FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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;
Slovenian: • 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;
English: Austria aniMedica GmbH Im Südfeld 9
Slovenian: Avstrija aniMedica GmbH Im Südfeld 9
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.
Slovenian: Opravili so terensko študijo za ocenjevanje učinka enrofloksacina proti patogenom, povezanim s prebavili pri sesnih in odstavljenih pujskih z drisko.
English: The available data does fully demonstrate the efficacy of this veterinary medicinal product for the treatment of septicaemia.
Slovenian: Učinkovitost tega zdravila za uporabo v veterinarski medicini pri zdravljenju septikemije je bila popolnoma dokazana na podlagi razpoložljivih podatkov.
English: Rodents, reptiles and ornamental birds
Slovenian: Glodavci, plazilci in okrasne ptice
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.
Slovenian: 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.
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.
Slovenian: Zdravljenje okužb prebavil in dihal, kadar klinične izkušnje, po možnosti podprte s preskusi občutljivosti povzročiteljev, kažejo, da je enrofloksacin priporočena učinkovina.
English: PK/PD and antimicrobial resistance data have been taken into account to justify this indication.
Slovenian: Za utemeljitev te indikacije so bili upoštevani FK/FD podatki in podatki o antimikrobni odpornosti.
English: At the recommended dose residues in all tissues were below the MRLs at day 1 postadministration.
Slovenian: Pri priporočenem odmerku so bili ostanki v vseh tkivih 1 dan po uporabi pod mejno vrednostjo ostankov (MVO).
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.
Slovenian: 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.
English: Belgium EMDOKA bvba John Lijsenstraat 16
Slovenian: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgija
English: Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła
Slovenian: Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła govedo
English: This withdrawal period should be applied to all the concerned products.
Slovenian: Ta karenca mora veljati za vsa zadevna zdravila.
English: Cattle, pigs weighing more than 25 kg, dogs, cats
Slovenian: govedo, prašiči s telesno maso več kot 25 kg, psi, mačke
English: Roxacin injection
Slovenian: Roxacin injection prašiči
English: Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Slovenian: Razlogi za spremembo povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
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.
Slovenian: Vendar je odbor na podlagi razpoložljivih FK/FD podatkov in podatkov o odpornosti sklenil, da je za to indikacijo mogoče sprejeti samo odmerek enrofloksacina 5 mg na kg telesne mase enkrat na dan 3 dni, ki se daje z intramuskularnim injiciranjem.
English: Baytril 2,5% inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów
Slovenian: Baytril 2,5% inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów psi, mačke
English: Where the following target species have already been approved, the following withdrawal periods apply:
Slovenian: Če so bile spodaj navedene ciljne živalske vrste že odobrene, veljajo naslednje karence:
English: Pigs, cattle
Slovenian: prašiči, govedo
English: 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.
Slovenian: preudarni uporabi6, je treba uporabo fluorokinolonov omejiti na zdravljenje kliničnih stanj, ki se slabo odzivajo ali za katere je pričakovati, da se bodo slabo odzivala na druge razrede antibiotikov.
English: Laboratorios Syva S.A. Parroco Pablo Diez, 49 - 57 24010 Leon
Slovenian: Bolgarija Laboratorios Syva S.A. Parroco Pablo Diez, 49 - 57 24010 Leon
English: Three different doses of enrofloxacin were administered: 1.25, 2.5 or 5 mg/kg bw/day for 3 days.
Slovenian: Uporabili so tri različne odmerke enrofloksacina: 1,25, 2,5 ali 5 mg/kg telesne mase/dan 3 dni.
English: (e.g. Pasteurella multocida), against Gram-positive bacteria such as Staphylococcus spp.
Slovenian: (npr. Pasteurella multocida), proti grampozitivnim bakterijam, kot so na primer Staphylococcus spp.
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 12 days.
Slovenian: Odbor je menil, da je za kompenzacijo za biološke negotovosti in variabilnost podatkov, ustrezen 30odstotni varnostni razpon, kar pomeni karenco 12 dni.
English: Milk (100 mg/ml strength):
Slovenian: Mleko (jakost 100 mg/ml):
English: 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)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable in povezanih imen ter z njimi povezanih zdravil za uporabo v veterinarski medicini, odobrenih skladno s členom 13 Direktive 2001/82/ES, kot je bila spremenjena (glejte Prilogo I)
English: 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.
Slovenian: Meso in organi (jakost 25 mg/ml): Predloženi sta bili dve študiji izločanja ostankov, vendar so samo v eni študiji živali zdravili s priporočenim odmerkom 10 mg/kg telesne mase do 10 dni.
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.
