FrancophonIA/ELRC3.0 huggingface dataset:
English: Additionally, as the IDMM has been taken into consideration for the EFSA assessment of zinc exposure, it may also be considered relevant for the assessment of veterinary medicinal products in terms of environmental exposure assessment.
Danish: Da der er taget hensyn til IDMM-modellen i EFSA's vurdering af zinkeksponering, kan modellen også være relevant ved vurdering af veterinærlægemidler, hvad angår miljøeksponering.
English: However, the CVMP was not able to establish the validity of the PNEC values reported as the Arche Soil PNEC calculator and the set of relevant input parameters was not made available to the CVMP during the initial assessment.
Danish: CVMP kunne imidlertid ikke vurdere validiteten af de rapporterede PNEC-værdier, da Arche-værktøjet og de relevante input-parametre ikke blev fremlagt for CVMP under den første vurdering.
English: • The absence of a multicentre field study conducted through Europe according to GCP to test the efficacy of such products in various field conditions does not permit to define the indication more precise than ‘post-weaning diarrhoea', neither to conclude on the efficacy of the products in situations where specific pathogen(s) is (are) involved nor in situations other than e.g. weaning piglets at 3-4 weeks of age.
Danish: • Da der ikke er udført multicenter-feltundersøgelser flere steder i Europa i henhold til god klinisk praksis til test af effektiviteten af sådanne produkter under forskellige forhold, har det ikke været muligt at definere indikationen mere præcist end "diarré efter fravænning"; det har heller ikke været muligt at foretage en konklusiv vurdering af produkternes effektivitet, hvor et eller flere specifikke patogener er involveret, endsige hvor der er tale om andet end fravænnede smågrise i alderen 3-4 uger.
English: The CVMP notes that after further considerations regarding the current EU rules and Good Agricultural Practice on manure spreading, and how the target animals are kept and how manure is be managed, the initially suggested risk mitigation measures would slow down the accumulation of zinc in each compartment.
Danish: CVMP bemærker, at efter yderligere vurdering af de gældende EU-regler og gode landbrugspraksisser for spredning af gødning samt af den måde, hvorpå måldyrene holdes og gødningen håndteres, vil de oprindeligt foreslåede risikoreducerende foranstaltninger bremse akkumuleringen af zink i de enkelte delmiljøer.
English: The marketing authorisation holder's justification of the combination is based on the addition of the two effects: bactericidal activity of colistin and unspecific protective effect of zinc oxide during the post-weaning period.
Danish: Markedsføringstilladelsesindehaverens begrundelse for kombinationen er baseret på sammenlægningen af to virkninger: colistins antibakterielle aktivitet og zinkoxids uspecificerede beskyttende effekt efter fravænning.
English: Based on the totality of the data available, including the information submitted during the original assessment procedure and the detailed scientific grounds for re-examination put forward by the marketing authorisation holders, the CVMP concluded that there were not sufficient scientific grounds to revise its previous conclusions as included in its opinion of 8 December 2016, which concluded that the overall benefit-risk balance for the veterinary medicinal products containing zinc oxide to be administered orally to food producing species is negative.
Danish: Ud fra de samlede tilgængelige data, herunder oplysninger indsendt under den oprindelige vurderingsprocedure og de detaljerede videnskabelige begrundelser for revurdering fremsat af markedsføringstilladelsesindehaverne, har CVMP konkluderet, at der ikke foreligger tilstrækkelig videnskabelig begrundelse for at revurdere udvalgets oprindelige konklusion, jf. udvalgets udtalelse af 8. december 2016, hvor den overordnede benefit/risk-balance for veterinærlægemidler, der indeholder zinkoxid og skal administreres oralt til fødevareproducerende arter, vurderes at være negativ.
English: Curative treatment of post-weaning diarrhoeas in piglets is not supported by data provided.
Danish: Kurativ behandling af diarré hos fravænnede smågrise understøttes ikke af de fremlagte data.
English: The efficacy in piglets weaned later is not documented neither in less intensive breeding conditions.
