FrancophonIA/ELRC3.0 huggingface dataset:
English: Substances metabolised through cytochrome P450 and particularly cytochrome 3A4: Mitotane is a hepatic enzyme inducer and it should be used with caution in case of concomitant use of medicinal products influenced by hepatic metabolism (see section 4.5).
Maltese: Mitotane jinduċi l-enżimi tal-fwied u għandu jittieħed b'kawtela f'każi meta jintuża fl-istess ħin ma' prodotti mediċinali li jiġu nfluwenzati mill-metaboliżmu tal-fwied (ara sezzjoni 4.5).
English: Bleeding time: Prolonged bleeding time has been reported in patients treated with mitotane and this should be taken into account when surgery is considered (see section 4.8).
Maltese: Fsada fit-tul ġiet rrappurtata f'pazjenti li kienu qed jieħdu mitotane u dan għandu jingħata importanza meta tkun qed tiġi kkunsidrata l-kirurġija (ara sezzjoni 4.8).
English: There were recurrences in 40% of children; the survival rate at 5 years was 49%.
Maltese: Kien hemm 40 % tal-każijiet fejn it-tumur fit-tfal reġa' tfaċċa; ir-rata ta' sopravivenza ta' ħames snin kienet ta' 49 %.
English: There are some data suggesting that mitotane plasma above 14 mg/l may result in enhanced efficacy (see section 5.1).
Maltese: Teżisti xi evidenza li tissuġġerixxi li livelli ta' mitotane fil-plażma 'l fuq minn 14 mg/l jistgħu jirriżultaw f'żieda fl-effikaċja (ara sezzjoni 5.1).
English: Use in children and adolescents The starting daily dose of Lysodren is 1.5 to 3.5 g/m2 body surface (this will be calculated by your doctor according to the weight and the size of the child).
Maltese: Id-doża tal-bidu ta' kuljum ta' Lysodren hija 1.5 sa 3.5 g/m tal-wiċċ talġisem (dan jiġi kkalkulat mit-tabib tiegħek skond il-piż u d-daqs tat-tifel/tifla).
English: Ovarian macrocysts
Maltese: Makroċesti ovarji
English: Other effects should be treated symptomatically.
Maltese: Effetti oħra għandhom jiġu trattati sintomatikalment.
English: In a study performed in 8 patients with adrenal carcinoma treated with 2 to 3 g daily of mitotane, a highly significant correlation was found between plasma mitotane concentration and the total mitotane dose.
Maltese: Fi studju li sar fuq 8 pazjenti b'karċinoma adrenali li ngħataw 2 sa 3 g kuljum ta' mitotane, instabet korrelazzjoni ta' sinifikat għoli bejn il-konċentrazzjoni ta' mitotane fil-plażma u d-doża totali ta' mitotane.
English: Dosing should be individually adjusted based on mitotane plasma levels monitoring and clinical tolerance until mitotane plasma levels reach the therapeutic window 14 - 20 mg/l.
Maltese: Id-dożaġġ għandu jiġi aġġustat individwalment abbażi tal-monitoraġġ u t-tolleranza klinika tal-livelli tal-plażma ta' mitotane sakemm il-livelli tal-plażma ta' mitotane jilħqu l-marġni terapewtika 1420 mg/l.
English: Lysodren is an antitumoral medicine.
Maltese: X'inhu Lysodren u għalxiex jintuża Lysodren huwa mediċina antitumorali.
English: Available data suggest that mitotane modifies the peripheral metabolism of steroids and that it also directly suppresses the adrenal cortex.
Maltese: L-informazzjoni disponibbli tissuġġerixxi li mitotane jimmodifika l-metaboliżmu periferali ta' l-isterojdi kif ukoll irażżan direttament il-kortiċi adrenali.
English: Although no specific information on pharmacodynamic interactions in the central nervous system is available, this should be borne in mind when co-prescribing medicinal products with central nervous system depressant action.
Maltese: Għalkemm ma' hemm l-ebda informazzjoni speċifika dwar interazzjonijiet farmakodinamiċi fissistema nervuża ċentrali, dawn għandhom jittieħdu in konsiderazzjoni meta jiġu ko-preskritti prodotti mediċinali b'azzjoni dipressanti fuq is-sistema nervuża ċentrali.
English: Non-clinical data on the general toxicity of mitotane is limited.
Maltese: Tagħrif mhux kliniku dwar it-tossiċità ġenerali ta' mitotane huwa limitat.
