natgillin/translations-raw huggingface dataset:
Confirmatory field trials showed clinical efficacy of the dose of 5 mg/kg bw/day rather than the lower dose. 
Potrditvena terenska preskušanja so pokazala klinično učinkovitost odmerka 5 mg/kg telesne mase/dan in ne manjšega odmerka.
Milk (50 mg/ml and 100 mg/ml strengths): As the relevant products will not leave local residues in milk, the withdrawal period established for the major species can be directly extrapolated to the minor species without the need to apply a safety span. 
Mleko (jakosti 50 mg/ml in 100 mg/ml): Ker zadevna zdravila ne puščajo lokalnih ostankov v mleku, se lahko karenca, določena za pomembnejše vrste, neposredno ekstrapolira na manj pomembne vrste brez uporabe varnostnega razpona.
The efficacy of enrofloxacin for the treatment of acute mastitis was investigated in a field trial in sheep with clinical signs of acute mastitis. 
Učinkovitost enrofloksacina pri zdravljenju akutnega mastitisa so preučevali v terenskem preskušanju na ovcah s kliničnimi znaki akutnega mastitisa.
aureus in rabbits, no other veterinary medicinal products are authorised for this indication in this animal species in the EU. 
aureus, v EU ni odobreno nobeno drugo zdravilo za uporabo v veterinarski medicini.
However, the provided results do not allow assessing the efficacy of the products for each one of these agents individually because only data about M. haemolytica have been provided. 
Vendar pa predloženi rezultati niso omogočili ocene učinkovitosti zdravil za posamezne povzročitelje, saj so bili predloženi samo podatki za
Documentation that describes the uses of the injectable veterinary medicinal product in the treatment of infections of both the alimentary and respiratory tract, as well as for the treatment of skin and wound infections was provided. 
Predložena je bila dokumentacija, ki opisuje uporabo zdravil za injiciranje za uporabo v veterinarski medicini pri zdravljenju okužb prebavil ter dihal in zdravljenju okužb kože in ran.
Germany Virbac S.A. 1ére Avenue L.I.D. 
Nizozemska Virbac S.A. 1ére Avenue L.I.D.
The decrease in drug clearances as a result of co-administration of flunixin and enrofloxacin indicates that these substances interact during the elimination phase. 
Zmanjšanje očistkov zdravil, ki je posledica sočasne uporabe fluniksina in enrofloksacina, kaže na medsebojno delovanje teh dveh zdravil med procesom izločanja.
A second dose-titration trial was conducted in Japan with natural infection caused by E. coli in suckling piglets. 
Drugo preskušanje za titracijo odmerka so izvedli na Japonskem z naravno okužbo, ki jo pri sesnih pujskih povzroča E. coli.
The PK/PD analysis shows that the PK/PD ratios are largely exceeded for Gram-negative pathogens. 
Analiza FK/FD podatkov je pokazala, da so razmerja FK/FD za gramnegativne patogene izjemno presežena.
• 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 alimentary tract infections and septicaemia due to E. coli in pigs; 
• odbor CVMP je menil, da je treba na podlagi razpoložljivih podatkov odmerjanje 2,5 mg/kg telesne mase/dan izbrisati pri indikacijah za okužbe prebavil in septikemije zaradi E. coli pri prašičih;
Enrofloxacin is reported to have deleterious effect on articular cartilage in growing horses. 
Poročali so, da ima enrofloksacin škodljiv učinek na sklepni hrustanec pri rastočih konjih.
It is therefore appropriate to derive a single harmonised withdrawal period based on the totality of residue data from all formulation groups. 
Zato je primerno, da se na podlagi skupnih podatkov o ostankih iz vseh skupin formulacij izpelje ena usklajena karenca.
Therefore only the dose of 5 mg/kg bw for 3-5 days is supported. 
Zato je bil podprt samo odmerek 5 mg/kg telesne mase od 3 do 5 dni.
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. 
Mleko (jakost 100 mg/ml): Samo ena študija izločanja ostankov iz kravjega mleka se je štela za zadostno za namene ugotavljanja karence za mleko.
Replication forks and translational complexes cannot proceed beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent killing of pathogenic bacteria. 
Replikacijske vilice in kompleksi za translacijo ne morejo preko kompleksov, ki jih tvorijo encim, DNA in fluorokinolon, zaviranje sinteze DNA in mRNA pa sproži dogodke, ki privedejo do hitrega, od koncentracije odvisnega uničenja patogenih bakterij.
aureus and E. coli were identified. 
aureus in E. coli.
