FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recognised that colistin combination products could be efficacious for the treatment and metaphylaxis of gastrointestinal diseases caused by E. coli susceptible to both active substances in piglets, poultry, neonatal calves and lambs, provided the dose and duration of treatment are adjusted according to those previously recommended by CVMP.
Danish: Det anerkendes, at kombinationsprodukter, der indeholder colistin kan tænkes at være effektive til behandling og metafylakse af gastrointestinale sygdomme forårsaget af E. coli, der er følsomme for begge aktive stoffer, hos smågrise, fjerkræ, nyfødte kalve og lam, forudsat at dosis og behandlingsvarighed tilpasses efter CVMP's tidligere anbefalinger.
English: Colibacillosis is defined as an infection of the colon by Enterobacteriaceae, especially E. coli, resulting in a disease manifestation, typically diarrhoea and other manifestations in poultry.
Danish: Colibacillose defineres som en infektion af colon med Enterobacteriaceae, specielt E. coli, resulterende i sygdomstegn, typisk diarré og andre tegn, hos fjerkræ.
English: Murgašova 5 949 01 Nitra Slovakia
Danish: 949 01 Nitra Slovakia
English: The risk to public health identified is that treatment of clinical or subclinical Salmonella infections with the objective to reduce the number of bacteria can interfere with EU control
Danish: Den konstaterede risiko for den offentlige sundhed består i, at behandling af kliniske eller subkliniske infektioner med Salmonella med det formål at nedsætte antallet af bakterier kan gribe ind i EU's kontrolprogrammer og derved sætte den offentlige sundhed og fødevaresikkerheden på spil.
English: Gastrointestinal infection caused by E. coli (colibacillosis) is not a recognised clinical disease in foals or adult horses.
Danish: Gastrointestinal infektion forårsaget af E. coli (colibacillose) er ikke en anerkendt klinisk sygdom hos føl eller voksne heste.
English: While in cases involving other substances used in veterinary medicine there were still therapeutic options for human medicine, in this case any potential food-chain related contributions to colistin resistance in human medicine would lead to no therapeutic options for human infections against MDR, XDR and PDR bacteria.
Danish: Mens der for andre stoffer, som anvendes i veterinærmedicinen, stadig vil være behandlingsmuligheder i humanmedicinen, vil eventuelle fødevarerelaterede bidrag til resistens over for colistin i humanmedicinen føre til, at der savnes en behandlingsmulighed for humane infektioner med MDR-, XDR- og PDR-bakterier.
English: In the above mentioned Article 35 referral procedure (EMEA/V/A/106) for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species, the CVMP reached certain conclusions (described below) on some indications, dosages and target species, which would also apply to colistin combination products.
Danish: I ovennævnte artikel 35-indbringelsesprocedure (EMEA/V/A/106) for alle veterinærmedicinske produkter, der indeholder colistin som eneste aktive stof til oral administration til fødevareproducerende dyr nåede CVMP frem til visse konklusioner (som beskrevet nedenfor) for visse indikationer, doseringer og måldyrearter, som også finder anvendelse på kombinationsprodukter, der indeholder colistin.
English: Based on the information provided by MAHs, including proprietary data, scientific references and expert reports, a possible risk mitigation measure considered in this Article 35 referral was to further limit the use of colistin combination products to treatment of individual animals only and remove presentations of products intended for group treatment.
Danish: Baseret på de oplysninger, der er fremlagt af markedsføringstilladelsesindehaverne, herunder interne data, videnskabelige henvisninger og ekspertrapporter, blev der ved denne artikel 35-indbringelse overvejet en mulig risikoafbødende foranstaltning i form af yderligere begrænsning af anvendelsen af kombinationsprodukter, der indeholder colistin til enkeltvis behandling og afskaffelse af pakninger med produkter bestemt til gruppebehandling.
English: • the CVMP considered that even a limited use of colistin combinations products is deemed to lead to unnecessary use of colistin and could potentially contribute to the development of antimicrobial resistance;
Danish: • CVMP fandt, at selv begrænset anvendelse af kombinationsprodukter, der indeholder colistin må anses for at føre til unødig anvendelse af colistin og potentielt kan bidrage til udviklingen af antimikrobiel resistens,
English: Regarding combinations of colistin with other antimicrobials the advice indicates that “The marketing authorisations for these products should be reviewed and unless sound justification can be provided that the combination is in line with responsible use principles, combination products should be withdrawn.”
