FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Na temelju dostupnih podataka razmotren je okolišni profil drugih terapijskih rješenja, uključujući skupinu makrocikličkih laktona (ivermektin, abamektin, eprinomektin i doramektin) i druge skupine paraziticida kao što su organofosfati, sintetski piretroidi i regulatori rasta insekata.
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.
Croatian: Kao što je prethodno navedeno, i kao što je istaknuto u smjernicama CVMP-a o procjeni tvari sa svojstvima PBT/vPvB u veterinarsko-medicinskim proizvodima (EMA/CVMP/ERA/52740/2012), kvantitativna procjena rizika nije primjerena za procjenu opasnosti od svojstava PBT.
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.
Croatian: Posebne mjere opreza pri odlaganju neupotrijebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda Svi neupotrijebljeni veterinarsko-medicinski proizvodi ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s nacionalnim propisima.
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.
Croatian: CVMP je zaključio da je pokusno laboratorijsko ispitivanje o pretvorbi [3H]-moksidektina u različitim tlima, usklađeno sa smjernicom OECD-a br. 307, najpouzdanija i najprimjerenija referenca za ocjenu postojanosti moksidektina u različitim vrstama tla te za utvrđivanje vrijednosti DT50 te tvari.
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.
Croatian: CVMP smatra da je ispitivanje pouzdano te je zaključio da moksidektin ispunjava kriterij bioakumulacije (B) (BCFKL 2543 l/kg) kako je naveden u smjernicama CVMP-a o procjeni tvari sa svojstvima PBT/vPvB u veterinarsko-medicinskim proizvodima (EMA/CVMP/ERA/52740/2012), tj. da je faktor biokoncentracije u vodenim vrstama veći od 2000.
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Croatian: Znanstveni zaključci i razlozi za izmjenu sažetaka opisa svojstava VMP-a, označivanja i uputa o VMP-u
English: The marketing authorisation holders argued that under realistic conditions, aquatic exposure to moxidectin will be either unlikely or extremely low due to strong adsorption of moxidectin onto soil or will not be maintained longer than 24 hours due to rapid partitioning into sediment.
Croatian: Nositelji odobrenja za stavljanje VMP-a u promet tvrdili su da je vjerojatnost za izloženost moksidektinu u vodenom okolišu u stvarnim uvjetima mala ili iznimno mala zbog snažne adsorpcije moksidektina na tlo te da izloženost ne bi trajala dulje od 24 sata zbog brzog raspoređivanja u sediment.
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.
Croatian: Srednja vrijednost neekstrahirajućih ostataka 120. dana (% primijenjene radioaktivnosti) iznosila je 7,22 %, 5,23 %, 10,15 % odnosno 5,38 % za pjeskovitu ilovaču, pijesak, glinastu ilovaču i ilovaču.
English: Toxicity the conditions of the study, the LC50 value for moxidectin was established as 0.16 µg/l.
Croatian: U uvjetima ispitivanja, utvrđena je vrijednost LC50 za moksidektin od 0,16 µg/l.
English: Acute Immobilisation Test - link US FDA Environmental Assessment Technical Handbook.
Croatian: 202: Daphnia sp. Acute Immobilisation Test - link 7 US FDA Environmental Assessment Technical Handbook.
English: Dung fauna
Croatian: Fauna prisutna u gnoju
English: An impact on dung flies was shown for all target species (cattle, sheep, and horses) and all routes of administration (pour-on, injectable, oral).
Croatian: Dokazan je učinak na jesenje kućne muhe u svih ciljnih vrsta (goveda, ovce i konji) i svih putova primjene (polijevanje po koži, injektiranje, peroralna primjena).
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.
Croatian: Na temelju dostupnih informacija, Njemačka je smatrala da djelatna tvar moksidektin može imati postojana, bioakumulativna i toksična (PBT) svojstva u skladu sa smjernicama CVMP-a o procjeni tvari sa svojstavima PBT ili vrlo postojanim i vrlo bioakumulativnim svojstvima (vPvB) u veterinarsko-medicinskim proizvodima (EMA/CVMP/ERA/52740/2012)1.
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.
Croatian: Stoga, kako bi se provjerio pristup na osnovi dokazne snage, u skladu s prijedlogom nositelja odobrenja za stavljanje VMP-a u promet, i kako bi se ocijenilo predstavljaju li teoretske opasnosti stvarni utjecaj na okoliš, CVMP je zaključio da je potrebno izraditi podatke o sudbini i ponašanju moksidektina u okolišu u uvjetima stvarne uporabe.
