FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk to the environment has been identified due to accumulation of zinc, particularly to the aquatic compartment.
Slovenian: Ugotovljeno je bilo tveganje za okolje zaradi kopičenja cinka, zlasti tveganje za vodno okolje.
English: It is acknowledged that due to the physico-chemical properties of zinc (non-volatile and nondegradable), continual application of manure from treated animals to land under practices of intensive pig breeding will cause a gradual increase in the topsoil zinc concentration, followed by an increase in other relevant compartments, over time.
Slovenian: Znano je, da zaradi fizikalnih in kemijskih lastnosti cinka (nehlapen in nerazgradljiv) stalno nanašanje gnoja zdravljenih živali na zemljo v okviru intenzivne prašičereje povzroči postopno povečanje koncentracije cinka v humusu, sčasoma pa tudi v drugih zadevnih delih okolja.
English: There are a number of uncertainties associated with use of the IDMM for predicting the environmental exposure of zinc from use in veterinary medicinal products, such as the effects of hydrology, dissolved organic carbon and metal aging.
Slovenian: Po drugi strani obstaja več nejasnosti, povezanih z uporabo modela IDMM za napovedovanje izpostavljenosti okolja cinku zaradi uporabe zdravil za uporabo v veterinarski medicini, med drugim glede hidroloških vplivov ter vpliva organskega ogljika in staranja kovin.
English: In terms of RMMs and in view of the necessity to prevent the accumulation of zinc in environmental compartments above PNEC levels, it has been proposed that undiluted manure from treated piglets should not be applied to land and manure from treated animals be diluted with manure from untreated animals, so that the treated manure comprises 40% or less of the total mixture.
Slovenian: V okviru ukrepov za zmanjšanje tveganja in ob upoštevanju potrebe po preprečevanju kopičenja cinka v delih okolja v koncentracijah nad vrednostmi PNEC je bilo predlagano, da se nerazredčen gnoj zdravljenih prašičkov ne bi smel nanašati na zemljo in da bi se gnoj zdravljenih živali razredčil z gnojem nezdravljenih živali, tako da bi gnoj zdravljenih živali predstavljal največ 40 % celotne mešanice.
English: However, in contrast to the CVMP/VICH approach, the IDMM predicts the fate and behaviour of zinc in soil, differentiates sites on zinc sensitivity, accommodates aged zinc, considers environmental sources of potential toxicants, and accommodates for ambient levels of naturally occurring substances.
Slovenian: Vendar pa v nasprotju s pristopi iz smernic CVMP/VICH model IDMM napove usodo in obnašanje cinka v tleh, razlikuje območja glede na občutljivost za cink ter upošteva staranje cinka, vire morebitnih strupenih snovi v okolju in količino naravno prisotnih snovi v okolju.
English: In the aquatic compartment, zinc bioavailability in water has been predicted using the Metal Bioavailability Assessment Tool (United Kingdom Environment Agency)
Slovenian: Za vodno okolje je bila predvidena biološka uporabnost cinka v vodi določena s pomočjo orodja za oceno biološke uporabnosti kovin (Agencija Združenega kraljestva za okolje)
English: For two of the FOCUS scenarios (acidic, sandy soils) the risk quotients (RQs) are >1 for both loading rates at all time points.
Slovenian: Pri dveh scenarijih v modelu FOCUS (kisla, peščena tla) so bili količniki tveganja (KT) > 1 pri obeh stopnjah obremenitve in ob vseh časovnih točkah.
English: Environment Agency, United Kingdom for zinc), and were used by the applicant to establish different PNECs for each environmental compartment.
Slovenian: 2 za cink), ki jih je predlagatelj uporabil za določitev različnih vrednosti PNEC za vsak del okolja.
English: The Metal Bioavailability Assessment Tool requires fewer data inputs to predict zinc bioavailability in water than the Biotic Ligand Model, and can be used to calculate site-specific PNECs.
