Country: Malta
Language: English
Source: HMA (Heads of Medicines Agencies)
danofloxacin mesilate 180 mg/ml
Pfizer Limited
QJ01MA92
Solution for injection
danofloxacine
Cattle
2012-02-13
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ADVOCIN 180, 180 mg/ml, Solution for Injection for Cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains Active substance: Danofloxacin 180.00 mg (Equivalent to 228.4mg Danofloxacin mesylate) Excipients: Phenol 2.50 mg Monothioglycerol 5.00 mg Excipient qsp 1 ml For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Medium yellow to amber solution. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cattle 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: Treatment of bovine respiratory disease caused by _Mannheimia _ _haemolytica_, _Pasteurella multocida _and_ Histophilus somni _sensitive to danofloxacin. For the treatment of acute bovine mastitis caused by _Escherichia coli_ sensitive to danofloxacin. In neo-natal calves: Treatment of enteric infections caused by _Escherichia coli_ sensitive to danofloxacin. 4.3. CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active ingredient, to other (fluoro)quinolones or to any ingredients of the product. Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance) 2 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES The safety of the product has not been assessed in breeding bulls. 4.5. SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use of fluoroquinolones should be based on suscep Read the complete document