FrancophonIA/ELRC3.0 huggingface dataset:
English: Service quality will be measured by a number of performance indicators, such as systems availability, helpdesk response times and problem resolution times
Maltese: Il-Kwalità tas-servizz titkejjel minn numru ta' indikaturi ta' prestazzjoni, bħad-disponibbiltà tas-sistemi, u ż-żminijiet li fihom tingħata tweġiba mill-helpdesk u jiġu solvuti l-problemi
English: To be finalised by Q3 2005
Maltese: Għandu jiġi ffinalizzat fl-2005
English: Core SPC released for further consultation in 2004 and to be finalised in 2005
Maltese: SPC Prinċipali maħruġ għallkonsultazzjoni ulterjuri fl-2004 u għandu jiġi ffinalizzat fl-2005
English: Completion of the internal evaluation work with new Member States (the EC-Canada MRA) Provision of assistance to the new Member States for external evaluations (the EC-Canada MRA) Expansion of scope of the MRA with Japan to include sterile medicinal products and biologicals
Maltese: Il-Provviżjoni ta' assistenza lill-Istati Membri l-ġodda għal valutazzjonijiet esterni (l-MRA KEKanada)
English: Documentation services
Maltese: Quality issues
English: Education: Bachelor of law from the University of Birmingham, qualified as a member of the Institute of Chartered Accountants in England and Wales.
Maltese: Baċċellerat tal-Liġi mill-Università ta' Birmingham, kwalifikat bħala Membru ta' l
English: Discussion of interested parties with working parties and/or ad hoc groups on specific technical/scientific issues
Maltese: Id-Diskussjoni bejn partijiet interessati u gruppi ta' ħidma u/jew gruppi ad hoc dwar kwistjonijiet speċifiċi tekniċi/xjentifiċi
English: In 2005, the Integrated Quality Management/Audit group will also have a training and coordination role in the EU benchmarking system, involving the national competent authorities of the European medicines network.
Maltese: Fl-2005, il-Grupp ta' Ġestjoni Integrata tal-Kwalità/ta'Verifika ikollu wkoll rwol ta' taħriġ u koordinazzjoni fis-sistema ta' referenza ta' l-UE, li jinvolvi l-awtoritajiet nazzjonali kompetenti tan network Ewropew tal-mediċini.
English: Joint CHMP/CVMP Quality Working Party
Maltese: Il-Grupp ta' Ħidma Konġunt tal-CPMP/CVMP dwar il-Kwalità
English: The Executive Director is responsible for setting up administrative structures and procedures in consultation with scientific committees allowing the development of advice for undertakings, particularly regarding new therapies, on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products.
Maltese: Id-Direttur Eżekuttiv huwa responsabbli mit-twaqqif ta' strutturi u proċeduri amministrattivi f'konsultazzjoni ma' kumitati xjentifiċi li jippermettu l-iżvilupp ta' pariri għal intrapriżi, partikolarment fir-rigward ta' terapiji ġodda, dwar it-twettieq tat-testijiet u l provi varji neċessarji sabiex juru l-kwalità, is-sigurtà u l-effikaċja ta' prodotti mediċinali.
English: Development of a new document with PEG (Paediatrics Working Party)
Maltese: L-Iżvilupp ta' dokument ġdid mal-PEG (Il-Grupp ta' Ħidma Pedjatriku)
English: Her responsibilities there included coordination of ICH activities, relations with the FDA, pharmaceutical aspects of mutual recognition agreements, GMP and inspection-related matters, orphan medicinal products, preparatory work on a regulation on paediatric medicinal products and issues relating to EU enlargement.
Maltese: Matul l-implimentazzjoni tal-leġislazzjoni farmaċewtika l-ġdida ta' l-UE, issir emfasi sinifikanti fuq il-preparazzjoni ta' gwida regolatorja u proċedurali, bħala parti mir-reviżjoni li għaddejja tad-dokumenti ta' gwida li huma disponibbli
English: Arbitration procedures (either under Article 29 of Directive 2001/83/EC or Article 6(12) of Commission Regulation (EC) No 1084/2003) are initiated because of disagreement between Member States in the framework of the mutual recognition procedure.