Slovenian: Orodje za oceno biološke uporabnosti kovin (Metal Bioavailability Assessment Tool) zahteva manj vhodnih podatkov za napoved biološke uporabnosti cinka v vodi kot biotski ligandski model in se lahko uporabi za izračun vrednosti PNEC za določeno območje.
English: In the terrestrial and aquatic compartments a risk (RQ >1) was found at 4 out of 19 scenarios and at 5 of out 15 scenarios from 2060 onwards, for the worst case and lower application rate, respectively.
Slovenian: Pri zemeljskem in vodnem delu okolja je bilo tveganje (KT > 1) ugotovljeno pri 4 od 19 scenarijev za odmerek v najslabšem možnem primeru in pri 5 od 15 scenarijev za manjši odmerek od leta 2060 naprej.
English: 4 which incorporates parameters relevant to determine soil zinc bioavailability, such as pH, organic and clay content, and the cation exchanged capacity.
Slovenian: 4, ki vključuje parametre, pomembne za določitev biološke uporabnosti cinka v tleh, kot so pH, vsebnost organskih snovi in gline ter kationska izmenjalna kapaciteta.
English: There is some uncertainty associated with the scale of this risk.
Slovenian: Obseg tega tveganja ni povsem jasen.
English: Despite these uncertainties, and in the absence of a better alternative, it is considered that the IDMM can be used to gain a reasonable assessment of the risk to the environment posed by the use of Gutal.
Slovenian: Kljub tem nejasnostim je bilo ob odsotnosti boljše alternative ocenjeno, da se z modelom IDMM lahko pridobi sprejemljiva ocena tveganja, ki ga za okolje predstavlja uporaba zdravila Gutal.
English: Quality, target animal safety, user safety, impact on antimicrobial resistance development and residues and efficacy were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Slovenian: V tem napotitvenem postopku niso ocenjevali kakovosti, varnosti za ciljne živali, varnosti za uporabnika, vpliva na razvoj protimikrobne odpornosti, ostankov in učinkovitosti, saj referenčna država članica ni priglasila nobenega pomisleka.
English: Firstly, that undiluted manure from treated piglets should be diluted before being applied to land (so that the treated manure comprises 40% or less of the total mixture).
Slovenian: Prvi ukrep je, da je treba nerazredčen gnoj zdravljenih prašičkov pred nanosom na zemljo razredčiti (tako da gnoj zdravljenih živali predstavlja največ 40 % celotne mešanice).
English: Overall summary of the scientific evaluation of Gutal 1000 g/kg premix for medicated feeding stuff for piglets (see Annex I)
Slovenian: Splošen povzetek znanstvenega vrednotenja zdravila Gutal 1000 g/kg predmešanica za zdravilno krmno mešanico za prašičke (glejte Prilogo I)
English: The results of the environmental risk assessment for Gutal reflect the conclusion from EFSA on zinc i.e. there is a potential environmental concern related to the aquatic compartment (including sediment), with acidic, sandy, well-drained soils being most vulnerable to these processes.
Slovenian: Rezultati ocene tveganja za okolje za zdravilo Gutal so skladni z zaključki iz poročila agencije EFSA za cink, da obstaja morebitna nevarnost za okolje, povezana z vodnim delom okolja (vključno s sedimenti), pri čemer so najbolj ranljiva kisla, peščena in dobro propustna tla.
English: Various RMMs are proposed which are anticipated to reduce the accumulation of zinc.
Slovenian: Predlaganih je bilo več ukrepov za zmanjšanje tveganja, ki naj bi zmanjšali kopičenje cinka.
English: Although it is recognised that the proposed RMMs have deficiencies, and the extent to which they reduce the environmental risk cannot be fully quantified, they can be anticipated to slow down the accumulation of zinc in the environment.
