FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: Laboratorietests har fastslået, at moxidectin midlertidigt kan påvirke reproduktionen af gødningsbiller; undersøgelser med dannede rester tyder dog ikke på langvarige virkninger.
English: • 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;
Danish: • 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,
English: 16 CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010) - link with periods of local high activity of dung beetles.
Danish: CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010) - link
English: 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.
Danish: 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.
English: The Netherlands
Danish: Nederlanden e
English: • 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;
Danish: • 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),
English: 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).
Danish: 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).
English: It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, field studies indicate no long-term effects.
Danish: Det er i laboratorietests fastslået, at moxidectin midlertidigt kan påvirke reproduktionen af gødningsbiller; feltundersøgelser tyder dog ikke på langsigtede virkninger.
English: 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.
Danish: 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)).
English: CYDECTIN oral sheep Moxidectin Oral solution 1 mg/ml
Danish: CYDECTIN oral sheep Moxidectin Oral opløsning 1 mg/ml
English: 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.
Danish: 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.
English: 3690 (cattle, solution for injection containing 100 mg moxidectin per ml)
Danish: 3690 (kvæg, injektionsvæske, opløsning, indeholdende mg moxidectin/ml)
English: CYDECTIN 2% sheep Moxidectin Solution for injection
Danish: CYDECTIN 2% sheep Moxidectin Injektionsvæske, opløsning
English: Cydectin 0,1% Moxidectin Oral solution 1 mg/ml
Danish: Cydectin 0,1% Moxidectin Oral opløsning 1 mg/ml
English: 18,92 mg/g Horse
Danish: 18,92 mg/g Heste
English: 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.
Danish: 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.
English: 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.
Danish: For får resulterede subkutan administration (injektionspræparater) i et PECsurfacewater (PEC-overfladevand) på 0,122 ng/l for afstrømning.
English: 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.
Danish: Technical Assistance Document no. 4.08 Daphnia Acute Toxicity 8 OECD guideline for the testing of chemicals no. 211: Daphnia magna Reproduction Test - link
English: Algae
Danish: Alger
English: 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
Danish: 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.
English: Two GLP compliant studies were provided on toxicity to earthworms.
Danish: Der er forelagt to GLP-undersøgelser af toksicitet over for regnorm.
English: CYDECTIN LA Cattle Moxidectin Solution for injection
Danish: CYDECTIN LA Cattle Moxidectin Injektionsvæske, opløsning
English: 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).
Danish: 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.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Danish: Belgien Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
English: In sheep, oral administration of the monoproducts is intended for the treatment and prevention of gastro-intestinal nematodes and respiratory tract nematodes.
Danish: Hos får er oral administration af monoprodukterne beregnet til behandling og forebyggelse af angreb af gastrointestinale nematoder og luftvejsnematoder.
English: 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.
Danish: 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.
English: • 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;
Danish: • 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,
English: 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.
Danish: 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.
English: 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)
Danish: 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.
English: 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
Danish: 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
English: Route of administration
Danish: Europaweg 26
English: • 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.
Danish: • CVMP vurderede, at der bør tilføjes risikoreducerende foranstaltninger i produktinformationen for at mindske de identificerede risici for vandlevende og sedimentlevende organismer.
English: A. For veterinary medicinal products listed in Annex I as pour-on solution and administered to cattle containing 5 mg moxidectin per ml or 5 mg moxidectin and 200 mg triclabendazole per ml
Danish: A. For veterinærlægemidler, der er opført i bilag I som pouron-opløsning, administreres til kvæg og indeholder 5 mg moxidectin/ml eller 5 mg moxidectin og 200 mg triclabendazol/ml
English: Considering that degradation mechanisms in soil are in place, together with the high immobility of moxidectin in soil, the marketing
Danish: I betragtning af, at der findes nedbrydningsmekanismer i jorden, sammen med moxidectins høje immobilitet i jord, konkluderede indehaverne af markedsføringstilladelsen, at eksponering af overfladevand for moxidectin er usandsynlig eller vil være yderst lav.
English: In sheep, oral administration of the combination products is intended for the treatment of gastrointestinal nematodes, respiratory tract nematodes and trematode (fluke) infestations.
Danish: Hos får er oral administration af kombinationsprodukterne beregnet til behandling af angreb af gastrointestinale nematoder, luftvejsnematoder og trematoder (ikter).
English: 3 OECD guideline for the testing of chemicals no. 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure - link organism were in total sixty (60) rainbow trout (Oncorhynchus mykiss) with a mean total length of 5.6 cm and a mean wet weight of 1.738 g at the start of the test.
Danish: Testorganismen var i alt 60 regnbueørreder (Oncorhynchus mykiss) med en gennemsnitlig total længde på 5,6 cm og en gennemsnitlig våd vægt på 1,738 g ved testens begyndelse.
