natgillin/translations-raw huggingface dataset:
Offentlige høringer gennemføres i henhold til procedurereglerne for offentlige høringer. 
Public hearings are conducted according to the rules of procedure for public hearings.
Det sidste trin i gennemgangen er Europa-Kommissionens vedtagelse af en retligt bindende afgørelse med gyldighed i alle EU's medlemsstater. 
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
• Patienterne blev ikke oplyst om risiciene. 
• Patients were not given information about risks.
Patienterne burde desuden skulle give informeret samtykke før behandling. 
Patients should also have to give informed consent before treatment.
Næste trin 
Next steps
Nigel Stacey fremsatte kommentarer efter at videooptagelsen var ophørt. 
Nigel Stacey provided comments after the video recording had been stopped.
Som slutning på diskussionerne roste Dr. Raine de modige vidnesbyrd fra patienter og andre deltagere. 
In closing the discussions, Dr Raine praised the courageous testimonies from patients and other participants.
Høringen blev udsendt live, og en optagelse af den er tilgængelig på EMA's websted. 
The hearing was broadcast live and a recording is available on EMA's website.
Mange andre medlemmer af offentligheden, som ikke selv kunne være til stede, indsendte skriftlige indlæg, der alle vil blive taget i betragtning under gennemgangen. 
Many other members of the public who could not attend sent submissions in writing, which will all be taken into account during the review.
De understregede desuden vigtigheden af mikrobiel testning for at sikre, at lægemidlerne kun anvendes, når det er nødvendigt. 
They also stressed the importance of microbial testing to make sure the medicines are only used when necessary.
Det Europæiske Lægemiddelagentur 
European Medicines Agency
Offentligheden (patientrepræsentanter, omsorgsgivere, familier) Taler 1: 
General public (patient representatives, carers, families) Speaker 1:
Flere oplysninger om arbejdet i Det Europæiske Lægemiddelagentur findes på agenturets websted: www.ema.europa.eu 
More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu
Han talte om behovet for forbedringer i indlægssedlerne for at tage hensyn til dem, der måske har svært ved at forstå teksten. 
He spoke of the need for improvements in package leaflets to take account of those who may not be able to understand the text.
Retsgrundlaget for offentlige høringer er artikel 107j i direktiv 2001/83/EF om lægemiddelovervågning, som giver PRAC mulighed for at afholde offentlige høringer med henblik på en sikkerhedsmæssig gennemgang, der foretages af udvalget i medfør af artikel 20 i forordning (EF) nr. 726/2004 og artikel 31 eller 107i i direktiv 2001/83/EF. 
The legal basis for public hearings is Article 107j of Directive 2001/83/EC of the pharmacovigilance legislation, which gives the PRAC the possibility to hold public hearings for safety reviews conducted by the Committee under Article 20 of Regulation (EC) No 726/2004, and Articles 31 or 107i of Directive 2001/83/EC.
Henstillingerne vil derefter blive overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vil vedtage agenturets indstilling. 
The recommendations will then be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency's opinion.
PRAC vil nu gennemgå alle synspunkter, der blev udtrykt under høringen, herunder skriftlige indlæg, og vil tage dem i betragtning i vurderingen af sine henstillinger om brugen af disse antibiotika. 
The PRAC will now reflect on all the views expressed at the hearing, including written submissions, and will take them into account as it considers its recommendations on the use of these antibiotics.
Liste over talere 
List of Speakers
Forslag 
Proposals
Endnu et spørgsmål, der blev bragt op, var reaktionen på fødevarer, som patienterne udtalte burde undersøges nærmere. 
Another issue raised was the reaction to foods, which patients said should be further investigated.
Spørgsmål, der blev stillet til deltagerne 
Questions addressed to participants
Et mindretal gik ind for et direkte forbud mod disse lægemidler, og nogle patienter støttede begrænsning af anvendelsen til hospitaler. 
There was minority support for an outright ban of these medicines, and some patients supported restricting use to hospitals.
• Tilskynd til forskning i, hvordan lægemidlerne forårsager bivirkninger, herunder genetisk forskning. 
• Encourage research on how the medicines cause side effects, including genetic research.
I mangel af svar fra sundhedspersonerne har patienterne måttet forlade sig på oplysninger på internettet for at forstå de symptomer, de oplevede. 
In the absence of answers from healthcare professionals, patients have had to rely on information on the Internet to understand the symptoms they were experiencing.
