natgillin/translations-raw huggingface dataset:
A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S. A. in France on 6 July 2004 based on an abridged application citing Duphamox LA as reference medicinal product.
Dovoljenje za promet za zdravilo Suramox 15% LA je bilo prvotno podeljeno podjetju Virbac S. A. iz Francije dne 6. julija 2004, in sicer na podlagi skrajšane vloge, v kateri je bilo zdravilo Duphamox LA navedeno kot referenčno zdravilo.
The withdrawal periods established for Suramox 15% LA were 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Karenca, določena za zdravilo Suramox 15% LA, je bila 58 dni pri govedu za meso in drobovino ter 35 dni pri prašičih za meso in drobovino.
The withdrawal period for milk was 2.5 days.
Karenca za mleko je bila 2, 5 dneva.
The rapporteur was Mr.
Poročevalec je bil dr.
Schefferlie and the co-rapporteur was Prof.
Schefferlie, soporočevalec pa prof.
During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the marketing authorisations for Suramox 15% LA and the Stabox 15% LA, for cattle and pigs.
Med svojim zasedanjem maja 2006 je CVMP na podlagi vseh posredovanih podatkov in znanstvene razprave soglasno sprejel mnenje in z njim priporočil začasni preklic dovoljenja za promet z zdraviloma Suramox 15% LA in Stabox 15% LA, namenjenima za zdravljenje goveda in prašičev.
1 Article 35 of Directive 2001/82/EC, as amended 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
1 Člen 35 Direktive 2001/ 82/ ES, kakor je bila spremenjena 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
na podlagi predloženih podatkov ni bilo mogoče določiti karence za govedo in prašiče; trenutno določene karence za govedo in prašiče ne zagotavljajo, da ostanki ne bodo presegli mejnih vrednosti ostankov (MRL);
the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard to the consumer.
trenutno odobrene karence ne zagotavljajo, da živila, proizvedena s predelavo zdravljenih živali, ne vsebujejo za potrošnikovo zdravje potencialno nevarnih ostankov.
On 1 June 2006, the MAH notified the EMEA of its intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Dne 1. junija 2006 je imetnik dovoljenja za promet obvestil agencijo EMEA, da namerava ponovno zaprositi CVMP za preučitev karence v skladu s členom 36( 4) 2.
During its June 2006 meeting, the CVMP appointed Dr.
Med svojim zasedanjem junija 2006 je CVMP določil dr.
Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Breathnacha za poročevalca pri ocenjevanju oz. za ponovno presojo mnenja.
On 13 September 2006 the CVMP considered the detailed grounds for the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Dne 13. septembra 2006 je CVMP obravnaval dostavljeno dokumentacijo in potrdil svoje prvotno mnenje, s katerim priporoča začasni preklic dovoljenja za promet za zdravilo Suramox 15% LA.
On 14 March 2007 the CVMP, having considered the new residue studies, concluded that it was not possible to set a withdrawal period for Suramox 15% LA and Stabox 15% LA, for either cattle or pig meat and offal and therefore recommended by consensus the suspension of the above marketing authorisations for the above-mentioned products.
Dne 14. marca 2007 je CVMP ob upoštevanju novih študij ostankov zaključil, da za zdravili Suramox 15% LA in Stabox 15% LA ni mogoče določiti karence ne za goveje meso in drobovino niti za meso in drobovino prašičev, zaradi česar je soglasno sprejel priporočilo, da se zgoraj omenjena dovoljenja za promet za zadevna zdravila začasno prekličejo.
On 13 June 2007 the European Commission adopted a Commission Decision suspending the national marketing authorisations for Suramox 15% LA and Stabox 15% LA, but providing an opportunity for the decision to be reviewed further to a new opinion formulated by the CVMP on the basis of the assessment of new residue depletion studies.
