FrancophonIA/ELRC3.0 huggingface dataset:
English: The data presented support the use of veterinary medicinal product containing zinc oxide for prevention of post-weaning diarrhoea in piglets at the dose of 100 mg/kg bw per day (equivalent to 2500 ppm zinc in feed), for a duration of 14 days.
Danish: De fremlagte data understøtter anvendelse af zinkoxid-holdige veterinærlægemidler til forebyggelse af diarré hos fravænnede smågrise med en daglig dosis på 100 mg/kg legemsvægt (svarende til 2 500 ppm zink i foder) i 14 dage.
English: • the CVMP considered that based on the available data the clinical benefit of the veterinary medicinal products containing colistin sulfate and zinc oxide cannot be demonstrated;
Danish: • CVMP mener, at de kliniske fordele ved veterinærlægemidler, der indeholder colistinsulfat og zinkoxid, ikke kan påvises ud fra de tilgængelige data.
English: Nonetheless, for each compartment, risks have been identified for some scenarios at each application rate investigated.
Danish: For de enkelte delmiljøer er der identificeret nogle scenarier for hver af de undersøgte doseringer.
English: The CVMP considers that the environmental risks identified by the yearly accumulation of zinc in soil from the spreading of manure in agricultural land cannot be controlled with risk mitigation measures.
Danish: CVMP mener, at de miljørisici, der er forbundet med zinkakkumulering i jord ved spredning af gødning på landbrugsjord år efter år, ikke kan kontrolleres ved risikoreducerende foranstaltninger.
English: Consequently, the CVMP considers that in the light of overall data available, environmental risks identified by the continuous annual accumulation of zinc in soil from the spreading of manure in agricultural land cannot be effectively controlled through the application of the two risk mitigation measures presented above.
Danish: I lyset af de samlede tilgængelige data er CVMP derfor af den opfattelse, at de miljørisici, der er forbundet med kontinuerlig zinkakkumulering i jord fra spredning af gødning på landbrugsjord år efter år, ikke kan kontrolleres effektivt ved anvendelse af de to ovenfor omtalte risikoreducerende foranstaltninger.
English: Combination of zinc oxide and colistin or sulfaguanidine Based on the data presented, the combinations of zinc oxide, recommended for the prevention of unspecific diarrhoea during the post-weaning period, with any antimicrobial substance recommended for treatment and metaphylaxis of diarrhoea induced by target pathogen(s), are not justified.
Danish: Kombination af zinkoxid og colistin eller sulfaguanidin Ud fra de fremlagte data er der ikke belæg for at kombinere zinkoxid (der anbefales til forebyggelse af uspecificeret diarré efter fravænning) og et givet antibiotikum (der anbefales til behandling og metafylakse af diarré forårsaget af et eller flere målpatogener).
English: According to recently published data, zinc used in animal farming might promote the spread of antimicrobial resistance (MRSA) due to co-resistance.
Danish: I henhold til nyligt publicerede data kan anvendelse af zink i husdyrbrug øge spredningen af antibiotikaresistens (MRSA) som følge af co-resistens.
English: Report to the European Food Safety Authority - link 20 EFSA Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additive for all animal species: Zinc oxide, based on a dossier submitted by Grillo Zinkoxid GmbH/EMFEMA - link validation of the IDMM has been performed by the comparison of model predictions against published monitoring data for zinc applications.
Danish: 20 EFSA Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additive for all animal species: Zinc oxide, based on a dossier submitted by Grillo Zinkoxid GmbH/EMFEMA - link 21 Forum for Co-ordination of Pesticide Fate Models and their Use (FOCUS) - link for sedimenter, tages der ikke hensyn til akkumuleringsfaktorer (f.eks. aflejring, resuspension og nedgravning af zink), idet det antages, at suspenderede sedimenter er repræsentative for aflejrede sedimenter, og idet der ikke tages højde for niveauet af syreflygtigt sulfid.
English: Potential additional exposure concentrations, e.g., from feed additives containing zinc or other industrial sources, have not been taken into account for this environmental risk assessment.
Danish: I denne miljørisikovurdering tages der ikke hensyn til yderligere eksponeringskoncentrationer fra f.eks. zinkholdige fodertilsætninger eller andre industrikilder.
English: According to recently published data, zinc used in animal farming might promote the spread of antibiotic resistance due to co-resistance.
Danish: I henhold til nyligt publicerede data kan anvendelse af zink i husdyrbrug øge spredningen af antibiotikaresistens som følge af co-resistens.
