FrancophonIA/ELRC3.0 huggingface dataset:
English: The principal safety outcome (i.e. composite of fatal bleeding or bleeding into a critical space with a potential for permanent disability), occurred in 18 (0.7%) patients in the rivaroxaban 2.5 mg twice daily treatment group and in 23 (0.9%) patients in the placebo group, respectively (HR=0.80; 95% CI 0.43 - 1.49; p=0.484).
Maltese: Ir-riżultat prinċipali tassigurtà (jiġifieri kompost ta' fsada fatali jew fsada fi spazju kritiku b'potenzjal ta' diżabilità permanenti), seħħ fi 18-il pazjent (0.7%) fil-grupp ta' trattament ta' rivaroxaban 2.5 mg darbtejn kuljum u fi 23 pazjent (0.9%) fil-grupp tal-plaċebo, rispettivament (HR=0.80; CI ta' 95% 0.43 - 1.49; p=0.484).
English: a) intention-to-treat analysis set, primary analyses b) vs. ASA 100 mg; Log-Rank p-value bid: twice daily; CI: confidence interval; Cum.
Maltese: ASA 100 mg; Valur p Log-Rank bid: darbtejn kuljum; CI: intervall ta' kunfidenza;
English: 93.2% of patients received ASA concomitantly plus thienopyridine treatment and 6.8% ASA only.
Maltese: 93.2% tal-pazjenti rċevew ASA fl-istess waqt flimkien ma' kura b'thienopyridine u 6.8% irċevew ASA biss.
English: 0.70 (0.51, 0.97) p = 0.033** a) modified intent to treat analysis set (intent to treat total analysis set for stent thrombosis) b) vs. placebo; Log-Rank p-value * statistically superior ** nominally significant
Maltese: 033** a) grupp ta' analiżi b'intenzjoni li jiġi kkurat immodifikat (grupp ta' analiżi totali b'intenzjoni li jiġi kkurat għal trombożi tal-istent) b) kontra placebo; valur p Log-Rank * statistikament superjuri ** nominalment sinifikanti
English: Xarelto 20 mg tablets rivaroxaban
Maltese: Xarelto 20 mg pilloli rivaroxaban
English: When Xarelto 20 mg tablets are taken together with food increases in mean AUC by 39% were observed when compared to tablet intake under fasting conditions, indicating almost complete absorption and high oral bioavailability.
Maltese: Meta pilloli Xarelto 20 mg jittieħdu mal-ikel kienu osservati żjidiet fl-AUC medja ta' 39% meta mqabbla ma' teħid tal-pillola taħt kundizzjonijiet ta' sawm, u dan jindika assorbiment kważi komplet u bijodisponibilità orali għolja.
English: All patients were then randomized 1:1:1 to rivaroxaban 2.5 mg twice daily/ASA 100 mg once daily, to rivaroxaban 5 mg twice daily, or ASA 100 mg once daily alone, and their matching placebos.
Maltese: Il-pazjenti kollha mbagħad kienu randomised 1:1:1 għal rivaroxaban 2.5 mg darbtejn kuljum/ASA 100 mg darba kuljum, għal rivaroxaban 5 mg darbtejn kuljum, jew ASA 100 mg darba kuljum waħedhom, u l-plaċebo li jaqbel magħhom.
English: 42 film-coated tablets
Maltese: T-TRATTAMENT (42 PILLOLA
English: Anticoagulants
Maltese: Tromboċitopenija
English: In patients at high risk of ischaemic events with CAD/PAD, efficacy and safety of Xarelto 2.5 mg have only been investigated in combination with ASA.
Maltese: F'pazjenti li għandhom riskju għoli ta' avvenimenti iskemiċi b'CAD/PAD, l-effikaċja u s-sigurtà ta' Xarelto 2.5 mg ġew investigati flimkien ma' ASA biss.
English: In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein 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 pożittivi trippli (għall-antikoagulant lupus, għall-antikorpi kontra cardiolipin, u għall-antikorpi anti-beta 2-glycoprotein I), it-trattament b'DOACs jista' jkun assoċjat ma' rati miżjuda ta' avvenimenti trombotiċi rikorrenti mqabbla ma' terapija ta' antagonisti tal-vitamina K.
English: Xarelto 20 mg once daily and Xarelto 10 mg once daily were compared with 100 mg acetylsalicylic acid once daily.
Maltese: Xarelto 20 mg darba kuljum u Xarelto 10 mg darba kuljum ġew imqabbla ma' 100 mg acetylsalicylic acid darba kuljum.
