FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect in patients with type 1 diabetes (which may affect up to 1 in 10 people) is genital infection, especially in women and a common side effect (which may affect up to 1 in 100 people) is diabetic ketoacidosis.
Danish: Den hyppigste bivirkning hos type 1diabetespatienter (som kan forekomme hos op til 1 ud af 10 personer) er infektion i kønsorganerne, navnlig hos kvinder, og en almindelig bivirkning (som kan forekomme hos op til 1 ud af 100 personer) er diabetisk ketoacidose (højt indhold af ketonstoffer i blodet).
English: How is Edistride used?
Danish: Hvordan anvendes Edistride?
English: In type 1 diabetes, Edistride is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control the diabetes well enough.
Danish: Ved type 1-diabetes anvendes Edistride sammen med insulin hos overvægtige patienter (BMI på mindst 27 kg/m2), når insulin alene ikke regulerer diabetes tilstrækkeligt.
English: The company will also conduct a study to estimate the frequency of diabetic ketoacidosis in patients with type 1 diabetes treated with Edistride.
Danish: Virksomheden vil også udføre et studie til vurdering af, hvor hyppigt der forekommer diabetisk ketoacidose hos patienter med type 1-diabetes, som behandles med Edistride.
English: The most common side effect with Edistride in patients with type 2 diabetes (which may affect more than 1 in 10 people) is hypoglycaemia, especially when used in combination with a sulphonylurea or insulin.
Danish: Den hyppigste bivirkning ved Edistride hos type 2-diabetespatienter (som kan forekomme hos mere end 1 ud af 10 personer) er for lavt blodsukker (hypoglykæmi), navnlig hvis det anvendes i kombination med et sulfonylurinstof eller insulin.
English: The active substance in Edistride, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Danish: Det aktive stof i Edistride, dapagliflozin, virker ved at blokere proteinet natriumglukose kotransporter 2 (SGLT2) i nyrerne.
English: What benefits of Edistride have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Edistride?
English: In two studies involving 1,648 patients with type 1 diabetes whose blood sugar was not controlled well enough on insulin alone, adding Edistride 5 mg decreased HbA1c levels after 24 hours by 0.37% and by 0.42% more than adding placebo.
Danish: I to studier med deltagelse af 1.648 type 1-diabetespatienter, hvis blodsukker ikke var tilstrækkeligt reguleret ved behandling med insulin alene, medførte tillæg af Edistride 5 mg, at HbA1c-niveauet faldt med 0,37 % efter 24 timer, svarende til 0,42 % mere end ved tillæg af placebo.
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Danish: Når blodet filtreres i nyrerne, forhindrer SGLT2 sukkeret i blodbanen i at blive udskilt i urinen.
English: In four other studies involving 2,370 patients, adding Edistride to other diabetes medicines decreased HbA1c levels by 0.54-0.68 percentage points more than adding placebo after 24 weeks.
Danish: I fire andre studier med deltagelse af 2.370 patienter, hvor Edistride blev givet i tillæg til andre lægemidler mod diabetes, var HbA1c-niveauet faldet med 0,54-0,68 procentpoint mere end med placebo efter 24 uger.
English: How does Edistride work?
Danish: Hvordan virker Edistride?
English: By blocking the action of SGLT2, dapagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Danish: Ved at blokere virkningen af SGLT2 bevirker dapagliflozin, at der udskilles mere blodsukker gennem urinen, så blodsukkerniveauet sænkes.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Edistride have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Edistride.
English: In two studies involving 840 patients with type 2 diabetes, Edistride when used alone decreased HbA1c levels by 0.66 percentage points more than placebo (a dummy treatment) after 24 weeks.
Danish: I to studier med deltagelse af 840 type 2-diabetespatienter fik Edistride som enebehandling HbA1cniveauet til at falde med 0,66 procentpoint mere end placebo (en virkningsløs behandling) efter 24 uger.
