FrancophonIA/ELRC3.0 huggingface dataset:
English: • Letter from EURODIS (dated 7 December 2009).
Maltese: • Ittra minn EURODIS (datata s-7 ta' Diċembru 2009).
English: European Commission Heinz Zourek Isabel de la Mata
Maltese: Heinz Zourek Isabel de la Mata
English: Chair: Pat O'Mahony Vice-chair: Lisette Engwirda-Tiddens
Maltese: President: Pat O'Mahony Viċi President: Lisette Engwirda-Tiddens
English: March 2010 meeting
Maltese: Laqgħa ta' Marzu 2010
English: • Supplement to Agenda point 12b.
Maltese: • Suppliment għall-punt 12b tal-Aġenda.
English: The budget is €13.6 million lower than the preliminary draft budget adopted in March 2009.
Maltese: €13.6 miljuni inqas mill-abbozz tal-baġit preliminari li ġie adottat f'Marzu 2009.
English: • safety-monitoring of medicines;
Maltese: • monitoraġġ tas-sigurtà tal-mediċini;
English: Professor Larry Phillips of the London School of Economics will lead the discussions.
Maltese: Il-Professur Larry Phillips tal-Iskola talEkonomija f'Londra sejjer imexxi d-diskussjonijiet.
English: Rannveig Gunnarsdóttir (Iceland) Gro Ramsten Wesenberg (Norway) Brigitte Batliner (Liechtenstein)
Maltese: Rannveig Gunnarsdóttir (L-Iżlanda) Gro Ramsten Wesenberg (InNorveġja)
English: • Charter of the Internal Audit Service of the Commission.
Maltese: • Karta tas-Servizz ta' Verifika Interna tal-Kummissjoni.
English: The budget is in line with the work programme and totals €198.2 million (1.95% increase over the 2009 budget), which includes a general EU contribution of €32.6 million and the €4.5 million orphan medicinal products fund.
Maltese: Il-baġit huwa konformi mal-programm ta' ħidma u jammonta għal total ta' €198.2 miljuni (żieda ta' 1.95% fuq il-baġit tal-2009), li jinkludi kontribuzzjoni ġenerali tal-UE ta' €32.6 miljuni u l-fond ta' €4.5 miljuni għal prodotti mediċinali orfni.
English: H1N1 pandemic update
Maltese: Aġġornament dwar il-pandemija tal-H1N1
English: 18 March 2010 EMA/MB/806136/2009
Maltese: EMA/440674/2011
English: Financial compensation for Members States' participation in linguistic checks
Maltese: Kumpens finanzjarju għall-parteċipazzjoni tal-Istati Membri f'kontrolli lingwistiċi
English: • move of the Pharmaceutical Units F2 and F3 (cosmetics and medical devices) to DG Sanco;
Maltese: F2 u F3 (kosmetiċi u tagħmir mediku) għad-DĠ Sanco;
English: 8 January 2010);
Maltese: 18 ta' Marzu 2010
English: Report from the Heads of Medicines Agencies The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including: publication of information on e-readiness in each of the national competent authorities; the creation of the network of HMA contacts on medicines advertising; the veterinary SPC harmonisation project; and revision of the action plan in the field of antimicrobial resistance.
Maltese: Il-membri ħadu nota tar-rapport ta' aġġornament mill-Kapijiet tal-Aġenziji tal-Mediċini (HMA) fuq għadd ta' suġġetti, inklużi: il-pubblikazzjoni ta' informazzjoni dwar il-prontezza elettronika f'kull waħda mill-awtoritajiet kompetenti nazzjonali; il-ħolqien tan-netwerk ta' kuntatti tal-HMA dwar ir-reklamar tal-mediċini; il-proġett ta' armonizzazzjoni veterinarja ta' SPC; u r-reviżjoni tal-pjan ta' azzjoni filqasam tar-reżistenza antimikrobjali.
English: London, 10 December 2009
Maltese: Londra, l-10 ta' Diċembru 2009
English: [EMEA/MB/672992/2009] The agenda was adopted.
Maltese: [EMEA/MB/672992/2009] L-aġenda ġiet adottata.
English: − Minutes of the 64th meeting of the Management Board.
Maltese: Minuti tal-64 laqgħa tal-Bord ta' Tmexxija.
English: Revised reimbursement rules for delegates
Maltese: Regoli riveduti dwar ir-rimborż għad-delegati
English: New visual identity
Maltese: Identità viżiva ġdida
English: [EMEA/MB/728947/2009] The Board adopted the revised reimbursement rules for delegates.
