FrancophonIA/ELRC3.0 huggingface dataset:
English: The diarrhoea resolved within seven days in about one third of patients, however 80 patients (50%) experienced diarrhoea with a duration of more than 28 days (representing 9.9% of all patients treated with linaclotide).
Maltese: Id-dijarea għaddiet fi żmien sebat ijiem f'madwar terz tal-pazjenti, madankollu 80 pazjent (50%) esperjenzaw dijarea li damet aktar minn 28 jum (jirrappreżentaw 9.9% tal-pazjenti kollha kkurati b'linaclotide).
English: - Laxatives.
Maltese: Tiblagħhomx.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
Maltese: U KONTENUT Kapsula iebsa.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.
English: If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended.
Maltese: Jekk ikollok dijarea qawwija, il-pillola kontraċettiva tista' ma taħdimx sewwa u huwa rrakkomandat l-użu ta' metodu addizzjonali ta' kontraċezzjoni.
English: Some medicines may increase the risk of diarrhoea when taken with Constella, such as: - Medicines to treat stomach ulcers or excessive production of stomach acid called Proton Pump Inhibitors.
Maltese: Xi mediċini jistgħu jżidu r-riskju ta' dijarea meta jittieħdu ma' Constella, bħal: - Mediċini li jikkuraw ulċeri fl-istonku jew produzzjoni eċċessiva ta' aċidu tal-istonku imsejħin Inibituri tal-Pompa tal-Proton.
English: EU/1/12/801/001 EU/1/12/801/002 EU/1/12/801/004 EU/1/12/801/005
Maltese: EU/1/12/801/005
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Maltese: Ara l-istruzzjonijiet filfuljett ta' tagħrif tal-pillola kontraċettiva li tkun qed tieħu.
English: MA (EU) number (Invented) name
Maltese: Numru talproċedura ta' lEMEA
English: --1 Live aroA gene deleted Escherichia coli, type O78, strain EC34195 - 5.2x106 - 9.1x108 CFU* * Colony forming units when grown on tryptic soy agar plates.
Maltese: --1 Ġene aroA ħaj mneħħi ta' Escherichia coli, tip O78, razza EC34195 - 5.2x106 sa 9.1x108 CFU* * Unitajiet li jifformaw kolonja (Colony forming units) meta mkabbra fuq trypticase soy agar plates
English: Strength Pharmaceutical form Target species
Maltese: Qawwa Għamla Farmaċewtika
English: EU (MA) number
Maltese: Numru(i) talawtorizzazzjoni(ji et) għat-tqegħid fis-suq
English: 12 (3 x 4) pre-filled syringes (multipack)
Maltese: 12 (3 x 4)-il siringa mimlija għallest (pakkett multiplu)
English: Content (concentration)
Maltese: Kontenut (konċentra zzjoni)
English: 12 (3 x 4) pre-filled pens (multipack)
Maltese: 12 (3 x 4)-il pinna mimlija għal-lest (pakkett multiplu)
English: 4 pre-filled syringes
Maltese: 4 pinen mimlija għallest
English: OTHER MON, TUE, WED, THU, FRI, SAT, SUN
Maltese: MON, TUE, WED, THU, FRI, SAT, SUN
English: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
Maltese: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin
English: Intracranial haemorrhage (ICH)
Maltese: Emorraġija intrakranjali (ICH)
English: ≥ 30 to ≤ 50 1,302 96
Maltese: ≥ 30 sa ≤ 50 1,302 96
English: The absolute bioavailability is approximately 62%.
Maltese: Ilbijodisponibilità assoluta hi ta' madwar 62%.
English: 85276 Pfaffenhofen, Bayern Germany
Maltese: 85276 Pfaffenhofen, Bayern
English: p-value < 0.0001 (non-inferiority)
Maltese: valur p < 0.0001 (non-inferjorità)
English: > 110 to ≤ 130 497 20
Maltese: > 110 sa ≤ 130 497 20
English: If possible, Roteas should be stopped at least 24 hours before an operation.
Maltese: Jekk ikun possibbli, Roteas għandu jitwaqqaf mill-inqas 24 siegħa qabel operazzjoni.
