natgillin/translations-raw huggingface dataset:
B. For products listed in Annex I containing 50 mg enrofloxacin per ml
B. Za zdravila, navedena v Prilogi I, ki vsebujejo 50 mg enrofloksacina na ml
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.
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.
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.
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.
Cats, dogs
mačke, psi
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 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).
Two different enrofloxacin treatment schemes were investigated: 5 mg/kg bw for 3 days and 2.5 mg/kg for 5 days.
Proučevali so dve različni shemi zdravljenja z enrofloksacinom: 5 mg/kg telesne mase 3 dni in 2,5 mg/kg telesne mase 5 dni.
The first time point at which all residues fell below the MRL was 60 hours.
Prva časovna točka, ko so bile vse vrednosti ostankov pod MVO, je bila 60 ur.
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.
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.
Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles)
prašiči, kunci, psi, mačke, eksotične živali (sesalci, ptice, plazilci)
4.2 Indications for use, specifying the target species Dogs
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Psi
The first time point at which all residue values fell below the MRL was 9 days.
Prva časovna točka, ko so bile vse vrednosti ostankov pod MVO, je bila 9 dni.
4.9 Amounts to be administered and administration route Intravenous, subcutaneous or intramuscular use.
Za intravensko, subkutano ali intramuskularno uporabo.
A dose of 2.5 mg/kg bw/day intramuscularly for 1 or 3 days was tested comparing with oral administration.
Intramuskularni odmerek 2,5 mg/kg telesne mase/dan od 1 do 3 dni so primerjali s peroralno uporabo.
Non-inferiority of the test product was demonstrated.
Preiskovano zdravilo ni bilo inferiorno.
Enrofloxacin 100 mg/ml (or 50 mg/ml)
Enrofloxacin 100 mg/ml (ali 50 mg/ml)
Denmark Krka d.d.
Romunija Krka d.d.
Two enzymes essential in DNA replication and transcription, DNA gyrase and topoisomerase IV, have been identified as the molecular targets of fluoroquinolones.
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.
4.2 Indications for use, specifying the target species Cattle
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Govedo
from the period 2004-2006 until the period 2008-2009 in the isolates tested in Germany.
- V nemški študiji, v kateri so med letoma 2006 in 2007 zbrali 71 izolatov Staph.
TENOTRIL 100mg/ml soluzione iniettabile epr bovini, suini, ovicaprini
TENOTRIL 100mg/ml soluzione iniettabile epr bovini, suini, ovicaprini govedo, prašiči, ovce, koze
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old.
Zdravljenje akutnega artritisa, povezanega z mikoplazmo, ki ga povzročajo za enrofloksacin občutljivi sevi vrste Mycoplasma bovis, pri govedu, mlajšem od 2 let.
Denmark Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Bolgarija Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp.
Enrofloksacin je v priporočenih terapevtskih odmerkih učinkovit proti mnogim gramnegativnim bakterijam, kot so Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp.
Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Portugalska Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5
Moderate to high resistance rates to ciprofloxacin were found for Campylobacter spp.
V zadnjih letih so ugotovili zmerne do velike deleže odpornosti Campylobacter spp.
Germany Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Norveška Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Therefore PK/PD and resistance data were taken into account when considering the efficacy of enrofloxacin against Pasteurella multocida.
Pri presoji učinkovitosti enrofloksacina proti Pasteurella multocida so bili zato upoštevani FK/FD podatki in podatki o odpornosti.
On the other hand, no resistance or very low resistance rates were observed for bacteria causing mastitis in ruminants (E. coli, Staph.
Pri bakterijah, ki povzročajo mastitis pri prežvekovalcih (E. coli, Staph.
5 days.
5 do 10 zaporednih dni.
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.
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.
Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp.
Enrofloksacin je v priporočenih terapevtskih odmerkih učinkovit proti mnogim gramnegativnim bakterijam, kot so Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp.
(100 mg/ml strength)
(jakost 100 mg/ml)
ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims
ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims govedo, prašiči, psi
The first time point at which all residue values fell below the MRL was 10 days.
Prva časovna točka, ko so bile vse vrednosti ostankov pod MVO, je bila 10 dni.
Baytril Swine 100mg/ml
Baytril Swine 100mg/ml prašiči
Meat and offal: 6 days.
Meso in organi: 6 dni.
Meat and offal: 4 days.
Meso in organi: 4 dni.
Dogs, cats, exotic Animals (small mammals, reptiles and avian species)
psi, mačke, eksotične živali (mali sesalci, plazilci in aviarne vrste)
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.
