FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients called for better recognition of patterns of toxicity with quinolones and fluoroquinolones (sometimes referred to as ‘fluoroquinolone-associated disability syndrome').
Slovenian: Bolniki pozivajo k izboljšanju prepoznavanja vzorcev toksičnosti kinolonov in fluorokinolonov (ki jih včasih imenujejo »sindrom invalidnosti, povezan s fluorokinoloni«).
English: The consensus among patients was that the use of quinolone and fluoroquinolone antibiotics should be greatly restricted.
Slovenian: Bolniki soglašajo, da bi bilo treba uporabo kinolonskih in fluorokinolonskih antibiotikov močno omejiti.
English: In many cases, quinolones and fluoroquinolones had been prescribed for minor infections or were used to prevent infections.
Slovenian: V številnih primerih so bili kinoloni in fluorokinoloni predpisani za zdravljenje blagih okužb ali so se uporabljali samo za preprečevanje okužb.
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.
Slovenian: Številni bolniki niso bili obveščeni o tveganjih in pravijo, da jim ni nihče prisluhnil, ko so poskusili opozoriti na možno povezavo s predpisanimi zdravili.
English: • What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
Slovenian: • Kakšno je vaše mnenje o vlogi kinolonov in fluorokinolonov pri zdravljenju okužb?
English: The tendon problems generally affected multiple tendons, in contrast to many other tendon disorders which usually affect one.
Slovenian: Težave s kitami na splošno zadevajo več kit, kar je v nasprotju s številnimi drugimi boleznimi, ki običajno prizadenejo posamezno kito.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: Bolniki, ki od zdravstvenih delavcev niso dobili odgovorov, so se za pojasnitev svojih simptomov morali zateči k informacijam na internetu.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Ber Oomen, European Specialist Nurses Organisations (ESNO) Speaker 20:
Slovenian: Ber Oomen, Evropsko združenje specialistov zdravstvene nege (ESNO) 20. govornik:
English: • Healthcare professionals were generally unaware of the range and severity of possible symptoms,
Slovenian: • Zdravstveni delavci na splošno niso bili seznanjeni z obsegom in resnostjo možnih simptomov, z izjemo bolezni Ahilove kite.
English: Graham Bothamley, European Respiratory Society (ERS) Speaker 17:
Slovenian: Graham Bothamley, Evropsko združenje pulmologov (ERS) 17. govornik:
English: Some patients also reported a worsening of symptoms when they were subsequently given NSAID painkillers or steroids.
Slovenian: Nekateri bolniki so poročali tudi o poslabšanju simptomov, ko so se pozneje zdravili z nesteroidnimi antirevmatiki (NSAID) za lajšanje bolečin ali s steroidi.
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.
Slovenian: 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.
English: • What is your view of the risks associated with quinolone and fluoroquinolone use?
Slovenian: • Kakšen je vaš pogled na tveganja, povezana z uporabo kinolonov in fluorokinolonov?
English: Mary McCarthy, European Union of General Practioners (UEMO) Speaker 18:
Slovenian: Mary McCarthy, Evropska zveza splošnih zdravnikov (UEMO) 18. govornik:
English: • In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?
Slovenian: • Kakšne dodatne ukrepe predlagate za izboljšanje varnosti uporabe kinolonov in fluorokinolonov?
English: • Improve communication on quinolone and fluoroquinolone toxicity, including possible risk factors,
Slovenian: • Izboljšanje obveščanja o toksičnosti kinolonov in fluorokinolonov, vključno z možnimi dejavniki tveganja, in dopolnitev informacij o zdravilih, vključno z navodilom za uporabo.
English: • Consider how certain foods affect patients' symptoms, particularly meat treated with quinolones and fluoroquinolones.
Slovenian: • Obravnava vpliva določenih živil, zlasti mesa živali, zdravljenih s kinoloni in fluorokinoloni, na simptome pri bolnikih.
English: Manex Bettan Arguinzoniz, Spain Speaker 3:
Slovenian: Manex Bettan Arguinzoniz, Španija
English: A recurring theme was the lack of knowledge of the possible side effects among doctors.
Slovenian: Rdeča nit pri teh primerih je bila nevednost zdravnikov glede možnih neželenih učinkov.
