FrancophonIA/ELRC3.0 huggingface dataset:
English: In the clinical study 1160.88 in total, 9 adolescent patients (age 12 to < 18 years) with diagnosis of primary VTE received an initial oral dose of dabigatran etexilate of 1.71 (± 10 %) mg/kg bodyweight.
Maltese: 88 b'kollox, 9 pazjenti adolexxenti (età minn 12 sa < 18-il sena) b'dijanjosi ta' VTE primarja, irċivew doża orali inizjali ta' dabigatran etexilate ta' 1.71 (± 10%) mg/kg piż tal-ġisem.
English: Posaconazole Posaconazole also inhibits P-gp to some extent but has not been clinically studied.
Maltese: Posaconazole jinibixxi wkoll P-gp sa ċertu punt iżda ma ġiex studjat klinikament.
English: INFORMATION IN BRAILLE Pradaxa 75 mg (only applicable for folding box, not applicable for bottle label)
Maltese: INFORMAZZJONI BIL-BRAILLE Pradaxa 75 mg (japplika biss għall-kaxxa li tintewa, mhux applikabbli għat-tikketta tal-flixkun)
English: Cartons containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated aluminium unit dose blisters.
Maltese: Kaxxi tal-kartun li fihom 10 x 1, 30 x 1 jew 60 x 1 kapsuli ibsin f'folji perforati tal-aluminju b'doża waħda.
English: Pradaxa is not recommended in children and adolescents below 18 years old.
Maltese: Pradaxa mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: - if you are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation.
Maltese: - jekk qed tieħu cyclosporine orali, mediċina biex jiġi evitat ir-rifjut ta' organu wara trapjant.
English: th percentile of aPTT at trough (20-28 hours after the previous dose) was 51 seconds, which would be 1.3-fold upper limit of normal.
Maltese: th 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: INFORMATION IN BRAILLE Pradaxa 110 mg (only applicable for folding box, not applicable for bottle label)
Maltese: INFORMAZZJONI BIL-BRAILLE Pradaxa 110 mg (japplika biss għall-kaxxa li tintewa, mhux applikabbli għat-tikketta tal-flixkun)
English: A surgery / intervention should be delayed if possible until at least 12 hours after the last dose.
Maltese: Operazzjoni/intervent għandhom jiġu ttardjati jekk ikun possibbli b'mill-inqas 12-il siegħa wara l-aħħar doża.
English: In the RE-MODEL trial (knee replacement) treatment was for 6-10 days and in the RE-NOVATE trial (hip replacement) for 28-35 days.
Maltese: Fil-prova RE-MODEL (sostituzzjoni tal-irkoppa) il-kura kienet għal 6-10 ijiem u fil-prova RENOVATE (sostituzzjoni tal-ġenbejn) għal 28-35 jum.
English: Direct acting Oral Anticoagulants (DOACs) including dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Maltese: Orali b'azzjoni diretta (DOACs) inklużi dabigatran etexilate mhumiex rakkomandati għal pazjenti bi storja ta' trombożi li huma dijanjostikati bis-sindrome antifosfolipid.
English: Dabigatran inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.
Maltese: Dabigatran jinibixxi t-thrombin ħieles, it-thrombin imwaħħal mal-fibrin u l-aggregazzjoni tal-plejtlits ikkaġunata mit-thrombin.
English: Rare Injury, poisoning and procedural complications Traumatic haemorrhage
Maltese: Rari Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Emorraġija trawmatika
English: 95% confidence interval non-inferiority margin Secondary efficacy endpoints Recurrent symptomatic VTE and allcause deaths
Maltese: 95% intervall ta' kunfidenza marġini ta' non-inferjorità Punti aħħarin għall-effikaċja sekondarja
English: Hence, the integrity of the HPMC capsules should always be preserved in clinical use to avoid unintentionally increased bioavailability of dabigatran etexilate (see section 4.2).
Maltese: Għaldaqstant, l-integrità tal-kapsuli HPMC għandha tinżamm dejjem waqt l-użu kliniku biex tiġi evitata żieda mhux intenzjonata tal-bijodisponibilità ta' dabigatran etexilate (ara sezzjoni 4.2).
