FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bonviva, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
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 Bonviva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Bonviva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The patient should not lie down for one hour after taking the tablet.
Slovenian: Bolnica vsaj eno uro po zaužitju tablete ne sme leči.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Slovenian: Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko raven ženskega hormona estrogena, ki prispeva k ohranjanju zdravih kosti, pade.
English: What is the risk associated with Bonviva?
Slovenian: Kakšna tveganja so povezana z zdravilom Bonviva?
English: In addition, the company that markets Bonviva will provide a card to inform patients receiving Bonviva infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Slovenian: Poleg tega bo družba, ki trži zdravilo Bonviva, pripravila kartico, s katero bo bolnike seznanila s tveganjem pojava osteonekroze čeljusti in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
English: The most common side effects with Bonviva (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms.
Slovenian: Najpogostejši neželeni učinki zdravila Bonviva (opaženi pri 1 do 10 bolnic od 100) so artralgija (bolečine v sklepih) in gripi podobni simptomi.
English: Bonviva must not be used in patients who have hypocalcaemia (low blood calcium levels).
Slovenian: Zdravilo se ne sme uporabljati pri bolnicah, ki imajo hipokalciemijo (nizke ravni kalcija).
English: Bonviva is a medicine that contains the active substance ibandronic acid.
Slovenian: Bonviva je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
English: Bonviva can be given either as a tablet or as an injection into a vein.
Slovenian: Zdravilo Bonviva se daje bodisi s tabletami ali injiciranjem v veno.
English: Why has Bonviva been approved?
Slovenian: Zakaj je bilo zdravilo Bonviva odobreno?
English: In the first study, daily treatment with Bonviva 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
Slovenian: V prvi študiji je dnevno zdravljenje z 2,5-miligramskimi tabletami Bonviva v primerjavi s placebom za 62 % zmanjšalo tveganje za nove zlome hrbtenice.
English: Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets.
Slovenian: V dveh letih se je gostota kosti v hrbtenici povečala za 7 % pri uporabi mesečnih tablet in za 6 % pri uporabi injekcij, pri uporabi dnevnih tablet pa za 5 %.
English: The active substance in Bonviva, ibandronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina v zdravilu Bonviva, ibandronska kislina, je difosfonat.
English: Bonviva is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Slovenian: Zdravilo Bonviva se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pojav zlomov.
English: In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.
Slovenian: V kolkih se je gostota kosti povečala za 4 % pri uporabi mesečnih tablet in za 3 % pri uporabi injekcij, pri uporabi dnevnih tablet pa za 2 %.
English: The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5-mg once-daily tablets.
Slovenian: V drugih dveh študijah so mesečne odmerke 150-miligramskih tablet (pri 1 609 bolnicah) in injekcije (pri 1 395 bolnicah) primerjali z 2,5-miligramskimi tabletami, ki so jih bolnice jemale enkrat na dan.
English: For the full list of all side effects reported with Bonviva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bonviva, glejte navodilo za uporabo.
English: The other two studies showed that the 150-mg monthly tablets and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in the spine and the hip.
Slovenian: Drugi dve študiji sta pokazali, da so 150-miligramske mesečne tablete in injekcije pri povečevanju kostne gostote v hrbtenici in kolkih učinkovitejše od 2,5-miligramskih tablet, ki se jemljejo enkrat na dan.
English: The first study compared Bonviva 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
Slovenian: V prvi študiji so zdravilo Bonviva v obliki 2,5-miligramskih tablet, ki so jih bolnice jemale enkrat dnevno, primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skoraj 3 000 bolnicah in ugotavljali število novih zlomov hrbtenice pri bolnicah v triletnem obdobju študije.
English: For the full list of restrictions with Bonviva, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Bonviva glejte navodilo za uporabo.
English: What is Bonviva used for?
Slovenian: Za kaj se zdravilo Bonviva uporablja?
English: How has Bonviva been studied?
Slovenian: Kako je bilo zdravilo Bonviva raziskano?
English: What is Bonviva?
Slovenian: Kaj je zdravilo Bonviva?
English: How is Bonviva used?
Slovenian: Kako se zdravilo Bonviva uporablja?
English: How does Bonviva work?
Slovenian: Kako zdravilo Bonviva deluje?
English: Next steps
Slovenian: Naslednji koraki
English: 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.
Slovenian: V zaključni fazi postopka pregleda bo Evropska komisija sprejela pravno zavezujoč sklep, ki bo veljal v vseh državah članicah EU.
English: • Patients were not given information about risks.
Slovenian: • Bolniki niso dobili informacij o tveganjih.
English: Public hearings are conducted according to the rules of procedure for public hearings.
Slovenian: Javne obravnave potekajo po postopkovnih pravilih za javne obravnave.
