FrancophonIA/ELRC3.0 huggingface dataset:
English: • “In children below the age of 12 years due to an increased risk of developing serious and lifethreatening adverse reactions.
Maltese: • “Fi tfal ta' età inqas minn 12-il sena minħabba riskju miżjud li jiżviluppaw reazzjonijiet avversi serji u ta' periklu għall-ħajja.
English: Caucasian
Maltese: Kawkaża
English: Population
Maltese: Popolazzjoni
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Maltese: [Għall-prodotti kollha f'Anness I, l-informazzjoni tal-prodott eżistenti għandha tiġi emendata (inserzjoni, sostituzzjoni jew tħassir tal-kitba, kif xieraq) biex tirrifletti l-kliem miftiehem kif ipprovdut taħt]
English: Pregnancy and breastfeeding
Maltese: Tramuntana tal-Ewropa
English: Asian
Maltese: Asjatika
English: In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.
Maltese: F'każijiet severi dawn jistgħu jinkludu sintomi ta' depressjoni ċirkolatorja u respiratorja, li jistgħu jkunu ta' periklu għall-ħajja u b'mod rari ħafna fatali.
English: These factors may worsen symptoms of morphine toxicity.”
Maltese: Dawn il-fatturi jistgħu jaggravaw is-sintomi ta' tossiċità ta' morphine."
English: Children aged 12 years to 18 years <Codeine><Product name (if a combination product)> is not recommended for use in children aged 12 years to 18 years with compromised respiratory function (see section 4.4).” [Note: For products authorised in the cough and/or cold and pain indications:]
Maltese: Tfal ta' età minn 12-il sena sa 18-il sena <Codeine><Isem il-prodott (jekk prodott ta' aktar minn ingredjent wieħed)> mhux rakkomandat għall-użu fi tfal ta' età minn 12-il sena sa 18-il sena b'funzjoni respiratorja kompromessa għall-kura sintomatika ta' <sogħla><u/jew><riħ>1 (ara sezzjoni 4.4).” Sezzjoni 4.3 - Kontraindikazzjonijiet [Nota: Għall-prodotti awtorizzati fl-indikazzjoni ta' sogħla u/jew riħ biss:]
English: “<Codeine><Product name (if a combination product)> is contraindicated in women during breastfeeding (see section 4.3).
Maltese: “<Codeine><Isem il-prodott (jekk prodotti ta' aktar minn ingredjent wieħed)> huwa kontraindikat f'nisa li qed ireddgħu (ara sezzjoni 4.3).
English: Children aged less than 12 years: <Codeine><Product name (if a combination product)> is contraindicated in children below the age of 12 years for the symptomatic treatment of <cough><and/or><cold>1see sections 4.3).
Maltese: Tfal ta' età inqas minn 12-il sena: <Codeine><Isem il-prodott (jekk prodott ta' aktar minn ingredjent wieħed)> huwa kontraindikat fi tfal ta' età inqas minn 12-il sena għall-kura sintomatika ta' <sogħla><u/jew><riħ>1 (ara sezzjoni 4.3).
English: Adolescents older than 12 years of age <Codeine><Product name (if a combination product)> is not recommended in adolescents with compromised respiratory function for the treatment of <cough><and/or><cold>1.
Maltese: <Codeine><Isem il-prodott (jekk prodott ta' aktar minn ingredjent wieħed)> mhux rakkomandat f'adolexxenti b'funzjoni respiratorja kompromessa għall-kura ta' <sogħla><u/jew><riħ>1.
English: • “In women during breastfeeding (see section 4.6)” • “In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers”
Maltese: • “F'pazjenti li huwa magħruf li huma metabolizzaturi mgħaġġla ħafna ta' CYP2D6”
English: Children aged less than 12 years: <Codeine><product name (if a combination products)> is contraindicated in children below the age of 12 years (see sections 4.3).
