FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients receiving rivaroxaban 2.5 mg twice daily for the prevention of atherothrombotic events in patients with ACS the geometric mean concentration (90% prediction interval) 2 - 4 h and about 12 h after dose (roughly representing maximum and minimum concentrations during the dose interval) was 47 (13 - 123) and 9.2 (4.4 - 18) mcg/l, respectively.
Maltese: F'pazjenti li jirċievu rivaroxaban 2.5 mg darbtejn kuljum għall-prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti b'ACS il-konċentrazzjoni ġeometrika medja (intervall ta' tbassir ta' 90%) 24 sigħat u madwar 12-il siegħa wara doża (bejn wieħed u ieħor jirrappreżentaw il-konċentrazzjonijiet massimi u minimi matul l-intervall tad-doża) kienet ta' 47 (13 - 123) u 9.2 (4.4 - 18) mcg/l, rispettivament.
English: 168 film-coated tablets 196 film-coated tablets 10 x 1 film-coated tablets 100 x 1 film-coated tablets 30 film-coated tablets
Maltese: 168 pillola miksija b'rita 10 x 1 pilloli miksija b'rita 100 x 1 pillola miksija b'rita 30 pillola miksija b'rita
English: The overall median study treatment duration was 504 days.
Maltese: It-tul medjan globali tat-trattament tal-istudju kien ta' 504 ijiem.
English: Bayer plc Tel: +44-(0) 118 206 3000
Maltese: Tel: +44-(0)118 206 3000
English: Patients with CAD/PAD
Maltese: Pazjenti b'CAD/PAD
English: Elderly population No dose adjustment (see section 5.2)
Maltese: L-ebda aġġustament fid-doża (ara sezzjoni 5.2)
English: Converting patients from the vitamin K antagonist warfarin (INR 2.0 to 3.0) to rivaroxaban (20 mg) or from rivaroxaban (20 mg) to warfarin (INR 2.0 to 3.0) increased prothrombin time/INR (Neoplastin) more than additively (individual INR values up to 12 may be observed), whereas effects on aPTT, inhibition of factor Xa activity and endogenous thrombin potential were additive.
Maltese: Bidla tal-pazjenti mill-antagonist ta' vitamina K, warfarin (INR 2.0 sa 3.0 ) għal rivaroxaban (20 mg) jew minn rivaroxaban (20 mg) għal warfarin (INR 2.0 sa 3.0 ) żiedet il-ħin ta' prothrombin/INR (Neoplastin) aktar minn b'mod addittiv (jistgħu jiġu osservati valuri individwali ta' INR sa 12), filwaqt li l-effetti fuq aPTT, inibizzjoni tal-attività ta' fattur Xa u l-potenzjal ta' thrombin endoġenu kienu addittivi.
English: Spinal/epidural anaesthesia or puncture
Maltese: Anestesija jew titqib fis-sinsla tad-dahar/epidurali
English: In patients receiving rivaroxaban for prevention of VTE 10 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 101 (7 - 273) and 14 (4 ‑ 51) mcg/l, respectively.
Maltese: F'pazjenti li jirċievu rivaroxaban 10 mg darba kuljum għall-prevenzjoni ta' VTE il-konċentrazzjoni ġeometrika medja (intervall ta' tbassir ta' 90%) 2 - 4 sigħat u madwar 24 siegħa wara doża (bejn wieħed u ieħor jirrappreżentaw il-konċentrazzjonijiet massimi u minimi matul l-intervall tad-doża ) kienet ta' 101 (7 - 273) u 14 (4 - 51) mcg/l, rispettivament.
English: ▪ some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital) ▪ St John's Wort (Hypericum perforatum), a herbal product used for depression ▪ rifampicin, an antibiotic
Maltese: - Jekk qed tieħu xi mediċini għall-kura ta' l-epilessija (phenytoin, carbamazepine, phenobarbital) St John's Wort (Hypericum perforatum), prodott mill-ħxejjex użat għad-depressjoni rifampicin, antibijotiku
English: For the primary efficacy outcome, the observed benefit of Xarelto 2.5 mg twice daily plus ASA 100 mg once daily compared with ASA 100 mg once daily was HR=0.89 (95% CI 0.7-1.1) in patients ≥75 years (incidence: 6.3% vs 7.0%) and HR=0.70 (95% CI 0.6-0.8) in patients <75 years (3.6% vs 5.0%).
