FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of rivaroxaban with the strong CYP3A4 inducer rifampicin led to an approximate 50% decrease in mean rivaroxaban AUC, with parallel decreases in its pharmacodynamic effects.
Maltese: L-għoti ta' rivaroxaban flimkien ma' l-indottur qawwi ta' CYP3A4, rifampicin , wassal għal tnaqqis ta' madwar 50% fl-AUC medja ta' rivaroxaban, bi tnaqqis parallel fl-effetti farmakodinamiċi tiegħu.
English: Each pack of 49 film-coated tablets contains: 42 film-coated tablets of 15 mg rivaroxaban 7 film-coated tablets of 20 mg rivaroxaban
Maltese: 42 pillola miksija b'rita ta' 15 mg rivaroxaban 7 pilloli miksija b'rita ta' 20 mg rivaroxaban
English: 1.73; modified ITT population).
Maltese: 21-2.67; popolazzjoni ta' sigurtà).
English: 5 mg or 10 mg respectively, co-administered with either ASA or ASA plus clopidogrel or ticlopidine
Maltese: 5 mg jew 10 mg rispettivament, mogħti flimkien ma' ASA jew flimkien ma' ASA uclopidogrel jew ticlopidine
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) FOR 10 MG
Maltese: KARTUNA TA' BARRA TA' PAKKETT MULTIPLU (INKLUŻ
English: Patients with non-valvular atrial fibrillation who undergo PCI with stent placement A randomised, open-label, multicentre study (PIONEER AF-PCI) was conducted in 2,124 patients with non-valvular atrial fibrillation who underwent PCI with stent placement for primary atherosclerotic disease to compare safety of two rivaroxaban regimens and one VKA regimen.
Maltese: III EINSTEIN, twettaq studju prospettiv, mingħajr intervent, open-label, ta' ko-orti (XALIA) b'aġġudikazzjoni tar-riżultati ċentrali inklużi VTE rikorrenti, fsada maġġuri u mewt. 5,142 pazjent b'DVT akuta kienu rreġistrati biex tiġi nvestigata s-sigurtà fit-tul ta' rivaroxaban meta mqabbla ma' terapija standard kontra l-koagulazzjoni tad-demm fil-prattika klinika.
English: Paediatric population Safety and efficacy have not been established for children and adolescents up to 18 years.
Maltese: Is-sigurtà u l-effikaċja ma ġewx determinati għal tfal u adolexxenti b'età sa 18-il sena.
English: Information about excipients
Maltese: Informazzjoni għall-utent
English: Once Xarelto is discontinued INR testing may be done reliably at least 24 hours after the last dose (see sections 4.5 and 5.2).
Maltese: Ladarba jitwaqqaf Xarelto l-ittestjar ta' INR jista' jsir b'mod affidabbli mill-inqas 24 siegħa wara l-aħħar doża (ara sezzjonijiet 4.5 u 5.2).
English: Each film-coated tablet contains 26.51 mg lactose (as monohydrate), see section 4.4.
Maltese: 51 mg ta' lactose (bħala monohydrate), ara sezzjoni 4.4.
English: Common (may affect up to 1 in 10 people) - reduction in red blood cells which can make the skin pale and cause weakness or breathlessness - bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleed, bleeding in the gum - bleeding into the eye (including bleeding from the whites of the eyes) - bleeding into tissue or a cavity of the body (haematoma, bruising) - coughing up blood - bleeding from the skin or under the skin - bleeding following an operation - oozing of blood or fluid from surgical wound- swelling in the limbs - pain in the limbs - impaired function of the kidneys (may be seen in tests performed by your doctor) - fever - stomach ache, indigestion, feeling or being sick, constipation, diarrhoea - low blood pressure (symptoms may be feeling dizzy or fainting when standing up) - decreased general strength and energy (weakness, tiredness), headache, dizziness - rash, itchy skin - blood tests may show an increase in some liver enzymes
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - tnaqqis fl-għadd ta' ċelluli ħomor tad-demm li jista' jikkawża ġilda pallida u dgħjufija jew qtugħ ta' nifs - fsada fl-istonku jew fl-imsaren, fsada fil-partijiet uroġenitali, (inkluż demm fl-awrina u fsada mestrwali qawwija), fsada mill-imnieħer, fsada mill-ħanek - fsada fl-għajn (inkluż fsada mill-abjad tal-għajnejn) - fsada f'tessut jew f'xi spazju fil-ġisem (ematoma, tbenġil) - tisgħol id-demm - fsada mill-ġilda jew taħt il-ġilda - fsada wara kirurġija - ħruġ ta' demm jew fluwidu minn ferita kirurġika - nefħa fir-riġlejn u d-dirgħajn - uġigħ fir-riġlejn u d-dirgħajn - funzjoni tal-kliewi indebolita (tista' tiġi osservata fit-testijiet imwettqa mit-tabib tiegħek)
English: Light yellow, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "2.5" and a triangle on the other side.