Dne 13. junija 2007 je Evropska komisija sprejela sklep, s katerim izreka začasni preklic nacionalnih dovoljenj za promet za zdravili Suramox 15% LA in Stabox 15% LA, ki pa hkrati dopušča možnost ponovne presoje tega sklepa v primeru, da bo CVMP na podlagi ocene novih študij o izločanju ostankov sprejel novo mnenje.
The rapporteur was Mrs.
Poročevalka je bila ga. dr.
Kearsley and the co-rapporteur was Prof.
Kearsley, soporočevalec pa prof.
During its June 2008 meeting the CVMP considered the new residue studies submitted with regard to Suramox 15% LA and concluded that withdrawal periods can now be set for both cattle and pigs for Suramox 15% LA and Stabox 15% LA.
CVMP je na svojem zasedanju v juniju 2008 preučil nove študije ostankov, predložene za zdravilo Suramox 15% LA, in zaključil, da je sedaj za zdravili Suramox 15% LA in Stabox 15% LA možno določiti karenco tako za govedo kot tudi za prašiče.
2 Article 36(4) of Directive 2001/82/EC, as amended
2 Člen 36( 4) Direktive 2001/ 82/ ES, kakor je bila spremenjena
The list of product names concerned is given in Annex I.
EMEA/ 344321/ 2008- SL Seznam zadevnih imen proizvodov je naveden v Dodatku I.
The scientific conclusions are provided in Annex II, together with the SPC in Annex III.
Znanstveni zaključki so podani v Dodatku II, povzetek glavnih značilnosti zdravila pa v Dodatku III.
EMEA/344321/2008-EN
EMEA/ 344321/ 2008- SL
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London, 24 July 2007 EMEA/ 301122/ 2007
London, 24. julij 2007 EMEA/ 301122/ 2007
Amoxicillin
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA zdravilo Suramox 15% LA in z njim povezano ime Stabox 15% LA Mednarodno nelastniško ime (INN): amoksicilin
Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic, belonging to the group of penicillins.
Zdravilo Suramox 15% LA je suspenzija za injiciranje, ki vsebuje amoksicilin, t. j. beta- laktamski antibiotik iz skupine penicilinov.
In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/ kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice at 48 hours interval.
Pri obeh vrstah se zdravilo daje intramuskularno v odmerku 15 mg amoksicilina/ 1 kg tm (enakovredno 1 ml zdravila Suramox 15% LA/ 10 kg tm) dvakrat v 48- urnem razmiku.
A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S. A. in France on 6 July 2004 based on an abridged application having Duphamox LA as reference medicinal product, with a withdrawal period of 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Dovoljenje za promet za zdravilo Suramox 15% LA je bilo prvotno podeljeno podjetju Virbac S. A. iz Francije dne 6. julija 2004, in sicer na podlagi skrajšane vloge za Duphamox LA kot referenčno zdravilo, s karenco 58 dni pri govedu za meso in drobovino ter 35 dni pri prašičih za meso in drobovino.
Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries.
Belgija, Nemčija in Velika Britanija so izrazile pomisleke v zvezi z (ne) ustreznostjo karenc in vloge so bile v teh državah umaknjene.
1 Article 35 of Directive 2001/ 82/ EC, as amended 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
1 Člen 35 Direktive 2001/ 82/ ES, kakor je bila spremenjena 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged marketing authorisations for Suramox 15% LA and the associated invented name Stabox 15% LA, for cattle and pigs.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Med svojim zasedanjem maja 2006 je CVMP, z ozirom na vse posredovane podatke in znanstveno razpravo v okviru Odbora, soglasno sprejel mnenje in z njim priporočil začasni preklic dovoljenja za promet z zdravilom Suramox 15% LA in z njim povezanim izmišljenim imenom Stabox 15% LA, namenjenim za govedo in prašiče.
it was not possible to establish a withdrawal period for cattle and pigs based on the data available;
na podlagi predloženih podatkov karence za govedo in prašiče ni bilo mogoče določiti; trenutno določene karence za govedo in prašiče ne zagotavljajo, da ostanki ne presegajo MRL;
the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
trenutno odobrene karence ne zagotavljajo, da živila, proizvedena iz zdravljenih živali, ne vsebujejo za potrošnikovo zdravje potencialno nevarnih ostankov.