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.
Croatian: CVMP preporučuje unošenje izmjena u odobrenja za stavljanje u promet veterinarsko-medicinskih proizvoda koji sadržavaju moksidektin za peroralnu, topikalnu ili supkutanu primjenu u goveda, ovaca i konja (vidjeti Prilog I.) kako bi se izmijenili sažetci opisa svojstava VMP-a, označivanje i upute o VMP-u u skladu s preporučenim izmjenama u informacijama o VMP-u kako je utvrđeno u Prilogu III.
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;
Croatian: • CVMP smatra da, na temelju dostupnih podataka i sukladno s rezultatima laboratorijskih ispitivanja, moksidektin ispunjava kriterije postojanosti, bioakumulativnosti i toksičnosti te da stoga treba biti razvrstan kao postojana, bioakumulativna i toksična (PBT) tvar;
English: Plants
Croatian: Biljke
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.
Croatian: Podatci koji su dodatno izrađeni radi ispunjavanja tih uvjeta, kao i sve druge relevantne informacije koje bi mogle postati dostupne, činit će osnovu za naknadnu procjenu CVMP-a u pogledu njegovih zaključaka o omjeru koristi i rizika za veterinarsko-medicinske proizvode koji sadržavaju moksidektin za primjenu u goveda, ovaca i konja u obliku formulacija za polijevanje po koži i ubrizgavanje injekcijom te oralnih formulacija.
English: Read the package leaflet before use.
Croatian: Prije uporabe pročitajte uputu o VMP-u.
English: SPECIAL WARNING(S)
Croatian: 12. POSEBNO(-A) UPOZORENJE(-A)
English: The LC50 for mortality was established as 37.2 mg/kg; the corresponding NOEC was 20 mg/kg.
Croatian: Utvrđen je LC50 za smrtnost od 37,2 mg/kg.
English: • the CVMP considered that veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses as pour-on, injectable and oral formulations are effective veterinary medicines in the treatment of the internal and external parasites in cattle, sheep and horses;
Croatian: • CVMP smatra da su veterinarsko-medicinski proizvodi koji sadržavaju moksidektin za primjenu u goveda, ovaca i konja u obliku formulacija za polijevanje po koži i ubrizgavanje injekcijom te oralnih formulacija djelotvorni veterinarsko-medicinski proizvodi za liječenje unutarnjih i vanjskih parazita u goveda, ovaca i konja;
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
Croatian: Za veterinarsko-medicinske proizvode navedene u Prilogu I. u obliku oralnog gela za primjenu u konja i ponija koji sadržava 18,92 mg moksidektina po gramu ili 19,5 mg moksidektina i 121,7 mg prazikvantela po gramu
English: Three GLP compliant studies on acute toxicity in fish were provided.
Croatian: Dostavljena su tri ispitivanja usklađena s načelima dobre laboratorijske prakse o akutnoj toksičnosti za ribe.
English: Conclusion on the PBT assessment
Croatian: Zaključak procjene svojstava PBT
English: The Tier A studies have been performed according to OECD standard guidelines.
Croatian: Ispitivanja razine A provedena su sukladno sa standardnim smjernicama OECD-a.
English: Persistence
Croatian: Postojanost
English: The subacute toxicity was investigated in a GLP compliant study according to US FDA Environmental Assessment Technical Assistance Document no. 4.1214.
Croatian: Subakutna toksičnost ispitana je u ispitivanju usklađenom s načelima dobre laboratorijske prakse, u skladu s Dokumentom o tehničkoj pomoći za procjenu utjecaja na okoliš br. 4.1214.
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.
Croatian: • Treba upotrijebiti poliv, otopinu koja sadržava 5 mg moksidektina po ml ili otopinu za injekciju koja sadržava 100 mg moksidektina po ml u goveda na ispaši jer to u stvarnosti predstavlja najgori scenarij u pogledu ispuštanja.
English: Two GLP compliant studies on algae were performed in accordance with OECD guideline no. 2015.
Croatian: Provedena su dva ispitivanja na algama usklađena s načelima dobre laboratorijske prakse, u skladu sa smjernicom OECD-a br. 2015.
English: Holland Animal Care B.V. Rijssensestraat 158
Croatian: Nizozemska Holland Animal Care B.V.