English: Overall list of possible side effects:
Maltese: Lista globali ta' effetti sekondarji possibbli:
English: • rifampicin, an antibiotic
Maltese: • rifampicin, antibijotiku
English: Vitamin K Antagonist (VKA)
Maltese: Antagonist ta' Vitamina K (VKA)
English: Do not take Roteas:
Maltese: Tiħux Roteas:
English: Aspartate aminotransferase increased
Maltese: Żieda f'aspartate aminotransferase
English: Cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.
Maltese: Kaxxi tal-kartun ta' 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 pillola miksija b'rita.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' April, 2017
English: • Clinically significant active bleeding.
Maltese: • Emorraġija attiva klinikament sinifikanti.
English: Edoxaban Anti-FXa activity post-dose (IU/mL)1
Maltese: Edoxaban Attività anti-FXa wara d-doża (IU/mL)1
English: Parenteral anticoagulants
Maltese: Antikoagulanti parenterali
English: Retroperitoneal haemorrhage
Maltese: Emorraġija retroperitonali
English: • antibiotic medicines (e.g. erythromycin)
Maltese: • mediċini antibijotiċi (eż. erythromycin)
English: • Contraindications
Maltese: • Kontraindikazzjonijiet
English: 0.004 (for superiority)
Maltese: 0.004 (għas-superjorità)
English: • For creatinine in mg/dL:
Maltese: • Għal kreatinina f'mg/dL:
English: Patients with antiphospholipid syndrome
Maltese: Pazjenti bis-sindrome antifosfolipid
English: • For creatinine in µmol/L:
Maltese: • Għal kreatinina f'µmol/L:
English: (140-age [years]) × weight [kg] (× 0.85 if female) 72 × serum creatinine [mg/dL]
Maltese: (140-età [snin]) × piż [kg] × (0.85 jekk mara) 72 × kreatinina fis-serum [mg/dL]
English: Table 12: Edoxaban Anti-FXa activity by creatinine clearance Edoxaban Dose
Maltese: Tabella 12: Attività Anti-FXa ta' edoxaban skont it-tneħħija tal-kreatinina Edoxaban
English: Ciclosporin, dronedarone, erythromycin, ketoconazole
Maltese: Inibituri ta' P-gp Ciclosporin, dronedarone, erythromycin, ketoconazole
English: 1.23 × (140-age [years]) × weight [kg] (× 0.85 if female) serum creatinine [µmol/L]
Maltese: 1.23 × (140-età [snin]) × piż [kg] × (0.85 jekk mara) kreatinina fis-serum [µmol/L]
English: Continued anticoagulant therapy is important in patients with NVAF and VTE.
Maltese: Il-kontinwazzjoni ta' terapija b'antikoagulanti hi importanti f'pazjenti b'NVAF u VTE.
English: A total of 2149 subjects were treated with either edoxaban (N = 1067) or enoxaparin/warfarin (N = 1082).
Maltese: Total ta' 2,149 individwu ġew ikkurati jew b'edoxaban (N = 1,067) jew enoxaparin/warfarin (N = 1,082).
English: > 50 to ≤ 70 > 70 to ≤ 90 > 90 to ≤ 110 > 110 to ≤ 130
Maltese: > 50 sa ≤ 70 > 70 sa ≤ 90 > 90 sa ≤ 110 > 110 sa ≤ 130
English: • some medicines for treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
Maltese: • xi mediċini għall-kura tal-epilessija (eż. phenytoin, carbamazepine, phenobarbital)
English: Subcutaneous anticoagulant (i.e.: LMWH, fondaparinux):
Maltese: Antikoagulant taħt il-ġilda (i.e.: LMWH,
English: Assessment of renal function:
Maltese: Evalwazzjoni tal-funzjoni tal-kliewi:
English: Table 1: Summary of posology in NVAF and VTE (DVT and PE) Summary Guide for Dosing
Maltese: Tabella 1: Sommarju ta' pożoloġija f'Pazjenti b'NVAF u VTE (DVT u PE)
English: Tables 7, 8 and 9 show major, fatal and intracranial bleedings, respectively, by creatinine clearance category in NVAF patients in ENGAGE AF-TIMI 48.
