FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the second risk, spread of resistant zoonotic bacteria and resistance genes via food, this is a well characterised risk for which CVMP in November 2006 recommended risk mitigation measures7.
Danish: Vedrørende den anden risiko - spredning af resistente zoonotiske bakterier og resistensgener via fødevarer - er denne risiko velkarakteriseret og blev i november 2006 genstand for en anbefaling fra CVMP om foranstaltninger til risikonedsættelse7.
English: The enrofloxacin is an antimicrobial belonging to the class of fluoroquinolones, which are listed by the WHO as a critically important class of antimicrobials for human health (Critically important antimicrobials for human medicine, WHO/AGISAR, Copenhagen, 2009).
Danish: Enrofloxacin er et antibiotikum tilhørende fluorquinolonerne, der af WHO er klassificeret som kritisk vigtige for menneskers sundhed ("Critically important antimicrobials for human medicine, WHO/AGISAR, Copenhagen, 2009").
English: The use of fluoroquinolones in rabbits may therefore have a higher risk on development of antimicrobial resistance, however this risk is theoretical.
Danish: Anvendelsen af fluorquinoloner hos kaniner kan derfor medføre større risiko for udvikling af antimikrobiel resistens, men der er tale om en teoretisk risiko.
English: It is very important that those antimicrobials are used in veterinary and human medicine according to responsible use principles to safeguard the efficacy of these substances and minimise the development of and dissemination of antimicrobial resistance.
Danish: Det er meget vigtigt, at anvendelse af sådanne antibiotika i veterinær- og humanmedicin finder sted i henhold til principperne om ansvarlig brug, dels for at bevare stoffernes virkning, dels for at mindske udviklingen og spredningen af antimikrobiel resistens til det mindst mulige.
English: The species for which spread of MRSA would be important is therefore mainly swine (high prevalence) and companion animals (close contact).
Danish: Spredning af MRSA vil derfor først og fremmest forekomme fra svin (høj forekomst) og selskabsdyr (nær kontakt).
English: Unfortunately, there is insufficient information on the interpretation criteria used on the RESAPATH annual reports.
Danish: Uheldigvis er det ikke tilstrækkeligt oplyst, hvilke kriterier der er lagt til grund for fortolkningen af årsberetningerne fra RESAPATH.
English: Risk to animals health
Danish: Risiko for dyrs sundhed
English: From the route of administration it can be concluded that the risk of rabbit treatment would be similar to that of poultry.
Danish: Ud fra administrationsmetoden kan det konkluderes, at risikoen ved behandling af kaniner svarer til risikoen ved behandling af fjerkræ.
English: Therefore it could be considered that the use of enrofloxacin in rabbits should not significantly increase overall use of enrofloxacin in the EU when compared to its use in other animal species.
Danish: Det kan derfor antages at anvendelsen af enrofloxacin hos kaniner ikke væsentligt øger den samlede anvendelse af enrofloxacin i EU, sammenholdt med dets anvendelse hos andre dyrearter.
English: Sensitivity of various strains of P. multocida was analysed in Spain between 2009 and 2011 and the antibiogram results showed that of a total of 61 P. multocida isolates all 61 strains were sensitive.
Danish: Der blev foretaget følsomhedsbestemmelse af en række stammer af P. multocida i Spanien mellem 2009 og 2011, og antibiogrammet viste, at samtlige 61 testede isolater af P. multocida var følsomme.
English: Taking into account the above reasoning the Committee considered that withdrawing or not authorising the use of these products in rabbit was considered not proportionate as this would create a negative impact on the availability of tools to treat respiratory diseases in this minor species, in cases when other antibiotics cannot be used or would not be sufficiently effective.
Danish: Af ovenstående grunde fandt udvalget det ikke rimeligt at tilbagekalde eller afslå godkendelse af disse produkter til kaniner, da det vil få negativ indvirkning på tilgængeligheden af midler til behandling af luftvejssygdomme i denne mindre betydningsfulde dyreart i tilfælde, hvor andre antibiotika ikke kan anvendes eller ikke er tilstrækkeligt effektive.
English: With regard to intensively reared rabbits, the risk is likely to be minor in comparison with the other species due to the size of rabbits production and no measures have been deemed necessary to minimise the risk for spread of MRSA from those.
Danish: For intensivt opdrættede kaniner må risikoen forventes at være lille i forhold til andre arter på grund af kaninproduktionens størrelse, og det anses ikke for nødvendigt at indføre foranstaltninger til minimering af risikoen for spredning af MRSA fra disse dyr.
