FrancophonIA/ELRC3.0 huggingface dataset:
English: The Management Board noted the presentation summarising the discussions on the implementation of the pharmacovigilance legislation which were held during the meeting of the Heads of Medicines Agencies on 5 October 2011.
Slovenian: Upravni odbor se je seznanil s predstavitvijo, ki povzema razprave o izvajanju zakonodaje o farmakovigilanci, ki so potekale 5. oktobra 2011 med sejo vodij agencij za zdravila.
English: The Agency hosted visits of many interested parties, including the French Senate, The French National Assembly and the IGAS inspectorate, and responded to enquires of committees conducting investigations into the circumstances surrounding the product, as well as to enquiries from the media.
Slovenian: Agencija je gostila obiske številnih zainteresiranih strani, vključno s francoskim senatom, francoskim državnim zborom in inšpektoratom IGAS (Inspection générale des affaires sociales), ter odgovarjala na poizvedbe odborov, ki so opravljali preiskave v zvezi z okoliščinami zdravila, in na vprašanja medijev.
English: In cases where discussions are controversial, meeting minutes shall provide further details of the discussion and shall record dissenting opinions.
Slovenian: Kadar so razprave sporne, bodo v zapisniku navedene dodatne podrobnosti o razpravi in odklonilna mnenja.
English: Reinstatement of the Accounting officer
Slovenian: Vrnitev računovodje na delovno mesto
English: First update on the implementation of conflicts of interests policy for experts and staff
Slovenian: Prve novice o izvajanju politike o navzkrižju interesov za strokovnjake in osebje
English: The Board was informed that the European Court of Auditors is conducting an audit on systems and policies for managing conflicts of interest in several EU agencies.
Slovenian: Odbor je bil obveščen, da Evropsko računsko sodišče opravlja revizijo sistemov in politik za upravljanje navzkrižij interesov v več agencijah EU.
English: [EMA/MB/650168/2011] The agenda was adopted.
Slovenian: [EMA/MB/650168/2011] Dnevni red je bil sprejet.
English: Jytte Lyngvig, the chair of the group, informed the Board that the work takes place in the areas of negotiated procedures, centralised oversight of tendering and use of exceptions.
Slovenian: Jytte Lyngvig, predsednica skupine, je odbor obvestila, da se ukvarjajo s področji, kot so postopki s pogajanji, centralizirani pregled zbiranja ponudb in uporaba izjem.
English: New premises for the Agency
Slovenian: Novi prostori agencije
English: • Falsified medicines directive (the date of implementation is January 2013; the three areas of activity for implementing measures are the implementation of the safety feature, control of import of active pharmaceutical ingredients and preparing a logo for online pharmacies).
Slovenian: • direktiva o ponarejenih zdravilih (datum začetka izvajanja je januar 2013; tri področja dejavnosti za izvedbene ukrepe so izvajanje zaščitnega elementa, nadzor nad uvozom aktivnih farmacevtskih učinkovin ter priprava logotipa za spletne lekarne);
English: A parallel project is ongoing to organise the work of staff.
Slovenian: Sočasno se izvaja projekt organizacije dela osebja.
English: Following the appointment, Guido Rasi joined the meeting of the Management Board.
Slovenian: Po imenovanju se je Guido Rasi pridružil seji upravnega odbora.
English: Apart from elections, the Board generally only votes in exceptional situations.
Slovenian: Odbor običajno glasuje samo v izjemnih primerih, razen pri volitvah.
English: The group aims to provide its recommendations for the December Management Board meeting.
Slovenian: Cilj skupine je predložiti priporočila za decembrsko sejo upravnega odbora.
English: • The Commission is preparing an impact assessment for the revision of the legislation on clinical trials (the aim is to prepare a proposal in the third quarter of 2012).
Slovenian: • Komisija pripravlja oceno učinka za spremembo zakonodaje o kliničnem preskušanju (cilj je pripraviti predlog v tretjem četrtletju leta 2012);
English: Processes that are subject to this approach are Type I variations, validation, management of requests to access documents and information.
