FrancophonIA/ELRC3.0 huggingface dataset:
English: It is considered that indications relating to swine dysentery caused by B. hyodyenteriae, and associated pathogens, are not sufficiently supported and that the use of the products in such conditions entails a risk of treatment failure, which, in addition, is linked to a risk of further resistance selection and co-selection.
Danish: Indikationerne vedrørende svinedysenteri forårsaget af B. hyodysenteriae og tilknyttede patogener findes ikke at være sufficient dokumenteret, og brug af produkterne under sådanne betingelser medfører risiko for behandlingssvigt, som desuden er forbundet med risiko for yderligere selektion af resistens og co-selektion.
English: Considering that formulations for administration in the drinking water are available, which are recommended for shorter treatment courses based on sufficient efficacy data, it is considered that the overall benefit-risk balance for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin is negative and consequently the marketing authorisations for these products should be withdrawn.
Danish: I betragtning af, at der til administration i drikkevandet forefindes formuleringer, som anbefales til kortere behandlingsforløb og er baseret på tilstrækkelige data om virkning, anses det overordnede benefit/risk-forhold for premix til foderlægemiddel og pulver til administration i foderet indeholdende en kombination af lincomycin og spectinomycin for at være negativt, hvorfor markedsføringstilladelserne for disse produkter bør inddrages.
English: Rivium Westlaan 74 2909 LD Capelle a/d Ijssel
Danish: 2909 LD Capelle a/d Ijssel The Netherlands
English: 4.2 Indications for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer, med angivelse af de dyrearter, som lægemidlet er beregnet til
English: Zoetis Belgium SA Rue Laid Burniat, 1 1348 Louvain-laNeuve
Danish: Zoetis Belgium SA Rue Laid Burniat, 1 1348 Louvain-la-Neuve Belgium
English: 1902 Paiania Attiki Greece
Danish: Grækenland AVICO AE 2 Km Paiania-Spata Av 1902 Paiania Attiki Greece
English: Therefore, the benefit-risk balance in relation to the use of the concerned class of products against swine dysentery caused by B. hyodysenteriae, is considered to be negative due to development of acquired resistance and high uncertainty about its impact in terms of in vivo efficacy.
Danish: Benefit/risk-forholdet for anvendelse af den pågældende klasse af produkter mod svinedysenteri forårsaget af B. hyodysenteriae anses derfor for negativt på grund af udviklingen af erhvervet resistens og stor usikkerhed om betydningen heraf for virkningen in vivo.
English: From the data provided, it appears that within the lincomycin-spectinomycin combination only lincomycin is active against the primary causal agent of swine dysentery, the anaerobic spirochete B. hyodysenteriae, which is intrinsically resistant to spectinomycin.
Danish: Af de forelagte data fremgår det, at det i kombinationen lincomycin-spectinomycin kun er lincomycin, der er aktivt mod den primære kausale agens for svinedysenteri, den anaerobe spirokæt B. hyodysenteriae, som er naturligt resistent over for spectinomycin.
English: Therefore the overall benefit-risk balance for veterinary medicinal products containing a combination of lincomycin and spectinomycin as powders for use in drinking water, remains positive and the product information should be amended in line with the recommended changes in Annex III.
Danish: Det overordnede benefit/risk-forhold for veterinærlægemidler indeholdende en kombination af lincomycin og spectinomycin som pulver til anvendelse i drikkevand er derfor uændret positivt, og produktinformationen bør ændres i overensstemmelse med de anbefalede ændringer i bilag III.
English: Indications, dosages and residue data in pigs
Danish: Indikationer, dosering og restkoncentrationsdata for svin
English: When considering lincomycin in vitro susceptibility data against B. hyodysenteriae, even if differences occur between geographical areas, and variability arises from the absence of standardised testing methodology, it appears clearly that the minimum inhibitory concentration (MIC) range is broad and http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/LincoSpectin_100_and_associated_names/vet_referral_000097.jsp&mid=WC0b01ac05805c5170
Danish: Når man betragter in vitro-data for følsomheden af B. hyodysenteriae over for lincomycin, er det tydeligt, at uanset geografiske forskelle og variation som følge af manglende standardiserede testmetoder dækker den mindste hæmmende koncentration (MIC) et stort interval, og de fleste http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/LincoSpectin_100_and_associated_names/vet_referral_000097.jsp&mid=WC0b01ac05805c5170
English: Messogeion Ave 15451 Neo Psychiko Athens
Danish: Zoetis Hellas SA 253-255 Messogeion Ave 15451 Neo Psychiko Athens
English: Laboratorios Ovejero S.A.
