FrancophonIA/ELRC3.0 huggingface dataset:
English: • the CHMP carried out a benefit-risk evaluation of polymyxin-based products under Article 31 of Directive 2001/83/EC, reviewing all available data, including responses submitted by the marketing authorisation holders during the procedure and recommendations from the Pharmacokinetics and the Infectious Disease working parties,
Maltese: • is-CHMP wettaq evalwazzjoni tal-benefiċċji/riskji ta' prodotti bbażati fuq polymyxin skont lArtikolu 31 tad-Direttiva 2001/83/KE, li tirrevedi d-dejta kollha disponibbli, inklużi r-risponsi sottomessi mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq matul il-proċedura u rrakkomandazzjonijiet mill-gruppi ta' ħidma dwar il-Farmakokinetika u l-Mard Infettiv,
English: The scope of the procedure includes nationally-authorised medicinal products and a centrally-authorised medicinal product, Colobreathe (dry powder for inhalation), authorised in February 2012.
Maltese: Il-kamp ta' applikazzjoni tal-proċedura jinkludi prodotti mediċinali awtorizzati fil-livell nazzjonali u prodott mediċinali awtorizzat ċentralment, Colobreathe (trab xott biex jinġibed man-nifs), awtorizzat fi Frar 2012.
English: • the existing preclinical and clinical data and the product information including the indications, dosage recommendations and pharmacokinetic and pharmacodynamic information for polymyxin-based products in the EU are not up to date or based on robust data, as highlighted by recent reports of suboptimal efficacy and the emergence of colistin resistance,
Maltese: • id-dejta eżistenti preklinika u klinika u l-informazzjoni dwar il-prodott, inklużi l-indikazzjonijiet, ir-rakkomandazzjonijiet ta' dożaġġ u l-informazzjoni farmakokinetika u farmakodinamika għal prodotti bbażati fuq polymyxin fl-UE mhumiex aġġornati jew ibbażati fuq dejta robusta, kif enfasizzat minn rapporti reċenti ta' effikaċja subottimali u l-emerġenza ta' reżistenza għal colistin,
English: It was agreed that colistin can be used without age restrictions, but only for the treatment of serious infections.
Maltese: Kien hemm qbil li colistin jista' jintuża mingħajr restrizzjonijiet ta' età, iżda għallkura ta' infezzjonijiet serji biss.
English: However, the CHMP introduced a dose content conversion table between CMS expressed in IU, CMS expressed in mg and CBA expressed in mg, to raise awareness of the different ways of expressing the strength and dose and to help prescribers who obtain additional information from the literature.
Maltese: Madankollu, is-CHMP introduċa tabella ta' konverżjoni tal-kontenut taddoża bejn CMS imfisser f'IU, CMS imfisser f'mg u CBA mfisser f'mg, biex titqajjem kuxjenza dwar ilmodi differenti li permezz tagħhom tista' titfisser il-qawwa u d-doża biex it-tobba li jiktbu r-riċetti jiġu megħjunin jiksbu informazzjoni addizzjonali mid-dokumentazzjoni.
English: • the CHMP made extensive revisions to the SmPC to reflect current pharmacokinetic and pharmacodynamic data, including an update of the EUCAST breakpoints and the list of susceptible species,
Maltese: • is-CHMP għamel reviżjonijiet estensivi fl-SmPC biex jirrifletti d-dejta farmakokinetika jew farmakodinamika attwali, inkluż aġġornament tal-valuri kritiċi tal-EUCAST u l-lista' ta' speċijiet suxxettibbli,
English: Limited therapeutic options have led to an increased clinical use of colistin, a polymyxin antibiotic developed over 50 years ago and which has retained activity against a number of multi-drug resistant pathogens.
Maltese: L-għażliet terapewtiċi limitati wasslu għal żieda fl-użu kliniku ta' colistin, antibijotiku ta' polymyxin żviluppat aktar minn 50 sena ilu u li żamm attività kontra numru ta' patoġeni reżistenti għal diversi mediċini.
English: The CHMP reviewed the optimal way of expressing the strength and dose of polymyxin-containing products and was of the opinion that given the established use of international units (IU) in EU clinical practice and in the European and British Pharmacopoeia, the EU product information for CMS should continue to be expressed in IU.
Maltese: Is-CHMP irreveda l-mod ottimali li permezz tiegħu titfisser il-qawwa u d-doża ta' prodotti li fihom polymyxin u kien tal-opinjoni li fid-dawl tal-użu stabbilit ta' unitajiet internazzjonali (IU) fil-prattika klinika tal-UE u fil-Farmakopea Brittanika u Ewropea, l-informazzjoni dwar il-prodott tal-UE għal CMS għandha tibqa' titfisser f'IU.
