FrancophonIA/ELRC3.0 huggingface dataset:
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 għarriżultat 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: Nervous system disorders Dizziness
Maltese: Disturbi fis-sistema nervuża Sturdament
English: 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: Co-administration of high dose ASA (325 mg) increased the steady state Cmax and AUC of edoxaban by 35% and 32%, respectively.
Maltese: L-għoti flimkien ta' doża għolja ta' ASA (325 mg) żied is-Cmax u l-AUC fl-istat fiss ta' edoxaban b'35% u 32%, rispettivament.
English: The plasma AUCs 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 were increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function.
Maltese: L-AUCs tal-plażma għal individwi b'indeboliment tal-kliewi ħafif (CrCL > 50 - 80 mL/min), moderat (CrCL 30 - 50 mL/min) u sever (CrCL < 30 mL/min iżda li ma tkunx qed issirilhom dijalisi) żdiedu bi 32%, 74%, u 72%, rispettivament, meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
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) inkluż edoxaban mhumiex rakkomandati għal pazjenti bi storja ta' trombożi li huma dijanjostikati bis-sindrome antifosfolipid.
English: In patients with moderate or severe renal impairment (CrCL 15 - 50 mL/min), the recommended dose is 30 mg Lixiana 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' Lixiana darba kuljum (ara sezzjoni 5.2).
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: Ketoconazole 400 mg darbtejn kuljum għal 7 ijiem ma' doża waħda fl-istess ħin ta' edoxaban 60 mg f'Jum 4, żied l-AUC u s-Cmax ta' edoxaban b'87% u 89%, rispettivament.
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: L-AUC tal-plażma għal individwi b'indeboliment tal-kliewi ħafif (CrCL > 50 - 80 mL/min), moderat (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: 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: Fl-istudju ENGAGE AF-TIMI 48 kien hemm titjib sinifikanti fir-Riżultat Kliniku Nett (l-Ewwel 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: The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section 5.1).
Maltese: Id-doża rakkomandata hija ta' 60 mg ta' edoxaban darba kuljum wara l-użu inizjali ta' antikoagulant parenterali għal mill-inqas 5 ijiem (ara sezzjoni 5.1).
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, puplesija mhux fatali, SEE mhux fatali, u mewt minħabba kawża CV jew emorraġija; kompost ta' puplesija, SEE, u mortalità mill-kawżi kollha.
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE)
Maltese: Trattament ta' DVT, trattament ta' PE u l-prevenzjoni ta' DVT u PE rikorrenti (VTE)
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: Fi studji kliniċi farmakoloġiċi, individwi b'saħħithom irċivew rivaroxaban 20 mg darba kuljum, dabigatran 150 mg darbtejn kuljum, jew apixaban 5 mg darbtejn kuljum, segwit minn doża waħda ta' edoxaban 60 mg f'Jum 4.
English: Eye disorders Conjunctival/Scleral haemorrhage
Maltese: Disturbi fl-għajnejn Emorraġija tal-konġuntiva/Sklerali
English: Lixiana administration should be discontinued if severe haemorrhage occurs (see sections 4.8 and 4.9).
Maltese: L-għoti ta' Lixiana għandu jitwaqqaf jekk isseħħ emorraġija severa (ara sezzjonijiet 4.8 u 4.9).
English: b Primary Safety Endpoint: Clinically relevant bleeding (composite of major and clinically relevant non-major bleeding).
Maltese: Emorraġija klinikament rilevanti (kompost ta' emorraġija maġġuri u emorraġija klinikament rilevanti mhux maġġuri).
English: RISK OF BLEEDING
Maltese: RISKJU TA' EMORRAĠIJA
English: In patients with severe hepatic impairment Lixiana is not recommended (see sections 4.4 and 5.2).
Maltese: F'pazjenti b'indeboliment sever tal-fwied Lixiana mhuwiex rakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: QR code to be included
Maltese: Kodiċi QR biex tiġi inkluża
English: Median [2.5 - 97.5% range] Prevention of stroke and systemic embolism: NVAF 30 mg QD ≥ 30 to ≤ 50
Maltese: Medjan [medda 2.5 - 97.5%] Prevenzjoni ta' puplesija u emboliżmu sistemiku:
English: The primary efficacy outcome consisted of a composite of all stroke, SEE, MI and CV mortality.