Maltese: Pilloli ta' kulur isfar ċar, tondi, ibbuzzati fuq iż-żewġ naħat (dijametru 6 mm, raġġ ta' kurvatura 9 mm) immarkati bis-salib tal-BAYER fuq naħa waħda, u b'“2.5” u trijangolu fuq in-naħa l-oħra.
English: Xarelto administration should be discontinued if severe haemorrhage occurs (see section 4.9).
Maltese: L-għoti ta' Xarelto għandu jitwaqqaf jekk isseħħ emorraġija severa (ara sezzjoni 4.9).
English: The recommendation for the use of 15 mg is based on PK modelling and has not been studied in this clinical setting (see sections 4.4, 5.1 and 5.2).
Maltese: Ir-rakkomandazzjoni għall-użu ta' 15 mg hija bbażata fuq immudellar tal-PK u ma ġietx studjata f'dan l-ambjent kliniku (ara sezzjonijiet 4.4, 5.1 u 5.2).
English: - if you have an increased risk of bleeding, as could be the case in situations such as: moderate or 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 - 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 moderata jew severa tal-kliewi, peress li l-funzjoni tal-kliewi tiegħek jista' jkollha effett fuq l-ammont 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 kateter f'vina jew f'arterja biex dan jinżamm miftuħ (ara sezzjoni “Mediċini oħra u Xarelto”) disturbi ta' fsada pressjoni tad-demm 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-vini jew l-arterji 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 - 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: Patients with moderate hepatic impairment were more sensitive to rivaroxaban resulting in a steeper PK/PD relationship between concentration and PT.
Maltese: Pazjenti b'indeboliment moderat tal-fwied kienu aktar sensittivi għal rivaroxaban u wasslu għal relazzjoni ta' PK/PD aktar wieqfa bejn il-konċentrazzjoni u PT.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Maltese: Prevenzjoni ta' VTE f'pazjenti morda medikament
English: Brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” and a triangle on the other side.
Maltese: Pilloli ħomor fil-kannella, tondi, ibbuzzati fuq iż-żewġ naħat (dijametru 6 mm, raġġ ta' kurvatura 9 mm) immarkati bis-salib tal-BAYER fuq naħa waħda, u b'“20” u trijangolu fuq in-naħa l-oħra.
English: For the initial 3 week treatment of acute DVT 15 mg rivaroxaban was administered twice daily.
Maltese: Għat-trattament inizjali ta' 3 ġimgħat għal DVT akuta 15 mg rivaroxaban ingħata darbtejn kuljum.
English: Each 20 mg film-coated tablet contains 20 mg rivaroxaban.
Maltese: Kull pillola miksija b'rita ta' 20 mg fiha 20 mg rivaroxaban.
English: 95% CI: (0.72, 0.97) P-value=0.020*
Maltese: 0.84 (0.72, 0.97) p = 0.020*
English: Stroke and non-CNS systemic embolism
Maltese: Puplesija u emboliżmu sistemiku mhux fis-CNS
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 10 MG
Maltese: It-tabib tiegħek ippreskrivielek Xarelto 10 mg darba kuljum.
English: Treatment Dosage
Maltese: Doża tat-trattament
English: EU/1/08/472/002 10 film-coated tablets
Maltese: EU/1/08/472/002 10 pilloli miksija b'rita
English: Prevention of venous thromboembolism in medically ill patients
Maltese: Prevenzjoni ta' tromboemboliżmu fil vini (VTE - venous thromboembolism)
English: Relationship:
Maltese: Sími:
English: CAD/PAD patients with previous haemorrhagic or lacunar stroke, or an ischaemic, non-lacunar stroke with in the previous month were not studied (see section 4.3).
