FrancophonIA/ELRC3.0 huggingface dataset:
English: Recurrent UTIs are common among young, healthy women, even though they generally have anatomically and physiologically normal urinary tracts (Hooton 2001).
Danish: Recidiverende urinvejsinfektioner er almindelige blandt unge, raske kvinder, selvom de generelt har anatomisk og fysiologisk normale urinveje (Hooton, 2001).
English: Prostatitis, epididymo-orchitis
Danish: Prostatitis, epididymitis/orchitis
English: Fluoroquinolones and quinolones (hereinafter ‘(fluoro)quinolones') are a class of synthetic antibacterial agents that have been used in clinical practice since 1961.
Danish: Fluorquinoloner og quinoloner (herefter "(fluor)quinoloner") er en klasse syntetiske antibakterielle stoffer, der er blevet anvendt i klinisk praksis siden 1961.
English: Inappropriate use of (fluoro)quinolones is associated with rapidly increasing bacterial resistance to these agents (Committee on Infectious Diseases 2006; Murray and Baltimore 2007).
Danish: Uhensigtsmæssig brug af (fluor)quinoloner er forbundet med hurtigt stigende bakterieresistens over for disse stoffer (Committee on Infectious Diseases 2006; Murray and Baltimore 2007).
English: The agent used for peri-procedural prophylaxis should ideally not be one that may be required for treatment of infections.
Danish: Det stof, der anvendes til perioperativ profylakse, bør ideelt set ikke være ét, som kan blive nødvendigt til behandling af infektioner.
English: It is also noted that these substances are not mentioned in any clinical guidelines and their place in the therapeutic armamentarium of urinary / genital / gastro-intestinal infections is not justified anymore.
Danish: Det bemærkes også, at disse stoffer ikke er nævnt i nogen kliniske retningslinjer, og deres plads blandt behandlingsmulighederne ved infektioner i urinvejene, kønsdelene og mave-tarmkanalen er ikke længere berettiget.
English: Based on the available data, approximately 90% cases of pharyngitis and 70% cases of tonsillitis in adults and children are of viral origin (Zoorob et al 2012).
Danish: På baggrund af de tilgængelige data er ca. 90 % af tilfældene af faryngitis og 70 % af tilfældene af tonsilitis hos voksne og børn af viral oprindelse (Zoorob et al., 2012).
English: (Fluoro)quinolones are sometimes recommended in the initial treatment of serious and/or complicated cases of aerobic vaginitis (i.e. to control acute symptoms in severe cases such as staphylococcal or macular streptococcal vaginitis).
Danish: (Fluor)quinoloner anbefales indimellem i den indledende behandling af alvorlige og/eller komplicerede tilfælde af aerob vaginitis (dvs. til at kontrollere akutte symptomer i svære tilfælde som f.eks. stafylokokker eller makulær streptokok-vaginitis).
English: It should be noted that pefloxacin has a poor antimicrobial activity against P. aeruginosa, thus, the benefit is very limited.
Danish: Det bør bemærkes, at pefloxacin har en ringe antimikrobiel virkning mod P. aeruginosa, og derfor er fordelen meget begrænset.
English: Vaginal rinsing with povidone iodine can provide rapid relieve of symptoms but does not provide long-term cure of the bacterial loads.
Danish: Rensning af vagina med povidonjod kan give hurtig lindring af symptomerne, men er ingen langvarig helbredelse af bakteriebelastningen.
English: Pefloxacin antimicrobial activity against bacterial strains relevant for this indication is low (Hoogkamp-Korstanje 1997).
Danish: Pefloxacins antimikrobielle virkning mod bakteriestammer, der er relevante for denne indikation, er lav(Hoogkamp-Korstanje 1997).
English: In addition, pefloxacin has low urinary excretion (34% of pefloxacin dose including its active metabolite norfloxacin) (Naber 2001).
Danish: Derudover udskilles pefloxacin i ringe grad i urinen (34 % af pefloxacin-dosen, herunder dets aktive metabolit norfloxacin) (Naber 2001).
