FrancophonIA/ELRC3.0 huggingface dataset:
English: When advanced age is associated with decrease in renal function Lisonorm dose adjustments for patients with renal impairment apply (see section 4.2).
Maltese: Meta età avvanzata hija assoċjata ma' tnaqqis fil-funzjoni renali, tibdiliet fid-doża ta' Lisonorm għal pazjenti b'indeboliment tal-kliewi għandhom jiġu fis-seħħ (ara sezzjoni 4.2).
English: Patients at risk for the development of hyperkalaemia include those with renal impairment, diabetes mellitus, acute cardiac decompensation, dehydration, metabolic acidosis, or concomitant use of potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes, or any medicinal products associated with increases in potassium serum levels (e.g. heparin).
Maltese: Pazjenti f'riskju li jistgħu jiżviluppaw iperkalemja jinkludu dawk b'indeboliment renali, dijabete mellitus, dekompensazzjoni kardijata akuta, deidrazzjoni, aċidosi metabolika, jew l-użu konkomitanti ta' dijuretiċi li ma jħallux il-potassju joħroġ fl-awrina, supplimenti tal-potassju jew mluħa sostituti li jkun fihom il-potassju, jew kull prodott mediċinali ieħor assoċjat ma żidiet fil-livell ta' potassju fisserum (eż. heparin).
English: Potassium-sparing diuretics (such as spironolactone, amiloride, triamterene, used to reduce fluid retention) may only be taken together with Lisonorm under close medical supervision.
Maltese: Dijuretiċi li jħallux il-potassju joħroġ fl-awrina (bħal spironolactone, amiloride, triamterene, użati biex inaqqsu l-akkumulazzjoni tal-fluwidi) jistgħu jittieħdu flimkien ma' Lisonorm taħt superviżjoni medika attenta.
English: 24 November 2010.
Maltese: sal-24 ta' Novembru 2010.
English: Fred Hargreaves of BNP Paribas Real Estate (point 16)
Maltese: Fred Hargreaves tal-BNP Paribas Real Estate (punt 16)
English: Maarit Kokki of ECDC (point 17)
Maltese: Maarit Kokki tal-ECDC (punt 17)
English: Thomas Lönngren ends his 10-year mandate on 31 December 2010.
Maltese: Thomas Lönngren itemm il-mandat ta' 10 snin tiegħu fil-31 ta' Diċembru 2010.
English: • Review of the Transparency Directive.
Maltese: • Reviżjoni tad-Direttiva dwar it-Trasparenza.
English: List of participants
Maltese: Lista ta' parteċipanti
English: The budget is €10.1 million lower than the preliminary draft budget adopted in March 2010.
Maltese: Il-baġit huwa €10.1 miljun inqas mill-abbozz ta' baġit preliminari adottat f'Marzu 2010.
English: The reduction is largely due to a lower than requested Community contribution (-€8.64 million) and reduced fee revenue estimates (-€1.96 million).
Maltese: It-tnaqqis huwa primarjament dovut għal kontribuzzjoni Komunitarja aktar baxxa milli mitlub (€8.64 miljun inqas) u għal tnaqqis fl-estimi taddħul mill-ħlasijiet (€1.96 miljun inqas).
English: Sara Mendosa Agnès Saint Raymond Vincenzo Salvatore Hans-Georg Eichler Emer Cooke Arielle North Nerimantas Steikūnas Zuzana O'Callaghan
Maltese: Sara Mendosa Agnès Saint Raymond Vincenzo Salvatore Hans-Georg Eichler Emer Cooke Arielle North Nerimantas Steikūnas Zuzana
English: The following members agreed to participate in this work: Aginus Kalis, Marcus Müllner, Björn Lemmer, Tamás Paál, Rita Purcell, Guido Rasi, Lisette Tiddens and Gro Wesenberg.
Maltese: Aginus Kalis, Marcus Müllner, Björn Lemmer, Tamás Paál, Rita Purcell, Guido Rasi, Lisette Tiddens u Gro Wesenberg.
