FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, for pefloxacin PRAC considered that some of the indications mentioned above in Table 1 should be removed as below:
Danish: For så vidt angår pefloxacin, fandt PRAC dog, at nogle af de ovennævnte indikationer i tabel 1 bør slettes som følger:
English: • Prevention of traveller's diarrhoea Preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone Septicaemia Selective decontamination of gastrointestinal tract in patients with compromised immune system Prevention of exacerbations in women with recurring urinary tract
Danish: • Forebyggelse af turistdiarré Præoperative forberedelser ved kronisk cholesteatomatøs otitis og kronisk otitis, der har spredt sig til knoglerne Sepsis Selektiv dekontaminering af mave-tarm-kanalen hos patienter med kompromitteret immunsystem Forebyggelse af eksacerbationer hos kvinder med recidiverende urinvejsinfektion
English: Category 3: deletion of indications
Danish: Kategori 3: sletning af indikationer
English: Regarding the indication “Selective decontamination of gastrointestinal tract in patients with compromised immune system” the benefit of using (fluoro)quinolones is extremely limited.
Danish: Ved indikationen "Selektiv dekontaminering af mave-tarm-kanalen hos patienter med kompromitteret immunsystem" er fordelen ved brug af (fluor)quinoloner ekstremt begrænset.
English: Table 2 - Category 2 indications
Danish: Tabel 2 - kategori 2-indikationer
English: • Recurrent cystitis in women
Danish: • Recidiverende cystitis hos kvinder
English: The recommendation for the restriction to last line is based on the below:
Danish: Anbefalingen om begrænsning til sidstelinjebehandling er baseret på følgende:
English: • Category 1: The newly identified nature of the safety concerns does not substantially modify the existing benefit/risk balance and no change to the indication is warranted.
Danish: • Kategori 1: Den nyligt identificerede sikkerhedsmæssige betænkelighed ændrer ikke afgørende ved det eksisterende benefit/risk-forhold, og det er ikke nødvendigt at ændre indikationen.
English: The poor pefloxacin antimicrobial activity against indication specific pathogen precludes its use in this indication as there is a high risk of inadequate coverage and resistance development.
Danish: Pefloxacins ringe antimikrobielle virkning mod indikationsspecifikke patogener gør det umuligt at anvende stoffet i denne indikation, da der er høj risiko for utilstrækkelig virkning og udvikling af resistens.
English: Mainly CRS is caused by the following pathogens: Streptococcus pneumoniae, Haemophilus influenza, Staphylococcus spp., Streptococcus pyogenes, Moraxella catarrhalis, Klebsiella pneumoniae, anaerobes, and Chlamydia spp.
Danish: Kronisk bihulebetændelse skyldes især følgende patogener: Streptococcus pneumoniae, Haemophilus influenza, Staphylococcus spp., Streptococcus pyogenes, Moraxella catarrhalis, Klebsiella pneumoniae, anaerobe bakterier, og Chlamydia spp.
English: For these indications, the (fluoro)quinolones medicinal products should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Danish: For disse indikationer bør (fluor)quinolonholdige lægemidler kun anvendes, når det anses for uhensigtsmæssigt at bruge andre antibakterielle stoffer, der sædvanligvis anbefales til behandling af disse infektioner.
English: Malignant otitis externa (MOE), also known as necrotizing otitis externa, is a severe invasive bacterial infection that involves the external auditory canal and skull base.
Danish: Malign otitis externa, også kendt som nekrotiserende otitis externa, er en svær invasiv bakterieinfektion, der involverer den ydre øregang og kraniet.
English: Preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone
Danish: Præoperative forberedelser ved kronisk cholesteatomatøs otitis og kronisk otitis, der har spredt sig til knoglerne
English: For the purpose of this review, the indications are grouped under heading/cover terms, taking into account all available data, in particular the impact of the long-lasting, disabling and potentially irreversible adverse drug reactions on the benefit-risk balance of these indications:
Danish: I forbindelse med denne gennemgang er indikationerne grupperet i henhold til overskrifter/paraplytermer, idet der tages højde for alle tilgængelige data, især indvirkningen af langvarige, invaliderende og potentielt irreversible bivirkninger på benefit/risk-forholdet for disse indikationer:
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for medicinal products containing substances related to quinolones and fluoroquinolones for systemic and inhaled use.
