Enrox Flavour Tablets for Dogs

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Enrox Flavour Tablets contain a broad spectrum antibiotic which is effective for infections affecting the respiratory, alimentary and urogenital systems. It is also used for infections of the skin and ear canal, as well as infected wounds. Where circumstances permit, culture and sensitivity testing of the disease causing organism should be performed first. This helps to confirm that the appropriate antibiotic is being used. Enrox Flavour Tablets are given once daily with or without food, usually for 5 days or more.

Presentation

Round slightly biconvex, scored, cream to light brownish tablets with possible visible white or darker spots, one side scored and bevel-edged, containing enrofloxacin in two strengths: 50mg and 150mg.

Uses

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.

Dosage and administration

Do not exceed the recommended dose. The dosage rate of enrofloxacin is 5 mg/kg given orally once daily or as a divided dose twice daily for 5 to 10 days 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 is achieved as follows:

Medium dogs: one 50mg tablet per 10 kg body weight.

Large dogs: one 150mg tablet per 30 kg body weight.

Contra-indications, warnings, etc

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.

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 increase 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.

The product should not be used for prophylaxis.

Do not exceed the recommended dosage.

Use the product with caution in dogs with severe renal or hepatic impairment.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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 to the physician.

People with known hypersensitivity to fluoroquinolones should avoid contact with the product.

Adverse reactions (frequency and seriousness)

During the period of rapid growth, enrofloxacin may affect articular cartilage development.

In rare cases vomiting and anorexia are observed.

Use during pregnancy, lactation or lay

Use only according to the benefit: risk assessment by the veterinary surgeon.

Interaction with other medicinal products and other forms of interaction

Do not combine with tetracyclines, phenicols or macrolides because of potential antagonistic effects.

Concurrent administration of fluoroquinolones may increase the action of oral anticoagulants.

Do not combine with theophylline 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.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In accidental overdose vomiting, diarrhoea and CNS/behavioural changes may occur. There is no antidote and treatment should be symptomatic.

Pharmaceutical precautions

Keep out of the reach and sight of children.

This veterinary medicinal product does not require any special storage conditions.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Heat sealed aluminium foil blisters containing 10 tablets/blister. Each cardboard carton contains 10 blister packs.

Further information

Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the super coiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.

Bacterial resistance to fluoroquinolones most commonly occurs by alteration of the target, DNA-gyrase, via mutation. Less commonly mutation occurs at the topoisomerase-IV target. Other mechanisms of resistance occur when bacteria decrease the ability of the drug to enter the cell or increase active transport out of the cell. Resistance is usually chromosomally developed and, therefore, remains after antimicrobial therapy ends. Cross-resistance of enrofloxacin with other fluoroquinolones can occur. Changes in levels of resistance to fluoroquinolones over time by Campylobacter and Salmonella species are being monitored because of their possible impact on human health.