English: • Sustainable and responsible competitiveness: the Process on Corporate Responsibility in the field of Pharmaceuticals.
Maltese: • Kompetittività sostenibbli u responsabbli: il-Proċess dwar ir-Responsabbiltà Korporattiva fil-qasam tal-Prodotti Farmaċewtiċi.
English: Rannveig Gunnarsdóttir (Iceland)
Maltese: Rannveig Gunnarsdóttir (lIslanda)
English: (The Board noted that a shortlist of candidates will be presented to the Board by the end of March 2011 at the earliest.
Maltese: (Il-Bord innota li lista qasira ta' kandidati ser tiġi ppreżentata lill-Bord sal-aħħar ta' Marzu 2011 l-aktar kmieni.
English: The budget is in line with the work programme and totals €208.9 million (0.23% increase over the 2010 budget), which includes a general EU contribution of €28 million, the 2009 surplus of €5.4 million and the €4.9 million orphan medicinal products fund.
Maltese: Il-baġit huwa konformi mal-programm ta' ħidma u jammonta għal total ta' €208.9 miljun (żieda ta' 0.23% fuq il-baġit tal-2010), li jinkludi kontribuzzjoni ġenerali tal-UE ta' €28 miljun, l-eċċess ta' €5.4 miljun tal-2009 u l-fond ta' €4.9 miljun għall-prodotti mediċinali orfni.
English: • [EMA/MB/821069/2010] Periodic report on signal detection activities and EudraVigilance - Interim report - 01/01/10 to 30/06/10.
Maltese: EudraViġilanza - Rapport Interim - 01/01/10 sat-30/06/10.
English: Members were invited to provide their comments and alternative proposals for the 16 March meeting.
Maltese: Il-membri kienu mistiedna jipprovdu l-kummenti u l-proposti alternattivi tagħhom għal-laqgħa tas-16 ta' Marzu.
English: The road map underwent extensive public consultation, during which 71 contributions were received from EU Institutions, Member State competent authorities, European patients/consumers' organisations, European healthcare professionals' organisations and other stakeholders.
Maltese: Il-pjan direzzjonali għadda minn konsultazzjoni pubblika estensiva, li matulha ġew irċevuti 71 kontribuzzjoni mill-Istituzzjonijiet tal-UE, mill-awtoritajiet kompetenti tal-Istati Membri, minn organizzazzjonijiet Ewropej tal-pazjenti/konsumaturi, minn organizzazzjonijiet Ewropej talprofessjonisti tal-kura tas-saħħa u minn partijiet interessati oħrajn.
English: The earlier announced date of 24 February 2011 has been cancelled.)
Maltese: Id-data tal24 ta' Frar 2011 imħabbra aktar kmieni tħassret.)
English: 7 February 2011 EMA/MB/808316/2010 corr.
Maltese: 7 ta' Frar 2011 EMA/440498/2011 corr.
English: Held in London on 16 December 2010
Maltese: Li saret f'Londra fis-16 ta' Diċembru 2010
English: [EMA/MB/783955/2010; EMA/520678/2010] The Management Board endorsed the working arrangements with ECDC.
Maltese: [EMA/MB/783955/2010; EMA/520678/2010] Il-Bord ta' Tmexxija approva l-arranġamenti tax-xogħol mal-ECDC.
English: Once implemented, the policies will provide stakeholders with different levels of access to suspected adverse reaction reports contained in the EudraVigilance database.
Maltese: Ladarba jiġu implimentati, il-politiki jipprovdu lill-partijiet interessati b'livelli differenti ta' aċċess għal rapporti dwar suspetti ta' reazzjonijiet avversi li jinsabu fid-database tal-EudraViġilanza.
English: This will be discussed at the Heads of Medicines Agencies meeting and then with stakeholders.
Maltese: Dan ser jiġi diskuss waqt illaqgħa tal-Kapijiet tal-Aġenziji tal-Mediċina u mbagħad mal-partijiet interessati.
