natgillin/translations-raw huggingface dataset:
The following dissipation half-lives (DT50) at 20 °C were calculated using the best fit kinetic model i.e. simple first-order: 78.6, 139.0, 78.7 and 133.6 days for the soils sandy loam, sand, clay loam and loam, respectively.
Naslednje razpolovne dobe razkroja (DT50) pri 20 °C so izračunali po kinetičnem modelu najboljšega prileganja, tj. preprostem modelu prvega reda: 78,6 dneva v peščeno-glinenih tleh, 139,0 dneva v peščenih tleh, 78,7 dneva v glineno-ilovnatih tleh in 133,6 dneva v ilovnatih tleh.
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.
Ukrepov za zmanjšanje tveganja za insekte v gnoju, ki bi izpolnjevali merila dokumenta o presoji odbora CVMP glede ukrepov za zmanjšanje tveganja, povezanih z oceno tveganja za okolje zdravil za uporabo v veterinarski medicini (EMA/CVMP/ERAWP/409328/2010),16 ni mogoče vzpostaviti.
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.
Na podlagi razpoložljivih podatkov je bila ugotovljena visoka strupenost moksidektina za vodne organizme in organizme v sedimentu, tj. NOEC 3,1 ng/l za Daphnia magna, NOEC 3,2 ng/l za ribe in NOEC 111 µg/kg suhe teže za trzače.
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.
Zaključek imetnikov dovoljenj za promet z zdravilom, da je verjetnost za obstojnost, kopičenje v organizmih in strupenost v realnih pogojih majhna, temelji na teoretičnih premislekih, kot je navedeno zgoraj.
The NOEC for reproduction was determined as 0.84 mg/kg dry soil based on nominal concentrations.
Vrednost NOEC za razmnoževanje je bila na podlagi nazivnih koncentracij določena kot 0,84 mg/kg suhih tal.
Furthermore, the PBT status of moxidectin should be communicated in the product information;
Poleg tega je treba v informacijah o zdravilu navesti oceno moksidektina kot snovi PBT;
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.
odbor CVMP je priporočil spremembo dovoljenj za promet z zdravilom za zdravila za uporabo v veterinarski medicini, ki vsebujejo moksidektin, za peroralno, topično ali subkutano dajanje govedu, ovcam in konjem (glejte Prilogo I), da se spremenijo povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
PECsediment direct (ng/kg)* 35 (sheep, solution for injection containing 20 mg moxidectin per ml)
PECsediment_neposredno (ng/kg)* 35 (govedo, raztopina za injiciranje, ki vsebuje 20 mg moksidektina na ml)
Data on the fate and behaviour of moxidectin in the environment to verify the proposed low likelihood under real conditions are not available.
Podatki o končnem stanju in obnašanju moksidektina v okolju, s katerimi bi lahko preverili predlagano majhno verjetnost v realnih razmerah, niso na voljo.
• 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;
• odbor CVMP je presodil, da so zdravila za uporabo v veterinarski medicini, ki vsebujejo moksidektin, za dajanje govedu, ovcam in konjem v obliki kožnega poliva, injekcij in peroralnih formulacij učinkovita zdravila za uporabo v veterinarski medicini pri zdravljenju notranjih in zunanjih parazitov pri govedu, ovcah in konjih;
Other precautions regarding impact on the environment Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible.
Drugi previdnostni ukrepi v zvezi z vplivom na okolje Moksidektin izpolnjuje merila za (zelo) obstojno snov, ki se kopiči v organizmih in je strupena (PBT), zato je treba izpostavljenost okolja moksidektinu čim bolj omejiti.
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.
Podatki, pridobljeni v zvezi z izpolnjevanjem teh pogojev, skupaj z drugimi relevantnimi informacijami, ki bodo morda na voljo, bodo podlaga za nadaljnjo oceno odbora CVMP in njegovih zaključkov o razmerju med tveganji in koristmi zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, za dajanje govedu, ovcam in konjem v obliki kožnega poliva, injekcij in peroralnih formulacij.
• the CVMP considered that based on the available data high toxicity of moxidectin to aquatic and sediment organisms and a risk for dung fauna have been identified;
• odbor CVMP je presodil, da je bila na podlagi razpoložljivih podatkov ugotovljena velika strupenost moksidektina za vodne organizme in organizme v sedimentu ter tveganje za organizme v gnoju;
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.
