FrancophonIA/ELRC3.0 huggingface dataset:
English: It is possible that the substances are synergistic, act at different locations (intra- and extracellularly), or act by influencing the concurrent gut flora conditions.
Danish: Det er muligt, at stofferne er synergistiske, virker på forskellige steder (intra- og ekstracellulært) eller virker ved at påvirke betingelserne for den medvirkende tarmflora.
English: and against some gram-negative bacteria such as E. coli.
Danish: og visse Gram-negative bakterier såsom E. coli.
English: PYANOSID, geriamieji milteliai g/146,36 g g/146,36 g
Danish: PYANOSID, geriamieji milteliai g/146,36
English: Pfizer Animal Health MA EEIG
Danish: Rumænien Pfizer Animal Health MA EEIG
English: The macrolide tylosin is closely related to lincosamides and binds to an overlapping ribosomal site.
Danish: Makrolidet tylosin er nært beslægtet med lincosamider og bindes til et overlappende ribosomalt bindingssted.
English: Spectinomycin is active against avian E. coli, with observed rates of in vitro resistance of less than 20%.
Danish: Spectinomycin er aktivt mod aviære E. coli, med iagttagne in vitro-resistensrater på under 20 %.
English: Its added value above the single substances in that context has been demonstrated in old clinical studies, although with limitations at the level of bacteriological inclusion criteria and bacteriological follow-up.
Danish: Dens merværdi i forhold til enkeltstofferne i denne forbindelse er påvist i gamle kliniske undersøgelser, dog med begrænsninger hvad angår bakteriologiske inklusionskriterier og bakteriologisk opfølgning.
English: 25191 Lérida Spain
Danish: 25191 Lérida
English: This major uncertainty cannot be addressed until new clinical studies are conducted, under well controlled conditions including proper diagnoses and follow-up of the bacterial pathogens involved and determination of their in vitro susceptibility.
Danish: Denne store usikkerhed kan ikke tages op før der udføres nye kliniske undersøgelser under velkontrollerede betingelser med tilbørlig diagnosticering og opfølgning af de involverede bakterielle patogener og bestemmelse af deres in vitro-følsomhed.
English: In addition, in the study the induced clinical signs can only be considered only as moderate, since no mortality occurred and clinical scores were rather low.
Danish: De kliniske tegn, der blev påført i undersøgelsen, kan desuden kun anses for moderate, da der ikke var nogen dødsfald, og da de kliniske scoreværdier var ret lave.
English: Add, to all products: 4.4 Special warnings for each target species
Danish: For alle produkter tilføjes: 4.4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
English: Deletion of target species chickens from the concerned products could increase the use of antimicrobial substances currently considered as even more critical in terms of the consequences of selection of resistance and relevance for public health, such as fluoroquinolones.
Danish: Sletning af måldyrearten kyllinger for de omhandlede produkter kan tænkes at øge brugen af antimikrobielle stoffer, som på nuværende tidspunkt anses for endnu mere kritiske hvad angår konsekvenserne for selektion af resistens og relevansen for den offentlige sundhed, såsom fluorquinoloner.
English: During the Article 34 referral procedure (EMA/V/A/088) for Linco-Spectin 100, the limited efficacy data that were provided and the lack of residue data did not lead to the approval of any harmonised indications in poultry species other than chickens.
Danish: Under artikel 34 indbringelsesproceduren (EMA/V/A/088) for Linco-Spectin 100 blev der som følge af de begrænsede forelagte data vedrørende virkning og de manglende restkoncentrationsdata ikke godkendt nogen harmoniserede indikationer hos andre fjerkræarter end kyllinger.
English: Zoetis France 23-25 Avenue du Docteur
Danish: Zoetis France 23-25 Avenue du Docteur Lannelongue
English: Therefore, the Committee considers that there is no need to amend the currently approved withdrawal periods for pigs meat and offal for the products concerned by the procedure.
Danish: Udvalget finder derfor ikke behov for at ændre de aktuelt godkendte tilbageholdelsestider på svinekød og -indmad for produkterne omfattet af proceduren.
English: Via Emilia, 285 40064 Ozzano Emilia (BO) Italy
Danish: 40064 Ozzano Emilia (BO) Italy
English: Nevertheless, the available in vitro susceptibility data suggest that the expected benefit is now considerably reduced due to a rapid and widespread MIC increase in B. hyodysenteriae.
Danish: Alligevel tyder de foreliggende in vitro-følsomhedsdata på, at den forventede gavnlige virkning nu er betydelig formindsket på grund af en hurtig og udbredt stigning i MIC-værdien over for B. hyodysenteriae.