English: [EMA/MB/482208/2010] The Management Board adopted the work programme 2011.
Maltese: [EMA/MB/482208/2010] Il-Bord ta' Tmexxija adotta l-programm ta' ħidma 2011.
English: [EMA/MB/751837/2010] The Management Board endorsed the hourly cost for 2011 of €40 (the same rate as in 2009 and 2010).
Maltese: [EMA/MB/751837/2010] Il-Bord ta' Tmexxija approva l-ispiża ta' €40 fis-siegħa għall-2011 (l-istess rata bħal fl-2009 u fl-2010).
English: Other priority areas remain similar to the previous years'.
Maltese: Oqsma prijoritarji oħrajn jibqgħu simili għas-snin ta' qabel'.
English: Members added a new point about potential quality defects of certain medicinal products for peritoneal dialysis.
Maltese: Il-membri żiedu punt ġdid dwar id-difetti potenzjali fil-kwalità ta' ċerti prodotti mediċinali għad-dijalisi tal-peritonew.
English: The priorities for 2011 are in line with the 'Road map to 2015' and ensure continuity from the previous years.
Maltese: Il-prijoritajiet għall2011 huma konformi mal-‘Pjan direzzjonali għall-2015' u jassiguraw il-kontinwità mis-snin ta' qabel.
English: The Board endorsed the document that was prepared following a teleconference with the Management Board topic coordinators (the Chair, Austria, Denmark and France).
Maltese: Il-Bord approva d-dokument li tħejja wara telekonferenza mal-koordinaturi tas-suġġetti tal-Bord ta' Tmexxija (il-President, l-Awstrija, idDanimarka u Franza).
English: [EMA/MB/784261/2010; EMA/MB/132208/2010; EMA/MB/637740/2010] Following the adoption of the EU budget, this agenda point was presented to the Management Board for adoption.
Maltese: [EMA/MB/784261/2010; EMA/MB/132208/2010; EMA/MB/637740/2010] Wara l-adozzjoni tal-baġit talUE, dan il-punt tal-aġenda ġie ppreżentat lill-Bord ta' Tmexxija għall-adozzjoni.
English: • [EMA/674449/2010] Update report on the Agency's implementation of the EU telematics strategy.
Maltese: • [EMA/674449/2010] Rapport ta' aġġornament dwar l-implimentazzjoni tal-istrateġija tat telematika tal-UE mill-Aġenzija.
English: The members stressed that remuneration of national competent authorities for non-fee related activities is particularly acute, and needs to be addressed to assure sustainable performance of the network.
Maltese: Il-membri enfasizzaw li r-rimunerazzjoni tal-awtoritajiet nazzjonali kompetenti għal attivitajiet relatati mingħajr ħlas hija partikolarment qawwija, u jeħtieġ li tiġi indirizzata sabiex tiġi assigurata prestazzjoni sostenibbli tan-netwerk.
English: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Maltese: Brigitte Batliner (il-Liechtenstein)
English: ICT planning and priorities 2011
Maltese: Programm ta' ħidma 2011
English: Members exchanged information about the handling of the quality defects of certain medicinal products for peritoneal dialysis.
Maltese: Il-membri skambjaw l-informazzjoni dwar it-trattament tad-difetti fil-kwalità ta' ċerti prodotti mediċinali għad-dijalisi tal-peritonew.
English: • [EMA/MB/694689/2010] Summary of transfers of appropriations in the budget 2010.
Maltese: • [EMA/MB/694689/2010] Sommarju tat-trasferimenti tal-approprjazzjonijiet fil-baġit għall-2010.
English: The arrangements outline the areas in which enhanced cooperation may take place, make provision for mutual consultation and coordination, and address confidentiality issues.
Maltese: L-arranġamenti jiddeskrivu l-oqsma fejn jista' jkun hemm kooperazzjoni mtejba, jagħmlu dispożizzjoni għal konsultazzjoni reċiproka u koordinazzjoni, u jindirizzaw il-kwistjonijiet ta' kunfidenzjalità.
