FrancophonIA/ELRC3.0 huggingface dataset:
English: Bonviva is a medicine that contains the active substance ibandronic acid.
Croatian: Bonviva je lijek koji sadrži ibandronatnu kiselinu kao djelatnu tvar.
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).
Croatian: Lijek Bonviva koristi se za liječenje osteoporoze (bolesti koja kosti čini lomljivima) u žena u postmenopauzi koje su izložene većem riziku od fraktura (lomova) kostiju.
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.
Croatian: U razdoblju od dvije godine, gustoća kostiju u kralježnici povećala se za 7 % uz pomoć mjesečnih tableta i 6 % uz pomoć injekcija u usporedbi s 5 % za koliko se povećala uz pomoć dnevnih tableta.
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.
Croatian: U prvom ispitivanju uspoređivano je djelovanje lijeka Bonviva, u tabletama u dozi od 2,5 mg koje su se uzimale jedanput dnevno, s placebom (prividno liječenje) na otprilike 3000 žena, pri čemu se promatralo koliko je bilo novih prijeloma kralježnice u bolesnica u razdoblju od tri godine.
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.
Croatian: U prvom je ispitivanju, dnevnom terapijom lijekom Bonviva u obliku tableta od 2,5 mg, rizik od prijeloma kralježnice smanjen za 62 % u usporedbi s placebom.
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.
Croatian: U kuku se gustoća kostiju povećala za 4 % uz pomoć mjesečnih tableta i 3 % uz pomoć injekcija, u usporedbi s 2 % za koliko se povećala uz pomoć dnevnih tableta.
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.
Croatian: Druga su dva ispitivanja pokazala da je primjena lijeka u obliku mjesečnih tableta u dozi od 150 mg i injekcija učinkovitija od primjene lijeka u obliku dnevnih tableta u dozi od 2,5 mg u povećanju gustoće kostiju u kralježnici i kuku.
English: Why has Bonviva been approved?
Croatian: Zašto je lijek Bonviva odobren?
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.
Croatian: U ostalim dvama ispitivanjima uspoređivano je djelovanje lijeka u obliku tableta u dozi od 150 mg koja se uzima jedanput mjesečno (1609 bolesnica) i injekcija (1395 bolesnica) s djelovanjem lijeka u obliku tableta u dozi od 2,5 mg koja se uzima jedanput dnevno.
English: What is Bonviva used for?
Croatian: Za što se Bonviva koristi?
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Croatian: Osteoporoza nastupa kada se kosti, koje se razgrađuju prirodnim putem, nedovoljno obnavljaju.
English: What benefit has Bonviva shown during the studies?
Croatian: Koje su koristi lijeka Bonviva utvrđene u ispitivanjima?
English: For the full list of restrictions with Bonviva, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Bonviva potražite u uputi o lijeku.
English: How is Bonviva used?
Croatian: Kako se koristi Bonviva?
English: For the full list of all side effects reported with Bonviva, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Bonviva potražite u uputi o lijeku.
English: How does Bonviva work?
Croatian: Kako djeluje Bonviva?
English: How has Bonviva been studied?
Croatian: Kako je lijek Bonviva ispitivan?
English: Next steps
Croatian: Sljedeći koraci
English: Public hearing held on 13 June 2018
Croatian: Održano 13. lipnja 2018.
English: Nigel Stacey provided comments after the video recording had been stopped.
Croatian: Nigel Stacey dao je komentar nakon što je zaustavljena videosnimka.
English: EMA would like to express its warmest gratitude to all those who have contributed to this public hearing.
Croatian: EMA isto tako izražava najdublju zahvalnost svima onima koji su doprinijeli javnoj raspravi.
English: Healthcare professionals and academia
Croatian: Zdravstveni radnici i akademici
English: General public (patient representatives, carers, families) Speaker 1:
Croatian: Javnost (predstavnici bolesnika, skrbnici, obitelji) 1. govornik:
English: Patients should also have to give informed consent before treatment.
Croatian: Bolesnici bi također trebali prije liječenja dati informirani pristanak.
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.
Croatian: Preporuku nakon toga šalje Odboru za lijekove za humanu uporabu (CHMP), odgovornom za pitanja koja se odnose na lijekove za humanu uporabu, koji će usvojiti mišljenje Agencije.
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.
Croatian: U završnoj fazi postupka procjene, Europska komisija donosi pravno obvezujuće odluke koje se primjenjuju u svim državama članicama EU-a.
English: They also stressed the importance of microbial testing to make sure the medicines are only used when necessary.
Croatian: Također su istaknuli važnost mikrobiološkog testiranja kako bi se lijekovi upotrebljavali samo onda kada je to neophodno.
English: European Medicines Agency
Croatian: Europska agencija za lijekove
English: • Patients were not given information about risks.