Danish: Laboratorios Ovejero S.A. Ctra.
English: For pigs and poultry three pharmaceutical forms for oral administration exist with a combination of lincomycin and spectinomycin - premixes for medicated feeding stuff, powders to be administered with the feed and powders for use in drinking water.
Danish: Til svin og fjerkræ findes der tre orale lægemiddelformer med en kombination af lincomycin og spectinomycin - premix til foderlægemiddel, pulver til anvendelse i foder og pulver til opløsning i drikkevand.
English: Several pig enteric pathogens can be associated with B. hyodysenteriae infections and constitute possible targets for spectinomycin.
Danish: Infektioner med B. hyodysenteriae hos svin kan være forbundet med flere forskellige enteropatogener, som er potentielle mål for spectinomycin.
English: Chickens Oral
Danish: Slagtekyllinger Oral
English: Overall summary of the scientific evaluation of veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af veterinærlægemidler, der indeholder en kombination af lincomycin og spectinomycin og administreres oralt til svin og/eller fjerkræ (jfr.
English: 2740-271 Porto Salvo
Danish: Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal
English: Nonetheless, there are indications (from laboratory clinical studies) of clinical efficacy against E. coli located in and acquired via the respiratory tract, and against mycoplasmas, which are intracellular infections.
Danish: Alligevel tyder kliniske undersøgelser i laboratoriet på klinisk virkning mod E. coli lokaliseret i luftvejene og erhvervet via luftvejene, og mod mycoplasma, som bevirker intracellulære infektioner.
English: The administration of the lincomycin and spectinomycin combination with the animal feed is currently recommended at relatively low doses and for prolonged periods (approximately 1 to 2.5 mg combined actives per kg bw (which is between 10% and 25% of the daily dose for powders for use in drinking water) for a relatively long period of 21 days).
Danish: På nuværende tidspunkt anbefales administration af kombinationen lincomycin-spectinomycin i foder i relativt lave doser og i lang tid (ca. 1-2,5 mg af de kombinerede aktive stoffer/kg kropsvægt (svarende til mellem 10 % og 25 % af den daglige dosis for pulver til opløsning i drikkevand) i en relativt lang periode på 21 dage).
English: 1348 Louvain-laNeuve
Danish: 1348 Louvain-la-Neuve Belgium
English: No further data have been presented in the framework of this referral to support any indications in poultry species other than chickens.
Danish: Der er ved indbringelsen ikke forelagt yderligere data til dokumentation af indikationerne hos andre fjerkræarter end kyllinger.
English: Special warnings for each target species:
Danish: Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
English: Indications, dosages and residue data in poultry species other than chickens
Danish: Indikationer, dosering og restkoncentrationsdata for andre fjerkræarter end kyllinger
English: 2 under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs, the CVMP recommended the indication ‘swine dysentery caused by B. hyodysenteriae' to be deleted from the http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp&mid=WC0b01 ac05805c5170
Danish: 2 i medfør af artikel 35 i direktiv 2001/82/EF, at indikationen "svinedysenteri forårsaget af B. hyodysenteriae" slettes fra produktinformationen for veterinærmedicinske produkter indeholdende tylosin til administration oralt i foder eller drikkevand til http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp&mid=WC0b01 ac05805c5170
English: The recommended dosage rates are:
Danish: Anbefalet dosering:
English: The use of premixes for medicated feeding stuff or powders to be administered with the feed containing a combination of lincomycin and spectinomycin is currently recommended at relatively low doses and for prolonged periods, which infers use for growth promotion.
Danish: Anvendelse af premix til foderlægemiddel eller pulver til administration i foderet indeholdende en kombination af lincomycin og spectinomycin anbefales på nuværende tidspunkt i relativt lave doser og længere perioder, ensbetydende med anvendelse som vækstfremmer.
English: On the basis of in vitro tests, some have hypothesised that a metabolite or degradation product of spectinomycin was produced in the gut and was able to reach the infection site and interfere with E. coli adherence to the respiratory mucosa.
