natgillin/translations-raw huggingface dataset:
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. 
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.
A statistical analysis of the data could not be undertaken and consequently the withdrawal period was derived using the alternative approach. 
Nije se mogla provesti statistička analiza podataka te je posljedično određeno razdoblje karencije primjenom alternativnog pristupa.
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). 
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).
The first time point at which all residue values fell below the MRL was 9 days. 
Prva vremenska točka u kojoj su svi rezultati pali ispod MRL bila je 9 dana.
105b D-06406 Bernburg 
Njemačka Serumwerk Bernburg AG Hallesche Landstr. 105b D-06406 Bernburg
Mode of action 
Mehanizam djelovanja
In this case, the withdrawal period following subcutaneous injection applies. 
U tom slučaju primjenjuje se vrijeme karencije navedeno kod potkožne primjene.
The first time point at which all residues fell below the MRL was 60 hours. 
Prva vremenska točka u kojoj su svi rezidui pali ispod MRL-a bila je 60 sati.
Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days. 
Degenerativne promjene hrskavice zglobova uočene su u teladi kojoj je kroz usta primijenjeno 30 mg enrofloksacina/kg tjelesne mase tijekom 14 dana.
Meat and offal (25 mg/ml strength): Two residue depletion studies were provided, but only in one of the studies were the animals treated at the recommended dose of 10 mg/kg bw for up to 10 days. 
Meso i iznutrice (jačine 25 mg/ml): Dostavljena su dva ispitivanja pražnjenja rezidua, no samo je jedno ispitivanje provedeno u životinja liječenih preporučenom dozom od 10 mg/kg tjelesne težine tijekom 10 dana.
Meat and offal (25 mg/ml, 50 mg/ml and 100 mg/ml strengths): Four studies were considered adequate for use in deriving the withdrawal period: one complete study performed with the recommended dose and three limited studies focused on the injection site, which was the withdrawal period determining tissue. 
Meso i iznutrice (jačine 25 mg/ml, 50 mg/ml i 100 mg/ml): Zaključeno je da su četiri ispitivanja primjerena za primjenu izvođenja karencije: jedno potpuno ispitivanje provedeno s preporučenom dozom i tri ograničena ispitivanja usredotočena na mjesto injekcije, koje je bilo tkivo korišteno za utvrđivanje karencije.
Acute severe mastitis caused by Staphylococcus aureus (100 mg/ml strength) Taking into account the available data, the CVMP concluded that the poor bacteriological results obtained in vivo and the results from the PK/PD analysis do not sufficiently support this indication. 
Uzimajući u obzir dostupne podatke, CVMP je zaključio da slabi bakteriološki rezultati dobiveni in vivo i rezultati iz FK/FD analiza u dostatnoj mjeri ne podržavaju ovu indikaciju.
Following intravenous injection: Meat and offal: 5 days. 
Nakon primjene u venu: Meso i jestive iznutrice: 5 dana.
aureus and E. coli were identified. 
U uzorcima mlijeka identificirani su patogeni Staph. aureus i E. coli.
In the second study, lambs with septicaemia caused by E. coli and Cl. perfringens were treated intramuscularly at the dosage of 5 mg/kg bw for 5 days. 
U drugom ispitivanju je janjad koja je bolovala od septikemije koju uzrokuje E. coli i Cl. perfringens liječena intramuskularno u dozi od 5 mg/kg tjelesne težine tijekom 5 dana.
Dogs, cats 
Psi, mačke
Meat and offal (50 mg/ml and 100 mg/ml strengths): Data were available from two studies, one performed with a dose of 2.5 mg/kg bw/day for 5 days and one with a dose of 5 mg/kg bw/day for 5 days. 
Meso i iznutrice (jačine 50 mg/ml i 100 mg/ml): Dostavljeni su podaci iz dva ispitivanja, pri čemu je jedno provedeno s dozom od 2,5 mg/kg tjelesne težine/dan tijekom 5 dana, a drugo s dozom od 5 mg/kg tjelesne težine/dan tijekom 5 dana.
