FrancophonIA/ELRC3.0 huggingface dataset:
English: Some new potential, very rare and reversible adverse effects were highlighted during the referral procedure, including trombocytopenia, agranulocytosis and liver dysfunction and have been included in the risk management plan (RMP) and reflected in the relative sections of the SmPC.
Maltese: Matul il-proċedura ta' riferiment, inxteħet dawl fuq l-effetti ħżiena potenzjali ġodda, rari ħafna u riversibbli, inklużi tromboċitopenja, agranuloċitożi, u funzjoni ħażina tal-fwied u dawn ġew inklużi fil-pjan ta' ġestjoni tar-riskju (RMP) u riflessi fis-sezzjonijiet korrispondenti tal-SmPC.
English: This risk has been identified in post marketing setting and in literature based on: positive dechallenge of Parkinson symptoms after the only withdrawal of TMZ, positive rechallenge, significant higher coprescription of antiparkinson drugs in TMZ group compared to control group (IMS study) and significant higher number of patients that begin antiparkinson drugs after the introduction of TMZ compared to control group (IMS study).
Maltese: Dan ir-riskju ġie identifikat fil-fażi ta' wara t-tqegħid fis-suq u fit-tagħrif fuq il-bażi ta': trażżin pożittiv tas-sintomi ta' Parkinson wara l-uniku waqfien minn TMZ, użu mill-ġdid pożittiv, għoti sinifikament ogħla fl-istess ħin ta' mediċini oħrajn kontra lParkinson fil-grupp tat-TMZ meta mqabbel mal-grupp ta' kontroll (studju IMS) u numru notevolment ogħla ta' pazjenti li jibdew jieħdu mediċini kontra l-Parkinson wara l-introduzzjoni ta' TMZ meta mqabbel mal-grupp ta' kontroll (studju IMS).
English: Considering all the currently available data the CHMP concluded that the trimetazidine should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders as well as in patients with severe renal impairment (creatinine clearance < 30ml/min).
Maltese: Wara li kkunsidra d-dejta kollha disponibbli bħalissa, is-CHMP ikkonkluda li trimetazidine għandu jkun kontraindikat f'pazjenti bil-marda ta' Parkinson, sintomi ta' Parkinson, rogħda, sindromu tas-saqajn bla kwiet, u disturbi relatati oħrajn tal-moviment kif ukoll f'pazjenti b'indeboliment renali sever (tneħħija tal-kreatinina < 30ml/min).
English: Most ophthalmologic trimetazidine clinical trials have been conducted with the 20 mg strength but in some studies the daily doses used (20mg and 40 mg/day) were lower than those recommended in the current marketing authorisation (60 mg or 70 mg), which is also a limit of these studies, particularly in documenting the safety at the registered dosage.
Maltese: Il-parti l-kbira tal-provi kliniċi oftalmoloġiċi ta' trimetazidine saru bil-qawwa ta' 20 mg iżda f'ċerti studji d-dożi ta' kuljum użati (20mg u 40 mg/jum) kienu aktar baxxi minn dawk irrakkomandati f'din l-awtorizzazzjoni għat-tqegħid fissuq (60 mg jew 70 mg), li hija wkoll limitu ieħor ta' dawn l-istudji, b'mod partikolari fiddokumentazzjoni dwar is-sigurtà fid-doża rreġistrata.
English: Three studies were conducted against betahistine (Haguenauer, 1980; Kluyskens, 1990; Martini, 1990) to demonstrate a clinical benefit of trimetazidine in the treatment of dizziness.
Maltese: Saru tliet studji f'konfront ma' betahistine (Haguenauer, 1980; Kluyskens, 1990;
English: The CHMP agreed that trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients.
Maltese: Is-CHMP qabel li trimetazidine jista' jikkawża jew jaggrava s-sintomi ta' Parkinson (rogħda, akineżija, ipertonja), li għandhom ikunu investigati b'mod regolari, b'mod speċjali fil-pazjenti anzjani.
