natgillin/translations-raw huggingface dataset:
EMA would like to express its warmest gratitude to all those who have contributed to this public hearing.
Evropska agencija za zdravila se prisrčno zahvaljuje vsem, ki so prispevali k tej javni obravnavi.
Questions addressed to participants
Vprašanja, ki so bila zastavljena udeležencem
Another issue raised was the reaction to foods, which patients said should be further investigated.
Še ena obravnavana težava so bile reakcije na živila, ki bi jih bilo treba po mnenju bolnikov nadalje raziskati.
Comments were provided by Stephanie Fowler, Elizabeth Pyne (attending on behalf of her son), Deborah Kinrade and David Morison.
Pripombe so prispevali Stephanie Fowler, Elizabeth Pyne (ki je sodelovala v imenu svojega sina), Deborah Kinrade in David Morison.
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”.
Glede na resnost neželenih učinkov je Melanie Carr, vodja oddelka agencije EMA za zainteresirane strani in komunikacije, v svojem uvodnem govoru opozorila na to, da je ta javna obravnava „še posebej pomembna, ker nam omogoča, da razmislimo o vaših pogledih na tveganje, povezano s temi zdravili, in o možnostih za regulativne ukrepe v kontekstu širšega javnega zdravja“.
Patients should also have to give informed consent before treatment.
Bolniki naj bi pred zdravljenjem tudi podpisali informirano privolitev.
• Symptoms were life-changing and wide ranging.
• Simptomi so bili življenje spreminjajoči in raznovrstni.
Other symptoms include mood disturbances and other mental health effects as well as effects on the heart.
Med drugimi simptomi so motnje razpoloženja in drugi učinki na duševno zdravje ter učinki na srce.
• Improve education for healthcare professionals (including during medical training).
• Izboljšanje izobraževanja zdravstvenih delavcev (vključno z medicinskim usposabljanjem).
• Encourage research on how the medicines cause side effects, including genetic research.
• Spodbujanje raziskav o tem, kako zdravila povzročajo neželene učinke, vključno z genskimi raziskavami.
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.
Nazadnje je predstavnik ene od farmacevtskih družb, ki tržijo to skupino antibiotikov, poudaril potrebo po izboljšanju informacij o tveganju teh zdravil v njihovi dokumentaciji, zlasti navodilu za uporabo.
Julie Le Normand, France
Julie Le Normand, Francija
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.
Poleg tega nekateri bolniki niso več zmožni delati, se ukvarjati s telesno vadbo ali aktivnimi dejavnostmi ali celo opravljati vsakodnevnih nalog, kot sta zavezovanje čevljev ali zapenjanje srajce; nekateri so ves čas v bolečinah in imajo simptome, ki prizadenejo številne mišice in kite.
The reports have included life-changing disabilities and long-term pain.
Poročila vključujejo življenje spreminjajoče vrste invalidnosti in dolgotrajne bolečine.
Pharmaceutical companies
Farmacevtske družbe
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.
Odbor PRAC bo zdaj obravnaval vsa stališča, izražena med obravnavo in v pisnih prispevkih, ter jih upošteval pri oblikovanju priporočil za uporabo teh antibiotikov.
He spoke of the need for improvements in package leaflets to take account of those who may not be able to understand the text.
Predlagal je izboljšavo navodila za uporabo, namenjeno tistim, ki morda ne zmorejo razumeti besedila.
There was minority support for an outright ban of these medicines, and some patients supported restricting use to hospitals.
Manjšina bolnikov se zavzema za popolno prepoved teh zdravil, medtem ko nekateri podpirajo omejitev uporabe na bolnišnice.
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.
V obravnavi, ki je potekala v prostorih Evropske agencije za zdravila v Londonu, je osebno (ali po telefonu) sodelovalo 69 udeležencev, od tega 40 bolnikov in predstavnikov bolnikov, 14 zdravstvenih delavcev in akademikov ter 13 predstavnikov farmacevtske industrije in medijev.
The hearing was broadcast live and a recording is available on EMA's website.
Obravnava je bila predvajana v živo in posnetek je na voljo na spletnem mestu Evropske agencije za zdravila.
“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.
»Potrebujemo predvsem povrnitev zaupanja,« je dejala in dodala, da je za bolnike s temi izčrpavajočimi simptomi ena od najtežjih stvari, da niso deležni razumevanja za to, kar doživljajo.
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.
Čeprav so bili sami neželeni učinki znani že prej, ta pregled obravnava vztrajnost in dolgotrajnost neželenih učinkov ter njihov vpliv na življenje bolnikov.
Andrea Noya, Italy
Andrea Noya, Italija
Elizabeth Carmouche, Belgium
Elizabeth Carmouche, Belgija
Paul Tulkens, Louvain Drug Research Institute, Belgium Speaker 21:
Paul Tulkens, Louvain Drug Research Institute, Belgija 21. govornik:
Richard Cooknell, UK
Richard Cooknell, Združeno kraljestvo
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.
