FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Strokovnjakom z višjo stopnjo navzkrižij interesov, kot jo dovoljuje sedanja politika, bi se lahko dovolila predložitev priporočil, vendar ti strokovnjaki ne bi smeli sodelovati pri odločanju.
English: The European Commission guidelines state that directors of EU agencies are appointed at the AD14 grade.
Slovenian: V smernicah Evropske komisije je določeno, da so direktorji agencij EU imenovani na ravni razreda AD14.
English: The members suggested sending the public vacancy notice through the Heads of Medicines Agencies to the national authorities for publishing on national websites.
Slovenian: Člani so predlagali, naj se javna objava prostega delovnega mesta prek vodij agencij za zdravila pošlje nacionalnim organom za objavo na nacionalnih spletnih straneh.
English: The proposal will then be submitted to the Heads of Medicines Agencies for discussion.
Slovenian: Predlog se bo nato predložil vodjem agencij za zdravila v razpravo.
English: In preparation for the bird flu pandemic, the Agency has developed a novel approach using a mock-up virus for assessment of pandemic vaccines.
Slovenian: Agencija je med pripravami na pandemijo ptičje gripe razvila nov pristop z uporabo modelnega virusa za ocenjevanje pandemičnih cepiv.
English: In addition to the centralised regulatory approval, there may be for some A/H1N1 vaccines the option to obtain approval via national authorisation routes.
Slovenian: Poleg centralizirane odobritve cepiv po centraliziranem postopku je mogoče nekatera cepiva za gripo A/H1N1 odobriti tudi z nacionalnimi postopki za izdajo dovoljenja.
English: Report from the Heads of Medicines Agencies The members noted the written report.
Slovenian: Poročilo vodij agencij za zdravila Člani so se seznanili s pisnim poročilom.
English: Draft agenda for 11 June 2009 meeting [EMEA/MB/45799/2009] The agenda was adopted.
Slovenian: Osnutek dnevnega reda za sestanek 11. junija 2009 [EMEA/MB/45799/2009] Dnevni red je bil sprejet.
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.
Slovenian: * Kot del sodelovanja med upravnim odborom in vodji agencij za zdravila se je seje upravnega odbora kot opazovalec udeležil Johannes Löwer, predsednik uprave skupine HMA.
English: European Medicines Network, as having different practices would have a negative impact on the network, and robust policies need to be implemented alongside the transparency policy.
Slovenian: Zato je treba poiskati načine za zagotavljanje doslednega pristopa v Evropski mreži zdravil, saj bi različne prakse negativno vplivale na mrežo, poleg politike preglednosti pa je treba izvajati tudi trdne politike.
English: The Board expressed concern about the European Commission's intention to cancel the arrangements which allowed treating positive balance of the Agency's outturn account as ‘earmarked revenue' for the Agency for subsequent years.
Slovenian: Upravni odbor je izrazil zaskrbljenost glede namere Evropske komisije, da bo ukinila ureditev, v skladu s katero je pozitivno stanje v izkazu poslovnega izida Agencije mogoče obravnavati kot „namenski prihodek“ Agencije za prihodnja leta.
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.
Slovenian: Agencija sodeluje s proizvajalci cepiv pri opredeljevanju potrebnih podatkov, ki bodo omogočili spremembo dovoljenja za promet z zdravilom, s čimer bi se sedanji modelni virus v skladu s priporočili SZO nadomestil z enim od sevov, ki je podoben pandemičnemu in je bil razvit iz virusa gripe A/H1N1.
English: The Agency has done significant work on antiviral medicines to date.
Slovenian: Agencija je opravila že veliko dela v zvezi s protivirusnimi zdravili.
English: Draft EMEA transparency policy
Slovenian: Osnutek politike preglednosti agencije EMEA
English: The group will continue its work presenting the proposals at a Heads of Medicines Agencies meeting.
Slovenian: Skupina bo nadaljevala svoje delo in predloge predstavila na sestanku vodij agencij za zdravila.
English: The new corporate identity will be rolled out in December 2009, together with the new public website of the Agency.
Slovenian: Nova celostna podoba bo skupaj z novo javno spletno stranjo Agencije predstavljena decembra 2009.
English: Update on EMEA work in relation to novel influenza
Slovenian: Posodobljene informacije o delu agencije EMEA v zvezi z novo gripo
English: The Management Board discussed that the grade should reflect the size and complexity of an agency.
Slovenian: Upravni odbor je razpravljal o tem, da bi moral biti razred odvisen od velikosti in kompleksnosti agencije.