Maltese: [EMEA/MB/728947/2009] Il-Bord adotta r-regoli riveduti dwar ir-rimborż għad-delegati.
English: Alternates and other participants veterinarians' organisations Observers
Maltese: Rappreżentant talorganizzazzjonijiet veterinarji
English: The EudraVigilance Veterinary (EVVet) status report will be made available to the Board at the same time.
Maltese: Ir-rapport ta' status EudraVigilance Veterinary (EVVet) sejjer jitpoġġa disponibbli għall-Bord fl-istess ħin.
English: Lenka Balážová
Maltese: Ir-Repubblika Ċeka Lenka Balážová
English: 10(a) Management Board Telematics Committee
Maltese: 10(a) Kumitat tat-Telematika tal-Bord ta' Tmexxija
English: Payment system to Member States
Maltese: Sistema ta' ħlas lill-Istati Membri
English: • [EMEA/MB/617640/2009] Summary of transfers of appropriations in the budget 2009.
Maltese: • [EMEA/MB/617640/2009] Sommarju tat-trasferimenti tal-approprijazzjonijiet fil-baġit 2009.
English: • progress on the two legal proposals (pharmacovigilance and falsified medicines legislation);
Maltese: • il-progress dwar iż-żewġ proposti legali (farmakoviġilanza u leġiżlazzjoni dwar il-mediċini ffalsifikati);
English: • [EMEA/MB/528743/2009] Update report on EMEA implementation of the EU telematics strategy.
Maltese: • [EMEA/MB/528743/2009] Rapport ta' aġġornament dwar l-implimentazzjoni tal-EMEA tal istrateġija tat-telematika tal-UE.
English: The Executive Director met with Mr John Dalli to discuss the trends in the pharmaceutical environment and future challenges.
Maltese: Id-Direttur Eżekuttiv iltaqa' mas-Sur John Dalli sabiex jiddiskutu x-xejriet fl-ambjent farmaċewtiku u lisfidi futuri.
English: Participation of patients/consumers' representatives as observers to the PhVWP
Maltese: Il-parteċipazzjoni tar-rappreżentanti tal-pazjenti/konsumaturi bħala osservaturi għallPhVWP
English: • [EMEA/MB/715154/2009] Outcome of written procedures:
Maltese: • [EMEA/MB/715154/2009] Eżitu tal-proċeduri bil-miktub:
English: Slovenia
Maltese: Is-Slovenija
English: • focus on core business (including addressing the growing volume of activities in such areas as post-authorisation activities and orphan medicinal products);
Maltese: • enfasi fuq l-attivitajiet prinċipali (inkluż l-indirizzar tal-volum dejjem jikber ta' attivitajiet f'oqsma bħal attivitajiet ta' wara l-awtorizzazzjoni u prodotti mediċinali orfni);
English: [EMEA/MB/628139/2009; EMEA/MB/700124/2009; EMEA/MB/579221/2008] The Board adopted the budget, the establishment plan and the staff policy plan for 2010, pending the budget decision by the European Parliament.
Maltese: [EMEA/MB/628139/2009; EMEA/MB/700124/2009; EMEA/MB/579221/2008] Il-Bord adotta l-baġit, ilpjan ta' stabbiliment u l-pjan ta' politika tal-persunal għall-2010, sakemm tingħata d-deċiżjoni tal-baġit mill-Parlament Ewropew.
English: The Board was concerned that not all national competent authorities provided data in the pilot phase (18 out of 46 invited), and that the data made available by the participating national competent authorities is still preliminary.
Maltese: Il-Bord kien imħasseb minħabba li mhux l-awtoritajiet kompetenti nazzjonali kollha pprovdew dejta fil-fażi pilota (18 minn fost is-46 mistiedna), u li d-dejta magħmula disponibbli mill-awtoritajiet kompetenti nazzjonali parteċipanti għadha preliminari.
English: The establishment plan increases staffing numbers by 37 posts, brining the maximum permissible number of temporary agents to 567.
Maltese: Il-pjan ta' stabbiliment iżid in-numri tal-persunal b'37 impjieg, biex b'hekk in-numru permissibbli massimu ta' aġenti temporanji jitla' għal 567.
English: [EMEA/MB/752624/2009; EMEA/MB/786453/2009] The Board discussed and adopted the draft road map to 2015 for public consultation.
