FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific reasons could be identified for the need of a colistin combination product for food-producing animals in the EU with either an improvement of activity (synergistic or additive activity), or broadening of the activity spectrum.
Danish: Der kunne ikke peges på nogen specifik begrundelse for, at der skulle være behov for et kombinationsprodukt med colistin til fødevareproducerende dyr i EU, hverken i form af bedre aktivitet (synergistisk eller additiv aktivitet) eller bredere aktivitetsspektrum.
English: This is a very different situation in Europe since colistin has traditionally only been used in veterinary medicine and not critically important for human health.
Danish: Dette er en meget anderledes situation i EU, da colistin traditionelt kun har været anvendt i veterinærmedicinen uden at have kritisk betydning for menneskers sundhed.
English: with elevated MICs to colistin could constitute a risk to public health.
Danish: med forhøjede MIC-værdier over for colistin kan udgøre en risiko for den offentlige sundhed.
English: and P. aeruginosa), including those displaying carbapenem resistance, as well as certain Mycobacterium spp.
Danish: og P. aeruginosa), herunder dem, der er carbapenem-resistente, samt visse Mycobacterium spp.
English: In the light of the increase in bacterial resistance to antimicrobial substances, discussions are ongoing in the EU and on an international level on how to contain and minimise this phenomenon for the benefit of human and animal health.
Danish: På baggrund af stigningen i bakteriel resistens mod antimikrobielle stoffer drøftes det i EU og internationalt, hvordan man kan begrænse og minimere dette fænomen til gavn for menneskers og dyrs sundhed.
English: In veterinary medicine, it is used typically as the sulphate salt for oral preparations and as the methanesulphonate for parenteral administration.
Danish: I veterinærmedicinen anvendes det typisk som sulfatsaltet til orale præparater og som methansulfonatet til parenteral administration.
English: Until recently, polymyxin resistance had involved only chromosomal mutations but had never been reported via horizontal gene transfer.
Danish: Indtil for nylig havde polymyxinresistens kun omfattet kromosommutationer, men var aldrig beskrevet at have fundet sted ved horisontal genoverførsel.
English: Historically, this instability of polymyxin resistance, and the absence of horizontal gene transfer of these mutations, was thought to reduce the risk of rapid spread of resistance to colistin
Danish: Historisk blev denne ustabilitet af polymyxinresistens og den manglende horisontale genoverførsel af disse mutationer antaget at mindske risikoen for hurtig spredning af resistens mod colistin
English: Thus, it is unknown if a combination product provides an added value over a monotherapy product for this indication.
Danish: Det vides således ikke, om et kombinationsprodukt giver merværdi i forhold til et monoterapiprodukt ved denne indikation.
English: Administer the dose subdivided into two administrations each day, dissolved in drinking water or in milk.
Danish: Gives som to doser dagligt, opløst i drikkevandet eller i mælk.
English: 1ere Avenue 2065m L.I.D.
Danish: Frankrig VIRBAC 1ere Avenue 2065m L.I.D.
English: 3 restricting the indications, target species, and duration of treatment of the concerned products, as well as adding prudent use warnings to the product information.
Danish: 3 om at begrænse indikationer, måldyrearter og behandlingsvarighed for de pågældende produkter og tilføje advarsler om forsvarlig brug i produktinformationen.
English: PREMELANGE MEDICAMENTEUX CS FRANVET
Danish: PREMELANGE MEDICAMENTE UX CS FRANVET
English: Due to colistin's new status as critically important in human medicine, the public health impact of the current or future use of colistin products in animals needs to be re-assessed at this time.
Danish: Med colistins nye status som kritisk vigtigt i humanmedicinen må de folkesundhedsmæssige konsekvenser af den nuværende eller fremtidige anvendelse af colistinholdige produkter til dyr nu revurderes.
English: Scientific conclusions and grounds for the withdrawal of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelse for inddragelsen af markedsføringstilladelserne
English: Some of the products included in the scope of this referral procedure are indicated for use in foals.
Danish: Nogle af produkterne omfattet af denne indbringelsesprocedure er indikeret til anvendelse hos føl.
English: Arnika Veterina d.o.o.
Danish: Kroatien Arnika Veterina d.o.o.
