FrancophonIA/ELRC3.0 huggingface dataset:
English: To mitigate this risk, all precautions for use and disposal must be adhered to.
Slovenian: Za zmanjšanje tega tveganja je treba upoštevati vse previdnostne ukrepe za uporabo in odstranjevanje.
English: The CVMP considered that such warning is not in line with good agricultural practice and therefore should be deleted from the product information.
Slovenian: Odbor CVMP je presodil, da tako opozorilo ni v skladu z dobro kmetijsko prakso, zato ga je treba izbrisati iz informacij o zdravilu.
English: If the study is conducted in one geographical region, the marketing authorisation holders should justify that this is truly the worst case.
Slovenian: Če se študija izvaja samo v eni geografski regiji, morajo imetniki dovoljenj za promet z zdravilom utemeljiti, da je tam res najslabši možni primer.
English: A terrestrial plant study with 12 weed species was also provided which was considered not relevant for the current assessment.
Slovenian: Predložena je bila tudi študija s kopenskimi rastlinami z 12 vrstami plevela, ki za trenutno oceno ni bila relevantna.
English: It can be concluded that there is a negligible risk for secondary poisoning from moxidectin.
Slovenian: Zaključiti je mogoče, da obstaja zanemarljivo tveganje za sekundarno zastrupitev zaradi moksidektina.
English: Within 12 months of Commission Decision for this procedure
Slovenian: V 12 mesecih po odločbi Komisije glede tega postopka
English: Ireland Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
Slovenian: Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
English: Environmental profile of alternatives
Slovenian: Okoljski profil drugih možnosti
English: Concentration
Slovenian: Koncentracija
English: 6100 (horse, oral)
Slovenian: 6 100 (konji, peroralno)
English: The subsequent evaluation of data generated further to the fulfilment of these conditions should be undertaken by the CVMP due to the complexity of the data thus generated and in the interest of maintaining the harmonised EU approach achieved by this referral procedure.
Slovenian: Odbor CVMP mora nadalje ovrednotiti podatke, pridobljene v zvezi z izpolnjevanjem teh pogojev, in sicer zaradi kompleksnosti tako pridobljenih podatkov in v interesu ohranitve usklajenega pristopa EU, doseženega s tem napotitvenim postopkom.
English: The abovementioned data should be provided to the CVMP for assessment not later than 5 years after the Commission Decision on this referral procedure.
Slovenian: Zgornje podatke je treba predložiti odboru CVMP v oceno najpozneje v 5 letih po odločbi Komisije glede tega postopka.
English: Levels of radioactivity recovered in the organic soil extracts at the end of the study at day 63 ranged between 74-82%.
Slovenian: Ravni radioaktivnosti v organskih talnih ekstraktih ob koncu študije na 63. dan so bile med 74 in 82 %.
English: The Committee was also asked to recommend whether the marketing authorisations for the aforementioned veterinary medicinal products should be maintained, varied, suspended or withdrawn.
Slovenian: Odbor je zaprosila tudi, naj priporoči, ali naj se dovoljenja za promet z zgoraj navedenimi zdravili za uporabo v veterinarski medicini ohranijo, spremenijo, začasno umaknejo ali odvzamejo.
English: Within 60 months of Commission Decision for this procedure
Slovenian: V 60 mesecih po odločbi Komisije glede tega postopka
English: As exposure of aquatic organism is unlikely to occur, the toxicity will be reduced significantly.
Slovenian: Ker je izpostavljenost vodnih organizmov malo verjetna, se strupenost bistveno zmanjša.
English: On the other hand, there is evidence from literature (Prichard et al., 2012)18 that the resistance against avermectins and moxidectin is not always genetically identical, which implies that avermectin resistant parasite strains can be successfully treated with moxidectin.
Slovenian: Po drugi strani v literaturi obstajajo dokazi (Prichard idr., 2012),18 da odpornost proti avermektinom in moksidektinu ni vedno genetsko enaka, kar pomeni, da seve parazitov, ki so odporni proti avermektinom, lahko uspešno zdravimo z moksidektinom.