English: Xarelto 2.5 mg film-coated tablets are light yellow, round, biconvex and marked with the BAYERcross on one side and “2.5” and a triangle on the other side.
Maltese: Il-pilloli miksija b'rita ta' Xarelto 2.5 mg huma ta' kulur isfar ċar, tondi, ibbuzzati fuq iż-żewġ naħat u mmarkati bis-salib tal-BAYER fuq naħa waħda, u bin-numru “2.5” u trijangolu fuq in-naħa l-oħra.
English: Bayer d. o. o. Tel: +386-(0)1-58 14 400
Maltese: Tel: +386-(0)1-58 14 400
English: 42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban (treatment initiation pack)
Maltese: 42 pillola miksija b'rita ta' 15 mg rivaroxaban u 7 pilloli miksija b'rita ta' 20 mg rivaroxaban (pakkett biex tibda t-trattament)
English: Hypromellose 2910 Titanium dioxide (E 171) Iron oxide yellow (E 172)
Maltese: Titanium dioxide (E 171) Iron oxide isfar (E 172)
English: Vascular pseudoaneurysmC
Maltese: Piż: Mediċini / kundizzjonijiet oħra
English: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery
Maltese: Prevenzjoni ta' tromboemboliżmu filvini (VTE) f'pazjenti adulti li qed jagħmlu kirurġija ppjanata ta' sostituzzjoni tal-ġenbejn jew tal-irkoppa
English: The 4-week treatment initiation pack of Xarelto is dedicated to patients who will transition from 15 mg twice daily to 20 mg once daily from Day 22 onwards (see section 6.5).
Maltese: Il-pakkett biex tibda t-trattament ta' 4 ġimgħat ta' Xarelto huwa dedikat għall-pazjenti li se jaqilbu minn 15 mg darbtejn kuljum għal 20 mg darba kuljum minn Jum 22 'il quddiem (ara sezzjoni 6.5).
English: Fluconazole (400 mg once daily), considered as a moderate CYP3A4 inhibitor, led to a 1.4 fold increase in mean rivaroxaban AUC and a 1.3 fold increase in mean Cmax.
Maltese: Fluconazole (400 mg darba kuljum), ikkunsidrat bħala inibitur moderat ta' CYP3A4, wassal għal żieda ta' 1.4 darbiet fl-AUC medja ta' rivaroxaban u żieda ta' 1.3 darbiet f'Cmax medja.
English: Table 1: Number of patients studied, total daily dose and maximum treatment duration in phase III studies
Maltese: Tabella 1: Numru ta' pazjenti studjati, id-doża totali ta' kuljum u t-tul massimu tal-kura fi studji ta' fażi
English: Table 9: Efficacy and safety results from phase III Einstein Choice Study population
Maltese: Tabella 9: Riżultati tal-effikaċja u s-sigurtà minn Einstein Choice ta' fażi
English: Safety and efficacy of Xarelto 2.5 mg twice daily in combination with ASA plus clopidogrel/ticlopidine has only been studied in patients with recent ACS (see section 4.1).
Maltese: Is-sigurtà u l-effikaċja ta' Xarelto 2.5 mg darbtejn kuljum flimkien ma' ASA flimkien ma' clopidogrel/ticlopidine ġew studjati biss f'pazjenti b'ACS reċenti (ara sezzjoni 4.1).
English: In all three phase III studies (see table 4), rivaroxaban significantly reduced the rate of total VTE (any venographically detected or symptomatic DVT, non-fatal PE and death) and major VTE (proximal DVT, non-fatal PE and VTE-related death), the pre-specified primary and major secondary efficacy endpoints.
Maltese: III (ara tabella 4), rivaroxaban naqqas b'mod sinifikanti ir-rata ta' VTE totali (kwalunkwe DVT osservata venografikament jew sintomatika, PE mhux fatali u mewt) u VTE maġġuri (DVT prossimali, PE mhux fatali u mewt assoċjata ma' VTE), il-mira ta' l-effikaċja primarja speċifikata minn qabel u dik sekondarja maġġuri.
English: • For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.
Maltese: • Għall-pazjenti li jkollhom kirurġija maġġuri fl-irkoppa, hija rrakkomandata kura li ddum ġimagħtejn.
English: PP/Aluminium foil blisters in cartons of 14, 20, 28, 30, 56, 60, 98, 168 or 196 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1 or 100 x 1 or in multipacks containing 100 (10 packs of 10 x 1) film-coated tablets.