English: Overall, septicaemia is non-specific and is generally a secondary condition (a consequence) to a primary infection.
Danish: Generelt er sepsis ikkespecifik og en sekundær lidelse (en konsekvens) til en primær infektion.
English: Infective endocarditis is a severe and life-threatening disease associated with high mortality.
Danish: Infektiøs endocarditis er en svær og livstruende sygdom, der er forbundet med høj dødelighed.
English: Local antibiotics most suitable are preferably non-absorbed and broad spectrum, especially covering enteric gram-positive and gram-negative aerobes, like kanamycin.
Danish: De mest egnede lokale antibiotika er især ikkeabsorberede og bredspektrede, især dem, der omfatter enteriske grampositive og gramnegative aerober, som f.eks. kanamycin.
English: Table 5 - Category 4 indications to be reworded according to accurate medical terms
Danish: Tabel 5 - kategori 4-indikationer, der skal omformuleres i overensstemmelse med korrekte medicinske termer
English: However, lack of symptoms relief and risk of complications (specifically pyelonephritis) have been found to be higher in non-antibiotic group.
Danish: Imidlertid er manglende lindring af symptomer og risikoen for komplikationer (især pyelonefritis) højere i den gruppe, der ikke fik antibiotika.
English: According to the European Association of Urology (EAU) guideline (Bonkat et al 2017), prevention of uncomplicated rUTIs includes counselling and behavioural modifications.
Danish: I henhold til det europæiske urologiselskabs retningslinje (Bonkat et al., 2017) omfatter forebyggelse af ukomplicerede urinvejsinfektioner rådgivning og adfærdsændringer.
English: Antibiotic prophylaxis is not recommended for most travellers (CDC 2017; Hill et al 2006; Public Health Agency of Canada 2015; Riddle et al 2016).
Danish: Antibiotisk profylakse anbefales ikke hos de fleste turister (CDC, 2017; Hill et al., 2006; Public Health Agency of Canada, 2015; Riddle et al., 2016).
English: Based on the evaluation of available guidelines and position papers, the prophylaxis of travellers´ diarrhoea should be limited to high-risk short-term travellers only.
Danish: På grundlag af evalueringen af tilgængelige retningslinjer og holdningspapirer bør profylaksen af turistdiarré begrænses til højrisikopersoner, der foretager rejser af kortere varighed.
English: Therefore fluoroquinolones should be reserved as a last line treatment in patients where other therapeutic options are not effective or not tolerated.
Danish: Fluorquinoloner bør derfor forbeholdes til sidstelinjebehandling hos patienter, hvor andre terapeutiske muligheder ikke er effektive eller ikke tolereres.
English: While the efficacy of topical antibacterial therapy was confirmed in clinical trials, the use of systemic therapy is questionable (Freedman 1978; Yelland 1993; Cannon 1970) and should be limited to persistent otitis externa or local or systemic spread of the infection (Sander 2001).
Danish: Selvom virkningen af topisk behandling med antibakterielle midler blev bekræftet i kliniske studier, er brugen til systemisk behandling tvivlsom (Freedman 1978; Yelland 1993; Cannon 1970) og bør begrænses til vedvarende otitis externa eller lokal eller systemisk spredning af infektionen (Sander 2001).
English: The earliest substances of this class (starting with nalidixic acid) are non-fluorinated, possess only a narrow spectrum of activity against Gram-negative bacteria and have generally been replaced in clinical practices by more recent antibiotics.
Danish: De tidligste stoffer i denne klasse (startende med nalidixinsyre) er ikkefluorinerede, har kun et snævert virkningsspektrum mod gramnegative bakterier og er generelt blevet erstattet i klinisk praksis af nyere antibiotika.
English: Risk factors associated with appearance of the assessed ADRs remain one of the main uncertainties and further examination of the risk factors should be further explored.
Danish: De risikofaktorer, der er forbundet med forekomsten af de vurderede bivirkninger, er fortsat en af de primære betænkeligheder og bør undersøges yderligere.
