natgillin/translations-raw huggingface dataset:
Pellet storage stability was evaluated by examining the difference in the level of tilmicosin assay over a 12 week period at 25 °C/60% relative humidity (RH) and 40 °C/70% RH.
Stabilnost shranjevanja pelet je bila ocenjena na podlagi poizkusa preučitve razlike v ravni tilmikozina v obdobju 12 tednov pri 25 °C/60 % relativne vlažnosti (RH) in 40 °C/70 % RH.
CVMP opinion following an Article 34 referral on Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names (2009)http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
Mnenje CVMP na podlagi napotitve po 34. členu za zdravila Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix in z njimi povezana imena (2009)http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
kg pre-mix/ton feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x pre-mix strength (g/kg)
kg predmešanice/tono krmila = odmerek (mg/kg telesne mase) x telesna masa (kg) dnevni vnos krme (kg) x jakost predmešanice (g/kg)
The CVMP therefore requests that conditioning/pelleting stability studies with three batches of medicated rabbit feeds are carried out in order to confirm whether or not the high tilmiscosin valuies are typical results (see Annex IV).
Odbor CVMP zato zahteva, da se izvede študije stabilnosti kondicioniranja/peletiranja s tremi serijami medicirane krme za kunce, da se potrdi, ali so visoke vrednosti tilmikozina tipične ali ne (glejte Prilogo IV).
Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
Danska Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
The relevant advice given in the product literature should be provided along with a discussion of whether this is in line with CVMP's Note for guidance (EMEA/CVMP/080/95).
V podatkih o zdravilu pa mora biti poleg ustreznega nasveta tudi razprava o tem, ali je predpis v skladu z navodili Odbora CVMP (EMEA/CVMP/080/95).
Mean content in pelleted feeds was in the range of 90-110% of the nominal content therefore, the homogeneity of those medicated feeds is considered demonstrated.
Povprečna vsebnost v peletiranih krmilih je bila med 90 in 110 % nominalne vsebnosti, zato velja, da je homogenost teh mediciranih krmil dokazana.
This dose should be maintained by a proper mixing of medicated pre-mixes of different concentrations into feedingstuffs.
Ta odmerek je treba vzdrževati s pravilnim mešanjem različnih koncentracij medicirane predmešanice v krmno mešanico.
Shelf life after incorporation into meal or pelleted feed: 3 months
Rok uporabnosti po dodajanju v moko ali peletirano krmo: 3 mesece
On 8 April 2011, the European Commission initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for all pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
8. aprila 2011 je Evropska komisija sprožila napotitev v skladu s 35. členom Direktive 2001/82/ES, kot je bila spremenjena, za vse predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem.
Concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Koncentracije so za 10-13 % večje od pričakovane nominalne koncentracije 200 mg/kg.
The marketing authorisation holders reported that the administration of feed to the food producing rabbits is via complete feedingstuff.
Imetniki dovoljenja za promet z zdravili so poročali, da odmerjanje krme za kunce, namenjene za proizvodnjo hrane, poteka prek popolne krmne mešanice.
Note: The text in grey shading below is not applicable for MICLOZAN 200 pre-mix (see Annex I):
Opomba: Sivo osenčeno besedilo spodaj ne velja za predmešanico MICLOZAN 200 (glejte Prilogo I):
The high values of tilmicosin in the medicated feed prior to the pelleting process need further explanation.
Visoke vrednosti tilmikozina v medicirani krmi pred postopkom peletiranja je treba dodatno razložiti.
The CVMP's Note for guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (medicated pre-mixes) (EMEA/CVMP/080/95)
V navodilu Odbora CVMP o dodatnih zahtevah glede kakovosti zdravil, namenjenih za dodajanje v krmo za živali (mediciranih predmešanic) (EMEA/CVMP/080/95)
Shelf life after incorporation into pelleted feed containing more than 30% wheat: 1 month
Rok uporabnosti po dodajanju v peletirano krmo, ki vsebuje več kot 30 % pšenice: 1 mesec
CVMP Note for Guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (mediciated premixes)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004466.pdf
Navodilo odbora CVMP o dodatnih zahtevah glede kakovosti zdravil, namenjenih za dodajanje v krmo za živali (mediciranih predmešanic)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004466.pdf
Whilst the demonstration of homogeneity was considered acceptable, the higher than expected values need explanation, taking into account that if those meal feeds were administered to animals, the concentration in those feeds would be higher than the target dose of 200 ppm.