English: COLIMIX (116 g/kg /40 g/kg), prémistura medicamentosa para alimento medicamentoso para suínos
Danish: COLIMIX (116 g/kg /40 g/kg), pré-mistura medicamentosa para alimento medicamentoso para suínos
English: No clinical studies or justification was given for the under-dosing which could constitute a risk to public health by promoting colistin resistant bacteria.
Danish: Der blev ikke forelagt kliniske undersøgelser eller begrundelse for denne underdosering, der kan udgøre en risiko for den offentlige sundhed ved at fremme colistinresistente bakterier.
English: This is especially a concern for certain colistin combination products (e.g. colistin and neomycin or colistin and oxytetracycline) where both active substances are not absorbed but yet the products are currently authorised with non-gastrointestinal tract indications.
Danish: Dette medfører navnlig betænkelighed ved visse kombinationsprodukter med colistin (f.eks. colistin og neomycin eller colistin og oxytetracyclin), hvor begge aktive stoffer ikke absorberes, men hvor produkterne alligevel er godkendt til ikkegastrointestinale indikationer.
English: In the aforementioned Commission Decision it is stated that in line with the agreed stepwise approach “The combinations of colistin with another antimicrobial substance and the non-oral administration of products containing colistin may be addressed as a next step following the completion of this referral procedure.”
Danish: Det anføres i den nævnte kommissionsbeslutning, at i overensstemmelse med den vedtagne trinvise tilgang "kan kombinationer af colistin med et andet antimikrobielt stof og ikke-oral administration af produkter, der indeholder colistin tages op som næste skridt efter gennemførelsen af denne indbringelsesprocedure."
English: “Transfer of resistance either on mobile genetic elements (such as plasmids) between bacteria or from animals to humans has not been reported.”
Danish: "Der er ikke beskrevet overførsel af resistens, hverken mellem bakterier gennem overførbare genetiske elementer (såsom plasmider) eller fra dyr til mennesker.”
English: In May 2014 the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species (EMEA/V/A/106).
Danish: I maj 2014 indledte Europa-Kommissionen en indbringelsesprocedure i medfør af artikel 35 i direktiv 2001/82/EF for alle veterinærlægemidler, der indeholder colistin som eneste aktive stof til oral administration til fødevareproducerende arter (EMEA/V/A/106).
English: A substantial change has occurred over the last five years regarding the importance of colistin in human and veterinary medicine - from a molecule used only in veterinary medicine, colistin has become a critically important molecule in human medicine.
Danish: I løbet af de sidste fem år er der sket en væsentlig ændring af betydningen af colistin i human- og veterinærmedicinen - fra at være et molekyle, der kun anvendes i veterinærmedicinen, er colistin
English: Farma vet Ltd. 40 Otec Paisii str. Shumen
Danish: Bulgarien Farma vet Ltd. 40 Otec Paisii str.
English: On the status of colistin as a critically important antimicrobial in human medicine, the advice stated:
Danish: Om colistins status som et kritisk vigtigt antimikrobielt middel i humanmedicinen hed det i anvisningerne:
English: This means that with the lack of international standard techniques for colistin susceptibility testing no agreed standards exist for in vitro synergy evaluation for colistin combinations.
Danish: Dette er ensbetydende med, at der i mangel af internationale standardteknikker til følsomhedstestning for colistin ikke findes anerkendte standarder for vurdering af in vitro-synergi for kombinationer med colistin.
English: Several scientific reports and EU surveillance data have demonstrated continued very low level of resistance to colistin in food-producing animals, as well as reduced levels of resistance to several other antimicrobials used in colistin combination products, despite the wide use of these products in the EU for some years.
Danish: Flere videnskabelige rapporter og EU-overvågningsdata har vist vedholdende meget lav resistens over for colistin hos fødevareproducerende dyr samt nedsat resistens over for flere andre antimikrobielle stoffer, der anvendes i produkter, der indeholder colistin, trods disse produkters udbredte anvendelse i EU i en årrække.
English: Thus, it is no longer the case that colistin-resistant bacteria in animals are unrelated to public health and the example found in China does demonstrate that transferable mcr-1 gene colistin resistance can occur in food animals and meat products and potentially constitute a public health risk.
