FrancophonIA/ELRC3.0 huggingface dataset:
English: The edoxaban clinical programme for atrial fibrillation was designed to demonstrate the efficacy and safety of two dose groups of edoxaban compared to warfarin for the prevention of stroke and systemic embolism in subjects with nonvalvular atrial fibrillation and at moderate to high risk of stroke and systemic embolic events (SEE).
Maltese: Il-prevenzjoni ta' puplesija u emboliżmu sistemiku Il-programm kliniku ta' edoxaban għal fibrillazzjoni atrijali kien maħsub biex juri l-effikaċja u s sigurtà ta' żewġ gruppi ta' doża ta' edoxaban meta mqabbel ma' warfarin għall-prevenzjoni ta' puplesija u emboliżmu sistemiku f'individwi b'fibrillazzjoni atrijali mhux valvulari u li jkunu f'riskju minn moderat sa għoli ta' puplesija u każijiet sistemiċi emboliċi (SEE).
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: 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
English: There is very limited experience on the use of edoxaban with dual antiplatelet therapy or fibrinolytic agents.
Maltese: Hemm esperjenza limitata ħafna dwar l-użu ta' edoxaban ma' terapija doppja kontra l-plejtlits jew mediċini fibrinolitiċi.
English: Edoxaban has a half-life of approximately 10 to 14 hours (see section 5.2).
Maltese: Edoxaban għandu half-life ta' madwar 10 sa 14-il siegħa (ara sezzjoni 5.2).
English: Abbreviations: N = number of subjects; mITT population overall study period; n = number of patients in subgroup *HR not computed if number of events < 5 in one treatment group.
Maltese: Taqsiriet: N = numru ta' individwi fil-popolazzjoni mITT fil-perjodu globali tal-istudju; n = numru ta' pazjenti fis-sottogrupp *HR mhux ikkalkulat jekk in-numru ta' avvenimenti hu ta' < 5 fi grupp wieħed ta' kura.
English: Roteas 15 mg is only to be used when changing from Roteas 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3.
Maltese: Roteas 15 mg għandu jintuża biss meta tibdel minn Roteas 30 mg għal antagonist ta' vitamina K (eż. warfarin) (ara sezzjoni 3.
English: The Hazard Ratio (Edoxaban 60 mg vs. warfarin) for the primary endpoint in the centres with a lower average time of INR in the target range (INR TTR) for warfarin was 0.73 - 0.80 for the lowest 3 quartiles (INR TTR ≤ 57.7% to ≤ 73.9%).
Maltese: 80 għat-3 kwartili l-iktar baxxi (INR TTR ≤ 57.7% sa ≤ 73.9%).
English: The duration of therapy was at least 3 months for 3,718 (91.6%) edoxaban subjects versus 3,727 (91.4%) of warfarin subjects; at least 6 months for 3,495 (86.1%) of edoxaban subjects versus 3,491 (85.6%) of warfarin subjects; and 12 months for 1,643 (40.5%) edoxaban subjects versus 1,659 (40.4%) of warfarin subjects.
Maltese: It-tul ta' żmien tat-terapija kien mill-inqas 3 xhur għal 3,718-il individwu (91.6%) li kienu fuq edoxaban kontra 3,727 (91.4%) individwu li kienu fuq warfarin; mill-inqas 6 xhur għal 3,495 (86.1%) individwu li kienu fuq edoxaban kontra 3,491 (85.
English: Immune system disorders Hypersensitivity
Maltese: Disturbi fis-sistema immuni
English: In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study in NVAF, Cmax and AUC in patients with median low body weight (55 kg) were increased by 40% and 13%, respectively, as compared with patients with median high body weight (84 kg).
Maltese: F'analiżi farmakokinetika tal-popolazzjoni tal-istudju ENGAGE AF-TIMI 48 f'NVAF, is-Cmax u l-AUC f'pazjenti b'medjan ta' piż baxx tal-ġisem (55 kg) żdiedu b'40% u 13%, rispettivament, meta mqabbla ma' pazjenti b'medjan ta' piż għoli tal-ġisem (84 kg).
English: Population PK modeling indicates that exposure approximately doubles in patients with severe renal impairment (CrCL 15 - 29 mL/min) relative to patients with normal renal function.