English: In cattle, topical administration of the pour-on monoproducts (moxidectin only) is intended for the treatment of gastro-intestinal nematodes, respiratory tract nematodes, warble grubs, lice, mange mites and horn flies.
Danish: Hos kvæg er topisk administration af pour-on-monoprodukter (kun moxidectin) beregnet til behandling af gastrointestinale nematoder, luftvejsnematoder, oksebremselarver, lus, skabmider og stikfluer.
English: Daphnids
Danish: Dafnier
English: CYDECTIN 10% LA Moxidectin Solution for injection
Danish: CYDECTIN 10% LA Moxidectin Injektionsvæske, opløsning
English: In cattle, subcutaneous administration of the injectable products is intended for the treatment and prevention of gastro-intestinal nematodes, respiratory tract nematodes, warble grubs, lice and mange mites.
Danish: Hos kvæg er subkutan administration af injektionspræparaterne beregnet til behandling og forebyggelse af angreb af gastrointestinale nematoder, luftvejsnematoder, oksebremselarver, lus og skabmider.
English: CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link OECD guideline for the testing of chemicals no. 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test - link OECD guideline for the testing of chemicals no. 202: Daphnia sp.
Danish: GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link 5 OECD guideline for the testing of chemicals no. 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test - link 6 OECD guideline for the testing of chemicals no. 202: Daphnia sp. Acute Immobilisation Test - link 7 US FDA Environmental Assessment Technical Handbook.
English: Moxidectin Oral suspension 1 mg/ml
Danish: Moxidectin Oral opløsning 1 mg/ml
English: Moxidectin Oral solution 1 mg/ml 50 mg/ml
Danish: Moxidectin Oral opløsning 1 mg/ml 50 mg/ml
English: B. For veterinary medicinal products listed in Annex I as solution for injection and administered to cattle containing 10 mg moxidectin per ml or 100 mg moxidectin per ml
Danish: B. For veterinærlægemidler, der er opført i bilag I som injektionsvæske, opløsning, administreres til kvæg og indeholder 10 mg moxidectin/ml eller 100 mg moxidectin/ml
English: Moxidectin Solution for injection
Danish: Moxidectin Injektionsvæske, opløsning
English: Oral solution 1 mg/ml 50 mg/ml
Danish: Oral opløsning 1 mg/ml 50 mg/ ml
English: Oral solution 1 mg/ml 50 mg/ ml
Danish: Oral opløsning 1 mg/ml 50 mg/ml
English: Cydectin Pour-On vet Moxidectin Pour-on solution 5 mg/ml
Danish: Cydectin Pour-On vet Moxidectin Pour-on, opløsning
English: Pharmaceutical form
Danish: Lægemiddelfor m
English: Although the efficacy of veterinary medicinal products containing moxidectin has not been re-assessed specifically in this referral procedure, these pour-on, injectable and oral products are considered effective veterinary medicines in the treatment of the abovementioned internal and external parasites in cattle, sheep and horses.
Danish: injektionspræparater og orale præparater for at være effektive veterinærlægemidler til behandling af ovennævnte interne og eksterne parasitter hos kvæg, får og heste.
English: Following treatment of horses with the product, levels of moxidectin that are potentially toxic to dung beetles and flies may be excreted over a period of more than 1 week and may decrease dung fauna abundance.
Danish: Efter behandling af heste med produktet kan der udskilles koncentrationer af moxidectin, som er potentielt toksiske over for gødningsbiller og -fluer, i en periode på over 1 uge, hvilket kan nedsætte mængden af gødningsorganismer.
English: Luxemburg Zoetis Belgium SA Rue Laid Burniat, 1
Danish: Luxembourg Zoetis Belgium SA Rue Laid Burniat, 1
English: CYDECTIN 1% Moxidectin Solution for injection
Danish: CYDECTIN 1% Moxidectin Injektionsvæske, opløsning
English: Based on the excretion profile of moxidectin when administered as the pour-on formulation, treated animals should not have access to watercourses during the first week after treatment.
Danish: Når moxidectin administreres som pour-on-formulering, bør behandlede dyr på grund af udskillelsesprofilen ikke have adgang til vandløb i den første uge efter behandling.
English: D. For veterinary medicinal products listed in Annex I as solution for injection and administered to sheep containing 10 mg moxidectin per ml or 20 mg moxidectin per ml
Danish: A. For veterinærlægemidler, der er opført i bilag I som injektionsvæske, opløsning, administreres til får og indeholder 10 mg moxidectin/ml eller 20 mg moxidectin/ml
English: Based on the excretion profile of moxidectin when administered as the oral formulation to sheep, treated animals should not have access to watercourses during the first 3 days after treatment.