English: Interaction with P-gp inducers
Maltese: Interazzjoni ma' indutturi ta' P-gp
English: 95 % confidence interval Symptomatic DVT 95 % confidence interval Symptomatic PE
Maltese: 95% intervall ta' kunfidenza DVT sintomatika
English: Table 2: Duration of use for SPAF and DVT/PE Indication Duration of use
Maltese: Tabella 2: It-tul tal-użu għal SPAF u DVT/PE Indikazzjoni Tul tal-użu
English: (maintenance dose) with 110 mg dabigatran etexilate increased the adjusted dabigatran AUCτ,ss and Cmax,ss 1.26-fold and 1.29-fold, respectively, compared with dabigatran etexilate given alone.
Maltese: (doża ta' manteniment) ma' 110 mg ta' dabigatran etexilate żied l-AUCτ,ss u s-Cmax,ss aġġustati ta' dabigatran b'1.26 darba u 1.29 darba, rispettivament, meta mqabbel ma' dabigatran etexilate mogħti waħdu.
English: RELY-ABLE (Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial)
Maltese: RELY-ABLE (Estensjoni multiċenetrika fit-tul tal-kura b'dabigatran f'pazjenti b'fibrillazzjoni atrijali li lestew il-prova RE-LY)
English: Indication for anticoagulation
Maltese: Indikazzjoni għal antikoagulazzjoni
English: Dose of Pradaxa
Maltese: Tiħux Pradaxa
English: Pradaxa 110 mg twice daily vs. Warfarin
Maltese: Pradaxa 110 mg darbtejn kuljum vs. warfarin
English: The dabigatran AUC and Cmax were increased by about 1.6-fold and 1.5-fold, respectively.
Maltese: L-AUC u s-Cmax ta' dabigatran żdiedu b'madwar 1.6 darbiet u 1.5 darbiet, rispettivament.
English: INFORMATION IN BRAILLE Pradaxa 150 mg (only applicable for folding box, not applicable for bottle label)
Maltese: INFORMAZZJONI BIL-BRAILLE Pradaxa 150 mg (japplika biss għall-kaxxa li tintewa, mhux applikabbli għat-tikketta tal-flixkun)
English: Blister and bottle 3 years
Maltese: Folja u flixkun 3 snin
English: clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid) - Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin - Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil).
Maltese: - Mediċini biex inaqqsu t-tagħqid tad-demm (eż. warfarin, phenprocoumon, acenocoumarol, eparina, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid) - Mediċini għat-trattament ta' infezzjonijiet fungali (eż. ketoconazole, itraconazole), ħlief jekk jiġu applikati fuq il-ġilda biss - Mediċini għat-trattament ta' taħbit mhux normali tal-qalb (eż. amiodarone, dronedarone, quinidine, verapamil).
English: Duration of dabigatran etexilate treatment ranged from 6 to 36 months (median 534.0 days).
Maltese: It-tul ta' żmien tal-kura b'dabigatran etexilate varja minn 6 sa 36 xahar (medjan ta' 534.0 jum).
English: Pradaxa can be given as soon as the INR is < 2.0.
Maltese: Pradaxa jista' jingħata hekk kif l-INR ikun ta' < 2.0.
English: Table 8 shows the adverse reactions ranked under headings of System Organ Classes (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: Tabella 8 turi r-reazzjonijiet avversi kklassifikati skond kategoriji tas-Sistema tal-Klassifika tal-Organi (SOC) 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: dTT [ng/mL] ECT [x-fold upper limit of normal]
Maltese: ECT [x-darbiet tal-limitu ta' fuq tannormal]
English: Table 1: Dose recommendations and duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery
Maltese: Tabella 1: Rakkomandazzjonijiet tad-doża u tul tat-terapija għall-prevenzjoni primarja ta' tromboemboliżmu venuż f'operazzjoni ortopedika
English: Table 11 shows the adverse reactions identified from studies and post-marketing data in the indications primary VTE prevention after hip or knee replacement surgery, prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation, DVT/PE treatment and DVT/PE prevention.
Maltese: Tabella 11 turi r-reazzjonijiet avversi identifikati minn studji u data ta' wara t-tqegħid fis-suq flindikazzjonijiet għall-prevenzjoni ta' VTE primarja wara operazzjoni tas-sostituzzjoni tal-ġenbejn jew tal-irkoppa, prevenzjoni ta' puplesija tromboembolika u emboliżmu sistemiku f'pazjenti bi programm ta' fibrillazzjoni atrijali, kura għal DVT/PE u prevenzjoni ta' DVT/PE.
English: The half-life was independent of dose.
Maltese: Il-half-life kienet indipendenti mid-doża.
