FrancophonIA/ELRC3.0 huggingface dataset:
English: When discussing the merits of holding a public hearing, the PRAC should consider the following elements:
Danish: Når PRAC drøfter fordelene ved at afholde en offentlig høring, bør det tage følgende elementer i betragtning:
English: A record of the meeting, the list of speakers and all other participants, including their affiliation, their declared interests, any supporting documentation presented by speakers and a summary of the conclusions of the meeting will be made available following the public hearing on the Agency's website.
Danish: Et referat fra mødet, listen over talere og alle andre deltagere, herunder deres tilhørsforhold, deres erklærede interesser, eventuel ekstra dokumentation fremlagt af talerne og et resumé af mødets konklusioner vil efter den offentlige høring blive stillet til rådighed på agenturets websted.
English: Where time permits, the PRAC Chair can open the floor to all participants in the room, for additional statements on the points made during the hearing.
Danish: Hvis der er tid til det, kan PRAC's formand give ordet til alle deltagere i lokalet med henblik på at komme med yderligere bemærkninger til de punkter, der blev fremsat under høringen.
English: Requesters will receive a confirmation of their request in advance of the hearing.
Danish: De anmodende vil modtage en bekræftelse på deres anmodning inden høringen.
English: The outcome of the discussion on the need to hold a public hearing, including a justification of the decision taken will be recorded in the minutes of the PRAC which are published on the Agency's website.
Danish: Resultatet af drøftelsen om behovet for at afholde en offentlig høring, herunder en begrundelse for den trufne beslutning, vil blive anført i PRAC's mødereferat, der offentliggøres på agenturets websted.
English: A public hearing is a forum to which the public is invited to express its views, guided by a pre-defined set of questions, on issues related to the safety of a particular medicinal product, a medicinal substance or a therapeutic class, whilst also considering the therapeutic effects of these products.
Danish: En offentlig høring er et forum, hvor offentligheden på grundlag af et forud fastsat sæt spørgsmål opfordres til at tilkendegive sit syn på emner vedrørende sikkerheden i forbindelse med et bestemt lægemiddel, et lægemiddelstof eller en terapeutisk gruppe, samtidig med at de terapeutiske virkninger af disse midler tages i betragtning.
English: These documents will be published in advance of the public hearing on the Agency's website.
Danish: Disse dokumenter vil blive offentliggjort forud for den offentlige høring på agenturets websted.
English: However, if a large number of requests have been received to attend the public hearing as a speaker, the Agency may reduce the time allocated for each speaker and/or extend the duration of the public hearing.
Danish: Hvis der er modtaget et stort antal anmodninger om deltagelse i den offentlige høring som taler, kan agenturet dog begrænse den tid, som hver taler får tildelt, og/eller forlænge varigheden af den offentlige høring
English: The PRAC Chair concludes the public hearing and explains the next steps of the procedure.
Danish: PRAC's formand afslutter den offentlige høring og redegør for de næste trin i sagsforløbet.
English: The PRAC members may ask questions for clarification from the speaker once the speaker's intervention has finished.
Danish: PRAC's medlemmer kan stille uddybende spørgsmål til taleren, når denne har afsluttet sit indlæg.
English: The primary purpose of a public hearing is to hear the public's view on the acceptability of the risks associated with the medicinal product/medicinal substance/class of medicinal products concerned, particularly in relation to its therapeutic effects and therapeutic alternatives available, as well as to seek suggestions and recommendations on the feasibility and acceptability of risk management and minimisation activities.
Danish: Hovedformålet med en offentlig høring er at få kendskab til offentlighedens syn på, hvorvidt de risici, der er forbundet med det/den pågældende lægemiddel/lægemiddelstof/gruppe af lægemidler, navnlig i relation til dets/dens terapeutiske virkninger og de terapeutiske alternativer, der er til rådighed, er acceptable, samt at modtage forslag og anbefalinger vedrørende muligheden for at gennemføre risikostyrings- og minimeringsaktiviteter og acceptere dem.
English: Different modalities of participation will help to ensure that as many citizens as possible have access to the public hearing.
