FrancophonIA/ELRC3.0 huggingface dataset:
English: Concentrate for oral solution for use in drinking water
Danish: Koncentrat til oral opløsning til brug i drikkevand
English: 3 days.
Danish: 3 dage.
English: Furthermore, the Committee noted that treatment of subclinical Salmonella with the objective to reduce the number of bacteria might interfere with control programmes for this disease1.
Danish: Desuden bemærkede CVMP, at behandling af subklinisk Salmonella med henblik på at mindske antallet af bakterier kan interferere med bekæmpelsesprogrammer for denne sygdom1.
English: With regard to the efficacy in chickens a study report from public literature was provided where E. coli infections were treated with colistin sulfate given in feed.
Danish: Med hensyn til effekten hos kyllinger blev der fremlagt en undersøgelsesrapport fra den offentligt tilgængelige litteratur, hvor E. coli-infektioner blev behandlet med colistinsulfat i foderet.
English: Consequently, the use of colistin for the treatment of infections caused by Salmonella may interfere with specific control methods and national programmes for the control of Salmonella;
Danish: Følgelig kan anvendelse af colistin til behandling af infektioner forårsaget af Salmonella interferere med specifikke bekæmpelsesmetoder og nationale programmer til bekæmpelse af Salmonella.
English: IU/ML/DIVASA -FARMANIC
Danish: IU/ML/DIVASAFARMANIC
English: CENAVISA, S.A. Camí Pedra Estela S/N
Danish: Rumænien CENAVISA, S.A. Camí Pedra Estela S/N
English: In addition it was noted that the recommended daily dose for calves, lambs and pigs should be divided into two if the product is to be administered directly into the mouth of the animal.
Danish: Desuden blev det bemærket, at den anbefalede daglige dosis til kalve, lam og svin bør opdeles i to, hvis produktet skal administreres direkte i dyrets mund.
English: With regard to the efficacy in pigs the pre-clinical data revealed that the selection of dose rate and dose interval for colistin sulfate in pigs was chosen by using a pharmacokinetic/pharmacodynamic (PK/PD) analysis.
Danish: Med hensyn til effekten hos svin viste de prækliniske data, at doseringshastighed og doseringsinterval for colistinsulfat hos svin var valgt ud fra en farmakokinetisk/farmakodynamisk (PK/PD) analyse.
English: In the submitted Periodic Safety Update Reports no lack of efficacy has been reported for the claimed indications in calves and lambs.
Danish: I de indsendte periodiske, opdaterede sikkerhedsindberetninger er der ikke rapporteret om manglende effekt for de påståede indikationer hos kalve og lam.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET
English: Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.
Danish: Kalve, lam, svin, fjerkræ: i 3 på hinanden følgende dage i drikkevand.
English: This said, it was agreed that the suggested dose of 50 000 IU per kg body weight twice daily was reasonable.
Danish: Der var dog enighed om, at den foreslåede dosis på 50 000 IE pr. kg legemsvægt to gange dagligt var rimelig.
English: With regard to the duration of treatment, considering the fact that treatment effect is easily monitored and thus treatment duration can be adjusted according to the course of the disease the Committee agreed to recommend a harmonised duration of treatment of 3-5 days for all products intended for calves and lambs.
Danish: Med hensyn til behandlingsvarigheden besluttede CVMP i betragtning af, at behandlingen nemt kan monitoreres og behandlingsvarigheden dermed justeres efter sygdomsforløbet, at anbefale en harmoniseret behandlingsvarighed på 3-5 dage for alle produkter til kalve og lam.
English: For three consecutive days in drinking water
Danish: I 3 på hinanden følgende dage i drikkevand
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION To be administered orally.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ Administreres oralt.
English: With regard to the duration of treatment of gastrointestinal infections caused by non-invasive E. coli in the target species it was noted that the treatment effect is easily monitored and thus treatment duration can be adjusted according to the course of the disease.