Croatian: • Bolesnici nisu bili informirani o rizicima.
English: List of Speakers
Croatian: Popis govornika
English: More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu
Croatian: 5. Više informacija o radu Europske agencije za lijekove nalazi se na internetskim stranicama Agencije: www.ema.europa.eu
English: Comments were provided by Stephanie Fowler, Elizabeth Pyne (attending on behalf of her son), Deborah Kinrade and David Morison.
Croatian: Komentare su dali Stephanie Fowler, Elizabeth Pyne (koja je prisustvovala u ime svog sina), Deborah Kinrade i David Morison.
English: As time permitted, the Chair invited additional comments from the floor.
Croatian: Budući da je ostalo dovoljno vremena, predsjednica je pozvala na dodatnu raspravu s podija.
English: • Improve education for healthcare professionals (including during medical training).
Croatian: • Poboljšati obrazovanje zdravstvenih radnika (uključujući tijekom liječničkoga osposobljavanja).
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.
Croatian: Šezdeset i devet sudionika sudjelovalo je osobno u EMA-inim uredima u Londonu (ili putem telefonskog poziva), uključujući 40 bolesnika, 14 zdravstvenih radnika i pripadnika akademske zajednice, 13 predstavnika farmaceutske industrije te članovi medija.
English: The hearing was broadcast live and a recording is available on EMA's website.
Croatian: Rasprava se prenosila uživo, a snimka je dostupna na EMA-inom mrežnom mjestu.
English: Public hearings are conducted according to the rules of procedure for public hearings.
Croatian: 3. Javne se rasprave provode sukladno poslovniku za javne rasprave.
English: John Crowley, Luxembourg
Croatian: John Crowley, iz Luksemburga
English: 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.
Croatian: Budući da zdravstveni radnici nisu imali odgovore, bolesnici su se morali osloniti na informacije na internetu kako bi razumjeli simptome koje su osjećali.
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.
Croatian: PRAC će sada razmotriti sva stajališta koja su iznesena na raspravi, uključujući pisane podneske, te će ih uzeti u obzir tijekom donošenja preporuka o primjeni tih antibiotika.
English: Leo Plouffe, Bayer AG
Croatian: Leo Plouffe, iz tvrtke Bayer AG
English: Julie Le Normand, France
Croatian: Julie Le Normand, iz Francuske
English: Questions addressed to participants
Croatian: Pitanja upućena sudionicima
English: In closing the discussions, Dr Raine praised the courageous testimonies from patients and other participants.
Croatian: Raine je u završnoj raspravi pohvalila hrabra svjedočenja bolesnika i ostalih sudionika.
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”.
Croatian: S obzirom na težinu tih nuspojava, upraviteljica EMA-inog odjela za zainteresirane strane i komunikaciju Melanie Carr naglasila je u svome govoru dobrodošlice kako je ta javna rasprava „iznimno važna zato što njome možemo razmotriti vaša mišljenja o rizicima koji su povezani s ovim lijekovima i mogućnosti regulatornih mjera u širem kontekstu javnog zdravstva“.
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.
Croatian: Brojni drugi pripadnici javnosti koji nisu mogli sudjelovati poslali su pisane podneske koji će isto biti uzeti u obzir tijekom procjene.
English: Elizabeth Carmouche, Belgium
Croatian: Elizabeth Carmouche, iz Belgije
English: Andrea Noya, Italy
Croatian: Andrea Noya, iz Italije
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.
Croatian: „Prije svega moramo popraviti lanac povjerenja,” rekla je dodavši da je jedna od najtežih činjenica za bolesnike koji imaju navedene simptome invaliditeta neraspoznavanje onoga što proživljavaju.
English: Pharmaceutical companies
Croatian: Farmaceutska društva
English: Speaker 13 (joining via telephone):
Croatian: 13. govornik (putem telefona):
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.
Croatian: Nadalje, neki bolesnici više ne mogu raditi, vježbati ili sudjelovati u aktivnostima, pa čak ni obavljati svakodnevne poslove poput vezanja vezica na cipelama ili zakopčavanja gumbi; neki osjećaju stalne bolove sa simptomima koji utječu na cijeli niz mišića i tetiva.
English: Another issue raised was the reaction to foods, which patients said should be further investigated.
Croatian: Naveden je i problem reakcije na hranu za koji su bolesnici rekli da ga je potrebno dodatno istražiti.
English: Patients also called for better education of healthcare professionals, including during medical training when they first learn about this class of medicines.
Croatian: Bolesnici su pozvali i na bolju obuku zdravstvenih radnika, uključujući i tijekom liječničkoga osposobljavanja kada prvi put uče o tom razredu lijekova.
