FrancophonIA/ELRC3.0 huggingface dataset:
English: The NOEC for fry survival, the most sensitive study endpoint, was established as 3.2 ng/l.
Croatian: Utvrđena vrijednost najosjetljivije krajnje točke ispitivanja, NOEC-a za preživljavanje riblje mlađi, iznosila je 3,2 ng/l.
English: Stable Scenarios
Croatian: Scenariji za stajski uzgoj
English: Wirtz Farma B.V. Europaweg 26
Croatian: Nizozemska Wirtz Farma B.V.
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.
Croatian: CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010) - link
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).
Croatian: Stoga standardni pristup procjeni rizika, pri čemu se rizik utvrđuje izračunom omjera predviđene koncentracije u okolišu (PEC) i predviđene koncentracija bez učinka (PNEC), nije primjeren za tvari sa svojstvima PBT, kako je istaknuto u smjernicama CVMP-a o procjeni tvari sa svojstvima PBT/vPvB u veterinarsko-medicinskim proizvodima (EMA/CVMP/ERA/52740/2012).
English: Zoetis Česká republika, s.r.o.
Croatian: Slovačka Zoetis Česká republika, s.r.o. Stroupežnického 17
English: Furthermore, the PBT status of moxidectin should be communicated in the product information;
Croatian: Nadalje, u informacijama o VMP-u potrebno je navesti da moksidektin ima svojstva PBT;
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;
Croatian: • CVMP smatra da je potrebno ciljano uzorkovanje u okolišu nakon primjene veterinarskomedicinskih proizvoda u obliku poliva, otopine koja sadržava 5 mg moksidektina po ml ili otopine za injekciju koja sadržava 100 mg moksidektina po ml u goveda na ispaši kako bi se bolje razumjela stvarna izloženost okoliša;
English: A number of GLP compliant laboratory studies on toxicity in aquatic invertebrates, fish, green algae, sediment invertebrates and dung insects were provided.
Croatian: Dostavljeno je više ispitivanja usklađenih s načelima dobre laboratorijske prakse na vodenim beskralježnjacima, ribama, zelenim algama, beskralježnjacima koji žive u sedimentu i insektima prisutnima u gnoju.
English: The EC50 (the concentration of a test substance which results in 50% of the test animals being adversely affected, i.e., both mortality and sub-lethal effects) of moxidectin was therefore concluded to be >0.11 mg/l; the No Observed Effect Concentration (NOEC) was determined as ≥ 0.11 mg/l based on geometric mean of measured test concentrations.
Croatian: Stoga je zaključeno da je EC50 (koncentracija ispitne tvari koja rezultira s 50 % neželjenih učinaka na pokusnim životinjama, tj. smrtnosti i subletalnih učinaka) za moksidektin > 0,11 mg/l.
English: Two GLP compliant studies on the effects on daphnid reproduction in accordance with OECD guideline no. 2118 were submitted.
Croatian: Dostavljena su dva ispitivanja o učinku na reprodukciju dafnija usklađena s načelima dobre laboratorijske prakse, u skladu sa smjernicom OECD-a br. 2118.
English: Moxidectin, praziquatel
Croatian: Moksidektin, prazikvantel
English: In the context of marketing authorisation applications submitted to the German national competent authority, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, under Article 13 of Directive 2001/82/EC as amended, i.e., a generic application, for veterinary medicinal products containing moxidectin, as pour-on solution for cattle, a study on bioaccumulation was provided.
Croatian: Direktive 2001/82/EZ kako je izmijenjena, tj. zahtjeva za generičke veterinarskomedicinske proizvode koji sadržavaju moksidektin u obliku poliva, otopine za goveda dostavljeno je ispitivanje o bioakumulaciji.
English: CYDECTIN 2% sheep Moxidectin Solution for injection
Croatian: CYDECTIN 2% sheep Moksidektin Otopina za injekciju
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.
Croatian: U goveda, topikalna primjena kombiniranih proizvoda za polijevanje po koži (moksidektin u kombinaciji s triklabendazolom) namijenjena je za liječenje gastrointestinalnih nematoda, nematoda dišnih putova, trematoda (metilja) i određenih infestacija artropodima.
English: Moxidectin Oral suspension 1 mg/ml
Croatian: Moksidektin Oralna suspenzija 1 mg/ml
English: The experimental bioconcentration factor of 2543 l/kg is supported by the QSAR modelled bioconcentration factor of 2244 l/kg.
Croatian: Pokusni rezultat faktora biokoncentracije od 2543 l/kg potkrijepljen je rezultatom faktora
English: A LC50 value of 0.62 µg/l was calculated based on measured concentrations.
Croatian: Na temelju izmjerenih koncentracija, izračunana je vrijednost LC50 od 0,62 µg/l.
English: 18,92 mg/g Horse
Croatian: 18,92 mg/g Konji
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.