Čeprav je bil dokaz homogenosti sprejemljiv, pa je treba pojasniti vrednosti, višje od pričakovanih, saj bi bila v primeru, da bi te krmne obroke dali živalim, koncentracija v teh krmilih večja od ciljnega odmerka 200 ppm.
The CVMP also considered that rabbits are minor species, with specific problems concerning availability of authorised veterinary products for this species and considered the history of use and the various management steps now set out in the harmonised SPC (bacteriological sampling and susceptibility testing are recommended).
Odbor CVMP je prav tako menil, da so kunci manjša vrsta, za katere so odobrena veterinarska zdravila še posebej težko dostopna, in preučil tudi zgodovino uporabe ter različne ukrepe zdravljenja, ki so sedaj navedeni v usklajenem povzetku glavnih značilnosti zdravila (priporočeno je bakteriološko vzorčenje in testiranje občutljivosti).
The pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g of tilmicosin per kg premix, are veterinary medicinal products which are indicated in pigs for the prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Predmešanice za medicirano krmo, ki vsebujejo 40 g, 100 g ali 200 g tilmikozina na kg predmešanice, so zdravila za uporabo v veterinarski medicini in so indicirana za preprečevanje in zdravljenje bolezni dihal pri prašičih, ki jih povzročajo Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida in drugi organizmi, občutljivi na tilmikozin.
Amendments in the relevant sections of the labelling
Dopolnila v ustreznih poglavjih označevanja
Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
Nemčija Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
The results of a mixing uniformity study (with tilmicosin 100 g and 200 g pre-mixes) the homogeneity results obtained from ten analysed samples per batch, showed no samples out of the 85-115% range of the mean content.
Rezultati o homogenosti v študiji o enotnem mešanju (s 100-gramskimi in 200-gramskimi predmešanicami), ki so pridobljeni iz desetih analiziranih vzorcev na serijo, niso pokazali nobenih primerov izven 85-115-odstotnega razpona povprečne vsebnosti.
Dose of tilmicosin Duration of treatment Inclusion rate in feed
Odmerek tilmikozina Trajanje zdravljenja Stopnja dodajanja v krmo
The marketing authorisation holders should conduct conditioning/pelleting stability studies with three batches of medicated rabbit feeds (manufactured using tilmicosin 200 g per kg pre-mix) in order to confirm that if meal rabbit feed was correctly formulated with a concentration of 200 ppm, tilmicosin content in the pelleted feed would still be within the specification range of ±15 % of nominal value over a period of 3 months.
Imetniki dovoljenja za promet z zdravilom morajo opraviti študije o stabilnosti kondicioniranja/peletiranja s tremi serijami medicirane krme za kunce (izdelane z uporabo 200 g tilmikozina na kg predmešanice) in potrditi, da bi bila v primeru, da bi bil krmni obrok za kunce pravilno sestavljen s koncentracijo 200 ppm, vsebnost tilmikozina v peletirani krmi v obdobju 3 mesecev še vedno v območju specifikacije v višini ± 15 % nominalne vrednosti.
Taking into account the characteristics of a rabbit feed used to prepare pelleted medicated feedingstuffs, it was concluded that the maximum limit of cereal meals that can be used in commercial feedingstuffs for fattening rabbits should be less than 30% (the inclusion of 30% of wheat meal is not appropriate due to the risk of triggering severe enteric problems).
Glede na značilnosti krme za kunce, ki se je uporabljala za pripravo mediciranih krmil, je bilo zaključeno, da se v komercialnih krmilih za pitanje kuncev lahko uporablja največ do 30 % žitne moke (dodajanje 30 % pšenične moke ni primerno zaradi nevarnosti sprožitve hudih črevesnih težav).
Scientific conclusions and grounds for amendment of the Summary of Product Characteristics and labelling
Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila in označevanja
Consequently, since the inclusion of 30% of wheat meal in medicated pelleted feed in rabbits would not be appropriate, it was considered that there would be no problem with the restriction on the shelf life after incorporation into meal adopted through a worksharing procedure because that case was not expected to be presented in rabbit.
Ker dodajanje 30 odstotkov pšenične moke v medicirane brikete za kunce ne bi bilo primerno, ni bilo nobene težave glede omejitve roka uporabnosti po dodajanju v moko, ki je bil sprejet skozi postopek za delitev dela, saj ni bilo pričakovano, da se bo to pokazalo pri kuncih.
