Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Universal Farma, S.L.
QJ01MA90
ENROFLOXACIN
25 Mg/Ml
Oral Solution
POM
Bovine
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. 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. Aqueous, clear solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (Pre-ruminant calves). 4.2 INDICATIONS FOR USE, SPECIFYING THE 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. 4.3 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/05/2015_ _CRN 7021093_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE 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 Прочитать полный документ