FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 mg film-coated tablet: brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” and a triangle on the other side.
Maltese: Pillola miksija b'rita ta' 20 mg: pilloli ħomor fil-kannella, tondi, ibbuzzati fuq iż-żewġ naħat (dijametru ta' 6 mm, raġġ ta' kurvatura ta' 9 mm) immarkati bis-salib tal-BAYER fuq naħa waħda, u b'“20” u trijangolu fuq in-naħa l-oħra.
English: Non-CNS systemic embolism
Maltese: Emboliżmu sistemiku mhux fis-CNS
English: platelet count increased)A, Thrombocytopenia
Maltese: (li jinkludi żjieda tal-krejatinina fiddemm, żjieda talurea fid-demm) A
English: Xarelto was non-inferior to warfarin for the primary composite endpoint of stroke and non-CNS systemic embolism.
Maltese: Xarelto ma kienx inferjuri għal warfarin għall-mira primarja komposta minn puplesija u emboliżmu sistemiku mhux fis-CNS.
English: • other gastrointestinal disease without active ulceration that can potentially lead to bleeding complications (e.g. inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease)
Maltese: • mard gastro-intestinali ieħor mingħajr ulċeri attivi li potenzjalment jista' jwassal għal komplikazzjonijiet ta' fsada (eż. marda infjammatorja tal-musrana, esofaġite, gastrite u marda ta'
English: After intravenous administration of a 1 mg dose the elimination half-life is about 4.5 hours.
Maltese: Wara għoti fil-vini ta' doża ta' 1 mg il-half-life ta' l-eliminazzjoni hija madwar 4.5 sigħat.
English: Xarelto is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients with Child Pugh B and C (see section 4.3).
Maltese: Xarelto huwa kontra-indikat f'pazjenti b'mard epatiku assoċjat ma' koagulopatija u riskju ta' fsada ta' rilevanza klinika, inkluż pazjenti b'ċirrożi, b'Child Pugh B u Ċ (ara sezzjoni 4.3).
English: Relative to placebo, Xarelto significantly reduced the primary composite endpoint of CV death, MI or stroke.
Maltese: Mqabbel mal-plaċebo, Xarelto naqqas b'mod sinifikanti l-punt finali primarju kompost ta' mewt CV, MI jew puplesija.
English: After at least 6 months: 10 mg or 20 mg
Maltese: Wara mill-inqas 6 xhur: 10 mg jew 20 mg
English: The use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir).
Maltese: L-użu ta' Xarelto mhux rakkomandat f'pazjenti li jkunu qed jirċievu kura sistemika fl-istess waqt b'azoleantimycotics (bħal ketoconazole, itraconazole, voriconazole u posaconazole) jew b'inibituri tal-protease tal-HIV (eż. ritonavir).
English: - For the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery, no dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) or moderate renal impairment (creatinine clearance 30- 49 ml/min) (see section 5.2).
Maltese: - Għall-prevenzjoni ta' VTE f'pazjenti adulti li qed jagħmlu kirurġija ppjanata ta' sostituzzjoni talġenbejn jew tal-irkoppa, l-ebda aġġustament fid-doża ma huwa meħtieġ f'pazjenti b'indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50 - 80 ml/min) jew b'indeboliment renali moderat (tneħħija tal-krejatinina ta' 30 - 49 ml/min) (ara sezzjoni 5.2).
English: Clotting parameters (e.g. PT, aPTT, HepTest) are affected as expected by the mode of action of rivaroxaban (see section 5.1).
Maltese: Il-parametri tat-tagħqid tad-demm (e.ż. PT, aPTT, Hep Test) huma affettwati kif mistenni mill-mod ta' azzjoni ta' rivaroxaban (ara sezzjoni 5.1).
English: Fatal bleeding event
Maltese: Avveniment ta' fsada fatali
English: Your doctor will tell you how much of these to take (usually between 75 to 100 mg acetylsalicylic acid daily or a daily dose of 75 to 100 mg acetylsalicylic acid plus a daily dose of either 75 mg clopidogrel or a standard daily dose of ticlopidine).