Slovenian: Postopki, pri katerih se uporablja ta pristop, so spremembe tipa I, potrjevanje, upravljanje zahtev za dostop do dokumentov in obveščanje.
English: The Board was reminded that the group on procurement is reviewing the Agency's procedures and will make recommendations to reinforce procurement practices at the Agency.
Slovenian: Odbor je bil opomnjen, da skupina za javna naročila pregleduje postopke agencije in da bo predložila priporočila za okrepitev praks za javna naročila v agenciji.
English: The Chair informed the Board that he had reviewed declarations of interests of Board members and alternates and will send a number of letters to clarify certain issues.
Slovenian: Predsednik je odbor obvestil, da je pregledal izjave o interesih članov odbora in namestnikov ter da bo poslal več dopisov za pojasnitev nekaterih vprašanj.
English: It was agreed that the website information on this topic would be made more specific to explicitly confirm that any experts who have not submitted a valid, signed declaration will not be involved in any EMA activities.
Slovenian: Dogovorjeno je bilo, da bodo na spletni strani posredovane natančnejše informacije o tej temi, tako da bo iz njih jasno razvidno, da strokovnjaki, ki niso predložili veljavne, podpisane izjave, ne bodo sodelovali pri nobenih dejavnostih agencije EMA.
English: Implementing rules for Staff Regulations
Slovenian: Izvedbena pravila za kadrovske predpise
English: Two representatives of the Board, Walter Schwerdtfeger and Lisette Tiddens, were appointed to the steering group set up by the European Commission to provide support to the implementation of arrangements in the area of traceability of tissues and cells.
Slovenian: Dva predstavnika odbora, Walter Schwerdtfeger in Lisette Tiddens, sta bila imenovana za člana usmerjevalne skupine, ki jo je Evropska komisija ustanovila za zagotavljanje podpore pri uresničevanju dogovorov na področju sledljivosti tkiv in celic.
English: The group will aim to propose a draft for discussion at the December 2011 meeting.
Slovenian: Skupina namerava osnutek predložiti v razpravo na seji decembra 2011.
English: Management Board Members of the European Centre for Disease Prevention and Control (ECDC) and representatives of national competent authorities (NCAs) also participate in the work of the group.
Slovenian: Pri delu skupine so sodelovali tudi člani upravnega odbora Evropskega centra za preprečevanje in obvladovanje bolezni (ECDC) in predstavniki nacionalnih pristojnih organov.
English: The Board thanked the topic coordinators (Christina Åkerman, Aginus Kalis, Jytte Lyngvig, Marcus Müllner, Giuseppe Nisticó and Lisette Tiddens) for their role in preparing this document.
Slovenian: Odbor se je zahvalil tematskim koordinatorjem (Christina Åkerman, Aginus Kalis, Jytte Lyngvig, Marcus Müllner, Giuseppe Nisticó in Lisette Tiddens) za njihovo vlogo pri pripravi tega dokumenta.
English: • The review of the legislation on veterinary medicinal products (the proposal will be made as a package with the legislation on medicated feed; the timeline for the proposal is to be set).
Slovenian: • sprememba zakonodaje o zdravilih za uporabo v veterinarski medicini (predlog bo predložen kot paket z zakonodajo o medicirani krmi; rok za predlog je treba še določiti);
English: EudraVigilance status report for veterinary medicinal products
Slovenian: Poročilo o stanju sistema EudraVigilance za zdravila za uporabo v veterinarski medicini
English: The Management Board topic coordinators Xavier De Cuyper (Belgium), Walter Schwerdtfeger (Germany) and Lisette Tiddens (Vice-chair) are revising the conflicts of interests policy applicable to the Board.
Slovenian: Tematski koordinatorji upravnega odbora Xavier De Cuyper (Belgija), Walter Schwerdtfeger (Nemčija) in Lisette Tiddens (podpredsednica) pregledujejo politiko o navzkrižju interesov, ki velja za odbor.
English: • Wednesday, 21 March & Thursday, 22 March;
Slovenian: • sreda, 21. marec, in četrtek, 22. marec;
English: This is the last meeting of the Board for Andreas Pott in his capacity as the Acting Executive Director of the Agency.
