FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have an increased risk of bleeding, as could be the case in situations such as: severe kidney disease, since your kidney function may affect the amount of medicine that works in your body if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see section “Other medicines and Xarelto”) bleeding disorders very high blood pressure, not controlled by medical treatment diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus) a problem with the blood vessels in the back of your eyes (retinopathy) a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung you are older than 75 years you weigh 60 kg or less you have a coronary artery disease with severe symptomatic heart failure - if you have a prosthetic heart valve - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Maltese: Oqgħod attent ħafna b'Xarelto - jekk għandek riskju miżjud ta' fsada, kif jista' jkun il-każ f'situazzjonijiet bħal: marda severa tal-kliewi, peress li l-funzjoni tal-kliewi tiegħek jista' jkollha effett fuq lammont ta' mediċina li taħdem f'ġismek jekk qed tieħu mediċini oħra biex jipprevjenu t-tagħqid tad-demm (eż. warfarin, dabigatran, apixaban jew eparina), meta tkun qed taqleb il-kura ta' kontra t-tagħqid tad-demm jew waqt li tkun qed tieħu eparina minn ġo pajp f'vina jew f'arterja biex dan jinżamm miftuħ (ara sezzjoni “Mediċini oħra u Xarelto”) disturbi ta' fsada pressjoni għolja ħafna, li ma tkunx ikkontrollata minn kura medika mard tal-istonku jew tal-imsaren li jista' jwassal għal fsada, eż. infjammazzjoni tal-imsaren jew tal-istonku, jew infjammazzjoni tal-esofagu, eż. minħabba marda ta' rifluss gastroesofagali (marda fejn l-aċidu tal-istonku jitla' 'l fuq fl-esofagu) problema fil-kanali tad-demm fin-naħa ta' wara t'għajnejk (retinopatija) marda tal-pulmun fejn il-bronki tiegħek jitwessgħu u jkunu mimlija bil-materja (bronkjektasi), jew fsada preċedenti mill-pulmun tiegħek għandek aktar minn 75 sena tiżen 60 kg jew inqas għandek marda tal-arterja koronarja b'insuffiċjenza severa, tal-qalb - jekk għandek valv prostetiku tal-qalb - jekk taf li għandek marda msejħa sindrome ta' kontra l-fosfolipidi (disturb tas-sistema immuni li jikkawża riskju akbar ta' emboli tad-demm), għid lit-tabib tiegħek li se jiddeċiedi jekk jistax ikun hemm bżonn li t-trattament jinbidel.
English: Cerebral and intracranial haemorrhage, syncope
Maltese: Emorraġija ċerebrali u filkranju, sinkope
English: Prevention of VTE in medically ill patients
Maltese: IL-PRODOTT MEDIĊINALI
English: Data on efficacy in this population are limited (see sections 4.2 and 5.1).
Maltese: Data dwar leffikaċja f'din il-popolazzjoni hija limitata (ara sezzjonijiet 4.2 u 5.1).
English: However, if clinically indicated, rivaroxaban levels can be measured by calibrated quantitative antifactor-Xa tests (see section 5.2).
Maltese: Madankollu, jekk klinikament indikat, il-livelli ta' rivaroxaban jistgħu jiġu mkejjla permezz ta' testijiet kwantitattivi kkalibrati li jkejjlu l-attività kontra l-fattur Xa (ara sezzjoni 5.2).
English: The MAH must agree the content and format of the Prescriber Guide together with a communication plan, with the national competent authority in each Member State prior to distribution of the educational pack in their territory.
Maltese: L-MAH għandu jiftiehem dwar il-kontenut u d-disinn tal-Gwida għal Min Jippreskrivi, flimkien ma' pjan ta' komunikazzjoni, mal-awtorità kompetenti nazzjonali f'kull Stat Membru qabel ma jiġi mqassam ilpakkett edukattiv fit-territorju tagħhom.
English: EU/1/08/472/029 98 film-coated tablets
Maltese: EU/1/08/472/029 98 pillola miksija b'rita
English: EU/1/08/472/028 60 film-coated tablets
Maltese: EU/1/08/472/028 60 pillola miksija b'rita
English: Epistaxis, haemoptysis
Maltese: TWISSIJA(IET) SPEĊJALI
English: If you have had a major hip operation you will usually take the tablets for 5 weeks.
