FrancophonIA/ELRC3.0 huggingface dataset:
English: Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Croatian: Križna rezistencija unutar skupine fluorokinolona relativno je česta.
English: A dose-confirmation study and a field study showed clinical efficacy of the dose of 5 mg/kg bw/day against enzootic pneumonia caused by M. haemolytica and P. multocida.
Croatian: Ispitivanje kojim se potvrđuje doza i terensko ispitivanje dokazali su kliničku djelotvornost doze od 5 mg/kg tjelesne težine/dan u slučaju enzootične pneumonije koju uzrokuje M. haemolytica i P. multocida.
English: In a study the pharmacokinetics of enrofloxacin were compared in Desert sheep and Nubian goats after intravenous and intramuscular administration at 5 mg/kg bw dose.
Croatian: U ispitivanju je farmakokinetika enrofloksacina uspoređena u pustinjskih ovaca i nubijski ovaca nakon intravenozne i intramuskularne primjene doze od 5 mg/kg tjelesne težine.
English: The first time point where all residues were below the MRLs, in both studies, was 3 days post-treatment.
Croatian: Prva vremenska točka u kojoj su svi rezidui bili niži od MRL-ova, u oba ispitivanja, bila je 3 dana nakon tretiranja.
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Croatian: Znanstveni zaključci i razlozi za izmjenu sažetaka opisa svojstava proizvoda, etiketa i upute o VMP-u
English: • on the basis of the available data, the CVMP considered that the dose rate of 2.5 mg/kg bw/day should be deleted for all the indications in cattle.
Croatian: • je na temelju dostupnih podataka CVMP zaključio da dozu od 2,5 mg/kg tjelesne težine/dan treba obrisati za sve indikacije u stoke;
English: Repeated injections should be made at different injection sites.
Croatian: Svaka injekcija mora se primijeniti na drugo mjesto.
English: Data on resistance to enrofloxacin in target pathogens have been provided for cattle, pigs, sheep, goats, dogs and cats.
Croatian: Podaci o rezistenciji na enrofloksacin u ciljnih patogena dostavljeni su za goveda, svinje, ovce, koze, pse i mačke.
English: Do not use in growing horses because of possible deleterious damage on articular cartilage.
Croatian: Nemojte koristiti kod konja u razvoju jer postoji mogućnost štetnog djelovanja na hrskavicu zglobova.
English: Biowet Puławy Sp. z o.o.
Croatian: Biowet Puławy Sp. z o.o. 2 Arciucha Str.
English: At the recommended dose residues in all tissues were below the MRLs at day 1 postadministration.
Croatian: U preporučenim dozama, rezidui u svim tkivima bili su manji od MRL-a u 1. danu nakon primjene.
English: The efficacy at the dosage of 2.5 mg/kg bw daily for 3 days was compared to the one of a trimetroprim-sulfamid fixed combination (30 mg/kg bw daily for 3 days).
Croatian: Djelotvornost doze od 2,5 mg/kg tjelesne težine primijenjene tijekom 3 dana uspoređena je s djelotvornošću fiksne kombinacije trimetroprim sulfamida (30 mg/kg tjelesne težine tijekom 3 dana).
English: Confirmatory field trials showed clinical efficacy of the dose of 5 mg/kg bw/day rather than the lower dose.
Croatian: Potvrdna terenska ispitivanja dokazala su kliničku djelotvornost doze od 5 mg/kg tjelesne težine/dan u odnosu na manju dozu.
English: Milk (100 mg/ml strength): Only one residue depletion study in cattle milk was considered adequate for the purpose of setting a withdrawal period in milk.
Croatian: Mlijeko (jačina 100 mg/ml): Samo se jedno ispitivanje pražnjenja rezidua provedeno za goveđe mlijeko može smatrati primjerenim za potrebe određivanja razdoblja karencije za mlijeko.
English: 08041 Barcelona Spain
Croatian: 08041 Barcelona
English: in the last years: bovine: 45 to 86%; porcine: 4% to 27%.
Croatian: Umjerene do visoke stope rezistencije na ciprofloksacin utvrđene su za Campylobacter spp. posljednjih godina za: goveda: 45 do 86%; svinje: 4% do 27%.