English: [EMA/MB/660138/2010] The agenda was adopted with amendments.
Maltese: [EMA/MB/660138/2010] L-aġenda ġiet adottata b'xi emendi.
English: Points 8 (Implementation of budget 2011 with provisional twelfth) and 10 (transfers of appropriations in accordance with Article 23 (2) of the Financial Regulation) were cancelled.
Maltese: Il-Punti 8 (Implimentazzjoni tal-baġit 2011 b'parti minn kull tnax provviżorja) u 10 (trasferimenti ta' approprjazzjonijiet skont l-Artikolu 23 (2) tar-Regolament Finanzjarju) tħassru.
English: (An impact assessment has been launched, to be followed by a public consultation by March 2011, before issuing a final report by June 2011.)
Maltese: (Kienet imnedija valutazzjoni tal-impatt, li għandha tiġi segwita minn konsultazzjoni pubblika sa Marzu 2011, qabel jinħareġ rapport finali sa Ġunju
English: • [EMA/MB/743560/2010] Update report from the Management Board Telematics Committee.
Maltese: • [EMA/MB/743560/2010] Rapport ta' aġġornament mill-Kumitat tat-Telematika tal-Bord ta'
English: Point 6 (budget 2011) was changed from ‘for endorsement' to ‘for adoption'.
Maltese: Il-Punt 6 (baġit 2011) inbidel minn ‘għallapprovazzjoni' għal ‘għall-adozzjoni'.
English: • [EMA/MB/719548/2010] Ash cloud impact report.
Maltese: • [EMA/MB/719548/2010] Rapport dwar l-impatt tal-isħaba ta' rmied.
English: [EMA/MB/628133/2010] The Management Board adopted the minutes.
Maltese: [EMA/MB/628133/2010] Il-Bord ta' Tmexxija adotta l-minuti.
English: Members did not raise additional questions.
Maltese: Ilmembri ma għamlu ebda mistoqsija addizzjonali.
English: Financial compensation for Member States' participation in linguistic checking - fixed flat hourly cost for 2011
Maltese: Kumpens finanzjarju għall-parteċipazzjoni tal-Istati Membri fil-verifika lingwistika - spiża b'rata fissa fis-siegħa għall-2011
English: [EMA/MB/739310/2010] Following the comments received during the written consultation procedure, the Management Board endorsed the nomination to the CVMP and concluded the consultation procedure.
Maltese: [EMA/MB/739310/2010] Wara l-kummenti rċevuti matul il-proċedura ta' konsultazzjoni bil-miktub, ilBord ta' Tmexxija approva n-nominazzjoni għas-CVMP u kkonkluda l-proċedura ta' konsultazzjoni.
English: [EMA/MB/739310/2010] The Management Board discussed ways to streamline the consultation procedure.
Maltese: [EMA/MB/739310/2010] Il-Bord ta' Tmexxija ddiskuta modi kif tista' tiġi ssimplifikata l-proċedura ta' konsultazzjoni.
English: • Progress on review of the veterinary medicines legislation.
Maltese: • Progress dwar ir-reviżjoni tal-leġiżlazzjoni dwar il-mediċini veterinarji.
English: [EMA/MB/784727/2010; EMA/MB/791259/2010] According to the legislation, the European Commission has to set up a system for vigilance and traceability of SoHO. ECDC had prepared a paper outlining the management of operational EU-level tasks related to substances of human origin.
Maltese: [EMA/MB/784727/2010; EMA/MB/791259/2010] Skont il-leġiżlazzjoni, il-Kummissjoni Ewropea waqqfet sistema għall-viġilanza u t-traċċabilità tal-SoHO.
English: A number of meetings with stakeholders took place.
Maltese: Saru wkoll għadd ta' laqgħat ma' partijiet interessati.
English: From vision to reality
Maltese: Minn viżjoni għar-realtà
English: The extraordinary meeting for interviewing and nominating the Executive Director is scheduled for 5 May 2011.