English: Overall summary of the scientific evaluation of HIPRALONA ENRO-S and its generics intended for use in rabbits (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af HIPRALONA ENRO-S og de tilsvarende generiske præparater bestemt til anvendelse hos kaniner (se bilag I)
English: The practice of coprophagy (consumption of faeces) that is part of rabbits behaviour/physiology may hypothetically have an impact on development of antimicrobial resistance.
Danish: Koprofagi (spisning af fæces), som er en del af kaniners adfærd/fysiologi, kan have hypotetisk betydning for udviklingen af antimikrobiel resistens.
English: France considered that these resistances would possibly be directly or indirectly transmitted to humans and may represent a potential serious risk to public health as enrofloxacin belongs to the fluoroquinolones family which is considered a highly critical class of antimicrobials for human health.
Danish: Frankrig fandt, at sådanne resistente bakterier direkte eller indirekte kan overføres til mennesker og derved udgøre en potentiel alvorlig risiko for folkesundheden, da enrofloxacin tilhører fluorquinolongruppen, der anses for at være kritisk vigtig for menneskers sundhed.
English: The transfer of resistant bacteria from animals to humans may occur via consumption of meat carrying enteric zoonotic bacteria e.g. E. coli or by direct contact with animals, e.g. Staph.
Danish: Overførsel af resistente bakterier fra dyr til mennesker kan ske via konsum af kød, der indeholder zoonotiske enterobakterier, f.eks. E. coli, eller ved kontakt med dyr, f.eks. Staph.
English: On 30 September 2011, France initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for the veterinary medicinal product HIPRALONA ENRO-S and its generics indicated for use in rabbits.
Danish: Den 30. september 2011 indledte Frankrig en henvisningsprocedure i henhold til artikel 35 i Rådets direktiv 2001/82/EF, som ændret, for veterinærlægemidlet HIPRALONA ENRO-S og de tilsvarende generiske præparater, der er indiceret til anvendelse hos kaniner.
English: The route of administration for pigs is injectable or oral.
Danish: Til svin benyttes injektion eller oral administration.
English: Most of the MICs obtained were above the range expected for wild-type isolates, data from EUCAST (European Committee on Antimicrobial Susceptibility Testing) indicate that the distribution of MICs of enrofloxacin for the wild type of the target pathogen, P. multocida, is between 0.004 and 0.03 µg/ml.
Danish: De fleste af disse MIC-værdier lå over det forventede for vildtype-isolater, og data fra EUCAST ("European Committee on Antimicrobial Susceptibility Testing") tyder på, at MIC-værdierne af enrofloxacin over for vildtypen af den patogene målorganisme, P. multocida, er mellem 0,004 og 0,03 µg/ml.
English: SP VETERINARIA Ctra.Reus-Vinyols, Km, 43330 Ruidoms SPAIN
Danish: SP VETERINARIA Ctra.Reus-Vinyols, Km, 43330 Ruidoms SPANIEN
English: • on the basis of the available data on antimicrobial resistance, and taking into account the very limited data on resistance that are available in rabbit production, the CVMP considered that the use of the concerned products in rabbits would not represent a higher risk for public health when compared with use in other animals species;
Danish: • på grundlag af de foreliggende data om antimikrobiel resistens og i betragtning af de meget begrænsede foreliggende data om resistens ved kaninproduktion fandt CVMP, at anvendelse af de pågældende produkter til kaniner ikke udgør en større risiko for den offentlige sundhed end anvendelse i andre dyrearter
English: It is anticipated that the risk on individual level might be increased for rabbit as compared to other species.
Danish: Risikoen på det individuelle plan forventes større for kaniner end for andre dyrearter.
English: In the absence of specific data concerning transmission of resistant bacteria from rabbits to humans, the risk analysis from other animal species where enrofloxacin is used (poultry and pigs) is extrapolated to rabbits.
Danish: Da der savnes specifikke oplysninger om overførsel af resistente bakterier fra kaniner til mennesker, ekstrapoleres risikoanalysen til kaniner fra andre dyrearter, hos hvem enrofloxacin anvendes (fjerkræ og svin).
English: • Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Danish: • Hvis produktet anvendes på en måde, der afviger fra anvisningerne i produktresuméet, kan det øge udbredelsen af bakterier, der er resistente mod fluorquinoloner, og forringe effektiviteten af behandling med andre quinoloner på grund af potentialet for krydsresistens.