English: Antimicrobial resistance in food borne bacteria
Croatian: Antimikrobna rezistencija u bakterija koje se prenose hranom
English: Rabbits
Croatian: Zečevi
English: Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice.
Croatian: Liječenje infekcija probavnog i respiratornog trakta, u slučaju kada kliničko iskustvo, po mogućnosti podržano osjetljivim testiranjem kauzalnog organizma, indicira enrofloksacin kao odabrano sredstvo.
English: Therefore PK/PD and resistance data were taken into account when considering the efficacy of enrofloxacin against Pasteurella multocida.
Croatian: Stoga su FK/FD podaci i podaci o rezistentnosti uzeti u obzir prilikom razmatranja djelotvornosti enrofloksacina protiv patogena Pasteurella multocida.
English: Cattle, pigs weighing more than 25 kg, dogs, cats
Croatian: Goveda, svinje teže od 25 kg, psi, mačke
English: Austria aniMedica GmbH Im Südfeld 9
Croatian: Austrija aniMedica GmbH Im Südfeld 9
English: Product name
Croatian: Naziv lijeka
English: Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions.
Croatian: Potreban je oprez prilikom istodobne primjene fluniksina i enrofloksacina u pasa kako bi se izbjegle nuspojave.
English: Treatment may be initiated with injectable product and maintained with enrofloxacin tablets.
Croatian: Liječenje se može započeti otopinom za injekciju, a nastaviti enrofloksacinom u tabletama.
English: Target inhibition is caused by noncovalent binding of fluoroquinolone molecules to these enzymes.
Croatian: Ciljanu inhibiciju tij enzima uzrokuje nekovalentno vezanje molekula fluorokinolona za njih.
English: Slovenia aniMedica GmbH Im Südfeld 9
Croatian: Slovenija aniMedica GmbH Im Südfeld 9
English: Therefore only the dose of 5 mg/kg bw for 3-5 days is supported.
Croatian: Stoga je podržana samo doza od 5 mg/kg tjelesne težine tijekom 3-5 dana.
English: Due to deficiencies in the data provided a withdrawal period could not be derived using the statistical approach.
Croatian: Uslijed nedostataka dostavljenih podataka, razdoblje karencije nije moglo biti izračunato statističkim pristupom.
English: It was considered appropriate to derive a single withdrawal period based on the combined data from these 2 studies using the alternative approach.
Croatian: Zaključeno je da je primjereno izvesti jedno razdoblje karencije na temelju kombiniranih podataka iz ova 2 ispitivanja primjenom alternativnog pristupa.
English: Acute severe mastitis caused by Escherichia coli (100 mg/ml strength)
Croatian: Akutni ozbiljni mastitis kojeg uzrokuje Escherichia coli (jačina 100 mg/ml)
English: The latter also applies for alimentary tract infections and septicaemia caused by E. coli in pigs.
Croatian: Ovo potonje je također primjenjivo za infekcije probavnog trakta i septikemiju koje uzrokuje E. coli u svinja.
English: The second dose may be administered by the subcutaneous route.
Croatian: Druga doza može se primijeniti potkožno.
English: aureus isolated from goat mastitis was also very low.
Croatian: Iako su ograničeni podaci bili dostupni, postotak rezistencije izolata Staph. aureus iz mastitisa u koza bio je također vrlo nizak.
English: The following information addressing the concern of the risk to public health (consumers and handlers) due to the potential for selection of antibiotic resistant strains of Staph.
Croatian: U obzir su uzete slijedeće informacije koje navode zabrinutost od rizika za javno zdravstvo (potrošači i rukovatelji) uslijed potencijala za odabir sojeva otpornih na antibiotik patogena Staph. aureus nakon primjene proizvoda u hrani za zečeve:
English: Degenerative changes of articular cartilage were observed with doses of 30 mg enrofloxacin/kg bw/day during 14 days.
Croatian: Degenerativne promjene zglobne hrskavice uočene su s dozama od 30 mg enrofloksacina/kg tjelesne težine/dan tijekom 14 dana.
