FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients received an initial oral dose of 1.71 (± 10%) mg/kg of dabigatran etexilate (80 % of the adult dose of 150 mg/70 kg adjusted for the patient's weight).
Maltese: Il-pazjenti kollha rċivew doża orali inizjali ta' 1.71 (± 10%) mg/kg ta' dabigatran etexilate (80% tad-doża fl-adulti ta' 150 mg/70 kg aġġustata għall-piż tal-pazjent).
English: Dose reductions may be required in combination with some P-gp inhibitors (see sections 4.2, 4.3, 4.4 and 5.1).
Maltese: F'kombinazzjoni ma' xi inibituri ta' P-gp jista' jkun meħtieġ tnaqqis fid-doża (ara sezzjonijiet 4.2, 4.3, 4.4 u 5.1).
English: ASA use Clopidogrel use
Maltese: Użu ta' ASA Użu ta' Clopidogrel
English: • Mild to moderate P-gp inhibitor co-medication (e.g. amiodarone, verapamil, quinidine and ticagrelor; see section 4.5)
Maltese: • Komedikazzjoni b'inibitur ħafif sa moderat ta' P-gp (eż. amiodarone, verapamil, quinidine u ticagrelor; ara sezzjoni 4.5)
English: rd day either with or without quinidine.
Maltese: et jum bi jew mingħajr quinidine.
English: single capsule of 75 mg Pradaxa
Maltese: kapsula waħda ta' 75 mg Pradaxa
English: Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events
Maltese: Pazjenti f'riskju għoli ta' mortalità kirurġika u b'fatturi intrinsiċi ta' riskju għal każijiet tromboemboliċi
English: - Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin,
Maltese: - Mediċini biex inaqqsu t-tagħqid tad-demm (eż. warfarin, phenprocoumon, acenocoumarol,
English: Treatment initiation on the day of surgery 1-4 hours after completed surgery
Maltese: Bidu tat-trattament fil-jum taloperazzjoni 1-4 sigħat wara li titlesta l-operazzjoni
English: Dabigatran plasma concentrations observed at 72 hrs were relatively low, between 32.9 ng/mL and 97.2 ng/mL at final doses between 100 mg and 150 mg (gMean dose normalized total dabigatran plasma concentration of 0.493 ng/mL/mg).
Maltese: Il-konċentrazzjonijiet ta' dabigatran fil-plażma osservati wara 72 siegħa kienu relattivament baxxi, bejn 32.9 ng/mL u 97.2 ng/mL fid-dożi finali bejn 100 mg u 150 mg (total tal-konċentrazzjoni fil-plażma ta' dabigatran normalizzat għad-doża medja ta' 0.493 ng/mL/mg).
English: Dosing should be reduced as indicated in table 1 (see also sections 4.4 and 4.5).
Maltese: Id-dożaġġ ta' Pradaxa għandu jitnaqqas kif indikat fit-tabella 1 (ara wkoll sezzjonijiet 4.4 u 4.5).
English: The ECT can provide a direct measure of the activity of direct thrombin inhibitors.
Maltese: L-ECT jista' jipprovdi kejl dirett tal-attività ta' inibituri diretti ta' thrombin.
English: Myocardial infarction rates were slightly increased with dabigatran etexilate 110 mg twice daily and 150 mg twice daily compared to warfarin (hazard ratio 1.29; p=0.0929 and hazard ratio 1.27; p=0.1240, respectively).
Maltese: Ir-rati ta' infart mijokardijaku żdiedu bi ftit b'dabigatran etexilate 110 mg darbtejn kuljum u 150 mg darbtejn kuljum meta mqabbla ma' warfarin (proporzjon ta' periklu 1.29; p=0.0929 u proporzjon ta' periklu 1.27; p=0.1240, rispettivament).
English: Pradaxa is available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsules, a multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in aluminium perforated unit dose blisters.
