Enroxil Flavour Tablets 50 mg
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
07-04-2013
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Active ingredient:
enrofloxacin 50 mg
Available from:
Krka d.d.
ATC code:
QJ01MA90
Pharmaceutical form:
Tablet
Therapeutic group:
enrofloxacin
Therapeutic area:
Cats, Dogs
Authorization date:
2009-10-12
Summary of Product characteristics
Revised: December 2009
AN: 01103/2009
SUMMARY OF PTODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enroxil Flavour 50 mg Tablets for dogs
Enrox Flavour 50 mg Tablets for dogs (United Kingdom, Austria, Belgium,
Germany, Denmark, Greece, Ireland, Italy, Luxembourg, Netherlands)
Enrox Sabor 50 mg Tablets for dogs (Spain, Portugal)
Enroxil Flavour 50 mg Tablets for dogs (Bulgaria, Czech Republic, Hungary,
Lithuania, Latvia, Poland, Romania, Slovenia, Slovakia)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Enrofloxacin 50 mg
EXCIPIENTS: For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Round slightly biconvex, cream to light brownish tablets with possible visible
white or darker spots, one side scored and bevel-edged. The tablets can be
divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in dogs for the treatment of bacterial infections of the
alimentary, respiratory and urogenital tracts, skin, secondary wound infections
and otitis externa 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 in dogs less than 1 year of age or in exceptionally large breeds of
dog with a longer growth period less than 18 months of age, as articular
cartilage may
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