Enrox Flavour 50 mg Tablets for Dogs

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)

Aktīvā sastāvdaļa:

Enrofloxacin

Pieejams no:

Krka d.d., Novo Mesto

ATĶ kods:

QJ01MA90

SNN (starptautisko nepatentēto nosaukumu):

Enrofloxacin

Zāļu forma:

Tablet

Receptes veids:

POM-V - Prescription Only Medicine – Veterinarian

Ārstniecības grupa:

Dogs

Ārstniecības joma:

Antimicrobial

Autorizācija statuss:

Authorized

Autorizācija datums:

2009-06-18

Produkta apraksts

Revised: March 2021
AN: 01209/2020
Page 1 of 6
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.
Revised: March 2021
AN: 01209/2020
Page 2 of 6
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 quino