FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of Xigris is 24 micrograms per kilogram body weight per hour, given as a continuous infusion for 96 hours.
Maltese: Id-doża rakkomandata hija 24 mikrogramma kull kilogramma tal-piż tal-ġisem, kull siegħa, mogħtija bħala infużjoni kontinwa għal 96 siegħa.
English: Xigris has been studied in three studies in severe sepsis:
Maltese: Xigris ġie studjat fi tliet studji f'sepsis gravi:
English: The active substance in Xigris, drotrecogin alfa (activated), is very similar to a natural anticoagulant found in the body called activated protein C. Drotrecogin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce drotrecogin alfa.
Maltese: Drotrecogin alfa hija magħmula permezz ta' metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': huwa magħmul minn ċellola li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi drotrecogin alfa.
English: • in the ADDRESS study, Xigris was compared with placebo in almost 3,000 patients who were at a lower risk of death than in the first two studies.
Maltese: • fl-istudju ADDRESS, Xigris tqabbel ma' plaċebo fi kważi 3,000 pazjent li kienu f'riskju inqas li jmutu mill-ewwel żewġ studji.
English: Xigris is used in adult patients with severe sepsis.
Maltese: Xigris jintuża għal kura ta' pazjenti adulti li għandhom sepsis gravi.
English: What is Xigris?
Maltese: X'inhu Xigris?
English: In the body, drotrecogin alfa limits how much thrombin (one of the factors involved in blood clotting) is produced, and also reduces the inflammation caused by the infection.
Maltese: Fil-ġisem, drotrecogin alfa tillimita l-produzzjoni ta' thrombin (wieħed mill-fatturi involut fit-tgħaqqid tad-demm), u tnaqqas ukoll l-infjammazzjoni kkaġunata mill-infezzjoni.
English: By using Xigris during sepsis, the risk of blood clots forming and damaging the organs is reduced.
Maltese: Bl-użu ta' Xigris waqt sepsis, ir-riskju li jifformaw emboli tad-demm u lħsara lill-organi jonqsu.
English: What is the risk associated with Xigris?
Maltese: X'inhu r-riskju assoċjat ma' Xigris?
English: Xigris should not be used in people who may be hypersensitive (allergic) to drotrecogin alfa (activated), any of the other ingredients or bovine thrombin (a cow protein).
Maltese: Xigris ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għal drotrecogin alfa (attivata) jew kwalunkwe mill-ingredjenti l-oħra jew għat-trombina bovina (proteina tal-baqar).
English: For the full list of all side effects reported with Xigris, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha irrapportati b'Xigris, ara l-Fuljett ta' Tagħrif.
English: For the full list of restrictions, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara l-Fuljett ta' Tagħrif.
English: Xigris is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: Xigris huwa trab li jsir soluzzjoni għall-infużjoni (dripp fil-vina).
English: Xigris is used when the patient has two or more organs failing, in addition to best standard care such as antibiotics, medicines to support the organs and treatment in a specialised unit.
Maltese: Xigris jintuża meta pazjent ikollu żewġ organi jew aktar li ma jkunux qegħdin jaħdmu sewwa, flimkien mal-aħjar kura standard bħalma huma antibijotiċi, mediċini ta' appoġġ għall-organi u kura f'taqsima speċjalizzata.
English: How is Xigris used?
Maltese: Għal xiex jintuża Xigris?
English: Other information about Xigris:
Maltese: Tagħrif ieħor dwar Xigris:
English: The company that makes Xigris will conduct an additional study looking at the safety and effectiveness of Xigris in patients with severe sepsis.
Maltese: Il-kumpanija li tagħmel Xigris se tagħmel studju addizzjonali li se jistudja s-sigurtà u l-effettività ta' Xigris f'pazjenti b'sepsis serja.
English: The toxins cause the patient's organs to fail, such as the heart, lungs and kidneys.
Maltese: It-tossini jikkaġunaw ħsara fl-organi tal-pazjent bħall-qalb, il-pulmun u l-kliewi.
English: How has Xigris been studied?
Maltese: Kif ġie studjat Xigris?
English: The full EPAR for Xigris is available here.
Maltese: Kif jintuża Xigris?