English: Assessment of potential benefits associated with the use of zinc oxide in food producing animals
Danish: Vurdering af de potentielle fordele ved brug af zinkoxid til fødevareproducerende arter Zinkoxid som eneste aktive stof
English: The data available shows a beneficial effect of zinc oxide at the dose of 100 mg/kg bw per day (equivalent to 2500 ppm zinc in feed), given in the feed for 12-14 days.
Danish: De tilgængelige data viser en gavnlig effekt af zinkoxid ved en daglig dosis på 100 mg/kg legemsvægt (svarende til 2 500 ppm zink i foder), der indgives med foderet i 12-14 dage.
English: Zinc oxide 1000 mg/g Oral powder
Danish: Zinkoxid 1000 mg/g Oralt pulver
English: Supporting field studies on zinc accumulation in soils were not available during the referral procedure under Article 33(4) of Directive 2001/82/EC for Gutal (EMEA/V/A/108).
Danish: Der forelå ingen understøttende feltundersøgelser af zinkakkumulering i jord under indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82/EF.
English: Zinc oxide 622mg/g (500 mg zinc/g)
Danish: Zinkoxid 622mg/g (500 mg zinc/g)
English: • the CVMP considered that based on the available data the combination of zinc oxide, for the prevention of unspecific diarrhoea during the post-weaning period, with sulfaguanidine, for treatment and metaphylaxis of diarrhoea induced by target pathogen(s), is not justified;
Danish: • Ud fra de tilgængelige data vurderer CVMP, at der ikke er belæg for at kombinere zinkoxid (til forebyggelse af uspecificeret diarré efter fravænning) og sulfaguanidin (til behandling og metafylakse af diarré forårsaget af et eller flere målpatogener).
English: This beneficial effect of zinc oxide was demonstrated at a dose of 100 mg/kg bw per day (equivalent to 2500 ppm in feed), administered during 12-14 days from weaning.
Danish: Det er påvist, at zinkoxid har gavnlig effekt ved en daglig dosis på 100 mg/kg legemsvægt (svarende til 2 500 ppm i foder) administreret i 12-14 dage efter fravænning.
English: Even applying the risk mitigation measures above it will only be a matter of time before risks are present in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land.
Danish: Selv hvis de omtalte risikoreducerende foranstaltninger anvendes, vil det kun være et spørgsmål om tid, før alle delmiljøerne belastes, hvis man gødsker jord med gødning fra svin, der er behandlet med zinkoxid-holdige veterinærlægemidler.
English: Risk mitigation measures
Danish: Risikoreducerende foranstaltninger
English: Colistin and zinc oxide combination
Danish: Colistin og zinkoxid i kombination
English: • A risk of zinc to soil dwelling species is already present in clay soil; • A risk of zinc to soil dwelling species is already present in sandy soil.
Danish: • Zink udgør allerede en risiko for arter, der findes i sandjord.
English: Zinc oxide 622 mg/g (500 mg zinc/g)
Danish: Zinkoxid 622 mg/g (500 mg zinc/g)
English: CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005) - link
Danish: GL6 and GL38 (EMEA/CVMP/ERA/418282/2005) - link
English: Also, piglets are weaned between 3-4 weeks of age (i.e. 7-8 kg), but the claim for the aforementioned products is for pigs up to 40 kg bw.
Danish: Derudover fravænnes smågrise i alderen 3-4 uger (dvs. 7-8 kg), mens de omhandlede produkter er tiltænkt svin med en legemsvægt på op til 40 kg. Zinkoxids kliniske relevans med henblik på at reducere omfanget af E. coli-relateret diarré hos svin i denne vægtklasse kendes ikke.
English: The CVMP considered that the combinations of zinc oxide, recommended for the prevention of nonspecific diarrhoea during the post-weaning period, with any antimicrobial substance recommended for treatment and metaphylaxis of diarrhoea induced by target pathogen(s), are not justified.
Danish: CVMP vurderer, at der ikke er belæg for at kombinere zinkoxid (der anbefales til forebyggelse af uspecificeret diarré efter fravænning) og et givet antibiotikum (der anbefales til behandling og metafylakse af diarré forårsaget af et eller flere målpatogener).
English: Consequently, the CVMP considers that the environmental risks identified by the yearly accumulation of zinc in soil from the spreading of manure in agricultural land cannot be solely controlled with the aforementioned risk mitigation measures.
