Neptra Ear Drops Solution for Dogs

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.
In cases of parasitic otitis, an appropriate acaricidal treatment should be implemented
Ears must be cleaned before administration of the product. It is recommended not to
repeat ear cleaning until 28 days after administration of the product. In clinical trials,
only saline was used for ear cleaning before treatment initiation with the veterinary
medicinal product.
This combination is intended for the treatment of acute otitis when mixed
infections caused by Staphylococcus pseudintermedius
and
demonstrated.

Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been established in dogs
less than 3 months of age. Target animal safety was not studied in dogs under
4 kg bodyweight. However, no safety issues were identified in field studies in
dogs weighing less than 4kg.
Before the veterinary medicinal product is applied, the external auditory canal
must be examined thoroughly to ensure that the ear drum is not perforated.
Re-evaluate the dog if hearing loss or signs of vestibular dysfunction are observed
during treatment.
After the administration, wet ears or clear discharge can be observed which is not
related to the disease pathology.
Use of the product should be based on identification and susceptibility testing
of the target pathogen(s). If this is not possible, 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.
Use of the veterinary medicinal product deviating from the instructions given in
the Summary of Product Characteristics (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.
Decreased cortisol levels were observed after product instillation in tolerance
studies (before and after ACTH stimulation), indicating that mometasone furoate
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is absorbed and enters the systemic circulation. The main findings observed at
the 1X dose were decreases in cortical response to ACTH stimulation,
decreased absolute lymphocyte and eosinophil counts, and decreased adrenal
weight.
Prolonged and intensive use of topical corticosteroid preparations is known to trigger
systemic effects, including suppression of adrenal function (see section 4.10).
If hypersensitivity to any of the components occurs, the ear should be thoroughly
washed. Additional corticosteroid treatments should be avoided.
Use with caution in dogs with a suspected or confirmed endocrine disorder
(e.g., diabetes mellitus, hypo- or hyperthyroidism, etc.).
Caution should be taken to prevent the veterinary medicinal product from getting
into the eyes of the dog being treated e.g. by restraining the dog’s head to
prevent shaking (see section 4.9). In case of exposure to the eye, rinse with
plenty of water.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
The veterinary medicinal product has serious eye irritation potential. Accidental
eye exposure may occur when the dog shakes its head during or just after
administration. To avoid this risk for the owners, it is recommended that this
veterinary product is administered only by veterinarians or under their close
supervision. Appropriate measures (e.g. wearing safety glasses during
administration, massaging the ear canal well after administration to ensure even
distribution of product, restraining the dog after administration) are needed to
avoid exposure to the eyes. In case of accidental ocular exposure, flush the eyes
thoroughly with water for 10 to 15 minutes. If symptoms develop, seek medical
advice and show the package leaflet or the label to the 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 exposed skin thoroughly with water.
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.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
The safety and efficacy of the veterinary medicinal product in cats has not been
evaluated. Post- marketing surveillance shows that the use of the product in cats
can be associated with neurological signs (including ataxia, Horner’s syndrome
with protrusion of membrane nictitans, miosis, anisocoria), internal ear disorders
(head tilt) and systemic signs (anorexia and lethargy). The use of the veterinary
medicinal product in cats should therefore be avoided.
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