English: that most of the isolates show an increased MIC in a bacterial population where the wild-type is reduced (or even absent).
Danish: isolater udviser forhøjet MIC i en bakteriepopulation, hvor vildtypen er reduceret (eller helt mangler).
English: Zavet AD Ul.
Danish: Bulgarien Zavet AD Ul.
English: From the available information it appears that the resistance rates in the target bacteria are relatively low, and there is no indication of an evolving status.
Danish: De foreliggende oplysninger viser, at resistensraterne i målbakterierne er relativt lave, og der er ikke tegn på at status udvikler sig.
English: It was concluded that most Brachyspira isolates demonstrated in vitro resistance and that it could not be expected that oral tylosin would be sufficiently efficacious for the treatment of swine dysentery.
Danish: Det konkluderedes, at de fleste isolater af Brachyspira udviste in vitro-resistens, og at oralt tylosin ikke kunne forventes at være tilstrækkelig effektivt til behandling af svinedysenteri.
English: For similar reasons, i.e. because of high in vitro resistance rates, in 2014, in the context of a referral procedure (EMEA/V/A/100)
Danish: Af tilsvarende grunde, dvs. høje in vitro-resistensrater, anbefalede CVMP i 2014 i forbindelse med indbringelsesproceduren (EMEA/V/A/100)
English: Spectinomycin is also active against Salmonella spp., and both compounds are active against Campylobacter spp.
Danish: Spectinomycin er også aktivt mod Salmonella spp., og begge stoffer er aktive mod Campylobacter spp.
English: Lincomycin-Spectinomycin 1,1% "Animed Service"Pulver zum Eingeben für Schweine
Danish: Spectinomycin 1,1% "Animed Service"Pulver zum Eingeben für Schweine
English: SPC warnings informing the user about that resistance status are not considered sufficient to mitigate that risk, notably because of the absence of interpretive criteria and standardised methods for susceptibility testing.
Danish: Produktresuméets advarsler om resistensstatus anses ikke for tilstrækkelige til at afbøde denne risiko, navnlig fordi der savnes fortolkningskriterier og standardiserede metoder til følsomhedstestning.
English: Those data indicate that strains with some level of MIC increase might nevertheless be effectively treated, leading to a favourable clinical outcome.
Danish: Disse data viser, at selv stammer med nogen stigning i MIC-værdierne kan behandles effektivt med et gunstigt klinisk udfald til følge.
English: No firm clinical breakpoint could be proposed which would allow the prediction of clinical efficacy in the presence of poorly susceptible isolates, which currently represent the majority of isolates.
Danish: Der kunne ikke fastlægges en klinisk afskæringsværdi, der gør det muligt at forudsige den kliniske virkning i tilstedeværelse af isolater med ringe følsomhed, som aktuelt udgør de fleste isolater.
English: The data available do not allow the establishment of a clear time pattern for the evolution of MICs.
Danish: De foreliggende data giver ikke mulighed for at udpege en klar tendens i udviklingen i MIC-værdier.
English: SUPER´S DIANA, S.L
Danish: SUPER´S DIANA, S.L Ctra.
English: It is generally considered that the resistance status against tylosin closely follows that for lincomycin because of cross-resistance (see e.g. the CVMP reflection paper (EMA/CVMP/SAGAM/741087/2009))
Danish: Sædvanligvis antages resistensstatus over for tylosin at svare nøje til status over for lincomycin på grund af krydsresistens (se f.eks. CVMP's oplæg (EMA/CVMP/SAGAM/741087/2009))
English: Therefore, most available clinical data do not take into account the current status of in vitro susceptibility/resistance of the concerned bacterial species.
Danish: De fleste foreliggende kliniske data tager derfor ikke hensyn til den nuværende in vitro-følsomheds- og resistensstatus af de pågældende bakteriearter.
English: Although doses are only expressed as levels in water, it can be estimated that the optimal doses range from 75 to 300 mg combined actives/kg bw.
Danish: Doserne er kun angivet som koncentration i vandet, men de optimale doser kan anslås at være mellem 75 og 300 mg kombinerede aktive stoffer/kg kropsvægt.
English: Data from a pilot challenge study suggest efficacy in case of proliferative enteropathy associated with a colibacillosis outbreak, although the study was not formally designed to investigate efficacy against E. coli.
Danish: Data fra en pilot-belastningsundersøgelse tyder på virkning ved proliferativ enteropati forbundet med et udbrud af colibacillose, skønt undersøgelsen ikke var formelt udformet med henblik på at undersøge virkningen mod E. coli.
English: The typical dosing regimen in these studies comprises a first phase at about 150 mg combined actives/kg bw/day and a second phase at about 50 mg combined actives/kg bw/day.
