natgillin/translations-raw huggingface dataset:
Members of the Parliament raised a number of questions, including ones about the use of single versus two doses of the approved vaccines and the use of the vaccines in children and pregnant woman.
Poslanci Evropskega parlamenta so postavili številna vprašanja, vključno z vprašanjem o uporabi enega oziroma dveh odmerkov odobrenega cepiva in uporabi cepiv za otroke in nosečnice.
− 3 members of the Management Board, plus 1 representative of the patients' organisations which are members of the Management Board;
3 člani upravnega odbora in en predstavnik organizacij bolnikov, ki so člani upravnega odbora;
The proposal should be finalised for the March 2010 Management Board meeting.
Predlog mora biti dokončno oblikovan do seje upravnega odbora, ki bo potekala marca 2010.
Consultation on appointment of a CVMP member
Posvetovanje o imenovanju člana odbora CVMP
The changes to the procedure will be introduced in the future revision of the EMEA policy on the handling of conflicts of interests.
Spremembe postopka bodo uvedene pri prihodnji reviziji politike agencije EMEA glede obravnavanja navzkrižij interesov.
Item 11 (rules on attachment of staff) was taken off the agenda taking into account the interpretation of the Staff Regulations provided by the European Commission whereby the proposed rules may not be applied to govern the attachment of EMEA staff.
Točka 11 (Dodelitev osebja) je bila umaknjena z dnevnega reda zaradi upoštevanja razlage Evropske komisije o Kadrovskih predpisih, po kateri se predlagana pravila ne smejo uporabljati za urejanje dodelitve osebja EMEA.
Lisette Tiddens-Engwirda was nominated as chair of the committee.
Lisette Tiddens-Engwirda je bila imenovana za predsednico odbora.
Participants at the sixty-fourth meeting of the Management Board London, 1 October 2009
Udeleženci štiriinšestdesete seje upravnega odbora London, 1. oktobra 2009
The Board noted that at present there is no legal basis to request fees for site visits or to compensate national competent authorities for the work carried out for site visits in the context of advanced therapy medicinal products.
Upravni odbor je ugotovil, da trenutno ni pravne podlage za zahtevo po pristojbinah za obiske lokacij ali povračilo nacionalnim pristojnim organom za delo v okviru obiskov lokacij v zvezi z zdravili za napredno zdravljenje.
Some deviations from the work programme were recorded, relating to the number and complexity of referrals in the veterinary field, which requires significant scientific resources, and to lower-thanplanned productivity of the Committee on Herbal Medicinal Products (HMPC).
Zabeleženo je bilo nekaj odstopanj od delovnega programa v zvezi s številom in zapletenostjo napotitev na veterinarskem področju, za katere je potrebno veliko znanstvenih virov, in nižjo produktivnostjo Odbora za zdravila rastlinskega izvora (HMPC) od načrtovane.
The Board heard that the current estimate for revenue from fees is €8.5m lower than originally forecast, due to a decrease in the proportion of fee-earning applications expected to be received.
Upravni odbor je zvedel, da je po sedanji oceni prihodek od pristojbin za 8,5 milijona EUR manjši od prvotne napovedi, ker je bilo število plačljivih vlog manjše od pričakovanega.
There is a significant increase in applications for authorisation of generic medicinal products, with 31 applications received.
Število vlog za izdajo dovoljenja za generična zdravila se je zelo povečalo, saj je agencija prejela 31 vlog.
The Board reiterated the need to agree on telematics projects well in advance, to enable the national competent authorities to develop their IT systems in line with the needs at the EU level.
Upravni odbor je znova ponovil, da morajo biti sporazumi o projektih telematike sprejeti precej pred izvedbo, da se nacionalnim pristojnim organom omogoči razvijanje sistemov informacijske tehnologije v skladu s potrebami na ravni EU.
Mandate of the Ad Hoc Pharmacovigilance Inspectors Working Group
Pristojnosti ad hoc delovne skupine inšpektorjev za farmakovigilanco
The authority will be informed about the concerns expressed by the Board with regards to the suitability of the nominee.
Organ bo obveščen o pomislekih upravnega odbora glede primernosti kandidata.
The Board asked the task force to further elaborate its proposal on the training of experts involved in the work of the committees in the light of the significant training already provided by the Agency.
Upravni odbor je zaprosil projektno skupino, da dodatno izpopolni svoj predlog o usposabljanju strokovnjakov, vključenih v delo odborov, glede na obsežno usposabljanje, ki ga je že zagotovila agencija.
− Hans-Georg Wagner.
