natgillin/translations-raw huggingface dataset:
Target inhibition is caused by noncovalent binding of fluoroquinolone molecules to these enzymes.
Ciljanu inhibiciju tih enzima uzrokuje nekovalentno vezanje molekula fluorokinolona za njih.
The warning regarding possible degenerative changes of articular cartilage in calves is supported by a study in which calves (2 weeks old) were orally administered with 0, 30 or 90 mg/kg bw of enrofloxacin per day for 14 days.
Upozorenje vezano uz moguće degenerativne promjene zglobne hrskavice u teladi potkrijepljeno je ispitivanjem, u kojem je telad (2 tjedan stara) peroralno primila 0.30 ili 90 mg/kg tjelesne težine enrofloksacina na dan tijekom 14 dana.
People with known hypersensitivity to fluoroquinolones should avoid any contact with the product.
Osobe preosjetljive na fluorokinolone trebaju izbjegavati dodir s ovim VMP-om.
Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names are solutions for injection containing enrofloxacin at 25 mg/ml, 50 mg/ml and 100 mg/ml respectively.
Baytril 2,5% injektabilan, Baytril 5% injektabilan i Baytril 10% injektabilan i povezani nazivi su otopine za injekciju koje sadrže enrofloksacin od 25 mg/ml, 50 mg/ml odnosno 100 mg/ml.
Accumulation in plasma does not occur following a treatment interval of 24 h.
Do nakupljanja u plazmi ne dolazi kada je razmak između primjena VMP-a 24 sata.
Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols).
Enrofloksacin se ne smije primjenjivati istodobno s antimikrobnim tvarima koje djeluju antagonistički na kinolone (npr. makrolidi, tetraciklini ili fenikoli).
Enrofloxacin is rapidly absorbed after parenteral injection.
Enrofloksacin se brzo resorbira nakon parenteralne primjene.
The safety of the veterinary medicinal product has been established in pregnant cows during the 1st quarter of pregnancy.
Neškodljivost veterinarsko-medicinskog proizvoda utvrđena je kod gravidnih krava tijekom 1. četvrtine graviditeta.
In rabbits, reactions (from reddening to ulcerative lesions with deep loss of tissue), may occur.
U kunića se mogu javiti reakcije (od crvenila do čireva s opsežnim gubitkom tkiva).
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).
Zečevi su klasificirani kao manje vrste, te su stoga dostupni podaci procijenjeni u kontekstu smjernice CVMP-a o zahtjevima za podatke o djelotvornosti i sigurnoj primjeni u ciljnih životinja za veterinarsko-medicinske proizvode predviđene za manju uporabu ili manje vrste (EMEA/CVMP/EWP/117899/2004).
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
U nedostatku studija kompatibilnosti, ovaj veterinarsko-medicinski proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima.
The use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated to clinical signs.
Primjena enrofloksacin u janjadi u razvoju u preporučenoj dozi u trajanju od 15 dana uzrokovalo je histološke promjene u zglobnoj hrskavici, što nije povezano s kliničkim znakovima.
The discard date should be recorded on the label of the glass vial after the vial was broached for the first time.
Datum prestanka valjanosti treba zabilježiti na etiketu bočice nakon prvog otvaranja.
Digestive tract disorders (e.g. diarrhoea) may occur in very rare cases.
Probavni poremećaji (npr. proljev) mogu se javiti u vrlo rijetkim slučajevima.
Enrofloxacin:
Enrofloksacin:
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 rašlje i translacijski kompleksi ne mogu se nastaviti uslijed stvaranja kompleksa enzim-DNK-fluorokinolon, te je inhibicija sinteze DNK i mRNK okidač koji dovodi do brzog i o koncentraciji ovisnog uništavanja patogenih bakterija.
Parent substance and active metabolite are cleared from the body via urine and faeces.
Izvorna tvar i aktivni metabolit izlučuju se iz organizma mokraćom i izmetom.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6.6 Posebne mjere opreza prilikom odlaganja neupotrjebljenog veterinarskomedicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE Pročitati uputu o VMP-u prije primjene.