English: Miriam Knight, Quinolone Toxicity Support UK Raymond Miller, Quinolone Toxicity Support UK Geoffrey Robinson, Fluoroquinolone Toxicity Victims in Europe Speaker 6:
Slovenian: Miriam Knight, Quinolone Toxicity Support UK (spletno mesto za podporo v zvezi s toksičnostjo kinolonov)
English: Notes
Slovenian: Opombe
English: Miriam van Staveren, The Netherlands Speaker 12 (joining via telephone):
Slovenian: Miriam van Staveren, Nizozemska
English: MA (EU) number (Invented) name
Slovenian: (Izmišljeno) ime
English: Pharmaceutical Form Route of Administration
Slovenian: Farmacevtska oblika
English: Immediate Packaging Pack size
Slovenian: Velikost pakiranja
English: More about the procedure
Slovenian: Več o postopku
English: 30 October 2014 EMA/698187/2014
Slovenian: 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.
Slovenian: 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.
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.
Slovenian: Pregled peroralnega bromokriptina se je začel na zahtevo Francije 17. julija 2013 v skladu s členom 31 Direktive 2001/83/ES.
English: Products with strengths of 5 or 10 mg are not indicated for such use.
Slovenian: Zdravila z jakostjo 5 ali 10 mg niso indicirana za tovrstno uporabo.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Pregled teh podatkov je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: Information to healthcare professionals
Slovenian: Informacije za zdravstvene delavce
English: • Women who have any questions or concerns should consult their doctor or pharmacist.
Slovenian: • Ženske, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z zdravnikom ali farmacevtom.
English: Bromocriptine is a dopamine receptor agonist.
Slovenian: Bromokriptin je agonist dopaminskih receptorjev.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Slovenian: 1 CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
English: More about the medicine
Slovenian: Več o zdravilu
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%.
Slovenian: 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 %.
English: Blood pressure should be monitored so that early signs of an increase can be detected and treatment stopped immediately.
Slovenian: Krvni tlak je treba spremljati, da se lahko ugotovijo zgodnji znaki povišanja in takoj prekine zdravljenje.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Slovenian: Stopite v stik z našo tiskovno predstavnico Monika Benstetter tel. +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
English: The product information for bromocriptine-containing medicines has been updated accordingly.
Slovenian: Informacije o zdravilu za zdravila, ki vsebujejo bromokriptin, so bile ustrezno posodobljene.
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.
Slovenian: 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.
English: • Blood pressure should be carefully monitored especially during the first day of therapy.
Slovenian: • Skrbno je treba spremljati krvni tlak, zlasti prvi dan zdravljenja.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Slovenian: Priporočila odbora PRAC so bila posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
English: Since lactation is a natural process that eventually stops if the infant is not breastfed, and other means of management are available, the French medicines agency (ANSM) asked the EMA to review the medicines and see if the benefits of such use still outweighed the risks.
Slovenian: Glede na to, da je laktacija naravni proces, ki se sčasoma ustavi, če se otrok ne doji, in se lahko uravnava tudi na druge načine, je francoska agencija za zdravila (ANSM) zaprosila Evropsko agencijo za zdravila, da pregleda zdravila in ugotovi, ali so koristi tovrstne uporabe še vedno večje od tveganj.
English: Although milk production eventually stops, women in the meantime can experience breast engorgement, leakage of milk, discomfort and pain.
Slovenian: Čeprav se tvorjenje mleka sčasoma ustavi, se lahko medtem pri ženskah pojavijo nabreklost dojk, iztekanje mleka, neugodje in bolečina.
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.
Slovenian: Zaradi možnega tveganja za resne neželene učinke so bila izdana priporočila, ki pojasnjujejo, da se ta zdravila ne smejo več uporabljati za rutinsko preprečevanje ali zaustavljanje tvorjenja mleka.
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.
Slovenian: Skupina CMDh je organ, ki zastopa države članice EU in je odgovoren za zagotovitev enotnih varnostnih standardov za zdravila, ki so v EU odobrena po nacionalnih postopkih.
English: • Patients who develop chest pain or an unusually severe headache should consult their doctor urgently.
Slovenian: • Bolnice, pri katerih se pojavi bolečina v prsnem košu ali neobičajno hud glavobol, se morajo nujno posvetovati z zdravnikom.
English: Restrictions in use of bromocriptine for stopping breast milk production
Slovenian: Omejitev uporabe bromokriptina za zaustavitev tvorjenja materinega mleka
English: Information to patients
Slovenian: Informacije za bolnice
English: Bromocriptine is also used to treat other conditions, such as hyperprolactinaemia (high levels of prolactin in the body) and Parkinson's disease; however these uses are not covered by this review.