Danish: Forskellige former for deltagelse vil bidrage til at sikre, at så mange borgere som muligt har adgang til den offentlige høring.
English: All members of the public who wish to attend the public hearing as a speaker should submit their request in advance of the meeting, by the deadline specified in the Agency's announcement of the public hearing.
Danish: Alle privatpersoner, der ønsker at deltage i den offentlige høring som talere, bør indgive deres anmodning forud for mødet og inden den frist, der er fastsat i agenturets bekendtgørelse af den offentlige høring.
English: However, it may decline a request to speak at the public hearing if the outline of the planned intervention addresses a matter that is not prima facie related to the subject matter of the public hearing.
Danish: Det kan dog afvise en anmodning om at tale ved den offentlige høring, hvis det fremgår af redegørelsen for det planlagte indlæg, at der vil blive taget et spørgsmål op, som ikke umiddelbart vedrører emnet for den offentlige høring.
English: The requests to speak at the public hearing will be reviewed by the Agency.
Danish: Anmodninger om at tale ved den offentlige høring vil blive gennemgået af agenturet.
English: Concluding the hearing
Danish: Høringens afslutning
English: Different modalities of participation help to ensure that as many citizens as possible have access to the public hearing process.
Danish: Mange former for deltagelse bidrager til at sikre, at så mange borgere som muligt får adgang til den offentlige høringsproces.
English: • Affiliation (i.e. name of the organisation/pharmaceutical company the individual represents), if applicable.
Danish: • eventuelt tilhørsforhold (dvs. navnet på den organisation/lægemiddelvirksomhed, som personen repræsenterer)
English: • Where space permits, requests to observe the public hearing in person without making an intervention will be accommodated.
Danish: • Når der er plads til det, vil anmodninger om personligt at være til stede ved den offentlige høring uden at fremsætte et indlæg blive imødekommet.
English: The questions asked by the PRAC to be addressed during the hearing determine the target audience.
Danish: De spørgsmål fra PRAC, der skal tages op under høringen, er bestemmende for målgruppen.
English: 1.4. Who can attend a public hearing
Danish: Hvem kan deltage i en offentlig høring
English: Participants have to request this when they register to speak at the public hearing.
Danish: Deltagerne skal anmode herom, når de indskriver sig som talere ved den offentlige høring.
English: At the end of the interventions the PRAC Chair summarises the interventions heard.
Danish: Når indlæggene er afsluttet, opsummerer PRAC's formand de fremlagte indlæg.
English: The announcement of a public hearing is made in advance of the hearing.
Danish: Bekendtgørelsen af en offentlig høring finder sted inden høringen.
English: Public hearings give the PRAC a channel to hear the public's views and concerns and take them into account in its opinion-making, particularly where options for regulatory actions to manage and/or minimise risks will need to be considered in a wider public health context.
Danish: Offentlige høringer er en kanal, hvorigennem PRAC kan få kendskab til offentlighedens synspunkter og bekymringer og tage hensyn til dem i sin stillingtagen, navnlig når mulighederne for lovgivningsmæssige foranstaltninger til at styre og/eller minimere risici skal overvejes i en bredere folkesundhedssammenhæng.
English: The assessment report will reference how the outcome of the public hearing has been addressed during the considerations at the level of the PRAC.
Danish: Det vil fremgå af vurderingsrapporten, hvordan resultatet af den offentlige høring er blevet taget op under overvejelserne i PRAC.
English: In the absence of the PRAC Chair, the PRAC Vice-Chair will chair the public hearing.
Danish: Hvis formanden for PRAC ikke er til stede, vil næstformanden lede den offentlige høring.
English: and will allocate time to each group, giving priority to civil society representatives, such as patients, consumers, healthcare professionals and academic research groups or organisations, particularly those relevant to the therapeutic area.
Danish: Agenturet vil opdele talerne efter status (se punkt 3.3) og tildele taletid til hver enkelt gruppe med prioritet til repræsentanter for civilsamfundet såsom patienter, forbrugere, sundhedspersoner og akademiske forskningsgrupper eller organisationer, navnlig dem, der er relevante for det terapeutiske område.
