FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP concluded that, in accordance with EU requirements, Dasselta has been shown to have comparable quality and to be bioequivalent to Aerius.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Dasselta għandu kwalità li tixbah lill-prodott mediċinali bijoekwivalenti Aerius.
English: Johannes Löwer (HMA Group)*
Maltese: Johannes Löwer (Grupp HMA)*
English: 1 October 2009
Maltese: 1 ta' Ottubru 2009
English: London, 11 June 2009
Maltese: Londra, 11 ta' Ġunju 2009
English: Representative of veterinarians' organisations
Maltese: Rappreżentant talorganizzazzjonijiet talveterinarji
English: Participants at the sixty-third meeting of the Management Board London, 11 June 2009
Maltese: Parteċipanti fit-tlieta u sittin laqgħa tal-Bord ta' Tmexxija Londra, 11 ta' Ġunju 2009
English: EMEA/MB/366757/2009/EN/Rev.1*
Maltese: EMEA/718013/2009/MT/Rev.1
English: EMEA corporate-identity project
Maltese: Il-proġett dwar l-identità korporattiva tal-EMEA
English: A similar extension was approved for Relenza by the Member States.
Maltese: Estensjoni simili ġiet approvata għal Relenza mill-Istati Membri.
English: Draft EMEA transparency policy
Maltese: Abbozz tal-politika ta' trasparenza tal-EMEA
English: [EMEA/MB/170391/2009/Rev.2] The Management Board adopted the revisions to Articles 3(2) and 4 of the Fee implementing rules.
Maltese: [EMEA/MB/170391/2009/Rev.2] Il-Bord ta' Tmexxija adotta r-reviżjonijiet tal-Artikoli 3(2) u 4 tarregoli tal-implimentazzjoni tal-Miżati.
English: The comments received at the meeting will be incorporated and the policy will be published for public consultation.
Maltese: Il-kummenti li jiġu riċevuti fil-laqgħa sejrin jiġu inkorporati u l-politika sejra tiġi ppubblikata għallfinijiet ta' konsultazzjoni pubblika.
English: The European Commission indicated that it will propose to reduce this request by € 9 million.
Maltese: Il-Kummissjoni Ewropea indikat li sejra tipproponi li tnaqqas din it-talba b'€ 9 miljuni.
English: [EMEA/MB/174828/2009] Revision timing for Implementing Rules to EMEA Financial Regulation.
Maltese: [EMEA/MB/174828/2009] Iż-żminijiet tar-reviżjoni għar-Regoli Implimentattivi tar-Regolament Finanzjarju tal-EMEA.
English: This becomes an emerging risk for the financing of the Agency in the light of the likely negative financial impact of the revised variations regulation, uncertainty of the impact of a new payment system to Member States and the current economic climate.
Maltese: Dan isir riskju emerġenti għall-finanzjament tal-Aġenzija fid-dawl tal-impatt finanzjarju negattiv possibbli tar-regolament rivedut dwar ilvarjazzjonijiet, l-inċertezza tal-impatt ta' sistema ta' pagament ġdida lill-Istati Membri u l-klima ekonomika attwali.
English: The topic coordinators (Jean Marimbert and Marcus Müllner) were thanked for their contributions.
Maltese: Intradd ħajr lill-koordinaturi tematiċi (Jean Marimbert u Marcus Müllner) għall-kontribut tagħhom.
English: The Board also considered that the nomination of a candidate can take place before June 2010 in a two-day meeting.
Maltese: Il-Bord ikkunsidra wkoll li n-nomina ta' kandidat tista' sseħħ qabel Ġunju 2010 f'laqgħa ta' jumejn.
English: Minutes from the 62nd meeting, held on 4-5 March 2009 [EMEA/MB/45799/2009] The Management Board noted the adoption of the minutes by written procedure.
Maltese: Minuti mit-62 laqgħa, 4-5 ta' Marzu 2009 [EMEA/MB/45799/2009] Il-Bord ta' Tmexxija ħa nota tal-adozzjoni tal-minuti bi proċedura bilmiktub.