Danish: Det typiske doseringsregime i disse undersøgelser består af en første fase med omkring 150 mg kombinerede aktive stoffer/kg kropsvægt/dag og en næste fase med omkring 50 mg kombinerede aktive stoffer/kg kropsvægt/dag.
English: Pleuromutilins also share with lincosamides overlapping binding sites at the ribosomal peptidyl transferase center, and multi-resistant strains (to pleuromutilins, macrolides and lincosamides) have arisen.
Danish: Pleuromutiliner deler også overlappende bindingssteder med lincosamiderne på det ribosomale peptidyltransferasecenter, og der er fremkommet stammer med multiresistens (over for pleuromutiliner, makrolider og lincosamider).
English: No data were provided to support the use of a premix for medicated feeding stuff in chickens.
Danish: Der er ikke forelagt data til dokumentation af anvendelsen af en premix til foderlægemiddel hos kyllinger.
English: It follows that, while concerns could be expressed if pleuromutilins would remain the sole antimicrobial class indicated in swine dysentery, on the other hand the use of lincomycin against strains of intermediate susceptibility, might possibly contribute to pleuromutilin resistance development through co-selection.
Danish: Deraf følger, at man kunne være bekymret, hvis pleuromutiliner fortsat var den eneste klasse antimikrobielle stoffer indiceret ved svinedysenteri, men brugen af lincomycin mod stammer med intermediær følsomhed kan på den anden side tænkes at bidrage til udvikling af resistens over for pleuromutiliner gennem co-selektion.
English: A likely explanation to the mechanism of action of spectinomycin against respiratory E. coli is rather an indirect effect on the gut flora, leading to a reduction of the shedding into the environment.
Danish: En sandsynlig forklaring på spectinomycins virkningsmekanisme mod respiratoriske E. coli er snarere en indirekte virkning på tarmfloraen, som fører til reduktion af spredningen til omgivelserne.
English: Any other product use than powders for use in drinking water entails a risk of treatment failure and of resistance development in pathogenic and commensal bacteria through unnecessary or inadequate exposure to the antimicrobial agents, and is not counterbalanced by a demonstrated benefit.
Danish: Anvendelse af ethvert andet produkt end pulver til anvendelse i drikkevand medfører risiko for behandlingssvigt og for udvikling af resistens hos patogene og kommensale bakterier gennem unødig eller utilstrækkelig eksponering for de antimikrobielle stoffer og opvejes ikke af en påvist fordel.
English: 200 Avenue de Mayenne Zone Industrielle des Touches 53000 Laval France
Danish: 200 Avenue de Mayenne Zone Industrielle des Touches
English: The CVMP considers that the obvious increase in MIC values in European B. hyodysenteriae isolates with regard to wild-type strains, impacts the benefit-risk assessment for the group of products under assessment since this is not taken into account in most available clinical efficacy studies which were conducted at the time of product development.
Danish: CVMP finder, at den åbenbare stigning i MIC-værdier i europæiske isolater af B. hyodysenteriae hos vildtypestammer har betydning for benefit/risk-vurderingen for den vurderede produktgruppe, da dette ikke er taget i betragtning i størstedelen af de foreliggende kliniske undersøgelser, som er udført på tidspunktet for produkternes udvikling.
English: The mechanism by which spectinomycin administered orally acts on pathogens at the systemic level despite a poor absorption is not fully elucidated, and might rely partly on indirect effects on the gut flora.
Danish: Den mekanisme, ved hvilken oralt administreret spectinomycin virker systemisk på patogener trods ringe absorption, er ikke fuldt afklaret og kan til dels bestå i indirekte virkninger på tarmfloraen.
English: This low dose for a long period entails a high risk of antimicrobial resistance selection in pathogenic and commensal bacteria and treatment failure.
Danish: Denne lave dosis i lang tid medfører høj risiko for selektion af antimikrobiel resistens hos patogene og kommensale organismer og for behandlingssvigt.
English: In addition, spectinomycin is polar and does not readily cross membranes to distribute into the intracellular compartment.
Danish: Desuden er spectinomycin polært og passerer ikke let gennem membraner eller fordeles til det intracellulære rum.
English: A series of old field studies, which investigated the impact of a systematic treatment on the zootechnical performances of flocks in comparison to a positive control, are also presented.
Danish: Der er desuden forelagt en serie ældre feltundersøgelser af, hvordan systematisk behandling påvirker de avlstekniske ydelser hos flokke sammenlignet med en positiv kontrolgruppe.