English: Favourable results from ‘Dizziness Handicap Inventory questionnaire' were suggested by the small Sterckers and Vitte studies.
Maltese: Riżultati favorevoli mill-‘kwestjonarju talInventarju tad-Diżabilità tal-Isturdament' kienu ssuġġeriti mill-istudji żgħar Sterckers u Vitte.
English: Accordingly, the SmPC has been amended to include dose information in the elderly and in patients with moderate renal impairment (creatinine clearance [30-60] ml/min).
Maltese: Għalhekk, l-SmPC ġie emendat sabiex jinkludi informazzjoni dwar id-doża fl-anzjani u f'pazjenti b'indeboliment renali moderat (tneħħija tal-kreatinina [30-60] ml/min).
English: The Committee, therefore, concluded that the benefit-risk balance of trimetazidine- containing medicinal products remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed, only as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line anti-anginal therapies.
Maltese: Għaldaqstant, il-Kumitat ikkonkluda li l-bilanċ bejn il-benefiċċji u r-riskji ta' prodotti mediċinali li fihom trimetazidine għadu pożittiv f'kundizzjonijiet normali ta' użu, soġġett għar-restrizzjonijiet, ittwissijiet, il-bidliet fl-informazzjoni dwar il-prodott, attivitajiet ta' farmakoviġilanza oħrajn u miżuri ta' tnaqqis tar-riskju li sar qbil dwarhom, bħala terapija supplementari biss għat-trattament sintomatiku ta' pazjenti b'anġina pectoris stabbli li mhumiex ikkontrollati b'mod adegwat minn mediċini ppreferuti ta' kontra l-anġina pectoris jew ma jittollerawhomx.
English: The improvement in the primary end point with trimetazidine was observed in the pooled analysis of patients receiving 35 and 70 mg twice daily and in the analysis of patients receiving either 35 mg twice daily or 70 mg twice daily.
Maltese: Ġie osservat titjib fil-punt aħħari primarju bi trimetazidine fl-analiżi miġbura ta' pazjenti li ngħataw 35 u 70 mg darbtejn kuljum u fl-analiżi ta' pazjenti li ngħataw 35 mg darbtejn kuljum jew 70 mg darbtejn kuljum.
English: Each study generally included multiple objectives (pharmacodynamic or clinical evaluations).
Maltese: Kull studju ġeneralment kien jinkludi għanijiet multipli (evalwazzjonijiet farmakodinamiċi jew kliniċi).
English: Considering all currently available data, the CHMP concluded that trimetazidine-containing medicines should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Maltese: Wara li qies id-dejta kollha disponibbli fil-preżent, is-CHMP ikkonkluda li l-mediċini li fihom trimetazidine għandhom ikunu kontraindikati f'pazjenti bil-marda ta' Parkinson, b'sintomi ta' Parkinson, rogħda, sindromu tas-saqajn bla kwiet, u disturbi relatati oħrajn tal-moviment.
English: Considering all currently available data, the CHMP concluded that trimetazidine-containing medicinal products should be contraindicated in patients with severe renal impairment (creatinine clearance < 30ml/min).
Maltese: Wara li qies id-dejta kollha disponibbli fil-preżent, is-CHMP ikkonkluda li l-mediċini li fihom trimetazidine għandhom ikunu kontraindikati f'pazjenti b'indeboliment renali sever (tneħħija talkreatinina < 30ml/min).
English: was added to 50 mg atenolol (o.d.) for 8 weeks and produced a significant increase (+34.4s, p=0.03) in the time to 1-mm ST-segment depression in exercise tests, in a sub-group of patients (n=173), when compared to placebo, 12 hours after taking the drug.
Maltese: Intgħażlu 223 pazjent b'mod aleatorju għal dan l-istudju double blind u kkontrollat bi plaċebo fejn pillola waħda ta' rilaxx modifikat ta' 35 mg trimetazidine (b.i.d.) ġiet miżjuda ma' 50 mg atenolol (o.d.) għal 8 ġimgħat u pproduċiet żieda konsiderevoli (+34.4s, p=0.03) fil-ħin għad-depressjoni tas-segment tal-1-mm ST fit-testijiet tal-eżerċizzju, f'sottogrupp ta' pazjenti (n=173), meta mqabbla mal-plaċebo, 12-il siegħa wara li ttieħdet ilmediċina.