Regarding meal feeds, concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Glede krmnih obrokov so koncentracije za 10-13 % višje od pričakovane nominalne koncentracije 200 mg/kg.
Decrease on tilmicosin content for swine medicated pelleted feeds containing more than 30% wheat was noted.
Opazili so zmanjšano vsebnost tilmikozina v mediciranih briketih za prašiče, ki vsebujejo več kot 30 % pšenice.
Note: The text in grey shading below is not applicable for MICLOZAN 200 premix (see Annex I of the opinion)
Opomba: Sivo osenčeno besedilo spodaj ne velja za predmešanico MICLOZAN 200 (glejte Prilogo I mnenja)
Regardless of the unexplained high meal assay results, it has been considered that if rabbit feed meal was correctly formulated with a concentration of 200 ppm (instead of the high values reported) it would be expected that the tilmicosin content in the pelleted feed would still be within the specification range of ±15 % of nominal value.
Ne glede na nepojasnjeno visoke rezultate testnega obroka, je bil Odbor CVMP mnenja, da bi v primeru, da bi bil krmni obrok za kunce pravilno sestavljen s koncentracijo 200 ppm (namesto prijavljenih visokih vrednosti), pričakovali, da bo vsebnost tilmikozina v peletirani krmi še vedno v območju specifikacije v višini ± 15 % nominalne vrednosti.
Additionally, these veterinary medicinal products are indicated in rabbits for the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Poleg tega so ta zdravila za uporabo v veterinarski medicini indicirana za preprečevanje in zdravljenje bolezni dihal pri kuncih, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, ki sta občutljivi na tilmikozin.
The pharmakokinetic/pharmacodynamic study and MIC data to support use in respiratory disease in rabbits at dose of 12.5 mg/kg bw/day for 7 days (submitted previously) were referenced in the answers to the CVMP list of questions and were found to be acceptable.
Podatki farmakokinetične/farmakodinamične študije in MIK za uporabo pri bolezni dihal pri kuncih v odmerku 12,5 mg/kg telesne mase/dan v obdobju 7 dni (ki so bili predloženi predhodno) so bili navedeni v odgovorih na seznam vprašanj Odbora CVMP, ki je ugotovil, da so sprejemljivi.
When comparing tilmicosin content in the meal feeds during the mixing uniformity test (i.e. prior to pelleting) versus tilmicosin content of the pelleted feeds, a significant decrease in tilmicosin content was observed, although that decrease was within the ± 15% preset acceptance range.
Primerjava vsebnosti tilmikozina v krmnih obrokih v testih za enotno mešanje (tj. pred peletiranjem) in vsebnosti tilmikozina v peletiranih krmilih je pokazala pomembno zmanjšanje vsebnosti tilmikozina, čeprav je bilo to zmanjšanje v okviru ± 15 % vnaprej določenega razpona sprejemljivosti.
Conditions of the marketing authorisation
Pogoji za pridobitev dovoljenja za promet z zdravilom
Taking into account that stability results on medicated pelleted rabbit feeds were similar to those obtained for medicated pelleted pig feeds, a shelf life period of 3 months after incorporation into feeding stuffs was considered acceptable.
Ob upoštevanju rezultatov o stabilnosti mediciranih briketov za kunce, ki so bili podobni rezultatom za medicirane brikete za prašiče, se je zdelo sprejemljivo, da se določi 3-mesečni rok uporabnosti po dodajanju v krmila.
Netherlands Eli Lilly Nederland B.V.Elanco Animal Health
Nizozemska Eli Lilly Nederland B.V.Elanco Animal Health
The use of tilmicosin in rabbits orally at 12.5 mg/kg bw/day for 7 days showed that from the second day of treatment, tilmicosin concentrations attained in lung tissue and pulmonary alveolar macrophages exceeded those in plasma by 7 and 400 fold, respectively, and high levels were maintained in lung tissues during the entire treatment duration.
Peroralna uporaba tilmikozina pri kuncih v odmerkih 12,5 mg/kg telesne mase/dan v obdobju 7 dni je pokazala, da je od drugega dne zdravljenja koncentracija tilmikozina v pljučnem tkivu in pljučnih alveolarnih makrofagih za 7- oziroma 400-krat presegla koncentracije tilmikozina v plazmi, visoke ravni v pljučnih tkivih pa so se ohranile ves čas zdravljenja.
Only medicated rabbit feed prepared with tilmicosin 100 g pre-mix was used.