Slovenian: Čeprav je bilo ugotovljeno, da imajo predlagani ukrepi za zmanjšanje tveganja pomanjkljivosti, niti ni mogoče povsem jasno določiti, v kolikšni meri bodo zmanjšali tveganje za okolje, je mogoče pričakovati, da bodo upočasnili kopičenje cinka v okolju.
English: Quality, target animal safety, user safety impact on antimicrobial resistance development and residues were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Slovenian: V tem napotitvenem postopku niso ocenjevali kakovosti, varnosti za ciljne živali, varnosti za uporabnika, vpliva na razvoj protimikrobne odpornosti in ostankov, saj referenčna država članica ni priglasila nobenega pomisleka.
English: Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet
Slovenian: Dopolnila, ki se vključijo v ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo
English: The product should not be used on farms where dilution of manure is not possible.
Slovenian: Zdravilo se ne sme uporabljati na kmetijah, kjer redčenje gnoja ni mogoče.
English: Due to the intrinsic nature of zinc (non-volatile and non-degradable) the potential for PNECs to be eventually surpassed as a result of continual application of manure from treated animals to land over an extended period is a significant environmental concern, particularly with regard to the most vulnerable soil types (acidic, freely draining, sandy soils) and organisms of the aquatic compartments.
Slovenian: Zaradi naravnih lastnosti cinka (nehlapen in nerazgradljiv) možnost, da bi bile zaradi dolgotrajnejšega stalnega nanašanja gnoja zdravljenih živali na zemljo sčasoma presežene vrednosti PNEC, predstavlja veliko nevarnost za okolje, zlasti za najranljivejše vrste tal (kisla, dobro propustna, peščena tla) in organizme vodnih delov okolja.
English: Zinc may accumulate in soil following continual application of manure from treated animals; with acidic sandy soils being most vulnerable.
Slovenian: Cink se lahko zbira v prsti po stalni uporabi gnoja zdravljenih živali; najbolj občutljive so kisla, peščena tla.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Gutal 1000 g/kg premix for medicated feeding stuff for piglets
Slovenian: Znanstveni zaključki in podlaga za odobritev dovoljenja za promet z zdravilom Gutal 1000 g/kg predmešanica za zdravilno krmno mešanico za prašičke
English: The product should not be used on farms where appropriate dilution of manure is not possible.
Slovenian: Zdravilo se ne sme uporabljati na kmetijah, kjer gnoja ni mogoče ustrezno razredčiti.
English: The applicant Huvepharma NV submitted a marketing authorisation application, via the decentralised procedure, for Gutal according to Article 13(1) Directive 2001/82/EC, referring to the reference product ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff authorised in the United Kingdom.
Slovenian: Predlagatelj Huvepharma NV je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Gutal po decentraliziranem postopku v skladu s členom 13(1) Direktive 2001/82/ES, ki se sklicuje na referenčno zdravilo ZincoTec Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico, ki je odobreno v Združenem kraljestvu.
English: For each compartment (soil, water and sediment), zinc bioavailability is dependent on various biotic and abiotic factors.
Slovenian: Biološka uporabnost cinka v posameznem delu okolja (v tleh, vodi in usedlinah) je odvisna od različnih biotskih in abiotskih dejavnikov.
English: Despite these uncertainties, considering the nature of the active substance, as an inorganic molecule, and the difficulties identified throughout the application procedure in terms of assessing the environmental risk for a compound ‘outside' of current CVMP/VICH guidance, it may be accepted that the estimated PEC values extrapolated from the IDMM outputs offer an reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Slovenian: Kljub tem nejasnostim se ob upoštevanju narave zdravilne učinkovine, ki je anorganska molekula, in težav pri oceni tveganja za okolje za spojino, ki ni obravnavana v veljavnih smernicah CVMP/VICH, ki so jih opažali skozi celoten postopek obravnavanja vloge, lahko zaključi, da ocenjene vrednosti PEC, ekstrapolirane iz izhodnih podatkov modela IDMM, zadovoljivo odražajo izpostavljenost okolja, da se lahko uporabijo pri opredelitvi tveganja za zdravilo Gutal.