Hansa-Georga Wagnerja.
The procedure will enable the Agency to inform the nominating authority of a potential conflict of interests of a nominee at the start of the nomination procedure.
Postopek bo agenciji omogočil, da obvesti organ za imenovanje o morebitnem navzkrižju interesov kandidata na začetku postopka imenovanja.
The Board stated, however, that the final decision as to the nomination lies with the Member State.
Upravni odbor pa je vseeno izjavil, da končno odločitev o imenovanju sprejme država članica.
The Board also endorsed the proposal to establish a procedure for advanced screening of potential conflicts of interests ahead of the nomination.
Upravni odbor je tudi potrdil predlog o vzpostavitvi postopka za napredno pregledovanje morebitnih navzkrižij interesov pred imenovanjem.
EMEA mid-year report 2009
Vmesno poročilo agencije EMEA za leto 2009
The Agency is now preparing a report based on the data received, and will submit the report to the December Management Board meeting, at which time the Board will also be able to discuss options for a possible decision in the future.
Agencija zdaj na podlagi prejetih podatkov pripravlja poročilo, ki ga bo upravnemu odboru predložila za decembrsko sejo, na kateri bo ta lahko razpravljal o možnostih za morebitne prihodnje odločitve.
Telematics master plan 2009-2013
Glavni načrt za telematiko 2009-2013
The Agency will consider this information in the context of the ongoing revision of the Agency's policy governing the handling of conflicts of interest and will inform the corresponding parties accordingly.
Agencija bo te informacije proučila v okviru tekoče reforme politike agencije, ki ureja obravnavanje navzkrižij interesov, in bo zadevne strani obvestila o izidu.
The findings will be presented to the EMEA Management Board topic coordinators and to the Management Board in December.
Ugotovitve bodo decembra predstavljene tematskim koordinatorjem upravnega odbora agencije EMEA in upravnemu odboru.
Feedback form the members is expected in a week's time, following which the proposal will be finalised and re-presented at the October Heads of Medicines Agencies meeting, and later submitted for adoption by the Board in December.
Povratne informacije članov se pričakuje v enem tednu, nato bo predlog dokončno oblikovan in znova predstavljen na oktobrskem sestanku vodij agencij za zdravila, zatem pa predložen v sprejetje na decembrski seji upravnega odbora.
The members noted the update report from the European Commission on a range of topics, including: the European Commission's work in the field of pandemic influenza, progress on the inter-service consultation on the variations regulation, the entry into force of the new regulation on maximum residue limits, and work in the field of health technology assessment.
Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah, vključno z: delom Evropske komisije na področju pandemične gripe, napredkom pri posvetovanju med službami o uredbi o spremembah, začetku veljavnosti uredbe o najvišjih mejnih vrednostih ostankov in delom pri ocenjevanju zdravstvenih tehnologij.
The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including: the development of the new HMA strategy paper, expected to be completed by the end of 2010; the ongoing discussion on transparency issues, with focus on commercially confidential information; and the reflection on the future of the veterinary medicines legislation.
Člani so se seznanili s posodobljenim poročilom vodij agencij za zdravila o različnih temah, vključno z: razvojem novega strateškega dokumenta HMA (Heads of Medicines Agencies), za katerega se pričakuje, da bo dokončan do konca leta 2010; tekočo razpravo o vprašanjih preglednosti, s poudarkom na komercialni zaupnosti podatkov, in razmislekom o prihodnji zakonodaji na področju veterinarske medicine.
Amendments to the CV template for experts and to the EMEA letter inviting nominations were introduced.
Uvedene so bile spremembe v zvezi s predlogo življenjepisa za strokovnjake in dopisom agencije EMEA za poziv k imenovanju.
It was asked that for future versions of the telematics master plan the document should be tabled with track changes for a more easy comparison with previous versions.
Prosili so, naj bodo dokumenti prihodnjih različic glavnega načrta za telematiko oblikovani z vključeno funkcijo Sledi spremembam za lažjo primerjavo s prejšnjimi različicami.
A robust system to monitor the safety and efficacy of vaccines has been put in place, in cooperation with the European Centre for Disease Prevention and Control.
V sodelovanju z Evropskim centrom za preprečevanje in obvladovanje bolezni je bil uveden učinkovit sistem nadzora varnosti in učinkovitosti cepiv.
[EXT/548688/2009] Further to the decision of the Telematics steering committee and the proposal of the European Commission, the Management Board adopted the decision to create the EMEA Management Board Telematics Committee (MBTC) as a subgroup of the Management Board.