Uporabljena je bila le medicirana krma za kunce, pripravljena s 100-gramsko predmešanico tilmikozina.
The CVMP has recommended variations of the Marketing Authorisation for all the pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits (see Annex I) in order to amend the Summary of Product Characteristics and labelling in line with recommended changes in the product information as set out in Annex III.
Odbor CVMP je zato priporočil spremembo dovoljenja za promet z zdravilom za vse predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem (glejte Prilogo I), da se povzetek glavnih značilnosti zdravila in označevanje dopolnita v skladu s priporočenimi spremembami v informacijah o zdravilu, kot je določeno v Prilogi III.
12.5 mg/kg bodyweight/day
12,5 mg/kg telesne mase/dan
A risk has been identified on the assessment due to the high values of tilmicosin content in the meal feed prior to the conditioning/pelleting process and no explanation has been provided
Pri oceni je bilo ugotovljeno tveganje zaradi visokih vrednosti vsebnosti tilmikozina na krmni obrok pred postopkom kondicioniranja/peletiranja, za kar ni bila podana nobena obrazložitev.
As the product information is common for pigs and rabbits, the one month shelf life after incorporation into pelleted feed containing more than 30% wheat was considered acceptable.
Ker so informacije o izdelku skupne za prašiče in kunce, se je zdelo sprejemljivo, da se določi enomesečni rok uporabnosti po dodajanju v peletirano krmo, ki vsebuje več kot 30 % pšenice.
The approved dose is 12.5 mg/kg bw/day for 7 days, which is achieved by incorporating tilmicosin at a rate of 200 g per ton of finished feed (equivalent to 200 ppm).
Odobreni odmerek je 12,5 mg/kg telesne mase/dan v obdobju 7 dni, kar se doseže z dodajanjem 200 g tilmikozina na tono končne krme (enakovredno 200 ppm (delov na milijon)).
In a study provided on the homogeneity of a 200 g pre-mix two different batches of 200 g premix were used to prepare 4 pilot batches of medicated feedingstuff (2 batches of crumble feed and 2 batches of pelleted feed).
V študiji o homogenosti 200-gramske predmešanice so z dvema različnima serijama 200-gramske predmešanice pripravili 4 pilotne serije medicirane krme (2 seriji drobljenca in 2 seriji peletirane krme).
Overall summary of the scientific evaluation of all pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits (see Annex I)
Splošni povzetek znanstvenega vrednotenja vseh predmešanic za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem (glejte Prilogo I)
CVMP assessed the efficacy of tilmicosin in rabbits and considered that, notwithstanding the fact that the clinical field study using dosage of the product had some shortcomings, the pre-clinical studies and the minimal inhibitory concentration (MICs) data suggested the effective dosage in feed is 12.5 mg/kg bw/day for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in rabbits.
Odbor CVMP ocenil učinkovitost tilmikozina pri kuncih in menil, da so ne glede na to, da je imela klinična terenska študija z uporabo odmerka zdravila nekaj pomanjkljivosti, podatki predkliničnih študij in minimalna inhibitorna koncentracija (MIK) pokazali, da je za preprečevanje in zdravljenje bolezni dihal pri kuncih, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, učinkovito odmerjanje v krmi 12,5 mg/kg telesne mase/dan v obdobju 7 dni.
Inclusion rates
Stopnje dodajanja
Administer in the feed at 12.5 mg/kg bodyweight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
V krmo dajajte 12,5 mg tilmikozina/kg telesne mase/dan (enakovredno 200 ppm v krmi) v obdobju 7 dni.
• the CVMP considered that high values of tilmicosin content in the meal rabbit feed have been observed prior to the conditioning/pelleting process.
• menil, da so bile visoke vrednosti vsebnosti tilmikozina v krmnih obrokih za kunce opažene pred postopkom kondicioniranja/peletiranja.
Grounds for amendment of the Summary of Product Characteristics and labelling
Podlaga za dopolnilo povzetka glavnih značilnosti zdravila in označevanja
Taking into account the information provided, it is considered that the target of 200 g of tilmicosin per ton of rabbit pelleted feed (200 ppm) could be achieved with the appropriate inclusion rate of the tilmicosin 40 g pre-mix, tilmicosin 100 g pre-mix and tilmicosin 200 g pre-mix, and with all of the pack sizes mentioned.