Maltese: Tabelli 7, 8 u 9 juru ħruġ ta' demm maġġuri, fatali u intrakranjali, rispettivament, skont il-kategorija ta' tneħħija tal-kreatinina f'pazjenti b'NVAF f'ENGAGE AF-TIMI 48.
English: • antidepressant medicines called selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors
Maltese: • mediċini antidepressivi msejħa inibituri selettivi tal-assorbiment mill-ġdid ta' serotonina jew inibituri tal-assorbiment mill-ġdid ta' serotonina-norepinefrina
English: Gammaglutamyltransferase increased
Maltese: Żieda f'gammaglutamyltransferase
English: PVC/Aluminium blisters.
Maltese: Folji tal-PVC/Aluminju.
English: Edoxaban is a substrate for the efflux transporter P-glycoprotein (P-gp), but not a substrate for uptake transporters such as organic anion transporter polypeptide OATP1B1, organic anion transporters OAT1 or OAT3 or organic cation transporter OCT2.
Maltese: Edoxaban hu sottostrat għat-trasportatur tal-effluss Pglikoproteina (P-gp), iżda mhuwiex sottostrat għat-trasportaturi tal-assorbiment bħat-trasportatur enajoniku organiku ta' polypeptide OATP1B1, trasportaturi enajoniċi organiċi OAT1 jew OAT3 jew trasportatur organiku tal-ketajoni OCT2.
English: Edoxaban is metabolised via hydrolysis (mediated by carboxylesterase 1), conjugation or oxidation by CYP3A4/5 (< 10%).
Maltese: Edoxaban jiġi metabolizzat permezz ta' idrolisi (medjata b'carboxylesterase 1), konjugazzjoni jew ossidazzjoni minn CYP3A4/5 (< 10%).
English: Renal function in NVAF
Maltese: Funzjoni tal-kliewi f'NVAF
English: Edoxaban is a substrate for the efflux transporter P-gp.
Maltese: Edoxaban hu sottostrat għat-trasportatur tal-effluss P-gp.
English: PVC/Aluminium perforated unit dose blisters of 10 x 1, 50 x 1 and 100 x 1 film-coated tablets.
Maltese: PVC/Folji tad-doża tal-unità ipperforati tal-aluminju ta' 10 x 1, 50 x 1 u 100 x 1 pillola miksija b'rita.
English: CLINICAL PARTICULARS
Maltese: Emorraġija klinikament rilevanti
English: HR (95% CI) p-value
Maltese: HR (95% CI) valur p
English: Its active metabolite is a substrate for OATP1B1.
Maltese: Il-metabolit attiv tiegħu hu sottostrat għal OATP1B1.
English: INFORMATION IN BRAILLE Roteas 60 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Roteas 60 mg
English: What you need to know before you take Roteas 3.
Maltese: X'għandek tkun taf qabel ma tieħu Roteas 3.
English: These include acetylsalicylic acid (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and chronic nonsteroidal anti-inflammatory drugs (NSAIDs) (see section 4.5).
Maltese: Dawn jinkludu acetylsalicylic acid (ASA), inibituri tal-plejtlits P2Y12, mediċini antitrombotiċi oħrajn, terapija fibrinolitika, inibituri selettivi ta' assorbiment mill-ġdid ta' serotonina (SSRIs, selective serotonin reuptake inhibitors) jew inibituri ta' assorbiment mill-ġdid ta' serotonina norepinefrina (SNRIs, serotonin norepinephrine reuptake inhibitors), u mediċini mhux sterojdi kontra linfjammazzjoni (NSAIDs) kronika (ara sezzjoni 4.5).
English: What Roteas contains - The active substance is edoxaban (as tosilate).
Maltese: X'fih Roteas - Is-sustanza attiva hi edoxaban (bħala tosilate).