Maltese: Jekk kellek operazzjoni maġġuri fil-ġenbejn, normalment ser tieħu l-pilloli għal 5 ġimgħat.
English: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Maltese: Għall-prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'fibrillazzjoni tal-atriju mhux valvulari u b'fattur ta' riskju wieħed jew aktar, bħal insuffiċjenza konġestiva tal-qalb, pressjoni għolja, età ta' ≥ 75 sena, dijabete mellitus, puplesija minn qabel jew attakk iskemiku temporanju.
English: I am under anticoagulation treatment with Xarelto (rivaroxaban)
Maltese: Qed nieħu kura kontra il-koagulazzjoni tad-demm b'Xarelto (rivaroxaban) Isem:
English: Converting from Vitamin K Antagonists (VKA) to Xarelto When converting patients from VKAs to Xarelto, International Normalised Ratio (INR) values could be falsely elevated after the intake of Xarelto.
Maltese: Bidla minn Antagonisti tal-Vitamina K (VKA) għal Xarelto Meta pazjenti jinqalbu minn VKAs għal Xarelto, il-valuri tal-Proporzjon Normalizzat Internazzjonali (INR - International Normalised Ratio) jistgħu jkunu elevati b'mod falz wara t-teħid ta' Xarelto.
English: In the per-protocol population on treatment, stroke or systemic embolism occurred in 188 patients on rivaroxaban (1.71% per year) and 241 on warfarin (2.16% per year) (HR 0.79;
Maltese: Fil-popolazzjoni fuq kura skont il-protokol, puplesija jew emboliżmu sistemiku seħħew f'188 pazjent fuq rivaroxaban (1.71% kull sena) u f'241 fuq warfarin (2.16% kull sena) (HR 0.79; 95% CI, 0.66 - 0.96; P<0.
English: Major bleeding events a) Rivaroxaban 15 mg twice daily for 3 weeks followed by 20 mg once daily b) Enoxaparin for at least 5 days, overlapped with and followed by VKA * p < 0.0001 (non-inferiority to a prespecified HR of 1.75); HR: 0.886 (0.661 - 1.186)
Maltese: Avvenimenti ta' fsada maġġuri a) Rivaroxaban 15 mg darbtejn kuljum għal 3 ġimgħat segwit minn 20 mg darba kuljum b) Enoxaparin għal tal-inqas 5 ijiem, flimkien ma' u segwit minn VKA * p < 0.0001 (nuqqas ta' inferjorità għal HR speċifikat minn qabel ta' 1.75); HR: 0.886 (0.661
English: Xarelto 15 mg Xarelto 20 mg film-coated tablets rivaroxaban
Maltese: Xarelto 15 mg Xarelto 20 mg pilloli miksija b'rita rivaroxaban
English: In the enoxaparin/VKA group, there was no clear relation between the level of mean centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized tertiles and the incidence of the recurrent VTE (P=0.932 for interaction).
Maltese: Filgrupp ta' enoxaparin/VKA, ma kien hemm l-ebda relazzjoni ċara bejn il-livell ta' TTR medju ċentrali (Ħin fil-Firxa ta' INR Immirat ta' 2.0 - 3.0) fit-tertiles tal-istess daqs u l-inċidenza ta' VTE rikorrenti (P = 0.932 għall-interazzjoni).
English: - For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE, no dose adjustment from the recommended dose is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) (see section 5.2).
Maltese: - Għat-trattament ta' DVT, għat-trattament ta' PE u għall-prevenzjoni ta' DVT u PE rikorrenti, mhux meħtieġ aġġustament fid-doża mid-doża rakkomandata f'pazjenti b'indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50 - 80 ml/min) (ara sezzjoni 5.2).
English: When converting patients from VKAs to Xarelto, International Normalised Ratio (INR) values will be falsely elevated after the intake of Xarelto.
