FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients randomized to warfarin, the median time in therapeutic range (INR 2.0 to 3.0) was 60.6 %.
Maltese: Għal pazjenti li ntgħażlu b'mod każwali għal warfarin, il-medjan taż-żmien fil-medda terapewtika (INR 2.0 għal 3.0) kien ta' 60.6%.
English: The ECT was not measured in patients treated for prevention of VTEs after hip or knee replacement surgery with 220 mg dabigatran etexilate once daily.
Maltese: L-ECT ma tkejjilx f'pazjenti kkurati għal prevenzjoni ta' VTEs wara operazzjoni tas-sostituzzjoni talġenbejn jew tal-irkoppa b'220 mg ta' dabigatran etexilate darba kuljum.
English: Percutaneous coronary intervention (PCI) with stenting (SPAF) Patients with non valvular atrial fibrillation who undergo a PCI with stenting can be treated with Pradaxa in combination with antiplatelets after haemostasis is achieved (see section 5.1).
Maltese: Intervent koronarju perkutanju (PCI - percutaneous coronary intervention) bi stent (SPAF) Pazjenti b'fibrillazzjoni atrijali mhux valvulari li jgħaddu minn PCI bi stent jistgħu jiġu ttrattati bi Pradaxa flimkien ma' sustanzi kontra l-plejtlits wara li tinkiseb l-emostasi (ara sezzjoni 5.1).
English: Patients with mild and moderate renal impairment had at steady state an average 1.8-fold and 3.6-fold higher pre-dose dabigatran plasma concentrations compared with patients with CrCL > 80 mL/min, respectively.
Maltese: Pazjenti b'indeboliment ħafif u moderat tal-kliewi kellhom fl-istat fiss medja ta'konċentrazzjonijiet ta' dabigatran fil-plażma li kienu 1.8-darbiet u 3.6 darbiet ogħla minn dawk ta' qabel id-doża meta mqabbla ma' pazjenti b'CrCL ta' > 80 mL/min, rispettivament.
English: The trials, demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to the treatment with warfarin (non-inferiority margin for RE-COVER, and RE-COVER II: 3.6 for risk difference and 2.75 for hazard ratio).
Maltese: Il-provi wrew li l-kura b'dabigatran etexilate 150 mg darbtejn kuljum kienet mhux inferjuri għall-kura b'marġini ta' non-inferjorità ta' warfarin għal RE-COVER u RE-COVER II: 3.6 għad-differenza firriskju u 2.75 għall-proporzjon ta' periklu).
English: A coagulation test (see section 4.4) may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure.
Maltese: Test tal-koagulazzjoni (ara sezzjoni 4.4) jista' jgħin biex jidentifika pazjenti b'żieda fir-riskju ta' ħruġ ta' demm kkawżat minn espożizzjoni eċċessiva għal dabigatran.
English: Additional requirements in patients with mild to moderate renal impairment and in patients aged over 75 years:
Maltese: Ħtiġijiet addizzjonali f'pazjenti b'indeboliment minn ħafif sa moderat tal-kliewi u f'pazjenti li għandhom iktar minn 75 sena:
English: Table 13 shows bleeding events in pivotal study RE-MEDY testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Maltese: Tabella 13 turi avvenimenti ta' ħruġ ta' demm fl-istudju importanti ħafna RE-MEDY li ttestja lprevenzjoni ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE).
English: Hepatobiliary disorders Hepatic function abnormal/ Liver function Test abnormal
Maltese: Disturbi fil-fwied u fil-marrara Funzjoni tal-fwied anormali/Test tal-funzjoni talfwied anormali
English: Life-threatening bleeding was reported in 0.46 per 100 patient-years, intracranial haemorrhage in 0.17 per 100 patient-years and gastrointestinal bleeding in 0.60 per 100 patient-years.
Maltese: Fsada li kienet ta' periklu għall-ħajja kienet irrappurtata f'0.46 għal kull 100 sena ta' pazjent, emorraġija intrakranjali f'0.17 għal kull 100 sena ta' pazjent u fsada gastrointestinali f'0.60 għal kull 100 sena ta' pazjent.
