FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure to the other metabolites is less than 5%.
Maltese: L-esponiment għal metaboliti oħrajn hu inqas minn 5%.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with edoxaban in one or more subsets of the paediatric population in prevention of arterial thrombosis, treatment of thromboembolism and prevention of thromboembolism (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'edoxaban f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-prevenzjoni ta' trombożi arterjali, kura ta' tromboemboliżmu u l-prevenzjoni ta' tromboemboliżmu {ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku}.
English: NAME OF THE MEDICINAL PRODUCT Roteas 15 mg film-coated tablets edoxaban
Maltese: Roteas 15 mg, pilloli miksija b'rita edoxaban
English: What is in this leaflet
Maltese: Kien hemm rata ta'
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 60 MG
Maltese: FOLJA TAD-DOŻA TAL-UNITÀ (10 x 1 PILLOLA) GĦAL 60
English: Recommendation
Maltese: Epistassi
English: In subgroup analyses, for subjects who were dose reduced to 30 mg in the Hokusai-VTE study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 58 (7.9%) of edoxaban 30 mg dose reduced subjects and 92 (12.8%) of warfarin subjects had a major bleeding or CRNM event [HR (95%): 0.62 (0.44, 0.86)].
Maltese: VTE minħabba piż tal-ġisem ta' ≤ 60 kg, indeboliment moderat tal-kliewi, jew l-użu fl-istess ħin ta' inibituri ta' P-gp, 58 (7.9%) ta' individwi li ngħataw doża imnaqqsa ta' edoxaban 30 mg u 92 (12.8%)
English: Concomitant use of edoxaban with ciclosporin, dronedarone, erythromycin, or ketoconazole requires dose reduction to 30 mg once daily.
Maltese: ciclosporin, dronedarone, erythromycin, jew ketoconazole, id-doża rakkomandata hi ta' pillola waħda ta' 30 mg darba kuljum.
English: Upper GI haemorrhage
Maltese: Tfal u adolexxenti
English: Edoxaban has not been studied in patients with severe hepatic impairment (see section 4.2).
Maltese: Edoxaban ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 4.2).
English: Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, the serine protease located in the final common pathway of the coagulation cascade.
Maltese: Edoxaban hu inibitur selettiv ħafna, dirett u riversibbli ta' fattur Xa, is-serine protease li jinsab filpassaġġ komuni finali tal-kaskata tal-koagulazzjoni.
English: Abbreviations: CI = Confidence Interval; DVT = deep vein thrombosis; mITT = modified intent-totreat; HR = Hazard Ratio vs. warfarin; n = number of subjects with events; N = number of subjects in mITT population; PE = pulmonary embolism; VTE = venous thromboembolic events.
Maltese: CI = Intervall ta' Kunfidenza; DVT = trombożi tal-vini profondi; mITT (modified Intent To Treat) = Intenzjoni Ta' Kura modifikata;
English: In healthy subjects, the total clearance is estimated as 22 (± 3) L/hour; 50% is renally cleared (11 L/hour).
Maltese: F'individwi b'saħħithom, it-tneħħija totali hi stmata bħala 22 (± 3) L/siegħa; 50% titneħħa mill-kliewi (11 L/siegħa).
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section 5.1).
Maltese: Id-doża rakkomandata hija ta' 60 mg ta' edoxaban darba kuljum wara l-użu inizjali ta' antikoagulant parenterali għal mill-inqas 5 ijiem (ara sezzjoni 5.1).