Maltese: Folji tal-fojl tal-PP/Aluminju f'kaxxi tal-kartun ta' 14, 20, 28, 30, 56, 60, 98, 168 jew 196 pillola miksija b'rita jew folji perforati b'dożi uniċi f'kaxxi tal-kartun ta' 10 x 1 jew 100 x 1 jew f'pakketti multipli li fihom 100 (10 pakketti ta' 10 x 1) pillola miksija b'rita.
English: In the Einstein DVT study (see Table 4) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p < 0.0001 (test for non-inferiority); Hazard Ratio (HR): 0.680 (0.443 - 1.042), p=0.076 (test for superiority)).
Maltese: Fl-istudju Einstein DVT (ara Tabella 4) rivaroxaban intwera li mhux inferjuri għal enoxaparin/VKA għarriżultat primarju tal-effikaċja (p < 0.0001 (test għal nuqqas ta' inferjorità); Proporzjon ta' Periklu (HRHazard Ratio): 0.680 (0.443 - 1.042), p=0.076 (test għal superjorità)).
English: In Einstein Extension 1,197 patients with DVT or PE were studied for the prevention of recurrent
Maltese: F'Einstein Extension 1,197 pazjenti b'DVT jew PE ġew studjati għall-prevenzjoni ta' DVT u PE rikorrenti.
English: Table 9: Efficacy and safety results from phase III Einstein Extension Study population
Maltese: Tabella 9: Riżultati tal-effikaċja u s-sigurtà minn Einstein Extension ta' fażi
English: EU/1/08/472/030 168 film-coated tablets
Maltese: EU/1/08/472/030 168 pillola miksija b'rita
English: Patients with an ACS under the age of 55 had to have either diabetes mellitus or a previous MI.
Maltese: Pazjenti b'ACS b'età inqas minn 55 ried ikollhom dijabete mellitus jew MI preċedenti.
English: In the pivotal double-blind ATLAS ACS 2 TIMI 51 study, 15,526 patients were randomly assigned in a 1:1:1 fashion to one of three treatment groups: Xarelto 2.5 mg orally twice daily, 5 mg orally twice daily or to placebo twice daily co-administered with ASA alone or with ASA plus a thienopyridine (clopidogrel or ticlopidine).
Maltese: Fl-istudju pivitali double-blind ATLAS ACS 2 TIMI 51, 15,526 pazjent kienu assenjati b'mod każwali f'sistema ta' 1:1:1 lil wieħed minn tliet gruppi ta' kura:
English: Dose change
Maltese: Tqala u treddigħ
English: There is limited experience of a reduced dose of 15 mg Xarelto once daily (or 10 mg Xarelto once daily for patients with moderate renal impairment [creatinine clearance 30 - 49 ml/min]) in addition to a P2Y12 inhibitor for a maximum of 12 months in patients with non-valvular atrial fibrillation who require oral anticoagulation and undergo PCI with stent placement (see sections 4.4 and 5.1).
Maltese: [percutaneous coronary intervention]) bi tqegħid ta' stent Hemm esperjenza limitata ta' doża mnaqqsa ta' 15 mg Xarelto darba kuljum (jew 10 mg Xarelto darba kuljum għal pazjenti b'indeboliment moderat tal-kliewi [tneħħija tal-krejatinina ta' 30 - 49 ml/min]) flimkien ma' inibitur ta' P2Y12 għal massimu ta' 12-il xahar f'pazjenti b'fibrillazzjoni mhux valvulari tal-atriju li jeħtieġu antikoagulazzjoni orali u jgħaddu minn PCI bi tqegħid ta' stent (ara sezzjonijiet 4.4 u 5.1).
English: Day 1 to 21: 15 mg 1 tablet twice a day (one 15 mg tablet in the morning and one in the evening) together with food.
Maltese: Jum 1 sa 21: 15 mg, pillola waħda darbtejn kuljum (pillola waħda ta' 15 mg filgħodu u waħda filgħaxija)
English: EU/1/08/472/031 196 film-coated tablets
Maltese: EU/1/08/472/031 196 pillola miksija b'rita
English: The 2.5 mg twice daily regimen reduced mortality, and there is evidence that the lower dose had lower bleeding risks, therefore rivaroxaban 2.5 mg twice daily co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine is recommended for the prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers.