Croatian: Kako bi se smanjilo ispuštanje moksidektina u površinsku vodu te na temelju profila izlučivanja moksidektina prilikom primjene u obliku oralne formulacije u konja, tretiranim životinjama treba onemogućiti pristup vodenim tokovima tijekom prvog tjedna nakon liječenja.
English: CYDECTIN oral sheep Moxidectin Oral solution 1 mg/ml
Croatian: CYDECTIN oral sheep Moksidektin Oralna otopina 1 mg/ml
English: With regards to the metabolism in the target animal, the lack of accumulation in mammals does not automatically exclude the potential for accumulation in fish; in general the activity of enzymes involved in the transformation of xenobiotics decrease at lower trophic levels as stated in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005
Croatian: Aktivnost enzima uključenih u pretvorbu ksenobiotika uglavnom se smanjuje na nižim trofičkim razinama, kako je navedeno u smjernicama CVMP-a o procjeni utjecaja veterinarsko-medicinskih proizvoda na okoliš koje su potpora smjernicama VICH-a GL6 i GL38 (EMEA/CVMP/418282/2005Rev.1)4.
English: Emission and risk assessment
Croatian: Ispuštanje i procjena rizika
English: Cydectin 0,1% Moxidectin Oral solution 1 mg/ml
Croatian: Cydectin 0,1% Moksidektin Oralna otopina 1 mg/ml
English: Crustaceans (Water fleas)
Croatian: Ljuskari (vodena buha)
English: in cattle, sheep and horses, taking into account the specific pattern of use in each target species and the maximum number of treatments that might be applied within one year.
Croatian: Kako bi se ispitala ispuštanja u okoliš veterinarsko-medicinskih proizvoda koji sadržavaju moksidektin, izračunani su najgori mogući ishodi za sve vrste proizvoda (polivi, proizvodi za injektiranje, za peroralnu primjenu) u goveda, ovaca i konja, uzimajući u obzir poseban način primjene za svaku ciljnu vrstu i najveći broj liječenja koji se može provesti unutar jedne godine.
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.
Croatian: Na početku ispitivanja bilo je ukupno šezdeset (60) ispitnih organizama vrste kalifornijska pastrva (Oncorhynchus mykiss) srednje ukupne dužine od 5,6 cm i srednje mokre mase od 1,738 g.
English: It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, field studies indicate no-long term effects.
Croatian: U laboratorijskom ispitivanjima utvrđeno je da moksidektin može privremeno utjecati na reprodukciju balegara.
English: Amendments in the relevant sections of the summaries of product characteristics, labelling and package leaflets
Croatian: Izmjene odgovarajućih dijelova sažetaka opisa svojstava VMP-a, označivanja i uputa o VMP-u
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.
Croatian: U konja i ponija, peroralna primjena kombiniranih proizvoda (moksidektin u kombinaciji s prazikvantelom) namijenjena je za liječenje velikih i malih strongilida, glista iz porodice Ascarididae, trakavica i drugih parazita, npr. glista Oxyuris equi, kukca Gasterophilus nasalis.
English: Further PEC refinements were performed by the marketing authorisation holders for each concerned product and for all target animal species and routes of administration by application of the FOCUS models.
Croatian: Nositelji odobrenja za stavljanje VMP-a u promet dobili su primjenom FOCUS-ovih modela dodatne precizne podatke o predviđenoj koncentraciji u okolišu za sve dotične proizvode te za sve ciljne životinjske vrste i putove primjene.
English: Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Croatian: Razlozi za izmjenu sažetaka opisa svojstava VMP-a, označivanja i uputa o VMP-u
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
Croatian: Za veterinarsko-medicinske proizvode navedene u Prilogu I. u obliku oralne otopine za primjenu u ovaca koja sadržava 1 mg moksidektina po ml ili 1 mg moksidektina i 50 mg triklabendazola po ml
English: CYDECTIN LA Cattle Moxidectin Solution for injection
Croatian: CYDECTIN LA Cattle Moksidektin Otopina za injekciju
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.
Croatian: 4.08 Daphnia Acute Toxicity 8 OECD guideline for the testing of chemicals no.
English: Under
Croatian: Supkutano
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).
Croatian: 307: Aerobic and Anaerobic Transformation in Soil - link ilovači, pijesku, glinastoj ilovači i ilovači s udjelom organskog ugljika od 1,0 %, 0,4 %, 2,0 % odnosno 4,5 % te udjelom vlage prilagođenim na 50 % najvećeg mogućeg vodnog kapaciteta).
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.
Croatian: Stoga su nositelji odobrenja za stavljanje VMP-a u promet proveli kvalitativnu procjenu rizika, tj. procjenu vjerojatnosti postojanosti, bioakumulativnosti i toksičnosti u stvarnim uvjetima, uzimajući u obzir pristup na osnovi dokazne snage.