Danish: Derfor forholder det sig ikke længere sådan, at colistinresistente bakterier hos dyr er uden relation til den offentlige sundhed, og eksemplet i Kina viser, at overførsel af resistens over for colistin gennem mcr-1- genet faktisk kan finde sted gennem fødevareproducerende dyr og kødprodukter og er en potentiel risiko for den offentlige sundhed.
English: In light of the renewed use of colistin use in human medicine and its critical importance for public health then it is essential to ensure prudent use of the substance in veterinary medicine in order to avoid an increase in the development of antimicrobial resistance.
Danish: På baggrund af den fornyede anvendelse af colistin i humanmedicinen og dets kritiske vigtighed for den offentlige sundhed er det væsentligt at sikre forsvarlig anvendelse af stoffet i veterinærmedicinen for at undgå en stigning i udviklingen af antimikrobiel resistens.
English: The disk diffusion test is applied routinely worldwide yet is seldom reliable due to the inability of colistin to regularly diffuse in the agar and produce a consistent concentration gradient.
Danish: Pladediffusionstesten anvendes rutinemæssigt i hele verden, men er sjældent pålidelig på grund af colistins manglende evne til at diffundere jævnt i agaren og danne en jævn koncentrationsgradient.
English: This advice critically reviewed information on the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health, and the possible impact on human and animal health.
Danish: Disse anvisninger gennemgik kritisk oplysninger om anvendelsen af colistin hos fødevareproducerende dyr i EU, dets effekt på udviklingen af resistens over for denne kategori af antimikrobielle stoffer hos bakteriearter, der er vigtige for menneskers og dyrs sundhed, og den mulige indvirkning heraf på menneskers og dyrs sundhed.
English: The risk identified by maintaining this indication is that it promotes the treatment of an unknown clinical disease, leading to treatment failures because the true cause (e.g. viral, other bacteria, protozoans, parasites) is unaffected by colistin combination treatments.
Danish: Den konstaterede risiko ved at opretholde denne indikation er, at den fremmer behandling af en ukendt klinisk sygdom, hvilket fører til behandlingssvigt, da den egentlige årsag (f.eks. virus, andre bakterier, protozoer eller parasitter) ikke påvirkes af kombinationspræparater, der indeholder colistin.
English: In the present Article 35 referral, several colistin combinations veterinary medicinal products were identified with colistin doses of below 50,000 IU per kg body weight.
Danish: I nærværende artikel 35-indbringelse blev der fundet flere veterinære kombinationsprodukter med colistindoser under 50 000 IU pr. kg kropsvægt.
English: In the present procedure no data or evidence was presented for the indication of salmonellosis in any target species.
Danish: I denne procedure blev der ikke forelagt data eller evidens med henblik på indikationen salmonellose for nogen måldyreart.
English: Combinations of colistin with other antimicrobials are available for group treatments of gastrointestinal and respiratory infections in food-producing animals in some European Member States.
Danish: Kombinationer af colistin med andre antimikrobielle stoffer fås til gruppebehandling af gastrointestinale og respiratoriske infektioner hos fødevareproducerende dyr i nogle EU-medlemsstater.
English: No published data is available that has identified the mechanism by which synergism could occur for colistin combinations.
Danish: Der findes ingen publicerede data, som har fastlagt mekanismen for en eventuel synergi for kombinationer med colistin.
English: Also, the previous Article 35 referral procedure confirmed a dose of 100,000 IU colistin per kg body weight daily for calves, lambs and pigs, and a dose of 75,000 IU colistin per kg body weight daily in poultry for 3-5 consecutive days.
Danish: Desuden blev der ved den foregående artikel 35-indbringelsesprocedure fastsat en dosis på 100 000 IU colistin dagligt pr. kg kropsvægt til kalve, lam og svin og en dosis på 75 000 IU colistin pr. kg kropsvægt dagligt til fjerkræ i 3-5 på hinanden følgende dage.
English: Also, it is unclear whether at the time of systemic complications from colibacillosis the main clinical disease is still the gastrointestinal disease or the systemic complications.
Danish: Det er ligeledes uklart, om den kliniske hovedsygdom på tidspunktet for de systemiske komplikationer af colibacillose stadig er mave-tarmsygdommen eller dens systemiske komplikationer.