Maltese: Proċeduri ta' arbitraġġ (jew taħt l-Artikolu 29 tad-Direttiva 2001/83/KE jew l-Artikolu 6(12) tarRegolament tal-Kummissjoni (KE) Nru 1084/2003) jinbdew minħabba nuqqas ta' ftehim bejn Stati
English: Safety Working Party
Maltese: Healthcare Professional
English: Revision of current procedures, including incorporation of reduced timelines of communication of opinions to the Commission from 30 to 15 days
Maltese: 30 sa 15-il jum li fihom jiġu kkomunikati opinjonijiet lill-Kummissjoni
English: Continuous support to observers from candidate countries
Maltese: Status products containing known constituents
English: 1.4 European medicines network 1.5 Transparency and communication in the European network 1.6 EU institutions, agencies and international partners 1.7 Corporate governance - Integrated management system2 MEDICINES FOR HUMAN USE 2.1 Orphan medicinal products
Maltese: 1.1 Il-Bord ta' Tmexxija 1.2 L-Implimentazzjoni tal-leġislazzjoni farmaċewtika l-ġdida
English: The actions fall within a number of areas, including:
Maltese: L-Azzjonijiet jaqgħu taħt numru ta' oqsma, li jinkludu:
English: The growing number of meetings managed by the Agency and increasing number of delegate days will require the development of meeting technologies such as IP telephony, videoconferencing and web streaming.
Maltese: In-numru dejjem jiżdied ta' laqgħat ġestiti mill-Aġenzija u n-numru dejjem jiżdied ta' jiem li fihom jattendu delegati jeħtieġu l-iżvilupp ta' teknoloġiji għall-laqgħat bħat-telefonija bl-IP, ilvidjokonferenzi u l-web streaming.
English: The CVMP will meet 11 times during the year.
Maltese: Il-CVMP jiltaqa' 11-il darba matul is-sena.
English: Education: Master's degree in business administration from the Institut Superieur de Gestion in Paris.
Maltese: Lawrea Masters fl-Amministrazzjoni Kummerċjali mill-Institut Superieur de Gestion f'
English: Guideline on the clinical investigation To be released for consultation in
Maltese: Note for guidance on the clinical investigation of recombinant Factor
English: 4.2 Implementation of the Clinical Trials Directive
Maltese: .2 L-Implimentazzjoni tad-direttiva dwar provi kliniċi
English: Administration Unit
Maltese: Infiq Operazzjonali
English: Patrick Le Courtois, Head of Unit, b. 9 August 1950, n. French
Maltese: Unità għall-valutazzjoni ta' qabel l-awtorizzazzjoni ta' mediċini għall-użu tal-bniedem Patrick Le Courtois, Kap ta' l-Unità, twieled fid-9 ta' Awwissu 1950, ċittadinanza
English: He joined the Pharmaceutical Inspectorate of the Belgian Ministry of Public Health as head of medical assessors in 1997.
Maltese: Ingħaqad ma' l-Ispettorat Farmaċewtiku tal-Ministeru tas-Saħħa Pubblika Belġjan bħala kap tal valutaturi mediċi fl-1997.
English: Career to date: From 1976 to 1986, Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Maltese: Iktar tard hu għallem bħala lecturer u senior lecturer fl-istess università sakemm ingħaqad mal-Kummissjoni Ewropea fil-Lussemburgu f'Jannar ta' l-1986.
English: For enquiries concerning PMF certificates
Maltese: Għal informazzjoni dwar ċertifikati ta' PMF
English: 26 May
Maltese: 14-il jum.
English: Committee on Orphan Medicinal Products (COMP)
Maltese: Il-Kumitat dwar Prodotti Mediċinali Ltiema (COMP)
English: He was first elected chairman of the CVMP in January 2003 and was re-elected in 2004.
Maltese: Inħatar lewwel bħala president tal-CVMP f'Jannar 2003 u reġa' inħatar fl-2004.
English: The EMEA anticipates that interest in seeking such advice will continue and grow with the establishment of a new Scientific Advice Working Party for veterinary medicines Nine applications for scientific advice are expected this year Only a few applications for free scientific advice for products intended for minor uses/minor species have been received - for food animals
Maltese: Hija pprovduta konsulenza regolatorja u proċedurali lill-industrija farmaċewtika tul iċ-ċiklu ta' ħajja ta' prodotti mediċinali, minn laqgħat ta' qabel is-sottomissjoni ma' applikanti għal laqgħat annwali ma' detenturi ta' awtorizzazzjoni għal tqegħid fis-suq.
English: Periodic safety update reports received/forecast (Input)
Maltese: Rapporti perjodici ta' aggornament dwar issigurtà ricevuti/mbassra (Dehlin)
English: Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Community, or where for economic reasons such medicines would not be developed without incentives.