English: The Management Board thanked the Board topic coordinators (Aginus Kalis, Jean Marimbert, Marcus Müllner, Gro Wesenberg) for their contribution.
Maltese: Il-Bord ta' Tmexxija radd ħajr lill-koordinaturi tematiċi tal-Bord (Aginus Kalis, Jean Marimbert, Marcus Müllner, Gro Wesenberg) għall-kontribut tagħhom.
English: [EMEA/MB/284297/2009/Rev.1] The Management Board discussed the first proposal on simplification of contractual arrangements in December 2006.
Maltese: [EMEA/MB/284297/2009/Rev.1] Il-Bord ta' Tmexxija ddiskuta l-ewwel proposta għassimplifikazzjoni tal-arranġamenti kuntrattwali f'Diċembru 2006.
English: An operational task force for the implementation of the transparency policy will be considered.
Maltese: Sejjer jiġi kkunsidrat task force operattiv għall-implimentazzjoni tal-politika ta' trasparenza.
English: [EMEA/MB/138548/2009; EMEA/MB/305863/2009; EMEA/MB/356427/2009] The Board heard a presentation on the experience with the policy on the handling of conflicts of interests at the EMEA committees and working parties.
Maltese: [EMEA/MB/138548/2009; EMEA/MB/305863/2009; EMEA/MB/356427/2009] Il-Bord sema' preżentazzjoni dwar l-esperjenza mal-politika dwar l-immaniġġjar tal-kunflitti ta' interessi fil-kumitati u fil-gruppi ta' ħidma tal-EMEA.
English: Changes to the Mission rules [EMEA/MB/694348/2008] The Management Board adopted the rules on missions.
Maltese: Bidliet fir-regoli tal-Missjoni [EMEA/MB/694348/2008] Il-Bord ta' Tmexxija adotta r-regoli dwar il-missjonijiet.
English: For 2010, the EMEA requested a European Commission contribution of € 45 million for the conduct of public health-related activities.
Maltese: Għall-2010, l-EMEA talbet għal kontribuzzjoni mill-Kummissjoni Ewropea ta' € 45 miljun għat-twettiq ta' attivitajiet pubbliċi relatati mas-saħħa.
English: Paediatric investigation plans
Maltese: Pjanijiet ta' investigazzjoni pedjatrika
English: [EMEA/MB/186559/2009; EMEA/MB/319028/2009] The Management Board adopted the analysis and assessment of the Executive Director's annual activity report 2008.
Maltese: [EMEA/MB/186559/2009; EMEA/MB/319028/2009] Il-Bord ta' Tmexxija adotta l-analiżi u lvalutazzjoni tar-rapport annwali dwar l-attività fl-2008 tad-Direttur Eżekuttiv.
English: [EMEA/MB/90876/2009] Summary of transfers of appropriations in the budget 2009.
Maltese: [EMEA/MB/90876/2009] Sommarju tat-trasferimenti tal-approprijazzjonijiet fil-baġit 2009.
English: Rannveig Gunnarsdóttir (Iceland) Gro Ramsten Wesenberg (Norway) Brigitte Batliner (Liechtenstein)
Maltese: Gro Ramsten Wesenberg (InNorveġja)
English: [EMEA/MB/246063/2009; EMEA/MB/251948/2009] The members noted the information on upcoming written procedures.
Maltese: [EMEA/MB/246063/2009; EMEA/MB/251948/2009] Il-membri ħadu nota tal-informazzjoni dwar ilproċeduri bil-miktub li ġejjin.
English: [EMEA/MB/300234/2009] The topic coordinators presented three proposals to improve the consultation procedure: the revision of the CV template to obtain more information on scientific qualifications of nominees; a pre-selection panel listing its advantages and disadvantages; and amendments to the request for nomination letter.
