Enrofloxacin HCS 100 mg/ml oral solution for chickens and turkeys
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
06-05-2013
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Active ingredient:
enrofloxacin 100 mg
Available from:
HCS bvba
ATC code:
QJ01MA90
Pharmaceutical form:
Oral solution
Therapeutic group:
enrofloxacin
Therapeutic area:
Chicken Food, Other Birds Food
Authorization date:
2013-02-20
Summary of Product characteristics
1.3.1
Enrofloxacin
SPC, Labeling and Package Leaflet
IE
SmPCPIL037021/1
20.02.2013 – Updated: 20.02.2013
Page 1 of 5
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrofloxacin
HCS
100 mg/ml oral solution for chickens and turkeys
Enroxil 100 mg/ml oral solution for chickens and turkeys
Floxatryl 100 mg/ml oral solution for chickens and turkeys
Enrofloxacin
HCS
100 mg/ml oral solution for chickens and turkeys (Ireland, Germany, Belgium,
Poland, Netherlands, Italy)
Enroxil 100 mg/ml oral solution for chickens and turkeys (Bulgaria)
Floxatryl 100 mg/ml oral solution for chickens and turkeys (Cyprus)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral solution contains:
ACTIVE SUBSTANCE:
Enrofloxacin 100 mg
EXCIPIENTS:
Benzyl alcohol 14 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution.
Clear, yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chicken and turkey.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of the respiratory tract and of the digestive tract infections caused by the following bacteria
susceptible to enrofloxacin:
CHICKENS
_Mycoplasma gallisepticum, _
_Mycoplasma synoviae, _
_Avibacterium paragallinarum, _
_Pasteurella multocida, _
_Escherichia coli. _
_ _
TURKEYS
_Mycoplasma gallisepticum, _
1.3.1
Enrofloxacin
SPC, Labeling and Package Leaflet
IE
SmPCPIL037021/1
20.02.2013 – Updated: 20.02.2013
Page 2 of 5
_Mycoplasma synoviae, _
_Pasteurella multocida, _
_Escherichia coli. _
Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing
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