Maltese: Immudellar PK tal-popolazzjoni jindika li l-esponiment bejn wieħed u ieħor jirdoppja f'pazjenti b'indeboliment sever tal-kliewi (CrCL 15 - 29 mL/min) meta mqabbel ma' pazjenti b'funzjoni normali tal-kliewi.
English: Discontinue dabigatran, rivaroxaban or apixaban and start Roteas at the time of the next dose of the oral anticoagulant (see section 5.1).
Maltese: Waqqaf dabigatran, rivaroxaban or apixaban u ibda Roteas fil-ħin tad-doża mhux talantikoagulant orali li jkun imiss (ara sezzjoni 5.1).
English: There was a statistically significant interaction between the effect of edoxaban versus warfarin on the main study outcome (stroke/SEE) and renal function (p-value 0.0042; mITT, overall study period).
Maltese: Kien hemm interazzjoni statistikament sinifikanti bejn l-effett ta' edoxaban kontra fuq ir-riżultat talistudju ewlieni (puplesija/SEE) u l-funzjoni tal-kliewi (valur p 0.
English: Table 10: Efficacy Results from the Hokusai-VTE Study - mITT population, overall study period Primary endpointa
Maltese: Riżultati tal-Effikaċja mill-Istudju Hokusai-VTE - popolazzjoni mITT, perjodu globali tal-istudju
English: P-gp inducers
Maltese: Indutturi ta' P-gp
English: In patients with severe hepatic impairment Roteas is not recommended (see sections 4.4 and 5.2).
Maltese: F'pazjenti b'indeboliment sever tal-fwied Roteas mhuwiex rakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 15 MG
Maltese: FOLJA TAD-DOŻA TAL-UNITÀ (10 x 1 PILLOLI) GĦAL 15 MG
English: Prevention of stroke and systemic embolism
Maltese: Il-prevenzjoni ta' puplesija u emboliżmu sistemiku
English: Increased post-implantation pregnancy losses occurred in rats at 300 mg/kg/day (approximately 49 times the MRHD) and in rabbits at 200 mg/kg/day (approximately 65 times the MRHD) respectively.
Maltese: Żieda fit-telf ta' tqala wara l-impjantazzjoni seħħ fil-firien f'doża ta' 300 mg/kg/jum (madwar 49 darba talMRHD) u fil-fniek f'doża ta' 200 mg/kg/jum (madwar 65 darba tal-MRHD) rispettivament.
English: In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study (for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors), the event rate was: 2.29% per year for the primary endpoint, compared to the event rate of 2.66% per year for the matching subjects in the warfarin group [HR (95% CI): 0.86 (0.66, 1.13)].
Maltese: 30 mg fl-istudju ENGAGE AF-TIMI 48 (minħabba piż tal-ġisem ta' ≤ 60 kg, indeboliment moderat tal-kliewi, jew l-użu fl-istess ħin ta' inibituri ta' P-gp), ir-rata t'avvenimenti kienet: 2.29% kull sena għall-punt aħħari primarja, meta mqabbla mar-rata ta' avvenimenti ta' 2.66% kull sena għall-individwi mqabbla fil-grupp ta' warfarin [HR (95% CI): 0.86 (0.66, 1.13)].
English: In the ENGAGE AF-TIMI 48 study there was a significant improvement in Net Clinical Outcome (First Stroke, SEE, Major Bleed, or All-Cause Mortality; mITT population, overall study period) in favour of edoxaban, HR (95% CI): 0.89 (0.83, 0.96); p = 0.0024, when edoxaban 60 mg treatment group was compared to warfarin.
Maltese: Puplesija, SEE, Emorraġija Maġġuri, jew Mortalità mill-Kawżi Kollha; popolazzjoni mITT, perjodu ta' studju globali) favur edoxaban, HR (95% CI): 0.89 (0.83, 0.96); p = 0.0024, meta l-grupp ta' kura ta' edoxaban 60 mg tqabbel ma' warfarin.
English: In both studies, the most common adverse reactions related to bleeding with edoxaban 60 mg based on adjudicated terms included cutaneous soft tissue haemorrhage (up to 5.9%) and epistaxis (up to 4.7%), while vaginal haemorrhage (9.0%) was the most common bleeding-related adverse reaction in Hokusai-VTE only.
