FrancophonIA/ELRC3.0 huggingface dataset:
English: Localised oedemaA
Maltese: Edima lokalizzata
English: Rates of major bleeding, recurrent VTE and all-cause mortality for rivaroxaban were 0.7%, 1.4% and 0.5%, respectively.
Maltese: Ir-rati ta' fsada maġġuri, VTE rikorrenti u mortalità minn kull kawża għal rivaroxaban kienu 0.7%, 1.4% u 0.5%, rispettivament.
English: Τηλ: +30-210-618 75 00
Maltese: Bayer Ελλάς ΑΒΕΕ Τηλ: +30-210-618 75 00
English: Information for health care providers:
Maltese: Kategorija farmakoterapewtika:
English: Xarelto 2.5 mg, twice daily, N=3114 n (%)
Maltese: Xarelto 2.5 mg, darbtejn kuljum, N=3114 n (%)
English: Symptomatic intracranial haemorrhage
Maltese: VTE sintomatika Fsada maġġuri
English: Non-major clinically relevant bleeding events
Maltese: Fsada mhux maġġuri klinikament rilevanti
English: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery The rivaroxaban clinical programme was designed to demonstrate the efficacy of rivaroxaban for the prevention of VTE, i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs.
Maltese: Il-programm kliniku b'rivaroxaban kien maħsub biex juri l-effikaċja ta' rivaroxaban għall-prevenzjoni ta' VTE, i.e. trombożi fil-vini l-kbar (DVT) prossimali u distali u emboliżmu pulmonari (PE) f'pazjenti li jkollhom kirurġija ortopedika maġġuri fir-riġlejn.
English: Among patients in the warfarin group, INR values were within the therapeutic range (2.0 to 3.0) a mean of 55% of the time (median, 58%; interquartile range, 43 to 71).
Maltese: Fost pazjenti fil-grupp ta' warfarin, valuri tal-INR kienu fil-firxa terapewtika (2.0 sa 3.0) medja ta' 55% tal-ħin (medjan, 58%; firxa interquartile, 43 sa 71).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza totali ta' lactase jew assorbiment ħażin ta' glucose-galactose, m'għandhomx jieħdu din il-mediċina.
English: Other medicines and Xarelto
Maltese: Mediċini oħra u Xarelto
English: 3,396 patients continued prevention of recurrent venous thromboembolism
Maltese: 3,396 pazjent komplew il-prevenzjoni ta' tromboemboliżmu rikorrenti fil-vini
English: PVC/PVDC/Aluminium foil blisters in cartons of 14 film-coated tablets.
Maltese: Folji tal-fojl tal-PVC/PVDC/Aluminju f'kaxxi tal-kartun ta' 14-il pillola miksija b'rita.
English: 2,531 patients undergoing total knee replacement surgery
Maltese: 2,531 pazjent li kellhom kirurġija ta' bdil totali ta' l-irkoppa
English: Stroke, non-CNS systemic embolism, vascular death and myocardial infarction
Maltese: Puplesija u emboliżmu sistemiku mhux fis-CNS, mewt vaskulari u infart mijokardijaku
English: Elderly population Increasing age may increase haemorrhagic risk (see sections 5.1 and 5.2).
Maltese: Popolazzjoni anzjana Żieda fl-età tista' iżżid ir-riskju emorraġiku (ara sezzjonijiet 5.1 u 5.2).
English: Enoxaparin/VKAb) 3, 6 or 12 months N=1,718
Maltese: Enoxaparin/VKAb) 3, 6 jew 12-il xahar N=1,718
English: Table 8: Safety results from phase III COMPASS Study population
Maltese: Tabella 8:: Riżultati tas-sigurtà minn COMPASS ta' fażi
English: Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
Maltese: Xarelto, mogħti flimkien ma' acetylsalicylic acid (ASA), huwa indikat għall-prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti adulti b'marda tal-arterji koronarji (CAD - coronary artery disease) jew marda sintomatika tal-arterji periferali (PAD - peripheral artery disease) li għandhom riskju għoli ta' avvenimenti iskemiċi.