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.
Croatian: Srednja vrijednost nastale tricirane vode 120. dana (% primijenjene radioaktivnosti) iznosila je 6,48 %, 3,22 %, 7,6 % odnosno 5,10 % za pjeskovitu ilovaču, pijesak, glinastu ilovaču i ilovaču.
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.
Croatian: Nije bilo moguće utvrditi mjere za ublažavanje rizika za insekte prisutne u gnoju koje ispunjavaju kriterije iz osvrta CVMP-a o mjerama za ublažavanje rizika u vezi s procjenom rizika za okoliš veterinarsko-medicinskih proizvoda (EMA/CVMP/ERAWP/409328/2010)16.
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.
Croatian: Iako u ovom arbitražnom postupku nije provedena ponovna procjena veterinarsko-medicinskih proizvoda koji sadržavaju moksidektin, smatra se da su ti proizvodi za polijevanje po koži, injektiranje i peroralnu primjenu djelotvorni veterinarsko-medicinski proizvodi za liječenje prethodno navedenih unutarnjih i vanjskih parazita u goveda, ovaca i konja.
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.
Croatian: Zaključak nositelja odobrenja za stavljanje VMP-a u promet da je vjerojatnost postojanosti, bioakumulativnosti i toksičnosti u stvarnim uvjetima mala temelji se na teoretskim razmatranjima, kako je prethodno navedeno.
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.
Croatian: Na temelju dostupnih podataka ustanovljena je visoka toksičnost moksidektina za vodene organizme i organizme koji žive u sedimentu, tj. NOEC od 3,1 ng/l za vrstu Daphnia magna, NOEC od 3,2 ng/l za ribe i NOEC od 111 µg/kg suhe mase za trzalce.
English: Two GLP compliant studies were provided on toxicity to sediment dwelling organisms in accordance with OECD guideline 21812.
Croatian: Dostavljena su dva ispitivanja o toksičnosti za organizme koji žive u sedimentu usklađena s načelima dobre laboratorijske prakse, u skladu sa smjernicom OECD-a br. 21812.
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
Croatian: Osim toga, Odbor je napomenuo da se u informacijama o VMP-u za neke proizvode za polijevanje po koži nalazi upozorenje u kojem se navodi da se rizik za faunu prisutnu u gnoju može smanjiti izbjegavanjem razdoblja primjene koja se podudaraju s razdobljima visoke lokalne aktivnosti balegara.
English: CVMP reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances (EMA/CVMP/448211/2015) - link
Croatian: bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances (EMA/CVMP/448211/2015) - link
English: Applicant/Marketing authorisation holder
Croatian: Podnositelj zahtjeva / nositelj odobrenja za stavljanje VMP-a u promet
English: The NOEC for bodyweight change, the most sensitive study endpoint, was established as 1 mg/kg.
Croatian: Utvrđena vrijednost najosjetljivije krajnje točke ispitivanja, NOEC-a za promjenu tjelesne težine, iznosila je 1 mg/kg.
English: The maximum PECsoil_initial equals 4.18 µg/kg dry weight for cattle after subcutaneous route of administration (injectable products) using a dose of 0.5 mg/kg bodyweight and the respective default values.
Croatian: Najveća početna predviđena koncentracija u okolišu za tlo (PECtlo_početna) iznosi 4,18 µg/kg suhe mase u goveda nakon supkutane primjene (injekcijski VMP-ovi) prilikom primjene doze od 0,5mg/kg tjelesne težine i odgovarajućih zadanih vrijednosti.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: Posebne mjere opreza pri odlaganju neupotrijebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: MOXIQUEST GEL ORAL Moxidectin Gel oral
Croatian: MOXIQUEST GEL ORAL Moksidektin Oralni gel
English: Moxidectin, triclabendazole
Croatian: Moksidektin, triklabendazol
English: Zoetis Česká republika s.r.o.
Croatian: Zoetis Česká republika s.r.o. Stroupežnického 17
English: Sediment dwelling organisms
Croatian: Organizmi koji žive u sedimentu
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.
Croatian: Stoga, kako bi se provjerio pristup na osnovi dokazne snage, u skladu s prijedlogom nositelja odobrenja za stavljanje VMP-a u promet, i kako bi se ocijenilo predstavljaju li teoretske opasnosti stvarni utjecaj na okoliš, Odbor je zaključio 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, kako bi se bolje razumjela stvarna izloženost okoliša.