English: • no additional risk management or mitigation measures nor prohibition of enrofloxacin in rabbits was considered proportionate;
Danish: • det blev ikke fundet rimeligt at indføre yderligere foranstaltninger til risikohåndtering eller risikonedsættelse eller forbyde anvendelse af enrofloxacin hos kaniner
English: There are two risks for public health identified with the use of enrofloxacin in rabbits: (i) the risk for spread of methicillin resistant Staphylococcus aureus (MRSA) from rabbits to people in contact with these animals and (ii) the risk of spread of resistant zoonotic bacteria and transmissible resistance genes via food, e.g. Salmonella and E. coli.
Danish: Der kan peges på to risici for folkesundheden ved anvendelse af enrofloxacin hos kaniner: i) risikoen for spredning af meticillinresistente Staphylococcus aureus (MRSA) fra kaniner til personer, der har kontakt med dyrene, og ii) risikoen for spredning af resistente zoonotiske bakterier og overførbare resistensgener via fødevarer, f.eks.
English: In another study carried out in Spain in 2011 to address the evolution of the level of resistances the MIC50 and the MIC90 of the P. multocida strains examined were 0.125 and 0.380 µg/ml, respectively.
Danish: I en anden undersøgelse, der blev udført i Spanien i 2011 for at belyse udviklingen i resistensforholdene, bestemtes MIC50- og MIC90-værdierne af de testede stammer af P. multocida til henholdsvis 0,125 og 0,380 µg/ml.
English: This observed decrease of susceptibility could either be explained by methodological factors, or it could reflect a true emergence of decreased susceptibility, that could be related to the use of enrofloxacin in rabbits or other animal species.
Danish: Dette fald i følsomhed skyldes enten metodologiske faktorer eller en faktisk indtrædende nedsat følsomhed, som kan tænkes at hænge sammen med anvendelsen af enrofloxacin hos kaniner eller andre dyrearter.
English: From the RESAPATH annual reports, the highest susceptibility levels to enrofloxacin in E. coli in rabbits were 90% (2009) and 85% (2010).
Danish: Af RESAPATH's årsberetninger fremgår, at andelen med højeste følsomhed for enrofloxacin af E. coli i kaniner var 90 % (2009) og 85 % (2010).
English: The current knowledge regarding the occurrence of antimicrobial resistance in food animals and the influence of the animal production on its transmission is incomplete.
Danish: På nuværende tidspunkt foreligger der kun ufuldstændige oplysninger om forekomsten af antimikrobiel resistens hos fødevareproducerende dyr og dyreproduktionens indvirkning på overførsel af resistens.
English: Furthermore, several studies were presented in order to address the susceptibility of different field strains of P. multocida to enrofloxacin.
Danish: Desuden blev der fremlagt flere undersøgelser af følsomheden af forskellige feltstammer af P. multocida for enrofloxacin.
English: The concerns raised by France were that the use of HIPRALONA ENRO-S and its generics in rabbit production would increase Escherichia coli and Staphylococcus aureus resistance to enrofloxacin.
Danish: Frankrigs betænkeligheder bestod i, at anvendelsen af HIPRALONA ENRO-S og de tilsvarende generiske præparater i kaninproduktion ville medføre øget resistens af Escherichia coli og Staphylococcus aureus over for enrofloxacin.
English: The dosage is 10 mg enrofloxacin per kg bodyweight (bw) during 5 days.
Danish: Doseringen er 10 mg enrofloxacin pr. kg kropsvægt i fem dage.
English: • prudent use warnings for fluoroquinolones were recommended by the CVMP for the products concerned and should be strictly followed;
Danish: • CVMP's advarsler om hensigtsmæssig brug af fluorquinoloner for de pågældende produkter bør overholdes strengt
English: 08028 - BARCELONA SPAIN
Danish: 08028 - BARCELONA SPANIEN
English: The evaluation of the risk related antimicrobial resistance has to consider both effects; on the target animal species and in humans.
Danish: Vurderingen af denne risikorelaterede antimikrobielle resistens må omfatte konsekvenserne både for måldyrearten og for mennesker.
English: It should also be noted that coprophagy involves the ingestion of the own rabbit faeces and that there are no data to assess if this would have any impact on increase of resistance.
Danish: Det må desuden bemærkes, at koprofagi indebærer, at dyret æder sin egen afføring, og at der ikke findes data, der giver mulighed for at vurdere betydningen heraf for resistensudviklingen.
English: • the CVMP considered that the overall benefit-risk balance is positive for the products concerned by this procedure; the CVMP recommended the maintenance of the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics (see Annex I) in accordance with the previously approved product information.