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.
Croatian: U ovaca je supkutana primjena (injekcijski VMP-ovi) rezultirala predviđenom koncentracijom u okolišu za površinsku vodu (PECpovršinska voda) od 0,122 ng/l za otjecanje.
English: 5.3 Environmental properties
Croatian: 5.3. Svojstva koja utječu na okoliš
English: CYDECTIN 10% LA Moxidectin Solution for injection
Croatian: CYDECTIN 10% LA Moksidektin Otopina za injekciju
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
Croatian: Za veterinarsko-medicinske proizvode navedene u Prilogu I. u obliku poliva, otopine za primjenu u goveda koja sadržava 5 mg moksidektina po ml ili 5 mg moksidektina i 200 mg triklabendazola po ml
English: In sheep, oral administration of the combination products is intended for the treatment of gastrointestinal nematodes, respiratory tract nematodes and trematode (fluke) infestations.
Croatian: U ovaca, peroralna primjena kombiniranih proizvoda namijenjena je za liječenje gastrointestinalnih nematoda, nematoda dišnih putova i infestacija trematodima (metilji).
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.
Croatian: U konja i ponija, peroralna primjena monokomponenti namijenjena je za liječenje velikih i malih strongilida, glista iz porodice Ascarididae i drugih parazita, npr. glista Oxyuris equi, kukca Gasterophilus nasalis.
English: In sheep, oral administration of the monoproducts is intended for the treatment and prevention of gastro-intestinal nematodes and respiratory tract nematodes.
Croatian: U ovaca, peroralna primjena monokomponenti namijenjena je za liječenje i sprečavanje gastrointestinalnih nematoda, nematoda dišnih putova.
English: Sweden Zoetis Finland Oy Tietokuja 4
Croatian: Zoetis Finland Oy Tietokuja 4
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
Croatian: Za veterinarsko-medicinske proizvode navedene u Prilogu I. u obliku otopine za injekciju za primjenu u ovaca koja sadržava 10 mg moksidektina po ml ili 20 mg moksidektina po ml
English: Moxidectin Solution for Injection
Croatian: Moksidektin Otopina za injekciju
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.
Croatian: U goveda, supkutana primjena injekcijskih VMP-ova namijenjena je za liječenje i sprečavanje gastrointestinalnih nematoda, nematoda dišnih putova, ličinaka štrkova, uši i grinja šugarca.
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
Croatian: Za veterinarsko-medicinske proizvode navedene u Prilogu I. u obliku otopine za injekciju za primjenu u goveda koja sadržava 10 mg moksidektina po ml ili 100 mg moksidektina po ml
English: Luxemburg Zoetis Belgium SA Rue Laid Burniat, 1
Croatian: Luksemburg Zoetis Belgium SA Rue Laid Burniat, 1
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.
Croatian: • CVMP smatra da je u informacije o VMP-u potrebno uvrstiti mjere za ublažavanje rizika kako bi se smanjio utvrđeni rizik za vodene organizme i organizme koji žive u sedimentu.
English: Slovenia Continental Farmaceutica, Rue Laid Burniat 1,
Croatian: Slovenija Continental Farmaceutica, Rue Laid Burniat 1,
English: Slovenia Zoetis Belgium SA Rue Laid Burniat, 1
Croatian: Slovenija Zoetis Belgium SA Rue Laid Burniat, 1
English: Romania Zoetis Belgium SA Rue Laid Burniat, 1
Croatian: Rumunjska Zoetis Belgium SA Rue Laid Burniat, 1
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.
Croatian: Nakon liječenja konja ovim VMP-om, moguće je izlučivanje razina moksidektina koje su potencijalno toksične za balegare i jesenje kućne muhe tijekom razdoblja od više od jednog tjedna te je moguće smanjenje zastupljenosti faune prisutne u gnoju.
English: Iceland Zoetis Finland Oy Tietokuja 4
Croatian: Norveška Zoetis Finland Oy Tietokuja 4
English: The non-standard field studies indicated that the risk derived from laboratory tests may not fully reflect what is observed under field conditions of use; differences were shown in sensitivity of dung beetle and dung fly and additionally a lower toxicity of moxidectin compared to other avermectins.
Croatian: Zabilježene su razlike u osjetljivosti balegara i jesenje kućne muhe te, osim toga, manja toksičnost moksidektina u usporedbi s drugim avermektinima.
English: Moxidectin Oral solution 1 mg/ml 50 mg/ml
Croatian: Moksidektin Oralna otopina 1 mg/ml 50 mg/ml
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.
Croatian: U goveda, topikalna primjena monokomponenti za polijevanje po koži (samo moksidektin) namijenjena je za liječenje gastrointestinalnih nematoda, nematoda dišnih putova, ličinaka štrkova, uši, grinja šugarca i rožnih muha.
