FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of those studies should be provided to the relevant authorities for assessment not later than 12 months after the Commission Decision on this referral procedure.
Slovenian: Rezultate teh študij je treba predložiti ustreznim organom v oceno, najpozneje 12 mesecev po odločbi Komisije o tem napotitvenem postopku.
English: 20041 Agrate Brianza (MB) ITALY
Slovenian: 20041 Agrate Brianza (MB) ITALIJA
English: During the previous referral procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/037)
Slovenian: V prejšnjem napotitvenem postopku v skladu s 34. členom Direktive 2001/82/EC (EMEA/V/A/037)
English: These higher values require further consideration as they would lead to higher than target dose.
Slovenian: Te višje vrednosti zahtevajo nadaljnji razmislek, saj pomenijo višji odmerek od ciljnega.
English: 1000 Brussel
Slovenian: 1000 Brussel BELGIJA
English: The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Slovenian: Komisija je prav tako prosila Odbor, naj predlaga, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: Lilly Portugal - Produtos Farmacêuticos, Lda.
Slovenian: Portugalska Lilly Portugal - Produtos Farmacêuticos, Lda.
English: The condition of the Marketing Authorisations is described in Annex IV.
Slovenian: Pogoj za pridobitev dovoljenja za promet z zdravilom je opisan v Prilogi IV.
English: Prevention and treatment of respiratory disease
Slovenian: Preprečevanje in zdravljenje bolezni dihal
English: According to stability results, after 3 months no significant change was observed for appearance and loss on drying.
Slovenian: Glede na rezultate stabilnosti po 3 mesecih ni bilo opaziti pomembne spremembe v videzu in izgube pri sušenju.
English: National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure that following conditions are fulfilled by the marketing authorisation holders:
Slovenian: Pristojni nacionalni organi, ki jih koordinira referenčna država članica, kot je ustrezno, morajo zagotoviti, da imetniki dovoljenja za promet z zdravilom izpolnjujejo naslednje pogoje:
English: The marketing authorisation holders were requested to provide the following:
Slovenian: Imetniki dovoljenja za promet so morali zagotoviti naslednje:
English: A-4600 Wels AUSTRIA
Slovenian: A-4600 Wels
English: The pharmacokinetic parameters confirm the effective dose of tilmicosin.
Slovenian: Farmakokinetični parametri potrjujejo učinkovit odmerek tilmikozina.
English: The conditioning and pelleting were described.
Slovenian: Postopka kondicioniranja in peletiranja sta bila opisana.
English: Sick animals hereby consume less, being acceptable at 100 g per day.
Slovenian: Bolne živali zaužijejo manj, in sicer 100 g na dan.
English: Even though it was confirmed that no overage was used in the formulation, no justification was found for those results and it was considered that the results do not fall into the normal range observed in other feed studies.
Slovenian: Čeprav je bilo potrjeno, da pri sestavi ni bil uporabljen presežek, ni bilo nobene utemeljitve za te rezultate in se je štelo, da rezultati ne spadajo v običajni obseg, opažen v drugih študijah o krmi.
English: Thus, one rabbit of 1.5 kg can consume in average 180 g of feed per day.
Slovenian: Tako en kunec, ki tehta 1,5 kg, lahko zaužije v povprečju 180 g krme na dan.
English: This discussion should be supported with the appropriate data, i.e. data confirming the pelleting conditions suitability and demonstrating that these conditions do not affect the shelf-life granted for the medicated feedingstuff (1 month).
Slovenian: Ta razprava bi morala biti podprta z ustreznimi podatki, npr. s podatki, ki potrjujejo ustreznost pogojev peletiranja in dokazujejo, da ti pogoji ne vplivajo na rok uporabnosti, odobren za medicirano krmo (1 mesec).
English: Homogeneity was demonstrated as the coefficient of variation was less than 5 % in all the cases tested.
Slovenian: Homogenost je bila dokazana, ko je bil koeficient variacije v vseh testiranih primerih manj kot 5
English: This was further supported considering further data provided in which no such problems were presented thus far with pilot scale batches.
Slovenian: To je bilo še dodatno potrjeno ob upoštevanju dodatnih posredovanih podatkov, v katerih doslej takšne težave pri serijah manjše velikosti niso bile predstavljene.
English: ELANCO VALQUÍMICA, S.A. Avda.
Slovenian: Španija ELANCO VALQUÍMICA, S.A. Avda.
