Cortotic 0.584 mg/ml Ear Spray Solution for Dogs

None.

Special precautions for use in animals
Clinical signs of atopic dermatitis such as pruritus and skin inflammation are not
specific for this disease and therefore other causes of dermatitis such as
ectoparasitic infestations and infections which cause dermatological signs should be
ruled out before treatment is started, and underlying causes should be investigated.

Issued: July 2021
AN: 00259/2020
In the case of concurrent microbial disease or parasitic infestation, the dog should
receive appropriate treatment for such condition.
In the absence of specific information, the use in animal suffering from Cushing’s
syndrome shall be based on the risk-benefit assessment.
Since glucocorticosteroids are known to slow growth, use in young animals (under 7
months of age) shall be based on the risk-benefit assessment and subject to regular
clinical evaluations.
Total body surface treated should not exceed approximately 1/3 of the dog’s surface
corresponding for example to a treatment of two flanks from the spine to the
mammary chains including the shoulders and the thighs. See also section 4.10.
Otherwise, use only according to the risk-benefit assessment of the responsible
veterinary surgeon and subject the dog to regular clinical evaluations as further
described in section 4.9.
Care should be taken to avoid spraying into the eyes of the animal.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
The active substance is potentially pharmacologically active at high doses of
exposure.
The formulation may cause eye irritation following accidental ocular contact.
The formulation is flammable.
Wash hands after use. Avoid contact with eyes.
To avoid skin contact, recently treated animals should not be handled until the
application site is dry.
To avoid inhalation of the product, apply the spray in a well-ventilated area.
Do not spray on naked flame or any incandescent material.
Do not smoke while handling the veterinary medicinal product.
Replace the bottle in the outer carton and in a safe place out of the sight and the
reach of children immediately after use.
In case of accidental skin contact, avoid hand-to-mouth contact and wash the
exposed area immediately with water.
In case of accidental eye contact, rinse with abundant quantities of water.
If eye irritation persists, seek medical advice.
In case of accidental ingestion, especially by children, seek medical advice
immediately and show the leaflet or the label to the physician.
Other precautions
The solvent in this product may stain certain materials including painted, varnished or
other household surfaces or furnishings. Allow the application site to dry before
permitting contact with such materials.

Issued: July 2021
AN: 00259/2020