Slovenian: Odbor je menil, da je za kompenzacijo za biološke negotovosti in variabilnost podatkov ustrezen 30odstotni varnostni razpon, kar pomeni karenco 13 dni.
English: A. For products listed in Annex I containing 25 mg enrofloxacin per ml
Slovenian: A. Za zdravila, navedena v Prilogi I, ki vsebujejo 25 mg enrofloksacina na ml
English: Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions.
Slovenian: Pri sočasni uporabi fluniksina in enrofloksacina pri psih je potrebna previdnost, da se prepreči neželene učinke zdravila.
English: In this case, the withdrawal period following subcutaneous injection applies.
Slovenian: V tem primeru je treba upoštevati karenco po subkutanem injiciranju.
English: 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.
Slovenian: Meso in organi (jakosti 50 mg/ml in 100 mg/ml): Na voljo so bili podatki iz dveh študij; ena je bila izvedena z odmerkom 2,5 mg/kg telesne mase/dan 5 dni, druga pa z odmerkom 5 mg/kg telesne mase/dan 5 dni.
English: and Histophilus somni (50 mg/ml and 100 mg/ml strengths)
Slovenian: in Histophilus somni (jakosti 50 mg/ml in 100 mg/ml)
English: It was considered appropriate to derive a single harmonised withdrawal period based on the combined data from the 4 studies.
Slovenian: Odbor je menil, da je primerno, da se na podlagi združenih podatkov iz 4 študij izpelje ena usklajena karenca.
English: Baytril Piglet 25 mg/ml inspuitbare oplossing
Slovenian: Baytril Piglet 25 mg/ml inspuitbare oplossing prašiči
English: C. For products listed in Annex I containing 100 mg enrofloxacin per ml
Slovenian: C. Za zdravila, navedena v Prilogi I, ki vsebujejo 100 mg enrofloksacina na ml
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).
Slovenian: Ugotovili so, da indikacije, odmerjanje in karence, odobrene v državah članicah 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, v državah članicah (EU/EGS) niso usklajene.
English: Agnoletti et al. First reporting of methicillin-resistant Staphylococcus aureus (MRSA) ST398 in an industrial rabbit holding and in farm-related people.
Slovenian: Rev Sci Tech Off Int Epiz 2009;28:1119-1128 5 Agnoletti et al. First reporting of methicillin-resistant Staphylococcus aureus (MRSA) ST398 in an industrial rabbit holding and in farm-related people.
English: Baytril - Das Original - 2,5% Injektionslösung für Hunde, Katzen, Schweine und Kaninchen
Slovenian: Baytril - Das Original - 2,5% Injektionslösung für Hunde, Katzen, Schweine und Kaninchen prašiči, kunci, psi, mačke
English: 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.
Slovenian: Meso in organi (jakosti 25 mg/ml, 50 mg/ml in 100 mg/ml): Za uporabo pri izpeljavi karence so bile primerne štiri študije: ena popolna študija, izvedena s priporočenim odmerkom, in tri omejene študije, ki so se osredotočile na mesto injiciranja, ki je bilo tkivo za določanje karence.
English: Pigs (piglets)
Slovenian: Prašiči (pujski)
English: Pigs: Meat and offal: 13 days.
Slovenian: Prašiči: Meso in organi: 13 dni.
English: Two field studies were provided to demonstrate the efficacy of enrofloxacin in the treatment of infections of the alimentary tract caused by E.coli and septicaemia caused by E.coli.
Slovenian: Za dokazovanje učinkovitosti enrofloksacina pri zdravljenju okužb prebavil in septikemije, ki ju povzroča E. coli, sta bili predloženi dve terenski študiji.
English: Taking into account all data, the CVMP considered that both indications can be accepted.
Slovenian: Upoštevajoč vse podatke je odbor CVMP menil, da sta sprejemljivi obe indikaciji.
English: Treatment of post-partum dysgalactiae syndrome (PDS), mastitis, metritis, agalactia (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli, Klebsiella spp.
Slovenian: Zdravljenje poporodnega sindroma disgalaktije (post-partum dysgalactiae syndrome - PDS), mastitisa, metritisa, agalaktije (sindrom MMA), ki ga povzročajo za enrofloksacin občutljivi sevi bakterij Escherichia coli in Klebsiella spp.
English: Baytril piglet 25mg/ml
Slovenian: Baytril piglet 25mg/ml prašiči
English: Following subcutaneous injection: Meat and offal: 12 days.
Slovenian: Po subkutanem injiciranju: Meso in organi: 12 dni.