[EXT/548688/2009]Po odločitvi usmerjevalnega odbora za telematiko in predlogu Evropske komisije je upravni odbor sprejel odločitev o ustanovitvi odbora za telematiko pri upravnem odboru agencije EMEA (MBTC) kot podskupine upravnega odbora.
Thomas Lönngren Patrick Le Courtois David Mackay Andreas Pott Hans-Georg Wagner Noël Wathion Sylvie Benefice Riccardo Ettore Martin Harvey Allchurch Frances Nuttall John Purves
Thomas Lönngren Patrick Le Courtois David Mackay Andreas Pott Hans-Georg Wagner Noël Wathion Sylvie Bénéfice Riccardo Ettore Martin Harvey Allchurch Frances Nuttall John Purves
The letter informed the Board, inter alia, that these persons were members of an editorial team for a book, which was sponsored by a pharmaceutical company.
Upravni odbor se je z dopisom med drugim seznanil, da sta bili ti osebi člana uredniškega odbora za izdajo knjige, ki jo je finančno podprla neka farmacevtska družba.
The patients' representative on the Board asked to address in the reflection paper the increasing difficulty of patients' representatives to participate in the Agency's activities due to resource constraints.
Predstavnik bolnikov v upravnem odboru je prosil, naj se v proučitvenem dokumentu obravnavajo tudi vse večje težave predstavnikov bolnikov glede sodelovanja v dejavnostih agencije zaradi omejenih virov.
Report from the Task force on scientific qualifications of CHMP and CVMP members
Poročilo projektne skupine za znanstvene kvalifikacije članov odborov CHMP in CVMP
[EMEA/MB/518171/2009] The Board adopted the following meeting dates for 2010: 17 and 18 March, 10 June, 7 October and 16 December.
[EMEA/MB/518171/2009] Upravni odbor je sprejel naslednje datume sej za leto 2010: 17. in 18. marec, 10. junij, 7. oktober in 16. december.
A reflection paper, which will be presented at the December meeting, will provide proposals on further involvement of patients' and consumers' organisations in the Agency's activities, including in the scientific review process.
V proučitvenem dokumentu, ki bo predstavljen na decembrski seji, bodo navedeni predlogi o nadaljnjem vključevanju organizacij bolnikov in potrošnikov v dejavnosti agencije in tudi v postopek znanstvene presoje.
[EMEA/MB/358420/2009] The agenda was adopted.
[EMEA/MB/358420/2009] Dnevni red je bil sprejet.
The mandate has been endorsed by the Heads of Medicines Agencies.
Pristojnosti so potrdili vodje agencij za zdravila.
The Board's substantial concern remains that the grading level proposed by the European Commission is too low.
Upravni odbor najbolj skrbi, da je razvrstitev tega delovnega mesta na lestvici, ki jo predlaga Evropska komisija, prenizka.
The Management Board was notified of the letter received about a former member of the Management Board and a CHMP alternate Member concerning their past activities.
Upravni odbor je bil obveščen, da je prispel dopis o nekdanjem članu upravnega odbora in o nadomestnem članu Odbora za zdravila za uporabo v humani medicini (CHMP) v zvezi z njunimi preteklimi dejavnostmi.
Minutes of the sixty-fourth meeting of the Management Board
Zapisnik štiriinšestdesete seje upravnega odbora
− 3 members of the Heads of Medicines Agencies;
3 člani izmed vodij agencij za zdravila;
The revisions concern the fees for consultation on line-extensions for ancillary substances, including blood derivates, incorporated in medical devices; and the implementation of the new regulation on maximum residue limits.
Spremembe se nanašajo na pristojbine za posvetovanje o razširitvi indikacij za pomožne snovi, kamor sodijo tudi krvni derivati, vključeni v medicinske pripomočke, in izvajanje nove uredbe o najvišjih mejnih vrednosti ostankov.
The CHMP has provided an explanatory note about the rationale for benefit-risk assessment of the vaccines, and published the information on the Agency's website.
Odbor za zdravila za uporabo v humani medicini je predložil pojasnilo z utemeljitvijo ocene razmerja med koristjo in tveganjem cepiv in informacijo objavil na spletni strani agencije.
The Board was invited to send comments with regards to the outlined proposal ahead of its presentation in December.
Upravni odbor je bil pozvan, naj predloži pripombe v zvezi z osnutkom predloga pred njegovo predstavitvijo v decembru.
The first discussion on the draft road map at the HMA level is planned for later this year, in time to submit the document for discussion at the EMEA Management Board in December.