Maltese: [EMEA/MB/300234/2009] Il-koordinaturi tematiċi ppreżentaw tliet proposti biex titjieb il-proċedura ta' konsultazzjoni: ir-reviżjoni tal-mudell tas-CV biex tinkiseb aktar informazzjoni dwar il-kwalifiki xjentifiċi tan-nominati; panil ta' preselezzjoni li jelenka l-vantaġġi u l-iżvantaġġi tiegħu; u emendi għat-talba għall-ittra ta' nomina.
English: [EMEA/MB/279887/2009] Following the consultation process, the Management Board considered and endorsed the proposals for the new corporate identity of the EMEA, including the new logo and acronym of the Agency.
Maltese: [EMEA/MB/279887/2009] Wara l-proċess ta' konsultazzjoni, il-Bord ta' Tmexxija kkunsidra u approva l-proposti għall-identità korporattiva l-ġdida tal-EMEA, inkluż il-logo l-ġdid u l-akronimu talAġenzija.
English: [EMEA/MB/305975/2009] The Board adopted the draft EMEA transparency policy for release for public consultation.
Maltese: [EMEA/MB/305975/2009] Il-Bord adotta l-abbozz tal-politika ta' trasparenza tal-EMEA biex jiġi rilaxxat għall-konsultazzjoni pubblika.
English: The Management Board is involved in 4 stages of the process: the provision of the opinion on the vacancy notice, nomination of an observer to a pre-selection committee at the European Commission, nomination of a director from a shortlist proposed by the European Commission, and appointment of the director after the nominee's presentation at a committee of the European Parliament (in the case of the EMEA - the concerned committee is the Committee on Environment, Public Health and Food Safety).
Maltese: Il-Bord ta' Tmexxija huwa involut f'4 stadji tal-proċess: il-provvista tal-opinjoni dwar l-avviż tal-post battal, in-nomina ta' osservatur għal kumitat ta' pre-selezzjoni fil-Kummissjoni Ewropea, in-nomina ta' direttur minn lista qasira proposta mill-Kummissjoni Ewropea, u l-ħatra tad-direttur wara l-preżentazzjoni tan-nominat f'kumitat tal-Parlament Ewropew (fil-każ tal-EMEA - il-kumitat ikkonċernat huwa l-Kumitat għall
English: Draft agenda for 11 June 2009 meeting [EMEA/MB/45799/2009] The agenda was adopted.
Maltese: Abbozz ta' aġenda għal-laqgħa tal-11 ta' Ġunju 2009 [EMEA/MB/45799/2009] L-aġenda ġiet adottata.
English: Specifically, the scientific committee reviewed scientific information and recommended extending the shelf life of Tamiflu from 5 to 7 years; it also provided an opinion on the use of antiviral medicine Tamiflu in children under one year and in pregnant and breastfeeding women.
Maltese: B'mod speċifiku, il-kumitat xjentifiku rreveda l-informazzjoni xjentifika u rrakkomanda li jiġi estiż il-perijodu ta' konservazzjoni ta' Tamiflu minn 5 sa 7 snin; ipprovda wkoll opinjoni dwar lużu tal-mediċina antivirali Tamiflu fi tfal ta' inqas minn sena u f'nisa tqal u li qegħdin ireddgħu.
English: Governance of EU agencies
Maltese: Governanza tal-aġenziji tal-UE
English: European Commission Heinz Zourek Isabel de la Mata
Maltese: Kent Woods Il-Parlament Ewropew Björn Lemmer Il-Kummissjoni Ewropea Heinz Zourek Isabel de la Mata
English: Documents for information [EMEA/MB/287743/2009] Update report on EMEA implementation of EU telematics strategy.
Maltese: [EMEA/MB/287743/2009] Rapport ta' aġġornament dwar l-implimentazzjoni mill-EMEA talistrateġija tat-Telematika tal-UE.
English: The Board thanked the topic coordinators (Mindaugas Būta, Jytte Lyngvig Marcus Müllner, Pat O'Mahony and Kristin Raudsepp) for detailed review of the report and the proposed analysis and assessment.