Maltese: Fiż-żewġ studji, l-iktar reazzjonijiet avversi komuni marbuta ma' emorraġija b'edoxaban 60 mg ibbażati fuq termini aġġudikati kienu jinkludu emorraġija tal-ġilda fit-tessut artab (sa 5.9%) u epistassi (sa 4.7%), filwaqt li emorraġija vaġinali (9.0%) kienet l-iktar reazzjoni avversa komuni relatata ma'
English: ≥ 30 to ≤ 50 1,302 63 > 50 to ≤ 70 2,093 85 > 70 to ≤ 90 1,661 45 > 90 to ≤ 110 927 27 > 110 to ≤ 130 497 14
Maltese: ≥ 30 sa ≤ 50 1,302 63 > 50 sa ≤ 70 2,093 85 > 70 sa ≤ 90 1,661 45 > 90 sa ≤ 110 927 27 > 110 sa ≤ 130 497 14
English: 30 mg film-coated tablet: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”.
Maltese: Pilloli miksija b'rita tondi, ta' lewn roża (dijametru ta' 8.5 mm) imnaqqxa b'“DSC L30”.
English: Renal and urinary disorders Macroscopic haematuria/urethral haemorrhage
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Ematurija makroskopika/emorraġija uretrali
English: The primary safety endpoint was clinically relevant bleeding (major or clinically relevant non-major).
Maltese: Il-punt aħħari tas-sigurtà primarja kien emorraġija klinikament rilevanti (maġġuri jew klinikament rilevanti mhux maġġuri).
English: Concomitant Roteas and VKA can increase the INR post Roteas dose by up to 46%.
Maltese: VKA fl-istess ħin jistgħu jżidu l-INR wara Roteas b'sa 46%.
English: Concomitant use of edoxaban with quinidine, verapamil, or amiodarone does not require dose reduction based on clinical data (see section 4.2).
Maltese: L-użu fl-istess ħin ta' edoxaban ma' quinidine, verapamil, jew amiodarone m'għandux bżonn ta' tnaqqis fid-doża bbażat fuq dejta klinika (ara sezzjoni 4.2).
English: ≥ 30 to ≤ 50 1,302 9 > 50 to ≤ 70 2,093 8 > 70 to ≤ 90 1,661 10 > 90 to ≤ 110 927 2 > 110 to ≤ 130 497 1
Maltese: ≥ 30 sa ≤ 50 1,302 9 > 50 sa ≤ 70 2,093 8 > 70 sa ≤ 90 1,661 10 > 90 sa ≤ 110 927 2 > 110 sa ≤ 130 497 1
English: Unchanged edoxaban is the predominant form in plasma.
Maltese: Edoxaban mhux mibdul hu l-forma predominanti fil-plażma.
English: ≥ 30 to ≤ 50 1,302 16 > 50 to ≤ 70 2,093 19 > 70 to ≤ 90 1,661 17 > 90 to ≤ 110 927 5 > 110 to ≤ 130 497 2
Maltese: ≥ 30 sa ≤ 50 1,302 16 > 50 sa ≤ 70 2,093 19 > 70 sa ≤ 90 1,661 17 > 90 sa ≤ 110 927 5 > 110 sa ≤ 130 497 2
English: The median study drug exposure for both the edoxaban 60 mg and 30 mg treatment groups was 2.5 years.
Maltese: L-esponiment medjan tal-mediċina tal-istudju għaż-żewġ gruppi ta' kura ta' edoxaban 60 mg u 30 mg kien ta' 2.5 snin.
English: Edoxaban decreased the Cmax and AUC of concomitantly administered verapamil by 14% and 16%, respectively.
Maltese: Edoxaban naqqas is-Cmax u l-AUC ta' verapamil mogħti fl-istess ħin b'14% u 16%, rispettivament.
English: ICH non-fatal CRNM Bleeding n
Maltese: valur p għal noninferjoritàc
English: 30 mg once daily
Maltese: (30 mg Doża
English: The reduction in fatal bleeds was also significant for the edoxaban 60 mg treatment group compared with the warfarin group (0.21%, and 0.38%) [HR (95% CI): 0.55 (0.36, 0.84); p = 0.0059 for superiority], primarily because of the reduction in fatal ICH bleeds [HR (95% CI): 0.58 (0.35, 0.95); p = 0.0312].