English: In view of the long half-life of amiodarone the potential for an interaction may exist for weeks after discontinuation of amiodarone (see sections 4.2 and 4.4).
Maltese: Minħabba l-half-life twila ta' amiodarone, il-potenzjal ta' interazzjoni jista' jeżisti għal ġimgħat wara t-twaqqif ta' amiodarone (ara sezzjonijiet 4.2 u 4.4).
English: • Moderate renal impairment (30-50 mL/min
Maltese: • Indeboliment moderat tal-kliewi (30-50 mL/min CrCL)
English: Patients who receive concomitant verapamil*, amiodarone, quinidine
Maltese: Pazjenti li jirċievu verapamil*, amiodarone u quinidine fl-istess ħin
English: EU/1/08/442/001 EU/1/08/442/002 EU/1/08/442/003 EU/1/08/442/004 EU/1/08/442/017
Maltese: EU/1/08/442/001 EU/1/08/442/002 EU/1/08/442/003 EU/1/08/442/004
English: The incidence of the primary endpoint was 15.4 % (151 patients) in the dabigatran etexilate 110 mg dual-therapy group as compared with 26.9 % (264 patients) in the warfarin triple-therapy group (HR 0.52; 95% CI 0.42, 0.63; P<0.0001 for non-inferiority and P<0.0001 for superiority) and 20.2 % (154 patients) in the dabigatran etexilate 150 mg dual-therapy group as compared with 25.7 % (196 patients) in the corresponding warfarin triple-therapy group (HR 0.72; 95% CI 0.58, 0.88; P<0.0001 for non-inferiority and P=0.002 for superiority).
Maltese: 4% (151 pazjent) fil-grupp ta' terapija doppja b'dabigatran etexilate 110 mg meta mqabbla ma' 26.9% (264 pazjent) fil-grupp ta' terapija tripla b'warfarin (HR 0.52; CI ta' 95% 0.42, 0.63; P<0.0001 għal nuqqas ta' inferjorità u P<0.0001 għal superjorità) u 20.2% (154 pazjent) fil-grupp ta' terapija doppja b'dabigatran etexilate 150 mg meta mqabbel ma' 25.
English: The clinical evidence for the efficacy of dabigatran etexilate is derived from the RE-LY study (Randomized Evaluation of Long-term anticoagulant therapy) a multi-centre, multi-national, randomized parallel group study of two blinded doses of dabigatran etexilate (110 mg and 150 mg twice daily) compared to open-label warfarin in patients with atrial fibrillation at moderate to high risk of stroke and systemic embolism.
Maltese: L-evidenza klinika għall-effikaċja ta' dabigatran etexilate tinkiseb mill-istudju RE-LY (Randomized Evaluation of Long-term anticoagulant therapy), studju multiċentriku, multinazzjonali, grupp parallel li fih il-parteċipanti ntgħażlu b'mod każwali, ta' żewġ dożi blinded ta' dabigatran etexilate (110 mg u 150 mg darbtejn kuljum) meta mqabbla ma' warfarin open-label f'pazjenti b'fibrillazzjoni atrijali f'riskju moderat sa għoli ta' puplesija u emboliżmu sistemiku.
English: Table 8: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Maltese: Tabella 8: Interazzjonijiet ma' mediċini kontra l-koagulazzjoni tad-demm u prodotti mediċinali kontra l-aggregazzjoni tal-plejtlits
English: SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in RE-LY in all treatment groups,
Maltese: SSRIs, SNRIs SSRIs u SNRIs żiedu r-riskju ta' ħruġ ta' demm f'RE-LY fil-gruppi kollha ta' trattament.
English: For patients with NVAF treated for prevention of stroke and systemic embolism with 150 mg dabigatran etexilate twice daily,
Maltese: Għal pazjenti b'NVAF kkurati għal prevenzjoni ta' puplesija u emboliżmu sistemiku b'150 mg ta' dabigatran etexilate darbtejn kuljum,
English: In the RE-LY study, a total of 18,113 patients were randomized, with a mean age of 71.5 years and a mean CHADS2 score of 2.1.
Maltese: Fl-istudju RE-LY, total ta' 18,113-il pazjent intgħażlu b'mod każwali, b'medja ta' età ta' 71.5 sena u medja tal-punteġġ CHADS2 ta' 2.1.