Maltese: Prodotti mediċinali ltiema huma maħsuba għad-djanjożi, il-prevenzjoni jew it-trattament ta' kondizzjonjiet li jheddu l-ħajja jew huma kronikament debilitanti u li ma jaffettwawx iktar minn ħamsa minn kull 10,000 persuna fil-Komunità Ewropea, jew meta għal raġunijiet ekonomiċi dawn ilmediċini ma kienux jiġu żviluppati li kieku ma kienx hemm inċentivi.
English: A Community marketing authorisation is valid throughout the EU and a centrally authorised medicinal product is by definition identical in all Member States.
Maltese: Distribuzzjoni parallela Awtorizzazzjoni Komunitarja għal tqegħid fis-suq hija valida fl-UE kollha u prodott mediċinali awtorizzat b'mod ċentrali huwa b'definizzjoni identiku fl-Istati Membri kollha.
English: The EMEA will continue to support the European Commission in the updating and further development of the Notice to Applicants, providing advice on the centralised procedure and regulatory guidance for issues affecting the CHMP and its standing and temporary working parties
Maltese: Notifika lill-Applikanti, u tipprovdi konsulenza dwar il-proċedura ċentralizzata u gwida regolatorja dwar kwistjonijiet li jeffettwaw lill-CHMP u l-gruppi ta' ħidma permanenti u temporanji tiegħu
English: Agnès Saint Raymond, Head of Sector for orphan drugs and scientific advice and Acting Head of Sector for safety & efficacy of medicines, b. 7 September 1956, n. French
Maltese: Agnès Saint Raymond, Kap tas-Settur għal mediċini ltiema u pariri xjentifiċi u Kap filKariga tas-Settur għas-sigurtà u l-effikaċja tal-mediċini, twieldet fis-7 ta' Settembru
English: She joined the EMEA in April 1996.
Maltese: Ingħaqdet ma' l-EMEA f'April ta' l-1996.
English: 3.5 Pharmacovigilance and maintenance activities
Maltese: 3.5 Il-Farmakoviġilanza u attivitajiet ta' manutenzjoni
English: Full composition of the Management Board will be completed in 2005 with the appointment of four members from civil society representing patients', doctors' and veterinarians' organisations.
Maltese: Il-Kompożizzjoni sħiħa tal-Bord ta' Tmexxija tiġi kompletata fl-2005 bil-ħatra ta' erba' membri mis-soċjetà ċivili li jirrappreżentaw organizzazzjonijiet ta' pazjenti, tobba u veterinarji.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int
Maltese: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
English: Undertake the initial phase of the implementation plan for the EMEA Road Map to 2010 in relation to veterinary medicines, with particular emphasis on risk management of antimicrobial resistance, which may result from use of antimicrobials in animals, and on ensuring the adequacy of the environmental risk assessment in accordance with new EU legislation
Maltese: fir-rigward ta' mediċini veterinarji, b'emfasi partikolari fuq il-ġestjoni tar-riskju ta' reżistenza antimikrobika, li tista' tirriżulta mill-użu ta' antimikrobiċi fl-annimali, u ta' l-assigurazzjoni ta' ladegwatezza tal-valutazzjoni tar-riskju ambjentali skond il-leġislazzjoni l-ġdida ta' l-UE
English: The EMEA publishes a European public assessment report (EPAR) once the Commission decision has been taken.
Maltese: L-EMEA tippubblika rapport Ewropew pubbliku ta' valutazzjoni (EPAR) ladarba tkun ittieħdet id-Deċiżjoni tal-Kummissjoni.
English: The Agency will improve handling of referral procedures to provide faster opinions on questions related to safety of medicines 9 The Agency will remain committed to managing effectively and efficiently its increased tasks and responsibilities, ensuring that patients and users of medicines have access to safe and effective medicinal products within the timelines laid down in the legislation 9 The Agency will work for greater transparency of its operations and activities 9 EMEA will further extend its capacity to provide scientific advice and the quality of that advice 9 It will strive to increase availability of veterinary medicines intended for minor uses and minor species
Maltese: L-Iżvilupp ulterjuri ta' l-istrateġija għall-ġestjoni tar-riskju ta' l-EMEA, b'mod partikolari firrigward tal-kunċett ta' pjanijiet għall-ġestjoni tar-riskju u implimentazzjoni ulterjuri tal-proġett EudraVigilance, li jinkludi r-rappurtaġġ ta' reazzjonijiet mhux mixtieqa għall-mediċini fi provi kliniċi L-Iżvilupp ta' strumenti għall-provviżjoni ta' informazzjoni lil pazjenti u lil professjonisti fil-kura tas-saħħa, u t-tisħiħ ta' interazzjoni mal-partijiet interessati ta' l-Aġenzija L-Assigurazzjoni ta' operazzjoni ta' kwalità għolja fl-attivitajiet prinċipali permezz ta' tmexxija effettiva ta' l-ammont tax-xogħol dejjem jiżdied u osservanza tal-limiti ta' żmien regolatorji mnaqqsa għal attivitajiet ta' qabel u wara l-awtorizzazzjoni It-Tisħiħ tal-kunċett ta' ġestjoni taċ-ċiklu tal-ħajja u ta' konsistenza xjentifika
English: In 1995 she returned to Germany to the Ministry for Environment as scientific administrator.