English: Prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS)
Maltese: Prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti wara sindrome akut koronarja (ACS - acute coronary syndrome)
English: In a clinical pharmacology study on the reversal of rivaroxaban pharmacodynamics in healthy adult subjects (n=22), the effects of single doses (50 IU/kg) of two different types of PCCs, a 3-factor PCC (Factors II, IX and X) and a 4-factor PCC (Factors II, VII, IX and X) were assessed.
Maltese: IU/kg) ta' żewġ tipi differenti ta' PCCs, PCC ta' 3 fatturi (Fatturi II, IX u X) u PCC ta' 4 fatturi (Fatturi II, VII, IX u X).
English: In Einstein PE, 4,832 patients with acute PE were studied for the treatment of PE and the prevention of recurrent DVT and PE.
Maltese: F'Einstein PE, 4,832 pazjent b'PE akut ġew studjati għat-trattament ta' PE u l-prevenzjoni ta' DVT u PE rikorrenti.
English: Bayer AB Tel: +46-(0)8-580 223 00
Maltese: Tel: +46-(0)8-580 223 00
English: Adverse reactions like syncope (frequency: uncommon) and dizziness (frequency: common) have been reported (see section 4.8).
Maltese: Kienu rrappurtati reazzjonijiet avversi bħal sinkope (frekwenza: mhux komuni) u sturdament (frekwenza: komuni) (ara sezzjoni 4.8).
English: Clinically relevant non-major bleeding a) Rivaroxaban 20 mg once daily * p < 0.0001 (superiority), HR: 0.185 (0.087 - 0.393)
Maltese: Fsada mhux maġġuri iżda klinikament rilevanti a) Rivaroxaban 20 mg darba kuljum * p < 0.0001 (superjorità), HR: 0.185 (0.
English: Allergic reaction, dermatitis allergic, Angioedema and allergic oedema
Maltese: Disturbi fis-sistema immuni Reazzjoni allerġika, dermatite allerġika, Anġjoedima u edima allerġika
English: The volume of distribution is moderate with Vss being approximately 50 litres.
Maltese: Il-volum ta' distribuzzjoni huwa moderat b'Vss madwar 50 litru.
English: The event rates for MI per 100 patient-years (rivaroxaban vs placebo) were 2.08 vs 2.52 (HR 0.83; 95% CI: 0.63 to 1.08; p=0.165) and for stroke the event rates per 100 patient-years were 1.08 vs 1.62 (HR: 0.66; 95% CI: 0.47 to 0.95; p=0.023).
Maltese: Ir-rati ta' avvenimenti għal MI għal kull 100 sena ta' pazjent (rivaroxaban vs plaċebo) kienu 2.08 vs 2.52 (HR 0.83; CI ta' 95%: 0.63 sa 1.08; p=0.165) u għall-puplesija r-rati ta' avvenimenti għal kull 100 sena ta' pazjent kienu ta' 1.08 vs 1.62 (HR: 0.66; CI ta' 95%: 0.47 sa 0.95; p=0.023).
English: Patients were randomly assigned in a 1:1:1 fashion for an overall 12-month-therapy.
Maltese: Il-pazjenti tqassmu b'mod każwali f'mod ta' 1:1:1 għal terapija globali ta' 12-il xahar.
English: Patients with ACS
Maltese: dwar ACS
English: Extremes in body weight (< 50 kg or > 120 kg) had only a small influence on rivaroxaban plasma concentrations (less than 25%).
Maltese: Estremitajiet fil-piż tal-ġisem (< 50 kg jew > 120 kg) kellhom biss influwenza żgħira fuq ilkonċentrazzjonijiet ta' rivaroxaban fil-plażma (inqas minn 25%).
English: Among patients receiving dual antiplatelets therapy 98.8% received clopidogrel, 0.9% received ticlopidine and 0.3% received prasugrel.