Glede na navedene informacije, se lahko ciljnih 200 g tilmikozina na tono peletirane krme za kunce (200 ppm) doseže z ustrezno stopnjo dodajanja 40-gramske predmešanice tilmikozina, 100-gramske predmešanice tilmikozina in 200-gramske predmešanice tilmikozina, in sicer za vse omenjene velikosti pakiranja.
34 Rue Jean Monnet Zi D'Etriche 49500 Serge FRANCE
Francija QALIAN 34 Rue Jean Monnet Zi D'Etriche
No data on incorporation were provided for Tilmicosin 40 g pre-mix.
Za 40-gramsko predmešanico tilmikozina ni bilo podatkov o dodajanju.
Tilmicosin content was around 105% of the theoretical value of 200 ppm for crumble
Vsebnost tilmikozina v drobljencu je bila okoli 105 % teoretične vrednosti 200 ppm, v peletirani krmi pa 100-103 %.
Elli Lilly and Company Limited.Speke OperationsFleming RoadSpeke Liverpool
Slovaška Elli Lilly and Company Limited.Speke
Conclusion on the benefit-risk balance
Zaključek o oceni razmerja med koristmi in tveganji
High values of tilmicosin content in the rabbit feed meal have been observed prior to the conditioning/pelleting process.
Opazili so visoke vrednosti vsebnosti tilmikozina v krmnih obrokih za kunce pred postopkom kondicioniranja/peletiranja.
Supporting data for the recommended dose
Podatki o priporočenem odmerku
5 kg tilmicosin 40 g premix /ton
5 kg predmešanice, ki vsebuje 40 g tilmikozina/tono
The CVMP was requested to give its opinion on the recommended dose and inclusion rates in feed for pre-mixes for medicated feedingstuffs containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
Odbor CVMP je zaprosila, naj poda svoje mnenje o priporočenem odmerku in stopnjah dodajanja v krmo za predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem.
Hungary Eli Lilly Regional Operations GmbH
Madžarska Eli Lilly Regional Operations GmbH
Romania Eli Lilly Regional Operations GmbH
Romunija Eli Lilly Regional Operations GmbH
• the CVMP considered the data provided regarding the inclusion rates and agreed that the requirement for the dose being in at least half the daily ration was fulfilled, and that the target of 200 ppm of tilmicosin per ton of feed could be achieved with all the pack sizes of the different strengths (40 g, 100 g and 200 g).
• preučil podatke glede stopenj dodajanja in soglašal, da je bila zahteva za odmerjanje v vsaj polovici dnevnih obrokov izpolnjena ter da se ciljnih 200 ppm tilmikozina na tono krme lahko doseže pri vseh velikostih pakiranj različnih jakosti (40 g, 100 g in 200 g);
Justification and relevant supporting data for the recommended dose and inclusion rates in feed for pre-mixes for medicated feedingstuffs containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
1. utemeljitev in ustrezne informacije glede priporočenega odmerka in stopenj dodajanja v krmo za predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem.
With regard to the inclusion rates it is considered that the requirement for the dose being in at least half the daily ration was fulfilled, and that the target of 200 ppm of tilmicosin per ton of feed could be achieved with all the pack sizes of the different strengths (40 g, 100 g and 200 g).
Glede na stopnje dodajanja velja, da je bila zahteva za odmerjanje v vsaj polovici dnevnih obrokov izpolnjena ter da se ciljnih 200 ppm tilmikozina na tono krme lahko doseže pri vseh velikostih pakiranj različnih jakosti (40 g, 100 g in 200 g).
• the CVMP considered the recommended dose and inclusion rates in feed for pre-mixes for medicated feedingstuffs containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
• preučil priporočeni odmerek in stopnje dodajanja v krmo za predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem;
Amendments in the relevant sections of the Summary of Product Characteristics and labelling
Dopolnila v ustreznih poglavjih povzetka glavnih značilnosti zdravila in označevanja
Taking into account the information provided, the CVMP considered that the requirement for the dose being in at least half the daily ration was fulfilled, and that the target of 200 ppm of tilmicosin per ton of feed could be achieved with all the pack sizes of the different strengths (40 g, 100 g and 200 g).
Odbor CVMP je upošteval predložene podatke in menil, da je bila zahteva za odmerek v vsaj polovici dnevnih obrokov izpolnjena ter da se ciljnih 200 ppm tilmikozina na tono krme lahko doseže pri vseh velikostih pakiranj različnih jakosti (40 g, 100 g in 200 g).
Evaluation of the benefit-risk balance
Ocena razmerja med koristmi in tveganji
INN
je