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 ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
Maltese: Prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'fibrillazzjoni atrijali mhux valvulari (NVAF) b'wieħed jew aktar fatturi ta' riskju bħal puplesija fil-passat jew attakk iskemiku li jgħaddi malajr (TIA); età ta' ≥ 75 sena; insuffiċjenza tal-qalb (NYHA Klassi ≥ II); dijabete mellitus; pressjoni għolja.
English: Pradaxa 150 mg are hard capsules with an opaque, light blue-coloured cap and an opaque, white body.
Maltese: Pradaxa 150 mg huma kapsuli ibsin b'għatu blu ċar u opak, u korp abjad, opak.
English: CrCL)
Maltese: diclofenac)
English: Intracranial bleeding
Maltese: Emorraġija trawmatika
English: There are no data available for 110 mg twice daily Pradaxa treatment in patients undergoing catheter ablation for atrial fibrillation (see section 4.2).
Maltese: M'hemm l-ebda data disponibbli għal trattament bi Pradaxa 110 mg darbtejn kuljum f'pazjenti li jkollhom asportazzjoni talkateter għal fibrillazzjoni atrijali (ara sezzjoni 4.2).
English: Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma.
Maltese: Dabigatran hu inibitur potenti, kompetittiv, riversibbli u dirett tat-thrombin, u hu l-prinċipju attiv ewlieni fil-plażma.
English: Haemorrhagic risk
Maltese: Evalwazzjoni tal-benefiċċju u tar-riskju
English: Pradaxa 150 mg twice daily vs. Warfarin
Maltese: Pradaxa 150 mg darbtejn kuljum vs. warfarin
English: There was no stroke/systemic embolism/TIA (composite) event in the dabigatran etexilate arm, and one event (TIA) in the warfarin arm from the time of ablation and until 8 weeks post-ablation.
Maltese: Ma kien hemm l-ebda avveniment (kompost) ta' puplesija/emboliżmu sistemiku/TIA filgrupp tal-istudju b'dabigatran etexilate, u avveniment wieħed (TIA) fil-grupp tal-istudju b'warfarin minn meta twettqet l-asportazzjoni u sa 8 ġimgħat wara l-asportazzjoni.
English: 150 mg once daily N (%)
Maltese: 150 mg darba kuljum N (%)
English: Excessive anticoagulation may require interruption of Pradaxa treatment.
Maltese: Antikoagulazzjoni eċċessiva jista' jkollha bżonn ta' interruzzjoni tat-trattament bi Pradaxa.
English: In patients with moderate renal impairment (CrCL 30-50 mL/min), a dose reduction is recommended (see table 1 above and sections 4.4 and 5.1).
Maltese: F'pazjenti b'indeboliment renali moderat (CrCL 30-50 mL/min), huwa rakkomandat tnaqqis fid-doża (ara tabella 1 hawn fuq u sezzjonijiet 4.4 u 5.1).
English: Relative risk was highest in patients ≥ 75 years.
Maltese: Ir-riskju relattiv kien l-ogħla f'pazjenti li kellhom ≥ 75 sena.
English: Elderly patients outside of the United States (≥80 years of age for all countries, ≥70 years of age for Japan) were randomly assigned to the dabigatran etexilate 110 mg dual-therapy group or the warfarin triple-therapy group.
Maltese: Pazjenti anzjani barra mill-Istati Uniti (età ta' ≥80 sena għall-pajjiżi kollha, età ta' ≥70 sena għall-Ġappun) ġew assenjati b'mod każwali għall-grupp ta' terapija doppja b'dabigatran etexilate 110 mg jew għall-grupp ta' terapija tripla b'warfarin.
English: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Maltese: Prevenzjoni primarja ta' avvenimenti tromboemboliċi venużi f'pazjenti adulti li kellhom operazzjoni mhux urġenti tas-sostituzzjoni totali tal-ġenbejn jew operazzjoni tas-sostituzzjoni sħiħa ta' l-irkoppa.
English: • an aPTT ratio greater than 2-fold upper limit of normal (aPTT prolongation of about 80 seconds), at trough (10-16 hours after the previous dose) reflects the 90
Maltese: • proporzjon akbar ta' aPTT mid-doppju tal-limitu ta' fuq tan-normal (titwil ta' aPTT ta' madwar 80 sekonda), fil-livell minimu (10-16-il siegħa wara d-doża ta' qabel) jirrifletti in-90
English: Immune system disorder Drug hypersensitivity
Maltese: Disturbi fis-sistema immuni Sensittività eċċessiva għall-mediċina
English: Clarithromycin When clarithromycin (500 mg twice daily) was administered together with dabigatran etexilate in healthy volunteers, increase of AUC by about 1.19-fold and Cmax by about 1.15-fold was observed.
