FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregabalin Pfizer 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Danish: Pregabalin Pfizer 300 mg hårde kapsler 1 hård kapsel indeholder 300 mg pregabalin.
English: Pregabalin Pfizer 300 mg hard capsules PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules.
Danish: Pregabalin Pfizer 300 mg hårde kapsler PVC/aluminiumblister, der indeholder 14, 56, 100 eller 112 hårde kapsler.
English: Pregabalin Pfizer 50 mg hard capsules Each hard capsule also contains 70 mg lactose monohydrate.
Danish: Pregabalin Pfizer 50 mg hårde kapsler Hver kapsel indeholder 70 mg lactosemonohydrat.
English: Pregabalin Pfizer 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Danish: Pregabalin Pfizer 100 mg hårde kapsler 1 hård kapsel indeholder 100 mg pregabalin.
English: Pregabalin Pfizer 200 mg hard capsules Light orange, marked “Pfizer” on the cap and “PGN 200” on the body with black ink.
Danish: Pregabalin 200 mg hårde kapsler Lyseorange mærket ”Pfizer” på overdelen og ”PGN 200” på underdelen med sort blæk.
English: Pregabalin Pfizer 150 mg hard capsules PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules.
Danish: Pregabalin Pfizer 150 mg hårde kapsler PVC/aluminiumblister, der indeholder 14, 56, 100 eller 112 hårde kapsler.
English: Pregabalin Pfizer 50 mg hard capsules
Danish: Pregabalin Pfizer 50 mg hårde kapsler
English: Pregabalin Pfizer 25 mg hard capsules
Danish: Pregabalin Pfizer 25 mg hårde kapsler
English: Pregabalin Pfizer 200 mg hard capsules Pregabalin
Danish: Pregabalin Pfizer 200 mg hårde kapsler Pregabalin
English: Pregabalin Pfizer 75 mg hard capsules Pregabalin
Danish: Pregabalin Pfizer 75 mg hårde kapsler Pregabalin
English: Pregabalin Pfizer 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin.
Danish: Pregabalin Pfizer 25 mg hårde kapsler 1 hård kapsel indeholder 25 mg pregabalin.
English: How to take Pregabalin Pfizer
Danish: Sådan skal du tage Pregabalin Pfizer
English: Pregabalin Pfizer 25 mg hard capsules EU/1/14/916/001-007
Danish: Pregabalin Pfizer 25 mg hårde kapsler EU/1/14/916/001-007
English: Pregabalin Pfizer 100 mg hard capsules Pregabalin
Danish: Pregabalin Pfizer 100 mg hårde kapsler Pregabalin
English: Pregabalin Pfizer 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin.
Danish: Pregabalin Pfizer 50 mg hårde kapsler 1 hård kapsel indeholder 50 mg pregabalin.
English: Pregabalin Pfizer 150 mg hard capsules Pregabalin
Danish: Pregabalin Pfizer 150 mg hårde kapsler Pregabalin
English: Pregabalin Pfizer 300 mg hard capsules Pregabalin
Danish: Pregabalin Pfizer 300 mg hårde kapsler Pregabalin
English: Pregabalin Pfizer 25 mg hard capsules Pregabalin
Danish: Pregabalin Pfizer 25 mg hårde kapsler Pregabalin
English: Carton of blister pack (14, 56, 100, and 112) and perforated unit dose blister pack (100) for 75 mg hard capsules
Danish: Karton med blisterpakning (14, 56, 100 og 112) og perforeret enkeltdosisblister pakning (100) til 75 mg hårde kapsler
English: Pregabalin Pfizer 50 mg hard capsules Pregabalin
Danish: Pregabalin Pfizer 50 mg hårde kapsler Pregabalin
English: Blister pack (14, 56, 100 or 112) and perforated unit dose blister pack (100) for 75 mg hard capsules
Danish: Blisterpakning (14, 56, 100 eller 112) og perforeret enkeltdosisblister pakning (100) til 75 mg hårde kapsler
English: Carton of blister pack (14, 21, 56, 84, 100, and 112) and perforated unit dose blister pack (100) for 25 mg hard capsules.
Danish: Karton til blisterpakning (14, 21, 56, 84, 100 og 112) og perforeret enkeltdosisblister pakning (100) til 25 mg hårde kapsler
English: PHARMACEUTICAL FORM Hard capsules
Danish: Hårde kapsler.
English: • There have been reports of heart failure in some patients when taking Pregabalin Pfizer; these patients were mostly elderly with cardiovascular conditions.
Danish: • Hos nogle patienter, der tager Pregabalin Pfizer, er der set kronisk venstresidig hjertesvigt.