Maltese: Pradaxa hu disponibbli f'pakketti li fihom 10 x 1, 30 x 1 jew 60 x 1 kapsula, jew pakkett multiplu li jkun fih 3 pakketti ta' 60 x 1 kapsuli (180 kapsula ibsin) jew pakkett multiplu li jkun fih 2 pakketti ta' 50 x 1 kapsuli ibsin (100 kapsula iebsa) f'folji tad-doża tal-unità magħmulin minn aluminju perforat.
English: Almost half (45.8 %) of the RE-LY patients had a CrCL > 50-< 80 mL/min.
Maltese: Kważi n-nofs (45.8%) tal-pazjenti RE-LY kellhom CrCL ta' > 50-< 80 mL/min.
English: Hazard ratio vs warfarin (95% confidence interval) non-inferiority margin Patients with event at 18 months Cumulative risk at
Maltese: Proporzjon ta' periklu kontra warfarin (95% intervall ta' kunfidenza) marġini ta' non-inferjorità Pazjenti b'avveniment wara 18-il xahar Riskju kumulattiv wara 18-il xahar (%)
English: At the end of the follow-up VTE events in patients treated with dabigatran etexilate was 6.9 % vs. 10.7 % among the placebo group (hazard ratio 0.61 (95% CI 0.42, 0.88), p=0.0082).
Maltese: 7% fost il-fil-grupp tal-plaċebo (proporzjon ta' periklu 0.61 (95% CI 0.42, 0.88), p=0.0082).
English: Gastrointestinal ulcer, including oesophageal ulcer
Maltese: Ulċera gastrointestinali, li tinkludi ulċera esofagali
English: Subjects randomized Stroke and/or systemic embolism Incidences (%) Hazard ratio over warfarin (95 % CI) p value superiority p=0.2721
Maltese: Persuni magħżula b'mod każwali Puplesija u/jew emboliżmu sistemiku Inċidenzi (%) Proporzjon ta' periklu fuq warfarin (95% CI) superjorità ta' valur p p=0.2721
English: PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60 kapsula iebsa
English: There are no data available for 110 mg twice daily Pradaxa treatment.
Maltese: M'hemm l-ebda data disponibbli għal trattament bi Pradaxa 110 mg darbtejn kuljum.
English: In the phase III study RE-LY (SPAF, see section 5.1) the overall rate of MI was 0.82, 0.81, and 0.64 % / year for dabigatran etexilate 110 mg twice daily, dabigatran etexilate 150 mg twice daily and warfarin, respectively, an increase in relative risk for dabigatran of 29 % and 27 % compared to warfarin.
Maltese: III RE-LY (SPAF, ara sezzjoni 5.1), ir-rata globali ta' MI kienet ta' 0.82, 0.81, u 0.64%/sena għal dabigatran etexilate 110 mg darbtejn kuljum, dabigatran etexilate 150 mg darbtejn kuljum u warfarin, rispettivament, żieda fir-riskju relattiv għal dabigatran ta' 29% u 27% meta mqabbel ma' warfarin.
English: Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value
Maltese: Proporzjon ta' periklu vs. warfarin (95% CI) valur p
English: The pharmacokinetics and pharmacodynamics of dabigatran etexilate administered twice daily for three consecutive days (total 6 doses) at the end of standard anticoagulant therapy were assessed in an open-label safety and tolerability study in 9 stable adolescents (12 to < 18 years).
Maltese: Il-farmakokinetika u l-farmakodinamika ta' dabigatran etexilate mogħti darbtejn kuljum għal tlett ijiem konsekuttivi (total ta' 6 dożi) fit-tmiem ta' terapija antikoagulanti standard ġew evalwati fi studju open-label dwar is-sigurtà u t-tollerabilità f'9 adolexxenti stabbli (li kellhom minn 12 sa < 18il sena).
English: Pradaxa 150 mg hard capsules dabigatran etexilate
Maltese: Pradaxa 150 mg kapsuli iebsin dabigatran etexilate
English: Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily.