English: Your doctor may start treatment at higher doses such as 4 to 6 g (8 to 12 tablets).
Maltese: It-tabib tiegħek jista' jibda kura b'dożi iktar qawwijin bħal 4 sa 6 g (8 sa 12-il pillola)
English: Autoimmune hepatitis has been reported in 7 % of patients with no other information on mechanism.
Maltese: Epatite awtoimmunitarja ġiet rappurtata f'7 % tal-pazjenti mingħajr ebda informazzjoni oħra dwar il-mekkaniżmu.
English: Epigastric discomfort
Maltese: Skumdità epigastrika
English: Liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) should be periodically monitored, especially during the first months of treatment or when it is necessary to increase the dose.
Maltese: It-testijiet tal-funzjoni tal-fwied (alanine transaminase [ALT], aspartate transaminase [AST], livelli tal-bilirubin) għandhom jiġu mmonitorjati perjodikament, b'mod speċjali matul l-ewwel xhur tal-kura jew meta jkun neċessarju li tiżdied id-doża.
English: Treatment in adults should be started with 2 - 3 g mitotane per day and increased progressively (e.g. at two-week intervals) until mitotane plasma levels reach the therapeutic window 14 - 20 mg/l.
Maltese: Il-kura fl-adulti għandha tinbeda minn 2 - 3 g mitotane kuljum u għandha tiżdied progressivament (eż. wara intervalli ta' ġimagħtejn) sakemm il-livelli tal-plażma ta' mitotane jilħqu l-livell terapewtiku 14
English: Vascular disorders
Maltese: Atassja Parasteżija
English: - peripheral nervous system disorders (association of sensory disorders, muscular weakness and atrophy, decrease of tendon reflex and vasomotor symptoms such as hot flushes, sweat and sleep disorders) - mental impairment (such as memory loss, concentration difficulty) - movement disorder - decrease of red blood cells (anaemia, with symptoms such as skin pallor and fatigue), decrease in blood platelets (may make you more prone to bruising and bleeding) - hepatitis (auto-immune) (may cause yellowing of the skin and eyes, dark coloured urine) - difficulty of coordinating muscles
Maltese: - disturbi periferali fis-sistema nervuża: assoċjazzjoni ta' disturbi sensorji, dgħjufija muskolari u atrofija, tnaqqis fir-riflessi tat-tendini u sintomi vażomotorili bħal fwawar sħan, għaraq u disturbi waqt l-irqad) - indeboliment mentali (bħal telfien fil-memorja, diffikultà fil-konċentrazzjoni)
English: This dose of Lysodren was continued or decreased in function of side effects and plasma mitotane levels.
Maltese: Din id-doża ta' Lysodren tkompliet jew tnaqqset skond l-effetti sekondarji u l-livelli ta' mitotane fil-plażma.
English: The dose of your anticoagulant may need adjustment.
Maltese: Riskju ta' indeboliment Adrenali:
English: Therefore, the plasma concentrations of the substances metabolised via cytochrome 3A4 may be modified.
Maltese: Għaldaqstant, il-konċentrazzjonijiet fil-plażma tas-sustanzi metabolizzati permezz ta' cytochrome 3A4 jistgħu jiġu mmodifikati.
English: Caution should be taken when co-prescribing active substances metabolised by this pathway such as, among others, sunitinib and midazolam.
Maltese: Għandha tingħata attenzjoni meta jingħataw sustanzi attivi fl-istess ħin, li jiġu metabolizzati minn dan il-passaġġ bħal, fost l-oħrajn, sunitinib u midazolam.
English: Liver damage (hepatocellular/cholestatic /mixed)
Maltese: Ħsara fil-fwied (epatoċellulari/kolestatika/im ħallta)
English: Renal and urinary disorders
Maltese: Disturbi fil-kliewi u fissistema urinarja
English: Mitotane plasma levels higher than 20 mg/l may be associated with severe undesirable effects and offer no further benefit in terms of efficacy.
Maltese: Livelli tal-plażma ta' mitotane ogħla minn 20 mg/l jistgħu jkunu assoċjati ma' effetti serji mhux mixtieqa u ma joffru ebda benefiċċju addizzjonali f'termini ta' effikaċja.
English: Balance disorders
Maltese: Indeboliment mentali
English: In two of the 3 patients, plasma levels of more than 14 mg/l were achieved within 15 days and in one of them levels above 20 mg/l were achieved within approximately 30 days.