Maltese: Għar-riżultat primarju tal-effikaċja, il-benefiċċju osservat ta' Xarelto 2.5 mg darbtejn kuljum flimkien ma' ASA 100 mg darba kuljum meta mqabbel ma' ASA 100 mg darba kuljum kien HR=0.89 (CI ta' 95% 0.7-1.1) f'pazjenti b'età ta' ≥75 sena (inċidenza: 6.3% vs 7.0%) u HR=0.70 (CI ta' 95% 0.6-0.8) f'pazjenti ta' <75 sena (3.6% vs 5.0%).
English: Xareltoa) 6 or 12 months N=602
Maltese: 6 jew 12-il xahar N=602
English: There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin in individuals receiving rivaroxaban.
Maltese: Hemm esperjenza limitata b'tranexamic acid u m'hemmx esperjenza b'aminocaproic acid u aprotinin f'individwi li jkunu qed jirċievu rivaroxaban.
English: Co-administration of rivaroxaban with ketoconazole (400 mg once a day) or ritonavir (600 mg twice a day) led to a 2.6 fold / 2.5 fold increase in mean rivaroxaban AUC and a 1.7 fold / 1.6 fold increase in mean rivaroxaban Cmax, with significant increases in pharmacodynamic effects which may lead to an increased bleeding risk.
Maltese: L-għoti ta' rivaroxaban flimkien ma' ketoconazole (400 mg darba kuljum) jew ritonavir (600 mg darbtejn kuljum), wasslu għal żieda ta' 2.6 darbiet / 2.5 darbiet fil-medja ta' l-AUC ta' rivaroxaban, u żieda ta' 1.7 darbiet / 1.6 darbiet fil-medja ta' Cmax ta' rivaroxaban, b'żidiet sinifikanti fl-effetti farmakodinamiċi li jistgħu jwasslu għal żieda fir-riskju ta' fsada.
English: or
Maltese: Ċ
English: Xarelto 10 mg tablets rivaroxaban
Maltese: Xarelto 10 mg pilloli rivaroxaban
English: EU/1/08/472/011-016, EU/1/08/472/023, EU/1/08/472/036, EU/1/08/472/038, EU/1/08/472/048.
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/472/011-016, EU/1/08/472/023, EU/1/08/472/036, EU/1/08/472/038, EU/1/08/472/048.
English: The incidence rates for the primary safety outcome (major or clinically relevant non-major bleeding events) were slightly lower in the rivaroxaban treatment group (10.3% (249/2412)) than in the enoxaparin/VKA treatment group (11.4% (274/2405)).
Maltese: Ir-rati ta' inċidenza għar-riżultat primarju tas-sigurtà (avvenimenti ta' fsada maġġuri jew mhux maġġuri iżda ta' rilevanza klinika) kienu ftit aktar baxxi fil-grupp ta' trattament b'rivaroxaban (10.3% (249/2412)) milli fil-grupp ta' trattament b'enoxaparin/VKA (11.4% (274/2405)).
English: Xarelto 2.5 mg tablets rivaroxaban
Maltese: Xarelto 2.5 mg pilloli rivaroxaban
English: Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction with rivaroxaban (15 mg) but a relevant increase in bleeding time was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/IIIa receptor levels.
Maltese: Clopidogrel (doża għolja tal-bidu ta' 300 mg segwita minn doża ta' manteniment ta' 75 mg) ma weriex interazzjoni farmakokinetika b'rivaroxaban (15 mg), iżda kienet osservata żieda rilevanti fil-ħin ta' fsada f'sotto-grupp ta' pazjenti li ma kienitx ikkorrelata ma' l-aggregazzjoni tal-plejtlits, P-selectin, jew mallivelli ta' riċetturi ta' GPIIb/IIIa.
English: In Einstein DVT 3,449 patients with acute DVT were studied for the treatment of DVT and the prevention of recurrent DVT and PE (patients who presented with symptomatic PE were excluded from this study).