English: Belgium Bayer SA-NV J.E.
Croatian: Bayer SA-NV J.E.
English: Clinical outcome was demonstrated on sows with MMA/PDS treated with enrofloxacin.
Croatian: Klinički su ishodi na krmačama sa sindromima MMA/PDS koje su liječene enrofloksacinom.
English: aureus collected between 2006-2007 in Germany were resistant to enrofloxacin.
Croatian: - u ispitivanju, 4,2% od 71 izolata Staph. aureus prikupljenih od 2006. do 2007. u Njemačkoj bilo je otporno na enrofloksacin;
English: Laboratorios Syva S.A. Parroco Pablo Diez, 49 - 57 24010 Leon
Croatian: Parroco Pablo Diez, 49 - 57 24010 Leon
English: Taking into account all (clinical, PK/PD and antimicrobial resistance) data, the CVMP considered that this indication can be accepted.
Croatian: Uzimajući u obzir sve (kliničku, FK/FD i antimikrobnu rezistenciju) podatke, CVMP smatra da se ova indikacija može prihvatiti.
English: In order to compensate for the biological uncertainties and the variability of the data, a safety span of 30% was used, resulting in a withdrawal period of 13 days.
Croatian: Kako bi se kompenzirale biološke nesigurnosti i varijabilnost podataka, primijenjen je sigurnosni raspon od 30%,
English: A dose of 2.5 mg/kg bw/day intramuscularly for 1 or 3 days was tested comparing with oral administration.
Croatian: Doza od 2,5 mg/kg tjelesne težine/dan primijenjena je intramuskularno tijekom 1 ili 3 dana te je testirana usporedno s oralnom primjenom.
English: Therefore PK/PD and resistance data were taken into account when considering the efficacy of enrofloxacin against Mycoplasma spp.
Croatian: Stoga su FK/FD podaci kao i podaci o rezistentnosti uzeti u obzir prilikom razmatranja djelotvornosti enrofloksacina protiv patogena Mycoplasma spp.
English: Bayer Hungária Kft. Alkotás u. 50.
Croatian: Mađarska Bayer Hungária Kft.
English: Belgium EMDOKA bvba John Lijsenstraat 16
Croatian: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgija
English: Results of a dose-titration study with experimentally induced infection with enterotoxigenic E. coli in suckling piglets and weaners were also reported.
Croatian: Prijavljeni su također rezultati ispitivanja titranja doze s eksperimentalno induciranom infekcijom s enterotoksičnom E. coli u praščića koji sisaju i odbijenih praščića.
English: The use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated with clinical signs.
Croatian: Primjena enrofloksacina u janjadi u razvoju u preporučenoj dozi tijekom 15 dana uzrokovala je histološke promjene zglobne hrskavice koje nisu povezane s kliničkim znakovima.
English: Sheep intended for milk production and goats do not fall into the category of major species, are by default are classified as minor species and, thus, assessed in the context of the CVMP guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/EWP/117899/2004)2.
Croatian: Ovce namijenjene za proizvodnju mlijeka i koze ne ubrajaju se u kategoriju većih vrsta i automatski su razvrstane kao manje vrste, te su stoga ocijenjene u kontekstu smjernice CVMP-a o djelotvornosti i zahtjevima za podatke o sigurnoj primjeni u ciljnih vrsta za veterinarsko-medicinske proizvode namijenjene za manju uporabu ili manje vrste (EMEA/CVMP/EWP/117899/2004)2.
English: Rabbits are classified as minor species and thus the available data is assessed in the context of the CVMP guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/EWP/117899/2004).
Croatian: Zečevi su klasificirani kao manje vrste, te su stoga dostupni podaci procijenjeni u kontekstu smjernice CVMP-a o zahtjevima za podatke o djelotvornosti i sigurnoj primjeni u ciljnih životinja za veterinarskomedicinske proizvode predviđene za manju uporabu ili manje vrste (EMEA/CVMP/EWP/117899/2004).