English: The contributions made by the public during a public hearing will be considered by the PRAC.
Danish: Bidragene fra offentligheden under en offentlig høring vil blive overvejet af PRAC.
English: Supporting documentation presented by the speakers during the intervention will be published on the Agency's website following the public hearing.
Danish: Ekstra dokumentation, som fremlægges af taleren under indlægget, vil blive offentliggjort på agenturets websted efter den offentlige høring.
English: “Where the urgency of the matter permits, the Pharmacovigilance Risk Assessment Committee may hold public hearings, where it considers that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.
Danish: "Hvis sagens hastende karakter tillader det, kan Udvalget for Risikovurdering inden for Lægemiddelovervågning afholde offentlige høringer, når det finder det hensigtsmæssigt og begrundet, især set i lyset af sikkerhedsbekymringernes omfang og alvor.
English: • Information on the location of the public hearing.
Danish: • oplysninger om stedet for den offentlige høring
English: The decision to hold a public hearing is taken by the Committee on a case-by-case basis, depending on the urgency of the matter in question and on other justified grounds, particularly with regard to the extent and seriousness of the safety issue.
Danish: Beslutningen om at afholde en offentlig høring træffes af udvalget i konkrete tilfælde afhængigt af den pågældende sags hastende karakter og andre berettigede grunde med hensyn til sikkerhedsbekymringernes omfang og alvor.
English: All individuals admitted as speakers will receive confirmation in advance of the hearing.
Danish: Alle personer, der godkendes til at tale, modtager bekræftelse forud for høringen.
English: The PRAC Chair opens the public hearing.
Danish: Formanden for PRAC indleder den offentlige høring.
English: Organisation of a public hearing - before the hearing
Danish: Afholdelse af en offentlig høring - inden høringen
English: Submitting a request to speak at the public hearing
Danish: Indgivelse af en anmodning om at tale ved den offentlige høring
English: • The proceedings of the public hearing can also be observed via video broadcast on the Agency's website.
Danish: • Drøftelserne i forbindelse med den offentlige høring kan også følges via tv-transmission på agenturets websted.
English: Chair
Danish: Formand
English: The Committee takes the decision to hold a public hearing on a case-by-case basis, where the urgency of the matter in question permits and after considering that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.
Danish: Udvalget beslutter at afholde en offentlig høring i konkrete tilfælde, hvis sagens hastende karakter tillader det, og efter at have fundet det hensigtsmæssigt af berettigede grunde med hensyn til sikkerhedsbekymringernes omfang og alvor.
English: The announcement shall specify the modalities of participation.
Danish: Meddelelsen skal indeholde nærmere bestemmelser om deltagelse i høringer.
English: The information gathered in the public hearing will be taken into account during the considerations within the PRAC.
Danish: De oplysninger, der er indsamlet under den offentlige høring, vil indgå i PRAC's overvejelser.
English: Anybody who has submitted a request to speak at the public hearing to the Agency and who has not been admitted
Danish: Enhver, der til agenturet har indgivet en anmodning om at tale ved den offentlige høring, og som ikke er blevet godkendt som taler, vil blive underrettet samtidig.
English: The proceedings of the public hearing can also be followed via video broadcast on the Agency's website.
Danish: Drøftelserne i forbindelse med den offentlige høring kan også følges via tv-transmission på agenturets websted.
English: • Information on date and time of the public hearing.
Danish: • oplysninger om dato og klokkeslæt for den offentlige høring
English: Follow-up to the public hearing
Danish: Opfølgning på den offentlige høring
English: Purpose of a public hearing
Danish: Formålet med en offentlig høring
English: In case of cancellation, the Agency will publically announce as early as possible, and will provide a justification for such cancellation.
Danish: Agenturet forbeholder sig ret til at aflyse en offentlig høring, hvis der opstår omstændigheder, som indvirker på muligheden for at afholde den. I tilfælde af aflysning vil agenturet bekendtgøre dette så tidligt som muligt og give en begrundelse herfor.
English: Opening statements
Danish: Indledning
English: If the number of requests still exceeds the allocated time, the Agency will review the requests and decide on the list of speakers, taking into account elements such as the most relevant speakers with regard to the questions to be addressed at the public hearing and/or the geographical spread of the speakers.