Vetoquinol Biowet Sp z o.o. 
Vetoquinol Biowet Sp z o.o. 13/14 Kosynierów Gdyńskich St.
Taking into account all data, the CVMP considered that both indications can be accepted. 
Uzimajući u obzir sve podatke, CVMP je zaključio da se obje indikacije mogu prihvatiti.
Pigs and calves 
Svinje i telad
CENAVISA SA LABORATORIOS Cami Pedra Estela s/n 43205 REUS 
Rumunjska CENAVISA SA LABORATORIOS Cami Pedra Estela s/n
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old. 
Liječenje artritisa uzrokovanog sojevima Mycoplasma bovis osjetljivih na enrofloksacin kod goveda mlađih od 2 godine.
Cats, dogs 
Mačke, psi
GENERA Slovenia d.o.o. 
Slovenija GENERA Slovenia d.o.o. Dunajska 51
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intravenous, subcutaneous or intramuscular use. 
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE Primjena u venu, potkožno ili u mišić.
aureus isolates originating from rabbits is relatively rare compared to resistance in Staph. 
Autori su zaključili da je rezistencija na antimikrobici u izolata Staph. aureus koja proizlazi iz zečeva relativno rijetka u usporedbi s rezistencijom u izolata Staph. aureus koja proizlazi iz drugih životinja i ljudi;
Meat and offal (50 mg/ml and 100 mg/ml strengths): Four studies were considered adequate for use in deriving the withdrawal period: two complete residue depletion studies performed with the proposed dose and two limited studies focused on the injection site, which was the withdrawal period determining tissue. 
Meso i iznutrice (jačine 50 mg/ml i 100 mg/ml): Zaključeno je da su četiri ispitivanja primjerena za primjenu za potrebe izvođenja karencije: dva ispitivanja potpunog pražnjena rezidua provedena s predloženom dozom i dva ograničena ispitivanja usmjerena na mjesto injekcije, koje je bilo tkivo za utvrđivanje karencije.
Applicant/Marketing Authorisation Holder 
Podnositelj zahtjeva/Nositelj odobrenja za stavljanje gotovog lijeka u promet
Treatment of post-partum dysgalactiae syndrome (PDS), mastitis, metritis, agalactia (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli, Klebsiella spp. 
Liječenje sindroma postpartalne dizgalaktije (PDS), mastitisa, metritisa, agalaktije (sindroma MMA) uzrokovanih sojevima Escherichia coli, Klebsiella spp. podložnih enrofloksacinu (jačine 100 mg/ml)
Due to variability of the data the statistical method was not considered appropriate and a withdrawal period was derived using the alternative approach. 
Uslijed varijabilnosti podataka, statistička metoda se nije smatrala primjerenom te je karencija izvedena primjenom alternativnog pristupa.
Consequently, based on the recommended withdrawal period of 4 days for sheep meat and offal and applying a safety span of 1.5, a withdrawal period of 6 days can be recommended for goat meat and offal when animals are treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strenghts by subcutaneous injection. 
Posljedično, na temelju preporučenog razdoblja karencije od 4 dana za ovčje mlijeko i iznutrice te primjenu sigurnosnog raspona od 1,5, karencija od 6 dana može se preporučiti za kozje meso i iznutrice u slučaju kada su životinje liječene preporučenom dozom od 5 mg/kg tjelesne težine supkutanom injekcijom jačina 50 mg/ml i 100 mg/ml.
C. For products listed in Annex I containing 100 mg enrofloxacin per ml 
Za lijekove navedene u Prilogu I. koji sadrže 100 mg enrofloksacina po ml
Overall summary of the scientific evaluation of 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 (see Annex I) 
Cjelokupni sažetak znanstvene ocjene VMP-ova Baytril 2,5% injectable, Baytril 5% injectable, Baytril 10% injectable i njihovih povezanih naziva, kao i povezanih veterinarskomedicinskih proizvoda u skladu s člankom 13. Direktive 2001/82/EZ, s izmjenama (vidjeti Dodatak I.)