English: Edoxaban Anti-FXa activity pre-dose (IU/mL)2 Median [2.5 - 97.5% range] Prevention of stroke and systemic embolism: NVAF 30 mg QD ≥ 30 to ≤ 50 60 mg QD*
Maltese: L-individwi fiż-żewġ gruppi ta' kura b'edoxaban kellhom doża mnaqqsa bin-nofs jekk xi wieħed jew aktar mill-fatturi kliniċi li ġejjin kienu preżenti: indeboliment moderat tal-kliewi (CrCL 30 - 50 mL/min), piż baxx tal-ġisem (60 kg) jew l-użu fl-istess ħin ta'
English: NAME OF THE MEDICINAL PRODUCT Roteas 30 mg film-coated tablets edoxaban
Maltese: Roteas 30 mg, pilloli miksija b'rita edoxaban
English: MARKETING AUTHORISATION NUMBER(S) 15 mg film-coated tablets: EU/1/16/1152/001-002 30 mg film-coated tablets: EU/1/16/1152/003-015 60 mg film-coated tablets: EU/1/16/1152/016-028
Maltese: x 1 pillola miksija b'rita EU/1/16/1152/015 100 x 1 pillola miksija b'rita
English: • Stomach ache
Maltese: • Tħossok imdardar
English: Concomitant administration of higher doses than 100 mg ASA should only be performed under medical supervision.
Maltese: L-għoti fl-istess ħin ta' dożi ogħla minn 100 mg ASA għandu jitwettaq biss taħt superviżjoni medika.
English: There is a linear correlation between edoxaban plasma concentration and anti-FXa activity regardless of renal function.
Maltese: Hemm korrelazzjoni lineari bejn il-konċentrazzjoni ta' edoxaban fil-plażma u l-attività anti-FXa mingħajr ma jingħata kas tal-funzjoni tal-funzjoni tal-kliewi.
English: Changing from Roteas to vitamin K antagonists (e.g. warfarin) If you currently take 60 mg Roteas:
Maltese: Meta tibdel minn antagonisti ta' vitamina K (eż. warfarin) għal Roteas
English: • Bleeding in the muscles
Maltese: • Emorraġija fil-muskoli
English: Skin and subcutaneous tissue disorders Cutaneous soft tissue haemorrhage
Maltese: Valvoli prostetiċi tal-qalb u stenożi mitrali moderata sa severa
English: Table 9: Number of Intracranial Bleeding Events by creatinine clearance category in ENGAGE AF-TIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Maltese: kreatinina f'ENGAGE AF-TIMI 48, Analiżi dwar is-Sigurtà Waqt il-Kuraa Sottogrupp ta' CrCL (mL/min)
English: 60 mg film-coated tablet: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”.
Maltese: Pilloli miksija b'rita tondi, ta' lewn isfar (dijametru ta' 10.5 mm) imnaqqxa b'“DSC L60”.
English: They come in blisters in cartons of 10 film-coated tablets or unit dose blisters in cartons of 10 x 1 filmcoated tablets.
Maltese: Jiġu f'folji f'kaxxi tal-kartun ta' 10 pilloli miksija b'rita jew folji tad-doża tal-unità f'kaxxi tal-kartun ta' 10 x 1 pillola miksija b'rita.
English: • Ciclosporin: Concurrent administration of a single dose of ciclosporin 500 mg with a single dose of edoxaban 60 mg increased edoxaban AUC and Cmax by 73% and 74%, respectively.
Maltese: edoxaban 60 mg, żied l-AUC u s-Cmax ta' edoxaban b'73% u 74%, rispettivament.
English: Subjects in both edoxaban treatment groups had their dose halved if one or more of the following clinical factors were present: moderate renal impairment (CrCL 30 - 50 mL/min), low body weight (≤ 60 kg) or concomitant use of specific P-gp inhibitors (verapamil, quinidine, dronedarone).
Maltese: L-individwi fil-grupp ta' kura ta' edoxaban irċivew doża ta' 30 mg darba kuljum jekk xi wieħed jew aktar mill-fatturi kliniċi li ġejjin kienu preżenti: indeboliment moderat tal-kliewi (CrCL 30 - 50 mL/min), piż baxx tal-ġisem (≤ 60 kg) jew l-użu fl-istess ħin ta' inibituri speċifiċi ta' P-gp.
English: Appropriate symptomatic treatment could be used as needed, such as mechanical compression (e.g. for severe epistaxis), surgical haemostasis with bleeding control procedures, fluid replacement and haemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anaemia or coagulopathy) or platelets.
