natgillin/translations-raw huggingface dataset:
De har været tilgængelige i EU siden 1962 og har været anvendt til at behandle millioner af patienter med bakterielle infektioner, herunder alvorlige eller livstruende infektioner og infektioner med resistens over for andre behandlinger.
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.
Et tilbagevendende emne var lægernes manglende viden om de mulige bivirkninger.
A recurring theme was the lack of knowledge of the possible side effects among doctors.
Ordineringen af disse lægemidler bør desuden overvåges bedre, og der bør advares, så patienter, der har haft sådanne bivirkninger, tilrådes at stoppe behandlingen straks og aldrig igen få ordineret disse lægemidler.
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.
Andrea Noya, Italien
Andrea Noya, Italy
Den 13. juni 2018 afholdt Det Europæiske Lægemiddelagentur (EMA) en offentlig høring om antibiotika af quinolon- og fluoroquinolontypen for at høre patienternes og offentlighedens synspunkter om vedvaren af bivirkninger, der er indberettet ved denne lægemiddelgruppe.
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.
En repræsentant for en medicinalvirksomhed, der markedsfører denne klasse af antibiotika, anerkendte til slut nødvendigheden af at oplyse bedre om risikoen ved disse lægemidler i produktinformationen, navnlig indlægssedlerne.
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.
Bivirkningerne i sig selv har været kendt, men ved denne gennemgang ses der på deres vedholdende og langvarige karakter og indvirkningen heraf på patienternes liv.
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.
Elizabeth Carmouche, Belgien
Elizabeth Carmouche, Belgium
Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, Det Forenede Kongerige
Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, UK Speaker 19:
Sundhedspersoner og forskere
Healthcare professionals and academia
Markus Hamedinger, Østrig
Markus Hamedinger, Austria
Næsten alle patienter sagde, at de ikke ville have taget deres behandling, hvis de havde kendt til omfanget af de potentielle risici, eller sådanne risici havde været beskrevet tilstrækkeligt i indlægssedlerne.
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.
Ber Oomen, European Specialist Nurses Organisations (ESNO) Taler 20:
Ber Oomen, European Specialist Nurses Organisations (ESNO) Speaker 20:
Enikő Pongrácz, Ungarn
Enikő Pongrácz, Hungary
EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) indledte en gennemgang af denne klasse af lægemidler efter indberetninger om alvorlige og langvarige bivirkninger, hovedsagelig fra muskler, sener, led og nervesystemet.
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.
• Sørg for bedre uddannelse af sundhedspersoner (bl.a. under medicinstudiet).
• Improve education for healthcare professionals (including during medical training).
Patienterne opfordrede også til bedre uddannelse af sundhedspersonale, bl.a. under medicinstudiet, ved den indledende undervisning i denne klasse af lægemidler.
Patients also called for better education of healthcare professionals, including during medical training when they first learn about this class of medicines.
Patienter og sundhedspersoner bemærkede, at der var behov for at forbedre behandlingen af patienter med bivirkninger og sammenbringe ekspertise på forskellige områder til at behandle den brede række af symptomer.
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.
Andre deltagere, herunder sundhedspersoner og forskere, opfordrede til mere forskning, herunder genetisk forskning, til at fastlægge præcis, ved hvilke mekanismer lægemidlerne forårsager disse bivirkninger, hvordan bivirkningerne påvirker forskellige populationer, og det samlede omfang af risikoen.
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.
I dag anvendes quinoloner og fluoroquinoloner til over 120 indikationer i EU, herunder forskellige typer urinvejs- og respirationsinfektioner, genitale og gastrointestinale infektioner og hud-, knogle- og ledinfektioner.
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.
Graham Bothamley, European Respiratory Society (ERS) Taler 17:
Graham Bothamley, European Respiratory Society (ERS) Speaker 17:
I mange tilfælde var quinoloner og fluoroquinoloner blevet ordineret for mindre infektioner eller anvendt til at forebygge infektioner.
In many cases, quinolones and fluoroquinolones had been prescribed for minor infections or were used to prevent infections.