The authors concluded that resistance to antimicrobial agents in Staph. 
Avtorji so zaključili, da je odpornost na antibiotike pri izolatih Staph.
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. 
Študija za potrditev odmerka in terenska študija sta pokazali klinično učinkovitost odmerka 5 mg/kg telesne mase/dan proti enzootični pljučnici, ki jo povzročata M. haemolytica in
The terms ‘Sheep and Goats' should be used instead of ‘Dairy ewes / lambs' and ‘Dairy goats/kids'. 
Namesto izrazov „ovce molznice/jagnjeta“ in „koze molznice/kozlički“ je treba uporabiti izraza „ovce in koze“.
Injectable enrofloxacin decreased diarrhoea incidence up to 70% in suckling piglets. 
Injicirani enrofloksacin je incidenco driske pri sesnih pujskih zmanjšal za do 70 %.
4.8 Interaction with other medicinal products and other forms of interaction Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions. 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri sočasni uporabi fluniksina in enrofloksacina pri psih je potrebna previdnost, da se prepreči neželene učinke zdravila.
Intestinal bacterial counts were significantly reduced by treatment with 2.5 mg/kg bw/day. 
Število črevesnih bakterij se je pomembno zmanjšalo pri zdravljenju z odmerkom 2,5 mg/kg telesne mase/dan.
aureus) was 39.5% in the 2.5 mg/kg group and 82% in the 5 mg/kg group. 
aureus) v skupini 2,5 mg/kg telesne mase je bil 39,5 %, v skupini s 5 mg/kg telesne mase pa
08041 Barcelona Spain 
08041 Barcelona Španija
Different tolerance studies were conducted in calves with oral administration of enrofloxacin. 
Pri teletih so izvedli različne študije tolerance s peroralnim enrofloksacinom.
The results of the studies provided show that the variation in the residue profile due to sources of variation associated with the injectable use of these products (e.g. sampling procedure) was much higher than the variation due to formulation effect. 
Rezultati predloženih študij kažejo, da je bila spremenljivost profila ostankov zaradi virov spremenljivosti, povezanih z injiciranjem teh zdravil (npr.
Target species, indications and posology 
Ciljne vrste, indikacije in odmerjanje
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. 
V študiji so primerjali farmakokinetiko enrofloksacina pri puščavskih ovcah ter nubijskih kozah po intravenski in intramuskularni uporabi odmerka 5 mg/kg telesne mase.
• on the basis of the available data, the CVMP considered that indications as provided in Annex III 
• odbor CVMP je na podlagi razpoložljivih podatkov menil, da so te indikacije, kot so navedene v Prilogi III, utemeljene;
Meat and offal (50 mg/ml and 100 mg/ml strengths): In line with the CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)9, in relation to identical products the withdrawal period established for a major ruminant species may be extrapolated to a minor ruminant species applying a safety span of 1.5 where there is the potential for local residues. 
Meso in organi (jakosti 50 mg/ml in 100 mg/ml): Skladno s smernico CVMP o zahtevah za podatke o varnosti in ostankih za zdravila za uporabo v veterinarski medicini, ki so namenjena manjši uporabi ali uporabi pri manj pomembnih vrstah (EMEA/CVMP/SWP/66781/2005)9, in v povezavi z identičnimi zdravili se lahko karenca, določena za pomembnejše prežvekovalce, ekstrapolira na manj pomembne prežvekovalce, pri čemer se uporabi varnostni razpon 1,5, če obstaja možnost lokalnih ostankov.
Lower isolation index of E. coli in treated animals was observed. 
Pri zdravljenih živalih so opazili manjši indeks izolacije E. coli.
The first time point where all residues were below the MRLs, in both studies, was 3 days post-treatment. 
Prva časovna točka, ko so bile vse vrednosti ostankov pod MVO v obeh študijah, je bila 3 dni po zdravljenju.
In both studies the first time point at which residues in milk from all animals were below the MRL was 72 hours. 
V obeh študijah je bila prva časovna točka, ko so bile vse vrednosti ostankov v mleku pod MVO, 72 ur.
However, at the lower dose, residues were above the MRLs at day 1 but below the MRLs by the second time point (day 4 after administration). 