Maltese: [EMEA/MB/752624/2009; EMEA/MB/786453/2009] Il-Bord iddiskuta u adotta l-abbozz tal-pjan direzzjonali sal-2015 għal konsultazzjoni pubblika.
English: [EMEA/MB/761723/2009; EMEA/MB/736762/2009] The Board noted the status reports on the implementation of EudraVigilance for human and veterinary medicines.
Maltese: [EMEA/MB/761723/2009; EMEA/MB/736762/2009] Il-Bord ħa nota tar-rapporti dwar l-istatus talimplimentazzjoni tal-EudraViġilanza għall-mediċini għal użu mill-bniedem u għal skop veterinarju.
English: 10(b) Amendments to the Management Board rules of procedure
Maltese: 10(b) Emendi fir-regoli ta' proċedura tal-Bord ta' Tmexxija
English: United Kingdom Kent Woods European Parliament
Maltese: Kent Woods
English: [EMEA/MB/752664/2009] The Board adopted the proposal whereby one patients/consumers' representative will be nominated to the Pharmacovigilance Working Party (PhVWP) as an observer and a second representative will be nominated as an alternate.
Maltese: [EMEA/MB/752664/2009] Il-Bord adotta l-proposta li permezz tagħha sejjer jiġi nnominat rappreżentant wieħed tal-pazjenti/konsumaturi fil-Grupp ta' Ħidma dwar il-Farmakoviġilanza (PhVWP) bħala osservatur u jiġi nnominat rappreżentant ieħor bħala membru alternattiv.
English: Held in London on 10 December 2009
Maltese: Li saret f'Londra fl-10 ta' Diċembru 2009
English: • public consultation on the assessment of the functioning of the Clinical Trials Directive (closing date
Maltese: • konsultazzjoni pubblika dwar il-valutazzjoni tal-funzjonament tad-Direttiva dwar il-Provi Kliniċi
English: The Agency is completing the development of an entirely new public website that offers muchimproved content structure, user-friendliness and functionality for the Agency's audiences.
Maltese: L-Aġenzija qiegħda tikkompleta l-iżvilupp ta' websajt pubblika totalment ġdida li toffri struttura ta' kontenut, użu faċli għall-utenti u funzjonalità mtejba ħafna għall-udjenzi tal-Aġenzija.
English: [EMEA/MB/780575/2009; EMEA/MB/762513/2009] The Management Board reviewed the outcomes of the pilot which aimed to assess the costs of assessment of centralised applications by national competent authorities.
Maltese: [EMEA/MB/780575/2009; EMEA/MB/762513/2009] Il-Bord ta' Tmexxija rreveda l-eżiti tal-pilota li kienet immirata biex tevalwa l-ispejjeż tal-valutazzjoni ta' applikazzjonijiet ċentralizzati minn awtoritajiet kompetenti nazzjonali.
English: Topic coordinators (the Vice-chair, Austria, Denmark, the Netherlands, Sweden and Prof. Nisticó) provided positive feedback on the vision outlined in the draft road map.
Maltese: Il-koordinaturi tas-suġġetti (il-Viċi President, l-Awstrija, id-Danimarka, l-Olanda, l-Iżvezja u l-Prof.
English: Public consultation on the road map will last three months, during which time meetings with stakeholders will be organised.
Maltese: Il-konsultazzjoni pubblika dwar il-pjan direzzjonali għandha ddum għaddejja tliet xhur, li matulhom sejrin jiġu organizzati laqgħat mal-partijiet interessati.
English: The topic coordinators (the Chair, Austria and the Netherlands) proposed an alternative solution: to introduce, for a transitional period, a payment system based on Eurostat correction coefficients, and to continue collecting costing data for assessment of centralised applications.
Maltese: Il-koordinaturi tas-suġġetti (il-President, l-Awstrija u l-Olanda) ipproponew soluzzjoni alternattiva: biex jintroduċu, għal perjodu transizzjonali, sistema ta' ħlas ibbażata fuq il-koeffiċjenti ta' korrezzjoni talEurostat, u biex ikomplu jiġbru dejta dwar l-infiq għall-valutazzjoni ta' applikazzjonijiet ċentralizzati.
English: Taking into account the mandate of the PhVWP, the proposal will now be put to the January 2010 HMA meeting for adoption.