Danish: Med hensyn til behandlingsvarigheden for gastrointestinale infektioner forårsaget af non-invasiv E. coli hos de dyrearter, lægemidlet er beregnet til, blev det bemærket, at behandlingseffekten er let at monitorere, og behandlingsvarigheden kan dermed justeres efter sygdomsforløbet.
English: Eggs: Zero days Not permitted for use in animals producing milk for human consumption
Danish: Æg: nul dage Må ikke anvendes til lakterende dyr, der producerer mælk bestemt til menneskeføde
English: Current SPCs establish withdrawal periods of 7 days for these species.
Danish: Det nuværende produktresumé fastlægger en tilbageholdelsestid på 7 dage for disse arter.
English: It was noted that the analysis, based on the determination of colistin sulfate concentration in the gastrointestinal tract after different levels of exposure and minimum inhibitory concentrations (MIC) data from E. coli strains collected in five European countries could be questioned as the surrogate endpoint Cmax/MIC was not validated for local exposure in the gastrointestinal tract and the fraction of active compound bound to the faecal content was not known.
Danish: Det blev bemærket, at der kunne sættes spørgsmålstegn ved analysen, som var baseret på bestemmelse af colistinsulfatkoncentrationen i gastrointestinalkanalen efter forskellige eksponeringsniveauer og data for mindste hæmmende koncentration (MIC) fra E. coli-stammer indsamlet i fem europæiske lande, da surrogateffektmålet Cmax/MIC ikke blev valideret for lokal eksponering i gastrointestinalkanalen, og fraktionen af aktivt stof, som er bundet til fækalindhold, ikke var kendt.
English: The dose currently recommended in all products authorised for calves and lambs is a harmonised dose of 100 000 IU colistin per kg body weight daily.
Danish: Den nuværende anbefalede dosis for alle produkter, som er godkendt til kalve og lam, er en harmoniseret dosis på 100 000 IE colistin pr. kg legemsvægt dagligt.
English: Poultry For three consecutive days in drinking water
Danish: Fjerkræ I 3 på hinanden følgende dage i drikkevand
English: infection in calves, lambs, pigs and poultry, no or very limited clinical data was presented to support this indication currently approved for the products within the scope of this procedure.
Danish: Med hensyn til behandling af Salmonella spp.-infektion hos kalve, lam, svin og fjerkræ blev der ikke fremlagt data, eller der blev fremlagt meget begrænsede data, til støtte for denne indikation, som i øjeblikket er godkendt for produkterne inden for denne procedure.
English: In view of the residue data submitted in support of the withdrawal periods in calves, pigs and chickens, and general knowledge that the substance is poorly absorbed from the gastrointestinal tract, the Committee considered that the same withdrawal period of 1 day could be recommended for these animal species.
Danish: I betragtning af de indsendte restkoncentrationsdata til støtte for tilbageholdelsestiderne for kalve, svin og kyllinger og den generelle viden om, at stoffet absorberes dårligt fra gastrointestinalkanalen, mente CVMP, at den samme tilbageholdelsestid på 1 dag kan anbefales for disse arter.
English: 43205 Reus SPAIN
Danish: 43205 Reus
English: Colistin (as colistin sulfate)
Danish: Colistin (som colistinsulfat)
English: S.C. CRIDA PHARM S.R.L.
Danish: Rumænien S.C. CRIDA PHARM S.R.L.
English: These studies provide sufficient support for the treatment of colibacilosis in chickens although the correspondence between the in-feed doses used in these studies and the dose recommended for most products within this referral (75 000 IU colistin per kg body weight once daily for 3 days) was not fully justified.
Danish: Disse undersøgelser yder tilstrækkelig støtte til behandling af colibacilose hos kyllinger, selvom forbindelsen mellem de foderdoser, som blev anvendt i disse undersøgelser, og den dosis, som anbefales for de fleste produkter i denne indbringelsesprocedure (75 000 IE colistin pr. kg legemsvægt én gang dagligt i 3 dage) ikke var fyldestgørende begrundet.