Maltese: Il-kors ta' 2.5 mg darbtejn kuljum naqqas il-mortalità, u hemm evidenza li l-aktar doża baxxa kellha inqas riskji ta' fsada, għalhekk rivaroxaban 2.5 mg darbtejn kuljum mogħti flimkien ma' acetylsalicylic acid (ASA - acetylsalicylic acid) waħdu jew ma' ASA flimkien ma' clopidogrel jew ticlopidine huwa rrakkomandat għall-prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti adulti wara ACS b'bijomarkaturi kardijaċi elevati.
English: In patients receiving rivaroxaban for treatment of acute DVT 20 mg once daily the geometric mean concentration (90% prediction interval) 2 - 4 h and about 24 h after dose (roughly representing maximum and minimum concentrations during the dose interval) was 215 (22 - 535) and 32 (6239) mcg/l, respectively.
Maltese: 2 - 4 sigħat u madwar 24 siegħa wara doża (bejn wieħed u ieħor jirrappreżentaw il-konċentrazzjonijiet massimi u minimi matul l-intervall taddoża ) kienet ta' 215 (22 - 535) u 32 (6 - 239) mcg/l, rispettivament.
English: - For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, the recommended dose is 15 mg once daily (see section 5.2).
Maltese: - Għall-prevenzjoni ta' puplesija jew emboliżmu sistemiku f'pazjenti b'fibrillazzjoni tal-atriju mhux valvulari, id-doża rrakkomandata hija 15 mg darba kuljum (ara sezzjoni 5.2).
English: Table 8: Efficacy and safety results from phase III Einstein Choice Study population
Maltese: Tabella 8: Riżultati tal-effikaċja u s-sigurtà minn Einstein Choice ta' fażi
English: Birth date:
Maltese: Riskju kumulattiv:
English: Hazard Ratio (HR) (95% CI) pvalue b)
Maltese: Proporzjon ta' periklu (95% CI) valur p
English: • If the first and second characters are IT, the manufacturer is Bayer HealthCare Manufacturing Srl.
Maltese: • Jekk l-ewwel u t-tieni karattri huma IT, il-manifattur huwa Bayer HealthCare Manufacturing Srl.
English: In the Einstein Extension study (see Table 8) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Maltese: Fl-istudju Einstein Extension (ara Tabella 8) rivaroxaban kien superjuri għal plaċebo għar-riżultati primarji u sekondarji tal-effikaċja.
English: Each film-coated tablet contains 2.5 mg rivaroxaban.
Maltese: Kull pillola miksija b'rita fiha 2.5 mg rivaroxaban.
English: Bayer S.p.A. Tel: +39-02-3978 1
Maltese: Tel: +39-02-3978 1
English: The effect of rivaroxaban did not differ across the level of centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized quartiles (P=0.74 for interaction).
Maltese: L-effett ta' rivaroxaban ma varjax tul il-livell ta' TTR ċentrali (Ħin fil-Firxa ta' INR Immirat ta' 2.0 - 3.0) fil-quartiles tal-istess daqs (P=0.74 għallinterazzjoni).
English: In cirrhotic patients with moderate hepatic impairment (classified as Child Pugh B), rivaroxaban mean AUC was significantly increased by 2.3 fold compared to healthy volunteers.
Maltese: F'pazjenti b'ċirrożi, b'indeboliment epatiku moderat (ikklassifikat bħala Child Pugh B), l-AUC medja ta' rivaroxaban żdiedet b'mod sinifikanti bi 2.3 darbiet meta mqabbla ma' voluntiera b'saħħithom.
English: Xarelto contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents.
Maltese: Xarelto fih is-sustanza attiva rivaroxaban u jagħmel parti minn grupp ta' mediċini msejħa sustanzi antitrombotiċi.
English: Oxidative degradation of the morpholinone moiety and hydrolysis of the amide bonds are the major sites of biotransformation.
Maltese: Id-degradazzjoni ossidattiva tal-morpholinone moiety u l-idrolisi tal-amide bonds huma s-siti maġġuri ta' biotrasformazzjoni.
English: Converting from Vitamin K Antagonists (VKA) to Xarelto For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Xarelto therapy should be initiated once the International Normalised Ratio (INR) is ≤ 2.5.
Maltese: Bidla minn Antagonisti tal-Vitamina K (VKA) għal Xarelto Għall-pazjenti ttrattati għal DVT, PE u għall-prevenzjoni ta' rikorrenza, trattament b'VKA għandu jitwaqqaf u terapija b'Xarelto għandha tinbeda meta l-Proporzjon Normalizzat Internazzjonali (INRInternational Normalised Ratio) ikun ≤ 2.5.