English: Steady state (after day 3) geometric mean dabigatran peak plasma concentration, measured around 2 hours after 220 mg dabigatran etexilate administration, was 70.8 ng/mL, with a range of 35.2-162 ng/mL (25
Maltese: Il-medja ġeometrika tal-istat fiss (wara jum 3) tal-konċentrazzjoni massima ta' dabigatran fil-plażma, imkejla madwar 2 sigħat wara l-għoti ta' 220 mg ta' dabigatran etexilate, kienet ta' 70.8 ng/mL, b'medda ta' 35.2-162 ng/mL (medda ta' 25-75 percentwali).
English: Assessment of renal function prior to and during Pradaxa treatment
Maltese: Evalwazzjoni tal-funzjoni tal-kliewi qabel it-trattament u matul it-trattament bi Pradaxa
English: The effect was progressively decreased with administration of an extended release formulation (increase of Cmax by about 1.9-fold and AUC by about 1.7-fold) or administration of multiple doses of verapamil (increase of Cmax by about 1.6-fold and AUC by about 1.5-fold).
Maltese: L-effett tnaqqas b'mod progressiv bl-għoti ta' formulazzjoni li terħi b'mod estiż (żieda tas-Cmax b'madwar 1.9 darbiet u tal-AUC b'madwar 1.7 darbiet) jew l-għoti ta' dożi multipli ta' verapamil (żieda tas-Cmax b'madwar 1.6 darbiet u tal-AUC b'madwar 1.5 darbiet).
English: Table 17: Analysis of all cause and cardiovascular survival during the study period in RE-LY. Pradaxa 110 mg twice daily
Maltese: Tabella 17: Analiżi tal-kawżi kollha u sopravivenza kardjovaskulari matul il-perjodu tal-istudju f'RE-LY.
English: Potassium hydroxide
Maltese: Tfal u adolexxenti
English: • Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Pradaxa to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min) (see sections 4.3, 4.4 and 5.2).
Maltese: • Il-funzjoni tal-kliewi għandha tiġi evalwata billi tiġi kkalkulata t-tneħħija tal-krejatinina (CrCL) qabel il-bidu tal-kura bi Pradaxa biex jiġu esklużi pazjenti b'indeboliment sever tal-kliewi (i.e. CrCL < 30 mL/min) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 150 mg hard capsules
Maltese: Pradaxa 150 mg kapsuli ibsin
English: Thromboembolism in Orthopaedic Surgery
Maltese: Proċeduri kirurġiċi u mediċi Tnixxija tal-ferita
English: Tables 15-17 display details of key results in the overall population: Table 15: Analysis of first occurrence of stroke or systemic embolism (primary endpoint) during the study period in RE-LY. Pradaxa 110 mg twice daily
Maltese: Tabelli 15-17 juru dettalji tar-riżultati ewlenin fil-popolazzjoni totali: Tabella 15:
English: The recommended doses of Pradaxa in the indications SPAF, DVT and PE are shown in table 1.
Maltese: Id-dożi rakkomandati ta' Pradaxa fl-indikazzjonijiet SPAF, DVT u PE huma murija fit-tabella 1.
English: A dose reduction is recommended as indicated in section 4.2.
Maltese: Huwa rakkomandat tnaqqis fid-doża kif indikat fis-sezzjoni 4.2.
English: Half-life is prolonged if renal function is impaired as shown in table 13.
Maltese: Il-half-life titwal jekk il-funzjoni tal-kliewi tkun indebolita kif muri f'tabella 13.
English: Table 22: Analysis of all cause and cardiovascular survival during the study period in RE-LY. Pradaxa 110 mg twice daily
Maltese: Tabella 22: Analiżi tal-kawżi kollha u sopravivenza kardjovaskulari matul il-perjodu tal-istudju f'RE-LY.
English: Half-life is prolonged if renal function is impaired as shown in table 23.
Maltese: Il-half-life titwal jekk il-funzjoni tal-kliewi tkun indebolita kif muri f'tabella 23.
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 75 mg hard capsules
Maltese: Pradaxa 75 mg, kapsuli iebsin
English: Table 13: Half-life of total dabigatran in healthy subjects and subjects with impaired renal function.
Maltese: Tabella 13: Il-half-life ta' dabigatran totali f'persuni b'saħħithom u persuni b'indeboliment filfunzjoni tal-kliewi.
English: Pruritus
Maltese: Ċarrat
English: • Do not peel off the blister foil until a capsule is required.
Maltese: • Tqaxxarx il-fojl tal-folja ħlief jekk ikollok bżonn tieħu kapsula.
English: For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding (see table 1 above and section 4.4).
