FrancophonIA/ELRC3.0 huggingface dataset:
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, apixaban)
English: Edoxaban can be co-administered with low dose ASA (≤ 100 mg/day).
Maltese: Edoxaban jista' jingħata flimkien ma' doża baxxa ta' ASA (≤ 100 mg/jum).
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: (pulmonary embolism, PE), u l-prevenzjoni ta' DVT u PE rikorrenti fl-adulti (ara sezzjoni 4.4 għal pazjenti b'PE emodinamikament instabbli).
English: • Quinidine: Quinidine 300 mg once daily on Days 1 and 4 and three times daily on Days 2 and 3, with a single concomitant dose of edoxaban 60 mg on Day 3, increased edoxaban AUC over 24 hours by 77% and Cmax by 85%, respectively.
Maltese: Quinidine 300 mg darba kuljum f'Jiem 1 u 4 u tliet darbiet kuljum f'Jiem 2 u 3, ma' doża waħda fl-istess ħin ta' edoxaban 60 mg f'Jum 3, żied l-AUC ta' edoxaban fuq perjodu ta' 24 siegħa b'77% u s-Cmax b'85%, rispettivament.
English: P-gp substrates
Maltese: Sottostrati ta' P-gp
English: Allergic oedema
Maltese: Edema allerġika
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1152/001 10 film-coated tablets EU/1/16/1152/002 10 x 1 film-coated tablets
Maltese: EU/1/16/1152/001 10 pilloli miksija b'rita EU/1/16/1152/002 10 x 1 pillola miksija b'rita
English: • Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole.
Maltese: • L-użu fl-istess ħin tal-inibituri ta' P-glikoproteina (P-gp) li ġejjin: ciclosporin, dronedarone, erythromycin, jew ketoconazole.
English: Edoxaban 60 mg (30 mg dose reduced) resulted in a lower rate of cardiovascular mortality compared to warfarin [HR (95% CI): 0.86 (0.77, 0.97)].
Maltese: Edoxaban 60 mg (doża imnaqqsa ta' 30 mg) irriżulta f'rata aktar baxxa ta' mortalità kardjovaskulari meta mqabbel ma' warfarin [HR (95% CI): 0.86 (0.77, 0.97)].
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,
English: b ICH includes primary haemorrhagic stroke, subarachnoid haemorrhage, epi/subdural haemorrhage, and ischaemic stroke with major haemorrhagic conversion.
Maltese: b ICH tinkludi puplesija emorraġika primarja, emorraġija subarakinojde, emorraġija epi-/subdurali, u puplesija iskemika b'konverżjoni emorraġika maġġuri.
English: ICH fatal
Maltese: PE mhux fatali
English: n Number of Events
Maltese: n Numru ta' Avvenim enti
English: The primary efficacy outcome occurred in 14 (3.1%) and 30 (6.2%) of edoxaban and warfarin subjects, respectively [HR (95% CI): 0.50 (0.26, 0.94)].
Maltese: Ir-riżultat tal-effikaċja primarja seħħ f'14-individwu (3.1%) u fi 30 (6.2%) individwu li kienu fuq edoxaban u warfarin, rispettivament [HR (95% CI): 0.50 (0.26, 0.94)].
English: Clinically Relevant Bleeding (Major and CRNM)b, n (%) n
Maltese: (Maġġuri u CRNM),b n (%)
English: Eye disorders Conjunctival/Scleral haemorrhage
Maltese: Emorraġija tal-konġuntiva/Sklerali
English: The plasma AUC for subjects with mild (CrCL > 50 - 80 mL/min), moderate (CrCL 30 - 50 mL/min) and severe (CrCL < 30 mL/min but not undergoing dialysis) renal impairment was increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function (see section 4.2 for dose reduction).
Maltese: (CrCL 30 - 50 mL/min) u sever (CrCL < 30 mL/min iżda li ma tkunx qed issirilhom dijalisi) żdiedet b'32%, 74%, u 72%, rispettivament, meta mqabbla ma' individwi b'funzjoni normali tal-kliewi (ara sezzjoni 4.2 għal tnaqqis fid-doża).