English: It belongs to the polymyxin therapeutic class and is identical to polymyxin E. Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats.
Danish: Det tilhører den terapeutiske klasse polymyxiner og er identisk med polymyxin E. Colistin anvendes til behandling og forebyggelse af følsomme bakterier (f.eks. Escherichia coli) hos svin, fjerkræ, kaniner, kvæg, får og geder.
English: Following the Article 35 referral procedure for veterinary medicinal products containing colistin as sole active substance (EMEA/V/A/106), colistin is no longer recommended for treatment of gastrointestinal infections caused by Salmonella spp.
Danish: Siden artikel 35-indbringelsesproceduren for veterinærmedicinske produkter med colistin som eneste aktive stof (EMEA/V/A/106) anbefales colistin ikke længere til behandling af gastrointestinale infektioner forårsaget af Salmonella spp.
English: This is for the reason that colistin is not absorbed from the gastrointestinal tract after oral administration and thus does not contribute to the overall therapeutic efficacy for these indications.
Danish: Dette skyldes, at colistin ikke absorberes fra mavetarmkanalen efter oral administration og derfor ikke bidrager til den samlede terapeutiske virkning ved disse indikationer.
English: Given the recent critical importance of colistin in human medicine, then veterinary use can only be justified under prudent use principles, which is not the case for colistin combinations products for non-gastrointestinal indications.
Danish: På baggrund af den nyligt konstaterede kritiske vigtighed af colistin i humanmedicinen kan den veterinære anvendelse kun begrundes i principperne for forsvarlig brug, hvilket ikke er tilfældet for kombinationsprodukter med colistin til ikke-gastrointestinale indikationer.
English: Considering the significant number of products containing colistin authorised in the EU it was considered appropriate to follow a stepwise approach based on risk for the revision of summary of the product characteristics of products containing colistin.
Danish: I betragtning af det betydelige antal colistinholdige produkter, der er godkendt i EU, blev det anset for hensigtsmæssigt at benytte en risikobaseret trinvis tilgang til revisionen af produktresuméerne for produkter, der indeholder colistin.
English: Overall summary of the scientific evaluation of all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af alle veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration (se bilag I)
English: Human infections with such highly resistant bacteria are associated with higher patient morbidity and mortality, higher costs and longer length of hospital stay
Danish: Humane infektioner med sådanne højresistente bakterier medfører øget morbiditet og mortalitet, større omkostninger og længere indlæggelse
English: The vast majority of consumption of polymyxins in food-producing animals is accounted for by colistin administered orally, in a variety of different formulations (e.g. premix, powder, oral solutions).
Danish: Langt det største forbrug af polymyxiner til fødevareproducerende dyr udgøres af colistin administreret oralt i en række forskellige formuleringer (f.eks. premix, pulver og orale opløsninger).
English: The use of combination products represents a risk of unnecessary use of colistin in cases where no additional benefit has been shown over the use of one substance alone.
Danish: Anvendelse af kombinationsprodukter repræsenteret en unødvendig brug af colistin i tilfælde, hvor der ikke er påvist større fordel end ved anvendelse af ét stof alene.
English: Current European Committee on Antimicrobial Susceptibility Testing clinical breakpoints for Enterobacteriaceae are under revision because of these issues.
Danish: Committee on Antimicrobial Susceptibility Testing (den europæiske komité for følsomhedstestning af antimikrobielle stoffer) er under revision på grund af disse problemer.
English: In a previous Article 35 referral procedure for all veterinary medicinal products containing colistin to be administered orally the Committee agreed a harmonised indication, a limitation of the duration of treatment up to 7 days and warning sentences on prudent use.
Danish: I en tidligere artikel 35indbringelsesprocedure for alle veterinærmedicinske produkter, der indeholder colistin til oral administration vedtog udvalget en harmoniseret indikation, en begrænsning af behandlingsvarigheden til op til 7 dage og advarselssætninger om forsvarlig brug.
English: Romania SC ROMVAC COMPANY SA
Danish: Rumænien SC ROMVAC COMPANY SA Sos.
English: Non-gastrointestinal indications are considered an unnecessary use of colistin as the substance does not contribute to any therapeutic effect of other organs infected with bacterial infections.
