Baytril Flavour Tablets 50 mg

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Enrofloxacin

Available from:

Bayer plc

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1992-04-22

Summary of Product characteristics

Revised: September 2020
AN: 00778/2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Flavour Tablets 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
ACTIVE CONSTITUENTS
MG PER TABLET
Enrofloxacin
50.0
2.2
RELEVANT CONSTITUENTS OF THE
EXCIPIENTS
Artificial beef flavour Irradiated
12.0
For 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 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.
Page 1 of 5
Revised: September 2020
AN: 00778/2020
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not exceed the recommended dose.
ii.
Special precautions to be taken by the person administering the
medicinal product to animals
None.
iii.
Other precautions
None.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In dogs enrofloxacin may affect articular cartilage during the period
of rapid
growth.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The product may be used safely in pregnant and lactating animals.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNT(S) TO BE ADMINISTERED AND ADMINISTRATION ROUTE
The dosage rate of enrofloxacin is 5 mg/kg given orally onc