English: By decreasing fatty acid oxidation at the level of 3-ketoacyl coenzyme A thiolase, it favours glucose oxidation, which improves the use of the cells' energy reserves in the event of ischaemia.
Maltese: Is-CHMP qabel ukoll dwar protokoll ta' studju li jevalwa l-effett tal-indeboliment renali u l-età fuq ilfarmakokinetika ta' trimetazidine u biex l-istudju jsir.
English: Population pharmacokinetics data indicate that serious adverse events were more frequent in treated elderly patients with high trimetazidine plasma concentrations.
Maltese: Id-dejta farmakokinetika dwar il-popolazzjoni tindika li effetti avversi serji kienu aktar spissi f'pazjenti anzjani ttrattati b'konċentrazzjonijiet għolja ta' trimetazidine fil-plażma.
English: The studies suggested limited methodology in the ENT field and do not confirm the current methodology of investigation by applying the basic statistical principles of clinical trials methodology.
Maltese: L-istudji ssuġġerew metodoloġija limitata fil-qasam tal-ENT u ma jikkonfermawx il-metodoloġija attwali ta' investigazzjoni bl-applikazzjoni tal-prinċipji statistiċi bażiċi tal-metodoloġija tal-provi kliniċi.
English: The aim of the Sellier study (2003) was to assess the efficacy of the combination of trimetazidine MR 70 mg/day in patients suffering from angina pectoris who were insufficiently controlled on 50 mg/day of atenolol after two months of treatment.
Maltese: L-għan tal-istudju ta' Sellier (2003) kien li tiġi evalwata l-effikaċja tat-taħlit ta' trimetazidine MR 70 mg/jum f'pazjenti li jbatu minn anġina pectoris li ma kinux ikkontrollati biżżejjed b'50 mg/jum ta' atenolol wara xahrejn trattament.
English: Therefore, trimetazidine as add-on therapy may represent an optional treatment drug to be used in association with first-line anti-anginal drugs especially in those patients for whom optimally control of symptoms cannot be achieved with other anti-anginal drugs in monotherapy due to haemodynamic intolerance or chronotropic incompetence.
Maltese: Għalhekk, trimetazidine bħala terapija supplementari jista' jirrappreżenta mediċina fakultattiva li tista' tintuża flimkien b'rabta mal-mediċini ppreferuti ta' kontra l-anġina b'mod speċjali f'dawk il-pazjenti li ssintomi tagħhom ma jistgħux jiġu kkontrollati bl-aħjar mod b'monoterapija b'mediċini oħrajn ta' kontra l-anġina minħabba nuqqas ta' tolleranza emodinamika jew inkompetenza kronotropika.
English: The presence of stable angina pectoris is a pivotal inclusion criterion as it identifies the target population for the use of anti-anginal drugs.
Maltese: Il-preżenza ta' anġina pectoris stabbli hija kriterju ta' inklużjoni ewlieni peress li tidentifika l-popolazzjoni fil-mira għall-użu ta' mediċini ta' kontra lanġina.
English: Overall summary of the scientific evaluation of trimetazidine containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali li fihom trimetazidine (ara Anness I)
English: This analysis showed that in patients with chronic stable angina trimetazidine given as add-on to atenolol significantly improved exercise tolerance (p<0.01), time to 1 mm ST segment depression and time to angina.
Maltese: Din l-analiżi uriet li f'pazjenti b'anġina stabbli kronika, trimetazidine mogħti bħala sustanza supplementari għal atenolol tejjeb b'mod sinifikanti t-tolleranza għall-eżerċizzju (p<0.01), il-ħin għad-depressjoni tas-segment tal1mm ST u l-ħin għall-anġina.