English: The PBT hazard assessment clearly identifies moxidectin as a PBT substance based on the laboratory data provided.
Croatian: U okviru procjene opasnosti od svojstava PBT, na temelju dostavljenih laboratorijskih podataka jasno je utvrđeno da je moksidektin tvar sa svojstvima PBT.
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;
Croatian: • CVMP smatra da je, na temelju trenutačno dostupnih podataka, ukupni omjer koristi i rizika pozitivan za veterinarsko-medicinske proizvode koji sadržavaju moksidektin za primjenu u goveda, ovaca i konja u formulacijama za polijevanje po koži i ubrizgavanje injekcijom te oralnim formulacijama (vidjeti Prilog I.), podložno izmjenama u informacijama o VMP-u i uvjetima za odobrenja za stavljanje VMP-a u promet;
English: 3690 (cattle, solution for injection containing 100 mg moxidectin per ml)
Croatian: 3690 (goveda, otopina za injekciju koja sadržava 100 mg moksidektina po ml)
English: These have been discussed by target species (cattle, sheep, and horses) and by route of administration (pour-on, injectable, oral).
Croatian: Ti su podatci razmotreni prema ciljnoj vrsti (goveda, ovce i konji) te prema putu primjene (polijevanje po koži, injektiranje, peroralna primjena).
English: The 21-day LC50 for parental mortality (based on immobilisation) was determined to be 0.028 μg/l, with complete mortality observed at the highest mean measured test concentration of 0.14 μg/l.
Croatian: 211: Daphnia magna Reproduction Test - link imobilizacije) od 0,028 μg/l, a ukupna smrtnost zabilježena je na najvišoj srednjoj vrijednosti izmjerenih ispitnih koncentracija od 0,14 μg/l.
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
Croatian: 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: Data on the fate and behaviour of moxidectin in the environment to verify the proposed low likelihood under real conditions are not available.
Croatian: Nisu dostupni podatci o sudbini i ponašanju moksidektina u okolišu koji bi potvrdili utvrđenu malu vjerojatnost u stvarnim uvjetima.
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%,
Croatian: Razgradnja [3H]-moksidektina ispitana je u aerobnim uvjetima pri 20±2 °C tijekom 120 dana u tami nakon primjene pri nominalnoj stopi od 0,01 mg/kg tla na četirima različitim vrstama tla (tj. pjeskovitoj
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.
Croatian: CVMP je zaključio da, prema rezultatima laboratorijskih ispitivanja, moksidektin ispunjava kriterije postojanosti (P), bioakumulativnosti (B) i toksičnosti (T) te da ga stoga treba razvrstati kao tvar sa svojstvima PBT.
English: The effect on the reproduction of Eisenia foetida was investigated in a GLP compliant study according to OECD guideline 22215.
Croatian: Učinak na reprodukciju vrste Eisenia foetida ispitan je u ispitivanju usklađenom s načelima dobre laboratorijske prakse, u skladu sa smjernicom OECD-a br. 22215.
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;
Croatian: • CVMP smatra da će dodatno izrađeni podatci radi ispunjavanja tih uvjeta, kao i sve druge relevantne informacije koje bi mogle postati dostupne, činiti osnovu za naknadnu procjenu CVMP-a u pogledu njegovih zaključaka o omjeru koristi i rizika za veterinarsko-medicinske proizvode koji sadržavaju moksidektin za primjenu u goveda, ovaca i konja u formulacijama za polijevanje po koži i ubrizgavanje injekcijom te oralnim formulacijama;
English: Two GLP compliant studies on acute toxicity to daphnids were provided.
Croatian: Dostavljena su dva ispitivanja usklađena s načelima dobre laboratorijske prakse o akutnoj toksičnosti za dafnije.
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).
Croatian: Ukupni omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadržavaju moksidektin za primjenu u goveda, ovaca i konja u formulacijama za polijevanje po koži i ubrizgavanje injekcijom te oralnim formulacijama (vidjeti Prilog I.) smatra se pozitivnim ako se provedu preporučene izmjene u informacijama o VMP-u (vidjeti Prilog III.).
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.
Croatian: Nisu dostupni podatci o sudbini i ponašanju moksidektina u okolišu u stvarnim uvjetima koji bi potvrdili utvrđenu malu vjerojatnost utjecaja na okoliš.
English: PBT Assessment
Croatian: Procjena svojstava PBT