English: Parque Empresarial La Moraleja Alcobendas 28108 Spain
Danish: Alcobendas 28108 Spain
English: Delete, where applicable, any references to swine dysentery caused by Brachyspira hyodysenteriae, or to other bacterial species than those specified in the indications.
Danish: Når det er relevant, fjernes enhver omtale af svinedysenteri forårsaget af Brachyspira hyodysenteriae, og af enhver anden bakterieart end dem, der er angivet i indikationerne.
English: Powder to be administered with the feed
Danish: Pulver til administration i foder
English: Therefore, when considering the high in vitro resistance rate in B. hyodysenteriae, and to a lesser extent in possible associated pathogens, together with the limitations of the available clinical data, it appears that in the current situation the combination may remain effective only in a minority of field situations, and no well-established interpretive criterion or standardised test method exists which allows the user to predict efficacy against B. hyodysenteriae.
Danish: Når den høje in vitro-resistensrate hos B. hyodysenteriae og i mindre omfang de mulige tilknyttede patogener tages i betragtning ved siden af begrænsningerne i de foreliggende kliniske data, synes kombinationen i den nuværende situation derfor fortsat kun at være effektiv i et mindretal af feltsituationerne, og der er intet anerkendt fortolkningskriterium eller en standardiseret testmetode, som giver brugeren mulighed for at forudsige virkningen mod B. hyodysenteriae.
English: In those studies the superiority of the combination over spectinomycin alone is not clearly established.
Danish: Disse undersøgelser viser ikke klart, at kombinationen skulle være overlegen i forhold til spectinomycin alene.
English: However this has not been validated and it has not been shown that spectinomycin undergoes any metabolism in any species and it appears from PK data that most of the therapeutic dose can be recovered from faeces and urine.
Danish: Dette er dog ikke valideret, og der er ikke påvist metabolisering af spectinomycin hos nogen dyreart, ligesom de farmakokinetiske data viser, at størstedelen af den terapeutiske dosis genfindes i fæces og urinen.
English: In E. coli the MIC distribution appears to be bimodal, with a significant number of strains showing high MIC values; this could partly correspond to natural (intrinsic) resistance.
Danish: Hos E. coli synes MIC-fordelingen af at være bimodal, idet en væsentlig del af stammerne udviser høje MIC-værdier, hvilket til dels kan svare til naturlig (intrinsisk) resistens.
English: These include notably, Escherichia coli, Salmonella spp., and Campylobacter spp.
Danish: Hertil hører især Escherichia coli, Salmonella spp.
English: However, some attempts were made to establish relationships between MIC values and the clinical outcome, using limited clinical and/or PK (colonic content concentration) data.
Danish: Sammenhængen mellem MIC-værdier og det kliniske udfald er dog forsøgt fastlagt flere gange ved hjælp af begrænsede kliniske og/eller farmakokinetiske (koncentration i kolonindholdet) data.
English: All indications and dosing instructions corresponding to systematic prevention in healthy animals or to fixed antimicrobial levels in the drinking water relate to variable and uncontrolled antimicrobial exposures, should be deleted from the product literature.
Danish: Alle indikationer og doseringsanvisninger svarende til systematisk forebyggelse hos raske dyr eller faste koncentrationer af antimikrobielle stoffer i drikkevandet medfører variabel og ukontrolleret udsættelse for antimikrobielle stoffer og bør slettes fra produktlitteraturen.
English: 1 under Article 34 of Directive 2001/82/EC, the product information was harmonised for Linco-Spectin 100, powder for use in drinking water for pigs and chickens, containing 222 mg lincomycin/g and 444.7 mg spectinomycin/g.
Danish: 1 i medfør af artikel 34 i direktiv 2001/82/EF blev produktoplysningerne harmoniseret for Linco-Spectin 100, pulver til opløsning i drikkevand til svin og kyllinger, indeholdende 222 mg lincomycin/g og 444,7 mg spectinomycin/g.
English: There is only weak evidence that the effect on L. intracellularis infection would be superior to the single substances, and the respective roles of lincomycin and spectinomycin in the context of pig ileitis have not been well established.
Danish: Der kun svag evidens for, at virkningen på infektion med L. intracellularis er større end for enkeltstofferne, og den respektive rolle af lincomycin og spectinomycin ved svineileitis er ikke fastlagt.
English: Some sparse literature data relating to in-feed administration of lincomycin alone, show a majority of treatment failures or relapses.
Danish: De sparsomme litteraturdata om administration i foderet af lincomycin alene viser for størstedelens vedkommende behandlingssvigt eller tilbagefald.
English: Such use has not been associated with substantial evidence of efficacy of treatment or associated metaphylaxis; therefore, this also entails a high risk of resistance selection and treatment failure.
