natgillin/translations-raw huggingface dataset:
Wherever possible the CVMP used the statistical method for calculating the individual withdrawal periods based on single studies, but in line with the CVMP Note for Guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1, where the necessary parameters were not shown to be valid for the statistical analysis, the alternative approach was used for calculating withdrawal periods. 
Kjer je bilo mogoče, je CVMP uporabil statistično metodo za izračun posameznih karenc na podlagi posameznih študij, vendar v skladu z Navodili CVMP: pristop k usklajevanju karenc (EMEA/CVMP/036/95)1; kjer se za potrebne parametre ni dokazala veljavnost za statistično analizo, so za izračun karenc uporabili alternativni pristop.
Marketing Authorisation Holder and address 
Imetnik dovoljenja za promet z zdravilom in naslov
On a log-scale, the total ivermectin residue intake (µg) for a consumer, calculated from data of each animal (data points), compared with the ADI (µg/person, horizontal line). 
Logaritemska vrednost skupnega vnosa zaostankov ivermektina (µg) za potrošnika, izračunana iz podatkov za vsako žival (podatkovne točke), v primerjavi z ADI (µg/osebo, vodoravna črta).
In these studies, different formulations showed different absorption patterns of avermectins (including ivermectin), while all other parameters were the same (such as species, breed, weight, and place of injection). 
V teh študijah so različne formulacije pokazale različne vzorce absorpcije avermektinov (vključno z ivermektinom), medtem ko so bili drugi parametri enaki (kot so živalska vrsta, pasma, telesna masa in mesto injiciranja).
From the data available no correlations were found that could explain the difference in depletion profiles or estimated withdrawal periods, and none of the parameters recorded could be identified as a large single source of variation. 
V razpoložljivih podatkih niso našli korelacij, ki bi lahko pojasnile razlike v profilih izločanja ali ocenjenih karencah, hkrati pa se noben ugotovljen parameter ni pokazal kot velik in edini vir variacije.
From the overall data submitted by the MAHs and the National Competent Authorities of the Member States only 11 ivermectin residue depletion studies were considered of adequate quality for the purpose of calculating withdrawal periods, as only in these studies the relevant tissues including the injection sites were sampled and analysed. 
Od vseh podatkov, ki so jih imetniki dovoljenj za promet z zdravilom predložili nacionalnim pristojnim organom držav članic, je le 11 študij o izločanju ostankov ivermektina bilo primerno kakovostnih za izračun karenc, ker so v teh študijah vzeli vzorce primernih tkiv, vključno z mesti injiciranja, ter jih analizirali.
Considering the totality of the data on clorsulon residue depletion, the statistical method could not be used for calculating the withdrawal periods as the relevant statistical assumptions were not met. 
Če upoštevamo celoten nabor podatkov o izločanju zaostankov klorsulona, ni možno uporabiti statistične metode za izračun karenc, saj niso izpolnjene ustrezne statistične predpostavke.
Czech Republic Bioveta a.s., Komenského 212 
Romunija Bioveta a.s., Komenského 212
Using the alternative approach and applying safety span of 10% a withdrawal period of 66 days was derived. 
Z alternativnim pristopom in uporabo varnostnega faktorja 10 % so izpeljali karenco 66 dni.
Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60. 
Madžarska Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60.
As a matter of principle with regards to products that have been shown to be bioequivalent, it should be noted that the definition of bioequivalence does not guarantee equal levels of residues at the injection site far beyond the time points where plasma samples were taken. 
Upoštevati je treba, da načelno pri zdravilih z dokazano bioekvivalenco definicija bioekvivalence ne zagotavlja enakih ravni zaostankov na mestu injiciranja na časovnih točkah dolgo po odvzemu vzorcev plazme.
• the CVMP assessed the original data provided during this referral and concluded that, based on these data, an impact of formulation on residue depletion could not be demonstrated and that the variability in the data was such that an effect of formulation on residue depletion could have been masked; 
• CVMP je ovrednotil izvirne podatke, ki so bili predloženi v tem napotitvenem postopku, ter zaključil, da na podlagi teh podatkov ni možno dokazati vpliva formulacije na izločanje ostankov, ter da je variabilnost podatkov lahko zakrila učinek formulacije na izločanje ostankov;
Bremer Pharma GmbH. 
Madžarska Bremer Pharma GmbH.
While the data examined by the CVMP did lead to the calculation of different withdrawal periods for products that are essentially the same, this variability is not considered to reflect product specific effects but is rather a feature of the way the products were used (i.e. the variation results from differences such as animal bodyweight, breed, sex, age, injection volume and sampling procedure). 