Special caution should be taken when using enrofloxacin in animals with impaired renal function.
Poseban oprez potreban je prilikom primjene enrofloksacina životinjama s poremećenom funkcijom bubrega.
In dogs, rabbits, small rodents, reptiles and birds, overdose has not been documented.
U pasa, kunića, malih glodavaca, gmazova i ptica nisu zabilježeni slučajevi predoziranja.
Do not use in animals with known hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients.
Ne primjenjivati životinjama preosjetljivim na enrofloksacin ili druge fluorokinolone ili na bilo koju pomoćnu tvar.
6.1 List of excipients n-Butyl alcohol
6.1 Popis pomoćnih tvari n-butil-alkohol
Overall summary of the scientific evaluation of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names (see Annex I)
Cjelokupni sažetak znanstvene ocjene VMP-ova Baytril 2,5% injektabilan, Baytril 5% injektabilan i Baytril 10% injektabilan i njihovih povezanih naziva (vidjeti Dodatak I)
The product can be used in cows during lactation.
VMP se može primjenjivati kravama tijekom laktacije.
Enrofloxacin
Enrofloksacin
Goat meat and offal (50 mg/ml and 100 mg/ml strengths) No residue depletion data were made available.
Kozje meso i iznutrice (jačine 50 mg/ml i 100 mg/ml) Nisu dostavljeni podaci o pražnjenu rezidua.
Acute severe mastitis caused by Staphylococcus aureus (100 mg/ml strength)
Akutni ozbiljni mastitis kojeg uzrokuje Staphylococcus aureus (jačine 100 mg/ml)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Glass vials
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Staklena bočica
the CVMP has recommended variations of the marketing authorisations for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names as referred in Annex I for which the summaries of the product characteristics, labelling and package leaflets are set out in Annex III.
CVMP je preporučio varijacije odobrenja za stavljanje VMP-a u promet za VMP-ove Baytril 2,5% injektabilan, Baytril 5% injektabilan i Baytril 10% injektabilan i njihove povezane nazive kako je navedeno u Dodatku I, za koje su sažetci opisa svojstava za VMP, etiketa i uputa za uporabu navedeni u Dodatku III.
Wash any splashes from skin or eyes immediately with water.
Ako VMP kapne na kožu ili u oči treba ga odmah isprati vodom.
Potassium hydroxide
Kalijev hidroksid
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
Ispitivanje kojim se potvrđuje doza i terensko ispitivanje dokazali su kliničku djelotvornost doze od 5 mg/kg tjelesne težine/dan u slučaju enzootične pneumonije koju uzrokuje M. haemolytica i P. multocida.
Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Znanstveni zaključci i razlozi za dopunu sažetaka opisa svojstava VMP-a, etikete i uputa za uporabu
In other species, the safety of the veterinary medicinal product has not been established during pregnancy and lactation.
U drugih vrsta, sigurnost veterinarsko-medicinskog proizvoda nije utvrđena tijekom gravidnost i laktacije.
{Name and address} <{Tel.}> <{Fax}> <{E-mail}>
{Naziv i adresa} <{Tel.}> <{Fax}> <{E-mail}>
Enrofloxacin and ciprofloxacin distribute well into all target tissues, e.g. lung, kidney, skin and liver, reaching 2- to 3-fold higher concentrations than in plasma.
Enrofloksacin i ciprofloksacin se dobro raspodjeljuju u sva ciljna tkiva, pr. pluća, bubreg, kožu i jetru, u kojima postižu 2-3 puta veće koncentracije negoli u plazmi.
Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany
Njemačka Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Njemačka
MANUFACTURER'S BATCH NUMBER Batch{number}
17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
Advice for handling: Do not refrigerate or freeze
Savjet za rukovanje: ne stavljati u hladnjak ili zamrzivač
MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET Popunjava se na nacionalnoj razini.
Special caution should be taken when using enrofloxacin in cats because higher doses than recommended can cause retinal damage and blindness (see section 4.10).
Poseban oprez nužan je kada se enrofloksacin primjenjuje mačkama jer doze veće od preporučenih mogu uzrokovati oštećenje mrežnice i sljepoću (vidi odjeljak 4.10).