Pri manjšem odmerku pa so bili ostanki 1. dan večji od vrednosti MVO, vendar so ob drugi časovni točki (4. dan po uporabi) padli pod vrednost MVO.
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). 
Učinkovitost odmerjanja 2,5 mg/kg telesne mase/dan 3 dni so primerjali z eno od fiksnih kombinacij trimetoprima/sulfamida (30 mg/kg telesne mase/dan 3 dni).
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 podatkov karence ni bilo mogoče izpeljati s statističnim pristopom.
Baytril 5%, Ενέσιμο διάλυμα για μόσχους, χοίρους και σκύλους 
Baytril 5%, Ενέσιμο διάλυμα για μόσχους, χοίρους και σκύλους teleta, prašiči, psi
All residues were below the MRLs at 5 days. 
Vse vrednosti ostankov so bile pod MVO po 5 dneh.
(e.g. Staphylococcus aureus) and against Mycoplasma spp. 
(npr. Staphylococcus aureus), in proti bakterijam Mycoplasma spp.
aureus in commercial dairy herds was investigated. 
aureus v čredah za komercialno proizvodnjo mleka.
Warning sentences have been included in sections 4.5 and 4.6 of the SPC regarding the potential articular cartilage damage in growing cattle and lambs, based on the available literature. 
Na podlagi razpoložljive literature je treba v poglavji 4.5 in 4.6 povzetka glavnih značilnosti zdravila vključiti opozorilne stavke glede morebitne poškodbe hrustanca pri rastočem govedu in jagnjetih.
Supporting literature for use of enrofloxacin was provided in rodents (e.g. hamsters, gerbils, guinea pigs), in reptiles (snakes, lizards and chelonia) and in ornamental birds. 
Literatura, ki podpira uporabo enrofloksacina, je bila predložena za glodavce (npr. hrčke, skakače, morske prašičke), plazilce (kače, kuščarje in želve) ter okrasne ptice.
The second dose may be administered by the subcutaneous route. 
Drugi odmerek se lahko da subkutano.
Due to the variability of the data the statistical method was not considered appropriate and a withdrawal period was derived using the alternative approach. 
Zaradi variabilnosti podatkov statistična metoda ni bila primerna, zato so karenco izpeljali z uporabo alternativnega pristopa.
The product can be administered by slow intravenous or subcutaneous administration. 
Zdravilo se lahko daje s počasnim intravenskim ali subkutanim injiciranjem.
Data on resistance to enrofloxacin in target pathogens have been provided for cattle, pigs, sheep, goats, dogs and cats. 
Podatki o odpornosti ciljnih patogenov proti enrofloksacinu so bili predloženi za govedo, prašiče, ovce, koze, pse in mačke.
Only few data have been submitted by the MAHs regarding resistance in food borne bacteria. 
Imetniki dovoljenj za promet z zdravilom so predložili samo nekaj podatkov o odpornosti pri bakterijah, ki se prenašajo s hrano.
Dogs, cats, exotic animals 
psi, mačke, eksotične živali
Low to moderate (8% to 20%) resistance rates to ciprofloxacin have been observed in indicator isolates of E. coli for the different target species in different European countries. 
Pri indikatorskih izolatih E. coli za različne ciljne živalske vrste v različnih evropskih državah so opazili majhno do zmerno (8- do 20-odstotno) stopnjo odpornost proti ciprofloksacinu.
Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany 
Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Nemčija
In view of the lack of therapeutic alternatives, if this indication was not accepted, this product as well as many other antimicrobial products, could be used off-label (under the so-called cascade). 
Če ta indikacija ne bi bila sprejeta, bi se zaradi pomanjkanja drugih oblik zdravljenja to zdravilo in mnogi drugi antibiotiki uporabljali neskladno z informacijami o zdravilu.
Rodents, reptiles and ornamental birds (25 mg/ml strength) Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible supported by sensitive testing of the causal organism, indicates enrofloxacin as the substance of choice. 
Glodavci, plazilci in okrasne ptice (jakost 25 mg/ml) Zdravljenje okužb prebavil in dihal, kadar klinične izkušnje, po možnosti podprte s preskusi občutljivosti povzročiteljev, kažejo, da je enrofloksacin priporočena učinkovina.
In conclusion the Committee can accept this indication considering that it is an injectable formulation, and that necessary restrictions provided in the SPC, together with the withdrawal period, would be in favour of a more adequate use of the veterinary medicinal product in rabbits compared to the use under the cascade. 
