FrancophonIA/ELRC3.0 huggingface dataset:
English: Another important issue for the Agency is assuring the continuity of its operations during the 2012 London Olympic Games.
Danish: Et andet vigtigt emne for agenturet er at sikre kontinuitet i dets aktiviteter under De Olympiske Lege i London i 2012.
English: The challenge for the Agency is that it is increasingly difficult to match the growing workload and new tasks with adequate resources.
Danish: Udfordringen for agenturet er, at det bliver stadigt vanskeligere at matche den stigende arbejdsbyrde og opgaver med tilstrækkelige ressourcer.
English: One of the pillars of the implementation will be the strengthening of the Agency's collaboration with the national competent authorities in the area of communication and provision of information.
Danish: En af søjlerne i gennemførelsen vil være en styrkelse af agenturets samarbejde med de nationale kompetente myndigheder omkring kommunikation og levering af oplysninger.
English: The Agency will further develop processes and systems to make information of interest to the public available quicker and in a more efficient manner.
Danish: Agenturet vil videreudvikle processer og systemer, der skal gøre oplysninger af interesse for offentligheden tilgængelige hurtigere og mere effektivt.
English: This requires that the Agency step up the implementation of its rationalisation programme, to generate internal resources for the conduct of new and existing responsibilities to the highest quality standards.
Danish: Det kræver, at agenturet optrapper gennemførelsen af sit rationaliseringsprogram for at skabe interne ressourcer, der kan sikre, at nye og eksisterende ansvarsområder udøves efter de højeste kvalitetsstandarder.
English: The Agency will continue to strengthen and widen the scope of interactions with civil society by revising the framework for interaction with patients' organisations, and by gradually implementing the framework for interaction with healthcare professionals.
Danish: Agenturet vil fortsat styrke og udvide interaktionen med civilsamfundet ved at revidere rammerne for interaktion med patientorganisationer, og ved gradvist at implementere rammerne for interaktion med sundhedspersonale.
English: In the area of availability of medicines, the Agency will implement a number of initiatives outlined in the road map implementation plan.
Danish: Med hensyn til adgang til lægemidler vil agenturet gennemføre en række initiativer, der er beskrevet i gennemførelsesplanen for køreplanen.
English: The scope of the legislation covers centrally and nationally authorised products.
Danish: Lovgivningen omfatter centralt og nationalt godkendte lægemidler.
English: With respect to veterinary medicines, the European Commission is expected to finalise the legislative proposals arising from its consultation on better regulation in the veterinary sector and the impact assessment of the veterinary legislation that took place during 2010.
Danish: For så vidt angår veterinærlægemidler, forventes Europa-Kommissionen at lægge sidste hånd på de lovgivningsforslag, der er resultatet af dens høringer om bedre regulering i veterinærsektoren og på konsekvensanalysen af veterinærlovgivningen, der fandt sted i 2010.
English: Work is ongoing within the network to define what information is considered commercially confidential and how to best comply with protection of personal data.
Danish: Netværket fortsætter sit arbejde med at definere, hvilke oplysninger der skal betragtes som kommercielt fortrolige, og hvordan man bedst overholder kravet om beskyttelse af personoplysninger.
English: The Agency will support the work of the Commission by providing technical advice, particularly with respect to how the proposals will impact on the availability of veterinary medicinal products in general and centrally authorised products in particular.
Danish: Agenturet vil støtte Kommissionens arbejde ved at yde teknisk bistand, navnlig med hensyn til, hvordan forslagene vil have virkning på adgangen til veterinærlægemidler i almindelighed og centralt godkendte produkter i særdeleshed.
English: The work programme takes into account the above factors, the broader context of the Agency's legislative, economic, social and technological environment, and relevant measures outlined in the implementation plan for the Agency's 'Road map to 2015'.
Danish: Arbejdsprogrammet tager højde for ovennævnte faktorer, den bredere sammenhæng mellem agenturets lovgivningsmæssige, økonomiske, sociale og teknologiske miljø, og relevante foranstaltninger, der er beskrevet i gennemførelsesplanen for agenturets køreplan frem til 2015.
English: Following the implementation of the revised policies on handling of conflicts of interests in 2011, the Agency will focus on ensuring the full implementation and effective functioning of its updated policies on managing potential conflicts of interests with respect to the Management Board, experts and staff.