English: Florian Wagenlehner, European Association of Urology (EAU) Additional interventions
Croatian: Florian Wagenlehner, iz Europskog udruženja za urologiju (EAU) Dodatne intervencije
English: Markus Hamedinger, Austria
Croatian: Markus Hamedinger, iz Austrije
English: • Encourage research on how the medicines cause side effects, including genetic research.
Croatian: • Potaknuti istraživanja o načinu na koji ti lijekovi uzrokuju nuspojave, uključujući genetska istraživanja.
English: There was minority support for an outright ban of these medicines, and some patients supported restricting use to hospitals.
Croatian: Manja skupina podržavala je izravnu zabranu tih lijekova, a neki su bolesnici podržavali zabranu njihove primjene u bolnicama.
English: Other symptoms include mood disturbances and other mental health effects as well as effects on the heart.
Croatian: U druge simptome spadaju poremećaji raspoloženja i ostali učinci na mentalno zdravlje te učinci na srce.
English: Enikő Pongrácz, Hungary
Croatian: Enikő Pongrácz, iz Mađarske
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.
Croatian: Drugi sudionici, uključujući zdravstvene radnike i akademike, zatražili su više istraživanja, uključujući i genetska istraživanja, za utvrđivanje točnih mehanizama putem kojih lijekovi uzrokuju navedene nuspojave, određivanje načina na koji utječu na različite populacije i povećavaju ukupni intenzitet rizika.
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.
Croatian: Raspravom je predsjedala predsjednica PRAC-a June Raine s uvodom o temi koji je održala PRAC-ova izvjestiteljica Eva Jirsová (vodeća procjeniteljica) uz dodatnu pomoć upravitelja EMA-inog odjela za javno djelovanje Juana Garcije-Burgosa.
English: 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20. lipnja 2018.
English: • Improve management of patients with side effects (taking account of wide-ranging symptoms).
Croatian: • Poboljšati upravljanje bolesnicima s nuspojavama (uzimajući u obzir raznolike simptome).
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.
Croatian: Nadalje, propisivanje tih lijekova trebalo bi se bolje nadzirati te bi se trebalo aktivno upozoravati na rizike kako bi se bolesnicima koji imaju te simptome moglo savjetovati da odmah prestanu s liječenjem i da im se više nikad ne propišu ti lijekovi.
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.
Croatian: Iako su nuspojave bile poznate, ovom se procjenom pregledava njihova trajnost i dugoročna priroda te njihov učinak na živote bolesnika.
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.
Croatian: Na kraju, predstavnik farmaceutskog društva koje taj razred antibiotika stavlja u promet priznao je da postoji potreba za boljim informacijama o riziku lijekova u njihovim informacijama o lijeku, pogotovo u uputi o lijeku.
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.
Croatian: U EU-u su dostupni od 1962. i od tada se primjenjuju za liječenje milijuna bolesnika koji imaju bakterijske infekcije, uključujući teške infekcije ili infekcije opasne po život te infekcije koje su otporne na druge vrste liječenja.
English: Main points raised
Croatian: Iznošenje glavnih točaka
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.
Croatian: Kinoloni i fluorokinoloni danas se primjenjuju na više od 120 indikacija u EU-u, uključujući različite vrste infekcija mokraćnog sustava, respiratorne infekcije, genitalne infekcije te infekcije gastrointestinalnog trakta, kože, kostiju i zglobova.
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.
Croatian: EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC) pokrenuo je procjenu ovog razreda lijekova nakon izvješća o teškim i dugoročnim nuspojavama koje se uglavnom odnose na mišiće, tetive, zglobove i živčani sustav.
English: Jaroslaw Linka, Poland
Croatian: Jaroslaw Linka, iz Poljske
English: Richard Cooknell, UK
Croatian: Richard Cooknell, iz UK-a
English: Graham Bothamley, European Respiratory Society (ERS) Speaker 17:
Croatian: Graham Bothamley, iz Europskog respiratornog društva (ERS) 17. govornik:
English: • Consider how certain foods affect patients' symptoms, particularly meat treated with quinolones and fluoroquinolones.
Croatian: • Razmotriti način na koji određena hrana utječe na simptome bolesnika, posebno meso koje je tretirano kinolonima i fluorokinolonima.
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.
Croatian: Bolesnici i zdravstveni radnici istaknuli su potrebu za boljim upravljanjem bolesnicima koji imaju nuspojave i spajanjem stručnog znanja iz različitih polja kako bi se riješili raznoliki simptomi.
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.
Croatian: Bolesnici su izjavili da te lijekove treba primjenjivati samo u situacijama kada je u pitanju smrtna opasnost ili za vrlo teške infekcije koje su utvrđene laboratorijskim ispitivanjima.
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.