English: • the CHMP considered that colistimethate sodium and colistin represent a crucial therapeutic option in the context of the treatment of infections caused by multi-drug resistant Gramnegative pathogens,
Maltese: • is-CHMP ikkunsidra li colistimethate sodium u colistin jirrappreżentaw għażla terapewtika kruċjali fil-kuntest tal-kura ta' infezzjonijiet ikkawżati minn patoġeni Gram-negattivi reżistenti għal diversi mediċini,
English: Finally, extensive revisions were made to reflect current pharmacokinetic and pharmacodynamic data, including an update of the EUCAST breakpoints and the list of susceptible species.
Maltese: Fl-aħħar nett, saru reviżjonijiet estensivi biex jirriflettu d-dejta farmakokinetika u farmakodinamika attwali, inkluż aġġornament tal-valuri kritiċi tal-EUCAST u l-lista ta' speċijiet suxxettibbli.
English: The CHMP also reviewed the data on adverse events observed with the use of colistin and agreed that the use of colistin for parenteral use is associated with nephrotoxicity and neurotoxicity but considered that these risks must be balanced against the risk of the underlying disease and the high mortality from the treated conditions and that they can be satisfactorily mitigated by statements in the SmPC.
Maltese: Is-CHMP irreveda wkoll id-dejta dwar l-avvenimenti avversi osservati bl-użu ta' colistin u qabel li l-użu ta' colistin għal użu parenterali huwa assoċjat ma' nefrotossiċità u newrotossiċità, iżda kkunsidra li dawn ir-riskji għandhom jiġu bbilanċjati mar-riskju tal-marda sottostanti u l-mortalità għolja millkondizzjonijiet ikkurati u li jistgħu jitnaqqsu b'mod sodisfaċenti b'dikjarazzjonijiet fl-SmPC.
English: As a consequence, the existing preclinical and clinical pharmacokinetic (PK) and pharmacodynamic (PD) information is limited, the product information has not been significantly updated over the years and the dosage regimens in use today are not based upon robust PK/PD data.
Maltese: Bħala konsegwenza, l-informazzjoni eżistenti preklinika u klinika dwar il-farmakokinetika (PK) u l-farmakodinamika (PD) hija limitata, l-informazzjoni dwar il-prodott ma ġietx aġġornata b'mod sinifikanti matul is-snin u l-korsijiet ta' dożaġġ li jintużaw illum mhumiex ibbażati fuq dejta PK/PD robusta.
English: CMS for parenteral use is indicated for the treatment of serious infections caused by Gram-negative pathogens and CMS for inhalation use is indicated for the management of chronic pulmonary infections due to P. aeruginosa in patients with cystic fibrosis.
Maltese: CMS għal użu parenterali huwa indikat għall-kura ta' infezzjonijiet serji kkawżati minn patoġeni Gram-negattivi filwaqt li CMS biex jinġibed man-nifs huwa indikat għall-ġestjoni ta' infezzjonijiet pulmonari kroniċi minħabba P. aeruginosa f'pazjenti b'fibrożi ċistika.
English: A key concern is to maintain the efficacy of colistin against multi-drug resistant pathogens and to avoid the selection of resistance arising from monotherapy and the CHMP therefore agreed recommendations for the co-administration of parenteral colistin with other antibiotics.
Maltese: Tħassib ewlieni huwa li tinżamm l-effikaċja ta' colistin kontra patoġeni reżistenti għal diversi mediċini u biex tiġi evitata s-selezzjoni ta' reżistenza li tirriżulta minn monoterapija u s-CHMP għalhekk laħaq qbil dwar rakkomandazzjonijiet għall-għoti flimkien ta' colistin parenterali ma' antibijotiċi oħra.
English: A large number of PK/PD studies were reviewed together with data from clinical experience and the CHMP considered the available data to be sufficient to support revisions of the indication for both parenteral and inhalation use products, in line with clinical experience and current therapeutic guidelines.
Maltese: Ġie rrevedut numru kbir ta' studji PK/PD flimkien ma' dejta minn esperjenza klinika u s-CHMP ikkunsidra d-dejta disponibbli bħala suffiċjenti biex tappoġġja r-reviżjonijiet tal-indikazzjoni kemm għal prodotti għal użu parenterali kif ukoll għal dawk li jinġibdu man-nifs, f'konformità mal-esperjenza klinika u l-linji gwida terapewtiċi attwali.