Maltese: Ketoconazole Ketoconazole żied il-valuri totali tal-AUC0-∞ u s-Cmax ta' dabigatran bi 2.38 darba u 2.35 darba, rispettivament, wara doża orali waħda ta' 400 mg, u bi 2.53 darba u 2.49 darba, rispettivament, wara li ngħatat doża orali multipla ta' 400 mg ta' ketoconazole darba kuljum.
English: Dabigatran AUCτ,ss and Cmax,ss were increased on average by 1.53-fold and 1.56-fold, respectively with concomitant quinidine (see sections 4.2 and 4.4).
Maltese: L-AUCτ,ss u Cmax,ss ta' dabigatran żdiedu bħala medja b'1.53 darba u 1.56 darba, rispettivament bl-użu fl-istess ħin ta' quinidine (ara sezzjonijiet 4.2 u 4.4).
English: INFORMATION IN BRAILLE Pradaxa 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pradaxa 150 mg
English: PHARMACEUTICAL FORM AND CONTENTS 50x1 hard capsules.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 50x1 kapsula iebsa.
English: There was no significant interaction of treatment effects with the subgroups of renal function and CHADS2 score.
Maltese: Ma kien hemm l-ebda interazzjoni sinifikanti tal-effetti tal-kura bis-sottogruppi talfunzjoni tal-kliewi u l-punteġġ CHADS2.
English: Pre-dosing of the probe inducer rifampicin at a dose of 600 mg once daily for 7 days decreased total dabigatran peak and total exposure by 65.5 % and 67 %, respectively.
Maltese: Dożaġġ minn qabel tal-probe inducer rifampicin b'doża ta' 600 mg darba kuljum għal 7 ijiem naqqas il-massimu ta' dabigatran totali u l-espożizzjoni totali b'65.5% u 67%, rispettivament.
English: 95% confidence interval Symptomatic DVT 95% confidence interval Symptomatic PE 95% confidence interval VTE-related deaths 95% confidence interval Unexplained deaths 95% confidence interval All-cause deaths 95% confidence interval
Maltese: 95% intervall ta' kunfidenza Imwiet marbuta ma' VTE 95% intervall ta' kunfidenza Imwiet mill-kawżi kollha 95% intervall ta' kunfidenza
English: The safety of Pradaxa has been evaluated in ten phase III studies including 23,393 patients exposed to Pradaxa (see Table 10).
Maltese: III li kienu jinkludu 23,393 pazjent esposti għal Pradaxa (ara Tabella 10).
English: 220 mg Pradaxa once daily taken as 2 capsules of 110 mg
Maltese: 220 mg Pradaxa darba kuljum meħuda bħala 2 kapsuli ta' 110 mg
English: • Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole, cyclosporine, itraconazole, dronedarone and the fixed-dose combination glecaprevir/pibrentasvir (see section 4.5)
Maltese: • Il-kura fl-istess ħin bl-inibituri qawwija ta' P-gp li ġejjin: ketoconazole sistemiku, cyclosporine, itraconazole, dronedarone u l-kombinazzjoni ta' doża fissa glecaprevir/pibrentasvir (ara sezzjoni 4.5).
English: A prospective, randomized, open-label, blinded endpoint (PROBE) study (Phase IIIb) to evaluate dual-therapy with dabigatran etexilate (110 mg or 150 mg bid) plus clopidogrel or ticagrelor (P2Y12 antagonist) vs. triple-therapy with warfarin (adjusted to a INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin was conducted in 2725 patients with non valvular atrial fibrillation who underwent a PCI with stenting (RE-DUAL PCI).
Maltese: Studju prospettiv, randomised, open-label, b'punt aħħari blinded (PROBE - prospective, randomized, open-label, blinded endpoint) (Fażi IIIb) biex jevalwa terapija doppja b'dabigatran etexilate (110 mg jew 150 mg bid) flimkien ma' clopidogrel jew ticagrelor (antagonist ta' P2Y12) kontra terapija tripla b'warfarin (aġġustat għal INR 2.0 - 3.0) flimkien ma' clopidogrel jew ticagrelor u aspirin twettaq fuq 2725 pazjent b'fibrillazzjoni atrijali mhux valvulari li għaddew minn PCI bi stent (RE-DUAL PCI).