Maltese: Meta pazjenti jinqalbu minn VKAs għal Xarelto, il-valuri tal-Proporzjoni Normalizzat Internazzjonali (INR - International Normalized Ratio) se jkunu elevati b'mod falz wara t-teħid ta' Xarelto.
English: PP/Aluminium foil blisters in cartons of 5, 10, 14, 28, 30 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1, 100 x 1, or in multipacks containing 100 (10 packs of 10 x 1) filmcoated tablets.
Maltese: Folji tal-fojl tal-PP/Aluminju f'kaxxi tal-kartun ta' 5, 10, 14, 28, 30 jew 98 pillola miksija b'rita jew folji perforati b'dożi uniċi f'kaxxi tal-kartun ta' 10 x 1, 100 x 1, jew f'pakketti multipli li fihom 100 (10 pakketti ta' 10 x 1) pillola miksija b'rita.
English: Xarelto is to be used with caution in patients with creatinine clearance 15 - 29 ml/min.
Maltese: Xarelto għandu jintuża b'attenzjoni f'pazjenti bi tneħħija tal-krejatinina ta' 15 - 29 ml/min.
English: The results of this patient population were also consistent with the overall efficacy and safety results.
Maltese: Ir-riżultati ta' din il-popolazzjoni ta' pazjenti wkoll kienu konsistenti mar-riżultati globali ta' effikaċja u sigurtà.
English: Dry mouth
Maltese: Bidla fid-doża
English: EU/1/08/472/041 20 film-coated tablets
Maltese: EU/1/08/472/041 20 pillola miksija b'rita
English: In subjects with mild renal impairment erythromycin (500 mg three times a day) led to a 1.8 fold increase in mean rivaroxaban AUC and 1.6 fold increase in CRmax when compared to subjects with normal renal function.
Maltese: F'individwi b'indeboliment renali ħafif erythromycin (500 mg tliet darbiet kuljum) wassal għal żieda ta' 1.8 darbiet fl-AUC medja ta' rivaroxaban u żieda ta' 1.6 darbiet fis-Cmax meta mqabbel ma' individwi b'funzjoni renali normali.
English: EU/1/08/472/003 30 film-coated tablets
Maltese: EU/1/08/472/003 30 pillola miksija b'rita
English: Xarelto 2.5 mg is contraindicated for the treatment of ACS in patients with a prior stroke or TIA (see section 4.3).
Maltese: Xarelto 2.5 mg huwa kontra-indikat għall-kura ta' ACS f'pazjenti li kellhom puplesija jew TIA qabel (ara sezzjoni 4.3).
English: No data are available for such patients with a history of stroke/ transient ischaemic attack (TIA).
Maltese: M'hemmx data disponibbli għal pazjenti bħal dawn bi storja ta' puplesija/ attakk iskemiku temporanju (TIA - transient ischaemic attack).
English: 42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban in a wallet.
Maltese: 42 pillola miksija b'rita ta' 15 mg rivaroxaban u 7 pilloli miksija b'rita ta' 20 mg rivaroxaban f'portafoll.
English: Initial treatment Xarelto 15 mg twice a day First 3 weeks Continuous treatment Xarelto 20 mg once a day Week 4 onwards Visit your doctor to ensure continued treatment.
Maltese: Trattament inizjali Xarelto 15 mg darbtejn kuljum L-ewwel 3 ġimgħat Trattament kontinwu Xarelto 20 mg darba kuljum Minn ġimgħa 4 'il quddiem Żur it-tabib tiegħek biex tiżgura trattament kontinwu.
English: When to take Xarelto
Maltese: X'fih Xarelto
English: In the enoxaparin/VKA group, there was no clear relation between the level of mean centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized tertiles and the incidence of the recurrent VTE (p=0.082 for interaction).
Maltese: Fil-grupp ta' enoxaparin/VKA, ma kien hemm l-ebda relazzjoni ċara bejn illivell ta' TTR medju ċentrali (Ħin fil-Firxa ta' INR Immirat ta' 2.0 - 3.0) fit-tertiles tal-istess daqs u linċidenza ta' VTE rikorrenti (p=0.082 għall-interazzjoni).
