natgillin/translations-raw huggingface dataset:
Vurderingen af spontane data efter markedsføring og litteraturdata samt evalueringen af de tilgængelige ikkekliniske og kliniske oplysninger vedrørende de mulige underliggende mekanismer ved langvarige, invaliderende og potentielt permanente bivirkninger gav tilstrækkelig evidens til at støtte en årsagssammenhæng mellem (fluor)quinoloner og potentielt invaliderende bivirkninger.
Assessment of the post-marketing spontaneous and literature data together with the evaluation of available non-clinical and clinical information related to the possible underlying mechanisms of longlasting, disabling and potentially permanent ADRs provided enough evidence to support causal relationship between the (fluoro)quinolones and potentially disabling ADRs.
Benefit/risk-forholdet for anvendelsen af (fluor)quinoloner mod faryngitis og/eller tonsilitis af bakteriel oprindelse anses derfor som negativt.
The benefitrisk balance of (fluoro)quinolone use in pharyngitis and/or tonsillitis of bacterial origin is therefore considered negative.
I betragtning af ovenstående fandt PRAC, at benefit/risk-forholdet for (fluor)quinoloner til præoperative forberedelser ved kronisk cholesteatomatøs otitis og kronisk otitis, der har spredt sig til knoglerne, er negativt.
Having considered the above, the PRAC considered that the benefit-risk balance of (fluoro)quinolones in preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone is negative.
Selektiv dekontaminering af mave-tarm-kanalen hos patienter med kompromitteret immunsystem
Selective decontamination of gastrointestinal tract in patients with compromised immune system
Genitale/gynækologiske infektioner
Genital tract / gynaecological infections
I EU er kun pefloxacin godkendt i indikationen "meningitis".
In EU, the indication of meningitis is only authorised for pefloxacin.
Benefit/risk-forholdet for anvendelse af (fluor)quinoloner ved sepsis anses derfor som negativt, og indikationen bør slettes.
The risk/benefit balance of (fluoro)quinolone use in septicaemia as stated is considered negative and the indication should be deleted.
I EU er kun pefloxacin godkendt i indikationen "endocarditis".
In the EU, the indication endocarditis is approved exclusively for pefloxacin.
Udvalget anbefaler som følge heraf, at betingelserne for markedsføringstilladelserne ændres for pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin og rufloxacin.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin.
• Akut ukompliceret infektion i de nedre urinveje (simpel cystitis) Akut eksacerbation af KOL, herunder kronisk bronkitis
• Acute uncomplicated infection of lower urinary tract (simple cystitis) Acute exacerbation of COPD including chronic bronchitis
• Kategori 3: Den nyligt identificerede sikkerhedsmæssige betænkelighed gør benefit/riskforholdet negativt, og disse indikationer skal slettes.
• Category 3: The newly identified safety concern changes benefit risk to negative and these indications shall be deleted.
I lyset af ovenstående konkluderede PRAC, at benefit/risk-forholdet for de fluorquinolonholdige lægemidler pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin og rufloxacin fortsat er positivt, forudsat at de aftalte ændringer i produktinformationen og andre risikominimerende foranstaltninger indføres.
In view of the above, the PRAC concluded that the benefit-risk balance of the following fluoroquinolone medicinal products, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin remains favourable subject to the agreed amendments to the product information and other risk minimisation measures.
Kroniske lungeinfektioner forårsaget af Pseudomonas aeruginosa hos voksne patienter med cystisk fibrose
Chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis
Derudover bør den stigende resistens over for (fluor)quinoloner og risikoen for invaliderende bivirkninger i denne som oftest ikkesvære indikation tages i betragtning.
Moreover, increasing resistance to (fluoro)quinolones and a possibility of disabling ADRs in this mostly non-severe condition needs to be considered.
Vurderingen er baseret på sværhedsgraden af målsygdommene, deres mulige alvorlige komplikationer, herunder forebyggelse af manifestationer af irreversible anatomiske eller funktionelle læsioner, den gunstige vævsfordeling af (fluor)quinoloner og specificiteten af det patogen, der er omfattet af (fluor)quinoloners mikrobiologiske spektrum.
This is in view of the severity of the diseases targeted, their possible serious complications including prevention of manifestations of irreversible anatomical or functional lesions, the favourable tissue distribution of (fluoro)quinolones and specificity of the pathogen covered by the microbiological spectrum of (fluoro)quinolones.