Maltese: Fl-1995 reġgħet lura il-Ġermanja fil-Ministeru għall-Ambjent bħala amministratur xjentifiku.
English: Priorities for inspections in 2005:
Maltese: Revised guideline on specifications:
English: Ulunar Breezhaler showed similar adverse reactions to the individual components.
Maltese: Ulunar Breezhaler wera reazzjonijiet avversi simili għall-komponenti individwali.
English: Date of first authorisation: 23 April 2014 Date of latest renewal: 15 January 2019
Maltese: Data tal-aħħar tiġdid: 15 Jannar 2019
English: The highest dose level of 464 micrograms/86 micrograms Ulunar Breezhaler also showed a higher proportion of absolute QTcF values >450 ms (12.2% vs. 5.7% for placebo).
Maltese: L-ogħla livell ta' doża ta' 464 mikrogramma/86 mikrogramma Ulunar Breezhaler wera wkoll proporzjon ogħla talvaluri assoluti tal-QTcF ta' >450 ms (12.2% kontra 5.7% għall-plaċebo).
English: The Ulunar Breezhaler clinical Phase III development programme included six studies in which over 8,000 patients were enrolled: 1) a 26-week placebo- and active-controlled (indacaterol once daily, glycopyrronium once daily, open-label tiotropium once daily) study; 2) a 26-week active-controlled (fluticasone/salmeterol twice daily) study; 3) a 64-week active-controlled (glycopyrronium once daily, open-label tiotropium once daily) study; 4) a 52-week placebo-controlled study; 5) a 3-week placeboand active-controlled (tiotropium once daily) exercise tolerance study; and 6) a 52-week activecontrolled (fluticasone/salmeterol twice daily) study.
Maltese: Il-programm ta' żvilupp ta' Ulunar Breezhaler f'Fażi III kien jinkludi sitt studji li matulhom issieħbu aktar minn 8,000 pazjent: 1) studju ta' 26 ġimgħa kkontrollat bil-plaċebo u bl-attiv (indacaterol darba kuljum, glycopyrronium darba kuljum, tiotropium open-label darba kuljum); 2) studju ta' 26 ġimgħa kkontrollat bl-attiv (fluticasone/salmeterol darbtejn kuljum); 3) studju ta' 64 ġimgħa kkontrollat blattiv (glycopyrronium darba kuljum, tiotropium open-label darba kuljum); 4) studju ta' 52 ġimgħa kkontrollat bi plaċebo; 5) studju ta' 3 ġimgħat dwar it-tolleranza għall-eżerċizzju ikkontrollat bi plaċebo u b'attiv (tiotropium darba kuljum); u 6) studju ta' 52 ġimgħa kkontrollat bl-attiv (fluticasone/salmeterol darbtejn kuljum).
English: Ulunar Breezhaler 85 mcg/43 mcg inhalation powder indacaterol/glycopyrronium
Maltese: Ulunar Breezhaler 85 mkg/43 mkg trab li jittieħed man-nifs indacaterol/glycopyrronium
English: The number of all COPD exacerbations/patient-years was 3.34 for Ulunar Breezhaler (2,893 events), 3.92 for glycopyrronium (3,294 events) and 3.89 for tiotropium (3,301 events).
Maltese: In-numru ta' kull taħrix ta' COPD/snin ta' pazjent kien ta' 3.34 għal Ulunar Breezhaler (2,893 avveniment), 3.92 għal glycopyrronium (3,294 avveniment) u 3.89 għal tiotropium (3,301 avveniment).