Maltese: It-tnaqqis f'emorraġija fatali kien wkoll sinifikanti għall-grupp ta' kura ta' edoxaban 60 mg meta mqabbel mal-grupp ta' warfarin (0.21%, u 0.38%) [HR (95% CI): 0.55 (0.36, 0.84); p = 0.0059 għas superjorità], primarjament minħabba t-tnaqqis f'emorraġija ICH fatali
English: Major Bleeding n Event rate (%/yr)a HR (95% CI) p-value ICHb n Event rate (%/yr)a HR (95% CI) Fatal Bleeding n Event rate (%/yr)a HR (95% CI) CRNM Bleeding n Event rate (%/yr)a HR (95% CI) Any Confirmed Bleedingc n Event rate (%/yr)a HR (95% CI) Abbreviations: ICH = Intracranial Haemorrhage, HR = Hazard Ratio versus warfarin, CI = Confidence Interval, CRNM = Clinically Relevant Non-Major, n = number of subjects with events, N = number of subjects in Safety population, yr = year.
Maltese: Emorraġija Maġġuri n Rata ta' każijiet (%/yr)a HR (95% CI) valur p ICHb n Rata ta' każijiet (%/yr)a HR (95% CI)
English: Roteas 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Maltese: Roteas 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (pilloli ta' 15 u 30 mg biss) (E172), iron oxide yellow (pillola ta' 15 u 60 mg biss) (E172).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Berlin-Chemie (logo)
Maltese: Berlin-Chemie (logo) DATA TA' SKADENZA
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,
English: 15 mg film-coated tablets:
Maltese: 15 mg pilloli miksija b'rita:
English: Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Maltese: Kull 15 mg pillola miksija b'rita fiha 15 mg ta' edoxaban (bħala tosilate).
English: • medicines to prevent organ rejection after transplantation (e.g. ciclosporin)
Maltese: • mediċini biex jipprevjenu r-rifjut ta' organu wara trapjant (eż. ciclosporin)
English: Do not stop taking Roteas without talking to your doctor first, because Roteas treats and prevents serious conditions.
Maltese: Trattament ta' DVT, trattament ta' PE u l-prevenzjoni ta' DVT u PE rikorrenti (VTE)
English: • Ketoconazole: Ketoconazole 400 mg once daily for 7 days with a single concomitant dose of edoxaban 60 mg on Day 4, increased edoxaban AUC and Cmax by 87% and 89%, respectively.
Maltese: edoxaban 60 mg f'Jum 4, żied l-AUC u s-Cmax ta' edoxaban b'87% u 89%, rispettivament.
English: Disposition is biphasic.
Maltese: Id-dispożizzjoni hi bifażika.
English: HR (95% CI) All Bleeding n
Maltese: n HR (95% CI) ICH fatali ICH mhux fatali
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention:
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont is-Sistema talKlassifika tal-Organi u l-frekwenza, bl-użu tal-konvenzjoni li ġejja:
English: Roteas 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.
Maltese: Kif jidher Roteas u l-kontenut tal-pakkett Roteas 15 mg pilloli miksija b'rita huma ta' lewn oranġjo, tondi (dijametru ta' 6.7 mm) u mnaqqxa b'“DSC L15” fuq naħa waħda.
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),
English: Digoxin: Edoxaban 60 mg once daily on days 1 to 14 with coadministration of multiple daily doses of digoxin 0.25 mg twice daily (days 8 and 9) and 0.25 mg once daily (days 10 to 14) increased the Cmax of edoxaban by 17%, with no significant effect on AUC or renal clearance at steady state.
Maltese: Edoxaban 60 mg darba kuljum f'jiem 1 sa 14 mal-għoti flimkien ta' dożi multipli ta' digoxin 0.25 mg darbtejn kuljum (jiem 8 u 9) u 0.25 mg darba kuljum (jiem 10 sa 14) żied is-Cmax ta' edoxaban b'17%, mingħajr l-ebda effett sinifikanti fuq l-AUC jew tneħħija mill-kliewi fl-istat fiss.
English: Vaginal bleeds were reported commonly in women under the age of 50 years, while it was uncommon in women over the age of 50 years.