Maltese: Ir-riżultat tal-effikaċja primarja kien jikkonsisti f'kompost globali ta' puplesija, SEE, MI u mortalità CV.
English: Lixiana film-coated tablets edoxaban
Maltese: Disturbi fil-qalb Emorraġija perikardjali
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 Lixiana 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' Lixiana 30 minuta wara li titlesta l-infużjoni.
English: Once an INR ≥ 2.0 is achieved, Lixiana should be discontinued.
Maltese: Ġaladarba jinkiseb INR ta' ≥ 2.0, Lixiana għandu jitwaqqaf.
English: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
Maltese: Il-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'fibrillazzjoni tal-atriju mhux valvulari (NVAF) u b'fattur ta' riskju wieħed jew aktar bħal insuffiċjenza konġestiva tal-qalb, pressjoni għolja, età ta' ≥ 75 sena, dijabete mellitus, puplesija jew attakk iskemiku għal żmien qasir (TIA) li jkunu ġraw qabel.
English: Lixiana 15 mg: Each tablet contains 15 mg edoxaban (as tosilate).
Maltese: Lixiana 15 mg: Kull pillola fiha 15 mg ta' edoxaban (bħala tosilate).
English: Lixiana 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Maltese: Lixiana 15 mg: Qalba tal-pillola: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
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: n Rata ta' każijiet (%/yr)a HR (95% CI) Emorraġija CRNM n Rata ta' każijiet (%/yr)a HR (95% CI) Kwalunkwe Emorraġija Ikkonfermatċ n Rata ta' każijiet (%/yr)a HR (95% CI) Taqsiriet:
English: Changing from vitamin K antagonists (e.g. warfarin) to Lixiana
Maltese: Meta tibdel minn antagonisti ta' vitamina K (eż. warfarin) għal Lixiana
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 tattrattament kontra r-riskju ta' ħruġ ta' demm (ara sezzjoni 4.4).
English: Vascular disorders Other haemorrhage
Maltese: Disturbi vaskulari Emorraġija oħra
English: The method used to estimate renal function (CrCL in mL/min) during the clinical development of Lixiana 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' Lixiana kien il-metodu Cockcroft-Gault.
English: Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Lixiana
Maltese: Meta tibdel minn antikoagulanti orali mhux VKA (dabigatran, rivaroxaban, jew apixaban) għal Lixiana
English: Changing from Lixiana to vitamin K antagonists (e.g. warfarin)
Maltese: Meta tibdel minn Lixiana għal antagonisti ta' vitamina K (eż. warfarin)
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: F'analiżijiet tas-sottogruppi, għal individwi fil-grupp ta' kura ta' 60 mg li tnaqqsitilhom id-doża għal 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' warfarin, kellhom każ ta' emorraġija maġġuri [HR (95% CI): 0.63 (0.50, 0.81)].
English: 30 mg and 60 mg film-coated tablets:
Maltese: 15 mg u 60 mg pilloli miksija b'rita:
English: Changing from parenteral anticoagulants (e.g. heparin) to Lixiana
Maltese: Meta tibdel minn antikoagulanti parenterali (eż. eparin) għal Lixiana
English: Table 6: Bleeding Events in ENGAGE AF-TIMI 48 Study - Safety Analysis On-Treatment Edoxaban 60 mg (30 mg Dose Reduced) (N = 7,012)
Maltese: Tabella 11: Każijiet ta' emorraġija fl-Istudju Hokusai-VTE - Analiżi tas-Sigurtà fil-Perjodu Meta l-Individwi kienu fuq il-Kuraa Edoxaban 60 mg (Doża Mnaqqsa ta' 30 mg) (N = 4,118)
English: ICH non-fatal CRNM Bleeding n
Maltese: ICH mhux fatali Emorraġija CRNM n
English: Lixiana 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).
Maltese: Lixiana 60 mg: Kull pillola fiha 60 mg ta' edoxaban (bħala tosilate).
