FrancophonIA/ELRC3.0 huggingface dataset:
English: Some medicines cannot be taken with Norvir when it is used in this way.
Danish: Visse lægemidler kan ikke anvendes sammen med Norvir på denne måde.
English: The dose depends on which other protease inhibitor is being taken.
Danish: Dosis afhænger af, hvilke andre proteasehæmmere patienten får.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its rate of multiplication.
Danish: Når enzymet blokeres, formerer virussen sig ikke normalt, og formeringen af den bliver langsommere.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Norvir, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Norvir, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The CHMP decided that Norvir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Norvir opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Norvir.
English: Norvir can also be used as an HIV medicine, where it acts directly against the virus.
Danish: Norvir kan desuden anvendes som lægemiddel mod hiv, hvor det virker direkte på virussen.
English: When it is used as an HIV medicine, the most common side effects with Norvir (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), paraesthesia (unusual tingling sensations) around the mouth and in the limbs, headache, dizziness, peripheral neuropathy (damage to the nerves in the limbs), pharyngitis (sore throat), mouth and throat pain, cough, abdominal pain (stomach ache), nausea (feeling sick), diarrhoea, vomiting, dyspepsia (heartburn), pruritis (itching), rash, joint and back pain, tiredness, flushing and feeling hot.
Danish: De hyppigste bivirkninger ved Norvir anvendt som hivlægemiddel (som optræder hos flere end 1 ud af 10 patienter) er smagsforstyrrelser, paræstesi (unormal snurrende fornemmelse) omkring munden og i lemmerne, hovedpine, svimmelhed, perifer neuropati (beskadigelse af nerverne i lemmerne), pharyngitis (ondt i halsen), smerter i mund og hals, hoste, mavesmerter, kvalme, diarré, opkastning, dyspepsi (halsbrand), kløe, udslæt, led- og rygsmerter, træthed, rødme og varmefornemmelse.
English: Norvir has been studied as a booster in clinical studies that were designed to assess the effects of the antiviral medicines that it is used to boost.
Danish: Norvir blev undersøgt som booster i kliniske undersøgelser, der havde til formål at vurdere virkningerne af de antivirale lægemidler, som det anvendes til at forstærke.
English: When the active substance, ritonavir, acts as a ‘booster' it does so by slowing down the rate at which certain antiviral medicines given in combination with ritonavir are broken down in the body.
Danish: Når det aktive stof, ritonavir, fungerer som en booster, sænker det hastigheden, hvormed visse antivirale lægemidler indgivet i kombination med ritonavir nedbrydes i kroppen.
English: What is the risk associated with Norvir?
Danish: Hvilken risiko er der forbundet med Norvir?
English: Norvir must not be used in patients who have severe problems with their liver or patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Norvir and are harmful at high levels in the blood.
Danish: Norvir må ikke anvendes til patienter med svær leversygdom eller patienter, som tager perikum (en drogetilberedning til behandling af depression) eller lægemidler, der nedbrydes på samme måde som Norvir, og som er skadelige i store mængder i blodet.
English: Norvir can be used as a ‘‘pharmacokinetic enhancer' (booster' to increase the blood levels of other antiviral medicines that belong to the same group as Norvir (protease inhibitors) called amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and darunavir.
Danish: Norvir kan anvendes som en "farmakokinetisk forstærker" (booster) til at øge koncentrationen i blodet af andre antivirale lægemidler, der tilhører samme gruppe som Norvir, (proteasehæmmere), nemlig amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir og darunavir.
English: At higher doses, ritonavir acts as a ‘protease inhibitor'.
Danish: I større doser virker ritonavir som en "proteasehæmmer".
English: Information on these studies can be found in the EPAR summaries for the other medicines.
Danish: Oplysninger om disse undersøgelser findes i EPAR-sammendragene for de andre lægemidler.
English: The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) and CD4 T cell levels in the blood (CD4 cell count).
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen af blodets indhold af hiv og CD4 T-celler (CD4-celletal).
English: What is Norvir?
Danish: Hvad er Norvir?
English: Why has Norvir been approved?
Danish: Hvorfor blev Norvir godkendt?
English: The second study compared Norvir taken alone, zidovudine (another antiviral medicine) taken alone and the combination of Norvir and zidovudine in 356 adults who had not taken treatment for HIV infection before.