English: RISK OF BLEEDING
Maltese: Riskju emorraġiku
English: Anti-FXa activity by CrCL category Table 12 below shows the edoxaban anti-Factor Xa activity by CrCL category for each indication.
Maltese: Tabella 12 hawn taħt turi l-attività anti-Fattur Xa ta' edoxaban skont il-kategorija ta' CrCL għal kull indikazzjoni.
English: Started on:
Maltese: Isem:
English: • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
Maltese: • Mard tal-fwied assoċjat ma' koagulopatija u riskju ta' fsada klinikament relevanti.
English: • some medicines for fungal infections (e.g. ketoconazole)
Maltese: • xi mediċini għal infezzjonijiet tal-fungu (eż. ketoconazole)
English: In patients with renal impairment the metabolite profile changes and a higher quantity of active metabolites are formed.
Maltese: F'pazjenti b'indeboliment tal-kliewi, il-profil tal-metaboliti jinbidel u tifforma kwantità ogħla ta' metaboliti attivi.
English: Primary Endpoint
Maltese: Punt Aħħari Primarjua
English: In the Hokusai-VTE study (Table 10) edoxaban was demonstrated to be non-inferior to warfarin for the primary efficacy outcome, recurrent VTE, which occurred in 130 of 4,118 subjects (3.2%) in the edoxaban group versus 146 of 4,122 subjects (3.5%) in the warfarin group [HR (95% CI): 0.89 (0.70, 1.13); p < 0.0001 for non-inferiority].
Maltese: Fl-istudju Hokusai-VTE (Tabella 10), intwera li edoxaban ma kienx inferjuri għal warfarin għar riżultat tal-effikaċja primarja, VTE rikorrenti, li seħħet f'130 mill-4,118-il individwu (3.2%) fil-grupp ta' edoxaban kontra 146 ta' 4,122 individwu (3.5%) fil-grupp ta' warfarin [HR (95% CI): 0.89 (0.70, 1.13); p < 0.0001 għal noninferjorità].
English: First Stroke/SEEa n Event Rate (%/yr)b
Maltese: L-Ewwel Puplesija Emorraġika n Rata ta' Avvenimenti (%/yr)b
English: Abbreviations: HR = Hazard Ratio versus warfarin, CI = Confidence Interval, n = number of events, mITT = modified Intent To Treat, N = number of subjects in mITT population, SEE = Systemic Embolic Event, yr = year.
Maltese: HR = Proporzjon ta' Periklu kontra warfarin, CI = Intervall ta' Kunfidenza, n = numru ta' avvenimenti, mITT (modified Intent To Treat) = Intenzjoni Ta' Kura modifikata; N = numru ta' individwi fil-popolazzjoni mITT, SEE = Avveniment Sistemiku Emboliku, yr = sena.
English: • medicines to treat abnormal heart beat (e.g. dronedarone, quinidine, verapamil)
Maltese: • mediċini għall-kura ta' taħbit mhux normali tal-qalb (eż. dronedarone, quinidine, verapamil)
English: c The p-value is for the pre-defined non-inferiority margin of 1.5.
Maltese: c Il-valur p hu għall-marġni ta' noninferjorità definita minn qabel ta' 1.5.
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
English: Subjects with ESRD undergoing peritoneal dialysis had 93% higher total exposure compared with healthy subjects.
Maltese: Individwi b'ESRD li kienu fuq dijalisi peritoneali, kellhom 93% esponiment totali ogħla meta mqabbala ma' individwi b'saħħithom.
English: Event rate (%/year)
Maltese: Rata ta' avvenim enti (%/sena)
English: Once an INR ≥ 2.0 is achieved, Roteas should be discontinued.
Maltese: Ġaladarba jinkiseb INR ta' ≥ 2.0, Roteas għandu jitwaqqaf.
English: • Amiodarone: Co-administration of amiodarone 400 mg once daily with edoxaban 60 mg once daily increased AUC by 40% and Cmax by 66%.
Maltese: L-għoti flimkien ta' amiodarone 400 mg darba kuljum ma' edoxaban 60 mg darba kuljum żied l-AUC b'40% u s-Cmax b'66%.