Pigs: Meat and offal: 13 days. 
Svinje: Meso i jestive iznutrice: 13 dana.
Germany Krka d.d. 
Njemačka Krka d.d. Novo mesto
Grounds for amendment of the summaries of product characteristics, labelling and package leaflets 
Razlozi za izmjenu sažetka opisa svojstava proizvoda, etikete i upute o VMP-u
Rodents, reptiles and ornamental birds 
Glodavci, gmazovi i ukrasne ptice
Data show low resistance rates to enrofloxacin/ciprofloxacin in Salmonella spp. 
Podaci ukazuju na niske stope rezistencije na enrofloksacin/ciprofloksacin u izolata Salmonella spp. u goveda i svinja.
The first time point at which all residue values fell below the MRL was 10 days. 
Prva vremenska točka u kojoj su sve vrijednosti rezidua bile manje od MRL-a bila je 10 dana.
Rabbits (25 mg/ml strength) 
Zečevi (jačina 25 mg/ml)
Two enzymes essential in DNA replication and transcription, DNA gyrase and topoisomerase IV, have been identified as the molecular targets of fluoroquinolones. 
Ciljne molekule fluorokinolona su DNK-giraza i topoizomeraza IV, dva enzima ključna u replikaciji i transkripciji DNK.
A. For products listed in Annex I containing 25 mg enrofloxacin per ml 
Za lijekove navedene u Prilogu I. koji sadrže 25 mg enrofloksacina po ml
Dogs, cattle and pigs 
Psi, goveda i svinje
Cattle (100 mg/ml strength) 
Goveda (jačina od 100 mg/ml)
Consequently, the recommended withdrawal period of 4 days for cattle milk can be directly extrapolated to goat's milk when animals are treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection. 
Posljedično, preporučena karencija od 4 dana za goveđe mlijeko može se izravno ekstrapolirati na kozje mlijeko ako su životinje tretirane u preporučenoj dozi od 5 mg/kg tjelesne težine supkutanom injekcijom u jačinama od 50 mg/ml i 100 mg/ml.
Calves, pigs 
Telad, svinje
The Cmax/MIC and AUC/MIC ratios for Staphylococcus spp. 
Omjeri Cmax/MIC i AUC/MIC za Staphylococcus spp. Također su primjereni za gram-pozitivne infekcije za obje vrste.
It was considered appropriate to derive a single harmonised withdrawal period based on the combined data from the 4 studies. 
Smatrano je primjerenim da se izvede jedna usklađena karencija na temelju kombiniranih podataka iz 4 ispitivanja.
aureus multi-resistant to several types of antimicrobials are currently documented and (iii) that there can be a transfer of resistant bacteria from animals to humans, involving both consumers and handlers of rabbits. 
Odbor je upoznat da (i.) primjena enrofloksacina u uzgoju zečeva može rezultirati povećanjem rezistentnosti Staph. aureus, (ii.) su izolati Staph. aureus multirezistentni na nekoliko tipova antimikrobika trenutno dobro dokumentirani i (iii.) može doći do prijenosa rezistentnih bakterija sa životinja na ljude, i to kako na potrošače tako i na osobe koje rukuju životinjama.
- Dosage for reptiles: 5-10 mg/kg bw, once daily by intramuscular injection for 5 consecutive days. 
- Doziranje za reptile: 5-10 mg/kg tjelesne težine, jednom dnevno intramuskularnom injekcijom tijekom 5 uzastopnih dana.
Thus a withdrawal period of 72 hours (3 days) is recommended for milk from cattle treated at the recommended dose of 5 mg/kg bw/day with the 100 mg/ml strength intravenously. 