Danish: • I henhold til artikel 31 i direktiv 2001/83/EF behandlede PRAC sagen på grundlag af data fra bivirkningsovervågning af lægemidler indeholdende stoffer, der er relateret til quinoloner og fluorquinoloner, til systemisk anvendelse og inhalation.
English: For the indications falling within this category 1, the PRAC considered that their benefit overweighs the risks, in particular the identified risk of occurrence of long-lasting, disabling and potentially irreversible adverse drug reactions.
Danish: For så vidt angår de indikationer, der hører til i denne kategori 1, vurderede PRAC, at deres fordel opvejer risiciene, især den identificerede risiko for forekomst af langvarige, invaliderende og potentielt irreversible bivirkninger.
English: Thus, the current role of pefloxacin for the management of bacterial prostatitis and the benefit of using pefloxacin to treat these infections is unknown.
Danish: Derfor er pefloxacins aktuelle rolle i behandlingen af bakteriel prostatitis og fordelen ved at anvende stoffet til behandling af disse infektioner ukendt.
English: Regarding the high success rate in placebo treated patients and the mild severity of sinusitis in majority of the cases, the benefit of antibiotics should be carefully weight against the occurrence of adverse drug reactions and the potential risk of selection of resistance.
Danish: I forhold til den høje succesrate hos placebo-behandlede patienter og den milde sværhedsgrad af bihulebetændelse i de fleste af tilfældene bør fordelen ved antibiotika afvejes nøje mod forekomsten af bivirkninger og den mulige risiko for selektiv resistens.
English: Considering the limited benefit and in view of the overall risk related to the use of these medicinal products including the risk of long-lasting, disabling and potentially irreversible reactions, the benefit-risk balance of these medicinal products is negative.
Danish: I betragtning af den begrænsede fordel og den samlede risiko ved brug af disse lægemidler, herunder risikoen for langvarige, invaliderende og potentielt irreversible bivirkninger, er benefit/risk-forholdet for disse lægemidler negativt.
English: No updated data (e.g. in relation to the current prevalence of resistance in Enterobacterales and other Gram-negative bacteria) are available regarding the antimicrobial activity of pefloxacin, as no clinical breakpoints were defined by EUCAST.
Danish: Der findes ingen opdaterede data (f.eks. i forhold til den aktuelle prævalens af resistens hos Enterobacteriaceae og andre gramnegative bakterier) for pefloxacins antimikrobielle virkning, da EUCAST ikke har defineret nogen kliniske grænseværdier.
English: Therefore, the benefit-risk balance in the indication of uncomplicated cystitis is considered changed and (fluoro)quinolones should only be used in patients who have no alternative treatment options.
Danish: Benefit/riskforholdet i indikationen ukompliceret cystitis anses derfor for ændret, og (fluor)quinoloner bør kun anvendes hos patienter, der ikke har andre behandlingsmuligheder.
English: In case of bacterial otitis externa, the main common causative pathogens are Pseudomonas aeruginosa and Staphylococcus aureus, often occurring as a polymicrobial infection (Dibb 1991; Clark et al. 1997).
Danish: Ved bakteriel otitis externa er de primære almindelige patogener, der forårsager sygdommen, Pseudomonas aeruginosa og Staphylococcus aureus; sygdommen opstår ofte som en polymikrobiel infektion (Dibb 1991; Clark et al. 1997).
English: • Prophylaxis after surgeries or interventions in the urogenital system o prophylaxis after surgeries or interventions in the urogenital system o Prophylaxis of recurrent urinary infections following trans-urethral surgery or transrectal prostatic biopsy
Danish: • Profylakse efter kirurgi eller indgreb i det urogenitale system o profylakse efter kirurgi eller indgreb i det urogenitale system o Profylakse af recidiverende urinvejsinfektion efter transuretralkirurgi eller transrektal prostatabiopsi Vaginale infektioner
English: In patients with cystic fibrosis, the predominant pathogen causing broncho-pulmonary infections is Pseudomonas aeruginosa.
Danish: Hos patienter med cystisk fibrose er det primære patogen, der medfører bronkopulmonale infektioner, Pseudomonas aeruginosa.
English: The benefit risk balance of four substances (pipemidic acid, nalidixic acid, flumequine and cinoxacin) is considered negative.
Danish: Benefit/risk-forholdet for fire stoffer (nalidixinsyre, pipemedinsyre, cinoxacin og flumequin) vurderes at være negativt.