English: 95 % confidence interval
Maltese: 95% intervall ta' kunfidenza
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 180 (3 packs of 60x1) hard capsules.
Maltese: U KONTENUT Pakkett multiplu: 180 (3 pakketti ta' 60x1) kapsula iebsa.
English: Of the 704 enrolled patients, 317 underwent atrial fibrillation ablation on uninterrupted dabigatran and 318 underwent atrial fibrillation ablation on uninterrupted warfarin.
Maltese: Mis-704 pazjenti rreġistrati, 317 kellhom asportazzjoni għal fibrillazzjoni atrijali waqt li kienu fuq dabigatran mingħajr interruzzjoni u 318 kellhom asportazzjoni għal fibrillazzjoni atrijali waqt li kienu fuq warfarin mingħajr interruzzjoni.
English: Concomitant use of Pradaxa with mild to moderate P-glycoprotein (P-gp) inhibitors, i.e. amiodarone, quinidine or verapamil
Maltese: L-użu fl-istess ħin ta' Pradaxa ma' inibituri ħfief u moderati ta' P-glikoproteina (P-gp), i.e. amiodarone, quinidine jew verapamil
English: Pradaxa 110 mg are hard capsules with an opaque, light blue-coloured cap and an opaque, light blue -coloured body.
Maltese: Pradaxa 110 mg huma kapsuli ibsin b'għatu blu ċar u opak, u korp blu ċar, opak.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 100 (2 packs of 50x1) hard capsules.
Maltese: U KONTENUT Pakkett multiplu: 100 (2 pakketti ta' 50x1) kapsula iebsa.
English: 150 mg Pradaxa once daily taken as 2 capsules of 75 mg
Maltese: 150 mg Pradaxa darba kuljum meħuda bħala 2 kapsuli ta' 75 mg
English: DVT/PE treatment (RECOVER, RE-COVER II)
Maltese: 300 mg 220 mg trattament għal DVT/PE (RE-COVER, RECOVER II)
English: There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Pradaxa: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparins (LMWH), and heparin derivatives (fondaparinux, desirudin), thrombolytic medicinal products, and vitamin K antagonists, rivaroxaban or other oral anticoagulants (see section 4.3), and antiplatelet aggregation medicinal products such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinpyrazone (see section 4.4).
Maltese: M'hemmx esperjenza jew hemm esperjenza limitata biss bit-trattamenti li ġejjin li jistgħu jżidu rriskju ta' ħruġ ta' demm meta jintużaw fl-istess ħin ma' Pradaxa: mediċini kontra l-koagulazzjoni taddemm bħal eparina mhux frazzjonata (UFH - unfractionated heparin), eparini b'piż molekulari baxx (LMWH - low molecular weight heparins), u derivattivi tal-eparina (fondaparinux, desirudin), prodotti mediċinali trombolitiċi, u antagonisti tal-vitamina K, rivaroxaban jew mediċini kontra l-koagulazzjoni tad-demm orali oħrajn (ara sezzjoni 4.3), u prodotti mediċinali kontra l-aggregazzjoni tal-plejtlits bħal antagonisti tar-riċettur GPIIb/IIIa, ticlopidine, prasugrel, ticagrelor, dextran, u sulfinpyrazone (ara sezzjoni 4.4).
English: RE-SONATE demonstrated dabigatran etexilate was superior to placebo for the prevention of recurrent symptomatic DVT/PE events including unexplained deaths, with a risk reduction from 5.6 % to 0.4 % (relative risk reduction 92 % based on hazard ratio ) during the treatment period (p<0.0001).
Maltese: RE-SONATE wera li dabigatran etexilate kien superjuri għal plaċebo għall-prevenzjoni ta' avvenimenti ta' DVT/PE rikorrenti sintomatiċi li jinkludu imwiet mhux spjegabbli, bi tnaqqis firriskju minn 5.6% għal 0.4% (tnaqqis fir-riskju relattiv ta' 92% ibbażat fuq il-proporzjon ta' periklu) matul il-perjodu ta' kura (p<0.0001).
