Dogs

For the treatment of clinical signs associated with acute erythroceruminous otitis externa.

Do not use in cases of hypersensitivity to the active substance, to other corticosteroids or to any of the excipients.

Do not use in animals with perforated tympanic membrane.

Do not use on cutaneous ulcers.

In the clinical field trial, an ear cleanser was used for cleaning the ears before the first product application.

Bacterial and fungal otitis is often secondary in nature. The underlying dermatological condition should be identified and treated.

In cases of parasitic otitis, an appropriate acaricidal treatment should be implemented.

In the clinical field trial, 201 dogs were included diagnosed with acute erythroceruminous otitis externa, all with the presence of bacterial and/or yeast overgrowth. It was demonstrated that the veterinary medicinal product was non-inferior in treating acute otitis compared to a topic fixed-combination product containing a corticosteroid, an antibiotic and an antimycotic as active substances. A secondary reduction of bacterial and yeast overgrowth was demonstrated and a concomitant treatment with an antimicrobial was unnecessary.

Before the veterinary medicinal 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.

Avoid contact with dog’s eyes by restraining the dog’s head to prevent shaking. In case of accidental contact, rinse thoroughly with water.

Safety and efficacy have not been assessed in dogs under 4 months of age or weighing less than 2.8 kg. In these cases, the product should be used according to a benefit/risk assessment by the veterinarian.

In the absence of specific information, the use in animals suffering from Cushing’s syndrome or with a suspected or confirmed endocrine disorder (e.g. diabetes mellitus) or with generalised demodicosis shall be based on the risk-benefit assessment.

The product has not been assessed in suppurative otitis externa. Use only according to the benefit-risk assessment by the responsible veterinarian.

The product is an eye irritant. Avoid contact with eyes including hand-to-eye contact. In case of accidental eye contact, rinse with large quantities of water. In case of eye irritation, seek medical advice immediately and show the leaflet or the label to the physician.

This active substance is potentially pharmacologically active at high doses of exposure. Avoid skin contact. Avoid oral exposure (including hand-to-mouth contacts). Replace the bottle in the outer carton and store in a safe place out of the sight and reach of children.

In case of accidental ingestion, particularly by children, seek medical advice immediately and show the leaflet or the label to the physician.

In case of accidental skin contact, it is recommended to wash thoroughly with water.

The product may have effects on the foetus if absorbed through the skin or ingested.

Wash hands after use.

The product is flammable. Do not spray on naked flame or any incandescent material. Do not smoke while handling the product.

The solvent in this product may stain certain materials including painted, vanished, or other household surfaces of furnishings.

Dogs:

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.

Use only according to the risk-benefit assessment by the responsible veterinarian.

None.

Auricular use.

The recommended dosage is 0.44 ml of the veterinary medicinal product per affected ear once a day for 7 consecutive days. This dose is adequately delivered by two pump activations.

If the condition is not considered completely cured by the veterinarian within 7 days, treatment may be extended until 14 days. The maximum clinical response may not be seen until 28 days after the first administration.

It is recommended that the external ear canal should be cleaned and dried before the first treatment.

It is recommended not to repeat ear cleaning before further applications.

Before first administration, remove the cap and screw the spray pump on the bottle.

Then prime the pump by pressing it until the product is released.

Introduce the atraumatic cannula in the ear canal and apply the product by two pump activations. Hold the product upright while administering the product in the affected ear(s). After each application massage the ear and auditory canal gently but thoroughly to ensure proper distribution.

Keep the pump screwed after use.

If the pump has not been used for a long time, activate it once before you apply the spray again.

The volume of the bottle allows the treatment of 2 ears for 14 days.

In an overdose study in 4-month-old puppies, reversible and non-adverse reduction of the capacity for production of cortisol (temporary suppression of the adrenal function) was reported after repeated ear administration at 3 times the therapeutic dose or 3 times the treatment duration.