FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall summary of the scientific evaluation of all veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af alle veterinærlægemidler indeholdende enrofloxacin til administration gennem drikkevandet til kyllinger og/eller kalkuner (se bilag I)
English: Amend where applicable:
Danish: Rettes, hvor det er relevant:
English: Data collected from EU surveillance programmes showed that levels of resistance in E.coli to enrofloxacin varied from 0-47% depending on the EU Member State from which the isolates were sourced.
Danish: Data fra EU's overvågningsprogrammer viste, at resistensniveauet blandt E.coli over for enrofloxacin varierede fra 0 til 47 %, alt efter hvilken EU-medlemsstat, isolaterne hidrørte fra.
English: The CLSI breakpoint of ≥2 mg/l was used.
Danish: Der blev anvendt et CLSI-breakpoint på ≥2 mg/l.
English: Resistance has also been reported in Mycoplasma synoviae in the EU.
Danish: Der er desuden beskrevet resistens af Mycoplasma synoviae i EU.
English: 66-400 Gorzów Wlkp., Poland
Danish: 66-400 Gorzów Wlkp., Polen
English: Two studies were submitted to support the indication for A.paragallinarum, one using an experimental infection and one field study.
Danish: Der blev forelagt to undersøgelser til støtte for indikationen infektion med A.paragallinarum, hvoraf den ene var en eksperimentel infektion og den anden en feltundersøgelse.
English: 48308 Senden-Bosensell Germany
Danish: 48308 Senden-Bosensell Tyskland
English: CEVA SALUD ANIMAL, Carabela La Niña 12, 5ª 08017 Barcelona Spain
Danish: CEVA SALUD ANIMAL, Carabela La Niña 12, 5ª 08017 Barcelona Spanien
English: From the public health perspective, the main concern in regards to E.coli is the potential to transfer resistance genes from commensal E.coli in poultry to potentially pathogenic bacterial strains in man.
Danish: Fra et offentligt sundhedsperspektiv er hovedbetænkeligheden vedrørende E.coli potentialet for overførsel af resistente gener fra kommensale E.coli hos fjerkræ til bakteriestammer, der er potentielt patogene for mennesket.
English: Veterinary medicinal products as oral solutions contain 50 mg, 100 mg or 200 mg enrofloxacin per ml for use in drinking water.
Danish: Veterinærlægemidler som orale opløsninger indeholder 50 mg, 100 mg eller 200 mg enrofloxacin/ml til brug i drikkevandet.
English: However, from the data submitted it is not possible to determine an optimum dose rate to treat E.coli infection in chickens.
Danish: Af de forelagte data kan der imidlertid ikke fastlægges en optimal dosis til behandling af infektion med E.coli hos kyllinger.
English: 1ere Avenue 2065 M L I D 06516 Carros Cedex Spain
Danish: 1ere Avenue 2065 M L I D 06516 Carros Cedex Spanien
English: The data are sparse but show that lung levels and plasma Cmax are similar, while AUC is greater in turkeys.
Danish: Dataene er sparsomme, men viser, at koncentrationerne i lungevæv og Cmax i plasma hos de to arter svarer til hinanden, mens AUC er større hos kalkuner.
English: All but four studies were conducted with an experimental infection of E.coli.
Danish: Alle undersøgelserne undtagen fire blev udført med eksperimentel infektion med E.coli.
English: • Most of the studies provided were not reported to current standards, omitting raw data, analytical method validation data and storage stability data.
Danish: • I størstedelen af undersøgelserne var beskrivelsen ikke i overensstemmelse med nuværende standarder, idet der manglede rådata, valideringsdata for analysemetoder og data om stabilitet ved opbevaring.
English: The field studies were old and poor methods and reporting mean that the results cannot be considered supportive of the dose rate.
Danish: Feltundersøgelserne var gamle, og de anvendte metoder af ringe kvalitet, hvorfor resultaterne ikke kan anses for at støtte doseringen.
English: Les Corts 23, 08028 Barcelona Spain
Danish: Les Corts 23, 08028 Barcelona Spanien
English: A further study by the same authors determined that treatment with a therapeutic dose of enrofloxacin for a prolonged duration (up to 35 days) to 21 day old broiler chickens did not cause arthropathy in growing chickens and toxicity is not caused by cumulative effects.