English: The United Kingdom expressed concerns that differences in the posology and withdrawal periods established across the European Union for veterinary medicinal formulations containing colistin at 2 000 000 IU/ml and intended for administration in drinking water to any food producing species may present a potential serious risk to public and animal health.
Danish: Det Forenede Kongerige udtrykte bekymring for, at de forskelle i dosering og tilbageholdelsestid, der er fastlagt i EU for veterinærlægemidler indeholdende colistin 2 000 000 IE/ml og beregnet til administration i drikkevand til arter bestemt til levnedsmiddelproduktion, kan udgøre en potentielt alvorlig risiko for sundheden hos dyr og mennesker.
English: In the absence of any such data it is considered that this use may constitute a risk to public and animal health as treatment might make the bacteria difficult to detect without completely eliminating the infection/colonisation and therefore result in persistence of zoonotic organisms in treated animals and in the environment and delays in effective elimination.
Danish: I mangel af sådanne data vurderes det, at denne anvendelse kan udgøre en risiko for menneskers og dyrs sundhed, da behandlingen kan gøre det vanskeligt at påvise bakterien uden helt at eliminere infektionen/koloniseringen og derfor medføre, at der er zoonotiske organismer tilbage i behandlede dyr og i miljøet, og at effektiv eliminering forsinkes.
English: Do not use in laying hens producing eggs for human consumption.
Danish: Må ikke anvendes til æglæggende høns, hvis æg er bestemt til menneskeføde.
English: Oral administration treatment: 3 - 4 days
Danish: Oral administration: 3-4 dage
English: 4.9 Amounts to be administered and administration route To be administered orally.
Danish: 4.9 Dosering og indgivelsesvej Administreres oralt.
English: Furthermore there is no new information indicating any new risk associated with the use of colistin in calves and lambs in relation to lack of efficacy or emerging resistance relevant to public or animal health.
Danish: Desuden foreligger der ingen nye oplysninger, som tyder på en ny risiko i forbindelse med anvendelse af colistin hos kalve og lam i forhold til manglende effekt eller begyndende resistens, som er relevant for menneskers og dyrs sundhed.
English: Lithuania Ceva Santé Animale Zone Industrielle La Ballastiere
Danish: Bulgarien Ceva Santé Animale Zone Industrielle La Ballastiere
English: With regard to gastrointestinal infections caused by non-invasive E. coli in calves and lambs the data submitted to support the indication were limited.
Danish: Med hensyn til gastrointestinale infektioner forårsaget af non-invasiv E. coli hos kalve og lam var de indsendte data til støtte for denne indikation begrænsede.
English: 5 Chindiei , sector 4 040185 Bucharest ROMANIA
Danish: 040185 Bucharest RUMÆNIEN
English: Denmark Ceva Animal Health A/S
Danish: Ceva Animal Health A/S
English: No residue depletion studies were provided for lambs and for poultry species other than chickens.
Danish: Der blev ikke fremsendt restkoncentrationsstudier for lam og fjerkræarter ud over kyllinger.
English: Considering the general knowledge that the substance is poorly absorbed from the gastro-intestinal tract the Committee considered that the withdrawal period of 1 day as recommended for calves, pigs and chicken can also be supported for lambs and poultry species other than chickens.
Danish: I betragtning af den generelle viden om, at stoffet absorberes dårligt fra gastrointestinalkanalen mente CVMP, at tilbageholdelsestiden på 1 dag, som anbefales for kalve, svin og kyllinger, også kan støttes for lam og andre fjerkræarter end kyllinger.
English: Orally via drinking water.
Danish: Oralt i drikkevand.
English: • the CVMP considered that the Applicants/Marketing Authorisation Holders did not provide any data or argumentation in support of a claim “…for treatment of gastrointestinal infections caused by Salmonella spp…” in calves, lambs, pigs or poultry.
Danish: • CVMP vurderede, at ansøgerne/indehaverne af markedsføringstilladelserne ikke havde indsendt data eller argumentation til støtte for en påstand om "... til behandling af gastrointestinale infektioner forårsaget af Salmonella spp..." hos kalve, lam, svin eller fjerkræ.
