natgillin/translations-raw huggingface dataset:
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.
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.
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).
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).
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.
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.
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.
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.
Der er udført to GLP-undersøgelser i overensstemmelse med OECD's retningslinje nr. 2015.
Two GLP compliant studies on algae were performed in accordance with OECD guideline no. 2015.
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.
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.
risikobegrænsende foranstaltninger) er de maksimale PEC-værdier for de relevante delmiljøer sammenfattet som følger:
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:
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).
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).
Markedsføringstilladelsesindehavernes konklusion om, at der under realistiske forhold er lav sandsynlighed for persistens, bioakkumulering og toksicitet, er baseret på teoretiske overvejelser som beskrevet ovenfor.
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.
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.
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.
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
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
Niveau A-undersøgelserne er udført i overensstemmelse med OECD's standardretningslinjer.
The Tier A studies have been performed according to OECD standard guidelines.
Der er forelagt en række GLP-laboratorieundersøgelser af toksicitet over for vandlevende hvirvelløse dyr, fisk, grønalger, sedimentlevende hvirvelløse dyr og gødningsinsekter.
A number of GLP compliant laboratory studies on toxicity in aquatic invertebrates, fish, green algae, sediment invertebrates and dung insects were provided.
• 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,
• 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;
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.
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.
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.
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
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.
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.
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
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
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.
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.
Holland Animal Care B.V.
Holland Animal Care B.V. Rijssensestraat 158
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.
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.
Moxidectin triclabendazol
Moxidectin triclabendazole
Der er forelagt to GLP-undersøgelser af akut toksicitet over for dafnier.
Two GLP compliant studies on acute toxicity to daphnids were provided.
Begrundelse for ændringen af produktresuméerne, etiketteringen og indlægssedlerne
Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Wirtz Farma B.V.
Wirtz Farma B.V. Europaweg 26
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
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).
MOXIQUEST GEL ORAL Moxidectin Oral gel
MOXIQUEST GEL ORAL Moxidectin Gel oral
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.
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.
Moxidectin, triclabendazol
Moxidectin, triclabendazole
Danmark Zoetis Finland OY Tietokuja 4
Denmark Zoetis Finland OY Tietokuja 4
CVMP fandt, at moxidectin opfylder kriterierne for persistens (P), bioakkumulering (B) og toksicitet (T) i henhold til resultaterne af laboratorieundersøgelserne og følgelig skal klassificeres som et PBT-stof.
The CVMP considered that moxidectin fulfils the criteria for persistence (P), bioaccumulation (B) and toxicity (T) according to the results of the laboratory studies and consequently, has to be classified as a PBT substance.
Laboratorietests har fastslået, at moxidectin midlertidigt kan påvirke reproduktionen af gødningsbiller; undersøgelser med dannede rester tyder dog ikke på langvarige virkninger.
It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, studies with incurred residues indicate no long-term effects.
• ud fra de foreliggende data anså CVMP det overordnede benefit/risk-forhold for at være positivt for veterinærlægemidler indeholdende moxidectin til administration til kvæg, får og heste som pouron, injektionspræparat og orale formuleringer (se bilag I), forudsat at der foretages ændringer i produktinformationen og fastsættes betingelser for markedsføringstilladelserne,
• the CVMP considered that based on the currently available data the overall benefit-risk balance is positive for the veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses as pour-on, injectable and oral formulations (see Annex I), subject to amendments in the product information and conditions on the marketing authorisations;
Indehaverne af markedsføringstilladelse har derfor foretaget en kvalitativ vurdering af risikoen, dvs. sandsynligheden for persistens, bioakkumulering og toksicitet under realistiske forhold, med anvendelse af en tilgang baseret på oplysningernes vægt.
Therefore, a qualitative risk assessment, i.e. the likelihood of persistence, bioaccumulation and toxicity to occur under realistic conditions, has been performed by the marketing authorisation holders, taking into account a weight of evidence approach.
