FrancophonIA/ELRC3.0 huggingface dataset:
English: Other side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are behavioural disorders such as increased activity, barking or signs of anxiety, lethargy (lack of energy), or anorexia (loss of appetite), and nervous system signs such as muscle tremor (shaking).
Danish: Andre bivirkninger ved Vectra 3D (som kan optræde hos op til 1 ud af 1.000 hunde) er adfærdsmæssige forstyrrelser, såsom øget aktivitet, gøen eller tegn på angst, letargi (mangel på energi) eller anoreksi (nedsat appetit) og symptomer i nervesystemet, såsom muskelrysten.
English: Dinotefuran acts on nerve receptors called nicotinic acetylcholine receptors and permethrin interferes with sodium channels on nerves that play a role in transmitting signals; when given together, they reinforce each other's action.
Danish: Dinotefuran virker på receptorer kaldet nikotinerge acetylkolinreceptorer, og permethrin griber ind i funktionen af nervernes natriumkanaler, der medvirker ved signaloverførslen; tilsammen forstærker de to stoffer hinandens virkning.
English: What is Vectra 3D and what is it used for?
Danish: Hvad er Vectra 3D, og hvad anvendes det til?
English: Vectra 3D contains three active substances: dinotefuran, pyriproxyfen and permethrin.
Danish: Vectra 3D indeholder de tre aktive stoffer dinotefuran, pyriproxyfen og permethrin.
English: What are the risks associated with Vectra 3D?
Danish: Hvilke risici er der forbundet med Vectra 3D?
English: Why is Vectra 3D authorised in the EU?
Danish: Hvorfor blev Vectra 3D godkendt i EU?
English: The second field study involved 278 dogs with flea infestations which were treated three times at monthly intervals either with Vectra 3D or another spot-on product containing fipronil and (s)methoprene.
Danish: I et andet feltstudie blev 278 hunde med loppeangreb behandlet tre gange med en måneds mellemrum enten med Vectra 3D eller med et andet spot-on-produkt indeholdende fipronil og (s)-methopren.
English: The dogs treated with Vectra 3D had an average tick reduction of 94% over 4 weeks compared with 97% with the other product.
Danish: De hunde, der blev behandlet med Vectra 3D, fik i løbet af fire uger i gennemsnit mindsket antallet af flåter med 94 %, sammenlignet med 97 % med det andet produkt.
English: For a full list of all side-effects reported with Vectra 3D, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Vectra 3D fremgår af indlægssedlen.
English: The most common side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are short-lived redness, itching or other signs of discomfort at the application site.
Danish: De hyppigste bivirkninger ved Vectra 3D (som kan optræde hos op til 1 ud af 1.000 hunde) er kortvarig rødme, kløe eller andre gener på påføringsstedet.
English: Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as blocking development of juvenile flea stages into adults.
Danish: Pyriproxyfen regulerer insekters vækst og blokerer loppers livscyklus ved at medføre produktion af ufrugtbare æg og standse loppernes udvikling i et tidligt stadium, så de ikke udvikler sig til voksne individer.
English: Vectra 3D can be obtained without a prescription and is available as a spot-on solution in applicators of five different strengths for use on dogs of different weights.
Danish: Vectra 3D udleveres uden recept og leveres som spot-on, opløsning, i applikatorer i fem forskellige styrker til hunde med forskellig kropsvægt.
English: It showed that Vectra 3D-treated dogs had an average flea count reduction of 95% compared with 97% for the dogs treated with fipronil and (s)-methoprene.
Danish: Det viste, at hunde ved behandling med Vectra 3D i gennemsnit fik reduceret antallet af lopper med 95 % sammenlignet med 97 % for de hunde, der blev handlet med fipronil og (s)-methopren.
English: How is Vectra 3D used?
Danish: Hvordan anvendes Vectra 3D?
English: It showed that dogs treated once with Vectra 3D had fleas reduced by 79% over the 4 week study period compared with a reduction of 57% for dogs treated once with another spot-on product containing two other substances
Danish: Det viste, at hunde, der var blevet behandlet en gang med Vectra 3D, fik reduceret antallet af lopper med 79 % i løbet af den fire ugers studieperiode sammenlignet med en reduktion på 57 % hos hunde, der blev behandlet én gang med en anden spot-on indeholdende to andre stoffer mod lopper og flåter, nemlig fipronil og (s)-methopren.