English: Taking into account all the documentation provided, the CVMP considered that this indication can be accepted, but in the 50 mg/ml strength it should be stated as “Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of
Slovenian: menil, da je ta indikacija sprejemljiva, vendar je treba pri jakosti 50 mg/ml navesti »Zdravljenje akutnega, z mikoplazmo povezanega artritisa, ki ga povzročajo za enrofloksacin občutljivi sevi Mycoplasma bovis«.
English: Dogs, cats
Slovenian: psi, mačke
English: CENAVISA SA LABORATORIOS Cami Pedra Estela s/n 43205 REUS
Slovenian: Romunija CENAVISA SA LABORATORIOS Cami Pedra Estela s/n
English: Pigs
Slovenian: prašiči
English: B. For products listed in Annex I containing 50 mg enrofloxacin per ml
Slovenian: B. Za zdravila, navedena v Prilogi I, ki vsebujejo 50 mg enrofloksacina na ml
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.
Slovenian: Obe jakosti imata enake indikacije, vendar obstaja razlika pri ciljnih živalskih vrstah, tj. pri jakosti 50 mg/ml so kot ciljne živalske vrste navedene ovce molznice/jagnjeta in koze molznice/kozlički, pri jakosti 100 mg/ml pa ovce in koze.
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.
Slovenian: V prvi študiji so dve skupini jagnjet z enteritisom zaradi E. coli zdravili z intramuskularnim enrofloksacinom v odmerku 2,5 mg/kg telesne mase 5 dni ali 5 mg/kg telesne mase 4 dni.
English: Cats, dogs
Slovenian: mačke, psi
English: 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.
Slovenian: Meso in organi (jakosti 50 mg/ml in 100 mg/ml): Za uporabo pri izpeljavi karence so bile primerne štiri študije: dve popolni študiji izločanja ostankov, izvedene s predlaganim odmerkom, in dve omejeni študiji, ki sta se osredotočili na mesto injiciranja (mesto določanja karence).
English: Two different enrofloxacin treatment schemes were investigated: 5 mg/kg bw for 3 days and 2.5 mg/kg for 5 days.
Slovenian: Proučevali so dve različni shemi zdravljenja z enrofloksacinom: 5 mg/kg telesne mase 3 dni in 2,5 mg/kg telesne mase 5 dni.
English: Bayer d.o.o.
Slovenian: Slovenija Bayer d.o.o.
English: The first time point at which all residues fell below the MRL was 60 hours.
Slovenian: Prva časovna točka, ko so bile vse vrednosti ostankov pod MVO, je bila 60 ur.
English: 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.
Slovenian: Posledično se lahko priporočena karenca 4 dni za mleko govedi neposredno ekstrapolira na mleko koz, če se živali zdravijo s priporočenim odmerkom 5 mg/kg telesne mase z jakostma 50 mg/ml ter 100 mg/ml, ki se dajeta s subkutanim injiciranjem.
English: Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles)
Slovenian: prašiči, kunci, psi, mačke, eksotične živali (sesalci, ptice, plazilci)
English: 4.2 Indications for use, specifying the target species Dogs
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Psi
English: The first time point at which all residue values fell below the MRL was 9 days.
Slovenian: Prva časovna točka, ko so bile vse vrednosti ostankov pod MVO, je bila 9 dni.
English: 4.9 Amounts to be administered and administration route Intravenous, subcutaneous or intramuscular use.
Slovenian: Za intravensko, subkutano ali intramuskularno uporabo.
English: A dose of 2.5 mg/kg bw/day intramuscularly for 1 or 3 days was tested comparing with oral administration.
Slovenian: Intramuskularni odmerek 2,5 mg/kg telesne mase/dan od 1 do 3 dni so primerjali s peroralno uporabo.
English: Non-inferiority of the test product was demonstrated.
Slovenian: Preiskovano zdravilo ni bilo inferiorno.
English: Enrofloxacin 100 mg/ml (or 50 mg/ml)
Slovenian: Enrofloxacin 100 mg/ml (ali 50 mg/ml)
English: Denmark Krka d.d.
Slovenian: Romunija Krka d.d.
English: Two enzymes essential in DNA replication and transcription, DNA gyrase and topoisomerase IV, have been identified as the molecular targets of fluoroquinolones.
Slovenian: Ugotovljeno je bilo, da sta molekulski tarči fluorokinolonov dva encima, ki imata ključno vlogo pri podvojevanju in transkripciji DNA, in sicer DNA-giraza ter topoizomeraza IV. Zaviranje tarč je posledica nekovalentne vezave molekul fluorokinolonov na ta encima.
English: 4.2 Indications for use, specifying the target species Cattle
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Govedo
English: from the period 2004-2006 until the period 2008-2009 in the isolates tested in Germany.