English: In addition, beneficial reductions in weight and blood pressure occurred in patients treated with Edistride.
Danish: Desuden havde behandlingen med Edistride den gavnlige virkning, at patienterne tabte sig og fik lavere blodtryk.
English: Precautions have been recommended to reduce the risk of diabetic ketoacidosis and the Agency has asked for further studies to determine its frequency in patients with type 1 diabetes treated with Edistride.
Danish: Agenturet har anmodet om gennemførelse af yderligere studier til vurdering af, hvor hyppigt der forekommer diabetisk ketoacidose hos type 1-diabetespatienter, der behandles med Edistride.
English: Edistride increased the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes and it is recommended for this condition only in overweight and obese patients.
Danish: diabetespatienter og anbefales kun til behandling af denne sygdom hos overvægtige og svært overvægtige patienter.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dasselta on 28 November 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dasselta den 28 november 2011.
English: The full EPAR for Dasselta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Dasselta findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What are the benefits and risks of Dasselta?
Danish: Hvilken fordel og risiko er der forbundet med Dasselta?
English: This is a summary of the European public assessment report (EPAR) for Dasselta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dasselta.
English: This means that Dasselta is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
Danish: Det betyder, at Dasselta er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Aerius.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dasselta.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Dasselta.
English: Other information about Dasselta
Danish: Andre oplysninger om Dasselta
English: The Committee recommended that Dasselta be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Dasselta.
English: For more information about treatment with Dasselta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dasselta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Dasselta is a ‘generic medicine'.
Danish: Dasselta er et ‘generisk lægemiddel'.
English: Dasselta is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Danish: Dasselta anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi, f.eks. høfeber eller allergi over for støvmider) eller urticaria (en hudlidelse forårsaget af allergi med symptomer, der omfatter kløe og nældefeber).
English: The active substance in Dasselta, desloratadine, is an antihistamine.
Danish: Det aktive stof i Dasselta, desloratadin, er et antihistamin.
English: The CHMP concluded that, in accordance with EU requirements, Dasselta has been shown to have comparable quality and to be bioequivalent to Aerius.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Dasselta er af sammenlignelig kvalitet og er bioækvivalent med Aerius.
English: Dasselta is a medicine containing the active substance desloratadine.
Danish: Dasselta er et lægemiddel, der indeholder det aktive stof desloratadin.
English: What is Dasselta?
Danish: Hvad er Dasselta?
English: Because Dasselta is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Dasselta er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Why has Dasselta been approved?
Danish: Hvorfor blev Dasselta godkendt?
English: What is Dasselta used for?
Danish: Hvad anvendes Dasselta til?
English: Because Dasselta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Danish: Da Dasselta er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Aerius.
English: How has Dasselta been studied?
Danish: Hvordan blev Dasselta undersøgt?
English: How is Dasselta used?
Danish: Hvordan anvendes Dasselta?
English: How does Dasselta work?
Danish: Hvordan virker Dasselta?
English: The European Commission indicated that it will propose to reduce this request by € 9 million.
Danish: Europa-Kommissionen indikerede, at den vil foreslå en reduktion af denne anmodning med 9 mio. EUR.
English: A similar extension was approved for Relenza by the Member States.
Danish: En lignende forlængelse blev godkendt af medlemsstaterne for Relenza.
English: This may impact on the Committee's ability to conduct its normal work.
Danish: Det kunne påvirke udvalgets evne til at udføre sit normale arbejde.
English: The analysis and assessment will be sent to the budgetary authority and the Court of Auditors.
Danish: Analysen og vurderingen ville blive fremsendt til budgetmyndigheden og til Revisionsretten.
English: The selection and appointment process usually takes approximately 12 months.
Danish: Proceduren for udvælgelse og udnævnelse varede ca. 12 måneder.
English: An operational task force for the implementation of the transparency policy will be considered.