English: The main identified serious ADR is related to Parkinson syndrome and related symptoms.
Maltese: L-aktar reazzjoni avversa (ADR) serja u ewlenija għall-mediċina li ġiet identifikata hija marbuta mas-sindromu ta' Parkinson u sintomi relatati.
English: • The Committee reviewed all available submitted data from clinical studies, published literature and post-marketing experience on the safety of trimetazidine containing medicinal products, in particular with regards to the Parkinson syndrome and related events.
Maltese: • Il-Kumitat irreveda d-dejta kollha disponibbli ppreżentata mill-istudji kliniċi, it-tagħrif ippubblikat u l-esperjenza ta' wara t-tqegħid fis-suq dwar is-sigurtà ta' prodotti mediċinali li fihom trimetazidine, b'mod partikolari fir-rigward tas-sindromu ta' Parkinson u avvenimenti relatati.
English: The CHMP concluded that following the assessment of all these studies the efficacy of trimetazidine is not proven on the ophthalmological indication.
Maltese: Is-CHMP ikkonkluda li wara l-evalwazzjoni ta' dawn l-istudji kollha, l-effikaċja ta' trimetazidine mhijiex ippruvata fl-indikazzjoni oftalmoloġika.
English: Therefore, the Committee concluded that the benefit-risk balance of trimetazidine- containing medicinal products in the add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies, remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed.
Maltese: Għaldaqstant, il-Kumitat ikkonkluda li l-bilanċ bejn il-benefiċċji u r-riskji ta' prodotti mediċinali li fihom trimetazidine bħala terapija supplementari għat-trattament sintomatiku ta' pazjenti b'anġina pectoris stabbli li mhumiex ikkontrollati b'mod adegwat minn mediċini ppreferuti ta' kontra l-anġina pectoris jew ma jittollerawhomx, għadu pożittiv f'kundizzjonijiet normali ta' użu, soġġett għarrestrizzjonijiet, it-twissijiet, il-bidliet fl-informazzjoni tal-prodott, attivitajiet oħrajn ta' farmakoviġilanza u l-miżuri ta' tnaqqis tar-riskju li sar qbil dwarhom.
English: Among these studies, five studies were conducted against placebo including the additional study published in 1990 by Coyas.
Maltese: Fost dawn l-istudji, saru ħames studji mqabbla ma' plaċebo inkluż l-istudju addizzjonali ppubblikat fl-1990 minn Coyas.
English: • Considering all the currently available safety data the Committee concluded that trimetazidine should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders as well as in patients with severe renal impairment (creatinine clearance < 30ml/min).
Maltese: • Wara li kkunsidra d-dejta kollha disponibbli bħalissa dwar is-sigurtà, il-Kumitat ikkonkluda li trimetazidine għandu jkun kontraindikat f'pazjenti bil-marda ta' Parkinson, sintomi ta' Parkinson, rogħda, sindromu tas-saqajn bla kwiet, u disturbi oħrajn tal-moviment relatati kif ukoll fil-pazjenti b'indeboliment renali sever (tneħħija tal-kreatinina < 30ml/min).
English: The Emeriau PK study has shown high plasma concentrations of trimetazidine in old patients, receiving the usual dose of 35 mg twice daily.
Maltese: L-istudju PK Emeriau wera konċentrazzjonijiet għolja ta' trimetazidine filplażma f'pazjenti anzjani li ngħataw id-doża normali ta' 35 mg darbtejn kuljum.
English: Finally, the most recent study using an appropriate methodology was submitted only for safety purpose as the efficacy objective was not reached (France ARMD 2, 2008).
Maltese: Finalment, l-aktar studju reċenti li uża metodoloġija xierqa ġie ppreżentat biss għall-finijiet ta' sigurtà peress li l-għan tal-effikaċja ma ntlaħaqx (Franza ARMD 2, 2008).
English: France on 22 April 2011 requested the CHMP to give its opinion under Article 31 of Directive 2001/83/EC on whether the marketing authorisation for trimetazidine-containing medicinal products should be maintained, varied, suspended or withdrawn on the basis of the increased Parkinson's reports.