Maltese: Filwaqt li jiġi kkunsidrat il-mandat tal-PhVWP, il-proposta issa sejra tiġi ppreżentata fil-laqgħa tal-HMA ta' Jannar 2010 għall-adozzjoni.
English: EU telematics master plan
Maltese: Il-pjan prinċipali tat-telematika tal-UE
English: [EMEA/768926/2009] The Board adopted the 2010 part of the telematics master plan, which forms part of the work programme and budget 2010.
Maltese: [EMEA/768926/2009] Il-Bord ta' Tmexxija adotta l-parti tal-2010 tal-pjan prinċipali tat-telematika, li jifforma parti mill-programm ta' ħidma u l-baġit tal-2010.
English: [EMEA/MB/753771/2009] The Board adopted the proposals aimed at more structured involvement of patients/consumers in the various activities of the Agency.
Maltese: [EMEA/MB/753771/2009] Il-Bord adotta l-proposti mmirati lejn involviment aktar strutturat talpazjenti/konsumaturi fl-attivitajiet varji tal-Aġenzija.
English: The Board discussed the concern that a higher proportion of the telematics budget will be consumed by maintenance of the systems as more telematics systems come into operation over the years.
Maltese: Il-Bord iddiskuta t-tħassib li proporzjon ogħla tal-baġit tat-telematika sejjer jiġi kkonsmat mill-manutenzjoni tas-sistemi hekk kif aktar sistemi ta' telematika jidħlu fis-seħħ matul issnin.
English: Status report on EudraVigilance implementation
Maltese: Rapport mill-Kummissjoni Ewropea
English: [EMEA/MB/170391/2009/Rev.4] The Board adopted the amendments to the fee implementing rules to come into effect on 1 January 2010.
Maltese: [EMEA/MB/170391/2009/Rev.4] Il-Bord adotta l-emendi għar-regoli tal-implimentazzjoni tal-miżati li għandhom jidħlu fis-seħħ fl-1 ta' Jannar 2010.
English: Minutes from the 64th meeting, held on 1 October 2009 [EMEA/MB/642672/2009] The Management Board noted the adoption of the minutes by written procedure on 13 November 2009.
Maltese: [EMEA/MB/642672/2009] Il-Bord ta' Tmexxija ħa nota tal-adozzjoni tal-minuti permezz ta' proċedura bil-miktub fit-13 ta' Novembru 2009.
English: The document has now been submitted for translation.
Maltese: Id-dokument issa ġie sottomess għat-traduzzjoni.
English: [EMEA/MB/727972/2009] The Board discussed this agenda point under the work programme and the EU telematics master plan 2010.
Maltese: [EMEA/MB/727972/2009] Il-Bord iddiskuta dan il-punt tal-aġenda taħt il-programm ta' ħidma u l-pjan prinċipali tat-telematika tal-UE għall-2010.
English: The members noted the update report from the European Commission on a range of topics, including:
Maltese: Il-membri ħadu nota tar-rapport ta' aġġornament mill-Kummissjoni Ewropea fuq firxa ta' suġġetti, inklużi:
English: The meeting underlined that good coordination between the Management Board's and the Heads of Medicines Agencies' telematics committees is essential.
Maltese: Il-laqgħa enfasizzat li l-koordinazzjoni tajba bejn il-kumitati tat-telematika tal-Bord ta' Tmexxija u tal-Kapijiet tal-Aġenziji tal-Mediċini hija essenzjali.
English: Participants at the 65th meeting of the Management Board
Maltese: Parteċipanti fil-65 laqgħa tal-Bord ta' Tmexxija
English: ICT planning and priorities 2010
Maltese: Ippjanar u prijoritajiet tal-ICT għall-2010
English: [EMEA/MB/115339/2004] The Board adopted the revised Management Board rules of procedure, which now include a provision for the setting-up of Management Board committees and groups.
Maltese: [EMEA/MB/115339/2004] Il-Bord adotta r-regoli ta' proċedura riveduti tal-Bord ta' Tmexxija, li issa jinkludu dispożizzjoni għat-twaqqif ta' kumitati u gruppi tal-Bord ta' Tmexxija.
English: No conflicts of interests were declared.
Maltese: Dikjarazzjoni ta' kunflitti ta' interessi
English: The terms of reference will be submitted for adoption at the March 2010 meeting.
Maltese: It-termini ta' referenza sejrin jiġu sottomessi għall-adozzjoni waqt il-laqgħa ta' Marzu 2010.