Odbor lahko torej sprejme to indikacijo za formulacijo za injiciranje, če bi bile potrebne omejitve v povzetku glavnih značilnosti zdravila skupaj s karenco v korist primernejši uporabi zdravila za uporabo v veterinarski medicini pri kuncih v primerjavi z uporabo, neskladno z informacijami o zdravilu.
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). 
Kunci so razvrščeni kot manj pomembna živalska vrsta, zato se razpoložljivi podatki ocenjujejo v sklopu smernice CVMP o zahtevah za podatke o učinkovitosti in varnosti ciljnih živalskih vrst za zdravila za uporabo v veterinarski medicini, namenjena manj pomembni uporabi ali manj pomembnim vrstam (EMEA/CVMP/EWP/117899/2004).
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. 
Ovce, namenjene proizvodnji mleka, in koze ne spadajo v kategorijo pomembnejših živalskih vrst, zato so privzeto razvrščene kot manj pomembne živalske vrste in se posledično ocenjujejo v sklopu smernice CVMP o zahtevah za podatke o učinkovitosti in varnosti ciljnih živalskih vrst za zdravila za uporabo v veterinarski medicini, namenjena manj pomembni uporabi ali manj pomembnim vrstam (EMEA/CVMP/EWP/117899/2004)2.
In another study piglets were challenged with E. coli and displayed signs of diarrhoea and enterotoxaemia. 
V drugi študiji so pri pujskih opravili provokacijski test z E. coli, pri čemer so se pojavili znaki driske in enterotoksemije.
Taking into account all data available (clinical, PK/PD and antimicrobial resistance data), the CVMP considered that this indication can be accepted. 
Upoštevajoč vse razpoložljive podatke (klinične, FK/FD in o antimikrobni odpornosti) je odbor CVMP menil, da je ta indikacija sprejemljiva.
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) 
Zdravljenje okužb prebavil in septikemije, ki jih povzročajo za enrofloksacin občutljivi sevi bakterije Escherichia coli (jakosti 50 mg/ml in 100 mg/ml)
In the field study, calves (from 15 kg to 150 kg bw) with naturally occurring gastrointestinal infections due to E.coli, were treated every day with enrofloxacin either orally, by a parenteral (intramuscular, subcutaneous or intravenous) route followed by oral, or only parenteral route. 
V terenski študiji so teleta (od 15 do 150 kg telesne mase) z naravnimi okužbami prebavil z E. coli vsak dan zdravili s peroralnim, parenteralnim (intramuskularnim, subkutanim ali intravenskim) enrofloksacinom, ki mu je sledil peroralni enrofloksacin, ali samo s parenteralnim enrofloksacinom.
Antimicrobial resistance in food borne bacteria 
Protimikrobna odpornost pri bakterijah, ki se prenašajo s hrano
Arthritis caused by Mycoplasma bovis (50 mg/ml and 100 mg/ml strengths) 
Artritis, ki ga povzroča Mycoplasma bovis (jakosti 50 mg/ml in 100 mg/ml)
Cattle, pigs weighing more than 25 kg 
govedo, prašiči s telesno maso več kot 25 kg
Acute severe mastitis caused by Escherichia coli (100 mg/ml strength) 
Hudi akutni mastitis, ki ga povzroča Escherichia coli (jakost 100 mg/ml)
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. 
V drugi študiji so jagnjeta s septikemijo, ki jo povzročata E. coli in Cl. perfringens, zdravili z intramuskularnim odmerkom 5 mg/kg telesne mase 5 dni.
Results of a dose-titration study with experimentally induced infection with enterotoxigenic E. coli in suckling piglets and weaners were also reported. 
Poročali so tudi o rezultatih študije za titracijo odmerka pri eksperimentalno sproženi okužbi z enterotoksigeno E. coli pri sesnih in odstavljenih pujskih.
• 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. 
• odbor CVMP je menil, da je treba na podlagi razpoložljivih podatkov odmerjanje 2,5 mg/kg telesne mase/dan izbrisati pri vseh indikacijah za govedo;
Taking into account all (clinical, PK/PD and antimicrobial resistance) data, the CVMP considered that this indication can be accepted. 
Upoštevajoč vse podatke (klinične, FK/FD in o antimikrobni odpornosti) je odbor CVMP menil, da je ta indikacija sprejemljiva.