Maltese: Fost il-pazjenti li kienu qed jirċievu terapija b'żewġ mediċini kontra l-plejtlits 98.8% irċevew clopidogrel, 0.9% irċevew ticlopidine u 0.3% irċevew prasugrel.
English: België / Belgique / Belgien
Maltese: België / Belgique / Belgien Bayer SA-NV Tél/Tel:
English: Xareltoa) 3, 6 or 12 months N=4,150
Maltese: 3, 6 jew 12-il xahar N=4,150
English: 20 mg od (15 mg od in patients with moderate renal impairment) Event rate (100 ptyr)
Maltese: 20 mg od (15 mg od f'pazjenti b'indeboliment renali moderat)
English: Xarelto 15 mg tablets Xarelto 20 mg tablets rivaroxaban
Maltese: Xarelto 15 mg pilloli Xarelto 20 mg pilloli rivaroxaban
English: The frequencies of adverse reactions reported with Xarelto are summarised in Table 3 below by system organ class (in MedDRA) and by frequency.
Maltese: Il-frekwenza tar-reazzjonijiet avversi rrappurtati b'Xarelto huma miġbura fil-qosor f'Tabella 3 taħt skont il-klassi tas-sistemi u tal-organi (f'MedDRA) u l-frekwenza.
English: Luxembourg / Luxemburg
Maltese: Luxembourg / Luxemburg Bayer SA-NV
English: When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/(100 mcg/l).
Maltese: Meta ntuża Neoplastin PT, PT fil-linja bażi kien madwar 13 s u s-slope kienet madwar 3 sa 4 s/(100 mcg/l).
English: There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine.
Maltese: M'hemmx bżonn ta' monitoraġġ tal-parametri tal-koagulazzjoni waqt kura b'rivaroxaban f'rutina klinika.
English: Major bleeding occurred in 35 (0.4%) and 29 (0.3%) of patients in the rivaroxaban and standard-of-care groups (HR 1.10; 95% CI 0.67-1.80).
Maltese: Fsada maġġuri seħħet f'35 (0.4%) u 29 (0.3%) pazjent fil-gruppi ta' rivaroxaban u ta' kura standard (HR 1.10; CI ta' 95% 0.67-1.80).
English: 59 patients were randomized to rivaroxaban 20 mg (15 mg for patients with creatinine clearance (CrCl) <50 mL/min) and 61 to warfarin (INR 2.0-3.0).
Maltese: Segwitu medju kien ta' 569 jum. 59 pazjent kienu randomised għal rivaroxaban 20 mg (15 mg għal pazjenti bi tneħħija tal-krejatinina (CrCl - creatinine clearance) <50 mL/min) u 61 għal warfarin (INR 2.0-3.0).
English: Xareltoa) 3, 6 or 12 months N=2,419
Maltese: 3, 6 jew 12-il xahar N=2,419
English: The COMMANDER HF study included 5,022 patients with heart failure and significant coronary artery disease (CAD) following a hospitalization of decompensated heart failure (HF) which were randomly assigned into one of the two treatment groups: rivaroxaban 2.5 mg twice daily (N=2,507) or matching placebo (N=2,515), respectively.
Maltese: L-istudju COMMANDER HF inkluda 5,022 pazjent b'insuffiċjenza tal-qalb u marda tal-arterja koronarja (CAD - coronary artery disease) sinifikanti wara dħul l-isptar minħabba insuffiċjenza tal-qalb (HF - heart failure) dekumpensata li ġew assenjati b'mod każwali f'wieħed miż-żewġ gruppi ta' trattament: rivaroxaban 2.5 mg darbtejn kuljum (N=2,507) jew plaċebo li jaqbel miegħu (N=2,515), rispettivament.
English: Limited clinical data for patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased.
Maltese: Data klinika limitata għal pazjenti b'indeboliment renali sever (tneħħija tal-krejatinina ta' 15 - 29 ml/min) tindika li konċentrazzjonijiet ta' rivaroxaban fil-plażma jiżdiedu b'mod sinifikanti.