Javna obravnava se organizira za vsak primer posebej, kadar odbor PRAC ugotovi, da bi preverjanje stališč javnosti prineslo dodano vrednost njegovemu pregledu poleg uporabe drugih poti vključevanja zainteresiranih strani, kot so prispevki zainteresiranih strani, ali sodelovanja bolnikov in zdravstvenih delavcev na strokovnih srečanjih.
Speaker 13 (joining via telephone):
13. govornik (sodelovanje po telefonu):
• Improve management of patients with side effects (taking account of wide-ranging symptoms).
• Izboljšanje obravnave bolnikov, ki imajo neželene učinke (ob upoštevanju raznovrstnosti simptomov).
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.
Skoraj vsi bolniki pravijo, da se ne bi odločili za zdravljenje, če bi vedeli za obseg možnih tveganj in če bi bila ta tveganja ustrezno opisana v navodilu za uporabo.
Nigel Stacey provided comments after the video recording had been stopped.
Po ustavitvi video posnetka je posredoval pripombe še Nigel Stacey.
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.
Evropska agencija za zdravila (EMA) je 13. junija 2018 organizirala javno obravnavo kinolonskih in fluorokinolonskih antibiotikov, da bi se seznanila s stališči bolnikov in širše javnosti v zvezi z vztrajnostjo neželenih učinkov, o katerih poročajo pri tej skupini zdravil.
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.
Ta zdravila, ki so v EU na voljo od leta 1962, so že bila uporabljena za zdravljenje milijonov bolnikov z bakterijskimi okužbami, vključno z resnimi ali smrtno nevarnimi okužbami in takimi, ki so odporne proti drugim zdravilom.
Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, UK Speaker 19:
Neal L. Millar, Inštitut za okužbe, imunost in vnetja, Univerza v Glasgowu, Združeno kraljestvo 19. govornik:
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.
Danes se kinoloni in fluorokinoloni uporabljajo v EU za več kot 120 indikacij, vključno z različnimi vrstami okužb sečil, dihal, genitalij, prebavil, kože, kosti in sklepov.
Markus Hamedinger, Austria
Markus Hamedinger, Avstrija
Summary of issues raised
Povzetek opisanih težav
Joshua Sutton, UK
Joshua Sutton, Združeno kraljestvo
Enikő Pongrácz, Hungary
Enikő Pongrácz, Madžarska
Patients also called for better education of healthcare professionals, including during medical training when they first learn about this class of medicines.
Bolniki pozivajo tudi k boljšemu izobraževanju zdravstvenih delavcev, vključno z medicinskim usposabljanjem, med katerim se delavci prvič srečajo s to skupino zdravil.
Florian Wagenlehner, European Association of Urology (EAU) Additional interventions
Florian Wagenlehner, Evropsko združenje za urologijo (EAU) Dodatni ukrepi
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.
Pravijo, da bi se ta zdravila smela uporabljati samo v primerih, ko je ogroženo življenje bolnika, ko ne deluje nobeno drugo zdravilo ali pri zelo resnih okužbah, potrjenih z laboratorijskimi testi.
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.
Odbor EMA za ocenjevanje tveganja na področju farmakovigilance (PRAC) je začel pregled te skupine zdravil, potem ko so se pojavila poročila o resnih in dolgotrajnih neželenih učinkih, ki prizadenejo predvsem mišice, kite, sklepe in živčevje.
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.
Drugi udeleženci, vključno z zdravstvenimi strokovnjaki in akademiki, pozivajo k več raziskavam, vključno z genskimi raziskavami, za ugotavljanje natančnih mehanizmov, s katerimi zdravila povzročajo te neželene učinke, vpliva neželenih učinkov na različne skupine bolnikov in količinsko ovrednotenje splošnega obsega tveganja.
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.
Poleg tega je treba bolje nadzorovati predpisovanje teh zdravil in poskrbeti za ustrezna opozorila; bolnikom, pri katerih se ti neželeni učinki pojavijo, je treba svetovati, naj nemudoma prenehajo uporabljati zdravilo, zadevno zdravilo pa se jim ne sme nikoli več predpisati.
More information on the ongoing review of quinolone and fluoroquinolone antibiotics is available on a dedicated webpage.
Več informacij o tekočem pregledu kinolonskih in fluorokinolonskih antibiotikov je na voljo na ustrezni spletni strani.
Elsa Leitão, Germany
Elsa Leitão, Nemčija
Quinolones and fluoroquinolones are synthetic antibiotics used for a wide range of bacterial infections.
Kinoloni in fluorokinoloni so sintetični antibiotiki, ki se uporabljajo za zdravljenje širokega spektra bakterijskih okužb.
