FrancophonIA/ELRC3.0 huggingface dataset:
English: The aPTT test is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran.
Maltese: It-test tal-aPTT hu disponibbli ħafna u jipprovdi indikazzjoni approssimattiva tal-intensità talantikoagulazzjoni miksuba b'dabigatran.
English: There is very limited clinical experience in patients with a body weight < 50 kg or > 110 kg at the recommended posology.
Maltese: Hemm esperjenza klinika limitata ħafna f'pazjenti b'piż tal-ġisem ta' < 50 kg jew > 110 kg fil-pożoloġija rakkomandata.
English: For patients randomized to warfarin, the mean percentage of time in therapeutic range (TTR) (INR 2-3) was 64.4 % (median TTR 67 %).
Maltese: Għal pazjenti li ntgħażlu b'mod każwali għal warfarin, il-medja tal-perċentwali ta' ħin fil-medda terapewtika (TTR) (INR 2-3) kienet ta' 64.4% (medjan ta' TTR ta' 67%).
English: There was no meaningful interaction observed when verapamil was given 2 hours after dabigatran etexilate (increase of Cmax by about 1.1-fold and AUC by about 1.2-fold).
Maltese: Ma kien hemm l-ebda interazzjoni sinifikanti osservata meta verapamil ingħata sagħtejn wara dabigatran etexilate (żieda tas-Cmax b'madwar 1.1 darbiet u tal-AUC b'madwar 1.2 darbiet).
English: The dose of 150 mg twice daily reduces significantly the risk of ischemic and haemorrhagic stroke, vascular death, ICH and total bleeding compared to warfarin.
Maltese: Id-doża ta' 150 mg darbtejn kuljum tnaqqas b'mod sinifikanti r-riskju ta' puplesija iskemika u emorraġika, mewt vaskulari, ICH u ħruġ ta' demm totali meta mqabbla ma' warfarin.
English: Table 18: Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies.
Maltese: Tabella 18: Analiżi ta' VTE totali u mortalità mill-kawżi kollha matul il-perjodu tal-kura flistudji dwar l-operazzjonijiet ortopediċi f'RE-NOVATE u RE-MODEL
English: The oral bioavailability may be increased by 75 % after a single dose and 37 % at steady state compared to the reference capsule formulation when the pellets are taken without the Hydroxypropylmethylcellulose (HPMC) capsule shell.
Maltese: Il-bijodisponibilità orali tista' tiżdied b'75% wara doża waħda u 37% fl-istat fiss meta mqabbla malformulazzjoni tal-kapsula ta' referenza meta l-pellets jittieħdu mingħajr il-qoxra talHydroxypropylmethylcellulose (HPMC) tal-kapsuli.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula iebsa fiha 110 mg ta' dabigatran etexilate (bħala mesilate)
English: Swallow whole, do not chew or break the capsule.
Maltese: Ibla' sħiħa, tomgħodx u taqsamx il-kapsula.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula iebsa fiha 75 mg ta' dabigatran etexilate (bħala mesilate)
English: • Recent biopsy, major trauma
Maltese: • Bijopsija riċenti, trawma maġġuri
English: Risk difference vs. warfarin (%)
Maltese: Differenza ta' riskju kontra warfarin
English: Currently available data are described in section 4.8 and 5.1, but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8 u 5.1 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Injury, poisoning and procedural complications Traumatic haemorrhage
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Emorraġija trawmatika
English: Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants.
Maltese: Pradaxa fiha s-sustanza attiva dabigatran etexilate u tagħmel parti minn grupp ta' mediċini msejħa mediċini kontra il-koagulazzjoni tad-demm.
English: The inducing effect was diminished resulting in dabigatran exposure close to the reference by day 7 after cessation of rifampicin treatment.
Maltese: L-effett li jinduċi tnaqqas u dan irriżulta f'espożizzjoni għal dabigatran li kienet qrib dik ta' referenza sa jum 7 wara lwaqfien tat-trattament b'rifampicin.