Nederlanden e
The Netherlands
• CVMP fandt, at moxidectin på grundlag af de foreliggende data opfylder kriterierne for persistens (P), bioakkumulering (B) og toksicitet (T) i henhold til resultaterne af laboratorieundersøgelserne og følgelig skal klassificeres som et persistent, bioakkumulerende og toksisk stof (PBT-stof),
• the CVMP considered that based on the available data moxidectin fulfils the criteria for persistence, bioaccumulation and toxicity according to the results of the laboratory studies and consequently, has to be classified as a persistent, bioaccumulative and toxic (PBT) substance;
Det overordnede benefit/risk-forhold anses for positivt for veterinærlægemidler indeholdende moxidectin til administration til kvæg, får og heste som pour-on, injektionspræparater og orale formuleringer (se bilag I), forudsat at der foretages de anbefalede ændringer i produktinformationen (se bilag III).
The overall benefit-risk balance for veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses as pour-on, injectable and oral formulations (see Annex I) is deemed positive subject to the recommended changes in the product information (see Annex III).
Det er i laboratorietests fastslået, at moxidectin midlertidigt kan påvirke reproduktionen af gødningsbiller; feltundersøgelser tyder dog ikke på langsigtede virkninger.
It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, field studies indicate no long-term effects.
15 OECD guideline for the testing of chemicals no. 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) - link risikokvotienttilgangen, hvor risikoen karakteriseres ved beregning af forholdet mellem den forventede eksponeringskoncentration (PEC) og den forventede koncentration uden virkning (PNEC)).
15 OECD guideline for the testing of chemicals no. 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) - link authorisation holders concluded that exposure of surface water to moxidectin is unlikely or extremely low.
CYDECTIN oral sheep Moxidectin Oral opløsning 1 mg/ml
CYDECTIN oral sheep Moxidectin Oral solution 1 mg/ml
Hos kvæg er topisk administration af pour-on-kombinationsprodukter (moxidectin kombineret med triclabendazol) beregnet til behandling af angreb af gastrointestinale nematoder, luftvejsnematoder, trematoder (ikter) og visse arthropoder.
In cattle, topical administration of the pour-on combination products (moxidectin in combination with triclabendazole) is intended for the treatment of gastro-intestinal nematodes, respiratory tract nematodes, trematode (fluke) and certain arthropod infestations.
3690 (kvæg, injektionsvæske, opløsning, indeholdende mg moxidectin/ml)
3690 (cattle, solution for injection containing 100 mg moxidectin per ml)
CYDECTIN 2% sheep Moxidectin Injektionsvæske, opløsning
CYDECTIN 2% sheep Moxidectin Solution for injection
Cydectin 0,1% Moxidectin Oral opløsning 1 mg/ml
Cydectin 0,1% Moxidectin Oral solution 1 mg/ml
18,92 mg/g Heste
18,92 mg/g Horse
Det blev anset for nødvendigt med 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, hos kødkvæg på græs i tre på hinanden følgende år, for at skaffe bedre indsigt i den faktiske miljøpåvirkning.
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 for three consecutive years was considered necessary in order to obtain a better understanding of the actual environmental exposure.
For får resulterede subkutan administration (injektionspræparater) i et PECsurfacewater (PEC-overfladevand) på 0,122 ng/l for afstrømning.
For sheep, the subcutaneous route of administration (injectable products) resulted in a PECsurfacewater of 0.122 ng/l for run-off. For horses, the oral use resulted in a PEC of 0.3 ng/l for run-off.
Technical Assistance Document no. 4.08 Daphnia Acute Toxicity 8 OECD guideline for the testing of chemicals no. 211: Daphnia magna Reproduction Test - link
Technical Assistance Document no. 4.08 Daphnia Acute Toxicity 8 OECD guideline for the testing of chemicals no. 211: Daphnia magna Reproduction Test - link 9 OECD guideline for the testing of chemicals no. 203: Fish, Acute Toxicity Test - link 10 US FDA Environmental Assessment Technical Handbook.
Alger
Algae
CVMP fandt, at moxidectin opfylder kriterierne for persistens (P), bioakkumulering (B) og toksicitet (T) i henhold til resultaterne af laboratorieundersøgelserne og derfor skal klassificeres som et PBT-stof.