English: • international cooperation (particularly important in light of the number of clinical trials and amount of manufacturing being done in countries outside the EU);
Maltese: • kooperazzjoni internazzjonali (partikolarment importanti fid-dawl tan-numru ta' provi kliniċi u l ammont ta' manifattura li ssir fil-pajjiżi barra l-UE);
English: In light of the earlier discussions on the grade level and in view of the Agency's move to the responsibility of DG Sanco, the Board enquired whether the publication could be delayed to allow the new Commissioner to express his views with regards to the grading of the Executive Director's post.
Maltese: Bħalissa qiegħed jitħejja pjan ta' implimentazzjoni u dan mistenni jiġi ffinalizzat ladarba jkunu ġew riveduti l-kummenti li joħorġu mill-konsultazzjoni pubblika dwar il-pjan direzzjonali u jkunu saru l-emendi meħtieġa.
English: [EMEA/MB/767563/2009] The Board endorsed the fixed, flat hourly cost for 2010, which is set at the same rate as in 2009.
Maltese: [EMEA/MB/737155/2009] Il-Bord adotta r-regoli ta' implimentazzjoni, soġġetti għall-approvazzjoni formali tagħhom mill-Kummissjoni Ewropea.
English: The EVVet status report is updated continuously and is also available on the EVVeT website.
Maltese: Ir-rapport ta' status EVVet jiġi aġġornat kontinwament u huwa disponibbli wkoll fuq il-websajt tal-EVVeT.
English: The proposals include revising the current framework of interaction between the Agency and patients' and consumers' organisations, and providing financial support by doubling the daily allowance in defined cases.
Maltese: Il-proposti jinkludu r-reviżjoni tal-qafas attwali ta' interazzjoni bejn l-Aġenzija u l-organizzazzjonijiet tal-pazjenti u tal-konsumaturi, u l-għoti ta' appoġġ finanzjarju billi tiġi rduppjata l-allokazzjoni ta' kuljum f'każijiet definiti.
English: The pilot concluded that the national competent authorities, which participated in the pilot, are in a position to identify their hourly rates for services provided.
Maltese: Il-pilota kkonkludiet li l-awtoritajiet kompetenti nazzjonali, li pparteċipaw fil-pilota, jinsabu f'pożizzjoni li jidentifikaw ir-rati tagħhom fis-siegħa għas-servizzi pprovduti.
English: • publication of the guidelines on variations;
Maltese: • diskussjoni dwar id-Direttiva tal-Kura tas-Saħħa Transkonfinali;
English: • Draft terms of reference for the Management Board Telematics Committee.
Maltese: • Abbozz tat-termini ta' referenza għall-Kumitat tat-Telematika tal-Bord ta' Tmexxija.
English: According to the data collected, the benefit/risk balance of the vaccines remains positive.
Maltese: Skont id-dejta miġbura, il-bilanċ bejn ilbenefiċċji u r-riskji tal-vaċċini jibqa' wieħed pożittiv.
English: Alternates and other participants
Maltese: Alternati u parteċipanti oħrajn
English: EMA/662579/2014 EMEA/H/C/003969
Maltese: EMEA/H/C/003969
English: The full EPAR and risk management plan summary for Brimica Genuair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Brimica Genuair jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Brimica Genuair aclidinium bromide / formoterol fumarate dihydrate
Maltese: Brimica Genuair bromur tal-aklidinju / diidrat tal-fumarat tal-formoterol
English: Other information about Brimica Genuair
Maltese: Informazzjoni oħra dwar Brimica Genuair
English: Brimica Genuair is used for maintenance (regular) treatment.
Maltese: Brimica Genuair jintuża għal trattament ta' manutenzjoni (regolari).
English: The inhaler delivers 340 micrograms of aclidinium and 12 micrograms of formoterol fumarate dihydrate for each inhalation.
Maltese: L-inalatur jagħti 340 mikrogramma tal-aklidinju u 12-il mikrogramma ta' diidrat tal-fumarat tal-formoterol għal kull nifs.
English: This is a summary of the European public assessment report (EPAR) for Brimica Genuair.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Brimica Genuair.
English: Results showed that, after six months of treatment, the increase in FEV1 (measured one hour after an inhalation) was 293 milliliters (ml) more with Brimica Genuair than with placebo and 118 ml more with Brimica Genuair than with aclidinium alone.