Danish: In vitro-test har givet anledning til en hypotese om, at der i tarmen frembringes en metabolit eller et nedbrydningsprodukt af spectinomycin som er i stand til at nå frem til infektionsfokus og interferere med vedhæftningen af E. coli til luftvejsslimhinden.
English: It is known from the PK properties of spectinomycin that only negligible amounts are absorbed from the gut and that in any case, blood levels do not reach MIC levels.
Danish: De farmakokinetiske egenskaber af spectinomycin viser, at der kun optages ubetydelige mængder fra tarmen, og at blodkoncentrationen efter oral administration under alle omstændigheder ikke når op på MIC i kyllingernes luftveje.
English: Pigs: 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days.
Danish: Svin: 3,33 mg lincomycin og 6,67 mg spectinomycin/kg kropsvægt/dag i 7 dage.
English: For the treatment and metaphylaxis of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis, and associated enteric pathogens (Escherichia coli) susceptible to lincomycin and spectinomycin.
Danish: Til behandling og metafylakse af porcin proliferativ enteropati (ileitis) forårsaget af Lawsonia intracellularis og tilknyttede enteropatogener (Escherichia coli), som er følsomme for lincomycin og spectinomycin.
English: Due to technical constraints the susceptibility of L. intracellularis is difficult to test in vitro, and data about the lincomycin-spectinomycin resistance status in that species are lacking.
Danish: Tekniske begrænsninger vanskeliggør in vitro-følsomhedsbestemmelse af L. intracellularis, og der savnes data om status af lincomycin-spectinomycin-resistens hos denne art.
English: Via Andrea Doria, 41 M
Danish: Via Andrea Doria, 41 M 00192 Roma Italy
English: Germany Kon-Pharma GmbH Senator-Bauer-Str.
Danish: Tyskland Kon-Pharma GmbH Senator-Bauer-Str. 34
English: 2320 Hoogstraten Belgium
Danish: Sint Lenaartseweg 48 2320 Hoogstraten Belgium
English: In view of the available in vitro susceptibility and clinical data in pigs, it appears that the combination is justified on theoretical grounds by its extended spectrum of activity, in the case of swine dysentery caused by B. hyodysenteriae and associated enteric pathogens susceptible to spectinomycin.
Danish: På baggrund af de foreliggende in vitro-følsomhedsdata og kliniske data hos svin synes kombinationen at være teoretisk begrundet ved det udvidede aktivitetsspektrum mod svinedysenteri forårsaget af B. hyodysenteriae og de tilknyttede spectinomycin-følsomme enteropatogener.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet for all powders for use in drinking water containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or chickens
Danish: Ændringer i de relevante punkter i produktresuméet, etiketteringen og indlægssedlen for alle pulvere til anvendelse i drikkevandet indeholdende en kombination af lincomycin og spectinomycin til svin og/eller kyllinger
English: Denmark Pfizer Oy Animal Health
Danish: Pfizer Oy Animal Health Tietokuja 4
English: Despite the poor in vitro activity of the active substances against L. intracellularis, which appears from the scarce data available, the results of a relatively recent, multicentric field study support efficacy of the lincomycin-spectinomycin combination at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days in drinking water.
Danish: Trods de aktive stoffers ringe in vitro -aktivitet mod L. intracellularis, som fremgår af de foreliggende sparsomme data, støtter en forholdsvis ny multicenter-feltundersøgelse virkningen af kombinationen lincomycin-spectinomycin i en dosis er 3,33 mg lincomycin og 6,67 mg spectinomycin/kg kropsvægt/dag i 7 dage i drikkevandet.
English: 25/28 North Wall Quay
Danish: Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
English: Grounds for withdrawal of the marketing authorisations for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin and variation of the marketing authorisations for powders for use in drinking water containing a combination of lincomycin and spectinomycin
Danish: Begrundelse for inddragelse af markedsføringstilladelserne for premix til foderlægemiddel og pulver til administration i foder indeholdende en kombination af lincomycin og spectinomycin, og ændringer af markedsføringstilladelserne for pulver til anvendelse i drikkevand indeholdende en kombination af lincomycin og spectinomycin
English: Indications, dosages and residue data in chickens
Danish: Indikationer, dosering og restkoncentrationsdata for kyllinger
English: • the CVMP considered that the use of powders to be administered with the feed containing a combination of lincomycin and spectinomycin is not supported by data and the currently recommended dosing regimens entails a higher risk of selection and development of resistance due to exposition to low antimicrobial levels for prolonged periods.