English: The Board considered that the recruitment grade for a future director of the Agency should be increased.
Slovenian: Upravni odbor je menil, da je treba zvišati razred zaposlitve prihodnjega direktorja Agencije.
English: The Board expressed a concern that once vaccines are developed the regulators will be under significant pressure from various parties to authorise the products.
Slovenian: Upravni odbor je izrazil zaskrbljenost, da bodo regulatorji po končanem razvoju cepiv izpostavljeni velikim pritiskom različnih strani, ki si bodo prizadevale za pridobitev dovoljenja za promet z zdravilom.
English: The proposal will be further reflected upon at the October meeting.
Slovenian: O tem predlogu se bo nadalje razpravljalo na oktobrski seji.
English: Necessary mitigating actions need to be implemented and their conflicts of interests should be made public.
Slovenian: Treba je izvajati potrebne ukrepe za ublažitev posledic in javno objaviti navzkrižja interesov strokovnjakov.
English: The Board will approach the European Commission with a request to review the recruitment grade for the EMEA's director.
Slovenian: Upravni odbor se bo obrnil na Evropsko komisijo z zahtevo po proučitvi razreda zaposlitve za direktorja agencije EMEA.
English: The Executive Director undertook to update the Management Board on the progress of the inter-institutional discussions.
Slovenian: Izvršni direktor se je zavezal k sprotnemu obveščanju upravnega odbora o napredku medinstitucionalnih razprav.
English: This process should be seen as a possibility to recognise EU agencies in the governance landscape of the EU.
Slovenian: Zavedati se je treba, da ta proces lahko prispeva k priznanju vloge agencij EU na področju vodenja v EU.
English: The Board was briefed about the ongoing inter-institutional debate on the creation and role of EU agencies.
Slovenian: Upravni odbor se je seznanil s tekočo medinstitucionalno razpravo o oblikovanju in vlogi agencij EU.
English: The notice will be sent to all Board members for comments.
Slovenian: Obvestilo bo poslano vsem članom upravnega odbora, ki nato podajo pripombe.
English: Changes to the Mission rules [EMEA/MB/694348/2008] The Management Board adopted the rules on missions.
Slovenian: Spremembe pravil o misijah [EMEA/MB/694348/2008] Upravni odbor je sprejel pravila o misijah.
English: Members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Slovenian: Člani so bili pozvani, naj navedejo kakršne koli posebne interese v zvezi s katero koli točko dnevnega reda, ki bi lahko vplivali na njihovo neodvisnost.
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.
Slovenian: Upravni odbor poudarja, da je treba v zvezi z zahtevami glede pandemičnih cepiv doseči sporazum na ravni EU in mednarodni ravni.
English: The Management Board discussed the guidelines for appointment of executive directors of EU agencies.
Slovenian: Upravni odbor je razpravljal o smernicah za imenovanje izvršnih direktorjev agencij EU.
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.
Slovenian: [EMEA/MB/300234/2009] Tematski koordinatorji so predstavili tri predloge za izboljšanje posvetovalnega postopka: spremembo modela življenjepisa za pridobitev več informacij o znanstvenih kvalifikacijah kandidatov, predizbirni seznam, na katerem se navedejo njihove prednosti in slabosti, in spremembe zahtevka za pismo o imenovanju.
English: The EMEA will approach the Commission's Directorate-General for Budget expressing these concerns.
Slovenian: Agencija EMEA bo svoje pomisleke posredovala Generalnemu direktoratu za proračun pri Komisiji.
English: Irene Sacristan - Sannchez
Slovenian: Irene Sacristan - Sanchez
English: [EMEA/MB/301036/2009] The members heard EMEA concerns that due to high number of referrals, the ability of the Committee for Medicinal Products for Veterinary Use (CVMP) to handle these procedures is reaching capacity.
Slovenian: [EMEA/MB/301036/2009] Člani so se seznanili z zaskrbljenostjo agencije EMEA, da bo Odbor za zdravila za uporabo v veterinarski medicini (CVMP) zaradi velikega števila napotitev kmalu dosegel zgornjo mejo svojih zmogljivosti za izvajanje teh postopkov.
English: Recommendations from the Management Board group on the consultation of nominations to the committees
Slovenian: Priporočilo upravnega odbora v zvezi s posvetovanji o imenovanjih v odbore
English: [EMEA/MB/170391/2009/Rev.2] The Management Board adopted the revisions to Articles 3(2) and 4 of the Fee implementing rules.
Slovenian: [EMEA/MB/170391/2009/Rev.2] Upravni odbor je sprejel spremembe členov 3(2) in 4 izvedbenih pravil o pristojbinah.