Croatian: Govorio je o tome da je pri ažuriranju informacija u uputi o lijeku potrebno uzeti u obzir osobe koji možda ne mogu razumjeti tekst.
English: Elsa Leitão, Germany
Croatian: Elsa Leitão, iz Njemačke
English: Joshua Sutton, UK
Croatian: Joshua Sutton, iz UK-a
English: The most commonly used medicines in this class are ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.
Croatian: Najčešće korišteni lijekovi iz ovog razreda su ciprofloksacin, levofloksacin, moksifloksacin, norfloksacin i ofloksacin.
English: Paul Tulkens, Louvain Drug Research Institute, Belgium Speaker 21:
Croatian: Paul Tulkens, iz Instituta za istraživanje droga u Louvainu u Belgiji 21. govornik:
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.
Croatian: Pravna je osnova za javnu raspravu članak 107. točka (j) Direktive 2001/83/EZ pravnih propisa o farmakovigilanciji, kojim se PRAC-u omogućuje održavanje javnih rasprava za procjenu sigurnosti koju provodi Odbor sukladno članku 20.
English: The tendon problems generally affected multiple tendons, in contrast to many other tendon disorders which usually affect one.
Croatian: Problemi s tetivama uglavnom se odnose na više tetiva odjednom, za razliku od brojnih drugih poremećaja tetiva koji se obično odnose samo na jednu tetivu.
English: Miriam Knight, Quinolone Toxicity Support UK Raymond Miller, Quinolone Toxicity Support UK Geoffrey Robinson, Fluoroquinolone Toxicity Victims in Europe Speaker 6:
Croatian: Miriam Knight, iz udruge za podršku osobama koje pate od toksičnosti kinolona iz UK-a Raymond Miller, iz udruge za podršku osobama koje pate od toksičnosti kinolona iz UK-a Geoffrey Robinson, iz udruge za žrtve toksičnosti fluorokinolona iz Europe 6. govornik:
English: The reports have included life-changing disabilities and long-term pain.
Croatian: U izvješćima su navedeni i oblici invaliditeta koji mijenjaju život te dugoročna bol.
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.
Croatian: Bolesnici su opisali simptome koji su im promijenili život, koji su uslijedili nakon liječenja kinolonskim i fluorokinolonskim antibioticima, uključujući bol i invaliditet koji traju nekoliko godina, a neki bolesnici doživjeli su samo ograničena poboljšanja nakon određenog vremena.
English: • What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
Croatian: • Koje je vaše mišljenje o ulozi kinolona i fluorokinolona u liječenju infekcija?
English: Quinolones and fluoroquinolones are synthetic antibiotics used for a wide range of bacterial infections.
Croatian: Kinoloni i fluorokinoloni sintetički su antibiotici koji se upotrebljavaju za liječenje velikog broja bakterijskih infekcija.
English: Patients called for better recognition of patterns of toxicity with quinolones and fluoroquinolones (sometimes referred to as ‘fluoroquinolone-associated disability syndrome').
Croatian: Bolesnici su pozvali na bolje prepoznavanje uzoraka toksičnosti kinolona i fluorokinolona (koja se ponekad naziva sindromom invaliditeta povezanog s fluorokinolonom).
English: • Restrict quinolone and fluoroquinolone use to situations where there are no alternatives.
Croatian: • Ograničiti primjenu kinolona i fluorokinolona na situacije u kojima nema drugog izbora.
English: In many cases, quinolones and fluoroquinolones had been prescribed for minor infections or were used to prevent infections.
Croatian: U brojnim slučajevima kinoloni i fluorokinoloni propisivani su za manje infekcije ili su primjenjivani za sprečavanje infekcija.
English: Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, UK Speaker 19:
Croatian: Millar, iz Instituta za infekcije, imunitet i upale Sveučilišta u Glasglowu, iz UK-a 19. govornik:
English: • Symptoms were life-changing and wide ranging.
Croatian: • Simptomi su utjecali na život i bili su raznoliki.
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.
Croatian: Mnogi bolesnici nisu bili obaviješteni o rizicima i smatrali su da ih se ne sluša nakon što su prijavili moguću povezanost s liječenjem.
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.
Croatian: 2. Javne rasprave održavaju se od slučaja do slučaja, kad Odbor smatra da prikupljanje mišljenja javnosti dodatno pridonosi procjeni uz druge kanale sudjelovanja dionika poput podnesaka sudionika ili uključivanjem bolesnika i zdravstvenih radnika u stručne sastanke.
English: Many patients continued taking these medicines while they had symptoms, unaware of a possible link to their treatments.
Croatian: Mnogi su bolesnici nastavili s primjenom tih lijekova dok su osjećali simptome jer nisu bili svjesni moguće povezanosti s liječenjem.