ENROX FLAVOUR 50 MG TABLETS FOR DOGS
País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Fitxa tècnica
(SPC)
14-05-2015
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ingredients actius:
ENROFLOXACIN
Disponible des:
Krka, d.d., Novo mesto
Codi ATC:
QJ01MA90
Designació comuna internacional (DCI):
ENROFLOXACIN
Dosis:
50 mg/tablet
formulario farmacéutico:
Tablets
tipo de receta:
POM
Grupo terapéutico:
Canine
Área terapéutica:
Enrofloxacin
indicaciones terapéuticas:
Antibacterial
Estat d'Autorització:
Authorised
Data d'autorització:
2009-06-12
Fitxa tècnica
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
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 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 29/04/2015_
_CRN 7020561_
_page number: 1_
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
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