FrancophonIA/ELRC3.0 huggingface dataset:
English: Two GLP compliant studies were provided on toxicity to sediment dwelling organisms in accordance with OECD guideline 21812.
Danish: Der er forelagt to GLP-undersøgelser af toksicitet over for sedimentlevende organismer i overensstemmelse med OECD's retningslinje 21812.
English: Three GLP compliant studies on acute toxicity in fish were provided.
Danish: Der er forelagt tre GLP-undersøgelser af akut toksicitet hos fisk.
English: Zoetis Hungary Kft. 1123 Budapest Alkotás u. 53.
Danish: Ungarn Zoetis Hungary Kft. 1123 Budapest
English: Pasture Scenarios
Danish: Græsningsscenarier
English: Thus, the Committee recommended warning sentences to be added to the product information, taking account of the risk of toxic residues in dung to dung fauna.
Danish: Udvalget anbefalede derfor, at der blev tilføjet advarselssætninger til produktinformationen i betragtning af risikoen for, at gødningen indeholder restkoncentrationer, som er giftige for gødningsfaunaen.
English: Evaluation and conclusions on the benefit-risk assessment
Danish: Vurdering og konklusioner om benefit/risk-forholdet
English: Apart from macrocyclic lactones, established classes of antiparasitics in cattle, sheep and horses include benzimidazoles, tetrahydropyrimidines (pyrantel), imidazothiazoles (levamisole), amino-acetonitril derivates (monepantel), spiroindoles (derquantel).
Danish: Ud over makrocykliske lactoner omfatter etablerede klasser af anthelmintika til kvæg, får og heste benzimidazoler, tetrahydropyrimidiner (pyrantel), imidazothiazoler (levamisol), amino-acetonitrilderivater (monepantel) og spiroindoler (derquantel).
English: Quality, target animal safety, user safety, consumer safety and efficacy were not assessed in this referral procedure.
Danish: Denne henvisningsprocedure omfatter ikke sikkerhed for måldyrearten, brugersikkerhed, forbrugersikkerhed eller virkning.
English: The CVMP considered the experimental laboratory study on [3H]-moxidectin transformation in soils in accordance with OECD guideline no. 307 the most reliable and appropriate reference for assessing the persistence of moxidectin in different soil types and determining the DT50 for the substance.
Danish: CVMP anså den eksperimentelle laboratorieundersøgelse af omdannelse af [3H]-moxidectin i jord (som var i overensstemmelse med OECD's retningslinje nr. 307) for at være det mest pålidelige og bedst egnede grundlag for vurdering af moxidectins persistens i forskellige jordtyper og bestemmelse af stoffets DT50.
English: A qualitative risk assessment based on a weight of evidence discussion was provided and this considered the likelihood of persistence, bioaccumulation and toxicity to occur under real environmental conditions.
Danish: Der er forelagt en kvalitativ risikovurdering baseret på en diskussion af oplysningernes vægt med vurdering af, hvilken sandsynlighed der under praktiske miljøforhold er for persistens, bioakkumulering og toksicitet.
English: • the CVMP considered that based on the available data high toxicity of moxidectin to aquatic and sediment organisms and a risk for dung fauna have been identified;
Danish: • CVMP fandt, at der ud fra de foreliggende data er fundet høj toksicitet af moxidectin for vandlevende og sedimentlevende organismer, og at der er identificeret en risiko for gødningsfaunaen,
English: It is noted that according to the CVMP reflection paper on the authorisation of VMPs containing PBT or vPvB substances (EMA/CVMP/448211/2015)17 further measures intended to ensure responsible use of antiparasitic veterinary medicinal products, for example, targeted selective treatment of individual animals on farm level, are considered to limit environmental exposure.
Danish: Det bemærkes, at ifølge CVMP's oplæg om godkendelse af veterinærmedicinske produkter indeholdende PBT- eller vPvB-stoffer (EMA/CVMP/448211/2015)17 anses eksponering af miljøet for at kunne begrænses gennem supplerende foranstaltninger til at sikre forsvarlig anvendelse af veterinærmedicinske anthelmintika, f.eks. målrettet selektiv behandling af de enkelte dyr på bedriftsniveau.
English: • A pour-on solution containing 5 mg moxidectin per ml or a solution for injection containing 100 mg moxidectin per ml in beef cattle on pasture should be used as this represents a realistic worst case emission scenario.
Danish: • Der anvendes en pour-on-opløsning indeholdende 5 mg moxidectin/ml eller en injektionsvæske indeholdende 100 mg moxidectin/ml til kødkvæg på græs, da dette repræsenterer et realistisk værste tilfælde-emissionsscenarie.