English: Whereas
Maltese: L
English: Scientific discussion
Maltese: Diskussjoni xjentifika
English: Overall conclusion
Maltese: Konklużjoni ġenerali
English: Background information
Maltese: Informazzjoni ta' sfond
English: However, in the pre-specified subgroup of symptomatic angina patients (n=12049), a statistically significant increase in PCE was observed (HR=1.18; 95%CI [1.03-1.35]).
Maltese: Madankollu, fis-sottogrupp speċifikat minn qabel ta' pazjenti b'anġina sintomatika (n=12049), kienet osservata żieda statistikament sinifikanti fil-PCE (HR=1.18; 95%CI [1.03-1.35]).
English: • The PRAC considered Procoralan and Corlentor (ivabradine) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission.
Maltese: • Il-PRAC qies Procoralan u Corlentor (ivabradine) fil-proċedura skont l-Artikolu 20 tarRegolament (KE) Nru 726/2004, li nbdiet mill-Kummissjoni Ewropea.
English: • The PRAC concluded that there are clinically relevant benefits to the symptomatic treatment of angina pectoris with ivabradine.
Maltese: • Il-PRAC ikkonkluda li hemm benefiċċji klinikament rilevanti għall-kura sintomatika ta' anġina pectoris b'ivabradine.
English: Patients exposed to 10 mg dose versus not exposed to 10 mg showed a higher risk for bradycardia (E=2.54 [1.54-4.82]), observation supported by data from two small parallel studies also using the 10 mg dose.
Maltese: Il-pazjenti esposti għal doża ta' 10 mg meta mqabbel ma' dawk esposti għal 10 mg urew riskju ogħla għal bradikardija (E=2.54 [1.54-4.82]), osservazzjoni appoġġjata minn dejta minn żewġ studji paralleli żgħar li jużaw ukoll id-doża ta' 10 mg.
English: On 30 April 2014, the EMA received from the MAH a communication on the preliminary results of the SIGNIFY3 study.
Maltese: Fit-30 ta' April 2014, l-MAH bagħat komunikazzjoni lill-EMA dwar ir-riżultati preliminari tal-Istudju SIGNIFY3.
English: An additional risk minimisation activity was required by the PRAC.
Maltese: Il-PRAC talab attività ta' minimizzazzjoni tar-riskju addizzjonali.
English: CHMP opinion
Maltese: Il-Fehma tas-CHMP
English: In another clinical study evaluating the impact of grapefruit juice on ivabradine pharmacokinetics, an intake of 600 ml given as 200 ml three times a day for 3 days a moderate interaction level was observed with a 2.3-fold increase in ivabradine exposure.
Maltese: Fi studju kliniku ieħor li jevalwa l-impatt tal-meraq tal-grejpfrut fuq il-farmakokinetika ta' ivabradine, b'teħid ta' 600 ml mogħtija bħala 200 ml tliet drabiet kuljum għal 3 ijiem, ġie osservat livell ta' interazzjoni moderata b'żieda ta' 2.3 darbiet fl-esponiment għal ivabradine.
English: There was no significant difference in the incidence of the primary endpoint between the ivabradine group and the placebo group (6.8% and 6.4%, respectively; HR=1.08, 95% CI [0.96 -1.20]; p=0.2).
Maltese: HR=1.08, 95% CI [0.96 -1.20]; p=0.2).
English: In angina, the usual recommended starting dose of ivabradine is 5 mg twice daily (b.i.d.).
Maltese: Fl-anġina, id-doża tal-bidu rakkomandata normalment ta' ivabradine hija 5 mg darbtejn kuljum (b.i.d.).
English: The safety profile was dominated by adverse reactions already described for the product, notably all forms of bradycardia (17.9% ivabradine vs 2.1% placebo) and phosphenes (5.3% ivabradine vs 0.5% placebo).
Maltese: Il-profil tas-sigurtà kien iddominat minn reazzjonijiet avversi diġà deskritti għall-prodott, b'mod partikolari l-forom kollha ta' bradikardija (17.9% ivabradine meta mqabbel ma' 2.1% plaċebo) u fosfeni (5.3% ivabradine meta mqabbel ma' 0.5% plaċebo). Fibrillazzjoni atrijali (AF) seħħet f'5.3% tal-pazjenti li jieħdu ivabradine meta' mqabbel ma' 3.8% tal-pazjenti li jieħdu plaċebo.