Elsa Leitão, Tyskland
Elsa Leitão, Germany
Mange patienter fortsatte med at tage disse lægemidler, mens de havde symptomer, uden at de var klar over en mulig sammenhæng med deres behandling.
Many patients continued taking these medicines while they had symptoms, unaware of a possible link to their treatments.
Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Taler 16:
Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Speaker 16:
• Begræns anvendelsen af quinoloner og fluoroquinoloner til situationer, hvor der ikke er andre alternativer.
• Restrict quinolone and fluoroquinolone use to situations where there are no alternatives.
Mary McCarthy, European Union of General Practioners (UEMO) Taler 18:
Mary McCarthy, European Union of General Practioners (UEMO) Speaker 18:
Quinoloner og fluoroquinoloner er syntetiske antibiotika, der anvendes mod en bred vifte af bakterielle infektioner.
Quinolones and fluoroquinolones are synthetic antibiotics used for a wide range of bacterial infections.
Seneproblemerne gjaldt sædvanligvis flere sener, modsat mange andre senelidelser, der normalt kun omfatter en enkelt sene.
The tendon problems generally affected multiple tendons, in contrast to many other tendon disorders which usually affect one.
• Tag højde for, hvordan visse fødevarer påvirker patienternes symptomer, især kød fra dyr behandlet med quinoloner og fluoroquinoloner.
• Consider how certain foods affect patients' symptoms, particularly meat treated with quinolones and fluoroquinolones.
Nogle patienter beskrev også, at symptomerne forværredes, da de senere fik smertestillende NSAID'er eller steroider.
Some patients also reported a worsening of symptoms when they were subsequently given NSAID painkillers or steroids.
Jaroslaw Linka, Polen
Jaroslaw Linka, Poland
Mange patienter blev ikke orienteret om risiciene og sagde, at de ikke følte, at der blev lyttet til dem, da de beskrev en mulig sammenhæng med deres behandling.
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.
Sammendrag af EMA's offentlige høring om antibiotika af quinolon- og fluoroquinolontypen
Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics
Patienterne opfordrede til bedre anerkendelse af toksicitetsmønsteret for quinoloner og fluoroquinoloner (undertiden betegnet "fluoroquinolon-associeret handicapsyndrom").
Patients called for better recognition of patterns of toxicity with quinolones and fluoroquinolones (sometimes referred to as ‘fluoroquinolone-associated disability syndrome').
Nogle læger var opmærksomme på symptomer fra akillessenen, men der var mange, som ikke havde kendskab til, anerkendte eller indberettede andre bivirkninger med mulig sammenhæng med quinoloner og fluoroquinoloner.
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.
Patienter beskrev livsforandrende symptomer efter behandling med antibiotika af quinolon- og fluoroquinolontypen, herunder smerter og handicap af flere års varighed, og hvor nogle patienter kun oplevede begrænset bedring med tiden.
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.
Patienternes var enige om, at anvendelsen af antibiotika af quinolon- og fluoroquinolontypen burde begrænses stærkt.
The consensus among patients was that the use of quinolone and fluoroquinolone antibiotics should be greatly restricted.
Nogle patienter beskrev forværring af symptomerne efter at have spist visse fødevarer, herunder kød og fisk, og patienterne var bekymrede for kunne have været blevet udsat for quinoloner og fluoroquinoloner, som var anvendt til at behandle husdyr.
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.
• Hvilke yderligere foranstaltninger kan der efter din mening træffes for at optimere sikkerheden ved anvendelse af quinoloner og fluoroquinoloner?
• In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?
• Hvad er din opfattelse af quinoloners og fluoroquinoloners rolle i behandlingen af infektioner?
• What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
EMA/413844/2018
Telephone +44 (0)20 3660 6000
Manex Bettan Arguinzoniz, Spanien
Manex Bettan Arguinzoniz, Spain Speaker 3:
• Sundhedspersonerne var sædvanligvis uvidende om omfanget og sværhedsgraden af de mulige symptomer bortset fra lidelser i akillessenen.
• Healthcare professionals were generally unaware of the range and severity of possible symptoms,
• Hvad er din opfattelse af de risici, der forbindes med anvendelse af quinoloner og fluoroquinoloner?