English: EU/1/16/1152/016 10 film-coated tablets EU/1/16/1152/017 14 film-coated tablets EU/1/16/1152/018 28 film-coated tablets EU/1/16/1152/019 30 film-coated tablets EU/1/16/1152/020 56 film-coated tablets EU/1/16/1152/021 60 film-coated tablets EU/1/16/1152/022 84 film-coated tablets EU/1/16/1152/023 90 film-coated tablets EU/1/16/1152/024 98 film-coated tablets EU/1/16/1152/025 100 film-coated tablets EU/1/16/1152/026 10 x 1 film-coated tablets EU/1/16/1152/027 50 x 1 film-coated tablets EU/1/16/1152/028 100 x1 film-coated tablets
Maltese: EU/1/16/1152/016 10 pilloli miksija b'rita EU/1/16/1152/017 14-il pillola miksija b'rita EU/1/16/1152/018 28 pillola miksija b'rita EU/1/16/1152/019 30 pillola miksija b'rita EU/1/16/1152/020 56 pillola miksija b'rita EU/1/16/1152/021 60 pillola miksija b'rita EU/1/16/1152/022 84 pillola miksija b'rita EU/1/16/1152/023 90 pillola miksija b'rita EU/1/16/1152/024 98 pillola miksija b'rita EU/1/16/1152/025 100 pillola miksija b'rita EU/1/16/1152/026 10 x 1 pillola miksija b'rita EU/1/16/1152/027 50 x 1 pillola miksija b'rita EU/1/16/1152/028 100 x 1 pillola miksija b'rita
English: First SEE n (%/yr)a
Maltese: n Rata ta' każijiet (%/yr)a
English: Discontinue the VKA and start Roteas when the international normalised ratio (INR) is ≤ 2.5.
Maltese: Waqqaf il-VKA u ibda Roteas meta l-proporzjon normalizzat internazzjonali (INR) ikun ta' ≤ 2.5.
English: Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of edoxaban.
Maltese: Mhux mistenni li protamine sulfate u vitamina K jaffettwaw l-attività kontra l-koagulazzjoni ta' edoxaban.
English: EU/1/16/1152/003 10 film-coated tablets EU/1/16/1152/004 14 film-coated tablets EU/1/16/1152/005 28 film-coated tablets EU/1/16/1152/006 30 film-coated tablets EU/1/16/1152/007 56 film-coated tablets EU/1/16/1152/008 60 film-coated tablets EU/1/16/1152/009 84 film-coated tablets EU/1/16/1152/010 90 film-coated tablets EU/1/16/1152/011 98 film-coated tablets EU/1/16/1152/012 100 film-coated tablets EU/1/16/1152/013 10 x 1 film-coated tablets EU/1/16/1152/014 50 x 1 film-coated tablets EU/1/16/1152/015 100 x1 film-coated tablets
Maltese: EU/1/16/1152/003 10 pilloli miksija b'rita EU/1/16/1152/004 14-il pillola miksija b'rita EU/1/16/1152/005 28 pillola miksija b'rita EU/1/16/1152/006 30 pillola miksija b'rita EU/1/16/1152/007 56 pillola miksija b'rita EU/1/16/1152/008 60 pillola miksija b'rita EU/1/16/1152/009 84 pillola miksija b'rita EU/1/16/1152/010 90 pillola miksija b'rita EU/1/16/1152/011 98 pillola miksija b'rita EU/1/16/1152/012 100 pillola miksija b'rita EU/1/16/1152/013 10 x 1 pillola miksija b'rita EU/1/16/1152/014 50
English: Patients with elevated liver enzymes (ALT/AST > 2 x ULN) or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Maltese: Pazjenti b'enzimi tal-fwied għoljin (ALT/AST >2 x ULN) jew bilirubina totali ta' ≥1.5 x ULN ġew esklużi fil-provi kliniċi.
English: Edoxaban vs Warfarin HR (95% CI)b p-valuec
Maltese: Edoxaban kontra Warfarin HR (95% C
English: • Uncontrolled severe hypertension.
Maltese: • Pressjoni għolja severa mhux ikkontrollata.
English: The volume of distribution is 107 (19.9) L mean (SD).
Maltese: Il-volum tad-distribuzzjoni hu ta' medja ta' 107 (19.9) L (SD).