På baggrund af bivirkningernes alvorlighed bemærkede Melanie Carr, leder af EMA's afdeling for berørte parter og kommunikation, i sin velkomsttale, at denne offentlige høring var "særlig vigtig, fordi den giver os mulighed for at tage jeres synspunkter om risikoen ved disse lægemidler i betragtning og overveje muligheder for regulerende indgreb i en bredere sundhedssammenhæng". 
Given the seriousness of the side effects, Melanie Carr, Head of EMA's Stakeholders and Communication Division remarked in her welcome address that this public hearing was “particularly important because it allows us to consider your views on the risk associated with these medicines and consider options for regulatory action in a wider public health context”.
69 deltagere var personligt til stede på EMA's kontorer i London (eller deltog via telefon), herunder 40 patienter og patientrepræsentanter, 14 sundhedspersoner og forskere, 13 repræsentanter fra medicinalindustrien samt medierepræsentanter. 
Sixty-nine participants attended in person at EMA offices in London (or called in by telephone), including 40 patients and patient representatives, 14 healthcare professionals and academics, 13 representatives from pharmaceutical industry as well as members of the media.
Der blev fremsat kommentarer af Stephanie Fowler, Elizabeth Pyne (som deltog på vegne af sin søn), Deborah Kinrade og David Morison. 
Comments were provided by Stephanie Fowler, Elizabeth Pyne (attending on behalf of her son), Deborah Kinrade and David Morison.
Medicinalvirksomheder 
Pharmaceutical companies
Patienterne gav udtryk for, at disse lægemidler kun burde anvendes i livstruende situationer, når intet andet virker, eller ved meget alvorlige infektioner, som er bekræftet ved laboratorieprøver. 
Patients said that these medicines should be used only in life-and-death situations, when nothing else works, or for very serious infections that have been confirmed by laboratory tests.
"Mere end noget har vi brug for at genoprette tillidskæden," bemærkede hun og tilføjede, at for patienter med sådanne invaliderende symptomer var noget af det sværeste den manglende anerkendelse af, hvad de kommer ud for. 
“More than anything we need to restore the chain of trust,” she noted, adding that one of the hardest things for patients with these debilitating symptoms was the lack of recognition of what they are experiencing.
Taler 13 (via telefon): 
Speaker 13 (joining via telephone):
Andre symptomer er humørsvingninger og andre virkninger på det psykiske helbred foruden virkninger på hjertet. 
Other symptoms include mood disturbances and other mental health effects as well as effects on the heart.
Julie Le Normand, Frankrig 
Julie Le Normand, France
Høringen blev ledet af June Raine, formand for PRAC, med en introduktion til emnet af Eva Jirsová, PRAC-rapportør (ledende bedømmer) og supplerende vejledning fra Juan Garcia-Burgos, EMA's chef for offentlig inddragelse. 
The hearing was chaired by June Raine, the Chair of the PRAC, with an introduction of the topic from by Eva Jirsová, the PRAC Rapporteur (lead assessor) and additional guidance from Juan Garcia-Burgos, EMA's Head of Public Engagement.
De hyppigst anvendte lægemidler i denne klasse er ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin og ofloxacin. 
The most commonly used medicines in this class are ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.
Miriam Knight, Quinolone Toxicity Support UK Raymond Miller, Quinolone Toxicity Support UK Geoffrey Robinson, Fluoroquinolone Toxicity Victims in Europe Taler 6: 
Miriam Knight, Quinolone Toxicity Support UK Raymond Miller, Quinolone Toxicity Support UK Geoffrey Robinson, Fluoroquinolone Toxicity Victims in Europe Speaker 6:
Sammenfatning af de rejste problemer 
Summary of issues raised
Offentlige høringer afholdes, når udvalget i hvert enkelt tilfælde finder, at indsamling af offentlighedens synspunkter vil tilføre ekstra nytteværdi til dens gennemgang ud over de andre kanaler, hvorigennem interessenter inddrages, såsom indlæg fra interessenter eller deltagelse af patienter og sundhedspersoner i ekspertmøder. 
Public hearings are held on a case-by-case basis, where the Committee determines that collecting the views of the public would bring added value to its review, in addition to the other channels of stakeholder engagement such as stakeholder submissions or through inclusion of patients and healthcare professionals in expert meetings.