Danish: I den anden undersøgelse sammenlignedes Norvir anvendt alene, zidovudin (et andet antiviralt lægemiddel) anvendt alene og kombinationen af Norvir og zidovudin hos 356 voksne, der ikke tidligere var blevet behandlet for hivinfektion.
English: Norvir is used in combination with other HIV medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Norvir anvendes sammen med andre hivlægemidler til behandling af patienter på over to år, som er smittet med humant immundefektvirus type 1 (hiv-1).
English: For the full list of all restrictions and side effects reported with Norvir, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Norvir fremgår af indlægssedlen.
English: The combination of Norvir and zidovudine was less effective than Norvir alone, although the reasons for this were unclear.
Danish: Kombinationen af Norvir og zidovudin var ikke så effektiv som Norvir alene.
English: Norvir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Norvir anvendes i kombination med andre antivirale lægemidler, nedsætter det hivmængden i blodet og holder den nede.
English: The first compared Norvir with placebo (a dummy treatment) in 1,090 adults, as an add-on to the antiviral medicines the patients were already taking.
Danish: I den første undersøgelse blev Norvir sammenlignet med placebo (en virkningsløs behandling) hos 1 090 voksne som tillægsbehandling til de antivirale lægemidler, patienterne fik i forvejen.
English: In the second study, patients taking Norvir had greater reductions in viral load and increases in CD4 cell counts than those taking zidovudine alone.
Danish: I den anden undersøgelse blev virusindholdet og stigningen i CD4 celletal mindsket væsentligt mere hos patienter, som fik Norvir, end hos dem, der kun fik zidovudin.
English: When it is used as a booster, the side effects of Norvir depend on the other antiviral medicine being taken.
Danish: Når Norvir anvendes som booster, afhænger dets bivirkninger af de andre antivirale lægemidler, patienten får.
English: How has Norvir been studied?
Danish: Hvordan blev Norvir undersøgt?
English: Norvir, in combination with other antiviral medicines, also reduced viral loads in children.
Danish: Når Norvir blev anvendt i kombination med andre antivirale lægemidler, mindskede det også virusindholdet hos børn.
English: What benefit has Norvir shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Norvir?
English: What is Norvir used for?
Danish: Hvad anvendes Norvir til?
English: How is Norvir used?
Danish: Hvordan anvendes Norvir?
English: The effects of Norvir as an antiviral medicine in combination with other antiviral medicines were also studied in four studies of children.
Danish: I fire undersøgelser af børn undersøgte man desuden Norvirs virkning som antiviralt lægemiddel i kombination med andre antivirale midler.
English: How does Norvir work?
Danish: Hvordan virker Norvir?
English: It should be taken with food.
Danish: Norvir skal indtages sammen med et måltid.
English: For more information, see the package leaflet provided with the other medicine.
Danish: De nærmere oplysninger fremgår af indlægssedlen for det andet lægemiddel.
English: See the package leaflet provided with the other medicine for full details.
Danish: De fuldstændige oplysninger herom fremgår af indlægssedlen for det andet lægemiddel.
English: 1.850 GBq/ml Radiopharmaceutical precursor
Danish: 1,850 GBq/ml
English: Invented name Strength Pharmaceutical form
Danish: Særnavn Styrke
English: EU/1/18/1301/001
Danish: EU/1/18/1301/001 Mepsevii
English: MA (EU) number
Danish: MF (EU)-nummer (Sær-) navn Styrke
English: Immediate Packaging
Danish: Pakkestørrelse
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administrationsform Indre emballage Indhold (koncentration)
English: MA (EU) number (Invented)
Danish: MF (EU)-nummer
English: The Board adopted the decision with two votes against.
Danish: Bestyrelsen vedtog beslutningen med to stemmer imod.
English: The reason for the delays will need to be clarified over time.
Danish: Årsagen til forsinkelserne vil blive klarlagt over tid.
English: Meeting with Commissioner Dalli
Danish: Møde med kommissær Dalli
English: The document should be agreed in two weeks' time.
Danish: Dokumentet skulle blive vedtaget om to uger.
English: • Road map to 2015.
Danish: • Køreplan frem til 2015.
English: The report identified areas where some delays occurred.
Danish: Rapporten identificerede områder, hvor der forekom nogle forsinkelser.
English: The European Parliament Budget Control Committee received the proposal to postpone the discharge for the financial year 2009 for the Agency, although both the European Parliament Committee on the Environment, Public Health and Food Safety and the European Court of Auditors recommended the discharge.