English: Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Ulunar Breezhaler hu indikat bħala trattament bronkodilatatur ta' manutenzjoni biex iserraħ lil pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD) mis-sintomi.
English: A higher percentage of patients receiving Ulunar Breezhaler responded with a clinically meaningful improvement in SGRQ score (defined as a decrease of at least 4 units from baseline) at week 26 compared to placebo (63.7% and 56.6% respectively, p=0.088) and tiotropium (63.7% Ulunar Breezhaler vs. 56.4% tiotropium, p=0.047), at week 64 compared to glycopyrronium and tiotropium (57.3% Ulunar Breezhaler versus 51.8% glycopyrronium, p=0.055; versus 50.8% tiotropium, p=0.051, respectively), and at week 52 compared to fluticasone/salmeterol (49.2% Ulunar Breezhaler vs. 43.7% fluticasone/salmeterol, odds ratio: 1.30, p<0.001).
Maltese: Persentaġġ ogħla ta' pazjenti mogħtija Ulunar Breezhaler irrispondew b'titjib sinjifikanti klinikament fl-iskor tal-SGRQ (iddefinit bħala tnaqqis ta' mill-inqas 4 unitajiet mil-linjabażi) fis-26 ġimgħa mqabbel mal-plaċebo (63.7% u 56.6% rispettivament, p=0.088) u tiotropium (63.7% Ulunar Breezhaler kontra 56.4% tiotropium, p=0.047), fl-64 ġimgħa mqabbel ma' glycopyrronium u tiotropium (57.3% Ulunar Breezhaler kontra 51.8% glycopyrronium, p=0.055; kontra 50.8% tiotropium, p=0.051, rispettivament), u mat-52 ġimgħa meta mqabbel ma' fluticasone/salmeterol (49.2% Ulunar Breezhaler vs. 43.7% fluticasone/salmeterol, proporzjon ta' probabbiltà:
English: Ulunar Breezhaler increased post-dose FEV1 AUC0-12 (primary endpoint) by 140 ml at 26 weeks (p<0.001) compared to fluticasone/salmeterol.
Maltese: Ulunar Breezhaler żied il-FEV1 u l-AUC0-12 (endpoint primarju) wara l-għoti tad-doża b'140 ml wara 26 ġimgħa (p<0.001) imqabbel ma' fluticasone/salmeterol.
English: The number of moderate or severe COPD exacerbations/patient-years was 0.98 for Ulunar Breezhaler (1,265 events) and 1.19 for fluticasone/salmeterol (1,452 events).
Maltese: In-numru ta' taħrix moderat jew sever ta' COPD/snin ta' pazjent kien ta' 0.98 għal Ulunar Breezhaler (1,265 avveniment) u 1.19 għal fluticasone/salmeterol (1,452 avveniment).
English: In a 64-week study comparing Ulunar Breezhaler (n=729), glycopyrronium (n=739) and tiotropium (n=737), Ulunar Breezhaler reduced the annualised rate of moderate or severe COPD exacerbations by 12% compared to glycopyrronium (p=0.038) and by 10% compared to tiotropium (p=0.096).
Maltese: Fi studju ta' 64 ġimgħa li qabbel Ulunar Breezhaler (n=729), glycopyrronium (n=739) u tiotropium (n=737), Ulunar Breezhaler naqqas ir-rata anwalizzata ta' taħrix moderat jew serju tas-COPD bi 12% mqabbel ma' glycopyrronium (p=0.038) u b'10% mqabbel ma' tiotropium (p=0.096).
English: A higher proportion of patients demonstrated clinically meaningful response at week 26 on Ulunar Breezhaler as compared to tiotropium (68.1% Ulunar Breezhaler versus 59.2% tiotropium, p=0.016) and fluticasone/salmeterol (65.1% Ulunar Breezhaler versus 55.5% fluticasone/salmeterol, p=0.088).
Maltese: Proporzjon akbar ta' pazjenti wrew rispons sinjifikanti klinikament fis-26 ġimgħa b'Ulunar Breezhaler imqabbel ma' tiotropium (68.1% Ulunar Breezhaler kontra 59.2% tiotropium, p=0.016) u fluticasone/salmeterol (65.1% Ulunar Breezhaler kontra 55.5% fluticasone/salmeterol, p=0.088).
English: There is no information on clinically relevant overdosing with Ulunar Breezhaler.
Maltese: M'hemm l-ebda informazzjoni dwar doża eċċessiva klinikament rilevanti b'Ulunar Breezhaler.