Maltese: Clarithromycin Meta clarithromycin (500 mg darbtejn kuljum) ingħata flimkien ma' dabigatran etexilate f'voluntiera f'saħħithom, kienet osservata żieda tal-AUC b'madwar 1.19-il darba u tas-Cmax b'madwar 1.15-il darba.
English: There is no relevant use of Pradaxa in the paediatric population for the indication of prevention of stroke and systemic embolism in patients with NVAF.
Maltese: M'hemm l-ebda użu rilevanti ta' Pradaxa fil-popolazzjoni pedjatrika għall-indikazzjoni ta' prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'NVAF.
English: Tacrolimus has been found in vitro to have a similar level of inhibitory effect on Pgp as that seen with itraconazole and cyclosporine.
Maltese: Instab li tacrolimus in vitro kellu livell simili ta' effett inibitorju fuq P-gp bħal dak li ġie osservat b'itraconazole u cyclosporine.
English: Spinal anaesthesia/epidural anaesthesia/lumbar puncture
Maltese: Loppju fil-kolonna vertebrali/loppju epidurali/titqiba fis-sinsla
English: Pradaxa 75 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Maltese: Pradaxa 75 mg kapsuli iebsin huma disponibbli wkoll fi fliexken tal-polypropylene (plastik) b'60 kapsula iebsa.
English: th percentile of dabigatran plasma concentrations was 67 ng/mL, measured at trough (20-28 hours after the previous dose) (see section 4.4 and 4.9),
Maltese: th percentile tal-konċentrazzjonijiet fil-plażma ta' dabigatran kienet ta' 67 ng/mL, imkejla fil-livell minimu (20-28 siegħa wara d-doża ta' qabel) (ara sezzjoni 4.4 u 4.9),
English: Table 23: Half-life of total dabigatran in healthy subjects and subjects with impaired renal function.
Maltese: Tabella 23: Il-half-life ta' dabigatran totali f'persuni b'saħħithom u persuni b'indeboliment fil-funzjoni tal-kliewi.
English: EU/1/08/442/009 10 x 1 capsules EU/1/08/442/01030 x 1 capsules EU/1/08/442/011 60 x 1 capsules EU/1/08/442/019 60 x 1 capsules
Maltese: EU/1/08/442/009 10 x 1 kapsula EU/1/08/442/010 30 x 1 kapsula EU/1/08/442/011 60 x 1 kapsula EU/1/08/442/019 60 x 1 kapsula
English: 2-3 days before (> 48 hours)
Maltese: 4 ijiem qabel jumejn sa 3 ijiem qabel (> 48 siegħa)
English: In a small number of volunteers with severe renal insufficiency (CrCL 10-30 mL/min), the exposure (AUC) to dabigatran was approximately 6 times higher and the half-life approximately 2 times longer than that observed in a population without renal insufficiency (see sections 4.2, 4.3 and 4.4).
Maltese: F'numru żgħir ta' voluntiera b'insuffiċjenza severa renali (CrCL 10-30 mL/min), l-espożizzjoni (AUC) għal dabigatran kienet ta' madwar 6 darbiet ogħla u l-half-life ta' madwar darbtejn itwal minn dik osservata f'popolazzjoni mingħajr insuffiċjenza renali (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: Table 9: Number of patients studied, maximum daily dose in phase III studies Indication
Maltese: Tabella 9: Numru ta' pazjenti studjati, doża massima ta' kuljum fl-istudji ta' fażi
English: Table 6: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Maltese: Tabella 6: Interazzjonijiet ma' mediċini kontra l-koagulazzjoni tad-demm u prodotti mediċinali kontra l-aggregazzjoni tal-plejtlits
English: Standard risk
Maltese: Riskju standard jumejn qabel
English: Dabigatran etexilate and dabigatran are not metabolised by the cytochrome P450 system and have no in vitro effects on human cytochrome P450 enzymes.
Maltese: Dabigatran etexilate u dabigatran mhumiex metabolati mis-sistema taċ-ċitokrom P450 u m'għandhom l-ebda effetti in vitro fuq l-enzimi taċ-ċitokrom P450 tal-bniedem.