Maltese: Pazjenti b'CAD/PAD li kellhom puplesija emorraġika jew lakunari qabel, jew puplesija iskemika, mhux lakunari fix-xahar preċedenti ma ġewx studjati (ara sezzjoni 4.3).
English: Symptomatic recurrent PE 20
Maltese: VTE sintomatiku u rikorrenti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) FOR 2.5 MG
Maltese: KARTUNA LI TMISS MAL-PRODOTT TA' PAKKETT MULTIPLU (MINGĦAJR IL-KAXXA L-BLU) TA' 2.5
English: Xarelto 15 mg film-coated tablets Xarelto 20 mg film-coated tablets
Maltese: Xarelto 15 mg pilloli miksija b'rita Xarelto 20 mg pilloli miksija b'rita
English: a) Rivaroxaban 20 mg once daily * p < 0.0001 (superiority), HR: 0.185 (0.087 - 0.393)
Maltese: Xarelto 20 mg od vs ASA 100 mg od; HR=0.34 (0.20-0.59) ** p<0.001 (superjorità)
English: Treatment of DVT, PE and prevention of recurrent DVT and PE The Xarelto clinical programme was designed to demonstrate the efficacy of Xarelto in the initial and continued treatment of acute DVT and PE and prevention of recurrence.
Maltese: Il-programm kliniku ta' Xarelto kien maħsub biex juri l-effikaċja ta' Xarelto fit-trattament inizjali u kontinwu ta' DVT u PE akuti u l-prevenzjoni ta' rikorrenza.
English: EU/1/08/472/022 100 film-coated tablets (10 x 10 x 1) (multipack) (PP/Aluminium foil blisters)
Maltese: EU/1/08/472/021 100 x 1 pillola miksija b'rita (Folji magħmula minn fojl ta' PP/Aluminju)
English: Dose-dependent inhibition of factor Xa activity was observed in humans.
Maltese: Inibizzjoni dipendenti mid-doża tal-attività tal-fattur Xa kienet osservata fil-bnedmin.
English: How much to take
Maltese: Tul massimu ta' kura
English: Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily in fasting state.
Maltese: Fi stat sajjem il-farmakokinetika ta' Rivaroxaban hija kważi lineari sa madwar 15 mg darba kuljum.
English: Sun.
Maltese: - deni
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 - 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 sever 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 tagħqid tad-demm (eż. warfarin, dabigatran etexilate, apixaban jew eparina), meta tkun qed taqleb il-kura ta' kontra t-tagħqid taddemm jew waqt li tkun qed tieħu eparina minn kateter f'vina jew f'arterja biex dan jinżamm miftuħ (ara sezzjoni “Mediċini oħra u Xarelto”) disturbi ta' fsada pressjoni tad-demm 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-vini jew l-arterji 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 - 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: The inhibition of factor Xa activity was increased by a factor of 2.6 in patients with moderate hepatic impairment as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 2.1.
Maltese: L-inibizzjoni tal-attività ta' fattur Xa żdiedet b'fattur ta' 2.6 f'pazjenti b'indeboliment moderat tal-fwied meta mqabbla ma' voluntiera b'saħħithom; it-titwil ta' PT żdied b'mod simili b'fattur ta' 2.1.
English: Table 4: Efficacy and safety results from phase III Einstein DVT Study population
Maltese: Tabella 4: Riżultati tal-effikaċja u s-sigurtà minn Einstein DVT ta' fażi
English: Xarelto 2.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Xarelto 2.5 mg
English: Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-factor Xa assay may be useful in exceptional situations where knowledge of rivaroxaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery (see sections 5.1 and 5.2).
Maltese: Għalkemm kura b'rivaroxaban ma teħtieġx monitoraġġ ta' rutina tal-esponiment, il-livelli ta' rivaroxaban imkejla b'analiżi kwantitattiva u kkalibrata kontra l-fattur Xa jistgħu jkunu utli f'sitwazzjonijiet eċċezzjonali fejn tagħrif dwar l-esponiment għal rivaroxaban jista' jgħin jgħarraf deċiżjonijiet kliniċi, eż. doża eċċessiva u kirurġija ta' emerġenza (ara sezzjonijiet 5.1 u 5.2).
English: Xarelto 15 mg film-coated tablets are red, round, biconvex and marked with the BAYER-cross on one side and “15” and a triangle on the other side.