Prva razprava o osnutku časovnega načrta na ravni vodij agencij za zdravila je predvidena enkrat v tem letu, a dovolj zgodaj, da bo dokument lahko predložen v razpravo na seji upravnega odbora agencije EMEA v decembru.
[EMEA/MB/320040/2009] Summary of transfers of appropriations in the budget 2009.
[EMEA/MB/320040/2009] Povzetek prenosov dodeljenih sredstev v proračun za leto 2009.
The Management Board proposed to invite the chair of the HMPC to present the work of the Committee and the challenges it encounters at its December meetings.
Upravni odbor je predlagal, naj se na decembrsko sejo povabi predsednik odbora HMPC, da predstavi delo odbora in izzive, s katerimi se spopada.
Report on interaction with patients' organisations
Poročilo o sodelovanju z organizacijami bolnikov
The experience with the revised CV template will be reviewed in the future.
Izkušnje s spremenjeno predlogo življenjepisa bodo pregledane na prihodnjih sestankih.
[EMEA/MB/517929/2009] The Board adopted the proposals aiming to improve the consultation process on nomination of scientific committee members.
[EMEA/MB/517929/2009] Upravni odbor je sprejel predloge, katerih namen je izboljšati posvetovalni postopek imenovanja članov znanstvenega odbora.
The Agency's current road map covers the period up to 2010.
Dolgoročna strategija agencije EMEA - Časovni načrt Sedanji časovni načrt agencije zajema obdobje do leta 2010.
[EMEA/MB/517930/2009] Outcome of written procedures: - On consultation on changes in the membership of the CHMP and CVMP scientific committees; - Final accounts 2008; - Minutes of the 64th meeting of the Management Board;
[EMEA/MB/517930/2009] Rezultat pisnih postopkov o: - posvetovanju o spremembah članstva v odborih CHMP in CVMP; - zaključnem računu za leto 2008; - zapisniku štiriinšestdesete seje upravnega odbora; - spremembi proračuna 01-2009.
[EMEA/433259/2009] The Board noted the outcome of the written procedure on consultation on the nomination to the CVMP and considered the nomination as insufficient.
[EMEA/433259/2009] Upravni odbor se je seznanil s pisnim postopkom o posvetovanju o imenovanju v Odbor za zdravila za uporabo v veterinarski medicini (CVMP) in menil, da je kandidatura pomanjkljiva.
[EMEA/MB/366757/2009] The Management Board noted the adoption of the minutes by written procedure on 28 July 2009.
[EMEA/MB/366757/2009] Upravni odbor se je seznanil s sprejetjem zapisnika s pisnim postopkom z dne 28. julija 2009.
Vacancy notice for the Executive Director's function
Objava prostega delovnega mesta za položaj izvršnega direktorja
[EMEA/MB/589426/2009] The Board further considered the proposal on contractual arrangements following the discussion in June and a subsequent round of consultation.
[EMEA/MB/589426/2009] Upravni odbor je dodatno proučil predlog o pogodbeni ureditvi po junijski razpravi in naknadnem posvetovanju.
EMEA/MB/642672/2009/EN/Adopted 13 November 2009
EMA/MB/151648/2010/SL/sprejeto 13. novembra 2009
[EMEA/MB/565964/2009] The Board also noted the proposed future amendment of the fee implementing rules in relation to the new legislation on variations.
[EMEA/MB/565964/2009] Upravni odbor se je tudi seznanil s predlagano spremembo izvedbenih pravil o pristojbinah v povezavi z novo zakonodajo o spremembah.
[EMEA/MB/503751/2009] The Management Board reviewed the progress of the implementation of the Agency's work programme 2009.
[EMEA/MB/503751/2009] Upravni odbor je pregledal izvajanje delovnega programa agencije v letu 2009.
[EMEA/MB/575748/2009] The Board noted the mandate and the report on the first year of operation of the Ad Hoc Pharmacovigilance Inspectors Working Group.
[EMEA/MB/575748/2009] Upravni odbor se je seznanil s pristojnostmi in poročilom o prvem letu delovanja ad hoc delovne skupine inšpektorjev za farmakovigilanco.
Management Board members reviewed and provided written comments on the proposed vacancy notice for the Executive Director's post.
Člani upravnega odbora so pregledali predlagano objavo prostega delovnega mesta izvršnega direktorja in predložili pisne pripombe.
[EMEA/MB/170391/2009/Rev.3] The Management Board adopted the revisions to the fee implementing rules.
[EMEA/MB/170391/2009/Rev.3] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah.