Danish: der fravænnes senere, er ikke dokumenteret, heller ikke på svinefarme med mindre intensiv avl.
English: The marketing authorisation holders presented an environmental risk assessment by: a) addressing measured soil concentrations of zinc in (Danish) soils - but not taking into consideration the contributing from the repeated (annual) load of zinc from non-aged pig slurry; and b) by combining two methods for incorporating bioavailability (the so called ‘added risk approach' together with the ‘bioavailability correction approach'), yet the combination of both is not supported by the CVMP.
Danish: Markedsføringstilladelsesindehaverne fremlagde en miljørisikovurdering på følgende måde: a) ved at henvise til målte zinkkoncentrationer i (dansk) jord, men uden at tage hensyn til bidraget fra den gentagne (årlige) zinkbelastning fra ungsvinegylle b) ved at kombinere to metoder til inddragelse af biotilgængeligheden (den såkaldte "added risk"-tilgang sammen med "korrektion for biotilgængelighed"-tilgangen); kombinationen heraf støttes dog ikke af CVMP.
English: At a site-specific level, PNEC bioavailability corrections in sediment as a result of AVS/SEM content in sediment, can be made if the necessary data are available; however, such data are scarce.
Danish: Stedsspecifikt ville der kunne foretages biotilgængelighedsbaserede korrektioner af PNEC-værdien for sediment ud fra sedimentets indhold af AVS/SEM, hvis de nødvendige data var tilgængelige, men sådanne data er begrænsede.
English: In order to better indicate the risks posed at application rates considered particularly relevant by the use of Gutal of 8.2 kg zinc ha-1 y-1, 7.2 kg zinc ha-1 a-1, 3.3 kg zinc ha-1 a-1 and 2.8 kg zinc ha-1 a-1, RQs have been extrapolated (linearly) from application rates of 4 and 7 kg zinc ha-1 a-1.
Danish: For bedre at kunne angive risiciene ved de forskellige doseringer, som anses for at være særlig relevante ved brug af Gutal med 8,2 kg zink ha-1 y-1, 7,2 kg zink ha-1 a-1, 3,3 kg zink ha-1 a-1 og 2,8 kg zink ha-1 a-1, er RQ'erne blevet ekstrapoleret (lineært) fra doseringerne på 4 og 7 kg zink ha-1 a-1.
English: Scarce information with only summaries of study
Danish: Der er dog tale om sparsomme data, der kun omfatter resuméer af undersøgelsesresultaterne, og der er kun gjort rede for
English: Scarce data have been presented on the potential effect of using zinc oxide in the reduction of use of antibiotics and therefore no conclusions can be made in this regard.
Danish: Der er kun fremlagt begrænsede data om, hvorvidt anvendelse af zinkoxid kan medvirke til at reducere brugen af antibiotika, og derfor kan der ikke drages nogen konklusion i den henseende.
English: The marketing authorisation holder also chose to include bioavailability aspects in soil by calculating PNECbioavailable for 19 European soils by means of the Arche Soil PNEC calculator.
Danish: Markedsføringstilladelsesindehaveren har også valgt at inddrage biotilgængeligheden i jord ved at beregne PNECbioavailable for 19 europæiske jorder ved brug af Arche Consultings værktøj til beregning af PNEC-værdien i jord.
English: This duration of treatment differs from all other products containing zinc oxide (i.e. 14 consecutive days).
Danish: Behandlingsvarigheden er anderledes end for alle andre zinkoxid-holdige produkter (hvor behandlingsvarigheden er 14 dage i træk).
English: Other parameters affecting (lowering) zinc bioavailability in sediments are the presence of precipitated mineral phases, e.g. iron (oxy)hydroxides and manganese oxides, as well as the organic matter content in sediments.
Danish: Andre parametre, der påvirker (reducerer) zinks biotilgængelighed i sedimenter, er tilstedeværelsen af udfældede mineralfaser, f.eks. jernoxid-hydroxider og manganoxider samt indholdet af organisk materiale i sedimenter.