English: 15 mg and 60 mg film-coated tablets: Iron oxide yellow (E172) 15 mg and 30 mg film-coated tablets: Iron oxide red (E172)
Maltese: Iron oxide yellow (E172) 15 mg u 30 mg pilloli miksija b'rita:
English: The duration of therapy for treatment of DVT and PE (venous thromboembolism, VTE), and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Maltese: It-tul ta' żmien tat-terapija għall-kura ta' DVT u PE (tromboemboliżmu venuż, VTE), u l-prevenzjoni ta' VTE rikorrenti għandu jiġi individwalizzat wara evalwazzjoni b'attenzjoni tal-benefiċċju tat trattament kontra r-riskju ta' ħruġ ta' demm (ara sezzjoni 4.4).
English: In the Hokusai-VTE study the Net Clinical Outcome (Recurrent VTE, Major Bleed, or All-Cause Mortality; mITT population, overall study period) HR (95% CI) was 1.00 (0.85, 1.18) when edoxaban was compared to warfarin.
Maltese: Fl-istudju Hokusai-VTE, l-Eżitu Kliniku Nett (VTE Rikorrenti, Emorraġija Maġġuri, jew Mortalità mill-Kawżi Kollha; popolazzjoni mITT, perjodu ta' studju globali) (95% CI) kien ta' 1.00 (0.85, 1.18) meta edoxaban kien imqabbel ma' warfarin.
English: The primary safety outcome was a composite of major and CRNM bleeding.
Maltese: Ir-riżultat tas-sigurtà primarja kien kompost minn emorraġija maġġuri u CRNM.
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
English: The median study follow-up for both the edoxaban 60 mg and 30 mg treatment groups was 2.8 years.
Maltese: Il-follow-up medjan tal-istudju għaż-żewġ gruppi ta' kura ta' edoxaban 60 mg u 30 mg kien ta' 2.8 snin.
English: A specific anticoagulant reversal agent for edoxaban is not available (see section 4.9).
Maltese: Mediċina speċifika li treġġa' lura lill-antikoagulant għal edoxaban mhijiex disponibbli (ara sezzjoni 4.9).
English: Tablet core:
Maltese: Tabella 10:
English: Phone no:
Maltese: Numru tat-telefon:
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Roteas 15 mg: Each tablet contains 15 mg edoxaban (as tosilate).
Maltese: Roteas 15 mg: Kull pillola fiha 15 mg ta' edoxaban (bħala tosilate).
English: Other medicines and Roteas
Maltese: Mediċini oħra u Roteas
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, 104 (3.05% per year) of edoxaban 30 mg dose reduced subjects and 166 (4.85% per year) of warfarin dose reduced subjects had a major bleeding event [HR (95% CI): 0.63 (0.50,
Maltese: 30 mg fl-istudju ENGAGE AF-TIMI 48 minħabba piż tal-ġisem ta' ≤ 60 kg, indeboliment moderat talkliewi, jew l-użu fl-istess ħin ta' inibituri ta' P-gp, 104 (3.05% kull sena) ta' individwi li ngħataw doża imnaqqsa ta' edoxaban 30 mg u 166 (4.85% kull sena) ta' individwi li ngħataw doża mnaqqsa ta'
English: Direct acting Oral Anticoagulants (DOACs) including edoxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Maltese: Orali b'azzjoni diretta (DOACs) inklużi edoxaban mhumiex rakkomandati għal pazjenti bi storja ta' trombożi li huma dijanjostikati bis-sindrome antifosfolipid.
English: All-cause mortality (adjudicated deaths) per renal subgroups (edoxaban vs. warfarin): CrCL 30 to ≤ 50 mL/min [HR (95% CI): 0.81 (0.68, 0.97)]; CrCL > 50 to < 80 mL/min [HR (95% CI): 0.87 (0.75, 1.02)]; CrCL ≥ 80 mL/min [HR (95% CI): 1.15 (0.95, 1.40)].
Maltese: Mortalità mill-kawżi kollha (imwiet aġġudikati) skont is-sottogruppi renali (edoxaban vs. warfarin): CrCL 30 sa ≤ 50 mL/min [HR (95% CI): 0.81 (0.68, 0.97)]; CrCL > 50 sa < 80 mL/min [HR (95% CI): 0.