English: Patients with antiphospholipid syndrome
Maltese: Pazjenti bis-sindrome ta' kontra l-fosfolipidi
English: Total VTE 18 (1.1%) 58 (3.7%) < 0.001 17 (2.0%) 81 (9.3%) < 0.001 79 (9.6%) 166 (18.9%) < 0.001 Major
Maltese: VTE totali VTE maġġuri 4 (0.2%) 33 (2.0%) <0.001 6 (0.6%)
English: Xarelto is to be used with caution in patients with creatinine clearance 15 - 29 ml/min (see section 4.4).
Maltese: Xarelto għandu jintuża b'attenzjoni f'pazjenti bi tneħħija tal-krejatinina ta' 15 - 29 ml/min (ara sezzjoni 4.4).
English: EU/1/08/472/019 98 film-coated tablets
Maltese: EU/1/08/472/019 98 pillola miksija b'rita
English: Gingival bleeding, gastrointestinal tract haemorrhage (incl.
Maltese: - Jekk il-kirurġija tiegħek tinvolvi kateter jew injezzjoni fis-sinsla tad-dahar (e.ż.
English: When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis.
Maltese: Meta tintuża anestesija newro-assjali (asestesija fis-sinsla tad-dahar/epidurali) jew titqiba fis-sinsla taddahar/epidurali, pazjenti kkurati b'sustanzi antitrombotiċi għall-prevenzjoni ta' komplikazzjonijiet tromboemboliċi, huma f'riskju li jiżviluppaw ematoma epidurali jew fis-sinsla tad-dahar li tista' tirriżulta f'paralisi fit-tul jew permanenti.
English: Table 6: Efficacy and safety results from phase III Einstein PE Study population
Maltese: Tabella 6: Riżultati tal-effikaċja u s-sigurtà minn Einstein PE ta' fażi
English: These active substances are strong inhibitors of both CYP3A4 and P-gp (see section 4.4).
Maltese: Dawn is-sustanzi attivi huma inibituri qawwija kemm ta' CYP3A4 kif ukoll ta' P-gp (ara sezzjoni 4.4).
English: EU/1/08/472/006 10 film-coated tablets
Maltese: EU/1/08/472/006 10 pilloli miksija b'rita
English: In ACS patients, efficacy and safety of Xarelto 2.5 mg have been investigated in combination with the antiplatelet agents ASA alone or ASA plus clopidogrel/ticlopidine.
Maltese: F'pazjenti b'ACS, l-effikaċja u s-sigurtà ta' Xarelto 2.5 mg ġew investigati flimkien mas-sustanzi kontra l-plejtlits ASA waħdu jew ASA flimkien ma' clopidogrel/ticlopidine.
English: EU/1/08/472/014 98 film-coated tablets
Maltese: EU/1/08/472/014 98 pillola miksija b'rita
English: 28 per 100 patient years
Maltese: 28 kull 100 sena ta' pazjent
English: EU/1/08/472/012 28 film-coated tablets
Maltese: EU/1/08/472/012 28 pillola miksija b'rita
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)
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)
English: • Patient Alert Cards [Text included in Annex III]
Maltese: • Kartun ta' Twissija għall-Pazjent [Kitba inkluża f'Anness
English: In a study on male and female fertility in rats no effects were seen (see section 5.3).
Maltese: Fi studju dwar il-fertilità maskili u femminili fuq il-firien ma kienux osservati effetti (ara sezzjoni 5.3).
English: However, if clinically indicated rivaroxaban levels can be measured by calibrated quantitative antifactor Xa tests (see section 5.2).
Maltese: Madankollu, jekk klinikament indikat il-livelli ta' rivaroxaban jistgħu jiġu mkejjla permezz ta' testijiet kwantitattivi kkalibrati li jkejjlu l-attività kontra l-fattur Xa (ara sezzjoni 5.2).
English: Each film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4.
Maltese: Kull pillola miksija b'rita fiha 24.13 mg ta' lactose (bħala monohydrate), ara sezzjoni 4.4.