Maltese: F'żewġ pazjenti minn tlieta, livelli fil-plażma ta' aktar minn 14 mg/l intlaħqu fi ħmistax-il ġurnata u f'wieħed minnhom livelli ogħla minn 20 mg/l intlaħqu f'madwar 30 ġurnata.
English: Salivary hypersecretion Dysgeusia
Maltese: Ipersekrezzjoni tas-saliva Disgewżja
English: Blood uric acid decreased Blood androstenedione decreased (in females) Blood testosterone decreased (in females) Sex hormone binding globulin increased Blood free testosterone decreased (in males)
Maltese: Androstenedjon tad-demm imnaqqas (fin-nisa) Testosteron tad-demm imnaqqas (fin-nisa) Globulina li tgħaqqad lormon sesswali żdiedet Testosteron ħieles tad-demm naqas (fl-irġiel)
English: dichlorodiphenyl)-2,2 dichloroethene (o,p'-DDE) analogue of mitotane.
Maltese: mitotane hija rrakkomandat speċjalment f'dawn il-pazjenti (ara sezzjoni 4.4).
English: Hypertension Orthostatic hypotension Flushing
Maltese: Pressjoni għolja Pressjoni ortostatika baxxa
English: The administration of mitotane alters the extra-adrenal metabolism of cortisol in humans, leading to a reduction in measurable 17-hydroxy corticosteroids, even though plasma levels of corticosteroids do not fall.
Maltese: It-teħid ta' mitotane ibiddel ilmetaboliżmu estra-adrenali tal-cortisol fil-bniedem, u jwassal għal tnaqqis fl-ammont ta' 17-hydroxy corticosteroids li jista' jitkejjel, anke jekk il-livelli ta' kortikosterojdi fil-plażma ma jitbaxxewx.
English: Due to the lipophilic nature of mitotane, it is likely to be excreted in breast milk.
Maltese: - Din il-mediċina ġiet mogħtija lilek biss.
English: Monitoring of mitotane plasma levels is specially recommended in these patients (see section 4.4).
Maltese: Losservazzjoni tal-livelli tal-plażma ta' mitotane hija rrakkomandata speċjalment f'dawn il-pazjenti (ara sezzjoni 4.4).
English: In children and adolescents, thyroid problems, neuro-psychological, growth retardation and one case of encephalopathy have been observed.
Maltese: Fi tfal u adoloxxenti, ġew osservati problemi fit-tirojde, nuqqas ta' avvanz newro-psikoloġiku, nuqqas ta' żvilupp fid-daqs u każ wieħed ta' enċefalopatija.
English: Skin rash
Maltese: Raxx tal-ġilda
English: Some of these effects (anorexia) may constitute the hallmark of initial central nervous system impairment.
Maltese: Xi wħud minn dawn l-effetti (anoreksja) jistgħu jindikaw l-bidu ta' indeboliment fis-sistema nervuża ċentrali.
English: Its biochemical mechanism of action is unknown.
Maltese: Il-mekkaniżmu biokimiku ta' l-azzjoni tiegħu mhux magħruf.
English: Breast-feeding is contraindicated while taking mitotane (see section 4.3) and after treatment discontinuation as long as mitotane plasma levels are detectable.
Maltese: It-treddigħ huwa kontra-indikat waqt li jkun qed jingħata mitotane (ara sezzjoni 4.3) u wara li titwaqqaf il-kura diment li l-livelli tal-plażma ta' mitotane ikunu traċċabbli.
English: If it is urgent to control Cushing's symptoms in highly symptomatic patients, higher starting doses between 4 - 6 g per day could be necessary and daily dose increased more rapidly (e.g. every week).
Maltese: Jekk ikun urġenti li s-sintomi ta' Cushing jiġu kkontrollati f'pazjenti b'sintomi qawwijin, jista' jkun hemm bżonn ta' dożi tal-bidu ogħla ta' bejn 4 - 6 g fil-ġurnata u mbagħad id-doża ta' kuljum tiżdied b'rata aktar mgħaġġla (eż. kull ġimgħa).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2)
English: Thyroid impairment
Maltese: Indeboliment tat-tirojde
English: Isolated cases of complicated cysts have been reported (adnexal torsion and haemorrhagic cyst rupture).
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: Always keep with you the Lysodren Patient Card included at the end of this leaflet.
Maltese: Dejjem żomm il-Karta għall-Pazjent ta' Lysodren li hija inkluża fit-tmiem ta' dan il-fuljett.