Danish: Europa-Parlamentets Budgetkontroludvalg modtog forslaget om at udsætte decharge for regnskabsåret 2009 for agenturet, selvom både Europa-Parlamentets Udvalg om Miljø, Folkesundhed og Fødevaresikkerhed og Revisionsretten anbefalede decharge.
English: In the field of IT, a more strategic approach with clear prioritisation is called for.
Danish: Inden for it er en mere strategisk tilgang med klar prioritering nødvendig.
English: However, it remains to be seen whether this is a temporary increase or the level of activity will remain high for a longer period.
Danish: Det er dog endnu ikke til at se, om dette er en midlertidig stigning, eller om aktivitetsniveauet vil holde sig højt i en længere periode.
English: • Report from BNP Paribas Real Estate.
Danish: • Rapport fra BNP Paribas Real Estate.
English: The Acting Executive Director met with Commissioner Dalli on 11 March 2011.
Danish: Den fungerende administrerende direktør mødtes med kommissær Dalli den 11. marts 2011.
English: Information on the Agency's cooperation with the World Organisation for Animal Health (OIE) will also be added.
Danish: Der tilføjes også oplysninger om agenturets samarbejde med Verdensorganisationen for Dyresundhed (OIE).
English: Two new agencies joined the meeting.
Danish: To nye agenturer deltog i mødet.
English: The total staffing needed for the full implementation of the legislation (phased over five years) may be higher.
Danish: Det antal medarbejdere, som er nødvendigt for at kunne gennemføre lovgivningen fuldt ud (indfaset over fem år), kan være højere.
English: The provisional draft budget (PDB) 2012 amounts to EUR 238.4 million, representing an increase of EUR 29.5 million over the 2011 budget.
Danish: Det foreløbige budgetudkast (PDB) for 2012 er på 238,4 mio. euro, og det er en stigning på 29,5 mio. euro i forhold til 2011-budgettet.
English: Therefore we cannot give our approval for current activities of Thomas Lönngren."
Danish: Vi kan derfor ikke give vores godkendelse af Thomas Lönngrens nuværende aktiviteter."
English: In this context, reference was made to the joint HMA/EMA training strategy.
Danish: I den sammenhæng henvistes der til den fælles HMA/EMA-uddannelsesstrategi.
English: The Agency will receive a list of questions to which the Agency will reply in order to receive the discharge in June.
Danish: Agenturet vil få en liste med spørgsmål, som agenturet vil besvare for at modtage decharge i juni.
English: However, the Agency expects that the Budgetary Authority will grant some posts later this year.
Danish: Agenturet forventer imidlertid, at budgetmyndigheden vil bevilge nogle stillinger senere i år.
English: During the period from 25 November 2010 to 15 March 2011, the Board finalised eight written procedures.
Danish: I perioden 25. november 2010 til 15 marts 2011 færdiggjorde bestyrelsen otte skriftlige procedurer.
English: The Management Board has its representative at the AAC.
Danish: Bestyrelsen har en repræsentant i AAC.
English: This may be due to the decrease in the number of applications and to fluctuations in submission of applications during the year.
Danish: Det kan skyldes faldet i antallet af ansøgninger og udsving i indsendelsen af ansøgninger i løbet af året.
English: The document follows the revised rules laid down by the European Commission.
Danish: Dokumentet følger de reviderede regler, som er vedtaget af Europa-Kommissionen.
English: The Acting Executive Director has also informed the Commissioner about 'project 2014'.
Danish: Den fungerende administrerende direktør informerede også kommissæren om "projekt 2014".
English: The Board noted that the number of new chemical entities and the number of opinions were lower than those received in the previous three years.
Danish: Bestyrelsen tog til efterretning, at antallet af nye kemiske enheder og antallet af udtalelser var lavere end det antal, der blev modtaget i de foregående tre år.
English: Discharge
Danish: Decharge
English: • A meeting with the medical device authorities.
Danish: • Et møde med myndighederne for medicinsk udstyr.
English: The full annual report will be submitted to the Board in May 2011 for adoption at the June 2011 meeting.
Danish: Den fulde årsberetning indsendes til bestyrelsen i maj 2011, således at den kan vedtages på mødet i juni 2011.
English: There has been a significant increase in the numbers of paediatric procedures (around 20% higher than in 2009) and inspections (a 30% increase), and a very high increase in veterinary scientific advice applications (21 applications received, which is a 90% increase).
