Zobuxa 15mg tablet for cats and small dogs
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
27-04-2013
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Active ingredient:
enrofloxacin 15 mg
Available from:
Novartis Animal Health UK Limited
ATC code:
QJ01MA90
Pharmaceutical form:
Tablet
Therapeutic group:
enrofloxacin
Therapeutic area:
Cats, Dogs
Authorization date:
2012-01-03
Summary of Product characteristics
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Zobuxa SmPC 100mg tablet dogs clean version_20120130
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zobuxa 100 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE(S):
Enrofloxacin
100 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Beige-coloured, round, slightly dotted tablet with score line on both sides. 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
Treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin,
wound infections and otitis externa.
4.3 CONTRAINDICATIONS
Do not use in young or growing dogs (dogs aged less than 12 months (small breed)) or
less than 18 months (large breed) as the product may cause epiphyseal cartilage
alterations in growing puppies.
Do not use in dogs that have seizure disorders, since enrofloxacin may cause CNS
stimulation.
Do not use in dogs with known hypersensitivity to fluoroquinolones or to any of the
excipients of the product.
Do not use with tetracyclines, phenicols or macrolides because of potential antagonistic
effects.
Pregnant and lactating animals, please see section 4.7.
Do not use for prophylaxis.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
It is prudent to r
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