Danish: En operationel taskforce for gennemførelsen af gennemsigtighedspolitikken ville blive taget under overvejelse.
English: Members recognised that the Member States have different legislation and interpretation with regards to transparency and information.
Danish: Medlemmerne erkendte, at medlemsstaterne havde forskellig lovgivning og fortolkning med hensyn til gennemsigtighed og information.
English: The appointment process can be done by a written procedure.
Danish: Udnævnelsen kunne ske ved skriftlig procedure.
English: Staffing issue Closed session.
Danish: Personaleanliggende Lukket møde.
English: The document also includes provisions regarding performance indicators and quality assurance.
Danish: Dokumentet omfattede ligeledes bestemmelser vedrørende resultatindikatorer og kvalitetssikring.
English: Preparation for written procedures:
Danish: Forberedelse af skriftlige procedurer:
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 Europa-Kommissionen.
English: The FDA colleague will join the EMEA in June.
Danish: Kollegaen fra FDA ville slutte sig til EMEA i juni.
English: United Kingdom Kent Woods European Parliament
Danish: Det Forenede Kongerige Kent Woods Europa-Parlamentet
English: The Agency has done significant work on antiviral medicines to date.
Danish: Agenturet havde hidtil gjort et betydeligt stykke arbejde omkring antivirale lægemidler.
English: Stakeholders' expectations should be managed appropriately.
Danish: Der skulle tages behørigt hensyn til interessenternes forventninger.
English: Johannes Löwer (HMA Group)*
Danish: Johannes Löwer (HMA-gruppen)*
English: Budget 2010 update
Danish: Opdatering af budgettet for 2010
English: This agenda item will be further discussed at the October meeting.
Danish: Dette dagsordenspunkt ville blive diskuteret videre på mødet til oktober.
English: The Management Board will also be informed of the 35 statements once all the findings have been consolidated.
Danish: Bestyrelsen ville ligeledes blive underrettet om de 35 udtalelser, når først alle konklusionerne var blevet samlet under ét.
English: The amended rules will be published on the Agency's website.
Danish: De ændrede bestemmelser ville blive offentliggjort på agenturets websted.
English: The Management Board is invited to send additional written comments to the EMEA by the end of July.
Danish: Bestyrelsen opfordredes til at fremsende yderligere skriftlige kommentarer til EMEA inden udgangen af juli.
English: The Agency is preparing proposals on how to manage this increase in workload (some referrals are very large, complex and include some 300-800 products).
Danish: Agenturet var ved at udforme forslag til, hvordan man håndterede denne stigende arbejdsbyrde (nogle henvisningssager var meget store, komplekse og omfattede ca. 300-800 produkter).
English: The Board also considered that the nomination of a candidate can take place before June 2010 in a two-day meeting.
Danish: Bestyrelsen havde desuden den opfattelse, at udpegelsen af en kandidat kunne finde sted før juni 2010 på et todages møde.
English: The comments received at the meeting will be incorporated and the policy will be published for public consultation.
Danish: De modtagne kommentarer på mødet ville blive indarbejdet, og politikken ville blive offentliggjort med henblik på offentlig høring.
English: The new corporate identity will be rolled out in December 2009, together with the new public website of the Agency.
Danish: Den nye virksomhedsidentitet ville blive lanceret i december 2009 sammen med agenturets nye offentlige websted.
English: The members welcomed the significant work done in the area to date.
Danish: Medlemmerne udtrykte deres påskønnelse af det betydelige arbejde, der indtil nu var gjort på området.
English: The Management Board noted the developments in the budgetary procedure for 2010.
Danish: Bestyrelsen tog udviklingen med hensyn til budgetproceduren for 2010 til efterretning.
English: For 2010, the EMEA requested a European Commission contribution of € 45 million for the conduct of public health-related activities.
Danish: For 2010 anmodede EMEA om et tilskud fra Europa-Kommissionen på 45 mio. EUR til gennemførelsen af aktiviteter på folkesundhedsområdet.
