FrancophonIA/ELRC3.0 huggingface dataset:
English: The following indications for Girolan and its associated names can be supported based on the data provided:
Croatian: Na temelju dostavljenih podataka moguće je potkrijepiti sljedeće indikacije za Girolan i pridružena imena:
English: Girolan and its associated name Apralan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
Croatian: Girolan, i njegovo pridruženo ime Apralan, prašak je koji se primjenjuje u vodi za piće/mlijeku koji sadržava djelatnu tvar apramicin sulfat.
English: Oral doses of apramycin administered from 6th to the 18th day of pregnancy (including doses below the therapeutic doses), have shown evidence of foetotoxic effects.
Croatian: Oralne doze apramicina primijenjene između 6. i 18. dana graviditeta (uključujući doze niže od terapijskih doza) pokazale su fetotoksične učinke.
English: With regard to field studies, twenty-three trials were provided using Girolan soluble powder for the treatment of post-weaning colibacillosis.
Croatian: U pogledu terenskih studija, dostavljeni su podatci o 23 ispitivanja u kojima se topivi prašak Girolan upotrebljavao za liječenje kolibaciloze nakon odbijanja.
English: Apramycin is mainly excreted through faeces, under active form, and only a small quantity is excreted in the urine.
Croatian: Distribucija, biotransformacija i izlučivanje: Apramicin se uglavnom izlučuje putem izmeta, u aktivnom obliku, a samo se mala količina izlučuje putem urina.
English: Therefore, the CVMP concluded that the indication for the treatment of Salmonella in poultry could not be justified and should be deleted from the product information for Girolan.
Croatian: Stoga je CVMP zaključio da se indikacija za liječenje bakterije Salmonella u peradi ne može opravdati te da je treba izbrisati iz informacija o VMP-u Girolan.
English: In conclusion, the documentation provided supports the therapeutic use of Girolan for collibacilosis in chickens.
Croatian: Zaključno, dostavljena dokumentacija ide u prilog terapijskoj primjeni Girolana za kolibacilozu u pilića.
English: The results obtained from these trials showed that for both treatment and prevention of experimental salmonellosis in calves, apramycin sulfate and apramycin base perform equally.
Croatian: Rezultati tih ispitivanja pokazali su da apramicin sulfat i apramicin baza imaju jednako djelovanje u liječenju i prevenciji pokusne salmoneloze u teladi.
English: Rabbits: Oral doses of apramycin administered from 6th to the 18th day of pregnancy (including doses below the therapeutic doses), have shown evidence of foetotoxic effects.
Croatian: Kunići: Oralne doze apramicina primijenjene između 6. i 18. dana graviditeta (uključujući doze niže od terapijskih doza) pokazale su fetotoksične učinke.
English: Salmonella strains were considered generally susceptible to apramycin (MIC≤16 μg/ml) and <5% of Salmonella Dublin strains were shown to be resistant to apramycin.
Croatian: Općenito se smatra da su sojevi bakterijeSalmonella osjetljivi na apramicin (MIC≤16 μg/ml), a za <5% sojeva bakterije Salmonella Dublin pokazalo se da su otporni na apramicin.
English: From this study, a withdrawal period of 28 days for calves meat and offal has been established, which is supported by the other references provided.
Croatian: Na osnovi te studije, za meso i iznutrice teladi utvrđeno je razdoblje karencije od 28 dana, što je potkrijepljeno drugim dostavljenim navodima.
English: Calves: Meat and offal: 28 days.
Croatian: Telad: Meso i iznutrice: 28 dana.
English: Evaluation and conclusions on the benefit-risk balance Girolan and its associated name Apralan has been shown to be efficacious in the indications in pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits listed above.
Croatian: Girolan, i njegovo pridruženo ime Apralan, pokazao se djelotvornim u prethodno navedenim indikacijama u svinja (odbijena prasad), predpreživačke teladi, pilića (tovnih) i kunića.
English: The CVMP accepted this deletion of Salmonella.
