FrancophonIA/ELRC3.0 huggingface dataset:
English: To limit the duration of treatment in food-producing animals to a maximum of 7 days would reduce the selection pressure for resistance without hampering the effective use of the products against justifiable indications.
Danish: Begrænsning af behandlingsvarigheden hos fødevareproducerende dyr til højst 7 dage vil nedsætte selektionstrykket til fordel for resistens, uden at det hæmmer effektiv brug af produkterne til velbegrundede indikationer.
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 mobile genetiske elementer (såsom plasmider) eller fra dyr til mennesker.«
English: 47122 Forlì Italy
Danish: 47122 Forlì Italien
English: Reus-Vinyols, Km.4,1 43330 Riudoms Spain
Danish: Reus-Vinyols, Km.4,1 43330 Riudoms Spanien
English: The indication salmonellosis is no longer maintained and gastrointestinal infection caused by E. coli (colibacillosis) is not a recognised clinical disease in foals or adult horses.
Danish: Indikationen salmonellose er ikke længere bibeholdt, og gastrointestinal infektion forårsaget af E. coli (colibacillose) er ikke en anerkendt klinisk sygdom hos føl eller voksne heste.
English: Bulgaria Zavet Kiril and Metodiy str. 5 Zavet 7330
Danish: Kiril and Metodiy str. 5 Zavet 7330
English: 62-200 Gniezno
Danish: 62-200 Gniezno Polen
English: In order to strengthen the importance of an adequate treatment period, the Committee considered it useful for the veterinarian to add relevant information on the pharmacological properties of colistin in the SPC (“Colistin exerts concentration-dependent activity against Gram-negative bacteria.
Danish: For at understrege vigtigheden af en tilstrækkelig behandlingsperiode fandt udvalget det nyttigt for dyrlægen, at der i produktresuméet tilføjes relevant information om de farmakologiske egenskaber af colistin (»Colistin har koncentrationsafhængig aktivitet mod gramnegative bakterier.
English: In order to address these treatment conditions more accurately and to exclude routine preventive use in healthy animals where the bacterial disease has not been established in the group or flock at the time of treatment, the indication for group or flock treatment should be changed to “treatment and metaphylaxis” 6.
Danish: For bedre at tage disse behandlingsomstændigheder i betragtning og udelukke præventiv anvendelse hos sunde dyr, når der på behandlingstidspunktet endnu ikke er konstateret bakteriesygdom i gruppen eller flokken, bør indikationen for gruppe- eller flokbehandling ændres til »behandling og metafylakse« 6.
English: Currently, there is no evidence of spread of colistin resistance from food-producing animals to human patients, or vice versa.”
Danish: Der er i øjeblikket ikke evidens for spredning af resistens mod colistin fra fødevareproducerende dyr til mennesker eller omvendt.«
English: In conclusion the CVMP recommended to add advice in the SPC that the duration of treatment should be limited to the minimum time necessary for the treatment of the disease, and that treatment duration should not exceed 7 days.
Danish: Som konklusion anbefalede CVMP, at det i produktresuméet tilføjes, at behandlingsvarigheden bør begrænses til det minimum, der er nødvendigt til behandling af sygdommen, og ikke bør overskride 7 dage.
English: 1161 Budapest Hungary
Danish: 1161 Budapest Ungarn
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)3.
Danish: CVMP blev anmodet om at fremsætte en udtalelse om de foranstaltninger, der bør træffes for at sikre forsvarlig brug af colistin hos fødevareproducerende dyr i hele EU og minimere potentielle risici ved brug af de pågældende produkter, herunder om der er behov for at indsætte passende anvisninger og advarsler om forsvarlig brug i produktinformationen og/eller begrænse indikationerne for de pågældende produkter i overensstemmelse med CVMP's reviderede retningslinjer for produktresuméer for antimikrobielle produkter (EMEA/CVMP/SAGAM/383441/2005)3.