English: • Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
Maltese: • Il-kura fl-istess ħin bi kwalunkwe mediċini li jraqqu d-demm, eż. eparina mhux frazzjonata (UFH), eparini b'piż molekulari baxx (enoxaparin, dalteparin, eċċ.), derivattivi tal-eparina (fondaparinux, eċċ.), mediċini orali kontra l-koagulazzjoni tad-demm (warfarin, rivaroxaban, apixaban, eċċ.) ħlief f'ċirkustanzi speċifiċi.
English: In addition, dabigatran AUCτ,ss and Cmax,ss and the coagulation measures for dabigatran effect or the inhibition of platelet aggregation as measure of clopidogrel effect remained essentially unchanged comparing combined treatment and the respective mono-treatments.
Maltese: Flimkien ma' dan, lAUCτ,ss u s-Cmax,ss ta' dabigatran u l-miżuri tal-koagulazzjoni għall-effett ta' dabigatran jew l-inibizzjoni tal-aggregazzjoni tal-plejtlits bħala miżura tal-effett ta' clopidogrel, baqgħu essenzjalment mhux mibdula meta tqabblu trattament ikkombinat u t-trattamenti rispettivi b'mediċina waħda.
English: Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
Maltese: Kull kapsula iebsa fiha 110 mg ta' dabigatran etexilate (bħala mesilate).
English: Primary Prevention of Venous Thromboembolism in Orthopaedic Surgery 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 (25th-75th percentile range).The dabigatran geometric mean trough concentration, measured at the end of the dosing interval (i.e. 24 hours after a 220 mg dabigatran dose), was on average 22.0 ng/mL, with a range of 13.0-35.7 ng/mL (25th-75th percentile range).
Maltese: Il-medja ġeometrika tal-inqas konċentrazzjoni ta' dabigatran, imkejla fit-tmiem ta' l-intervall tad-dożaġġ (i.e. 24 siegħa wara doża ta' 220 mg ta' dabigatran), bħala medja kienet ta' 22.0 ng/mL, b'medda ta' 13.0-35.7 ng/mL (medda ta' 25-75 perċentwali) (ara sezzjoni 4.4).
English: Specific treatment options are available.
Maltese: Hemm disponibbli għażliet speċifiċi ta' trattament.
English: 22.9 % and 22.5 % of the patients had a CrCL > 50-< 80 mL/min, and 4.1 % and 4.8 % had a CrCL between 30 and 50 mL/min in the RE-MEDY and RE-SONATE studies.
Maltese: Il-medjan ta' CrCL fl-istudji RE-MEDY u RE-SONATE kien ta' 99.0 mL/min u 99.7 mL/min, rispettivament. 22.9% u 22.5% tal-pazjenti kellhom CrCL ta' > 50-< 80 mL/min, u 4.1% u 4.8% kellhom CrCL bejn 30 u 50 mL/min fl-istudji RE-MEDY u RE-SONATE.
English: Your doctor has initiated treatment with Pradaxa
Maltese: Mediċini oħra u Pradaxa
English: The dose of 150 mg twice daily, reduces significantly the risk of ischemic and haemorrhagic stroke, vascular death, ICH and total bleeding compared to warfarin.
Maltese: Id-doża ta' 150 mg darbtejn kuljum, tnaqqas b'mod sinifikanti r-riskju ta' puplesija iskemika u emorraġika, mewt vaskulari, ICH u ħruġ ta' demm totali meta mqabbla ma' warfarin.
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 110 mg hard capsules
Maltese: BLU - 110 mg KAPSULI
English: Patients following elective hip replacement surgery
Maltese: Wara operazzjoni tas-sostituzzjoni tal-ġenbejn
English: The RE-LY extension study (RELY-ABLE) provided additional safety information for a cohort of patients which continued the same dose of dabigatran etexilate as assigned in the RE-LY trial.
Maltese: L-istudju ta' estensjoni (RELY-ABLE) ipprovda informazzjoni addizzjonali dwar is-sigurtà għal koorti ta' pazjenti li komplew bl-istess doża ta' dabigatran etexilate kif assenjat fil-prova RE-LY.
English: The Boehringer Ingelheim logo is printed on the cap and “R75” on the body of the capsule.
Maltese: Il-logo ta' Boehringer Ingelheim hu stampat fuq l-għatu u “R75” fuq il-korp tal-kapsula.