English: Healthcare professionals and academia
Slovenian: Zdravstveni delavci in akademiki
English: Public hearing held on 13 June 2018
Slovenian: Datum obravnave: 13. junij 2018
English: Proposals
Slovenian: Predlogi
English: They also stressed the importance of microbial testing to make sure the medicines are only used when necessary.
Slovenian: Poudarjajo tudi pomembnost mikrobnega testiranja za zagotavljanje, da se zdravila uporabljajo samo po potrebi.
English: In closing the discussions, Dr Raine praised the courageous testimonies from patients and other participants.
Slovenian: V zaključku razprave je dr. Raine pohvalila pogumna pričevanja bolnikov in drugih udeležencev.
English: European Medicines Agency
Slovenian: Evropska agencija za zdravila
English: General public (patient representatives, carers, families) Speaker 1:
Slovenian: Splošna javnost (predstavniki bolnikov, negovalci, družinski člani) 1. govornik:
English: More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu
Slovenian: Več informacij o delu Evropske agencije za zdravila je na voljo na njenem spletnem mestu: www.ema.europa.eu
English: As time permitted, the Chair invited additional comments from the floor.
Slovenian: Ker je čas to dopuščal, je predsednica zaprosila udeležence obravnave za dodatne pripombe.
English: 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.
Slovenian: Pravna podlaga za javne obravnave je člen 107j Direktive 2001/83/ES o farmakovigilančni zakonodaji, ki odboru PRAC daje možnost, da organizira javne obravnave za namen pregledov varnosti, ki jih Odbor izvaja skladno s členom 20 Uredbe (ES) št. 726/2004 ter člena 31 ali člena 107i Direktive 2001/83/ES.
English: List of Speakers
Slovenian: Seznam govornikov
English: Many other members of the public who could not attend sent submissions in writing, which will all be taken into account during the review.
Slovenian: Številni drugi člani javnosti, ki se obravnave niso mogli udeležiti, so poslali pisne prispevke, ki bodo vsi upoštevani pri pregledu.
English: 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.
Slovenian: Priporočila bodo nato poslana Odboru za zdravila za uporabo v humani medicini (CHMP), ki je odgovoren za vprašanja o zdravilih za uporabo v humani medicini in bo upošteval mnenje Agencije za zdravila.
English: EMA would like to express its warmest gratitude to all those who have contributed to this public hearing.
Slovenian: Evropska agencija za zdravila se prisrčno zahvaljuje vsem, ki so prispevali k tej javni obravnavi.
English: Questions addressed to participants
Slovenian: Vprašanja, ki so bila zastavljena udeležencem
English: Another issue raised was the reaction to foods, which patients said should be further investigated.
Slovenian: Še ena obravnavana težava so bile reakcije na živila, ki bi jih bilo treba po mnenju bolnikov nadalje raziskati.
English: Comments were provided by Stephanie Fowler, Elizabeth Pyne (attending on behalf of her son), Deborah Kinrade and David Morison.
Slovenian: Pripombe so prispevali Stephanie Fowler, Elizabeth Pyne (ki je sodelovala v imenu svojega sina), Deborah Kinrade in David Morison.
English: 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”.
Slovenian: 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“.
English: Patients should also have to give informed consent before treatment.
Slovenian: Bolniki naj bi pred zdravljenjem tudi podpisali informirano privolitev.
English: • Symptoms were life-changing and wide ranging.
Slovenian: • Simptomi so bili življenje spreminjajoči in raznovrstni.
English: Other symptoms include mood disturbances and other mental health effects as well as effects on the heart.
Slovenian: Med drugimi simptomi so motnje razpoloženja in drugi učinki na duševno zdravje ter učinki na srce.
English: • Improve education for healthcare professionals (including during medical training).
Slovenian: • Izboljšanje izobraževanja zdravstvenih delavcev (vključno z medicinskim usposabljanjem).
English: • Encourage research on how the medicines cause side effects, including genetic research.
Slovenian: • Spodbujanje raziskav o tem, kako zdravila povzročajo neželene učinke, vključno z genskimi raziskavami.
English: Background
Slovenian: Ozadje
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.
Slovenian: 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.
English: Julie Le Normand, France
Slovenian: Julie Le Normand, Francija
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.
Slovenian: 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.
English: The reports have included life-changing disabilities and long-term pain.
Slovenian: Poročila vključujejo življenje spreminjajoče vrste invalidnosti in dolgotrajne bolečine.
English: Pharmaceutical companies
Slovenian: Farmacevtske družbe
English: John Crowley, Luxembourg
Slovenian: John Crowley, Luksemburg
English: 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.
Slovenian: Odbor PRAC bo zdaj obravnaval vsa stališča, izražena med obravnavo in v pisnih prispevkih, ter jih upošteval pri oblikovanju priporočil za uporabo teh antibiotikov.
