Floxabactin 150 mg tablets for 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:

150 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

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 150 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Enrofloxacin 150.0 mg
EXCIPIENTS
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A white to slightly yellow, round, convex tablet.
The tablet can be divided into two equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 (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 dogs having seizure disorders, since enrofloxacin may
cause CNS stimulation.
Do not use in 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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
It is prudent to reserve the fluoroquinolones for the treatment of
clinical conditions that have responded poorly, or are
expected to respond poorly, to other classes of antibiotics. Whenever
possible, fluoroquinolones should only be used based on
susceptibility testing. Official and local antimicrobial policies
should be taken into account when the product is used. Use of the
Health