Danish: Endnu en undersøgelse fra de samme forfattere fastslog, at behandling med en terapeutisk dosis af enrofloxacin af længere varighed (op til 35 dage) hos 21 dage gamle slagtekyllinger ikke forårsagede artropati hos kyllinger under opvækst, og at der ikke er toksicitet som følge af kumulative effekter.
English: Three references were provided to justify that the pharmacokinetics of enrofloxacin in turkeys is very similar to that of chickens.
Danish: Der blev forelagt tre referencer til påvisning af, at farmakokinetikken af enrofloxacin hos kalkuner er meget tæt på forholdene hos kyllinger.
English: Pharmacotherapeutic group: quinolone and quinoxaline antibacterials, fluoroquinolones.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle quinoloner og quinoxaliner, fluorquinoloner.
English: Clinical resistance of E.coli in chickens to ciprofloxacin was 1.9% in 1999-2000 and increased through 2002-2003 to 5.9% in 2005-2006.
Danish: Den kliniske resistens af E.coli hos kyllinger over for ciprofloxacin var 1,9 % i 1999-2000 og steg i løbet af 2002-2003 til 5,9 % i 2005-2006.
English: Although APEC is generally considered to be non-pathogenic in man, there is evidence that some strains may constitute a potential zoonotic risk.
Danish: Skønt fuglepatogene E. coli sædvanligvis anses for ikke-patogene for mennesker, er der evidens for, at visse stammer kan udgøre en potentiel zoonotisk risiko.
English: A considerable number of studies and references have been submitted to support the indication of E.coli.
Danish: Der er forelagt et betydeligt antal undersøgelser og referencer til støtte for indikationen infektion med E.coli.
English: Romania S.C. Romvac Company S.A. Şos.
Danish: Rumænien S.C. Romvac Company S.A. Şos.
English: Rákóczi u. 146.
Danish: TolnAgro Kft. Rákóczi u. 146.
English: Rates of decreased susceptibility of E. coli to ciprofloxacin (based on an epidemiological cut-off of 0.06 mg/l) were 19.3% in 1999-2000 and 33.5% in 2005-2006.
Danish: Andelen af E. coli med nedsat følsomhed over for ciprofloxacin (baseret på en epidemiologisk afskæringsværdi på 0,06 mg/l) var 19,3 % i 1999-2000 og 33,5 % i 2005-2006.
English: Arciucha 2, 24-100 Puławy Poland
Danish: Arciucha 2, 24-100 Puławy Polen
English: The active metabolite of enrofloxacin, ciprofloxacin, is categorised as a critically important antibiotic for use in human medicine.
Danish: Den aktive metabolit af enrofloxacin, ciprofloxacin, er kategoriseret som et afgørende vigtigt antibiotikum i humanmedicin.
English: Given the inter-individual variability surrounding Css values and the fact that several studies quoted MIC90 values for enrofloxacin against E. coli of 0.5-1 µg/ml, it seems that plasma concentrations greater than the MIC would not be achieved in all individuals against all isolates.
Danish: I betragtning af den interindividuelle variabilitet af Css-værdier og det forhold, at der i flere undersøgelser angives MIC90-værdier for enrofloxacin over for E. coli på 0,5-1 µg/ml, ser det ud til, at plasmakoncentrationerne ikke vil være over MIC hos alle individer over for alle isolater.
English: This review states that multiple studies have demonstrated the rapid development of fluoroquinolone resistant mutants in chickens originally infected with fluoroquinolone-susceptible C.jejuni, but treated with enrofloxacin.
Danish: I oversigten anføres det, at en lang række undersøgelser har vist hurtig udvikling af fluorquinolonresistente mutanter hos kyllinger, der oprindeligt blev inficeret med fluorquinolon-følsomme C.jejuni, men blev behandlet med enrofloxacin.
English: 4.11 Withdrawal period(s) Chickens: Meat and offal: 7 days.
Danish: 4.11 Tilbageholdelsestid(er) Kyllinger: Kød og indmad: 7 dage.