Maltese: It-tabib tiegħek se jgħidlek kemm għandek tieħu minn dawn (normalment minn 75 sa 100 mg kuljum ta' acetylsalicylic acid jew doża ta' kuljum ta' 75 sa 100 mg ta' acetylsalicylic acid flimkien ma' doża ta' kuljum ta' 75 mg clopidogrel jew doża standard ta' kuljum ta' ticlopidine).
English: - If you are taking some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin ketoconazole tablets (used to treat Cushing's syndrome - when the body produces an excess of cortisol) some medicines for bacterial infections (e.g. clarithromycin, erythromycin) some anti-viral medicines for HIV / AIDS (e.g. ritonavir) other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section “Warnings and Precautions”)) anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid) dronedarone, a medicine to treat abnormal heart beat some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))
Maltese: - Jekk qed tieħu xi mediċini għal infezzjonijiet tal-fungu (eż. fluconazole, itraconazole, voriconazole, posaconazole), ħlief jekk tapplikahom fuq il-ġilda biss pilloli ketoconazole (jintużaw biex jittrattaw s-sindrome ta' Cushing - meta l-ġisem jipproduċi cortisol żejjed) xi mediċini għal infezzjonijiet ikkawżati minn batterja (eż. clarithromycin, erythromycin) xi mediċini kontra l-virus għall-HIV/AIDS (eż. ritonavir) mediċini oħrajn biex inaqqsu t-tagħqid tad-demm (eż. enoxaparin, clopidogrel jew antagonisti tal-vitamina K bħal warfarin u acenocoumarol) mediċini kontra l-infjammazzjoni u li jtaffu l-uġigħ (eż. naproxen jew acetylsalicylic acid) dronedarone, mediċina biex tikkura rata ta' taħbit tal-qalb mhux normali xi mediċini biex jittrattaw id-depressjoni (inibituri selettivi ta' teħid mill-ġdid ta' serotonin (SSRIs - serotonin reuptake inhibitors) jew inibituri ta' teħid mill-ġdid ta' serotonin norepinephrine (SNRIs - serotonin norepinephrine reuptake inhibitors))
English: In the Einstein Choice study (Table 9) 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 9) Xarelto 20 mg u 10 mg it-tnejn kienu superjuri għal 100 mg acetylsalicylic acid għar-riżultat primarju tal-effikaċja.
English: Rivaroxaban is rapidly absorbed with maximum concentrations (Cmax) appearing 2 - 4 hours after tablet intake.
Maltese: Rivaroxaban huwa assorbit malajr b'konċentrazzjonijiet massimi (Cmax) osservati minn 2 - 4 sigħat wara li tittieħed il-pillola.
English: In the Einstein Choice study (see Table 10) 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 10) Xarelto 20 mg u 10 mg it-tnejn kienu superjuri għal 100 mg acetylsalicylic acid għar-riżultat primarju tal-effikaċja.
English: Cirrhotic patients with mild hepatic impairment (classified as Child Pugh A) exhibited only minor changes in rivaroxaban pharmacokinetics (1.2 fold increase in rivaroxaban AUC on average), nearly comparable to their matched healthy control group.
Maltese: Pazjenti b'ċirrożi, b'indeboliment epatiku ħafif (ikklassifikat bħala Child Pugh A), urew biss tibdil minuri fil-farmakokinetika ta' rivaroxaban (żieda medja ta' 1.2 darbiet fl-AUC ta' rivaroxaban), kważi komparabbli mal-grupp ta' kontroll korrispondenti magħmul minn persuni b'saħħithom.
English: Einstein DVT, PE and Extension used the same pre-defined primary and secondary efficacy outcomes.
Maltese: Einstein DVT, PE u Extension użaw l-istess riżultat primarju u sekondarju tal-effikaċja definiti minn qabel.
English: The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) of the pooled analysis was reported with a HR of 0.771 ((95% CI: 0.614 - 0.967), nominal p value p = 0.0244).
Maltese: Il-benefiċċju kliniku globali speċifikat minn qabel (riżultat primarju tal-effikaċja flimkien ma' avvenimenti ta' fsada maġġuri) tal-analiżi globali kien irrappurtat b'HR ta' 0.771 ((95% CI: 0.6140.967), valur p nominali p = 0.0244).