Danish: CVMP er således af den opfattelse, at de miljørisici, der er forbundet med zinkakkumulering i jord ved spredning af gødning på landbrugsjord år efter år, ikke kan kontrolleres ved ovenfor omtalte risikoreducerende foranstaltninger alene.
English: Although during the aforementioned referral procedure for Gutal, the possibility of not spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc was considered as a possible risk mitigation measure, and despite being in line with the criteria set out by the CVMP reflection paper on risk mitigation measures23, it may prove difficult to enact in reality; not only in instances where there may not be the possibility to apply
Danish: Selv om man under ovennævnte indbringelsesprocedure for Gutal drøftede muligheden af at undlade at sprede gødning på samme jordområde flere år i træk for at bremse akkumuleringen af zink som en eventuel risikoreducerende foranstaltning, og selv om et sådant tiltag er i overensstemmelse med kriterierne i CVMP's arbejdsdokument om risikoreducerende foranstaltninger23, kan det vise sig at være svært at gennemføre i praksis; dette skyldes ikke alene de tilfælde, hvor der ikke er mulighed for at anvende behandlet gødning på forskellige jordområder, men også handlen med gødning medlemsstaterne imellem og muligheden for, at gødning, der indeholder høje koncentrationer af zinkoxid, anvendes på følsomme jordtyper.
English: During the aforementioned referral procedure for Gutal, the possibility of not spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc was considered as a possible risk mitigation measure.
Danish: Under indbringelsesproceduren for Gutal drøftede man som en eventuel risikoreducerende foranstaltning muligheden af at undlade at sprede gødning på det samme jordområde flere år i træk for at bremse zinkakkumuleringen.
English: Zinc oxide Colistin sulfate
Danish: Zinkoxid Colistinsulf at
English: Sulfaguanidine and zinc oxide combination
Danish: Sulfaguanidin og zinkoxid i kombination
English: • Based on the studies provided, the efficacy of high content of zinc oxide in feed was shown in weaned piglets aged 3-4 weeks old in particular breeding conditions (intensive breeding, housing in building, grouping in pens with piglets of different litters/origins, premature separation with the sow, abrupt feeding transition from milk to cereal based feed).
Danish: • I de fremlagte undersøgelser har man dokumenteret effektiviteten af foder med et højt indhold af zinkoxid hos fravænnede smågrise i alderen 3-4 uger under særlige avlsforhold (intensiv avl,
English: Strength
Danish: INN Styrke
English: Zinc oxide Sulfaguanidin um
Danish: Zinkoxid Sulfaguani din
English: • the CVMP considered that the efficacy of veterinary medicinal products containing zinc oxide for treatment of post-weaning diarrhoea in piglets is not supported by data and cannot be demonstrated;
Danish: • CVMP mener, at virkningen af zinkoxid-holdige veterinærlægemidler til behandling af diarré hos smågrise efter fravænning ikke kan påvises ud fra de tilgængelige data.
English: Regarding the potential for risk reduction when complying with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to limit direct entry to water courses, but would not affect the zinc reaching water surface by leaching and run-off processes.
Danish: Hvad angår potentialet for risikoreduktion ved opfyldelse af lokale eller nationale regler om, at gødning skal spredes i en minimumsafstand fra åbent vand, mener CVMP, at dette kun vil begrænse direkte spredning til vandløb og ikke vil have nogen indvirkning på, hvor meget zink der når frem til vandoverflader ved udvasknings- og afstrømningsprocesser.
English: Zinc supplementation may also directly influence the antimicrobial resistance profiles of bacteria via other mechanisms based on work in E. coli (Bednortz C. et al., 2013)26.
Danish: E. coli (Bednortz C. et al., 2013)26 kan zinktilskud også have direkte indvirkning på bakteriers antibiotikaresistensprofil via andre mekanismer.
English: Treatment of post-weaning diarrhoea in piglets In the absence of data the indication ‘treatment of post-weaning diarrhoea in piglets' is not supported.
Danish: Da der ikke foreligger relevante data, understøttes indikationen "behandling af diarré hos fravænnede smågrise" ikke.
English: The CVMP confirmed that, at this level, zinc oxide cannot be considered as an excipient only and that furthermore, considering the substantial amount of zinc oxide present in the aforementioned products (Enteroxid N AMV aniMedica and aniMedica Enteroxid N), the classification of the substance as an excipient or active substance is not relevant.