Maltese: Emorraġija vaġinali ġie rrappurtat b'mod komuni f'nisa taħt il-50 sena, filwaqt li ma kienx komuni f'nisa fuq il-50 sena.
English: • Rash
Maltese: • Sturdament
English: Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy
Maltese: Pazjenti b'PE emodinamikament instabbli jew pazjenti li jeħtieġu trombolisi jew embolektomija pulmonari
English: Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Maltese: Kull 30 mg pillola miksija b'rita fiha 30 mg ta' edoxaban (bħala tosilate).
English: Blood and lymphatic system disorders Anaemia
Maltese: Disturbi tad-demm u tas-sistema limfatika Anemija
English: *Dose reduction to 30 mg for low body weight ≤ 60 kg or specific concomitant P-glycoprotein (P-gp)
Maltese: *Tnaqqis fid-doża għal 30 mg għal piż baxx tal-ġisem ta' ≤ 60 kg jew inibituri speċifiċi ta' P
English: The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see section 4.9 Management of bleeding).
Maltese: Is-sinjali, sintomi, u s-severità (inkluż riżultat fatali) se jvarjaw skont il-post u l-grad, jew skont il vastità tal-fsada u/jew anemija (ara sezzjoni 4.9 Immaniġġar ta' Fsada).
English: The primary efficacy endpoint was the recurrence of symptomatic VTE, defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE in subjects during the 12-month study period.
Maltese: Il-punt aħħari tal-effikaċja primarja kienet ir-rikorrenza ta' VTE sintomatika, definita bħala l-kompost ta' DVT sintomatika rikorrenti, PE sintomatika mhux fatali u PE fatali f'individwi matul il-perjodu ta'
English: In case of clinically significant bleeding, stop treatment immediately.
Maltese: F'każ ta' emorraġija klinikament sinifikanti, waqqaf ilkura immedjatament.
English: Hepatic impairment
Maltese: Emorraġija intrartikulari
English: Compared to warfarin-treated subjects, the HR in the edoxaban 60 mg group was 0.87 (99% CI: 0.71, 1.07, p = 0.08 for superiority).
Maltese: 87 (99% CI: 0.71, 1.07, p = 0.08 għas-superjorità).
English: b The HR, two-sided CI are based on the Cox proportional hazards regression model including treatment and the following randomisation stratification factors as covariates: presenting diagnosis (PE with or without DVT, DVT only), baseline risk factors (temporary factors, all others), and the need for 30 mg edoxaban/edoxaban placebo dose at randomisation (yes/no).
Maltese: b Il-HR, two-sided CI huma bbażati fuq il-mudell ta' rigressjoni ta' perikli proporzjonali Cox li jinkludi l-kura u l-fatturi ta' stratifikazzjoni tal-għażla b'mod każwali bħala kovarjanti: ikun hemm dijanjosi (PE bi jew mingħajr DVT, DVT biss), fatturi ta' riskju fil-linja bażi (fatturi temporanji, loħrajn kollha), u l-ħtieġa għal doża ta' plaċebo ta' 30 mg edoxaban/edoxaban fl-għażla b'mod każwali (iva/le).
English: Edoxaban was administered with or without food in the ENGAGE AF-TIMI 48 and the Hokusai-VTE studies.
Maltese: ENGAGE AF-TIMI 48 u Hokusai-VTE.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 30 MG
Maltese: FOLJA TAD-DOŻA TAL-UNITÀ (10 x 1 PILLOLA) GĦAL 30
English: In patients with mild to moderate hepatic impairment the recommended dose is 60 mg Roteas once daily (see section 5.2).
Maltese: F'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat, id-doża rakkomandata hija ta' 60 mg ta' Roteas darba kuljum (ara sezzjoni 5.2).
English: Roteas film-coated tablets edoxaban
Maltese: klinikament rilevanti mhux maġġuri a Fil-perjodu meta l-Individwi
English: Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate).
Maltese: Kull pillola miksija b'rita fiha 60 mg ta' edoxaban (bħala tosilate).
English: Acetylsalicylic acid (ASA): Co-administration of ASA (100 mg or 325 mg) and edoxaban increased bleeding time relative to either medicine alone.