Maltese: Il-laqgħa straordinarja għallintervistar u n-nominazzjoni tad-Direttur Eżekuttiv hija skedata għall-5 ta' Mejju 2011.
English: • [EMA/MB/739297/2010] Outcome of written procedures during the period from 17 October 2010 to
Maltese: • [EMA/MB/739297/2010] Riżultat tal-proċeduri bil-miktub matul il-perjodu mis-17 ta' Ottubru 2010
English: The Board was unanimous in its opinion that the procedures should not be suspended in all cases where observations from members are received.
Maltese: Il-Bord kien unanimu fil-fehma tiegħu li l-proċeduri m'għandhomx jiġu sospiżi fil-każijiet kollha fejn ġew irċevuti osservazzjonijiet mill-membri.
English: The meeting reflected on a wider issue: potential risks to supply of medicines in cases where patients become dependent on special delivery systems that lack intercompatibility across products.
Maltese: Il-laqgħa rriflettiet fuq kwistjoni usa': ir-riskji potenzjali għallprovvista ta' mediċini f'każijiet fejn il-pazjenti jsiru dipendenti fuq sistemi ta' kunsinna speċjali li għandhom nuqqas ta' interkompatibbiltà fost il-prodotti.
English: Road map to 2015
Maltese: Pjan direzzjonali għall-2015.
English: Management Board consultation procedure for nominations to Committees for Medicinal Products for Human and Veterinary Use (CHMP and CVMP)
Maltese: Proċedura ta' konsultazzjoni tal-Bord ta' Tmexxija għal nominazzjonijiet għall-Kumitati għall-Prodotti Mediċinali għal Użu mill-Bniedem u dawk għal Użu Veterinarju (CHMP u CVMP)
English: As discussed at earlier meetings, one of the options is to amend the format of application dossiers in such a way that publication of non-confidential information can be done without redaction.
Maltese: Kif ġie diskuss f'laqgħat li saru aktar kmieni, waħda mill-għażliet hija li l-format tad-dossiers talapplikazzjoni jiġi emendat b'tali mod li l-pubblikazzjoni tal-informazzjoni mhux kunfidenzjali tkun tista' ssir mingħajr redazzjoni.
English: European Commission Paola Testori Coggi Pedro Ortun Silvan
Maltese: Il-Parlament Ewropew Björn Lemmer Il-Kummissjoni Ewropea Paola Testori Coggi
English: • Legislative proposals on information to patients (the European Parliament adopted its resolution in November 2010, and on this basis the Commission will present a modified proposal).
Maltese: • Proposti leġiżlattivi dwar l-informazzjoni lill-pazjenti (il-Parlament Ewropew adotta r-riżoluzzjoni tiegħu f'Novembru 2010, u fuq din il-bażi l-Kummissjoni sejra tippreżenta proposta mmodifikata).
English: [EMA/MB/761407/2010] The Management Board adopted the 'Road map to 2015', which outlines the Agency's vision for the coming years.
Maltese: [EMA/MB/761407/2010] Il-Bord ta' Tmexxija adotta l-‘Pjan Direzzjonali għall-2015', li jispjega l-viżjoni tal-Aġenzija għas-snin li ġejjin.
English: [EMA/MB/754407/2010; EMA/MB/777113/2010] The Management Board adopted the EudraVigilance access policies for medicinal products for human and veterinary use.
Maltese: EMA/MB/777113/2010] Il-Bord ta' Tmexxija adotta l-politiki ta' aċċess talEudraviġilanza għal prodotti mediċinali għal użu mill-bniedem u dawk għal użu veterinarju.
English: The members noted the written update from the Heads of Medicines Agencies (HMA).
Maltese: Il-membri ħadu nota tal-aġġornament bil-miktub mill-Kapijiet tal-Aġenziji tal-Mediċini (Heads of Medicines Agencies - HMA).