English: This indication concerns use in chronic heart failure New York Heart Association (NYHA) class II to IV with systolic dysfunction, in patients in sinus rhythm with heart rate ≥75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Maltese: Din l-indikazzjoni tikkonċerna l-użu fil-klassi II sa IV talAssoċjazzjoni tal-Qalb ta' New York (New York Heart Association (NYHA)) ta' insuffiċjenza tal-qalb kronika b'disfunzjoni sistolika, f'pazjenti f'ritmu tas-sinus b'rata tat-taħbit tal-qalb ta' ≥75 bpm, flimkien ma' terapija standard li tinkludi terapija b'imblokkaturi tar-riċetturi beta jew meta tterapija b'imblokkaturi tar-riċetturi beta hija kontraindikata jew mhux ittollerata.
English: The SIGNIFY is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, event-driven study which was designed to test the hypothesis that heart rate lowering with ivabradine reduces cardiovascular (CV) event rates in patients with stable coronary artery disease (CAD).
Maltese: SIGNIFY huwa studju mmexxi mill-avvenimenti, ikkontrollat bi plaċebo, ta' grupp parallel, double-blind, każwali, multiċentriku li kien imfassal biex jittestja l-ipoteżi li t-tnaqqis firritmu tat-taħbit tal-qalb b'ivabradine jnaqqas ir-rati ta' avvenimenti kardjovaskulari (CV) f'pazjenti b'marda tal-arterja koronarja (CAD) stabbli.
English: Several pre-specified subgroup analyses were performed and the only significant interaction identified was in the incidence of the primary composite endpoint in the angina Canadian Cardiovascular Society (CCS) class ≥ II patients.
Maltese: Twettqu diversi analiżijiet ta' sottogruppi speċifikati minn qabel u l-unika interazzjoni sinifikanti identifikata kienet fl-inċidenza tal-punt aħħari kompost primarju f'pazjenti tal-klassi ≥ II tasSoċjetà Kardjovaskulari Kanadiża (CCS) tal-anġina.
English: Ivabradine was also associated with a significantly higher risk of bradycardia.
Maltese: Ivabradine kien assoċjat ukoll ma' riskju sinifikament ogħla ta' bradikardija.
English: Procoralan and Corlentor (both containing ivabradine) were granted a marketing authorisation in October 2005 for the indication “symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contraindication or intolerance for beta-blockers”.
Maltese: Procoralan u Corlentor (li t-tnejn fihom ivabradine) ingħataw awtorizzazzjoni għat-tqegħid fis-suq f'Ottubru 2005 għall-indikazzjoni “kura sintomatika ta' anġina pectoris kronika stabbli f'pazjenti b'ritmu tas-sinus normali, li jkollhom kontraindikazzjoni jew intolleranza għal imblokkaturi tarriċetturi beta”.
English: In the whole population (n=19102), ivabradine did not significantly affect the primary composite endpoint (PCE) or its individual components (CV death and non-fatal myocardial infarction).
Maltese: Fil-popolazzjoni kollha (n=19102), ivabradine ma affettwax b'mod sinifikanti il-punt aħħari kompost primarju (PCE) jew il-komponenti individwali tiegħu (mewt minħabba CV u infart mijokardijaku mhux fatali).
English: • In symptomatic treatment of chronic stable angina pectoris, treatment should only be initiated in patients with HR ≥ 70 bpm.
Maltese: • F'kura sintomatika ta' anġina pectoris kronika stabbli, il-kura għandha tinbeda biss f'pazjenti b'HR ≥ 70 bpm.
English: This study used doses of ivabradine higher than the currently recommended in the product information (starting dose in SIGNIFY: 7.5 mg twice daily [5 mg twice daily if age>75 years], that could be increased up to 10 mg twice daily).
Maltese: 7.5 mg darbtejn kuljum [5 mg darbtejn kuljum għal età ta' >75 sena], li tista' tiżdied sa 10 mg darbtejn kuljum).
English: The beneficial effect of symptomatic improvement of angina is considered of clinical relevance.
Maltese: L-effett ta' benefiċċju ta' titjib sintomatiku tal-anġina jitqies ta' rilevanza klinika.
English: • Concomitant treatment with moderate CYP3A4 inhibitors with heart rate reducing properties such as diltiazem or verapamil is now contraindicated.
Maltese: • Il-kura konkomitanti b'inibituri moderati ta' CYP3A4 bi proprjetajiet ta' tnaqqis fir-rata tattaħbit tal-qalb bħal diltiazem jew verapamil issa hija kontraindikata.