Danish: • CVMP fandt, at anvendelse af pulver til administration i foderet indeholdende en kombination af lincomycin og spectinomycin ikke understøttes af data, og at de aktuelt anbefalede doseringsregimer medfører højere risiko for selektion og udvikling af resistens som følge af eksponering for lave koncentrationer af antimikrobielle stoffer i længere perioder.
English: Where the following target species have already been approved, the following withdrawal periods apply:
Danish: Når følgende måldyrearter i forvejen er godkendt, gælder nedenstående tilbageholdelsestider: 10. TILBAGEHOLDELSESTID
English: More generally, treatment with premixes for medicated feeding stuff and oral powders to be administered with the feed to pigs containing the combination lincomycinspectinomycin as currently recommended exposes the target pathogens and other bacteria to low doses for prolonged periods, which increases risk of resistance selection.
Danish: Mere generelt vil den aktuelt anbefalede behandling med kombinationen lincomycinspectinomycin som premix til foderlægemiddel og oralt pulver til administration i foderet til svin udsætte målpatogenerne og andre bakterier for lave doser i længere tid, hvilket forhøjer risikoen for selektion af resistens.
English: In a GCP-compliant randomised, blinded and negatively controlled challenge study, chickens were treated with powder for use in drinking water containing a combination of lincomycin and spectinomycin against induced E. coli, M. gallisepticum and combined E. coli plus M. gallisepticum infection.
Danish: I en GCP-overensstemmende randomiseret, blindet belastningsundersøgelse med negativ kontrolgruppe blev kyllinger påført en infektion med E. coli, M. gallisepticum og kombinerede E. coli plus M. gallisepticum og behandlet med pulver til anvendelse i drikkevand indeholdende en kombination af lincomycin og spectinomycin.
English: The available clinical data show that the combination, administered in the drinking water at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days (i.e. the harmonised dose for Linco-Spectin 100), is clinically effective in treating mixed infections involving B. hyodysenteriae and other enteric pathogens targeted by spectinomycin, and that in those situations it is superior to the individual substances.
Danish: De foreliggende kliniske data viser, at kombinationen administreret i drikkevandet i en dosis på 3,33 mg lincomycin og 6,67 mg spectinomycin/kg kropsvægt/dag i 7 dage (dvs. den harmoniserede dosis for Linco-Spectin 100) er klinisk effektiv til behandling af blandede infektioner med B. hyodysenteriae og andre enteropatogener, som er mål for spectinomycin, og at kombinationen i sådanne situationer er overlegen i forhold til enkeltstofferne.
English: • the CVMP considered that the use of premixes for medicated feeding stuff containing a combination of lincomycin and spectinomycin is supported by inadequate clinical data and the currently recommended dosing regimens entails a higher risk of selection and development of resistance due to exposition to low antimicrobial levels for prolonged periods.
Danish: • CVMP fandt, at anvendelse af premix til foderlægemiddel indeholdende en kombination af lincomycin og spectinomycin bygger på utilstrækkelige kliniske data, og at de aktuelt anbefalede doseringsregimer medfører højere risiko for selektion og udvikling af resistens som følge af eksponering for lave koncentrationer af antimikrobielle stoffer i længere perioder.
English: Chickens: 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days.
Danish: Kyllinger: 16,65 mg lincomycin og 33,35 mg spectinomycin/kg kropsvægt/dag i 7 dage.
English: For the treatment and metaphylaxis of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli susceptible to lincomycin and spectinomycin, and associated with a low mortality rate.
Danish: Til behandling og metafylakse af kronisk luftvejssygdom, som er forårsaget af lincomycin- og spectinomycin-følsomme Mycoplasma gallisepticum og Escherichia coli og forbundet med lav dødelighed.
English: The residue data presented for powders for use in drinking water do not call into question the withdrawal periods approved for each product individually at the dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days.
Danish: De forelagte restkoncentrationsdata for pulvere til anvendelse i drikkevandet rejser ikke tvivl om de godkendte tilbageholdelsestider for de enkelte produkter ved en dosis på 16,65 mg lincomycin og 33,35 mg spectinomycin/kg kropsvægt/dag i 7 dage.