English: Hifarmax, Produtos e serviços veterinários, Lda Av. Marechal Craveiro Lopes nº96 R/C
Croatian: Av. Marechal Craveiro Lopes nº96 R/C
English: HIPRALONA ENRO I
Croatian: HIPRALONA ENRO
English: Furthermore, the veterinary practitioner will be left without an authorised product for the treatment of skin and wound infections caused by Staph.
Croatian: Nadalje, veterinari neće imati na raspolaganju odobreni proizvoda za liječenje kožnih infekcija i infekcija rana uzrokovanih patogenom Staph. aureus u zečeva.
English: Laboratorios Syva S.A. Parroco Pablo Diez, 49-57 24010 Leon
Croatian: Parroco Pablo Diez, 49-57 24010 Leon
English: A field study was conducted to evaluate effect of enrofloxacin against pathogens related to the alimentary tract in suckling and weaning piglets with diarrhoea.
Croatian: Provedeno je terensko ispitivanje sa ciljem ocjene učinka enrofloksacina protiv patogena povezanih s probavnim traktom u praščića koji sisaju i odbijenih praščića s proljevom.
English: Three different doses of enrofloxacin were administered: 1.25, 2.5 or 5 mg/kg bw/day for 3 days.
Croatian: Primijenjene su tri različite doze enrofloksacina: 1,25, 2,5 ili 5 mg/kg tjelesne težine/dan tijekom 3 dana.
English: Pigs, cattle
Croatian: Svinje, goveda
English: Cattle (subcutaneous)
Croatian: Goveda (supkutano)
English: To ensure a correct dosage, body weight (bw) should be determined as accurately as possible to avoid underdosing.
Croatian: Kako bi se osiguralo točno doziranje i izbjeglo subdoziranje trebalo bi što točnije odrediti tjelesnu masu (t.m.).
English: Several proprietary studies and numerous scientific publications, documenting the efficacy of enrofloxacin, either by injectable and/or oral route of administration, were provided to demonstrate the efficacy against the above specified bacteria for the intended indications in both dogs and cats The data provided consist of studies performed with several posology regimens where the more frequent dose of 5 mg/kg bw was used.
Croatian: Dostavljeno je nekoliko vlasničkih ispitivanja i brojne znanstvene publikacije, koje dokumentiraju djelotvornost enrofloksacina bilo primjenom injekcije i/ili oralnim putem, kako bi se demonstrirala djelotvornost protiv gore navedenih bakterija za predviđene indikacije kako u pasa tako i u mačaka.
English: Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products authorised under Article 13 of Directive 2001/82/EC, as amended are solutions for injection containing enrofloxacin at 25 mg/ml, 50 mg/ml and 100 mg/ml respectively.
Croatian: Baytril 2,5% injectible, Baytril 5% injectible, Baytril 10% injectible i povezani nazivi, kao i povezani veterinarsko-medicinski proizvodi odobreni u skladu s člankom 13. Direktive 2001/82/EZ, s izmjenama, su otopine za injekciju koje sadrže enrofloksacin od 25 mg/ml, 50 mg/ml, odnosno 100 mg/ml.
English: On 22 April 2013, Spain presented to the European Medicines Agency (the Agency) a referral notification under Article 35 of Directive 2001/82/EC for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products authorised under Article 13 of Directive 2001/82/EC, as amended.
Croatian: Dana 22. travnja 2013., Španjolska je Europskoj agenciji za lijekove (Agenciji) dostavila obavijest o postupku upućivanja u skladu sa člankom 35. Direktive 2001/82/EZ za Baytril 2,5% injectable, Baytril 5% injectable, Baytril 10% injectable i povezane nazive, kao i povezane veterinarsko-medicinske proizvode odobrene u skladu s člankom 13. Direktive 2001/82/EZ, s izmjenama.
English: Enrofloxacin was administered at 2.5 and 5 mg/kg bw/day intramuscularly for 3 days and by oral route.
Croatian: Enrofloksacin je primijenjen u dozi od 2,5 i 5 mg/kg tjelesne težine/dan intramuskularno tijekom 3 dana i oralnim putem.