English: Czysta 4, 96-100 Skierniewice, Poland
Danish: Czysta 4, 96-100 Skierniewice, Polen
English: Dolgos u. 2., 1126 Budapest, Hungary
Danish: Dolgos u. 2., 1126 Budapest, Ungarn
English: 24010 Leon, Spain
Danish: 24010 Leon, Spanien
English: In this paper, clinical resistance was assessed against the CLSI break-point for ciprofloxacin of ≥4 mg/l.
Danish: I denne rapport blev den kliniske resistens vurderet efter et CLSI-breakpoint for ciprofloxacin på ≥4 mg/l.
English: The Joint ECDC/EFSA/EMA scientific opinion15 identified resistance to fluoroquinolones in salmonella of major concern for public health as ciprofloxacin is the antimicrobial of choice for treatment of severe or invasive Salmonella infections in humans.
Danish: Den fælles videnskabelige udtalelse fra ECDC/EFSA/EMA15 fastslog, at resistens over for fluorquinoloner hos salmonella er et stort problem for den offentlige sundhed, da ciprofloxacin er det foretrukne antibiotikum til behandling af svære eller invasive infektioner med Salmonella hos mennesker.
English: Dose rates less than 8.3 mg/kg bw were highly effective and the MIC study indicated that A.paragallinarium is highly susceptible to enrofloxacin.
Danish: En dosering på under 8,3 mg/kg kropsvægt var højeffektiv, og MIC-undersøgelsen viste, at A.paragallinarium er meget følsom over for enrofloxacin.
English: Although there is some evidence of resistance development in Mycoplasma, these organisms are rarely included in surveillance schemes and evidence of widespread resistance in the EU or lack of efficacy of the dose is hard to find.
Danish: Skønt der er nogen evidens for udvikling af resistens af Mycoplasma, er disse organismer sjældent omfattet af overvågningsordninger, og det er vanskeligt at finde evidens for udbredt resistens i EU eller manglende virkning af dosis.
English: Dose rates up to 35.4 mg/kg in young broilers showed optimum reduction in mortality and reduction in E.coli reisolation rate.
Danish: En dosering på op til 35,4 mg/kg hos unge slagtekyllinger viste optimal reduktion i mortalitet og reduktion og den andel, hos hvilken E.coli blev reisoleret.
English: The MIC of the challenge strain was 0.06 µg/ml, where reported.
Danish: MIC for belastningsstammen var 0,06 µg/ml i de tilfælde, hvor den blev oplyst.
English: Alternative treatments include amoxicillin, tetracyclines, macrolides and sulphonamides.
Danish: Behandlingsalternativerne er amoxicillin, tetracykliner, makrolider og sulfonamider.
English: • on the basis of the available residue depletion data in chickens and turkeys, the CVMP considered that withdrawal periods of 7 days for chicken meat and offal and 13 days for turkeys meat and offal were safe;
Danish: • ud fra de foreliggende restkoncentrationsdata hos kyllinger og kalkuner fandt CVMP, at en tilbageholdelsesperiode på 7 dage for kød og indmad fra kyllinger og 13 dage for kød og indmad fra kalkuner var sikker
English: Ireland HCS bvba, H. Kennisstraat 53, 2650 Edegem, Belgium
Danish: HCS bvba, H. Kennisstraat 53, 2650 Edegem, Belgien
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to consider the indications, dosage regimens and withdrawal periods for chickens and turkeys in order to ensure consumer safety, efficacious treatment in chickens and turkeys, as well as lower the risk of development of antimicrobial resistance to enrofloxacin.
Danish: Udvalget for Veterinærlægemidler (CVMP) blev her anmodet om at gennemgå indikationer, dosisregimer og tilbageholdelsestider for kyllinger og kalkuner for at opnå sikkerhed for forbrugerne og effektiv behandling af kyllinger og kalkuner og for at mindske risikoen for udvikling af antimikrobiel resistens over for enrofloxacin.
English: Bayer Sante 220 Avenue de la Recherche 59120 Loos France
Danish: 220 Avenue de la Recherche 59120 Loos
English: Netherlands Bayer B.V.