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.
Taking into account all data, the CVMP considered that this indication can be accepted.
Upoštevajoč vse podatke je odbor CVMP menil, da je ta indikacija sprejemljiva.
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.
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.
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.
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.
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.
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.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis.
Zdravljenje akutnega artritisa, povezanega z mikoplazmo, ki ga povzročajo za enrofloksacin občutljivi sevi vrste Mycoplasma bovis.
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.
Akutni artritis, povezan z mikoplazmo, ki ga povzročajo za enrofloksacin občutljivi sevi vrste Mycoplasma bovis: 5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/10 kg telesne mase) enkrat na dan 5 dni.
Enrofloxacyna 10% iniekcja, enrofloksacyna 10 g/100 ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów
Enrofloxacyna 10% iniekcja, enrofloksacyna 10 g/100 ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów govedo, prašiči, psi, mačke
Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus, Escherichia coli.
Zdravljenje mastitisa, ki ga povzročajo za enrofloksacin občutljivi sevi bakterij Staphylococcus aureus in Escherichia coli.
Calves, pigs
teleta, prašiči
Enrofloxacyna 5% iniekcja, enrofloxacyna 5g/100ml, roztwór dla bydła, świń, psów i kotów
Enrofloxacyna 5% iniekcja, enrofloxacyna 5g/100ml, roztwór dla bydła, świń, psów i kotów govedo, prašiči, psi, mačke
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.
Za meso in organe goveda se lahko sprejme usklajena karenca 5 dni, če se živali zdravijo s priporočenim odmerkom 5 mg/kg telesne mase z jakostma 50 mg/ml ali 100 mg/ml, ki se dajeta intravensko.
Treatment of septicaemia caused by enrofloxacin susceptible strains of E. coli.
Zdravljenje septikemije, ki jo povzročajo za enrofloksacin občutljivi sevi bakterije E. coli.
Treatment of infections of the alimentary and respiratory tracts caused by enrofloxacin susceptible strains of: Escherichia coli, Pasteurella multocida and Staphylococcus spp.
Zdravljenje okužb prebavil in dihal, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij: Escherichia coli, Pasteurella multocida in Staphylococcus spp.
Rabbits: Meat and offal: 6 days.
Kunci: Meso in organi: 6 dni.
ALSIR 25mg/ml solução injectável para Cães e Gatos
ALSIR 25mg/ml solução injectável para Cães e Gatos psi, mačke
- Dosage: 5 mg/kg bw, once daily by subcutaneous injection for up to 5 days.
- Odmerjanje: 5 mg/kg telesne mase, enkrat na dan s subkutanim injiciranjem do 5 dni.
Not more than 3 ml should be administered at one intramuscular injection site.
Na eno mesto intramuskularnega injiciranja se lahko injicira največ 3 ml zdravila.
Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli and Klebsiella spp.
Zdravljenje poporodnega sindroma disgalakcije (post-partum dysgalactiae syndrome - PDS) (sindrom MMA), ki ga povzročajo za enrofloksacin občutljivi sevi bakterij Escherichia coli in Klebsiella spp.
On the basis of the available data the CVMP considered that this indication can be accepted.
Na podlagi razpoložljivih podatkov je odbor CVMP menil, da je ta indikacija sprejemljiva.
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 in organi (jakosti 50 mg/ml in 100 mg/ml): Predloženi sta bili dve študiji izločanja ostankov, v katerih so ovce 5 dni zdravili z odmerkom 5 mg/kg telesne mase.
consecutive days.
so redki.
- Dosage: 2.5 mg/kg bw, once daily for 3 days by intramuscular injection.
- Odmerjanje: 2,5 mg/kg telesne mase enkrat na dan, 3 dni z intramuskularnim injiciranjem.
- Dosage for reptiles: 5-10 mg/kg bw, once daily by intramuscular injection for 5 consecutive days.
- Odmerjanje za plazilce: od 5 do 10 mg/kg telesne mase, enkrat na dan z intramuskularnim injiciranjem 5 zaporednih dni.
Calves:
Koze:
- Dosage: 5 mg/kg bw, once daily for 3 to 5 days.
- Odmerjanje: 5 mg/kg telesne mase, enkrat na dan od 3 do 5 dni.
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma spp.
Zdravljenje okužb dihal, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij Actinobacillus pleuropneumoniae, Pasteurella multocida in Mycoplasma spp.
