Osurnia Ear Gel for Dogs

Clean the ears before the initial treatment is applied. Ear cleaning should not be
repeated until 21 days after the second administration. In clinical trials, sodium
chloride solution only was used for ear cleaning.
Transient wetness of the inner and outer pinna can be observed. This observation is
attributed to presence of product and is not of clinical concern. Bacterial and fungal
otitis is often secondary to other conditions. Appropriate diagnosis should be used,
and therapy of causative conditions should be investigated before antimicrobial
treatment is considered.
In animals with a history of chronic or recurrent otitis externa, efficacy of the
veterinary medicinal product may be affected if the underlying causes of the
condition such as allergy or anatomical conformation of the ear are not
addressed

Special precautions for safe use in the target species:
If hypersensitivity to any of the components occurs, the ear should be thoroughly
washed.
The safety of the veterinary medicinal product has not been established in dogs less
than 2 months of age or weighing less than 1.4 kg.
Whenever possible the use of the veterinary medicinal product should be based on
identification of infecting organisms and susceptibility testing.
Use of the veterinary medicinal product deviating from the instructions given in the
SPC may increase the prevalence of bacteria resistant to florfenicol and fungi
resistant to terbinafine and may decrease the effectiveness of treatment with other
antibiotics and antifungal agents.
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.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger
systemic effects, including suppression of adrenal function (see section 3.10).
Decreased cortisol levels were observed after product instillation in tolerance studies
(before and after ACTH stimulation), indicating that betamethasone is absorbed and
enters the systemic circulation. The finding was not correlated with pathological or
clinical signs and was reversible.
Additional corticosteroid treatments should be avoided.
Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e.
diabetes mellitus; hypo- or hyper-thyroid disease, etc.).
The veterinary medicinal product may be irritating to eyes. Avoid accidental contact
to the dog’s eyes. If accidental ocular exposure does occur, the eyes should be
flushed thoroughly with water for 10 to 15 minutes. If clinical signs develop, seek
veterinary advice.
Owners should be recommended to monitor ocular signs (such as squinting, redness
and discharge) in the hours and days following the product application, and to
promptly consult a veterinarian in case such signs appear.
See section