English: Xarelto reduces the risk in adults of getting blot clots (atherothrombotic events).
Maltese: Xarelto jnaqqas ir-riskju fl-adulti li jkollhom emboli tad-demm (avvenimenti aterotrombotiċi).
English: In individuals with mild (creatinine clearance 50 - 80 ml/min), moderate (creatinine clearance 30 - 49 ml/min) and severe (creatinine clearance 15 - 29 ml/min) renal impairment, rivaroxaban plasma concentrations (AUC) were increased 1.4, 1.5 and 1.6 fold respectively.
Maltese: F'individwi b'indeboliment renali ħafif (tneħħija talkrejatinina ta' 50 - 80 ml/min), moderat (tneħħija tal-krejatinina ta' 30 - 49 ml/min) u sever (tneħħija talkrejatinina ta' 15 - 29 ml/min), il-konċentrazzjonijiet ta' rivaroxaban fil-plażma (AUC) kienu miżjuda b'1.4, 1.5 u 1.6 darbiet rispettivament.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodiumfree”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment “ħieles mis-sodium”.
English: The incidence of the secondary safety outcome (major bleeding events) was lower in the rivaroxaban group (1.1% (26/2412)) than in the enoxaparin/VKA group (2.2% (52/2405)) with a HR 0.493 (95% CI: 0.308 - 0.789).
Maltese: L-inċidenza tar-riżultat sekondarju tas-sigurtà (avvenimenti ta' fsada maġġuri) kienet aktar baxxa fil-grupp ta' rivaroxaban (1.1% (26/2412)) milli filgrupp ta' enoxaparin/VKA (2.2% (52/2405)) b'HR ta' 0.493 (95% CI: 0.308 - 0.789).
English: For modified ISTH major bleeding, the observed risk increase was HR=2.12 (95% CI 1.5-3.0) in patients ≥75 years (5.2% vs 2.5%) and HR=1.53 (95% CI 1.2-1.9) in patients <75 years (2.6% vs
Maltese: Għal fsada maġġuri ta' ISTH modifikata, iż-żieda tar-riskju osservata kienet ta' HR=2.12 (CI ta' 95% 1.5-3.0) f'pazjenti b'età ta' ≥75 sena (5.2% vs 2.5%) u HR=1.53 (CI ta' 95% 1.2-1.9) f'pazjenti b'età ta' <75 sena (2.6% vs 1.7%).
English: Patients with high risk triple positive antiphospholipid syndrome In an investigator sponsored, randomized open-label multicenter study with blinded endpoint adjudication, rivaroxaban was compared to warfarin in patients with a history of thrombosis, diagnosed with antiphospholipid syndrome and at high risk for thromboembolic events (positive for all 3 antiphospholipid tests: lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).
Maltese: Pazjenti bis-sindrome ta' kontra l-fosfolipidi pożittiva trippla ta' riskju għoli Fi studju sponsorjat mill-investigatur, randomised, open-label u b'aktar minn ċentru wieħed b'aġġudikazzjoni blinded tal-punt finali, rivaroxaban ġie mqabbel ma' warfarin f'pazjenti bi storja ta' trombożi, dijanjostikati bis-sindrome ta' kontra l-fosfolipidi u b'riskju għoli ta' avvenimenti tromboemboliċi (pożittivi għat-3 testijiet ta' kontra l-fosfolipidi kollha: antikoagulant lupus, antikorpi kontra cardiolipin, u antikorpi anti-beta 2-glycoprotein I).