English: Detailed information on the field study design (protocol), including proposals for timelines for the provision of interim reports, should be submitted to the CVMP.
Slovenian: Odboru CVMP je treba predložiti podrobne informacije o zasnovi terenske študije (protokolu), vključno s predlogi za časovnice za predložitev vmesnih poročil.
English: Residues in dung were toxic to dung flies for more than 7 days or for more than 28 days after treatment, depending on study duration, species and formulation.
Slovenian: Ostanki v gnoju so bili za jesensko muho strupeni več kot 7 dni ali več kot 28 dni po zdravljenju, odvisno od trajanja študije, vrste in formulacije.
English: PBT substances pose a hazard where the fate and behaviour in the environment and its toxicity in the long-term cannot be predicted.
Slovenian: Snovi PBT so nevarne, kadar njihovega končnega stanja in obnašanja v okolju ter njihove dolgoročne strupenosti ni mogoče napovedati.
English: When considering persistence under field conditions, the Committee acknowledged that degradation mechanisms exist and that a soil temperature of 12 °C might not be representative for all European regions.
Slovenian: Pri ocenjevanju obstojnosti v terenskih pogojih je odbor priznal, da obstajajo mehanizmi razgradnje in da temperatura tal 12 °C morda ni reprezentativna za vse evropske regije.
English: So far, no criteria for bioaccumulation assessment in sediment or soil organisms have been established and the classification is based on the standard bioaccumulation study in fish.
Slovenian: Do zdaj še ni uveljavljenih meril za ocenjevanje kopičenja v organizmih sedimenta ali tal, razvrstitev pa temelji na standardnih študijah kopičenja v ribah.
English: This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life.
Slovenian: To pomeni, da vnos moksidektina v vodna telesa lahko povzroči resne in dolgotrajne učinke na vodno življenje.
English: Germany Continental Farmaceutica s.p.r.
Slovenian: Continental Farmaceutica s.p.r.
English: It was concluded that moxidectin degrades in soil with a dissipation half-life (DT50) of approximately 2 months and slowly mineralises.
Slovenian: Zaključili so, da moksidektin v tleh razpada z razpolovno dobo razkroja (DT50) približno 2 meseca in se počasi mineralizira.
English: Both studies were performed with Chironomus riparius exposed via spiked sediment.
Slovenian: Obe študiji so opravili na organizmu Chironomus riparius, izpostavljenem prek sedimenta z dodano učinkovino.
English: Material balance, calculated as the percent of applied radioactivity, was maintained within guideline specification (90-110% of applied radioactivity) for all four soils.
Slovenian: Materialno ravnovesje, izračunano kot odstotek dodane radioaktivnosti, so pri vseh štirih vrstah tal vzdrževali znotraj specifikacij v smernici (90-110 % dodane radioaktivnosti).
English: The bioconcentration factor was also calculated as the ratio between uptake rate constant (k1) and depuration rate constant (k2).
Slovenian: Biokoncentracijski faktor so izračunali tudi kot razmerje med konstanto stopnje absorpcije (k1) in konstanto stopnje očiščenja (k2).
English: Moxidectin, Clostridium septicum, Clostridium perfringens D, Clostridium tetani,
Slovenian: moksidektin, Clostridium septicum, Clostridium perfringens D, Clostridium tetani,
English: That is, the marketing authorisation holders argued that mean land surface temperatures during spring/summer in predominant agricultural regions in Europe are likely to be higher leading to a faster degradation.
Slovenian: Imetniki dovoljenj za promet z zdravilom so torej trdili, da so povprečne temperature površin zemljišč spomladi/poleti v glavnih kmetijskih regijah v Evropi verjetno višje, kar pomeni hitrejšo razgradnjo.
English: Consequently, risk mitigation measures tempering a quantitative risk are considered suitable neither to eliminate the hazard nor to prevent emission into the environment.