{Name and address} <{Tel}> <{Fax}> <{E-mail}>
{ Naziv i adresa } <{Tel}> <{Fax}> <{E-mail}>
Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg body weight 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.
In pigs, after intramuscular administration of the product, inflammatory reactions may occur.
U svinja se nakon primjene u mišić, mogu javiti upalne reakcije.
7 CVMP public statement on the use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
6.5 Nature and composition of immediate packaging Brown glass (type I) vials with a chlorobutyl polytetrafluoroethylene (PTFE) stopper and with a flipoff cap with aluminium case and plastic flip-off button.
6.5 Osobine i sastav unutarnjeg pakovanja Bočica od smeđeg stakla (tip I) s čepom od brombutil gume (PTFE) i zapečaćena aluminijskom kapicom.
In cases of accidental overdoses digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur.
U slučaju slučajnog predoziranja mogu nastupiti poremećaji probavnog trakta (primjerice povraćanje, proljev) i neurološki poremećaji.
CVMP position paper regarding availability of products for minor uses and minor species (EMEA/CVMP/477/03)http://www.ema.europa.eu/docs/en_GB/document_library/Position_statement/2009/10/WC500005163.pdf 2 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)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004678.pdf
1 CVMP position paper regarding availability of products for minor uses and minor species (EMEA/CVMP/477/03)http://www.ema.europa.eu/docs/en_GB/document_library/Position_statement/2009/10/WC500005163.pdf 2 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)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004678.pdf podložnim sojevima patogena: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp., Proteus spp.
Intravenous, subcutaneous or intramuscular use.
Primjena u venu, potkožno ili u mišić.
Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana))
Psi, mačke i druge egzotične vrste (glodavci, kunići, kavezne ptice i gmazovi (zmije, kornjače i iguana))
Advice for handling: Do not refrigerate or freeze.
Savjet za rukovanje: ne stavljati u hladnjak ili zamrzivač.
Use of the product including use deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to enrofloxacin and may decrease the effectiveness of treatment with all fluoroquinolones due to the potential for cross-resistance.
PrimjenaVMP-a, uključujući upotrebu koja nije u skladu s preporukama navedenim u SPC-u, može povećati učestalost bakterija otpornih na enrofloksacin, a zbog pojave križne rezistencije umanjiti učinkovitost liječenja sa svim fluorokinolonima.
Bayer Hungária Kft. Alkotás u. 50
Mađarska Bayer Hungária Kft.
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
A withdrawal period of 4 days following a subcutaneous injection at the recommended dose of 5 mg/kg bw is recommended based on extrapolation of the withdrawal period established for cattle milk.
Karencija u trajanju od 4 dana nakon supkutane injekcije u preporučenoj dozi od 5 mg/kg tjelesne težine preporučena je na temelju ekstrapolacije karencije utvrđene za goveđe mlijeko.
Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation.
Ne primjenjivati životinjama s epilepsijom ili napadima tj. poremećajima središnjeg živčanog sustava (SŽS) jer enrofloksacin može stimulirati SŽS.
The use should be done only accordingly to the benefit-risk assessment by the responsible veterinarian.
VMP se treba koristiti samo u skladu s ocjenom omjera koristi i rizika koju će donijeti odgovoran veterinar.
3 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Hipralona_Enro
3 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Hipralona_EnroS/vet_referral_000067.jsp&mid=WC0b01ac05805c5170
• the CVMP considered the scope of the referral was the harmonisation of the summaries of product characteristics, labelling and package leaflets;
• je CVMP zaključio da je predmet postupka upućivanja bio usklađivanje sažetka opisa svojstava
Subcutaneous or intramuscular use.
Primjena u mišić ili potkožno.
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 mišić ili potkožno.
Based on the available data in sheep and with the addition of an uncertainty factor of 1.5 a goat meat and offal withdrawal period of 6 days is supported following a subcutaneous injection at the recommended dose of 5 mg/kg bw.