English: In patients receiving rivaroxaban for treatment of DVT and PE and prevention of recurrence, the 5/95 percentiles for PT (Neoplastin) 2 - 4 hours after tablet intake (i.e. at the time of maximum effect) for 15 mg rivaroxaban twice daily ranged from 17 to 32 s and for 20 mg rivaroxaban once daily from 15 to 30 s. At trough (8 - 16 h after tablet intake) the 5/95 percentiles for 15 mg twice daily ranged from 14 to 24 s and for 20 mg once daily (18 - 30 h after tablet intake) from 13 to 20 s. In patients with non-valvular atrial fibrillation receiving rivaroxaban for the prevention of stroke and systemic embolism, the 5/95 percentiles for PT (Neoplastin) 1 - 4 hours after tablet intake (i.e. at the time of maximum effect) in patients treated with 20 mg once daily ranged from 14 to 40 s and in patients with moderate renal impairment treated with 15 mg once daily from 10 to 50 s. At trough (16 - 36 h after tablet intake) the 5/95 percentiles in patients treated with 20 mg once daily ranged from 12 to 26 s and in patients with moderate renal impairment treated with 15 mg once daily from 12 to 26 s.
Maltese: F'pazjenti b'fibrillazzjoni tal-atriju mhux valvulari li qed jirċievu rivaroxaban għall-prevenzjoni ta' puplesija u emboliżmu sistemiku, il-percentiles 5/95 għal PT (Neoplastin) 1 - 4 sigħat wara li tittieħed ilpillola (i.e. il-ħin tal-effett massimu) f'pazjenti kkurati b'20 mg darba kuljum varja minn 14 sa 40 s u f'pazjenti b'indeboliment renali moderat ikkurati bi 15 mg darba kuljum minn 10 sa 50 s. Fl-aktar punt baxx (16 - 36 siegħa wara t-teħid tal-pillola) il-percentiles 5/95 f'pazjenti kkurati b'20 mg darba kuljum varjaw minn 12 sa 26 s u f'pazjenti b'indeboliment renali moderat ikkurati bi 15 mg darba kuljum varjaw minn 12 sa 26 s.
English: bid: twice daily; CI: confidence interval; KM %: Kaplan-Meier estimates of cumulative incidence risk calculated at 900 days; CV: cardiovascular; MI: myocardial infarction; od: once daily
Maltese: ASA 100 mg; Valur p Log-Rank * It-tnaqqis fir-riżultat primarju tal-effikaċja kien statistikament superjuri. bid: darbtejn kuljum; CI: intervall ta' kunfidenza; KM %: stimi Kaplan-Meier tar-riskju kumulattiv ta' inċidenza kkalkulat wara 900 ġurnata; CV: kardjovaskulari;
English: Data on efficacy (including thromboembolic events) in this population are limited.
Maltese: Data dwar l-effikaċja (inkluż avvenimenti tromboemboliċi) f'din il-popolazzjoni hija limitata.
English: Symptomatic VTE occurred in 57 (0.6%) patients in the rivaroxaban group (n=8,778) and 88 (1.0%) of patients in the standard-of-care group (n=8,635; HR 0.63; 95% CI 0.43-0.91); safety population).
Maltese: VTE sintomatika seħħet f'57 (0.6%) pazjent fil-grupp ta' rivaroxaban (n = 8,778) u fi 88 (1.0%) pazjent fil-grupp ta' kura standard (n = 8,635; HR 0.63; CI ta' 95% 0.
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with 500 mg acetylsalicylic acid.
Maltese: Ma kienu osservati l-ebda interazzjonijiet farmakokinetiċi jew farmakodinamiċi ta' sinifikanza klinika meta rivaroxaban ingħata flimkien ma' 500 mg ta' acetylsalicylic acid.
English: Table 5: Efficacy results from phase III ATLAS ACS 2 TIMI 51 in patients undergoing PCI Study population
Maltese: III ta' ATLAS ACS 2 TIMI 51 Popolazzjoni taħt studju
English: Enoxaparin/VKAb) 3, 6 or 12 months N=4,131
Maltese: Enoxaparin/VKAb) 3, 6 jew 12-il xahar N=4,131
English: Treatment duration median [interquartile range]
Maltese: [firxa interquartile]
English: EU/1/08/472/017-021, EU/1/08/472/024, EU/1/08/472/037, EU/1/08/472/039, EU/1/08/472/049.
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/472/017-021, EU/1/08/472/024, EU/1/08/472/037, EU/1/08/472/039, EU/1/08/472/049.