English: • The PRAC further considered data on the incidence of atrial fibrillation, which is higher than previously recognised, and concluded that ivabradine treated patients should be monitored for the occurrence of atrial fibrillation to minimise the risk of atrial fibrillation.
Maltese: • Il-PRAC ikkunsidra wkoll dejta dwar l-inċidenza ta' fibrillazzjoni atrijali, li hija ogħla milli rikonoxxut preċedentement, u kkonkluda li l-pazjenti kkurati b'ivabradine għandhom jiġu ssorveljati għall-okkorrenza ta' fibrillazzjoni atrijali biex jiġi minimizzat ir-riskju ta' fibrillazzjoni atrijali.
English: • The PRAC also noted a small but significant increase of the combined risk of cardiovascular death and non-fatal myocardial infarction in a subgroup of symptomatic angina patients in the SIGNIFY study.
Maltese: • Il-PRAC innota wkoll żieda żgħira iżda sinifikanti tar-riskju kkombinat ta' mewt kardjovaskulari u infart mijokardijaku mhux fatali f'sottogrupp ta' pazjenti b'anġina sintomatika fl-istudju SIGNIFY.
English: 2 - Detailed explanation of the scientific differences from PRAC recommendation
Maltese: 2. - Spjegazzjoni ddettaljata tad-differenzi xjentifiċi mirrakkomandazzjoni tal-PRAC
English: This will be a multinational retrospective cohort study that will collect data from medical record abstraction (chart review) for patients with chronic stable angina pectoris initiating treatment with ivabradine in routine clinical practice in selected European countries.
Maltese: Dan ser ikun studju ta' koorti retrospettiv multinazzjonali li ser jiġbor dejta minn estrazzjoni ta' rekords mediċi (reviżjoni taċ-ċarts) għal pazjenti b'anġina pectoris kronika stabbli li jibdew kura b'ivabradine fi prattika klinika ta' rutina f'pajjiżi Ewropej magħżula.
English: MorBidity-mortality EvAlUaTion of the If inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction.
Maltese: 1 Evalwazzjoni tal-morbidità u l-mortalità tal-inibitur If ivabradine f'pazjenti b'mard koronarju u disfunzjoni ventrikulari tax-xellug.
English: Risk minimisation measures
Maltese: Miżuri ta' minimizzazzjoni tar-riskju
English: Although not reaching statistical significance, similar trends were observed for the individual components of CV death and non-fatal myocardial infarction (MI).
Maltese: Għalkemm ma laħqux sinifikat statistiku, kienu osservati xejriet simili għallkomponenti individwali ta' mewt minħabba CV u infart mijokardijaku (MI) mhux fatali.
English: Systolic Heart failure treatment with the If inhibitor ivabradine Trial.
Maltese: 2 Kura għal Insuffiċjenza tal-Qalb sistolika bil-Prova tal-inibitur If ivabradine.
English: Although baseline heart rate ≥ 70 bpm was an inclusion criteria in the SIGNIFY study, data from BEAUTIFUL study indicate a significant p-value for interaction for the primary composite endpoint when patient are divided around the 70 bpm cut-off level, although a significant beneficial effect was only observed for the MI endpoint in the heart rate ≥70 subgroup.
Maltese: aħħari kompost primarju meta l-pazjenti jinqasmu madwar il-livell tal-valur ta' limitu ta' 70 bpm, għalkemm effett ta' benefiċċju sinifikanti kien osservat biss għall-punt aħħari ta' MI fis-sottogrupp ta' rata tat-taħbit tal-qalb ta' ≥70.
English: Although it does not fully explain the findings, a contributor to the increased risk of CV events appears to be the high starting dose and maximum dose used in the SIGNIFY study, exceeding the currently approved maximum dose.
Maltese: Għalkemm ma jispjegax b'mod sħiħ is-sejbiet, kontributur għaż-żieda fir-riskju ta' avvenimenti CV jidher li huwa d-doża ta' bidu għolja u d-doża massima użata fl-istudju SIGNIFY, li taqbeż id-doża massima approvata attwalment.
English: The potential impact of the SIGNIFY results in the heart failure indication was considered, but the two populations are substantially different in terms of underlying cardiac function and presence or absence of clinical heart failure.