English: DVT/PE The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Maltese: DVT/PE It-tul ta' żmien tat-terapija għandu jiġi individwalizzat wara evalwazzjoni b'attenzjoni tal-benefiċċju tat-trattament kontra r-riskju ta' ħruġ ta' demm (ara sezzjoni 4.4).
English: Table 2: Factors which may increase the haemorrhagic risk.
Maltese: Tabella 2: Fatturi li jistgħu jżidu r-riskju emorraġiku.
English: Pradaxa 75 mg are hard capsules with an opaque, white cap and an opaque, white body.
Maltese: Pradaxa 75 mg huma kapsuli ibsin b'għatu abjad, opak, u korp abjad, opak.
English: Wound haemorrhage
Maltese: - MINGĦAJR ILKAXXA
English: Table 12: Bleeding events in the studies RE-COVER and RE-COVER II testing the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Maltese: Tabella 12: Avvenimenti ta' ħruġ ta' demm fl-istudji RE-COVER u RE-COVER II li ttestjaw ittrattament ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE)
English: Table 4: Factors which may increase the haemorrhagic risk.
Maltese: Tabella 4: Fatturi li jistgħu jżidu r-riskju emorraġiku.
English: The duration of treatment with fixed dose of dabigatran was 174.0 days without coagulation monitoring.
Maltese: It-tul ta' żmien tal-kura b'doża fissa ta' dabigatran kien ta' 174.0 jum mingħajr monitoraġġ talkoagulazzjoni.
English: The safety of Pradaxa has been evaluated in a pivotal study investigating the prevention of stroke and systemic embolism in patients with atrial fibrillation, in two active controlled DVT/PE treatment trials and in one active controlled DVT/PE prevention trial.
Maltese: Is-sigurtà ta' Pradaxa ġiet evalwata fi studju pivotali li investiga l-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'fibrillazzjoni atrijali, f'żewġ provi dwar trattament ta' DVT/PE ikkontrollati b'mod attiv u fi prova waħda dwar prevenzjoni ta' DVT/PE ikkontrollata b'mod attiv.
English: Recurrent symptomatic VTE and all-cause deaths
Maltese: VTE sintomatika rikorrenti u mwiet relatati ma' VTE
English: Carrageenan
Maltese: koagulazzjoni
English: Table 3: Duration of use for SPAF and DVT/PE Indication Duration of use
Maltese: Tabella 3: It-tul tal-użu għal SPAF u DVT/PE
English: Table 16 shows bleeding events in pivotal study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Maltese: Tabella 16 turi avvenimenti ta' ħruġ ta' demm fl-istudju importanti ħafna RE-SONATE li ttestja lprevenzjoni ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE).
English: This regimen resulted in a geometric mean trough concentration of 155 ng/ml (gCV of 76.9 %), measured immediately before administration of the next dose and in a geometric mean peak concentration of 202 ng/ml (gCV of 70.6 %) measured two hours after the administration of the last dose.
Maltese: Dan il-kors wassal għall-aktar konċentrazzjoni ġeometrika medja baxxa ta' 155 ng/ml (gCV ta' 76.9 %), imkejla immedjatament qabel l-għoti tad-doża li jmiss u għall-aktar konċentrazzjoni ġeometrika medja għolja ta' 202 ng/ml (gCV ta' 70.6 %) imkejla sagħtejn wara l-għoti tal-aħħar doża.
English: A prospective, randomized, open-label, multicenter, exploratory study with blinded, centrally adjudicated endpoint evaluation (RE-CIRCUIT) was conducted in 704 patients who were under stable anticoagulant treatment.
Maltese: Twettaq studju esploratorju prospettiv, open label u multiċentriku li fih il-parteċipanti ntgħażlu b'mod każwali b'evalwazzjoni blinded tal-punt finali aġġudikat ċentralment (RE-CIRCUIT) f'704 pazjenti li kienu fuq kura stabbli b'antikoagulanti.
English: No dose adjustment is necessary for concomitant use of amiodarone or quinidine (see sections 4.4, 4.5 and 5.2).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ għall-użu fl-istess ħin ta' amiodarone jew quinidine (ara sezzjonijiet 4.4, 4.5 u 5.2).