English: The study was performed on 260 piglets from 36 litters weaned at the age of 28 days and assigned, according to initial body weight and the litter of origin, to one of six treatment groups: 0 ppm zinc, 100 ppm zinc; 200 ppm zinc; 1000 ppm zinc; 2500 ppm zinc and 4000 ppm zinc.
Danish: Undersøgelsen omfattede 260 smågrise fra 36 kuld, der blev fravænnet i alderen 28 dage, og som ud fra indledende legemsvægt og oprindelseskuld blev inddelt i seks behandlingsgrupper: 0 ppm zink, 100 ppm zink, 200 ppm zink, 1 000 ppm zink, 2 500 ppm zink og 4 000 ppm zink.
English: The available data did not include a multicentre GCP field study conducted in several geographical arears Europe and on animals representing the range of various husbandry practices.
Danish: De tilgængelige data omfatter ikke en multicenter-feltundersøgelse flere forskellige steder i Europa, hvor god klinisk praksis er overholdt, og som repræsenterer de forskellige praksisser for husdyrbrug.
English: However, this would just delay the total zinc accumulation in the environment (i.e. the time when PEC will exceed PNECs), but given the nature of zinc risk mitigation measures cannot guarantee that they can effectively eliminate short term (2020) risks identified in the risk assessment.
Danish: Dette vil imidlertid blot forsinke den samlede zinkakkumulering i miljøet (dvs. tidspunktet for, hvornår PECværdierne vil overskride PNEC-værdierne), og i betragtning af zinks iboende egenskaber kan risikoreducerende foranstaltninger ikke garantere, at de effektivt kan eliminere de kortsigtede (2020) risici, der er identificeret i risikovurderingen.
English: The published data from Hu et al. (Hu et al., 2013a3; Hu et al., 2013b4) showed in two different nonGCP studies a statistically significant effect on faecal consistency (scored from 1 to 5) of the feed supplementation with 2250 ppm zinc in weaned piglets (aged 21 days) for 14 days, in comparison with a negative control.
Danish: De publicerede data fra Hu et al. (Hu et al., 2013a3; Hu et al., 2013b4) viste i to forskellige undersøgelser (ikke-GCP), at der var en klinisk signifikant effekt på afføringens konsistens (scoret fra 1-5) hos fravænnede smågrise (i alderen 21 dage) ved tilsætning i foderet af 2 250 ppm zink i 14 dage, sammenholdt med en negativ kontrol.
English: The degree of stress experienced during the weaning period in piglets varies with age of weaning (more stress in younger piglets) and husbandry conditions, and can influence the severity of post-weaning diarrhoea.
Danish: Fravænningsrelateret stress hos smågrise varierer i sværhedsgrad alt efter fravænningsalder (mere stress hos de yngste smågrise) og forholdene på husdyrbruget i øvrigt, og denne stress kan påvirke sværhedsgraden af diarré efter fravænning.
English: The posology of aniMedica's veterinary medicinal products (daily dose of 1 g product per 5 kg bw, equivalent to 5 mg colistin sulphate and 96 mg zinc oxide per kg bw, for 5 - 7 days), means that the concentration of zinc oxide in-feed will be 3000 ppm (approximately 2400 ppm zinc).
Danish: Doseringen af aniMedica's veterinærlægemidler (daglig dosis på 1 g produkt pr. 5 kg legemsvægt, svarende til 5 mg colistinsulfat og 96 mg zinkoxid pr. kg legemsvægt, i 5-7 dage), betyder, at koncentrationen af zinkoxid i foder vil være 3 000 ppm (ca. 2 400 ppm zink).
English: If current practices remain unchanged in the near future, the continual application of manure from treated animals will result in risks (defined by RQ values >1) being established in 4 of 19 soil scenarios, 5 of 15 surface water scenarios and each of the 15 sediment scenarios by 2060.