Maltese: Tfal ta' età inqas minn 12-il sena: <Codeine><isem il-prodott (jekk prodotti ta' aktar minn ingredjent wieħed)> huwa kontraindikat fi tfal ta' età inqas minn 12-il sena (ara sezzjoni 4.3).
English: If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Maltese: Jekk tinnota xi wieħed mill-effetti sekondarji li ġejjin, għandek tieqaf tieħu din il-mediċina u tfittex parir mediku immedjatament: nifs baxx jew bil-mod, konfużjoni, ngħas, pupilli tal-għajnejn żgħar, tħossok imdardar jew tirremetti, stitikezza, nuqqas ta' aptit.
English: However, if the patient is an ultrarapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.”
Maltese: morphine, jistgħu jkunu preżenti fil-ħalib tas-sider u f'okkażjonijiet rari ħafna jistgħu jwasslu għal sintomi ta ' tossiċità tal-opojdi fit-tarbija, li jistgħu jkunu fatali.”
English: If a patient has a deficiency or is completely lacking this enzyme an adequate therapeutic effect will not be obtained.
Maltese: Jekk pazjent għandu defiċjenza jew huwa kompletament nieqes minn din l-enzima ma jinkisibx effett terapewtiku adegwat.
English: Children aged 12 years to 18 years <Codeine><Product name (if a combination product)> is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of <cough><and/or><cold>1 (see section 4.4).”
Maltese: Tfal ta' età minn 12-il sena sa 18-il sena <Codeine><Isem il-prodott (jekk prodotti ta' aktar minn ingredjent wieħed)> mhux rakkomandat għall-użu fi tfal ta' età minn 12-il sena sa 18-il sena b'funzjoni respiratorja kompromessa (ara sezzjoni
English: However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.
Maltese: Madankollu, jekk il-pazjent huwa metabolizzatur estensiv jew mgħaġġel ħafna hemm riskju akbar ta' żvilupp ta' effetti ta' tossiċità tal-opojdi anke b'dożi preskritti b'mod komuni.
English: • “In children below the age of 12 years for the symptomatic treatment of
Maltese: Adolexxenti ta' età 'l fuq minn 12-il sena
English: • Final Study Reports submitted by Q4 2020
Maltese: • Rapporti finali tal-istudju sottomessi sa Q4 2020
English: DAY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
Maltese: ĠIMGĦA 1, ĠIMGĦA 2, ĠIMGĦA 3 JUM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
English: 349 [189-362] days 353 [190-362] days 350 [186-362] days
Maltese: 349 [189-362] jum 353 [190-362] jum 350 [186-362] jum
English: Event rate (100 pt-yr)
Maltese: Rata ta' avveniment (100 pt-yr)
English: Day 1-21
Maltese: Jum 1-21
English: Phone:
Maltese: Telefon:
English: Xarelto contains lactose.
Maltese: Xarelto fih lactose.
English: risk %)
Maltese: n (Riskju kumulattiv %)
English: - The active substance is rivaroxaban.
Maltese: - Is-sustanza attiva hi rivaroxaban.
English: - Fatal bleeding event p = 0.32164
Maltese: - Avveniment ta' fsada fatali p = 0.32164
English: Bayer Bitterfeld GmbH Ortsteil Greppin, Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Germany
Maltese: Bayer Bitterfeld GmbH Ortsteil Greppin, Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Il-Ġermanja
English: • acetylsalicylic acid or
Maltese: • acetylsalicylic acid jew
English: p-value b)
Maltese: valur p b)
English: 6.8% of patients
Maltese: 6.8% tal-pazjenti
English: 5.9% of patients
Maltese: 5.9% tal-pazjenti
English: Major intracranial bleeding p = 0.59858
Maltese: Fsada maġġuri fil-kranju p = 0.59858
English: Patients with CAD/PAD a)
Maltese: Pazjenti b'CAD/PAD a)
English: • vascular retinopathy
Maltese: • retinopatija vaskulari
English: Placebo N=3096 n (%)
Maltese: Plaċebo N=3096 n (%)
English: Bayer A/S Tlf: +45-45 235 000
Maltese: Danmark Bayer A/S Tlf: +45-45 235 000
English: 4,832 patients with an acute symptomatic PE
Maltese: 4,832 pazjent b'PE akut u sintomatiku
English: RECORD 3
Maltese: REKORD 3
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Hypromellose 2910
Maltese: Il-qalba tal-pillola Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Hypromellose 2910
English: Swallow the tablet(s) preferably with water.