Maltese: Għal persuni b'gastrite, esofagite, jew rifluss gastroesofagali, tnaqqis fid-doża jista' jiġi kkunsidrat minħabba r-riskju għoli ta' ħruġ ta' demm gastrointestinali maġġuri (ara tabella 1 hawn fuq u sezzjoni 4.4).
English: Prevention of blood clot formation after knee or hip replacement surgery The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).
Maltese: Id-doża rakkomandata hija ta' 220 mg darba kuljum (li tittieħed bħala 2 kapsuli ta' 110 mg).
English: Active Cancer Patients (DVT/PE)
Maltese: Pazjenti b'Kanċer Attiv (DVT/PE)
English: ulcer in the gullet) - Inflammation of the gullet and stomach - Reflux of gastric juice into the gullet - Vomiting - Difficulty in swallowing - Unusual laboratory test results on liver function
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): - Tnaqqis fl-ammont ta' emoglobina fid-demm (is-sustanza fiċ-ċelluli ħomor tad-demm) - Riżultati mhux tas-soltu tat-testijiet tal-laboratorju fuq il-funzjoni tal-fwied
English: Close clinical surveillance is recommended in patients with renal impairment.
Maltese: Sorveljanza klinika mill-qrib hi rakkomandata f'pazjenti b'indeboliment filkliewi.
English: These studies compared dabigatran etexilate (150 mg bid) with warfarin (target INR 2.0-3.0) in patients with acute DVT and/or PE.
Maltese: Kien osservat li dabigatran jeħel ftit (34-35%) mal-proteini tal-plażma umana u dan hu indipendenti mill-konċentrazzjoni.
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (DVT/PE treatment)
Maltese: Trattament ta' trombożi fil-vini tal-fond (DVT - deep vein thrombosis) u emboliżmu pulmonari (PE - pulmonary embolism), u l-prevenzjoni ta' DVT u PE rikorrenti fl-adulti (DVT/PE - deep vein thrombosis/pulmonary embolism)
English: The study compared 150 mg twice daily uninterrupted dabigatran etexilate with uninterrupted INR-adjusted warfarin in catheter ablation of paroxysmal or persistent atrial fibrillation.
Maltese: L-istudju qabbel dabigatran etexilate 150 mg darbtejn kuljum mingħajr interuzzjoni ma' warfarin mingħajr interruzzjoni b'INR aġġustat fl-asportazzjoni tal-kateter għal fibrillazzjoni atrijali parossimali jew persistenti.
English: The recommended doses of Pradaxa in the indications SPAF, DVT and PE are shown in table 2.
Maltese: It-tul tal-użu ta' Pradaxa fl-indikazzjonijiet SPAF, DVT u PE huwa muri fit-tabella 2.
English: Enrolled patients continued to receive the same double-blind dabigatran etexilate dose randomly allocated in RE-LY, for up to 43 months of follow up after RE-LY (total mean follow-up RE-LY + RELY-ABLE, 4.5 years).
Maltese: Il-pazjenti rreġistrati komplew jirċievu l-istess doża double-blind ta' dabigatran etexilate allokata b'mod każwali f'RE-LY, għal sa 43 xahar ta' follow wara RE-LY (il-medja totali ta' follow-up RE-LY + RELY-ABLE, 4.5 snin).
English: Pradaxa is co-administered with verapamil, amiodarone, quinidine or clarithromycin (P-gp inhibitors) and particularly in the occurrence of bleeding, notably in patients having a mild to moderate renal impairment (see section 4.5).
Maltese: Għandu jkun hemm attenzjoni partikulari meta Pradaxa jingħata flimkien ma' verapamil, amiodarone, quinidine jew clarithromycin (inibituri ta' P-gp) u partikularment meta jseħħ ħruġ ta' demm, speċjalment f'pazjenti li jkollhom indeboliment ħafif sa moderat tal-kliewi (ara sezzjoni 4.5).
English: FOLDING BOX AND LABEL FOR BOTTLE for 75 mg
Maltese: KAXXA LI TINTEWA U TIKKETTA GĦALL-FLIXKUN għal 75 mg
English: Further risk factors (see also table 3) comprise co-medication with platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux.
Maltese: Fatturi ta' riskju ulterjuri (ara wkoll tabella 3) jinkludu medikazzjoni fl-istess waqt b'inibituri talaggregazzjoni tal-plejtlits bħal clopidogrel u acetylsalicylic acid (ASA - acetylsalicylic acid) jew mediċini mhux sterojdi kontra l-infjammazzjoni (NSAID - non steroidal antiinflammatory drugs), kif ukoll il-preżenza ta' esofagite, gastrite jew rifluss gastroesofagali.