Croatian: CVMP je prihvatio brisanje te indikacije za bakteriju Salmonella.
English: It was demonstrated that 22 to 44 mg apramycin per kg bw during 5-10 consecutive days resulted in effective therapy against experimental salmonellosis in calves.
Croatian: Dokazano je da je primjena od 22 do 44 mg apramicina po kg tm tijekom 5 - 10 uzastopnih dana djelotvorna terapija protiv pokusne salmoneloze u teladi.
English: The use is not intended during pregnancy or lactation.
Croatian: Proizvod nije namijenjen za upotrebu tijekom graviditeta ili laktacije.
English: Apramycin is a broad-spectrum aminocyclitol antibiotic produced by a strain of Streptomyces tenebrarius.
Croatian: Apramicin je aminociklitolni antibiotik širokog spektra koji se dobiva iz soja bakterije Streptomyces tenebrarius.
English: After the beginning of medication, the cumulative mortality increased similarly, with noinferiority results in the apramycin group versus colistin group.
Croatian: Nakon početka liječenja, na sličan se način povećala stopa kumulativne smrtnosti, pri čemu u skupini koja je primala apramicin nije bilo inferiornih rezultata u odnosu na skupinu koja je primala kolistin.
English: Taking into account the available information the proposed withdrawal period of zero days for chicken meat and offal was considered acceptable.
Croatian: Uzimajući u obzir dostupne informacije, predloženo razdoblje karencije od „nula dana” za meso i iznutrice pilića smatralo se prihvatljivim.
English: For multidose presentations (bottle and bag):
Croatian: Za više doza (boca i vreća):
English: With regard to the withdrawal periods for chicken meat and offal, a number of residues depletion studies have been presented by the marketing authorisation holder.
Croatian: U pogledu razdoblja karencije za meso i iznutrice pilića, nositelj odobrenja predstavio je velik broj studija o izlučivanju rezidua.
English: Shelf life after dilution in drinking water/milk replacer according to directions: 24 hours.
Croatian: Rok valjanosti poslije razrjeđenja u vodi za piće / mliječnoj zamjeni prema uputama: 24 sata.
English: While it was considered that Salmonella strains are generally susceptible to apramycin (MIC≤16 μg/ml) it should be noted that only Salmonella outbreaks with clinical signs (in the case of calves, caused by Salmonella Dublin) should be treated with apramycin.
Croatian: Iako se smatralo da su sojevi bakterije Salmonella općenito osjetljivi na apramicin (MIK ≤16 μg/ml), potrebno je napomenuti da bi apramicinom trebalo liječiti samo epidemije prouzročene bakterijom Salmonella s kliničkim znakovima (prouzročene bakterijom Salmonella Dublin u slučaju teladi).
English: Light to medium brown granular powder.
Croatian: Granulirani prašak svijetle do srednje smeđe boje.
English: • In general, from a food safety/public health viewpoint, using antimicrobials to control Salmonella spp.
Croatian: • Općenito govoreći, uzimajući u obzir sigurnost hrane/javno zdravlje, malo je opravdanja za primjenu antimikrobnih lijekova za kontrolu bakterije Salmonella spp. u peradi.
English: Overall summary of the scientific evaluation of Girolan and its associated name Apralan (see Annex I)
Croatian: Cjelokupni sažetak znanstvene ocjene veterinarskomedicinskog proizvoda (VMP) Girolan i njegova pridruženog imena Apralan (vidjeti Prilog I.)
English: Girolan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
Croatian: Girolan je prašak koji se upotrebljava u vodi za piće/mlijeku i koji sadržava djelatnu tvar apramicin sulfat.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED <DD/MM/YYYY>
Croatian: 14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA <DD/MM/GGGG>
English: The studies analysed the effect of apramycin dosages between 3.45 mg/kg bodyweight (bw)/day and 75 mg/kg bw/day, via drinking water, during 3, 5 or 7 consecutive days.