Slovenian: Zato ukrepi za zmanjšanje tveganja, ki omilijo kvantitativno tveganje, niso primerni ne za odpravo nevarnosti ne za preprečevanje emisij v okolju.
English: Nevertheless, in case of repeated treatments with moxidectin (as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.
Slovenian: Kljub temu je v primeru ponavljajočega se zdravljenja z moksidektinom (kot velja tudi za druga zdravila iz istega razreda antihelmintikov) priporočljivo, da se ne zdravijo vsakič živali na istem pašniku, s čimer omogočimo okrevanje populacij organizmov v gnoju.
English: Zoetis Portugal, Lda.
Slovenian: Portugalska Zoetis Portugal, Lda.
English: • Evidence of a trend i.e. increasing/decreasing concentrations or plateau.
Slovenian: • Dokaz za trend, tj. naraščajoče/padajoče koncentracije, ali konstantno vrednost.
English: The bioconcentration factors were also determined as a function of lipid content of the fish following normalisation for a lipid content of 5%.
Slovenian: Biokoncentracijske faktorje so določali tudi kot funkcijo vsebnosti maščob v ribah po normalizaciji na 5-odstotno vsebnost maščob.
English: As the mean recovery of moxidectin at the end of the study (63 days) was less than 50%, a value of 63 days is used as half-life value of moxidectin.
Slovenian: Ker je bil povprečen izplen moksidektina na koncu študije (63 dni) manj kot 50 %, se kot razpolovna vrednost moksidektina uporablja vrednost 63 dni.
English: Emission and risk assessment
Slovenian: Ocena emisij in tveganja
English: Non-extractable residues accounted for 4-10% of the radioactivity applied to the soil.
Slovenian: Neizločljivi ostanki so obsegali 4-10 % radioaktivnosti, dodane v tla.
English: Based on the [3H]-residues as [3H]-moxidectin in the test media, the bioconcentration factors for whole fish tissue were as follows:
Slovenian: Na osnovi [3H]-ostankov v obliki [3H]-moksidektina v testnem mediju so bili biokoncentracijski faktorji za celotno tkivo ribe naslednji:
English: It was argued that laboratory conditions, as used for the determination of the PBT properties, may not reflect the real world situation.
Slovenian: Trdili so, da laboratorijski pogoji, kakršni so se uporabljali pri določanju lastnosti PBT, morda ne odražajo realnih razmer.
English: However, when considering PBT status, the established criteria are based on evaluation of persistence at a soil temperature of 12 °C and this is accepted as mean European temperature.
Slovenian: Vendar pri ocenjevanju PBT uveljavljena merila temeljijo na vrednotenju obstojnosti pri temperaturi tal 12 °C, ki je sprejeta kot povprečna evropska temperatura.
English: Environmental risks have been identified for this product and special precautions apply.
Slovenian: Za to zdravilo so bila ugotovljena tveganja za okolje, zato veljajo posebni previdnostni ukrepi.
English: The duration of the uptake (exposure) and depuration phases were 28 and 49 days, respectively.
Slovenian: Faza absorpcije (izpostavljenosti) je trajala 28 dni, faza očiščenja pa 49 dni.
English: The second study was performed in accordance with the US FDA Environmental Assessment Technical Assistance Document no. 4.087 which is comparable to the current OECD methods.
Slovenian: Druga študija je bila opravljena v skladu z dokumentom za tehnično pomoč pri ocenjevanju vpliva na okolje ameriške agencije FDA št. 4.087, ki je primerljiv s trenutnimi metodami OECD.
English: It appeared that the therapeutic alternatives to moxidectin do not necessarily have more favourable environmental profiles, in particular in terms of toxicity to aquatic and dung insects.
Slovenian: Izkazalo se je, da terapevtske alternative moksidektinu nimajo nujno ugodnejših okoljskih profilov, zlasti v smislu strupenosti za vodne insekte in insekte v gnoju.