English: Indeed, recent clinical experience and the medical literature point to the urgent need to update the product information, in particular the indications, the dosage recommendations and the PK/PD information, as highlighted by recent reports of suboptimal efficacy and the emergence of colistin resistance, in particular when used as monotherapy.
Maltese: Fil-fatt, l-esperjenza klinika reċenti u d-dokumentazzjoni medika jindikaw il-ħtieġa urġenti li linformazzjoni dwar il-prodotti tiġi aġġornata, b'mod partikolari l-indikazzjonijiet, irrakkomandazzjonijiet ta' dożaġġ u l-informazzjoni PK/PD, kif enfasizzat mir-rapporti reċenti ta' effikaċja subottimali u l-emerġenza ta' reżistenza għal colistin, b'mod partikolari meta jintuża bħala monoterapija.
English: Having reviewed all available data, the CHMP considered that CMS and colistin represent a crucial therapeutic option in the armamentarium available to prescribers in the context of the treatment of infections caused by multi-drug resistant Gram-negative pathogens.
Maltese: Wara li rreveda d-dejta kollha disponibbli, is-CHMP ikkunsidra li CMS u colistin jirrappreżentaw għażla terapewtika kruċjali fl-armamentarju disponibbli għat-tobba li jiktbu r-riċetti fil-kuntest tal-kura ta' infezzjonijiet ikkawżati minn patoġeni Gram-negattivi reżistenti għal diversi mediċini.
English: • the CHMP considered that the risks of nephrotoxicity and neurotoxicity observed with colistin for parenteral use should be balanced against the risk of the underlying disease and the high mortality from the treated conditions and that it can be satisfactorily mitigated by warnings and recommendations in the SmPC,
Maltese: • is-CHMP ikkunsidra li r-riskji ta' nefrotossiċità u newrotossiċità osservati b'colistin għal użu parenterali għandhom jiġu bbilanċjati mar-riskju tal-marda sottostanti u l-mortalità għolja millkondizzjonijiet ikkurati u li jistgħu jitnaqqsu b'mod sodisfaċenti bi twissijiet u birrakkomandazzjonijiet fl-SmPC,
English: Data was also particularly limited for paediatric patients.
Maltese: Id-dejta kienet ukoll partikolarment limitata għall-pazjenti pedjatriċi.
English: The emergence of multi-drug resistant Gram-negative bacteria that cause nosocomial infections is a growing problem worldwide.
Maltese: L-emerġenza ta' batterji Gram-negattivi reżistenti għal diversi mediċini li jikkawżaw infezzjonijiet nosokomjali hija problema dejjem tikber madwar id-dinja.
English: OTHER MON, TUE, WED, THU, FRI, SAT, SUN
Maltese: OĦRAJN MON, TUE, WED, THU, FRI, SAT, SUN
English: ICH fatal
Maltese: ICH fatali
English: 85276 Pfaffenhofen, Bayern Germany
Maltese: 85276 Pfaffenhofen, Bayern Il-Ġermanja
English: erythromycin, or ketoconazole.
Maltese: erythromycin, jew ketoconazole.
English: Event Rate (%/yr)b
Maltese: Rata ta' Avvenimenti (%/yr)b
English: Anticoagulants, antiplatelets, NSAIDs and SSRIs/SNRIs
Maltese: Antikoagulanti, antiplejtlits, NSAIDs u SSRIs/SNRIs Antikoagulanti:
English: Anti-FXa activity by CrCL category
Maltese: Attività anti-FXa skont il-kategorija ta' CrCL
English: 85276 Pfaffenhofen Germany
Maltese: 85276 Pfaffenhofen Il-Ġermanja
English: HR (95% CI) First SEE n (%/yr)a
Maltese: HR (95% CI) L-Ewwel SEE n (%/yr)a
English: HR (97.5% CI) p-value for non-inferiorityc
Maltese: HR (97.5% CI) valur p għal noninferjoritàc
English: If possible, Lixiana should be stopped at least 24 hours before an operation.
Maltese: Jekk ikun possibbli, Lixiana għandu jitwaqqaf mill-inqas 24 siegħa qabel operazzjoni.
English: Clinically Relevant Bleeding (Major and CRNM)b, n (%) n
Maltese: Emorraġija klinikament rilevanti (Maġġuri u CRNM),b n (%) n
English: • Lixiana is an oral anticoagulant factor Xa inhibitor.