Danish: • CVMP anså det overordnede benefit/risk-forhold for at være positivt for de produkter, der er omfattet af denne procedure anbefalede CVMP opretholdelse af markedsføringstilladelserne for veterinærlægemidlet HIPRALONA ENRO-S og de tilsvarende generiske produkter (se bilag I) i overensstemmelse med den tidligere godkendte produktinformation.
English: The route of administration for rabbits is oral via drinking water, similar to the route of administration for poultry.
Danish: Til kaniner anvendes oral administration via drikkevandet ligesom til fjerkræ.
English: 7 CVMP Reflection paper on the use of fluoroquinolones in food- producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf that are less likely to produce resistances of public health concern are used as a first option instead of fluoroquinolones.
Danish: 7 CVMP Reflection paper on the use of fluoroquinolones in food- producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf at vælge antimikrobielle stoffer med mindre tilbøjelighed til sundhedstruende resistensudvikling end fluorquinoloner.
English: It is acknowledged that the limited availability of authorised veterinary medicinal products containing first line antimicrobials as active substance make it difficult to comply with the responsible use recommendations for fluoroquinolones and the recommendation that it is desirable that antimicrobials
Danish: Det er anerkendt, at hvis man begrænser adgangen til godkendte veterinærlægemidler med førstevalgsantibiotika som aktivt stof, vil det vanskeliggøre overholdelsen af anbefalingerne om forsvarlig brug af fluorquinoloner og om primært
English: The conclusion of a comparative study of plasma levels of enrofloxacin and its metabolite ciprofloxacin during treatment with the product at doses equivalent to 5 and 10 mg/kg bw of enrofloxacin administered in drinking water for 5 consecutive days was that the effective dose regimen of enrofloxacin for the treatment of respiratory infections caused by P. multocida in rabbits is 10 mg/kg bw.
Danish: En sammenlignende undersøgelse af plasmaniveauerne af enrofloxacin og dets metabolit ciprofloxacin ved behandling med produktet i doser svarende til 5 og 10 mg enrofloxacin/kg kropsvægt administreret i drikkevandet i fem på hinanden følgende dage mundede ud i, at det effektive dosisregime for enrofloxacin er 10 mg/kg kropsvægt til behandling af luftvejsinfektioner forårsaget af P. multocida.
English: The development of antimicrobial resistance is a risk for target animal species resulting in lack of efficacious treatment and for humans by transferring resistant bacteria from animals to humans.
Danish: For måldyrearterne vil udvikling af antimikrobiel resistens medføre risiko for manglende behandlingseffekt, mens det for mennesker medfører risiko for overførsel af resistente bakterier fra dyr til mennesker.
English: Data on susceptibility of enrofloxacin from a study conducted in Spain in 2005 showed a MIC90 of 0.06 µg/ml.
Danish: En følsomhedsundersøgelse udført i Spanien i 2005 viste en MIC90-værdi af enrofloxacin på 0,06 µg/ml.
English: Furthermore, as a consequence of restriction on availability, off-label use could be anticipated and this would compromise correct monitoring of use and reporting of adverse reactions.
Danish: Sådanne begrænsninger må desuden forventes at ville føre til ikke-godkendt brug på bekostning af den korrekte overvågning af anvendelsen og bivirkningsindberetning.
English: The data from published literature (RESAPATH annual reports) show that the sensitivity of P. multocida strains to enrofloxacin in rabbits was high (100% and 99% in 2009 and 2010, respectively).
Danish: RESAPATH's årsberetninger viser, at en høj andel af stammerne af P. multocida var følsom for enrofloxacin hos kaniner (100 % og 99 % i henholdsvis 2009 og 2010).
English: Capsanes, 12 - Polígono Agro-Reus E-43206 - REUS (Tarragona) SPAIN
Danish: Capsanes, 12 - Polígono Agro-Reus E-43206 - REUS (Tarragona) SPANIEN
English: HIPRALONA ENRO-S, and its generics, contain enrofloxacin as active ingredient, and are indicated in rabbits for the treatment of respiratory infections due to Pasteurella multocida.
Danish: HIPRALONA ENRO-S og de tilsvarende generiske præparater indeholder enrofloxacin som aktivt indholdsstof og er indiceret til behandling af luftvejsinfektioner hos kaniner forårsaget af P. multocida.
English: HIPRALONA ENRO-S and its generics were involved in the referral under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species (EMEA/V/A/049) and the adequate prudent use warnings were recommended for these products.