English: INFORMATION IN BRAILLE Roteas 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Roteas 30 mg
English: Table 3: List of adverse reactions for NVAF and VTE System Organ Class
Maltese: Tabella 3: Lista ta' reazzjonijiet avversi għal NVAF u VTE
English: Oral anticoagulants other than VKA
Maltese: Antikoagulanti orali ħlief VKA
English: Moderate or severe (CrCL 15 - 50 mL/min)
Maltese: Indeboliment tal-kliewi Moderat jew sever (CrCL 15 - 50 mL/min)
English: In the warfarin group, the median TTR (time in therapeutic range, INR 2.0 to 3.0) was 65.6%.
Maltese: Fil-grupp ta' warfarin, il-medjan ta' TTR (ħin fil-medda terapewtika, INR 2.0 sa 3.0) kien ta' 65.6%.
English: Musculoskeletal and connective tissue disorders Intramuscular haemorrhage (no compartment syndrome)
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Emorraġija intramuskolari (l-ebda sindrome tal-kompartiment)
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) 30 mg QD ≥ 30 to ≤ 50
Maltese: Kura ta' DVT, kura ta' PE u prevenzjoni ta' DVT u PE (VTE) rikorrenti 30 mg QD ≥ 30 sa ≤ 50
English: Safety in patients with VTE (DVT and PE) in Hokusai-VTE
Maltese: Sigurtà f'pazjenti b'VTE (DVT u PE) fl-istudju Hokusai-VTE
English: Pharmocokinetic/pharmacodynamic relationship(s) PT, INR, aPTT and Anti-factor Xa correlate linearly with edoxaban concentrations.
Maltese: Relazzjoni(jiet) farmakokineti(ka/ċi)/farmakodinami(ka/ċi) PT, INR, aPTT u Anti-Fattur Xa jikkorrelaw b'mod lineari mal-konċentrazzjonijiet ta' edoxaban.
English: Phone number, practice stamp:
Maltese: Numru tat-telefon, timbru tal-prattika:
English: b Primary Safety Endpoint: Clinically relevant bleeding (composite of major and clinically relevant non-major bleeding).
Maltese: b Punt Aħħari tas-Sigurtà Primarja: Emorraġija klinikament rilevanti (kompost ta' emorraġija maġġuri u emorraġija klinikament rilevanti mhux maġġuri).
English: How to take the tablet Swallow the tablet, preferably with water.
Maltese: Ibla' l-pillola, preferibbilment mal-ilma.
English: • Roteas may increase the risk of bleeding.
Maltese: • Roteas jista' jżid ir-riskju ta' emorraġija.
English: INFORMATION IN BRAILLE Roteas 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Roteas 15 mg
English: • Roteas is an oral anticoagulant factor Xa inhibitor.
Maltese: MEDIKU • Roteas hu antikoagulant orali b'inibitur ta' fattur Xa.
English: Oral/Pharyngeal haemorrhage
Maltese: Emorraġija orali/farinġeali
English: a The primary efficacy endpoint is adjudicated symptomatic recurrent VTE (i.e., the composite endpoint of DVT, non-fatal PE, and fatal PE).
Maltese: a Il-punt aħħari tal-effikaċja primarja hi VTE sintomatika rikorrenti aġġudikata (i.e., il-punt aħħari tal-kompost ta' DVT, PE mhux fatali u PE fatali).
English: The median subject-year exposure was 15,471, and 15,840 for the 60 mg and 30 mg treatment groups, respectively; and the median subject-year follow-up was 19,191 and 19,216 for the 60 mg and 30 mg treatment groups, respectively.
Maltese: Il-medjan tal-esponiment ta' individwu-sena kien ta' 15,471, u 15,840 għallgruppi ta' kura ta' 60 mg u 30 mg, rispettivament; u l-medjan tal-follow-up individwu-sena kien ta' 19,191 u 19,216 għall-gruppi ta' kura ta' 60 mg u 30 mg, rispettivament.
English: In the warfarin group, the median TTR (time in therapeutic range, INR 2.0 to 3.0) was 68.4%.
Maltese: Fil-grupp ta' warfarin, il-medjan ta' TTR (ħin fil-medda terapewtika, INR 2.0 sa 3.0) kien ta' 68.4%.