On 1 June 2006, the representative of the MAH notified the EMEA on his intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Dne 1. junija 2006 je zastopnik imetnika dovoljenja za promet z zdravilom obvestil EMEA, da namerava zaprositi za ponovno preučitev mnenja CVMP v skladu s členom 36( 4) 2.
During their June 2006 meeting, the CVMP appointed Dr.
Med svojim zasedanjem junija 2006 je CVMP določil dr.
Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Breathnacha za poročevalca pri ocenjevanju podlage prošnje za ponovno presojo mnenja.
On 13 September 2006 the CVMP, considered the detailed grounds the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
13. septembra 2006 je CVMP obravnaval podrobno podlago za ponovno presojo mnenja in potrdil svoje prvotno mnenje, s katerim priporoča začasni preklic dovoljenja za promet za zdravilo Suramox 15% LA.
During its March 2007 meeting, the CVMP, c onsidered the new residue studies submitted with regard to Suramox 15% LA and concluded that the new data did not allow establishment of withdrawal periods for edible tissues in cattle and pigs.
Med svojim zasedanjem marca 2007 je CVMP preučil nove študije ostankov za zdravilo Suramox 15% LA ter zaključil, da novi podatki ne omogočajo določitve karence za užitna tkiva goveda in prašičev.
Therefore the Committee adopted by consensus a revised op inion confirming its previous recommendation for the suspension of the marketing authorizations for Suramox 15% LA and the associated invented name, Stabox 15% LA.
Posledično je Odbor soglasno sprejel revidirano mnenje, potrjujoče njegovo predhodno priporočilo za začasni preklic dovoljenja za promet z zdravilom Suramox 15% LA in z njim povezanim izmišljenim imenom Stabox 15% LA.
The reas ons being the following:
Razlogi so bili naslednji: o pri govedu so bile koncentracije ostankov na mestu injiciranja še pri zadnji časovni točki zakola višje od MRL; o pri prašičih so bile koncentracije ostankov na mestu injiciranja še pri zadnji časovni točki zakola višje od MRL.
in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point;
Znanstveni zaključki so podani v dodatku II.
in pigs, residue concentrations at the injection site were still above the MRL at the last slaughter time point.
Končno mnenje je Evropska komisija v Odločbo spremenila dne 13. junija 2007.
The list of product names concerned is given in Annex I.
2 Člen 36( 4) Direktive 2001/ 82/ ES, kakor je bila spremenjena
The final opinion was converted into a Decision by the European Commission on 13 June 2007.
EMEA/ 301122/ 2007- SL
2 Article 36(4) of Directive 2001/82/EC, as amended
Stran 2/ 2
EN 1/ 8 Member
SL 1/ 8 Država
Two intramuscular injections at 48 hours interval
Dve injekciji
15 mg amoxicillin/ kg bw (equivalent to 1ml/ 10 kg)
15 mg amoksicilina/ kg tt
58 days Pigs:
58 dni
1 Marketing Authorisation pending 2 Reference Member State for the Mutual recognition Procedure
1 Odobritev dovoljenja za promet v teku 2 Referenčna država članica za postopek medsebojnega priznavanja
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ZAČASNI PREKLIC DOVOLJENJA ZA PROMET Z ZDRAVILOM
EN 3/ 8 SCIENTIFIC CONCLUSIONS
SL 3/ 8 ZNANSTVENI ZAKLJUČKI SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SURAMOX 15% LA3 1.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SURAMOX 15% LA3
Uvod Zdravilo Suramox 15% LA vsebuje amoksicilin, t. j. beta- laktamski antibiotik iz skupine penicilinov.