Danish: Der har været en betydelig stigning i antallet af pædiatriske procedurer (omkring 20 % højere end i 2009) og inspektioner (en stigning på 30 %) samt en meget stor stigning i anmodninger om videnskabelig rådgivning vedrørende veterinærlægemidler (der er modtaget 21 anmodninger, hvilket er en stigning på 90 %).
English: They discussed a number of topics pertinent to the Agency.
Danish: De drøftede en række emner, der berører agenturet.
English: • The task force on the availability of medicines, which has completed its mandate.
Danish: • Arbejdsgruppen om tilgængelighed af lægemidler, hvis mandat er udløbet.
English: A formal letter can be issued to the IMI board as part of the process to improve prospects of obtaining funding.
Danish: Der kan sendes en formel skrivelse til IMI's bestyrelse som led i processen for at forbedre mulighederne for at opnå finansiering.
English: The revised procedure now foresees that unless five or more members expressed their reservations with regards to the nomination, the candidate is considered accepted and the procedure is closed.
Danish: Den reviderede procedure siger nu, at medmindre fem eller flere medlemmer har udtrykt deres forbehold over for udnævnelsen, anses kandidaten for accepteret, og proceduren afsluttes.
English: The Board was also informed that the Agency is reviewing the efficiency of its procedures and is introducing changes in other areas where savings can be made.
Danish: Bestyrelsen er også blevet informeret om, at agenturet gennemgår effektiviteten af sine procedurer og indfører ændringer på andre områder, hvor der kan gennemføres besparelser.
English: • The legislative proposal on information to patients (the discussions will restart at the Council level).
Danish: • Lovgivningsforslaget vedrørende information til patienter (drøftelserne starter igen på rådsniveau).
English: The Board noted the oral report on the activities of the Agency in 2010.
Danish: Bestyrelsen tog den mundtlige rapport om agenturets aktiviteter i 2010 til efterretning.
English: With regard to the staffing for 2011, the Commissioner indicated that the Agency may receive some of the posts requested for 2011.
Danish: Med hensyn til personale for 2011 sagde kommissæren, at agenturet måske vil få bevilget nogle af de stillinger, man har anmodet om for 2011.
English: The Agency has not received new posts for 2011 and has difficulty recruiting scientific staff as contract agents, due to the short term of the contracts and lower remuneration level.
Danish: Agenturet har ikke fået nye stillinger for 2011 og har vanskeligt ved at rekruttere videnskabeligt personale som kontraktansatte, da kontrakterne er korte, og vederlaget lavere.
English: The group is currently working on a set of documents, including one on the role of the chairs of management boards, to set out best practice in the area.
Danish: Gruppen arbejder i øjeblikket på et sæt dokumenter, herunder et om bestyrelsesformændenes rolle, for at opstille bedste praksis på området.
English: The Agency will provide national competent authorities with individual line listings to enable them to review their own performance.
Danish: Agenturet vil forsyne de kompetente nationale myndigheder med individuelle "line listings" for at sætte dem i stand til at overvåge egne resultater.
English: [EMA/MB/19969/2011] The agenda was adopted.
Danish: [EMA/MB/19969/2011] Dagsordenen blev vedtaget.
English: Currently, the Agency provides annual reports drawn up by the internal audit capability and by the Audit Advisory Committee (AAC), as well as final reports from the European Court of Auditors, with the Agency's replies.
Danish: I øjeblikket fremsender agenturet årsrapporter, som er udarbejdet af den interne revisionsfunktion og af det rådgivende revisionsudvalg (AAC), samt endelige rapporter fra Revisionsretten med agenturets svar.
English: 1 Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP).
Danish: 1 Udvalget for Lægemidler til Mennesker (CHMP) eller Udvalget for Veterinærlægemidler (CVMP).
English: A smaller number of generic medicines in the centralised procedure comes as a result of the European Commission's policy on multiple applications for centrally authorised products.
Danish: Et mindre antal generiske lægemidler i den centraliserede procedure er et resultat af Europa-Kommissionens politik om flere ansøgninger om centralte godkendt lægemidler.