Maltese: Il-Bord radd ħajr lill-koordinaturi tematiċi (Mindaugas Būta, Jytte Lyngvig Marcus Müllner, Pat O'Mahony u Kristin Raudsepp) għar-reviżjoni fid-dettall tar-rapport u għall-analiżi u għall valutazzjoni proposti.
English: The Chair invited the members to submit their expression of interests to participate as observers in the preselection committee.
Maltese: Il-President ħeġġeġ lill-membri biex jissottomettu t-turija ta' interess tagħhom li jipparteċipaw bħala osservaturi fil-kumitat ta' pre-selezzjoni.
English: [EMEA/MB/306935/2009] The Management Board discussed the proposal to establish a European medical information network.
Maltese: [EMEA/MB/306935/2009] Il-Bord ta' Tmexxija ddiskuta l-proposta biex jiġi stabbilit netwerk Ewropew għall-informazzjoni medika.
English: Experts with a higher level of conflicts of interests than permitted under the present policy could be allowed to provide their recommendations, but they would not participate in the decision making.
Maltese: L-esperti b'livell aktar għoli ta' kunflitti ta' interessi milli permissibbli taħt din il-politika jistgħu jingħataw il-permess li jipprovdu r-rakkomandazzjonijiet tagħhom, iżda ma jiħdux sehem fit-teħid tad-deċiżjonijiet.
English: [EMEA/MB/295158/2009] The Board discussed the EMEA rules on attachment of staff.
Maltese: [EMEA/MB/295158/2009] Il-Bord iddiskuta r-regoli tal-EMEA dwar l-assenjazzjoni ta' persunal.
English: The document also includes provisions regarding performance indicators and quality assurance.
Maltese: Id-dokument jinkludi wkoll dispożizzjonijiet rigward indikaturi talprestazzjoni u l-garanzija tal-kwalità.
English: The Board discussed that it is important to understand that EU agencies differ in their roles, the sectors they operate in and the stakeholders they are accountable for.
Maltese: Il-Bord iddiskuta li huwa importanti li wieħed jifhem li l-aġenziji tal-UE huma differenti fl-irwoli tagħhom, fis-setturi li joperaw fihom u fil-partijiet interessati li huma responsabbli għalihom.
English: EMEA/FDA liaison exchange
Maltese: Skambju bejn il-kollegament EMEA/FDA
English: Amendments to the Fee implementing rules
Maltese: Emendi għar-regoli tal-implimentazzjoni tal-Miżati
English: Christina Åkerman
Maltese: Åkerman
English: [EMEA/MB/321843/2009] Outcome of written procedures on: Consultation on changes in the membership of the CHMP and CVMP committees; Fee implementing rules; Annual Report 2008; Fee implementing rules relating to MUMs; Fee implementing rules relating to Pandemic situations.
Maltese: [EMEA/MB/321843/2009] L-eżitu tal-proċeduri bil-miktub dwar: il-konsultazzjoni fuq il-bidliet fis-sħubija tal-kumitati tas-CHMP u tas-CVMP; Regoli implimentattivi dwar il-Miżati; Rapport Annwali 2008;
English: Simplification of the contractual arrangements between the EMEA and the National Competent Authorities of the Member States: development of a cooperation agreement
Maltese: Simplifikazzjoni tal-ftehimiet kuntrattwali bejn l-EMEA u l-Awtoritajiet Kompetenti Nazzjonali tal-Istati Membri: żvilupp ta' ftehim ta' kooperazzjoni
English: The Management Board stressed that it is essential to come to an agreement at the EU and intentional levels on the requirements for pandemic vaccines.
Maltese: Il-Bord ta' Tmexxija enfasizza li huwa essenzjali li wieħed jilħaq ftehim fuq il-livelli tal-UE u internazzjonali dwar ir-rekwiżiti għall-vaċċini pandemiċi.
