Target Species
Dogs.
Indications for use
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.
Contraindications
Do not administer to dogs with a perforated eardrum.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.
Special precautions for use
Contact with eyes should be avoided. In case of accidental contact, flush with plenty of water.
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.
The outer ear should be cleaned meticulously and dried before treatment. Excess hair around the treatment area should be cut.
Use of the veterinary medicinal 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 veterinary medicinal 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.
Operator warnings
Avoid contact with the veterinary medicinal product.
Wash hands carefully after applying the veterinary medicinal product. In case of accidental contact with the eyes, rinse with plenty of water.
People with known hypersensitivity to ingredients should avoid contact with the veterinary medicinal product.
Adverse Reactions
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Application site erythema1; application site papule1; Impaired hearing2,3,5, loss of hearing 3,4,5, vestibular disorder5. |
1 These lesions regress when treatment is discontinued.
2 Temporary.
3 Especially in elderly animals.
4 Can be irreversible in extremely rare cases.
5 In the event of auditory or vestibular dysfunction, treatment must be discontinued immediately and the auditory canal cleaned carefully using a non-ototoxic solution.
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 the package leaflet for respective contact details.
Use during pregnancy or lactation
Do not administer to pregnant or lactating bitches.
Interactions
Do not administer the veterinary medicinal product concurrently with other substances known to cause ototoxicity.
Amounts to be administered and administration route
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.
Overdose
Local and transient eruptions of papules have been observed at 5 times the recommended dosage.
Withdrawal periods
Not applicable.