• Tonsillitis Laryngitis Akut bronkitis Profylakse af turistdiarré
• Tonsillitis Laryngitis Acute bronchitis Prophylaxis of travellers´ diarrhoea
Ligesom ved tilfældene af faryngitis af bakteriel ætiologi er det mest almindelige patogen, der forårsager bakteriel akut faryngitis, Streptococcus pyogenes.
As for the cases of pharyngitis of bacterial aetiology, the most common pathogen causing bacterial acute pharyngitis is Streptococcus pyogenes.
PRAC anbefalede også suspendering af de quinolonholdige lægemidler nalidixinsyre, pipemedinsyre, cinoxacin og flumequin.
The PRAC also recommended the suspension of the following quinolones medicinal products, nalidixic acid, pipemidic acid, cinoxacin and flumequine.
• Simpel ukompliceret akut cystitis
• Simple uncomplicated acute cystitis
Indikationsoverskrift
Indication heading
Problemer relateret til anvendelsen af (fluor)quinoloner ved kirurgisk profylakse skal altid overvejes, herunder udviklingen og spredningen af resistente patogener og forekomsten af bivirkninger relateret til (fluor)quinoloner, herunder risikoen for potentielt invaliderende bivirkninger.
Problems related to the use of (fluoro)quinolones in surgical prophylaxis must always be considered, including the development and dissemination of resistant pathogens and the occurrence of adverse drug reactions due to (fluoro)quinolones, including the risk of potentially disabling ADRs.
Gynækologiske infektioner
Gyneacological infections
Benefit/risk-forholdet er derfor negativt, og indikationen bør slettes.
The benefit-risk balance is therefore negative and the indication should be deleted.
• Akut bakteriel bihulebetændelse Akut otitis media
• Acute bacterial sinusitis Acute otitis media
• Som konsekvens anbefalede PRAC suspendering af de quinolonholdige lægemidler nalidixinsyre, pipemidinsyre, cinoxacin og flumequin, da de ikke længere har et positivt benefit/risk-forhold i nogen indikationer.
• As a consequence, the PRAC recommended the suspension of the following quinolones medicinal products, nalidixic acid, pipemidic acid, cinoxacin and flumequine, as they do not retain any indication with a positive benefit-risk.
• PRAC anbefalede også ændringer i produktinformationen, herunder indikationen og yderligere advarsler og forsigtighedsregler i forhold til langvarige, invaliderende og potentielt irreversible bivirkninger.
• Also, the PRAC recommended changes to the product information including the indication and further warnings and precautions of use relating to the long-lasting, disabling and potentially irreversible adverse drug reactions.
Indikationsoverskrift Ukompliceret cystitis
Indication heading Uncomplicated cystitis
Faryngitis-tonsilitis
Pharyngitis-Tonsillitis
Pefloxacins aktuelle rolle i behandlingen af denne indikation anses ikke for klarlagt.
The current role of pefloxacin for the treatment of this indication is considered as not established.
Benefit/risk-forholdet i indikationen akut eksacerbation af kronisk bronkitis og KOL anses kun som positivt hos patienter, der ikke har andre behandlingsmuligheder.
Overall, the benefit-risk balance in the indication of acute exacerbation of chronic bronchitis and COPD is considered positive only in patients who have no alternative treatment options.
• PRAC konkluderede, at nogle af de alvorlige bivirkninger, der er forbundet med brug af quinoloner og fluorquinoloner, i meget sjældne tilfælde kan være langvarige, invaliderende og potentielt irreversible, og at disse risici er en klasseeffekt.
• The PRAC concluded that some of the serious adverse drug reactions associated with the use of quinolones and fluoroquinolones could very rarely be long-lasting, disabling and potentially irreversible and that these risks are a class effect.
På grundlag af den manglende videnskabelige evidens for virkning og anbefalingen fra IDWP anses benefit/risk-forholdet for anvendelse af (fluor)quinoloner til "Selektiv dekontaminering af mave-tarmkanalen hos patienter med kompromitteret immunsystem" som negativt.
Based on the lack of scientific evidence on efficacy and the recommendation of the IDWP, the benefit/risk balance of (fluoro)quinolone use in “Selective decontamination of gastrointestinal tract in patients with compromised immune system” is considered negative.
Luftvejsinfektioner
Respiratory infections
I betragtning af den utilstrækkelige virkning over for de patogener, der er involveret i disse infektioner, konkluderede PRAC, at anvendelsen af pefloxacin bør begrænses til de patienter, hos hvem det vurderes uhensigtsmæssigt at anvende andre antibakterielle stoffer til behandling af disse infektioner (sidstelinjebehandling).