English: List of the names, pharmaceutical forms, active substance, strengths of the veterinary medicinal products, animal species, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, zdravilnih učinkovin, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst ter imetnikov dovoljenja za promet z zdravilom v državah članicah
English: 4.9 Amounts to be administered and administration route:
Slovenian: 4.9 Količine za odmerjanje in način uporabe:
English: de la Industria 30 28108 Alcobendas Madrid
Slovenian: 28108 Alcobendas
English: In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
Slovenian: Da bi dosegli pravilno odmerjanje, je treba ustrezno prilagoditi koncentracijo tilmikozina.
English: Regarding the target species feeding behaviour, it is known that rabbits feed frequently (up to 30 times per day of 2-8 g of feed over 4-6 minute periods
Slovenian: Glede prehranjevalnega vedenja ciljne vrste je znano, da se kunci prehranjujejo pogosto (do 30-krat na dan 2-8 g krme v 4-6-minutnih obdobjih
English: 200 Route de Mayenne Zi des Touches 53000 Laval FRANCE
Slovenian: Francija SOGEVAL 200 Route de Mayenne Zi des Touches 53000 Laval
English: Confirmation should be provided that this requirement will be fulfilled by all of the pack sizes for all the different strengths.
Slovenian: Potrditev, da bo ta zahteva izpolnjena, mora biti zagotovljena za vse velikosti pakiranja in za različne jakosti.
English: Richter Pharma AG Feldgasse 19
Slovenian: Avstrija Richter Pharma AG Feldgasse 19
English: “To ensure through dispersion of the product, it should first be mixed with a suitable quantity of feed ingredients (20 - 50 kg) before incorporation into the finished feed.
Slovenian: „Da bi zagotovili temeljito porazdelitev zdravila, ga je treba najprej zmešati z ustrezno količino krmnih sestavin (20-50 kg) in šele nato dodati v končno krmo.
English: The uptake of medicated feed depends on the clinical condition of the animals.
Slovenian: Izkoristek medicirane krme je odvisen od zdravstvenega stanja živali.
English: states that the daily dose of the medicated pre-mix must be contained in at least half the daily ration of the animals under treatment.
Slovenian: 1, je navedeno, da je treba dnevni odmerek medicirane predmešanice dodati v vsaj polovico dnevnih obrokov živali, ki se zdravijo.
English: Germany Lilly Deutschland GmbHAbt.
Slovenian: Nemčija Lilly Deutschland GmbHAbt.
English: This was considered acceptable, as homogeneity of medicated feedingstuffs is reached with low concentrations of medicated pre-mixes.
Slovenian: To se je zdelo sprejemljivo, saj je bila homogenost medicirane krme dosežena z nizkimi koncentracijami mediciranih predmešanic.
English: The average size of a feed mixer can vary from 3 to 5 tons and complete medicated rabbit feedingstuff is produced in the same size mixers.
Slovenian: Povprečna velikost mešalnika za krmo je lahko od 3 do 5 ton, popolna medicirana krmna mešanica za kunce pa je proizvedena v enako velikih mešalnikih.
English: Regarding meal feeds, mean content was not in the range of 90-110% of the nominal content (180220 ppm), since concentration values were higher than the expected nominal concentration of 200 ppm ± 10% (values rate between 198.1 - 243.6 ppm).
Slovenian: Glede krmnih obrokov, povprečna vsebnost ni bila v razponu 90-110 % nominalne vsebnosti (180-220 ppm), saj so bile vrednosti koncentracije višje od pričakovane nominalne koncentracije 200 ppm ± 10% (vrednosti so bile med 198,1-243,6 ppm).
English: D-61352 Bad Homburg GERMANY
Slovenian: D-61352 Bad Homburg NEMČIJA
English: As outlined in the CVMP's Note for guidance (EMEA/CVMP/080/95) a description should be provided of how the pre-mix is to be incorporated into the feedingstuff.
Slovenian: Kot je navedeno v navodilu Odbora CVMP (EMEA/CVMP/080/95), je treba predpisati, kako naj se predmešanica doda v krmo.
English: The testing of only one strength was considered valid because the concentration of tilmicosin in the final medicated feeding stuffs would be 200 ppm in all cases, as the homogenicity of the other medicated premixes was sufficiently justified.
Slovenian: Testiranje ene same jakosti je veljavno, ker bi bila koncentracija tilmikozina v končni medicirani krmi v vseh primerih 200 ppm, saj je bila homogenost drugih mediciranih predmešanic dovolj utemeljena.