Slovenian: Bromokriptin se uporablja tudi za zdravljenje drugih bolezni, kot sta hiperprolaktinemija (visoke ravni prolaktina v telesu) in Parkinsonova bolezen, vendar tovrstna uporaba ni zajeta v tem pregledu.
English: • Blood pressure should be monitored in those who take the medicine (especially on the first day of taking it) so that early signs of problems can be detected, and the medicine stopped.
Slovenian: • Pri vseh, ki jemljejo zdravilo, je treba spremljati krvni tlak (zlasti prvi dan jemanja zdravila), da se lahko ugotovijo zgodnji znaki težav in prekine jemanje zdravila.
English: On 20 August 2014, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed by majority recommendations on the use of bromocriptine-containing medicines by mouth to prevent or suppress breast milk production (lactation) after childbirth.
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh)1 je 20. avgusta 2014 z večino podprla priporočila za uporabo zdravil, ki vsebujejo bromokriptin in se jemljejo peroralnno za preprečevanje ali zaviranje tvorjenja materinega mleka (laktacije) po porodu.
English: Bromocriptine should not be used routinely for preventing or stopping milk production, and must not be used in women at increased risk of serious side effects, including women with various disorders that increase blood pressure or who have or have had heart disease or severe psychiatric disorders.
Slovenian: Bromokriptin se ne sme uporabljati za rutinsko preprečevanje ali zaustavitev tvorjenja mleka, prav tako pa se ne sme uporabljati pri ženskah, pri katerih obstaja večje tveganje za resne neželene učinke, kar vključuje ženske z različnimi motnjami, ki zvišujejo krvni tlak, in tiste, ki imajo ali so kdaj imele bolezen srca ali hude psihiatrične motnje.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which took an EU-wide legally binding decision on 30 October 2014.
Slovenian: Ker je skupina CMDh stališče sprejela z večino glasov, je bilo posredovano Evropski komisiji, ki je 30. oktobra 2014 sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
English: The CMDh position followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety and effectiveness of bromocriptine in controlling breast milk production after childbirth, which led to these recommendations.
Slovenian: Skupina CMDh je stališče sprejela, potem ko je Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila opravil pregled razpoložljivih podatkov o varnosti in učinkovitosti bromokriptina pri nadzorovanju tvorjenja materinega mleka po porodu, na podlagi katerega je podal ta priporočila.
English: • On the basis of available safety data, a causal association between use of bromocriptine and serious cardiovascular, neurological or psychiatric events could not be excluded.
Slovenian: • Na podlagi razpoložljivih podatkov o varnosti ni bilo mogoče izključiti vzročne povezave med uporabo bromokriptina in resnimi srčno-žilnimi, nevrološkimi in psihiatričnimi dogodki.
English: • Medicines containing bromocriptine are licensed in many EU countries for use by mouth to prevent or stop milk production after childbirth in women who are not breastfeeding.
Slovenian: • Zdravila, ki vsebujejo bromokriptin, so v številnih državah EU odobrena za peroralno uporabo za preprečevanje ali zaustavljanje tvorjenja mleka po porodu pri ženskah, ki ne dojijo.
English: The review was triggered by concerns in France over increased reports of rare but potentially serious or fatal side effects, particularly cardiovascular side effects (such as heart attack and stroke), neurological side effects such as seizures (fits) and psychiatric side effects (such as hallucinations and manic episodes).
Slovenian: Pregled je bil sprožen, ker se je v Franciji pojavila zaskrbljenost zaradi povečanega števila poročil o redkih, vendar potencialno resnih ali smrtnih neželenih učinkih, zlasti srčno-žilnih (na primer srčna in možganska kap), nevroloških, kot so epileptični napadi (krči), in psihiatričnih (na primer halucinacije in manične epizode).
English: As the CMDh position on bromocriptine was adopted by majority vote, it was sent to the European Commission, which took an EU-wide legally binding decision on 30 October 2014.
Slovenian: Ker je skupina CMDh stališče o bromokriptinu sprejela z večino glasov, je bilo posredovano Evropski komisiji, ki je dne 30. oktobra 2014 sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
English: However, the data available were such that conclusions on the efficacy of bromocriptine in mastitis, breast engorgement and painful breast engorgement could not be made.
Slovenian: Vendar na podlagi razpoložljivih podatkov ni bilo mogoče podati zaključkov o učinkovitosti bromokriptina pri mastitisu, nabreklosti dojk in boleči nabreklosti dojk.
