FrancophonIA/ELRC3.0 huggingface dataset:
English: Pre-Assessment of Environmental Impact of Zinc and Copper Used in Animal
Danish: Pre-Assessment of Environmental Impact of Zinc and Copper Used in Animal Nutrition.
English: During the weaning period, piglets loose the benefit of passive immunity from the sow's milk and experience gastrointestinal changes that accompany the change in diet, which causes them a degree of stress and leaves them vulnerable to secondary infections.
Danish: I fravænningsperioden mister smågrise den gavnlige passive immunitet fra soens mælk og oplever gastrointestinale ændringer parallelt med kostændringen, hvilket giver dem en vis stresspåvirkning og gør dem sårbare over for sekundære infektioner.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing zinc oxide to be administered orally to food producing species (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af veterinærlægemidler, der indeholder zinkoxid og administreres oralt til fødevareproducerende arter (se bilag I)
English: Some of the grounds for re-examination raised by the marketing authorisation holders related to considerations of a procedural and legal nature.
Danish: Nogle af de begrundelser for revurdering, som markedsføringstilladelseindehaverne har fremsat, har med proceduremæssige og retlige spørgsmål at gøre.
English: It has to be noted that bioavailability was not considered but the PNECs used in this study were higher (less worst-case) than those reported in the EU RAR and that the annual application of manure was based on 140 kg/N/ha/year which is less worst-case than the European limit for sensitive soils of 170 kg/N/ha/year.
Danish: Det skal bemærkes, at der ikke er taget hensyn til biotilgængeligheden, men at PNECværdierne i undersøgelsen er højere (mindre worst-case) end de PNEC-værdier, der er rapporteret i EU's risikovurderingsrapport, og at den årlige anvendelse af gødning er baseret på 140 kg/N/ha/år, hvilket er mindre worst-case end EU's grænse for følsomme jordtyper, der ligger på 170 kg/N/ha/år.
English: Several marketing authorisation holders provided proprietary studies for veterinary medicinal products containing zinc oxide as single active substance.
Danish: Mange markedsføringstilladelsesindehavere har indsendt egne undersøgelsesdata for veterinærlægemidler, der indeholder zinkoxid som eneste aktive stof.
English: The specific action (on some pathogens) or unspecific action (local action on the digestive tract) is thus not yet fully elucidated.
Danish: Den specifikke virkning (på nogle patogener) og den uspecificerede virkning (lokal virkning på fordøjelseskanalen) er således endnu ikke fuldt belyst.
English: In 45% of all soil samples, PNECs were already exceeded.
Danish: I 45 % af de samlede jordprøver var PNECværdierne allerede overskredet.
English: However, the potential reduction in antimicrobial use secondary to zinc oxide use is not considered to qualify as an 'additional benefit' in this case.
Danish: En eventuel reduktion i brugen af antibiotika som følge af anvendelse af zinkoxid vurderes dog ikke at udgøre en "yderligere fordel" i dette tilfælde.
English: Indeed, there are examples that some EU Member States already monitor veterinary medicinal products containing zinc oxide consumption (e.g., Denmark, Czech Republic), as well as zinc soil concentrations (e.g., Denmark).
Danish: Der er således eksempler på EU-lande, der allerede overvåger forbruget af zinkoxidholdige veterinærlægemidler (f.eks. Danmark og Tjekkiet) og zinkindholdet i jord (f.eks. Danmark).
English: A reduction in the use of antimicrobials to treat post-weaning diarrhoea in piglets is likely to reduce the selective pressure for antimicrobial resistance development.
Danish: En reduktion i brugen af antibiotika til behandling af diarré hos fravænnede smågrise vil sandsynligvis reducere selektionspresset for udvikling af antibiotikaresistens.
English: No dose determination study or justification of the selected dose is given, neither confirmatory data supporting an optimal duration of administration of 14 days.
Danish: Der er ikke udført nogen undersøgelser til fastsættelse af dosis eller fremsat nogen begrundelse for dosisangivelsen, ligesom der ikke foreligger bekræftende data, der kan understøtte en optimal behandlingsvarighed på 14 dage.
English: Therefore, while soils and surface waters can both be corrected for bioavailability, a correction has not been possible for the calculation of the sediment PECs in this environmental risk assessment.
Danish: Mens både jord og overfladevand kan korrigeres for biotilgængelighed, er det således ikke muligt at foretage korrektioner i beregningen af PEC-værdierne for sedimenter i denne miljørisikovurdering.