English: • Flushing, hot flushes.
Danish: • Rødmen, hedeture.
English: The group plans to meet twice a year.
Danish: Gruppen havde til hensigt at mødes to gange om året.
English: Some of the objectives of the action plan include:
Danish: Nogle af målsætningerne i handlingsplanen omfattede:
English: Additional information was provided in a written report.
Danish: Yderligere oplysninger blev angivet i en skriftlig rapport.
English: This cooperation was a prerequisite for the successful response to the threat.
Danish: Dette samarbejde var en forudsætning for den vellykkede reaktion på truslen.
English: A number of countries chose not to participate in the pilot.
Danish: En række lande valgte ikke at deltage i pilotprojektet.
English: Commissioner John Dalli visited the Agency on 5 March 2010.
Danish: Kommissær John Dalli besøgte agenturet den 5. marts 2010.
English: 1 Directive 2004/24/EC of 31 March 2004.
Danish: 1 Direktiv 2004/24/EF af 31. marts 2004.
English: The two-day meeting started on 17 March with a presentation on decision making.
Danish: Det to dage lange møde startede den 17. marts med en præsentation om beslutningstagning.
English: Fourteen of the new posts are requested due to increased workload and/or new activities.
Danish: Der blev anmodet om fjorten af de nye stillinger på grund af en større arbejdsbyrde og/eller nye aktiviteter.
English: H1N1 pandemic update
Danish: Opdatering på H1N1-pandemien
English: If needed, the Court of Auditors will be contacted for further clarification.
Danish: Om nødvendigt ville Revisionsretten blive kontaktet med henblik på yderligere præcisering.
English: Depending on the outcome, the European Commission and the European Parliament will be informed about a preferred option.
Danish: Afhængigt af resultatet ville Europa-Kommissionen og Europa-Parlamentet blive orienteret om den foretrukne mulighed.
English: The Agency's partners and stakeholders will be invited to participate.
Danish: Agenturets partnere og interessenter opfordredes til at deltage.
English: A number of additional changes were made to the minutes as part of the written procedure which preceded this adoption.
Danish: Der blev foretaget en række yderligere ændringer af referatet som led i den skriftlige procedure, der gik forud for denne vedtagelse.
English: a) Update
Danish: a) Opdatering
English: Other members were invited to join.
Danish: Andre medlemmer blev opfordret til at deltage.
English: Prof. Lawrence Phillips of the London School of Economics led the sessions.
Danish: Prof. Lawrence Phillips fra London School of Economics ledede mødet.
English: Amendments to fees payable to the European Medicines Agency and other measures
Danish: Ændringer af gebyrer, der skal betales til Det Europæiske Lægemiddelagentur, og andre foranstaltninger
English: • implementation of the e-submissions system across the EU and the future workshop on this topic;
Danish: • implementering af det elektroniske indsendelsessystem i hele EU og den kommende workshop om dette emne
English: European Food Safety Agency (EFSA) in the area of health claims for food containing herbal ingredients.
Danish: Europæiske Fødevaresikkerhedsautoritet (EFSA) i forbindelse med sundhedsanprisninger af fødevarer, der indeholder plantebestanddele.
English: • Future revision of the transparency directive, with a view to promoting competitiveness of industry and innovation.
Danish: • Kommende revision af gennemsigtighedsdirektivet med henblik på at fremme industriens konkurrence- og innovationsevne.
English: This provision is in line with reimbursement rules of other EU institutions.
Danish: Denne bestemmelse var i overensstemmelse med refusionsreglerne for andre EUinstitutioner.
English: There is also a correlation between compliance with scientific advice and positive outcomes.
Danish: Der var også en sammenhæng mellem overensstemmelse med videnskabelig rådgivning og positive svar.
English: The above trends underline the importance of the operation of policies that support small and mediumsized enterprises.
Danish: De ovenfor anførte tendenser viste, hvor vigtigt det var, at de politikker, der støtter små og mellemstore virksomheder, fungerede.
English: Preparation for a written procedure on adoption of amending budget No 1/2010
Danish: Forberedelse af en skriftlig procedure om vedtagelse af ændringsbudget nr. 1/2010
English: A number of suggestions for future developments in the field were provided.
Danish: Der blev stillet en række forslag til fremtidige initiativer på området.
English: • Visits of Commissioner Dalli to EMA and EFSA.
Danish: • Kommissær Dallis besøg hos EMA og EFSA.
English: A few deviations occurred, notably in the field of herbal medicinal products.
Danish: Der var nogle få afvigelser, navnlig i forbindelse med plantelægemidler.
English: • Completion of the evaluation of the Agency and the upcoming conference on the report; the Board asked to see the report before its publication.