Z laboratorijskimi testi je bilo ugotovljeno, da lahko moksidektin začasno vpliva na razmnoževanje iztrebkarja, vendar študije z nakopičenimi ostanki kažejo, da dolgoročnih učinkov ni.
It was considered that degradation in soil might be faster under higher temperatures, that aquatic toxicity and bioaccumulation might be reduced due to intermittent rather than continuous exposure, and that moxidectin would adsorb rapidly to sediment.
Ugotavljali so, da je razgradnja v tleh pri višjih temperaturah morda hitrejša, da je strupenost za vodo in kopičenje v organizmih morda manjša, saj je izpostavljenost nestalna, ne pa neprekinjena, in da se moksidektin hitro adsorbira na sediment.
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.
Odbor CVMP je presodil, da je študija zanesljiva, in zaključil, da moksidektin izpolnjuje merilo B za kopičenje v organizmih (BCFKL 2 543 l/kg), kot določa smernica CVMP o ocenjevanju snovi PBT/vPvB v zdravilih za uporabo v veterinarski medicini (EMA/CVMP/ERA/52740/2012), tj. biokoncentracijski faktor v vodnih vrstah je večji od 2 000.
A number of GLP compliant laboratory studies on toxicity in aquatic invertebrates, fish, green algae, sediment invertebrates and dung insects were provided.
Predloženih je bilo več laboratorijskih študij, skladnih z dobro laboratorijsko prakso, o strupenosti pri vodnih nevretenčarjih, ribah, zelenih algah, nevretenčarjih v sedimentu in insektih v gnoju.
It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, field studies indicate no long-term effects.
Z laboratorijskimi testi je bilo ugotovljeno, da lahko moksidektin začasno vpliva na razmnoževanje iztrebkarja, vendar terenske študije kažejo, da dolgoročnih učinkov ni.
An EC50 for immobilisation was established as 26 ng/l based on geometric mean of measured test concentrations.
Vrednost EC50 za imobilizacijo so na podlagi geometrijske srednje vrednosti izmerjenih testnih koncentracij določili kot 26 ng/l.
Overall summary of the scientific evaluation of veterinary medicinal products containing moxidectin to be administered orally, topically or subcutaneously to cattle, sheep and horses (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, za peroralno, topično ali subkutano dajanje govedu, ovcam in konjem (glejte Prilogo I)
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
E. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki peroralnega gela, za dajanje konjem in ponijem, in vsebujejo 18,92 mg moksidektina na gram ali 19,5 mg moksidektina in 121,7 mg prazikantela na gram
Earthworms were exposed to moxidectin-treated cow manure in artificial soil over a 28-day exposure period.
Deževnike so za 28 dni izpostavili gnoju krav, zdravljenih z moksidektinom, v umetnih tleh.
The effect on the reproduction of Eisenia foetida was investigated in a GLP compliant study according to OECD guideline 22215.
Učinke na razmnoževanje kompostnega črva Eisenia foetida so preučevali v študiji, skladni z dobro laboratorijsko prakso in smernico OECD št. 22215.
• 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.
• Uporabiti je treba kožni poliv, raztopino, ki vsebuje 5 mg moksidektina na ml, ali raztopino za injiciranje, ki vsebuje 100 mg moksidektina na ml, pri pašnem govedu za prirejo mesa, saj ti dve možnosti predstavljata realen najslabši možni primer emisij.
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible.
Moksidektin izpolnjuje merila za (zelo) obstojno snov, ki se kopiči v organizmih in je strupena (PBT), zato je treba izpostavljenost okolja moksidektinu čim bolj omejiti.
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
Poleg tega je odbor poudaril, da je v informacije o zdravilu za nekatera zdravila v obliki kožnega poliva vključeno opozorilo, ki navaja, da se tveganje za organizme v gnoju lahko zmanjša tako, da se obdobja zdravljenja ne prekrivajo z obdobji visoke lokalne aktivnosti iztrebkarjev.
• 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;
• odbor CVMP je presodil, da bodo podatki, pridobljeni v zvezi z izpolnjevanjem teh pogojev, skupaj z drugimi relevantnimi informacijami, ki bodo morda na voljo, podlaga za nadaljnjo oceno odbora CVMP njegovih zaključkov o razmerju med tveganji in koristmi zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, za dajanje govedu, ovcam in konjem v obliki kožnega poliva, injekcij in peroralnih formulacij;
Toxicity the conditions of the study, the LC50 value for moxidectin was established as 0.16 µg/l.