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'
English: 30 mg and 60 mg film-coated tablets:
Maltese: 30 mg u 60 mg pilloli miksija b'rita:
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna):
English: The method used to estimate renal function (CrCL in mL/min) during the clinical development of Roteas was the Cockcroft-Gault method.
Maltese: Il-metodu li intuża biex saret stima tal-funzjoni tal-kliewi (CrCL f'mL/min) matul l-iżvilupp kliniku ta' Roteas kien il-metodu Cockcroft-Gault.
English: Table 3 provides the list of adverse reactions from the two pivotal Phase 3 studies in patients with VTE (DVT and PE) (Hokusai-VTE study) and AF (ENGAGE AF-TIMI 48 study) combined for both indications.
Maltese: f'pazjenti b'VTE (DVT u PE) (l-istudju Hokusai-VTE) u AF (l-istudju ENGAGE AF-TIMI 48) kombinat għaż-żewġ indikazzjonijiet.
English: Edoxaban has three active metabolites, the predominant metabolite (M-4), formed by hydrolysis, is active and reaches less than 10% of the exposure of the parent compound in healthy subjects.
Maltese: Edoxaban għandu tliet metaboliti attivi, il-metabolit predominanti (M-4), iffurmat mill-idrolisi hu attiv u jilħaq inqas minn 10% tal-esponiment tal-kompost prinċipali f'individwi b'saħħithom.
English: Major Bleeding n (%) n
Maltese: Emorraġija Maġġuri n (%)
English: In patients with moderate or severe renal impairment (CrCL 15 - 50 mL/min), the recommended dose is 30 mg Roteas once daily (see section 5.2).
Maltese: F'pazjenti b'indeboliment moderat jew sever tal-kliewi (CrCL > 15 - 50 mL/min), id-doża rakkomandata hija ta' 30 mg ta' Roteas darba kuljum (ara sezzjoni 5.2).
English: Table 8: Number of Fatal Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Maltese: Tabella 8: Numru ta' Avvenimenti ta' Emorraġija Fatali skont il-kategorija ta' tneħħija ta' kreatinina f'ENGAGE AF-TIMI 48, Analiżi dwar is-Sigurtà Waqt il-Kuraa Sottogrupp ta' CrCL (mL/min)
English: Signature of physician:
Maltese: Kategorija farmakoterapewtika:
English: Roteas 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).
Maltese: Roteas 60 mg: Kull pillola fiha 60 mg ta' edoxaban (bħala tosilate).
English: Changing from vitamin K antagonists (e.g. warfarin) to Roteas Stop taking the vitamin K antagonist (e.g. warfarin).
Maltese: Meta tibdel minn Roteas għal antagonisti ta' vitamina K (eż. warfarin)
English: In patients with mild renal impairment (CrCL > 50 - 80 mL/min), the recommended dose is 60 mg Roteas once daily.
Maltese: F'pazjenti b'indeboliment ħafif tal-kliewi (CrCL > 50 - 80 mL/min), id-doża rakkomandata hija ta' 60 mg ta' Roteas darba kuljum.
English: • Guidance regarding surgery or invasive procedure, and temporary discontinuation
Maltese: • Gwida dwar operazzjoni jew proċedura invażiva, u twaqqif temporanju
English: Table 11: Bleeding Events in Hokusai-VTE Study - Safety Analysis On-Treatment Perioda
Maltese: Tabella 11: Każijiet ta' emorraġija fl-Istudju Hokusai-VTE - Analiżi tas-Sigurtà fil-Perjodu Meta l-Individwi kienu fuq il-Kuraa
English: Roteas administration should be discontinued if severe haemorrhage occurs (see sections 4.8 and 4.9).
Maltese: L-għoti ta' Roteas għandu jitwaqqaf jekk isseħħ emorraġija severa (ara sezzjonijiet 4.8 u 4.9).
English: Roteas 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Maltese: Roteas 15 mg: Qalba tal-pillola: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
English: Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AF03
Maltese: Mediċini antitrombotiċi oħrajn, Kodiċi ATC:
English: Roteas 30 mg: Each tablet contains 30 mg edoxaban (as tosilate).