English: Streptococcus species have only moderate sensitivity to pefloxacin, with MIC90 values ranging from 3.1 to 32 mg/L (Gonzalez JP, Henwood JM.
Danish: Streptococcus-arter har kun moderat følsomhed over for pefloxacin med MIC90-værdier fra 3,1-32 mg/l (Gonzalez JP, Henwood JM.
English: (1) too broad and encompass too many medical entities in terms of the scientific evidence available for (fluoro)quinolone benefit/risk assessment, in view of the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) and in relation to the (sub) indications mentioned in categories 1, 2 or 3 above.
Danish: (1) de enten er for brede og omfatter for mange medicinske enheder i forhold til den videnskabelige evidens, der er tilgængelig for vurdering af (fluor)quinoloners benefit/riskforhold set i lyset af Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) og i forhold til de (under)indikationer, der er nævnt i kategori 1, 2 og 3 foroven.
English: • Category 2: The newly identified safety concern necessitates a restriction of (fluoro)quinolone use in these indications.
Danish: • Kategori 2: Den nyligt identificerede sikkerhedsmæssige betænkelighed nødvendiggør en begrænsning af brugen af (fluor)quinoloner i disse indikationer.
English: Indeed, due to their chemical structure and the related pharmacodynamic and pharmacokinetic profile (very narrow range of antibacterial activity, high minimal inhibitory concentrations) their benefit is limited based on the current available data.
Danish: På grund af deres kemiske struktur og den relaterede farmakodynamiske og farmakokinetiske profil (meget snævert interval for antibakteriel virkning, høje minimale hæmmende koncentrationer) er deres fordel faktisk begrænset vurderet ud fra de aktuelle, tilgængelige data.
English: (Fluoro)quinolones have not been extensively studied for the treatment of acute bacterial meningitis and therefore there is only sparse data available regarding the use of pefloxacin in patients with meningitis that do not allow establishing efficacy.
Danish: (Fluor)quinoloner er ikke blevet grundigt undersøgt til behandling af akut bakteriel meningitis, og der er derfor kun sparsomme oplysninger vedrørende brug af pefloxacin hos patienter med meningitis, som ikke gør det muligt at fastslå effekten.
English: The pathogens associated with pyelonephritis consists mainly of E. coli (75% to 95%), with occasional other species of Enterobacteriaceae, such as P. mirabilis and K. pneumoniae, and of Staphylococci.
Danish: De patogener, der er forbundet med pyelonefritis, består hovedsageligt af E. coli (75-95 %) og lejlighedsvist af andre arter af Enterobacteriaceae, som f.eks. P. mirabilis og K. pneumoniae, og af Staphylococci.
English: (Fluoro)quinolones do not sufficiently cover the spectrum of pathogens which are commonly identified in patients with pharyngitis and/or tonsillitis.
Danish: (Fluor)quinoloner dækker ikke i tilstrækkelig grad spektret af patogener, der typisk identificeres hos patienter med faryngitis og/eller tonsilitis.
English: Category 2: indications to be restricted
Danish: Kategori 2: indikationer, der skal begrænses
English: Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catharralis were isolated from sputum samples in up to 45% of patients with acute bronchitis (Macfarlane et al. 1993) but their role is difficult to distinguish because of potential oropharyngeal colonization in healthy individuals (Laurenzi et al. 1961; Smith and Lockwood 1986).
Danish: Streptococcus pneumoniae, Haemophilus influenzae og Moraxella catharralis blev isoleret fra sputumprøver hos op til 45 % af patienterne med akut bronkitis (Macfarlane et al., 1993), men deres rolle er vanskeligt at skelne mellem på grund af mulig orofaryngeal kolonisering hos raske personer (Laurenzi et al., 1961; Smith og Lockwood 1986).
English: Therefore, the risks outweigh the benefits in this indication and the indication should be deleted.
Danish: Derfor opvejer risiciene fordelene i denne indikation, og indikationen bør slettes.