English: • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
Maltese: • mediċini kontra l-infjammazzjoni u li jtaffu l-uġigħ (eż. naproxen jew acetylsalicylic acid)
English: Blood alkaline phosphatase increased
Maltese: Żieda f'alkaline phosphatase
English: PVC/Aluminium perforated unit dose blisters of 10 x 1 film-coated tablets.
Maltese: PVC/Folji tad-doża tal-unità ipperforati tal-aluminju ta' 10 x 1 pilloli miksija b'rita.
English: They come in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets.
Maltese: Jiġu f'folji f'kaxxi tal-kartun ta' 10, 14, 28, 30, 56, 60, 84, 90, 98 jew 100 pillola miksija b'rita jew folji tad-doża tal-unità f'kaxxi tal-kartun ta' 10 x 1, 50 x 1, jew 100 x 1 pillola miksija b'rita.
English: Subarachnoid haemorrhage
Maltese: Emorraġija subarakinojde
English: The majority of subjects in the edoxaban and warfarin groups had cardioversion performed (83.7% and 78.9%, respectively) or were auto-converted (6.6% and 8.6%, respectively).
Maltese: (83.7% u 78.9%, rispettivament) jew kienu konvertiti awtomatikament (6.6% u 8.6%, rispettivament).
English: The anticoagulant effect of edoxaban cannot be reliably monitored with standard laboratory testing.
Maltese: L-effett antikoagulanti ta' edoxaban ma jistax jiġi monitorjat b'mod affidabbli b'ittestjar standard tallaboratorju.
English: Nervous system disorders Dizziness
Maltese: Disturbi fis-sistema nervuża
English: There may be situations that warrant a change in anticoagulation therapy (Table 2).
Maltese: Jista' jkun hemm sitwazzjonijiet li jiġġustifikaw bidla fit-terapija b'antikoagulanti (Tabella 2).
English: • Low body weight ≤ 60 kg
Maltese: • Piż baxx tal-ġisem ta' ≤ 60 kg
English: • St John's Wort, a herbal product used for anxiety and mild depression
Maltese: • St John's Wort, prodott mill-ħxejjex li jintuża għall-ansjetà u depressjoni ħafifa
English: • Bleeding from a surgical wound following an operation
Maltese: • Emorraġija minn ferita kirurġika wara operazzjoni
English: A total of 16 (1.5%, 95% CI 0.86% - 2.42%) events occurred in subjects in the edoxaban (N = 1067) group and 11 (1.0%, 95% CI 0.51% - 1.81%) events in the warfarin (N = 1082) group; OR 1.48 (95% CI 0.64 - 3.55); safety analysis set on-treatment period.
Maltese: 95% CI 0.86% - 2.42%) avveniment seħħew f'individwi fil-grupp ta' edoxaban (N = 1,067) u 11-il (1.0%, 0.95% CI 0.51% - 1.81%) avveniment fil-grupp ta' warfarin (N = 1,082); Proporzjon ta' probabbiltajiet (OR (Odds Ratio)) 1.48 (95% CI 0.64 - 3.55); analiżi tas-sigurtà tul il-perjodu meta ngħatat il-kura.
English: • Pregnancy and breast-feeding (see section 4.6).
Maltese: • Tqala u treddigħ (ara sezzjoni 4.6).
English: Adjudicated efficacy cardiovascular mortality per renal subgroups (edoxaban vs. warfarin): CrCL 30 to ≤ 50 mL/min [HR (95% CI): 0.80 (0.65, 0.99)]; CrCL > 50 to < 80 mL/min [HR (95% CI): 0.75 (0.62, 0.90)]; CrCL ≥ 80 mL/min [HR (95% CI): 1.16 (0.92, 1.46)].
Maltese: Dejta dwar effikaċja aġġudikata għall-mortalità kardjovaskulari skont is-sottogruppi renali (edoxaban vs. warfarin): CrCL 30 sa ≤ 50 mL/min [HR (95% CI): 0.80 (0.65, 0.99)]; CrCL > 50 sa < 80 mL/min [HR (95% CI): 0.75 (0.62, 0.90)]; CrCL ≥ 80 mL/min [HR (95% CI): 1.16 (0.92, 1.46)].