English: The CVMP acknowledges that LA-MRSA is a rare cause of infection in pigs, but an emerging public health concern due to the high carrier status in pigs and the transference of MRSA to food products and in-contact humans (e.g. pig farmers, veterinarians, slaughter house employees).
Danish: CVMP anerkender, at LA-MRSA er en sjælden årsag til infektion hos svin, men der er en voksende bekymring for folkesundheden som følge af svins status som væsentlige smittebærere og overførslen af MRSA til fødevarer og mennesker, der er i kontakt med svin (f.eks. svineavlere, dyrlæger, slagtermedarbejdere).
English: However, it is apparent that, for all compartments, RQs will be exceeded either immediately (sediment) or eventually (soil, ground-, and surface waters), and these risks must be addressed.
Danish: Det er dog klart, at RQ'erne for alle delmiljøer vil blive overskredet enten straks (sedimenter) eller senere (jord, grundvand og overfladevand), og disse risici skal adresseres.
English: Additionally, as the model was not made available to the CVMP, the relevance of the default input parameters could not be assessed and the model could not be run using data on specific application rates for zinc.
Danish: Da modellen desuden ikke var stillet til rådighed for CVMP, kunne relevansen af standardinputparametrene ikke vurderes, og modellen kunne ikke køres ved hjælp af data om bestemte doseringer for zink.
English: The Committee considered that colistin mono-product alone would be sufficient to reduce clinical diarrhoea, when used for seven days in close connection to weaning, where E. coli diarrhoea is the primary cause of diarrhoea.
Danish: Udvalget vurderer, at enkeltstofprodukter med colistin alene vil være tilstrækkeligt til at reducere klinisk diarré ved administration i 7 dage i umiddelbar forbindelse med fravænning, hvor E. coli er den primære årsag til diarréen.
English: The marketing authorisation holder Huvepharma, however, did provide robust summaries of the additional peer-reviewed studies used in the effect assessment, that were not included in the EU RAR (2010), including a conclusion on the reliability and validity of each study.
Danish: Markedsføringstilladelsesindehaveren Huvepharma har imidlertid fremskaffet solide sammendrag af de yderligere fagfællebedømte undersøgelser, der er anvendt i effektvurderingen, og som ikke indgår i EU's risikovurderingsrapport (2010), herunder en konklusion vedrørende pålideligheden og gyldigheden af de enkelte undersøgelser.
English: No clinical data was identified to support the claimed indication ‘prevention and treatment of various types of diarrhoea occurring at the weaning'.
Danish: Der er ikke fremlagt kliniske data til understøttelse af den anførte indikation "forebyggelse og behandling af forskellige typer diarré i forbindelse med fravænning".
English: In some of the other trials, no diarrhoea was observed in the piglet groups.
Danish: I nogle af de andre undersøgelser er der ikke observeret diarré hos grupperne af smågrise.
English: Actually, the use of veterinary medicinal products containing zinc oxide contributes to about 30% of the total zinc present in manure.
Danish: Anvendelsen af zinkoxid-holdige veterinærlægemidler bidrager således til ca. 30 % af det samlede zinkindhold i gødning.
English: Considering that the recommended duration of colistin administration in pigs is seven days the concomitant administration of zinc oxide included in the product will also be for seven days.
Danish: Da den anbefalede varighed for colistin-behandling af svin er syv dage, vil samtidig behandling med zinkoxid som del af produktet også vare syv dage.
English: Higher yields were described in animals treated with 3000 ppm zinc in the first 21 days after weaning than in control animals, but the animals treated with zinc showed signs of toxicity in the three following weeks.
Danish: Der blev beskrevet et større udbytte hos dyr behandlet med 3 000 ppm zink i de første 21 dage efter fravænning end hos kontroldyrene, men de zinkbehandlede dyr udviste tegn på toksicitet i de efterfølgende tre uger.
English: At present it is uncertain as to what represents a reasonable worst case exposure scenario for the manure application rate.
Danish: Det er i øjeblikket usikkert, hvad det værst tænkelige eksponeringsscenarie for doseringen af gødning med rimelighed kan siges at være.
English: The Committee's conclusions on the points raised in the marketing authorisation holders' scientific grounds are given below.
Danish: Nedenfor følger udvalgets konklusioner til besvarelse af de punkter, der er rejst i markedsføringstilladelsesindehavernes videnskabelige begrundelser.
English: It should be noted that no information supporting a seven days administration of zinc oxide was available.
Danish: Det skal bemærkes, at der ikke foreligger data til understøttelse af 7 dages administration af zinkoxid.