English: • Moxidectin is inherently toxic to aquatic organisms including fish.
Slovenian: • Moksidektin je inherentno strupen za vodne organizme, vključno z ribami.
English: Most of these laboratory studies and field studies using incurred residues examined the duration after treatment that did impact dung fauna, rather than attempting to derive effect concentrations.
Slovenian: V večini teh laboratorijskih in terenskih študij, v katerih so uporabljali nakopičene ostanke, so preučevali čas po zdravljenju, v katerem je prišlo do vpliva na organizme v gnoju, niso pa skušali izpeljati koncentracij z učinkom.
English: The respective risk quotient for moxidectin is 0.01 which is below the trigger value of 1.
Slovenian: Ustrezni količnik tveganja za moksidektin je 0,01, kar je pod sprožitveno vrednostjo 1.
English: These exclusion times are based on refined risk quotients with refined PEC values.
Slovenian: Ti časi izključenosti temeljijo na natančneje določenih količnikih tveganja z natančneje določenimi vrednostmi PEC.
English: However, any consideration of risk to the environment must take into account knowledge on the aspects of the specific product and its use that contribute to the actual emission in the environment, e.g. route of administration (pour-on, injectable, oral), husbandry conditions (indoor/outdoor/confined), terrestrial/aquaculture, closed/open water systems, individual animal treatment/flock treatment, control of environmental release, waste management, metabolism in the target animal, etc.
Slovenian: Vendar mora vsaka preučitev tveganja za okolje upoštevati poznavanje vidikov določenega zdravila in njegove uporabe, ki prispevajo k dejanskim emisijam v okolje, npr. pot uporabe (kožni poliv, z injekcijo, peroralno), pogoji reje (v zaprtem prostoru/na odprtem/v omejenem prostoru), kmetijstvo/ribogojstvo, zaprti/odprti vodni sistemi, zdravljenje posameznih živali/črede, nadzor sproščanja v okolje, ravnanje z odpadki, presnova v ciljnih živalih itd.
English: Data were provided for laboratory (Tier A), extended laboratory with incurred residues (Tier B) and field studies (Tier C).
Slovenian: Predložili so podatke za laboratorijske študije (stopnja A), razširjene laboratorijske študije z nakopičenimi ostanki (stopnja B) in terenske študije (stopnja C).
English: Altogether, the marketing authorisation holders concluded that the likelihood of moxidectin to bioaccumulate in fish is rather low.
Slovenian: V celoti so imetniki dovoljenj za promet z zdravilom zaključili, da je verjetnost za kopičenje moksidektina v ribah precej majhna.
English: 0.025 (cattle, pour-on)
Slovenian: 0,025 (govedo, kožni poliv)
English: In case of insufficient space on the label: SPECIAL WARNING(S), IF NECESSARY
Slovenian: Če na nalepki ni dovolj prostora: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
English: The LC50 for mortality was established as 37.2 mg/kg; the corresponding NOEC was 20 mg/kg.
Slovenian: Vrednost LC50 za umrljivost je bila določena kot 37,2 mg/kg, ustrezna vrednost NOEC pa je bila 20 mg/kg.
English: This study was considered as being not valid, because: the reliability of the study cannot be evaluated; the study design and test requirements did not comply with the OECD guideline no. 307; the test substance concentrations were determined on one sample point only at day 63, consequently dissipation kinetics are not available and a sound DT50 cannot be derived; and, the reported DT50 of approximately 63 days is only a very rough estimation.
Slovenian: Študija je štela za neveljavno zaradi naslednjih razlogov: zanesljivosti študije ni mogoče oceniti, zasnova študije in preskusne zahteve niso bile v skladu s smernico OECD št. 307, koncentracije testne snovi so določali na enem vzorčnem mestu samo 63. dan, zato kinetika razkroja ni na voljo in zanesljive vrednosti DT50 ni mogoče izpeljati, poročana vrednost DT50 približno 63 dni je le zelo groba ocena.