Danish: Hvis den nuværende praksis ikke ændres i nær fremtid, vil der ved kontinuerlig anvendelse af gødning fra behandlede dyr inden 2060 ses en miljørisiko (defineret ved RQ-værdier > 1) i 4 ud af 19 scenarier for jord, 5 ud af 15 scenarier for overfladevand og 15 ud af 15 scenarier for sedimenter.
English: The combination of a conservative PNEC (not accounting for bioavailability) and PEC may result in an overestimate of the risk due to zinc in sediments.
Danish: Kombinationen af konservative PNEC-værdier (uden hensyn til biotilgængelighed) og PEC-værdier kan medføre en overvurdering af risikoen ved zink i sedimenter.
English: The czrC zinc resistance gene has been shown to occur on SCCmec of meticillin-resistant Staphylococcus aureus (MRSA) and zinc use has been shown to result in co-selection for MRSA carrying this gene (Cavaco et al., 2010)24.
Danish: Det er påvist, at zinkresistensgenet czrC forekommer på SCCmec-elementer hos methicillin-resistent Staphylococcus aureus (MRSA), samt at anvendelse af zink fører til co-selektion af MRSA-bakterier, der bærer dette gen (Cavaco et al., 2010)24.
English: Consequently, bioavailability was not considered for exposure calculations (establishing the PECs), thus leading to a risk assessment that did not account for the bioavailable fraction of zinc but rather for the total zinc concentrations (bioavailable and non-bioavailable).
Danish: Der blev derfor ikke taget højde for biotilgængelighed i eksponeringsberegningerne (der lå til grund for PEC-værdierne), hvilket medførte en risikovurdering, der ikke var baseret på den biotilgængelige del af zink, men i stedet de samlede zinkkoncentrationer (biotilgængelige og ikkebiotilgængelige).
English: In soil, properties such as pH, organic carbon content, cation exchange capacity, and clay content determine bioavailability in the terrestrial compartment.
Danish: I jord bestemmer egenskaber som pH, indhold af organisk kulstof, kationbytningskapacitet samt lerindhold biotilgængeligheden i delmiljøet jord.
English: This increase in zinc concentrations in soil and consequent risks identified for selected compartments is established in this assessment only considering exposure of zinc coming from veterinary products.
Danish: Den øgede zinkkoncentration i jord og de dermed forbundne risici for udvalgte delmiljøer bedømmes i denne vurdering alene ud fra eksponeringen for zink fra veterinærprodukter.
English: Despite these uncertainties, considering the nature of the active substance, as an inorganic molecule, and the difficulties identified throughout the application procedure in terms of assessing the environmental risk for a compound ‘outside' of current CVMP/VICH guidance, it may be accepted that the estimated PEC values extrapolated from the IDMM outputs offer a reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Danish: Trods denne usikkerhed og under hensyn til det aktive stofs natur som et uorganisk molekyle samt de vanskeligheder, der er identificeret under hele ansøgningsproceduren med hensyn til at vurdere miljørisikoen for en blanding, der ligger "uden for" de aktuelle CVMP/VICH-retningslinjer, kan det accepteres, at de skønnede PEC-værdier ekstrapoleret fra IDMM-output giver et rimeligt billede af miljøeksponeringen, som kan anvendes i risikokarakteriseringen af Gutal.
English: Overall, it is apparent that the long-term, continual use of zinc-containing veterinary medicinal products will result in a gradual net input of zinc to the environment.
Danish: Generelt fremgår det tydeligt, at kontinuerlig anvendelse af zinkholdige veterinærlægemidler i længere tid vil medføre en gradvis nettobelastning af miljøet.
English: Premix for medicated feedingstuff
Danish: Premix til medicineret foder
English: A target animal safety study was performed at the recommended dose (100 mg/kg bw per day during 14 days) and no significant side effects have been observed.
Danish: Der er udført en undersøgelse af sikkerheden ved den anbefalede daglige dosis (100 mg/kg legemsvægt i 14 dage) hos måldyrene, og der er ikke observeret nogen signifikante bivirkninger.
