Țară: Țările de Jos
Limbă: olandeză
Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENROFLOXACINE
aniMedica GmbH
QJ01MA90
ENROFLOXACINE
Vloeistof voor oraal gebruik
ENROFLOXACINE 5 mg/ml,
Oraal gebruik
Uitsluitend door dierenartsen te gebruiken
Varkens
Enrofloxacin
Wachttermijn: Varkens Vlees 7 dagen
NL/V/0165/001
2013-03-19
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron 5 mg/ml oral solution for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Enrofloxacin 5.0 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 Pigs (piglets) 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 _ spp. • Enzootic pneumonia To be used where clinical experience and/or sensitivity testing indicates enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS 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. 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. Do not use in case of confirmed or suspected resistance to quinolones, since a high degree of cross resistance between enrofloxacin and other quinolones does exist. 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. Susceptibility testing should be performed before treatment is initiated. Use of the veterinary medicinal product deviating from instructions given in the SPC may increase the prevalence of bac Citiți documentul complet