Danish: Nederlandene Bayer B.V.
English: Enrofloxacin is active against many Gram-negative bacteria, against Gram-positive bacteria and Mycoplasma spp.
Danish: Enrofloxacin er aktivt mod mange gramnegative bakterier, mod grampositive bakterier og mod Mycoplasma spp.
English: 10 mg enrofloxacin/kg bodyweight per day for 3-5 consecutive days.
Danish: 10 mg enrofloxacin/kg kropsvægt/dag i 3-5 på hinanden følgende dage.
English: Dzierżoniowska 21, 58-260 Bielawa Poland
Danish: Dzierżoniowska 21, 58-260 Bielawa Polen
English: Based on the Clinical Laboratory and Standards Institute (CLSI) resistance breakpoint of ≥2 µg/ml, one report shows that the upper range of MICs of M.synoviae increased further to 2/4 µg/ml in 2008 in The Netherlands with an 11.7% resistance noted.
Danish: Med baggrund i Clinical Laboratory and Standards Institute (CLSI's) resistens-breakpoint på ≥2 µg/ml viste en rapport, at den højeste MIC-værdi for M.synoviae i 2008 steg yderligere til 2-4 µg/ml i Nederlandene, og at der var konstateret en resistent andel på 11,7 %.
English: Concentrate for oral solution
Danish: Concentrate for Oral
English: Although there are some deficiencies in individual clinical studies, sufficient data have been presented to support the indications for M.synoviae and M.gallisepticum in chickens.
Danish: Skønt der er visse mangler i de enkelte kliniske undersøgelser, er de forelagte data tilstrækkelige til at underbygge indikationerne infektion med M.synoviae og M.gallisepticum hos kyllinger.
English: 24010 Leon Spain
Danish: 24010 Leon Spanien
English: MIC90 was determined as 0.5 µg/ml in most references.
Danish: MIC90 blev i de fleste kilder angivet til 0,5 µg/ml.
English: Romania INVESA C/ Esmeralda 19-21 08950 Esplugues de Llobregat, Barcelona Spain
Danish: Rumænien INVESA C/ Esmeralda 19-21 08950 Esplugues de Llobregat, Barcelona Spanien
English: The current dosing regimen for E. coli infections is not considered to be optimised in terms of efficacy or limiting the development of resistance in this target pathogen.
Danish: Det nuværende dosisregime ved infektion med E. coli anses ikke for at være optimeret hvad angår virkning eller begrænsning af resistensudvikling hos denne målpatogen.
English: A report by Sellyei et al, 20094, advised that although P.multocida isolates are susceptible to most widely used antimicrobials, remarkable resistance was detected to sulphonamides, tetracyclines, first generation quinolones and aminoglycosides.
Danish: En rapport af Sellyei et al, 20094, påpegede, at skønt isolater af P.multocida er følsomme for de mest udbredte antimikrobielle stoffer, var der bemærkelsesværdig resistens over for sulfonamider, tetracykliner, 1. generations quinoloner og aminoglykosider.
English: Kiszkowska 9, 62-200 Gniezno Poland
Danish: Kiszkowska 9, 62-200 Gniezno Polen
English: A risk has been identified regarding an insufficient dose rate against target pathogens, in particular E.coli, in both chickens and turkeys.
Danish: Der er konstateret risiko for utilstrækkelig dosering over for målpatogenerne, navnlig E.coli, både hos kyllinger og kalkuner.
English: Cmax was determined as approximately 0.67 µg/ml in healthy birds and 0.54 µg/ml in sick birds infected with APEC, and AUC0-24 as 7.4 mg/h/l in healthy birds and 7.7 mg/h/l in sick birds.
Danish: Cmax blev bestemt til ca. 0,67 µg/ml hos raske fugle og 0,54 µg/ml hos syge fugle inficeret med fuglepatogene E. coli og AUC0-24 til 7,4 mgh/l hos raske fugle og 7,7 mgh/l hos syge fugle.
English: Enrofloxacin is associated with a concentration-dependent bactericidal action and therefore AUC0-24h/MIC and Cmax/MIC ratios are considered indicators of efficacy.