Danish: Efter gennemførelsen af de reviderede politikker for håndtering af interessekonflikter i 2011 vil agenturet fokusere på at sikre, at dets opdaterede politikker for håndtering af potentielle interessekonflikter i forhold til bestyrelse, eksperter og personale gennemføres fuldt ud og fungerer effektivt.
English: Similarly, the Agency will continue its contribution to, and cooperation with, health technology assessment bodies.
Danish: Tilsvarende vil agenturet fortsætte sit bidrag til, og samarbejde med, organer for vurdering af sundhedsteknologi.
English: EMA/MB/554514/2011 Executive Director
Danish: EMA/468930/2012 Directorate
English: The Agency and its partners have set priorities for the stepwise implementation of the legislation in line with available resources.
Danish: Agenturet og dets partnere har fastlagt prioriterede indsatsområder for en trinvis gennemførelse af lovgivningen under hensyntagen til tilgængelige ressourcer.
English: To this end, the Agency will accelerate the rollout of the Operational Excellence (OpEx@EMA) programme, which, among other objectives, will progressively review core business processes and ensure they are underpinned by efficient and effective IT systems.
Danish: I den forbindelse vil agenturet fremskynde indførelsen af programmet for operationel kvalitet (Operational Excellence, OpEx@EMA), som blandt andre målsætninger fortløbende vil gennemgå centrale forretningsprocesser og sikre, at de bakkes op af effektive it-systemer.
English: By virtue of its unique position in the life sciences and healthcare environments, the Agency is a rich repository of data, information and knowledge.
Danish: I kraft af dens unikke position inden for biovidenskab og sundhed udgør agenturet en rig base hvad angår data, oplysninger og viden.
English: It is important to stress that the scope of the new pharmacovigilance legislation goes far beyond the traditional scope of pharmacovigilance for human medicines.
Danish: Det er vigtigt at understrege, at omfanget af den nye lægemiddelovervågningslovgivning går langt ud over det traditionelle anvendelsesområde for overvågning af humanmedicinske lægemidler.
English: The implementation of the pharmacovigilance legislation is a main area of focus for the Agency and for the European medicines network as a whole, due to the significance of this legislation for public health, the amount of work that will have to be undertaken over the coming years by both the Agency and the network, and the significant amount of resources that will have to be found through internal reallocation and efficiency gains to finance this work.
Danish: Gennemførelsen af lægemiddelovervågningslovgivningen er et centralt fokusområde for agenturet og for det europæiske lægemiddelnetværk som helhed på grund af denne lovgivnings betydning for folkesundheden, den mængde arbejde, der skal gennemføres i de kommende år både fra agenturets og fra netværkets side, og de betydelige ressourcer, der skal findes gennem intern omfordeling og effektivitetsforbedringer til finansiering af dette arbejde.
English: The Agency's website will be adapted to include a single point of entry for all requests for documents or information.
Danish: Agenturets websted vil blive tilpasset, så det bliver til en kvikskranke for alle henvendelser om dokumenter eller oplysninger.
English: The Agency will step up its efforts to share primary data and information, provide secondary analyses of data and experiences, and proactively communicate its knowledge and grounds for regulatory opinions to the scientific community.
Danish: Agenturet vil intensivere sine bestræbelser på at dele primære data og primær information, fremlægge sekundære analyser af data og erfaringer, og proaktivt kommunikere sin viden om og årsager til lovgivningsudtalelser ud til det videnskabelige samfund.
English: The majority of the pharmacovigilance work currently undertaken by the Agency relates to approximately 600 centrally authorised products for human use.
Danish: Det meste af det arbejde omkring lægemiddelovervågning, der i dag udføres af agenturet, vedrører ca. 600 centralt godkendte humanmedicinske lægemidler.
English: As reflected in the road map and its implementation plan, the Agency and its Committee for Medicinal Products for Veterinary Use will continue to contribute on a wide range of topics related to veterinary medicines at European Union and international level, such as antimicrobial resistance, maximum residue limits, risk assessment, benefit-risk analysis methodology and harmonisation of standards and requirements.
Danish: Som det fremgår af køreplanen og dens gennemførelsesplan vil agenturet og dets Udvalg for Veterinærmedicinske Lægemidler fortsætte med at bidrage til en lang række emner, der vedrører veterinærlægemidler på EU- og internationalt plan, såsom antimikrobiel resistens, maksimale grænseværdier for restkoncentrationer, risikovurdering, metoder til analyse af fordele/risici og harmonisering af standarder og krav.