• What is your view of the risks associated with quinolone and fluoroquinolone use?
• Sørg for bedre kommunikation om toksiciteten af quinoloner og fluoroquinoloner, herunder mulige risikofaktorer, og tilføj flere oplysninger i produktinformationen, herunder indlægssedlen.
• Improve communication on quinolone and fluoroquinolone toxicity, including possible risk factors,
Disse bivirkninger blev indberettet af patienter, der tog lægemidlerne gennem munden eller ved injektion.
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.
Noter
Notes
Richard Cooknell, Det Forenede Kongerige Taler 4:
Richard Cooknell, UK
En dedikeret webside indeholder flere oplysninger om den igangværende gennemgang af antibiotika af quinolon- og fluoroquinolontypen.
More information on the ongoing review of quinolone and fluoroquinolone antibiotics is available on a dedicated webpage.
Joshua Sutton, Det Forenede Kongerige Taler 11:
Joshua Sutton, UK
Miriam van Staveren, Nederlandene
Miriam van Staveren, The Netherlands Speaker 12 (joining via telephone):
Mere om proceduren
More about the procedure
Kontakt vores pressesekretær Monika Benstetter
Contact our press officer Monika Benstetter
Information til patienter
Information to patients
Den 30. oktober 2014 EMA/698187/2014
30 October 2014 EMA/698187/2014
Lægemidler med bromocriptin er godkendt via nationale procedurer til forskellige anvendelser i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Kroatien, Cypern, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Litauen, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige, samt i Norge.
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.
Lægemidler med styrkerne 5 og 10 mg er ikke indiceret til sådan anvendelse.
Products with strengths of 5 or 10 mg are not indicated for such use.
Gennemgangen af oralt bromocriptin blev indledt i den 17. juli 2013 på anmodning af Frankrig i medfør af artikel 31 i direktiv 2001/83/EF.
The review of oral bromocriptine was initiated at the request of France on 17 July 2013, under Article 31 of Directive 2001/83/EC.
Tlf. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
• Kvinder, der har spørgsmål eller bekymringer, bør kontakte lægen eller apoteket.
• Women who have any questions or concerns should consult their doctor or pharmacist.
Mere om lægemidlet
More about the medicine
Disse data blev først gennemgået af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
• Blodtrykket bør overvåges nøje, navnlig på den første behandlingsdag.
• Blood pressure should be carefully monitored especially during the first day of therapy.
Det absolutte antal indberettede tilfælde efter markedsføring er dog lavt, navnlig i betragtning af, at bromocriptin har været på markedet i EU siden 1973, og at patienteksponeringen har været betydelig; den totale incidensrate skønnes at være 0,005 % til
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%.
Produktinformationen for lægemidler indeholdende bromocriptin er ajourført i henhold hertil.
The product information for bromocriptine-containing medicines has been updated accordingly.
1 CMD(h) er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater.
1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Bromocriptin er et dopaminreceptorstimulerende middel.
Bromocriptine is a dopamine receptor agonist.
Anbefalingerne fra PRAC blev fremsendt til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)), som vedtog et endeligt standpunkt.
The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
På grund af den mulige risiko for alvorlige bivirkninger er der udsendt anbefalinger, der skal gøre det klart, at disse lægemidler ikke rutinemæssigt må bruges til at forhindre eller standse mælkeproduktionen.
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.
Skønt mælkeproduktionen til sidst standser af sig selv, kan kvinden i mellemtiden få brystforstørrelse, udsivning af mælk, ubehag og smerter.
Although milk production eventually stops, women in the meantime can experience breast engorgement, leakage of milk, discomfort and pain.
CMD(h) repræsenterer EU's medlemsstater og har ansvaret for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
De fås på recept til indtagelse gennem munden som tabletter og kapsler og har været markedsført under forskellige handelsnavne (bl.a. Parlodel) og som kopipræparater.
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.