Maltese: F'Einstein DVT 3,449 pazjent b'DVT akuta ġew studjati għall-kura ta' DVT u l-prevenzjoni ta' DVT u PE rikorrenti (pazjenti li ppreżentaw b'PE sintomatiku kienu esklużi minn dan l-istudju).
English: Ελλάδα Bayer Ελλάς ΑΒΕΕ
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Bayer AG
English: Possible side effects which may be a sign of severe allergic reactions
Maltese: Effetti sekondarji possibbli li jistgħu jkunu sinjal ta' reazzjonijiet allerġiċi severi
English: Symptomatic
Maltese: Indikazzjoni
English: In individuals with mild, moderate and severe renal impairment the overall inhibition of factor Xa activity was increased by a factor of 1.5, 1.9 and 2.0 respectively as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 1.3, 2.2 and 2.4 respectively.
Maltese: F'individwi b'indeboliment renali ħafif, moderat u sever, l-inibizzjoni totali tal-attività ta' fattur Xa żdiedet b'fattur ta' 1.5, 1.9 u 2.0 rispettivament, meta mqabbla ma' voluntiera b'saħħithom; t titwil ta' PT żdied b'mod simili b'fattur ta' 1.3, 2.2 u 2.4 rispettivament.
English: There were differences in patient baseline characteristics including age, cancer and renal impairment.
Maltese: Kien hemm differenzi fil-karatteristiċi fil-linja bażi tal-pazjenti inklużi l-età, kanċer u indeboliment tal-kliewi.
English: Patients with recent acute coronary syndrome undergoing PCI a)
Maltese: Pazjenti b'sindrome akut reċenti tal-koronarja li qed jagħmlu PCI a)
English: Non-CABG TIMI major bleeding event
Maltese: Avveniment magguri ta' fsad mhux CABG TIMI
English: The primary efficacy analysis (i.e. composite of all-cause mortality, MI, or stroke) showed no statistically significant difference between the rivaroxaban 2.5 mg bid group and the placebo group with a HR=0.94 (95% CI 0.84 - 1.05), p=0.270.
Maltese: L-analiżi primarja tal-effikaċja (jiġifieri kompost ta' mortalità minn kull kawża, MI, jew puplesija) ma wriet l-ebda differenza statistikament sinifikanti bejn il-grupp ta' rivaroxaban 2.5 mg bid u l-grupp tal plaċebo b'HR=0.94 (CI ta' 95% 0.84 - 1.05), p=0.270.
English: Xarelto belongs to a group of medicines called antithrombotic agents.
Maltese: Xarelto jappartjeni għall-grupp ta' mediċini msejħa sustanzi antitrombotiċi.
English: Component of a multipack, can't be sold separately.
Maltese: Parti minn pakkett multiplu, ma jistgħax jinbiegħ separatament.
English: The pharmacokinetic/pharmacodynamic (PK/PD) relationship between rivaroxaban plasma concentration and several PD endpoints (factor Xa inhibition, PT, aPTT, Heptest) has been evaluated after administration of a wide range of doses (5 - 30 mg twice a day).
Maltese: Ir-relazzjoni farmakokinetika/farmakodinamika (PK/PD) bejn il-konċentrazzjoni ta' rivaroxaban filplażma u diversi miri ta' PD (inibizzjoni tal-fattur Xa, PT, aPTT, Heptest) kienet evalwata wara l-għoti ta' firxa wiesgħa ta' dożi (5 - 30 mg darbtejn kuljum).
English: A prospective, randomised, open-label, multicentre, exploratory study with blinded endpoint evaluation (X-VERT) was conducted in 1504 patients (oral anticoagulant naive and pre-treated) with non-valvular atrial fibrillation scheduled for cardioversion to compare rivaroxaban with dose-adjusted VKA (randomised 2:1), for the prevention of cardiovascular events.