Maltese: Ibla' l-pillola(i) preferibbilment mal-ilma.
English: 23% of patients
Maltese: 23% tal-pazjenti
English: RECORD 1
Maltese: REKORD 1
English: Bayer Hungária KFT Tel: +36-1-487 4100
Maltese: Magyarország Bayer Hungária KFT Tel: +36-1-487 4100
English: Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose 2910, sodium laurilsulphate, magnesium stearate.
Maltese: Il-qalba tal-pillola: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose 2910, sodium laurilsulphate, magnesium stearate.
English: RECORD 2
Maltese: REKORD 2
English: sun as symbol moon as symbol
Maltese: xemx bħala simbolu qamar bħala simbolu
English: Multipack: 100 (10 packs of 10 x 1) film-coated tablets.
Maltese: U KONTENUT Pakkett multiplu: 100 (10 pakketti ta' 10 x 1) pillola miksija b'rita.
English: Overall list of possible side effects
Maltese: Lista kompleta ta' effetti sekondarji possibbli
English: (PVC/PVDC/Aluminium foil blisters)
Maltese: (folji tal-fojl tal-PVC/PVDC/Aluminju)
English: Thromboembolic events occurred in 12% of patients randomized to rivaroxaban (4 ischaemic strokes and 3 myocardial infarctions).
Maltese: Avvenimenti tromboemboliċi seħħew fi 12% tal-pazjenti randomised għal rivaroxaban (4 puplesiji iskemiċi u 3 infarti mijokardijaċi).
English: See section 2 “Xarelto contains lactose and sodium”.
Maltese: Ara sezzjonui 2 “Xarelto fih lactose u sodium”.
English: Placebo N=5,125 n(%)
Maltese: Plaċebo N=5,125 n(%)
English: HR (95% CI) p-value, test for superiority
Maltese: HR (95% CI) valur p, test għal superjorità
English: The secondary endpoint (composite of cardiovascular events CV death, MI, or stroke) occurred in 41 (5.9%), 36 (5.1%), and 36 (5.2%) subjects in the group 1, group 2 and group 3, respectively.
Maltese: Il-punt finali sekondarju (kompost ta' avvenimenti kardjovaskulari, mewt CV, MI, jew puplesija) seħħ f'41 (5.9%), 36 (5.1%), u 36 (5.2%) individwi fi grupp 1, grupp 2 u grupp 3, rispettivament.
English: - Symptomatic bleeding in critical organ (non-fatal)
Maltese: - Fsada sintomatika f'organu kritiku (mhux fatali)
English: 8,281 patients with an acute symptomatic DVT or PE
Maltese: 8,281 pazjent b'DVT jew PE akuti u sintomatiċi
English: Symptomatic recurrent VTE*
Maltese: VTE sintomatiku u rikorrenti*
English: Placebo N=5,113 n (%)
Maltese: Plaċebo N=5,113 n(%)
English: • acetylsalicylic acid plus clopidogrel or ticlopidine.
Maltese: • acetylsalicylic acid flimkien ma' clopidogrel jew ticlopidine.