However, several experimental controlled studies were conducted employing both 2.5 and 5 mg/kg body weight (bw) parenteral doses, but more consistent data on the higher dose were presented. 
2,5 in 5 mg/kg telesne mase, vendar so bili predloženi doslednejši podatki za večji odmerek.
Two different doses were examined: 2.5 mg/kg bw and 5 mg/kg bw, twice daily for 3 consecutive days. 
Raziskali so dva različna odmerka: 2,5 mg/kg telesne mase in 5 mg/kg telesne mase, dvakrat na dan, 3 zaporedne dneve.
08028 Barcelona Spain 
08028 Barcelona Španija
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. 
Zdravila Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable in povezana imena ter z njimi povezana zdravila za uporabo v veterinarski medicini, odobrena skladno s členom 13 Direktive 2001/82/ES, kot je bila spremenjena, so raztopine za injiciranje, ki vsebujejo 25 mg/ml, 50 mg/ml oziroma 100 mg/ml enrofloksacina.
Following intravenous injection: Meat and offal: 5 days. 
Po intravenskem injiciranju: meso in organi: 5 dni.
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. 
Španija je 22. aprila 2013 Evropski agenciji za zdravila (v nadaljevanju: agencija) predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za zdravila Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable in povezana imena ter z njimi povezana zdravila za uporabo v veterinarski medicini, odobrena skladno s členom 13 Direktive 2001/82/ES, kot je bila spremenjena.
It was considered appropriate to derive a single withdrawal period based on the combined data from these 2 studies using the alternative approach. 
Odbor je menil, da je primerno, da se na podlagi združenih podatkov iz teh 2 študij z alternativnim pristopom izpelje ena karenca.
All animals were treated intramuscularly with enrofloxacin at 2.5 mg/kg bw once daily. 
Vse živali so intramuskularno zdravili z enrofloksacinom v odmerku 2,5 mg/kg telesne mase enkrat na dan.
• on the basis of the available residue depletion data in cattle, pigs, sheep, goats and rabbits chickens and turkeys, the CVMP considered that withdrawal periods should be aligned to provide assurance for consumer safety; 
• odbor CVMP je menil, da je treba na podlagi razpoložljivih podatkov o izločanju ostankov pri govedu, prašičih, ovcah, kozah, kuncih, piščancih in puranih uskladiti karence, tako da bodo zagotavljale varnost potrošnikov;
Austria aniMedica GmbH Im Südfeld 9 
Avstrija aniMedica GmbH Im Südfeld 9
A field study was conducted to evaluate effect of enrofloxacin against pathogens related to the alimentary tract in suckling and weaning piglets with diarrhoea. 
Opravili so terensko študijo za ocenjevanje učinka enrofloksacina proti patogenom, povezanim s prebavili pri sesnih in odstavljenih pujskih z drisko.
The available data does fully demonstrate the efficacy of this veterinary medicinal product for the treatment of septicaemia. 
Učinkovitost tega zdravila za uporabo v veterinarski medicini pri zdravljenju septikemije je bila popolnoma dokazana na podlagi razpoložljivih podatkov.
Rodents, reptiles and ornamental birds 
Glodavci, plazilci in okrasne ptice
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. 
Uporaba enrofloksacina pri rastočih jagnjetih, ki so jih 15 dni zdravili s priporočenim odmerkom, je povzročila histološke spremembe sklepnega hrustanca, ki niso bile povezane s kliničnimi znaki.
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. 
Zdravljenje okužb prebavil in dihal, kadar klinične izkušnje, po možnosti podprte s preskusi občutljivosti povzročiteljev, kažejo, da je enrofloksacin priporočena učinkovina.
PK/PD and antimicrobial resistance data have been taken into account to justify this indication. 
Za utemeljitev te indikacije so bili upoštevani FK/FD podatki in podatki o antimikrobni odpornosti.
At the recommended dose residues in all tissues were below the MRLs at day 1 postadministration. 
Pri priporočenem odmerku so bili ostanki v vseh tkivih 1 dan po uporabi pod mejno vrednostjo ostankov (MVO).
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. 
Odbor je menil, da je bila predložena dokumentacija sprejemljiva za podporo učinkovitosti enrofloksacina proti okužbam prebavil in dihal, ki jih povzročajo Escherichia coli, Pasteurella multocida in Staphylococcus spp.
Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła 
Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła govedo