Enrobioflox 5% Injectio, 50 mg/ml roztwór do wstrzykiwań dla świń, bydła i psów
Enrobioflox 5% Injectio, 50 mg/ml roztwór do wstrzykiwań dla świń, bydła i psów govedo, prašiči, psi
On the basis of the available data the CVMP considered that these indications can be accepted.
Na podlagi razpoložljivih podatkov je odbor CVMP menil, da so te indikacije sprejemljive.
Enrotron 25, 25 mg/ml raztopina za injiciranje za pse, mačke, prašiče in kunce
Enrotron 25, 25 mg/ml raztopina za injiciranje za pse, mačke, prašiče in kunce psi, mačke, prašiči, kunci
- Dosage: 10 mg/kg bw, once daily for 5 to 10 consecutive days by subcutaneous administration.
- Odmerjanje: 10 mg/kg telesne mase, enkrat na dan, od 5 do 10 zaporednih dni subkutano.
20 mg/kg bw, corresponding to 0.8 ml/kg bw, once daily by intramuscular injection for 5 to 10 consecutive days.
20 mg/kg telesne mase (kar ustreza 0,8 ml/kg telesne mase) enkrat na dan z intramuskularnim injiciranjem od 5 do 10 zaporednih dni.
- Dosage for ornamental birds: 20 mg/kg bw, once daily by intramuscular injection for 5-10
- Odmerjanje za okrasne ptice: 20 mg/kg telesne mase, enkrat na dan z intramuskularnim injiciranjem od 5 do 10 zaporednih dni.
Lithuania FORTE Healthcare Limited Cougar Lane
Madžarska FORTE Healthcare Limited Cougar Lane
4.2 Indications for use, specifying the target species Calves
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Teleta
ENROXIL 50 mg/ml raztopina za injiciranje za govedo, ovce, koze, prašiče in pse
ENROXIL 50 mg/ml raztopina za injiciranje za govedo, ovce, koze, prašiče in pse govedo, ovce, koze, prašiči, psi
Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp., Proteus spp.
(npr. Pasteurella multocida), Bordetella spp., Proteus spp.
Enflocyna inj, 100 mg/ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów
Enflocyna inj, 100 mg/ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów govedo, prašiči, psi, mačke
Enrofloxacin 2,5% WDT, Injektionslösung
Enrofloxacin 2,5% WDT, Injektionslösung psi, mačke
Pigs (50 mg/ml and 100 mg/ml strengths)
Prašiči (jakosti 50 mg/ml in 100 mg/ml)
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.
Akutni mastitis, ki ga povzroča bakterija Escherichia coli: 5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/20 kg telesne mase) enkrat na dan s počasnim intravenskim injiciranjem dva zaporedna dneva.
5-10 mg/kg bw, corresponding to 0.2-0.4 ml/kg bw, once daily by intramuscular injection for 5 consecutive days.
5-10 mg/kg telesne mase (kar ustreza 0,2-0,4 ml/kg telesne mase) enkrat na dan z intramuskularnim injiciranjem 5 zaporednih dni.
Degenerative changes of articular cartilage were observed with doses of 30 mg enrofloxacin/kg bw/day during 14 days.
Pri teletih, ki so jih 14 dni zdravili z odmerki 30 mg enrofloksacina/kg telesne mase/dan, so opazili degenerativne spremembe sklepnega hrustanca.
Treatment of Escherichia coli infections of the alimentary tract or septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Zdravljenje okužb prebavil z Escherichia coli ali septikemije, ki jih povzročajo za enrofloksacin občutljivi sevi bakterije Escherichia coli
Cattle, pigs, sheep
govedo, prašiči, ovce
- Dosage: 5 mg/kg bw, once daily for 3 days by intramuscular injection.
- Odmerjanje: 5 mg/kg telesne mase enkrat na dan, 3 dni z intramuskularnim injiciranjem.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous or intramuscular use.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
This is recommended as the withdrawal period for milk from cattle treated at the recommended dose of 5 mg/kg bw with the 100 mg/ml strength subcutaneously.
To je priporočeno kot karenca za mleko govedi, zdravljene s priporočenim odmerkom 5 mg/kg telesne mase z jakostjo 100 mg/ml, ki se daje subkutano.
Regarding target species dog and cat, data submitted show an increase in resistance rates of non enteric E. coli and Staphylococcus spp.
Podatki, predloženi za ciljne živalske vrste, pse in mačke, so pokazali povečanje deležev odpornosti izolatov neenterične E. coli in Staphylococcus spp., testiranih v Nemčiji od obdobja med letoma 2004 in 2006 do obdobja med letoma 2008 in 2009.