Stoga je razdoblje karencije od 72 sata (3 dana) preporučeno za mlijeko dobiveno od goveda liječenih preporučenom dozom od 5 mg/kg tjelesne težine/dan intravenozno jačinom od 100 mg/ml.
- A study, conducted in intensive rabbit farms in Spain, has demonstrated a high prevalence of Staph. 
- ispitivanje provedeno na intenzivnim farmama zečeva u Španjolskoj pokazalo je visoku stopu pojavnosti sojeva Staph. aureus, od kojih je 17,2% bilo otporno na meticilin4.
Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 5 days. 
U slučaju akutnog mikoplazmatskog artritisa uzrokovanog sojevima Mycoplasma bovis osjetljivih na enrofloksacin kod goveda mlađih od 2 godine doza je 5 mg enroflokscina/kg t.m., što odgovara 1 mL/20 kg t.m., jednom dnevno tijekom 5 dana.
On the basis of the available data the CVMP considered that these indications can be accepted. 
Na temelju dostupnih podataka, CVMP smatra da se ove indikacije mogu prihvatiti.
Not more than 3 ml should be administered at one intramuscular injection site. 
Na isto mjesto u mišić ne smije se primijeniti više od 3 mL VMP-a.
TARGET SPECIES 
CILJNE VRTSE
Meat and offal (50 mg/ml and 100 mg/ml strengths): Two residue depletion studies were provided with sheep treated at 5 mg/kg bw for 5 days. 
Meso i iznutrice (jačine 50 mg/ml i 100 mg/ml): Dostavljena su dva ispitivanja pražnjenja rezidua za ovce liječene s 5 mg/kg tjelesne težine tijekom 5 dana.
Milk (50 mg/ml and 100 mg/ml strengths): One residue depletion studies was provided with animals treated at 5 mg/kg bw for 5 days. 
Mlijeko (jačine 50 mg/ml i 100 mg/ml): Dostavljeno je jedno ispitivanje pražnjenja rezidua sa životinjama liječenima dozom od 5 mg/kg tjelesne težine tijekom 5 dana.
Regarding target species dog and cat, data submitted show an increase in resistance rates of non enteric E. coli and Staphylococcus spp. 
Vezano uz ciljne vrste pse i mačke, dostavljeni podaci pokazuju povećanje rezistencije necrijevnih E. coli i Staphylococcus spp. u razdoblju od 2004. do 2006. sve do razdoblja od 2008. do 2009. u izolatima testiranima u Njemačkoj.
B. For products listed in Annex I containing 50 mg enrofloxacin per ml 
Za lijekove navedene u Prilogu I. koji sadrže 50 mg enrofloksacina po ml
Taking into account all data, the CVMP considered that this indication can be accepted. 
Uzimajući u obzir sve podatke, CVMP smatra da se ova indikacija može prihvatiti.
Not more than 6 ml should be administered at one subcutaneous injection site. 
Na isto mjesto potkožno se ne smije primijeniti više od 6 mL VMP-a.
Pharmagal, s.r.o. 
Pharmagal, s.r.o. Murgasova 5
Meat and offal: 4 days. 
Meso i jestive iznutrice: 4 dana.
Cage birds, cats, dogs, exotic animals, reptiles, small mammals 
Kućne ptice, mačke, psi, egzotične životinje, gmazovi, mali sisavci
Rabbits: Meat and offal: 6 days. 
Kunići: Meso i jestive iznutrice: 6 dana.
Not more than 10 ml should be administered at one subcutaneous injection site. 
Na isto mjesto potkožno se ne smije primijeniti više od 10 mL VMP-a.
A harmonised withdrawal period of 5 days can be accepted for cattle meat and offal when animals are treated at the recommended dose of 5 mg/kg bw with either the 50 mg/ml strength or the 100 mg/ml strengths administered intravenously. 