Maltese: • Lixiana hu antikoagulant orali b'inibitur ta' fattur Xa.
English: Edoxaban Anti-FXa activity pre-dose (IU/mL)2
Maltese: Edoxaban Attività anti-FXa qabel id-doża (IU/mL)2
English: Do not take Lixiana:
Maltese: Tiħux Lixiana:
English: Safety in patients with NVAF in ENGAGE AF-TIMI 48
Maltese: Is-Sigurtà f'pazjenti b'NVAF f'ENGAGE AF-TIMI 48
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' Ġunju, 2015
English: Edoxaban 60 mg (30 mg Dose Reduced) (N = 4,118)
Maltese: Edoxaban 60 mg (30 mg Doża Mnaqqsa) (N = 4,118)
English: Edoxaban is a substrate for the efflux transporter P-glycoprotein (Pgp), but not a substrate for uptake transporters such as organic anion transporter polypeptide OATP1B1, organic anion transporters OAT1 or OAT3 or organic cation transporter OCT2.
Maltese: Edoxaban hu sottostrat għat-trasportatur tal-effluss Pglikoproteina (P-gp), iżda mhuwiex sottostrat għat-trasportaturi tal-assorbiment bħat-trasportatur enajoniku organiku ta' polypeptide OATP1B1, trasportaturi enajoniċi organiċi OAT1 jew OAT3 jew trasportatur organiku tal-ketajoni OCT2.
English: The majority of subjects in the edoxaban and warfarin groups had cardioversion performed (83.7% and 78.9%, respectively) or were auto-converted (6.6% and 8.6%, respectively).
Maltese: Il-maġġoranza tal-individwi fil-gruppi ta' edoxaban u warfarin kellhom kardjoverżjoni mwettqa (83.7% u 78.9%, rispettivament) jew kienu konvertiti awtomatikament (6.6% u 8.6%, rispettivament).
English: Special populations Assessment of renal function:
Maltese: Evalwazzjoni tal-funzjoni tal-kliewi:
English: Table 12: Edoxaban Anti-FXa activity by creatinine clearance Edoxaban Dose
Maltese: Tabella 12: Attività Anti-FXa ta' edoxaban skont it-tneħħija tal-kreatinina Edoxaban Doża
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
Maltese: It-trattament ta' trombożi tal-vini profondi (deep vein thrombosis, DVT) u emboliżmu pulmonari (pulmonary embolism, PE), u l-prevenzjoni ta' DVT u PE rikorrenti fl-adulti (ara sezzjoni 4.4 għal pazjenti b'PE emodinamikament instabbli).
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Epistassi
English: INFORMATION IN BRAILLE Lixiana 60 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lixiana 60 mg
English: Reproductive system and breast disorders Vaginal haemorrhage1
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Emorraġija vaġinali1
English: Table 1: Summary of posology in NVAF and VTE (DVT and PE) Summary Guide for Dosing
Maltese: Tabella 1: Sommarju ta' pożoloġija f'Pazjenti b'NVAF u VTE (DVT u PE) Sommarju tal-Gwida għad-Dożaġġ
English: First Stroke/SEEa n Event Rate (%/yr)b
Maltese: L-ewwel Puplesija/SEEa n Rata ta' Avvenimenti (%/yr)b
English: INFORMATION IN BRAILLE Lixiana 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lixiana 15 mg
English: a The primary efficacy endpoint is adjudicated symptomatic recurrent VTE (i.e., the composite endpoint of DVT, non-fatal PE, and fatal PE).
Maltese: VTE sintomatika rikorrenti aġġudikata (i.e., il-punt aħħari tal-kompost ta' DVT, PE mhux fatali u PE fatali).
English: 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: 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: What Lixiana contains - The active substance is edoxaban (as tosilate).
Maltese: X'fih Lixiana - Is-sustanza attiva hi edoxaban (bħala tosilate).
English: • Lixiana may increase the risk of bleeding.
Maltese: • Lixiana jista' jżid ir-riskju ta' emorraġija.
English: Table 5 shows ischaemic strokes/SEE by creatinine clearance category in NVAF patients in ENGAGE AF-TIMI 48.
Maltese: Tabella 5 turi puplesiji iskemiċi/SEE skont il-kategorija ta' tneħħija tal-kreatinina f'pazjenti b'NVAF f'ENGAGE AF-TIMI 48.