Danish: Enrofloxacin har koncentrationsafhængig baktericid virkning, hvorfor forholdene AUC0-24h/MIC og Cmax/MIC anses for at være indikatorer for virkning.
English: The most recent report (Reinhardt et al 2005)2 demonstrated that, even with treatment with enrofloxacin at 10 mg/kg bw, the pathogen was not eradicated and when birds were stressed at up to 3 months after the initial inoculation, M.gallisepticum was reactivated.
Danish: Den nyeste rapport (Reinhardt et al 2005)2 viste, at uanset behandlingen med enrofloxacin ved 10 mg/kg kropsvægt blev den patogene organisme ikke udryddet, og at belastning af fuglene op til tre måneder efter den initiale inokulering medførte reaktivering af M.gallisepticum.
English: Usually resistance to fluoroquinolones arises spontaneously because of point mutations that result in amino acid substitutions within the topoisomeerase subunits gyrA, gyrB, parC or parE, a decreased expression of outer membrane porins, or an overexpression of multidrug efflux pumps.
Danish: Sædvanligvis opstår resistens over for fluorquinoloner spontant ved punktmutationer, der medfører aminosyresubstitutioner i topoisomerase-subunits gyrA, gyrB, parC eller parE, nedsat ekspression af poriner i ydermembranen eller overekspression af multistofudstrømningspumper.
English: Treatment of infections caused by the following bacteria susceptible to enrofloxacin: Chickens
Danish: Behandling af infektioner med følgende enrofloxacin-følsomme bakterier: Kyllinger
English: Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins.
Danish: Resistens over for fluorquinoloner er beskrevet at skyldes fem kilder, nemlig i) punktmutationer i de gener, der koder for DNA-gyrase og/eller topoisomerase IV med deraf følgende ændringer i det pågældende enzym, ii) ændringer i permeabiliteten for lægemidler hos gramnegative bakterier, iii) effluksmekanismer, iv) plasmidmedieret resistens og v) gyrase-beskyttende proteiner.
English: Add, to all products and amend where applicable:
Danish: For alle produkter indsættes følgende, og teksten rettes, hvor det er nødvendigt:
English: Two references were provided showing that in 1993, the Minimum Inhibitory Concentration (MIC) of enrofloxacin to M.gallisepticum isolates was 0.0125-0.1 µg/ml and for M.synoviae it was 0.01250.8 µg/ml, and in 1997, MIC for M.gallisepticum isolates was 0.025-1.0 µg/ml and for M.synoviae it was 0.05-0.5 µg/ml.
Danish: Der blev forelagt to referencer, der viste, at i 1993 var den mindste hæmmende koncentration (MIC) af enrofloxacin over for isolater af M.gallisepticum 0,0125-0,1 µg/ml og for M.synoviae 0,0125-0,8 µg/ml, mens MIC-værdien for isolater af M.gallisepticum i 1997 var 0,0251,0 µg/ml og for M.synoviae 0,05-0,5 µg/ml.
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylic acid derivatives.
Danish: Enrofloxacin er et syntetisk kemoterapeutikum, der tilhører klassen carboxylsyrederivater af fluorquinolon.
English: The mutant population continues to persist even after removal of the selection pressure as fluoroquinolone resistance mediated by gyrA mutations can be stably maintained in Campylobacter and possess an enhanced fitness.
Danish: Den muterede population persisterer også efter fjernelse af selektionstrykket, da resistensen over for fluorquinolon medieret af mutationer af gyrA hos Campylobacter kan holde sig stabil og indebærer en bedre tilpasning.
English: No abnormal findings were present according to palpation of the examined joints and articular cartilage surface.
Danish: Der fandtes ikke unormale forhold ved palpation af de undersøgte led og overfladen af ledbrusken.
English: Mommaertslaan 14 1831 Diegem (Machelen) Belgium
Danish: Mommaertslaan 14 1831 Diegem (Machelen) Belgien
English: Many of the studies submitted did not conform to current guidance, in that some MAHs provided only summaries of the data that they hold, and did not provide the details of the analytical method(s) used, the method validation data, nor data to demonstrate the stability of the analytes in the various matrices during storage between sampling and analysis, or during sample processing.
