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Contra-indications, warnings, etc
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 concurrently with substances known to cause ototoxicity.
Do not use in dogs with generalised demodecosis.
Special warnings
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
Special precautions for use
Special precautions for use in animals
If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing and take into account official and local antimicrobial policies.
Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance.
In case of parasitic otitis, an appropriate acaricidal treatment should be implemented. Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum 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.
Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental skin contact, it is recommended to wash thoroughly with water.
Avoid contact with eyes. In case of accidental contact, rinse with abundant quantities of water. In case of eye irritation, seek medical advice. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Mild to moderate redness of the ear was common (2.4% of treated dogs). Papules were observed uncommonly (less than 1% of treated dogs). In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy. In very rare cases, the use of the veterinary medicinal product has been associated with hearing impairment (partial hearing loss or deafness), primarily in geriatric dogs. Based on post-marketing safety experience, hearing improvement was observed in most dogs with deafness/loss of hearing and complete recovery was confirmed in 70% of cases with an adequate follow-up.
Among dogs with full recovery, improvement has been rapidly seen. Recovery has been observed as early as one week after onset of signs, the majority of dogs recovering within one month; in a minority of reports, the deafness lasted for up to two months.
If deafness or partial hearing loss occurs, treatment should be stopped. In very rare cases, type-I hypersensitivity reactions (facial swelling, allergic pruritus) have been observed. If this occurs, treatment should be stopped.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Systemic absorption of hydrocortisone aceponate, gentamicin sulphate and miconazole nitrate being negligible, it is unlikely for teratogenic, foetotoxic or maternotoxic effects to occur at the recommended dosage in dogs. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Compatibility with ear cleaners has not been demonstrated.
Overdose (symptoms, emergency procedures, antidotes), if necessary
At 3 and 5 times the recommended dose, no local or general adverse reactions were observed with the exception of some dogs showing erythema and papulae in the ear canal.
In dogs treated at the therapeutic dose for ten consecutive days, serum cortisol levels decreased from five days onward and returned to normal values within ten days after the end of treatment. However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended treatment period, indicating a preserved adrenal function.