English: Precautions and management of the haemorrhagic risk For the management of bleeding complications, see also section 4.9.
Maltese: Għall-immaniġġjar ta' komplikazzjonijiet ta' ħruġ ta' demm, ara wkoll sezzjoni 4.9.
English: An increased risk was seen in the elderly (≥ 75 years) for the 150 mg twice daily dose regimen.
Maltese: Ġie osservat riskju akbar fl-anzjani (≥ 75 sena) għall-kors ta' doża ta' 150 mg darbtejn kuljum.
English: Patients undergoing catheter ablation for atrial fibrillation
Maltese: Pazjenti li jkollhom asportazzjoni tal-kateter għal fibrillazzjoni atrijali
English: Clinical trials for the prevention of thromboembolism in patients with prosthetic heart valves
Maltese: Provi kliniċi għall-prevenzjoni ta' tromboemboliżmu f'pazjenti b'valvoli prostetiċi tal-qalb
English: For the indication DVT/PE, the safety and efficacy of Pradaxa in children from birth to less than 18 years of age have not yet been established.
Maltese: Għall-indikazzjoni DVT/PE, is-sigurtà u l-effikaċja ta' Pradaxa fi tfal li għandhom inqas minn 18il sena ma ġewx determinati s'issa.
English: Further risk factors (see also table 4) comprise co-medication with platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux.
Maltese: Fatturi ta' riskju ulterjuri (ara wkoll tabella 4) jinkludu medikazzjoni fl-istess waqt b'inibituri talaggregazzjoni tal-plejtlits bħal clopidogrel u acetylsalicylic acid (ASA - acetylsalicylic acid) jew mediċini mhux sterojdi kontra l-infjammazzjoni (NSAID - non steroidal antiinflammatory drugs), kif ukoll il-preżenza ta' esofagite, gastrite jew rifluss gastroesofagali.
English: Treated patients Recurrent symptomatic VTE and related deaths Hazard Ratio vs placebo (95% confidence interval) p-value for superiority Secondary efficacy endpoints
Maltese: VTE sintomatika rikorrenti u mwiet millkawżi kollha Proporzjon ta' Periklu kontra plaċebo (95% intervall ta' kunfidenza) valur p għas-superjorità Punti aħħarin għalleffikaċja sekondarja VTE sintomatika rikorrenti u mwiet millkawżi kollha 95% intervall ta' kunfidenza
English: Table 8: Adverse reactions SOC / Preferred term
Maltese: Tabella 8: Reazzjonijiet avversi
English: Characteristics of Pradaxa ® and Praxbind
Maltese: Kif għandek tuża Pradax
English: Pradaxa treatment (150 mg twice daily) does not need to be interrupted in patients undergoing catheter ablation for atrial fibrillation (see section
Maltese: It-trattament bi Pradaxa (150 mg darbtejn kuljum) m'għandux għalfejn jiġi interrott f'pazjenti li jkollhom asportazzjoni talkateter għal fibrillazzjoni atrijali (ara sezzjoni 4.2).
English: Uncrommon
Maltese: Flixkun
English: For DVT/PE the recommendation for the use of Pradaxa 220 mg taken as one 110 mg capsule twice daily is based on pharmacokinetic and pharmacodynamic analyses and has not been studied in this clinical setting.
Maltese: Għal DVT/PE ir-rakkomandazzjoni għall-użu ta' Pradaxa 220 mg li jittieħed bħala kapsula waħda ta' 110 mg darbtejn kuljum hija bbażata fuq analiżijiet farmakokinetiċi u farmakodinamiċi u ma ġietx studjata f'dan l-isfond kliniku.
English: For patients with moderate renal impairment (CrCL 30-50 mL/min) the recommended dose of Pradaxa is also 300 mg taken as one 150 mg capsule twice daily.
Maltese: Għal pazjenti b'indeboliment moderat tal-kliewi (CrCL 30-50 mL/min) id-doża rakkomandata ta' Pradaxa hi wkoll ta' 300 mg li tittieħed bħala kapsula waħda ta' 150 mg darbtejn kuljum.
English: The primary outcome (adjudicated major bleeding according to ISTH criteria) occurred in 5 (1.6 %) patients in the dabigatran etexilate group and 22 (6.9 %) patients in the warfarin group (risk difference −5.3%; 95% CI −8.4, −2.2; P=0.0009).