V pogojih študije so določili vrednost EC50 za moksidektin kot 0,16 µg/l.
• 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;
• odbor CVMP je presodil, da je na podlagi trenutno razpoložljivih podatkov splošno razmerje med tveganji in koristmi za zdravila za uporabo v veterinarski medicini, ki vsebujejo moksidektin, za dajanje govedu, ovcam in konjem v obliki kožnega poliva, injekcij in peroralnih formulacij (glejte Prilogo I), pozitivno, pod pogojem, da se upoštevajo spremembe informacij o zdravilu in pogojev dovoljenj za promet z zdravilom;
These have been discussed by target species (cattle, sheep, and horses) and by route of administration (pour-on, injectable, oral).
Podatki so bili obravnavani glede na ciljno vrsto (govedo, ovce in konji) in pot uporabe (kožni poliv, z injekcijo, peroralno).
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.
Torej je za preverjanje metode teže dokazov, kot predlagajo imetniki dovoljenj za promet z zdravilom, in za ocenjevanje, ali se teoretične nevarnosti preslikajo v vplive na okolje, odbor CVMP presodil, da je potrebno ciljno vzorčenje v okolju po uporabi zdravil za uporabo v veterinarski medicini v obliki kožnega poliva, raztopine, ki vsebuje 5 mg moksidektina na ml, ali raztopine za injiciranje, ki vsebuje 100 mg moksidektina na ml, pri pašnem govedu za prirejo mesa, da bi lahko bolje razumeli dejansko izpostavljenost okolja.
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).
Splošno razmerje med tveganji in koristmi zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, za dajanje govedu, ovcam in konjem v obliki kožnega poliva, injekcij ali peroralnih formulacij (glejte Prilogo I) je ocenjeno kot pozitivno, pod pogojem, da se upoštevajo priporočene spremembe informacij o zdravilu (glejte Prilogo III).
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.
Tako so vrednost EC50 (koncentracija testne snovi, ki povzroči škodljive učinke, tj. umrljivost in subletalne učinke, pri 50 % testnih živali) moksidektina ocenili na > 0,11 mg/l.
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.
Na podlagi razpoložljivih informacij je Nemčija presodila, da je zdravilna učinkovina moksidektin morda obstojna, se kopiči v organizmih in je strupena (PBT) v skladu s smernico CVMP o ocenjevanju snovi PBT ali zelo obstojnih snovi, ki se zelo kopičijo v organizmih (vPvB), v zdravilih za uporabo v veterinarski medicini (EMA/CVMP/ERA/52740/2012)1.
For the assessment of persistence, two Good Laboratory Practice (GLP ) compliant laboratory studies were provided.
V zvezi z oceno obstojnosti sta bili predloženi dve laboratorijski študiji, skladni z dobro laboratorijsko prakso.
Amendments in the relevant sections of the summaries of product characteristics, labelling and package leaflets
Spremembe ustreznih poglavij povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance.
Moksidektin izpolnjuje merila za (zelo) obstojno snov, ki se kopiči v organizmih in je strupena (PBT).
Two GLP compliant studies were provided on toxicity to sediment dwelling organisms in accordance with OECD guideline 21812.
Glede strupenosti na organizme, ki živijo v sedimentu, sta bili predloženi dve študiji, skladni z dobro laboratorijsko prakso in smernico OECD 21812.
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.
3 OECD guideline for the testing of chemicals no. 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure - link povprečno mokro težo 1,738 g na začetku testa.
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.
Povprečje neizločljivih ostankov na 120. dan (% dodane radioaktivnosti) je bilo 7,22 % v peščeno-glinenih tleh, 5,23 % v peščenih tleh, 10,15 % v glinenoilovnatih tleh in 5,38 % v ilovnatih tleh.
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.
Odbor VCMP je presodil, da glede na rezultate laboratorijskih študij moksidektin izpolnjuje merila za obstojnost (P), kopičenje v organizmih (B) in strupenost (T), zato mora biti razvrščen med snovi PBT.
Therefore, on 22 October 2015, Germany initiated a referral procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing moxidectin to be administered orally, topically or subcutaneously to cattle, sheep and horses.
Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo moksidektin, za peroralno, topično ali subkutano dajanje govedu, ovcam in konjem.
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.
Za zmanjšanje emisij moksidektina v površinske vode in na podlagi profila izločanja moksidektina, kadar se uporablja v obliki peroralne formulacije pri konjih, zdravljene živali v prvem tednu po zdravljenju ne smejo imeti dostopa do vodotokov.
Sediment dwelling organisms
Organizmi, ki živijo v sedimentu
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.
Povprečje nastale težke vode na 120. dan (% dodane radioaktivnosti) je bilo 6,48 % v peščeno-glinenih tleh, 3,22 % v peščenih tleh, 7,6 % v glinenoilovnatih tleh in 5,10 % v ilovnatih tleh.
MOXIQUEST GEL ORAL Moxidectin Gel oral
MOXIQUEST GEL ORAL moksidektin peroralni gel
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
Na splošno se aktivnost encimov, vključenih v pretvorbo ksenobiotikov, pri nižjih prehranjevalnih ravneh zmanjšuje, kot je navedeno v smernici CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1)4.
Based on the results, a DT50 of 296.6 days normalised to 12 °C (DT50 139.0 days at 20 °C) as recommended in the CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012), is used to confirm that moxidectin fulfils the vP (very persistent) criterion (i.e. the DT50 in soil is higher than 180 days).
Na podlagi rezultatov se za potrditev, da moksidektin izpolnjuje merilo vP (zelo obstojno) (tj. DT50 v tleh je daljša od 180 dni), uporablja DT50 296,6 dneva, normalizirano na 12 °C (DT50 139,0 dni pri 20 °C), kot priporoča smernica CVMP o ocenjevanju snovi PBT/vPvB v zdravilih za uporabo v veterinarski medicini (EMA/CVMP/ERA/52740/2012).
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.
Pri konjih in ponijih je peroralna uporaba kombiniranih zdravil (moksidektin v kombinaciji s prazikantelom) namenjena za zdravljenje velikih in malih strongilidov, askaridov, trakulj in drugih parazitov, npr. podančic in Gasterophilus haemorrhoidalis.
Equest 18,92 mg gél na perorálne použitie
Equest 18,92 mg gél na perorálne použitie moksidektin peroralni gel
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.
Pri ovcah je subkutana uporaba (zdravila za injiciranje) privedla do vrednosti PECpovršinske_vode 0,122 ng/l pri odtekanju.
Three GLP compliant studies on acute toxicity in fish were provided.
O akutni strupenosti za ribe so bile predložene tri študije, skladne z dobro laboratorijsko prakso.
A LC50 value of 0.62 µg/l was calculated based on measured concentrations.
Na podlagi izmerjenih koncentracij so izračunali vrednost LC50 0,62 µg/l.
• 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;
• odbor CVMP je presodil, da glede na rezultate laboratorijskih študij moksidektin izpolnjuje merila za obstojnost, kopičenje v organizmih in strupenost, zato mora biti razvrščen med snovi PBT;
• 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;
• odbor CVMP je presodil, da je potrebno ciljno vzorčenje v okolju po uporabi zdravil za uporabo v veterinarski medicini v obliki kožnega poliva, raztopine, ki vsebuje 5 mg moksidektina na ml, ali raztopine za injiciranje, ki vsebuje 100 mg moksidektina na ml, pri pašnem govedu za prirejo mesa, da bi lahko bolje razumeli dejansko izpostavljenost okolja;
Two GLP compliant studies on the effects on daphnid reproduction in accordance with OECD guideline no. 2118 were submitted.
O učinkih na razmnoževanje vodnih bolh v skladu s smernico OECD št. 2118 sta bili predloženi dve študiji, skladni z dobro laboratorijsko prakso.
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.
Zato morajo imetniki dovoljenj za promet z zdravilom opraviti kvalitativno oceno tveganja, tj. določiti, kakšna je verjetnost, da v realnih pogojih pride do obstojnosti, kopičenja v organizmih in strupenosti, ter pri tem upoštevati metodo teže dokazov.
Pasture Scenarios
Scenariji živali na pašniku
CYDECTIN 0,5 % POUR ON kožni poliv, raztopina za govedo
CYDECTIN 0,5 % POUR ON kožni poliv, raztopina za govedo moksidektin kožni poliv, raztopina govedo topično - na hrbet živali