Maltese: Fit-22 ta' April 2011 Franza talbet lis-CHMP sabiex jagħti l-opinjoni tiegħu skont l-Artikolu 31 tadDirettiva 2001/83/KE dwar jekk l-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali li fihom trimetazidine għandhiex tinżamm, tinbidel, tiġi sospiża jew irtirata fuq il-bażi ta' żieda firrapporti ta' Parkinson's.
English: The reporting rate of Parkinson's syndrome plausibly related to trimetazidine is stable over time since the last 8 years, despite the increase, since 2007, in the number of spontaneous reports of Parkinson's syndrome and related symptoms.
Maltese: Ir-rata ta' rapportar tas-sindromu ta' Parkinson plawżibbilment marbut ma' trimetazidine baqgħet stabbli maż-żmien tul dawn l-aħħar tmien snin, minkejja ż-żieda, mill-2007, fin-numru ta' rapporti spontanji tas-sindromu ta' Parkinson u sintomi relatati.
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all FVIII products.
Maltese: F'dan l-istudju, l-inċidenza taliżvilupp ta' inibituri kienet tvarja minn 28.2% għal 37.7% għall-prodotti kollha b'FVIII.
English: Post-hoc analysis of the RODIN study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitor than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08 -2.37).
Maltese: Analiżi post-hoc tal-istudju RODIN uriet li PUPs b'emofilja A severa li ngħataw Kogenate Bayer kienu aktar probabbli li jiżviluppaw inibitur minn dawk li ngħataw fattur VIII rikombinanti ieħor kontra l-emofilja (proporzjon aġġustat tal-periklu, 1.60; 95%-CI: 1.08 -2.37).
English: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500015512.pdf
Maltese: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500015512.pdf inklużi l-istudji 200021EU u 100074US f'PUPs u f'pazjenti li rċevew kura minima (MTPS).
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen (see annexes A).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għal Kogenate Bayer u Helixate NexGen (ara anness A).
English: The efficacy of Kogenate Bayer/Helixate NexGen is recognised and the PRAC reviewed the data related to inhibitor development in PUPs and MTPs.
Maltese: L-effikaċja ta' Kogenate Bayer/Helixate NexGen hija rikonoxxuta u l-PRAC irreveda d-dejta relatata mal-iżvilupp ta' inibituri f'PUPs u MTPs.
English: Overall summary of the scientific evaluation of Kogenate Bayer and Helixate NexGen (see Annex A)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' Kogenate Bayer u Helixate NexGen (ara Anness A)
English: The PRAC noted that the Factor VIII gene mutation profile of these study population (in studies 200021EU and 100074US) reflects the typical distribution seen in patients with severe haemophilia A, indicating that there was no bias in patient recruitment.
Maltese: Il-PRAC innota li l-profil tal-mutazzjoni tal-ġene tal-Fattur VIII ta' din il-popolazzjoni tal-istudju (fl-istudji 200021EU u 100074US) jirrifletti d-distribuzzjoni tipika li tidher f'pazjenti bl-emofilja A severa, li jindika li ma kienx hemm preġudizzju fir-reklutaġġ tal-pazjenti.
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC (see Annex A).
Maltese: Wara d-dispożizzjonijiet taħt l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, is-CHMP, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-5 ta' Diċembru 2013 huwa tal-fehma li lawtorizzazzjonijiet għat-tqegħid fis-suq għal Kogenate Bayer u Helixate NexGen għandhom jiġu varjati kif rakkomandat mill-PRAC (ara Anness A).
English: In view of the above, the PRAC agreed that the current evidence does not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A. However the PRAC considered that the frequency for inhibitor development in PUPs should be amended from “common” to “very common” in the section 4.8 of the SmPC and also recommended that the product information should be updated with results from the RODIN study as part of the routine risk minimisation activities.