English: These have been discussed by target species (cattle, sheep, and horses) and by route of administration (pour-on, injectable, oral).
Danish: Disse er analyseret efter måldyreart (kvæg, får og heste) og efter indgivelsesvej (pour-on, injektion, oral).
English: The NOEC for fry survival, the most sensitive study endpoint, was established as 3.2 ng/l.
Danish: NOEC-værdien for yngeloverlevelse (undersøgelsens mest følsomme endepunkt) blev bestemt til 3,2 ng/l.
English: Conclusion on the PBT assessment
Danish: Konklusion af PBT-vurderingen
English: The assumption that the likelihood of persistence, bioaccumulation and toxicity occurring under real-world environmental conditions is low is based on theoretical considerations, as outlined above.
Danish: Forudsætningen om lav sandsynlighed for persistens, bioakkumulering og toksicitet under realistiske miljøforhold bygger på teoretiske overvejelser som beskrevet ovenfor.
English: The threshold specified in the CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012) is NOEC or EC10 for marine or freshwater organisms less than 0.01 mg/l.
Danish: Tærskelværdien i CVMP-retningslinjen for vurdering af PBT-/vPvB-stoffer i veterinærlægemidler (EMA/CVMP/ERA/52740/2012) er en NOEC- eller EC10-værdi på mindre end 0,01 mg/l for marine organismer og ferskvandsorganismer.
English: Based on the available data high toxicity of moxidectin to aquatic and sediment organisms has been identified, i.e. a NOEC of 3.1 ng/l for Daphnia magna, a NOEC of 3.2 ng/l for fish and a NOEC of 111 µg/kg dry weight for chironomids.
Danish: De tilgængelige data viser, at moxidectin har høj toksicitet for vandlevende og sedimentlevende organismer, dvs. en NOEC på 3,1 ng/l for Daphnia magna, en NOEC på 3,2 ng/l for fisk og en NOEC på 111 μg/kg tør vægt for dansemyg (chironomider).
English: Two GLP compliant studies on the effects on daphnid reproduction in accordance with OECD guideline no. 2118 were submitted.
Danish: Der er forelagt to GLP-undersøgelser af virkningerne på dafniers reproduktion i overensstemmelse med OECD's retningslinje nr. 2118.
English: The environmental profile of therapeutic alternatives including the group of macrocyclic lactones (ivermectin, abamectin, eprinomectin, and doramectin) and other groups of parasiticides such as organophosphates, synthetic pyrethroids and insect growth regulators has been considered based on available data.
Danish: På grundlag af tilgængelige data er miljøprofilen afterapeutiske alternativer taget i betragtning, herunder gruppen af makrocykliske lactoner (ivermectin, abamectin, eprinomectin og doramectin) og andre grupper af parasiticider såsom organophosphater, syntetiske pyrethroider og vækstregulatorer for insekter.
English: As previously noted, and as outlined in the CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012), a quantitative risk assessment is not appropriate for the PBT hazard assessment.
Danish: Som tidligere nævnt og som beskrevet i CVMP's retningslinjer for vurdering af PBT/vPvB-stoffer i veterinærlægemidler (EMA/CVMP/ERA/52740/2012) er en kvantitativ risikovurdering ikke egnet til vurdering af PBT-risikoen.
English: The following findings should be reported:
Danish: Der beskrives følgende fund:
English: Amendments in the relevant sections of the summaries of product characteristics, labelling and package leaflets
Danish: Ændringer i de relevante afsnit af produktresuméerne, etiketteringen og indlægssedlerne
English: Thus, the standard risk assessment approach where the risk is characterised by calculating the PEC/PNEC ratio is not appropriate for PBT substances as outlined in the CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012).
Danish: Standardmetoden til risikovurdering, hvor risikoen karakteriseres ved at beregne forholdet mellem PEC og PNEC, er således ikke hensigtsmæssig for PBT-stoffer, hvilket der redegøres for i CVMP's retningslinjer om vurdering af PBT-/vPvB-stoffer i veterinærlægemidler (EMA/CVMP/ERA/52740/2012).
English: The degradation of [3H]-moxidectin was investigated under aerobic conditions at 20±2 ºC for 120 days in the dark, following application at a nominal rate of 0.01 mg/kg soil to four different types of soil (i.e. sandy loam, sand, clay loam and loam with organic carbon content of 1.0%, 0.4%, 2.0% and 4.5%,
Danish: Nedbrydningen af [3H]-moxidectin er undersøgt under aerobe forhold ved 20 ± 2 ºC i 120 dage i mørke efter tilførsel af en nominel mængde på 0,01 mg/kg jord til fire forskellige jordtyper (sandet lerjord, sand, lerjord og lermuld med et indhold af organisk kulstof på henholdsvis 1,0 %, 0,4 %, 2,0 % og 4, 5 % og fugtindholdet justeret til 50 % af den maksimale
English: PBT Assessment
Danish: PBT-vurdering
English: Transcutaneous solution
Danish: Transkutan opløsning
English: Data on the fate and behaviour of moxidectin in the environment to verify the proposed low likelihood under real conditions are not available.