Considering insufficient coverage of the pathogens involved in these infections, PRAC conclude that the use of pefloxacin should be restricted to the patients in whom it is considered inappropriate to use other antibacterial agents for the treatment of these infections (last line option).
I betragtning af pefloxacins potentielle utilstrækkelige virkning mod de patogener, der forårsager meningitis, og de risici, der er forbundet med uhensigtsmæssig behandling af meningitis, anses det overordnede benefit/risk-forhold som negativt, og indikationen bør derfor slettes.
Considering potential insufficient coverage of pathogens responsible for meningitis by pefloxacin and risks associated with inappropriate treatment of meningitis, the overall benefit-risk balance of this indication is considered negative and therefore should be deleted.
I lyset af risikoen ved brug af (fluor)quinoloner, herunder risikoen for langvarige, invaliderende og potentielt permanente bivirkninger, er det samlede benefit/risk-forhold i indikationen otitis media (akut) ændret, og stofferne bør kun anvendes hos patienter, der ikke har andre behandlingsmuligheder.
Therefore in view of the risk related to the use of (fluoro)quinolones, including the risk of long-lasting, disabling or potentially permanent ADRs, the overall benefit-risk balance in the indication of otitis media (acute) has changed and should be only used in patients who have no alternative treatment option.
PRAC vurderede alle de fremlagte data for (fluor)quinolonholdige lægemidler med hensyn til langvarige, invaliderende og potentielt irreversible bivirkninger.
The PRAC considered the totality of the data submitted for (fluoro)quinolones medicinal products with regard to long-lasting, disabling and potentially irreversible ADRs.
I betragtning af pneumokokkers ringe følsomhed over for pefloxacin og de mulige risici konkluderede PRAC, at anvendelsen af pefloxacin til behandling af akutte eksacerbationer af kronisk bihulebetændelse bør begrænses til de patienter, hos hvem det vurderes uhensigtsmæssigt at anvende andre antibakterielle stoffer til behandling af disse infektioner (sidstelinjebehandling).
Considering the poor pneumococcal susceptibility of pefloxacine and the potential risks, PRAC concluded that the use of pefloxacin in the treatment of acute exacerbations of chronic sinusitis should be restricted to the patients in whom it is considered inappropriate to use other antibacterial agents for the treatment of these infections (last line option).
Forebyggelse af infektioner under kirurgiske indgreb
Prevention of infection in surgical procedures
I lyset af risikoen ved anvendelse af (fluor)quinoloner, herunder risikoen for langvarige, invaliderende og potentielt permanente alvorlige bivirkninger, bør (fluor)quinoloner kun anvendes, når det vurderes uhensigtsmæssigt at bruge antibakterielle stoffer, der sædvanligvis anbefales til den indledende behandling af akut bakteriel rhinosinuit.
Therefore in view of the risk related to the use of (fluoro)quinolones, including the risk of long-lasting, disabling and potentially permanent serious ADRs, (fluoro)quinolones should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of ABS infections.
I betragtning af det høje resistensmønster over for pefloxacin, den mulige udvikling af krydsresistens over for andre quinoloner og den nyligt identificerede risiko for langvarige og potentielt invaliderende bivirkninger opvejer risiciene ved brug af pefloxacin stoffets fordele.
Considering the high resistance pattern to pefloxacin, possible development of cross resistance to other quinolones, and the newly recognised risk of long-lasting and potentially disabling adverse effects, the risks of using pefloxacin outweigh its benefits.
Lungebetændelse forårsaget af gramnegative bakterier Tuberkulose
Pneumonia due to Gram-negative bacteria
Under hensyntagen til effektdataene, risikoen for udvikling af resistens og risikoprofilen for (fluor)quinoloner samt den nye risiko for langvarige, invaliderende og potentielt irreversible bivirkninger vurderes det, at benefit/risk-forholdet kun er uændret i tilfælde af svære episoder af kronisk bronkitis og KOL, eller når andre behandlingsmuligheder ikke er effektive eller tåles.
Taking into consideration the efficacy data, the risk of developing resistance and the risk profile of (fluoro)quinolones together with the new risk of long-lasting, disabling and potentially irreversible ADRs it is concluded that benefit-risk balance is unchanged only in severe episodes of AECB and COPD or where other therapeutic options are not effective or tolerable.
Nosokomiel lungebetændelse
Nosocomial pneumonia
I betragtning af pefloxacins potentielle utilstrækkelige virkning mod de patogener, der forårsager endocarditis, og de risici, der er forbundet med uhensigtsmæssig behandling af endocarditis, anses benefit/risk-forholdet som negativt.