English: [EMEA/MB/284297/2009/Rev.1] The Management Board discussed the first proposal on simplification of contractual arrangements in December 2006.
Slovenian: [EMEA/MB/284297/2009/Rev.1] Upravni odbor je o prvem predlogu poenostavitve pogodbenih ureditev razpravljal decembra 2006.
English: The decision is at the discretion of the European Commission.
Slovenian: Evropska komisija bo odločitev sprejela po lastni presoji.
English: Minutes of the sixty-third meeting of the Management Board
Slovenian: Zapisnik triinšestdesete seje upravnega odbora
English: The Management Board noted the update report on progress of the preparations for exchange of staff between the EMEA and the US FDA.
Slovenian: Izmenjava osebja med agencijo EMEA in uradom FDA Upravni odbor se je seznanil s posodobljenim poročilom o napredku priprav za izmenjavo osebja med agencijo EMEA in ameriškim Uradom za živila in zdravila (FDA).
English: [EMEA/MB/306935/2009] The Management Board discussed the proposal to establish a European medical information network.
Slovenian: [EMEA/MB/306935/2009] Upravni odbor je razpravljal o predlogu oblikovanja evropske mreže zdravstvenih informacij.
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.
Slovenian: Upravni odbor se je tematskim koordinatorjem (Mindaugas Būta, Jytte Lyngvig Marcus Müllner, Pat O'Mahony in Kristin Raudsepp) zahvalil za podroben pregled poročila in predlagano analizo ter oceno.
English: Rules on attachment of staff
Slovenian: Dodelitev osebja
English: European Commission communication on EU agencies
Slovenian: Sporočilo Evropske komisije o agencijah EU
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.
Slovenian: [EMEA/MB/279887/2009] Upravni odbor je po posvetovalnem postopku obravnaval in potrdil predloge za novo celostno podobo agencije EMEA, vključno z novim logotipom in kratico Agencije.
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.
Slovenian: Zapisnik dvainšestdesete seje, ki je potekala 4. in 5. marca 2009 [EMEA/MB/45799/2009] Upravni odbor se je seznanil s sprejetjem zapisnika s pisnim postopkom.
English: [EMEA/MB/246063/2009; EMEA/MB/251948/2009] The members noted the information on upcoming written procedures.
Slovenian: [EMEA/MB/246063/2009; EMEA/MB/251948/2009] Člani so se seznanili z informacijami o prihodnjih pisnih postopkih.
English: EMEA highlights from the Executive Director
Slovenian: Poudarki izvršnega direktorja agencije EMEA
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.
Slovenian: [EMEA/MB/138548/2009; EMEA/MB/305863/2009; EMEA/MB/356427/2009] Upravnemu odboru so bile predstavljene izkušnje v zvezi s politiko o obravnavanju navzkrižij interesov v odborih in delovnih skupinah agencije EMEA.
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.
Slovenian: [EMEA/MB/186559/2009; EMEA/MB/319028/2009] Upravni odbor je sprejel analizo in oceno letnega poročila o dejavnostih za leto 2008, ki ga je predstavil izvršni direktor.
English: The topic coordinators (Jean Marimbert and Marcus Müllner) were thanked for their contributions.
Slovenian: Tematskima koordinatorjema (Jean Marimbert in Marcus Müllner) je bila izražena zahvala za njun prispevek.
English: EMEA policy and procedure on the handling of conflicts of interests of EMEA scientific committees' members and experts
Slovenian: Politika in postopek agencije EMEA za obravnavanje navzkrižij interesov članov in strokovnjakov znanstvenih odborov agencije EMEA poročilo o izkušnjah za obdobje 2006-2008 študija o smernicah za prihodnost pregled politike agencije EMEA za obravnavanje navzkrižij interesov znanstvenih odborov agencije EMEA
English: The Board thanked the EMEA and Management Board topic coordinators (Jean Marimbert and Lisette Tiddens-Engwirda) for their contributions.
Slovenian: Upravni odbor se je agenciji EMEA in tematskima koordinatorjema (Jean Marimbert in Lisette Tiddens-Engwirda) zahvalil za njihove prispevke.
English: [EMEA/MB/295158/2009] The Board discussed the EMEA rules on attachment of staff.
Slovenian: [EMEA/MB/295158/2009] Upravni odbor je razpravljal o pravilih agencije EMEA o dodelitvi osebja.
English: The Management Board thanked the Board topic coordinators (Aginus Kalis, Jean Marimbert, Marcus Müllner, Gro Wesenberg) for their contribution.
