Baytril Flavour Tablets 50 mg

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Enrofloxacin

Dostopno od:

Elanco Europe Ltd

Koda artikla:

QJ01MA90

INN (mednarodno ime):

Enrofloxacin

Farmacevtska oblika:

Tablet

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Dogs

Terapevtsko območje:

Antimicrobial

Status dovoljenje:

Authorized

Datum dovoljenje:

1992-04-22

Lastnosti izdelka

Revised: September 2023
AN: 03529/2022
Page 1 of 6
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.
Revised: September 2023
AN: 03529/2022
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Please see point 4.3.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
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 i