English: What benefits of Vectra 3D have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Vectra 3D?
English: If accidental exposure to the eyes occurs, the eyes should be thoroughly rinsed with water and in case of accidental exposure to the skin, the skin should be washed immediately with soap and water.
Danish: Ved utilsigtet kontakt med huden vaskes huden omgående med vand og sæbe.
English: How does Vectra 3D work?
Danish: Hvordan virker Vectra 3D?
English: − 1 member of the Commission.
Danish: 1 medlem fra Kommissionen.
English: The Agency is in the process of developing a new road map.
Danish: Agenturet var i færd med at udvikle en ny køreplan.
English: The Agency's current road map covers the period up to 2010.
Danish: Agenturets nuværende køreplan dækkede perioden indtil 2010.
English: The EU (European Commission/EMEA) - FDA meeting The meeting took place on the 27-29 September.
Danish: Mødet mellem EU (Europa-Kommissionen/EMEA) og FDA Mødet fandt sted den 27.-29. september.
English: EMEA long-term strategy - the Road Map
Danish: EMEA's langsigtede strategi - køreplanen
English: The rules will be submitted for adoption after a positive opinion of the European Commission.
Danish: Reglerne ville blive fremsendt til vedtagelse efter en positiv udtalelse fra EuropaKommissionen.
English: Update on the pilot project on revision of the payment system
Danish: Ajourføring om pilotprojektet om revision af betalingssystemet
English: The Agency's revenue and expenditure is in line with the plans.
Danish: Agenturets indtægter og udgifter var i overensstemmelse med planerne.
English: The number of applications is also in line with forecasts.
Danish: Antallet af ansøgninger stemte også overens med prognoserne.
English: Simplification of the contractual arrangements between the EMEA and the national competent authorities of the Member States: development of a cooperation agreement
Danish: Forenkling af kontraktordningerne mellem EMEA og medlemsstaternes kompetente myndigheder: udvikling af en samarbejdsaftale
English: In March 2009, the Management Board adopted a preliminary draft budget for 2010 of €211m.
Danish: I marts 2009 vedtog bestyrelsen et foreløbigt budgetudkast for 2010 på 211 mio. EUR.
English: The composition of the new MBTC is as follows:
Danish: Det nye MBTC ville blive sammensat som følger:
English: The requested Community contribution of €46m will be reduced to €37m.
Danish: Tilskuddet fra Fællesskabet på 46 mio. EUR ville blive sat ned til 37 mio. EUR.
English: 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.
Danish: Der var indført et solidt system til overvågning af vaccinernes sikkerhed og effektivitet i samarbejde med Det Europæiske Center for Forebyggelse af og Kontrol med Sygdomme.
English: The work to develop and introduce qualitative indicators will commence.
Danish: Arbejdet med at udvikle og indføre kvalitative indikatorer ville blive iværksat.
English: The assessment of cost-effectiveness and subsequent decisions on reimbursement, on the other hand, should be left at the level of individual Member States.
Danish: Vurderingen af omkostningseffektivitet og efterfølgende diskussioner om godtgørelse skulle på den anden side overlades til de enkelte medlemsstater.
English: The approval of vaccines was based on the concept of H5N1 mock-up vaccines developed by the Agency in 2003.
Danish: Godkendelsen af vaccinerne var baseret på konceptet med H5N1 mock-upvacciner, som agenturet havde udviklet i 2003.
English: Meeting dates for 2010 and provisional meeting dates for 2011
Danish: Mødedatoer for 2010 og foreløbige mødedatoer for 2011
English: Budget 2010 update
Danish: Budget for 2010, ajourført
English: Fifteen national competent authorities participate in the work of the costing group, and ten of them have submitted costing data.
Danish: Femten nationale kompetente myndigheder deltog i omkostningsgruppens arbejde, og ti havde indsendt oplysninger om udgifterne.
English: A significant amount of resources was allocated to work relating to the H1N1 pandemic.
Danish: Der var afsat store ressourcer til arbejde med H1N1pandemien.
English: The topic coordinators, Jean Marimbert and Marcus Müllner, have reviewed the proposal and gave positive feedback.
Danish: Emnekoordinatorerne Jean Marimbert og Marcus Müllner havde gennemgået forslaget og kom med positiv feedback.