Danish: Sådan anvendelse er ikke forbundet med fyldestgørende evidens for behandlingens virkning eller den tilknyttede metafylakse og medfører derfor også høj risiko for selektion af resistens og for behandlingssvigt.
English: A series of old studies using challenge models show efficacy of the combination, administered in the drinking water, in chickens infected by M. gallisepticum and/or E. coli, or by M. synoviae.
Danish: En række ældre undersøgelser med anvendelse af belastningsmodeller viser virkning af kombinationen ved administration i drikkevandet til kyllinger inficeret med M. gallisepticum og/eller E. coli eller med M. synoviae.
English: Floridsdorfer Hauptstrasse 1 1210 Wien Austria
Danish: Zoetis Österreich GmbH Floridsdorfer Hauptstrasse 1 1210 Wien
English: Extensive data are available in relation to the treatment of swine dysentery caused by Brachyspira hyodysenteriae and associated enteric pathogens, and for the treatment of porcine proliferative enteropathy caused by Lawsonia intracellularis.
Danish: Der foreligger omfattende data om behandling af svinedysenteri forårsaget af Brachyspira hyodysenteriae og tilknyttede enteropatogener, og om behandling af proliferativ enteropati hos svin forårsaget af Lawsonia intracellularis.
English: The available in vitro susceptibility data indicate that spectinomycin and lincomycin can act synergistically in avian mycoplasmas such as M. gallisepticum.
Danish: De foreliggende in vitro-følsomhedsdata tyder på, at spectinomycin og lincomycin kan virke synergistisk mod aviære Mycoplasma såsom M. gallisepticum.
English: In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincomycin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.
Danish: Blandt E. coli udviser en væsentlig del af stammerne høje værdier af MIC (mindste hæmmende koncentration) over for kombinationen lincomycin-spectinomycin og kan være klinisk resistente, skønt der ikke er fastlagt et afskæringspunkt.
English: One monocentric study concerning in-feed use is presented, which shows a beneficial effect in case of porcine proliferative enteropathy, but this uses lincomycin alone at a high dose in comparison to those used in the combination.
Danish: Der er forelagt en monocenterundersøgelse, der viser gavnlig virkning ved porcin proliferativ enteropati, men med anvendelse af lincomycin alene i en høj dosis i forhold til de doser, der anvendes i kombinationen.
English: In vitro studies as well as clinical efficacy data show that the lincomycin-spectinomycin combination is active against Lawsonia intracellularis.
Danish: In vitro-undersøgelser samt data vedrørende klinisk virkning viser, at kombinationen lincomycinspectinomycin er aktiv mod Lawsonia intracellularis.
English: Overall there is no significant evidence of a synergistic interaction in vitro between lincomycin and spectinomycin in B. hyodysenteriae, and most authors consider that the benefit of the combination with spectinomycin in the treatment of swine dysentery lies rather in the extension of the spectrum to a broader range of organisms, i.e. spectinomycin would act against concurrent pathogens or on enteric bacteria establishing conditions in the gut favourable to the development of swine dysentery.
Danish: Overordnet er der ikke nævneværdig evidens for synergistisk interaktion in vitro mellem lincomycin og spectinomycin over for B. hyodysenteriae, og de fleste forfattere finder, at fordelen ved kombinationen med spectinomycin til behandling af svinedysenteri snarere skal tilskrives, at spektret udvides til en bredere række organismer, dvs. at spectinomycin virker mod medvirkende patogener eller mod tarmbakterier, der frembringer gunstige betingelser i tarmen for udvikling af svinedysenteri.
English: Although that some disease outbreaks would still be treated with sufficient efficacy in the current field situation, the risks of treatment failure and delay of effective therapy by pleuromutilins, due to the high in vitro resistance rates and high uncertainty regarding the associated clinical outcome, are considered to outweigh the clinical benefit in a minority of field outbreaks.
Danish: Nogle sygdomsudbrud vil stadig kunne behandles med tilstrækkelig virkning i den nuværende feltsituation, men på grund af de høje in vitro-resistensrater og den store usikkerhed om det tilknyttede kliniske udfald anses risikoen for behandlingssvigt og forsinkelse af effektiv behandling med pleuromutiliner for at overstige den kliniske fordel, der gælder et mindretal af udbrud i felten.
English: Delete, where applicable, any references to any poultry species other than chickens.
Danish: Når det er relevant, slettes enhver omtale af andre fjerkræarter end kyllinger.
English: Germany Pharmacia GmbH Linkstr.
Danish: Tyskland Pharmacia GmbH Linkstr.
English: Stroupežnického 17 150 00 Praha 5
Danish: 150 00 Praha 5