English: The incorporation rate of Tilmicosin 40 g pre-mix in the feed would be 5 kg per ton (the requirement of the European Pharmacopoeia monograph on pre-mixes for medicated feedingstuffs for veterinary use).
Slovenian: Stopnja dodajanja za 40-gramsko predmešanico tilmikozina bi bila 5 kg na tono (zahteva v monografiji Evropske farmakopeje za predmešanice za medicirano krmo za veterinarsko uporabo).
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: kg pre-mix/ton feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x pre-mix strength (g/kg)
Slovenian: kg predmešanice/tono krmila = odmerek (mg/kg telesne mase) x telesna masa (kg) dnevni vnos krme (kg) x jakost predmešanice (g/kg)
English: 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).
Slovenian: 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).
English: Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
Slovenian: Danska Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Povprečna vsebnost v peletiranih krmilih je bila med 90 in 110 % nominalne vsebnosti, zato velja, da je homogenost teh mediciranih krmil dokazana.
English: This dose should be maintained by a proper mixing of medicated pre-mixes of different concentrations into feedingstuffs.
Slovenian: Ta odmerek je treba vzdrževati s pravilnim mešanjem različnih koncentracij medicirane predmešanice v krmno mešanico.
English: Shelf life after incorporation into meal or pelleted feed: 3 months
Slovenian: Rok uporabnosti po dodajanju v moko ali peletirano krmo: 3 mesece
English: 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.
Slovenian: 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.
English: Concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Slovenian: Koncentracije so za 10-13 % večje od pričakovane nominalne koncentracije 200 mg/kg.
English: The marketing authorisation holders reported that the administration of feed to the food producing rabbits is via complete feedingstuff.
Slovenian: Imetniki dovoljenja za promet z zdravili so poročali, da odmerjanje krme za kunce, namenjene za proizvodnjo hrane, poteka prek popolne krmne mešanice.
English: Note: The text in grey shading below is not applicable for MICLOZAN 200 pre-mix (see Annex I):
Slovenian: Opomba: Sivo osenčeno besedilo spodaj ne velja za predmešanico MICLOZAN 200 (glejte Prilogo I):
English: The high values of tilmicosin in the medicated feed prior to the pelleting process need further explanation.
Slovenian: Visoke vrednosti tilmikozina v medicirani krmi pred postopkom peletiranja je treba dodatno razložiti.
English: 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)
Slovenian: V navodilu Odbora CVMP o dodatnih zahtevah glede kakovosti zdravil, namenjenih za dodajanje v krmo za živali (mediciranih predmešanic) (EMEA/CVMP/080/95)
English: Shelf life after incorporation into pelleted feed containing more than 30% wheat: 1 month
Slovenian: Rok uporabnosti po dodajanju v peletirano krmo, ki vsebuje več kot 30 % pšenice: 1 mesec
English: 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
Slovenian: 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
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Amendments in the relevant sections of the labelling
Slovenian: Dopolnila v ustreznih poglavjih označevanja
English: Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
Slovenian: Nemčija Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
English: 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.
Slovenian: 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.
English: Dose of tilmicosin Duration of treatment Inclusion rate in feed
Slovenian: Odmerek tilmikozina Trajanje zdravljenja Stopnja dodajanja v krmo
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Scientific conclusions and grounds for amendment of the Summary of Product Characteristics and labelling
Slovenian: Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila in označevanja
English: 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.
Slovenian: 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.
English: Regarding meal feeds, concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Slovenian: Glede krmnih obrokov so koncentracije za 10-13 % višje od pričakovane nominalne koncentracije 200 mg/kg.
English: Decrease on tilmicosin content for swine medicated pelleted feeds containing more than 30% wheat was noted.
Slovenian: Opazili so zmanjšano vsebnost tilmikozina v mediciranih briketih za prašiče, ki vsebujejo več kot 30 % pšenice.
English: Note: The text in grey shading below is not applicable for MICLOZAN 200 premix (see Annex I of the opinion)
Slovenian: Opomba: Sivo osenčeno besedilo spodaj ne velja za predmešanico MICLOZAN 200 (glejte Prilogo I mnenja)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Conditions of the marketing authorisation
Slovenian: Pogoji za pridobitev dovoljenja za promet z zdravilom
English: 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.
Slovenian: 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.
English: Netherlands Eli Lilly Nederland B.V.Elanco Animal Health
Slovenian: Nizozemska Eli Lilly Nederland B.V.Elanco Animal Health