Danish: Der forefindes ikke data om moxidectins skæbne og opførsel i miljøet til verifikation af den anførte lave sandsynlighed under virkelige forhold.
English: Thus, to verify the weight of evidence approach as proposed by the marketing authorisation holders, and to assess whether the theoretical hazards translate into environmental impacts, the CVMP considered that data on fate and behaviour of moxidectin in the environment under actual use conditions should be generated.
Danish: For at verificere tilgangen med oplysningernes vægt som fremført af indehaverne af markedsføringstilladelsen og for at vurdere, om de teoretiske farer kan omsættes til miljøpåvirkninger, fandt CVMP, at der bør genereres data om moxidectins skæbne og opførsel i miljøet under faktiske anvendelsesforhold.
English: The CVMP considered the study as reliable and concluded that moxidectin fulfils the B criterion for bioaccumulation (BCFKL 2543 l/kg) as specified in CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012), i.e. the bioconcentration factor in aquatic species is higher than 2000.
Danish: CVMP vurderede undersøgelsen som pålidelig og konkluderede, at moxidectin opfylder kriterie B for bioakkumulering (BCFKL 2543 l/kg) som specificeret i CVMP's retningslinje for vurdering af PBT-/vPvBstoffer i veterinærlægemidler (EMA/CVMP/ERA/52740/2012), dvs. en biokoncentrationsfaktor i akvatiske arter på over 2000.
English: Crustaceans (Water fleas)
Danish: Krebsdyr (vandfluer)
English: Data on the fate and behaviour of moxidectin in the environment under real conditions to verify the proposed low likelihood of environmental impact are not available.
Danish: Der forefindes ikke data om moxidectins skæbne og opførsel i miljøet under virkelige betingelser til verifikation af den hævdede lave sandsynlighed for miljøpåvirkning.
English: the CVMP has recommended the variation of the marketing authorisations for veterinary medicinal products containing moxidectin to be administered orally, topically or subcutaneously to cattle, sheep and horses (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Danish: anbefalede CVMP ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende moxidectin til oral, topisk eller subkutan administration til kvæg, får og heste (se bilag I) med henblik på at ændre produktresuméerne, etiketteringen og indlægssedlerne i overensstemmelse med de anbefalede ændringer i produktinformationen, der fremgår af bilag III.
English: 2 Organisation for Economic Co-operation and Development (OECD) guideline for the testing of chemicals no. 307: Aerobic and Anaerobic Transformation in Soil - link respectively, and a moisture content adjusted to 50% of the maximum water holding capacity).
Danish: 2 Organisation for Economic Co-operation and Development (OECD) guideline for the testing of chemicals no. 307: Aerobic and Anaerobic Transformation in Soil - link vandbindingsevne).
English: Mean non-extractable residues at day 120 (% of applied radioactivity) were 7.22%, 5.23%, 10.15% and 5.38% for the soils sandy loam, sand, clay loam and loam, respectively.
Danish: Den gennemsnitlige mængde ikke-ekstraherbare rester på dag 120 (i % af den tilførte radioaktivitet), var henholdsvis 7,22 %, 5,23 %, 10,15 % og 5,38 % for jordtyperne sandet lerjord, sand, lerjord og lermuld.
English: The data generated further to the fulfilment of these conditions, along with any other relevant information which might become available, will form the basis of a subsequent assessment by the CVMP of its conclusions on the benefit-risk balance for veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses as pour-on, injectable and oral formulations.
Danish: De data, der genereres i tilslutning til opfyldelsen afdisse betingelser, vil sammen med andre relevante oplysninger, der måtte blive tilgængelige, være grundlag for CVMP's efterfølgende vurdering af sine konklusioner om benefit/risk-forholdet for veterinærlægemidler indeholdende moxidectin til administration til kvæg, får og heste som pour-on, injektionspræparater og orale formuleringer.
English: Two GLP compliant studies on algae were performed in accordance with OECD guideline no. 2015.
Danish: Der er udført to GLP-undersøgelser i overensstemmelse med OECD's retningslinje nr. 2015.
English: Based on the available information, Germany considered that the active substance moxidectin may have persistent, bioaccumulative and toxic (PBT) properties in accordance with the CVMP guideline on the assessment of PBT or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012)1.