English: Hyperpyrexia Generalised aching
Maltese: Iperpireksja Uġigħ ġeneralizzat
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX23
Maltese: John's wort (Hypericum perforatum) - Sunitinib: biex jikkura l-kanċer
English: (*) Antigen content (VP2 protein) by immune-assay
Maltese: (*) kontenut tal-antiġen (proteina VP2) permezz ta' immuno-assay
English: Invented name bottles
Maltese: Numru ta' l-UE Isem Ivvintat
English: BTV1 antigen ≥1.9 log10 pixels* BTV2 antigen ≥ 1.82 log10 pixels*
Maltese: BTV 1 antiġen ≥1.9 log10 pixels* BTV 2 antiġen ≥1.82 log10 pixels*
English: BTV4 antigen ≥1.86 log10 pixels* BTV8 antigen ≥ 2.12 log10 pixels*
Maltese: BTV 4 antiġen ≥1.86 log10 pixels* BTV 8 antiġen ≥2.1 log10 pixels*
English: BTV8 antigen ≥2.12 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay
Maltese: BTV 8 antiġen ≥2.12 log10 pixels* (*) kontenut tal-antiġen (proteina VP2) permezz ta' immuno-assay
English: BTV1 antigen ≥1.9 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay
Maltese: BTV 1 antiġen ≥1.9 log10 pixels* (*) kontenut tal-antiġen (proteina VP2) permezz ta' immuno-assay
English: BTV2 antigen ≥1.82 log10 pixels* BTV8 antigen ≥ 2.12 log10 pixels*
Maltese: BTV 2 antiġen ≥1.82 log10 pixels BTV 8 antiġen ≥2.12 log10 pixels
English: --1 BTV2 antigen ≥1.82 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay
Maltese: BTV 2 antiġen ≥1.82 log10 pixels* (*) kontenut tal-antiġen (proteina VP2) permezz ta' immuno-assay
English: --1 BTV4 antigen ≥1.86 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay
Maltese: BTV 4 antiġen ≥1.86 log10 pixels* (*) kontenut tal-antiġen (proteina VP2) permezz ta' immuno-assay
English: Benefit/risk
Maltese: Benefiċċji/riskji
English: Safety
Maltese: Sigurtà
English: Av. António Augusto de Aguiar 128, 1069-133 Lisboa Portugal
Maltese: António Augusto de Aguiar 128, 1069-133 Lisboa Portugal
English: The CHMP did not accept this proposal.
Maltese: Is-CHMP ma aċċettax din il-proposta.
English: Whereas,
Maltese: Billi,
English: LU - Luxembourg
Maltese: Il-Lussemburgu
English: Member State (EEA)
Maltese: MEMBRI (ŻEE)
English: Benfluorex has an action on carbohydrate metabolism.
Maltese: Benfluorex għandu azzjoni fuq il-metaboliżmu talkarboidrati.
English: PT - Portugal
Maltese: Il-Portugall
English: The CHMP considered the matter in accordance with Article 107(2) of Directive 2001/83/EC, as amended, during a written procedure, during the December 2009 and March 2010 CHMP plenary meetings.
Maltese: Is-CHMP ikkunsidra l-kwistjoni skont l-Artikolu 107 (2) tad-Direttiva 2001/83/KE, kif emendata, matul il-proċedura bil-miktub, matul il-laqgħat plenarji tas-CHMP ta' Diċembru 2009 u Marzu 2010.
English: Les laboratoires Servier 22 rue Garnier F-92200 Neuilly-sur-Seine France
Maltese: Les laboratoires Servier 22 rue Garnier F-92200
English: Strength
Maltese: Av.
English: Medicinal products containing benfluorex are authorised in four EU Member States with a tablet formulation, with only 2 countries (France and Portugal) in which the product was marketed up to the suspension of the Marketing Authorisations in November 2009 (see Annex I for the list of benfluorex containing medicinal products authorised in the EU).
Maltese: Il-prodotti mediċinali li fihom benfluorex huma awtorizzati f'erba' Stati Membri tal-UE bilformulazzjoni ta' pillola, b'2 pajjiżi biss (Franza u l-Portugall) fejn il-prodott kien ikkummerċjalizzat sas-sospensjoni tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq f'Novembru 2009 (ara l-Anness I għallista ta' prodotti mediċinali li fihom benfluorex awtorizzati fl-UE).
English: • The Committee considered the benefit-risk ratio of benfluorex under the normal conditions of use and considered that the aforementioned proven risk of cardiac valve disease is not acceptable, taking into account that the benefit of benfluorex is only limited in the treatment of type 2 diabetes.