English: 33500 Libourne FRANCE
Danish: 33500 Libourne FRANKRIG
English: The withdrawal periods established in the current SPCs for these species is 7 days.
Danish: Tilbageholdelsestiderne i det nuværende produktresumé er 7 dage for disse arter.
English: 06516 Carros Cedex FRANCE
Danish: 06516 Carros Cedex FRANKRIG
English: • the CVMP considered that colistin administered orally has been used to treat gastrointestinal infections caused by non-invasive E. coli infections in calves, lambs, pigs and poultry during decades.
Danish: • CVMP vurderede, at colistin administreret oralt har været anvendt til at behandle gastrointestinale infektioner forårsaget af non-invasiv E. coli hos kalve, lam, svin og fjerkræ i årtier.
English: Orally: 3 days
Danish: Oralt: 3 dage
English: COLICRID Colistin sulfate
Danish: COLICRID Colistinsulfat
English: Administration via drinking water or milk.
Danish: Administration i drikkevand eller mælk.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING
Danish: ÆNDRINGER, SOM SKAL TILFØJES DE RELEVANTE AFSNIT AF ETIKETTERINGEN
English: Twice a day for 3 to 5 consecutive days.
Danish: 2 gange dagligt i 3-5 på hinanden følgende dage.
English: However, in view of the well established use of the substance in these species and the fact that there was no new information indicating any new risk associated with the use of colistin in calves and lambs in relation to lack of efficacy or human health the Committee considered that the use of colistin in calves and lambs for the treatment of gastrointestinal infections caused by non-invasive E. coli can be maintained.
Danish: Da anvendelse af stoffet imidlertid er veldokumenteret hos disse arter, og da der ikke foreligger nogen nye oplysninger, som tyder på en ny risiko i forbindelse med anvendelse af colistin hos kalve og lam i forhold til manglende effekt eller menneskers sundhed, vurderede CVMP, at anvendelse af colistin til behandling af gastrointestinale infektioner hos kalve og lam forårsaget af non-invasiv E. coli kan opretholdes.
English: Veterinary medicinal formulations containing colistin sulfate at 2 000 000 IU/ml and intended for administration via drinking water to calves, pigs, lambs and poultry are used for the treatment of infections of the gastrointestinal tract caused by Escherichia coli and Salmonella spp susceptible to colistin.
Danish: Veterinærlægemidler indeholdende colistinsulfat 2 000 000 IE/ml og beregnet til administration i drikkevandet til kalve, svin, lam og fjerkræ anvendes til behandling af gastrointestinale infektioner forårsaget af Escherichia coli og Salmonella spp, som er følsomme over for colistin.
English: Complete or partial lack of efficacy can result in persistence of zoonotic organisms in treated animals (and in the environment) and delay effective elimination of Salmonella due to treatment failure.
Danish: Fuldstændig eller delvis mangel på effekt kan medføre, at der er zoonotiske organismer tilbage i behandlede dyr (og i miljøet), og at effektiv eliminering af Salmonella forsinkes på grund af behandlingssvigt.
English: 100 000 IU colistin / kg body weight daily for 3-5 days.
Danish: 100 000 IE colistin/kg legemsvægt dagligt i 3-5 dage.
English: No residue data were available with regard to lambs and poultry species other than chickens.
Danish: Der blev ikke fremsendt data vedrørende lam og fjerkræarter ud over kyllinger.
English: In summary withdrawal periods of one day for edible tissues and offal of calves, pigs and chickens and zero days for eggs are considered justified.
Danish: Sammenfattende anses tilbageholdelsestider på 1 dag for spiseligt væv og indvolde fra kalve, svin og kyllinger og nul dage for æg som berettigede.
English: 44153 Ancenis Cedex
Danish: 44153 Ancenis Cedex FRANKRIG
English: For 3 consecutive days.
Danish: I 3 på hinanden følgende dage.
