plasma concentration that can be compared to the expected dabigatran plasma concentrations.
Maltese: It-test tat-TT dilwit kwantitattiv ikkalibrat (dTT) jipprovdi stima tal-konċentrazzjoni fil-plażma ta' dabigatran li tista' titqabbel mal-konċentrazzjonijiet fil-plażma mistennija ta' dabigatran.
English: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors (SPAF)
Maltese: Prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'fibrillazzjoni atrijali mhux valvulari b'wieħed jew aktar fatturi ta' riskju (SPAF)
English: Dabigatran is eliminated primarily in the unchanged form in the urine, at a rate of approximately 100 mL/min corresponding to the glomerular filtration rate.
Maltese: Dabigatran hu eliminat primarjament fis-sura mhux mibdula flawrina, b'rata ta' madwar 100 mL/min, li tikkorrispondi għar-rata tal-filtrazzjoni glomerulari.
English: The clinical benefit of dabigatran with regard to stroke and systemic embolism prevention and decreased risk of ICH compared to warfarin is preserved across individual subgroups, e.g. renal impairment, age, concomitant medicinal product use such as anti-platelets or P-gp inhibitors.
Maltese: Il-benefiċċju kliniku ta' dabigatran fir-rigward tal-prevenzjoni ta' puplesija u emboliżmu sistemiku u tnaqqis fir-riskju ta' ICH meta mqabbel ma' warfarin hu ppreservat fis-sottogruppi individwali kollha, eż. indeboliment tal-kliewi, età, użu ta' prodotti mediċinali oħra fl-istess ħin bħal kontra l-plejtlits jew inibituri ta' P-gp.
English: The International Normalised Ratio (INR) test is unreliable in patients on Pradaxa and false positive INR elevations have been reported.
Maltese: It-test tal-Proporzjon Normalizzat Internazzjonali (INR - International Normalised Ratio) mhuwiex affidabbli f'pazjenti fuq Pradaxa u żidiet pożittivi foloz ta' INR ġew irrappurtati.
English: • the 90th percentile of aPTT at trough (10-16 hours after the previous dose) was 62 seconds, which would be 1.8-fold compared to baseline.
Maltese: • in-90th percentile ta' aPTT fil-livell minimu (20-28 siegħa wara d-doża ta' qabel kienet 51 sekonda, li hi 1.3 darbiet il-limitu ta' fuq tan-normal.
English: Additionally, dabigatran exposure (at trough and peak) was assessed in a prospective open label randomized pharmacokinetic study in NVAF patients with severe renal impairment (defined as creatinine clearance [CrCl] 15-30 mL/min) receiving dabigatran etexilate 75 mg twice daily.
Maltese: Barra dan, l-esponiment għal dabigatran (fl-aktar punt baxx u l-aktar punt għoli) kien evalwat fi studju farmakokinetiku prospettiv open label u li fih il-parteċipanti ntgħażlu b'mod każwali f'pazjenti b'NVAF b'indeboliment renali sever (definit bħala tneħħija tal-kreatinina [CrCl - creatinine clearance] ta' 15-30 mL/min) li kienu qed jirċievu dabigatran etexilate 75 mg darbtejn kuljum.
English: The cleavage of the prodrug dabigatran etexilate by esterase-catalysed hydrolysis to the active principle dabigatran is the predominant metabolic reaction.
Maltese: Il-ksur tal-prodrug dabigatran etexilate permezz ta' idrolisi kkatalizzata minn esterase għall-prinċipju attiv hi r-reazzjoni metabolika predominanti.
English: In 2 large randomized, parallel group, double-blind, dose-confirmatory trials, patients undergoing elective major orthopaedic surgery (one for knee replacement surgery and one for hip replacement surgery) received Pradaxa 75 mg or 110 mg within 1-4 hours of surgery followed by 150 mg or 220 mg once daily thereafter, haemostasis having been secured, or enoxaparin 40 mg on the day prior to surgery and daily thereafter.
Maltese: F'2 provi kbar biex jikkonfermaw id-doża, li kienu randomized, parallel grupp u double-blind, il-pazjenti li kienet qed issirilhom operazzjoni ortopedika maġġuri mhux urġenti (waħda għall-operazzjoni tas-sostituzzjoni ta' l-irkoppa u waħda għall-operazzjoni tas-sostituzzjoni tal-ġenbejn), irċivew Pradaxa 75 mg jew 110 mg fi żmien 1-4 sigħat mill-operazzjoni, segwiti minn 150 jew 220 mg darba kuljum wara dan il-perjodu, wara li kienet inkisbet l-emostasi, jew enoxaparin 40 mg fil-jum ta' qabel l-operazzjoni u kuljum wara l-operazzjoni.