Na temelju dostupnih podataka u ovaca i uz dodatak faktora nepouzdanosti 1,5, potvrđena je karencija za kozje meso i iznutrice u trajanju od 6 dana nakon supkutane injekcije u preporučenoj dozi od 5 mg/kg tjelesne težine.
In cattle, sheep and goat, overdose has not been documented.
U goveda, ovaca i koza nisu zabilježeni slučajevi predoziranja.
In dogs, cattle, sheep and goats, overdose has not been documented.
U pasa, goveda, ovaca i koza nisu zabilježeni slučajevi predoziranja.
Dogs, cats, rabbits, rodents (excluded: guinea pigs, hamster), exotic animals (reptiles, avian species), pigs (piglet, pigs < 30 kg bw)
Psi, mačke, kunići, glodavci (uključujući: zamorčić, hrčak), egzotične životinje (gmazovi, ptičje vrste), svinje (prasad,svinje < 30 kg tm)
<{MM/YYYY}>
Lot {number}
Following subcutaneous injection: Meat and offal: 10 days.
Nakon potkožne primjene: Meso i jestive iznutrice: 10 dana.
Official and local antimicrobial policies should be taken into account when the product is used.
Prilikom primjene VMP-a treba poštovati službene i lokalne preporuke za primjenu antimikrobnih lijekova.
Do not use in the case of known hypersensitivity to fluoroquinolones or to any of the excipients.
Ne primjenjivati u slučaju preosjetljivosti na fluorokinolone ili bilo koju pomoćnu tvar.
Special caution should be taken when using enrofloxacin in cats because higher doses than recommended can cause retinal damage and blindness.
Poseban oprez nužan je kada se enrofloksacin primjenjuje mačkama jer doze veće od preporučenih mogu uzrokovati oštećenje mrežnice i sljepoću.
Cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days.
Dokazano je da mačke pate od okularnog oštećenja nakon primitka doza koje su veće od 15 mg/kg tjelesne težine jednom dnevno tijekom 21 uzastopnih dana.
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.
Liječenje infekcija dišnog i probavnog sustava gdje je kliničko iskustvo, ako je moguće, potkrijepljeno nalazom antibiograma koji ukazuje da je enrofloksacin lijek izbora.
In cases of accidental overdose digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur.
U slučaju nehotičnog predoziranja mogu se javiti probavni poremećaji (npr. povraćanje, proljev) i neurološki simptomi.
Pigs: Meat and offal: 13 days
Svinje: Meso i jestive iznutrice: 13 dana
Excipient: n-Butyl alcohol:
Pomoćne tvari: n-butil-alkohol:
Special caution should be taken when using enrofloxacin in cats because higher doses than recommended can cause retinal damage and blindness (see Overdose).
Poseban oprez nužan je kada se enrofloksacin primjenjuje mačkama jer doze veće od preporučenih mogu uzrokovati oštećenje mrežnice i sljepoću (vidi Predoziranje).
Marketing authorisation holder: To be completed nationally
Nositelj odobrenja za stavljanje u promet: Popunjava se na nacionalnoj razini.
Pack-sizes:
Veličina pakovanja:
Excipient: n-Butyl alcohol
Pomoćne tvari: n-butil-alkohol
The product can be used in sows during lactation.
VMP se može primjenjivati krmačama tijekom laktacije.
Enrofloxacin is metabolized to the active substance ciprofloxacin at approximately 40 % in dogs and ruminants, less than 10 % in pigs and cats.
Enrofloksacin se razgrađuje na aktivni metabolit ciprofloksacin, približno 40% u pasa i preživača te manje od 10% u svinja i mačaka.
Enrofloxacin is metabolized to the active substance ciprofloxacin at approximately 40% in dogs and less than 10% in cats and pigs.
Enrofloksacin se razgrađuje na aktivni metabolit ciprofloksacin, približno 40% u pasa te manje od 10% kod mačaka i svinja.
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, Mannheimia haemolytica i Pasteurella spp. (pr. Pasteurella multocida), gram-pozitivnih bakterija kao što je Staphylococcus spp. (npr. Staphylococcus aureus) te protiv Mycoplasma spp..