English: • Moderate or severe renal impairment (creatinine clearance (CrCL) 15 - 50 mL/min)
Maltese: • Indeboliment moderat jew sever tal-kliewi (tneħħija tal-kreatinina (CrCL) ta' 15 - 50 mL/min)
English: ≤ 60 kg
Maltese: Edoxaban 60 mg
English: Laboratory coagulation parameters
Maltese: Parametri tal-koagulazzjoni fil-laboratorju
English: It was 1.07 in centres with the best control of warfarin therapy (4th quartile with > 73.9% of INR values in the therapeutic range).
Maltese: Kien 1.07 fiċ-ċentri bl-aħjar kontroll tat-terapija b'warfarin (4 kwartil b'> 73.9% tal-valuri ta' INR fil-medda terapewtika).
English: The majority of edoxaban treated patients were Caucasians (69.6%) and Asians (21.0%), 3.8% were Black, 5.3% were categorised as Other race.
Maltese: Il-maġġoranza ta' pazjenti kkurati b'edoxaban kienu Kawkasi (69.6%) u Asjatiċi (21.0%), 3.8% kienu Suwed, 5.3% kienu kkategorizzati bħala Razza oħra.
English: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare
Maltese: 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: > 50 to ≤ 70 2,093 148 3.31 2,106 171 3.77 0.88 (0.71, 1.10) > 70 to ≤ 90 1,661 108 2.88 1,703 119 3.08 0.93 (0.72, 1.21) > 90 to ≤ 110 927 29
Maltese: > 50 sa ≤ 70 2,093 148 3.31 2,106 171 3.77 0.88 (0.71, 1.10) > 70 sa ≤ 90 1,661 108 2.88 1,703 119 3.08 0.93 (0.72, 1.21) > 90 sa ≤ 110 927 29
English: A total of 5 (0.5%, 95% CI 0.15% - 1.06%) events occurred in subjects in the edoxaban group (N = 1095) and 11 (1.0%, 95% CI 0.50% - 1.78%) events in the warfarin group (N = 1104); OR 0.46 (95% CI 0.12 - 1.43); ITT analysis set overall study period with mean duration of 66 days.
Maltese: Total ta' 5 (0.5%, 0.95% CI 0.15% -1.06%) avvenimenti seħħew f'individwi fil-grupp ta' edoxaban (N = 1,095) u 11-il (1.0%, 95% CI 0.50%-1.78%) avveniment fil-grupp ta' warfarin (N = 1,104); Proporzjon ta' probabbiltajiet (OR (Odds Ratio)) 0.46 (95% CI 0.
English: Co-administration of high dose ASA (325 mg) increased the steady state Cmax and AUC of edoxaban by 35% and 32%, respectively.
Maltese: doża għolja ta' ASA (325 mg) żied is-Cmax u l-AUC fl-istat fiss ta' edoxaban b'35% u 32%, rispettivament.
English: b The event rate (%/yr) is calculated as number of events/subject-year exposure.
Maltese: b Ir-rata ta' avvenimenti (%/yr) hi kkalkulata bħala n-numru ta' avvenimenti/individwusena esponiment.
English: There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving edoxaban.
Maltese: M'hemmx esperjenza b'sustanzi antifibrinolitiċi (tranexamic acid, aminocaproic acid) f'individwi li jkunu qed jirċievu edoxaban.
English: The safety of edoxaban has been evaluated in two Phase 3 studies including 21,105 patients with NVAF (ENGAGE AF-TIMI 48 study), and 8,292 patients with VTE (DVT and PE) (Hokusai-VTE study).
Maltese: Is-sigurtà ta' edoxaban ġiet evalwata f'żewġ studji ta' Fażi 3 li kienu jinkludu 21,105 pazjenti b'NVAF (l-istudju ENGAGE AF-TIMI 48), u 8,292 pazjent b'VTE (DVT u PE) (l-istudju HokusaiVTE).
English: • Tar-coloured stools
Maltese: • mard sever tal-fwied
English: Intraocular haemorrhage
Maltese: Emorraġija intraokulari
English: All subjects with symptomatic recurrent VTEc, n (%)
Maltese: L-individwi kollha b'VTE sintomatika rikorrenti, VTEċ n (%)