English: After combined administration of enoxaparin (40 mg single dose) with rivaroxaban (10 mg single dose) an additive effect on anti-factor Xa activity was observed without any additional effects on clotting tests (PT, aPTT).
Maltese: Wara l-għoti ta' enoxaparin (doża waħda ta' 40 mg) flimkien ma' rivaroxaban (doża waħda ta' 10 mg), kien osservat effett addittiv fuq l-attività ta' kontra l-fattur Xa mingħajr l-ebda effetti oħrajn fuq it-testijiet tal-koagulazzjoni (PT, aPTT).
English: There was a significant increase of the primary safety outcome (modified ISTH major bleeding events) in patients treated with Xarelto 2.5 mg twice daily in combination with ASA 100 mg once daily compared to patients who received ASA 100 mg (see Table 8).
Maltese: Kien hemm żieda sinifikanti fir-riżultat tas-sigurtà primarja (avvenimenti modifikati ta' fsada maġġuri ta' ISTH) f'pazjenti ttrattati b'Xarelto 2.5 mg darbtejn kuljum flimkien ma' ASA 100 mg darba kuljum meta mqabbla ma' pazjenti li ngħataw ASA 100 mg (ara Tabella 8).
English: In both the Einstein DVT and the Einstein PE study, the comparator treatment regimen consisted of enoxaparin administered for at least 5 days in combination with vitamin K antagonist treatment until the PT/INR was in therapeutic range (≥ 2.0).
Maltese: Kemm fl-istudju Einstein DVT kif ukoll f'Einstein PE, il-kors ta' trattament ta' paragun kien jikkonsisti minn enoxaparin mogħti għal mill-inqas 5 ijiem flimkien ma' trattament b'antagonist tal-vitamina K sakemm PT/INR kien fil-firxa terapewtika (≥ 2.0).
English: hepatocellular injury (inflamed liver incl.
Maltese: Tromboċitosi (li tinkludi żieda fl-għadd tal-plejtlits)
English: A specific reversal agent (andexanet alfa) antagonising the pharmacodynamic effect of rivaroxaban is available (refer to the Summary of Product Characteristics of andexanet alfa).
Maltese: Hemm disponibbli sustanza speċifika li treġġa' lura (andexanet alfa) li tantagonizza l-effett farmakodinamiku ta' rivaroxaban (irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' andexanet alfa).
English: EU/1/08/472/027 56 film-coated tablets
Maltese: EU/1/08/472/027 56 pillola miksija b'rita
English: To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban.
Maltese: Biex jitnaqqas ir-riskju potenzjali ta' fsada assoċjata mal-użu fl-istess waqt ta' rivaroxaban u anestesija newroassjali (epidurali/fis-sinsla tad-dahar) jew titqiba fis-sinsla tad-dahar, ikkunsidra l-profil farmakokinetiku ta' rivaroxaban.
English: Muscle haemorrhage
Maltese: Mewt kardjovaskulari
English: Each film-coated tablet contains 20 mg rivaroxaban.
Maltese: Kull pillola miksija b'rita fiha 20 mg rivaroxaban.
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, apixaban, etc.) except under specific circumstances of switching 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 tal-eparina (fondaparinux, eċċ), sustanzi orali kontra l-koagulazzjoni tad-demm (warfarin, dabigatran etexilate, apixaban, eċċ) ħlief f'ċirkustanzi speċifiċi ta' bidla tat-terapija kontra lkoagulazzjoni (ara sezzjoni 4.2) jew meta UFH tingħata f'dożi meħtieġa biex jinżamm kateter ċentrali f'vina jew arterja miftuħ (ara sezzjoni 4.5).
English: Rivaroxaban has a half-life of approximately 5 to 13 hours (see section 5.2).
Maltese: Rivaroxaban għandu half-life ta' madwar 5 sa 13-il siegħa (ara sezzjoni 5.2).
English: Each tablet contains 15 mg or 20 mg of rivaroxaban, respectively.