English: In the Einstein Extension study (see Table 9) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Maltese: Fl-istudju Einstein Extension (ara Tabella 9) rivaroxaban kien superjuri għal plaċebo għar-riżultati primarji u sekondarji tal-effikaċja.
English: 22 per 100 patient years
Maltese: 22 kull 100 sena ta' pazjent
English: In the Einstein DVT study (see Table 5) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p < 0.0001 (test for non-inferiority); Hazard Ratio (HR): 0.680 (0.443 - 1.042), p=0.076 (test for superiority)).
Maltese: Fl-istudju Einstein DVT (ara Tabella 5) rivaroxaban intwera li mhux inferjuri għal enoxaparin/VKA għarriżultat primarju tal-effikaċja (p < 0.0001 (test għal nuqqas ta' inferjorità); Proporzjon ta' Periklu (HRHazard Ratio): 0.680 (0.443 - 1.042), p=0.076 (test għal superjorità)).
English: In the Einstein Extension study (see Table 7) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Maltese: Fl-istudju Einstein Extension (ara Tabella 7) rivaroxaban kien superjuri għal plaċebo għar-riżultati primarji u sekondarji tal-effikaċja.
English: Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.
Maltese: Peress li hemm disponibbli data klinika limitata b'dronedarone, għoti flimkien ma' rivaroxaban għandu jiġi evitat.
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 8).
Maltese: Twettqet analiżi globali speċifikat minn qabel tar-riżultat tal-istudji Einstein DVT u PE (ara Tabella 8).
English: 5 mg or 10 mg respectively, coadministered with either ASA or ASA plus clopidogrel or ticlopidine
Maltese: 5 mg jew 10 mg rispettivament, mogħti flimkien ma' ASA jew flimkien ma' ASA u clopidogrel jew ticlopidine
English: EU/1/08/472/025-035, EU/1/08/472/041, EU/1/08/472/046-047
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/472/025-035, EU/1/08/472/041, EU/1/08/472/046-047
English: For patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered (see section 4.5).
Maltese: Għall-pazjenti f'riskju ta' mard gastro-intestinali ulċerattiv tista' tiġi kkunsidrata kura profilattika xierqa (ara sezzjoni 4.5).
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 7).
Maltese: Twettqet analiżi globali speċifikat minn qabel tar-riżultat tal-istudji Einstein DVT u PE (ara Tabella 7).
English: Table 8: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Maltese: Tabella 8: Riżultati tal-effikaċja u s-sigurtà minn analiżi globali ta' Einstein DVT u Einstein PE ta' fażi
English: Day 1 - 21
Maltese: Jum 1 sa 21:
English: PVC/PVDC/Aluminium foil blisters in cartons of 5, 10 or 30 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1 or 100 x 1 film-coated tablets.
Maltese: Folji tal-fojl tal-PVC/PVDC/Aluminju f'kaxxi tal-kartun ta' 5, 10 jew 30 pillola miksija b'rita jew folji perforati b'dożi uniċi f'kaxxi tal-kartun ta' 10 x 1 jew 100 x 1 pillola miksija b'rita.
English: Oral absorption of rivaroxaban is almost complete and oral bioavailability is high (80 - 100%) for the 2.5 mg and 10 mg tablet dose, irrespective of fasting/fed conditions.
Maltese: Assorbiment orali ta' rivaroxaban huwa kważi komplut u l-bijodisponibilità orali hija għolja (80 - 100%) għad-doża ta' pillola ta' 2.5 mg u 10 mg, irrispettivament minn jekk il-pazjent ikunx sajjem jew wara likel.
English: The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a HR of 0.849 ((95% CI: 0.633 - 1.139), nominal p value p= 0.275).
Maltese: Ilbenefiċċju kliniku nett speċifikat minn qabel (riżultat primarju tal-effikaċja flimkien ma' avvenimenti ta' fsada maġġuri) kien irrappurtat b'HR ta' 0.849 ((95% CI: 0.633 - 1.139), valur p nominali p= 0.275).
English: Stent thrombosis
Maltese: Dan jgħinek biex tiftakar.
English: Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%, apart from on the day of surgery and the following day when variability in exposure is high (70%).
Maltese: Il-varjabilità fil-farmakokinetika ta' rivaroxaban hija moderata b'varjabilità bejn l-individwi (CV%) li tvarja minn 30% sa 40%, minbarra lġurnata tal-kirurġija u l-ġurnata ta' wara meta l-varjabilità fl-esponiment hija għolja (70 %).