English: Table 11: Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies
Maltese: Tabella 11: Analiżi ta' VTE totali u mortalità mill-kawżi kollha matul il-perjodu tal-kura flistudji dwar l-operazzjonijiet ortopediċi f'RE-NOVATE u RE-MODEL
English: In patients with moderate renal impairment and concomitantly treated with verapamil, a dose reduction of Pradaxa to 75 mg daily should be considered (see sections 4.4 and 4.5).
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi u li jkunu qed jiġu kkurati fl-istess ħin b'verapamil, tnaqqis fid-doża ta' Pradaxa għal 75 mg kuljum għandu jiġi kkunsidrat (ara sezzjonijiet 4.4 u 4.5).
English: • Patient Alert Cards
Maltese: • Kards ta' Allert tal-Pazjent
English: There is no relevant use of Pradaxa in the paediatric population for the indication of primary prevention of venous thromboembolic events in patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Maltese: M'hemm l-ebda użu rilevanti ta' Pradaxa fil-popolazzjoni pedjatrika għall-indikazzjoni ta' prevenzjoni primarja ta' każijiet tromboemboliċi venużi f'pazjenti li kellhom operazzjoni mhux obbligatorja tas-sostituzzjoni totali tal-ġenbejn jew operazzjoni tas-sostituzzjoni totali tal-irkoppa.
English: A calibrated quantitative dTT test or repetitive dTT measurements allow prediction of the time by when certain dabigatran levels will be reached (see section 5.1), also in case additional measures e.g. dialysis have been initiated.
Maltese: Test kwantitattiv ikkalibrat (dTT) jew kejl ripetut ta' dTT jippermettu t-tbassir tal-ħin li fih ser jintlaħqu ċerti livelli ta' dabigatran (ara sezzjoni 5.1), ukoll f'każ ta' miżuri addizzjonali, eż. id-dijalisi tkun inbdiet.
English: Table 26: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-MEDY study Pradaxa 150 mg twice daily
Maltese: Tabella 22: Analiżi tal-punti aħħarin tal-effikaċja primarja u sekondarja (VTE hu kompost ta' DVT u/jew PE) sat-tmien tal-perjodu ta' wara l-kura għall-istudju RE-SONATE Pradaxa 150 mg darbtejn kuljum
English: Based on dabigatran concentrations as determined by the diluted thrombin time test and clinical assessment, the dose was adjusted to the target dose of 2.14 (± 10%) mg/kg bodyweight of dabigatran etexilate.
Maltese: Ibbażat fuq il-konċentrazzjonijiet ta' dabigatran kif stabbilit mit-test tal-ħin ta' thrombin dilwit u evalwazzjoni klinika, id-doża ġiet aġġustata għad-doża fil-doża fil-mira ta' 2.14 (± 10%) mg/kg piż tal-ġisem ta' dabigatran etexilate.
English: The amount of substance cleared by dialysis is proportional to the blood flow rate up to a blood flow rate of 300 mL/min.
Maltese: L-ammont ta' sustanza mneħħija permezz tad-dijalisi hu proporzjonali għar-rata ta' fluss ta' demm sa rata ta' fluss ta' demm ta' 300 mL/min.
English: Use of fibrinolytic medicinal products for the treatment of acute ischemic stroke The use of fibrinolytic medicinal products for the treatment of acute ischemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the upper limit of normal (ULN) according to the local reference range.
Maltese: L-użu ta' prodotti mediċinali fibrinolitiċi għall-kura ta' puplesija iskemika akuta jista' jiġi kkunsidrat jekk il-pazjent ikollu dTT, ECT jew aPTT li ma jaqbżux l-limitu ta' fuq tan-normal (ULN - upper limit of normal) skont il-medda ta' referenza lokali.
English: Table 21: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-MEDY study
Maltese: Analiżi tal-punti aħħarin tal-effikaċja primarja u sekondarja (VTE hu kompost ta' DVT u/jew PE) sat-tmien tal-perjodu ta' wara l-kura għall-istudju RE-MEDY
English: On treatment 2 (22.1 %) patients experienced mild related adverse events (gastrooesophageal reflux / abdominal pain; abdominal discomfort) and 1 (11.1 %) patient experienced a not related serious adverse event (recurrent VTE of the leg) in the post treatment period > 3 days after stop of dabigatran etexilate.