English: COLISTIN 350/ANAFASIS
Danish: COLISTIN 350/ANAFASIS Colistin
English: 150 mg/tablet
Danish: 150 mg/tablet Tabletter
English: 2 Intrarea Vagonetului, Bl.
Danish: 2 Intrarea Vagonetului, Bl. 101,Ap.
English: Duration of treatment should be limited to the minimum time necessary for the treatment of the disease.
Danish: Behandlingsvarigheden skal begrænses til det minimum, der er nødvendigt til behandling af sygdommen.
English: The CVMP agreed that the treatment period should not exceed 7 days based on the following grounds: The most commonly recommended treatment duration for the products concerned is 3 to 7 days for both mammalians and poultry species, indicating that this has been concluded in many cases to be a
Danish: CVMP fastslog, at behandlingsperioden ikke bør være over 7 dage ud fra følgende begrundelse: Den oftest anbefalede behandlingsperiode for de omhandlede produkter er 3-7 dage for både pattedyrarter og fjerkræarter som tegn på, at denne behandlingsperiode i mange tilfælde er fundet tilstrækkelig.
English: St. Lenaartseweg 48, 2320 Hoogstraten, Belgium
Danish: St. Lenaartseweg 48, 2320 Hoogstraten, Belgien
English: Bulgaria Gabropharm OOD 16 Alei Vazrajdane str., app. 42
Danish: Gabropharm OOD 16 Alei Vazrajdane str., app.
English: Colistin sulfate is a polypeptide antibiotic belonging to the polymyxin group of antibiotics.
Danish: Colistinsulfat er et polypeptidantibiotikum i gruppen af polymyxiner.
English: These factors indicate that a longer duration of treatment than the one indicated, leading to unnecessary exposure is not recommended”.)
Danish: Disse faktorer tilsiger at fraråde længere behandlingsvarighed end den angivne, da dette vil medføre unødvendig eksponering.«)
English: Romania S.C. ROMVAC COMPANY S.A.
Danish: Rumænien S.C. ROMVAC COMPANY S.A.
English: 47122 Forlì -Cesena Italy
Danish: 47122 Forlì -Cesena Italien
English: Animed Service AG Liebochstrasse 9, 8143 Dobl, Austria
Danish: Animed Service AG Liebochstrasse 9, 8143 Dobl, Østrig
English: And concludes that: “Based on current evidence it is considered appropriate to maintain the use of colistin in veterinary medicine but to restrict indications to therapy or metaphylaxis and to remove all indications for prophylactic use in order to minimise any potential risk associated with a broader use.” and that “The SPCs of veterinary products containing colistin should be revised to take fully into account responsible use considerations.”
Danish: Og det konkluderes, at »Ud fra den nuværende evidens anses det for hensigtsmæssigt at opretholde anvendelsen af colistin i veterinærmedicinen, men at begrænse indikationerne til behandling eller metafylakse, og at slette alle indikationer til profylaktisk anvendelse for at minimere enhver potentiel risiko ved bredere anvendelse.«, og at »produktresuméerne for veterinærlægemidler indeholdende colistin bør revideres for at bringe dem i fuld overensstemmelse med principperne for ansvarlig brug.«
English: Krka - Farma d.o.o., Radnička cesta 48, 10000 Zagreb, Croatia
Danish: Krka - Farma d.o.o., Radnička cesta 48, 10000 Zagreb, Kroatien
English: In order to minimise any potential risk associated with widespread use of colistin, its use should be limited to treatment or treatment and metaphylaxis of diseases, and should not be used for prophylaxis.
Danish: For at minimere al potentiel risiko forbundet med udbredt anvendelse af colistin bør dets anvendelse begrænses til behandling eller til behandling og metafylakse af sygdomme, og det bør ikke anvendes profylaktisk.