Čeprav so podatki, ki jih je pregledal CVMP, dali izračune različnih karenc za zdravila, ki so bistveno enaka, velja, da ta variabilnost ne odraža za zdravilo specifičnih učinkov, ampak je posledica načina uporabe zdravil (tj. variacija je posledica razlik v telesni masi živali, pasmi, spolu, starosti, injiciranem volumnu in postopku vzorčenja).
Residue depletion data submitted for the formulation group containing ivermectin and closantel led to a withdrawal period of 36 days for closantel, calculated using the alternative approach and applying a safety span of 30%. 
Iz podatkov o izločanju ostankov, predloženih za formulacijsko skupino z ivermektinom in klosantelom, so za klosantel z alternativnim pristopom in uporabo varnostnega faktorja 30 % izračunali karenco 36 dni.
The variability in calculated withdrawal periods reflects the variability in the depletion profiles and particularly the variability in depletion of residues from the injection site. 
Variabilnost izračunanih karenc odraža variabilnost profilov izločanja in zlasti variabilnost izločanja zaostankov z mesta injiciranja.
• the CVMP considered that sources of variation linked to the subcutaneous use of ivermectin in cattle are present that lead to different depletion profiles in residue studies, and this variation is of much more importance than any variation that may be caused by formulation differences. 
• CVMP je upošteval, da so prisotni viri variacij, povezani s podkožno uporabo ivermektina pri govedu, ki povzročajo različne profile izločanja v študijah ostankov, ter da je ta variacija veliko pomembnejša od vseh variacij, ki so morda posledica razlik v formulacijah.
In cattle injectable veterinary medicinal products containing ivermectin, either as a single active ingredient or in combination with a second active substance, are used against infestations with endoparasites and ectoparasites by administering 200 μg ivermectin/kg bw subcutaneously. 
Pri govedu se zdravila za injiciranje, ki vsebujejo ivermektin kot edino zdravilno učinkovino ali v kombinaciji z drugo, uporabljajo za infestacije z endoparaziti in ektoparaziti z dajanjem subkutano 200 μg ivermektina/kg TM.
A key question raised by this referral asks whether there is a formulation effect on residue depletion from tissues and particularly from the injection site. 
Ključno vprašanje, zastavljeno v tem napotitvenem postopku, je, ali obstaja učinek formulacije na izločanje ostankov iz tkiv, zlasti iz mesta injiciranja.
Taking residue data from the studies into consideration, the first time point at which no values exceeded the MRL for clorsulon was 60 days. 
Če upoštevamo podatke o izločanju ostankov iz študij, je 60 dni prva točka, pri kateri vrednosti ne presežejo ravni MRL za klorsulon.
For the purposes of this referral, that means that the withdrawal periods for all products in a single formulation group should be the same. 
Za namene tega napotitvenega postopka to pomeni, da bi morale biti karence enake za vsa zdravila v posamezni formulacijski skupini.
Because the equivalence of local residue levels at the injection site cannot be predicted based on plasma bioequivalence, and because published data indicate that formulation can have an impact on residue depletion profiles for ivermectin, the CVMP considered that, in general, there is no basis for automatically extrapolating a withdrawal period established for one formulation to a second formulation, even if plasma bioequivalence has been shown. 
Ker ekvivalence lokalnih ravni zaostankov na mestu injiciranja ni mogoče predvideti na podlagi plazemske bioekvivalence in ker objavljeni podatki kažejo, da ima lahko formulacija vpliv na profile izločanja ostankov ivermektina, je CVMP ugotovil, da na splošno kljub dokazani plazemski bioekvivalenci ni podlage za samodejno ekstrapolacijo karence, ki je ugotovljena pri eni formulaciji, na drugo formulacijo.
It should be noted that for many of the studies the scatter of the data was such that the harmonised statistical method for the establishment of withdrawal periods could not be used, and the withdrawal period that results from use of the alternative method is always highly dependent on the choice of time points. 
Upoštevati je potrebno, da je bila za večino študij razpršenost podatkov tolikšna, da ni bilo mogoče uporabiti usklajene statistične metode za določitev karence ter da je karenca, ki se izračuna z alternativno metodo, vedno zelo odvisna od izbire časovnih točk.
ANTIBIOTICE IASI S.A. Str. Valea Lupului, nr. 1, Iaşi, jud. 
Str. Valea Lupului, nr. 1, Iaşi, jud.
Additionally, for a further 11 products for which residue depletion data were provided, it was concluded that no individual withdrawal period could be calculated due to the inadequacy of the submitted product-specific data. 