English: Currently, data specific to zinc are not available, however, the ability of buffer strips to reduce suspended sediment loads, which are the predominant route of transport of zinc to local water courses, may be used as an indicator.
Slovenian: Podatki, specifični za cink, trenutno niso na voljo, vendar se lahko kot vodilo uporabi sposobnost varovalnih pasov, da zmanjšajo obremenitev suspendiranih sedimentov, ki v glavnem prenašajo cink v lokalne vodotoke.
English: RQs have been extrapolated (linearly) from application rates of 4 and 7 kg zinc ha a-1
Slovenian: , so (linearno) ekstrapolirali količnike tveganja iz odmerkov 4 in 7 kg cinka ha a-1
English: , as indicated in the CVMP reflection paper on RMMs related to the environmental risk assessment of veterinary medicinal products
Slovenian: kot je navedeno v strokovni presoji ukrepov za zmanjšanje tveganja, povezanih z oceno tveganja za okolje za zdravila za uporabo v veterinarski medicini, odbora CVMP
English: The applicant has generated RQ values for alternative application rates via linear extrapolation of the IDMM results for application rates of 4 and 7 kg zinc ha a-1
Slovenian: Za boljšo obravnavo zadevnih ukrepov za zmanjšanje tveganja je predlagatelj zagotovil vrednosti KT za alternativne odmerke z linearno ekstrapolacijo rezultatov, dobljenih z modelom IDMM za odmerka cinka 4 in 7 kg ha a-1
English: Gutal contains zinc oxide as an active substance.
Slovenian: Zdravilo Gutal vsebuje zdravilno učinkovino cinkov oksid.
English: Although there are uncertainties with the linear extrapolation of the IDMM results, the PEC values extrapolated from the IDMM outputs are considered to offer a reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Slovenian: Kljub nejasnostim v zvezi z linearno ekstrapolacijo rezultatov, dobljenih z modelom IDMM, je bilo ocenjeno, da vrednosti PEC, ekstrapolirane iz izhodnih podatkov modela IDMM, zadovoljivo odražajo izpostavljenost okolja, da se lahko uporabijo pri opredelitvi tveganja za zdravilo Gutal.
English: ) and a lower application rate (4 kg zinc ha a-1
Slovenian: ) in manjši odmerek cinka (4 kg ha a-1
English: Thus, a model used by EFSA for estimating the environmental exposure from the use of zinc oxide as feed additive, the Intermediate Dynamic Model for Metal (IDMM) by Monteiro et al. (2010)
Slovenian: Zato je bil za izboljšanje ocene tveganja za zdravilo Gutal uporabljen model, ki ga je agencija EFSA uporabila za oceno izpostavljenosti okolja, povezane z uporabo cinkovega oksida kot krmnega dodatka, tj. vmesni dinamični model za kovine (Intermediate Dynamic Model for Metal - IDMM), ki so ga razvili Monteiro in sodelavci (2010) saj je bil ta model ocenjen kot ustrezen, ker se lahko uporablja za anorganske snovi.
English: , 3.3 kg zinc ha a-1
Slovenian: , 3,3 kg cinka ha a-1
English: , 7.2 kg zinc ha a-1
Slovenian: , 7,2 kg cinka ha a-1
English: Grounds for the granting of the marketing authorisations for Gutal 1000 g/kg premix for medicated feeding stuff for piglets
Slovenian: Podlaga za odobritev dovoljenja za promet z zdravilom Gutal 1000 g/kg predmešanica za zdravilno krmno mešanico za prašičke
English: Finally, the SPC advises compliance with measures taken by local/national authorities to prevent manure entering waters and excessive leakage of minerals with the implementation of a buffer zone.