English: Milk (100 mg/ml strength):
Croatian: Mlijeko (jačina 100 mg/ml):
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products(see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products authorised under Article 13 of Directive 2001/82/EC, as amended, as referred in Annex I, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
Croatian: • je CVMP zaključio da je cjelokupan omjer koristi i rizika pozitivan za veterinarsko-medicinske proizvode (vidjeti Dodatak I.), što je predmetom izmjena u informacijama o proizvodu; CVMP je preporučio varijacije odobrenja za stavljanje VMP-a u promet za VMP-ove Baytril 2,5% injectable, Baytril 5% injectable i Baytril 10% injectable i njihove povezane nazive te povezane veterinarsko-medicinske proizvode odobrene u skladu s člankom 13. Direktive 2001/82/EZ kako je navedeno u Dodatku I., kako bi se izmijenili sažetci opisa svojstava za VMP, etiketa i uputa o VMP-u kako je navedeno u Dodatku III.
English: The product can be administered by slow intravenous or subcutaneous administration.
Croatian: VMP se može primijeniti polako u venu ili potkožno.
English: Arthritis caused by Mycoplasma bovis (50 mg/ml and 100 mg/ml strengths)
Croatian: Artritis uzrokovan patogenom Mycoplasma bovis (jačine 50 mg/ml i 100 mg/ml)
English: Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany
Croatian: Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Njemačka
English: The documentation provided was considered acceptable to support the efficacy of enrofloxacin against infections of the alimentary and respiratory tracts caused by Escherichia coli, Pasteurella multocida and Staphylococcus spp.
Croatian: Zaključeno je da je dostavljena dokumentacija prihvatljiva za potrebe podržavanja djelotvornosti enrofloksacina protiv infekcija probavnog i respiratornog trakta uzrokovanih patogenima Escherichia coli, Pasteurella multocida i Staphylococcus spp.
English: 4.2 Indications for use, specifying the target species Cattle
Croatian: 4.2. Indikacije za uporabu, uz navođenje ciljnih vrste životinja Goveda
English: Pharmacodynamic properties
Croatian: Rezultati farmakokinetičke/
English: • on the basis of the available data, the CVMP considered that indications as provided in Annex III
Croatian: • na temelju dostupnih podataka CVMP zaključio da su indikacije dostavljene u Dodatku II.
English: Treatment of infections of the alimentary tract and septicaemia caused by enrofloxacin susceptible strains of Escherichia coli (50 mg/ml and 100 mg/ml strengths)
Croatian: Liječenje infekcija probavnog trakta i septikemije uzrokovane sojevima Escherichia coli podložnima enrofloksacinu (jačine 50 mg/ml i 100 mg/ml)
English: Two different doses were examined: 2.5 mg/kg bw and 5 mg/kg bw, twice daily for 3 consecutive days.
Croatian: Ispitane su dvije različite doze: 2,5 mg/kg tjelesne težine i 5 mg/kg tjelesne težine, dva puta dnevno tijekom 3 uzastopna dana.
English: 4.2 Indications for use, specifying the target species Dogs
Croatian: 4.2. Indikacije za primjenu, uz navođenje ciljnih životinjskih vrsta Psi
English: Taking into account all data available (clinical, PK/PD and antimicrobial resistance data), the CVMP considered that this indication can be accepted.
Croatian: Uzimajući u obzir sve dostupne (kliničke, FK/FD podatke i podatke o rezistenciji), CVMP smatra da se ova indikacija može prihvatiti.
English: Following subcutaneous injection: Meat and offal: 12 days.
Croatian: Nakon potkožne primjene: Meso i jestive iznutrice: 12 dana.
English: All animals were treated intramuscularly with enrofloxacin at 2.5 mg/kg bw once daily.
Croatian: Sve su životinje liječene intramuskularno enrofloksacinom u dozi od 2,5 mg/kg tjelesne težine jednom dnevno.
English: Sheep and Goats (50 mg/ml and 100 mg/ml strengths) Both strengths share the same indications, but differences exist in terms of target animal species i.e. in the 50 mg/ml strength the species were stated as dairy ewes/lambs and dairy goats/kids whereas in the 100 mg/ml strength the species were sheep and goats.