English: Concomitant administration of a loading dose of 180 mg ticagrelor and 110 mg dabigatran etexilate (in steady state) increased the dabigatran AUCτ,ss and Cmax,ss by 1.49-fold and 1.65-fold, respectively, compared with dabigatran etexilate given alone.
Maltese: L-għoti fl-istess ħin ta' doża għolja tal-bidu ta' 180 mg ta' ticagrelor u 110 mg ta' dabigatran etexilate (fi stat fiss) żied l-AUCτ,ss u s-Cmax,ss ta' dabigatran b'1.49 darba u 1.65 darba, rispettivament, meta mqabbel ma' dabigatran etexilate mogħti waħdu.
English: EU/1/08/442/009 EU/1/08/442/010 EU/1/08/442/011 EU/1/08/442/012 EU/1/08/442/013 EU/1/08/442/016 EU/1/08/442/019
Maltese: EU/1/08/442/011 EU/1/08/442/012 EU/1/08/442/013 EU/1/08/442/016
English: Pradaxa 150 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Maltese: Pradaxa 150 mg kapsuli ibsin huma disponibbli wkoll fi fliexken tal-polypropylene (plastik) b'60 kapsula ibsin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula iebsa fiha 150 mg ta' dabigatran etexilate (bħala mesilate)
English: Dose reduction recommended Patients with moderate renal impairment (creatinine clearance (CrCL) 30-50 mL/min)
Maltese: Pazjenti b'indeboliment moderat talkliewi (tneħħija tal-krejatinina (CrCL (creatinine clearance) 30-50 mL/min)
English: The primary endpoint was a combined endpoint of major bleeds based on ISTH definition or clinically relevant non-major bleeding event.
Maltese: Il-punt aħħari primarju kien punt aħħari kombinat ta' fsada maġġuri bbażata fuq iddefinizzjoni ta' ISTH jew avveniment ta' fsada mhux maġġuri klinikament rilevanti.
English: Table 10: Number of patients studied, maximum daily dose in phase III studies Indication
Maltese: Numru ta' pazjenti studjati, doża massima ta' kuljum fl-istudji ta' fażi III Indikazzjoni
English: Stroke and systemic embolism prevention in patients with atrial fibrillation
Maltese: Prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b' fibrillazzjoni atrijali
English: Composite of major VTE (including PE and proximal DVT, whatever symptomatic or asymptomatic detected by routine venography) and VTE-related mortality constituted a secondary end-point and is considered of better clinical relevance.
Maltese: Kompost ta' VTE totali (li jinkludi PE u DVT prossimali, kemm sintomatika jew asintomatika, osservata permezz ta' venografija ta' rutina) u mortalità marbuta ma' VTE, ikkostitwixxa punt aħħari sekondarju, u hu kkunsidrat li hu ta' rilevanza klinika aħjar.
English: Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg.
Maltese: Dronedarone Meta dabigatran etexilate u dronedarone ngħataw fl-istess ħin, il-valuri tal-AUC0-∞ u Cmax totali ta' dabigatran żdiedu b'madwar 2.4 darbiet u 2.3 darbiet rispettivament, wara dożaġġ multiplu ta' 400 mg ta' dronedarone bid, u b'madwar 2.1 darbiet u 1.9 darbiet, rispettivament, wara doża waħda ta' 400 mg.
English: They are ranked under headings of System Organ Class (SOC) 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).
Maltese: Dawn huma kklassifikati skond kategoriji tal-Klassi tas-Sistemi u tal-Organi (SOC, System Organ Class) u frekwenza 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 tistax tittieħed stima mid-data disponibbli.
English: Pradaxa 110 mg twice daily
Maltese: Pradaxa 110 mg darbtejn kuljum
English: In patients treated for prevention of recurrent of DVT and PE with 150 mg dabigatran etexilate twice daily no pharmacokinetic data are available.
Maltese: F'pazjenti kkurati għal prevenzjoni ta' rikorrenza ta' DVT u PE b'150 mg ta' dabigatran etexilate darbtejn kuljum, l-ebda dejta farmakokinetika mhi disponibbli.
English: Dialysis was conducted with 700 mL/min dialysate flow rate, four hour duration and a blood flow rate of either 200 mL/min or 350-390 mL/min.
Maltese: Id-dijalisi saret b'rata ta' fluss ta' dialysate ta' 700 mL/min, fuq erba' sigħat u b'rata ta' fluss ta' demm ta' 200 mL/min jew 350-390 mL/min.
English: The point estimate for incidence of major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 10).
Maltese: Il-point estimate għall-inċidenza ta' VTE maġġuri u mortalità marbuta ma' VTE għad-doża ta' 150 mg kien ftit agħar minn dak ta' enoxaparin (Tabella 10).