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.
Croatian: Na temelju profila izlučivanja moksidektina prilikom primjene u ovaca u obliku oralne formulacije, tretiranim životinjama treba onemogućiti pristup vodenim tokovima tijekom prva tri dana nakon liječenja.
English: Slovakia
Croatian: Litva
English: CYDECTIN 1% Moxidectin Solution for injection
Croatian: CYDECTIN 1% Moksidektin Otopina za injekciju
English: 18,92 mg Horse and pony
Croatian: 18,92 mg Konji i poniji
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.
Croatian: Na temelju profila izlučivanja moksidektina prilikom primjene u ovaca u obliku formulacije za ubrizgavanje injekcijom, tretiranim životinjama treba onemogućiti pristup vodenim tokovima tijekom prvih 11 dana nakon liječenja.
English: Considering that degradation mechanisms in soil are in place, together with the high immobility of moxidectin in soil, the marketing
Croatian: S obzirom na postojanje mehanizama razgradnje u tlu, uz visoku razinu nepokretljivosti moksidektina u tlu, nositelji odobrenja za stavljanje VMP-a u promet zaključili su da je vjerojatnost za izloženost površinskih voda moksidektinu mala ili iznimno mala.
English: In sheep, subcutaneous administration of the injectable products is intended for the treatment and prevention of gastro-intestinal nematodes, respiratory tract nematodes, larvae of bot fly and mange mites.
Croatian: U ovaca, supkutana primjena injekcijskih VMP-ova namijenjena je za liječenje i sprečavanje gastrointestinalnih nematoda, nematoda dišnih putova, ličinaka štrkova i grinja šugarca.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Croatian: Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
English: Based on the excretion profile of moxidectin when administered as the injectable formulation, treated animals should not have access to watercourses during the 10 days after treatment.
Croatian: Na temelju profila izlučivanja moksidektina prilikom primjene u obliku formulacije za ubrizgavanje injekcijom, tretiranim životinjama treba onemogućiti pristup vodenim tokovima tijekom deset dana nakon liječenja.
English: 0.058 (cattle, solution for injection containing 10 mg moxidectin per ml)
Croatian: 0,239 (goveda, otopina za injekciju koja sadržava 100 mg moksidektina po ml)
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.
Croatian: Na temelju profila izlučivanja moksidektina prilikom primjene u obliku formulacije za polijevanje po koži, tretiranim životinjama treba onemogućiti pristup vodenim tokovima tijekom prvog tjedna liječenja.
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.
Croatian: Kako bi se bolje razumjela stvarna izloženost okoliša, zaključeno je da je potrebno ciljano uzorkovanje u okolišu nakon primjene veterinarsko-medicinskih proizvoda u obliku poliva, otopine koja sadržava 5 mg moksidektina po ml ili otopine za injekciju koja sadržava 100 mg moksidektina po ml u goveda na ispaši tijekom tri uzastopne godine.
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.
Croatian: Na temelju profila izlučivanja moksidektina prilikom primjene u obliku formulacije za ubrizgavanje injekcijom, tretiranim životinjama treba onemogućiti pristup vodenim tokovima tijekom prvih deset dana nakon liječenja.
English: Oral solution 1 mg/ml 50 mg/ml
Croatian: Oralna otopina 1 mg/ml 50 mg/ml
English: Moxidectin Oral solution 1 mg/ml
Croatian: Moksidektin Oralna otopina 1 mg/ml
English: Moxidectin Gel oral
Croatian: Moksidektin Oralni gel
English: PECsediment direct (ng/kg)* 35 (sheep, solution for injection containing 20 mg moxidectin per ml)
Croatian: 35 (ovce, otopina za injekciju koja sadržava 20 mg moksidektina po ml)
English: Daphnids
Croatian: Dafnije
English: 18,92 mg/g Horse and pony
Croatian: 18.92 mg/g Konji i poniji
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.
Croatian: 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) - link
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.
Croatian: Nakon liječenja ovaca ovim VMP-om, moguće je izlučivanje razina moksidektina koje su potencijalno toksične za vrstu jesenja kućna muha tijekom razdoblja od četiri dana te je moguće smanjenje zastupljenosti jesenje kućne muhe u tom razdoblju.
English: Lithuania Continental Farmaceutica Rue Laid Burniat 1,
Croatian: Slovačka Continental Farmaceutica Rue Laid Burniat 1,
English: Camlough Road Newry, Co. Down BT35 6JP
Croatian: Camlough Road Newry, Co.
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.
Croatian: Nakon liječenja ovaca ovim VMP-om, moguće je izlučivanje razina moksidektina koje su potencijalno toksične za vrstu jesenja kućna muha tijekom razdoblja od više od četiri tjedna te je moguće smanjenje zastupljenosti jesenje kućne muhe u tom razdoblju.