Maltese: Xarelto 15 mg pilloli miksija b'rita huma ta' kulur aħmar, tondi, ibbuzzati fuq iż-żewġ naħat u mmarkati bis-salib tal-BAYER fuq naħa waħda, u bin-numru “15” u trijangolu fuq in-naħa l-oħra.
English: Symptomatic recurrent PE
Maltese: PE sintomatiku u rikorrenti
English: 1.4 per 100 patient years
Maltese: 1.4 kull 100 sena ta' pazjent
English: Each 15 mg film-coated tablet contains 15 mg rivaroxaban.
Maltese: Kull pillola miksija b'rita ta' 15 mg fiha 15 mg rivaroxaban.
English: Xarelto 15 mg Xarelto 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Xarelto 15 mg
English: Thrombocytosis (incl.
Maltese: rifluss gastroesofagali)
English: Of the administered rivaroxaban dose, approximately 2/3 undergoes metabolic degradation, with half then being eliminated renally and the other half eliminated by the faecal route.
Maltese: Mid-doża mogħtija ta' rivaroxaban, madwar 2/3 tgħaddi minn degradazzjoni metabolika, li wara nofs tiġi eliminata mill-kliewi u n-nofs l-ieħor tiġi eliminata mir-rotta tal-purgar.
English: In patients receiving Xarelto for VTE prevention following elective hip or knee replacement surgery, this may be done by regular physical examination of the patients, close observation of the surgical wound drainage and periodic measurements of haemoglobin.
Maltese: F'pazjenti li jirċievu Xarelto għal prevenzjoni ta' VTE wara kirurġija ppjanata ta' sostituzzjoni tal-ġenbejn jew tal-irkoppa, dan jista' jsir permezz ta' eżaminazzjoni fiżika regolari tal-pazjenti, osservazzjoni mill-qrib tal-ħruġ ta' likwidu mill-ferita kirurġika u kejl perjodiku ta' l-emoglobina.
English: In contrast, the 3-factor PCC had a greater and more rapid overall effect on reversing changes in endogenous thrombin generation than the 4-factor PCC (see section 4.9).
Maltese: B'kuntrast, il-PCC ta' 3 fatturi kellu effett globali akbar u aktar mgħaġġel fuq l-inverżjoni ta' bidliet fil-ġenerazzjoni ta' thrombin endoġenu mill-PCC ta' 4 fatturi (ara sezzjoni 4.9).
English: haematuria and menorrhagiaB), renal impairment (incl.
Maltese: Riżultat fir-Renju Unit, il-Ġermanja, l
English: 2.5 per 100 patient years
Maltese: 2.5 kull 100 sena ta' pazjent
English: Active substances strongly inhibiting only one of the rivaroxaban elimination pathways, either CYP3A4 or P-gp, are expected to increase rivaroxaban plasma concentrations to a lesser extent.
Maltese: Sustanzi attivi li jinibixxu b'mod qawwi wieħed biss mir-rotot ta' eliminazzjoni ta' rivaroxaban, CYP3A4 jew P-gp, huma mistennija li jżidu l-konċentrazzjonijiet fil-plażma ta' rivaroxaban fi kwantità inqas.
English: EU/1/08/472/032 10 x 1 film-coated tablets
Maltese: EU/1/08/472/038 10 pilloli miksija b'rita
English: For the initial treatment of acute PE 15 mg rivaroxaban was administered twice daily for three weeks.
Maltese: Għat-trattament inizjali ta' PE akut 15 mg rivaroxaban ingħataw darbtejn kuljum għal 3 ġimgħat.
English: EU/1/08/472/020 10 x 1 film-coated tablets
Maltese: EU/1/08/472/039 10 pilloli miksija b'rita
English: EU/1/08/472/001 5 film-coated tablets
Maltese: EU/1/08/472/005 5 pilloli miksija b'rita
English: Xarelto 2.5 mg, twice daily, N=5,114 n (%)
Maltese: Xarelto 2.5 mg, darbtejn kuljum, N=5,114 n(%) Proporzjon ta' Periklu (HR - Hazard Ratio) (95% CI) valur p b)
English: Each tablet contains 15 mg or 20 mg of rivaroxaban.
Maltese: Kull pillola fiha 15 mg jew 20 mg ta' rivaroxaban.
English: 10 x 1 film-coated tablets 100 x 1 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 10 x 1 pilloli miksija b'rita.