Slovenian: - V nemški študiji, v kateri so med letoma 2006 in 2007 zbrali 71 izolatov Staph.
English: TENOTRIL 100mg/ml soluzione iniettabile epr bovini, suini, ovicaprini
Slovenian: TENOTRIL 100mg/ml soluzione iniettabile epr bovini, suini, ovicaprini govedo, prašiči, ovce, koze
English: Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old.
Slovenian: Zdravljenje akutnega artritisa, povezanega z mikoplazmo, ki ga povzročajo za enrofloksacin občutljivi sevi vrste Mycoplasma bovis, pri govedu, mlajšem od 2 let.
English: Denmark Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Slovenian: Bolgarija Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
English: Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp.
Slovenian: Enrofloksacin je v priporočenih terapevtskih odmerkih učinkovit proti mnogim gramnegativnim bakterijam, kot so Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp.
English: Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Slovenian: Portugalska Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5
English: Moderate to high resistance rates to ciprofloxacin were found for Campylobacter spp.
Slovenian: V zadnjih letih so ugotovili zmerne do velike deleže odpornosti Campylobacter spp.
English: Germany Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Slovenian: Norveška Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
English: Therefore PK/PD and resistance data were taken into account when considering the efficacy of enrofloxacin against Pasteurella multocida.
Slovenian: Pri presoji učinkovitosti enrofloksacina proti Pasteurella multocida so bili zato upoštevani FK/FD podatki in podatki o odpornosti.
English: On the other hand, no resistance or very low resistance rates were observed for bacteria causing mastitis in ruminants (E. coli, Staph.
Slovenian: Pri bakterijah, ki povzročajo mastitis pri prežvekovalcih (E. coli, Staph.
English: 5 days.
Slovenian: 5 do 10 zaporednih dni.
English: 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.
Slovenian: Upoštevajoč razpoložljive podatke je odbor CVMP sklenil, da slabi bakteriološki rezultati, pridobljeni in vivo, in rezultati iz FK/FD analize niso zadostni za podporo te indikacije.
English: Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp.
Slovenian: Enrofloksacin je v priporočenih terapevtskih odmerkih učinkovit proti mnogim gramnegativnim bakterijam, kot so Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp.
English: (100 mg/ml strength)
Slovenian: (jakost 100 mg/ml)
English: ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims
Slovenian: ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims govedo, prašiči, psi
English: The first time point at which all residue values fell below the MRL was 10 days.
Slovenian: Prva časovna točka, ko so bile vse vrednosti ostankov pod MVO, je bila 10 dni.
English: Baytril Swine 100mg/ml
Slovenian: Baytril Swine 100mg/ml prašiči
English: Meat and offal: 6 days.
Slovenian: Meso in organi: 6 dni.
English: Meat and offal: 4 days.
Slovenian: Meso in organi: 4 dni.
English: Dogs, cats, exotic Animals (small mammals, reptiles and avian species)
Slovenian: psi, mačke, eksotične živali (mali sesalci, plazilci in aviarne vrste)
English: 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.
Slovenian: Na podlagi priporočene karence za meso in organe ovac 4 dni z uporabo varnostnega razpona 1,5 se lahko za meso in organe koz priporoči karenca 6 dni, če se živali zdravijo s priporočenim odmerkom 5 mg/kg telesne mase z jakostma 50 mg/ml ter 100 mg/ml, ki se dajeta s subkutanim injiciranjem.
English: Taking into account all data, the CVMP considered that this indication can be accepted.
Slovenian: Upoštevajoč vse podatke je odbor CVMP menil, da je ta indikacija sprejemljiva.
English: 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.
Slovenian: Mleko (jakosti 50 mg/ml in 100 mg/ml): Predložena je bila ena študija izločanja ostankov, v katerih so živali 5 dni zdravili z odmerkom 5 mg/kg telesne mase.
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.
Slovenian: Za dokazovanje učinkovitosti proti zgoraj navedenim bakterijam pri predvidenih indikacijah za pse in mačke se je predložilo več lastniških študij in veliko znanstvenih publikacij, ki so dokumentirale učinkovitost injiciranega in/ali peroralnega enrofloksacina.
English: 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.
Slovenian: Ta je priporočena za meso in organe prašičev, zdravljenih s priporočenim odmerkom 5 mg/kg telesne mase/dan 3 dni z jakostmi 25 mg/ml, 50 mg/ml ali 100 mg/ml, ki se dajejo z intramuskularnim injiciranjem.
English: Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis.
Slovenian: Zdravljenje akutnega artritisa, povezanega z mikoplazmo, ki ga povzročajo za enrofloksacin občutljivi sevi vrste Mycoplasma bovis.