Maltese: L-impatt potenzjali tar-riżultati ta' SIGNIFY fl-indikazzjoni ta' insuffiċjenza tal-qalb kien ikkunsidrat, iżda ż-żewġ popolazzjonijiet huma sostanzjalment differenti f'termini ta' funzjoni kardijaka sottostanti u l-preżenza jew in-nuqqas ta' insuffiċjenza tal-qalb klinika.
English: Concomitant use of diltiazem/verapamil (which also have an additional heart rate lowering effect) and strong CYP3A4 inhibitors have also shown to increase the incidence of bradycardia events and the risk of MI. Concomitant treatment is currently not recommended but this should be strengthened to a contraindication to minimize the risk of clinically relevant interactions.
Maltese: L-użu konkomitanti ta' diltiazem/verapamil (li wkoll għandhom effett addizzjonali ta' tnaqqis firrata tat-taħbit tal-qalb) u inibituri qawwija ta' CYP3A4 wera wkoll li jżid l-inċidenza ta' avvenimenti ta' bradikardija u r-riskju ta' MI.
English: Additional clarifications were also introduced in the DHPC.
Maltese: Ġew introdotti wkoll kjarifiki addizzjonali fid-DHPC.
English: • The PRAC reviewed all data presented by the MAH on the safety and efficacy of ivabradine, including the results of the SIGNIFY study, as well as the views expressed by the cardiovascular scientific advisory group.
Maltese: • Il-PRAC irreveda d-dejta kollha ppreżentata mill-MAH dwar is-sigurtà u l-effikaċja ta' ivabradine, li tinkludi r-riżultati tal-istudju SIGNIFY, kif ukoll il-fehmiet espressi mill-grupp konsultattiv xjentifiku kardjovaskulari.
English: The increased incidence of bradycardia in relation to the increased observed CV risk while on treatment with the higher initial dose and maximum dose (as in the SIGNIFY study), or concomitant diltiazem/verapamil or strong CYP3A4 inhibitors, indicates that the heart rate should not be extensively reduced.
Maltese: L-inċidenza akbar ta' bradikardija b'rabta ma' żieda fir-riskju CV osservat waqt kura b'doża tal-bidu ogħla u doża massima (bħal fl-istudju SIGNIFY), jew diltiazem/verapamil konkomitanti jew inibituri qawwija ta' CYP3A4, tindika li r-rata tat-taħbit tal-qalb ma għandhiex titnaqqas b'mod estensiv.
English: There were also no significant differences between the two groups in the incidences of the components of the primary composite endpoint (death from CV causes and nonfatal MI).
Maltese: Lanqas ma kien hemm xi differenza sinifikanti bejn iż-żewġ gruppi fl-inċidenzi talkomponenti tal-punt aħħari primarju (mewt minn kawżi CV u MI mhux fatali).
English: Ivabradine is a heart rate lowering agent with specific effect on the sinus node with no effects on intra-atrial, atrioventricular or intraventricular conduction times, myocardial contractility or ventricular repolarisation.
Maltese: Minbarra s-CAD, ivabradine attwalment huwa indikat ukoll għall-kura ta' insuffiċjenza tal-qalb kronika abbażi tar-riżultati mill-istudju SHIFT preċedenti.
English: The MAH shall distribute a Direct Healthcare Professional Communication (DHPC) to inform prescribers of the amendments to the product information.
Maltese: L-MAH għandu jqassam Komunikazzjoni Diretta tal-Professjonisti tal-Kura tas-Saħħa (DHPC) biex jinforma lil min jikteb irriċetti mediċi dwar l-emendi fl-informazzjoni dwar il-prodott.
English: The CHMP considered it necessary to introduce a statement in section 4.8 of the Summary of Product Characteristics reflecting the incidence of atrial fibrillation in the SIGNIFY study.
Maltese: Is-CHMP ħass il-ħtieġa li jintroduċi dikjarazzjoni fis-sezzjoni 4.8 tas-Sommarju tal-Karetteristiċi talProdott li tirrifletti l-inċidenza tal-fibrillazzjoni atrijali fl-istudju SIGNIFY.
English: Also a lower dose and different titration method was used in the SHIFT study when compared to the SIGNIFY study.
Maltese: Barra minn hekk, fl-istudju SHIFT intużat doża aktar baxxa u metodu ta' titrazzjoni differenti meta mqabbel mal-istudju SIGNIFY.
English: • The PRAC considered that the increased risks observed can be minimised by reinforcing the recommendation not to exceed the authorised posology, excluding patients with a resting heart rate < 70 bpm who are likely to be at greater risk, recommending discontinuation of treatment in the absence of improvement in angina symptoms within 3 months and contraindicating concomitant use of verapamil and diltiazem.