Danish: For kombinationer af colistin med andre antimikrobielle stoffer tilrådes det i anvisningerne, at "Markedsføringstilladelserne for disse produkter bør gennemgås, og kombinationsprodukter bør trækkes tilbage, medmindre der kan gives holdbar begrundelse for, at kombinationen er i overensstemmelse med principperne for forsvarlig brug.”
English: As even a limited use of colistin combinations products is deemed to lead to unnecessary use of colistin and could potentially contribute to the development of antimicrobial resistance, the measures discussed above were not considered sufficient to mitigate the identified risk.
Danish: Da selv begrænset anvendelse af kombinationsprodukter, der indeholder colistin, må anses for at være unødig brug af colistin og potentielt kunne bidrage til at udvikle antimikrobiel resistens, fandtes de ovenfor gennemgåede foranstaltninger ikke tilstrækkelige til at afbøde den konstaterede risiko.
English: Also, no proprietary data or valid justifications could be provided in support of Salmonella spp.
Danish: Der kunne desuden ikke forelægges interne data eller holdbar begrundelse til støtte for indikationerne vedrørende Salmonella spp.
English: These additional clinical needs can include a broader spectrum of antimicrobial coverage in the body to either extend antimicrobial coverage to the rest of the body as well as the gastrointestinal tract (e.g. gastrointestinal infection plus septicaemia), or extra antimicrobial coverage within the gastrointestinal tract due to extenuating circumstances (e.g. antimicrobial resistance or polymicrobial infections).
Danish: Disse andre kliniske behov kan være et større spektrum af antimikrobiel dækning, enten gennem udvidelse af den antimikrobielle dækning til resten af kroppen ud over mavetarmkanalen (f.eks. gastrointestinal infektion plus septikæmi) eller gennem ekstra antimikrobiel dækning i mave-tarmkanalen begrundet med skærpende omstændigheder (f.eks. antimikrobiel resistens eller polymikrobielle infektioner).
English: Otto u.14.
Danish: Ottó u.14
English: However, these in vitro studies are unreliable because the major problem with using in vitro susceptibility methods for establishing efficacy of colistin combinations against bacteria is that the accuracy of the different techniques available such as broth microdilution, agar dilution, and Etest is questionable because of the cationic properties of colistin
Danish: Disse in vitro-undersøgelser er imidlertid upålidelige, da det store problem ved at anvende in vitro-metoder til bestemmelse af bakteriers følsomhed over for kombinationer med colistin er den tvivlsomme nøjagtighed af de forskellige foreliggende teknikker, såsom substrat-mikrofortynding, agarfortynding og E-test, hvilket skyldes colistins kationiske egenskaber
English: Arguments for polymicrobial infections were mostly theoretical and only discussed by MAHs in relation to respiratory and skin indications.
Danish: Argumenterne for polymikrobielle infektioner var hovedsagelig teoretiske og blev af markedsføringstilladelsesindehaverne kun drøftet i forbindelse med luftvejs- og hudindikationer.
English: This combined with the lack of quality clinical studies and of other credible evidence to confirm the added value of colistin combination products over monotherapy, combined with lack of compliance with prudent use principles and the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005), leads to the conclusion that there is no valid justification for the use of colistin combination products in veterinary medicine.
Danish: I forbindelsen med fraværet af manglende kliniske undersøgelser af høj kvalitet eller anden troværdig evidens for merværdien af kombinationsprodukter med colistin i forhold til monoterapi og den manglende overensstemmelse med principperne om forsvarlig anvendelse og CVMP's retningslinjer om faste kombinationsprodukter af lægemidler (EMEA/CVMP/83804/2005) fører dette til den konklusion, at der savnes holdbar begrundelse for brug af kombinationsprodukter, der indeholder colistin i veterinærmedicinen.
English: E. coli septicaemia is a recognised disease in neonatal foals that can be sometimes be expressed as diarrhoea, among other symptoms.
Danish: E. coli-septikæmi er en anerkendt sygdom hos nyfødte føl og manifesterer sig undertiden med diarré blandt symptomerne.
English: The current scientific literature does not support the use of colistin combination products in foals as its use could disrupt the gastrointestinal microflora balance, leading to a well-recognised fatal antimicrobial-associated colitis, typically associated with Clostridium difficile.