English: The indications falling within the category 3 are considered to have a benefit-risk balance negative, taking into account the abovementioned safety concern and in view of the limited benefits of (fluoro)quinolones in the concerned diseases.
Danish: De indikationer, der hører til i kategori 3, anses for at have et negativt benefit/risk-forhold under hensyntagen til det førnævnte sikkerhedsproblem og i lyset af de begrænsede fordele ved (fluor)quinoloner i de pågældende sygdomme.
English: Chronic suppurative otitis media
Danish: Kronisk suppurativ otitis media
English: (Fluoro)quionolones therapy might be beneficial in patients with recurrent and/or non-responsive cases of AOM caused by the multidrug-resistant etiological agents where other conventional antibiotics are likely to be ineffective.
Danish: (Fluor)quinolon-behandling kan være gavnlig hos patienter med recidiverende og/eller ikkeresponsive tilfælde af akut otitis media, der skyldes multiresistente, ætiologiske stoffer, hvor andre konventionelle antibiotika sandsynligvis er ineffektive.
English: In category 1 indications, it is considered that the newly identified safety concern (long-lasting, disabling and potentially irreversible adverse drug reactions) has a limited impact on the benefit-risk balance of all quinolones/ fluoroquinolones containing products.
Danish: I kategori 1-indikationer vurderes det, at den nyligt identificerede sikkerhedsmæssige betænkelighed (langvarige, invaliderende og potentielt irreversible bivirkninger) har en begrænset indvirkning på benefit/risk-forholdet for alle quinolon-/fluorquinolonholdige lægemidler.
English: The role of pefloxacin in the treatment of bacterial prostatitis is considered as not being demonstrated.
Danish: Pefloxacins rolle i behandlingen af bakteriel prostatitis anses ikke for påvist.
English: Complicated skin and skin structure infections / Complicated skin and soft tissue infections Gastro-intestinal infections
Danish: Komplicerede hud- og hudstrukturinfektioner/komplicerede hud- og bløddelsinfektioner Gastrointestinale infektioner
English: In addition to the amendments to the indications mentioned above, the PRAC recommended other changes to the product information including further warnings and precautions of use relating to the long-lasting, disabling and potentially irreversible adverse drug reactions.
Danish: I tillæg til de ændringer af indikationerne, der er nævnt ovenfor, anbefalede PRAC andre ændringer af produktinformationen, herunder yderligere advarsler og forsigtighedsregler vedrørende brugen i relation til de langvarige, invaliderende og potentielt irreversible bivirkninger.
English: • Intra-abdominal infections
Danish: • Intraabdominale infektioner
English: For the indications falling under category 2, the risk benefit balance is considered impacted by the abovementioned safety concern in view of the benefits of (fluoro)quinolones in the concerned diseases, as well as the limited severity of some of these conditions and thus the use in these indications needs to be restricted.
Danish: For indikationerne i kategori 2 anses benefit/risk-forholdet for at være påvirket af ovenstående sikkerhedsmæssige betænkelighed i lyset af fordelene ved (fluor)quinoloner i de pågældende sygdomme og af den begrænsede sværhedsgrad af nogle af disse sygdomme, og derfor er det nødvendigt at begrænse brugen af dem i disse indikationer.
English: AOM is regarded as a multifactorial and polymicrobial disease, which usually occurs as a complication of viral upper respiratory tract infection (Marom et al 2012).
Danish: Akut otitis media anses for at være en multifaktoriel og polymikrobisk sygdom, der typisk opstår som en komplikation til en virusinfektion i de øvre luftveje (Marom et al., 2012).
English: Table 3 - Category 3 indications
Danish: Tabel 3 - kategori 3-indikationer
English: 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.
Danish: 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.
English: The benefitrisk balance of (fluoro)quinolone use in pharyngitis and/or tonsillitis of bacterial origin is therefore considered negative.
Danish: Benefit/risk-forholdet for anvendelsen af (fluor)quinoloner mod faryngitis og/eller tonsilitis af bakteriel oprindelse anses derfor som negativt.
English: 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.
Danish: 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.
English: Selective decontamination of gastrointestinal tract in patients with compromised immune system
Danish: Selektiv dekontaminering af mave-tarm-kanalen hos patienter med kompromitteret immunsystem
English: Genital tract / gynaecological infections
Danish: Genitale/gynækologiske infektioner
English: In EU, the indication of meningitis is only authorised for pefloxacin.