Slovenian: To je zadnja seja odbora, na kateri bo Andreas Pott opravljal mandat vršilca dolžnosti izvršnega direktorja agencije.
English: • Amendments of the fee regulation to include fees foreseen in the pharmacovigilance legislation (a European Commission proposal is expected later in 2012.
Slovenian: • sprememba uredbe o pristojbinah, tako da bo vključevala pristojbine, predvidene v zakonodaji o farmakovigilanci (predlog Evropske komisije je pričakovati pozneje v letu 2012.
English: Members of the group are: Björn Lemmer, Jytte Lyngvig, Guido De Clercq and Vincenzo Salvatore.
Slovenian: Člani te skupine so: Björn Lemmer, Jytte Lyngvig, Guido De Clercq in Vincenzo Salvatore.
English: • Thursday, 13 December.
Slovenian: • četrtek, 13. december.
English: The Management Board noted the presentation on the implementation of the policies on conflicts of interests for experts and for staff.
Slovenian: Upravni odbor se je seznanil s predstavitvijo o izvajanju politik o navzkrižju interesov za strokovnjake in osebje.
English: Historically, a complex governance structure, loss of knowledge during the implementation phase, loss of continuity between projects and inadequate representation of business users were among the negative factors that partly affected delivery of projects.
Slovenian: V preteklosti so na uresničitev projektov delno vplivali negativni dejavniki, kot so zapletena struktura vodenja, izguba znanja med fazo izvajanja, izguba stalnosti med projekti in nezadostna zastopanost poslovnih uporabnikov.
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 odbora so bili pozvani, naj se izrečejo o kakršnih koli posebnih interesih v zvezi s katero koli točko dnevnega reda, ki bi lahko vplivali na njihovo neodvisnost.
English: • HMA work in the area of support to innovation (health technology assessment, discussions on medical devices and the impact of the recast of the related legislation).
Slovenian: • delom vodij agencij za zdravila na področju podpore inovacijam (ocena zdravstvene tehnologij, razprave o medicinskih pripomočkih in učinek prenovitve s tem povezane zakonodaje);
English: The situation is such that it becomes increasingly difficult for the committee to achieve its work targets, despite the action plan that had been put in place earlier.
Slovenian: Odbor namreč kljub akcijskemu načrtu, ki je bil sprejet pred tem, vedno težje dosega svoje delovne cilje.
English: • [EMA/MB/730141/2011] Summary of transfers of appropriations in the budget 2011.
Slovenian: • [EMA/MB/730141/2011] Povzetek prenosov dodeljenih sredstev v proračun za leto 2011.
English: The objectives of the meeting were to address strategic issues requiring HMA orientation, with particular focus on challenging aspects impacting on the NCAs; and to raise awareness on specific areas.
Slovenian: Cilj seje je bila obravnava strateških vprašanj, ki zahtevajo smernice vodij agencij za zdravila, s posebnim poudarkom na težavnih vidikih, ki vplivajo na nacionalne pristojne organe, in ozaveščanje o posebnih področjih.
English: Management Board meeting dates
Slovenian: Datumi sej upravnega odbora
English: The Management Board noted the update on a number of items, including the following.
Slovenian: Upravni odbor se je seznanil s posodobljenimi informacijami o več temah, vključno z naslednjim:
English: [EMA/MB/751210/2011] The Management Board appointed Sir Kent Woods as a member of the Management Board Telematics Committee following the departure of Pat O'Mahony from the committee earlier this year.
Slovenian: [EMA/MB/751210/2011] Upravni odbor je imenoval Kenta Woodsa za člana Odbora upravnega odbora za telematiko po odhodu Pata O'Mahonyja iz odbora v začetku tega leta.