Indberetningerne har omfattet livsforandrende handicap og langvarige smerter. 
The reports have included life-changing disabilities and long-term pain.
Fremsatte hovedpunkter 
Main points raised
• Sørg for bedre behandling af patienter med bivirkninger (under hensyntagen til en bred vifte af symptomer). 
• Improve management of patients with side effects (taking account of wide-ranging symptoms).
Paul Tulkens, Louvain Drug Research Institute, Belgien Taler 21: 
Paul Tulkens, Louvain Drug Research Institute, Belgium Speaker 21:
Nogle patienter kan desuden ikke længere arbejde eller deltage i motion og aktiviteter eller endog udføre almindelige hverdagshandlinger, såsom at snøre skoene eller knappe skjorten, nogle har konstante smerter, og symptomerne berører en bred vifte af muskler og sener. 
Furthermore, some patients can no longer work or engage in exercise and active pursuits or even carry out daily tasks such as tying a shoe lace or buttoning a shirt; some are in constant pain, with symptoms affecting a wide range of muscles and tendons.
• Symptomerne var livsforandrende og omfattende. 
• Symptoms were life-changing and wide ranging.
Florian Wagenlehner, European Association of Urology (EAU) Supplerende indlæg 
Florian Wagenlehner, European Association of Urology (EAU) Additional interventions
De har været tilgængelige i EU siden 1962 og har været anvendt til at behandle millioner af patienter med bakterielle infektioner, herunder alvorlige eller livstruende infektioner og infektioner med resistens over for andre behandlinger. 
Available in the EU since 1962, they have been used to treat millions of patients with bacterial infections, including serious or life-threatening infections and those resistant to other treatments.
Et tilbagevendende emne var lægernes manglende viden om de mulige bivirkninger. 
A recurring theme was the lack of knowledge of the possible side effects among doctors.
Ordineringen af disse lægemidler bør desuden overvåges bedre, og der bør advares, så patienter, der har haft sådanne bivirkninger, tilrådes at stoppe behandlingen straks og aldrig igen få ordineret disse lægemidler. 
Furthermore, the prescribing of these medicines should be better monitored and ‘red flags' should be raised so that patients who have had these side effects are advised to stop treatment immediately and are never prescribed these medicines again.
Andrea Noya, Italien 
Andrea Noya, Italy
Den 13. juni 2018 afholdt Det Europæiske Lægemiddelagentur (EMA) en offentlig høring om antibiotika af quinolon- og fluoroquinolontypen for at høre patienternes og offentlighedens synspunkter om vedvaren af bivirkninger, der er indberettet ved denne lægemiddelgruppe. 
On 13 June 2018, the European Medicines Agency (EMA) held a public hearing on quinolone and fluoroquinolone antibiotics to hear the views of patients and the general public on the persistence of side effects reported with this group of medicines.
En repræsentant for en medicinalvirksomhed, der markedsfører denne klasse af antibiotika, anerkendte til slut nødvendigheden af at oplyse bedre om risikoen ved disse lægemidler i produktinformationen, navnlig indlægssedlerne. 
Finally, a representative of a pharmaceutical company that markets this class of antibiotics, acknowledged the need to improve information on the risk of these medicines in their product information, particularly the package leaflets.
Bivirkningerne i sig selv har været kendt, men ved denne gennemgang ses der på deres vedholdende og langvarige karakter og indvirkningen heraf på patienternes liv. 
Although the side effects themselves have been known, this review is looking at the persistence and long-lasting nature of the side effects and their impact on patients' lives.
Elizabeth Carmouche, Belgien 
Elizabeth Carmouche, Belgium
Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, Det Forenede Kongerige 
Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, UK Speaker 19:
Sundhedspersoner og forskere 
Healthcare professionals and academia
Markus Hamedinger, Østrig 
Markus Hamedinger, Austria
Næsten alle patienter sagde, at de ikke ville have taget deres behandling, hvis de havde kendt til omfanget af de potentielle risici, eller sådanne risici havde været beskrevet tilstrækkeligt i indlægssedlerne. 
Almost all patients said they would not have taken their treatments if they had known of the extent of the potential risks and if such risks were described properly in the package leaflets.
Ber Oomen, European Specialist Nurses Organisations (ESNO) Taler 20: 
Ber Oomen, European Specialist Nurses Organisations (ESNO) Speaker 20:
Enikő Pongrácz, Ungarn 
Enikő Pongrácz, Hungary
EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) indledte en gennemgang af denne klasse af lægemidler efter indberetninger om alvorlige og langvarige bivirkninger, hovedsagelig fra muskler, sener, led og nervesystemet. 