Maltese: Twettaq studju esploratorju prospettiv, randomised, open-label, multiċentriku, b'evalwazzjoni blinded filpunt finali (X-VERT) fuq 1504 pazjenti (li qatt ma ħadu sustanzi orali kontra l-koagulazzjoni tad-demm u kkurati minn qabel) b'fibrillazzjoni atrijali mhux valvulari skedati għal kardjoverżjoni biex iqabbel rivaroxaban ma' VKA aġġustati għad-doża (randomised 2:1), għall-prevenzjoni ta' episodji kardjovaskulari.
English: Swallow the tablet preferably with water.
Maltese: Ibla' l-pillola preferibbilment ma' l-ilma.
English: Xarelto 2.5 mg (tick box to tick the prescribed dose) Xarelto 10 mg (tick box to tick the prescribed dose) Xarelto 15 mg (tick box to tick the prescribed dose) Xarelto 20 mg (tick box to tick the prescribed dose)
Maltese: Xarelto 10 mg (immarka kaxxa biex timmarka d-doża preskritta) Xarelto 15 mg (immarka kaxxa biex timmarka d-doża preskritta)
English: Table 4: Efficacy results from phase III ROCKET AF Study population
Maltese: Tabella 4: Riżultati tal-effikaċja minn ROCKET AF ta' fażi
English: Patients with recent acute coronary syndrome a)
Maltese: Pazjenti b'sindrome akut tal-koronarja reċenti a)
English: Within the highest tertile according to centre, the HR with rivaroxaban versus warfarin was 0.642 (95% CI: 0.277 - 1.484).
Maltese: Fl-ogħla tertile skont iċ-ċentru, l-HR b'rivaroxaban kontra warfarin kien ta' 0.642 (95% CI: 0.277 - 1.484).
English: Risk: Cumulative incidence risk (Kaplan-Meier estimates) at 30 months; ISTH: International Society on Thrombosis and Haemostasis; od:
Maltese: Emostasi (International Society on Thrombosis and Haemostasis); od: darba kuljum
English: Eye haemorrhage (incl.
Maltese: jew anġina mhux stabbli [UA - unstable angina]).
English: The primary efficacy outcome (all stroke, transient ischaemic attack, non-CNS systemic embolism, myocardial infarction (MI) and cardiovascular death) occurred in 5 (0.5%) patients in the rivaroxaban group (n = 978) and 5 (1.0%) patients in the VKA group (n = 492; RR 0.50; 95% CI 0.15
Maltese: Ir-riżultat primarju tal-effikaċja (kull puplesija, attakk iskemiku temporanju, emboliżmu sistemiku mhux tas-CNS, infart mijokardijaku (MImyocardial infarction) u mewt kardjovaskulari) seħħew f'5 (0.5%) pazjenti fil-grupp ta' rivaroxaban (n = 978) u 5 (1.0%) pazjenti fil-grupp ta' VKA (n = 492; RR 0.50; CI ta' 95% 0.15-1.73; popolazzjoni ITT modifikata).
English: Hepatic impairment, Increased bilirubin, increased blood alkaline phosphataseA, increased GGTA
Maltese: Indeboliment tal-fwied, Żieda fil-bilirubina, żieda ta' alkaline phosphataseA fid-demm, żieda ta' GGTA
English: Symptomatic PE and DVT
Maltese: PE u DVT sintomatiċi
English: A: observed in prevention of VTE in adult patients undergoing elective hip or knee replacement surgery
Maltese: A: osservati fil-prevenzjoni ta' VTE f'pazjenti adulti li se jagħmlu kirurġija ta' sostituzzjoni tal-ġenbejn jew tal-irkoppa ppjanata
English: Prevention of atherothrombotic events in patients after an ACS
Maltese: Prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti wara ACS
English: Enoxaparin
Maltese: Plaċebo
English: Table 2: Bleeding* and anaemia events rates in patients exposed to rivaroxaban across the completed phase III studies
Maltese: Tabella 2: Rati ta' avvenimenti ta' fsada* u anemija f'pazjenti esposti għal rivaroxaban matul listudji kompluti ta' fażi
English: In patients undergoing major orthopaedic surgery, the 5/95 percentiles for PT (Neoplastin) 2 - 4 hours after tablet intake (i.e. at the time of maximum effect) ranged from 13 to 25 s (baseline values before surgery 12 to 15 s).