Croatian: U studijama se analizirao učinak apramicina u dozama od 3,45 mg/kg tjelesne mase (tm)/dan do 75 mg/kg tm/dan koje su se davale putem vode za piće tijekom 3, 5 ili 7 uzastopnih dana.
English: 100 g powder contain 100 g apramycin sulfate
Croatian: 100 g praška sadržava 100 g apramicin-sulfata
English: In those studies, the animals were examined to confirm the diagnosis prior to the initiation of treatment, bacteriologically and with lesions in different organs; treatment decreased mortality and carcases showed absence of lesions.
Croatian: U tim su studijama životinje pregledane radi potvrđivanja dijagnoze prije početka liječenja, bakteriološki i s obzirom na lezije u različitim organima.
English: Manufacturer responsible for batch release: To be completed nationally.
Croatian: Proizvođač odgovoran za puštanje serije u promet: Ispuniti na nacionalnoj razini.
English: Use of the veterinary medicinal product deviating from the instructions given in the Summary of product characteristics may increase the prevalence of bacteria resistant to the apramycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for cross-resistance.
Croatian: Primjena veterinarsko-medicinskog proizvoda na način koji odstupa od uputa navedenih u sažetku opisa svojstava može povećati učestalost rezistencije bakterija na apramicin i smanjiti djelotvornost liječenja aminoglikozidima zbog mogućnosti križne rezistencije.
English: Do not use in animals suffering from kidney disorders.
Croatian: Ne primjenjivati kod životinja s oštećenjima bubrega.
English: DATE ON WHICH THE LABEL WAS LAST APPROVED <DD/MM/YYYY>
Croatian: 16. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA <DD/MM/GGGG>
English: 552,000 IU/g powder for use in drinking water/milk for pigs, calves, chickens and rabbits Apramycin (sulfate)
Croatian: 552 000 IU/g prašak za uporabu u pitkoj vodi / mlijeku za svinje, telad, kokoši i kuniće Apramicin (sulfat)
English: Powder for use in drinking water/milk for pigs, calves, chickens and rabbits Apramycin (sulfate)
Croatian: Prašak za uporabu u pitkoj vodi / mlijeku za svinje, telad, kokoši i kuniće Apramicin (sulfat)
English: In this sense, in a recent EFSA scientific opinion (June 2017)13 Salmonella infection in poultry (Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae) has been assessed according to the criteria of the Animal Health Law.
Croatian: U tom je pogledu u nedavnom znanstvenom mišljenju EFSA-e (lipanj 2017.)13 infekcija bakterijom Salmonella u peradi (Salmonella Pullorum, Salmonella Gallinarum i Salmonella arizonae) procijenjena u skladu s kriterijima iz Zakona o zdravlju životinja.
English: The intake of medicated water depends on the clinical condition of the animals.
Croatian: Unos vode koja sadržava VMP ovisi o kliničkom stanju životinja.
English: Chicken:
Croatian: Pilići:
English: MIC90 of European isolates of E. coli for apramycin was demonstrated to be 8 μg/ml or less and the resistance proportion of E. coli of chicken origin against apramycin was below 10%.
Croatian: Dokazano je da MIC90 europskih izolata bakterije E. coli za apramicin iznosi 8 μg/ml ili manje i da je omjer otpornosti bakterije E. coli iz pilića na apramicin manji od 10%.
English: Pigs (piglets and growers)
Croatian: Svinje (prasad i tovne svinje)
English: Shelf life after first opening the immediate packaging: 28 days.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakiranja: 28 dana.
English: 4-ply polyethylene terephthalate (PET)/polyethylene/aluminium foil/surlyn ionomer sachet, sealed by heat and pressure.
Croatian: Četveroslojne surlyn ionomer vrećice pod tlakom izrađene od polietilentetraftalata (PET)/polietilena/aluminijske folije i zatvorene taljenjem.
English: IU (bag)
Croatian: (vrećica)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 1 x 106 IU
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Croatian: Znanstveni zaključci i razlozi za izmjenu sažetka opisa svojstava, označivanja i upute o veterinarsko-medicinskom proizvodu
English: Chickens have been authorised in Ireland, Italy, the Netherlands, Portugal, Spain and the UK.