English: Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.
Slovenian: Zdravljenje se sme izvajati le, ko je potrebno, temeljiti pa mora na številu jajčec v blatu ali ovrednotenju tveganja za infestacijo na ravni živali in/ali črede.
English: • Indication for seasonal variation of the moxidectin concentrations due to different temperature, humidity, soil properties and, if applicable, for regional variation as well.
Slovenian: • Navedbe sezonskih nihanj koncentracij moksidektina zaradi različnih temperatur, vlage, lastnosti tal in, kjer je ustrezno, tudi zaradi razlik med regijami.
English: As no valid and reliable higher Tier studies were provided, the PNECs derived from the Tier A standard laboratory studies with spiked cattle manure are used for further risk assessment for all target species.
Slovenian: Ker niso bile predložene nobene veljavne in zanesljive študije višjih stopenj, se za nadaljnjo oceno tveganja za vse ciljne vrste uporabljajo vrednosti PNEC, izpeljane iz standardnih laboratorijskih študij stopnje A z gnojem goveda z dodano učinkovino.
English: No appropriate risk mitigation measures can be established for dung fauna, hence, warning sentences should be included in the product information.
Slovenian: Za organizme v gnoju ni mogoče vzpostaviti nobenih primernih ukrepov za zmanjšanje tveganja, zato je treba v informacije o zdravilu vključiti opozorilni stavek.
English: Germany was of the opinion that a potential serious risk to the environment may arise from the use of veterinary medicinal products containing moxidectin and consequently, action should be taken at EU level since veterinary medicinal products containing moxidectin are authorised in the majority of the EU/EEA Member States.
Slovenian: Nemčija je menila, da uporaba zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, lahko pomeni morebitno resno tveganje za okolje, zato je treba ukrepati na ravni EU, saj so zdravila za uporabo v veterinarski medicini, ki vsebujejo moksidektin, odobrena v večini držav članic EU/EGP.
English: In a second study with Raphidocelis subcapitata over 72 hours, no inhibition in the growth was noted at 86.9 µg/l, the highest concentration tested.
Slovenian: V drugi študiji z algami Raphidocelis subcapitata v obdobju 72 ur pri najvišji testirani koncentraciji 86,9 µg/l niso opazili zavrtja rasti.
English: The third acute study following the same procedures was conducted in bluegill (Lepomis macrochirus).
Slovenian: Tretjo akutno študijo so po istih postopkih opravili na sončnem ostrižu (Lepomis macrochirus).
English: More importantly, moxidectin poses a hazard due to its PBT properties that can neither be eliminated by risk mitigation measures nor can the emission into the environment be prevented.
Slovenian: Še pomembneje je, da je moksidektin nevaren zaradi lastnosti PBT, ki jih ni mogoče odpraviti z ukrepi za zmanjšanje tveganja, prav tako pa ni mogoče preprečiti emisij v okolje.
English: Germany Zoetis Deutschland GmbH Schellingstr.
Slovenian: Zoetis Deutschland GmbH Schellingstr.
English: Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal
Slovenian: 2740-271 Porto Salvo Portugal
English: Transformation of moxidectin in soil will indeed be faster at higher temperatures but even at 20 °C, as in the laboratory degradation study in soil, moxidectin was shown to be persistent in sandy soil.
Slovenian: Pretvorba moksidektina v tleh bo res hitrejša pri višjih temperaturah, vendar so tudi pri 20 °C, kot v laboratorijski študiji razgradnje, dokazali, da je moksidektin v peščenih tleh obstojen.
English: The product should be used only according to the label instructions.
Slovenian: Zdravilo se sme uporabljati le v skladu z navodili za uporabo.
English: The marketing authorisation holders considered that degradation rates at 12 °C are overly conservative and do not reflect likely degradation rates under normal conditions of use.
Slovenian: Imetniki dovoljenj za promet z zdravilom so menili, da so hitrosti razgradnje pri 12 °C preveč konservativne in ne odražajo verjetnih hitrosti razgradnje v normalnih pogojih uporabe.
