Gentamicin base (as sulfate) 2640 IU

Betamethasone (as valerate) 0.88 mg

Clotrimazole 8.80 mg

For the full list of excipients, see section “Pharmaceutical particulars”.

Ear drops suspension. A smooth, uniform, white to off-white viscous suspension

Dogs

Treatment of acute external otitis. Also for treatment of short term exacerbation of the acute signs of chronic external otitis of bacterial and fungal origin due to bacteria susceptible to gentamicin, such as Staphylococcus intermedius, and fungi susceptible to clotrimazole, in particular Malassezia pachydermatis.

Do not administer to dogs with a perforated eardrum.

Do not administer in the case of known hypersensitivity to any of the ingredients.

Do not administer to pregnant or lactating bitches.

Do not administer the product concurrently with other substances known to cause ototoxicity.

Contact with eyes should be avoided. In case of accidental contact, flush with plenty of water. Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.

Before the product is applied, the external auditory canal must be examined thoroughly to ensure that the eardrum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.

The outer ear should be cleaned meticulously and dried before treatment. Excess hair around the treatment area should be cut.

Use of the product should be based on susceptibility of isolated bacteria and/or other appropriate diagnostic tests. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to gentamicin and may decrease the effectiveness of treatment with other aminoglycosides, due to the potential for cross resistance.

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

Avoid contact with the product.

Wash hands carefully after applying the product. In case of accidental contact with the eyes, rinse with copious amounts of water.

Do not handle the product if you have known hypersensitivity against compounds in the product.

Erythematous papules may appear locally; these lesions regress when treatment is discontinued.

Temporary impairment of hearing and extremely rare cases of irreversible loss of hearing have been observed, especially in elderly animals.

In the event of auditory or vestibular dysfunction, treatment must be discontinued immediately and the auditory canal cleaned carefully using a non-ototoxic solution.

Prolonged and extensive use of topical corticosteroid preparations have been known to induce local and systemic side-effects. These include suppression of adrenal function, epidermal thinning, and delayed wound healing.

If you notice any serious effects or other effects not mentioned in this datasheet, please inform your veterinary surgeon.

Do not administer to pregnant or lactating bitches.

Do not administer the product concurrently with other substances known to cause ototoxicity.

For otic use only.

Shake the product well before administration.

Dogs weighing less than 15 kg: Apply 4 drops to the ear twice a day.

Dogs weighing more than 15 kg: Apply 8 drops to the ear twice a day.

The duration of treatment is 7 days.

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.

1 drop of the product corresponds to 66.9 IU gentamicin, 22.3 µg betamethasone and 223 µg clotrimazole.

Local and transient eruptions of papules have been observed at 5 times the recommended dosage.

Not applicable.

ATC Vet Code: QS02CA90

Otologicals corticosteroids and antiinfectives in combination

Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs: Staphylococcus intermedius, coagulase-positive Staphylococcus spp. and Proteus mirabilis.

Betamethasone valerate is a synthetic dexamethasone-analogue corticosteroid with an anti-inflammatory, anti-pruritic activity when applied topically. It has mild mineralocorticoid properties. Betamethasone valerate is absorbed after topical application. Absorption may be increased if there is inflammation of the skin.

Clotrimazole is an antifungal agent which acts by causing changes in the cell membrane, which lead to a loss of intracellular components and consequently to a cessation of molecular synthesis. Clotrimazole has a broad spectrum of activity and is used in the treatment of skin conditions caused by various species of pathogenic dermatophytes and by moulds, in particular Malassezia pachydermatis.

Paraffin Liquid

Plasticized Hydrocarbon Gel Ointment Base

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging: 14 days

Do not use after the expiry date stated on the bottle or carton (EXP end of: MM/YY).

When the container is broached (opened) for the first time, using the in-use shelf life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.

Do not store above 25 °C. Keep the container in the outer carton.

Bottles:

High density polyethylene (HDPE) bottle with filling volumes of 14 mL or 34 mL with a

low density polyethylene (LDPE) cap and LDPE applicator/cap.

Tubes:

8.5 mL and 17 mL lined aluminium tubes with HDPE white screw cap and LDPE applicator/cap.

Box containing 1 tube of 8.5 mL

Box containing 1 tube of 17 mL

Box containing 1 plastic bottle of 14 mL

Box containing 1 plastic bottle of 34 mL

Box containing 6 tubes of 8.5 mL

Box containing 6 tubes of 17 mL

Box containing 12 tubes of 8.5 mL

Box containing 12 tubes of 17 mL

Not all pack sizes may be marketed.

Any unused product or waste materials should be disposed of in accordance with

national requirements.

UK: Vm 01708/4588

22 July 1999.

August 2020.

For animal treatment only. Keep out of the sight and reach of children.