Maltese: Meta ngħataw il-kura, 2 (22.1%) tal-pazjenti kellhom avvenimenti avversi relatati ħfief (rifluss gastrooesofagali/uġigħ addominali; skonfort addominali) u 1 (11.1%) talpazjenti kellhom avveniment avvers serju mhux relatat (VTE rikorrenti tal-riġel) fil-perjodu ta' wara lkura > 3 ijiem wara li twaqqaf dabigatran etexilate.
English: • Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
Maltese: • Valvoli prostetiċi tal-qalb li jeħtieġu kura antikoagulanti (ara sezzjoni 5.1).
English: After switching from 3-day treatment of once daily 40 mg enoxaparin s.c., 24 hours after the last dose of enoxaparin the exposure to dabigatran was slightly lower than that after administration of dabigatran etexilate (single dose of 220 mg) alone.
Maltese: Wara li t-trattament inbidel minn trattament ta' 3 ijiem b'40 mg enoxaparin s.c. darba kuljum, 24 siegħa wara l-aħħar doża ta' enoxaparin, lespożizzjoni għal dabigatran kienet ftit iktar baxxa minn dik wara l-għoti ta' dabigatran etexilate (doża waħda ta' 220 mg) waħdu.
English: Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity.
Maltese: Dabigatran etexilate hu prodrug ta' molekula żgħira li ma juri l-ebda attività farmakoloġika.
English: Table 17: Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopaedic surgery studies.
Maltese: Tabella 17: Analiżi ta' VTE maġġuri u mortalità assoċjata ma' VTE matul il-perjodu tal-kura fl-istudji dwar l-operazzjonijiet ortopediċi f'RE-MODEL u RE-NOVATE
English: Steady state geometric mean dabigatran peak plasma concentration, measured around 2 hours after 150 mg dabigatran etexilate administration twice daily, was 175 ng/mL, with a range of 117-275 ng/mL (25
Maltese: Il-medja ġeometrika fl-istat fiss tal-konċentrazzjoni massima ta' dabigatran fil-plażma, imkejla madwar sagħtejn wara doża ta' 150 mg dabigatran etexilate mogħtija darbtejn kuljum, kienet ta' 175 ng/mL, b'medda ta' 117-275 ng/mL (medda ta' 25-75 perċentwali).
English: After hip replacement surgery
Maltese: Wara operazzjoni tas-sostituzzjoni tal-irkoppa
English: Table 15 shows bleeding events in pivotal study RE-MEDY testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Maltese: Tabella 15 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: the increase of dabigatran exposure is 1.56-fold and 1.46fold for Cmax and AUC, respectively.
Maltese: Wara dożi multipli ta' ticagrelor 90 mg b.i.d. iż-żieda fl-esponiment ta' dabigatran kienet ta' 1.56 darba u 1.46 darba għas-Cmax u l-AUC rispettivament.
English: Breast-feeding
Maltese: Gastrooesofagite
English: Thereafter two capsules once a day should be taken for a total of 28-35 days.
Maltese: Wara dak il-perjodu, għandek tieħu żewġ kapsuli darba kuljum għal total ta' 28-35 jum.
English: The most commonly reported events are bleedings occurring in approximately 14 % of patients treated short-term for elective hip or knee replacement surgery, 16.6 % in patients with atrial fibrillation treated long-term for the prevention of stroke and systemic embolism, and in 14.4 % of patients treated for DVT/PE.
Maltese: L-iktar avveniment li kien irrappurtat b'mod komuni huwa ħruġ ta' demm li jseħħ f'madwar 16.6% tal-pazjenti b'fibrillazzjoni atrijali kkurati għal tul ta' żmien għall-prevenzjoni ta' puplesija u emboliżmu sistemiku, u f'14.4% tal-pazjenti kkurati għal DVT/PE.
English: Concomitant use contraindicated (see section 4.3)
Maltese: Interazzjonijiet farmakodinamiċi (ara sezzjoni 4.5)
English: Anaemia postoperative
Maltese: Anemija wara l-operazzjoni
English: When dabigatran etexilate (150 mg) was co-administered with oral verapamil, the Cmax and AUC of dabigatran were increased but the magnitude of this change differs depending on timing of administration and formulation of verapamil (see sections 4.2 and 4.4).