Minutes from the 63rd meeting, held on 11 June 2009
Zapisnik triinšestdesete seje, ki je potekala 11. junija 2009
Representative of veterinarians' organisations
Predstavniki organizacij veterinarjev
[EMEA/MB/589426/2009] The Management Board noted the report on interaction with patients' and consumers' organisations.
[EMEA/MB/589426/2009] Upravni odbor se je seznanil s poročilom o sodelovanju z organizacijami bolnikov in potrošnikov.
− Pat O'Mahony;
Pata O'Mahonyja,
A proposed framework on the interaction with HCPs' organisations will be discussed at the October meeting of the working group.
Delovna skupina bo o predlaganem okviru sodelovanja z organizacijami zdravstvenih strokovnjakov razpravljala na oktobrski seji.
The Board asked to convene the committee and present its terms of reference at the December meeting.
Upravni odbor je zaprosil za sklic odbora in predstavitev njegovih pristojnosti ter nalog na decembrski seji.
EMEA/MB/569756/2009] Reports on EudraVigilance implementation for human medicines and medicines for veterinary use.
[EMEA/MB/472819/2009*; EMEA/MB/569756/2009] Poročila o izvajanju sistema EudraVigilance za zdravila, namenjena uporabi v humani medicini in veterinarski medicini.
[A6-0162_2009_EN] European Parliament decision on discharge to the Executive Director of the EMEA [EMEA/MB/528743/2009] Update report on EMEA implementation of EU telematics strategy.
[A6-0162_2009_EN] Sklep Evropskega parlamenta o razrešnici izvršnemu direktorju agencije EMEA.
The authority will then decide whether to continue with the nomination in the light of the feedback received from the Agency.
Organ bo nato glede na povratno informacijo agencije odločil, ali naj postopek imenovanja nadaljuje.
Representative of doctors' organisations
Predstavniki organizacij zdravnikov
Lisette Engwirda-Tiddens
Lisette Tiddens-Engwirda
The composition of the new MBTC is as follows:
Sestava novega usmerjevalnega odbora z telematiko pri upravnem odboru agencije EMEA je:
− Thomas Lönngren;
Agencija EMEA je imenovala naslednje predstavnike: Thomasa Lönngrena;
[EMEA/MB/472819/2009*;
[EMEA/69619/2009].
[EMEA/69619/2009] The Management Board adopted the 2009 part of the telematics master plan.
Upravni odbor je sprejel del glavnega načrta za telematiko za leto 2009.
The Board nominated the following members:
Upravni odbor je imenoval naslednje člane: Marcusa Müllnerja;
Invented name Strength Pharmaceutical Form Route of Administration Packaging
Izmišljeno ime Jakost
--1 Each dose (0.007 ml) of undiluted vaccine contains: - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria maxima, strain 013 - 196 - 265 sporulated oocysts - Eimeria mitis, strain 006 - 293 - 397 sporulated oocysts - Eimeria praecox, strain 007 - 293 - 397 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts
--1 En odmerek (0,007 ml) nerazredčenega cepiva vsebuje: - Eimeria acervulina, sev 003 - 332-450 sporuliranih oocist - Eimeria maxima, sev 013 - 196-265 sporuliranih oocist - Eimeria mitis, sev 006 - 293-397 sporuliranih oocist - Eimeria praecox, sev 007 - 293-397 sporuliranih oocist - Eimeria tenella, sev 004 - 276-374 sporuliranih oocist
The full EPAR for Pioglitazone Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pioglitazone Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Teva on 26 March 2012.
Evropska komisija je dovoljenje za promet z zdravilom Pioglitazone Teva, veljavno po vsej Evropski uniji, odobrila dne 26. marca 2012.
Treatment with Pioglitazone Teva should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Zdravljenje z zdravilom Pioglitazone Teva je treba ponovno oceniti po treh do šestih mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
For more information about treatment with Pioglitazone Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pioglitazone Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Pioglitazone Teva, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Zdravilna učinkovina zdravila Pioglitazone Teva, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
This means that Pioglitazone Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.
Pioglitazone Teva is a ‘generic medicine'.
Pioglitazone Teva je „generično zdravilo“.
This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Priporočeni začetni odmerek zdravila Pioglitazone Teva je 15 ali 30 mg enkrat na dan. Odmerek bo po enem ali dveh tednih morda treba povečati do 45 mg enkrat na dan, če je potreben boljši nadzor glukoze (sladkorja) v krvi.
This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pioglitazone Teva.
What are the benefits and risks of Pioglitazone Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Pioglitazone Teva?