English: Grounds for the refusal of the marketing authorisations and for withdrawal of the existing marketing authorisations
Danish: Begrundelse for afslag på ansøgning om markedsføringstilladelse og for tilbagetrækning af de eksisterende markedsføringstilladelser
English: Veterinary medicinal products containing zinc oxide are used for the treatment and/or prevention and control of post-weaning diarrhoea in piglets.
Danish: Veterinærlægemidler, der indeholder zinkoxid, anvendes hos smågrise til behandling og/eller forebyggelse og kontrol af diarré efter fravænning.
English: The CVMP does not accept these arguments, where the marketing authorisation holder's products have the same proportional risk for selecting antimicrobial resistant bacteria as zinc oxide mono-products.
Danish: CVMP godtager ikke denne argumentation, hvor markedsføringstilladelsesindehaverens produkter indebærer samme proportionelle risiko for selektion af antibiotikaresistente bakterier som enkeltstofprodukter med zinkoxid alene.
English: Significant reduction of diarrhoea (p<0.02) was observed in animals treated with high zinc diets, although significant differences were not observed between both treatment periods.
Danish: Der sås en signifikant reduktion i forekomsten af diarré (p < 0,02) hos de dyr, der fik foder med højt zink-indhold; der sås imidlertid ingen signifikant forskel mellem de to behandlingsperioder.
English: The CVMP cannot support the claim by the marketing authorisation holder stating that determining the environmental risks should be based on consideration of the conditions in Germany only, as the products are nationally authorised in this Member State only.
Danish: CVMP kan ikke tilslutte sig markedsføringstilladelsesindehaverens påberåbelse af, at miljørisiciene bør defineres ud fra en vurdering af forholdene i Tyskland alene, fordi produkterne kun er nationalt godkendt i Tyskland.
English: The CVMP acknowledges that a fraction of the zinc added in soil through manure applications will be taken up by plants and can be mineralised and be sequestrated in soil particles and is thus unavailable.
Danish: CVMP anerkender, at en del af den zink, der tilføres jord ved anvendelse af gødning, optages af planter og kan mineraliseres og isoleres i jordpartikler og er dermed utilgængelig.
English: The zinc oxide supplementation was given for three weeks from weaning and the challenge performed four days after weaning.
Danish: Tilsætningen af zinkoxid blev givet i tre uger fra fravænning, og der sås en virkning fire dage efter fravænning.
English: It appears that zinc oxide administered at high doses may co-select for antimicrobial resistance, a phenomenon shown in vivo for LA-MRSA ST398.
Danish: Det tyder på, at zinkoxid administreret i høje doser kan medføre co-selektion for antibiotikaresistens, et fænomen der er påvist in vivo for LA-MRSA ST398.
English: Moreover the data provided only concern separate use of colistin and zinc oxide and not the clinical use of the
Danish: Desuden gælder de fremlagte data kun separat anvendelse af colistin og zinkoxid og ikke klinisk anvendelse af stofferne i kombination.
English: There is also the possibility for manure containing high concentrations of zinc oxide being applied to susceptible soil types.
Danish: Det kan også tænkes, at gødning, der indeholder høje koncentrationer af zinkoxid, anvendes på følsomme jordtyper.
English: No study was conducted with the combination in the proposed indication and thus the clinical benefit of the association was not demonstrated.
Danish: Der er ikke udført undersøgelser med en kombination af stofferne i den anførte indikation; den kliniske fordel ved kombinationsbehandling er således ikke påvist.
English: Fixed combination product can only be justified, if such combination offers an advantage over their active substances, when used as single substance products.
Danish: Et kombinationsprodukt kan kun retfærdiggøres, hvis kombinationen af de aktive stoffer giver større fordele end de aktive stoffer hver for dig.
English: Zinc oxide has been authorised for several years in a number of EU Member States and experience in some of these countries suggests that zinc oxide use may be correlated with a smaller magnitude of reduction in colistin use than was previously expected, in addition, zinc used in animal farming might have a role to play in increasing the prevalence of antibiotic resistance due to co-resistance.
Danish: Zinkoxid har været tilladt i mange år i en række EU-lande, og erfaringerne fra nogle af disse lande tyder på, at anvendelse af zinkoxid kan korreleres med en mindre reduktion i anvendelsen af colistin, end man havde forventet, og at anvendelse af zink i husdyrbrug desuden kan spille en rolle i den øgede prævalens af antibiotikaresistens som følge af co-resistens.
English: However, increases in MRSA prevalence during the administration of zinc oxide to piglets appear partly transient (Slifierz et al., 2015)25.
Danish: Øget MRSA-prævalens ved administration af zinkoxid til smågrise synes dog at være delvist forbigående (Slifierz et al., 2015)25.