Maltese: Kull pillola fiha 15 mg jew 20 mg ta' rivaroxaban, rispettivament.
English: Clarithromycin (500 mg twice a day), for instance, considered as a strong CYP3A4 inhibitor and moderate P-gp inhibitor, led to a 1.5 fold increase in mean rivaroxaban AUC and a 1.4 fold increase in Cmax.
Maltese: Per eżempju, clarithromycin (500 mg darbtejn kuljum), ikkunsidrat bħala inibitur qawwi ta' CYP3A4 u inibitur moderat ta' P-gp, wassal għal żieda ta' 1.5 darbiet fil-medja tal-AUC ta' rivaroxaban u żieda ta' 1.4 darbiet f'Cmax.
English: 15 mg film-coated tablet: red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “15” and a triangle on the other side.
Maltese: Pillola miksija b'rita ta' 15 mg: pilloli ħomor, tondi, ibbuzzati fuq iż-żewġ naħat (dijametru ta' 6 mm, raġġ ta' kurvatura ta' 9 mm) immarkati bis-salib tal-BAYER fuq naħa waħda, u b'“15” u trijangolu fuq in-naħa l-oħra.
English: Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily.
Maltese: Il-farmakokinetika ta' Rivaroxaban hija kważi lineari sa madwar 15 mg darba kuljum.
English: Treatment Dose
Maltese: TAL-PRODOTT MEDIĊINALI
English: Patients with prosthetic valves
Maltese: Pazjenti b'valvs prostetiċi
English: Xarelto 2.5 mg, twice daily, N=5,115 n (%)
Maltese: Xarelto 2.5 mg, darbtejn kuljum, N=5,115 n (%) HR (95% CI) valur p b)
English: No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min) or moderate renal impairment (creatinine clearance 30 - 49 ml/min) (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50 - 80 ml/min) jew b'indeboliment renali moderat (tneħħija tal-krejatinina ta' 30 - 49 ml/min) (ara sezzjoni 5.2).
English: EU/1/08/472/013 42 film-coated tablets
Maltese: EU/1/08/472/013 42 pillola miksija b'rita
English: Batch
Maltese: MG
English: Patients taking Xarelto 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA or a daily dose of 75 - 100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
Maltese: Il-pazjenti li jieħdu Xarelto 2.5 mg darbtejn kuljum għandhom jieħdu wkoll doża ta' kuljum ta' 75 - 100 mg ASA jew doża ta' kuljum ta' 75 - 100 mg ASA flimkien ma' doża ta' kuljum ta' 75 mg clopidogrel jew doża standard ta' kuljum ta' ticlopidine.
English: Treatment Initiation Pack rivaroxaban This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Stroke, non-CNS systemic embolism and vascular death
Maltese: Puplesija u emboliżmu sistemiku mhux fis-CNS u mewt vaskulari
English: Xarelto is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C (see sections 4.3 and 5.2).
Maltese: Xarelto huwa kontra-indikat f'pazjenti b'mard epatiku assoċjat ma' koagulopatija u riskju ta' fsada ta' rilevanza klinika inkluż pazjenti li għandhom ċirrożi b'Child Pugh B u Ċ (ara sezzjonijiet 4.3 u 5.2).
English: Each film-coated tablet contains 21.76 mg lactose (as monohydrate), see section 4.4.
Maltese: Kull pillola miksija b'rita fiha 21.76 mg ta' lactose (bħala monohydrate), ara sezzjoni 4.4.
English: Warnings and precautions
Maltese: Prevenzjoni ta' avvenimenti
English: • uncontrolled severe arterial hypertension
Maltese: • pressjoni għolja severa mhux ikkontrollata fl-arterji
English: Cumulative Event Rate (%)
Maltese: Monitoraġġ ta' Avvenimenti (SCEM
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: Issinjali, sintomi, u s-severità (inkluż riżultat fatali) se jvarjaw skont il-post u l-grad, jew skont il-vastità talfsada u/jew anemija (ara sezzjoni 4.9 “Immaniġġar ta' Fsada”).