English: Despite these uncertainties, and in the absence of a better alternative, it is considered that the IDMM can be used to gain a reasonable assessment of the risk to the environment posed by the use of Gutal or any other zinc containing veterinary product.
Danish: Trods denne usikkerhed og i mangel af et bedre alternativ skønnes det, at IDMM-modellen kan anvendes til at opnå en rimelig vurdering af den miljørisiko, som brug af Gutal eller andre zinkholdige veterinærprodukter udgør.
English: In the study from Trckova et al. (2015)5, clinical observation of weaned piglets challenged with enterotoxic E. coli demonstrated a lower diarrhoea score and diarrhoea incidence in the treated animals (fed with a diet containing 2500 ppm zinc oxide in feed) than in the control animals (untreated pigs).
Danish: I undersøgelsen fra Trckova et al. (2015)5 viste kliniske observationer af fravænnede smågrise, der havde problemer med enterotoksisk E. coli, en lavere score for diarré og diarré-hændelser hos behandlede dyr (fodret med foder tilsat 2 500 ppm zinkoxid) end hos kontroldyrene (ubehandlede svin).
English: Exposure: accumulation, bioavailability and model calculation of zinc concentrations in the environment It is acknowledged that due to the physico-chemical properties of zinc (non-volatile and nondegradable), continual application of manure from treated animals to land under practices of intensive pig breeding will cause a gradual increase in the topsoil zinc concentration, followed by an increase in other relevant compartments, over time.
Danish: Eksponering: akkumulering, biotilgængelighed og modelberegning af zinkkoncentrationer i miljøet Det er anerkendt, at zinks fysisk-kemiske egenskaber (ikkeflygtig og ikkenedbrydelig) betyder, at kontinuerlig anvendelse af gødning fra behandlede dyr på jord i forbindelse med intensivt svineopdræt vil medføre en gradvis forøgelse af zinkkoncentrationen i de øverste jordlag efterfulgt af en forøgelse i andre relevante delmiljøer over tid.
English: The marketing authorisation holder Huvepharma presented a pragmatic approach on their exposure assessment on Gutal and considered the results from a model used by EFSA (the Intermediate Dynamic Model for Metal (IDMM) by Monteiro et al. (2010))19 for estimating the environmental exposure from the use of zinc oxide as feed additive.
Danish: Markedsføringstilladelsesindehaveren Huvepharma havde en pragmatisk tilgang til deres eksponeringsvurdering af Gutal og inddrog resultaterne fra en såkaldt IDMM-model (Intermediate Dynamic Model for Metal udarbejdet af Monteiro et al. (2010))19, som EFSA anvender til vurdering af miljøeksponeringen ved anvendelse af zinkoxid som fodertilsætning.
English: In the terrestrial and aquatic compartments a risk (RQ >1) was found at 4 out of 19 scenarios and at 5 of out 15 scenarios from 2060 onwards, for the worst case and lower application rate, respectively.
Danish: I delmiljøet jord og det akvatiske delmiljø blev der fundet en risiko (RQ > 1) i 4 ud af 19 scenarier og i 5 ud af 15 scenarier fra 2060 og frem for henholdsvis worst-case doseringen og den laveste dosering.
English: This Danish national monitoring study confirms the results obtained with the IDMM and CVMP guidelines that the use of veterinary medicinal products containing zinc oxide leads to a significant increase in the soil zinc concentrations (and such is ultimately reflected in water concentrations).
Danish: Denne danske overvågningsundersøgelse bekræfter de resultater, man er nået frem til ved brug af IDMM-modellen og CVMP-retningslinjerne, nemlig at anvendelse af zinkoxid-holdige veterinærlægemidler medfører en signifikant stigning i jordens indhold af zink (der senere afspejles i zinkkoncentrationen i vandmiljøerne).