English: Lixiana 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Maltese: Lixiana 60 mg: Qalba tal-pillola: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
English: Prior to launch of Lixiana in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Lixiana f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi media talkomunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
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-programm kliniku ta' edoxaban għal fibrillazzjoni atrijali kien maħsub biex juri l-effikaċja u ssigurtà 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: Lixiana 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Maltese: Lixiana 30 mg: Qalba tal-pillola: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
English: Macroscopic haematuria/urethral haemorrhage
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Ematurija makroskopika/emorraġija uretrali
English: Discontinuation for surgery and other interventions
Maltese: Twaqqif għal operazzjoni u interventi oħrajn
English: In patients with mild renal impairment (CrCL > 50 - 80 mL/min), the recommended dose is 60 mg Lixiana once daily.
Maltese: F'pazjenti b'indeboliment ħafif tal-kliewi (CrCL > 50 - 80 mL/min), id-doża rakkomandata hija ta' 60 mg ta' Lixiana darba kuljum.
English: Lixiana 15 mg is only to be used when changing from Lixiana 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3.
Maltese: Lixiana 15 mg għandu jintuża biss meta tibdel minn Lixiana 30 mg għal antagonist ta' vitamina K (eż. warfarin) (ara sezzjoni 3.
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' emorraġija f'Hokusai-VTE.
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: Dronedarone 400 mg darbtejn kuljum għal 7 ijiem ma' doża waħda fl-istess ħin ta' edoxaban 60 mg f'Jum 5, żied l-AUC u s-Cmax ta' edoxaban b'85% u 46%, rispettivament.
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: Tabella 3 tipprovdi l-lista ta' reazzjonijiet avversi miż-żewġ studji importanti ħafna ta' Fażi 3 f'pazjenti b'VTE (DVT u PE) (l-istudju Hokusai-VTE) u AF (l-istudju ENGAGE
English: Lixiana 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
Maltese: Lixiana 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: • Coagulation tests such as INR, prothrombin time (PT), or activated partial thromboplastin time (aPTT) are not a useful measure of the effect of Lixiana.
Maltese: • Testijiet tal-koagulazzjoni, bħal INR, ħin tal-prothrombin (PT), jew ħin ta' thromboplastin parzjali attivat (aPTT), mhumiex kejl utli tal-effett ta' Lixiana.
English: *Dose reduction to 30 mg for low body weight ≤ 60 kg or specific concomitant P-glycoprotein (P-gp) inhibitors
Maltese: *Tnaqqis fid-doża għal 30 mg għal piż baxx tal-ġisem ta' ≤ 60 kg jew inibituri speċifiċi ta' P
English: Platelet inhibitors: In ENGAGE AF-TIMI 48 concomitant use of thienopyridines (e.g. clopidogrel) monotherapy was permitted and resulted in increased clinically relevant bleeding although with a lower risk of bleeding on edoxaban compared to warfarin (see section 4.4).
Maltese: F'ENGAGE AF-TIMI 48, l-użu fl-istess ħin ta' monoterapija b'thienopyridines (eż. clopidogrel), kien permess u rriżulta f'żieda klinikament rilevanti f'emorraġija, għalkemm b'riskju iktar baxx ta' emorraġija fuq edoxaban meta mqabbel ma' warfarin (ara sezzjoni 4.4).
English: Edoxaban was administered with or without food in the ENGAGE AF-TIMI 48 and the Hokusai-VTE studies.
Maltese: Edoxaban ingħata mal-ikel jew fuq stonku vojt fl-istudji ENGAGE AF-TIMI 48 u Hokusai-VTE.
English: • Stomach ache
Maltese: • Tisgħol id-demm
English: 30 mg once daily
Maltese: 30 mg darba kuljum
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; N = numru ta' individwi fil-popolazzjoni tas-sigurtà; n = numru ta' każijiet; CRNM = klinikament rilevanti mhux maġġuri a Fil-perjodu meta l-Individwi
English: EXPIRY DATE
Maltese: Fl-istudju ENGAGE
English: In patients with mild to moderate hepatic impairment the recommended dose is 60 mg Lixiana 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' Lixiana darba kuljum (ara sezzjoni 5.2).