Many patients continued taking these medicines while they had symptoms, unaware of a possible link to their treatments.
Številni bolniki so ta zdravila jemali še naprej kljub pojavu simptomov, ne vedoč za možno povezavo z zdravili.
The most commonly used medicines in this class are ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.
Zdravila iz te skupine, ki se uporabljajo najpogosteje, so ciprofloksacin, levofloksacin, moksifloksacin, norfloksacin in ofloksacin.
• Restrict quinolone and fluoroquinolone use to situations where there are no alternatives.
• Omejitev uporabe kinolonov in fluorokinolonov na okoliščine, kjer ni drugih možnosti.
Main points raised
Glavne obravnavane težave
Jaroslaw Linka, Poland
Jaroslaw Linka, Poljska
Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Speaker 16:
Jamie Wilkinson, Farmacevtska skupina Evropske unije (PGEU) 16. govornik:
Patients called for better recognition of patterns of toxicity with quinolones and fluoroquinolones (sometimes referred to as ‘fluoroquinolone-associated disability syndrome').
Bolniki pozivajo k izboljšanju prepoznavanja vzorcev toksičnosti kinolonov in fluorokinolonov (ki jih včasih imenujejo »sindrom invalidnosti, povezan s fluorokinoloni«).
The consensus among patients was that the use of quinolone and fluoroquinolone antibiotics should be greatly restricted.
Bolniki soglašajo, da bi bilo treba uporabo kinolonskih in fluorokinolonskih antibiotikov močno omejiti.
In many cases, quinolones and fluoroquinolones had been prescribed for minor infections or were used to prevent infections.
V številnih primerih so bili kinoloni in fluorokinoloni predpisani za zdravljenje blagih okužb ali so se uporabljali samo za preprečevanje okužb.
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.
Številni bolniki niso bili obveščeni o tveganjih in pravijo, da jim ni nihče prisluhnil, ko so poskusili opozoriti na možno povezavo s predpisanimi zdravili.
• What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
• Kakšno je vaše mnenje o vlogi kinolonov in fluorokinolonov pri zdravljenju okužb?
The tendon problems generally affected multiple tendons, in contrast to many other tendon disorders which usually affect one.
Težave s kitami na splošno zadevajo več kit, kar je v nasprotju s številnimi drugimi boleznimi, ki običajno prizadenejo posamezno kito.
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.
Bolniki in zdravstveni delavci opozarjajo na potrebo po učinkovitejši obravnavi bolnikov, ki imajo neželene učinke, in po združitvi strokovnega znanja z različnih področij, ki bi pomagala pri spoprijemu z raznolikimi simptomi.
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.
Čeprav so bili nekateri zdravniki seznanjeni s simptomi, ki prizadenejo Ahilovo kito, pa mnogi niso vedeli za druge neželene učinke, ki bi lahko bili povezani s kinoloni in fluorokinoloni, ali jih prepoznali ali poročali o njih.
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.
Nekateri bolniki so opisali poslabšanje simptomov po uživanju nekaterih živil, vključno z mesom in ribami, in so zaskrbljeni zaradi možne izpostavljenosti kinolonom in fluorokinolonom, ki se uporabljajo za zdravljenje rejnih živali.
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.
Bolniki, ki od zdravstvenih delavcev niso dobili odgovorov, so se za pojasnitev svojih simptomov morali zateči k informacijam na internetu.
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.
O teh neželenih učinkih so poročali bolniki, ki so zadevna zdravila jemali peroralno ali z injiciranjem, za povzročitelje naštetih učinkov pa veljajo tudi zdravila, ki se dajejo v obliki kapljic v ušesa in oči.
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.
Bolniki so po zdravljenju s kinolonskimi in fluorokinolonskimi antibiotiki opisali življenje spreminjajoče simptome, vključno z bolečinami in invalidnostjo, ki so trajali več let, pri čemer so samo nekateri bolniki sčasoma dosegli delno izboljšanje.
Ber Oomen, European Specialist Nurses Organisations (ESNO) Speaker 20:
Ber Oomen, Evropsko združenje specialistov zdravstvene nege (ESNO) 20. govornik:
• Healthcare professionals were generally unaware of the range and severity of possible symptoms,
• Zdravstveni delavci na splošno niso bili seznanjeni z obsegom in resnostjo možnih simptomov, z izjemo bolezni Ahilove kite.
Graham Bothamley, European Respiratory Society (ERS) Speaker 17:
Graham Bothamley, Evropsko združenje pulmologov (ERS) 17. govornik:
Some patients also reported a worsening of symptoms when they were subsequently given NSAID painkillers or steroids.
Nekateri bolniki so poročali tudi o poslabšanju simptomov, ko so se pozneje zdravili z nesteroidnimi antirevmatiki (NSAID) za lajšanje bolečin ali s steroidi.
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.