English: • They should only be used for this purpose if there are medical reasons for doing so, for example to avoid further distress in women who lose a baby during or just after birth, or in women who have HIV infection (to avoid any risk of passing the virus on in breast milk).
Slovenian: • Za ta namen se lahko uporabijo samo, če za to obstajajo zdravstveni razlogi, na primer, da se prepreči nadaljnji stres pri ženskah, ki izgubijo otroka med porodom ali takoj po njem, ali če je ženska okužena z virusom HIV (da se prepreči vsakršno tveganje za prenos virusa z materinim mlekom).
English: • Evidence from the clinical trials originally used to license the product as well as those in the published literature suggests that bromocriptine is efficacious in the prevention and inhibition of lactation.
Slovenian: • Dokazi iz kliničnih preskušanj, ki so bili prvotno uporabljeni za pridobitev dovoljenja za zdravilo, in dokazi iz objavljene literature kažejo, da je bromokriptin učinkovit pri preprečevanju in zaviranju laktacije.
English: It mimics some of the actions of dopamine, a hormone that regulates the release of another hormone, prolactin, which in turn controls lactation.
Slovenian: Deluje tako, da posnema določene načine delovanja dopamina, tj. hormona, ki uravnava sproščanje drugega hormona, prolaktina, ki nadzoruje laktacijo.
English: Women may not always breastfeed after childbirth for a variety of reasons ranging from stillbirth and HIVinfection of the mother to personal choice.
Slovenian: Ženske včasih po porodu ne dojijo zaradi različnih razlogov, ki vključujejo vse od mrtvorojenega otroka in okužbe matere z virusom HIV do osebne odločitve.
English: If hypertension, suggestive chest pain, severe, progressive, or unremitting headache (with or without visual disturbance) or evidence of central nervous system toxicity develops, treatment should be discontinued and the patient evaluated promptly.
Slovenian: Če se pojavi hipertenzija, pomenljiva bolečina v prsnem košu, hud, progresiven ali neprekinjen glavobol (z motnjami vida ali brez njih) ali znaki toksičnih učinkov na centralni živčni sistem, je treba zdravljenje prekiniti in bolnico takoj pregledati.
English: The medicine should not be used routinely for preventing or stopping milk production after childbirth
Slovenian: Zdravilo se ne sme uporabljati za rutinsko preprečevanje ali zaustavljanje tvorjenja mleka po porodu
English: The above recommendations are based on a review of the available evidence of safety and efficacy of oral bromocriptine for prevention and suppression of lactation.
Slovenian: Zgornja priporočila temeljijo na pregledu razpoložljivih dokazov o varnosti in učinkovitosti peroralnega bromokriptina pri preprečevanju in zaviranju laktacije.
English: • Use is contraindicated for patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium, a history of coronary artery disease or other severe cardiovascular conditions, or a history of severe psychiatric disorders.
Slovenian: • Uporaba je kontraindicirana pri bolnicah z nenadzorovano hipertenzijo, hipertenzivnimi motnjami v nosečnosti (vključno z eklampsijo, preeklampsijo in hipertenzijo zaradi nosečnosti), hipertenzijo po porodu in v puerperiju, boleznijo koronarnih arterij ali drugimi hudimi srčno-žilnimi boleznimi v anamnezi ali z anamnezo hudih psihiatričnih motenj.
English: • Women who are at greater risk of side effects, such as those who have a condition that increases blood pressure, or who have a history of serious mental illness, should not take bromocriptine.
Slovenian: • Ženske, pri katerih obstaja večje tveganje za neželene učinke, na primer ženske z boleznijo, ki zvišuje krvni tlak, in tiste, ki so kdaj imele resne psihiatrične motnje, bromokriptina ne smejo jemati.
English: As a result, bromocriptine prevents the secretion of prolactin, thereby preventing or suppressing milk production.
Slovenian: Bromokriptin tako preprečuje izločanje prolaktina in s tem prepreči ali zavira tvorjenje mleka.
English: • Bromocriptine should not be used to relieve symptoms of pain or swelling of the breasts after childbirth when such symptoms can be managed by measures such as breast support or applying ice, and the use of painkillers if needed.
Slovenian: • Bromokriptin se ne sme uporabljati za lajšanje simptomov bolečine v dojkah ali nabrekanja dojk po porodu, kadar je te simptome mogoče obvladati z ukrepi, kot so podpiranje dojk ali ledeni obkladki, in z uporabo protibolečinskih zdravil, če je to potrebno.