English: All-cause mortality a) Safety population, on treatment * Nominally significant
Maltese: Mortalità minn kull kawża a) popolazzjoni ta' sigurtà fuq kura * Nominalment sinifikanti
English: CYP3A4 inducers
Maltese: Indotturi ta' CYP3A4
English: 20024 Garbagnate Milanese Italy
Maltese: Garbagnate Milanese L-Italja
English: Major gastrointestinal bleeding p < 0.00001
Maltese: Fsada gastrointestinali maġġuri p < 0.00001
English: HR (95% CI) p-value b)
Maltese: HR (95% CI) valur p b)
English: 0.66 (0.46, 0.95) p = 0.026** a) modified intent to treat analysis set (intent to treat total analysis set for stent thrombosis) b) vs. placebo; Log-Rank p-value ** nominally significant
Maltese: 0.66 (0.46, 0.95) p = 0.026** a) grupp ta' analiżi b'intenzjoni li jiġi kkurat immodifikat (grupp ta' analiżi totali b'intenzjoni li jiġi kkurat għal trombożi tal-istent) b) kontra plaċebo; valur p Log-Rank ** nominalment sinifikanti
English: Date of first authorisation: 30 September 2008 Date of latest renewal: 22 May 2018
Maltese: Data tal-aħħar tiġdid: 22 ta' Mejju 2018
English: 40 mg od 12 ± 2 days p
Maltese: Enoxaparin 40 mg od 12 ± 2 ijiem p
English: Due to a reduced extent of absorption an oral bioavailability of 66% was determined for the 20 mg tablet under fasting conditions.
Maltese: Minħabba grad imnaqqas ta' assorbiment kienet determinata bijodisponibilità orali ta' 66% għall-pillola ta' 20 mg taħt kundizzjonijiet ta' sawm.
English: Xarelto contains lactose and sodium
Maltese: Xarelto fih lactose u sodium
English: (PP/Aluminium foil blisters)
Maltese: PP/Aluminium foil)
English: 1.6% of patients
Maltese: 1.6% tal-pazjenti
English: The mean CHADS2 and HAS-BLED scores were both 2.0 in XANTUS, compared to a mean CHADS2 and HAS-BLED score of 3.5 and 2.8 in ROCKET AF, respectively.
Maltese: Il-punteġġi medji ta' CHADS2 u HAS-BLED it-tnejn kienu 2.0 f'XANTUS, meta mqabbel mal-punteġġ medju ta' CHADS2 u HAS-BLED ta' 3.5 u 2.8 f'ROCKET AF, rispettivament.
English: 40 mg od 35 ± 4 days p Rivaroxaban 10 mg od 35 ± 4 days
Maltese: Enoxaparin 40 mg od 35 ± 4 ijiem p Rivaroxaban 10 mg od
English: Day 1 - 21: 30 mg Day 22 and onwards: 20 mg
Maltese: Jum 1 - 21: 30 mg Jum 22 u 'l quddiem: 20 mg
English: Pharmacokinetic data in patients
Maltese: Data farmakokinetika f'pazjenti
English: Stevens-Johnson syndrome/ Toxic Epidermal Necrolysis , DRESS syndrome
Maltese: Sindrome ta' Stevens-Johnson / Nekrolisi Tossika tal-Epidermide, sindrome DRESS
English: Titanium dioxide (E 171) Iron oxide red (E 172)
Maltese: Titanium dioxide (E 171) Iron oxide aħmar (E 172)
English: (HDPE Bottle)
Maltese: (Flixkun tal-HDPE)
English: Active clinically significant bleeding.
Maltese: Fsada attiva ta' sinifikanza klinika.
English: ** In the COMPASS study, there is a low anaemia incidence as a selective approach to adverse event collection was applied
Maltese: ** Fl-istudju COMPASS, hemm inċidenza baxxa ta' anemija peress li ġie applikat approċċ selettiv għall-ġbir ta' avvenimenti avversi
English: Based on in vitro investigations rivaroxaban is a substrate of the transporter proteins P-gp (P-glycoprotein) and Bcrp (breast cancer resistance protein).
Maltese: Ibbażat fuq investigazzjonijiet in vitro, rivaroxaban huwa substrat talproteini trasportaturi P-gp (P-glycoprotein) u Bcrp (proteina tar-reżistenza għall-kanċer tas-sider).