English: Minutes of the 69th meeting of the Management Board
Maltese: Minuti tad-69 laqgħa tal-Bord ta' Tmexxija
English: This is an overarching document that will be supplemented by specific annexes related to the operational areas in the future.
Maltese: Dan huwa dokument importanti ħafna li ser ikun supplimentat minn annessi speċifiċi relatati mal-oqsma operattivi fil-futur.
English: (It will be presented with medicated feed in a package in 2012.)
Maltese: (Dan sejjer jiġi ppreżentat b'għalf immedikat f'pakkett fl-2012.)
English: Members also reflected on what could be a desirable professional profile (scientific, regulatory, other) of members of the scientific committees, and how this can be demonstrated.
Maltese: Il-membri rriflettew ukoll fuq x'jista' jkun profil professjonali mixtieq (xjentifiku, regolatorju, oħrajn) tal-membri tal-kumitati xjentifiċi, u kif dan jista' jintwera.
English: The legislation vests new or extended responsibilities on the Agency in various areas, including periodic safety update reports, adverse drug reactions, communication, risk management and audits of pharmacovigilance systems.
Maltese: Il-leġiżlazzjoni tawtorizza responsabbiltajiet ġodda jew estiżi fuq l-Aġenzija f'diversi oqsma, inkluż ir-rapporti ta' aġġornament perjodiċi dwar is-sigurtà, irreazzjonijiet avversi tal-mediċina, il-komunikazzjoni, il-ġestjoni tar-riskji u l-verifiki tas-sistemi talfarmakoviġilanza.
English: Road map
Maltese: Dokumenti mressqa
English: This was the last Management Board meeting for Thomas Lönngren as the Executive Director of the Agency.
Maltese: Din kienet l-aħħar laqgħa tal-Bord ta' Tmexxija għal Thomas Lönngren bħala d-Direttur Eżekuttiv talAġenzija.
English: Those competencies should be clearly reflected in the CVs of nominees, and an explanation given in cases where the relevance of the expertise of proposed candidates is not obvious.
Maltese: Dawk il-kompetenzi għandhom ikunu riflessi b'mod ċar fisCVs tal-persuni nominati, u għandha tingħata spjegazzjoni f'dawk il-każijiet fejn ir-rilevanza talkompetenza tal-kandidati proposti ma tkunx ovvja.
English: The opinion relates to procurement cases.
Maltese: L-opinjoni hija relatata ma' każijiet ta' akkwist.
English: In March, the Management Board plans to hold a two-day meeting.
Maltese: F'Marzu, il-Bord ta' Tmexxija qiegħed jippjana li jorganizza laqgħa ta' jumejn.
English: • Pharmacovigilance legislation (the publication is imminent and the new legislation will be applicable mid 2012).
Maltese: • Il-leġiżlazzjoni dwar il-farmakoviġilanza (il-pubblikazzjoni hija imminenti u l-leġiżlazzjoni l-ġdida ser tkun applikabbli minn nofs l-2012).
English: 24 April 2012
Maltese: 24 ta' April 2012
English: EMA/CHMP/113837/2012 Rev. 1 EMEA/H/C/000854/A20/0029 EMEA/H/C/000154/A-20/0057 EMEA/H/A-31/1318
Maltese: 1 EMEA/H/C/000854/A20/0029 EMEA/H/C/000154/A-20/0057 EMEA/H/A-31/1318
English: Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 31 of Directive 2001/83/EC
Maltese: Riżultati tal-proċeduri taħt l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 u l-Artikolu 31 tad-Direttiva 2001/83/KE
English: The current European public assessment report for Alli can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is orlistat?
Maltese: X'inhu orlistat?
English: A number of generic orlistat-containing medicines have also been authorised via national procedures in Belgium, Bulgaria, Denmark, Estonia, Latvia, Lithuania, Norway, Portugal, Slovakia, the Netherlands, and the United Kingdom.