Slovenian: Zadnji ukrep pa je priporočilo v povzetku glavnih značilnosti zdravila o upoštevanju ukrepov lokalnih/nacionalnih organov oblasti, ki določajo varovalni pas, ki preprečuje vnos gnoja v vode ter čezmerno odtekanje mineralov.
English: mineral phases, e.g. iron (oxy)hydroxides and manganese oxides, as well as the organic matter content in sediments.
Slovenian: Ostala parametra, ki vplivata na (zmanjšujeta) biološko uporabnost cinka v sedimentih, sta prisotnost oborjenih mineralnih faz, npr. železovih (oksi)hidroksidov in manganovih oksidov, ter vsebnost organskih snovi v sedimentih.
English: It is believed that bioavailability of metals in sediment can be predicted by measuring the acid volatile sulphide (AVS) and the simultaneously extracted metal (SEM) contents of sediments.
Slovenian: sulfida (acid volatile sulphide - AVS) in sočasno ekstrahiranih kovin (simultaneously extracted metalSEM) v sedimentih.
English: In soil, properties such as pH, organic carbon content, cation exchange capacity, and clay content determine bioavailability in the terrestrial compartment.
Slovenian: Kar zadeva tla, je biološka uporabnost v tleh odvisna od lastnosti, kot so pH, vsebnost organskega ogljika, kationska izmenjalna kapaciteta in vsebnost gline.
English: IDMM (EFSA, 2012)
Slovenian: Vendar pa je pri odmerkih, večjih od tistih, izračunanih z modelom IDMM (EFSA, 2012)
English: Concerning sediment PECs particularly, accumulation factors are not considered (e.g. deposition, re-suspension, and burial of zinc), it is assumed that suspended sediments are representative of the deposited sediment, and no account is made for acid volatile sulfide levels.
Slovenian: Kar zadeva vrednosti PEC za sedimente, niso upoštevani dejavniki kopičenja (npr. usedanje, resuspenzija in zakopavanje cinka),
English: Additionally, advice to avoid the spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc would seem a suitable RMM.
Slovenian: Primeren ukrep za zmanjšanje tveganja bi bilo tudi priporočilo, da se je treba izogibati trošenju gnoja po istem predelu zemlje več let zapored, s čimer bi upočasnili kopičenje cinka.
English: Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC, the therapeutic benefits for Gutal are considered to be the same as those for the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff and are not reevaluated under this procedure.
Slovenian: Ker je bila vloga za pridobitev dovoljenja za promet z zdravilom predložena v skladu s členom 13(1) Direktive 2001/82/ES, se šteje, da so terapevtske koristi zdravila Gutal enake kot pri referenčnem zdravilu ZincoTec - Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico, zato v okviru tega postopka niso bile ponovno ovrednotene.
English: variable, where zinc sulfides are formed PNECs may be greatly exceeded before adverse effects are observed.
Slovenian: Slednji lahko zmanjšajo biološko uporabnost cinka, zato so kljub temu, da so koncentracije spremenljive, lahko vrednosti PNEC na območjih, kjer nastajajo cinkovi sulfidi, znatno presežene, preden je mogoče opaziti kakršne koli škodljive učinke.
English: Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the therapeutic benefits for Gutal are considered to be the same as those for the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff and have not been re-evaluated as part of this procedure.
Slovenian: Ker je bila vloga za pridobitev dovoljenja za promet z zdravilom predložena v skladu s členom 13(1) Direktive 2001/82/ES in ker je bila biološka enakovrednost potrjena, se šteje, da so terapevtske koristi zdravila Gutal enake kot pri referenčnem zdravilu ZincoTec - Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico, zato v okviru tega postopka niso bile ponovno ovrednotene.
English: Secondly, as the bioavailability of zinc varies between soil types, manure from treated piglets should not be spread on the soil types which have been identified as most vulnerable, i.e. freely draining, acidic (pH ≤6), sandy soils.