English: While these ADRs are already included in the EU product information of quinolones and fluoroquinolones, the severity and persistence of these known ADRs has not yet been systematically evaluated in the EU.
Danish: Disse bivirkninger er allerede nævnt i den europæiske produktinformation for quinoloner og fluorquinoloner, men sværhedsgraden og persistensen er endnu ikke blevet systematisk undersøgt i EU.
English: The benefit of systemic antibiotic prophylaxis in general in the clean-contaminated ear surgery is currently not sufficiently substantiated and the benefit over topical antibiotics is not proven.
Danish: Overordnet set er fordelen ved systemisk antibiotisk profylakse i forbindelse med ren-kontamineret ørekirurgi aktuelt ikke i tilstrækkelig grad dokumenteret, og fordelen i forhold til topiske antibiotika er ikke påvist.
English: Furthermore, the terminology ‘Infection of cerebrospinal fluid' is considered by the PRAC to be incorrect from a medical perspective.
Danish: Desuden anser PRAC termen "Infektion af rygmarvsvæsken" for at være ukorrekt set fra et medicinsk synspunkt.
English: Being one of the most common paediatric diseases, AOM with its spontaneous cure rate above 80% might be considered as a non-serious and inmost cases self-limited infection.
Danish: Det er en af de mest almindelige børnesygdomme, og som følge af den høje spontane helbredelsesrate på over 80 % anses den som en ikkealvorlig og i de fleste tilfælde selvbegrænsende infektion.
English: Furthermore, activity of ofloxacin against relevant pathogens is too limited to justify use in nosocomial pneumonia.
Danish: Desuden er ofloxacins virkning mod relevante patogener for begrænset til at berettige anvendelse mod nosokomiel lungebetændelse.
English: The later ones (starting with norfloxacin) possess an increasingly broader spectrum of activity; they are fluorinated at C-6 carbon of their basic ring structure, hence so-called fluoroquinolones.
Danish: De nyere antibiotika (startende med norfloxacin) har et stadig bredere virkningsspektrum; de er fluorinerede ved C-6kulstoffet i deres grundlæggende ringstruktur og kaldes derfor for fluorquinoloner.
English: Infectious laryngitis is mostly a self-limiting viral disease (caused by parainfluenza, rhinovirus, influenza and adenovirus) that does not respond to antibiotic therapy (Higgins, 1974).
Danish: Infektiøs laryngitis er som oftest en selvbegrænsende virussygdom (forårsaget af parainfluenza, rhinovirus, influenza og adenovirus), som ikke reagerer på antibiotikabehandling (Higgins, 1974).
English: In majority of cases, otitis externa is caused by bacterial infection (Dibb 1991; Rosenfeld et al. 2014), however, also other causative agents such as fungal infection or non-infectious dermatologic processes should be considered.
Danish: I de fleste tilfælde er otitis externa forårsaget af en bakterieinfektion (Dibb 1991; Rosenfeld et al. 2014), men andre årsager som f.eks. svampeinfektion eller ikkeinfektiøse dermatologiske processer bør dog også overvejes.
English: Acute bronchitis
Danish: Akut bronkitis
English: Apart from that, the available data shows a poor antimicrobial activity of pefloxacin against Pseudomonas (King and Phillips 1986) and no updated susceptibility data on pefloxacin are available as the European Committee on Antimicrobial Susceptibility Testing (EUCAST) has not defined clinical breakpoints for pefloxacin (http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Rationale_documents/Ciproflo xacin_rationale_1.9.pdf).
Danish: Bortset fra dette viser de tilgængelige data, at pefloxacin har en ringe antimikrobiel virkning mod Pseudomonas (King and Phillips 1986), og der findes ingen opdaterede følsomhedsdata for pefloxacin, da EUCAST-komitéen (European Committee on Antimicrobial Susceptibility Testing) ikke har defineret kliniske grænseværdier for pefloxacin (http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Rationale_documents/Ciproflo xacin_rationale_1.9.pdf).