English: The EC50 and the NOEC were established as >86.9 µg/l and 86.9 µg/l.
Slovenian: Vrednost EC50 je bila določena kot > 86,9 µg/l, vrednost NOEC pa kot 86,9 µg/l.
English: Moxidectin is an anthelmintic macrocyclic lactone endectocide that is widely used in veterinary medicine.
Slovenian: Moksidektin je antihelmintični makrociklični laktonski endektocid, ki se pogosto uporablja v veterinarski medicini.
English: Delete, where applicable, the following sentence: ‘Risk to dung fauna may be reduced by avoiding treatment that coincides with periods of local high activity of dung beetles.
Slovenian: Kjer je ustrezno, izbrišite naslednji stavek: „Tveganje za organizme v gnoju se lahko zmanjša tako, da se obdobja zdravljenja ne prekrivajo z obdobji visoke lokalne aktivnosti iztrebkarjev.“
English: The CVMP recommended risk mitigation measures to be included in the product information for all concerned products in order to mitigate the risk to aquatic and sediment organisms, including exclusion times for limited access to water courses for each target species.
Slovenian: Odbor CVMP je priporočil, da se v informacije o zdravilu za vsa zadevna zdravila vključijo ukrepi za zmanjšanje tveganja, da se ublaži tveganja za vodne organizme in organizme v sedimentu, vključno s časi izključenosti za omejen dostop do vodotokov za vsako od ciljnih vrst.
English: In conclusion, withdrawal of veterinary medicinal products containing moxidectin from the European market would limit the number of adequate therapeutic alternatives which is not considered desirable from a resistance perspective.
Slovenian: Zaključiti je mogoče, da bi umik zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, z evropskega trga omejil število primernih terapevtskih možnosti, kar z vidika odpornosti ni zaželeno.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in predlagateljev/imetnikov dovoljenj za promet z zdravilom v državah članicah
English: Earthworms were exposed to moxidectin in artificial soil over a 28-day exposure period, followed by an additional test period of four weeks where the number of offspring hatched from the cocoons was determined.
Slovenian: Deževnike so izpostavili moksidektinu v umetnih tleh za 28 dni, čemur je sledilo dodatno štiritedensko testno obdobje, ko so ugotavljali število potomcev, ki so se izvalili iz kokonov.
English: The mean DT50 value was 104 days at 20 °C and 222 days normalised to 12 °C.
Slovenian: Povprečna vrednost DT50 je bila 104 dni pri 20 °C in 222 dni, normalizirano na 12 °C.
English: This is supported by the non-standard degradation study in soil with an estimated DT50 of 63 days at 25 °C (= DT50 of 216.6 days normalised to 12 °C).
Slovenian: To podpira tudi nestandardna študija razgradnje v tleh z ocenjeno DT50 63 dni pri 25 C (= DT50 216,6 dneva, normalizirano na 12 °C).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to consider whether moxidectin meets the criteria to be classified as a PBT substance and if necessary to provide a recommendation on appropriate measures to prevent emission of moxidectin into the environment.
Slovenian: Zaprosila je, naj Odbor za zdravila za uporabo v veterinarski medicini (CVMP) preuči, ali moksidektin izpolnjuje merila za uvrstitev med snovi PBT, in po potrebi izda priporočilo o ustreznih ukrepih za preprečevanje emisij moksidektina v okolje.
English: However, on the basis of these studies it was not possible to conclude that abundance and diversity of dung insect populations (flies and beetles) will not be significantly affected by frequent and repeated use of moxidectin containing products over the years.
Slovenian: Vendar na podlagi teh študij ni bilo mogoče zaključiti, da pogosta in večletna ponavljajoča se uporaba zdravil, ki vsebujejo moksidektin, ne bo pomembno vplivala na številčnost in raznolikost populacij insektov v gnoju (muh in hroščev).