Maltese: • Il-Kumitat ikkunsidra l-proporzjon tal-benefiċċji-riskji ta' benfluorex taħt il-kundizzjonijiet normali ta' użu u kkunsidra li r-riskju ppruvat msemmi qabel ta' mard tal-valvoli tal-qalb mhuwiex aċċettabbli, filwaqt li qies li l-benefiċċju ta' benfluorex huwa limitat biss fit-trattament tad-dijabete tat-tip 2.
English: SCIENTIFIC CONCLUSIONS
Maltese: SOMMARJU GLOBALI
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing benfluorex.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata, għall-prodotti mediċinali li fihom benfluorex.
English: In Cyprus and Luxembourg, medicinal products containing benfluorex were not marketed any longer.
Maltese: F'Ċipru u l-Lussemburgu, ilprodotti mediċinali li fihom benfluorex ma kinux ikkummerċjalizzati aktar.
English: The MAH, in their written response, considers that there is a consistent significant clinical effect on blood glucose control in all the studies performed with benfluorex in overweight type 2 diabetic patients.
Maltese: IlMAH, fir-risposta bil-miktub tiegħu, iqis li hemm effett kliniku konsistenti sinifikanti fuq il-kontroll tal-glukożju fid-demm fl-istudji kollha mwettqa bi benfluorex f'pazjenti ħoxnin iżżejjed bid-dijabete tat-tip 2.
English: Benfluorex is used as an “Adjuvant therapy of overweight diabetics, in combination with an appropriate diet”.
Maltese: Benfluorex jigi uzat bhala "Terapija aggunta ghal dijabetici obezi, flimkien ma' dieta xierqa".
English: In animals, the following effects have been observed: - Facilitation of precipitation and use of glucose in cells (rats); - Reduction in hyperglycaemia in diabetic rats (insulin deprived or not), decrease in hyperglycaemia (measured by the glucose tolerance test area) in rabbits.
Maltese: - L-iffaċilitar tal-preċipitazzjoni u l-użu ta' glukożju fiċ-ċelloli (firien); - It-tnaqqis fl-ipergliċemija fil-firien dijabetiċi (deprivati mill-insulina jew le), tnaqqis fl-ipergliċemija (imkejla premezz taż-żona tat-test tat-tolleranza tal-glukożju) fil-fniek.
English: FR - France
Maltese: Franza
English: The MAH projected to discontinue the treatment in the event of echocardiographic anomalies.
Maltese: Il-MAH ippjana li jwaqqaf it-trattament fil-każ ta' anomaliji ekokardjografiċi.
English: The currently authorised therapeutic indication in France is as « Adjuvant therapy of overweight diabetics, in combination with an appropriate diet».
Maltese: Lindikazzjoni terapewtika awtorizzata bħalissa fi Franza hija bħala “Terapija addizzjonali ta' dijabetiċi ħoxnin iżżejjed, flimkien ma' dieta xierqa”.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING BENFLUOREX (see Annex I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' PRODOTTI MEDIĊINALI LI FIHOM BENFLUOREX (ara l-Anness I)
English: The updated results of the second national Pharmacovigilance survey, the preliminary data from 3 clinical studies (the retrospective case-control study performed in a Brest hospital, the REGULATE trial and the data from the French National Insurance Fund) and the recent publication from K. Boutet demonstrate the serious risk of cardiac morphological and functional valvulopathies and pulmonary hypertension associated with the use of benfluorex.
Maltese: Ir-riżultati aġġornati tat-tieni stħarriġ nazzjonali ta' Farmakoviġilanza, id-dejta preliminari mressqa minn 3 studji kliniċi (l-istudju retrospettiv bil-kontroll tal-każ imwettaq fl-isptar ta' Brest, il-prova REGULATE u d-dejta mill-Fond tal-Assigurazzjoni Nazzjonali Franċiż) u l-pubblikazzjoni reċenti ta' K. Boutet juru r-riskju serju ta' valvulopatiji kardijaċi morfoloġiċi u funzjonali u pressjoni għolja pulmonari assoċjat mal-użu ta' benfluorex.
English: Further to receipt of the Rapid Alert, the Portuguese Competent Authority also decided to suspend the marketing authorisation of all benfluorex containing medicinal products in Portugal on 30 November
Maltese: Wara li rċeviet it-Twissija Rapida, l-Awtorità Kompetenti Portugiża ddeċidiet ukoll li tissospendi lawtorizzazzjoni għat-tqegħid fis-suq tal-prodotti mediċinali kollha li fihom benfluorex fil-Portugall fit30 ta' Novembru 2009.