English: Management Board decision-making process
Slovenian: Postopek sprejemanja odločitev v upravnem odboru
English: Rannveig Gunnarsdóttir (Iceland) Brigitte Batliner (Liechtenstein) Apologies from Norway
Slovenian: Rannveig Gunnarsdóttir (Islandija) Brigitte Batliner (Lihtenštajn)
English: • [EMA/MB/714970/2011] Outcome of written procedures during the period from 17 May 2011 to 14
Slovenian: • [EMA/MB/714970/2011] Rezultat pisnih postopkov v obdobju od 17. maja 2011 do 14. septembra 2011.
English: 7bis EU telematics projects report
Slovenian: Telematski projekti EU
English: • [EMA/MB/793451/2011] EU telematics Operations Report.
Slovenian: • [EMA/MB/793451/2011] Poročilo o telematskih operacijah EU.
English: Membership of the Management Board Telematics Committee
Slovenian: Članstvo v Odboru upravnega odbora za telematiko.
English: Highlights from the Acting Executive Director
Slovenian: Poudarki vršilca dolžnosti izvršnega direktorja
English: • Thursday, 4 October;
Slovenian: • četrtek, 4. oktober;
English: EMA mid-year report 2011 from the Acting Executive Director (January - June 2011)
Slovenian: Vmesno poročilo agencije EMA za leto 2011, ki ga je pripravil vršilec dolžnosti izvršnega direktorja (januarjunij 2011)
English: [EMA/MB/376489/2011] The Management Board adopted the following meeting dates in 2012:
Slovenian: [EMA/MB/376489/2011] Upravni odbor je sprejel naslednje datume sej v letu 2012:
English: Review of meeting practices
Slovenian: Pregled prakse na sejah
English: [EMA/MB/746083/2011] The Management Board discussed whether to review the decision-making process in cases where there is evidence of a lack of consensus.
Slovenian: [EMA/MB/746083/2011] Upravni odbor je razpravljal o tem, ali naj prouči postopek sprejemanja odločitev, kadar je očitno, da soglasja ni mogoče doseči.
English: [EMA/MB/742275/2011; EMA/MB/751326/2011; EMA/MB/742295/2011; EMA/MB/752482/2011] The Management Board adopted the following implementing rules:
Slovenian: [EMA/MB/742275/2011; EMA/MB/751326/2011; EMA/MB/742295/2011; EMA/MB/752482/2011] Upravni odbor je sprejel izvedbena pravila za naslednja področja:
English: • HMA paper published in the context of the review of the veterinary legislation.
Slovenian: • dokumentom vodij agencij za zdravila, ki je bil objavljen v okviru spreminjanja veterinarske zakonodaje;
English: • Thursday, 7 June;
Slovenian: • četrtek, 7. junij;
English: Minutes from the 72nd meeting, held on 8-9 June 2011
Slovenian: Zapisnik 72. seje, ki je potekala 8. in 9. junija 2011
English: [EMA/MB/744682/2011] The Management Board noted the regular update report on the status of implementation of the European database for the collection of adverse events related to veterinary medicines.
Slovenian: [EMA/MB/744682/2011] Upravni odbor se je seznanil z rednim posodobljenim poročilom o stanju pri uvajanju evropske podatkovne zbirke za zbiranje neželenih učinkov, povezanih z zdravili za uporabo v veterinarski medicini.
English: • No 08/2011 - the appointment of Janne Komi as CHMP member, proposed by Finland, finalised on 14 July 2011.
Slovenian: • Št. 08/2011 - imenovanje Janneja Komija za člana odbora CHMP na predlog Finske, ki je bilo končano 14. julija 2011.
English: The Board appointed Guido Rasi as Executive Director of the Agency.
Slovenian: Odbor je imenoval Guida Rasija za izvršnega direktorja agencije.
English: • No 09/2011 - the appointment of Michel Tougouz Nevessignsky as CHMP alternate, proposed by Belgium, finalised on 9 September 2011.
Slovenian: • Št. 09/2011 - imenovanje Michela Tougouza Nevessignskyja za nadomestnega člana odbora CHMP na predlog Belgije, ki je bilo končano 9. septembra 2011.
English: [EMA/MB/744342/2011; EMA/MB/24913/2005/rev.1] The Management Board adopted the revised criteria that have to be fulfilled by patients' and consumers' organisations involved in EMA activities.
