SUMMARY OF PRODUCT CHARACTERISTICS

AURIZON ear drops, suspension

1 ml of AURIZON contains:

Active substances:

Marbofloxacin 3.0 mg

Clotrimazole 10.0 mg

Dexamethasone acetate 1.0 mg

(equivalent to dexamethasone 0.9 mg)

Excipients:

Propyl galate (E310) 1.0 mg

For a full list of excipients, see section 6.1.

Ear drops, suspension

Homogenous beige to yellow oily suspension

Dogs

Treatment of otitis externa of both bacterialandfungal origin respectively due to bacteria sensitive to marbofloxacin, and fungi especially Malassezia pachydermatis sensitive to clotrimazole.

The product should be used based on susceptibility testing.

Do not administer to dogs suffering from perforation of the tympanic membrane.Do not administer to dogs with known hypersensitivity to any of the ingredients.

Do not administer to pregnant or lactating bitches.

None.

Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antibiotics.

Before treating with the product, the integrity of the tympanic membrane must be verified.

The external ear canal should be meticulously cleaned and dried before treatment.

Wash hands carefully after applying the product.

Avoid contact with eyes. If splashed in the eye, rinse with copious amounts of water.

Persons with known hypersensitivity to compounds in the product should avoid any contact with the product.

Usual adverse reactions associated with corticosteroid drugs may be observed (changes in biochemical and hæmatological parameters, such as increase of alkaline phosphatase, and of aminotransferase, some limited neutrophilia).

Prolonged and intensive use of topical corticosteroid preparations is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed wound healing.

On rare occasions, the useof this product may be associated with deafness, mainly in elderly dogs andmostly of a transient nature.

See “Contraindications”.

None known

Shake well before use.

Apply ten drops into the ear once daily for 7 to 14 days.

After 7 days of treatment, the veterinary surgeon should evaluate the necessity to extend the treatment another week.

One drop of the preparation contains 71µg marbofloxacin, 237µg clotrimazole and 23.7µg dexamethasone acetate.

After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.

When the product is intended for use in several dogs, use one cannula per dog.

Changes in biochemical and hæmatological parameters (such as increase of alkaline phosphatase, aminotransferase, some limited neutrophilia, eosinopenia, lymphopenia) are observed with three fold the recommended dosage; such changes are not serious and will reverse once the treatment has stopped.

Not applicable.

Phramacotherapeutic group:corticosteroids and antiinfectives in combination

ATCVet Code:QS02CA06

The preparation combines three active ingredients:

• marbofloxacin, a synthetic bactericidal agent belonging to the fluoroquinolone family that acts by inhibiting DNA gyrase. It exhibits a broad spectrum of activity against Gram-positive bacteria (e.g. Staphylococcus intermedius) and against Gram-negative organisms (Pseudomonas aeruginosa, Escherichia coli and Proteus mirabilis).

• clotrimazole, an anti-fungal agent that belongs to the imidazole family and which acts by causing changes in membrane permeability, allowing intracellular compounds to leak from the cell and thus inhibiting cellular molecular synthesis. It exhibits a wide spectrum of activity and is aimed, in particular, at Malassezia pachydermatis;

• dexamethasone acetate, a synthetic glucocorticoid exhibiting anti-inflammatory and anti-pruritic activity.

Pharmacokinetics studies in dogs at the therapeutic dosage have shown that:

Marbofloxacin plasma concentrations peak at 0.06 µg/ml on the 14th day of treatment.

Marbofloxacin bonds weakly to plasma proteins (< 10% in dogs) and is eliminated slowly, mainly in the active form, over 2/3 in urine and over 1/3 in fæces. Clotrimazole absorption is extremely poor (plasma concentration < 0.04 µg/ml).

Dexamethasone acetate plasma concentration reaches 1.25 ng/ml on the 14^thday of treatment. Dexamethasone resorption is not increased by the inflammatory process induced by otitis.

Propyl gallate (E310),

Sorbitan oleate

Silica, colloidal hydrophobic

Triglycerides, medium-chain

Not applicable

2 years.

After opening: 2 months.

Do not store above 30°C.

Details of the primary packaging:

• Low-density polyethylene bottle.

• Low-density polyethylene nozzle.

• Threaded polypropylene cap.

• PVC cannula.

Presentation:

• Box containing 1 x 10 ml bottle and 1 cannula

• Box containing 1 x 20 ml bottle and 2 cannulae

• Box containing 1 x 30 ml bottle and 3 cannulae

Any unused product or waste material should be disposed of in accordance with national requirement.

Vetoquinol UK Limited

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

Vm:08007/4085

Date:19 July 2001

Date:February 2016

Approved: 15 February 2016