Poleg tega je za dodatnih 11 zdravil, za katera so bili predloženi podatki o izločanju ostankov, zaključil, da zaradi nezadostnosti predloženih podatkov, ki so specifični za to zdravilo, posameznih karenc ni mogoče izračunati.
When the alternative approach was used for individual residue study data the withdrawal period was derived from the first time point at which all calculated intakes were below the ADI, with the addition of a safety span. 
Če se je uporabil alternativni pristop za podatke posameznih študij zaostankov, so karenco izpeljali iz prve časovne točke, v kateri so bili vsi izračunani vnosi pod ADI po dodatku varnostnega faktorja.
The CVMP considers that products that are essentially the same (in formulation terms) should have identical withdrawal periods. 
CVMP ugotavlja, da bi morala imeti bistveno enaka zdravila (v smislu formulacije) enako karenco.
In the figure below, all available data for the total intake of ivermectin residues is plotted and compared to the ADI. 
Spodnja slika prikazuje vse razpoložljive podatke o skupnem vnosu ostankov ivermektina v primerjavi z ADI.
HEMOFARM - HEMOVET Beogradski Put BB Vrsac 
Romunija HEMOFARM - HEMOVET Beogradski Put BB
Belgium MERIAL Belgium S.A. Bld Sylvain Dupuis 243 
Luksemburg MERIAL Belgium S.A. Bld Sylvain Dupuis 243
Moreover, because of the fact that the variation in the residue profile due to sources of variation connected to the subcutaneous use of ivermectin is much greater than the formulation effect, the Committee concluded that it would be appropriate to consider the totality of ivermectin residue data from all formulation groups to derive a single harmonised withdrawal period. 
Ker je variacija profilov ostankov zaradi virov variacije, ki so povezani s podkožno uporabo ivermektina, veliko večja od učinka formulacije, je Odbor zaključil, da bi bilo primerno upoštevati skupne podatke o ostankih ivermektina iz vseh formulacijskih skupin za izpeljavo enotne usklajene karence.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING 
DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA OZNAČEVANJA
VET4VET d.o.o. 
Slovenija VET4VET d.o.o.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
Discussion of specific issues raised in the referral notification 
Razprava o specifičnih vprašanjih, zastavljenih med prijavo napotitvega postopka
VMD Animal Health Ltd. Közraktár u. 22/b. 
Madžarska VMD Animal Health Ltd. Közraktár u. 22/b.
Of the formulation groups to which products were allocated in this procedure, two contained combination products; one with products containing the active substances ivermectin and clorsulon, and the second with products containing the active substances ivermectin and closantel. 
Kombinirana zdravila so bila v dveh formulacijskih skupinah, v katere so bila zdravila razporejena v okviru tega postopka; v eni skupini so bila zdravila z zdravilnima učinkovinama ivermektin in klorsulon, v drugi skupini pa zdravila z zdravilnima učinkovinama ivermektin in klosantel.
the CVMP has recommended the amendment of the Marketing Authorisations for all injectable veterinary medicinal products containing ivermectin for use in cattle as refered in Annex I for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III. 
CVMP priporoča dopolnilo dovoljenj za promet za vsa v Dodatku I navedena zdravila za injiciranje, ki vsebujejo ivermektin in se uporabljajo pri govedu ter imajo v Dodatku III opredeljene povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo.
A toxicological Acceptable Daily Intake (ADI) of 10 µg/kg bw/day (600 µg/person per day) was established based on the NOEL of 0.5 mg/kg bw/day retained from a 14-week dog study, applying a safety factor of 50. 
Na podlagi odmerka brez opaznega učinka (NOEL) 0,5 mg/kg TM/dan, ugotovljenega v 14-tedenski študiji na psih, je bil z uporabo varnostnega faktorja 50 določen toksikološko sprejemljiv dnevni vnos (ADI) 10 µg/kg TM/dan (600 µg/osebo dnevno).
2.1 Calculation of a harmonised withdrawal period for ivermectin containing injectable products for use in cattle 
2.1 Izračun usklajene karence za zdravila za injiciranje, ki vsebujejo ivermektin, za uporabo pri govedu
Based on the 11 ivermectin residue depletion studies of adequate quality provided, the CVMP calculated the withdrawal periods for 12 products. 
CVMP je na podlagi 11 predloženih študij izločanja ostankov ivermektina z zadostno kakovostjo izračunal karence za 12 zdravil.