Uvod v temo je pripravila poročevalka in glavna ocenjevalka odbora PRAC Eva Jirsová, medtem ko je vodja javnega udejstvovanja Evropske agencije za zdravila Juan Garcia-Burgos poskrbel za dodatna navodila.
• What is your view of the risks associated with quinolone and fluoroquinolone use?
• Kakšen je vaš pogled na tveganja, povezana z uporabo kinolonov in fluorokinolonov?
Mary McCarthy, European Union of General Practioners (UEMO) Speaker 18:
Mary McCarthy, Evropska zveza splošnih zdravnikov (UEMO) 18. govornik:
• In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?
• Kakšne dodatne ukrepe predlagate za izboljšanje varnosti uporabe kinolonov in fluorokinolonov?
• Improve communication on quinolone and fluoroquinolone toxicity, including possible risk factors,
• Izboljšanje obveščanja o toksičnosti kinolonov in fluorokinolonov, vključno z možnimi dejavniki tveganja, in dopolnitev informacij o zdravilih, vključno z navodilom za uporabo.
• Consider how certain foods affect patients' symptoms, particularly meat treated with quinolones and fluoroquinolones.
• Obravnava vpliva določenih živil, zlasti mesa živali, zdravljenih s kinoloni in fluorokinoloni, na simptome pri bolnikih.
Manex Bettan Arguinzoniz, Spain Speaker 3:
Manex Bettan Arguinzoniz, Španija
A recurring theme was the lack of knowledge of the possible side effects among doctors.
Rdeča nit pri teh primerih je bila nevednost zdravnikov glede možnih neželenih učinkov.
Miriam Knight, Quinolone Toxicity Support UK Raymond Miller, Quinolone Toxicity Support UK Geoffrey Robinson, Fluoroquinolone Toxicity Victims in Europe Speaker 6:
Miriam Knight, Quinolone Toxicity Support UK (spletno mesto za podporo v zvezi s toksičnostjo kinolonov)
Miriam van Staveren, The Netherlands Speaker 12 (joining via telephone):
Miriam van Staveren, Nizozemska
MA (EU) number (Invented) name
(Izmišljeno) ime
Pharmaceutical Form Route of Administration
Farmacevtska oblika
Immediate Packaging Pack size
Velikost pakiranja
More about the procedure
Več o postopku
30 October 2014 EMA/698187/2014
30. oktober 2014 EMA/698187/2014
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.
Zdravila, ki vsebujejo bromokriptin, so bila po nacionalnih postopkih za različne indikacije odobrena v naslednjih državah članicah EU: v Avstriji, Belgiji, Bolgariji, na Hrvaškem, Cipru, v Češki republiki, na Danskem, v Estoniji, na Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Litvi, Luksemburgu, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem in v Združenem kraljestvu ter na Norveškem.
The review of oral bromocriptine was initiated at the request of France on 17 July 2013, under Article 31 of Directive 2001/83/EC.
Pregled peroralnega bromokriptina se je začel na zahtevo Francije 17. julija 2013 v skladu s členom 31 Direktive 2001/83/ES.
Products with strengths of 5 or 10 mg are not indicated for such use.
Zdravila z jakostjo 5 ali 10 mg niso indicirana za tovrstno uporabo.
A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Pregled teh podatkov je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC).
Information to healthcare professionals
Informacije za zdravstvene delavce
• Women who have any questions or concerns should consult their doctor or pharmacist.
• Ženske, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z zdravnikom ali farmacevtom.
Bromocriptine is a dopamine receptor agonist.
Bromokriptin je agonist dopaminskih receptorjev.
1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
1 CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
More about the medicine
Več o zdravilu
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%.
Vendar je absolutno število primerov, o katerih so poročali v obdobju trženja, majhno, zlasti glede na dejstvo, da je bromokriptin v EU na voljo od leta 1973 in da mu je bilo izpostavljeno precejšnje število bolnic - ocenjuje se, da je skupna incidenca med 0,005 % in 0,04 %.
Blood pressure should be monitored so that early signs of an increase can be detected and treatment stopped immediately.
Krvni tlak je treba spremljati, da se lahko ugotovijo zgodnji znaki povišanja in takoj prekine zdravljenje.
Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Stopite v stik z našo tiskovno predstavnico Monika Benstetter tel. +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
The product information for bromocriptine-containing medicines has been updated accordingly.
Informacije o zdravilu za zdravila, ki vsebujejo bromokriptin, so bile ustrezno posodobljene.
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.
Na voljo so na recept za peroralno uporabo v oblikah, kot so tablete in kapsule, ter se tržijo pod različnimi trgovskimi imeni (na primer Parlodel) in kot generična zdravila.
• Blood pressure should be carefully monitored especially during the first day of therapy.
• Skrbno je treba spremljati krvni tlak, zlasti prvi dan zdravljenja.