Maltese: Roteas 30 mg: Kull pillola fiha 30 mg ta' edoxaban (bħala tosilate).
English: During the overall study period in the ITT population (analysis set to show superiority), adjudicated stroke or SEE occurred in 296 subjects in the edoxaban 60 mg group (1.57% per year), and 337 subjects in the warfarin group (1.80% per year).
Maltese: puplesija aġġudikata jew SEE seħħew f'296 individwu fil-grupp ta' kura b'edoxaban 60 mg (1.57% kull sena), u 337 individwu fil-grupp ta' warfarin (1.80% kull sena).
English: For life-threatening bleeding that cannot be controlled with the measures such as transfusion or haemostasis, the administration of a 4-factor prothrombin complex concentrate (PCC) at 50 IU/kg has been shown to reverse the effects of Roteas 30 minutes after completing the infusion.
Maltese: Għal emorraġija li hi ta' theddida għall-ħajja li ma tistax tiġi kkontrollata bil-miżuri bħal trasfużjoni jew emostasi, l-għoti ta' 4-factor prothrombin complex concentrate (PCC) f'doża ta' 50 iU/kg, intwera li jreġġa' lura l-effetti ta' Roteas 30 minuta wara li titlesta l-infużjoni.
English: Assessment of renal function: CrCL should be monitored at the beginning of the treatment in all patients and afterwards when clinically indicated (see section 4.2).
Maltese: Evalwazzjoni tal-funzjoni tal-kliewi: Il-CrCL għandha tiġi mmonitorjata fil-bidu tal-kura fil-pazjenti kollha, u wara dan meta jkun klinikament indikat (ara sezzjoni 4.2).
English: Reproductive system and breast disorders Vaginal haemorrhage1
Maltese: Emorraġija vaġinali1
English: • Anaemia (low levels of red blood cells)
Maltese: • Anemija (livelli baxxi ta' ċelluli tad-demm ħomor)
English: • Erythromycin: Erythromycin 500 mg four times daily for 8 days with a single concomitant dose of edoxaban 60 mg on Day 7 increased the edoxaban AUC and Cmax by 85% and 68%, respectively.
Maltese: Erythromycin 500 mg erba' darbiet kuljum għal 8 ijiem ma' doża waħda fl-istess ħin ta' edoxaban 60 mg f'Jum 7, żied l-AUC u s-Cmax ta' edoxaban b'85% u 68%, rispettivament.
English: • Bleeding following a surgical procedure
Maltese: • Emorraġija wara proċedura kirurġika
English: In the pivotal Hokusai-VTE study, 8,292 subjects were randomised to receive initial heparin therapy (enoxaparin or unfractionated heparin) followed by edoxaban 60 mg once daily or the comparator.
Maltese: Fl-istudju importanti ħafna Hokusai-VTE, 8,292 individwu ntgħażlu b'mod każwali biex jirċievu terapija inizjali bl-eparina (enoxaparin jew eparina mhux frazzjonata) segwita minn edoxaban 60 mg darba kuljum jew il-komparatur.
English: Effects of coagulation markers when switching from rivaroxaban, dabigatran, or apixaban to edoxaban
Maltese: L-effetti tal-markaturi tal-koagulazzjoni meta taqleb minn rivaroxaban, dabigatran, jew apixaban għal edoxaban
English: 100 film-coated tablets 10 x 1 film-coated tablets 50 x 1 film-coated tablets 100 x 1 film-coated tablets
Maltese: 10 pilloli miksija b'rita 10 x 1 pillola miksija b'rita
English: In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Maltese: B'mod partikolari għal pazjenti li huma tripli pożittivi (għal antikoagulanti ta' lupus, antikorpi ta' antikardjolipin u antikorpi ta' kontra l-beta 2-glikoproteina I), il-kura b'DOACs tista' tiġi assoċjata ma' rati miżjuda ta' avvenimenti trombotiċi rikorrenti meta mqabbla mat-terapija b'antagonist ta' vitamina K.