B. For products listed in Annex I containing ivermectin as sole active ingredient or in combination with closantel: 
B. Za zdravila iz Dodatka I, ki vsebujejo ivermektin kot edino zdravilno učinkovino ali v kombinaciji s klosantelom:
An attempt was made to find a correlation between the slopes or intercepts of the depletion curves and any of the following parameters: formulation group, bodyweight, breed, sex, age, and injection volume, using ANOVA or Pearson's methodology. 
Z metodologijo ANOVA in Pearsonovo metodo so poskusili najti korelacijo med nakloni ali presečišči krivulj izločanja in katerim koli izmed naslednjih parametrov: formulacijsko skupino, telesno maso, pasmo, spolom, starostjo in injiciranim volumnom.
Therefore, a withdrawal period of at least 49 days will apply for the combination products in all cases. 
Zato imajo kombinacijska zdravila v vseh primerih karenco najmanj 49 dni.
• the CVMP considered that, taking into account the high variation observed, a single harmonised withdrawal period based on all available residue intake data should be established for all products concerned that contain ivermectin as the only active substance; 
• CVMP je ob upoštevanju ugotovljene velike variacije menil, da je potrebno na podlagi vseh razpoložljivih podatkov o vnosu ostankov določiti enotno, usklajeno karenco za vsa zadevna zdravila, ki vsebujejo ivermektin kot edino zdravilno učinkovino.
Pharmacologically active substance 
Farmakološka zdravilna učinkovina
Ganzestaartsedijk 8 - 5525 KC Duizel 
Romunija PANTEX Ganzestaartsedijk 8 - 5525 KC Duizel The Netherlands
A safety span of 10% was considered appropriate as the studies were large and robust. 
Ker so bile študije velike in robustne, se je za primernega štel 10-odstotni varnostni faktor.
Bayer Hungária Ltd. H-1123 Budapest Alkotás u. 50. 
Madžarska Bayer Hungária Ltd. H-1123 Budapest
The harmonised withdrawal period of 49 days is relevant only to the ivermectin component of injectable products containing ivermectin. 
Usklajena karenca v trajanju 49 dni velja le za ivermektinsko komponento zdravil za injiciranje.
Therefore, the Committee concluded that a harmonised withdrawal period of 49 days could be established for the ivermectin component of all injectable products containing ivermectin, for use in cattle. 
Zato je Odbor zaključil, da se lahko za ivermektinsko komponento vseh zdravil za injiciranje z ivermektinom, ki se uporabljajo za govedo, določi usklajena karenca 49 dni.
Approach towards harmonisation of withdrawal periods http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf 2 CVMP Guideline on Injection Site Residues. 
Pristop k usklajevanju karenc http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf
Box 78, 
Mogilska 80,
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS 
DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
Czech Republic Bremer Pharma GmbH Cherbourger Str. 25 
Romunija Bremer Pharma GmbH Cherbourger Str. 25
Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 - 335 Sintra Portugal 
Portugalska Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro
Invented name Strengths 
Izmišljeno ime
Cattle: Meat and offal - 66 days. 
Govedo: Meso in drobovina - 66 dni.
Since the withdrawal period calculated based on the clorsulon component for these product exceeds the 49 days derived for the ivermectin component, 66 days is recommended as the withdrawal period for the combination products containing ivermectin and clorsulon. 
Ker karenca, izračunana za klorsulonsko komponento teh zdravil, presega 49-dnevno karenco, izpeljano za ivermektinsko komponento, se za kombinirana zdravila z ivermektinom in klorsulonom določa karenca 66 dni.
ANNEX III AMENDMENT TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 
DODATEK III DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 
Portugalska Merial Portuguesa - Saúde Animal, Lda AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 2635-432 Rio de Mouro
BIOVET JSC 39 Petar Rakov Str. 4550 Pesthera Bulgaria 
Bolgarija BIOVET JSC 39 Petar Rakov Str.
Alfasan International B.V., P.O. 
Bolgarija Alfasan International B.V., P.O. Box 78,
For injectable veterinary medicinal products containing ivermectin in combination with another active substance residue depletion of the second active substance must also be considered, and a withdrawal period for the second active substance derived. 
Pri zdravilih za injiciranje z ivermektinom v kombinaciji z drugo zdravilno učinkovino je potrebno upoštevati tudi izločanje zaostankov druge zdravilne učinkovine.
Marker residue Animal species MRLs 
Živalska vrsta MRL Ciljna tkiva
If the withdrawal period determined on the basis of residue depletion data for the second active substance is less than 49 days, then a withdrawal period of 49 days is recommended for the product. 
Če je karenca, določena na osnovi podatkov izločanja ostankov druge zdravilne učinkovine, krajša od 49 dni, se za zdravilo določi karenca v trajanju 49 dni.