Usklađeno razdoblje karencije od 5 dana može se prihvatiti za goveđe meso i iznutrice u slučaju kada su životinje tretirane preporučenom dozom od 5 mg/kg tjelesne težine jačine 50 mg/ml ili 100 mg/ml primijenjeno intravenozno.
This is recommended as the withdrawal period for pig meat and offal for animals treated at the recommended dose of 5 mg/kg bw/day for 3 days with either the 25 mg/ml, 50 mg/ml or 100 mg/ml strenghts administered by intramuscular injection. 
Ovo je razdoblje preporučeno kao karencija za svinjsko meso i iznutrice za životinje liječene u preporučenoj dozi od 5 mg/kg tjelesne težine/dan tijekom 3 dana bilo s jačinama 25 mg/ml, 50 mg/ml ili 100 mg/ml intramuskularnom injekcijom.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis. 
Liječenje akutnog mikoplazmatskog artritisa uzrokovanog sojevima Mycoplasma bovis osjetljivih na enrofloksacin.
- Dosage: 10 mg/kg bw, once daily for 5 to 10 consecutive days by subcutaneous administration. 
- Doza: 10 mg/kg tjelesne težine, jednom dnevno tijekom 5 do 10 uzastopnih dana supkutanom primjenom.
Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles) 
Svinje, kunići, psi, mačke, egzotične životinje (sisavci, ptice, gmazovi)
- Dosage: 5 mg/kg bw, once daily by subcutaneous injection for up to 5 days. 
- Doza: 5 mg/kg tjelesne težine, jednom dnevno potkožnom injekcijom u trajanju do 5 dana.
Data regarding Pasteurella spp. 
Pasteurella spp. su ograničeni.
- Dosage: 5 mg/kg body weight (bw), once daily for 3 to 5 days. 
- Doza: 5 mg/kg tjelesne težine, jednom dnevno tijekom 3 do 5 dana.
On the basis of the available data the CVMP considered that this indication can be accepted. 
Na temelju dostupnih podataka, CVMP je zaključio da se ova indikacija može prihvatiti.
Meat and offal: 6 days. 
Meso i jestive iznutrice: 6 dana.
aureus in commercial dairy herds was investigated. 
U drugom je ispitivanju istražena djelotvornost protiv Staph. aureus u komercijalnih mliječnih stada.
Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily for 5 days. 
U slučaju akutnog mikoplazmatskog artritisa uzrokovanog sojevima Mycoplasma bovis osjetljivih na enrofloksacin doza je 5 mg enrofloksacina/kg t.m., što odgovara 1 mL/10 kg t.m., jednom dnevno tijekom 5 dana.
Lithuania FORTE Healthcare Limited Cougar Lane 
Slovačka FORTE Healthcare Limited Cougar Lane
Pigs (50 mg/ml and 100 mg/ml strengths) 
Svinje (jačina 50 mg/ml i 100 mg/ml)
A withdrawal period of 72 hours (3 days) is recommended for sheep milk for animals treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection. 
Razdoblje karencije u trajanju od 72 sata (3 dana) preporučeno je za ovčje mlijeko za životinje tretirane preporučenom dozom od 5 mg/kg tjelesne težine supkutanom injekcijom jačinama od 50 mg/ml i 100 mg/ml.
8 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf 
8 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf što je rezultiralo karencijom od 96 sati (4 dana), što je preporučeno kao karencija za mlijeko dobiveno iz goveda liječenih preporučenom dozom od 5 mg/kg tjelesne težine supkutano jačinom od 100 mg/ml.
Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp. 
U preporučenim terapijskim dozama enrofloksacin djeluje protiv mnogih gram-negativnih bakterija kao što su Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp. (pr. Pasteurella multocida), Bordetella spp., Proteus spp., Pseudomonas spp., gram-pozitivnih bakterija kao što je Staphylococcus spp. (pr. Staphylococcus aureus) te protiv Mycoplasma spp.
- Dosage: 2.5 mg/kg bw, once daily for 3 days by intramuscular injection. 