English: Opening up these resources to broader audiences could benefit drug development and improve patient care.
Danish: Ved at gøre disse ressourcer tilgængelige for bredere målgrupper vil man kunne gavne udviklingen af lægemidler og forbedre patientplejen.
English: The Agency will work with stakeholders and the regulatory network to ensure adequate and appropriate guidance is in place to facilitate the access to market of new technologies either in advance of, or as part of, the revision of veterinary legislation.
Danish: Agenturet vil arbejde sammen med aktører og netværket af regeludstedende myndigheder om at sikre en passende og relevant rådgivning, der skal lette adgangen til markedsføring af nye teknologier enten forud for, eller som en del af, revisionen af lovgivningen om lægemidler.
English: An increase in scientific-advice and marketing-authorisation applications for novel veterinary therapies is expected and encouraged.
Danish: Der forventes og tilskyndes til flere ansøgninger om videnskabelig rådgivning og om markedsføringstilladelser i forbindelse med nye veterinærmedicinske behandlingsformer.
English: Governance of the Agency
Danish: Agenturets styreform
English: Conducting ongoing scientific responsibilities to the highest quality standards remains the Agency's main priority.
Danish: Agenturets gennemførelse af løbende videnskabeligt arbejde inden for dets ansvarsområder efter de højeste kvalitetsstandarder er fortsat en hovedprioritet.
English: In the meantime, the most notable deliverables in the area of transparency in 2012 will be granting access to EudraVigilance data for human and veterinary medicines, providing more information on clinical trials and starting the publication of scientific committee agendas and minutes.
Danish: I mellemtiden vil de mest bemærkelsesværdige fremskridt omkring gennemsigtighed i 2012 være at give adgang til EudraVigilance-data for humanmedicinske lægemidler og veterinærlægemidler, at skaffe flere oplysninger om kliniske forsøg og at indlede offentliggørelsen af det videnskabelige udvalgs dagsordener og mødereferater.
English: Planned activities include identifying areas where additional medicines are needed, reflecting on the difficulties faced by SMEs in addressing unmet medical needs, and considering the merits and mechanics of an optional approach to the early authorisation of medicines in a restricted population.
Danish: Planlagte aktiviteter omfatter afdækning af områder, hvor yderligere lægemidler er nødvendige, hvilket afspejler de vanskeligheder, som SMV'er står over for, når de skal imødekomme uopfyldte lægemiddelbehov, og med tanke på fordele og mekanismer for en frivillig tilgang til tidlige godkendelse af lægemidler i en begrænset befolkningsgruppe.
English: The new legislation in particular places requirements on the Agency to develop and manage certain databases, to cooperate in the coordination of inspections in third countries, to cooperate in assessment and verification of third countries' regulatory framework for active pharmaceutical ingredients (APIs) and a number of other new measures.
Danish: Den nye lovgivning pålægger især krav til agenturet om at udvikle og forvalte visse databaser, at samarbejde om koordineringen af inspektioner til tredjelande, at samarbejde om vurdering og godkendelse af tredjelandes retsgrundlag for aktive ingredienser i lægemidler og en række andre nye tiltag.
English: The most important change in the new legislation is the direct involvement of the Agency in pharmacovigilance of the nationally authorised products.
Danish: Den vigtigste ændring i den nye lovgivning er agenturets direkte involvering i overvågning af nationalt godkendte lægemidler.
English: The resources needed to implement the legislation on falsified medicines and on pharmacovigilance will need to be reconciled.
Danish: Det vil være nødvendigt at samle de ressourcer, der er nødvendige for at gennemføre lovgivningen om forfalskede lægemidler og om lægemiddelovervågning.
English: Public-health needs and availability of medicines
Danish: Folkesundhedsbehov og adgang til lægemidler
English: Veterinary medicines
Danish: Veterinærlægemidler
English: The project to improve the European public assessment reports will come to fruition, and the pilot provision of joint scientific advice with health technology assessment bodies and payers will continue.
Danish: Projektet til forbedring af de europæiske offentlige vurderingsrapporter vil give afkast, og forsøgsordningen for fælles videnskabelig rådgivning sammen med organer for vurdering af sundhedsteknologi vil fortsætte.
