Baytril Flavour Tablets 50 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Elanco GmbH

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

50 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

enrofloxacin

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Health Products Regulatory Authority
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Flavour Tablets 50 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents
mg/tablet
Enrofloxacin
50.0
Relevant constituents of the Excipient
Artificial beef flavour Irradiated
12.0
For a full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Light brown to brown, slightly marbled, round, curved, scored tablets
for oral administration to dogs
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in dogs in 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 the choice.
4.3
CONTRAINDICATIONS
Not for use in dogs less than 1 year of age or in exceptionally large
breeds of dog with a longer growth period under 18
months of age, as articular cartilage may be affected during the
period of rapid growth.
Baytril Flavour Tablets 50 mg should not be used for prophylaxis.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Please see point 4.3.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the recommended dose.
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 instructions given in the SPC may
increase the prevalence of bacteria resistant to
fluoroquinolones and may decrease the effectiveness of treatment with
other quinolones due to the potential for cross
resistance.
Official and local antimicrobial policies should be taken into account
when the product is used. In cases of pyoderma, possible
underlying p