Danish: I betragtning af den anseelige mængde zinkoxid, der er i de omhandlede produkter (Enteroxid N AMV aniMedica og aniMedica Enteroxid N), er det desuden ikke relevant at klassificere stoffet som et hjælpestof eller et aktivt stof.
English: 13 Metal bioavailability assessment tool (M-BAT) - link 14 Arche Consulting Soil PNEC calculator - link making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)15.
Danish: 14 Arche Consulting Soil PNEC calculator - link 15 ECHA, 2014.
English: 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), will only delay the risks identified in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land.
Danish: CVMP vurderer således, at de tidligere anbefalede risikoreducerende foranstaltninger i forbindelse med indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82/EF, kun vil forsinke de risici, der er identificeret for alle delmiljøerne, hvis man gødsker jord med gødning fra svin, der er behandlet med zinkoxid-holdige veterinærlægemidler.
English: Regarding the risk mitigation measure for compliance with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to prevent direct entry to water courses, but would not affect the zinc reaching water surface and drinking water through leaching and run-off processes.
Danish: Hvad angår den risikoreducerende foranstaltning til opfyldelse af lokale eller nationale regler om, at gødning skal spredes i en minimumsafstand fra åbent vand, mener CVMP, at den kun vil kunne anvendes til forebyggelse af direkte spredning til vandløb og ikke vil have nogen indvirkning på, hvor meget zink der når frem til overfladevand og drikkevand ved udvasknings- og afstrømningsprocesser.
English: However, since the data search for the EU RAR (2010) was completed, more data have become available and were used by some of the
Danish: Da datasøgningen i forbindelse med EU's risikovurderingsrapport (2010) var gennemført, blev flere data imidlertid tilgængelige, og de blev anvendt af nogle af markedsføringstilladelsesindehaverne til fastsættelse (finjustering) af PNEC-værdierne for de pågældende delmiljøer.
English: On the other hand, using the bioavailability correction approach, and considering within this approach that bioavailability is dependent on soil type and the time zinc was incorporated onto soil (i.e., zinc aging), the bioavailable fraction was for both
Danish: Ved brug af "korrektion for biotilgængelighed"-tilgangen og under hensyn til, at biotilgængeligheden afhænger af jordtype og tidspunktet for, hvornår zinken er blevet indlejret i jorden (zinkældning), var den biotilgængelige del for både sand- og lerjord til gengæld under PNECsoil på 26 mg/kg (16,3 og 14,4 mg/kg for henholdsvis sandjord og lerjord).
English: • the CVMP considered that the overall benefit-risk balance for the for veterinary medicinal products containing zinc oxide to be administered orally to food producing species is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment; the CVMP has recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide to be administered orally to food producing species as referred in Annex I.
Danish: • CVMP mener, at den overordnede benefit/risk-balance for veterinærlægemidler, der indeholder zinkoxid og administreres oralt til fødevareproducerende arter, er negativ, da fordelene ved zinkoxid til forebyggelse af diarré hos svin ikke opvejer risikoen for miljøet.
English: The calculation of site-specific PNECs for Gutal was carried out using an Excel tool soil PNEC calculator (developed by Arche Consulting)14 which incorporates parameters relevant to determine soil zinc bioavailability, such as pH, organic and clay content, and the cation exchanged capacity.
Danish: 12 European Union Risk Assessment Report (EU RAR) on zinc (2010) - link 13 Metal bioavailability assessment tool (M-BAT) - link hjælp af et Excel-værktøj til beregning af PNEC-værdien i jord (udviklet af Arche Consulting)14, som anvender relevante parametre til bestemmelse af zinks biotilgængelighed i jord, herunder pH, organisk indhold, lerindhold og kationbytningskapacitet.
English: Pharmaceutical form
Danish: Lægemiddelform Dyrearter Administrations vej
English: Considering the use of these products, current EU rules and Good Agricultural Practice on manure spreading, how the target animals are kept and how manure is managed, the suggested risk mitigation measures (dilution of manure and distance to surface waters), although they are in line with the CVMP/VICH guideline (CVMP/VICH/790/03) and were recommended for the referral procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), in order to reduce the accumulation of zinc in each compartment, cannot guarantee that they can effectively eliminate either the imminent and future environmental risks identified from the risk assessment, but will just delay the total zinc accumulation in the environment (i.e. the time when the PEC will exceed the PNECs).