English: * Patients exposed to at least one dose of rivaroxaban The most commonly reported adverse reactions in patients receiving rivaroxaban were bleedings (see section 4.4. and ‘Description of selected adverse reactions' below) (Table 2).
Maltese: Ir- reazzjonijiet avversi rrappurtati bl-aktar mod komuni f'pazjenti li jirċievu rivaroxaban kienu fsad (ara wkoll sezzjoni 4.4. u “Deskrizzjoni ta' reazzjonijiet avversi magħżula” taħt) (Tabella 2).
English: Intracranial haemorrhage* Haemoglobin drop* 305
Maltese: Emorraġija fil-kranju* 55
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 2.5 MG
Maltese: Pożoloġija Id-doża rrakkomandata hija ta' 2.5 mg darbtejn kuljum.
English: • ≥ 75 years of age if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine.
Maltese: • b'età ta' ≥ 75 sena jekk jingħata flimkien ma' ASA waħdu jew flimkien ma' ASA u clopidogrel jew ticlopidine.
English: They come - in blisters in cartons of 14, 20, 28, 30, 56, 60, 98, 168 or 196 film-coated tablets or - in unit dose blisters in cartons of 10 x 1 or 100 x 1 or - in multipacks comprising 10 cartons, each containing 10 x 1 film-coated tablets or - in bottles of 100 film-coated tablets.
Maltese: Huma disponibbli - f'folji f'kaxxi tal-kartun ta' 14, 20, 28, 30, 56, 60, 98, 168 jew 196 pillola miksija b'rita jew - f'folji b'doża waħda f'kaxxi tal-kartun ta' 10 x 1 jew 100 x 1 jew - f'pakketti multipli li fihom 10 kaxxi tal-kartun, li kull waħda fiha 10 x 1 pillola miksija b'rita jew - fi fliexken ta' 100 pillola miksija b'rita.
English: Patients with elevated biomarkers (troponin or CK-MB) and without a prior stroke/TIA constituted 80% of the study population.
Maltese: Pazjenti b'bijomarkaturi (troponin jew CK-MB) elevati u li ma kellhomx puplesija/TIA minn qabel ikkostitwixxew 80% tal-popolazzjoni studjata.
English: Rivaroxaban 10 mg od 35 ± 4 days
Maltese: Rivaroxab an 10 mg od ijiem
English: EU/1/08/472/007 30 film-coated tablets
Maltese: EU/1/08/472/007 30 pillola miksija b'rita
English: Each film-coated tablet contains 15 mg rivaroxaban.
Maltese: Kull pillola miksija b'rita fiha 15 mg rivaroxaban.
English: Fatal haemorrhage was reported in 0.2 per 100 patient years and intracranial haemorrhage in 0.4 per 100 patient years.
Maltese: Emorraġija fatali kienet irrappurtata f'0.2 għal kull 100 sena ta' pazjent u emorraġija filkranju f'0.4 għal kull 100 sena ta' pazjent.
English: The incidence rates for the principal safety outcome (major and non-major clinically relevant bleeding events) were similar for both treatment groups (see Table 5).
Maltese: Ir-rati ta' inċidenza għar-riżultat prinċipali ta' sigurtà (avvenimenti ta' fsada klinikament rilevanti maġġuri u mhux maġġuri) kienu simili għaż-żewġ gruppi ta' kura (ara Tabella 5).
English: Group 2 received rivaroxaban 2.5 mg twice daily plus DAPT (dual antiplatelet therapy i.e. clopidogrel 75 mg [or alternate P2Y12 inhibitor] plus low-dose acetylsalicylic acid [ASA]) for 1, 6 or 12 months followed by rivaroxaban 15 mg (or 10 mg for subjects with creatinine clearance 30 - 49 ml/min) once daily plus low-dose ASA.