Maltese: F'pazjenti li jkollhom kirurġija ortopedika maġġuri, il-percentiles 5/95 għal PT (Neoplastin) 24 sigħat wara li tittieħed il-pillola (i.e. fil-ħin tal-effett massimu) varjaw minn 13 sa 25 s (valuri fil-linja bażi qabel il-kirurġja ta' 12 sa 15-il sekonda).
English: Kaplan-Meier Estimates (%) at 30 months:
Maltese: Riskju kumulattiv ta' inċidenza (stimi Kaplan-Meier) wara 30 xahar;
English: - If you are taking
Maltese: (CI ta'
English: The analysis of the pooled results of the phase III studies corroborated the data obtained in the individual studies regarding reduction of total VTE, major VTE and symptomatic VTE with rivaroxaban 10 mg once daily compared to enoxaparin 40 mg once daily.
Maltese: III, ikkonfermat l-informazzjoni miksuba fl-istudji individwali dwar it-tnaqqis ta' VTE totali, VTE maġġuri u VTE sintomatika, b'rivaroxaban 10 mg darba kuljum meta mqabbel ma' enoxaparin 40 mg darba kuljum.
English: Elderly population Increasing age may increase haemorrhagic risk (see section 5.2).
Maltese: Popolazzjoni anzjana Żieda fl-età tista' iżżid ir-riskju emorraġiku (ara sezzjoni 5.2).
English: Xarelto 15 mg and 20 mg are to be taken with food (see section 4.2).
Maltese: Xarelto 15 mg u 20 mg għandhom jittieħdu mal-ikel (ara sezzjoni 4.2).
English: The frequency of this side effect is very rare (up to 1 in 10,000).
Maltese: Il-frekwenza ta' dan l-effett sekondarju hija rari ħafna (sa persuna waħda minn kull 10,000).
English: Within the highest tertile according to centre, the HR with rivaroxaban versus warfarin was 0.69 (95% CI: 0.35 - 1.35).
Maltese: Fl-ogħla tertile skont iċ-ċentru, l-HR b'rivaroxaban kontra warfarin kien ta' 0.69 (CI ta' 95%: 0.35 - 1.35).
English: PAD patients had previous interventions such as bypass surgery or percutaneous transluminal angioplasty or limb or foot amputation for arterial vascular disease or intermittent claudication with ankle/arm blood pressure ratio < 0.90 and/ or significant peripheral artery stenosis or previous carotid revascularization or asymptomatic carotid artery stenosis ≥ 50%.
Maltese: Pazjenti b'PAD kellhom interventi preċedenti bħal kirurġija ta' bypass jew anġjoplastija transluminali perkutanja jew amputazzjoni ta' riġel, driegħ jew sieq minħabba marda vaskulari arterjali jew uġigħ intermittenti li jtellef il-mixi kkawżat minn ċirkolazzjoni batuta bi proporzjon ta' pressjoni tad-demm talgħaksa/driegħ ta' < 0.90 u/jew stenosi sinifikanti tal-arterji periferali jew rivaskularizzazzjoni preċedenti tal-karotidi jew stenosi mhux sintomatika tal-arterji karotidi ta' ≥ 50%.
English: Both the 2.5 mg twice daily and the 5 mg twice daily regimens of rivaroxaban were effective in further reducing the incidence of CV events on a background of standard antiplatelet care.
Maltese: Kemm il-kors ta' 2.5 mg darbtejn kuljum kif ukoll dak ta' 5 mg darbtejn kuljum ta' rivaroxaban kienu effettivi biex inaqqsu aktar l-inċidenza ta' avvenimenti CV meta mogħtija flimkien ma' kura standard kontra l-plejtlits.
English: rectal haemorrhage), gastrointestinal and abdominal pains, dyspepsia, nausea, constipationA, diarrhoea, vomitingA
Maltese: Tromboċitopenija Disturbi fis-sistema immuni Reazzjoni allerġika, dermatite allerġika, Anġjoedima u edima allerġika
English: In addition to the phase III RECORD programme, a post-authorization, non-interventional, open-label cohort study (XAMOS) has been conducted in 17,413 patients undergoing major orthopaedic surgery of the hip or knee, to compare rivaroxaban with other pharmacological thromboprophylaxis (standardof-care) under real-life setting.
