Enrox Flavour 15 mg Tablets for Dogs and Cats

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Enrofloxacin

Dostopno od:

Krka d.d., Novo Mesto

Koda artikla:

QJ01MA90

INN (mednarodno ime):

Enrofloxacin

Farmacevtska oblika:

Tablet

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cats, Dogs

Terapevtsko območje:

Antimicrobial

Status dovoljenje:

Authorized

Datum dovoljenje:

2009-06-18

Lastnosti izdelka

Revised: May 2014
AN: 00125/2013
Page 1 of 7
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
Revised: May 2014
AN: 00125/2013
Page 2 of 7
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