English: • Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone,
Maltese: • L-użu fl-istess ħin tal-inibituri ta' P-glikoproteina (P-gp) li ġejjin: ciclosporin, dronedarone,
English: INFORMATION IN BRAILLE Lixiana 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lixiana 30 mg
English: Table 4: Strokes and Systemic Embolic Events in the ENGAGE AF-TIMI 48 Study - mITT, on-treatment
Maltese: Sistemiċi Emboliċi fl-Istudju ENGAGE AF-TIMI 48 (mITT, waqt il-kura)
English: In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitors: ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, or verapamil resulted in increased plasma concentrations of edoxaban.
Maltese: Fi studji farmakokinetiċi (PK), l-għoti flistess ħin ta' edoxaban ma' inibituri ta' P-gp: ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, jew verapamil, irriżulta f'żieda fil-konċentrazzjonijiet ta' edoxaban fil-plażma.
English: A 4 hour haemodialysis session reduced total edoxaban exposures by less than 9%.
Maltese: Emodijalisi Sessjoni ta' emodijalisi li damet 4 sigħat naqqset l-esponimenti totali ta' edoxaban b'inqas minn 9%.
English: A total of 16 (1.5%, 95% CI 0.86% - 2.42%) events occurred in subjects in the edoxaban (N = 1067) group and 11 (1.0%, 95% CI 0.51% - 1.81%) events in the warfarin (N = 1082) group; OR 1.48 (95% CI 0.64 - 3.55); safety analysis set on-treatment period.
Maltese: Total ta' 16-il (1.5%, 95% CI 0.86% - 2.42%) avveniment seħħew f'individwi fil-grupp ta' edoxaban (N = 1,067) u 11-il (1.0%, 0.95% CI 0.51% - 1.81%) avveniment fil-grupp ta' warfarin (N = 1,082); Proporzjon ta' probabbiltajiet (OR (Odds Ratio)) 1.48 (95% CI 0.64 - 3.55); analiżi tas-sigurtà tul il-perjodu meta ngħatat il-kura.
English: Major Bleeding n (%) n
Maltese: Emorraġija Maġġuri n (%) n
English: The same information is also available on the following URL: www.dspatient.eu.
Maltese: L-istess informazzjoni hi disponibbli wkoll fuq dan il-URL: http://www.dspatient.eu.
English: The t½ for oral administration is 10 - 14 hours.
Maltese: It-t½ għall-għoti mill-ħalq hi ta' 10 - 14-il siegħa.
English: Lixiana Discontinue the VKA and start Lixiana when the international normalised ratio (INR) is ≤ 2.5.
Maltese: Waqqaf il-VKA u ibda Lixiana meta l-proporzjon normalizzat internazzjonali (INR) ikun ta' ≤ 2.5.
English: Stop taking the vitamin K antagonist (e.g. warfarin).
Maltese: Waqqaf it-teħid tal-antagonist ta' vitamina K (eż. warfarin).
English: b The event rate (%/yr) is calculated as number of events/subject-year exposure.
Maltese: b Ir-rata ta' avvenimenti (%/yr) hi kkalkulata bħala n-numru ta' avvenimenti/individwu sena esponiment.
English: • For creatinine in mg/dL: (140-age [years]) × weight [kg] (× 0.85 if female) 72 × serum creatinine [mg/dL]
Maltese: (140-età [snin]) × piż [kg] × (0.85 jekk mara) 72 × kreatinina fis-serum [mg/dL]
English: • Verapamil: Verapamil 240 mg once daily for 11 days with a single concomitant dose of edoxaban 60 mg on Day 10 increased the edoxaban AUC and Cmax by approximately 53%.
Maltese: • Verapamil: Verapamil 240 mg darba kuljum għal 11-il jum ma' doża waħda fl-istess ħin ta' edoxaban 60 mg f'Jum 10, żied l-AUC u s-Cmax ta' edoxaban b'madwar 53%.
English: First Ischaemic Stroke n
Maltese: L-Ewwel Puplesija Iskemika n
English: Phone no:
Maltese: Sími:
English: Adverse reactions were experienced by 2,256 (32.2%) of the patients treated with edoxaban 60 mg (30 mg dose reduced) in the ENGAGE AF-TIMI 48 study and 1,249 (30.3%) in the Hokusai-VTE study.
Maltese: Kien hemm reazzjonijiet avversi li seħħew f'2,256 (32.2%) tal-pazjenti kkurati ma' edoxaban 60 mg (doża mnaqqsa ta' 30 mg) fl-istudju ENGAGE AF-TIMI 48 u 1,249 (30.