English: Indication SPAF and DVT/PE
Maltese: Indikazzjoni SPAF u DVT/PE
English: Mean on-therapy follow-up time was 18.3 months.
Maltese: Iż-żmien medju ta' segwitu fuq terapija kien ta' 18.3 xhur.
English: 2015;131:157-164] in more than 134,000 elderly patients with NVAF in the United States (contributing more than 37,500 patientyears of on-therapy follow-up time) dabigatran etexilate (84 % patients treated with 150 mg bid, 16 % patients treated with 75 mg bid) was associated with a reduced risk of ischemic stroke (hazard ratio 0.80, 95 % confidence interval [CI] 0.67 - 0.96), intracranial haemorrhage (hazard ratio 0.34, CI 0.26 - 0.46), and mortality (hazard ratio 0.86, CI 0.77 - 0.96) and increased risk of gastrointestinal bleeding (hazard ratio 1.28, CI 1.14 - 1.44) compared to warfarin.
Maltese: Barra dan, fi studju mhux ta' intervent [Graham DJ et al., Circulation. 2015;131:157-164] f'aktar minn 134,000 pazjent anzjan b'NVAF fl-Istati Uniti (li jikkontribwixxu aktar minn 37,500 sena ta' pazjent ta' żmien ta' segwitu fuq it-terapija) dabigatran etexilate (84 % tal-pazjenti ttrattati b'150 mg bid, 16 % tal-pazjenti ttrattati b'75 mg bid) kien assoċjat ma' riskju mnaqqas ta' puplesija iskemika (proporzjon ta' periklu 0.80, intervall ta' kunfidenza [CI, confidence interval] ta' 95 % 0.67 - 0.96), emorraġija fil-kranju (proporzjon ta' periklu 0.34, CI 0.26 - 0.46), u mortalità (proporzjon ta' periklu 0.86, CI 0.77 - 0.96) u riskju akbar ta' fsada gastro-intestinali (proporzjon ta' periklu 1.28, CI 1.14 - 1.44) meta mqabbel ma' warfarin.
English: The volume of distribution of dabigatran of 60-70 L exceeded the volume of total body water indicating moderate tissue distribution of dabigatran.
Maltese: Il-volum tad-distribuzzjoni ta' dabigatran ta' 60-70 L qabeż il-volum tal-ilma totali tal-ġisem, li jindika distribuzzjoni moderata ta' dabigatran fit-tessut.
English: If possible, Pradaxa should be discontinued at least 24 hours before invasive or surgical procedures.
Maltese: Jekk ikun possibbli, Pradaxa għandu jitwaqqaf mill-inqas 24 siegħa qabel proċeduri invażivi jew kirurġiċi.
English: PHARMACEUTICAL FORM AND CONTENTS 60x1 hard capsules.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60x1 kapsula iebsa.
English: The increase was statistically significant in this study (p=0.022).
Maltese: Iżżieda kienet statistikament sinifikanti f'dan l-istudju (p=0.022).
English: • CrCL ≥ 50 mL/min, VKA should be started 3 days before discontinuing Pradaxa
Maltese: • CrCL ≥ 50 mL/min, VKA għandu jinbeda 3 ijiem qabel ma jitwaqqaf Pradaxa
English: This has been confirmed by in vivo studies with healthy volunteers, who did not show any interaction between this treatment and the following active substances: atorvastatin (CYP3A4), digoxin (P-gp transporter interaction) and diclofenac (CYP2C9).
Maltese: Dan kien ikkonfermat minn studji in vivo f'voluntiera b'saħħithom, li ma wrew lebda interazzjoni bejn din il-kura u s-sustanzi attivi li ġejjin: atorvastatin (CYP3A4), digoxin (interazzjoni tal-P-gp tat-trasportatur) u diclofenac (CYP2C9).
English: - The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, and hypromellose.
Maltese: - Il-qoxra tal-kapsula fiha carrageenan, potassium chloride, titanium dioxide, indigo carmine, u hypromellose.