Maltese: III RECORD, twettaq studju wara l-awtorizzazzjoni, mhux ta' intervent, open-label, ta' ko-orti (XAMOS) fi 17,413-il pazjent li kienu għaddejjin minn kirurġija ortopedika maġġuri tal-ġenbejn jew tal-irkoppa, biex iqabbel rivaroxaban ma' tromboprofilassi farmakoloġika oħra (kura standard) f'ambjent reali.
English: Therefore, Xarelto is not recommended for use in children below 18 years of age.
Maltese: Xarelto mhux irrakkomandat għall-persuni b'età inqas minn 18-il sena.
English: Under fed conditions Xarelto 10 mg, 15 mg and 20 mg tablets demonstrated dose-proportionality.
Maltese: Wara l-ikel pilloli Xarelto 10 mg, 15 mg u 20 mg urew proporzjonalità mad-doża.
English: common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) rare (≥ 1/10,000 to < 1/1,000) very rare ( < 1/10,000) not known (cannot be estimated from the available data)
Maltese: Il-frekwenza hija definita bħala: komuni ħafna (≥ 1/10) komuni (≥ 1/100 sa < 1/10) mhux komuni (≥ 1/1,000 sa < 1/100) rari (≥ 1/10,000 sa < 1/1,000) rari ħafna ( < 1/10,000) mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)
English: Animal studies have shown reproductive toxicity related to the pharmacological mode of action of rivaroxaban (e.g. haemorrhagic complications).
Maltese: Studji fuq l-annimali wrew effett tossiku fuq is-sistema riproduttiva relatat mal-mod ta' azzjoni farmakoloġika ta' rivaroxaban (eż. komplikazzjonijiet emorraġiċi).
English: In the pivotal double-blind ROCKET AF study, 14,264 patients were assigned either to Xarelto 20 mg once daily (15 mg once daily in patients with creatinine clearance 30 - 49 ml/min) or to warfarin titrated to a target INR of 2.5 (therapeutic range 2.0 to 3.0).
Maltese: Fl-istudju pivitali double-blind ROCKET-AF, 14,264 pazjent ġew assenjat għal Xarelto 20 mg darba kuljum (15 mg darba kuljum f'pazjenti bi tneħħija tal-krejatinina ta' 30 - 49ml/min) jew għal warfarin ittitrat għal INR immirat ta' 2.5 (firxa terapewtika
English: INR values were within the therapeutic range a mean of 60.3% of the time for the mean treatment duration of 189 days, and 55.4%, 60.1%, and 62.8% of the time in the 3-, 6-, and 12-month intended treatment duration groups, respectively.
Maltese: Valuri tal-INR kienu fil-firxa terapewtika, medja ta' 60.3% tal-ħin għat-tul medju ta' trattament ta' 189 jum, u 55.4%, 60.1%, u 62.8% tal-ħin fil-gruppi b'intenzjoni ta' tul ta' trattament ta' 3, 6, u 12-il xahar, rispettivament.
English: The principal safety outcome (major bleeding) occurred in 6 (0.6%)and 4 (0.8%) patients in the rivaroxaban (n = 988) and VKA (n = 499) groups, respectively (RR 0.76; 95% CI 0.21-2.67; safety population).
Maltese: Ir-riżultat prinċipali tas-sigurtà (fsada maġġuri) seħħ f'6 (0.6%) u 4 (0.8%) pazjenti filgruppi ta' rivaroxaban (n = 988) u VKA (n = 499), rispettivament (RR 0.76; CI ta' 95% 0.
English: SIA Bayer Tel: +371-67 84 55 63
Maltese: Tel: +371-67 84 55 63
English: Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA) (see section 4.4).
Maltese: Kura ta' ACS flimkien ma' terapija kontra l-plejtlits f'pazjenti li kellhom puplesija jew attakk iskemiku temporanju (TIA - transient ischaemic attack) qabel (ara sezzjoni 4.4).