Maltese: Ir-riżultat primarju (ħruġ ta' demm maġġuri aġġudikat skont il-kriterji ISTH) seħħ f'5 (1.6%) pazjenti fil-grupp ta' dabigatran etexilate u fi 22 (6.9%) pazjent fil-grupp ta' warfarin (differenza fir-riskju −5.
English: Clearance of dabigatran by haemodialysis was investigated in 7 patients with end-stage renal disease (ESRD) without atrial fibrillation.
Maltese: It-tneħħija ta' dabigatran permezz ta' emodijalisi ġiet investigata f'7 pazjenti b'mard tal-kliewi fl-aħħar stadju (ESRD) mingħajr fibrillazzjoni atrijali.
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults (DVT/PE treatment)
Maltese: Il-kura ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE) fl-adulti (kura għal DVT/PE)
English: Uncommon (may affect up to 1 in 100 people): - Bleeding - Bleeding may happen into a joint or from an injury - Bleeding may happen from piles - A fall in the number of red cells in the blood - Haematoma formation - Coughing of blood or blood stained sputum - Allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel - Inflammation of the gullet and stomach - Reflux of gastric juice into the gullet - Feeling sick - Vomiting - Belly ache or stomach ache - Frequent loose or liquid bowel movements - Unusual laboratory test results on liver function - Liver enzymes increased
Maltese: Dan jista' jinkludi ulċerazzjoni gastrointestinali kurrenti jew riċenti, il-preżenza ta' neoplażmi malinni f'riskju għoli ta' ħruġ ta' demm, korriment riċenti fil-moħħ jew fis-sinsla, operazzjoni riċenti fil-moħħ, fis-sinsla jew operazzjoni oftalmoloġika, emorraġija intrakranjali riċenti, variċi esofagali magħrufa jew issuspettati, malformazzjonijiet arterjovenużi, anewriżmi vaskulari jew anormalitajiet vaskulari maġġuri intraspinali jew intraċerebrali
English: The duration of use of Pradaxa in the indications SPAF, DVT and PE are shown in table 3.
Maltese: It-tul tal-użu ta' Pradaxa fl-indikazzjonijiet SPAF, DVT u PE huwa muri fit-tabella 3.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 100 (2 PACKS OF 50 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 150 mg HARD CAPSULES
Maltese: IMĠEŻWRIN ĠO FOJL TRASPARENTI - LI TINKLUDI L-KAXXA BLU - 150 mg KAPSULI
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (DVT/PE)
Maltese: Il-kura ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE), u l-prevenzjoni ta' DVT u PE rikorrenti fl-adulti (DVT/PE)
English: Cautions to be exercised in case concomitant use (see sections 4.2 and 4.4)
Maltese: Għandu jkun hemm kawtela f'każ ta' użu fl-istess ħin (ara sezzjonijiet 4.2 u 4.4)
English: The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.
Maltese: Il-metodu li għandu jintuża biex issir stima tal-funzjoni tal-kliewi (CrCL f'mL/min) huwa l-metodu Cockcroft-Gault.
English: Although Pradaxa does not in general require routine anticoagulant monitoring, the measurement of dabigatran related anticoagulation may be helpful to detect excessive high exposure to dabigatran in the presence of additional risk factors.
Maltese: Għalkemm ġeneralment Pradaxa m'għandux bżonn ta' monitoraġġ antikoagulanti ta' rutina, il-kejl talantikoagulazzjoni marbuta ma' dabigatran jista' jkun utli biex tiġi osservata espożizzjoni għolja eċċessiva għal dabigatran fil-preżenza ta' fatturi addizzjonali ta' riskju.
English: Amiodarone When Pradaxa was co-administered with a single oral dose of 600 mg amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.
Maltese: Meta Pradaxa ngħata flimkien ma' doża orali waħda ta' 600 mg ta' amiodarone, il-medda u r-rata tal-assorbiment ta' amiodarone u tal-metabolit attiv tiegħu DEA essenzjalment ma nbidlux.
English: In phase I studies the exposure (AUC) of dabigatran after the oral administration of Pradaxa is approximately 2.7-fold higher in volunteers with moderate renal insufficiency (CrCL between 30-50 mL/min) than in those without renal insufficiency.