English: NSAIDs/platelet aggregation inhibitors
Maltese: NSAIDs/inibituri tal-aggregazzjoni tal-plejtlits
English: 2,509 patients undergoing total hip replacement surgery
Maltese: 2,509 pazjent li kellhom kirurġija ta' bdil totali tal-ġenbejn
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp), atorvastatin (substrate of CYP3A4 and P-gp) or omeprazole (proton pump inhibitor).
Maltese: Ma kienu osservati l-ebda interazzjonijiet farmakokinetiċi jew farmakodinamiċi ta' sinifikanza klinika meta rivaroxaban ingħata flimkien ma' midazolam (substrat ta' CYP3A4), digoxin (substrat ta' P-gp), atorvastatin (substrat ta' CYP3A4 u P-gp) jew omeprazole (inibitur tal-pompi tal-protoni).
English: Different weight categories
Maltese: Kategoriji ta' piż differenti
English: Increase in transaminases
Maltese: Żieda fit transaminases
English: 34.9% of patients were treated with acetylsalicylic acid and 11.4% were treated with class III antiarrhythmic including amiodarone.
Maltese: 34.9% tal-pazjenti kienu kkurati b'acetylsalicylic acid u 11.4% kienu kkurati b'antiarritmiċi ta' klassi
English: The phase III COMPASS study (27,395 patients, 78.0% male, 22.0% female) demonstrated the efficacy and safety of Xarelto for the prevention of a composite of CV death, MI, stroke in patients with CAD or symptomatic PAD at high risk of ischaemic events.
Maltese: III COMPASS (27,395 pazjent, 78.0% maskili, 22.0% femminili) wera l-effikaċja u ssigurtà ta' Xarelto għall-prevenzjoni ta' kompost ta' mewt CV, MI, puplesija f'pazjenti b'CAD jew PAD sintomatika b'riskju għoli ta' avvenimenti iskemiċi.
English: 40 mg od 12 ± 2 days p Rivaroxaban 10 mg od 12 ± 2 days
Maltese: Enoxaparin 40 mg od 12 ± 2 ijiem p Rivaroxaban 10 mg od
English: Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability.
Maltese: Rivaroxaban huwa inibitur dirett selettiv ħafna tal-fattur Xa b'biodisponibiltà orali.
English: No pharmacokinetic interaction was observed between warfarin and rivaroxaban.
Maltese: Ma kienux osservati interazzjonijiet farmakokinetiċi bejn warfarin u rivaroxaban.
English: Transfusion of 4 or more units of blood over a 48 hour period a) safety population, on treatment b) vs. placebo; Log-Rank p-value * statistically significant
Maltese: Trasfużjoni ta' 4 unitajiet ta' demm jew aktar fuq perjodu ta' 48 siegħa a) popolazzjoni tas-sigurtà, fuq kura b) kontra placebo; valur p Log-Rank * statistikament sinifikanti
English: Protamine sulphate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban.
Maltese: Mhux mistenni li protamine sulphate u vitamina K jaffettwaw l-attività kontra l-koagulazzjoni ta' rivaroxaban.
English: There were no clinically relevant differences in pharmacokinetics and pharmacodynamics between male and female patients.
Maltese: Ma kien hemm l-ebda differenzi ta' rilevanza klinika fil-farmakokinetika u l-farmakodinamika bejn pazjenti maskili u dawk femminili.
English: Rivaroxaban is metabolised via CYP3A4, CYP2J2 and CYP-independent mechanisms.
Maltese: Rivaroxaban huwa metabolizzat permezz ta' mekkaniżmi li huma indipendenti minn CYP3A4, CYP2J2 u CYP.
English: 39 days
Maltese: 39 ġurnata
English: Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%.
Maltese: Il-varjabilità fil-farmakokinetika ta' rivaroxaban hija moderata b'varjabilità bejn l-individwi (CV%) li tvarja minn 30% sa 40%.