Maltese: Ir-riżultati wrew li, wara sitt xhur ta' kura, iż-żieda fl-FEV1 (imkejla siegħa wara teħid man-nifs) kienet ta' 293 millilitri (ml) aktar bi Brimica Genuair milli bi plaċebo u 118 ml aktar bi Brimica Genuair milli blaklidinju waħdu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Brimica Genuair on 19 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Brimica Genuair fid-19 ta' Novembru 2014.
English: Brimica Genuair is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Brimica Genuair huwa mediċina li tintuża biex ittaffi s-sintomi ta' mard pulmonari ostruttiv kroniku (COPD) fl-adulti.
English: Why is Brimica Genuair approved?
Maltese: Għaliex ġie approvat Brimica Genuair?
English: Brimica Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment).
Maltese: Brimica Genuair ġie studjat f'2 studji ewlenin li involvew aktar minn 3,400 pazjent b'COPD, fejn tqabbel mal-aklidinju waħdu, formoterol waħdu u plaċebo (kura finta).
English: Brimica Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.
Maltese: Brimica Genuair fih żewġ sustanzi attivi: bromur tal-aklidinju u diidrat tal-fumarat tal-formoterol.
English: Side effects with Brimica Genuair are similar to those with the individual components.
Maltese: L-effetti sekondarji bi Brimica Genuair huma simili għal dawk bil-komponenti individwali.
English: What are the risks associated with Brimica Genuair?
Maltese: X'inhuma r-riskji assoċjati ma' Brimica Genuair?
English: This summary was last updated in 11-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 11-2014.
English: Aclidinium bromide has been authorised in the EU as Bretaris Genuair and Eklira Genuair since July 2012; formoterol has been marketed in the EU since the 1990s.
Maltese: Il-bromur tal-aklidinju ġie awtorizzat fl-UE bħala Bretaris Genuair u Eklira Genuair minn Lulju 2012; formoterol ilu jiġi kkummerċjalizzat fl-UE mid-disgħinijiet.
English: Aclidinium bromide is a long-acting muscarinic antagonist.
Maltese: Il-bromur tal-aklidinju huwa antagonist muskariniku li jaħdem fit-tul.
English: Regarding safety, the number of side effects reported with Brimica Genuair was low and did not raise any major safety concern.
Maltese: Fir-rigward tas-sigurtà, in-numru ta' effetti sekondarji rrapportati bi Brimica Genuair kien baxx u ma qajjem ebda tħassib serju għas-sigurtà.
English: This means that it widens the airways by blocking some receptors in muscle cells in the lungs called muscarinic (also known as cholinergic) receptors, which control the contraction of muscles.
Maltese: Dan ifisser li jwessa' l-passaġġi tal-arja billi jimblokka ċerti riċetturi fiċ-ċelloli tal-muskoli fil-pulmuni msejħa riċetturi muskariniċi (magħrufa wkoll bħala kolinerġiċi), li jikkontrollaw il-kontrazzjoni tal-muskoli.
English: Long-acting muscarinic antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Maltese: L-antagonisti muskariniċi li jaħdmu fit-tul u l-agonisti beta-2 li jaħdmu fit-tul jintużaw flimkien flimmaniġġjar ta' COPD.
English: A risk management plan has been developed to ensure that Brimica Genuair is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Brimica Genuair jintuża bl-aktar mod sigur possibbli.
English: The most common side effects (seen in around 7 patients in 100) are nasopharyngitis (inflammation of the nose and throat) and headache.
Maltese: L-effetti sekondarji l-aktar komuni (li dehru f'bejn 7 minn kull 100) huma nażofarinġite (infjammazzjoni talimnieħer u tal-gerżuma) u uġigħ ta' ras.
English: The CHMP noted that Brimica Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Brimica Genuair was compared with one of the components on its own, formoterol, was small.
Maltese: Is-CHMP innota li Brimica Genuair intwera li jtejjeb b'mod sinifikanti l-funzjoni tal-pulmuni f'pazjenti b'COPD meta mqabbel mal-plaċebo, għalkemm it-titjib osservat meta Brimica Genuair tqabbel ma' wieħed millkomponenti waħdu, formoterol, kien wieħed żgħir.
English: In addition, the safety profile of the two components is well known, and there is no evidence that the combination is worse than the individual components.
Maltese: Barra minn hekk, il-profil tas-sigurtà taż-żewġ komponenti huwa magħruf sew, u m'hemm ebda evidenza li l-kombinazzjoni hija agħar mill-komponenti individwali.