- Doza: 2.5 mg/kg tjelesne težine, jednom dnevno tijekom 3 dana intramuskularnom injekcijom.
- A study described the first case of livestock-associated methicillin-resistant Staph. 
- ispitivanje je opisalo prvi slučaj Staph.
Germany Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà) 
Njemačka Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Germany Vetpharma Animal Health, S.L. 
Njemačka Vetpharma Animal Health, S.L. Les Corts 23.
Cattle, pigs, sheep 
Goveda, svinje, ovce
Vetpharma Animal Health, S.L. 
Vetpharma Animal Health, S.L. Les Corts 23.
- Dosage: 5 mg/kg bw, once daily for 3 to 5 days. 
- Doziranje: 5 mg/kg tjelesne mase, jednom dnevno tijekom 3 do 5 dana.
Treatment of septicaemia caused by enrofloxacin susceptible strains of E. coli. 
Liječenje septikemije uzrokovane sojevima E. coli podložnima enrofloksacinu.
Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, by slow intravenous injection once daily for two consecutive days. 
U slučaju akutnog mastitisa uzrokovanog s Escherichia coli doza je 5 mg enrofloksacina/kg t.m., što odgovara 1 mL/20 kg t.m., jednom dnevno, polako u venu tijekom dva uzastopna dana.
Belgium FORTE Healthcare Limited Cougar Lane 
Nizozemska FORTE Healthcare Limited Cougar Lane
Bravničarjeva 13 Ljubljana Slovenia 
Slovenija Bayer d.o.o. Bravničarjeva 13
PASTEUR 
Kunići
9 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf span of 20% to compensate for deficiencies in the study results in a withdrawal period of 6 days recommended for rabbit meat and offal for animals treated at the recommended dose of 10 mg/kg bw with the 25 mg/ml strength by subcutaneous injection. 
9 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf što je rezultiralo karencijom od 13 dana.
As stated in CVMP reflection paper on the use of fluoroquinolones in food producing animalsPrecautions for use in the SPC regarding prudent use guidance6, fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. 
Kako je navedeno u osvrtu CVMP-a o primjeni fluorkinolona u životinja koje se koriste u proizvodnji hrane - Mjere opreza za primjenu u SPC-u vezano uz smjernice za opreznu primjenu6, fluorkinoloni http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Hipralona_Enro
Dogs, cats, cage birds, reptiles 
Psi, mačke, kućne ptice, gmazovi
Treatment of infections of the alimentary and respiratory tracts caused by enrofloxacin susceptible strains of: Escherichia coli, Pasteurella multocida and Staphylococcus spp. 
Liječenje infekcija probavnog i dišnog sustava uzrokovanih sojevima bakterija: Escherichia coli, Pasteurella multocida i Staphylococcus spp. osjetljivih na enrofloksacin.
Sheep (50 mg/ml and 100 mg/ml strengths) 
Ovce (jačine 50 mg/ml i 100 mg/ml)
Germany Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 
Njemačka Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Amendments in the relevant sections of the summaries of product characteristics, labelling and package leaflets 
Izmjene u određenim dijelovima sažetaka opisa svojstava lijeka, označivanja i uputa o lijeku
- Dosage: 5 mg/kg bw, once daily for 3 days by intramuscular injection. 
- Doza: 5 mg/kg tjelesne težine, jednom dnevno tijekom 3 dana intramuskularnom injekcijom.
Treatment of Escherichia coli infections of the alimentary tract or septicaemia caused by enrofloxacin susceptible strains of Escherichia coli. 
Liječenje infekcija probavnog trakta patogenom Escherichia coli ili septikemijom uzrokovanom sojevima Escherichia coli podložnima enrofloksacinu.
Belgium Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà) 
Španjolska Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Belgium Industrial Veterinaria SA C/Esmeralda 19-21 
Bugarska Industrial Veterinaria SA C/Esmeralda 19-21