Pays: Royaume-Uni
Langue: anglais
Source: VMD (Veterinary Medicines Directorate)
Enrofloxacin
UNIVERSAL FARMA, S.L
QJ01MA90
Enrofloxacin
Expired
Revised: January 2011 AN: 01275/2010 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UNISOL 2.5% oral solution for calves [IE] UNISOL 2.5% w/v oral solution for calves [UK] UNISOL 25 mg/ml oral solution for calves [ES, DE, PL] LANFLOX 2.5 % oral solution for calves [FR, NL, HU, RO, SK] LANFLOX 25 mg/ml oral solution for calves [CZ] DORAFLOX 25 mg/ml oral solution for calves [BE] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin...................................25.0 mg EXCIPIENTS: Benzyl Alcohol (E 1519)................14.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Ready to use aqueous clear, oral solution. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Pre-ruminant calves 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In calves: - treatment of respiratory infections due to _Pasteurella multocida_ and _Manheimia haemolytica._ - treatment of gastro-intestinal infection due to _Escherichia coli_. 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 confirmed, or suspected, resistance to quinolones. Do not use in cases of hypersensitivity to the active substance. Page 1 of 6 Revised: January 2011 AN: 01275/2010 Do not use in case of disturbances in growth of cartilage and/or during injury of locomotory system particularly on functionally loaded joints or due to body weight loaded joints. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5. SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Do not use for prophylaxis. During the period of rapid growth, enrofloxacin may affect articular cartilage. 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. Where Lire le document complet