Maltese: Fi studji ta' fażi I, l-espożizzjoni (AUC) ta' dabigatran wara l-għoti orali ta' Pradaxa hi ta' madwar 2.7 darba ogħla f'voluntiera b'insuffiċjenza moderata tal-kliewi (CrCL bejn 30-50 mL/min) milli f'dawk mingħajr insuffiċjenza tal-kliewi.
English: Patients with gastritis, esophagitis or gastroesophageal reflux
Maltese: Pazjenti b'gastrite, esofaġite jew rifluss gastroesofagali
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 75 mg hard capsules dabigatran etexilate
Maltese: Pradaxa 75 mg kapsuli iebsin dabigatran etexilate
English: th percentile of ECT prolongation of 103 seconds,
Maltese: 103 sekondi,
English: Diseases / procedures with special haemorrhagic risks
Maltese: Mard/proċeduri b'riskji emorraġiċi speċjali
English: - Reflux of gastric juice into the gullet - Vomiting - Difficulty in swallowing - Unusual laboratory test results on liver function
Maltese: - Diffikultà biex tibla - Testijiet tal-laboratorju mhux tas-soltu dwar il-funzjoni tal-fwied.
English: Benefit-risk assessment The presence of lesions, conditions, procedures and/or pharmacological treatment (such as NSAIDs, antiplatelets, SSRIs and SNRIs, see section 4.5), which significantly increase the risk of major bleeding requires a careful benefit-risk assessment.
Maltese: Il-preżenza ta' leżjonijiet, kundizzjonijiet, proċeduri u/jew kura farmakoloġika (bħal NSAIDs, mediċini kontra l-plejtlits, SSRIs u SNRIs, ara sezzjoni 4.5), li jżidu b'mod sinifikanti r-riskju ta' ħruġ maġġuri ta' demm, teħtieġ evalwazzjoni b'attenzjoni tal-benefiċċju-riskju.
English: Endpoint
Maltese: Dardir
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults (DVT/PE treatment
Maltese: Trattament ta' trombożi fil-vini tal-fond (DVT - deep vein thrombosis) u emboliżmu pulmonari (PE - pulmonary embolism), u lprevenzjoni ta' DVT u PE rikorrenti fl-adulti (DVT/PE - deep vein thrombosis/pulmonary embolism)
English: Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs (see section 4.5).
Maltese: Osservazzjoni mill-qrib għal sinjali ta' ħruġ ta' demm hija rakkomandata f'pazjenti ttrattati fl-istess waqt b'NSAIDs (ara sezzjoni 4.5).
English: Table 12 shows bleeding events in the pooled pivotal studies RE-COVER and RE-COVER II testing the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Maltese: Tabella 12 turi avvenimenti ta' ħruġ ta' demm fl-istudji miġbura importanti ħafna RE-COVER u RECOVER II li ttestjaw il-kura ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE).
English: Age ≥ 75 years
Maltese: 65 ≤ u < 75
English: Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa.
Maltese: Pantoprazole u inibituri tal-pompa tal-protoni (PPIproton-pump inhibitors) oħrajn ingħataw flimkien ma' Pradaxa fi provi kliniċi, u ma deherx li trattament fl-istess ħin b'PPI inaqqas l-effikaċja ta' Pradaxa.
English: Catheter site haemorrhage
Maltese: Linka sewda tal-istampar Shellac
English: The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R110”.
Maltese: Lgħatu hu stampat bis-simbolu tal-kumpanija Boehringer Ingelheim, u l-korp stampat b'“R110”.
English: The incidence of the composite efficacy endpoint of death, thromboembolic events (myocardial infarction, stroke, or systemic embolism) or unplanned revascularization in the two dabigatran etexilate dual-therapy groups combined was non-inferior to the warfarin triple-therapy group (13.7% vs. 13.4% respectively; HR 1.04; 95% CI: 0.84, 1.29; P=0.0047 for non-inferiority).There were no statistical differences in the individual components of the efficacy endpoints between either dabigatran etexilate dual-therapy groups and warfarin triple-therapy.
Maltese: L-inċidenza tal-punt aħħari kompost tal-effikaċja ta' mewt, avvenimenti tromboemboliċi (infart mijokardijaku, puplesija jew emboliżmu sistemiku) jew vaskularizzazzjoni mhux ippjanata mill-ġdid fiż-żewġ gruppi ta' terapija doppja b'dabigatran etexilate ma kinitx inferjuri għall-grupp ta' terapija tripla b'warfarin (13.7% kontra 13.4% rispettivament;