Considering potential insufficient coverage of pathogens responsible for endocarditis by pefloxacin and risks associated with inappropriate treatment of endocarditis, the benefit-risk balance of this indication is considered negative.
• PRAC fandt, at fluorquinoloner fortsat udgør en vigtig behandlingsmulighed for patienter med en alvorlig infektion, der er følsom over for disse antibiotika, på trods af risikoen for meget sjældne tilfælde af langvarige, invaliderende og potentielt irreversible bivirkninger.
• The PRAC concluded that for patients with a serious infection that is susceptible to these antibiotics fluoroquinolones remain an important treatment option despite the very rare risk of long-lasting, disabling and potentially irreversible adverse reactions.
• For så vidt angår milde og/eller selvbegrænsende infektioner, vurderede PRAC også, at fordelen ved behandling med quinoloner og fluorquinoloner ikke opvejer den samlede risiko ved brug af disse lægemidler, herunder den alvorlige risiko for langvarige, invaliderende og potentielt irreversible bivirkninger.
• The PRAC also concluded that in case of mild and/or self-limiting infections, the benefit of quinolones and fluoroquinolones treatment does not outweigh the overall risk related to the use of these medicinal products including serious risk of long-lasting, disabling and potentially irreversible adverse drug reactions.
• Eksacerbationer af bronkopulmonale infektioner hos patienter med cystisk fibrose
• Exacerbations of broncho-pulmonary infections in cystic fibrosis
PRAC konkluderede også, at benefit/risk-forholdet for de quinolonholdige lægemidler nalidixinsyre, pipemidinsyre, cinoxacin og flumequin ikke længere er positivt, og at markedsføringstilladelsen for dem bør suspenderes.
The PRAC also concluded that the benefit-risk balance of the following quinolone medicinal products, nalidixic acid, pipemidic acid, cinoxacin and flumequine is no longer favourable and should be suspended.
Indehaverne af markedsføringstilladelse bør begrunde doseringsanbefalingen under hensyn til relevante farmakodynamiske og farmakokinetiske data, der støtter indikationen.
The MAHs should justify the dosage recommendation and consider appropriate PK/PD data in support of the indication.
Øre-, næse- og halsinfektioner Hud- og bløddelsinfektioner Genitalinfektioner
Ear, nose and throat infections Skin and soft tissue infections Genital tract infections
Denne indbringelsesprocedure er iværksat som følge af bivirkningsovervågning og fokuserer på indvirkningen af langvarige, invaliderende og potentielt irreversible bivirkninger på benefit/riskforholdet for quinolon- og fluorquinolonholdige lægemidler til systemisk anvendelse og inhalation og behovet for relevante risikominimeringsforanstaltninger.
This pharmacovigilance referral procedure focuses on the review of the impact of long-lasting, disabling and potentially irreversible known adverse drug reactions (ADRs) on the benefit-risk balance of quinolones and fluoroquinolones containing products for systemic and inhalation use and the need for adequate risk minimisation measures.
På baggrund af effektdataene, den aktuelle behandlingsvejledning, de kendte risici ved brug af (fluor)quinoloner, herunder invaliderende bivirkninger, fandt PRAC, at benefit/risk-forholdet for (fluor)quinoloner til behandling af vaginitis er negativt.
Based on the efficacy data, current treatment guideline, known risks related to the use of (fluoro)quinolones including disabling ADRs the PRAC considered that benefit-risk balance of (fluoro)quinolones in vaginitis is negative.
Forebyggelse af eksacerbationer hos kvinder med recidiverende urinvejsinfektioner
Prevention of exacerbations in women with recurring urinary tract infections (UTI)
I betragtning af risikoen for langvarige, invaliderende og potentielt irreversible bivirkninger anses benefit/risk-forholdet for (fluor)quinoloner i indikationen "Forebyggelse af eksacerbationer hos kvinder med recidiverende urinvejsinfektioner" som negativt.
Taking into consideration the risk of long-lasting, disabling and potentially irreversible ADRs the benefit-risk balance of (fluoro)quinolones in the indication of prevention of exacerbations in women with recurring urinary tract infection is considered negative.
På grundlag af den stigende resistens blandt patogene mikroorganismer over for (fluor)quinoloner, sammenhængen mellem (fluor)quinoloner og C. difficile-associeret diarré, deres andre velkendte risici i tillæg til risikoen for sjældne, men vedvarende og invaliderende bivirkninger anses benefit/riskforholdet for (fluor)quinoloner til forebyggelse af turistdiarré som negativt.