Birds and reptiles
Ptice i gmazovi
Reptiles: 5-10 mg of enrofloxacin/kg bw once daily by intramuscular injection for 5 days.
Reptili: 5-10 mg enrofloksacina/kg tjelesne težine jednom dnevno intramuskularnom injekcijom tijekom 5 dana.
Doses of 30 mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage.
Doza od 30 mg/kg primijenjena jedanput na dan tijekom 21 dana uzrokovala je nepovratno oštećenje oka.
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 enrofloksacina/kg t.m., što odgovara 1 mL/20 kg t.m., jednom dnevno tijekom 5 dana.
Not more than 3 ml should be administered at one intramuscular injection site.
Na isto mjesto u mišić ne smije se injicirati više od 3 mL VMP-a.
- Dosage: 5 mg/kg bw, once daily for two consecutive days
- Doza: 5 mg/kg tjelesne težine, jednom dnevno tijekom dva uzastopna dana
Do not use this veterinary medicinal product after the expiry date which is stated on the vial after {abbreviation used for expiry date}
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na bočici {EXP}
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 respiratornog trakta uzrokovanih sojevima sljedećih patogena podložnih enrofloksacinu: Escherichia coli, Pasteurella multocida i Staphylococcus spp.
Sheep meat and offal (50 mg/ml and 100 mg/ml strengths) Residue depletion data were made available and supported a sheep meat and offal withdrawal period of 4 days following a subcutaneous injection at the recommended dose of 5 mg/kg bw.
Ovčje meso i iznutrice (jačine 50 mg/ml i 100 mg/ml) Dostavljeni su podaci o pražnjenju rezidua koji govore u prilog karencije za ovčje meso i iznutrice u trajanju od 4 dana nakon supkutane injekcije u preporučenoj dozi od 5 mg/kg tjelesne težine.
Ornamental birds: 20 mg of enrofloxacin/kg bw once daily by intramuscular injection for 5-10 days.
Ukrasne ptice: 20 mg enrofloksacina/kg tjelesne težine jednom dnevno intramuskularnom injekcijom tijekom 5-10 dana.
Cattle meat and offal (50 mg/ml and 100 mg/ml strengths) Residue depletion data were made available and supported a cattle meat and offal withdrawal period of 5 days following an intravenous injection at the recommended dose of 5 mg/kg bw.
Goveđe meso i iznutrice (jačine 50 mg/ml i 100 mg/ml) Dostavljeni su podaci o pražnjenju rezidua koji govore u prilog karencije za goveđe meso i iznutrice u trajanju od 5 dana nakon intravenozne injekcije u preporučenoj dozi od 5 mg/kg tjelesne težine.
Rabbits and rodents: 10 mg of enrofloxacin/kg bw once daily by subcutaneous injection for 5-10 days.
Zečevi i glodavci: 10 mg enrofloksacina/kg tjelesne težine jednom dnevno supkutanom injekcijom tijekom 5-10 dana.
To be completed nationally Manufacturer responsible for batch release: To be completed nationally
Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet:> Popunjava se na nacionalnoj razini.
Pigs, rabbit, dogs, cats, exotic animals (mammals, birds, reptiles)
Svinje, kunići, psi, mačke, egzotične životinje (sisavci, ptice, gmazovi)
Sheep and goats: 5 mg of enrofloxacin/kg bw once daily by subcutaneous injection for 3 days.
Ovce i koze: 5 mg enrofloksacina/kg tjelesne težine jednom dnevno supkutanom injekcijom tijekom 3 dana.
and Actinobacillus pleuropneumoniae.
Actinobacillus pleuropneumoniae i Mycoplasma spp osjetljivih na enrofloksacin.
6 CVMP reflection paper on the use of fluoroquinolones in food producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf
regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf 7 CVMP public statement on the use of (fluoro)quinolones in food-producing animals in the European Union:
Dogs and cats: 5 mg of enrofloxacin/kg bw once daily by subcutaneous injection for up to 5 days.
Psi i mačke: 5 mg enrofloksacina/kg tjelesne težine jednom dnevno supkutanom injekcijom tijekom maksimalno 5 dana.