The CVMP considered that moxidectin fulfils the criteria for persistence (P), bioaccumulation (B) and toxicity (T) according to the results of the laboratory studies and consequently, has to be classified as
Der er forelagt to GLP-undersøgelser af toksicitet over for regnorm.
Two GLP compliant studies were provided on toxicity to earthworms.
CYDECTIN LA Cattle Moxidectin Injektionsvæske, opløsning
CYDECTIN LA Cattle Moxidectin Solution for injection
Det vurderes, at der desuden bør fastsættes betingelser for markedsføringstilladelserne (se bilag IV) på baggrund af behovet for en målrettet feltundersøgelse til at generere data om moxidectins skæbne og opførsel i forskellige delmiljøer under faktiske anvendelsesforhold og for at verificere, at der er ringe sandsynlighed for persistens, bioakkumulering og toksicitet i miljøet.
Moreover, in view of the need for a targeted field study to generate data on the fate and behaviour of moxidectin in different environmental compartments under actual use conditions and to verify that the likelihood of persistence, bioaccumulation and toxicity to occur in the environment is low, it is considered that conditions affecting the marketing authorisations should be imposed (see Annex IV).
Belgien Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Belgium Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Hos får er oral administration af monoprodukterne beregnet til behandling og forebyggelse af angreb af gastrointestinale nematoder og luftvejsnematoder.
In sheep, oral administration of the monoproducts is intended for the treatment and prevention of gastro-intestinal nematodes and respiratory tract nematodes.
CVMP-retningslinjen for vurdering af PBT-/vPvB-stoffer i veterinærlægemidler (EMA/CVMP/ERA/52740/2012) antyder, at for stoffer klassificeret som PBT er det ikke hensigtsmæssigt at bestemme miljørisikoen i forbindelse med veterinærlægemidler ved hjælp af standardmetoden (dvs.
The CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012) suggests that the standard approach used to determine the risk to the environment associated with veterinary medicinal products (risk quotient approach, where a risk is characterised by calculating the Predicted Environmental Concentration (PEC)/Predicted No Effect Concentration (PNEC) ratio) is not appropriate for substances classified as PBT.
• CVMP fandt, at der behøves målrettet prøveudtagning i miljøet, efter at der til kødkvæg på græs er anvendt veterinærlægemidler som pour-on, opløsning, indeholdende 5 mg moxidectin/ml eller som injektionsvæske, opløsning, indeholdende 100 mg moxidectin/ml, for at opnå bedre indsigt i den faktiske miljøpåvirkning,
• the CVMP 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;
For at reducere udledningen af moxidectin til overfladevand og på grundlag af udskillelsesprofilen af moxidectin ved administration som den orale formulering til heste bør behandlede dyr ikke have adgang til vandløb den første uge efter behandling.
In order to reduce the emission of moxidectin to surface water and based on the excretion profile of moxidectin when administered as the oral formulation to horses, treated animals should not have access to watercourses during the first week after treatment.
For at tage højde for emissioner af veterinærlægemidler indeholdende moxidectin til miljøet er der beregnet værste tilfælde-scenarier for alle typer produkter (pour-on, injektionspræparat, oral) hos kvæg, får og heste under hensyntagen til det specifikke anvendelsesmønster for hver måldyreart og det maksimale antal behandlinger, der kan tænkes at blive anvendt i løbet af et år.
In order to address the emissions of veterinary medicinal products containing moxidectin into the environment worst-case scenarios have been calculated for all product types (pour-on, injectable, oral)
C. For veterinærlægemidler, der er opført i bilag I som oral opløsning og administreres til får og indeholder 1 mg moxidectin/ml eller 1 mg moxidectin og 50 mg triclabendazol/ml
C. For veterinary medicinal products listed in Annex I as oral solution and administered to sheep containing 1 mg moxidectin per ml or 1 mg moxidectin and 50 mg triclabendazole per ml
Europaweg 26
Route of administration
• CVMP vurderede, at der bør tilføjes risikoreducerende foranstaltninger i produktinformationen for at mindske de identificerede risici for vandlevende og sedimentlevende organismer.
• the CVMP considered that in order to reduce the identified risks for aquatic and sediment organisms, risk mitigation measures should be included in the product information.