Maltese: Grupp 1 irċieva rivaroxaban 15 mg darba kuljum (10 mg darba kuljum f'pazjenti bi tneħħija talkrejatinina ta' 30 - 49 ml/min) flimkien ma' inibitur ta' P2Y12. Grupp 2 irċieva rivaroxaban 2.5 mg darbtejn kuljum flimkien ma' DAPT (terapija doppja kontra l-plejtlits [dual antiplatelet therapy] jiġifieri clopidogrel 75 mg [jew inibitur ta' P2Y12 b'mod alternattiv] flimkien ma' acetylsalicylic acid [ASA]) ta' doża baxxa għal 1, 6 jew 12-il xahar segwit minn rivaroxaban 15 mg (jew 10 mg għal individwi bi tneħħija tal-krejatinina ta' 30 - 49 ml/min) darba kuljum flimkien ma' ASA ta' doża baxxa.
English: Patients received the first dose of Xarelto at a minimum of 24 hours and up to 7 days (mean 4.7 days) after admission to the hospital, but as soon as possible after stabilisation of the ACS event, including revascularisation procedures and when parenteral anticoagulation therapy would normally be discontinued.
Maltese: Il-pazjenti rċevew l-ewwel doża ta' Xarelto wara minimu ta' 24 siegħa u sa 7 ijiem (medja 4.7 ijiem) wara dħul l-isptar, iżda kemm jista' jkun malajr wara listabbilizzazzjoni tal-avveniment ACS, inklużi proċeduri ta' rivaskularizzazzjoni u meta terapija parenterali kontra l-koagulazzjoni normalment tkun twaqqfet.
English: • CAD/PAD Patients taking Xarelto 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA.
Maltese: Pazjenti li jieħdu Xarelto 2.5 mg darbtejn kuljum għandhom jieħdu wkoll doża ta' kuljum ta' 75 - 100 mg ASA.
English: EU/1/08/472/043 28 film-coated tablets
Maltese: EU/1/08/472/043 28 pillola miksija b'rita
English: Symptomatic recurrent VTE or major bleeding (net clinical benefit) * p<0.001(superiority) Xarelto 20 mg od vs ASA 100 mg od; HR=0.34 (0.20-0.59) ** p<0.001 (superiority) Xarelto 10 mg od vs ASA 100 mg od; HR=0.26 (0.14-0.47) + Xarelto 20 mg od vs. ASA 100 mg od; HR=0.44 (0.27-0.71), p=0.0009 (nominal) ++ Xarelto 10 mg od vs. ASA 100 mg od; HR=0.32 (0.18-0.55), p<0.0001 (nominal)
Maltese: Xarelto 10 mg od vs ASA 100 mg od; HR=0.26 (0.14-0.47) + Xarelto 20 mg od vs.
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation The Xarelto clinical programme was designed to demonstrate the efficacy of Xarelto for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Maltese: Il-programm kliniku ta' Xarelto kien maħsub biex juri l-effikaċja ta' Xarelto għall-prevenzjoni ta' puplesija u ta' emboliżmu sistemiku f'pazjenti b'fibrillazzjoni tal-atriju mhux valvulari.
English: Xarelto 10 mg film-coated tablets are light red, round, biconvex and marked with the BAYER-cross on one side and “10” and a triangle on the other side.
Maltese: Il-pilloli miksija b'rita ta' Xarelto 10 mg huma ta' kulur aħmar ċar, tondi, ibbuzzati fuq iż-żewġ naħat u mmarkati bis-salib tal-BAYER fuq naħa waħda, u bin-numru “10” u trijangolu fuq in-naħa l-oħra.
English: Each film-coated tablet contains 33.92 mg lactose (as monohydrate), see section 4.4.
Maltese: Kull pillola miksija b'rita fiha 33.93 mg ta' lactose (bħala monohydrate), ara sezzjoni 4.4.
English: Prevention of stroke and systemic embolism
Maltese: Prevenzjoni ta' puplesija u emboliżmu sistemiku.
English: EU/1/08/472/018 28 film-coated tablets
Maltese: EU/1/08/472/018 28 pillola miksija b'rita
English: C: observed as uncommon in prevention of atherothrombotic events in patients after an ACS (following percutaneous coronary intervention) * A pre-specified selective approach to adverse event collection was applied.
Maltese: Ċ: osservat bħala mhux komuni fil-prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti wara ACS (wara intervent perkutanju fil-qalb) * Ġie applikat approċċ selettiv speċifikat minn qabel għall-ġbir ta' avvenimenti avversi.