Croatian: Primjena u pilića odobrena je u Irskoj, Italiji, Nizozemskoj, Portugalu, Španjolskoj i Ujedinjenoj Kraljevini.
English: All references to ‘g of apramycin activity' or measuring devices have been removed from the product information.
Croatian: Iz informacija o VMP-u uklonjena su sva upućivanja na „g djelovanja apramicina” ili uređaje za mjerenje.
English: apramycin and weight of 91 g of product.
Croatian: IU apramicin-sulfata i 91 g proizvoda.
English: Marketing authorisation holder
Croatian: Nositelj odobrenja
English: The daily administration of apramycin at a dose of 12,500 IU apramycin per kg bw (corresponding to 22.5 mg of product/kg bw), via drinking water, during seven days was shown to be an efficacious method to control the post-weaning colibacillosis in piglets.
Croatian: Dnevna primjena apramicina pri dozi od 12 500 IU apramicina po kg tm (što odgovara količini od 22,5 mg proizvoda/kg tm) putem vode za piće tijekom sedam dana pokazala se djelotvornom metodom za kontrolu kolibaciloze nakon odbijanja u prasadi.
English: Apramycin sulfate equivalent to 50 g apramycin activity per bottle.
Croatian: Apramicin-sulfat ekvivalentan 50 g aktivnosti apramicina po boci.
English: Calves have been authorised in Denmark, France, Ireland, the Netherlands, Portugal, Spain and the UK.
Croatian: Primjena u teladi odobrena je u Danskoj, Francuskoj, Irskoj, Nizozemskoj, Portugalu, Španjolskoj i Ujedinjenoj Kraljevini.
English: In this blind, randomised trial Girolan administered at 20,000 IU apramycin per kg bw (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days, was compared with a reference product containing colistin at a dose of 100,000 IU colistin/kg bw/day as the control group.
Croatian: U tom slijepom, randomiziranom ispitivanju Girolan, koji je primjenjivan uz dnevnu dozu od 20 000 IU apramicina po kg tm (što odgovara količini od 36 mg proizvoda/kg tm) tijekom 5 uzastopnih dana, uspoređen je s referentnim proizvodom koji sadržava kolistin u dozi od 100 000 IU kolistina/kg tm/dan, što je predstavljalo kontrolnu skupinu.
English: Powder for use in drinking water
Croatian: Prašak za primjenu u pitkoj vodi
English: Licence: CC BY-NC-SA 3.0 IGO - link show that the finished product is stable over 36 months with no significant change in active substance content.
Croatian: Rezultati pokazuju da je završni proizvod stabilan tijekom 36 mjeseci, bez znatnih promjena u sadržaju djelatne tvari.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation in sows.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena kod svinja za vrijeme graviditeta i laktacije.
English: In this sense, in a scientific opinion (2017) of EFSA13, Salmonella infection in poultry (Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae) has been assessed according to the criteria of the Animal Health Law.
Croatian: U tom je pogledu u znanstvenom mišljenju EFSA-e (2017.)13 infekcija bakterijom Salmonella u peradi (Salmonella Pullorum, Salmonella Gallinarum i Salmonella arizonae) procijenjena u skladu s kriterijima iz Zakona o zdravlju životinja.
English: Apramycin is bactericidal at minimum inhibitory concentrations and is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma.
Croatian: Apramicin je baktericidan pri minimalnim inhibitornim koncentracijama i djelotvoran je protiv gram-negativnih i gram-pozitivnih bakterija i nekih sojeva mikoplazme.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sachet
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Serum levels peak at approximately 6 hours with a value of 2.4 µg/ml following oral administration of 40 mg apramycin/kg of bodyweight.
Croatian: Vrhunac razine u serumu od 2,4 µg/ml, nalazi se približno 6 sati od oralne primjene 40 mg apramicina/kg t.m.