Slovenian: Upravni odbor se je zahvalil tematskim koordinatorjem (Aginus Kalis, Jean Marimbert, Marcus Müllner, Gro Wesenberg) za njihov prispevek.
English: European Commission guidelines on appointment of directors of the EU agencies
Slovenian: Smernice Evropske komisije o imenovanju direktorjev agencij EU
English: − Preparation for written procedure on amending budget 1/2009
Slovenian: Priprava na pisne postopke zahtevek za mnenje o letnih računovodskih izkazih Agencije za leto, ki se je končalo 31. decembra 2008; priprava na pisni postopek o spremembi proračuna št. 1/2009.
English: [EMEA/MB/305975/2009] The Board adopted the draft EMEA transparency policy for release for public consultation.
Slovenian: [EMEA/MB/305975/2009] Upravni odbor je sprejel osnutek politike preglednosti agencije EMEA, ki bo poslan v javno posvetovanje.
English: EMEA/MB/366757/2009/EN/Rev.1*
Slovenian: EMEA/718019/2009/SL/Rev.1
English: EMEA corporate-identity project
Slovenian: Projekt celostne podobe agencije EMEA
English: The assignment of the EMEA counterpart is in progress.
Slovenian: Imenovanje člana osebja EMEA, ki bo napoten v urad FDA, še poteka.
English: United Kingdom Kent Woods European Parliament
Slovenian: Kent Woods
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.
Slovenian: [EMEA/MB/287743/2009] Posodobljeno poročilo o izvajanju telematske strategije EU v agenciji EMEA [EMEA/MB/282675/2009; EMEA/MB/317275/2009] Poročila o izvajanju sistema EudraVigilance za zdravila, namenjena uporabi v humani medicini in veterinarski medicini [EMEA/MB/174828/2009] Časovni razpored revizije izvedbenih pravil k finančni uredbi agencije EMEA [EMEA/11007/2009; EMEA/18113/2009] Letna poročila v zvezi z revizijami: poročila revizijskega svetovalnega odbora, notranjega revizorja agencije EMEA in Službe Komisije za notranjo revizijo (IAS) [EMEA/MB/321843/2009] Rezultat pisnih postopkov o: posvetovanju o spremembah članstva v odborih CHMP in CVMP; izvedbenih pravilih o pristojbinah; letnem poročilu za leto 2008, izvedbenih pravilih o pristojbinah v zvezi z zdravili MUMS; izvedbenih pravilih o pristojbinah v zvezi s pandemijami [EMEA/MB/90876/2009] Povzetek prerazporeditve proračunskih sredstev za leto 2009
English: Unjustified and nonsubstantiated prophylactic use is not acceptable.
Slovenian: Neupravičena in neutemeljena profilaktična uporaba ni sprejemljiva.
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).
Slovenian: Zdravilo Tienam je bilo v EU odobreno leta 1985 in je trenutno odobreno v 28 evropskih državah (Norveška, Islandija in vse države EU razen Danske).
English: 500 mg every 6 hours OR 1000 mg every 8 hours OR every 6 hours
Slovenian: 500 mg vsakih 6 ur ALI 1 000 mg vsakih 8 ur ALI vsakih 6 ur
English: The maximum total daily dose should not exceed 4000 mg/day.
Slovenian: Največji skupni dnevni odmerek ne sme presegati 4 000 mg/dan.
English: SECTION 6 - PHARMACEUTICAL PARTICULARS
Slovenian: POGLAVJE 6 - FARMACEVTSKI PODATKI
English: In sections 6.3 and 6.6, a warning was added to state that diluted solutions should be used immediately and that the interval between beginning of reconstitution and the end of intravenous infusion should not exceed two hours.
Slovenian: V poglavji 6.3 in 6.6 je bilo dodano opozorilo, da je treba razredčeno raztopino uporabiti takoj ter da časovni interval med začetkom rekonstitucije in koncem intravenske infuzije ne sme biti daljši od dveh ur.
English: “Adults and adolescents
Slovenian: „Odrasli in mladostniki
English: During the course of the procedure, a Drafting Group meeting was convened by the CHMP.
Slovenian: Med postopkom je CHMP sklical sestanek redakcijske skupine.
English: Overall summary of the scientific evaluation of Tienam and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Tienam in povezanih imen (glejte Dodatek I)
English: Moreover, the use of imipenem in the management of any type of endocarditis has not been mentioned in the EU endocarditis Guideline, 2004.