English: On 25 November 2009, the French Competent Authority (Afssaps) issued a Rapid Alert informing the Members States, the European Medicines Agency and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of its decision to suspend the marketing authorisations of all benfluorex containing medicinal products in France due to an increased risk of a cardiotoxicity signal (valvular heart diseases) with benfluorex.
Maltese: Fil-25 ta' Novembru 2009, l-Awtorità Kompetenti Franċiża (Afssaps) ħarġet Twissija Rapida biex tinforma lill-Istati Membri, lill-Aġenzija Ewropea għall-Mediċini u lill-Kummissjoni Ewropea skont lArtikolu 107 tad-Direttiva 2001/83/KE, kif emendata, bid-deċiżjoni tagħha li tissospendi lawtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali kollha li fihom benfluorex fi Franza minħabba riskju akbar ta' sinjal ta' kardjotossiċità (mard tal-valvoli tal-qalb) bi benfluorex.
English: The decision of the French Competent Authority was based on updated results of a Pharmacovigilance (PV) survey, preliminary data from 3 clinical studies (the retrospective case-control study performed in a Brest hospital, the REGULATE trial and the data from the French National Insurance Fund) and from a recent publication (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex, Eur Respir.
Maltese: Id-deċiżjoni tal-Awtorità Kompetenti Franċiża kienet ibbażata fuq ir-riżultati aġġornati ta' stħarriġ ta' Farmakoviġilanza (Pharmacovigilance - PV), id-dejta preliminari minn 3 studji kliniċi (l-istudju retrospettiv bil-kontroll tal-każ imwettaq fl-isptar ta' Brest, il-prova REGULATE u d-dejta mill-Fond tal-Assigurazzjoni Nazzjonali Franċiż) u minn pubblikazzjoni reċenti (K. Boutet Effetti Sekondarji Kardjovaskulari ta' Benfluorex Simili għal Fenfluramine, Eur Respir. J. 2009; 33: 684-688) li urew riskju ta' mard tal-valvoli tal-qalb u pressjoni għolja pulmonarja (pulmonary hypertension - PHT) għall-pazjenti ttrattati bi benfluorex.
English: However, the CHMP maintains the opinion that these data further confirm the safety signal of a risk of cardiac valve disorders with the use of benfluorex.
Maltese: Madankollu, isCHMP isostni l-opinjoni li din id-dejta tikkonferma aktar is-sinjal ta' sigurtà ta' riskju ta' disturbi talvalvoli tal-qalb bl-użu ta' benfluorex.
English: As stated in the MAH's written response, at the time of the national evaluation of the cardiac valvular abnormality, the MAH proposed to maintain benfluorex on the market with a restriction to the indication in patients with no ultrasound evidence of valve anomalies and the implementation of echocardiographic monitoring.
Maltese: Kif iddikjarat fir-risposta bil-miktub tal-MAH, fil-mument tal-evalwazzjoni nazzjonali tal-anormalità valvulari tal-qalb, il-MAH ippropona li jżomm benfluorex fis-suq b'restrizzjoni għall-indikazzjoni f'pazjenti bl-ebda evidenza ultrasonika ta' anomaliji fil-valvoli u l-implimentazzjoni ta' monitoraġġ ekokardjografiku.
English: • The Committee concluded, after having reviewed the available data, that benfluorex is harmful under normal conditions of use leading to pulmonary hypertension and cardiac valvulopathies.
Maltese: • Il-Kumitat ikkonkluda, wara li rreveda d-dejta disponibbli, li benfluorex huwa ta' ħsara taħt kundizzjonijiet normali ta' użu u jwassal għal pressjoni għolja pulmonari u valvulopatiji kardijaċi.
English: Marketing Authorisation Holder Invented Name
Maltese: ANNESS I LISTA
English: The imprecision regarding information about the diagnosis of cardiac valve disease and the limited number of patients identified as presenting cardiac valve disease and treated with benfluorex (35 patients) were pointed out by the MAH.
Maltese: L-impreċiżjoni rigward l-informazzjoni dwar il-dijanjożi tal-mard tal-valvoli tal-qalb u l-għadd limitat ta' pazjenti identifikati bħala wħud li jippreżentaw mard talvalvoli tal-qalb u li huma trattati bi benfluorex (35 pazjent) ġew indikati mill-MAH.