English: • the climate of austerity, both for the Agency and the national competent authorities (NCAs).
Danish: • både agenturets og de nationale kompetente myndigheders sparebestræbelser.
English: The theme for 2012 in the veterinary field will be one of continuing to manage core activities against a backdrop of resource constraints.
Danish: Fokus for 2012 på veterinærlægemiddelområdet vil være på håndtering af kerneaktiviteter under hensyntagen til de ressourcemæssige begrænsninger.
English: In addition to assessing applications to set quality standards and timelines, the Agency will implement measures to strengthen the quality, scientific and regulatory consistency of assessments and of the regulatory science underpinning the Agency's work, in line with the road map implementation plan.
Danish: Ud over at vurdere ansøgningerne efter fastlagte kvalitetsstandarder og tidsfrister gennemfører agenturet foranstaltninger, der skal styrke kvaliteten, den videnskabelige og forskriftsmæssige konsekvens i forbindelse med videnskabelige vurderinger, og derved understreger agenturets arbejde i overensstemmelse med gennemførelsesplanen for køreplanen.
English: Main committee meetings during the critical July 2012 period will be hosted by national competent authorities and the European Commission.
Danish: Nationale kompetente myndigheder og Europa-Kommissionen vil stå for afholdelsen af vigtige udvalgsmøder i den kritiske periode i juli 2012.
English: While the new legislation significantly amends or adds to classic pharmacovigilance tasks, it also directly impacts many parts of the regulatory process related to patient safety that were not historically considered as pharmacovigilance.
Danish: Den nye lovgivning forbedrer og supplerer de klassiske lægemiddelovervågningsopgaver på væsentlige områder, samtidig med at den også har direkte virkninger for mange dele af den regeludstedende proces i relation til patientsikkerhed, der historisk ikke er blevet betragtet som lægemiddelovervågning.
English: Discussions on how to ensure patients' values are taken into account in benefit-risk assessments will start.
Danish: Der vil blive indledt drøftelser af, hvordan patientværdier tilgodeses i vurderinger af benefit/risk-forholdet.
English: • the new legislation on falsified medicines;
Danish: • den nye lovgivning om forfalskede lægemidler
English: Pharmacovigilance legislation
Danish: Lovgivning om lægemiddelovervågning
English: Anti-falsification legislation
Danish: Lovgivning til bekæmpelse af lægemiddelforfalskning
English: • the new pharmacovigilance legislation;
Danish: • den nye lovgivning om lægemiddelovervågning
English: European medicines network
Danish: Det Europæiske Lægemiddelagenturs arbejdsprogram
English: Applicant company name, address
Danish: Ansøger Virksomhedens navn, adresse
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CLOPIDOGREL TEVA AND ASSOCIATED NAMES
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF CLOPIDOGREL TEVA OG TILKNYTTEDE NAVNE
English: The CHMP noted that the primary purpose for the addition of BHA was to prevent the initiation of free radicals, by blocking the oxidative pathway, and was assured by the Applicant that the lowest level possible had been used.
Danish: CHMP bemærkede, at det primære formål med tilsætningen af BHA var at forhindre udviklingen af frie radikaler ved at blokere oxideringen, og ansøgeren forsikrede om, at den lavest mulige mængde var blevet anvendt.
English: The product developed with clopidogrel premix was found to be nonhygroscopic.
Danish: Det lægemiddel, der blev udviklet med clopidogrelpremix, blev anset for at være ikkehygroskopisk.
English: In conclusion, the CHMP agreed that although the choice of the clopidogrel base was not considered to be optimal, the use of BHA and the production process did not pose a potentially serious risk to public health.
Danish: CHMP konkluderede, at anvendelsen af BHA og produktionsprocessen ikke indebar nogen potentiel alvorlig risiko for folkesundheden, selv om valget af clopidogrelbasen ikke blev anset for at være optimal.
English: Whereas - the Applicant's choice of the clopidogrel base and consequently the use of BHA has been sufficiently explained - the overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base - the Applicant's Clopidogrel Base Tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
Danish: - Ansøgerens clopidogrelbasetabletter 75 mg er af tilstrækkelig kvalitet og har et tilstrækkeligt benefit/riskforhold og er sammenlignelige med referencelægemidletanbefaler CHMP, at der udstedes markedsføringstilladelse.