In setting maximum residue limits (MRLs) for the penicillins, the CVMP adopted the same approach as the Joint FAO/ WHO Expert Committee on Food Additives (JECFA).
Pri določanju najvišjih vrednosti ostankov (MRL) za peniciline, je CVMP sprejel enak pristop kot Skupni strokovni odbor FAO/ WHO za aditive za živila (JECFA).
Thus, the MRLs established by the CVMP for benzylpenicillin were 50 µg/ kg for edible tissues.
Tako je CVMP določil, da je najvišja mejna vrednost ostankov benzilpenicilina v užitnem tkivu 50 µg/ kg..
On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/ 90, in accordance with the following table:
2377/ 90, v skladu z naslednjo preglednico:
Target
Ciljno
active substance
učinkovina
tissue
tkivo
provisions
določbe
Amoxicillin Amoxicillin
Amoksicilin Amoksicilin
All food producing species
Vse vrste za proizvodnjo živil
Muscle Fat Liver Kidney Milk
Mišica Maščoba Jetra Ledvica Mleko
Assessment of residue depletion studies initially submitted For the referral procedure, the MAH presented one residue study in cattle and one in pigs.
Ocena prvotno predloženih raziskav izločanja ostankov Za napotitveni postopek obravnave je MAH predstavil eno raziskavo ostankov pri govedu in eno pri prašičih.
In cattle ten male and ten female (body weight:
Pri govedu je deset samcev in deset samic (telesna teža:
184 ± 24 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/ kg bw (1 ml per 10 kg).
184 ± 24 kg) prejelo dve intramuskularni injekciji zdravila Suramox 15% LA z odmerkom 15 mg/ kg tt (1 ml na 10 kg).
Injection volumes ranged from 15.0 to 25.9 ml.
Razpon vbrizgane količine je segal od 15, 0 do 25, 9 ml.
Groups of 4 animals (2 male and 2 female) were slaughtered at 1, 7, 14, 21, and 36 days after the final injection.
Skupine po 4 živali (2 samca in 2 samici) so bile zaklane 1, 7, 14, 21 in 36 dni po zadnjem injiciranju.
In addition, samples were taken from muscle (mixed sample of hindquarter/ forequarter muscle), fat (mixed sample of perirenal/ omental fat), the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Poleg tega so vzeli vzorce mišic (mešani vzorec zadnje in sprednje četrti), maščobe (mešani vzorec perirenalne maščobe/ maščobe pečice), cela jetra, obe ledvici in desno (zadnje) mesto injiciranja (približne dimenzije 10 cm premera in 6 cm globine).
These samples were chilled, homogenised and stored at -80°C until analysis 4 to 6 months later (storage stability confirmed).
Vzorce so ohladili, homogenizirali in do analize, 4 do 6 mesecev kasneje, hranili pri – 80 °C (obstojnost skladiščenja potrjena).
All samples were analysed for amoxicillin concentrations using an HPLC-UV method with a claimed limit of quantification of 25 µg/ kg for all tissues.
Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC- UV z zahtevano mejo kvantifikacije 25 µg/ kg za vsa tkiva.
3 Or variations of that name as referred to in Annex I
3 Ali različic tega imena, kot so navedene v Dodatku I.
In the injection sites, the amoxicillin concentrations were 5822 to 149831 µg/ kg at day 1, below the limit of quantification to 21724 µg/ kg at day 7, below the limit of quantification to 1651 µg/ kg at day 14, below the limit of quantification to 472 µg/ kg at day 21 and below the limit of quantification to 162 µg/ kg at day 36.
kvantifikacije do 21724 µg/ kg na 7. dan, pod mejo kvantifikacije do 1651 µg/ kg na 14. dan, pod mejo kvantifikacije do 472 µg/ kg na 21. dan in pod mejo kvantifikacije do 162 µg/ kg na 36. dan.
In pigs ten male and ten female (bw 42 ± 7 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/ kg bw (1 ml per 10 kg).