English: The members discussed that it is important to reach an agreement among the stakeholders of what constitutes commercially confidential information.
Danish: Medlemmerne diskuterede, at det var vigtigt at nå til enighed blandt interessenterne om, hvad der udgjorde forretningsmæssigt fortrolige oplysninger.
English: A revised version will be resubmitted for adoption in October and the signature of the contracts is expected by the end of the year.
Danish: En revideret version ville blive fremsendt på ny til vedtagelse i oktober, og kontrakten forventedes underskrevet sidst på året.
English: No conflicts of interests were declared.
Danish: Der blev ikke afgivet erklæringer om interessekonflikter.
English: In addition to the centralised regulatory approval, there may be for some A/H1N1 vaccines the option to obtain approval via national authorisation routes.
Danish: Ud over den centraliserede lovgivningsmæssige godkendelse kunne der for visse A/H1N1-vacciners vedkommende være mulighed for at opnå godkendelse via nationale godkendelser.
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 kontrakterne mellem EMEA og medlemsstaternes nationale kompetente myndigheder: udformning af en samarbejdsaftale
English: The members stressed that the policy should be implemented in a stepwise approach, taking into account available resources.
Danish: Medlemmerne understregede, at politikken skulle gennemføres etapevis og under hensyntagen til tilgængelige ressourcer.
English: The benefit/risk evaluation of vaccines needs to be conducted taking into account the infectivity and virulence potential of the virus.
Danish: Vurderingen af fordele/risici ved vacciner skulle foretages under hensyntagen til virussens smitsomme og ondartede potentiale.
English: The retention of surplus (reserve) is important to provide stability to the Agency in case of reduction in the fee revenue, particularly in the light of risk factors mentioned above.
Danish: Tilbageholdelsen af overskud (reserve) er vigtig for at skabe stabilitet i agenturet i tilfælde af et fald i gebyrindtægterne, navnlig set i lyset af ovennævnte risikofaktorer.
English: The Management Board wished to be engaged in the process and the discussions, and be involved more closely during the third stage.
Danish: Bestyrelsen så gerne, at den blev inddraget i processen og diskussionerne og blev tættere involveret i tredje etape.
English: Declaration of conflicts of interest
Danish: Erklæring om interessekonflikt
English: These changes would ensure that a future policy would not limit the availability of the best expertise for robust decision making.
Danish: Disse ændringer ville sikre, at en kommende politik ikke ville begrænse adgangen til den bedste ekspertise til brug for en omfattende beslutningsproces.
English: Paediatric investigation plans
Danish: Pædiatriske undersøgelsesplaner
English: The Board expressed a concern that once vaccines are developed the regulators will be under significant pressure from various parties to authorise the products.
Danish: Bestyrelsen udtrykte bekymring for, at når først der var udviklet vacciner, ville lovgiverne være under betydeligt pres fra forskellige parter for at godkende produkterne.
English: The revisions concern applications made under Article 29 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use.
Danish: Revisionerne vedrørte ansøgninger i medfør af artikel 29 i Europa-Parlamentets og Rådets forordning (EF) nr. 1901/2006 om lægemidler til pædiatrisk brug.
English: Measures for the implementation of the policy will be reflected annually in the Agency's work programme.
Danish: Forholdsregler vedrørende gennemførelsen af politikken ville indgå i agenturets årlige arbejdsprogram.
English: The Annual Activity Report 2008 and the Analysis and assessment of the Annual Activity Report 2008
Danish: Årsberetningen for 2008 og analysen og vurderingen af årsberetningen for 2008
English: The presented proposal takes into account Management Board comments.
Danish: Det fremlagte forslag tog højde for bestyrelsens kommentarer.
English: 1 October 2009
Danish: 1. oktober 2009
English: Experts with a higher level of conflicts of interests than permitted under the present policy could be allowed to provide their recommendations, but they would not participate in the decision making.