English: Fatal PE/death where PE cannot be ruled out
Maltese: PE fatali/mewt fejn PE ma jistax jiġi eskluż
English: The 3-factor PCC reduced mean Neoplastin PT values by approximately 1.0 second within 30 minutes, compared to reductions of approximately 3.5 seconds observed with the 4-factor PCC.
Maltese: Il-PCC ta' 3 fatturi naqqas il-valuri medji ta' Neoplastin PT b'madwar 1.0 sekonda fi żmien 30 minuta, meta mqabbel ma' tnaqqis ta' madwar 3.5 sekondi osservat bil-PCC ta' 4 fatturi.
English: Dizziness, headache
Maltese: Meta għandek tieħu Xarelto
English: At baseline, the median ejection fraction was 34% (IQR: 28%-38%) and 53% of subjects were NYHA Class III or IV.
Maltese: Fil-linja bażi, il-porzjon medjan imbuttat 'il barra kien ta' 34% (IQR: 28%-38%) u 53% tal-individwi kienu NYHA Klassi
English: Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors, ATC code: B01AF01 Mechanism of action
Maltese: Sustanzi antitrombotiċi, inibituri diretti tal-fattur Xa, Kodiċi ATC:
English: The most commonly reported bleedings were epistaxis (4.5 %) and gastrointestinal tract haemorrhage (3.8 %).
Maltese: L-aktar fsad rrappurtat b'mod komuni kien epistassi (4.5 %) u emorraġija mill-apparat gastrointestinali (3.8 %).
English: bid: twice daily; od: once daily; CI: confidence interval
Maltese: bid: darbtejn kuljum; od: darba kuljum; CI: intervall ta' kunfidenza
English: No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding rivaroxaban pharmacokinetics and pharmacodynamics.
Maltese: Ma kienet osservata l-ebda differenza bejn ir-razez ta' rilevanza klinika fost pazjenti Kawkasi, AfrikaniAmerikani, Ispaniċi, Ġappuniżi jew Ċiniżi, rigward il-farmakokinetika u l-farmakodinamika ta' rivaroxaban.
English: An additional retrospective analysis showed a nominally significant reduction in the incidence rates of stent thrombosis compared with placebo (see Table 4).
Maltese: Analiżi retrospettiva addizzjonali wriet tnaqqis nominalment sinifikanti fir-rati ta' inċidenza ta' trombożi talistent meta mqabbel mal-plaċebo (ara Tabella 4).
English: 3,449 patients with symptomatic acute deep vein thrombosis
Maltese: 3,449 pazjent bi trombożi akuta u sintomatika fil-vini tal-fond
English: 10 mg or 20 mg
Maltese: 10 mg jew 20 mg
English: Tablet film coat: macrogol 3350, hypromellose 2910, titanium dioxide (E 171), iron oxide red (E 172).
Maltese: Kisja b'rita: macrogol 3350, hypromellose 2910, titanium dioxide (E 171), iron oxide isfar (E 172).
English: CYP3A4 and P-gp inhibitors
Maltese: Inibituri ta' CYP3A4 u ta' P-gp
English: Dual antiplatelet therapy has not been studied in combination with Xarelto 2.5 mg twice daily in patients with CAD/PAD (see sections 4.4 and 5.1).
Maltese: Terapija doppja kontra l-plejtlits ma ġietx studjata flimkien ma' Xarelto 2.5 mg darbtejn kuljum f'pazjenti b'CAD/PAD (ara sezzjonijiet 4.4 u 5.1).
English: 1,197 patients continued treatment and prevention of recurrent venous thromboembolism
Maltese: 1,197 pazjent komplew it-trattament u l-prevenzjoni ta' tromboemboliżmu rikorrenti fil-vini
English: Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE) and prevention of recurrence
Maltese: - deep vein thrombosis), emboliżmu pulmonari (PE - pulmonary embolism) u prevenzjoni ta' rikorrenza
English: (See section 4.4 for haemodynamically unstable PE patients.)