English: The advice also indicates for combinations of colistin with other antimicrobials 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 desuden, at »Markedsføringstilladelserne for disse produkter bør gennemgås, og kombinationsprodukter bør trækkes tilbage, medmindre der er holdbar begrundelse for, at kombinationen er i overensstemmelse med principperne for ansvarlig brug.«
English: Romania KRKA, d. d. Novo mesto
Danish: Rumænien KRKA, d. d. Novo mesto
English: Poland PFO „Vetos-Farma” Sp. z o.o.
Danish: PFO „Vetos-Farma” Sp. z o.o.
English: BOX 205, 4940 AE Raamsdonksveer The Netherlands
Danish: BOX 205, 4940 AE Raamsdonksveer The Nederlandene
English: Slovakia Ceva Animal Health Slovakia, spol.
Danish: Ceva Animal Health Slovakiet, spol.
English: D-85276 Pfaffenhofen Germany
Danish: D-85276 Pfaffenhofen Tyskland
English: Colistin exerts concentration-dependent activity against Gram-negative bacteria.
Danish: Colistin har koncentrationsafhængig aktivitet mod gramnegative bakterier.
English: Some of the products included in the scope of this referral procedure are indicated for use in horses and, although not stated explicitly in the product literature, it is assumed that these products are used predominantly in foals.
Danish: Nogle af produkterne i denne indbringelsesprocedure er indiceret til heste og må antages hovedsagelig at blive anvendt hos føl, skønt dette ikke udtrykkelig angives i produktlitteraturen.
English: In addition, advice should be included in the SPC that the presence of the disease should be established in the group or herd before metaphylactic treatment.
Danish: Desuden bør det i produktresuméet anføres, at tilstedeværelse af sygdommen skal fastslås i gruppen eller besætningen før metafylaktisk behandling.
English: Therefore, it is prudent to minimise the possibility of resistance to colistin developing as a result of its use in animals and thereby also reduce the possibility that any resistance that does develop will be transferred to humans.
Danish: Det er derfor hensigtsmæssigt at minimere muligheden for, at der opstår resistens over for colistin som følge af dets anvendelse hos dyr, og dermed også minimere muligheden for overførsel af eventuel resistens til mennesker.
English: Therefore, any indication for prophylaxis or production enhancement (e.g. increase of feed efficiency or growth promotion) should be taken out of the SPC, and advice should be included in the SPC that colistin should not be used for prophylaxis.
Danish: Enhver indikation til profylakse eller øget produktion (f.eks. forøgelse af fodereffektivitet eller vækstfremme) skal derfor slettes fra produktresuméet, og det skal anføres, at colistin ikke må anvendes til profylakse.
English: Thus, any pathogens other than non-invasive E. coli that are typically not associated with non-invasive gastrointestinal infections, and/or associated with general infections should be taken out of the SPC.
Danish: Bortset fra ikke-invasive E. coli bør alle patogener, som ikke typisk er forbundet med ikke-invasive gastrointestinale infektioner og/eller er forbundet med generelle infektioner, slettes fra produktresuméet.
English: ARNIKA VETERINA d.o.o., Vidikovac 20, 1000 Zagreb, Croatia
Danish: ARNIKA VETERINA d.o.o., Vidikovac 20, 1000 Zagreb, Kroatien
English: Hence a maximum treatment period of 7 days would ensure sufficient efficacy in the treatment and metaphylaxis of enteric diseases associated with non-invasive E. coli and would also satisfy the requirement to avoid unnecessary exposure and thus reduce the risk of resistance development.
Danish: Følgelig vil en maksimal behandlingsperiode på 7 dage dels sikre tilstrækkelig virkning af behandling og metafylakse af tarmsygdomme associeret med ikkeinvasive E. coli, dels opfylde kravet om undgåelse af unødvendig eksponering, så risikoen for resistensudvikling mindskes.
