Dogs

Treatment of acute otitis externa or acute exacerbation of recurrent otitis externa caused by mixed bacterial and fungal infections with Staphylococcus pseudintermedius susceptible to gentamicin and Malassezia pachydermatis susceptible to posaconazole.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.

Do not use if the eardrum is perforated.

Do not use in pregnant or breeding animals.

Do not use concurrently with substances known to cause ototoxicity.

Do not use in dogs with generalised demodicosis.

Antimicrobial activity can be reduced by low pH and the presence of purulent and/or inflammatory debris. Ears must be cleaned before administration of the veterinary medicinal product. Compatibility with ear cleaners has not been demonstrated.

Bacterial and fungal otitis is often secondary to other conditions. In animals with a history of recurrent otitis externa, the underlying causes of the condition such as allergy or anatomical conformation of the ear must be addressed in order to avoid ineffective treatment with a veterinary medicinal product. Efficacy of this veterinary medicinal product was not assessed in dogs with atopic or allergic skin conditions.

Cross-resistance between gentamicin and other members of the aminoglycoside class has been shown in Staphylococcus pseudintermedius. Use of the product should be carefully considered when susceptibility testing has shown resistance to aminoglycosides because its effectiveness may be reduced. Co-selection for other classes of antimicrobials is common.

The safety of the product has not been established in dogs less than 3 months of age or weighing less than 3 kg.

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.

Re-evaluate the dog immediately if worsening of clinical signs, hearing loss or signs of vestibular dysfunction are observed during treatment or if the dog is not showing signs of improvement by day 14.

Cytology of ear canal is recommended prior to the use of the product to identify a mixed infection.

This antimicrobial combination should only be used where diagnostic testing has indicated the need for simultaneous administration of each of the active substances.

Use of the product should be based on identification and susceptibility testing of the target pathogens. Ideally, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at local/regional level.

Use of the product should be in accordance with official, national and regional antimicrobial policies.

If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted.

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

Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function.

Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e. diabetes mellitus; hypo-thyroid disease, etc).

Ototoxicity may be associated with gentamicin treatment. Experience shows that geriatric dogs are more at risk of hearing impairment after topical ear product administration.

Objective hearing assessments were not performed in the pivotal field trial. Dogs with signs of impaired balance or loss of hearing after administration should be re-examined.

The veterinary medicinal product may be slightly irritating to eyes. Accidental eye exposure may occur when the dog shakes its head during or just after administration. In case of accidental eye contact, flush the eyes thoroughly with water for 15 minutes. If symptoms develop, seek medical advice and show the package leaflet or the label to a physician.

Although no potential for skin irritation was indicated by experimental studies, contact of the product with the skin should be avoided. In case of accidental skin contact, wash the exposed skin with water.

Close contact between the dog and children should be limited in the days following the treatment due to unknown amount of the product possibly leaking from treated ear/s.

The product may be harmful after ingestion. Avoid ingestion of the product including hand-to-mouth exposure. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

No adverse reactions related to treatment were observed in clinical trials.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use during pregnancy and lactation.

Studies to determine the effect on fertility in dogs have not been conducted. Do not use in breeding animals.

None known.

Auricular use.

Single treatment.

The recommended dosage is a single dose of 0.8 ml per infected ear.

The maximum clinical response may not be seen until 28 to 42 days after administration.

Instructions for use:

The product should be administered only by veterinarians or by trained personnel under close veterinary supervision.

Clean and dry the external ear canal before administering the product.

The product is preservative-free and should be handled using clean technique.

Before first use, shake the bottle vigorously for 15 seconds. Unwrap the syringe with the adapter attached. Remove the cap from the bottle and insert the adapter by pressing it firmly into the top of the bottle using the attached syringe. Follow steps 1. to 5. of the dosing instructions.

Use a new syringe for each infected ear. Shake the bottle vigorously for 15 seconds before use. Remove the cap. Insert the syringe tip into the adapter. Follow steps 1. to 5. of the dosing instructions.

Dosing syringes compatible with the syringe adapter are provided. Some commercially available syringes may not be compatible with the syringe adapter.

Do not clean the ear canal for at least 28 days after the administration to allow contact of the product with the ear canal.

Auricular administration to puppies at up to 5 times the recommended dose to both ears on 3 occasions at 2-week intervals was evaluated in a target animals safety study.

All findings were consistent with glucocorticoid administration. Findings in the 3X and 5X overdose groups included mild eosinopenia, lower baseline and ACTH-induced cortisol levels, lower mean adrenal weights with correlating minimal to mild atrophy of the adrenal cortex. Minimal to mild atrophy of the epidermis of the external auditory canal and the epithelial lining of the external surface of the tympanic membrane was observed in the 1X, 3X and 5X groups, consistent with the pharmacological effects of glucocorticoids and known to be reversible after cessation of treatment. ACTH administration at the end of the study elicited an increase in cortisol levels in all study groups, indicative of sufficient adrenal function.

All findings were of low severity, are considered reversible after cessation of treatment, and were not associated with clinical signs or hearing effects.

Not applicable.