Target species
Dogs and cats.
Indications for use
For the treatment of otitis externa including the ear mite, Otodectes cynotis, infestation in the dog and cat.
Contraindications
Do not use in animals with a perforated eardrum.
Do not use concomitantly with products known to be ototoxic.
Do not use in animals with known hypersensitivity to the active substances or to the excipient.
Special warnings
For external use only.
To be used under veterinary supervision.
Special precautions for use
Official, national and regional antimicrobial polices should be taken into account when the product is used.
Special precautions for use in animals
Following recovery the ears should be checked at regular intervals for any signs of re-infection.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid contact with the product.
Wash hands after use.
If the product comes into contact with the eyes, rinse immediately with plenty of water.
People with known hypersensitivity to any of the active substances or the excipient in the product should avoid contact with the veterinary medicinal product.
Adverse reactions
On very rare occasions and primarily in geriatric animals, use of auricular preparations may be associated with hearing impairment which may be either transient or prolonged.
Allergy or hypersensitivity reactions to the active substances or the excipient might occur.
Anti-inflammatory corticosteroids such as Prednisolone can exert a wide range of side effects. Dosage in medium to long term use should therefore generally be kept to the minimum.
During therapy effective doses suppress the hypothalamic-pituitreal adrenal axis. Following cessation of treatment symptoms of adrenal insufficiency can arise and this may render the animal unable to deal adequately with stressful situations.
Corticosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to, or exacerbate existing infections.
Use during pregnancy and lactation
The safety of the veterinary medicinal product has not been established during pregnancy and/or lactation.
The use is not recommended during pregnancy and/or lactation.
Amounts to be administered and administration route
Where appropriate, prior to administration, the ear canal and the surrounding area should be cleaned mechanically or by irrigation taking care to avoid further damage to the skin. Any excess exudate, hair or debris should be carefully removed prior to the application of the ear drops. Animal owners should only do this on the direction of the prescribing veterinary surgeon.
Shake the bottle well before use.
Instil 5-10 drops into the ear according to the size of the animal and ear canal twice daily. Without allowing the animal to shake its head, very gently massage the ear canal after administration holding the pinna in an upright position to ensure penetration of the drops into the ear.
Where ear mite infection is present, consideration should be given to treating both ears, even if infection is apparent in only one. Treatment should continue for at least 3 weeks to ensure that successive generations of ear mites are killed. Animals that are in contact should also be treated.
Where treatment is for a period longer than 7 days regular clinical re-evaluation should be carried out.
Where gram-negative infections are involved, the use of the veterinary medicinal product should be based on bacterial sensitivity testing. In cases where the treatment period is prolonged, in vitro sensitivity should be re-evaluated.