Enrox Flavour 15 mg Tablets for dogs and cats

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Enrofloxacin

Verfügbar ab:

Krka, d.d., Novo mesto

ATC-Code:

QJ01MA90

INN (Internationale Bezeichnung):

Enrofloxacin

Dosierung:

15 mg/tablet

Darreichungsform:

Tablet

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Cats, Dogs

Therapiebereich:

enrofloxacin

Anwendungsgebiete:

Antibacterial

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2009-06-12

Fachinformation

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 15 mg Tablets for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE :
Enrofloxacin 15 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 and bevel-edged.
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
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 cats less than 8 weeks of age.
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
None.
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 d