Maltese: Meta dabigatran etexilate (150 mg) ingħata flimkien ma' verapamil orali, is-Cmax u l-AUC ta' dabigatran żdiedu, iżda l-kobor ta' din il-bidla jvarja skont il-ħin talgħoti u l-formulazzjoni ta' verapamil (ara sezzjonijiet 4.2 u 4.4).
English: Table 13: Bleeding events in study RE-MEDY testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Maltese: Tabella 13: Avvenimenti ta' ħruġ ta' demm fl-istudju RE-MEDY li ttestja l-prevenzjoni ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE)
English: Patients with moderate renal impairment (CrCL between 30-50 mL/min) had on average 2.29-fold and 1.81-fold higher pre- and post-dose dabigatran plasma concentrations, respectively, when compared with patients without renal impairment (CrCL ≥ 80 mL/min).
Maltese: Pazjenti b'indeboliment moderat tal-kliewi (CrCL bejn 30-50 mL/min) kellhom bħala medja konċentrazzjonijiet fil-plażma qabel u wara d-doża ta' dabigatran li kienu 2.29 u 1.81 darbiet ogħla rispettivament, meta mqabbla ma' pazjenti mingħajr indeboliment tal-kliewi (CrCL ≥ 80 mL/min).
English: Table 14 shows bleeding events in pivotal study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Maltese: Tabella 14 turi avvenimenti ta' ħruġ ta' demm fl-istudju importanti ħafna RE-SONATE li ttestja lprevenzjoni ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE).
English: Primary prevention of venous thromboembolism in orthopaedic surgery
Maltese: Prevenzjoni Primarja ta' Tromboemboliżmu Venuż f'Operazzjoni Ortopedika
English: Primary prevention of Venous Thromboembolism in Orthopaedic Surgery
Maltese: Prevenzjoni primarja ta' Tromboemboliżmu Venuż f'Operazzjoni Ortopedika
English: • the 90th percentile of aPTT at trough (10-16 hours after the previous dose) was 62 seconds,
Maltese: • In-90th percentile ta' aPTT fil-livell minimu (10-16-il siegħa wara d-doża ta' qabel) kienet ta'
English: 21.7 % of patients had mild renal impairment (CrCL > 50 - < 80 mL/min) and 4.5% of patients had a moderate renal impairment (CrCL between 30 and 50 mL/min).
Maltese: Il-medjan ta' CrCL fl-istudju RE-COVER kien ta' 100.4 mL/min. 21.7% tal-pazjenti kellhom indeboliment ħafif tal-kliewi (CrCL > 50 - < 80 mL/min) u 4.5% tal-pazjenti kellhom indeboliment moderat tal-kliewi (CrCL bejn 30 u 50 mL/min).
English: More thromboembolic events (mainly strokes and symptomatic/asymptomatic prosthetic valve thrombosis) and more bleeding events were observed with dabigatran etexilate than with warfarin.
Maltese: Iktar avvenimenti tromboemboliċi (il-biċċa l-kbira puplesiji u trombożi sintomatika/asintomatika tal-valv prostetiku) u iktar avvenimenti ta' ħruġ ta' demm ġew osservati b'dabigatran etexilate milli b'warfarin.
English: Quinidine was given as 200 mg dose every 2nd hour up to a total dose of 1,000 mg. Dabigatran etexilate was given twice daily over 3 consecutive days, on the 3
Maltese: Quinidine ngħata bħala doża ta' 200 mg kull sagħtejn sa doża totali ta' 1,000 mg.
English: Table 3: Factors which may increase the haemorrhagic risk.
Maltese: Tabella 3: Fatturi li jistgħu jżidu r-riskju emorraġiku.
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'warfarin (marġini ta' non-inferjorità għal RE-COVER u RE-COVER II: 3.6 għad-differenza firriskju u 2.75 għall-proporzjon ta' periklu).
English: For patients randomized to warfarin, the median time in therapeutic range (INR 2.0-3.0) was 64.9 %.
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' 64.9%.
English: Black printing ink
Maltese: Jekk tinsa tieħu Pradaxa