English: Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and mycoplasmas.
Danish: Lincomycin er aktivt mod grampositive bakterier, visse anaerobe gramnegative bakterier og mycoplasma.
English: de Europa, 20B
Danish: de Europa, 20B Parque Empresarial La Moraleja
English: Also pharmacovigilance data do not indicate a risk of MRL violation.
Danish: Lægemiddelovervågningsdata tyder heller ikke på risiko for overskridelse af maksimalgrænseværdierne for restkoncentrationer.
English: the CVMP has recommended the withdrawal of the marketing authorisations for premixes for medicated feeding stuff and powders to be administered with the feed to pigs and/or chickens containing a combination of lincomycin and spectinomycin as referred in Annex I.
Danish: anbefalede CVMP inddragelse af markedsføringstilladelserne for premix til foderlægemiddel og pulver til administration i foderet indeholdende en kombination af lincomycin og spectinomycin til svin og/eller kyllinger som omhandlet i bilag I,
English: • the CVMP considered that on the basis of the available data for powders for use in drinking water containing a combination of lincomycin and spectinomycin, the overall benefit-risk balance is positive and the product information should be amended as provided in Annex III.
Danish: • CVMP fandt, at det overordnede benefit/risk-forhold på grundlag af de foreliggende data er positivt for pulver til anvendelse i drikkevand indeholdende en kombination af lincomycin og spectinomycin, og at produktoplysningerne bør rettes som det fremgår af bilag III,
English: Lannelongue 75014 Paris France
Danish: 75014 Paris
English: The residue data presented for powders for use in drinking water do not call into question the withdrawal periods approved for each product individually at the dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days.
Danish: De forelagte restkoncentrationsdata for pulvere til anvendelse i drikkevandet rejser ikke tvivl om de godkendte tilbageholdelsestider for de enkelte produkter ved en dosis på 3,33 mg lincomycin og 6,67 mg spectinomycin/kg kropsvægt/dag i 7 dage.
English: Also, pharmacovigilance data do not indicate a risk of MRL violation.
Danish: Ligeledes tyder lægemiddelovervågningsdata ikke på risiko for overskridelse af maksimalgrænseværdierne for restkoncentrationer.
English: Based primarily on the latter experimental study, it is considered that the indication relating to chicken chronic respiratory disease (CRD) caused by M. gallisepticum and E. coli and associated with a low mortality rate, and the associated dosing regimen of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days, as approved during the Article 34 referral procedure (EMEA/V/A/088) for Linco-Spectin 100, are justified as the only validated indication and dosage in chickens.
Danish: Primært på grundlag af sidstnævnte eksperimentelle undersøgelse findes indikationen kronisk luftvejssygdom hos kyllinger, der forårsages af M. gallisepticum og E. coli og har en lav mortalitetsrate, og det tilknyttede dosisregime på 16,65 mg lincomycin og 33,35 mg spectinomycin/kg kropsvægt (50 mg kombinerede aktive stoffer/kg kropsvægt) pr. dag i 7 dage, som er godkendt under artikel 34 indbringelsesproceduren (EMEA/V/A/088) for Linco-Spectin 100, for at være begrundet som den eneste validerede indikation og dosering hos kyllinger.
English: Zoetis B.V.
Danish: Nederlandene Zoetis B.V.
English: Via Augusta, 302 08017 Barcelona Spain
Danish: 08017 Barcelona Spain
English: Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro, and data about the resistance status in that species are lacking.
Danish: Tekniske begrænsninger vanskeliggør in vitro-følsomhedsbestemmelse for Lawsonia intracellularis, og der savnes data om resistensstatus hos denne art over for lincomycin-spectinomycin.
English: Linco-Spectin 22 + 22 Lincomycin and Spectinomycin
Danish: Linco-Spectin 22 + 22 Lincomycin og spectinomycin
English: It appears that currently pleuromutilins still constitute an effective alternative for the treatment of the disease, although MIC increases, deemed as alarming, have been detected in several surveys (see CVMP reflection paper (EMA/CVMP/AWP/119489/2012))
Danish: Pleuromutiliner ser på nuværende tidspunkt ud til fortsat at være et effektivt alternativ ved behandling af sygdommen, skønt der i flere undersøgelser er påvist stigninger i MIC-værdierne, som anses for alarmerende (jfr.