A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 4.11 Withdrawal period(s) 
A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon: 4.11 Karenca(-e)
• the CVMP considered that for combination products containing ivermectin as well as a second active substance, residue depletion of the second active substance must also be considered when setting the withdrawal period and the withdrawal period for the product shall be the longest established for the individual components. 
• CVMP je menil, da je treba pri določanju karence za kombinirana zdravila z ivermektinom in drugo zdravilno učinkovino upoštevati tudi izločanje ostankov druge zdravilne učinkovine in da je karenca za zdravilo daljša karenca, določena za posamezni komponenti.
Cattle, Sheep, Goats, Pigs 
Govedo, ovce, koze, prašiči
Closiver Injection Ivermectin 5 mg/ml, Closantel 125 mg/ml 
Closiver Injection Ivermektin 5 mg/ml, klosantel 125 mg/ml
A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 10. 
A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon: 10.
Since this is below the 49 days limit applied for the ivermectin component, a withdrawal period of 49 days is recommended for the combination products containing ivermectin and closantel. 
Ker je ta karenca krajša od mejnih 49 dni za ivermektinsko komponento, se za kombinirana zdravila z ivermektinom in klosantelom določa karenca 49 dni.
WITHDRAWAL PERIOD 
Označevalec ostanka
A safety span of 30% was used in view of the large variation in the intake figures, which was primarily caused by the variation of residues found in injection sites. 
Zaradi velike variacije vrednosti vnosa, ki je bila zlasti posledica variacije zaostankov na mestih injiciranja, so uporabili varnostni faktor 30 %.
DUTCH FARM VETERINARY PHARMACEUTICALS B.V. 
Romunija DUTCH FARM VETERINARY PHARMACEUTICALS
If, on the other hand, the withdrawal period determined on the basis of residue depletion data for the second active substance is greater than 49 days, then the recommended withdrawal period for the product should be based on depletion of residues of the second active substance. 
Če pa je karenca, določena na osnovi podatkov izločanja ostankov druge zdravilne učinkovine, daljša od 49 dni, se za zdravilo določi karenca na osnovi izločanja ostankov druge zdravilne učinkovine.
Ivermectin 5 mg/ml, Closantel 125 mg/ml 
Ivermektin 5 mg/ml, klosantel 125 mg/ml
Mogilska 80, 31546 Krakow Poland 
31546 Krakow
2.2 Derivation of the withdrawal period for injectable veterinary medicinal products contains ivermectin as well as a second active substance (combination products) 
2.2 Izpeljava karence za zdravila v veterinarski medicini za injiciranje z ivermektinom ter drugo zdravilno učinkovino (kombinacijska zdravila)
The Netherlands Dopharma Research B.V. Zalmweg 24 
Nizozemska Dopharma Research B.V.
A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 
A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon:
DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. 
Romunija DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. Jordan NA UR 11710 PO BOX 285
Other sources of variation connected to the subcutaneous use of ivermectin were therefore considered to be of more importance than formulation with regard to residue depletion and withdrawal periods. 
Zato so glede izločanja zaostankov in karenc kot pomembnejše od formulacije šteli druge vire variacije, povezane s podkožno uporabo ivermektina.
INDUSTRIAL VETERINARIA, S.A. 
Romunija FARMAVET S.A.
WITHDRAWAL PERIOD Cattle: Meat and offal - 66 days. 
KARENCA Govedo: Meso in drobovina - 66 dni.
The Netherlands Chanelle Animal Health Ltd 7 Rodney Street 
Nizozemska Chanelle Animal Health Ltd 7 Rodney Street
WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days 
Govedo: Meso in drobovina - 49 dni
Cattle, Sheep, Reindeer, Pigs 
Govedo, ovce, jeleni, prašiči
Baymec Trio 1% Ivermectin 10 mg/ml 
Baymec Trio 1% Ivermektin 10 mg/ml
United Kingdom Chanelle Animal Health Ltd 7 Rodney Street 
Portugalska Chanelle Animal Health Ltd 7 Rodney Street
United Kingdom VIRBAC DE PORTUGAL Laboratorios LdaRua Dionísio Saraiva, Lote 1, 
Portugalska VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionísio Saraiva, Lote 1,
Belgium Laboratorios Calier SA Barcelones 
Madžarska Laboratorios Calier SA Barcelones
Cattle, Reindeer, Pigs 
Govedo, jeleni, prašiči
Wedemec R Ivermectin 10 mg/ml 
Wedemec R Ivermektin 10 mg/ml