English: EU/1/08/442/005 EU/1/08/442/006 EU/1/08/442/007 EU/1/08/442/008 EU/1/08/442/014 EU/1/08/442/015 EU/1/08/442/018
Maltese: EU/1/08/442/005 EU/1/08/442/006 EU/1/08/442/007 EU/1/08/442/008 EU/1/08/442/014
English: Capsules with light blue, opaque cap and light blue, opaque body of size 1 filled with yellowish pellets.
Maltese: Kapsuli b'għatu blu ċar u opak, u korp blu ċar, opak ta' daqs 1 mimli bi pritkuni jagħtu fl-isfar.
English: Patients with moderate renal impairment (CrCL 30-50 mL/min)
Maltese: Pazjenti b'indeboliment moderat tal-kliewi (CrCL 30-50 mL/min)
English: ASA Co-administration of ASA and 150 mg dabigatran etexilate twice daily may increase the risk for any bleeding from 12 % to 18 % and 24 % with 81 mg and 325 mg ASA, respectively (see section 4.4).
Maltese: ASA L-għoti flimkien ta' ASA u 150 mg ta' dabigatran etexilate darbtejn kuljum jista' jżid irriskju għal kwalunkwe ħruġ ta' demm minn 12% għal 18% u 24% b'81 mg u 325 mg ASA, rispettivament (ara sezzjoni 4.4).
English: Capsule content
Maltese: KAPSULI
English: Furthermore, bleeding occurred in 19.4 % of patients in the DVT/PE prevention trial RE-MEDY and in 10.5 % of patients in the DVT/PE prevention trial RE-SONATE.
Maltese: Flimkien ma' dan, ħruġ ta' demm seħħ f'19.4 % tal-pazjenti fil-prova dwar il-prevenzjoni ta' DVT/PE, RE-MEDY, u f'10.5 % talpazjenti fil-prova dwar il-prevenzjoni ta' DVT/PE, RE-SONATE.
English: Black printing ink Shellac
Maltese: Linka sewda ta' l-istampar Shellac
English: Multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) in perforated aluminium unit dose blisters.
Maltese: Pakkett multiplu li jkun fih 3 pakketti ta' 60 x 1 kapsuli ibsin (180 kapsuli ibsin) f'folji perforati talaluminju b'doża waħda.
English: Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
Maltese: Kull kapsula iebsa fiha 75 mg dabigatran etexilate (bħala mesilate).
English: Symptomatic PE
Maltese: PE sintomatika
English: 220 mg once daily N (%)
Maltese: 220 mg darba kuljum N (%)
English: Patients who underwent Percutaneous coronary intervention (PCI) with stenting
Maltese: Intervent koronarju perkutanju (PCI - percutaneous coronary intervention) bi stent (SPAF)
English: The anticoagulant activity of dabigatran decreased with decreasing plasma concentrations and the PK/PD relationship was not affected by the procedure.
Maltese: L-attività antikoagulanti ta' dabigatran naqset mat-tnaqqis tal-konċentrazzjonijiet fil-plażma u r-relazzjoni PK/PD ma ġietx affettwata mill-proċedura.
English: RE-MEDY, warfarin controlled study, enrolled patients already treated for 3 to 12 months with the need for further anticoagulant treatment and RE-SONATE, the placebo controlled study, enrolled patients already treated for 6 to 18 months with Vitamin K inhibitors.
Maltese: RE-MEDY, studju kkontrollat b'warfarin, irreġistra pazjenti li kienu diġà kkurati għal 3 sa 12-il xahar bil-ħtieġa ta' kura addizzjonali kontra l-koagulazzjoni, u RE-SONATE, studju kkontrollat bi plaċebo li rreġistrata pazjenti diġà kkurati għal 6 sa 18-il xahar b'inibituri ta' Vitamina K.
English: Table 7: Other interactions
Maltese: Tabella 7:
English: In total, 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, 22% ta' pazjenti b'fibrillazzjoni atrijali kkurati għall-prevenzjoni ta' puplesija u emboliżmu sistemiku (kura fit-tul għal sa 3 snin), 14% tal-pazjenti kkurati għal DVT/PE u 15% tal-pazjenti kkurati għal prevenzjoni ta' DVT/PE kellhom reazzjonijiet avversi.
English: Hazard ratio vs warfarin (95% confidence interval)
Maltese: Proporzjon ta' periklu kontra warfarin (95% intervall ta' kunfidenza)