English: The Board generally supported the introduction of quantitative indicators.
Danish: Bestyrelsen støttede generelt indførelsen af kvantitative indikatorer.
English: The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on two pandemic vaccines.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) havde afgivet en positiv udtalelse om to pandemiske vacciner.
English: Pandemic vaccines
Danish: Pandemiske vacciner
English: There is a significant increase in applications for authorisation of generic medicinal products, with 31 applications received.
Danish: Der var sket en betydelig stigning i antallet af ansøgninger om godkendelse af generiske lægemidler, idet der var indkommet 31 ansøgninger.
English: Good progress was made in the field of international collaboration on inspections.
Danish: Der var gjort store fremskridt med det internationale samarbejde om tilsyn.
English: Having reviewed the level of cooperation between the EU and FDA, all parties concluded that the cooperation between the two regulators is successful and both parties regard each other as primary international partners in the regulatory field.
Danish: Efter at have drøftet samarbejdet mellem EU og FDA konkluderede alle parter, at samarbejdet mellem de to tilsynsmyndigheder var vellykket, og begge parter opfattede den anden som primær international partner på dette tilsynsområde.
English: The Budget Committee of the European Parliament indicated that the fee-earning agencies would have access to the surplus revenue from previous years.
Danish: Europa-Parlamentets Budgetudvalg havde anført, at gebyrindtjenende agenturer ville få adgang til de overskydende indtægter fra tidligere år.
English: − Mike O'Donovan (representative of the patients' organisations).
Danish: Mike O'Donovan (repræsentant for patientorganisationerne).
English: 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.
Danish: Bestyrelsen hørte, at det nuværende skøn over indtægter fra afgifter er 8,5 mio. EUR lavere end oprindelig forventet på grund af en nedgang i andelen af gebyrpligtige ansøgninger, man forventede at modtage.
English: The information on conflicts of interests will also constitute a part of the documentation submitted during the formal consultation process.
Danish: Oplysningerne om interessekonflikter ville også indgå i den dokumentation, som skulle fremsendes under den formelle høringsproces.
English: The Agency's Committee for Advanced Therapies, inaugurated at the beginning of the year, has issued its first opinions.
Danish: Agenturets Udvalg for Avancerede Terapier, som havde påbegyndt arbejdet ved årets begyndelse, havde udsendt sine første udtalelser.
English: The present proposal contains comments received and also includes a new proposal for quantitative performance indicators - compliance with set timelines.
Danish: Det foreliggende forslag indeholdt indkomne bemærkninger og også et nyt forslag til kvantitative resultatindikatorer - overholdelse af fastsatte tidsfrister.
English: London, 1 October 2009
Danish: London, den 1. oktober 2009
English: Setting up a subgroup of the Management Board to replace the Telematics steering committee
Danish: Nedsættelse af en undergruppe under bestyrelsen som erstatning for telematikstyringsudvalget
English: The Board will be asked to approve the 2010 part of the plan as part of the work programme and budget discussion 2010 in December.
Danish: Bestyrelsen ville blive bedt om at godkende 2010delen af planen som led i diskussionen om arbejdsprogrammet og budgettet for 2010 i december.
English: The Board noted the proposed dates for 2011 as follows: 16 and 17 March, 16 June, 6 October and 15 December.
Danish: Bestyrelsen noterede sig følgende forslag til datoer for 2011: 16. og 17. marts, 16. juni, 6. oktober og 15. december.
English: The Board stated, however, that the final decision as to the nomination lies with the Member State.
Danish: Bestyrelsen anførte dog, at den endelige beslutning om udnævnelsen påhvilede medlemsstaten.
English: Implementation of Staff Regulation: Rules on attachment of staff The item was taken off the agenda.
Danish: Gennemførelse af personalevedtægten: Regler for udstationering af personale Punktet blev taget af dagsordenen.
English: The Executive Director has recently attended the European Parliament, where he discussed the topic of pandemic-influenza vaccines.
Danish: Den administrerende direktør havde for nylig i Europa-Parlamentet drøftet spørgsmålet om pandemiinfluenzavacciner.
English: In view of the reduction of planned revenue, the Agency's senior management is reviewing areas where savings could be made and projects scheduled for 2010 be cut.
