Baytril Flavour Tablets 15 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:

Cats, Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1992-05-20

Summary of Product characteristics

Revised: September 2020
AN: 00778/2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Flavour Tablets 15 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
ACTIVE CONSTITUENTS
MG PER TABLET
Enrofloxacin
15.0
2.2
RELEVANT CONSTITUENTS OF THE EXCIPIENTS
Artificial beef flavour Irradiated
6.0
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
A light brown to brown, slightly marbled, round, planar tablet for
oral
administration to dogs and cats.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in dogs and cats 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.
Not recommended for use in cats less than 8 weeks of age.
Baytril Flavour Tablets 15 mg should not be used for prophylaxis.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Please refer to item 4.3.
Page 1 of 5
Revised: September 2020
AN: 00778/2020
Cats: Retinotoxic effects including blindness can occur when the
recommended dose is exceeded.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not exceed the recommended dosage
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)
During the period of rapid growth, enrofloxacin may affect articular
cartilage
development.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The product may be used safely in pregnant and lactating animals.
4.8
INTERACTION WITH OTH