English: Indeed, the PRAC could not identify any solid evidence on the efficacy of (fluoro)quinolone use in this indication.
Danish: PRAC kunne faktisk ikke identificere nogen form for robust evidens for virkningen af (fluor)quinoloner i denne indikation.
English: The benefit-risk balance remains positive and its incremental change does not warrant any amendment to the indication.
Danish: Benefit/risk-forholdet er fortsat positivt, og dets gradvise ændring nødvendiggør ikke en ændring af indikationen.
English: Septicaemia is a severe and life-threatening disease associated with high mortality.
Danish: Sepsis er en svær og livstruende sygdom, der er forbundet med høj dødelighed.
English: Group B streptococci (GBS), Escherichia coli, Staphylococcus aureus and Enterococcus faecalis are the organisms most frequently associated with Aerobic Vagnitis (Rampersaud et al 2012).
Danish: Gruppe B-streptococci (GBS), Escherichia coli, Staphylococcus aureus og Enterococcus faecalis er de organismer, der oftest forbindes med aerob vaginitis (Rampersaud et al, 2012).
English: Table 1 - Category 1 indications: no modification of the indications
Danish: Tabel 1 - kategori 1-indikationer: ingen ændring af indikationerne
English: In case of atypical sexually transmitted pathogens, such as Mycoplasma hominis and Chlamydia trachomatis or Ureaplasma urealyticum, pefloxacin antimicrobial activity is low (Gonzales and Henwood 1989).
Danish: I tilfælde af atypiske seksuelt overførte patogener som f.eks. Mycoplasma hominis og Chlamydia trachomatis eller Ureaplasma urealyticum er pefloxacins antimikrobielle virkning lav (Gonzales and Henwood 1989).
English: Relevant stakeholders, including academia and MAHs, are encouraged to perform further research that would further characterise these disabling adverse drug reactions.
Danish: Relevante interessenter, herunder forskere og indehavere af markedsføringstilladelse, opfordres til at gennemføre yderligere forskning, som kan karakterisere disse invaliderende bivirkninger i endnu højere grad.
English: Typical microorganisms that can cause infective endocarditis include Viridans streptococci, Streptococcus bovis, HACEK group, Staphylococcus aureus or enterococci.
Danish: Typiske mikroorganismer, der kan forårsage infektiøs endocarditis, er bl.a. Viridans streptococci, Streptococcus bovis, HACEK-gruppen, Staphylococcus aureus eller enterococci.
English: • Core elements of a direct healthcare professional communication were agreed, together with the timelines for its distribution.
Danish: • Hovedelementerne i et direkte brev til sundhedspersoner blev vedtaget tillige med en tidsplan for udsendelsen heraf.
English: Acute otitis externa is a cellulitis of the ear canal skin and sub-dermis, with acute inflammation and variable oedema.
Danish: Akut otitis externa er en cellulitis i øregangens hud og subdermis med akut inflammation og variable ødemer.
English: Latter colonisations are frequent, but inflammatory infection rare, the use of oral antibiotics in women with AV is discouraged (Donders et al 2015; Wang et al. 2016).
Danish: Koloniseringer med sidstnævnte er hyppige, men inflammatorisk infektion er sjælden, og brugen af orale antibiotika hos kvinder med vaginale infektioner frarådes (Donders et al., 2015; Wang et al., 2016).
English: Almost 95% of MOE cases reported in the literature are attributed to Pseudomonas aeruginosa (Bovo et al. 2012).
Danish: Næsten 95 % af tilfældene af malign otitis externa i litteraturen skyldes Pseudomonas aeruginosa (Bovo et al. 2012).
English: The use of (fluoro)quinolones is not warranted in mild to moderate episodes with alternative treatment options.
Danish: Brugen af (fluor)quinoloner er ikke nødvendig ved milde til moderate tilfælde med alternative behandlingsmuligheder.
English: Indication heading Complicated urinary tract infections/pyelonephritis
Danish: Indikationsoverskrift Komplicerede urinvejsinfektioner/pyelonefritis
English: ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Danish: Akut bakteriel rhinosinuit er en ikkesvær infektion, der er forbundet med høje spontane helbredelsesrater (90 %).
