Neocell

Enrox Flavour 150 mg Tablets for dogs

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each tablet contains 150 mg of enrofloxacin.
Round slightly biconvex, cream to light brownish tablets with possible visible white or darker spots, one side scored and bevel-edged.


INDICATION(S)

The product is for use in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience indicates enrofloxacin as the drug of choice.


CONTRAINDICATIONS

Articular cartilage may be affected during the period of rapid growth, therefore 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.
Do not use in case the dog is allergic to the active substance or to any of the excipients.
Do not use in dogs having seizure disorders, since enrofloxacin may cause stimulation of the central nervous system.
Do not use for prophylaxis.


ADVERSE REACTIONS

During the period of rapid growth, enrofloxacin may affect the development of articular cartilage.
In very rare cases (less than 1 animal in 10,000 animals, including isolated reports) vomiting and anorexia are observed.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
   


TARGET SPECIES

Dogs


DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Do not exceed the recommended dosage. Dog should be given 5 mg/kg of the product for 5 to 10 days orally once daily or as a divided dose twice daily with or without food.
The duration of treatment in dogs may be extended depending on the clinical response and the judgement of the responsible veterinary surgeon.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
The daily dose for the large dogs is one tablet per 30 kg body weight.


ADVICE ON CORRECT ADMINISTRATION

The tablet is given orally once daily or as a divided dose twice daily with or without food.


WITHDRAWAL PERIOD

Not applicable.


SPECIAL STORAGE PRECAUTIONS
    
Keep out of the sight and reach of children.
Return any halved tablet to the opened strip-pack and use within 24 hours.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and blister after ‟EXP”. The expiry date refers to the last day of that month.


SPECIAL WARNING(S)

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 due to the potential for cross-resistance.
Official and local antimicrobial policies should be taken into account when the product is used.
Do not use in case of resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoroquinolones.
Do not exceed the recommended dosage.
Use the product with caution in dogs with severe renal or hepatic impairment.

As enrofloxacin passes into maternal milk, use only according to the benefit/risk assessment by the responsible veterinarian.

Do not combine with other drugs, such as tetracyclines, phenicols or macrolides because there is a potential that these drugs nullify the desired effect. of potential antagonistic effects.
Concurrent administration of fluoroquinolones may increase the action of oral anticoagulants (the drugs that prevent clotting of blood).
Do not combine with theophylline (a drug used in medicine as a bronchial dilator) as this could lead to a prolonged elimination of this substance.
Concurrent administration of magnesium or aluminum containing substances may be followed by retarded absorption of enrofloxacin.

In accidental overdose, vomiting, diarrhoea and central nervous system/behavioural changes may occur.
There is no antidote and treatment should be symptomatic. If necessary, administration of aluminium- or magnesium-containing antacids or activated carbon can be used to reduce absorption of enrofloxacin.
    
User warnings
Wash hands after use.
In case of contact with the eyes, wash with plenty of clean water.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
People with known allergy to (fluoro)quinolones (a group of antimicrobials) should avoid contact with the product.



OTHER INFORMATION

Polyamide/Aluminium/Polyvinyl chloride film (OPA/Al/PVC), heat sealed with aluminium foil containing 10 tablets / blister.  Each cardboard carton contains 100 tablets in 10 blister packs.
Polyamide/Aluminium/Polyvinyl chloride film (OPA/Al/PVC), heat sealed with aluminium foil containing 10 tablets / blister.  Each cardboard carton contains 10 tablets in 1 blister pack.

Not all pack sizes may be marketed.