Država: Nizozemska
Jezik: nizozemski
Izvor: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENROFLOXACINE
aniMedica GmbH
QJ01MA90
ENROFLOXACINE
Concentraat voor drank
ENROFLOXACINE 25 mg/ml,
Oraal gebruik
Uitsluitend door dierenartsen te gebruiken
Kalveren
Enrofloxacin
Wachttermijn: Kalveren Vlees 7 dagen
NL/V/0165/002
2013-03-19
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron 25 mg/ml oral solution for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Enrofloxacin 25.0 mg EXCIPIENTS: Benzyl alcohol (E-1519) 14.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections of the respiratory and alimentary tract caused by enrofloxacin-sensitive microorganisms. In particular: • Treatment of neonatal diarrhoea and septicaemia caused by enrofloxacin-sensitive _E. coli _ • Treatment of respiratory infections caused by enrofloxacin-sensitive _Pasteurella multocida_ , _Mannheimia haemolytica_ and _Mycoplasma bovis._ To be used where clinical experience and/or sensitivity testing indicates enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS Do not use in case of confirmed or suspected resistance to quinolones, since a high degree of cross resistance between enrofloxacin and other (fluoro)quinolones does exist. Do not use in cases of hypersensitivity to the active substance, to other (fluoro)quinolones or to any of the excipients. Do not use in cases of disturbances to the growth of cartilage and/or during injury to the locomotory system particularly if functionally loaded or body weight loaded joints are affected. Do not use for prophylaxis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Official and local antimicrobial policies should be taken into account when the product is used. 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. Wherever possible, fluoroquinolones should be used based on susceptibility testing. Use of the veterinary medicinal product deviating from instructions given in the SPC may in Pročitajte cijeli dokument