Croatian: Obje jačine dijele iste indikacije, no razlike postoje u pogledu vrsta ciljnih životinja, odnosno u slučaju jačine od 50 mg/ml navedene su mliječne ovce/janjad i mliječne koze/kozlići kao ciljne vrste, a ovce i koze su navedene kao ciljne vrste za jačinu od 100 mg/ml.
English: However, taking into account the available PK/PD and resistance data it has been concluded that the dose for this indication can be accepted only at 5 mg of enrofloxacin per kg bw once daily for 3 days by intramuscular injection.
Croatian: No, uzimajući u obzir dostupne FK/FD podatke i podatke o otpornosti, zaključeno je da se doza za ovu indikaciju može prihvatiti samo za 5 mg enrofloksacina po kg tjelesne težine jednom dnevno tijekom 3 dana intramuskularnom injekcijom.
English: In another study piglets were challenged with E. coli and displayed signs of diarrhoea and enterotoxaemia.
Croatian: U drugom su ispitivanju praščići bili izloženi patogenu E. coli, te su se kod praščića manifestirali znakovi proljeva i enterotoksemije.
English: The withdrawal period should be applied to all the concerned products.
Croatian: Karenciju treba primijeniti na sve predmetne proizvode.
English: In the first study two groups of lambs suffering from coli-enteritis were treated intramuscularly with enrofloxacin, at the dosage of 2.5 mg/kg bw for 5 days or 5 mg/kg bw for 4 days.
Croatian: U prvom su ispitivanju dvije grupe janjadi koje su bolovale od coli-enteritisa bile liječene intramuskularno enrofloksacinom, u dozi od 2,5 mg/kg tjelesne težine tijekom 5 dana ili 5 mg/kg tjelesne težine tijekom 4 dana.
English: Two different enrofloxacin treatment schemes were investigated: 5 mg/kg bw for 3 days and 2.5 mg/kg for 5 days.
Croatian: Istražene su dvije različite sheme liječenja enrofloksacinom: 5 mg/kg tjelesne težine tijekom 3 dana i 2,5 mg/kg tijekom 5 dana.
English: Nevertheless, taking into account the available PK/PD and resistance data it has been concluded that the dose for this indication can be accepted only at 5 mg of enrofloxacin per kg bw once daily for 3 days by intramuscular injection.
Croatian: Bez obzira na to, uzimajući u obzir dostupne FK/FD podatke i podatke o otpornosti, zaključeno je da se doza za ovu indikaciju može prihvatiti samo za 5 mg enrofloksacina po kg tjelesne težine jednom dnevno tijekom 3 dana, uz primjenu intramuskularnom injekcijom.
English: A statistical analysis of the data could not be undertaken and consequently the withdrawal period was derived using the alternative approach.
Croatian: Nije se mogla provesti statistička analiza podataka te je posljedično određeno razdoblje karencije primjenom alternativnog pristupa.
English: It has been noted that the indications, posology and withdrawal periods approved by the Member States for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products authorised under Article 13 of Directive 2001/82/EC are disharmonised across the Member States (EU/EEA).
Croatian: Uočeno je da su indikacije, doziranje i razdoblja karencije koje su odobrile države članice za Baytril 2,5% injectable, Baytril 5% injectable, Baytril 10% injectable i povezane nazive, kao i povezani veterinarsko-medicinski proizvodi odobreni u skladu s člankom 13. Direktive 2001/82/EZ, neusklađeni diljem država članica (EU/EEA).
English: The first time point at which all residue values fell below the MRL was 9 days.
Croatian: Prva vremenska točka u kojoj su svi rezultati pali ispod MRL bila je 9 dana.
English: 105b D-06406 Bernburg
Croatian: Njemačka Serumwerk Bernburg AG Hallesche Landstr. 105b D-06406 Bernburg
English: Mode of action
Croatian: Mehanizam djelovanja
English: In this case, the withdrawal period following subcutaneous injection applies.
Croatian: U tom slučaju primjenjuje se vrijeme karencije navedeno kod potkožne primjene.
English: The first time point at which all residues fell below the MRL was 60 hours.
Croatian: Prva vremenska točka u kojoj su svi rezidui pali ispod MRL-a bila je 60 sati.