English: Oral solution (directly into animal mouth, drinking water)
Danish: Oral opløsning (direkte i dyrets mund, i drikkevand)
English: PO 11 COLISTINE 100 LAPINVOLAILLE - PORC - VEAU
Danish: PO 11 COLISTINE 100 LAPIN - VOLAILLE - PORC - VEAU
English: Alvetra & Werfft GmbH Boltzmanngasse 11, 1090 Wien, Austria
Danish: Alvetra & Werfft GmbH Boltzmanngasse 11, 1090 Wien,
English: D-01689 Weinböhla Germany
Danish: D-01689 Weinböhla Tyskland
English: Whenever possible, colistin should only be used based on susceptibility testing.
Danish: Colistin bør kun anvendes efter foregående følsomhedsbestemmelse, når dette er muligt.
English: From a pharmacological point of view, colistin exerts concentration-dependent activity and high concentrations of colistin are achieved in the gut following oral administration due to the poor absorption of the substance.
Danish: I farmakologisk henseende har colistin koncentrationsafhængig aktivitet, og ved oral administration opnås høje koncentrationer af colistin i tarmen på grund af stoffets dårlige absorption.
English: Račianska 77, 81 02 Bratislava, Slovak Republic
Danish: Račianska 77, 81 02 Bratislava, Slovakiet
English: 34 Rue Jean Monnet Zi D'etriche 49500 Segre France
Danish: 34 Rue Jean Monnet Zi D'etriche 49500 Segre Frankrig
English: Bulgaria BIOSFERA FARM Ltd. 50 Yurii Gagarin str., Kostinbrod
Danish: BIOSFERA FARM Ltd. 50 Yurii Gagarin str., Kostinbrod Bulgarien
English: Pigs (piglets and pigs <40 kg)
Danish: Svin (smågrise og svin <40 kg)
English: The most common target species is pigs followed by chicken and cattle next to other poultry species (e.g. turkeys), horses, rabbits, sheep and goats.
Danish: Den mest almindelige måldyreart er svin, efterfulgt af kyllinger og kvæg foruden andre fjerkræarter (f.eks. kalkuner), heste, kaniner, får og geder.
English: In addition, further information in line with prudent use principles for antimicrobials should be added in the product literature.
Danish: Desuden bør der i produktlitteraturen indsættes yderligere oplysninger i overensstemmelse med principperne for forsvarlig brug af antimikrobielle stoffer.
English: Colistin is also a last resort antimicrobial for the treatment of infections due to highly resistant bacteria in humans, therefore its overall use in veterinary medicine needs to be decreased, to reduce the risk of resistance development and transmission to humans.
Danish: Colistin er også den sidste antimikrobielle behandlingsmulighed for infektioner med højresistente bakterier hos mennesker, hvorfor dets samlede anvendelse i veterinærmedicinen bør begrænses for at mindske risikoen for udvikling af resistens og overførsel til mennesker.
English: Austria aniMedica GmbH Im Südfeld 9, 48308 Senden-Bösensell, Germany
Danish: Østrig aniMedica GmbH Im Südfeld 9, 48308 Senden-Bösensell, Tyskland
English: Quality, target animal safety, user safety, environmental risk and residues were not assessed in this referral procedure.
Danish: Denne indbringelsesprocedure omfatter ikke kvalitet, brugersikkerhed, miljørisiko eller restkoncentrationer.
English: • on the basis of the available data, the CVMP considered that the duration of treatment should be amended as described in Annex III;
Danish: • CVMP på grundlag af de foreliggende data fandt, at behandlingsvarigheden bør ændres som beskrevet i bilag III
English: “Colistin is of therapeutic importance in veterinary medicine for the treatment of enteric diseases in certain food-producing species for which there are few effective alternatives available for certain indications.
Danish: »I veterinærmedicinen er colistin vigtig for behandlingen af tarmsygdomme hos visse fødevareproducerende arter, hvor der til visse indikationer kun er få effektive alternativer.
English: COLISTIN/DIVASA FARMAVIC Colistin
Danish: COLISTIN/DIVASA FARMAVIC
English: Vetoquinol Italia S.r.l.Via Piana, 265 47032 Bertinoro (FC) Italy
Danish: Vetoquinol Italia S.r.l.Via Piana, 265 47032 Bertinoro (FC) Italien
English: Delete, where applicable, any general indication or indication for any other pathogen.