Gennemgangen var foranlediget af betænkeligheder i Frankrig over et øget antal indberetninger af sjældne, men potentielt alvorlige eller dødbringende, bivirkninger, navnlig hjerte-kar-bivirkninger (såsom hjerteanfald og slagtilfælde), neurologiske bivirkninger såsom krampeanfald, og psykiske bivirkninger (såsom hallucinationer og maniske episoder).
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).
Da mælkeproduktionen til sidst standser af sig selv, hvis barnet ikke ammes, og da der findes andre behandlingsmuligheder, anmodede den franske lægemiddelstyrelse (ANSM) EMA om at gennemgå lægemidlerne og vurdere, om fordelene ved denne anvendelse af dem fortsat opvejer risiciene.
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.
Bromocriptin bør ikke rutinemæssigt anvendes til at forhindre eller standse mælkeproduktionen og må ikke anvendes hos kvinder med øget risiko for alvorlige bivirkninger, herunder kvinder med forskellige lidelser, der medfører forhøjet blodtryk, og hos kvinder, som lider af eller tidligere har lidt af hjertesygdom eller svære psykiske sygdomme.
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.
• Blodtrykket bør overvåges under behandlingen (navnlig den første dag), således at tidlige tegn på problemer kan opdages, og behandlingen standses.
• 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.
Det efterligner nogle af virkningerne af hormonet dopamin, som regulerer frigivelsen af et andet hormon, prolaktin, der igen kontrollerer mælkeproduktionen.
It mimics some of the actions of dopamine, a hormone that regulates the release of another hormone, prolactin, which in turn controls lactation.
Eftersom CMD(h) vedtog sit standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som vedtog en retligt bindende afgørelse for hele EU den 30. oktober 2014.
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.
Den 20. august 2014 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h))1 ved en flertalsafgørelse anbefalinger for oral brug af bromocriptinholdige lægemidler til at forebygge eller standse produktionen af brystmælk efter en fødsel.
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.
• De må kun anvendes til dette formål, hvis der er lægelig begrundelse for det, f.eks. for at undgå yderligere gener hos kvinder, der mister et spædbarn under eller lige efter fødslen, og hos kvinder, der er hivsmittet (for at undgå risiko for overførsel af virusset gennem mælken).
• 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).
Bromocriptin anvendes også til behandling af andre lidelser såsom for højt indhold af prolaktin i kroppen (hyperprolaktinæmi) og Parkinsons sygdom; disse anvendelser er dog ikke omfattet af denne gennemgang.
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.
Blodtrykket bør overvåges, så behandlingen omgående kan standses ved tegn på stigning.
Blood pressure should be monitored so that early signs of an increase can be detected and treatment stopped immediately.
Lægemidlet bør ikke rutinemæssigt anvendes til at forhindre eller standse mælkeproduktionen efter en fødsel
The medicine should not be used routinely for preventing or stopping milk production after childbirth
Ovenstående anbefalinger er baseret på en gennemgang af den foreliggende evidens for sikkerheden og virkningen af oralt bromocriptin til forebyggelse og suppression af laktation.
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.
Af de foreliggende data kunne der imidlertid ikke drages konklusioner om virkningen af bromocriptin ved mastitis, brystforstørrelse eller smertefuld brystforstørrelse.
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.
• Ved smerter i brystkassen eller usædvanligt svær hovedpine skal patienten øjeblikkelig kontakte lægen.
• Patients who develop chest pain or an unusually severe headache should consult their doctor urgently.
• Lægemidler med bromocriptin er i mange EU-lande godkendt til indtagelse gennem munden for at forhindre eller standse mælkeproduktionen efter fødsel hos kvinder, der ikke ammer.
• 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.
• Som konklusion udelukker de foreliggende sikkerhedsdata ikke en kausal sammenhæng mellem anvendelse af bromocriptin og alvorlige kardiovaskulære, neurologiske eller psykiatriske hændelser.
• 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.
Hvis der opstår hypertension, suspekte smerter i thorax, svær, progredierende eller ikkeremitterende hovedpine (med eller uden synsforstyrrelser) eller tegn på CNS-toksicitet, skal behandlingen seponeres, og patienten straks vurderes.
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.