English: In COPD patients, supratherapeutic doses between 116 micrograms/86 micrograms and 464 micrograms/86 micrograms of Ulunar Breezhaler showed a higher proportion of patients with QTcF increases vs. baseline between 30 ms and 60 ms (ranging from 16.0% to 21.6% vs. 1.9% for placebo), but there were no QTcF increases >60 ms from baseline.
Maltese: Fost pazjenti b'COPD, dożi supraterapewtiċi ta' bejn 116-il mikrogramma/86 mikrogramma u 464 mikrogramma/86 mikrogramma ta' Ulunar Breezhaler urew proporzjon ogħla ta' pazjenti b'żidiet fil-QTcF imqabbel mal-linja bażi ta' bejn 30 ms u 60 ms (fuq medda ta' bejn 16.0% u 21.6% kontra 1.9% għall-plaċebo), imma ma kienx hemm żidiet fil-QTcF ta' >60 ms mil-linja bażi.
English: The number of moderate or severe COPD exacerbations/patient-years was 0.94 for Ulunar Breezhaler (812 events), 1.07 for glycopyrronium (900 events) and 1.06 for tiotropium (898 events).
Maltese: In-numru ta' taħrix moderat jew sever ta' COPD/snin ta' pazjent kien ta' 0.94 għal Ulunar Breezhaler (812 ilavveniment), 1.07 għal glycopyrronium (900 avveniment) u 1.06 għal tiotropium (898 avveniment).
English: At week 64, Ulunar Breezhaler showed numerical improvement over glycopyrronium (LS mean treatment difference 1.95%; p=0.175) and statistical improvement over tiotropium (LS mean treatment difference 4.96%; p=0.001).
Maltese: Fl-64 ġimgħa, Ulunar Breezhaler wera titjib numeriku fuq glycopyrronium (differenza fil-medja tal-kura ta' LS ta' 1.95%, p=0.175) u titjib statistikament fuq tiotropium (differenza fil-medja tal-kura ta' LS ta' 4.96%; p=0.001).
English: The number of all COPD exacerbations/patient-years was 3.59 for Ulunar Breezhaler (4,531 events) and 4.03 for fluticasone/salmeterol (4,969 events).
Maltese: In-numru ta' kull taħrix ta' COPD/snin ta' pazjent kien ta' 3.59 għal Ulunar Breezhaler (4,531 avveniment) u 4.03 għal fluticasone/salmeterol (4,969 avveniment).
English: Ulunar Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Maltese: Ulunar Breezhaler għandu jintuża b'kawtela f'pazjenti b'disturbi kardjovaskulari (mard tal-arterja koronarja, infart mijokardijaku akut, arritmija kardijaka, pressjoni għolja).
English: Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.
Maltese: Pakkett b'wieħed li fih 6x1, 10x1, 12x1, 30x1 jew 90x1 kapsula iebsa, flimkien ma' inhaler wieħed.
English: Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
Maltese: Kull kapsula fiha 143 mikrogramma ta' indacaterol maleate ekwivalenti għal 110 mikrogramma ta' indacaterol u 63 mikrogramma ta' glycopyrronium bromide ekwivalenti għal 50 mikrogramma ta' glycopyrronium.
English: Clinically relevant effects of hypokalaemia have not been observed in clinical studies of Ulunar Breezhaler at the recommended therapeutic dose (see section 5.1).
Maltese: Fi studji kliniċi dwar Ulunar Breezhaler ma dehrux effetti relevanti klinikament ta' ipokalimja meta mogħti skont id-doża terapewtika rrakkomandata (ara sezzjoni 5.1).
English: Ulunar Breezhaler statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI); it demonstrated a statistically significant improvement in the TDI focal score at week 26 compared to placebo (LS mean treatment difference 1.09, p<0.001), tiotropium (LS mean treatment difference 0.51, p=0.007) and fluticasone/salmeterol (LS mean treatment difference 0.76, p=0.003).
Maltese: Ulunar Breezhaler naqqas b'mod sinjifikanti statistikament il-qtugħ ta' nifs kif evalwat skont itTransitional Dyspnoea Index (TDI); dan wera titjib sinjifikanti statistikament fl-iskor fokali TDI mas26 ġimgħa mqabbel ma' plaċebo (differenza medja fil-kura ta' LS ta' 1.09, p<0.001), tiotropium (differenza medja fil-kura ta' LS ta' 0.51, p=0.007) u fluticasone/salmeterol (differenza medja fil-kura ta' LS ta' 0.76, p=0.003).