English: D-48308 Senden-Bösensell Germany aniMedica Enteroxid N Zinc oxide Colistin sulfate
Danish: D-48308 Senden-Bösensell Germany aniMedica Enteroxid N Zinkoxid Colistinsulf at
English: Nevertheless, the CVMP would like to note that although these assessments are not considered further, the outcome of two of them also indicate a risk (PEC/PNEC≥1) for the only compartments assessed (soil and surface waters).For the other two, no Phase II data were provided.
Danish: CVMP skal imidlertid bemærke, at selv om disse vurderinger ikke er gennemgået yderligere, tyder resultatet af to af dem også på en risiko (PEC/PNEC ≥ 1) for de to delmiljøer, der er vurderet (jord og overfladevand).
English: The CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005)11 indicates: ‘Any fixed combination product can only be justified, if such a combination offers an advantage over their active substances, when used as single substance products.
Danish: I CVMP's "Guideline on pharmaceutical fixed combination products" (EMEA/CVMP/83804/2005)11 står der som følger: "Kombinationsprodukter kan kun accepteres, hvis kombinationen af de aktive stoffer giver større fordele end de aktive stoffer hver for sig.
English: The CVMP considered that the majority of risk assessments provided for concern products showed deficiencies in the fate models used.
Danish: CVMP mener, at størstedelen af de risikovurderinger, der er fremlagt for de pågældende produkter, udviser mangler i de anvendte skæbnemodeller.
English: Zinc does not degrade in the environment, and a zinc load in the environment, once established, is difficult to remedy with existing technologies.
Danish: Zink nedbrydes ikke i miljøet, og når først miljøet er zinkbelastet, er det vanskeligt at rette op på med de eksisterende teknologier.
English: A study to evaluate the effects of adding high amounts of zinc in the diets of weaned pigs (Lima et al., 1994)9 included 162 piglets from a farm with a previous history of diarrhoea due to E. coli.
Danish: En undersøgelse, der så på virkningen af at tilsætte store mængder zink i foderet til fravænnede smågrise (Lima et al., 1994)9, omfattede 162 smågrise fra en farm, der tidligere havde oplevet diarré forårsaget af E. coli.
English: Considering the specific conditions when the products should be recommended, it should be noted that it was not possible to identify a specific target pathogen for zinc oxide and that the published literature supports only the use of zinc oxide in conditions of physiological diarrhoea of the post-weaning period in piglets.
Danish: Hvad angår de specifikke omstændigheder, under hvilke produkterne bør anbefales, skal det bemærkes, at det ikke har været muligt at identificere et specifikt målpatogen for zinkoxid, og at den publicerede litteratur kun understøtter anvendelse af zinkoxid i situationer, hvor der er tale om fysiologisk diarré hos smågrise i fravænningsperioden.
English: The marketing authorisation holder concludes that the amount of zinc oxide released to the environment from the use of these products in Germany is significantly lower than that from other concerned products, and below established annual loads allowed for environmental release of zinc in Germany.
Danish: Markedsføringstilladelsesindehaveren anfører, at den mængde zinkoxid, der frigives til miljøet ved brug af disse produkter i Tyskland, er signifikant lavere end den mængde zinkoxid, der frigives fra andre af de omhandlede produkter, og lavere end den årlige zinkbelastning af miljøet, der er tilladt i Tyskland.
English: Hence, where an excess of AVS exists and zinc sulfides are formed, the PNEC may be exceeded considerably before any adverse effects are observed.
Danish: Hvor der således findes for meget AVS, og der dannes zinksulfider, kan PNECværdien overskrides væsentligt, inden der observeres nogen negative virkninger.
English: For this referral procedure, and to support the risk assessment on zinc from its oral use as a veterinary medicinal product in food producing animals, Bak et al. (2015)22 analysed for a 28 year period following application of pig slurry.
Danish: I forbindelse med denne indbringelsesprocedure, og for at understøtte risikovurderingen af zink som veterinærlægemiddel til oral anvendelse hos fødevareproducerende dyr, henvises til Bak et al. (2015)22, der har foretaget analyser af en periode på 28 år efter anvendelse af svinegylle.
English: For instance, soils contaminated over an extended period of time show reduced toxicity compared to freshly spiked soils.
Danish: Jord, der har været forurenet i længere tid, udviser f.eks. mindre toksicitet end jord, der lige er blevet forurenet.
English: Although this risk mitigation measure could be considered in line with the criteria set out by the CVMP reflection paper on risk mitigation measures (EMA/CVMP/ERAWP/409328/2010), the CVMP was of the view that, in practice, applying this risk mitigation measure will not be feasible where there may not be the possibility to apply treated manure on different areas of land or where there is trading of manure.