Based on the increasing resistance of pathogenic microorganisms to (fluoro)quinolones, the association of (fluoro)quinolones with C. difficile-associated diarrhoea, their other well-known risks in addition to the risk of rare, nevertheless persistent and disabling ADRs, the benefit/risk balance of (fluoro)quinolones in the prophylaxis of travellers´ diarrhoea is considered negative.
Profylakse af turistdiarré
Prophylaxis of travellers´ diarrhoea
Bronkopulmonale infektioner hos patienter med cystisk fibrose eller bronchiectasis Samfundserhvervet lungebetændelse
Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis Community acquired pneumonia
• Eksacerbation af kronisk obstruktiv lungesygdom Akut bakteriel bihulebetændelse
• Exacerbation of chronic obstructive pulmonary disease Acute bacterial sinusitis
For at få hævet suspenderingen anbefalede PRAC, at indehaveren af markedsføringstilladelsen bør fremlægge relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for lægemidlet i en given indikation.
For lifting the suspension, the PRAC recommended that the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product in any indication.
• PRAC vurderede alle de fremlagte data for quinolon- og fluorquinolonholdige lægemidler med hensyn til langvarige, invaliderende og potentielt irreversible bivirkninger.
• The PRAC considered the totality of the data submitted for quinolones and fluoroquinolones medicinal products with regard to long-lasting, disabling and potentially irreversible ADRs.
• Malign otitis externa
• Malignant external otitis
• Akut eksacerbation af kronisk obstruktiv lungesygdom, herunder kronisk bronkitis
• Acute exacerbation of chronic obstructive pulmonary disease including chronic bronchitis
I lyset af ovenstående anses benefit/risk-forholdet i denne indikation som negativt.
In view of the above, the benefit-risk balance for this indication is considered negative.
Indikationsoverskrift Faryngitis-tonsilitis
Indication heading Pharyngitis-Tonsillitis
Infektion af rygmarvsvæsken
Infection of cerebrospinal fluid
I betragtning af den hyppigt virale ætiologi ved akut bronkitis, dens som oftest selvbegrænsende karakter, den stigende resistens blandt almindelige mikroorganismer over for (fluor)quinoloner og den mulige risiko for invaliderende bivirkninger anses benefit/risk-forholdet for (fluor)quinolon-behandling af akut bronkitis som negativt.
Taking into consideration the frequently viral aetiology of acute bronchitis, its mostly self-limiting nature, increasing resistance of common microorganisms to (fluoro)quinolones and the potential risk of disabling ADRs, the benefit-risk balance of (fluoro)quinolone use in acute bronchitis is considered negative.
Akut bakteriel rhinosinuit
Acute bacterial rhinosinusitis (ABS)
For at få hævet suspenderingen bør indehaveren af markedsføringstilladelsen indsende relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for disse lægemidler.
To lift the suspension, the MAH should submit appropriate scientific evidence to demonstrate a positive benefit-risk balance of these medicinal products.
For at få hævet suspenderingen bør indehaveren af markedsføringstilladelsen indsende relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for lægemidlet.
To lift the suspension the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product.
• Langvarig profylakse af recidiverende urinvejsinfektion
• Long term prophylaxis of recurrent urinary infections
I betragtning af laryngitis' primært virale ætiologi, dens som oftest selvbegrænsende karakter, den stigende resistens blandt almindelige mikroorganismer over for (fluor)quinoloner og den konstaterede risiko for forekomst af langvarige, invaliderende og potentielt irreversible bivirkninger anses benefit/risk-forholdet for (fluor)quinoloner til behandling af laryngitis som negativt.
Taking into consideration the predominant viral aetiology of laryngitis, its mostly self-limiting nature, increasing resistance of common microorganisms to (fluoro)quinolones and the identified risk of occurrence of long-lasting, disabling and potentially irreversible adverse drug reactions, the benefit-risk balance of (fluoro)quinolone use in laryngitis is considered negative.
Malign otitis externa
Malignant external otitis
Infektioner i nyrerne, urinvejene og kønsdelene Urinvejsinfektion
Infections of kidney, urinary tract and genitals Urinary tract infection
Sepsis
Septicaemia
Det overordnede benefit/risk-forhold for denne indikation er derfor negativt.
The overall benefit-risk ratio for this indication for is therefore considered negative.
Vaginale infektioner
Vaginal infections (AV)
Derfor er benefit/risk-forholdet for pefloxacin i denne indikation negativt.
Therefore, the benefit-risk in using pefloxacin in this indication is negative.