English: Therefore the proposed withdrawal period of zero days for pig meat and offal was considered acceptable.
Croatian: Stoga se predloženo razdoblje karencije od „nula dana” za meso i iznutrice svinja smatralo prihvatljivim.
English: CVMP noted that data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is below 10%.
Croatian: CVMP je napomenuo da podatci o kliničkim izolatima iz različitih europskih zemalja pokazuju da je omjer otpornosti bakterije E. coli na apramicin manji od 10%.
English: Chicken: There was no mortality when chickens were given a single oral dose of 1,000 mg/kg of bodyweight.
Croatian: Kokoši: nije došlo do smrtnosti kada je kod kokoši primijenjena jednokratna oralna doza od
English: Medicated water must be renewed every 24 hours.
Croatian: Svježu otopinu VMP u pitkoj vodi treba pripremati svaka 24 sata.
English: Apramycin is bactericidal at minimum inhibitory concentrations (MICs) and is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma.
Croatian: Apramicin je baktericidan pri minimalnim inhibitornim koncentracijama (MIK) i djelotvoran je protiv gram-negativnih i gram-pozitivnih bakterija i nekih sojeva mikoplazme.
English: For single-dose presentations (sachets):
Croatian: Za jednu dozu (vrećice):
English: 1 g powder contains 1 g apramycin (as sulfate)
Croatian: 1 g praška sadržava 1 g apramicina (u obliku sulfata)
English: Denmark Elanco Animal Health A/S
Croatian: Elanco Animal Health A/S Eli Lilly Danmark A/S
English: NAME OF THE VETERINARY MEDICINAL PRODUCT (Invented name of veterinary medicinal product) Powder for use in drinking water/milk for pigs, calves, chickens and rabbits
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA (Izmišljeni naziv veterinarsko-medicinskog proizvoda) Prašak za uporabu u pitkoj vodi / mlijeku za svinje, telad, kokoši i kuniće.
English: PHARMACEUTICAL FORM Powder for use in drinking water/milk.
Croatian: OBLIK Prašak za uporabu u pitkoj vodi / mlijeku.
English: The oral administration of apramycin at 20 mg/kg bw or at 40 mg/kg bw during five consecutive days was shown to be efficacious for the treatment of colibacillosis and salmonellosis in young calves under field conditions.
Croatian: Pokazalo se da je oralna primjena apramicina pri dozi od 20 mg/kg tm ili od 40 mg/kg tm tijekom pet uzastopnih dana djelotvorna u liječenju kolibaciloze i salmoneloze u mlade teladi u terenskim uvjetima.
English: 100% w/w
Croatian: 100 % težinski postotak
English: Recent data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is increasing.
Croatian: Najnoviji podatci o kliničkim izolatima iz različitih europskih zemalja pokazuju da se omjer otpornosti bakterije E. coli na apramicin povećava.
English: Chickens were given up to 5 times the recommended level for 15 days with no untoward reaction.
Croatian: 1000 mg/kg t.m. Kokoši su dobile dozu do pet puta višu od preporučene razine u razdoblju od 15 dana bez neželjene reakcije.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally.
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Ispuniti na nacionalnoj razini.
English: Dose/response was clearly observed for the mortality rate.
Croatian: S obzirom na stopu smrtnosti jasno je uočen odnos doze i odgovora.
English: Block bottomed laminated paper bag closed by pressurized heat-sealing jaws.
Croatian: Laminirana papirnata vreća s ravnim dnom i pod tlakom, zatvorena taljenjem i brtvljenjem.
English: The total clinical score in the 40 mg apramycin/kg bw group improved more rapidly than the 20 mg apramycin/kg bw group which improved more rapidly than the 0 mg apramycin/kg bw group.
Croatian: Ukupni klinički rezultat brže se poboljšavao u skupini s dozom od 40 mg apramicina/kg tm nego u skupini s dozom od 20 mg apramicina/kg tm, u kojoj se taj rezultat poboljšavao brže nego u skupini s dozom od 0 mg apramicina/kg tm.