English: These comprised six consultations on new membership in the CHMP and CVMP, the adoption of the non-automatic carryover of appropriations from 2010 to 2011, and the adoption of the minutes of the 69th meeting of the Management Board from 16 December, as indicated below:
Danish: De omfattede seks høringer om nyt medlemskab i CHMP og CVMP, vedtagelse af ikke-automatisk overførsel af bevillinger fra 2010 til 2011 og vedtagelse af referatet af det 69. bestyrelsesmøde den 16. december som anført nedenfor:
English: The European Commission drew the attention of the Board to the fact that the EU contribution is still under discussion in the Commission, and that any increase in budget or staff needs to be duly substantiated, particularly in crisis periods.
Danish: Europa-Kommissionen gjorde bestyrelsen opmærksom på, at EU-tilskuddet stadig drøftes i Kommissionen, og at enhver stigning i budget eller personale skal begrundes behørigt, især i krisetider.
English: • The public consultation on the Transparency Directive (a proposal for the review of the Directive may be made by the end of 2011).
Danish: • Den offentlige høring om gennemsigtighedsdirektivet (et forslag til revision af direktivet kan blive stillet ved udgangen af 2011).
English: Request of the former Executive Director for authorisation of external activities after leaving the service
Danish: Anmodning fra tidligere administrerende direktør om godkendelse af eksterne aktiviteter efter dennes fratræden
English: With regard to the structural problems of the budget, Commissioner Dalli was of the opinion that the Agency should be allowed to retain the surplus revenue from fees.
Danish: Med hensyn til de strukturelle problemer i budgettet var det kommissær Dallis opfattelse, at agenturet bør have lov til at beholde overskuddet fra gebyrer.
English: Declarations of conflicts of interests
Danish: Erklæringer om interessekonflikter
English: The Board concluded that none of the activities as communicated presented a conflict of interests.
Danish: Bestyrelsen konkluderede, at ingen af aktiviteterne, som de er oplyst, udgjorde en interessekonflikt.
English: The Board stressed its role in protecting the public interest and the reputation of the Agency.
Danish: Bestyrelsen understregede sin rolle i at beskytte offentlige interesser og bestyrelsens omdømme.
English: Members regretted the late notification by Mr Lönngren of details of his activities.
Danish: Medlemmerne beklagede Thomas Lönngrens sene oplysning om hans aktiviteter.
English: The European Commission has initiated a review of the Fee Regulation.
Danish: Europa-Kommissionen har iværksat en revision af gebyrforordningen.
English: Mary G. Baker (morning session) Mike O'Donovan
Danish: Mary G. Baker (formiddag) Mike O'Donovan
English: The Chair invited the Board members to volunteer as topic coordinators for the analysis and assessment of the Acting Executive Director's Annual Activity Report 2010.
Danish: Formanden bad bestyrelsesmedlemmerne om at melde sig frivilligt som emnekoordinatorer til analyse og evaluering af den fungerende administrerende direktørs årlige aktivitetsrapport 2010.
English: Management Board consultation procedure for CHMP and CVMP nominations: follow-up from December 2010 discussion
Danish: Bestyrelsens høringsprocedure for udnævnelser til CHMP og CVMP: opfølgning fra drøftelsen i december 2010
English: The Agency also anticipates that the adoption of the legislation on falsified medicines and the conclusion of the discussions on substances of human origin will also impact on activities in the near future.
Danish: Agenturet forventer også, at vedtagelsen af lovgivningen om forfalskede lægemidler og afslutningen af diskussionen om stoffer af menneskelig oprindelse vil have indflydelse på aktiviteterne i den nærmeste fremtid.
English: • The procedure for the appointment of the Executive Director (the 5 May 2011 meeting of the Board will be maintained as planned).
Danish: • Proceduren for udnævnelse af den administrerende direktør (bestyrelsesmødet den 5. maj 2011 finder sted som planlagt).
English: The Board adopted the establishment plan of 612 posts, which represents an increase of 45 posts required for the preparation and implementation of the pharmacovigilance legislation.
Danish: Bestyrelsen vedtog stillingsfortegnelsen med 612 stillinger, hvilket er en stigning på 45 stillinger, som er nødvendige for forbedringen og gennemførelsen af lovgivningen om lægemiddelovervågning.
English: It attaches great importance to transparency, and, acting in the public interest, requested the Acting Executive Director to publish its decision, together with supporting documents on the EMA website.
Danish: Den tillægger gennemsigtighed stor betydning, og anmodede i offentlighedens interesse den fungerende administrerende direktør om at offentliggøre dens afgørelse sammen med understøttende dokumentation på EMA's websted.