Maltese: Madankollu l-PRAC qies li lfrekwenza għall-iżvilupp ta' inibituri f'PUPs għandha tiġi emendata minn “komuni” għal “komuni ħafna” fis-sezzjoni 4.8 tal-SmPC u rrakkomanda wkoll li l-informazzjoni dwar il-prodott tiġi aġġornata b'riżultati mill-istudju RODIN bħala parti mill-attivitajiet ta' rutina ta' minimizzazzjoni tar-riskju.
English: The PRAC considered results from the publication of the RODIN/PedNet study, the preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) registry and all available data submitted from clinical trials, observational studies, published literature as well as quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs) and minimally treated patients (MTPs).
Maltese: Il-PRAC ikkunsidra r-riżultati mill-pubblikazzjoni tal-istudju RODIN/PedNet, is-sejbiet preliminari mir-reġistru tas-Sistema Ewropea ta' Sorveljanza tas-Sigurtà tal-Emofilja (EUHASS) u d-dejta kollha disponibbli ppreżentata mill-provi kliniċi, studji ta' osservazzjoni, letteratura ppubblikata kif ukoll dejta dwar il-kwalità għal Kogenate Bayer u Helixate NexGen fir-rigward tar-riskju potenzjali tiegħu għall-iżvilupp ta' inibituri f'pazjenti li ma kienux irċevew kura preċedenti (PUPs) u pazjenti li rċevew kura minima (MTPs).
English: • The PRAC considered the publication of the results of the RODIN/PedNet study, the preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) registry and all available data submitted from clinical trials, observational studies, published literature and quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs).
Maltese: • Il-PRAC ikkunsidra l-pubblikazzjoni tar-riżultati tal-istudju RODIN/PedNet, is-sejbiet preliminari mir-reġistru tas-Sistema Ewropea ta' Sorveljanza tas-Sigurtà talEmofilja (EUHASS) u d-dejta kollha disponibbli ppreżentata minn provi kliniċi, studji ta' osservazzjoni, letteratura ppubblikata u dejta dwar il-kwalità għal Kogenate Bayer u Helixate NexGen fir-rigward tar-riskju potenzjali tiegħu għall-iżvilupp ta' inibituri f'pazjenti li ma kienux irċevew kura preċedenti (PUPs).
English: • The PRAC noted that the efficacy of Kogenate Bayer/Helixate NexGen is not questioned and, on the basis of the available data, concluded that the current results do not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A.
Maltese: NexGen mhijiex iddubitata u, abbażi tad-dejta disponibbli, ikkonkluda li r-riżultati attwali ma jikkonfermawx riskju akbar taliżvilupp ta' antikorpi kontra Kogenate Bayer u Helixate NexGen meta mqabbla ma' prodotti oħra tal-fattur VIII f'PUPs bid-disturb ta' fsada l-emofilja A.
English: Kogenate Bayer/Helixate NexGen are indicated for treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency).
Maltese: NexGen huma indikati għall-kura u l-profilassi ta' fsada f'pazjenti bl-emofilja A (defiċjenza konġenitali tal-fattur VIII).
English: In addition, the PRAC noted an update from the on-going EUHASS data, and results showed an inhibitor incidence for Kogenate Bayer and Helixate Nexgen comparable to other products: whereas no adjustment for known risk factors for inhibitor development could be performed due to the study design, the PRAC noted that the 95 % CIs of the point estimates of PUP inhibitor incidence were overlapping substantially between different products.
Maltese: Barra minn hekk, il-PRAC innota aġġornament middejta kontinwa tal-EUHASS, u r-riżultati wrew inċidenza ta' inibituri għal Kogenate Bayer u Helixate Nexgen komparabbli ma' prodotti oħra: għalkemm ma seta' jsir l-ebda aġġustament għall-fatturi ta' riskju magħrufa għall-iżvilupp ta' inibituri minħabba d-disinn tal-istudju, il-PRAC innota li l-95 % CIs tal-istimi tal-punt ta' inċidenza ta' inibituri f'PUPs kienu jikkoinċidu b'mod sostanzjali bejn ilprodotti differenti.