Pri prašičih je deset samcev in deset samic (tt 42 ± 7 kg) prejelo dve intramuskularni injekciji zdravila Suramox 15% LA z odmerkom 15 mg/ kg tt (1 ml na 10 kg).
Injection volumes ranged from 2.88 to 5.52 ml.
Razpon vbrizgane količine je segal od 2, 88 do 5, 52 ml.
Groups of 4 animals (2 male, 2 female) were slaughtered at 1, 7, 14, 21, and 27 days after the final injection.
Skupine po 4 živali (2 samca in 2 samici) so bile zaklane 1, 7, 14, 21 in 27 dni po zadnjem injiciranju.
In addition, samples were taken from muscle (mixed sample of hindquarter/ forequarter muscle), skin+fat in natural proportions, the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Poleg tega so vzeli vzorce mišic (mešan vzorec zadnje in sprednje četrti), kože in maščobe v naravnem razmerju, cela jetra, obe ledvici, in desno (zadnje) mesto injiciranja (približne dimenzije 10 cm premera in 6 cm globine).
These samples were chilled, homogenized and stored at -80°C until analysis 4 to 6 months later; the storage stability was confirmed.
Vzorce so ohladili, homogenizirali in do analize, 4 do 6 mesecev kasneje, hranili pri – 80 °C; obstojnost skladiščenja je bila potrjena.
All samples were analysed for amoxicillin concentrations using an HPLC-UV method (HPLC-fluorescence for liver) with a claimed limit of quantification of 25 µg/ kg for all tissues.
Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC- UV (HPLC- fluorescenca za jetra) z zahtevano mejo kvantifikacije 25 µg/ kg za vsa tkiva.
In the injection sites, the amoxicillin concentrations were 14209 to 109535 µg/ kg at day 1, 358 to 5429 µg/ kg at day 7, 182 to 2816 µg/ kg at day 14, below the limit of quantification to 211 µg/ kg at day 21 and below the limit of quantification to 38 µg/ kg at day 27.
Na mestih injiciranja so bile koncentracije amoksicilina 14209 do 109535 µg/ kg na 1. dan, 358 to 5429 µg/ kg na 7. dan, 182 to 2816 µg/ kg na 14. dan, pod mejo kvantifikacije do 211 µg/ kg na 21. dan in pod mejo kvantifikacije do 38 µg/ kg na 27. dan.
In kidney, amoxicillin concentrations were 5446 to 9896 µg/ kg at day 1, 45 to 811 µg/ kg at day 7, below the limit of quantification at day 14, below the limit of quantification to 180 µg/ kg at day 21 and below the limit of quantification to 62 µg/ kg at day 27.
V ledvicah so bile koncentracije amoksicilina 5446 do 9896 µg/ kg 1. dan, 45 do 811 µg/ kg na 7. dan, pod mejo kvantifikacije na 14. dan, pod mejo kvantifikacije do 180 µg/ kg na 21. dan in pod mejo kvantifikacije do 62 µg/ kg na 27. dan.
2.1 Calculation of withdrawal periods for Suramox 15% LA The MAH initially provided residue data in cattle and pigs using the product under consideration at the recommended dose treatment.
2. 1 Izračun karence za zdravilo Suramox 15% LA MAH je prvotno priskrbel podatke o ostankih pri govedu in prašičih, ki so bili zdravljeni s priporočenim odmerkom obravnavanega izdelka.
Neither the statistical (large extrapolation) nor the alternative approach (values above the MRL at the last time point) could be applied to the data provided, and therefore a withdrawal period could not be set according to the “ Note for guidance:
Ker ni bil za priskrbljene podatke primeren niti statističen (velika ekstrapolacija) niti alternativen pristop (vrednosti nad MRL ob zadnji časovni točki), karenca v skladu z » Navodila:
Approach towards harmonisation of withdrawal periods ” (EMEA/ CVMP/ 036/ 95-FINAL).