Slovenian: [EMA/MB/744342/2011, EMA/MB/24913/2005/rev.1] Upravni odbor je sprejel spremenjena merila, ki jih morajo izpolnjevati organizacije bolnikov in potrošnikov, vključene v dejavnosti agencije EMA.
English: [EMA/MB/729369/2011] The Management Board reinstated Gerard O'Malley as the Agency's accounting officer, effective 6 October 2011, following his return from long-term absence.
Slovenian: [EMA/MB/729369/2011] Upravni odbor je 6. oktobra 2011 na mesto računovodje agencije po dolgotrajni odsotnosti znova postavil Gerarda O'Malleya.
English: [EMA/MB/465305/2011] The Management Board noted the final minutes, adopted by written procedure on 11 August 2011.
Slovenian: [EMA/MB/465305/2011] Upravni odbor se je seznanil s končnim zapisnikom, ki je bil sprejet s pisnim postopkom 11. avgusta 2011.
English: [EMA/MB/743894/2011; EMA680110/2011] The Management Board noted the report on the implementation of the MUMS policy.
Slovenian: [EMA/MB/743894/2011; EMA680110/2011] Upravni odbor se je seznanil s poročilom o izvajanju politike MUMS.
English: [EMA/MB/744981/2011; EMA/632696/2011] The Management Board noted the report on the interactions with patients' and consumers' organisations within the framework agreed in 2005.
Slovenian: [EMA/MB/744981/2011, EMA/632696/2011] Upravni odbor se je seznanil s poročilom o sodelovanju z organizacijami bolnikov in potrošnikov v okviru, ki je bil dogovorjen v letu 2005.
English: [EMA/MB/550544/2011] The Management Board endorsed the implementation plan for the 'Road map to 2015'.
Slovenian: [EMA/MB/550544/2011] Upravni odbor je potrdil izvedbeni načrt za „časovni načrt agencije EMA do leta 2015“.
English: • No 07/2011 - the appointment of Helder Mota-Filipe as CHMP alternate, proposed by Portugal, finalised on 5 July 2011.
Slovenian: • Št. 07/2011 - imenovanje Helderja Mota-Filipeja za nadomestnega člana odbora CHMP na predlog Portugalske, ki je bilo končano 5. julija 2011.
English: [EMA/MB/793453/2011] The Management Board noted the report on the implementation of telematics projects.
Slovenian: [EMA/MB/793453/2011] Upravni odbor se je seznanil s poročilom o izvajanju telematskih projektov.
English: EMA/MB/828587/2011 Adopted Management Board
Slovenian: EMA/511034/2012 sprejet Upravni odbor
English: Minutes of the 73rd meeting of the Management Board
Slovenian: Zapisnik 73. seje upravnega odbora
English: 3bis Appointment of Guido Rasi as Executive Director
Slovenian: Imenovanje Guida Rasija za izvršnega direktorja
English: • [EMA/MB/711444/2011; EMA/MB/711456/2011; EMA/MB/711459/2011] Minutes from the
Slovenian: • [EMA/MB/711444/2011; EMA/MB/711456/2011; EMA/MB/711459/2011] Zapisniki marčevske, majske in junijske seje odbora upravnega odbora za telematiko (MBTC).
English: rd meeting of the Management Board, held in London on 6 October 2011
Slovenian: Seznam udeležencev 73. seje upravnega odbora v Londonu 6. oktobra 2011
English: • HMA initiatives in the area of clinical trials in the context of the review of clinical trials legislation
Slovenian: • pobudami vodij agencij za zdravila na področju kliničnih preskušanj v okviru spremembe zakonodaje o kliničnih preskušanjih (postopek prostovoljnega usklajevanja);
English: The Agency is on track to implement agreed objectives.
Slovenian: Uresničevanje sprejetih ciljev v agenciji poteka po načrtih.
English: [EMA/MB/653974/2011] The Management Board noted the mid-year report 2011.
Slovenian: [EMA/MB/653974/2011] Upravni odbor se je seznanil z vmesnim poročilom za leto 2011.