Danish: På baggrund af de foreliggende oplysninger fandt Tyskland, at det aktive stof moxidectin kunne have persistente, bioakkumulerende og toksiske (PBT-) egenskaber svarende til CVMP's retningslinjer for vurdering af stoffer som PBT-stoffer eller meget persistente og meget bioakkumulerende (vPvB-) stoffer i veterinærlægemidler (EMA/CVMP/ERA/52740/2012)1.
English: Considering further PEC-refinement (FOCUS SW - calculations and excretion pattern evaluation for risk mitigation measures) the maximum PEC values for the relevant environmental compartments are summarised as follows:
Danish: risikobegrænsende foranstaltninger) er de maksimale PEC-værdier for de relevante delmiljøer sammenfattet som følger:
English: Based on the results, a DT50 of 296.6 days normalised to 12 °C (DT50 139.0 days at 20 °C) as recommended in the CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012), is used to confirm that moxidectin fulfils the vP (very persistent) criterion (i.e. the DT50 in soil is higher than 180 days).
Danish: På grundlag af disse resultater blev der anvendt en DT50 på 296,6 dage normaliseret til 12 °C (DT50 139,0 dage ved 20 °C) som bekræftelse af, at moxidectin opfylder kriteriet vP (meget persistent) (dvs. DT50 i jord er mere end 180 dage); dette er i overensstemmelse med anbefalingerne i CVMP's retningslinjer for vurdering af PBT-/vPvB-stoffer i veterinærlægemidler (EMA/CVMP/ERA/52740/2012).
English: The marketing authorisation holders' conclusion that the likelihood of persistence, bioaccumulation and toxicity occurring under realistic conditions is low, is based on theoretical considerations, as outlined above.
Danish: Markedsføringstilladelsesindehavernes konklusion om, at der under realistiske forhold er lav sandsynlighed for persistens, bioakkumulering og toksicitet, er baseret på teoretiske overvejelser som beskrevet ovenfor.
English: Risk mitigation measures for dung insects fulfilling the criteria of the CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010)16 could not be established.
Danish: Der kunne ikke fastlægges foranstaltninger, der begrænser risikoen over for gødningsinsekter ved at opfylde kriterierne i CVMP's oplæg om risikobegrænsende foranstaltninger i forbindelse med miljørisikovurdering af veterinærlægemidler (EMA/CVMP/ERAWP/409328/2010)16.
English: 11 OECD guideline for the testing of chemicals no. 210: Fish, Early-life Stage Toxicity Test - link 12 OECD guideline for the testing of chemicals no. 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment - link 13 CVMP draft guideline on the higher tier testing of veterinary medicinal products to dung fauna
Danish: Technical Assistance Document no. 4.11 Freshwater Fish Acute Toxicity 11 OECD guideline for the testing of chemicals no. 210: Fish, Early-life Stage Toxicity Test - link 12 OECD guideline for the testing of chemicals no. 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment - link 13 CVMP draft guideline on the higher tier testing of veterinary medicinal products to dung fauna
English: The Tier A studies have been performed according to OECD standard guidelines.
Danish: Niveau A-undersøgelserne er udført i overensstemmelse med OECD's standardretningslinjer.
English: A number of GLP compliant laboratory studies on toxicity in aquatic invertebrates, fish, green algae, sediment invertebrates and dung insects were provided.
Danish: Der er forelagt en række GLP-laboratorieundersøgelser af toksicitet over for vandlevende hvirvelløse dyr, fisk, grønalger, sedimentlevende hvirvelløse dyr og gødningsinsekter.
English: • the CVMP considered that the data generated further to the fulfilment of these conditions, along with any other relevant information which might become available, will form the basis of a subsequent assessment by the CVMP of its conclusions on the benefit-risk balance for veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses as pouron, injectable and oral formulations;
Danish: • CVMP var den opfattelse, at de data, der genereres efter opfyldelse af disse betingelser, sammen med andre relevante oplysninger, der måtte blive tilgængelige, vil være grundlag for CVMP's efterfølgende vurdering af sine konklusioner om benefit/risk-forholdet for veterinærlægemidler indeholdende moxidectin til administration til kvæg, får og heste som pour-on, injektionspræparater og orale formuleringer,
English: The mean evolved tritiated water at day 120 (% of applied radioactivity) was 6.48%, 3.22%, 7.6% and 5.10% for the soils sandy loam, sand, clay loam and loam, respectively.