Danish: Selv om denne risikoreducerende foranstaltning kan anses for at være i overensstemmelse med de kriterier, der er anført i CVMP's arbejdsdokument om risikoreducerende foranstaltninger (EMA/CVMP/ERAWP/409328/2010), mener CVMP, at det ikke vil kunne lade sig gøre i praksis at anvende denne risikoreducerende foranstaltning i tilfælde, hvor det måske ikke er muligt at anvende behandlet gødning på forskellige jordområder, eller hvor der handles med gødning.
English: At the time of the zinc EU RAR (2010) there were too few effects or exposure data to be able to account for the effect of these two parameters (AVS/SEM) on zinc bioavailability in sediments.
Danish: Da EU's risikovurderingsrapport (2010) for zink blev udarbejdet, var der for få effekt- eller eksponeringsdata til at kunne redegøre for effekten af disse to parametre (AVS/SEM) på zinks biotilgængelighed i sedimenter.
English: It appears that one-week of administration is not sufficiently efficacious and a duration longer than 14 days is not justified either.
Danish: Det fremgår, at én uges behandling ikke er tilstrækkeligt; der er dog heller ikke belæg for en behandlingsvarighed på over 14 dage.
English: 1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no. EMEA/V/A/108) - link results was submitted and study methods were poorly reported (no study protocols, no raw data, no statistical analysis).
Danish: 1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no. EMEA/V/A/108) - link undersøgelsesmetoderne i begrænset omfang (ingen undersøgelsesprotokoller, ingen rådata, ingen statistisk analyse).
English: United Kingdom SCA NuTec (Provimi Ltd) Eastern Avenue
Danish: SCA NuTec (Provimi Ltd) Eastern Avenue Lichfield
English: All data provided for zinc oxide only refer to a prevention claim.
Danish: Alle de fremlagte data, der gælder zinkoxid, omhandler kun forebyggelse.
English: Czech Republic Trouw Nutrition Biofaktory s.r.o.
Danish: Trouw Nutrition Biofaktory s.r.o.
English: It is believed that bioavailability of metals in sediment can be predicted by measuring the acid volatile sulphide (AVS) and the simultaneously extracted metal (SEM) contents of sediments.
Danish: Det antages, at metallers biotilgængelighed i sedimenter kan beregnes ved at måle syreflygtigt sulfid (AVS) og de samtidigt ekstraherede metallers (SEM) indhold i sedimenter.
English: The most important factors in determining bioavailability (and, hence, ecotoxicity) in soils are soil type and the time between the addition of zinc to soil and toxicity testing (‘ageing').
Danish: De vigtigste faktorer i forhold til at bestemme biotilgængelighed (og dermed økotoksicitet) i jord er jordtype og den tid, der går, fra jorden tilføres zink, og til der testes for toksicitet ("ældning").
English: A summary of results from a study performed by Johansen et al. in Denmark in 20072 considering the effects of zinc oxide on post weaning diarrhoea in piglets have been provided.
Danish: Det er indsendt et resumé af resultaterne fra en undersøgelse, der er udført af Johansen et al. i Danmark i 20072 vedrørende effekten af zinkoxid på diarré hos fravænnede smågrise.
English: In sandy soils, PNECs were exceeded in 66% of all cases.
Danish: Hvad angår sandjord, var PNECværdierne overskredet i 66 % af tilfældene.
English: These application rates were chosen as they were the ones reported in the Monteiro et al. (2010) study for feed additives containing zinc oxide and do not represent a worst case scenario for veterinary medicinal products containing zinc oxide which would be in the range of 8 kg ha-1 a-1.
Danish: Disse doseringer blev valgt, da det var dem, der var rapporteret i Monteiro et al. (2010)-undersøgelsen af zinkoxid-holdige fodertilsætninger; de udgør ikke det værst tænkelige scenarie for zinkoxid-holdige veterinærlægemidler, da et sådant ville omfatte en dosering på 8 kg ha-1 a-1.
English: In addition, it appears that zinc oxide is useful to reduce the incidence of post-weaning diarrhoea but not to treat diarrhoea and that it is not possible to clearly identify the mechanism of action of zinc oxide and thus any specific target.
Danish: Desuden fremgår det, at zinkoxid kan anvendes til at reducere forekomsten af diarré efter fravænning, men ikke til at behandle diarré, og at det ikke er muligt at identificere zinkoxids virkningsmekanisme klart endsige definere et specifikt mål.