Slovenian: Drugi ukrep je, da se zaradi različne biološke uporabnosti cinka v različnih vrstah tal gnoj zdravljenih prašičkov ne sme trositi po vrstah tal, ki so opredeljena kot najranljivejša - to so dobro propustna, kisla (pH ≤ 6), peščena tla. Tretji ukrep je, da se gnoj zdravljenih živali ne sme trositi po istem predelu zemlje več let zapored, s čimer naj bi zmanjšali kopičenje cinka.
English: • Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the benefit-risk for Gutal is considered to be equivalent to that of the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff.
Slovenian: • ker je bila vloga za pridobitev dovoljenja za promet z zdravilom predložena v skladu s členom 13(1) Direktive 2001/82/ES in ker je bila biološka enakovrednost potrjena, se šteje, da je razmerje med tveganji in koristmi zdravila Gutal enako kot pri referenčnem zdravilu ZincoTec - Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico;
English: Romania Huvepharma NV Uitbreidingstraat 80
Slovenian: Romunija Huvepharma NV Uitbreidingstraat 80
English: Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the benefit-risk for Gutal is considered to be equivalent to that of the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff.
Slovenian: Ker je bila vloga za pridobitev dovoljenja za promet z zdravilom predložena v skladu s členom 13(1) Direktive 2001/82/ES in ker je bila biološka enakovrednost potrjena, se šteje, da je razmerje med tveganji in koristmi zdravila Gutal enako kot pri referenčnem zdravilu ZincoTec - Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico.
English: Slovenia Huvepharma NV Uitbreidingstraat 80
Slovenian: Slovenija Huvepharma NV Uitbreidingstraat 80
English: Slovakia Huvepharma NV Uitbreidingstraat 80
Slovenian: Slovaška Huvepharma NV Uitbreidingstraat 80
English: Luxembourg Huvepharma NV Uitbreidingstraat 80
Slovenian: Luksemburg Huvepharma NV Uitbreidingstraat 80
English: Bulgaria Huvepharma NV Uitbreidingstraat 80
Slovenian: Bolgarija Huvepharma NV Uitbreidingstraat 80
English: Hungary Huvepharma NV Uitbreidingstraat 80
Slovenian: Madžarska Huvepharma NV Uitbreidingstraat 80
English: Therefore, exposure on application rates that are considered relevant from the use of zinc containing veterinary medicinal products are calculated from the predefined loading rates of the IDMM.
Slovenian: Tako je bila izpostavljenost pri ustreznih odmerkih, značilnih za uporabo zdravil za uporabo v veterinarski medicini,
English: RMMs.
Slovenian: Ciper
English: However, in some cases, swelling may persist for up to 4 weeks.
Slovenian: Vendar je v nekaterih primerih oteklina vztrajala tudi do 4 tedne.
English: Protection of animals not vaccinated following this program has not been demonstrated.
Slovenian: Zaščita živali, ki niso cepljene po tem programu, ni bila dokazana.
English: This should be considered in case of herd vaccination.
Slovenian: To je treba upoštevati v primeru cepljenja črede.
English: ATCvet code: QI02AB .
Slovenian: Oznaka ATC vet: QI02AB.
English: This swelling will have disappeared or be clearly reduced in size by 17 days post vaccination.
Slovenian: Ta oteklina izgine ali se opazno zmanjša do 17. dne po cepljenju.
English: White homogeneous emulsion.
Slovenian: Bela homogena emulzija.
English: Duration of immunity: approximately the first 5 months of lactation.
Slovenian: Trajanje imunosti: približno prvih 5 mesecev laktacije.
English: <{MM/YYYY}>
Slovenian: {MM/LLLL}
English: The full immunisation program should be repeated with each gestation.
Slovenian: Celoten program imunizacije naj se ponovi ob vsaki brejosti
English: Onset of immunity: approximately 36 days after the second dose.
Slovenian: Nastop imunosti: približno 36 dni po drugem odmerku.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC so bodisi dovoljene snovi za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.