Danish: Når det er relevant, slettes alle generelle indikationer og indikationer for nogen anden patogen.
English: Ceva Animal Health Ltd Unit 3, Anglo Office Park White Lion Road, Amersham
Danish: Ceva Animal Health Ltd Unit 3, Anglo Office Park White Lion Road, Amersham Buckinghamshire, HP7 9FB Det Forenede Kongerige
English: According to the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)3 indications should be for the treatment of named pathogens and
Danish: I henhold til CVMP's reviderede retningslinjer for produktresuméer for antimikrobielle produkter (EMEA/CVMP/SAGAM/383441/2005)3 skal indikationerne bestå i behandling af navngivne patogener, og generelle indikationer skal undgås.
English: Germany Prodivet pharmaceuticals n.v./s.a.
Danish: Prodivet pharmaceuticals n.v./s.a.
English: Belgium Prodivet pharmaceuticals sa/nv
Danish: Prodivet pharmaceuticals sa/nv
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Delete, where applicable, any specific dosing recommendation related to pathogens other than E. coli.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ Når det er relevant, slettes enhver specifik dosisanbefaling vedrørende andre patogener end E. coli.
English: Promycine Bolus 3 MIO IE
Danish: Promycine Bolus 3 MIO IE Colistin
English: 3550 Heusden-Zolder Belgium
Danish: Poorthoevestraat 4 3550 Heusden-Zolder Belgien
English: 08150 Parets del Valles Spain
Danish: 08150 Parets del Valles Spanien
English: was recommended since none, very limited or non-conclusive clinical data was presented to support this indication.
Danish: Det blev anbefalet at slette Salmonella spp., da der for denne indikation ikke blev forelagt nogen kliniske data, eller også var de meget begrænsede eller inkonklusive.
English: Non-ruminating calves
Danish: Ikke-drøvtyggende kalve
English: Poland ScanVet Poland Sp. z o.o.
Danish: ScanVet Polen Sp. z o.o.
English: Oral colistin formulations including powder, solution, premix, tablets and paste have been authorised, mainly for group and flock treatment for the treatment and prevention of different specified gastrointestinal diseases caused by sensitive Enterobacteriacea species (e.g. Salmonella and Escherichia coli), but marketing authorisations without more specific indications do also exist.
Danish: Orale formuleringer af colistin i form af pulver, opløsning, premix, tabletter og pasta er godkendt hovedsagelig til gruppe- og flokbehandling og forebyggelse af en række specifikke gastrointestinale sygdomme forårsaget af følsomme Enterobacteriacea-arter (f.eks.
English: Germany Laboratorios Calier S. A. Barcelonas 26
Danish: Laboratorios Calier S. A. Barcelonas 26
English: 58-260 Bielawa
Danish: Dzierżoniowska 21 58-260 Bielawa Polen
English: The advice states:
Danish: I disse anvisninger anføres det:
English: Doxal Italia S.p.a. largo Donegani 2 20121 - Milano Italy
Danish: largo Donegani 2 20121 - Milano Italien
English: Poland Biofaktor Sp. z o.o.
Danish: Biofaktor Sp. z o.o.
English: Synamix Colistine 200 LapinVolaille-Porc
Danish: Synamix Colistine 200 Lapin-Volaille-Porc
English: Denmark Divasa-Farmavic S.A. PO Box 79,
Danish: Divasa-Farmavic S.A. PO Box 79,
English: Pigs (up to 40 kg bw)
Danish: Svin (op til 40 kg kropsvægt)
English: , Matije Gupca 42, 43500 Daruvar, Croatia
Danish: VET CONSULTING d.o.o., Matije Gupca 42, 43500 Daruvar, Kroatien
English: Sweden Bio Vet Aps, Kongevejen 66 3480 Fredensborg, Denmark
Danish: Bio Vet Aps, Kongevejen 66 3480 Fredensborg, Danmark
English: Germany Animedica Espana S. L. U. Esmeralda 19
Danish: Animedica Espana S. L. U. Esmeralda 19
English: Bulgaria Farma SIS OOD 4 San Stefano str.