English: • Recommendations for dose reduction in at risk populations
Maltese: • Rakkomandazzjonijiet għal tnaqqis fid-doża fil-popolazzjonijiet f'riskju
English: Therefore Xarelto is contraindicated during breastfeeding (see section 4.3).
Maltese: Għalhekk, Xarelto huwa kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: Each film-coated tablet contains 10 mg rivaroxaban.
Maltese: Kull pillola miksija b'rita fiha 10 mg rivaroxaban.
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 6).
Maltese: Twettqet analiżi globali speċifikat minn qabel tar-riżultat tal-istudji Einstein DVT u PE (ara Tabella 6).
English: Warfarin titrated to a target INR of 2.5 (therapeutic range 2.0 to 3.0)
Maltese: Warfarin ittitrat għall-INR immirat ta' 2.5 (firxa terapewtika
English: Each 15 mg film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4.
Maltese: Kull pillola miksija b'rita ta' 15 mg fiha 24.13 mg ta' lactose (bħala monohydrate), ara sezzjoni 4.4.
English: Vascular disorders
Maltese: Psewdoanewriżma vaskulari
English: Xarelto is for oral use.
Maltese: Xarelto huwa għall-użu orali.
English: For patients with moderate or severe renal impairment where the decision has been taken for 15 mg once daily from Day 22 onwards, other pack sizes only containing 15 mg film-coated tablets are available (see dosing instructions in section “Special populations” below).
Maltese: Għal pazjenti b'indeboliment renali moderat jew sever fejn ittieħdet id-deċiżjoni li jingħata 15 mg darba kuljum minn Jum 22 'il quddiem, hemm disponibbli daqsijiet tal-pakkett oħra li fihom pilloli miksija b'rita ta' 15 mg biss (ara l-istruzzjonijiet dwar id-dożaġġ fis-sezzjoni “Popolazzjonijiet speċjali” hawn taħt).
English: EU/1/08/472/001-010, EU/1/08/472/022, EU/1/08/472/042-045.
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/472/001-010, EU/1/08/472/022, EU/1/08/472/042-045.
English: Table 8: Efficacy and safety results from phase III Einstein Extension Study population
Maltese: Tabella 8: Riżultati tal-effikaċja u s-sigurtà minn Einstein Extension ta' fażi
English: Intake with food does not affect rivaroxaban AUC or Cmax at the 2.5 mg and 10 mg dose.
Maltese: Teħid mal-ikel ma jaffettwax l-AUC jew Cmax ta' rivaroxaban fid-doza ta' 2.5 mg u 10 mg.
English: Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C (see section 5.2).
Maltese: Mard epatiku assoċjat ma' koagulopatija u riskju ta' fsada ta' rilevanza klinika inkluż pazjenti li għandhom ċirrosi b'Child Pugh B u Ċ (ara sezzjoni 5.2).
English: Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.
Maltese: Trattament ta' DVT, trattament ta' PE u prevenzjoni ta' DVT u PE rikorrenti
English: - Bleeding into the surgical site requiring reoperation (nonfatal, not in critical organ)
Maltese: - Fsada f'sit kirurġiku li teħtieġ operazzjoni millġdid (mhux fatali, organu mhux kritiku)
English: In the Einstein Choice study (see Table 8) Xarelto 20 mg and 10 mg were both superior to 100 mg acetylsalicylic acid for the primary efficacy outcome.
Maltese: Fl-istudju Einstein Choice (ara Tabella 8) Xarelto 20 mg u 10 mg it-tnejn kienu superjuri għal 100 mg acetylsalicylic acid għar-riżultat primarju tal-effikaċja.
English: Study data indicate that such patients may benefit less from treatment with rivaroxaban (see section 5.1).
Maltese: Data mill-istudju tindika li pazjenti bħal dawn jistgħu jibbenefikaw inqas minn trattament b'rivaroxaban (ara sezzjoni 5.1).
English: The treatment duration was up to 12 months depending on the individual randomisation date (median: 351 days).
Maltese: It-tul tat-trattament kien sa 12-il xahar skont id-data individwali tar-randomisation (medjan: 351 jum).
English: Table 4: Efficacy and safety results from phase III clinical studies
Maltese: Tabella 4: Riżultati ta' l-effikaċja u s-sigurtà minn studji kliniċi ta' fażi