Maltese: Kura sintomatika xierqa, bħal kompressjoni mekkanika (eż. għall-epistassi severa), emostasi kirurġika flimkien ma' proċeduri ta' kontroll ta' fsada, sostituzzjoni ta' fluwidu u appoġġ emodinamiku, prodotti tad-demm (ċelluli ħomor ippakkjati jew plażma friska ffriżata), skont l-anemija assoċjata jew koagulopatija ) jew plejtlits, jistgħu jintużaw skont il-ħtieġa.
English: Changing from Roteas to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) Stop taking Roteas and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Roteas.
Maltese: Meta tibdel minn antikoagulanti orali mhux VKA (dabigatran, rivaroxaban, jew apixaban) għal Roteas
English: Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Maltese: Komplikazzjonijiet emorraġiċi jistgħu jidhru bħala dgħjufija, dehra pallida, sturdament, uġigħ ta' ras jew nefħa mhux spjegata, qtugħ ta' nifs u xokk mhux spjegat.
English: The efficacy results for pre-specified major subgroups (with dose reduction as required), including age, body weight, gender, status of renal function, prior stroke or TIA, diabetes and P-gp inhibitors were generally consistent with the primary efficacy results for the overall population studied in the trial.
Maltese: Ir-riżultati tal-effikaċja għal sottogruppi maġġuri speċifikati minn qabel (bi tnaqqis fid-doża skont il ħtieġa), li jinkludu l-età, il-piż tal-ġisem, is-sess tal-persuna, l-istat tal-funzjoni tal-kliewi, puplesija jew TIA fil-passat, dijabete u inibituri ta' P-gp, kienu ġeneralment konsistenti mar-riżultati taleffikaċja primarja għall-popolazzjoni globali studjata fil-prova.
English: Lower GI haemorrhage
Maltese: Punt Aħħari Primarju
English: Treatment of DVT, treatment of PE and the prevention of recurrent DVT and PE (VTE) The edoxaban clinical programme for VTE was designed to demonstrate the efficacy and safety of edoxaban in the treatment of DVT and PE, and the prevention of recurrent DVT and PE.
Maltese: Il-programm kliniku ta' edoxaban għal tromboemboliżmu venuż (VTE) kien maħsub biex juri l effikaċja u s-sigurtà ta' edoxaban fil-kura ta' DVT u PE, u l-prevenzjoni ta' DVT u PE rikorrenti.
English: 5.3 Preclinical safety data
Maltese: Sensittività eċċessiva
English: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation
Maltese: Korriment u avvelenament u komplikazzjonijiet ta' xi proċedura Emorraġija fis-sit kirurġiku
English: In the comparator arm, subjects received initial heparin therapy concurrently with warfarin, titrated to a target INR of 2.0 to 3.0, followed by warfarin alone.
Maltese: Fil-parti tal-istudju dwar il-komparatur, l-individwi rċivew terapija inizjali bl-eparina fl-istess ħin ma' warfarin, ittitrata għal mira INR ta' 2.0 sa 3.0, segwita minn warfarin waħdu.
English: • Renal function should be assessed in all patients by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Roteas to exclude patients with end stage renal disease (i.e. CrCL < 15 mL/min), to use the correct Roteas dose in patients with CrCL 15 - 50 mL/min (30 mg once daily), in patients with CrCL > 50 mL/min (60 mg once daily) and when deciding on the use of Roteas in patients with increased creatinine clearance (see section 4.4).
Maltese: CrCL ta' 15 - 50 mL/min (30 mg darba kuljum), f'pazjenti bi CrCL ta' > 50 mL/min (60 mg darba kuljum) u meta tkun trid tittieħed deċiżjoni dwar l-użu ta' Roteas f'pazjenti b'żieda fit tneħħija tal-kreatinina (ara sezzjoni 4.4).
English: Food increases peak exposure to a varying extent, but has minimal effect on total exposure.
Maltese: L-ikel iżid l-esponiment massimu sa grad li jvarja, iżda għandu effett minimu fuq l-esponiment totali.