Danish: Det samme gælder måden, hvorpå måldyrene holdes og gødningen håndteres, samt de foreslåede risikoreducerende foranstaltninger (fortynding af gødningen og afstand til overfladevand), selv om disse er i overensstemmelse med CVMP/VICH-retningslinjerne (CVMP/VICH/790/03) og blev anbefalet ved indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82, til at reducere akkumuleringen af zink i de enkelte delmiljøer.
English: Chapter R.7b:Endpoint specific guidance 16 VICH GL6: Guideline on Environmental Impact Assessment (EIAS) for Veterinary Medicinal Products - Phase I
Danish: Chapter R.7b:Endpoint specific guidance
English: • the CVMP considered that based on the available data the efficacy of veterinary medicinal products containing zinc oxide for prevention of post-weaning diarrhoea in piglets is demonstrated;
Danish: • CVMP mener, at virkningen af zinkoxidholdige veterinærlægemidler til forebyggelse af diarré hos smågrise efter fravænning er påvist ud fra de tilgængelige data.
English: • the CVMP considered that based on the available data risks to the environment have been identified, due to accumulation of zinc, for all scenarios, either immediately (sediment, some soil and surface water types) or delayed (other soil types, ground-, and surface waters); the CVMP acknowledged that all predictive models have an inherent degree of uncertainty in their parameterisation, and the results generated (i.e., time estimates) are based on a limited amount of input data which is likely to influence the model output;
Danish: • CVMP mener, at det ud fra de tilgængelige data kan fastslås, at der foreligger risici for miljøet i alle scenarier på grund af akkumuleringen af zink, enten straks (sedimenter, visse typer jord og overfladevand) eller forsinket (andre typer jord, grundvand og overfladevand).
English: Zinc oxide as a sole active substance
Danish: Det enkelte aktive stof i et
English: Slovak Republic Tekro, spol.
Danish: Sintofarm S.p.A, Tekro, spol.
English: Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a strong correlation between high doses of zinc supplementation in food and an increase in the prevalence of antimicrobial resistant bacteria.
Danish: En lang række publicerede undersøgelser har vist en stærk korrelation mellem høje doser af zinktilskud i næringsmidler og den øgede prævalens af antibiotikaresistente bakterier (ved in vivo-test eller ved analyse af miljøisolater).
English: Considering the use of these products, current EU rules and Good Agricultural Practice (GAP) on manure spreading, how the target animals are kept and how manure is managed, the risk mitigation measures proposed above, although they are in line with the CVMP/VICH guideline (CVMP/VICH/790/03) and were proposed for the referral procedure on Gutal under Article 33(4) of Directive 2001/82/EC (EMEA/V/A/108) in order to reduce the accumulation of zinc in each compartment, cannot guarantee that they can effectively eliminate imminent and future environmental risks identified in the risk assessment, but will just delay the total zinc accumulation in the environment, (i.e. the time when PEC will exceed PNECs).
Danish: Det samme gælder måden, hvorpå måldyrene holdes og gødningen håndteres, samt de ovenfor foreslåede risikoreducerende foranstaltninger, selv om disse er i overensstemmelse med CVMP/VICHretningslinjerne (CVMP/VICH/790/03) og blev foreslået ved indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82/EF, til at reducere akkumuleringen af zink i de enkelte delmiljøer.
English: Zinc oxide 492 mg/g
Danish: Zinkoxid 492 mg/g Premix
English: Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a correlation between high doses of zinc supplementation in food and the prevalence of antimicrobial resistance.
Danish: En lang række publicerede undersøgelser har vist en korrelation mellem høje doser af zinktilskud i næringsmidler og prævalensen af antibiotikaresistens (ved in vivo-test eller ved analyse af miljøisolater).
English: Zinc oxide 622 mg/g
Danish: Zinkoxid 622 mg/g Premix
English: Zinc oxide 600 mg/g
Danish: Zinkoxid 600 mg/g Premix
English: • Be careful how much alcohol you drink.
Danish: Vær forsigtig med, hvor meget alkohol du indtager.
English: Children and adolescents (10 to 17 years of age)
Danish: Børn og unge (10 til 17 år)
English: You have had a stroke, especially if you are elderly.
Danish: - du har haft et slagtilfælde, specielt hvis du er ældre.
English: (17) May lead to falls.
Danish: (17) Kan medføre fald.
English: Some medicines for HIV.
Danish: Visse lægemidler mod HIV.