Danish: Hvis antallet af anmodninger fortsat overstiger den tildelte tid, vil agenturet gennemgå anmodningerne og træffe afgørelse om listen af talere under hensyntagen
English: Announcement of the public hearing
Danish: Bekendtgørelse af den offentlige høring
English: 3.5. Review of requests to speak at the public hearing
Danish: Gennemgang af anmodninger om at tale ved den offentlige høring
English: Conduct of a public hearing - during the hearing
Danish: Afvikling af en offentlig høring - under høringen
English: Considering the need for a public hearing
Danish: Overvejelse af behovet for en offentlig høring
English: Evaluating the need for a public hearing
Danish: Evaluering af behovet for en offentlig høring
English: • General ground rules guiding the public hearing.
Danish: • almindelige grundregler for den offentlige høring
English: Decision to hold a public hearing
Danish: Beslutning om at afholde en offentlig høring
English: The public hearing will be chaired by the PRAC Chair.
Danish: Formanden for PRAC leder den offentlige høring.
English: • Agency's contact email address and phone number.
Danish: • agenturets kontakt-e-mailadresse
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cinryze on 15 June 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cinryze den 15. juni 2011.
English: This is a summary of the European public assessment report (EPAR) for Cinryze.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cinryze.
English: The full EPAR for Cinryze can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Cinryze findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The patients chosen for the second study were those with frequent attacks, at least two attacks per month on average.
Danish: De patienter, der blev udvalgt til den anden undersøgelse, var dem, der havde hyppige anfald, nemlig mindst to anfald om måneden i gennemsnit.
English: In addition, the company will maintain a patient registry to provide further data on long-term safety and the way the medicine is used in practice.
Danish: Virksomheden vil endvidere føre et patientregister med henblik på at tilvejebringe yderligere data om sikkerheden på langt sigt og måden, hvorpå lægemidlet anvendes i praksis.
English: Supportive data on the effectiveness of Cinryze in children aged 2 to 5 years were also provided.
Danish: Der blev også fremlagt understøttende data om effektiviteten af Cinryze hos børn mellem 2 og 5 år.
English: Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema.
Danish: Patienter med lave niveauer af dette protein har en overdrevent stor aktivitet i disse to systemer, hvilket medfører symptomer på angioødem.
English: Other information about Cinryze
Danish: Andre oplysninger om Cinryze
English: Two main studies involving children aged 6 to 11 years were also carried out.
Danish: Yderligere to hovedundersøgelser hos børn mellem 6 og 11 år blev gennemført.
English: C1 inhibitor (human)
Danish: C1-hæmmer (human)
English: What measures are being taken to ensure the safe and effective use of Cinryze?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cinryze?
English: For more information about treatment with Cinryze, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cinryze, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The main measure of effectiveness in this study was how long it took for the symptoms to start improving.
Danish: Behandlingens virkning blev i denne undersøgelse hovedsageligt bedømt på, hvor lang tid det tog, før symptomerne begyndte at blive bedre.
English: Cinryze was effective in preventing attacks triggered by these procedures, with 98% of procedures not triggering an attack within 72 hours.
Danish: Cinryze var effektivt til at forebygge anfald, der blev udløst af disse indgreb, idet 98 % af indgrebene ikke udløste et anfald inden for 72 timer.
English: What is Cinryze and what is it used for?
Danish: Hvad er Cinryze, og hvad anvendes det til?
English: A second dose of 1,000 Units may be given if the patient has not responded adequately after one hour, or sooner for attacks in the larynx (voice box) or if the start of the treatment had been delayed.
Danish: Der kan gives en yderligere dosis på 1 000 enheder, hvis patienten ikke har responderet tilstrækkeligt efter en time, eller tidligere for anfald i larynx (strubehovedet), eller hvis behandlingens start er blevet forsinket.
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 Cinryze.
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, hvordan Cinryze skal anvendes.
English: The doctor should review the need for routine prevention on a regular basis and can adjust the frequency of the injections or the dose according to how the patient is responding.