English: In deciding whether a procedure should be delayed until 24 hours after the last dose of Roteas, the increased risk of bleeding should be weighed against the urgency of the intervention.
Maltese: Meta tkun se ssir deċiżjoni jekk proċedura għandhiex tiġi ttardjata sa 24 siegħa wara l-aħħar doża ta' Roteas, iż-żieda fir-riskju ta' emorraġija għandu jintiżen kontra l-urġenza tal-intervent.
English: Table 5: Number of Ischaemic Strokes/SEE by creatinine clearance category in ENGAGE AFTIMI 48, mITT Analysis Set Overall Study CrCL subgroup (mL/min)
Maltese: Sett ta' Analiżi tal-Perjodu Globali tal-Istudju mITT f'ENGAGE AF-TIMI 48 Sottogrupp ta' CrCL (mL/min)
English: Platelet inhibitors: In ENGAGE AF-TIMI 48 concomitant use of thienopyridines (e.g. clopidogrel) monotherapy was permitted and resulted in increased clinically relevant bleeding although with a lower risk of bleeding on edoxaban compared to warfarin (see section 4.4).
Maltese: (eż. clopidogrel), kien permess u rriżulta f'żieda klinikament rilevanti f'emorraġija, għalkemm b'riskju iktar baxx ta' emorraġija fuq edoxaban meta mqabbel ma' warfarin (ara sezzjoni 4.4).
English: c The two-sided p-value is based on the non-inferiority margin of 1.38.
Maltese: ċ il-valur p two-sided hu bbażat fuq il-marġni ta' noninferjorità ta' 1.38.
English: Discontinuation for surgery and other interventions If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, Roteas should be stopped as soon as possible and preferably at least 24 hours before the procedure.
Maltese: Jekk l-antikoagulazzjoni tkun trid titwaqqaf biex jitnaqqas ir-riskju ta' emorraġija fi proċeduri kirurġiċi jew proċeduri oħrajn, Roteas għandu jitwaqqaf kemm jista' jkun malajr u preferibbilment mill-inqas 24 siegħa qabel il-proċedura.
English: P-gp Inhibitors
Maltese: Inibituri ta' P-gp
English: The average exposure to edoxaban 60 mg (including 30 mg dose reduced) was 2.5 years among 7,012 patients in ENGAGE AF-TIMI 48 and 251 days among 4,118 patients in Hokusai-VTE.
Maltese: AF-TIMI 48 u 251 jum fost 4,118-il pazjent f'Hokusai-VTE.
English: Non-fatal PE DVT only
Maltese: DVT biss
English: In clinical studies, co-administration of NSAIDs resulted in increased clinically relevant bleeding.
Maltese: Fl-istudji kliniċi, l-għoti flimkien ta' NSAIDs irriżulta f'żieda klinikament rilevanti ta'
English: Discontinue Roteas and start the parenteral anticoagulant at the time of the next scheduled dose of Roteas.
Maltese: Meta tibdel minn antikoagulanti parenterali (eż. eparin) għal Roteas
English: There is no clinically relevant accumulation of edoxaban (accumulation ratio 1.14) with once daily dosing.
Maltese: M'hemm l-ebda akkumulazzjoni klinikament rilevanti ta' edoxaban (proporzjon ta' akkumulazzjoni ta' 1.14) b'dożaġġ ta' darba kuljum.
English: Investigations Liver function test abnormal
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Roteas 30 mg film-coated tablets
Maltese: Roteas 30 mg pilloli miksija b'rita edoxaban
English: Pregnancy
Maltese: Investigazzjonijiet
English: • Coagulation tests such as INR, prothrombin time (PT), or activated partial thromboplastin time
Maltese: • Testijiet tal-koagulazzjoni, bħal INR, ħin tal-prothrombin (PT), jew ħin ta' thromboplastin parzjali attivat (aPTT), mhumiex kejl utli tal-effett ta' Roteas.
English: The results for all-cause mortality (adjudicated deaths) in the ENGAGE AF-TIMI 48 study were 769 (3.99% per year) for subjects taking edoxaban 60 mg (30 mg dose reduced) as opposed to 836 (4.35% per year) for warfarin [HR (95% CI): 0.91 (0.83, 1.01)].
