Baytril Flavour Tablets 15 mg

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Enrofloxacin

זמין מ:

Elanco Europe Ltd

קוד ATC:

QJ01MA90

INN (שם בינלאומי):

Enrofloxacin

טופס פרצבטיות:

Tablet

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Cats, Dogs

איזור תרפויטי:

Antimicrobial

מצב אישור:

Authorized

תאריך אישור:

1992-05-20

מאפייני מוצר

Revised: September 2023
AN: 03529/2022
Page 1 of 6
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.
Revised: September 2023
AN: 03529/2022
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Please refer to item 4.3.
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
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 fluoroquinol