English: The therapy should be targeted to the primary infection taking into account PK/PD characteristics of the treatment and site of the infection.
Danish: Behandlingen bør rettes mod den primære infektion under hensyntagen til de farmakokinetiske/farmakodynamiske karakteristika ved behandlingen og infektionsstedet.
English: Prophylaxis of invasive infections due to Neisseria meningitidis Inhalation anthrax (post-exposure prophylaxis and curative treatment) Infection in immunocompromised patients
Danish: Profylakse af invasive infektioner forårsaget af Neisseria meningitidis Lungemiltbrand (profylakse efter udsættelse for smitte og kurativ behandling) Infektion hos immunkompromitterede patienter
English: For these indications, the recommendation for the deletion of the indication is based on the below:
Danish: Anbefalingen om sletning af disse indikationer er baseret på følgende:
English: The research should focus on current gaps and uncertainties in knowledge, including but not exclusive to, risk factors associated with these specific ADRs, treatments for the ADRs, identification of possible biomarkers to predict these ADRs and underlying mechanisms of action that could lead to the respective reactions.
Danish: Forskningen bør fokusere på huller og usikkerheder i viden, herunder blandt andet risikofaktorer forbundet med disse specifikke bivirkninger, behandlinger for bivirkningerne, identificering af mulige biomarkører, der kan forudsige bivirkningerne, og underliggende virkningsmekanismer, der kan medføre de pågældende reaktioner.
English: Category 1: no modification of the indications
Danish: Kategori 1: ingen ændring af indikationerne
English: AV requires a treatment based on microscopy findings and a combined local treatment with any of the following may yield the best results: antibiotic (infectious component), steroids (inflammatory component) and/or oestrogen (atrophy component).
Danish: Vaginale infektioner kræver behandling baseret på mikroskopi-fund, og en kombineret lokal behandling med et af følgende midler kan give de bedste resultater: antibiotika (infektiøs bestanddel), steroider (inflammatorisk bestanddel) og/eller østrogener (atrofisk bestanddel).
English: Apart from that, same resistance patterns to pefloxacin are shared with other quinolones making pefloxacin not suitable for the use in peri-procedural prophylaxis.
Danish: Bortset fra dette deles de samme resistensmønstre over for pefloxacin med andre quinoloner, hvilket gør pefloxacin uegnet til perioperativ profylakse.
English: However, for pefloxacin PRAC considered that some of the indications mentioned above in Table 1 should be restricted as below:
Danish: For så vidt angår pefloxacin, fandt PRAC dog, at nogle af de ovennævnte indikationer i tabel 1 bør begrænses som følger:
English: • Simple uncomplicated acute cystitis in the premenopausal adult women
Danish: • Simpel ukompliceret akut cystitis hos præmenopausale voksne kvinder
English: The poor antimicrobial activity of pefloxacin to Pseudomonas aeruginosa precludes from its use in nosocomial pneumonia where P. aeruginosa is a frequent pathogen.
Danish: Pefloxacins ringe antimikrobielle virkning mod Pseudomonas aeruginosa gør, at det ikke kan bruges ved nosokomiel lungebetændelse, hvor P. aeruginosa er et hyppigt patogen.
English: It is considered that uncomplicated cystitis constitutes a non-severe, non-life-threatening indication for which the potential risk outweighs the benefit when using (fluoro)quinolones as first line treatment.
Danish: Det vurderes, at ukompliceret cystitis udgør en ikkesvær, ikkelivstruende indikation, for hvilken den mulige risiko opvejer fordelen, når (fluor)quinoloner anvendes som førstelinjebehandling.
English: Rhinosinusitis is a group of disorders characterized by inflammation of the mucosa of the nose and the paranasal sinuses.
Danish: Rhinosinuit er en gruppe sygdomme, der er kendetegnet ved inflammation af slimhinderne i næsen og de paranasale bihuler.