English: [EMEA/11007/2009; EMEA/18113/2009] Annual audit-related reports: Audit advisory committee; EMEA internal auditor; Internal Audit Service of the Commission.
Maltese: [EMEA/11007/2009; EMEA/18113/2009] Rapporti annwali relatati mal-verifika:
English: In addition, the members enquired whether it would be useful to determine the level of conflicts of interest of new nominees during the nomination procedure, raising potential issues with the nominating authority.
Maltese: Barra minn hekk, il-membri staqsew jekk ikunx utli li jiġi stabbilit il-livell ta' kunflitt ta' interess tan-nominati ġodda matul il-proċedura ta' nominazzjoni, filwaqt li kwistjonijiet potenzjali jitqajjmu mal-awtorità ta' nominazzjoni.
English: The Commission's Vice-President Margot Wallström leads the inter-institutional working group in which the EU agencies are represented.
Maltese: Il-Viċi-President tal-Kummissjoni Margot Wallström tmexxi l-grupp ta' ħidma inter-istituzzjonali li fih, l-aġenziji tal-UE huma rrappreżentati.
English: Members recognised that the Member States have different legislation and interpretation with regards to transparency and information.
Maltese: Il-membri għarfu li l-Istati Membri għandhom leġiżlazzjoni u interpretazzjoni differenti fir-rigward tattrasparenza u l-informazzjoni.
English: The Board thanked the EMEA and Management Board topic coordinators (Jean Marimbert and Lisette Tiddens-Engwirda) for their contributions.
Maltese: Il-Bord radd ħajr lill-EMEA u lill-koordinaturi tematiċi tal-Bord ta' Tmexxija (Jean Marimbert u Lisette Tiddens-Engwirda) għall-kontribut tagħhom.
English: The Agency works with vaccine manufacturers to identify the required data to allow for the modification of the marketing authorisation which would replace the current mock-up virus with one of the A/H1N1-derived pandemic-like strains as recommended by the WHO.
Maltese: L-Aġenzija taħdem ma' manifatturi ta' vaċċini biex tidentifika d-dejta meħtieġa sabiex tkun tista' ssir il-modifikazzjoni tal-awtorizzazzjoni għat-tqegħid fis-suq li tissostitwixxi lvajrus fint attwali b'wieħed mir-razez simili għal pandemija dderivat mill-A/H1N1 kif irrakkomandat mill-WHO.
English: The Management Board considered that it is feasible to increase the level of allowable conflicts of interests, but this needs to be matched with increased transparency to assure the public that opinions and decisions will continue to be reached with utmost independence.
Maltese: Lazzjonijiet ta' mitigazzjoni meħtieġa għandhom jiġu implimentati u l-kunflitti ta' interessi tagħhom għandhom isiru pubbliċi.
English: Apologies
Maltese: Skużati
English: Report from the Heads of Medicines Agencies The members noted the written report.
Maltese: Rapport mill-Kapijiet tal-Aġenziji tal-Mediċini Il-membri ħadu nota tar-rapport miktub.
English: The members noted the update report from the European Commission on a range of topics, including: work on novel influenza and the Council's conclusions regarding strategy for vaccine development; pharmaceutical package and good progress with pharmacovigilance and anticounterfeiting proposals, as well as Member States' concerns over the proposal for drug information provisions.
Maltese: Il-membri ħadu nota tar-rapport ta' aġġornament mill-Kummissjoni Ewropea dwar il-firxa ta' suġġetti, inkluż: xogħol fuq il-vajrus il-ġdid tal-influwenza u l-konklużjonijiet tal-Kunsill rigward l-istrateġija għall-iżvilupp ta' vaċċini; l-ippakkjar farmaċewtiku u progress tajjeb fuq il-proposti ta' farmakoviġilanza u dawk kontra l-iffalsifikar, kif ukoll it-tħassib tal-Istati Membri dwar il-proposta għad-dispożizzjonijiet tal-informazzjoni dwar il-mediċini.