Danish: Ikke-gastrointestinale indikationer anses for unødig anvendelse af colistin, da stoffet ikke bidrager til den terapeutiske virkning på andre organer, hvori der er bakterielle infektioner.
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelfor
English: • the CVMP considered that the development of antimicrobial resistance to colistin is considered a risk for human health as colistin is also used as a last resort treatment in human medicine in the context of treatment of specific highly drug-resistant bacterial infections;
Danish: • CVMP fandt, at udviklingen af antimikrobiel resistens mod colistin må anses for at udgøre en risiko for menneskers helbred, da colistin også anvendes som en sidste behandlingsmulighed i humanmedicinen ved behandling af specifikke bakterielle infektioner med højresistente organismer,
English: Polymyxins are active particularly against a wide range of species of Gram-negative bacilli (e.g. E. coli, Salmonella spp.
Danish: Polymyxiner er især aktive mod en lang række gramnegative baciller (f.eks. E. coli, Salmonella spp.
English: A recent paper identified another risk of colistin products and Salmonella spp.
Danish: I en nylig artikel peges der på endnu en risiko ved produkter, der indeholder colistin i forbindelse med Salmonella spp.
English: Colistin combination products are seen to serve a role for these more complex production-related diseases and clinical studies are available for some combinations, which demonstrated efficacy for some conditions.
Danish: Kombinationsprodukter, der indeholder colistin anses for at spille en rolle for disse mere komplekse produktionsrelaterede sygdomme, og for visse kombinationer foreligger der kliniske undersøgelser, der har vist virkning mod nogle sygdomme.
English: This was supported by a recent EU commissioned ad hoc expert group on antimicrobial resistance (AMEG) as well as a recent Article 35 referral procedure on veterinary medicinal products containing colistin as sole active substance to be administered orally.
Danish: Dette støttedes af en ad hoc-ekspertgruppe vedrørende antimikrobiel resistens (AMEG), der for nylig blev nedsat af EU, og en nylig artikel 35-indbringelsesprocedure for veterinærmedicinske produkter, der indeholder colistin som eneste aktive stof til oral administration.
English: The bactericidal effect of colistin (and polymyxin B) is the result of an interaction with divalent cations of the outer bacterial membrane, which causes a disruption of the cell structure, leakage of the cell contents and thereby cell lysis
Danish: Den baktericide virkning af colistin (og polymyxin B) skyldes en interaktion med divalente kationer i bakteriernes ydre cellemembran, som medfører et brud på cellens struktur, lækage af cellens indhold og dermed lysis af cellen
English: Until recently it was felt the public health concerns were small due to the known characteristics of colistin resistance identified in veterinary medicine, including that these colistinresistant bacteria are rare, possess only non-transferable genetic elements to other bacteria and are unstable, meaning colistin-resistant bacteria do not persist.
Danish: Indtil for nylig var det opfattelsen, at betænkelighederne vedrørende den offentlige sundhed var små på grund af de kendte resistensegenskaber af colistin, der var konstateret i veterinærmedicinen, herunder at colistinresistente bakterier er sjældne, kun indeholder genetiske elementer, der ikke kan overføres til andre bakterier, og er ustabile, ensbetydende med at der ikke vedblivende forekommer colistinresistente bakterier.
English: Previous CVMP conclusions applicable to colistin combination products
Danish: CVMP's tidligere konklusioner, der finder anvendelse på kombinationsprodukter, der indeholder colistin
English: The CVMP considered that the end result of using colistin combination products instead of monotherapy is an unnecessary use of colistin.
Danish: CVMP fandt, at det endelige resultat af at anvende kombinationsprodukter, der indeholder colistin i stedet for monoterapi er unødig anvendelse af colistin.
English: Specifically, in EU countries with known higher consumptions of colistin products, minimum inhibitory concentration (MIC) distributions were higher for Salmonella spp.
Danish: I EU-lande med kendt højere forbrug af produkter, der indeholder colistin var der således højere mindste hæmmende koncentrationer (MIC) over for isolater af Salmonella spp.
English: Quality, target animal safety, user safety, environmental risk and residues were not assessed in this referral procedure.
Danish: Denne henvisningsprocedure omfatter ikke kvalitet, brugersikkerhed, miljørisiko eller restkoncentrationer.