English: Concerning the withdrawal period, the residue depletion data indicated that apramycin is generally not well-absorbed from the gut after oral administration at the posology proposed in the product information.
Croatian: U pogledu razdoblja karencije, podatci o izlučivanju rezidua pokazali su da se apramicin uglavnom ne apsorbira dobro iz crijeva nakon oralne primjene pri doziranju predloženom u informacijama o VMP-u.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Croatian: Proizvod upotrebljavajte samo nakon procjene veterinara o odnosu koristi i rizika.
English: The proposed indication was ‘Treatment of colibacillosis caused by Escherichia coli and not zoonotic Salmonella (Salmonella Pullorum and Salmonella Gallinarum) susceptible to apramycin'.
Croatian: coli, a ne zoonotskom bakterijom Salmonella (Salmonella Pullorum i Salmonella Gallinarum) osjetljivom na apramicin”.
English: • Should antimicrobial resistance be already present, develop or be acquired, then the use of antimicrobials for the treatment of clinically infected flocks, for the prevention of Salmonella infection, or for the treatment of infected flocks without clinical signs, will enhance the selection and spread of resistant bacterial strains throughout the production pyramid.
Croatian: • Ako je antimikrobna otpornost već prisutna ili stečena ili ako se razvije, primjenom antimikrobnih lijekova u liječenju klinički zaraženih jata radi prevencije infekcije bakterijom
English: Further data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is up to 12%.
Croatian: Dodatni podatci o kliničkim izolatima iz različitih europskih zemalja pokazuju da omjer otpornosti bakterije E. coli na apramicin iznosi do 12%.
English: Marketing authorisation holder: To be completed nationally.
Croatian: Nositelj odobrenja za stavljanje u promet: Ispuniti na nacionalnoj razini.
English: because it is not possible to eliminate all the organisms from an infected flock.
Croatian: Salmonella spp. jer iz zaraženog jata nije moguće ukloniti sve organizme.
English: With regard to quality, a target potency of 552,000 IU/g of apramycin sulfate has been established for the medicinal product, based on the historical batch data provided.
Croatian: U pogledu kvalitete, na temelju dostavljenog skupa povijesnih podataka utvrđena je ciljana jačina medicinskog proizvoda koja iznosi 552 000 IU/g apramicin sulfata.
English: Pigs.
Croatian: Svinje:
English: Whereas
Croatian: The
English: Pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits.
Croatian: Svinje (odbijena prasad), predpreživačka telad, kokoši (tovni pilići) i kunići.
English: Pigs: Meat and offal: Zero days.
Croatian: Svinje: Meso i iznutrice: 0 dana.
English: PHARMACEUTICAL FORM Powder for use in drinking water/milk
Croatian: OBLIK Prašak za uporabu u pitkoj vodi / mlijeku
English: Apramycin administered orally to calves once daily for five days at 20 mg apramycin/kg bw or 40 mg apramycin/kg bw was effective in reducing mortality.
Croatian: Apramicin koji se primjenjivao oralnim putem u teladi jedanput dnevno u razdoblju od pet dana u dozi od 20 mg apramicina/kg tm ili 40 mg apramicina/kg tm pokazao se djelotvornim u smanjenju smrtnosti.
English: The limited MIC data indicated a MIC90 for apramycin of 3.5 μg/ml for E. coli isolates of rabbit origin and a proportion of <20% resistant strains.
Croatian: Ograničeni podatci o MIK-u pokazuju da MIK90 za apramicin iznosi 3,5 μg/ml za izolate bakterije E. coli koja potječe od kunića, uz udio od <20% otpornih sojeva.
English: Therefore, the proposed withdrawal period of zero days for rabbit meat and offal was considered acceptable.
Croatian: Stoga se predloženo razdoblje karencije od „nula dana” za meso i iznutrice kunića smatralo prihvatljivim.
English: mg product per litre of drinking water/milk
Croatian: mg VMP/l pitke vode/mlijeka