English: Minutes of the sixty-third meeting of the Management Board
Maltese: Minuti tat-tlieta u sittin laqgħa tal-Bord ta' Tmexxija
English: *As part of the cooperation between the Management Board and the Heads of Medicines Agencies, Mr Johannes Löwer, the chair of the HMA management group, participated in the Board meeting as an observer.
Maltese: *Bħala parti mill-koperazzjoni bejn il-Bord ta' Tmexxija u l-Kapijiet tal-Aġenziji tal-Mediċini, isSinjur Johannes Löwer, il-president tal-grupp ta' tmexxija tal-HMA, ipparteċipa fil-laqgħa tal-Bord bħala osservatur.
English: Adults and adolescents.
Maltese: Adulti u adoloxxenti.
English: Doses ≥ 4 gm/day
Maltese: Dożi ≥ 4 gm/kuljum
English: “Adults and adolescents
Maltese: “Adulti u adoloxxenti
English: 4.1.8 Endocarditis
Maltese: 4.1.8 Endokardite
English: 500 mg every 6 hours OR 1000 mg every 8 hours OR every 6 hours
Maltese: 500 mg kull 6 sigħat JEW 1000 mg kull 8 sigħat JEW kull 6 sigħat
English: 4.1.9 Prophylaxis
Maltese: 4.1.9 Profilassi
English: Tienam is approved as an intravenous (IV) formulation: Powder for solution for infusion, 250 mg/250mg and 500 mg/500 mg.
Maltese: Trab għal soluzzjoni għal infużjoni, 250 mg/250 mg u 500 mg/500 mg.
English: 4.1.4 Septicaemia
Maltese: 4.1.4 Settiċemija
English: Sections 4.3 - Contraindications, 4.5 - Interaction with other medicinal products and other forms of interaction, 4.6 - Fertility, Pregnancy and Lactation, 4.7 - Effects on ability to drive and use machines, 4.8 - Undesirable effects, 4.9 - Overdose, 5.1 - Pharmacodynamic properties, 5.2 - Pharmacokinetic properties and 5.3 - Preclinical safety data
Maltese: Sezzjonijiet 4.3 - Kontra-indikazzjonijiet, 4.5 - Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni, 4.6 - Fertilità, Tqala u Treddigħ, 4.7 - Effetti fuq il-ħila biex issuq u tħaddem magni, 4.8 - Effetti mhux mixtieqa, 4.9 - Doża eċċessiva, 5.1 - Tagħrif farmakodinamiku, 5.2 - Tagħrif farmakokinetiku u 5.3 - Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà
English: 4.1.1 Intra-abdominal infections
Maltese: 4.1.1 Infezzjonijiet intra-addominali
English: “complicated intra-abdominal infections”
Maltese: “infezzjonijiet intra-addominali kkumplikati”
English: For patients with normal renal function (creatinine clearance of >70 ml/min/1.73 m2), the recommended dose regimens are:
Maltese: Għal pazjenti b'funzjoni renali normali (tneħħija tal-kreatinina ta' >70 ml/min/1.73 m2), ir-reġimens tad-doża rakkomandata huma:
English: Imipenem has activity against a wide variety of bacteria, including Grampositive aerobic cocci, Gram-positive aerobic bacilli, Gram-negative aerobic bacteria, and anaerobes.
Maltese: Imipenem jaħdem kontra firxa wiesgħa ta' batterji, inkluż kokki ajrobiċi Grampożittivi, baċilli ajrobiċi Gram-pożittivi, batterji ajrobiċi Gram-negattivi, u anajrobiċi.
English: The MAH provided a cumulative review of adverse event reports received for imipenem/cilastatin in paediatric patients between 3 months to 3 years of age, which identified a total of 163 events in 82 reports.
Maltese: IlMAH ipprovda reviżjoni kumulattiva ta' rapporti ta' episodji avversi riċevuti għal imipenem/cilastatin f'pazjenti pedjatriċi ta' bejn 3 xhur u 3 snin, li identifikat total ta' 163 episodju fi 82 rapport.
