产品特点
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
阅读完整的文件