English: He spoke of the need for improvements in package leaflets to take account of those who may not be able to understand the text.
Slovenian: Predlagal je izboljšavo navodila za uporabo, namenjeno tistim, ki morda ne zmorejo razumeti besedila.
English: There was minority support for an outright ban of these medicines, and some patients supported restricting use to hospitals.
Slovenian: Manjšina bolnikov se zavzema za popolno prepoved teh zdravil, medtem ko nekateri podpirajo omejitev uporabe na bolnišnice.
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.
Slovenian: 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.
English: The hearing was broadcast live and a recording is available on EMA's website.
Slovenian: Obravnava je bila predvajana v živo in posnetek je na voljo na spletnem mestu Evropske agencije za zdravila.
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.
Slovenian: »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.
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.
Slovenian: Čeprav so bili sami neželeni učinki znani že prej, ta pregled obravnava vztrajnost in dolgotrajnost neželenih učinkov ter njihov vpliv na življenje bolnikov.
English: Andrea Noya, Italy
Slovenian: Andrea Noya, Italija
English: Elizabeth Carmouche, Belgium
Slovenian: Elizabeth Carmouche, Belgija
English: Paul Tulkens, Louvain Drug Research Institute, Belgium Speaker 21:
Slovenian: Paul Tulkens, Louvain Drug Research Institute, Belgija 21. govornik:
English: Richard Cooknell, UK
Slovenian: Richard Cooknell, Združeno kraljestvo
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.
Slovenian: 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.
English: Speaker 13 (joining via telephone):
Slovenian: 13. govornik (sodelovanje po telefonu):
English: • Improve management of patients with side effects (taking account of wide-ranging symptoms).
Slovenian: • Izboljšanje obravnave bolnikov, ki imajo neželene učinke (ob upoštevanju raznovrstnosti simptomov).
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.
Slovenian: 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.
English: Nigel Stacey provided comments after the video recording had been stopped.
Slovenian: Po ustavitvi video posnetka je posredoval pripombe še Nigel Stacey.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, UK Speaker 19:
Slovenian: Neal L. Millar, Inštitut za okužbe, imunost in vnetja, Univerza v Glasgowu, Združeno kraljestvo 19. govornik:
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.
Slovenian: 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.
English: Markus Hamedinger, Austria
Slovenian: Markus Hamedinger, Avstrija
English: Summary of issues raised
Slovenian: Povzetek opisanih težav
English: Joshua Sutton, UK
Slovenian: Joshua Sutton, Združeno kraljestvo
English: Enikő Pongrácz, Hungary
Slovenian: Enikő Pongrácz, Madžarska
English: Patients also called for better education of healthcare professionals, including during medical training when they first learn about this class of medicines.
Slovenian: Bolniki pozivajo tudi k boljšemu izobraževanju zdravstvenih delavcev, vključno z medicinskim usposabljanjem, med katerim se delavci prvič srečajo s to skupino zdravil.
English: Florian Wagenlehner, European Association of Urology (EAU) Additional interventions
Slovenian: Florian Wagenlehner, Evropsko združenje za urologijo (EAU) Dodatni ukrepi
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: More information on the ongoing review of quinolone and fluoroquinolone antibiotics is available on a dedicated webpage.
Slovenian: Več informacij o tekočem pregledu kinolonskih in fluorokinolonskih antibiotikov je na voljo na ustrezni spletni strani.
English: Elsa Leitão, Germany
Slovenian: Elsa Leitão, Nemčija
English: Quinolones and fluoroquinolones are synthetic antibiotics used for a wide range of bacterial infections.
Slovenian: Kinoloni in fluorokinoloni so sintetični antibiotiki, ki se uporabljajo za zdravljenje širokega spektra bakterijskih okužb.
English: Many patients continued taking these medicines while they had symptoms, unaware of a possible link to their treatments.
Slovenian: Številni bolniki so ta zdravila jemali še naprej kljub pojavu simptomov, ne vedoč za možno povezavo z zdravili.
English: The most commonly used medicines in this class are ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.
Slovenian: Zdravila iz te skupine, ki se uporabljajo najpogosteje, so ciprofloksacin, levofloksacin, moksifloksacin, norfloksacin in ofloksacin.
English: • Restrict quinolone and fluoroquinolone use to situations where there are no alternatives.
Slovenian: • Omejitev uporabe kinolonov in fluorokinolonov na okoliščine, kjer ni drugih možnosti.
English: Main points raised
Slovenian: Glavne obravnavane težave
English: Jaroslaw Linka, Poland
Slovenian: Jaroslaw Linka, Poljska
English: Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Speaker 16:
Slovenian: Jamie Wilkinson, Farmacevtska skupina Evropske unije (PGEU) 16. govornik: