FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Comments were provided by Stephanie Fowler, Elizabeth Pyne (attending on behalf of her son), Deborah Kinrade and David Morison.
Danish: Der blev fremsat kommentarer af Stephanie Fowler, Elizabeth Pyne (som deltog på vegne af sin søn), Deborah Kinrade og David Morison.
English: Pharmaceutical companies
Danish: Medicinalvirksomheder
English: 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.
Danish: 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.
English: “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.
Danish: "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.
English: Speaker 13 (joining via telephone):
Danish: Taler 13 (via telefon):
English: Other symptoms include mood disturbances and other mental health effects as well as effects on the heart.
Danish: Andre symptomer er humørsvingninger og andre virkninger på det psykiske helbred foruden virkninger på hjertet.
English: Julie Le Normand, France
Danish: Julie Le Normand, Frankrig
English: 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.
Danish: 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.
English: The most commonly used medicines in this class are ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.
Danish: De hyppigst anvendte lægemidler i denne klasse er ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin og ofloxacin.
English: Miriam Knight, Quinolone Toxicity Support UK Raymond Miller, Quinolone Toxicity Support UK Geoffrey Robinson, Fluoroquinolone Toxicity Victims in Europe Speaker 6:
Danish: Miriam Knight, Quinolone Toxicity Support UK Raymond Miller, Quinolone Toxicity Support UK Geoffrey Robinson, Fluoroquinolone Toxicity Victims in Europe Taler 6:
English: Summary of issues raised
Danish: Sammenfatning af de rejste problemer
English: 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.
Danish: 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.
English: The reports have included life-changing disabilities and long-term pain.
Danish: Indberetningerne har omfattet livsforandrende handicap og langvarige smerter.
English: Main points raised
Danish: Fremsatte hovedpunkter
English: • Improve management of patients with side effects (taking account of wide-ranging symptoms).
Danish: • Sørg for bedre behandling af patienter med bivirkninger (under hensyntagen til en bred vifte af symptomer).
English: Paul Tulkens, Louvain Drug Research Institute, Belgium Speaker 21:
Danish: Paul Tulkens, Louvain Drug Research Institute, Belgien Taler 21:
English: 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.
Danish: 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.
English: • Symptoms were life-changing and wide ranging.
Danish: • Symptomerne var livsforandrende og omfattende.
English: Florian Wagenlehner, European Association of Urology (EAU) Additional interventions
Danish: Florian Wagenlehner, European Association of Urology (EAU) Supplerende indlæg
English: 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.
Danish: 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.
English: A recurring theme was the lack of knowledge of the possible side effects among doctors.
Danish: Et tilbagevendende emne var lægernes manglende viden om de mulige bivirkninger.
English: 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.
Danish: 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.
English: Andrea Noya, Italy
Danish: Andrea Noya, Italien
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Elizabeth Carmouche, Belgium
Danish: Elizabeth Carmouche, Belgien
English: Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, UK Speaker 19:
Danish: Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, Det Forenede Kongerige
English: Healthcare professionals and academia
Danish: Sundhedspersoner og forskere
English: Markus Hamedinger, Austria
Danish: Markus Hamedinger, Østrig
English: 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.
Danish: 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.
English: Ber Oomen, European Specialist Nurses Organisations (ESNO) Speaker 20:
Danish: Ber Oomen, European Specialist Nurses Organisations (ESNO) Taler 20:
English: Enikő Pongrácz, Hungary
Danish: Enikő Pongrácz, Ungarn
English: 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.
Danish: 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.
English: • Improve education for healthcare professionals (including during medical training).
Danish: • Sørg for bedre uddannelse af sundhedspersoner (bl.a. under medicinstudiet).
English: Patients also called for better education of healthcare professionals, including during medical training when they first learn about this class of medicines.
Danish: Patienterne opfordrede også til bedre uddannelse af sundhedspersonale, bl.a. under medicinstudiet, ved den indledende undervisning i denne klasse af lægemidler.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Graham Bothamley, European Respiratory Society (ERS) Speaker 17:
Danish: Graham Bothamley, European Respiratory Society (ERS) Taler 17:
English: In many cases, quinolones and fluoroquinolones had been prescribed for minor infections or were used to prevent infections.
Danish: I mange tilfælde var quinoloner og fluoroquinoloner blevet ordineret for mindre infektioner eller anvendt til at forebygge infektioner.
English: Elsa Leitão, Germany
Danish: Elsa Leitão, Tyskland
English: Many patients continued taking these medicines while they had symptoms, unaware of a possible link to their treatments.
Danish: Mange patienter fortsatte med at tage disse lægemidler, mens de havde symptomer, uden at de var klar over en mulig sammenhæng med deres behandling.
English: Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Speaker 16:
Danish: Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Taler 16:
English: • Restrict quinolone and fluoroquinolone use to situations where there are no alternatives.
Danish: • Begræns anvendelsen af quinoloner og fluoroquinoloner til situationer, hvor der ikke er andre alternativer.
English: Mary McCarthy, European Union of General Practioners (UEMO) Speaker 18:
Danish: Mary McCarthy, European Union of General Practioners (UEMO) Taler 18:
English: Background
Danish: Baggrund
English: Quinolones and fluoroquinolones are synthetic antibiotics used for a wide range of bacterial infections.
Danish: Quinoloner og fluoroquinoloner er syntetiske antibiotika, der anvendes mod en bred vifte af bakterielle infektioner.
English: The tendon problems generally affected multiple tendons, in contrast to many other tendon disorders which usually affect one.
Danish: Seneproblemerne gjaldt sædvanligvis flere sener, modsat mange andre senelidelser, der normalt kun omfatter en enkelt sene.
English: • Consider how certain foods affect patients' symptoms, particularly meat treated with quinolones and fluoroquinolones.
Danish: • Tag højde for, hvordan visse fødevarer påvirker patienternes symptomer, især kød fra dyr behandlet med quinoloner og fluoroquinoloner.
English: Some patients also reported a worsening of symptoms when they were subsequently given NSAID painkillers or steroids.
Danish: Nogle patienter beskrev også, at symptomerne forværredes, da de senere fik smertestillende NSAID'er eller steroider.
English: Jaroslaw Linka, Poland
Danish: Jaroslaw Linka, Polen
English: 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.
Danish: 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.
English: Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics
Danish: Sammendrag af EMA's offentlige høring om antibiotika af quinolon- og fluoroquinolontypen
English: Patients called for better recognition of patterns of toxicity with quinolones and fluoroquinolones (sometimes referred to as ‘fluoroquinolone-associated disability syndrome').
Danish: Patienterne opfordrede til bedre anerkendelse af toksicitetsmønsteret for quinoloner og fluoroquinoloner (undertiden betegnet "fluoroquinolon-associeret handicapsyndrom").
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The consensus among patients was that the use of quinolone and fluoroquinolone antibiotics should be greatly restricted.
Danish: Patienternes var enige om, at anvendelsen af antibiotika af quinolon- og fluoroquinolontypen burde begrænses stærkt.
English: 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.
Danish: 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.
English: • In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?
Danish: • Hvilke yderligere foranstaltninger kan der efter din mening træffes for at optimere sikkerheden ved anvendelse af quinoloner og fluoroquinoloner?
English: • What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
Danish: • Hvad er din opfattelse af quinoloners og fluoroquinoloners rolle i behandlingen af infektioner?
English: Telephone +44 (0)20 3660 6000
Danish: EMA/413844/2018
English: Manex Bettan Arguinzoniz, Spain Speaker 3:
Danish: Manex Bettan Arguinzoniz, Spanien
English: • Healthcare professionals were generally unaware of the range and severity of possible symptoms,
Danish: • Sundhedspersonerne var sædvanligvis uvidende om omfanget og sværhedsgraden af de mulige symptomer bortset fra lidelser i akillessenen.
English: • What is your view of the risks associated with quinolone and fluoroquinolone use?
Danish: • Hvad er din opfattelse af de risici, der forbindes med anvendelse af quinoloner og fluoroquinoloner?
English: • Improve communication on quinolone and fluoroquinolone toxicity, including possible risk factors,
Danish: • Sørg for bedre kommunikation om toksiciteten af quinoloner og fluoroquinoloner, herunder mulige risikofaktorer, og tilføj flere oplysninger i produktinformationen, herunder indlægssedlen.
English: 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.
Danish: Disse bivirkninger blev indberettet af patienter, der tog lægemidlerne gennem munden eller ved injektion.