Danish: Lægen bør regelmæssigt vurdere behovet for rutineforebyggelse og kan justere injektionernes hyppighed eller dosen efter patientens reaktion.
English: All the patients were given Cinryze and started having improvements 4 hours into treatment.
Danish: Alle patienterne fik Cinryze og begyndte at mærke en forbedring fire timer inde i behandlingen.
English: There will also be a training leaflet for patients that should be kept at home.
Danish: Der vil ligeledes være en patientinstruktionsfolder, som bør opbevares i hjemmet.
English: Treatment should be started under the supervision of a doctor experienced in treating hereditary angioedema.
Danish: Behandling bør indledes under overvågning af en læge, der har erfaring med behandling af hereditært angioødem.
English: The company that makes Cinryze will ensure that healthcare professionals in all Member States who are expected to prescribe Cinryze are provided with an educational pack instructing them to ensure that caregivers and patients who will give the medicine at home are properly trained.
Danish: Virksomheden, der fremstiller Cinryze, vil sikre, at sundhedspersonale i alle medlemsstater, som forventes at ordinere Cinryze, modtager oplysningsmateriale med instruktioner om at sørge for, at plejere og patienter, der indgiver lægemidlet hjemme, modtager behørig undervisning.
English: Cinryze can only be obtained with a prescription.
Danish: Cinryze udleveres kun efter recept.
English: In children from 6 to 11 years of age the dose is reduced to 500 Units.
Danish: Hos børn mellem 6 og 11 år reduceres dosen til 500 enheder.
English: The doctor may decide that the caregivers and patients can carry out the injection provided that they have been adequately trained.
Danish: Lægen kan beslutte, at plejeren og patienten selv kan foretage injektionen, såfremt de har modtaget tilstrækkelige instruktioner.
English: Based on the evidence from the studies, the CHMP concluded that Cinryze's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP besluttede på baggrund af undersøgelsesresultaterne, at fordelene ved Cinryze opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The C1 inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Danish: C1-hæmmerproteinet er nødvendigt for at regulere "kontakt- og komplementsystemerne", som er samlinger af proteiner i blodet, der bekæmper infektioner og forårsager inflammation.
English: The only common side effect seen in studies with Cinryze (seen in between 1 and 10 patients in 100) is rash, which is not serious and typically involves the arms, chest, abdomen or the injection site.
Danish: Den eneste hyppige bivirkning i undersøgelser med Cinryze (som optræder hos mellem 1 og 10 ud af 100 patienter) er udslæt, som ikke er alvorligt, og som typisk omfatter armene, brystet, maven eller injektionsstedet.
English: The active substance in Cinryze, human C1 inhibitor, is a protein extracted from human blood.
Danish: Det aktive stof i Cinryze, human C1-hæmmer, er et protein, der er udvundet af humant blod.
English: It is also used to prevent angioedema attacks that can be triggered by medical, dental or surgical procedures.
Danish: Det anvendes desuden til at forebygge anfald af angioødem, som kan udløses af medicinske, dentale eller kirurgiske indgreb.
English: Patients with hereditary angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Danish: Patienter med hereditært angioødem får anfald af hævelse, som kan ramme en hvilken som helst del af kroppen, såsom ansigtet, lemmerne eller tarmregionen, og forårsage ubehag og smerte.
English: Why has Cinryze been approved?
Danish: Hvorfor blev Cinryze godkendt?
English: Cinryze contains the active substance C1 inhibitor (human).
Danish: Cinryze indeholder det aktive stof C1-hæmmer (human).
English: Cinryze is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks.
Danish: Cinryze anvendes til at erstatte den manglende C1-hæmmer, hvilket afhjælper manglen og bidrager til at forebygge eller behandle anfald af angioødem.
English: The average number of attacks experienced in patients treated with Cinryze was 6.1 over the 12-week period compared with 12.7 for patients on placebo.
Danish: Det gennemsnitlige antal anfald hos patienter, der blev behandlet med Cinryze, var 6,1 over den samlede 12-ugers periode sammenlignet med 12,7 hos patienter, der fik placebo.