Enrox Flavour 50 mg Tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Krka, d.d., Novo mesto

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

50 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:

2009-06-12

Summary of Product characteristics

Health Products Regulatory Authority
12 February 2021
CRN00C3CG
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrox Flavour 50 mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Enrofloxacin 50 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round slightly biconvex, cream to light brownish tablets with possible
visible white or darker spots, one side scored. The
tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in dogs for 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
Do not use in dogs less than 1 year of age or in exceptionally large
breeds of dog with a longer growth period less than 18
months of age, as articular cartilage may be affected during the
period of rapid growth.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs having seizure disorders, since enrofloxacin may
cause CNS stimulation.
Do not use for prophylaxis.
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
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, use of
fluoroquinolones should be based on susceptibility testing. Use of the
product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to the
fluoroquinolones and may decrease the effectiveness of treatment with
other quinolones due to the poten