Danish: Farma SIS OOD 4 San Stefano str. Dobrich
English: Delete, where applicable, any indication for prophylactic use or production enhancement.
Danish: Enhver indikation til profylaktisk anvendelse eller øget produktion slettes, hvor det er relevant.
English: The oral colistin products within the scope of this referral are effective medicines for the treatment and metaphylaxis of enteric diseases caused by non-invasive E. coli susceptible to colistin in certain foodproducing animal species for which there are few effective alternatives available due to increasing resistance development.
Danish: Orale colistinprodukter omfattet af denne indbringelse er effektive til behandling og metafylakse af tarmsygdomme, der forårsages af ikke-invasive colistinfølsomme E. coli hos visse fødevareproducerende dyrearter, og for hvilke der findes få effektive alternativer som følge af stigende resistensudvikling.
English: The current scientific literature does not support the use of colistin 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 nuværende videnskabelige litteratur støtter ikke brugen af colistin hos føl, da det kan give ubalance i den gastrointestinale mikroflora, hvilket kan føre til fatal colitis, typisk associeret med Clostridium difficile.
English: 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: Når denne indbringelsesprocedure er afsluttet, kan kombinationer af colistin med et andet antimikrobielt stof og ikke-oral administration af produkter indeholdende colistin blive taget op som næste skridt.
English: For products to be administered in feed or water (for group/herd treatment), it should be stated “treatment and metaphylaxis”, and the following advice should be added: The presence of the disease in the herd should be established before metaphylactic treatment.
Danish: For produkter til administration i foder eller drikkevand (til behandling af en hel gruppe/besætning) anvendes betegnelsen »behandling og metafylakse«, og følgende anvisning tilføjes: Sygdommens tilstedeværelse i besætningen skal være konstateret før metafylaktisk behandling.
English: Therefore, any general indication referring to infectious or noninfectious diseases should be deleted.
Danish: Generelle indikationer for smitsomme eller ikke-smitsomme
English: The target species “horse” and any indication for horses should be taken out of the SPC and information should be added in the SPC that the use of colistin in horses, particularly in foals, is contraindicated due to the shift in gastrointestinal microflora balance and the development of antimicrobial associated colitis, typically associated with Clostridium difficile, which may be fatal.
Danish: Måldyrearten »hest« og enhver indikation til heste skal slettes fra produktresuméet, og det skal tilføjes, at colistin er kontraindiceret hos heste, navnlig føl, på grund af ændringer i balancen i den gastrointestinale mikroflora og udvikling af antibiotikarelateret colitis, typisk med Clostridium difficile, som kan være fatal.
English: In addition, orally administered colistin would not be appropriate for systemic therapy due to poor absorption from the gastrointestinal tract.
Danish: Derudover er oralt administreret colistin uegnet til systemisk behandling på grund af sin ringe absorption fra mave-tarm-kanalen.
English: In the previous CVMP assessment (EMA/CVMP, 2010) 4 the Committee concluded that the benefit-risk balance regarding the use of colistin for treatment of gastrointestinal infections caused by Salmonella spp.
Danish: I CVMP's foregående gennemgang (EMA/CVMP, 2010)4 konkluderede udvalget, at benefit/risk-forholdet for colistin var negativt til behandling af gastrointestinale infektioner forårsaget af Salmonella spp., men fortsat var positivt til behandling af tarminfektioner forårsaget af ikke-invasive colistinfølsomme E. coli.
English: Lithuania Chemifarma S.p.A Via Don E. Servadei, 16-47100 Forlí,
Danish: Chemifarma S.p.A Via Don E. Servadei, 16-47100 Forlí, Italien