Danish: I lyset af nedgangen i forventede indtægter gennemgik agenturets øverste ledelse områder, hvor der kunne foretages besparelser, og hvilke nedskæringer der kunne foretages i projekterne i 2010.
English: A request will be sent to the Heads of Medicines Agencies and the European Commission to nominate representatives to the committee.
Danish: Der ville blive sendt en anmodning til cheferne for de nationale lægemiddelstyrelser og EuropaKommissionen om at udpege repræsentanter til udvalget.
English: EMEA mid-year report 2009
Danish: EMEA's halvårsberetning 2009
English: The proposed rules transpose the rules that are applied in the European Commission for secondment of their staff to organisations outside the EU.”
Danish: De foreslåede regler svarede til de regler, som blev anvendt i Europa-Kommissionen for udstationering af deres medarbejdere til organisationer uden for EU."
English: 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.
Danish: Medlemmer af Parlamentet havde stillet flere spørgsmål, bl.a. om brug af en i forhold til to doser af de godkendte vacciner og om brug af vacciner til børn og gravide.
English: The Board thanked the Agency, its staff and the members of the scientific committees for their effective work and the timeliness of the scientific opinions in light of the public-health benefits of the H1N1 pandemic vaccines.
Danish: Bestyrelsen takkede agenturet, dets personale og medlemmerne af de videnskabelige udvalg for deres effektive arbejde og rettidige videnskabelige udtalelser i lyset af fordelene for offentligheden ved de pandemiske H1N1-vacciner.
English: The document contains amendments discussed and agreed by the telematics steering committee in relation to the new pharmaceutical package and the funding gap.
Danish: Dokumentet indeholdt ændringer, som var blevet drøftet og vedtaget af telematikstyringsudvalget i relation til den nye lægemiddelpakke og finansieringsunderskuddet.
English: − 3 members of the Management Board, plus 1 representative of the patients' organisations which are members of the Management Board;
Danish: 3 medlemmer fra bestyrelsen plus 1 repræsentant for patientorganisationer, som var medlem af bestyrelsen
English: The first draft is undergoing internal consultation with the Agency's staff, members of the scientific committees and the working parties.
Danish: Det første udkast var nu i høring hos agenturets personale, medlemmer af de videnskabelige udvalg og arbejdsgrupperne.
English: Consultation on appointment of a CVMP member
Danish: Høring om udnævnelse af et CVMP-medlem
English: The proposal aims to simplify the governance structure, rationalise reporting lines and confirm the appropriate representation of the network.
Danish: Formålet med forslaget var at forenkle styringsstrukturen, rationalisere rapporteringssystemet og bekræfte netværkets hensigtsmæssige repræsentation.
English: The Board will send a summary of this discussion to the Director General of DG Enterprise and Industry.
Danish: Bestyrelsen ville sende et sammendrag af denne diskussion til generaldirektøren for GD for Erhvervspolitik.
English: The text should read: “The Board discussed the EMEA rules on attachment of staff.
Danish: Der skulle stå følgende: "Bestyrelsen drøftede EMEA's regler for udstationering af personale.
English: The data is provided in line with the costing methodology agreed by the Management Board.
Danish: Dataene var udarbejdet i overensstemmelse med den metodologi, som bestyrelsen havde vedtaget.
English: The Agency is largely on track with the implementation of its main objectives and is adhering to the majority of its performance indicators.
Danish: Agenturet overholdt i det store og hele planen for gennemførelsen af hovedmålsætningerne og opfyldte de fleste af resultatindikatorerne.
English: Telematics master plan 2009-2013
Danish: Masterplan for telematik 2009-2013
English: Work-sharing and collaboration among the Member States is necessary, since the evaluation of added therapeutic value is scientific work whose results can be used by all interested Member States.
Danish: Det var nødvendigt at dele arbejdet og at samarbejde medlemsstaterne imellem, da evalueringen af behandlingsmæssig merværdi var et videnskabeligt arbejde, som kunne bruges af alle interesserede medlemsstater.
English: Collaboration between the regulators and the HTA bodies also needs to be developed, in order to reduce avoidable differences in requirements in both fields.
Danish: Der skulle også udvikles et samarbejde mellem lovgivere og sundhedsteknologivurderingsorganer for at reducere overflødige forskelle i kravene på begge områder.
English: It was reiterated that the overall objective of the exercise is to bring the system better in line with the requirements of good governance and ensure that the remuneration system is justified, manageable and transparent.