Maltese: (Ara sezzjoni 4.4 għal pazjenti emodinamikament instabbli li għandhom PE.)
English: Over 9,500 patients (7,050 in total hip replacement surgery and 2,531 in total knee replacement surgery) were studied in controlled randomised double-blind phase III clinical studies, the RECORD-programme.
Maltese: Aktar minn 9,500 pazjent (7,050 li kellhom kirurġija ta' bdil totali tal-ġenbejn u 2,531 pazjent li kellhom kirurġija ta' bdil totali ta' l-irkoppa), kienu studjati filprogramm RECORD, studji kliniċi kkontrollati, randomised, double-blind, ta' fażi
English: (For patients with renal impairment: see section 4.4).
Maltese: (Għall-pazjenti b'indeboliment renali: ara sezzjoni 4.4).
English: Elimination of rivaroxaban from plasma occurs with terminal half-lives of 5 to 9 hours in young individuals, and with terminal half-lives of 11 to 13 hours in the elderly.
Maltese: Eliminazzjoni ta' rivaroxaban mill-plażma sseħħ b'half-lives terminali ta' 5 sa 9 sigħat f'individwi żgħażagħ, u b'half-lives terminali ta' 11 sa 13-il siegħa fl-anzjani.
English: Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).
Maltese: Xarelto, mogħti flimkien ma' acetylsalicylic acid (ASA) waħdu jew ma' ASA flimkien ma' clopidogrel jew ticlopidine, huwa indikat għall-prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti adulti wara sindrome akut tal-koronarja (ACS - acute coronary syndrome) b'bijomarkaturi kardijaċi elevati (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: Placebo 6 or 12 months N=594
Maltese: 6 jew 12-il xahar N=594
English: The primary objective of PIONEER AF-PCI was to assess safety.
Maltese: L-għan primarju ta' PIONEER AF-PCI kien biex tiġi evalwata s-sigurtà.
English: • Interim analyses reports provided annually beginning Q4 2015 until completion of the study programme.
Maltese: • Rapporti ta' analiżi interim pprovduti kull sena b'bidu fi Q4 2015 sakemm jitlesta l-programm ta' studju.
English: Unbound AUC was increased 2.6 fold.
Maltese: AUC mhux imwaħħal żdied b'2.6 darbiet.
English: Xarelto 2.5 mg twice daily in combination with ASA 100 mg once daily was superior to ASA 100 mg, in the reduction of the primary composite outcome of CV death, MI, stroke (see Table 7 and Figure 2).
Maltese: Xarelto 2.5 mg darbtejn kuljum flimkien ma' ASA 100 mg darba kuljum kien superjuri għal ASA 100 mg, fit-tnaqqis tar-riżultat primarju kompost ta' mewt CV, MI, puplesija ara Tabella 7 u Figura 2).
English: Xarelto 2.5 mg bid in combination with ASA 100 mg od
Maltese: Xarelto 2.5 mg bid flimkien ma' ASA 100 mg od
English: 4,541 patients undergoing total hip replacement surgery
Maltese: 4,541 pazjent li kellhom kirurġija ta' bdil totali tal-ġenbejn
English: 12.6% of patients 2.1% of patients
Maltese: 12.6% tal-pazjenti
English: Major bleeding occurred in 4 patients (7%) of the rivaroxaban group and 2 patients (3%) of the warfarin group.
Maltese: Fsada maġġuri seħħet f'4 pazjenti (7%) fil-grupp ta' rivaroxaban u 2 pazjenti (3%) fil-grupp ta' warfarin.
English: Xarelto 2.5 mg bid in combination with ASA 100 mg od, N=9152 n (Cum.
Maltese: Xarelto 2.5 mg bid flimkien ma' ASA 100 mg od, N=9152 n (Riskju kumulattiv %)