Enrox Flavour 150 mg Tablets for Dogs

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Enrofloxacin

Dostępny od:

Krka d.d., Novo Mesto

Kod ATC:

QJ01MA90

INN (International Nazwa):

Enrofloxacin

Forma farmaceutyczna:

Tablet

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Dogs

Dziedzina terapeutyczna:

Antimicrobial

Status autoryzacji:

Authorized

Data autoryzacji:

2009-06-18

Charakterystyka produktu

Revised: May 2014
AN: 00127/2013
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrox Flavour 150 mg Tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE :
Enrofloxacin
150 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 and bevel-edged.
The tablets can be divided into equal 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 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 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
Revised: May 2014
AN: 00127/2013
Page 2 of 6
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 treatm