English: - have had a heart attack in the last 3 months.
Danish: - Hvis du har haft et hjerteanfald inden for de sidste 3 måneder.
English: The result of this is an improved ability to do physical activity.
Danish: Dette resulterer i en forbedret evne til at udføre fysisk aktivitet.
English: You should take both tablets at the same time, one after the other.
Danish: Du skal tage begge tabletter på samme tidspunkt, 1 ad gangen.
English: - have low blood pressure.
Danish: - Hvis du har lavt blodtryk.
English: Do NOT take these tablets if you are already taking nitrates.
Danish: Tag IKKE disse tabletter, hvis du allerede tager nitrater.
English: (2) Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Danish: (2) De fleste patienter, som disse hændelser blev rapporteret hos, havde allerede eksisterende kardiovaskulære risikofaktorer.
English: Do not take ADCIRCA if you:
Danish: Tag ikke ADCIRCA:
English: Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose.
Danish: Tag din dosis, så snart du kommer i tanke om det, hvis det er indenfor 8 timer efter, du skulle have taget din dosis.
English: Swallow the tablets whole with a drink of water.
Danish: Tabletterne synkes hele med et glas vand.
English: Acute myocardial infarction within the last 90 days.
Danish: Akut myokardieinfarkt inden for de seneste 90 dage.
English: Long-term treatment
Danish: Langtidsbehandling
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Danish: Behandling bør kun initieres og monitoreres af en læge med erfaring i behandling af PAH.
English: Children and adolescents ADCIRCA is not indicated for use by children and adolescents under the age of 18.
Danish: Børn og unge ADCIRCA er ikke beregnet til børn og unge under 18 år.
English: Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued.
Danish: Hovedpine kan forekomme i begyndelsen af behandlingen og aftager med tiden, selvom behandlingen fortsættes.
English: Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA will work.
Danish: Visse typer af medicin kan blive påvirket af ADCIRCA, eller de kan påvirke, hvor godt ADCIRCA virker.
English: The adverse reactions reported were transient, and generally mild or moderate.
Danish: De rapporterede bivirkninger var forbigående og generelt milde eller moderate.
English: ADCIRCA has been shown to increase the effects of these medicines.
Danish: ADCIRCA har vist sig at øge virkningen af disse typer medicin.
English: Adverse reaction data are limited in patients over 75 years of age.
Danish: Bivirkningsdata er begrænsede hos patienter over 75 år.
English: Severe hypotension (<90/50 mm Hg).
Danish: Svær hypotension (<90/50 mmHg).
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af RMP er sammenfaldende, kan de fremsendes samtidig.
English: Before taking the tablets, tell your doctor if you have:
Danish: Før du tager tabletterne, skal du fortælle det til din læge, hvis du har:
English: If you forget to take ADCIRCA
Danish: Hvis du har glemt at tage ADCIRCA
English: Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
Danish: Du må ikke tage ADCIRCA, når du er gravid, medmindre det er absolut nødvendigt, og du har diskuteret det med lægen.
English: Date of latest renewal: 1 October 2013
Danish: Dato for første markedsføringstilladelse: 1. oktober 2008 Dato for seneste fornyelse: 1. oktober 2013
English: At therapeutic concentrations, 94 % of tadalafil in plasma is bound to proteins.
Danish: Ved terapeutiske koncentrationer er 94 % af tadalafil i plasma bundet til proteiner.
English: Prostacyclin and its analogues
Danish: Prostacyclin og dets analoger
English: Patients should be informed not to take ADCIRCA with these medicinal products.
Danish: Patienterne skal informeres om ikke at tage ADCIRCA sammen med disse præparater.
English: Adverse reactions were similar to those seen at lower doses.
Danish: Bivirkningerne var de samme som dem, der ses ved lavere doser.
English: Elderly patients Dose adjustments are not required in elderly patients.
Danish: Ældre patienter Dosisjustering hos ældre patienter er ikke nødvendigt.
English: - chest pain - do not use nitrates, but seek immediate medical assistance (frequency common).
Danish: - Brystsmerter - brug ikke nitrater, men søg straks lægehjælp (hyppighed: almindelig).
English: Each film-coated tablet contains 233 mg lactose (as monohydrate).
Danish: Hver filmovertrukken tablet indeholder 233 mg lactose (som monohydrat).