Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Vetpharma Animal Health, S.L.
QJ01MA90
Enrofloxacin
25 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
enrofloxacin
Antibacterial
Authorised
2009-07-10
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Unisol 25 mg/ml oral solution for calves [IE, IT] UNISOL 25 mg/ml oral solution for calves [ES] DORAFLOX 25 mg/ml oral solution for calves [BE] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin ..................................... 25.0 mg EXCIPIENTS: Qualitative composition of excipients and other constituents Quantitative composition if that information is essential for proper administration of the veterinary medicinal product Benzyl Alcohol (E 1519) 14.0 mg Potassium hydroxide -- Hypromellose -- Purified water -- Aqueous, clear solution. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle (Pre-ruminant calves). 3.2. INDICATIONS FOR USE FOR EACH TARGET SPECIES In calves: - treatment of respiratory infections due to _ Pasteurella multocida_ and _Mannheimia 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. 3.3. CONTRAINDICATIONS Do not use when resistance / cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment. Do not use in cases of hypersensitivity to the active substance, other (fluoro)quinolones or to any of the excipients. 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. 3.4 SPECIAL WARNINGS None. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: 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. Wherever possible, fluor Read the complete document