English: Serious skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and DRESS syndrome, have been reported during post-marketing surveillance in association with the use of rivaroxaban (see section 4.8).
Maltese: Reazzjonijiet serji tal-ġilda, li jinkludu is-sindrome ta' Stevens-Johnson/nekrolisi tossika tal-epidermide u s-sindrome DRESS, ġew irrappurtati waqt sorveljanza ta' wara t-tqegħid fis-suq f'assoċjazzjoni mal-użu ta' rivaroxaban (ara sezzjoni 4.8).
English: Over 12,800 patients were studied in four randomised controlled phase III clinical studies (Einstein DVT, Einstein PE, Einstein Extension and Einstein Choice) and additionally a predefined pooled analysis of the Einstein DVT and Einstein PE studies was conducted.
Maltese: III randomised u kkontrollati (Einstein DVT, Einstein PE, Einstein Extension u Einstein Choice) u barra dan twettqet analiżi globali definita minn qabel tal-istudji Einstein DVT u Einstein PE.
English: The safety of rivaroxaban has been evaluated in thirteen phase III studies including 53,103 patients exposed to rivaroxaban (see Table 1).
Maltese: III li kienu jinkludu 53,103 pazjent esposti għal rivaroxaban (ara Tabella 1).
English: In rats, increased IgG and IgA plasma levels were seen at clinically relevant exposure levels.
Maltese: Fil-firien, livelli miżjuda ta' IgG u IgA fil-plażma kienu osservati f'livelli ta' esponiment ta' rilevanza klinika.
English: Prevention of atherothrombotic events in patients with CAD/PAD
Maltese: Prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti b'CAD/PAD
English: Enoxaparin/VKAb) 3, 6 or 12 months N=2,413
Maltese: Enoxaparin/VKAb) 3, 6 jew 12-il xahar N=2,413
English: Symptomatic recurrent DVT
Maltese: DVT sintomatika u rikorrenti
English: INR values were within the therapeutic range a mean of 63% of the time for the mean treatment duration of 215 days, and 57%, 62%, and 65% 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' 63% tal-ħin għat-tul medju ta' trattament ta' 215il jum, u 57%, 62%, u 65% tal-ħin fil-gruppi b'intenzjoni ta' tul ta' tratatment ta' 3, 6, u 12-il xahar, rispettivament.
English: The use of pantoprazole 40 mg once daily in addition to antithrombotic study medication in patients with no clinical need for a proton pump inhibitor showed no benefit in the prevention of upper gastrointestinal events (i.e. composite of upper gastrointestinal bleeding, upper gastrointestinal ulceration, or upper gastrointestinal obstruction or perforation); the incidence rate of upper gastrointestinal events was 0.39/100 patient-years in the pantoprazole 40 mg once daily group and 0.44/100 patient-years in the placebo once daily group.
Maltese: L-użu ta' pantoprazole 40 mg darba kuljum flimkien mal-medikazzjoni antitrombotika tal-istudju f'pazjenti mingħajr ħtieġa klinika ta' inibitur tal-pompa tal-protoni ma wera l-ebda benefiċċju filprevenzjoni ta' avvenimenti fil-parti ta' fuq tal-apparat gastrointestinali (jiġifieri kompost ta' fsada filparti ta' fuq tal-apparat gastrointestinali, ulċerazzjoni fil-parti ta' fuq tal-apparat gastrointestinali jew ostruzzjoni jew perforazzjoni fil-parti ta' fuq tal-apparat gastrointestinali); ir-rata ta' inċidenza ta' avvenimenti fil-parti ta' fuq tal-apparat gastrointestinali kienet ta' 0.39/100 sena ta' pazjent fil-grupp ta' pantoprazole 40 mg darba kuljum u ta' 0.
English: The primary safety endpoint, clinically significant bleeding events, occurred in 109 (15.7%), 117 (16.6%), and 167 (24.0%) subjects in group 1, group 2 and group 3, respectively (HR 0.59; 95% CI 0.47-0.76; p<0.001, and HR 0.63; 95% CI 0.50-0.80; p<0.001, respectively).
