Enroxil Max 100 mg/ml Solution for Injection for Cattle
Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Summary of Product characteristics
(SPC)
30-03-2010
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Active ingredient:
Enrofloxacin
Available from:
Eurovet Animal Health BV
ATC code:
QJ01MA90
INN (International Name):
Enrofloxacin
Authorization status:
Expired
Summary of Product characteristics
Issued 30/03/2010 – AN 01402/2009
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enroxil Max 100 mg/ml solution for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Enrofloxacin 100 mg.
Excipients:
Benzyl alcohol (E1519)
20 mg
Antimicrobial preservative
Butyl alcohol
30 mg
Antimicrobial preservative
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection
Clear, yellow solution
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of bovine respiratory disease associated with _Mannheimia haemolytica_, _Pasteurella_
_multocida_, _Histophilus somni_ and _Mycoplasma_ spp. where clinical experience, supported where
possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
4.3 CONTRAINDICATIONS
Do not use for prophylaxis.
Do not administer in case of hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNING FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Normal sterile precautions should be taken.
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.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of
bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other
quinol
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