English: • the CVMP considered that risk mitigation measures will only dilute and not decrease the total zinc emission output to the environment, and thus it will only be a matter of time before risks are present in all compartments;
Danish: • CVMP mener, at de risikoreducerende foranstaltninger kun vil fortynde og ikke sænke den samlede zink-emission til miljøet, og at det derfor kun vil være et spørgsmål om tid, før risikoen er til stede i alle delmiljøer.
English: With regard to environmental risks, the marketing authorisation holders consider that in the initial assessment the CVMP did not use the risk assessment methodology applied during the EU RAR on zinc, and argues that the developments in the scientific literature published after the EU RAR on zinc, on how to incorporate metal bioavailability in the a risk assessment, were not taken into consideration.
Danish: Hvad angår miljørisici, mener markedsføringstilladelsesindehaverne, at CVMP i den første vurdering ikke har anvendt den risikovurderingsmetode, der er anvendt i EU's risikovurderingsrapport for zink, og henviser til, at der ikke er taget hensyn til udviklingen i den videnskabelige litteratur, der er publiceret efter EU's risikovurderingsrapport for zink, med hensyn til hvordan man inddrager metals biotilgængelighed i en risikovurdering.
English: Yet, for higher application rates than those reported using the IDMM (EFSA, 2012)20 extrapolation is required, and the relationship between the zinc loading rate and the PEC values calculated by the IDMM is not linear, which could question the validity of the extrapolated PECs at the highest zinc application rates.
Danish: For højere doseringer end dem, der rapporteres ved brug af IDMMmodellen (EFSA, 2012)20, er ekstrapolering nødvendigt; forholdet mellem zinkbelastningen og de PECværdier, der beregnes i henhold til IDMM-modellen, er ikke lineært, hvilket kan så tvivl om gyldigheden af de ekstrapolerede PEC-værdier ved den højeste zinkdosering.
English: 10 CVMP procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing colistin as a sole active substance to be administered orally (Procedure no. EMEA/V/A/106) - link 11 CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) - link combination.
Danish: 10 CVMP procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing colistin as a sole active substance to be administered orally (Procedure no. EMEA/V/A/106) - link 11 CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) - link kombinationsprodukt skal være indiceret til brug på behandlingstidspunktet og administreres i den korrekte dosis."
English: However, the marketing authorisation holders argue that additional risk mitigation measures could be considered to reduce or limit emission of zinc oxide to the environment from the use of pig manure, but did not propose any additional risk mitigation measures.
Danish: Markedsføringstilladelsesindehaverne påberåber sig imidlertid, at anvendelse af supplerende risikoreducerende foranstaltninger vil reducere eller begrænse emissionen af zinkoxid til miljøet fra brugen af svinegødning; de har dog ikke foreslået nogen supplerende risikoreducerende foranstaltninger.
English: The IDMM predicts the long-term mass balance of metals, with defined inputs (e.g. veterinary medicinal products usage) and outputs (e.g. crop off-take, ageing), and concludes that zinc will accumulate in soil following continual application of treated manure with acidic sandy soils being most vulnerable as these soils have a tendency to accumulate zinc more rapidly than other type of soils and will also have a higher drainage and run-off of zinc to surface water.
Danish: IDMM-modellen beregner den langsigtede massebalance af metaller med definerede input (f.eks. anvendelse af veterinærlægemidler) og output (f.eks. optagelse i afgrøder, ældning) og konkluderer, at zink akkumuleres i jord ved kontinuerlig anvendelse af behandlet gødning, idet sur sandjord er mest sårbar, da denne jordtype har en tendens til at akkumulere zink hurtigere end andre typer jord og også vil have en større dræning og afstrømning af zink til overfladevand.
English: Data indicates that the annual application of manure coming from farms where animals are treated with veterinary products containing zinc oxide, results in the gradual and continuous increase of zinc in soil, water and sediment systems.
Danish: Data tyder på, at anvendelse år efter år af gødning fra farme, hvor dyrene behandles med zinkoxidholdige veterinærprodukter, fører til gradvis og kontinuerlig øgning af zinkindholdet i jord, vand og sedimenter.