Pristop k usklajevanju karenc « (EMEA/ CVMP/ 036/ 95- FINAL) ni bila določena.
For pigs of 40-50 kg, it was possible to derive a withdrawal period of 35 days based on injection site residues.
Pri prašičih, težkih 40- 50 kg, je bila na podlagi ostankov na mestih injiciranja določena karenca 35 dni.
Re-examination of the opinion In the detailed grounds for the re-examination of the opinion the MAH argued that the three out of eight kidney samples with amoxicillin concentrations higher than the MRL at 21 and 27 days after the last administration should be considered artefacts because of the abnormal kinetic depletion residue profile.
Ponovna preučitev mnenja V podrobnostih o podlagi za svojo prošnjo za ponovno preučitev mnenja MAH trdi, da je treba tri izmed osmih vzorcev ledvic s koncentracijami amoksicilina višjimi od MRL na 21. in 27. dan po zadnjem dajanju, imeti za artefakte zaradi nenormalnega kinetičnega profila izločanja ostankov.
EN 5/ 8 Whilst the finding of amoxicillin concentrations above the MRL at two time points following the apparent clear result at 14 days could be an artefact, it could equally be argued that it was the results at 14 days that proved unreliable.
Medtem ko bi najdene koncentracije amoksicilina nad MRL v dveh časovnih točkah, ki sta sledili očitno čistem rezultatu po 14 dneh, lahko bile artefakt, pa je možno trditi tudi, da so rezultati dobljeni po 14 dneh tisti, ki so nezanesljivi.
Considering that the study was GLP-compliant, the CVMP cannot lightly dismiss the results in question, especially as there were a total of three ‘ positive’ samples found.
Ob upoštevanju, da je bila raziskava v skladu z dobro laboratorijsko prakso, CVMP ne more kar tako prezreti teh rezultatov, zlasti ker so bili v celoti najdeni trije "pozitivni" rezultati.
The MAH further argued that the method used was probably not robust enough and cited a recent publication that mentions the need for deproteinization steps to improve method recovery.
SL 5/ 8 MAH je nadalje trdil, da uporabljena metoda verjetno ni bila dovolj robustna in citiral nedavno publikacijo, v kateri je omenjeno, da so za izboljšanje metode obnovljivosti potrebni deproteinizacijski koraki.
Assessment of new data further to the request for re-consideration by the European Commission One new GLP-study in cattle and two complementary GLP-residue studies in pigs were submitted during the procedure for the reconsideration of the opinion.
Ocena novih podatkov, predloženih po zahtevi za ponovno preučitev s strani Evropske komisije Med postopkom ponovne preučitve mnenja je bila predložena ena nova raziskava, skladna z dobro laboratorijsko prakso, pri govedu in dve dopolnilni raziskavi ostankov, skladni z dobro laboratorijsko prakso, pri prašičih.
Residues in kidney ranged from below the limit of quantification to 150 µg/ kg at 7 days and were below the limit of quantification at later time points.
Ostanki v ledvicah so bili po 7 dneh v razponu od vrednosti pod mejo kvantifikacije do 150 µg/ kg, ob drugih časovnih točkah pa pod mejo kvantifikacije.
Residues at the injection sites were high and still up to 5 times above the muscle MRL at the latest time point.
Ostanki na mestih injiciranja so bili visoki in ob zadnji časovni točki še vedno petkrat višji od MRL za mišično maso.
The results reported indicated residue values below the muscle MRL at all time points except for 1 animal at the last time point, which had a concentration of 6 times above the muscle MRL.
Rezultati, o katerih so poročali, so nakazovali vrednosti ostankov pod MRL za mišično maso ob vseh časovnih točkah, razen pri eni živali ob zadnji časovni točki, pri kateri je bila koncentracija šestkrat večja od MRL za mišično maso.
For one animal the result at 30 days was not reported.
Za eno žival ni poročila o rezultatu ob 30 dnevu.