Danish: Man gentog, at projektets overordnede formål var at skabe større overensstemmelse mellem systemet og kravene til god forvaltning og sikre, at betalingssystemet var berettiget, praktisk og gennemsigtigt.
English: The pilot on the assessment of evaluation costs in the national competent authorities is ongoing.
Danish: Pilotprojektet om vurdering af evalueringsomkostninger hos de nationale kompetente myndigheder var endnu ikke afsluttet.
English: The authority will then decide whether to continue with the nomination in the light of the feedback received from the Agency.
Danish: Myndigheden kunne så beslutte, om den ønskede at gå videre med udnævnelsen i lyset af den feedback, der blev modtaget fra agenturet.
English: The latter seems to be due to the difficulty experienced by the Member States in allocating scientific resources to work in the field of traditional medicinal products.
Danish: Sidstnævnte skyldtes angiveligt medlemsstaternes problemer med at afsætte videnskabelige ressourcer til arbejdet med traditionelle lægemidler.
English: 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.
Danish: Punkt 11 (bestemmelser vedrørende udstationering af personale) blev slettet af dagsordenen på baggrund af fortolkningen af den af Europa-Kommissionen udleverede personalevedtægt, i henhold til hvilken de foreslåede bestemmelser ikke må finde anvendelse på udstationering af EMEA-personale.
English: The Board also endorsed the proposal to establish a procedure for advanced screening of potential conflicts of interests ahead of the nomination.
Danish: Bestyrelsen godkendte også forslaget om at indføre en procedure for avanceret screening af potentielle interessekonflikter forud for udnævnelsen.
English: Report from the Task force on scientific qualifications of CHMP and CVMP members
Danish: Rapport fra taskforcen om videnskabelige kvalifikationer for medlemmer af CHMP og CVMP
English: 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.
Danish: Bestyrelsen gentog, at telematikprojekter skulle udarbejdes længe i forvejen, således at de nationale kompetente myndigheder kunne udvikle deres it-systemer i overensstemmelse med behovene på EU-plan.
English: The Board's substantial concern remains that the grading level proposed by the European Commission is too low.
Danish: Bestyrelsens største bekymring er stadig, at Europa-Kommissionen har foreslået et for lavt løntrin.
English: The Agency's long-term strategy will be coordinated with the strategy paper of the Heads of Medicines Agencies (HMA).
Danish: Agenturets langsigtede strategi ville blive koordineret med strategidokumentet fra cheferne for de nationale lægemiddelstyrelser.
English: Some members of the Board requested additional time to review the proposal ahead of its approval.
Danish: Nogle bestyrelsesmedlemmer bad om mere tid til at gennemgå forslaget før dets godkendelse.
English: 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.
Danish: Bestyrelsen bemærkede, at der p.t. ikke var noget retsgrundlag for at opkræve gebyr for besøg på webstedet eller godtgøre nationale kompetente myndigheder for det arbejde, der blev udført i forbindelse med besøg på webstedet i forbindelse med lægemidler til avanceret terapi.
English: 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.
Danish: Bestyrelsen blev informeret om et brev fra et tidligere bestyrelsesmedlem og en suppleant fra CHMP om deres tidligere aktiviteter.
English: The changes to the procedure will be introduced in the future revision of the EMEA policy on the handling of conflicts of interests.
Danish: Proceduren ville blive ændret i forbindelse med den kommende revision af EMEA's politik om håndtering af interessekonflikter.
English: Amendments to the implementing rules based on this proposal will be submitted to the Board in December 2009.
Danish: Ændringer til gennemførelsesbestemmelserne baseret på dette forslag ville blive sendt til bestyrelsens møde i december 2009.
English: 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.
Danish: Bestyrelsen bad taskforcen om at videreudvikle sit forslag om uddannelse af eksperter, som deltog i udvalgenes arbejde, på baggrund af den betydelige uddannelse, som agenturet allerede tilbød.
English: The Commission representative agreed to inform the European Commission of the concerns raised, and reiterated the need to find a timely solution enabling the appointment procedure to be completed by mid 2010.
Danish: Kommissionens repræsentant ville informere Europa-Kommissionen om bestyrelsens bekymring og gentog, at der skulle findes en løsning snarest, således at ansættelsesproceduren kunne afsluttes medio 2010.