Maltese: L-għoti flimkien ta' ASA (100 mg jew 325 mg) u edoxaban żied il-ħin ta'
English: Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: NAME OF THE MEDICINAL PRODUCT Roteas 60 mg film-coated tablets edoxaban
Maltese: Roteas 60 mg pilloli miksija b'rita edoxaban
English: (mm/yy)
Maltese: (xx/ss)
English: Secondary efficacy endpoints included: Composite of stroke, SEE, and cardiovascular (CV) mortality; major adverse cardiovascular event (MACE), which is the composite of non-fatal MI, non-fatal stroke, non-fatal SEE, and death due to CV cause or bleeding; composite of stroke, SEE, and all-cause mortality.
Maltese: Kompost ta' puplesija, SEE, u mortalità kardjovaskulari (CV); avveniment kardjovaskulari avvers maġġuri (MACE), li hu l-kompost ta' MI (infart mijokardijaku) mhux fatali,
English: Stroke and SEE occurred in fewer subjects in the edoxaban 60 mg treatment group than in the warfarin group (1.57% and 1.80% per year, respectively), with a HR of 0.87 (99% CI: 0.71, 1.07, p = 0.0807 for superiority).
Maltese: Puplesija u SEE seħħew f'inqas individwi fil-grupp ta' kura ta' edoxaban 60 mg minn fil-grupp ta' warfarin (1.57% u 1.80% kull sena, rispettivament), b'HR ta' 0.
English: OTHER
Maltese: n
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: (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'
English: Taking an anticoagulant medicine such as Roteas can increase your risk of bleeding.
Maltese: Meta tieħu mediċina antikoagulanti bħal Roteas, dan jista' jżid ir-riskju tiegħek għal emorraġija.
English: In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study, peak and total exposure in Asian patients and non-Asian patients were comparable.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni tal-istudju ENGAGE AF-TIMI 48, l-esponiment massimu u l-esponiment totali f'pazjenti Asjatiċi u mhux Asjatiċi, kienu komparabbli.
English: The active substance edoxaban tosilate is persistent in the environment (for instructions on disposal see section 6.6).
Maltese: Is-sustanza attiva edoxaban tosilate hi persistenti fl-ambjent (għal istruzzjonijiet dwar ir-rimi ara sezzjoni 6.6).
English: The safety and efficacy of Roteas in children and adolescents less than 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Roteas fit-tfal u adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: • Feeling sick
Maltese: • disturbi ta' emorraġija
English: It is only indicated in the process of switching from Roteas 30 mg (patients with one or more clinical factors for increased exposure; see table 1) to VKA, together with an appropriate VKA dose (see table 2, section
Maltese: Hu indikat biss fil-proċess ta' qlib minn Roteas 30 mg (f'pazjenti b'fatturi kliniku wieħed jew aktar għal żieda fl-esponiment; ara tabella 1) għal VKA, flimkien ma' doża VKA adattata (ara tabella 2, sezzjoni
English: • Dronedarone: Dronedarone 400 mg twice daily for 7 days with a single concomitant dose of edoxaban 60 mg on Day 5 increased edoxaban AUC and Cmax by 85% and 46%, respectively.
Maltese: edoxaban 60 mg f'Jum 5, żied l-AUC u s-Cmax ta' edoxaban b'85% u 46%, rispettivament.
English: Edoxaban 30 mg once daily was used for subjects with one or more of the following clinical factors: moderate renal impairment (CrCL 30 - 50 mL/min); body weight ≤ 60 kg; concomitant use of specific P-gp inhibitors.
Maltese: indeboliment moderat tal-kliewi (CrCL 30 - 50 mL/min); piż tal-ġisem ta' ≤ 60 kg; l-użu fl-istess ħin ta' inibituri speċifiċi ta' P-gp.
English: Take special care with Roteas
Maltese: Kif taqleb minn Roteas
English: In clinical pharmacology studies, healthy subjects received rivaroxaban 20 mg once daily, dabigatran 150 mg twice daily, or apixaban 5 mg twice daily, followed by a single dose of edoxaban 60 mg on Day 4.
Maltese: Edoxaban juri farmakokinetika li hi bejn wieħed u ieħor proporzjonali għad-doża għal dożi ta' 15 mg sa 60 mg f'individwi b'saħħithom.