English: Tienam is a broad spectrum antibacterial agent that belongs to the group of carbapenems and consists of a fixed combination (1:1 ratio) of imipenem (a carbapenem antibiotic which is a derivative of thienamycin) and cilastatin (an inhibitor of dehydropeptidase I, a renal enzyme which metabolizes and inactivates imipenem).
Maltese: Tienam hija sustanza antibatterjali bi spettru wiesa' li tappartjeni għall-grupp ta' carbapenems u tikkonsisti f'kombinazzjoni fissa (proporzjon 1:1) ta' imipenem (antibijotiku carbapenem li huwa derivattiv ta' thienamycin) u cilastatin (inibitur ta' dehydropeptidase I, enzima renali li timmetabolizza imipenem u tagħmlu inattiv).
English: The maximum total daily dose should not exceed 4000 mg/day.
Maltese: Id-doża massima totali ta' kuljum ma għandhiex taqbeż 4000 mg/jum.
English: The CHMP noted the proposed the indication “septicaemia” but remarked on the limited and old clinical trial data available.
Maltese: Is-CHMP innota l-indikazzjoni proposta “settiċemija” iżda rrimarka dwar id-dejta klinika limitata u antika disponibbli.
English: Concomitant use of an aminoglycoside may be indicated when Pseudomonas aeruginosa infections are suspected or proven to be involved in the approved indications (see section 4.1).”
Maltese: L-użu konkomittanti ta' aminoglycoside jista' jkun indikat meta jiġi suspettat jew ipprovat li infezzjonijiet ta' Pseudomonas aeruginosa jkunu involuti fl-indikazzjonijiet approvati (see sezzjoni 4.1).”
English: Paediatric population ≥1 year of age
Maltese: Popolazzjoni pedjatrika ≥sena
English: In conclusion, the CHMP adopted the following harmonised indication:
Maltese: Finalment, is-CHMP adotta l-indikazzjoni armonizzata li ġejja:
English: 4.1.11 Mixed infections
Maltese: 4.1.11 Infezzjonijiet imħallta
English: The CHMP was of the opinion that in light of the present clinical and PK/PD data, for paediatric patients ≥1 year of age, a standard dose of 15 or 25 mg/kg/dose administered every 6 hours is recommended.
Maltese: Is-CHMP kien tal-opinjoni li fid-dawl tad-dejta klinika u PK/PD attwali, għal pazjenti pedjatriċi ≥sena, hija rakkomandata doża standard ta' 15 jew 25 mg/kg/doża amministrata kull 6 sigħat.
English: The CHMP noted the proposed indication “skin and soft tissue infections” (SSTI).
Maltese: Is-CHMP innota l-indikazzjoni proposta “infezzjonijiet tal-ġilda u tat-tessut artab” (SSTI).
English: 4.1.10 Management of bacterial infections in patients with febrile neutropenia
Maltese: 4.1.10 Ġestjoni ta' infezzjonijiet batterjali f'pazjenti b'newtropenja febrili
English: Tienam was approved in the EU in 1985 and is currently authorised in 28 European countries (Norway, Iceland and all EU countries with the exception of Denmark).
Maltese: Tienam ġie approvat fl-UE fl-1985 u bħalissa huwa awtorizzat fi 28 pajjiż Ewropew (in-Norveġja, lIslanda u fil-pajjiżi kollha tal-UE bl-eċċezzjoni tad-Danimarka).
English: The MAH discussed a number of specific indications, including community acquired pneumonia (CAP), cystic fibrosis, nosocomial pneumonia or ventilator associated pneumonia.
Maltese: Il-MAH iddiskuta għadd ta' indikazzjonijiet speċifiċi, inkluż pnewmonja akkwistata mill-komunità (CAP), fibrożi ċistika, pnewmonja nosokomjali jew pnewmonja assoċjata ma' ventilatur.