Danish: • Afslutning af evalueringen af agenturet og den kommende konference om rapporten; bestyrelsen bad om at få rapporten at se inden dens offentliggørelse.
English: Mr Dalli stressed that patients' interests are at the heart of his and our work.
Danish: John Dalli understregede, at patienternes interesser er centrale for hans og vores arbejde.
English: The H1N1 pandemic continues to affect Africa, and EU vaccine stock is being exported to affected countries.
Danish: H1N1-pandemien påvirkede fortsat Afrika, og EU's vaccinelager eksporteredes til de ramte lande.
English: The change took place on 1 March 2010.
Danish: Ændringen fandt sted den 1. marts 2010.
English: The Agency delivered opinions within legislative timelines and achieved the majority of set targets.
Danish: Agenturet afgav sine udtalelser inden for de lovgivningsmæssige tidsfrister og nåede størstedelen af sine målsætninger.
English: It was emphasised that there should be the right balance between the interests of patients and of industry.
Danish: Det blev understreget, at der skal være den rigtige balance mellem patienternes og industriens interesser.
English: The discussion is foreseen for the October meeting.
Danish: Dette forventedes drøftet på mødet i oktober.
English: For new active substances the negative outcome rate last year was 40%.
Danish: For nye aktive stoffer var andelen af negative svar sidste år 40 %.
English: All newly requested staff posts are financed through fee revenue.
Danish: Alle de nye stillinger, der blev anmodet om, skulle finansieres gennem gebyrindtægterne.
English: The Board had an opportunity to test the website during the break.
Danish: Bestyrelsen fik mulighed for at afprøve webstedet under en pause.
English: The new website of the Agency, which is under development, was demonstrated to the Management Board.
Danish: Agenturets nye websted, som var under udvikling, blev præsenteret for bestyrelsen.
English: Visit of the Commissioner for Health and Consumer Policy
Danish: Besøg af kommissæren for sundhed og forbrugerpolitik
English: New website of the Agency
Danish: 10. Agenturets nye websted
English: Although the Commission confirmed that the decision had already been taken, the Board called for further debate on this matter.
Danish: Selvom Kommissionen bekræftede, at beslutningen allerede var truffet, opfordrede bestyrelsen til yderligere drøftelser om denne sag.
English: A joint conference organised by the European Commission and the Agency will take place on 30 June 2010.
Danish: Europa-Kommissionen og agenturet ville den 30. juni 2010 afholde en fælles konference.
English: A representative of the European Commission will attend the next meeting to outline details of the recent evaluation of EU agencies and the Commission's response.
Danish: En repræsentant for Europa-Kommissionen ville deltage i det næste møde for at skitsere detaljerne i den seneste evaluering af EU-agenturerne og Kommissionens svar.
English: The proportion of new marketing authorisation applications for human medicines with negative outcomes increased to 33% last year, compared to 20-25% in previous years.
Danish: Andelen af nye ansøgninger om markedsføringstilladelse for humanmedicinske lægemidler, som blev afvist, steg til 33 % sidste år, sammenlignet med 20-25 % de foregående år.
English: • Benchmarking of European Medicines Agencies (BEMA).
Danish: • benchmarking af Det Europæiske Lægemiddelagentur (BEMA).
English: The group will examine in greater detail the requirement put forward by the Court of Auditors.
Danish: Gruppen undersøgte det krav, som Revisionsretten havde fremsat, nærmere.
English: In the meantime, the network needs to continue developing a coherent approach to the provision of information to patients and healthcare professionals across the EU.
Danish: I mellemtiden skulle netværket fortsat udvikle en sammenhængende fremgangsmåde for formidling af information til patienter og sundhedsmedarbejdere i hele EU.
English: The amendments clarify, among others, that the procedure does not apply to re-nominations of members/alternates for which the Management Board was already consulted.
Danish: I ændringerne præciseredes det bl.a., at proceduren ikke gjaldt genudnævnelser af medlemmer/suppleanter, i forbindelse med hvilke bestyrelsen allerede var blevet konsulteret.
English: The report will be sent to the topic coordinators by the end of April.
Danish: Rapporten ville blive sendt til emnekoordinatorerne i slutningen af april.
English: The budget represents an increase of €20.7 million (10.5%) over the 2010 budget.
Danish: Budgettet var steget med 20,7 mio. EUR (10,5 %) i forhold til budgettet for 2010.
English: The Board noted that the topic coordinators will continue reflecting on the payment system.
Danish: Bestyrelsen bemærkede, at emnekoordinatorerne fortsat ville reflektere over betalingssystemet.