English: Tear off one individual blister from the blister card along the perforated line
Maltese: Ċarrat folja waħda individwali mill-blister card tul is-sinjal perforat
English: Hazard ratio vs placebo (95% confidence interval)
Maltese: Proporzjon ta' periklu kontra plaċebo (95% intervall ta' kunfidenza)
English: Pradaxa 110 mg hard capsules dabigatran etexilate
Maltese: Pradaxa 110 mg kapsuli iebsin dabigatran etexilate
English: In the three active controlled DVT/PE phase III studies, a higher rate of MI was reported in patients who received dabigatran etexilate than in those who received warfarin: 0.4% vs. 0.2% in the shortterm RE-COVER and RE-COVER II studies; and 0.8% vs. 0.1% in the long-term RE-MEDY trial.
Maltese: III dwar DVT/PE ikkontrollati u attivi, rata ogħla ta' MI ġiet irrappurtata f'pazjenti li rċivew dabigatran etexilate milli f'dawk li rċivew warfarin: 0.4% kontra 0.2% fl-istudji fuq żmien qasir RE-COVER u RE-COVER II; u 0.8% kontra 0.1% fil-prova fit-tul RE-MEDY.
English: Musculoskeletal and connective tissue disorders Haemarthrosis
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Emartrożi
English: • CrCL ≥ 30-< 50 mL/min, VKA should be started 2 days before discontinuing Pradaxa
Maltese: • CrCL ≥ 30-< 50 mL/min, VKA għandu jinbeda jumejn qabel ma jitwaqqaf Pradaxa
English: Pradaxa is available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsules in aluminium perforated unit dose blisters.
Maltese: Pradaxa hu disponibbli f'pakketti li fihom 10 x 1, 30 x 1 jew 60 x 1 kapsuli f'folji ta' l-aluminju perforat tad-doża ta' l-unità.
English: Low (34-35 %) concentration independent binding of dabigatran to human plasma proteins was observed.
Maltese: Twaħħil baxx (34-35%) indipendenti mill-konċentrazzjoni ta' dabigatran mal-proteini tal-plażma umana kien osservat.
English: Clinical trials in Venous Thromboembolism (VTE) prophylaxis following major joint replacement surgery
Maltese: Provi kliniċi fil-profilassi ta' Tromboemboliżmu Venuż (VTE) wara operazzjoni maġġuri tas-sostituzzjoni tal-ġogi
English: After an intravenous dose, the dabigatran-derived radioactivity was eliminated primarily in the urine (85 %).
Maltese: Wara doża ġol-vina, ir-radjuattività miksuba minn dabigatran kienet eliminata primarjament fl-awrina (85%).
English: The majority (80.8 %) of the subjects were in the ≥ 50 kg and < 100 kg category with no clear difference detected (see sections 4.2 and 4.4).
Maltese: 8%) tal-persuni kienu fil-kategorija ta' ≥ 50 kg u < 100 kg mingħajr ma ġiet osservata l-ebda differenza ċara (ara sezzjonijiet 4.2 u 4.4).
English: For the primary endpoint, stroke and systemic embolism, no subgroups (i.e., age, weight, gender, renal function, ethnicity, etc.) were identified with a different risk ratio compared to warfarin.
Maltese: Għall-punt aħħari primarju, puplesija u emboliżmu sistemiku, l-ebda sottogruppi (i.e., età, piż, sess, funzjoni tal-kliewi, etniċità, eċċ.) ma ġew identifikati bi proporzjon ta' riskju differenti meta mqabbla ma' warfarin.