English: Notes
Danish: Noter
English: Richard Cooknell, UK
Danish: Richard Cooknell, Det Forenede Kongerige Taler 4:
English: More information on the ongoing review of quinolone and fluoroquinolone antibiotics is available on a dedicated webpage.
Danish: En dedikeret webside indeholder flere oplysninger om den igangværende gennemgang af antibiotika af quinolon- og fluoroquinolontypen.
English: Joshua Sutton, UK
Danish: Joshua Sutton, Det Forenede Kongerige Taler 11:
English: Miriam van Staveren, The Netherlands Speaker 12 (joining via telephone):
Danish: Miriam van Staveren, Nederlandene
English: More about the procedure
Danish: Mere om proceduren
English: Contact our press officer Monika Benstetter
Danish: Kontakt vores pressesekretær Monika Benstetter
English: Information to patients
Danish: Information til patienter
English: 30 October 2014 EMA/698187/2014
Danish: Den 30. oktober 2014 EMA/698187/2014
English: Bromocriptine medicines have been authorised via national procedures for various indications in the following EU Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxemburg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom, as well as Norway.
Danish: Lægemidler med bromocriptin er godkendt via nationale procedurer til forskellige anvendelser i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Kroatien, Cypern, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Litauen, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige, samt i Norge.
English: Products with strengths of 5 or 10 mg are not indicated for such use.
Danish: Lægemidler med styrkerne 5 og 10 mg er ikke indiceret til sådan anvendelse.
English: The review of oral bromocriptine was initiated at the request of France on 17 July 2013, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af oralt bromocriptin blev indledt i den 17. juli 2013 på anmodning af Frankrig i medfør af artikel 31 i direktiv 2001/83/EF.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Danish: Tlf. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
English: • Women who have any questions or concerns should consult their doctor or pharmacist.
Danish: • Kvinder, der har spørgsmål eller bekymringer, bør kontakte lægen eller apoteket.
English: More about the medicine
Danish: Mere om lægemidlet
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Disse data blev først gennemgået af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: • Blood pressure should be carefully monitored especially during the first day of therapy.
Danish: • Blodtrykket bør overvåges nøje, navnlig på den første behandlingsdag.
English: However, the absolute number of cases reported post-marketing is low especially given the fact that bromocriptine has been available in the EU since 1973, with a substantial patient exposure; overall incidence rates are estimated to be between 0.005% and 0.04%.
Danish: Det absolutte antal indberettede tilfælde efter markedsføring er dog lavt, navnlig i betragtning af, at bromocriptin har været på markedet i EU siden 1973, og at patienteksponeringen har været betydelig; den totale incidensrate skønnes at være 0,005 % til
English: The product information for bromocriptine-containing medicines has been updated accordingly.
Danish: Produktinformationen for lægemidler indeholdende bromocriptin er ajourført i henhold hertil.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Danish: 1 CMD(h) er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater.
English: Bromocriptine is a dopamine receptor agonist.
Danish: Bromocriptin er et dopaminreceptorstimulerende middel.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Danish: Anbefalingerne fra PRAC blev fremsendt til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)), som vedtog et endeligt standpunkt.
English: Because of a possible risk of serious side effects, recommendations have been issued to clarify that these medicines should not be used routinely for preventing or stopping milk production.
Danish: På grund af den mulige risiko for alvorlige bivirkninger er der udsendt anbefalinger, der skal gøre det klart, at disse lægemidler ikke rutinemæssigt må bruges til at forhindre eller standse mælkeproduktionen.
English: Although milk production eventually stops, women in the meantime can experience breast engorgement, leakage of milk, discomfort and pain.
Danish: Skønt mælkeproduktionen til sidst standser af sig selv, kan kvinden i mellemtiden få brystforstørrelse, udsivning af mælk, ubehag og smerter.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMD(h) repræsenterer EU's medlemsstater og har ansvaret for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
English: They are available on prescription for use by mouth in forms such as tablets and capsules, and have been marketed under various trade names (such as Parlodel) and as generics.
Danish: De fås på recept til indtagelse gennem munden som tabletter og kapsler og har været markedsført under forskellige handelsnavne (bl.a. Parlodel) og som kopipræparater.