Maltese: 30 mg) meta mqabbla ma' 836 (4.35% kull sena) għal warfarin [HR (95% CI): 0.91 (0.83, 1.01).
English: This was not considered clinically relevant.
Maltese: Dan ma ġiex ikkunsidrat li kien klinikament rilevanti.
English: Roteas is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of edoxaban have not been established in these clinical situations.
Maltese: Roteas mhuwiex rakkomandat bħala alternattiva għal eparina mhux frazzjonata f'pazjenti b'emboliżmu pulmonari li huma emodinamikament instabbli jew li jistgħu jirċievu trombolisi jew embolektomija pulmonari billi s-sigurtà u l-effikaċja ta' edoxaban ma ġewx stabbiliti f'dawn is sitwazzjonijiet kliniċi.
English: For the subjects who were dose reduced to 30 mg (predominantly low body weight or renal function) 15 (2.1%) edoxaban and 22 (3.1%) of warfarin subjects had a recurrent VTE [HR (95% CI): 0.69
Maltese: Għall-individwi li tnaqqsitilhom id-doża għal 30 mg (fil-biċċa l-kbira tagħhom kellhom piż baxx tal ġisem jew funzjoni tal-kliewi baxxa) 15 (2.1%) edoxaban u 22 (3.1%) tal-individwi li kienu fuq warfarin kellhom VTE rikorrenti [HR (95% CI): 0.69 (0.36, 1.34)].
English: A trend towards decreasing efficacy with increasing creatinine clearance was observed for edoxaban compared to well-managed warfarin (see section 5.1).
Maltese: Ġiet osservata tendenza lejn tnaqqis fl-effikaċja b'żieda fit-tneħħija tal-kreatinina għal edoxaban meta mqabbla ma' warfarin mmaniġġjat tajjeb (ara sezzjoni 5.1).
English: It is a ‘generic medicine'.
Maltese: Huwa "mediċina ġenerika".
English: The full EPAR for Ivabradine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Ivabradine Accord jinstab fis-sit elettroniku tal-Aġenzijaema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ivabradine Accord contains the active substance ivabradine.
Maltese: Ivabradine Accord fih is-sustanza attiva ivabradina.
English: Ivabradine Accord is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Maltese: Ivabradine Accord jiġi bħala pilloli (5 u 7.5 mg) u jista' jinkiseb biss b' riċetta ta' tabib.
English: The active substance in Ivabradine Accord, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Maltese: Is-sustanza attiva f'Ivabradine Accord, livabradina, timblokka l-"kurrent If" fin-nod tas-sinus, il-"pacemaker" naturali li jirregola r-rata ta' taħbit tal-qalb.
English: The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Maltese: Il-mediċina tintuża f' pazjenti b' ritmu tal-qalb normali li r-rata ta' taħbit tal-qalb tagħhom hija tal-inqas 70 taħbita fil-minuta.
English: Ivabradine Accord is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Maltese: Ivabradine Accord huwa mediċina tal-qalb li tintuża għall-kura tas-sintomi ta' anġina stabbli fit-tul (uġigħ fis-sider, ix-xedaq u d-dahar, ikkaġunat minn sforz fiżiku) f' adulti b' marda tal-arterja koronarja (marda fil-qalb ikkawżata minn imblukkar fl-arterji u fil-vini tad-demm li jfornu lill-muskolu tal-qalb).
English: In stable angina, these symptoms occur during physical effort.
Maltese: Flanġina stabbli, dawn is-sintomi jseħħu waqt sforzi fiżiċi.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Maltese: F' pazjenti li għandhom ' il fuq minn 75 sena, tista' tintuża doża inizjali iżjed baxxa ta' 2.5 mg darbtejn kuljum.
English: Other information about Ivabradine Accord
Maltese: Informazzjoni oħra dwar Ivabradine Accord
English: It is used in combination with standard therapy including beta-blockers, or in patients who cannot be treated with beta-blockers.