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: Matul il-perjodu globali tal-istudju fil-popolazzjoni ITT (analiżi ssettjata biex turi superjorità, 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: Table 9: Number of Intracranial Bleeding Events by creatinine clearance category in ENGAGE AF-TIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Maltese: Tabella 9: Numru ta' Avvenimenti ta' Emorraġija Intrakranjali skont il-Kategorija ta' Tneħħija ta' Kreatinina f'ENGAGE AF-TIMI 48, Analiżi dwar is-Sigurtà Waqt ilKuraa Sottogrupp ta' CrCL (mL/min)
English: Lixiana contains the active substance edoxaban and belongs to a group of medicines called anticoagulants.
Maltese: Lixiana fih is-sustanza attiva edoxaban u jappartjeni għal grupp ta' mediċini msejħin antikoagulanti.
English: How to take the tablet Swallow the tablet, preferably with water.
Maltese: Kif għandek tieħu l-pillola Ibla' l-pillola, preferibbilment mal-ilma.
English: • Renal function should be assessed in all patients by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Lixiana to exclude patients with end stage renal disease (i.e. CrCL < 15 mL/min), to use the correct Lixiana dose in patients with CrCL 15 - 50 mL/min (30 mg once daily), in patients with CrCL > 50 mL/min (60 mg once daily) and when deciding on the use of Lixiana in patients with increased creatinine clearance (see section 4.4).
Maltese: • Il-funzjoni tal-kliewi għandha tiġi evalwata fil-pazjenti kollha billi tiġi kkalkulata t-tneħħija talkreatinina (CrCL) qabel tinbeda l-kura b'Lixiana biex jiġu esklużi pazjenti b'mard tal-kliewi flaħħar stadju (i.e. CrCL ta' < 15 mL/min), biex tintuża d-doża korretta ta' Lixiana f'pazjenti bi CrCL ta' 15 - 50 mL/min (30 mg darba kuljum), f'pazjenti bi CrCL ta' > 50 mL/min (60 mg darba kuljum) u meta tkun trid tittieħed deċiżjoni dwar l-użu ta' Lixiana f'pazjenti b'żieda fittneħħija tal-kreatinina (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/993/001 10 film-coated tablets EU/1/15/993/016 10 x 1 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/993/001 10 pilloli miksija b'rita EU/1/15/993/016 10 x 1 pillola miksija b'rita
English: MARKETING AUTHORISATION NUMBER(S) 15 mg film-coated tablets: EU/1/15/993/001, EU/1/15/993/016 30 mg film-coated tablets: EU/1/15/993/002, EU/1/15/993/004-015 60 mg film-coated tablets: EU/1/15/993/003, EU/1/15/993/017-028
Maltese: EU/1/15/993/002 10 pilloli miksija b'rita EU/1/15/993/004 14-il pillola miksija b'rita EU/1/15/993/005 28 pillola miksija b'rita EU/1/15/993/006 30 pillola miksija b'rita EU/1/15/993/007 56 pillola miksija b'rita EU/1/15/993/008 60 pillola miksija b'rita EU/1/15/993/009 84 pillola miksija b'rita EU/1/15/993/010 90 pillola miksija b'rita EU/1/15/993/011 98 pillola miksija b'rita EU/1/15/993/012 100 pillola miksija b'rita EU/1/15/993/013 10 x 1 pillola miksija b'rita EU/1/15/993/014 50
English: • Ciclosporin: Concurrent administration of a single dose of ciclosporin 500 mg with a single dose of edoxaban 60 mg increased edoxaban AUC and Cmax by 73% and 74%, respectively.
Maltese: L-għoti fl-istess ħin ta' doża waħda ta' ciclosporin 500 mg ma' doża waħda ta' edoxaban 60 mg, żied l-AUC u s-Cmax ta' edoxaban b'73% u 74%, rispettivament.
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 għassuperjorità], primarjament minħabba t-tnaqqis f'emorraġija ICH fatali
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: Edoxaban 30 mg darba kuljum intuża għal individwi b'wieħed jew aktar mill-fatturi kliniċi li ġejjin: 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.