Danish: Eksperter med et højere niveau af interessekonflikter end tilladt i henhold til den nuværende politik kunne få lov til at komme med deres henstillinger, men de ville ikke deltage i beslutningsprocessen.
English: As discussed above, in addition there is a proposal at the Commission to cancel the earmarked revenue from the 2008 surplus.
Danish: Som drøftet ovenfor foreligger der derudover et forslag fra Kommissionen om at annullere de formålsbestemte indtægter som følge af overskuddet for 2008.
English: This becomes an emerging risk for the financing of the Agency in the light of the likely negative financial impact of the revised variations regulation, uncertainty of the impact of a new payment system to Member States and the current economic climate.
Danish: Derved opstod der en risiko for finansieringen af agenturet i lyset af de sandsynlige negative finansielle virkninger af den reviderede forordning om ændringer, usikkerheden omkring virkningen af et nyt betalingssystem for medlemsstaterne og det aktuelle økonomiske klima.
English: The permissible level of conflicts of interests of rapporteurs and co-rapporteurs should remain at the present level (level 1).
Danish: Det tilladte niveau for interessekonflikter hos rapportører og medrapportører burde bevares på det nuværende niveau (niveau
English: The Commission's Vice-President Margot Wallström leads the inter-institutional working group in which the EU agencies are represented.
Danish: Kommissionens næstformand Margot Wallström stod i spidsen for den interinstitutionelle arbejdsgruppe, hvor EU's agenturer var repræsenteret.
English: The Board noted the progress made in the previous year, major developments in the management and control systems and conclusions of audits.
Danish: Bestyrelsen tog de fremskridt, der var gjort i det foregående år, de vigtige udviklingstendenser i styrings- og kontrolsystemerne og afslutningen af revisioner til efterretning.
English: Resource requirements of the CVMP
Danish: Ressourcekrav vedrørende CVMP
English: Mr Johannes Löwer's invitation as an observer is extended to all future meetings of the Management Board.
Danish: Johannes Löwers invitation som observatør udvides til at omfatte samtlige kommende møder i bestyrelsen.
English: The EMEA will approach the Commission's Directorate-General for Budget expressing these concerns.
Danish: EMEA ville henvende sig til Kommissionens Generaldirektorat for Budget og gøre rede for disse problematikker.
English: The experience shows that the current low level of permissible conflicts of interests restricts the involvement of valuable scientific expertise, which impacts on the work of the scientific committees.
Danish: Erfaringen viste, at det nuværende lave niveau for tilladte interessekonflikter begrænsede inddragelsen af værdifuld videnskabelig ekspertise, hvilket igen havde konsekvenser for arbejdet i de videnskabelige udvalg.
English: The Commission will aim to publish a vacancy announcement before the summer break 2009.
Danish: Kommissionen ville tilstræbe at offentliggøre stillingsannoncen inden sommerferien 2009.
English: Currently, the Agency is in dialogue with manufacturers of vaccines and with European and international regulators to discuss scientific and regulatory issues in order to facilitate the availability of vaccines for use in an influenza pandemic situation.
Danish: Agenturet var i øjeblikket i dialog med producenter af vacciner og med europæiske og internationale lovgivere for at drøfte videnskabelige og lovgivningsmæssige spørgsmål med det formål at lette tilgængeligheden af vacciner til brug ved en influenzapandemi.
English: The Management Board welcomed the results of the Agency's operations in 2008 and the strong contribution of the EMEA to EU-wide efforts in support of making high-quality, safe and effective medicines available for use in human and animal populations.
Danish: Bestyrelsen udtrykte tilfredshed med resultaterne af agenturets aktiviteter i 2008 og det store bidrag, som EMEA havde ydet til indsatsen på EU-plan for at gøre sikre og effektive kvalitetslægemidler tilgængelige for brug i humane og animalske populationer.