English: For patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered (see sections 4.5 and 5.1).
Maltese: Għall-pazjenti f'riskju ta' mard gastro-intestinali ulċerattiv tista' tiġi kkunsidrata kura profilattika xierqa (ara sezzjonijiet 4.5 u 5.1).
English: Acute limb ischaemia a) intention to treat analysis set, primary analyses b) vs. ASA 100 mg; Log-Rank p-value * The reduction in the primary efficacy outcome was statistically superior.
Maltese: Iskemija akuta fir-riġlejn u/jew fid-dirgħajn a) grupp ta' analiżi b'intenzjoni li jiġi ttrattat, analiżi primarji b) vs.
English: There was a statistically significant increase in ISTH major bleeding in the rivaroxaban group compared with placebo (event rate per 100 patient-years: 2.04 vs 1.21, HR 1.68; 95% CI: 1.18 to 2.39; p=0.003).
Maltese: Kien hemm żieda statistikament sinifikanti fi fsada maġġuri skont ISTH fil-grupp ta' rivaroxaban meta mqabbel malplaċebo (rata ta' avveniment għal kull 100 sena ta' pazjent: 2.04 vs 1.21, HR 1.68; CI ta' 95%: 1.18 sa 2.39; p=0.003).
English: Adjusted HRs comparing rivaroxaban and standard-of-care for major bleeding, recurrent VTE and all-cause mortality were 0.77 (95% CI 0.40 - 1.50), 0.91 (95% CI 0.54 - 1.54) and 0.51 (95% CI 0.24 - 1.07), respectively.
Maltese: 77 (CI ta' 95% 0.40 - 1.50), 0.91 (CI ta' 95% 0.54 - 1.54) u 0.51 (CI ta' 95% 0.24 - 1.07), rispettivament.
English: The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a HR of 0.67 ((95% CI: 0.47 - 0.95), nominal p value p=0.027) in favour of rivaroxaban.
Maltese: Il-benefiċċju kliniku nett speċifikat minn qabel (riżultat primarju tal-effikaċja flimkien ma' avvenimenti ta' fsada maġġuri) kien irrappurtat b'HRta' 0.67 ((95% CI: 0.47 - 0.95), valur p nominali p=0.027) favur rivaroxaban.
English: Stroke, MI or CV death
Maltese: Mortalità minn kull kawża
English: Rivaroxaban neither inhibits nor induces any major CYP isoforms like CYP3A4.
Maltese: Rivaroxaban la jinibixxi u lanqas jindotta isoformi maġġuri ta' CYP bħal CYP3A4.
English: Figure 1: Time to first occurrence of primary efficacy endpoint (CV death, MI or stroke)
Maltese: Figura 1: Żmien sal-ewwel okkorenza tal-punt finali primarju tal-effikaċja (mewt CV, MI jew puplesija)
English: Erythromycin (500 mg three times a day), which inhibits CYP3A4 and P-gp moderately, led to a 1.3 fold increase in mean rivaroxaban AUC and Cmax.
Maltese: Erythromycin (500 mg tliet darbiet kuljum), li jinibixxi CYP3A4 u P-gp b'mod moderat, wassal għal żieda ta' 1.3 darbiet fil-medja ta' l-AUC u Cmax ta' rivaroxaban.
English: The principal safety outcome (major bleeding events) was similar for patients treated with Xarelto 20 mg and 10 mg once daily compared to 100 mg acetylsalicylic acid.
Maltese: Ir-riżultat prinċipali tas-sigurtà (avvenimenti ta' fsada maġġuri) kien simili għal pazjenti ttrattati b'Xarelto 20 mg u 10 mg darba kuljum meta mqabbel ma' 100 mg acetylsalicylic acid.
English: Each 20 mg film-coated tablet contains 21.76 mg lactose (as monohydrate), see section 4.4.
Maltese: Kull pillola miksija b'rita ta' 20 mg fiha 21.76 mg ta' lactose (bħala monohydrate), ara sezzjoni 4.4.
English: Xarelto 15 mg tablets rivaroxaban
Maltese: Xarelto 15 mg pilloli rivaroxaban