Danish: Når moxidectin administreres som oral formulering til får, bør behandlede dyr på grund af udskillelsesprofilen ikke have adgang til vandløb i de første 3 dage efter behandling.
English: Slovenia Continental Farmaceutica, Rue Laid Burniat 1,
Danish: Slovenien Continental Farmaceutica, Rue Laid Burniat 1,
English: Given the limited number of different classes of end-/ectoparasiticides and the responsible use principle requiring the use of substances of different classes of antiparasitics for the control of parasitoses in order to reduce the risk of resistance development, veterinary medicinal products containing moxidectin are considered an important therapeutic option.
Danish: Veterinærlægemidler indeholdende moxidectin anses for at være en vigtig terapeutisk mulighed i betragtning af det begrænsede antal forskellige klasser af endo-/ektoparasiticider og princippet om forsigtig brug, der kræver, at der anvendes stoffer af forskellige klasser af anthelmintika til bekæmpelse af parasitoser for at reducere risikoen for resistensudvikling.
English: 18,92 mg Horse and pony
Danish: 18,92 mg Heste og ponyer
English: Cydectin 0,5% Pour-on Moxidectin Pour-on solution 5 mg/ml
Danish: Cydectin 0,5% Pour-on Moxidectin Pour-on, opløsning
English: Acute Immobilisation Test - link US FDA Environmental Assessment Technical Handbook.
Danish: OECD guideline for the testing of chemicals no. 203: Fish, Acute Toxicity Test - link US FDA Environmental Assessment Technical Handbook.
English: Based on the excretion profile of moxidectin when administered as the injectable formulation to sheep, treated animals should not have access to watercourses during the first 11 days after treatment.
Danish: Når moxidectin administreres som injektionspræparat til får, bør behandlede dyr på grund af udskillelsesprofilen ikke have adgang til vandløb i de første 11 dage efter behandling.
English: Lithuania Continental Farmaceutica Rue Laid Burniat 1,
Danish: Litauen Continental Farmaceutica Rue Laid Burniat 1,
English: 0.058 (cattle, solution for injection containing 10 mg moxidectin per ml)
Danish: 0,239 (kvæg, injektionsvæske, opløsning, indeholdende mg moxidectin/ml)
English: Belgium Continental Farmaceutica Rue Laid Burniat 1,
Danish: Belgien Continental Farmaceutica Rue Laid Burniat 1,
English: Belgium Zoetis Belgium SA Rue Laid Burniat, 1
Danish: Belgien Zoetis Belgium SA Rue Laid Burniat, 1
English: Denmark Continental Farmaceutica Rue Laid Burniat 1,
Danish: Danmark Continental Farmaceutica Rue Laid Burniat 1,
English: Slovenia Zoetis Belgium SA Rue Laid Burniat, 1
Danish: Slovenien Zoetis Belgium SA Rue Laid Burniat, 1
English: Based on the excretion profile of moxidectin when administered as the injectable formulation, treated animals should not have access to watercourses during the first 10 days after treatment.
Danish: Når moxidectin administreres som injektionspræparat, bør behandlede dyr på grund af udskillelsesprofilen ikke have adgang til vandløb i de første 10 dage efter behandling.
English: Lithuania Zoetis Belgium SA Rue Laid Burniat, 1
Danish: Litauen Zoetis Belgium SA Rue Laid Burniat, 1
English: Romania Zoetis Belgium SA Rue Laid Burniat, 1
Danish: Rumænien Zoetis Belgium SA Rue Laid Burniat, 1
English: Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of 4 days and may decrease dung fly abundance during that period.
Danish: Efter behandling af får med produktet kan der udskilles koncentrationer af moxidectin, som er potentielt toksiske over for gødningsfluer i en periode på 4 dage, hvilket kan nedsætte mængden af gødningsfluer i denne periode.
English: 18.92 mg/g Horse and pony
Danish: 18.92 mg/g Heste og ponyer
English: Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period.
Danish: Efter behandling af får med produktet kan der udskilles koncentrationer af moxidectin, som er potentielt toksiske over for gødningsfluer, i en periode på over 4 uger, hvilket kan nedsætte mængden af gødningsfluer i denne periode.
English: 18,92 mg/g Horse and pony
Danish: 18,92 mg / g Heste og ponyer
English: Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 2 weeks and may decrease dung fly abundance during that period.
Danish: Efter behandling af kvæg med produktet kan der udskilles koncentrationer af moxidectin, som er potentielt toksiske over for gødningsfluer, i en periode på over 2 uger, hvilket kan nedsætte mængden afgødningsfluer i denne periode.
English: Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period.
Danish: Efter behandling af kvæg med produktet kan der udskilles koncentrationer af moxidectin, som er potentielt toksiske over for gødningsfluer, i en periode på over 4 uger, hvilket kan nedsætte mængden af gødningsfluer i denne periode.