Danish: Den gennemsnitlige mængde tritieret vand, der var dannet på dag 120 (i % af den tilførte radioaktivitet) var henholdsvis 6,48 %, 3,22 %, 7,6 % og 5,10 % for jordtyperne sandet lerjord, sand, lerjord og lermuld.
English: In addition, the Committee noted that in the product information of some pour-on products there is a warning advising that risk to dung fauna may be reduced by avoiding treatment periods that coincide
Danish: Udvalget bemærkede desuden, at produktinformationen for nogle pour-on-produkter indeholder en anvisning om, at risikoen for gødningsfaunaen kan reduceres ved at undgå, at behandlingsperioden falder sammen med perioder med lokal høj aktivitet af gødningsbiller.
English: Thus, to verify the weight of evidence approach as proposed by the marketing authorisation holders, and to assess whether the theoretical hazards translate into environmental impacts, the Committee considered that a targeted sampling in the environment following the use of veterinary medicinal products as a pour-on solution containing 5 mg moxidectin per ml or as a solution for injection containing 100 mg moxidectin per ml in beef cattle in pasture animals is necessary to obtain a better understanding of the actual environmental exposure.
Danish: For at efterprøve metoden baseret på oplysningernes vægt som foreslået af indehaverne af markedsføringstilladelsen og for at vurdere, om de teoretiske risici omsættes til miljøpåvirkninger, fandt udvalget, at der behøves målrettet prøvetagning i miljøet efter anvendelse af veterinærlægemidler som pour-on-opløsning indeholdende 5 mg moxidectin/ml eller som injektionsvæske, opløsning, indeholdende 100 mg moxidectin/ml, til kødkvæg på græs for at få bedre indsigt i den faktiske miljøpåvirkning.
English: E. For veterinary medicinal products listed in Annex I as oral gel and administered to horses and ponies containing 18.92 mg moxidectin per gram or 19.5 mg moxidectin and 121.7 praziquantel per gram
Danish: E. For veterinærlægemidler, der er opført i bilag I som oral gel til administration til heste og ponyer, og indeholder 18,92 mg moxidectin/g eller 19,5 mg moxidectin og 121,7 mg praziquantel/g
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT Eventuelle ubrugte veterinærlægemidler eller affald fra sådanne veterinærlægemidler skal destrueres i overensstemmelse med de lokale krav.
English: Holland Animal Care B.V. Rijssensestraat 158
Danish: Holland Animal Care B.V.
English: In horses and ponies, oral administration of the monoproducts is intended for the treatment of large and small strongyles, ascarids and other parasites e.g. pinworm, throat bot.
Danish: Hos heste og ponyer er oral administration af monoprodukterne beregnet til behandling af store og små strongyloider, ascarider og andre parasitter, f.eks. haleorm og halsbremselarver.
English: Moxidectin triclabendazole
Danish: Moxidectin triclabendazol
English: Two GLP compliant studies on acute toxicity to daphnids were provided.
Danish: Der er forelagt to GLP-undersøgelser af akut toksicitet over for dafnier.
English: Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Danish: Begrundelse for ændringen af produktresuméerne, etiketteringen og indlægssedlerne
English: Wirtz Farma B.V. Europaweg 26
Danish: Wirtz Farma B.V.
English: The bioaccumulation study in fish was performed in accordance with the OECD guideline no. 3053 via aqueous exposure under flow-through conditions with continuous renewal of the test media at nominal [3H]-moxidectin concentrations of 0.00055 and 0.0011 μg/l (based on an acute LC50 (the concentration of a test substance which results in a 50% mortality of the test species) value of 0.11 µg/l).
Danish: 3053 via vandig eksponering under gennemløbsbetingelser med kontinuerlig fornyelse af testmediet ved nominelle koncentrationer af [3H]-moxidectin på 0,00055 og 0,0011 μg/l (baseret på en akut LC50
English: Loughrea, Co. Galway Ireland
Danish: Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea, Co. Galway Ireland
English: MOXIQUEST GEL ORAL Moxidectin Gel oral
Danish: MOXIQUEST GEL ORAL Moxidectin Oral gel
English: In horses and ponies, oral administration of the combination products (moxidectin in combination with praziquantel) is intended for the treatment of large and small strongyles, ascarids, tapeworm and other parasites e.g. pinworm, throat bot.
Danish: Hos heste og ponyer er oral administration af kombinationsprodukterne (moxidectin kombineret med praziquantel) beregnet til behandling af store og små strongyloider, ascarider, bændelorm og andre parasitter, f.eks. haleorm og halsbremselarver.
English: Moxidectin, triclabendazole
Danish: Moxidectin, triclabendazol
English: Denmark Zoetis Finland OY Tietokuja 4
Danish: Danmark Zoetis Finland OY Tietokuja 4