Danish: Den aktuelle videnskabelige litteratur støtter ikke brugen af colistinkombinationspræparater hos føl, da de kan forstyrre den gastrointestinale mikroflora, medførende en velkendt fatal antibiotikarelateret colitis, typisk associeret med Clostridium difficile.
English: VETLIMA-Sociedade Distribuidora de Produtos AgroPecuários, S.A.
Danish: VETLIMA-Sociedade Distribuidora de Produtos Agro-Pecuários, S.A. Centro Empresarial da Rainha, Lote 27
English: Lithuania COOPHAVET S.A.S.
Danish: Litauen COOPHAVET S.A.S.
English: A recent global increase in Gram-negative bacteria in human medicine that are multidrug-resistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR)
Danish: En nylig stigning i gramnegative bakterier i humanmedicinen med multiresistens (MDR), ekstensiv antibiotikaresistens (XDR) og ekstrem resistens (PDR)
English: Concepts of colistin combination synergy are more relevant in human medicine since low doses of colistin are injected parenterally with other antimicrobials in order to avoid toxicity.
Danish: Koncepter med synergi af kombinationsprodukter, der indeholder colistin har større relevans i humanmedicinen, hvor der injiceres lave doser af colistin parenteralt sammen med andre antimikrobielle stoffer for at undgå toksicitet.
English: Pigs, chickens (except hens producing eggs for human consumption)
Danish: Svin, kyllinger (bortset fra høns, der producerer æg til konsum)
English: The same considerations taken for the colistin monotherapy products also apply to products containing colistin in combination with other antimicrobial substances.
Danish: Samme overvejelser som de, der gjorde sig gældende for produkter til colistin-monoterapi, gælder også for produkter med colistin i kombination med andre antimikrobielle stoffer.
English: In addition, colistin lacks therapeutic activity against inherently resistant species, including the genera Serratia, Stenotrophomonas and Proteus
Danish: 6 Desuden mangler colistin terapeutisk virkning mod naturligt resistente arter, herunder Serratia, Stenotrophomonas og Proteus.
English: antimicrobials, the number of marketing authorisations per pharmaceutical form/route of administration and types of use, the products containing colistin only and administered orally (group treatment) were considered a priority.
Danish: 2 (europæisk overvågning af salget af antimikrobielle stoffer til dyr), antallet af markedsføringstilladelser pr. farmaceutisk form/administrationsvej og anvendelsernes art var det kun produkter, der indeholder colistin og er til oral administration (gruppebehandling), der blev anset for at være en prioritet.
English: However, no benefit could be demonstrated of using colistin combination products over monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even a limited use of colistin combination products was considered an unnecessary use of colistin.
Danish: Der kunne imidlertid ikke påvises nogen fordel ved brug af kombinationsprodukter, der indeholder colistin frem for monoterapi, og der kunne ikke fastlægges realistiske afbødende foranstaltninger over for den konstaterede risiko for menneskers sundhed, da selv begrænset anvendelse af kombinationsprodukter, der indeholder colistin ansås for at være unødig brug af colistin.
English: has forced clinicians to reintroduce toxic systemic colistin treatment in the form of its less toxic inactive prodrug, colistin methanesulfonate, as a last-resort antimicrobial for infections with such bacteria, which are frequently the cause of healthcare-associated infections
Danish: har tvunget klinikerne til at genindføre den toksiske behandling med systemisk colistin i form af dets mindre toksiske inaktive prodrug colistinmethansulfonat som sidste antimikrobielle udvej til behandling af sådanne bakterier, der ofte er årsag til sygehusinfektioner
English: This emergence of MCR-1 in animals and human-related bacteria heralds the breach of the last group of antibiotics, polymyxins, by plasmid-mediated transferable resistance.
Danish: Denne nye forekomst af MCR-1 hos dyre- og menneskerelaterede bakterier indvarsler, at der er åbnet op for plasmidmedieret resistensoverførsel for den sidste gruppe antibiotika, polymyxiner.
English: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf European Medicines Agency, European Surveillance of Veterinary Antimicrobial Consumption.
Danish: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
English: 7 Saint Herblon 44153 ANCENIS Cedex
Danish: B.P. 7 Saint Herblon 44153 ANCENIS Cedex France
English: Therefore, the CVMP concluded that no gastrointestinal indications could be supported for colistin combination products.
Danish: CVMP konkluderede derfor, at der ikke var grundlag for gastrointestinale indikationer for kombinationsprodukter med colistin.