Maltese: Għadd ta' mediċini ġeneriċi li fihom l-orlistat ukoll ġew awtorizzati permezz ta' proċeduri nazzjonali filBelġju, il-Bulgarija, id-Danimarka, l-Estonja, il-Latvja, il-Litwanja, in-Norveġja, il-Portugall, is-Slovakja, il-Pajjiżi l-Baxxi u r-Renju Unit.
English: Xenical and Alli are together estimated to have been used by over 53 million people worldwide, with over 20 million in the EU.
Maltese: Xenical u Alli flimkien huma stmati li ntużaw minn aktar minn 53 miljun persuna mad-dinja kollha, b'aktar minn 20 miljun fl-UE.
English: The European Commission issued a decision for Orlistat Art. 31 on 24 April 2012.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar l-orlistat skont l-Artikolu 31 fl-24 ta' April 2012.
English: Alli was authorised in 2007 and is available as capsules (60 mg) and chewable tablets (27 mg) which can be obtained without a prescription (‘over-the-counter').
Maltese: Alli kien awtorizzat fl-2007 u jiġi f'kapsuli (60 mg) u pilloli li tomgħodhom (27 mg) li jistgħu jinkisbu mingħajr riċetta (‘over-the-counter').
English: Orlistat is an anti-obesity medicine, which does not affect appetite.
Maltese: L-orlistat hija mediċina ta' kontra l-obeżità, li ma taffettwax l-aptit.
English: Orlistat blocks the action of gastrointestinal lipases (enzymes that digest fat).
Maltese: L-orlistat timblokka l-azzjoni ta' lipażi gastrointestinali (enzimi li jimmetabolizzaw ix-xaħam).
English: Xenical was authorised in 1998 and is available as capsules (120 mg) which can only be obtained with a prescription.
Maltese: Xenical kien awtorizzat fl-1998 u jiġi f'kapsuli (120 mg) li jistgħu jinkisbu biss b'riċetta tat-tabib.
English: Recent safety monitoring showed that from August 2009 to January 2011 four cases of severe liver injury were reported in patients using Xenical where the role of orlistat could not be excluded, including one fatal case of liver failure and one case leading to liver transplantation.
Maltese: Sorveljanza reċenti tas-sigurtà wriet li minn Awwissu 2009 sa Jannar 2011 ġew irrappurtati erba' każi ta' ħsara serja fil-fwied f'pazjenti li kienu qegħdin jużaw Xenical fejn l-irwol tal-orlistat ma setax jiġi eskluż, inkluż każ fatali wieħed ta' insuffiċjenza talfwied u każ ieħor li wassal għal trapjant tal-fwied.
English: • Patients and prescribers should be aware that certain liver-related problems, including very rare serious reactions such as hepatitis, have been reported and are listed in the product information for orlistat-containing medicines as possible side effects.
Maltese: • Il-pazjenti u dawk li jippreskrivu għandhom ikunu jafu li ġew irrapportati ċerti problemi marbuta mal-fwied, inklużi reazzjonijiet serji rari ħafna bħall-epatite, u dawn huma elenkati fl-informazzjoni dwar il-prodott għall-mediċini li fihom l-orlistat bħala effetti sekondarji possibbli.
English: The product information for orlistat-containing medicines lists hepatitis, cholelithiasis (gall stones) and a change in liver enzyme levels as potential liver-related side effects.
Maltese: L-informazzjoni dwar il-prodott għall-mediċini li fihom l-orlistat issemmi l epatite, il-kolelitijażi (ġebla fil-marrara) u tibdil fil-livelli tal-enzimi fil-fwied bħala effetti sekondarji possibbli marbuta mal-fwied.
English: Since 2001 it has been recognised that some patients taking orlistat could experience very rare liverrelated side effects.
Maltese: Sa mill-2001 kien rikonoxxut li ċerti pazjenti li jieħdu l-orlistat jista' jkollhom effetti sekondarji rari ħafna marbuta mal-fwied.
English: Why was orlistat reviewed?
Maltese: Għalxiex ġiet ridevuta l-orlistat?