English: 5 film-coated tablets
Maltese: tromboemboliżmu rikorrenti fil-vini
English: Treatment of DVT, PE and prevention of recurrence
Maltese: Trattament ta' DVT, PE u prevenzjoni ta' rikorrenza
English: ♦ Xarelto thins the blood, which prevents you from getting dangerous blood clots.
Maltese: Li tieħu Xarelto żejjed iżid ir-riskju ta' fsada.
English: Bayer Oy Puh/Tel: +358-(0)20-78521
Maltese: Байер България ЕООД Тел: +359-(0)2-424
English: other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol) anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid) dronedarone, a medicine to treat abnormal heart beat some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))
Maltese: Għandu jkun hemm attenzjoni jekk il-pazjenti huma kkurati fl-istess waqt bi prodotti mediċinali li jaffettwaw l-emostasi bħall-prodotti mediċinali anti-infjammatorji mhux sterojdi (NSAIDs), acetylsalicylic acid (ASA) u inibituri tal-aggregazzjoni tal-plejtlits jew inibituri selettivi ta' teħid millġdid ta' serotonin (SSRIs - serotonin reuptake inhibitors), u inibituri ta' teħid mill-ġdid ta' serotonin norepinephrine (SNRIs - serotonin norepinephrine reuptake inhibitors).
English: Bioavailability (AUC and Cmax) was comparable for 20 mg rivaroxaban administered orally as a crushed tablet mixed in apple puree, or suspended in water and administered via a gastric tube followed by a liquid meal, compared to a whole tablet.
Maltese: Il-bijodisponibilità (AUC u Cmax) kienet komparabbli għal rivaroxaban 20 mg mogħti mill-ħalq bħala pillola mfarrka mħallta ma' purè tat-tuffieħ, jew sospiża fl-ilma u mogħtija permezz ta' tubu gastriku segwita minn ikla likwida, meta mqabbel ma' pillola sħiħa.
English: Date of dose change
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: PP/Aluminium foil blisters in cartons of 10, 14, 28 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 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: EU/1/08/472/034 100 film-coated tablets (10 x 10 x 1) (multipack) (PP/Aluminium foil blisters)
Maltese: EU/1/08/472/016 100 x 1 pillola miksija b'rita (Folji magħmula minn fojl ta' PP/Aluminju)
English: EU/1/08/472/024 100 film-coated tablets (10 x 10 x 1) (multipack) (PP/Aluminium foil blisters)
Maltese: EU/1/08/472/004 100 x 1 pillola miksija b'rita (folji tal-fojl tal-PVC/PVDC/Aluminju)
English: EU/1/08/472/023 100 film-coated tablets (10 x 10 x 1) (multipack) (PP/Aluminium foil blisters)
Maltese: EU/1/08/472/033 100 x 1 pillola miksija b'rita (folji tal-fojl tal-PP/Aluminju)
English: Depending on local availability, a consultation with a coagulation expert should be considered in case of major bleedings (see section 5.1).
Maltese: Skont id-disponibilità lokali, konsultazzjoni ma' espert tal-koagulazzjoni għandha tiġi kkunsidrata f'każ ta' fsad maġġuri (ara sezzjoni 5.1).
English: Fatal PE/death where PE cannot be ruled out Major or clinically relevant nonmajor bleeding
Maltese: PE fatali/mewt fejn PE ma jistax jiġi eskluż Fsada maġġuri jew mhux maġġuri iżda klinikament rilevanti
English: Body weight No dose adjustment (see sections 4.4 and 5.2)
Maltese: Piż tal-ġisem L-ebda aġġustament fid-doża (ara sezzjonijiet 4.4 u 5.2)
English: In some cases as a consequence of anaemia, symptoms of cardiac ischaemia like chest pain or angina pectoris have been observed.
Maltese: F'xi każijiet bħala konsegwenza ta' anemija kienu osservati sintomi ta' iskemija kardijaka bħal uġigħ fis-sider jew anġina pectoris.
English: No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min) (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50 - 80 ml/min) (ara sezzjoni 5.2).
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation
Maltese: Prevenzjoni ta' puplesija u ta' emboliżmu sistemiku f'pazjenti b'fibrillazzjoni tal-atriju mhux valvulari
English: Symptomatic PE and DVT 0
Maltese: Sindrome talkompartime nt sekondarju għall-fsada