English: The broad-spectrum activity of colistin against Gram-negative bacteria involves binding to lipid A, the anchor for lipopolysaccharide and the main constituent of the outer membrane of many bacteria
Danish: Den bredspektrede aktivitet af colistin over for gramnegative bakterier involverer binding til lipid A, der er anker for lipopolysakkarid og hovedbestanddelen i cellemembranen af mange bakterier
English: Polymicrobial gastrointestinal infections were not identified by the MAHs for the animal species and indications listed for their products.
Danish: Polymikrobielle gastrointestinale infektioner blev ikke nævnt af markedsføringstilladelsesindehaverne i forbindelse med de måldyrearter og indikationer, der er opført for deres produkter.
English: No specific clinical studies were provided for invasive E. coli secondary to gastrointestinal disease.
Danish: Der blev ikke forelagt specifikke kliniske undersøgelser vedrørende invasive E. coli-infektioner, som var sekundære til mavetarmsygdom.
English: As stated previously, this has no clinical relevance for colistin combination products, since colistin is not absorbed from the gastrointestinal tract and thus will never participate in combating polymicrobial infections in other target tissues.
Danish: Som nævnt har dette ingen klinisk relevans for kombinationsprodukter med colistin, da colistin ikke optages fra mave-tarmkanalen og således aldrig vil medvirke til at nedkæmpe polymikrobielle infektioner i andre målvæv.
English: CENAVISA, S.A. Camí Pedra Estela s/n. Reus (Tarragona)
Danish: Spanien CENAVISA, S.A. Camí Pedra Estela s/n.
English: However, concerns were raised whether gastrointestinal indications for colistin combinations products are justified when it would be more prudent to use a monotherapy product.
Danish: Der blev imidlertid rejst betænkeligheder ved, om der er begrundelse for gastrointestinale indikationer for kombinationsprodukter, der indeholder colistin, når det vil være mere forsvarligt at anvende et monoterapiprodukt.
English: Concurrent E. coli related gastrointestinal diseases (e.g. septicaemia) were identified by MAHs as occurring as complications from the original gastrointestinal disease through either direct systemic spread or immunosuppression.
Danish: Samtidige gastrointestinale sygdomme forbundet med E. coli (f.eks. septikæmi) blev af markedsføringstilladelsesindehaverne betegnet som komplikationer af den oprindelige mavetarmsygdom, enten gennem systemisk spredning eller immunsuppression.
English: Veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species represent commonly used antimicrobials in veterinary medicine.
Danish: Veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration til fødevareproducerende arter repræsenterer antimikrobielle stoffer med udbredt anvendelse i veterinærmedicinen.
English: In feed use
Danish: Til anvendelse i foder
English: Colistin is a cationic, multicomponent lipopeptide antibacterial agent produced by cultures of Bacillus polymyxa var. colistinus.
Danish: Colistin er et kationisk antibakterielt flerkomponentmiddel af lipopeptidtypen, der fremstilles af kulturer af Bacillus polymyxa-var colistinus.
English: Colibacillosis is not a term used in equine medicine, but a term used for pigs, poultry and ruminants.
Danish: Begrebet colibacillose anvendes ikke i hestemedicin, men i forbindelse med svin, fjerkræ og drøvtyggere.
English: The same conclusion was reached in the recent Article 35 referral procedure on oral colistin monotherapy products.
Danish: Samme konklusion blev nået i den nylige artikel 35indbringelsesprocedure vedrørende orale produkter til monoterapi med colistin.
English: Polymyxins have no clinically useful activity against Gram-positive bacteria, Gram-negative cocci, anaerobes and Mollicutes including Mycoplasma spp.
Danish: Polymyxiner har ingen klinisk nyttig aktivitet mod grampositive bakterier, gramnegative kokker, anaerobe bakterier eller Mollicutes, herunder Mycoplasma spp.
English: ENTEROGEL 30 Colistin sulphate
Danish: ENTEROGEL 30 Colistinsulfat
English: In conclusion, colistin combination products are intended to address different clinical needs to monotherapy products.
Danish: Som konklusion er kombinationsprodukter med colistin beregnet til at opfylde andre kliniske behov end monoterapiprodukter.