English: An exercise to define commercially confidential information is ongoing, in cooperation with the HMA.
Slovenian: V sodelovanju z vodji agencij za zdravila se trenutno opredeljujejo poslovno zaupne informacije.
English: Representative of doctors' organisations
Slovenian: Predstavnik zdravniških organizacij
English: • Written procedure for adoption of the draft minutes of the 72
Slovenian: • Pisni postopek za sprejetje osnutka zapisnika 72. seje upravnega odbora, ki je bil sprejet 10. avgusta 2011.
English: Personnel matter
Slovenian: Osebje
English: Date of first authorisation: 01 October 2009 Date of latest renewal: 18 July 2014
Slovenian: Datum prve odobritve: 01. oktober 2009 Datum zadnjega podaljšanja: 18. julij 2014
English: • if you are taking insulin.
Slovenian: • če jemljete insulin.
English: Never take two doses on the same day.
Slovenian: Nikdar ne vzemite dveh odmerkov na isti dan.
English: This is to help keep your blood sugar under control.
Slovenian: To omogoča ohranjati vaš krvni sladkor pod nadzorom.
English: • if you have or have had a disease of the pancreas;
Slovenian: • če imate ali ste kdaj imeli bolezen pankreasa (trebušne slinavke),
English: -0.6 (evening)
Slovenian: -0,6 (zvečer)
English: In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
Slovenian: Še zlasti morate zdravniku povedati, če uporabljate zdravila, ki vsebujejo katero od naslednjih učinkovin:
English: • if you have moderate or severe liver problems.
Slovenian: • če imate zmerne ali hude težave z jetri.
English: n=Randomised patients (primary efficacy-intention-to-treat analysis) with data available.
Slovenian: n = Randomizirani bolniki (primarna učinkovitost - analiza populacije z namenom zdravljenja) s podatki, ki so na voljo.
English: Swallow the tablet whole with some water.
Slovenian: Tableto zaužijte celo z nekaj vode.
English: The tablet can be taken at any time of the day, however, try to take your tablet at the same time each day.
Slovenian: Tableto lahko vzamete ob katerem koli času dneva, vendar jo po možnosti vzemite vsak dan ob istem času.
English: The safety and efficacy of Onglyza in children aged birth to < 18 years have not yet been established.
Slovenian: Učinkovitost in varnost zdravila Onglyza pri otrocih od rojstva do starosti < 18 let še nista ugotovljeni.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to 1/100), rare (≥ 1/10,000 to 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene takole: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana (ni mogoče oceniti na podlagi razpoložljivih podatkov).
English: You can take the tablet with or without food.
Slovenian: Tableto lahko vzamete s hrano ali brez nje.
English: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years).
Slovenian: Starejši bolniki (65-80 let) so imeli AUC približno 60 % večjo kot mladi (18-40 let).
English: • as monotherapy when metformin is inappropriate due to intolerance or contraindications
Slovenian: • kot monoterapija, ko metformin ni primeren zaradi neprenašanja ali kontraindikacij;
English: decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy to the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
English: • if you have a condition that reduces your defence against infections, such as a disease like AIDS, or from medicines that you might take after an organ transplant;
Slovenian: • če imate kakšno stanje, ki vam zmanjšuje obrambo pred okužbami, npr. bolezen, kakršna je AIDS, ali prejemate zdravila, kakršna se uporabljajo po presaditvi organa,
English: • Very common: low blood sugar (hypoglycaemia)
Slovenian: • Zelo pogosti: nizek krvni sladkor (hipoglikemija).
English: Onglyza is not recommended for children and adolescents under 18 years.
Slovenian: Zdravilo Onglyza ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
English: 7.9 -0.7 (morning)
Slovenian: -0,7 (zjutraj)
English: • if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
Slovenian: - če ste kdaj imeli resno alergijsko reakcijo na katera druga podobna zdravila, ki jih jemljete za uravnavanje vašega sladkorja v krvi.
English: Experience in NYHA class III-IV is still limited.
Slovenian: Izkušenj pri bolnikih v razredih III-IV po NYHA je še vedno malo.