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) started a review of this class of medicines following reports of serious, long-lasting side effects mainly affecting muscles, tendons, joints and the nervous system.
• Sørg for bedre uddannelse af sundhedspersoner (bl.a. under medicinstudiet). 
• Improve education for healthcare professionals (including during medical training).
Patienterne opfordrede også til bedre uddannelse af sundhedspersonale, bl.a. under medicinstudiet, ved den indledende undervisning i denne klasse af lægemidler. 
Patients also called for better education of healthcare professionals, including during medical training when they first learn about this class of medicines.
Patienter og sundhedspersoner bemærkede, at der var behov for at forbedre behandlingen af patienter med bivirkninger og sammenbringe ekspertise på forskellige områder til at behandle den brede række af symptomer. 
Patients and healthcare professionals noted the need to improve management of patients with side effects and bring together expertise from different fields to deal with the wide-ranging symptoms.
Andre deltagere, herunder sundhedspersoner og forskere, opfordrede til mere forskning, herunder genetisk forskning, til at fastlægge præcis, ved hvilke mekanismer lægemidlerne forårsager disse bivirkninger, hvordan bivirkningerne påvirker forskellige populationer, og det samlede omfang af risikoen. 
Other participants including healthcare professionals and academics called for more research, including genetic research, to establish the precise mechanisms through which the medicines cause these side effects, determine how they affect different populations and quantify the overall magnitude of the risk.
I dag anvendes quinoloner og fluoroquinoloner til over 120 indikationer i EU, herunder forskellige typer urinvejs- og respirationsinfektioner, genitale og gastrointestinale infektioner og hud-, knogle- og ledinfektioner. 
Today, quinolones and fluoroquinolones are used for over 120 indications in the EU, including different types of urinary tract, respiratory, genital, gastrointestinal tract, skin, bone, and joint infections.
Graham Bothamley, European Respiratory Society (ERS) Taler 17: 
Graham Bothamley, European Respiratory Society (ERS) Speaker 17:
I mange tilfælde var quinoloner og fluoroquinoloner blevet ordineret for mindre infektioner eller anvendt til at forebygge infektioner. 
In many cases, quinolones and fluoroquinolones had been prescribed for minor infections or were used to prevent infections.
Elsa Leitão, Tyskland 
Elsa Leitão, Germany
Mange patienter fortsatte med at tage disse lægemidler, mens de havde symptomer, uden at de var klar over en mulig sammenhæng med deres behandling. 
Many patients continued taking these medicines while they had symptoms, unaware of a possible link to their treatments.
Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Taler 16: 
Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Speaker 16:
• Begræns anvendelsen af quinoloner og fluoroquinoloner til situationer, hvor der ikke er andre alternativer. 
• Restrict quinolone and fluoroquinolone use to situations where there are no alternatives.
Mary McCarthy, European Union of General Practioners (UEMO) Taler 18: 
Mary McCarthy, European Union of General Practioners (UEMO) Speaker 18:
Quinoloner og fluoroquinoloner er syntetiske antibiotika, der anvendes mod en bred vifte af bakterielle infektioner. 
Quinolones and fluoroquinolones are synthetic antibiotics used for a wide range of bacterial infections.
Seneproblemerne gjaldt sædvanligvis flere sener, modsat mange andre senelidelser, der normalt kun omfatter en enkelt sene. 
The tendon problems generally affected multiple tendons, in contrast to many other tendon disorders which usually affect one.
• Tag højde for, hvordan visse fødevarer påvirker patienternes symptomer, især kød fra dyr behandlet med quinoloner og fluoroquinoloner. 
• Consider how certain foods affect patients' symptoms, particularly meat treated with quinolones and fluoroquinolones.
Nogle patienter beskrev også, at symptomerne forværredes, da de senere fik smertestillende NSAID'er eller steroider. 
Some patients also reported a worsening of symptoms when they were subsequently given NSAID painkillers or steroids.
Jaroslaw Linka, Polen 
Jaroslaw Linka, Poland
Mange patienter blev ikke orienteret om risiciene og sagde, at de ikke følte, at der blev lyttet til dem, da de beskrev en mulig sammenhæng med deres behandling. 