English: Table 6: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Maltese: Tabella 6: Riżultati tal-effikaċja u s-sigurtà minn Einstein DVT ta' fażi
English: and additionally a predefined pooled analysis of the Einstein DVT and Einstein PE studies was conducted.
Maltese: Riżultati tal-effikaċja u s-sigurtà minn analiżi globali ta' Einstein DVT u Einstein PE ta' fażi
English: EU/1/08/472/026 28 film-coated tablets
Maltese: EU/1/08/472/026 28 pillola miksija b'rita
English: No events were reported in patients randomized to warfarin.
Maltese: Ma ġewx irrappurtati avvenimenti f'pazjenti randomised għal warfarin.
English: Rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR).
Maltese: Rivaroxaban m'għandux jintuża għal tromboprofilassi f'pazjenti li reċentement għaddew minn sostituzzjoni transkateter ta' valv aortiku (TAVR - transcatheter aortic valve replacement).
English: Increased LDHA, increased lipaseA, increased amylaseA
Maltese: Żjieda fl-LDHA, żjieda fillipaseA, żjieda fl-amylaseA
English: Major bleeding events a) Rivaroxaban 15 mg twice daily for 3 weeks followed by 20 mg once daily b) Enoxaparin for at least 5 days, overlapped with and followed by VKA * p < 0.0026 (non-inferiority to a prespecified HR of 2.0); HR: 1.123 (0.749 - 1.684)
Maltese: Avvenimenti ta' fsada maġġuri a) Rivaroxaban 15 mg darbtejn kuljum għal 3 ġimgħat segwit minn 20 mg darba kuljum b) Enoxaparin għal tal-inqas 5 ijiem, flimkien ma' u segwit minn VKA * p < 0.0026 (nuqqas ta' inferjorità għal HR speċifikat minn qabel ta' 2.0); HR: 1.123 (0.749
English: PC (only applicable for outer carton, not applicable for bottle label) SN (only applicable for outer carton, not applicable for bottle label) NN (only applicable for outer carton, not applicable for bottle label)
Maltese: PC (japplika biss għall-kartuna ta' barra, mhux applikabbli għat-tikketta tal-flixkun) SN (japplika biss għall-kartuna ta' barra, mhux applikabbli għat-tikketta tal-flixkun) NN (japplika biss għall-kartuna ta' barra, mhux applikabbli għat-tikketta tal-flixkun)
English: Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks.
Maltese: Il-kura għandha tiġi evalwata b'mod regolari fil-pazjent individwali billi jitqiesu ir-riskji ta' avvenimenti iskemiċi kontra r-riskji ta' fsada.
English: Take special care with Xarelto
Maltese: Jekk tinsa tieħu Xarelto
English: Stroke or non-CNS systemic embolism was recorded in 0.8 per 100 patient years.
Maltese: Puplesija jew emboliżmu sistemiku mhux tas-CNS kienu rreġistrati f'0.8 għal kull 100 sena ta' pazjent.
English: Therefore, 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.
Maltese: L-użu ta' Xarelto mhux irrakkomandat f'pazjenti li jkunu qed jirċievu kura sistemika fl-istess waqt b'azole-antimycotics (bħal ketoconazole, itraconazole, voriconazole u posaconazole) jew b'inibituri tal protease tal-HIV (eż. ritonavir).
English: Xarelto 2.5 mg (only applicable for outer carton, not applicable for bottle label)
Maltese: Xarelto 2.5 mg (immarka kaxxa biex timmarka d-doża preskritta)
English: 95% CI, 0.66 - 0.96; P<0.001 for non-inferiority).
Maltese: 0.69 (95% CI: 0.35 - 1.35).
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 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-INR ikun ≤ 2.5.
English: In the clinical studies mucosal bleedings (i.e. epistaxis, gingival, gastrointestinal, genito urinary including abnormal vaginal or increased menstrual bleeding) and anaemia were seen more frequently during long term rivaroxaban treatment on top of single or dual anti-platelet therapy.
Maltese: Fl-istudji kliniċi fsada mill-mukuża (jiġifieri epistassi, mill-ħanek, gastro-intestinali, sistema ġenitali u tal-awrina inklużi fsada mhux normali mill-vaġina jew żieda ta' fsada menstruwali) u anemija kienu osservati aktar ta' spiss waqt kura fit-tul b'rivaroxaban meta mqabbla ma' kura b'VKA.