English: Roteas 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Maltese: Roteas 60 mg: Qalba tal-pillola: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
English: Roteas 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
Maltese: Roteas 30 mg pilloli miksija b'rita huma ta' lewn roża, tondi (dijametru ta' 8.5 mm) u mnaqqxa b'“DSC L30” fuq naħa waħda.
English: After taking renal function and body weight into account, age had no additional clinically significant effect on edoxaban pharmacokinetics in a population pharmacokinetic analysis of the pivotal Phase 3 study in NVAF (ENGAGE AF-TIMI 48).
Maltese: Wara li jiġu kkunsidrati l-funzjoni tal-kliewi u piż tal-ġisem, l-età ma kellha l-ebda effett klinikament sinifikanti addizzjonali fuq il-farmakokinetika ta' edoxaban f'analiżi farmakokinetika tal-popolazzjoni fl-istudju importanti ħafna ta' Fażi 3 f'NVAF (ENGAGE AF-TIMI 48).
English: The results for all-cause mortality (adjudicated deaths) in Hokusai-VTE were 136 (3.3%) for subjects taking edoxaban 60 mg (30 mg dose reduced) as opposed to 130 (3.2%) for warfarin.
Maltese: Ir-riżultati għall-mortalità mill-kawżi kollha (imwiet aġġudikati) fl-istudju Hokusai-VTE kienu 136 (3.3%) għal individwi li kienu qed jieħdu edoxaban 60 mg (doża imnaqqsa ta' 30 mg) meta mqabbla ma' 130 (3.2%) għal warfarin.
English: Gastrointestinal disorders Abdominal pain
Maltese: Disturbi gastro-intestinali
English: When the effects of edoxaban on digoxin PK were also examined, the Cmax of digoxin increased by approximately 28% and AUC by 7%.
Maltese: Meta l-effetti ta' edoxaban fuq il-PK ta' digoxin ġew eżaminati wkoll, is-Cmax ta' digoxin żdiedet b'madwar 28% u l-AUC b'7%.
English: Common other adverse reactions for edoxaban were anaemia, rash and abnormal liver function tests.
Maltese: Reazzjonijiet avversi komuni oħrajn għal edoxaban kienu anemija, raxx u testijiet tal-funzjoni talfwied b'riżultat anormali.
English: Roteas 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Maltese: Roteas 30 mg: Qalba tal-pillola: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
English: A specific antidote antagonising the pharmacodynamic effect of edoxaban is not available.
Maltese: Mhux disponibbli antidotu speċifiku li jantagonizza l-effett farmakodinamiku ta' edoxaban.
English: Haemodialysis 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: The secondary composite endpoint of recurrent VTE and all-cause mortality occurred in 138 subjects (3.4%) in the edoxaban group and 158 subjects (3.9%) in the warfarin group [HR (95% CI): 0.87
Maltese: Il-punt aħħari tal-kompost sekondarju ta' VTE rikorrenti u mortalità mill-kawżi kollha seħħ f'138 individwu (3.4%) fil-grupp ta' edoxaban u f'158 individwu (3.9%) fil-grupp ta' warfarin [HR (95% CI): 0.
English: and appropriate caution exercised.
Maltese: Kompetenti Nazzjonali.
English: Abbreviations: ICH = Intracranial Haemorrhage, HR = Hazard Ratio vs. warfarin; CI = Confidence Interval; N = number of subjects in safety population; n = number of events; CRNM = clinically relevant non-major a On-Treatment Period: Time from first dose of study drug to last dose plus 3 days.
Maltese: ICH = Emorraġija Intrakranjali, HR = Proporzjon ta' Periklu kontra warfarin, CI = Intervall ta' Kunfidenza, CRNM = Klinikament Rilevanti Mhux Maġġuri, n = numru ta' individwi b'każijiet, N = numru ta' individwi fil-Popolazzjoni tas-sigurtà, yr = sena.
English: 15 mg film-coated tablet: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”.
Maltese: Pilloli miksija b'rita tondi, ta' lewn oranġjo (dijametru ta' 6.7 mm) imnaqqxa b'“DSC L15”.
English: • Importance of treatment compliance
Maltese: • L-importanza ta' konformità mal-kura