English: Doxal Italia S.p.a. largo Donegani 2 20121 - Milano Italy
Danish: largo Donegani 2 20121 - Milano Italy
English: Grounds for withdrawal of the marketing authorisations
Danish: Begrundelse for at inddrage markedsføringstilladelserne
English: Thus, the use of colistin in foals is considered to present a serious risk in relation to target animal safety and foals cannot be supported as a target animal species for colistin combination products.
Danish: Anvendelse af colistin hos føl anses således for at udgøre en alvorlig risiko for måldyreartens sikkerhed, og føl kan ikke støttes som måldyreart for kombinationsprodukter med colistin.
English: Oral administration individually
Danish: Oral indgivelse, enkeltvis
English: For non-gastrointestinal indications there are concerns of lack of justification for colistin combination products.
Danish: For ikke-gastrointestinale indikationer er der betænkelighed ved den manglende begrundelse for kombinationsprodukter, der indeholder colistin.
English: Most clinical studies provided in this Article 35 referral procedure demonstrated that monotherapy products shared the same efficacy as colistin combination products.
Danish: De fleste kliniske undersøgelser, der er fremlagt ved denne artikel 35-indbringelsesprocedure, har vist, at monoterapiprodukter havde samme virkning som kombinationsprodukter med colistin.
English: Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha Portugal
Danish: 2050-501 Vila Nova da Rainha
English: Also, the clinical relevance of synergy with colistin combinations is highly doubtful for the reason that colonic concentrations of colistin alone are so much higher than the MIC (e.g. 20 times more than the MIC) for E. coli and other bacteria, as a monotherapy, hence there is no clinical added value for an in vitro synergy of colistin combinations.
Danish: Desuden er den kliniske relevans af synergi for kombinationer med colistin højst tvivlsom, fordi koncentrationen i kolon af colistin ved monoterapi er så meget højere end MIC-værdien (f.eks. 20 gange højere end MIC-værdien) for E. coli og andre bakterier, hvorfor der ikke er nogen klinisk merværdi ved in vitro-synergi af kombinationer med colistin.
English: With the renewed use of colistin use in human medicine, particularly as a last-resort therapeutic option to treat infections due to multidrugresistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR), lactose-fermenting and non-fermenting Gram-negative bacilli, including Pseudomonas aeruginosa and Acinetobacter baumannii, then there are potential public health concerns with continued veterinary use of the substance.
Danish: Med den fornyede anvendelse af colistin i humanmedicinen, navnlig som sidste behandlingsmulighed for infektioner forårsaget af multiresistente (MDR), ekstensivt medicinresistene (XDR) og ekstremt resistente (PDR) laktosefermenterende og ikkefermenterende gramnegative stave, herunder Pseudomonas aeruginosa og Acinetobacter baumannii, er der betænkelighed ved de potentielle problemer for den offentlige sundhed som følge af stoffets fortsatte veterinære anvendelse.
English: In this context, colistin combination products are not utilised under prudent use principles nor fulfil the criteria outlined in the fixed combinations guideline for the approval of these products.
Danish: I denne sammenhæng opfylder brug af kombinationsprodukter, der indeholder colistin ikke principperne for forsvarlig brug, og produkterne opfylder ikke godkendelseskriterierne i henhold til retningslinjerne for faste kombinationsprodukter.
English: For gastrointestinal indications, there are also concerns if colistin combinations products are necessary over monotherapy.
Danish: For gastrointestinale indikationer er der desuden betænkelighed ved, hvorvidt kombinationsprodukter med colistin er nødvendige frem for monoterapi.
English: Pigs, chickens In drinking water use
Danish: Svin, kyllinger Til anvendelse i drikkevandet
English: VETOQUINOL Magny Vernois 70200 Lure France
Danish: Frankrig VETOQUINOL Magny Vernois 70200 Lure
English: In this procedure the CVMP was requested to review the marketing authorisations of all veterinary medicinal products containing colistin in combination with other antimicrobial substances for oral administration to food-producing species in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Danish: Ved denne procedure blev CVMP anmodet om at gennemgå markedsføringstilladelserne for alle veterinærmedicinske produkter, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration til fødevareproducerende arter med henblik på at sikre forsvarlig brug af stoffet til beskyttelse af dyrs sundhed og begrænse muligheden for fremtidig risiko for den offentlige sundhed.
English: Biofilms are protective layers around bacteria that are formed, for example, in the
Danish: Biofilm er beskyttende lag omkring bakterierne, der f.eks. dannes i fordøjelseskanalen som slimhindesamfund