English: RE-NOVATE (hip) Treated patients N Number of MBE N(%) RE-MODEL (knee) Treated patients N Number of MBE N(%)
Maltese: Numru ta' MBE N(%) RE-MODEL (irkoppa) Pazjenti kkurati N
English: Use of proton-pump inhibitors
Maltese: Użu ta' inibituri tal-pompa tal-protoni
English: According to the relatively low exposure, coagulation at 72 hrs (presumed dabigatran trough level at steady state or close to steady state conditions) was only slightly prolonged with aPTT at maximum 1.60 fold, ECT 1.86 fold, and Hemoclot
Maltese: Skont l-esponiment relattivament baxx, il-koagulazzjoni wara 72 siegħa (livell minimu ssoponut ta' dabigatran fl-istat fiss jew qrib il-kondizzjonijiet fl-istat fiss) kien biss ftit imtawwal b'aPTT fil-livell massimu ta' 1.60 darbiet, ECT 1.86 darbiet, u Hemoclot
English: In the studied patient population of RE-MODEL and RE-NOVATE (5,539 patients treated), 51 % suffered from concomitant hypertension, 9 % from concomitant diabetes, 9 % from concomitant coronary artery disease and 20 % had a history of venous insufficiency.
Maltese: Fil-popolazzjoni ta' pazjenti li kienu studjati ta' RE-MODEL u RE-NOVATE (5,539 pazjenti kkurati), 51% kienu jbatu minn pressjoni għolja fl-istess ħin, 9% minn dijabete fl-istess ħin; 9% minn mard ta' l-arterji koronarji fl-istess ħin, u 20% kellhom storja medika ta' insuffiċjenza venuża.
English: Rectal haemorrhage
Maltese: Emorraġija fir-rektum
English: - The capsule shell contains carrageenan, potassium chloride, titanium dioxide, and hypromellose.
Maltese: - Il-qoxra tal-kapsula fiha carrageenan, potassium chloride, titanium dioxide, u hypromellose.
English: Uncommon Respiratory, thoracic and mediastinal disorders Epistaxis
Maltese: Mhux komuni Disturbi respiratorji, toraċiċi u medjastinali Epistassi
English: There were 5897 patients enrolled, representing 49 % of patients originally randomly assigned to receive dabigatran etexilate in RE-LY and 86 % of RELY-ABLE-eligible patients.
Maltese: Kien hemm 5897 pazjent irreġistrati, li jirrappreżentaw 49% tal-pazjenti oriġinarjament assenjati b'mod każwali biex jirċievu dabigatran etexilate f'RE-LY u 86% ta' pazjenti eliġibbli għal RELY-ABLE.
English: Treatment with Pradaxa in patients with severe renal impairment (CrCL < 30 mL/min) is contraindicated (see section 4.3).
Maltese: Il-kura bi Pradaxa f'pazjenti b'indeboliment renali sever (CrCL ta' < 30 mL/min) hi kontraindikata (ara sezzjoni 4.3).
English: • Strong P-gp inhibitors (see section 4.3 and
Maltese: • Inibituri qawwija ta' P-gp (ara sezzjoni 4.3 u 4.5)
English: • Patients with severe renal impairment (CrCL < 30 mL/min)
Maltese: • Pazjenti b'indeboliment sever renali (CrCL < 30 mL/min)
English: Based on dabigatran concentrations and clinical assessment, the dose was subsequently modified to a target dose of 2.14 (± 10 %) mg/kg of dabigatran etexilate (100 % of the adult dose adjusted for the patient's weight).
Maltese: Ibbażat fuq konċentrazzjonijiet ta' dabigatran u l-evalwazzjoni klinika, id-doża ġiet sussegwentement modifikata għal doża fil-mira ta' 2.14 (± 10%) mg/kg ta' dabigatran etexilate (100% tad-doża fl-adulti aġġustata għall-piż tal-pazjent).
English: • Low body weight (< 50 kg)
Maltese: • Piż baxx tal-ġisem (< 50 kg)
English: Subjects randomized All-cause mortality Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value Vascular mortality Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value % refers to yearly event rate
Maltese: Persuni magħżula b'mod każwali Mortalità mill-kawżi kollha Inċidenzi (%) Proporzjon ta' periklu vs. warfarin (95% CI) valur p Mortalità vaskulari Inċidenzi (%) Proporzjon ta' periklu vs. warfarin (95% CI) valur p % tirreferi għar-rata annwali ta' każijiet