Floxabactin 15 mg tablets for cats and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Le Vet BV

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

15 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2010-09-03

Summary of Product characteristics

Health Products Regulatory Authority
29 April 2021
CRN009XJV
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Floxabactin 15 mg tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Enrofloxacin 15.0 mg
EXCIPIENTS
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A slightly yellow, round, convex tablet.
The tablet can be divided into two equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats:
Treatment of upper respiratory tract infections
In dogs:
-Treatment of lower urinary tract infections (associated or not with
prostatitis) and upper urinary tract infections caused by
_Escherichia coli_ or _Proteus mirabilis_.
-Treatment of superficial and deep pyoderma.
4.3 CONTRAINDICATIONS
Do not use in young or growing dogs (dogs aged less than 12 months
(small breed) or less than 18 months (large breed) as
the product may cause epiphyseal cartilage alterations in growing
puppies.
Do not use in young, growing cats, because of the possibility of the
development of cartilage lesions (cats aged less than 3
months or weighing less than 1kg).
Do not use in cats or dogs having seizure disorders, since
enrofloxacin may cause CNS stimulation.
Do not use in cats or dogs with known hypersensitivity to
fluoroquinolones or to any of the excipients of the product.
Do not use in case of resistance to quinolones, as there exists almost
complete cross resistance to other quinolones and
complete cross resistance to other fluoroquinolones.
Do not use with tetracyclines, phenicols or macrolides because of
potential antagonistic effects.
Pregnant and lactating animals, please see section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
29 April 2021
CRN009XJV
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Retinotoxic effects, including blindness, can occur in cat