Danish: I EU er kun pefloxacin godkendt i indikationen "meningitis".
English: The risk/benefit balance of (fluoro)quinolone use in septicaemia as stated is considered negative and the indication should be deleted.
Danish: Benefit/risk-forholdet for anvendelse af (fluor)quinoloner ved sepsis anses derfor som negativt, og indikationen bør slettes.
English: In the EU, the indication endocarditis is approved exclusively for pefloxacin.
Danish: I EU er kun pefloxacin godkendt i indikationen "endocarditis".
English: 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.
Danish: Udvalget anbefaler som følge heraf, at betingelserne for markedsføringstilladelserne ændres for pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin og rufloxacin.
English: • Acute uncomplicated infection of lower urinary tract (simple cystitis) Acute exacerbation of COPD including chronic bronchitis
Danish: • Akut ukompliceret infektion i de nedre urinveje (simpel cystitis) Akut eksacerbation af KOL, herunder kronisk bronkitis
English: • Category 3: The newly identified safety concern changes benefit risk to negative and these indications shall be deleted.
Danish: • Kategori 3: Den nyligt identificerede sikkerhedsmæssige betænkelighed gør benefit/riskforholdet negativt, og disse indikationer skal slettes.
English: 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.
Danish: 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.
English: Chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis
Danish: Kroniske lungeinfektioner forårsaget af Pseudomonas aeruginosa hos voksne patienter med cystisk fibrose
English: Moreover, increasing resistance to (fluoro)quinolones and a possibility of disabling ADRs in this mostly non-severe condition needs to be considered.
Danish: Derudover bør den stigende resistens over for (fluor)quinoloner og risikoen for invaliderende bivirkninger i denne som oftest ikkesvære indikation tages i betragtning.
English: 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.
Danish: 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.
English: • Tonsillitis Laryngitis Acute bronchitis Prophylaxis of travellers´ diarrhoea
Danish: • Tonsillitis Laryngitis Akut bronkitis Profylakse af turistdiarré
English: As for the cases of pharyngitis of bacterial aetiology, the most common pathogen causing bacterial acute pharyngitis is Streptococcus pyogenes.
Danish: Ligesom ved tilfældene af faryngitis af bakteriel ætiologi er det mest almindelige patogen, der forårsager bakteriel akut faryngitis, Streptococcus pyogenes.
English: The PRAC also recommended the suspension of the following quinolones medicinal products, nalidixic acid, pipemidic acid, cinoxacin and flumequine.
Danish: PRAC anbefalede også suspendering af de quinolonholdige lægemidler nalidixinsyre, pipemedinsyre, cinoxacin og flumequin.
English: • Simple uncomplicated acute cystitis
Danish: • Simpel ukompliceret akut cystitis
English: Indication heading
Danish: Indikationsoverskrift
English: 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.
Danish: 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.
English: Gyneacological infections
Danish: Gynækologiske infektioner
English: The benefit-risk balance is therefore negative and the indication should be deleted.
Danish: Benefit/risk-forholdet er derfor negativt, og indikationen bør slettes.
English: • Acute bacterial sinusitis Acute otitis media
Danish: • Akut bakteriel bihulebetændelse Akut otitis media
English: • 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.
Danish: • 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.
English: • 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.
Danish: • PRAC anbefalede også ændringer i produktinformationen, herunder indikationen og yderligere advarsler og forsigtighedsregler i forhold til langvarige, invaliderende og potentielt irreversible bivirkninger.
English: Indication heading Uncomplicated cystitis
Danish: Indikationsoverskrift Ukompliceret cystitis
English: Pharyngitis-Tonsillitis
Danish: Faryngitis-tonsilitis
English: The current role of pefloxacin for the treatment of this indication is considered as not established.
Danish: Pefloxacins aktuelle rolle i behandlingen af denne indikation anses ikke for klarlagt.
English: 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.
Danish: Benefit/risk-forholdet i indikationen akut eksacerbation af kronisk bronkitis og KOL anses kun som positivt hos patienter, der ikke har andre behandlingsmuligheder.
English: • 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.
Danish: • 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.
English: 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.
Danish: 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.
English: Respiratory infections
Danish: Luftvejsinfektioner
English: 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).
Danish: 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).