English: Having considered the residue depletion data submitted by the Applicants/Marketing Authorisation Holders, a withdrawal period of one day for edible tissues and offal from calves, pigs and chickens and zero days for eggs were considered adequate.
Danish: På grundlag af de restkoncentrationsdata, som blev indsendt af ansøgerne/indehaverne af markedsføringstilladelserne, anses en tilbageholdelsestid på 1 dag for spiselige væv og indvolde fra kalve, svin og kyllinger og nul dage for æg for tilstrækkelig.
English: 08503 GURB - VIC (Barcelona) Spain
Danish: 08503 GURB - VIC (Barcelona) SPANIEN
English: The use of colistin sulfate for the treatment non-invasive E. coli in calves and lambs is considered wellestablished.
Danish: Anvendelse af colistinsulfat til behandling af non-invasiv E. coli hos kalve og lam anses for veldokumenteret.
English: Product name
Danish: Særnavn Internationalt fællesnavn
English: Complete or partial lack of efficacy can result in persistence of zoonotic organisms in treated animals and in the environment and delays in effective elimination due to treatment failure.
Danish: Fuldstændig eller delvis mangel på effekt kan medføre, at der er zoonotiske organismer tilbage i behandlede dyr og i miljøet, og at effektiv eliminering forsinkes på grund af behandlingssvigt.
English: The submitted residue depletion studies were reviewed and based on the recommended posology for cattle (100 000 IU colistin per kg body weight daily for 3-5 consecutive days) and the proposed harmonised posology for pigs and poultry (100 000 IU colistin per kg body weight daily for pigs and 75 000 IU colistin per kg body weight daily in poultry for 3-5 days) the withdrawal periods for calves, pigs and chickens were recalculated using the alternative method
Danish: De indsendte restkoncentrationsundersøgelser blev gennemgået, og ud fra den anbefalede dosis for kvæg (100 000 IE colistin pr. kg legemsvægt dagligt i 3-5 på hinanden følgende dage) og den foreslåede harmoniserede dosering til svin og fjerkræ (100 000 IE colistin pr. kg legemsvægt dagligt til svin og 75 000 IE colistin pr. kg. legemsvægt dagligt til fjerkræ i 3-5 dage) blev tilbageholdelsestiderne for kalve, svin og kyllinger beregnet på ny med den alternative metode3.
English: Consequently the benefit-risk balance for colistin was considered negative for treatment of gastrointestinal infections cased by Salmonella spp in calves, lambs, pigs and poultry.
Danish: Følgelig blev benefit/risk-forholdet for colistin vurderet som negativt for behandling af gastrointestinale infektioner forårsaget af Salmonella spp hos kalve, lam, svin og fjerkræ.
English: The recommended daily dose should be divided into two if the product is to be administered directly into the mouth of the animal.
Danish: Den anbefalede daglige dosis til kalve, lam og svin bør opdeles i to, hvis produktet skal administreres direkte i dyrets mund.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VETERINARY MEDICINAL FORMULATIONS CONTAINING COLISTIN SULFATE AT 2 000 000 IU/ML AND INTENDED FOR ADMINISTRATION VIA DRINKING WATER TO CALVES, LAMBS, PIGS AND POULTRY SPECIES
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF VETERINÆRLÆGEMIDLER INDEHOLDENDE COLISTINSULFAT 2 000 000 IE/ML OG BEREGNET TIL ADMINISTRATION I DRIKKEVANDET TIL KALVE, LAM, SVIN OG FJERKRÆARTER
English: Cattle (calves), sheep (lambs), swine and chickens
Danish: Kvæg (kalve), får (lam), svin og kyllinger
English: 08503 Gurb-Vic (Barcelona) SPAIN
Danish: 08503 Gurb-Vic (Barcelona) SPANIEN
English: Chicken: 1 day Other poultry: 7 days.
Danish: Kyllinger: 1 dag Andet fjerkræ: 7 dage
English: Treatment of gastrointestinal infections caused by non-invasive E. coli susceptible to colistin.