English: Information on the use of vaccines in those countries will add to the pool of knowledge on the safety and effectiveness of these vaccines.
Danish: Oplysninger om anvendelsen af vacciner i disse lande skabte yderligere viden om disse vacciners sikkerhed og effektivitet.
English: The Board proposed to develop a harmonised approach for use by all Member States after the expiry of the transitional period.
Danish: Bestyrelsen rejste forslag om at udvikle en harmoniseret tilgang for alle medlemsstaterne efter udløbet af overgangsperioden.
English: In this respect, the Board welcomed the Norwegian model, where the agency has involved universities in producing draft monographs.
Danish: I den henseende hilste bestyrelsen den norske model, hvor agenturet havde inddraget universiteter i udarbejdelsen af udkast til monografier, velkommen.
English: The Board suggested looking at the adequacy of some of the key performance indicators.
Danish: Bestyrelsen foreslog at kigge på relevansen af nogle af de centrale resultatindikatorer.
English: The Board noted that the evaluation of the Agency commissioned by the European Commission and carried out by Ernst & Young has been completed.
Danish: Bestyrelsen bemærkede, at den evaluering, som Europa-Kommissionen havde iværksat, og som Ernst & Young havde udført, var afsluttet.
English: It will review the existing governance structures and consider alternative arrangements to optimise the governance of the programme.
Danish: Det ville foretage en undersøgelse af de eksisterende ledelsesstrukturer og overveje alternative foranstaltninger for at optimere ledelsen af programmet.
English: Expiry of the building lease in 2014
Danish: Udløb af lejemålet i 2014
English: It was pointed out that the term of office of the current Chair of the Management Board will expire in June.
Danish: Det blev påpeget, at den nuværende bestyrelsesformands mandatperiode udløber i juni.
English: The members will have three weeks to draft an analysis and assessment, which will be submitted to the Management Board for adoption around 20 May 2010.
Danish: Medlemmerne havde tre uger til at udarbejde et udkast til en analyse og en vurdering, som skulle sendes til bestyrelsen med henblik på vedtagelse omkring den 20. maj 2010.
English: The Agency began to identify options for a future location of the Agency in London, once its current lease expires in 2014.
Danish: Agenturet er begyndt at overveje alternative muligheder for agenturets fremtidige placering i London, når det nuværende lejemål udløber i 2014.
English: The Board was concerned that few applications are submitted to national competent authorities in many Member States in light of the approaching deadline for registration of herbal medicinal products in Member States (April 2011)1.
Danish: Bestyrelsen udtrykte bekymring over, at der var indsendt få ansøgninger til de nationale kompetente myndigheder i mange medlemsstater, i lyset af den kommende frist for registrering af plantelægemidler i medlemsstaterne (april 2011)1.
English: to 25 February 2010.
Danish: februar 2010.
English: • collecting information on the uptake of the traditional use registration scheme in Member States;
Danish: • indsamling af oplysninger om indførelsen af det traditionelle registreringsskema i medlemsstaterne
English: With respect to the selection procedure for the appointment of the Agency's new Executive Director, the Commission expects to produce a shortlist of candidates before the summer or in early September.
Danish: Med hensyn til udvælgelsesproceduren i forbindelse med udnævnelsen af agenturets nye administrerende direktør forventede Kommissionen at udarbejde en begrænset liste over ansøgere før sommeren eller i starten af september.
English: The budget includes estimated fee revenue of €163 million and a requested Community contribution of €47.1 million, which the Commission representative indicated was beyond the current EU financial perspectives.
Danish: Budgettet omfattede anslåede gebyrindtægter på 163 mio. EUR og bidraget fra Fællesskabet på 47,1 mio. EUR, som ifølge Kommissionens repræsentant lå over EU's aktuelle finansielle overslag.
English: The Commission representative stated that the Agency's justification for the request to convert these posts was inappropriate, taking into account the Staff Regulations.
Danish: Kommissionens repræsentant bemærkede, at agenturets begrundelse for at anmode om at omdanne disse stillinger var uhensigtsmæssig, under hensyntagen til personalevedtægterne.
English: • The move of the Pharmaceutical Unit F2 (and Unit F3, cosmetics and medical devices) to DG
Danish: • Flytningen af den farmaceutiske enhed F2 (og enhed F3, kosmetiske midler og medicinsk udstyr)
English: • Note on the outcome of the selection procedure for patients'/consumers' representatives to participate as observers in the PhVWP.
Danish: • Note om resultatet af proceduren for udvælgelse af repræsentanter for patienter/forbrugere, der skal deltage som observatører i arbejdsgruppen vedrørende lægemiddelovervågning (PhVWP)
English: The Board thanked the topic coordinators (Chair, Austria and the Netherlands) for their contribution in preparing these documents.