Slovenian: Poleg tega uporaba imipenema pri zdravljenju katere koli vrste endokarditisa ni bila omenjena v smernici EU za endokarditis iz leta 2004.
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
Slovenian: Poglavja 4.3 - Kontraindikacije, 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij, 4.6 - Plodnost, nosečnost in dojenje, 4.7 - Vpliv na sposobnost vožnje in upravljanja s stroji, 4.8 - Neželeni učinki, 4.9 - Prekomerno odmerjanje, 5.1Farmakodinamične lastnosti, 5.2 - Farmakokinetične lastnosti in 5.3 - Predklinični podatki o varnosti
English: 4.1.8 Endocarditis
Slovenian: 4.1.8 Endokarditis
English: Paediatric patients above 1 year of age
Slovenian: Pediatrični bolniki, starejši od enega leta
English: A referral under Article 30 of Directive 2001/83, as amended, was started in May 2009 for Tienam and associated names.
Slovenian: Maja 2009 se je za zdravilo Tienam in povezana imena začel napotitveni postopek v skladu s členom 30 Direktive 2001/83, kakor je bila spremenjena.
English: Adults and adolescents.
Slovenian: Odrasli in mladostniki
English: Doses ≥ 4 gm/day
Slovenian: Odmerki ≥ 4 g/dan
English: For patients with normal renal function (creatinine clearance of >70 ml/min/1.73 m2), the recommended dose regimens are:
Slovenian: Za bolnike z normalnim delovanjem ledvic (očistek kreatinina > 70 ml/min/1,73 m2) je priporočeno odmerjanje:
English: The CHMP adopted a harmonised wording for these sections.
Slovenian: CHMP je sprejel usklajeno besedilo za ta poglavja.
English: In addition, the recommended solutions were specified as being 0.9% sodium chloride solution and water for injection, while the use of 5% glucose was restricted to exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons.
Slovenian: Poleg tega so bile priporočene raztopine določene kot 0,9-odstotne raztopine natrijevega klorida in vode za injiciranje, medtem ko je bila uporaba 5-odstotne glukoze omejena na izjemne okoliščine, kadar uporaba 0,9-odstotnega natrijevega klorida zaradi kliničnih razlogov ne bi bila možna.
English: Tienam is approved as an intravenous (IV) formulation: Powder for solution for infusion, 250 mg/250mg and 500 mg/500 mg.
Slovenian: Zdravilo Tienam je odobreno kot intravenozna formulacija: prašek za raztopino za infundiranje 250 mg/250 mg in 500 mg/500 mg.
English: The CHMP did not consider this to be an indication and removed this information from section 4.1.
Slovenian: CHMP je menil, da to ni indikacija, in je to informacijo izbrisal iz poglavja 4.1.
English: In addition, potential failure of Tienam therapy might lead to surgical interventions or amputations which should be considered as serious adverse outcomes.
Slovenian: Poleg tega bi lahko neuspešno zdravljenje z zdravilom Tienam pripeljalo do kirurških posegov ali amputacij, ki jih je treba upoštevati kot hude neželene izide.
English: These infections are mostly caused by Gram-positive bacteria, S. aureus being the most important.
Slovenian: Te okužbe večinoma povzročajo grampozitivne bakterije, najpomembnejša pa je bakterija S. aureus.
English: 4.1.12 Non-indication in the treatment of meningitis.
Slovenian: 4.1.12 Neindikacija za zdravljenje meningitisa
English: Based on information from the submitted studies, the CHMP considered that no dose adjustment is required in elderly patients, except in cases of moderate to severe renal impairment.
Slovenian: Na podlagi podatkov iz predloženih študij je CHMP menil, da za starejše bolnike prilagajanje odmerka ni potrebno, razen v primeru zmerne do hude okvare ledvic.
English: Paediatric population <1 year of age Clinical data are insufficient to recommend dosing for children less than 1 year of age.”
Slovenian: Pediatrična populacija, mlajša od 1 leta Klinični podatki so nezadostni za priporočilo odmerka za otroke, mlajše od 1 leta.“
English: The CHMP assessed the available data regarding use in children, in particular taking into account 2 large efficacy/safety paediatric studies (Paediatric Study 1 and Paediatric Study 2/3) and the available peer-review medical literature.
Slovenian: CHMP je ocenil razpoložljive podatke glede uporabe pri otrocih, pri čemer je upošteval predvsem dve veliki pediatrični študiji učinkovitosti/varnosti (Pediatrična študija 1 in Pediatrična študija 2/3) ter razpoložljivo strokovno recenzirano medicinsko literaturo.