Přípravek s indikačním omezením
Přípravek s indikačním omezením psi, mačke
Germany Vetpharma Animal Health, S.L.
Portugalska Vetpharma Animal Health, S.L.
ENROTRON 50, 50 mg/ml raztopina za injiciranje za govedo (teleta), prašiče in pse
ENROTRON 50, 50 mg/ml raztopina za injiciranje za govedo (teleta), prašiče in pse govedo (teleta), prašiči, psi
Not more than 6 ml should be administered at one subcutaneous injection site.
Na eno mesto subkutanega injiciranja se lahko injicira največ 6 ml zdravila.
aureus collected between 2006-2007 in Germany were resistant to enrofloxacin.
aureus, jih je bilo 4,2 % odpornih na enrofloksacin.
Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Escherichia coli.
Zdravljenje hudega akutnega mastitisa, ki ga povzročajo za enrofloksacin občutljivi sevi bakterije Escherichia coli.
Belgium Vetpharma Animal Health, S.L.
Madžarska Vetpharma Animal Health, S.L.
Floxadil 25 mg/ml, oplossing voor injectie voor honden, katten en exotische dieren
Floxadil 25 mg/ml, oplossing voor injectie voor honden, katten en exotische dieren psi, mačke, eksotične živali
10 mg/kg bw, corresponding to 2 ml/5 kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
10 mg/kg telesne mase (kar ustreza 2 ml/5 kg telesne mase) enkrat na dan s subkutanim injiciranjem od 5 do 10 zaporednih dni.
• 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.
je odbor CVMP je priporočil spremembe dovoljenj za promet z zdravili Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable in povezanimi imeni ter z njimi povezanimi zdravili za uporabo v veterinarski medicini, odobrenimi skladno s členom 13 Direktive 2001/82/ES, kot je bila spremenjena, ki so navedena v Prilogi I in katerih povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo so v Prilogi III.
Belgium Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Nizozemska Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Not more than 10 ml should be administered at one subcutaneous injection site.
Na eno mesto subkutanega injiciranja se lahko injicira največ 10 ml zdravila.
Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days.
Posebni previdnostni ukrepi za uporabo pri živalih Pri teletih, ki so jih 14 dni zdravili s peroralnimi odmerki 30 mg enrofloksacina/kg telesne mase, so opazili degenerativne spremembe sklepnega hrustanca.
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 analiza podatkov ni bila mogoča, zato so karenco izpeljali z uporabo alternativnega pristopa.
Floxadil 25mg/ml Injektionsl!osung für Hunde, katzen und exotische Tiere
Floxadil 25mg/ml Injektionsl!osung für Hunde, katzen und exotische Tiere psi, mačke, eksotične živali (mali sesalci, plazilci in ptice)
Enrotron 25, 25 mg/ml Injektionslösung für Hunde, Katzen, Schweine und Kaninchen
Enrotron 25, 25 mg/ml Injektionslösung für Hunde, Katzen, Schweine und Kaninchen psi, mačke, prašiči, kunci
4.9 Amounts to be administered and administration route Subcutaneous or intramuscular use.
Za subkutano ali intramuskularno uporabo.
Germany Industrial Veterinaria SA C/Esmeralda 19-21
Romunija Industrial Veterinaria SA C/Esmeralda 19-21
Sheep (50 mg/ml and 100 mg/ml strengths)
Ovce (jakosti 50 mg/ml in 100 mg/ml)
Germany Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Portugalska Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Dogs, pigs, cattle, cats
psi, prašiči, govedo, mačke
Treatment of skin and wound infections caused by enrofloxacin susceptible strains of Staphylococcus aureus.
Zdravljenje okužb kože in ran, ki jih povzročajo za enrofloksacin občutljivi sevi bakterije Staphylococcus aureus.
Cattle, pigs, dogs,
govedo, prašiči, psi,
Belgium Industrial Veterinaria SA C/Esmeralda 19-21
Bolgarija Industrial Veterinaria SA C/Esmeralda 19-21
Rodents
Karence
This is recommended as the withdrawal period for cattle meat and offal for animals treated at the recommended dose of 5 mg/kg bw/day for 5 days with either the 50 mg/ml or 100 mg/ml strenghts and administered subcutaneously.
Ta je priporočena za meso in organe govedi, zdravljene s priporočenim odmerkom 5 mg/kg telesne mase/dan 5 dni z jakostma 50 mg/ml ali 100 mg/ml, ki se dajeta subkutano.