Many patients were not informed of the risks and said that they did not feel they were listened to when they reported a possible link to their treatments.
Sammendrag af EMA's offentlige høring om antibiotika af quinolon- og fluoroquinolontypen 
Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics
Patienterne opfordrede til bedre anerkendelse af toksicitetsmønsteret for quinoloner og fluoroquinoloner (undertiden betegnet "fluoroquinolon-associeret handicapsyndrom"). 
Patients called for better recognition of patterns of toxicity with quinolones and fluoroquinolones (sometimes referred to as ‘fluoroquinolone-associated disability syndrome').
Nogle læger var opmærksomme på symptomer fra akillessenen, men der var mange, som ikke havde kendskab til, anerkendte eller indberettede andre bivirkninger med mulig sammenhæng med quinoloner og fluoroquinoloner. 
While some doctors were aware of symptoms affecting the Achilles tendon, many did not know of, recognise or report other side effects that could possibly have been linked to quinolones and fluoroquinolones.
Patienter beskrev livsforandrende symptomer efter behandling med antibiotika af quinolon- og fluoroquinolontypen, herunder smerter og handicap af flere års varighed, og hvor nogle patienter kun oplevede begrænset bedring med tiden. 
Patients described life-changing symptoms following treatment with quinolone and fluoroquinolone antibiotics, including pain and disability lasting several years, with some patients only experiencing limited improvement over time.
Patienternes var enige om, at anvendelsen af antibiotika af quinolon- og fluoroquinolontypen burde begrænses stærkt. 
The consensus among patients was that the use of quinolone and fluoroquinolone antibiotics should be greatly restricted.
Nogle patienter beskrev forværring af symptomerne efter at have spist visse fødevarer, herunder kød og fisk, og patienterne var bekymrede for kunne have været blevet udsat for quinoloner og fluoroquinoloner, som var anvendt til at behandle husdyr. 
Some patients described worsening of symptoms after eating certain foods, including meat and fish, and patients were concerned that they could have been exposed to quinolones and fluoroquinolones used to treat farmed animals.
• Hvilke yderligere foranstaltninger kan der efter din mening træffes for at optimere sikkerheden ved anvendelse af quinoloner og fluoroquinoloner? 
• In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?
• Hvad er din opfattelse af quinoloners og fluoroquinoloners rolle i behandlingen af infektioner? 
• What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
EMA/413844/2018 
Telephone +44 (0)20 3660 6000
Manex Bettan Arguinzoniz, Spanien 
Manex Bettan Arguinzoniz, Spain Speaker 3:
• Sundhedspersonerne var sædvanligvis uvidende om omfanget og sværhedsgraden af de mulige symptomer bortset fra lidelser i akillessenen. 
• Healthcare professionals were generally unaware of the range and severity of possible symptoms,
• Hvad er din opfattelse af de risici, der forbindes med anvendelse af quinoloner og fluoroquinoloner? 
• What is your view of the risks associated with quinolone and fluoroquinolone use?
• Sørg for bedre kommunikation om toksiciteten af quinoloner og fluoroquinoloner, herunder mulige risikofaktorer, og tilføj flere oplysninger i produktinformationen, herunder indlægssedlen. 
• Improve communication on quinolone and fluoroquinolone toxicity, including possible risk factors,
Disse bivirkninger blev indberettet af patienter, der tog lægemidlerne gennem munden eller ved injektion. 
These side effects were reported by patients who took medicines by mouth or injection and medicines given as ear and eye drops were also considered to cause them.
Noter 
Notes
Richard Cooknell, Det Forenede Kongerige Taler 4: 
Richard Cooknell, UK
En dedikeret webside indeholder flere oplysninger om den igangværende gennemgang af antibiotika af quinolon- og fluoroquinolontypen. 
More information on the ongoing review of quinolone and fluoroquinolone antibiotics is available on a dedicated webpage.
Joshua Sutton, Det Forenede Kongerige Taler 11: 
Joshua Sutton, UK
Miriam van Staveren, Nederlandene 
Miriam van Staveren, The Netherlands Speaker 12 (joining via telephone):
Mere om proceduren 
More about the procedure
Kontakt vores pressesekretær Monika Benstetter 
Contact our press officer Monika Benstetter
Information til patienter 
Information to patients
Den 30. oktober 2014 EMA/698187/2014 
30 October 2014 EMA/698187/2014