Maltese: Jintuża flimkien ma' terapija standard li tinkludi l-betablokkaturi, jew f' pazjenti li ma jistgħux jiġu kkurati b' beta-blokkaturi.
English: This is a summary of the European public assessment report (EPAR) for Ivabradine Accord.
Maltese: Dan huwa sommarju tar-rappport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ivabradine Accord.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Procoralan, and do not need to be repeated for Ivabradine Accord.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Procoralan, u ma għandhomx għalfejn jiġu ripetuti għal Ivabradine Accord.
English: Because Ivabradine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Ivabradine Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Ivabradine Accord ivabradine
Maltese: Kif jintuża Ivabradine Accord?
English: Why is Ivabradine Accord approved?
Maltese: Għaliex ġie approvat Ivabradine Accord?
English: The Committee recommended that Ivabradine Accord be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Ivabradine Accord ikun approvat għall-użu fl-UE.
English: Also, the doctor will consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Maltese: Barra minn hekk, it-tabib għandu jikkunsidra li jwaqqaf il-kura jekk il-mediċina jkollha biss effett limitat fuq it-tnaqqis tas-sintomi jew it-tnaqqis fir-rata ta' taħbit tal-qalb.
English: This means that Ivabradine Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
Maltese: Dan ifisser li Ivabradine Accord fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Procoralan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine Accord has been shown to have comparable quality and to be bioequivalent to Procoralan.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b' mod konformi mar-rekwiżiti tal-UE, Ivabradine Accord wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Procoralan.
English: What are the benefits and risks of Ivabradine Accord?
Maltese: X' inhuma l-benefiċċji u r-riskji ta' Ivabradine Accord?
English: Ivabradine Accord is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Maltese: Ivabradine Accord jintuża wkoll f' pazjenti b' insuffiċjenza tal-qalb fit-tul (meta l-qalb ma tkunx tista' tippompja biżżejjed demm lill-bqija tal-ġisem) u b' ritmu tal-qalb normali li r-rata ta' taħbit tal-qalb tagħhom hija tal-inqas 75 taħbita fil-minuta.
English: As for every medicine, the company provided studies on the quality of Ivabradine Accord.
Maltese: Bħal kull mediċina oħra, il-kumpanija pprovdiet studji dwar il-kwalità ta' Ivabradine Accord.
English: Therefore, the CHMP's view was that, as for Procoralan, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Procoralan, il-benefiċċju huwa akbar mir-riskju identifikat.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku ivabradina
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Ilkumpanija għamlet ukoll studji li wrew li hu "bijoekwivalenti" għall-mediċina ta' referenza.
English: It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by beta-blockers alone.
Maltese: Tintuża jew f' pazjenti li ma jistgħux jieħdu betablokkaturi (tip ta' mediċina oħra għall-kura tal-anġina), jew flimkien ma' betablokkatur f' pazjenti li l-marda tagħhom ma tkunx ikkontrollata b' beta-blokkaturi biss.
English: Bio-Set System:
Maltese: Sistema Bio-Set:
English: Repeat every 12 to 24 hours.
Maltese: Irrepeti kull 12 sa 24 siegħa.
English: Immune Tolerance Induction (ITI)
Maltese: Induzzjoni ta' Tolleranza Immuni (ITI - Immune Tolerance Induction)
English: 2 http://www.bloodjournal.org/content/109/11/4648.full.pdf 3 Gouw SC et al. PedNet and RODIN Study Group.
Maltese: 2 http://www.bloodjournal.org/content/109/11/4648.full.pdf 3 Gouw SC et al.
English: Bayer Corporation (license holder) Bayer HealthCare LLC 800 Dwight Way
Maltese: Bayer Corporation (detentur tal-liċenzja) Bayer HealthCare LLC 800 Dwight Way
English: Expert consultation
Maltese: Konsultazzjoni esperta
English: 20024 Garbagnate Milanese (MI) Italy
Maltese: Garbagnate Milanese (MI) L-Italja
English: Documentation
Maltese: Dokumentazzjoni