Danish: HIPRALONA ENRO-S og de tilsvarende generiske produkter var omfattet af henvisningen i henhold til artikel 35 i direktiv 2001/82/EF for alle veterinærlægemidler indeholdende quinoloner, herunder fluorquinoloner bestemt til anvendelse i fødevareproducerende arter (EMEA/V/A/049).
English: In order to confirm the adequate dose for rabbits two studies were carried out showing that the optimal dose for the treatment of respiratory infections caused by P. multocida in rabbits is 10 mg/kg bw for 5 consecutive days.
Danish: Til bekræftelse af adækvatheden af doseringen til kaniner blev der udført to undersøgelser, der viste, at den optimale dosis til behandling af luftvejsinfektioner forårsaget af P. multocida hos kaniner er 10 mg/kg kropsvægt i fem på hinanden følgende dage.
English: The safety and efficacy of the product have been demonstrated in a well conducted GCP compliant trial that fulfils the requirements of Directive 2001/82/EC and the relevant guidelines using a dose of 10 mg/kg bw for 5 consecutive days.
Danish: Produktets sikkerhed og virkning er godtgjort i en veludført GCP-overensstemmende undersøgelse, der opfylder kravene i direktiv 2001/82/EF og de relevante retningslinjer.
English: The antimicrobial prudent use recommendations and warnings that are included in the product information are as follows:
Danish: Produktinformationen indeholder følgende anbefalinger og advarsler om hensigtsmæssig brug af antibiotika:
English: The conclusion of this study was that the optimal dose for the treatment of respiratory infections caused by P. multocida in rabbits is 10 mg/kg bw for 5 consecutive days.
Danish: Af denne undersøgelse kunne det konkluderes, at den optimale dosis til behandling af luftvejsinfektioner forårsaget af P. multocida hos kaniner er 10 mg/kg kropsvægt i fem på hinanden følgende dage.
English: 63-100 Śrem POLAND
Danish: Medivet S.A. Szkolna 17 63-100 Śrem POLEN
English: Taking into account all available data it was considered that the use of HIPRALONA ENRO-S and its generics in rabbits would represent a comparable or lower risk for public health compared to the use of enrofloxacin in other animal species (e.g. poultry or pigs).
Danish: På grundlag af alle de foreliggende data fandt udvalget, at anvendelse af HIPRALONA ENRO-S og de tilsvarende generiske produkter hos kaniner medfører samme risiko for folkesundheden som anvendelse af enrofloxacin hos andre dyrearter (f.eks. fjerkræ og svin).
English: HIPRALONA ENRO-S and its generics contain 100 mg enrofloxacin per ml oral solution for use in drinking water.
Danish: HIPRALONA ENRO-S og de tilsvarende generiske præparater indeholder 100 mg enrofloxacin pr. 5 ml oral opløsning til administration gennem drikkevandet.
English: • the CVMP considered whether the benefit-risk ratio for HIPRALONA ENRO-S and its generics is positive when the products are administered to rabbits and whether the use of such highly critical antibiotics in a food producing species, used via oral route, is in line with the current recommendations to implement responsible use of antimicrobials.
Danish: • CVMP vurderede, om benefit/risk-forholdet for HIPRALONA ENRO-S og de tilsvarende generiske produkter er positivt, når produktet anvendes til kaniner, og om brug af sådanne kritisk vigtige antibiotika ved oral indgift i fødevareproducerende arter er i overensstemmelse med de gældende anbefalinger om hensigtsmæssig anvendelse af antimikrobielle stoffer
English: Belgium GLOBAL VET HEALTH SL C/Capçanes nº12-bajos
Danish: GLOBAL VET HEALTH SL C/Capçanes nº12-bajos
English: RESAPATH annual reports to reach a conclusion on the trends of resistance to enrofloxacin in E. coli in rabbits compared to other resistance studies provided.
Danish: Uheldigvis er kriterierne for fortolkningen af RESAPATH's årsberetninger ikke tilstrækkeligt oplyst til, at der kan drages konklusioner om udviklingen i resistens over for enrofloxacin af E. coli hos kaniner ved at sammenholde med andre forelagte resistensundersøgelser.
English: Poligono Agro-Reus 43206 Reus SPAIN
Danish: Poligono Agro-Reus 43206 Reus SPANIEN
English: Global Vet Health, SL Capcanes, 12 bajos Poligono Agro-Reus 43206 Reus SPAIN
Danish: Global Vet Health, SL Capcanes, 12 bajos Poligono Agro-Reus 43206 Reus SPANIEN