Maltese: • Il PRAC qies li r-riskji akbar osservati jistgħu jiġu minimizzati billi tissaħħaħ irrakkomandazzjoni biex ma tinqabiżx il-pożoloġija awtorizzata, bl-esklużjoni ta' pazjenti b'rata tat-taħbit tal-qalb fi stat mistrieħ <70 bpm li x'aktarx ikunu f'riskju akbar, filwaqt li jirrakkomanda t-twaqqif tal-kura fin-nuqqas ta' titjib fis-sintomi tal-anġina fi żmien 3 xhur u jagħmel kontraindikazzjoni dwar l-użu konkomitanti ta' verapamil u diltiazem.
English: Study assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease.
Maltese: 3 SIGNIFY li jivvaluta l-benefiċċji tal-morbidità u l-mortalità tal-inibitur If ivabradine f'pazjenti b'mard tal-arterja koronarja.
English: No significant differences were also observed in any of the secondary endpoints.
Maltese: Lanqas ma ġiet osservata xi differenza sinifikanti fi kwalunkwe punt aħħari sekondarju.
English: Given that the subgroup of symptomatic angina patients may correspond to the population of patients for whom one of the therapeutic indications for ivabradine is currently approved, the European Commission initiated on 8 May 2014 a procedure under Article 20 of Regulation (EC) No 726/2004 and requested the Agency to assess the above concerns and their impact on the benefit
Maltese: Peress li s-sottogrupp ta' pazjenti b'anġina sintomatika jista' jikkorrispondi għall-popolazzjoni ta' pazjenti għal liema attwalment hija approvata waħda mill-indikazzjonijiet terapewtiċi għal ivabradine, il-Kummissjoni Ewropea fit-8 ta' Mejju 2014 bdiet proċedura skont l-Artikolu 20 tarRegolament (KE) Nru 726/2004 u talbet lill-Aġenzija biex tivvaluta t-tħassib ta' hawn fuq u l-impatt tiegħu fuq il-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali awtorizzati ċentralment Procoralan u Corlentor.
English: Ivabradine, a specific heart rate lowering agent, has demonstrated symptomatic improvement of angina symptoms in patients with stable CAD. A large study in patients with CAD and left ventricular dysfunction (BEAUTIFUL study) could not demonstrate a benefit in terms of CV outcome.
Maltese: Studju kbir f'pazjenti b'CAD u disfunzjoni ventrikulari tax-xellug (studju BEAUTIFUL) ma setax juri benefiċċju f'termini ta' riżultat CV.
English: The MAH will conduct a drug utilisation study to describe the characteristics of users of ivabradine, as well as describing the patterns of use of ivabradine and adherence to the risk minimisation measures.
Maltese: Barra minn hekk, għandu jitwettaq studju ta' utilizzazzjoni tal-mediċina biex jiddeskrivi lkaratteristiċi tal-utenti ta' ivabradine, il-mudelli ta' użu u jivvaluta l-konformità mal-miżuri ta' minimizzazzjoni tar-riskju.
English: Based on the totality of the data assessed during the procedure and on the advice from the Scientific Advisory Group, the PRAC concluded that the benefit-risk balance of Procoralan/Corlentor remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activity agreed.
Maltese: Il-PRAC huwa għalhekk tal-fehma li l-bilanċ bejn il-benefiċċju u r-riskju ta' ivabradine jibqa' wieħed favorevoli, meta jitqiesu l-emendi fl-informazzjoni dwar il-prodott u soġġett għall-miżuri ta' minimizzazzjoni tar-riskju u l-attivitajiet addizzjonali ta' farmakoviġilanza maqbula.
English: The Product Information for Corlentor and Procoralan was revised to include the following:
Maltese: L-Informazzjoni dwar il-Prodott għal Corlentor u Procoralan kienet irriveduta biex tinkludi dan li ġej:
English: Ref. EMEA/610140/2008
Maltese: EMEA/610140/2008
English: London, 20 November 2008 Doc.
Maltese: Londra, 20 ta' Novembru 2008 Dok. Ref.
English: International non-proprietary name (INN): docetaxel
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): docetaxel
English: It contains the active substance docetaxel.
Maltese: Fih is-sustanza attiva docetaxel.