Danish: Bestyrelsen takkede emnekoordinatorerne (formanden, Østrig og Nederlandene) for deres bidrag til udarbejdelsen af disse dokumenter.
English: With regard to output of the Committee, the members also regretted that Member States do not have adequate resources to allow additional support for the work of the Committee.
Danish: Hvad angik udvalgets resultater, beklagede medlemmerne desuden, at medlemsstaterne ikke havde tilstrækkelige ressourcer til at støtte udvalgets arbejde yderligere.
English: The Commission also stated that any deficit in the EU contribution compared to the request should not lead to cuts in the telematics expenditure intended for the implementation of the proposed legislation.
Danish: Kommissionen bemærkede også, at et eventuelt underskud i EU-bidraget i forhold til anmodningen ikke skulle medføre en reduktion af telematikudgifterne til gennemførelsen af lovgivningsforslaget.
English: Committee on Herbal Medicinal Products: update from the Chair
Danish: Udvalget for Plantelægemidler: opdatering fra formanden
English: The Commissioner was satisfied with the work of the Agency, including achievements in the area of communication and the involvement of patients and healthcare professionals.
Danish: Kommissæren var tilfreds med agenturets arbejde, herunder dets resultater på kommunikationsområdet og inddragelsen af patienter og sundhedsmedarbejdere.
English: European Commission Isabel de la Mata Georgette Lalis
Danish: Europa-Kommissionen Isabel de la Mata Georgette Lalis
English: This topic links to the Agency's work on the methodology for the assessment of benefit/risk balance of medicinal products.
Danish: Dette emne har tilknytning til agenturets arbejde med metoder til vurdering af benefit/risk-forholdet for lægemidler.
English: • Creation of a task force on corporate social responsibility of the pharmaceutical industry.
Danish: • Oprettelse af en taskforce vedrørende socialt ansvar i lægemiddelindustrien.
English: • Performance of the Agency's scientific procedures:
Danish: • Resultater i forbindelse med agenturets videnskabelige procedurer:
English: The operations of the Agency and its work programme are shaped by various trends in the scientific and business environment of the Agency, including globalisation, scientific progress, and growing demand for openness and communication with stakeholders.
Danish: Agenturets virke og arbejdsprogram var udformet på baggrund af forskellige tendenser i agenturets videnskabelige og forretningsmæssige miljø, herunder globaliseringen, den videnskabelige udvikling og det stigende behov for åbenhed og kommunikation med interessenterne.
English: The agreement on an option may be needed as early as this autumn.
Danish: Det kunne blive nødvendigt at lægge sig fast på en mulighed allerede i efteråret 2010.
English: • responding to any Commission request for enhanced cooperation between the Agency and the
Danish: • opfyldelse af en anmodning fra Kommissionen om et udvidet samarbejde mellem agenturet og Den
English: A common statement by the Heads of Medicines Agencies could help to communicate with national parliaments and bodies in light of the ongoing debate on national strategies applied during the crisis.
Danish: En fælles erklæring fra cheferne for de nationale lægemiddelstyrelser (HMA) kunne bidrage til at kommunikere med nationale parlamenter og organer i lyset af den igangværende debat om de nationale strategier under krisen.
English: The Executive Director and the Board thanked the staff of the Agency and the national authorities for their deep commitment and highly effective performance in the face of this public-health threat.
Danish: Den administrerende direktør og bestyrelsen takkede agenturets personale og de nationale myndigheder for deres store engagement og yderst effektive arbejde i forbindelse med denne trussel mod folkesundheden.
English: When available, the options will be presented to the Management Board.
Danish: Når mulighederne forelå, ville de blive præsenteret for bestyrelsen.
English: The Board asked to accelerate the procedure to enable members to consider candidates in June.
Danish: Bestyrelsen bad om en fremskyndelse af proceduren, så medlemmerne kunne vurdere ansøgerne i juni.
English: The Chair invited members to volunteer as topic coordinators for the assessment of the Executive Director's annual activity report 2009.
Danish: Formanden opfordrede medlemmerne til at melde sig frivilligt som emnekoordinatorer i forbindelse med vurderingen af den administrerende direktørs årsberetning for 2009.
English: Members considered that the decision should take into account the fact that cells and tissues can be raw materials for medicinal products.
Danish: Medlemmerne gav udtryk for, at beslutningen skulle tage højde for, at celler og væv kunne være råvarer i forbindelse med lægemidler.
English: • progress with the HMA/EMA training strategy;
Danish: • fremskridt med uddannelsesstrategien for HMA/EMA