Danish: Mange af de forelagte undersøgelser var ikke i overensstemmelse med nuværende retningslinjer, idet nogle markedsføringstilladelsesindehavere kun forelagde sammenfatninger af de data, de er i besiddelse af, men ikke detaljer om de anvendte analysemetoder og metodevalideringsdata eller data til påvisning af analysandernes stabilitet i forskellige opbevaringsmedier i tidsrummet fra prøvetagning til analyse eller under behandling af prøverne.
English: In a previous study, the Minimal Bactericidal Concentration (MBC) of 0.06 µg/ml and mutant prevention concentrations (MPC) of 4 µg/ml were determined for this O78/H12 pathogenic strain.
Danish: I en tidligere undersøgelse blev der bestemt en minimal baktericid koncentration (MBC) på 0,06 µg/ml og en mutationshæmmende koncentration (MPC) på 4 µg/ml for denne patogene stamme O78/H12.
English: Resistance rates in E.coli from chickens and turkeys are reported as low in the study by Wallman 2007, where a clinical breakpoint of ≥ 2 mg/l was used and resistance was determined as up to 4.6% in isolates from 2004-2005.
Danish: Resistensandelen af E.coli fra kyllinger og kalkuner beskrives som lav i undersøgelsen af Wallman 2007, hvor der blev sat et klinisk breakpoint til ≥ 2 mg/l, og resistensandelen blev bestemt til at være op til 4,6 % i isolater fra 2004-2005.
English: Reus - Vinyols Km 4,1 Riudoms 43330 (Tarragona) Spain
Danish: Reus - Vinyols Km 4,1 Riudoms 43330 (Tarragona) Spanien
English: It has been postulated that AUC0-24h/MIC and Cmax/MIC ratios of >100 and >8, respectively, are predictive of clinical outcome for fluoroquinolones.
Danish: Det er blevet hævdet, at AUC0-24h/MIC- og Cmax/MIC-forhold på hhv. >100 og >8 er prædiktive for det kliniske udfald af behandling med fluorquinoloner.
English: When administered continuously in drinking water (based on a daily dose of 10 mg/kg bw), steadystate plasma concentrations (Css) for enrofloxacin were 0.33 ± 0.04 µg/ml in turkeys and 0.56 ± 0.13 µg/ml in chickens.
Danish: Ved kontinuerlig administration i drikkevandet (baseret på en daglig dosis på 10 mg/kg kropsvægt) var steady-state plasmakoncentrationerne (Css) for enrofloxacin 0,33 ± 0,04 µg/ml hos kalkuner og 0,56 ± 0,13 µg/ml hos kyllinger.
English: In Europe, several antimicrobials are authorised for treatment of colibacillosis in chickens and turkeys (apramycin, chlortetracycline, colistin, difloxacin, doxycycline and sulphadiazine + trimethoprim), but the widespread multidrug resistance of pathogenic E.coli has led to the extensive use of enrofloxacin.
Danish: I Europa er der godkendt en række antibiotika til behandling af coli-infektion hos kyllinger og kalkuner (apramycin, chlortetracyklin, colistin, difloxacin, doxycyclin og sulfadiazin + trimethoprim), men den udbredte multiresistens af patogene E.coli har ført til omfattende brug af enrofloxacin.
English: In a review by Luangtongkum et al (2009)16, it has been reported that a steady increase in fluoroquinolone-resistance among Campylobacter isolates has also been observed in many EU Member States and 17-99% of Campylobacter strains isolated from humans and animals in this region were resistant to fluoroquinolones with the highest resistance levels reported in Spain.
Danish: En oversigtsartikel af Luangtongkum et al (2009)16 nævner, at der også for isolater af Campylobacter i mange EU-medlemsstater er iagttaget en støt stigning i resistens over for fluorquinoloner, og at 1799 % af de stammer af Campylobacter, der var isoleret fra mennesker og dyr i regionen, var resistente mod fluorquinoloner, idet det højeste resistensniveau blev indberettet fra Spanien.
English: Antimicrobial resistance in target pathogens
Danish: Antimikrobiel resistens hos målpatogenerne