Danish: Behandling af gastrointestinale infektioner forårsaget af non-invasiv E. coli, som er følsom over for colistin.
English: By contrast, the CVMP considered that the absence of any data or argumentation from the Applicants/Marketing Authorisation Holders in support of a claim “…for treatment of gastrointestinal infections caused by Salmonella spp…” may constitute a risk to public and animal health as treatment might make the bacteria difficult to detect without completely eliminating the infection/colonisation.
Danish: Til gengæld vurderede CVMP, at manglende data eller argumentation fra ansøgerne/indehaverne af markedsføringstilladelserne til støtte for en påstand om "... behandling af gastrointestinale infektioner forårsaget af Salmonella spp..." kan udgøre en risiko for menneskers og dyrs sundhed, da behandlingen kan gøre det vanskeligt at påvise bakterien uden helt at eliminere infektionen/koloniseringen.
English: Meat: 9 days
Danish: Kød: 9 dage
English: Animal species
Danish: Ceva Saúde AnimalProdutos
English: Although the quality of the data provided was considered to be poor and in some cases lacking, and so failed to support some of the indications claimed, the Committee considered that there was sufficient documented evidence in support of efficacy of colistin sulfate when used in pigs for the treatment of gastrointestinal infections caused by non-invasive E. coli, susceptible to colistin, at dose of 100 000 IU colistin per kg body weight daily for 3-5 consecutive days.
Danish: Til trods for at kvaliteten af de indsendte data ansås for dårlig, og i nogle tilfælde manglede helt, og dermed ikke understøttede nogle af de påståede indikationer, vurderede CVMP, at der var tilstrækkelig dokumentation til støtte for effekten af colistinsulfat, når det anvendes til svin til behandling af gastrointestinale infektioner forårsaget af non-invasiv E. coli, som er følsom over for colistin, med en dosis på 100 000 IE colistin pr. kg. legemsvægt dagligt i 3-5 på hinanden følgende dage.
English: Meat: pigs: 7 days
Danish: Kød: svin: 7 dage
English: Administration vis drinking water or milk or direct application by mouth.
Danish: Administration i drikkevand eller mælk eller direkte oralt.
English: Daily for three consecutive days.
Danish: Dagligt i 3 på hinanden følgende dage.
English: 37075 Tours Cedex
Danish: 37075 Tours Cedex 2 FRANKRIG
English: Consequently the benefit-risk balance for colistin was considered positive for treatment of gastrointestinal infections caused by non-invasive E. coli in pigs and poultry when used with the posologies mentioned.
Danish: Følgelig blev benefit/risk-forholdet for colistin vurderet som positivt for behandling af gastrointestinale infektioner forårsaget af non-invasiv E. coli hos svin og fjerkræ, når det anvendes i de nævnte doser.
English: Chicken, Laying hen: 37,5 ml product /ton of living weight dissolved in drinking water for 3 days.
Danish: Kyllinger, æglæggende høns: 37,5 ml produkt/ton levende vægt opløst i drikkevandet i 3 dage.
English: The Committee considered that the absence of any data or argumentation from the Applicants/Marketing Authorisation Holders in support of a claim for treatment of Salmonella may constitute a risk to public and animal health as treatment might make the bacteria difficult to detect without completely eliminating the infection/colonisation.
Danish: Desuden vurderede CVMP også, at manglende data eller argumentation fra ansøgerne/indehaverne af markedsføringstilladelserne til støtte for en påstand om behandling af Salmonella kan udgøre en risiko for menneskers og dyrs sundhed, da behandlingen kan gøre det vanskeligt at påvise bakterien uden helt at eliminere infektionen/koloniseringen.
English: To support the established withdrawal periods eight residue depletion studies in calves, pigs and chickens were submitted by the Applicant/Marketing Authorisation Holders.
Danish: Til støtte for de etablerede tilbageholdelsestider indsendte ansøgerne/indehaverne af markedsføringstilladelserne 8 restkoncentrationsundersøgelser hos kalve,