English: Converting from Xarelto to Vitamin K antagonists (VKA) There is a potential for inadequate anticoagulation during the transition from Xarelto to VKA.
Maltese: Hemm possibbiltà ta' attività kontra l-koagulazzjoni inadegwata matul bidla minn Xarelto għal VKA.
English: Table 3: All adverse reactions reported in patients in phase III clinical trials or through postmarketing use*
Maltese: Tabella 3: Ir-reazzjonijiet avversi kollha rrappurtati f'pazjenti fi provi kliniċi ta' fażi
English: PP/Aluminium foil blisters in cartons of 10, 14, 28, 42 or 98 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) filmcoated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-fojl magħmula minn PP/Aluminju f'kaxxi tal-kartun ta' 10, 14, 28, 42 jew 98 pillola miksija b'rita jew folji perforati b'dożi uniċi f'kaxxi tal-kartun ta' 10 x 1, 100 x 1 jew f'pakketti multipli li fihom 100 (10 pakketti ta' 10 x 1) pillola miksija b'rita.
English: Converting from Vitamin K Antagonists (VKA) to Xarelto For patients treated for prevention of stroke and systemic embolism, VKA treatment should be stopped and Xarelto therapy should be initiated when the International Normalised Ratio (INR) is
Maltese: Bidla minn Antagonisti tal-Vitamina K (VKA) għal Xarelto Għall-pazjenti kkurati għall-prevenzjoni ta' puplesija u emboliżmu sistemiku, kura b'VKA għandha titwaqqaf u terapija b'Xarelto għandha tinbeda meta l-Proporzjoni Normalizzat Internazzjonali (INR
English: Xarelto 20 mg (only applicable for outer carton, not applicable for bottle label)
Maltese: Xarelto 20 mg (immarka kaxxa biex timmarka d-doża preskritta)
English: Xarelto 20 mg film-coated tablets are brown-red, round, biconvex and marked with the BAYER-cross on one side and “20” and a triangle on the other.
Maltese: Xarelto 20 mg pilloli miksija b'rita huma ta' kulur aħmar fil-kannella, tondi, ibbuzzati fuq iż-żewġ naħat u mmarkati bis-salib tal-BAYER fuq naħa waħda, u bin-numru “20” u trijangolu fuq in-naħa l-oħra.
English: • with lower body weight (< 60 kg) if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine.
Maltese: • b'piż tal-ġisem aktar baxx (< 60 kg) jekk jingħata flimkien ma' ASA waħdu jew flimkien ma' ASA u clopidogrel jew ticlopidine.
English: In patients with moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 1529 ml/min) renal impairment the following dose recommendations apply:
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-krejatinina ta' 30 - 49 ml/min) jew sever (tneħħija tal-krejatinina ta' 15 - 29 ml/min) japplikaw ir-rakkomandazzjonijiet ta' doża li ġejjin:
English: The rivaroxaban clinical programme was designed to demonstrate the efficacy of Xarelto for the prevention of cardiovascular (CV) death, myocardial infarction (MI) or stroke in subjects with a recent ACS (ST-elevation myocardial infarction [STEMI], non- ST-elevation myocardial infarction [NSTEMI] or unstable angina [UA]).
Maltese: Il-programm kliniku b'rivaroxaban kien maħsub biex juri l-effikaċja ta' rivaroxaban għall-prevenzjoni ta' mewt kardjovaskulari (CV - cardiovascular), infart mijokardijaku (MI - myocardial infarction) jew puplesija f'individwi b'ACS reċenti (infart mijokardijaku b'ST elevat
English: The trial was terminated prematurely after the enrolment of 120 patients due to an excess of events among patients in the rivaroxaban arm.
Maltese: Il-prova ntemmet qabel iż-żmien wara li ġew irreġistrati 120 pazjent minħabba avvenimenti eċċessivi fost pazjenti fil-grupp ta' rivaroxaban.
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=
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).