Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Vetpharma Animal Health, S.L.
QJ01MA90
Enrofloxacin
5 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
enrofloxacin
Antibacterial
Authorised
2009-07-10
1. NAME OF THE VETERINARY MEDICINAL PRODUCT UNISOL 5 mg/ml oral solution for piglets [ES, IE, PL, IT] LANFLOX 0.5% oral solution for piglets [HU] LANFLOX 5 mg/ml oral solution for piglets [PT] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin ................................................... 5.0 mg EXCIPIENTS: Oral solution. Aqueous, clear solution. 3. CLINICAL INFORMATION 3.1. TARGET SPECIES Pigs (Piglets). 3.2. INDICATIONS FOR USE FOR EACH TARGET SPECIES In piglets (up to 10 kg): - 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 known 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. QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ Benzyl alcohol (E 1519) 14.0 mg Potassium hydroxide Hypromellose Purified water 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. 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 only be used based on susceptibility testing. Use of the product deviating from instructions given in the SPC may increase the prevalence of bacteria resist Citiți documentul complet