Maltese: 6%), u 167 (24.0%) individwi fi grupp 1, grupp 2 u grupp 3, rispettivament (HR 0.59; CI ta' 95% 0.47-0.76; p<0.001, u HR 0.63; CI ta' 95% 0.50-0.80; p<0.001, rispettivament).
English: After oral administration the elimination becomes absorption rate limited.
Maltese: Wara għoti orali l-eliminazzjoni ssir limitata mir-rata ta' assorbiment.
English: Xareltoa) 3, 6 or 12 months N=1,731
Maltese: 3, 6 jew 12-il xahar N=1,731
English: m. b. H. Tel: +43-(0)1-711 460
Maltese: Bayer Austria Ges. m. b. H. Tel: +43-(0)1-711 460
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Maltese: Trattament ta' trombożi fil-vini tal-fond (DVT) u ta' emboliżmu pulmonari (PE), u prevenzjoni ta' DVT u PE rikorrenti fl-adulti.
English: Anaemia (incl.
Maltese: Icepharma hf.
English: Figure 2: Time to first occurrence of primary efficacy outcome (stroke, myocardial infarction, cardiovascular death) in COMPASS
Maltese: Figura 2: Żmien għall-ewwel okkorrenza tar-riżultat primarju tal-effikaċja (puplesija, infart mijokardijaku, mewt kardjovaskulari) f'COMPASS
English: Among all randomised patients analysed according to ITT, primary events occurred in 269 on rivaroxaban (2.12% per year) and 306 on warfarin (2.42% per year) (HR 0.88; 95% CI, 0.74 - 1.03; P<0.001 for non-inferiority; P=0.117 for superiority).
Maltese: Fost il-pazjenti randomised kollha analizzati skont ITT, avvenimenti primarji seħħew f'269 fuq rivaroxaban (2.12% kull sena) u f'306 fuq warfarin (2.42% kull sena) (HR 0.88; 95% CI, 0.74 - 1.03; P<0.001 għal nuqqas ta' inferjorità; P=0.117 għal superjorità).
English: In Einstein Choice, 3,396 patients with confirmed symptomatic DVT and/or PE who completed 6-12 months of anticoagulant treatment were studied for the prevention of fatal PE or non-fatal symptomatic recurrent DVT or PE.
Maltese: F'Einstein Choice, 3,396 pazjent b'DVT u/jew PE sintomatiċi kkonfermati li spiċċaw 6-12-il xahar ta' trattament kontra l-koagulazzjoni kienu studjati għall-prevenzjoni ta' PE fatali jew DVT jew PE rikorrenti sintomatiċi mhux fatali.
English: The effect of erythromycin is additive to that of renal impairment (see section 4.4).
Maltese: L-effett ta' erythromycin jiżdied ma dak ta' indeboliment renali (ara sezzjoni 4.4).
English: Xarelto may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ”Possible side effects”).
Maltese: Xarelto jista' jikkawża sturdament (effett sekondarju komuni) jew ħass ħażin (effett sekondarju mhux komuni) (ara sezzjoni 4, “Effetti sekondarji possibbli”).
English: Within the highest quartile according to centre, the Hazrad Ration (HR) with rivaroxaban versus warfarin was 0.74 (95% CI, 0.49 - 1.12).
Maltese: Fl-ogħla quartile skont iċ-ċentru, il-Proporzjon ta' Periklu (HR - Hazrad Ration) b'rivaroxaban kontra warfarin kien ta' 0.74 (95% CI, 0.49 - 1.12).
English: • If the first and second characters are BT, the manufacturer is Bayer Bitterfeld GmbH
Maltese: • Jekk l-ewwel u t-tieni karattri huma BT, il-manifattur huwa Bayer Bitterfeld GmbH
English: • CAD patients with severe symptomatic heart failure.
Maltese: • Pazjenti b'CAD b'insuffiċjenza severa, sintomatika tal-qalb.