English: A multicentre, prospective, randomised, open-label study with blinded endpoint evaluation (ENSUREAF) was conducted which randomised 2199 subjects (oral anticoagulant naïve and pre-treated) with non-valvular atrial fibrillation scheduled for cardioversion, to compare edoxaban 60 mg once daily with enoxaparin/warfarin to maintain a therapeutic INR of 2.0 to 3.0 (randomised 1:1), mean TTR on warfarin was 70.8%.
Maltese: Twettaq studju multiċentriku, prospettiv, open-label, b'evalwazzjoni blinded tal-punt aħħari (ENSURE-AF), li fih 2,199 individwu ntgħażlu b'mod każwali (li qatt ma rċivew antikoagulanti orali fil-passat u kkurati minn qabel) b'fibrillazzjoni atrijali mhux valvulari skedata għal kardjoverżjoni, biex jipparaguna edoxaban 60 mg darba kuljum ma' enoxaparin/warfarin biex iżomm INR terapewtika ta' 2.0 sa 3.0 (magħżula b'mod każwali fi proporzjon ta' 1:1), it-TTR medja fuq warfarin kienet ta' 70.8%.
English: Other medicines and Lixiana
Maltese: Mediċini oħra u Lixiana
English: The pre-specified composite endpoints for the comparison of the edoxaban 60 mg treatment group to warfarin for stroke, SEE, and CV mortality HR (99% CI) was 0.87 (0.76, 0.99), MACE 0.89 (0.78, 1.00), and stroke, SEE, and all-cause mortality 0.90 (0.80, 1.01).
Maltese: Il-punti aħħarin tal-kompost speċifikati minn qabel għall-paragun tal-grupp ta' kura ta' edoxaban 60 mg ma' warfarin għal puplesija, SEE, u mortalità CV HR (99% CI) kienu ta' 0.87 (0.76, 0.99), MACE 0.89 (0.78, 1.00), u puplesija, SEE, u mortalità mill-kawżi kollha 0.90 (0.80, 1.01).
English: Lixiana is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 4.3).
Maltese: Lixiana huwa kontra-indikat f'pazjenti b'mard epatiku assoċjat ma' koagulopatija u riskju ta' fsada ta' rilevanza klinika (ara sezzjoni 4.3).
English: 10 x 1 film-coated tablets
Maltese: 10 x 1 pillola miksija b'rita
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, dabigatran etexilate, rivaroxaban, apixaban etc.) except under specific circumstances of switching oral anticoagulant therapy (see section 4.2) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5).
Maltese: • Kura flimkien ma' kwalunkwe sustanza oħra kontra l-koagulazzjoni tad-demm eż. eparina mhux frazzjonata (UFH - unfractionated heparin), eparini ta' piż molekulari baxx (enoxaparin, dalteparin, eċċ), derivattivi taleparina (fondaparinux, eċċ), sustanzi orali kontra l-koagulazzjoni tad-demm (warfarin, dabigatran etexilate, rivaroxaban, apixaban, eċċ) ħlief f'ċirkustanzi speċifiċi ta' bidla tat-terapija kontra l-koagulazzjoni orali (ara sezzjoni 4.2) jew meta UFH tingħata f'dożi meħtieġa biex jinżamm kateter ċentrali f'vina jew arterja miftuħ (ara sezzjoni
English: In the pivotal ENGAGE AF-TIMI 48 study (an event-driven, Phase 3, multi-centre, randomised, double-blind double-dummy parallel-group study), 21,105 subjects, with a mean CHADS2 score of 2.8, were randomised to either edoxaban 30 mg once daily treatment group, or edoxaban 60 mg once daily treatment group or warfarin.
Maltese: Fl-istudju importanti ħafna ENGAGE AF-TIMI 48 (studju ta' Fażi 3, xprunat minn każijiet, multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, double-dummy, grupp parallel), 21,105 individwu, b'punteġġ medju ta' CHADS2 ta' 2.8, intgħażlu b'mod każwali jew għallgrupp ta' kura li ngħata edoxaban 30 mg darba kuljum, jew għall-grupp ta' kura li ngħata edoxaban 60 mg darba kuljum jew warfarin.
English: • other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban)
Maltese: vitamina K bħal warfarin, acenocoumarol, phenprocoumon jew dabigatran, rivaroxaban,
English: Edoxaban 60 mg (30 mg Dose Reduced) (N = 7,012)
Maltese: Edoxaban 60 mg (30 mg Doża Mnaqqsa) (N = 7,012)