Aurimic

1 x 20 ml

Ear drops/cutaneous suspension

Active substance

Miconazole (Miconazole nitrate) : 23 mg/ml

Prednisolone (Prednisolone actetate) : 5 mg/ml

Polymyxin B (Polymyxin B-sulfate) : 0,5293 mg/ml

ATC code

QS02CA01 Prednisolone (Corticosteroids - weak (group I)) and antiinfectives

QS02CA Corticosteroids and antiinfectives in comb.

QS02C Corticosteroids and antiinfectives in comb.

QS02 Otologicals

QS Sensory organs

Species

Dogs and cats

Indications

For the treatment of otitis externa and small localised superficial skin infections in dogs and cats caused by infections with the following bacteria and fungi:

Gram-positive bacteria
- Staphylococcus spp.
- Streptococcus spp.
Gram-negative bacteria
- Pseudomonas spp.
- Escherichia coli
Fungi
- Malassezia pachydermatis
- Candida spp.
- Microsporum spp.
- Trichophyton spp.

Treatment of Otodectes cynotis (ear mites) infestations where there is concurrent infection with miconazole and polymyxin B sensitive pathogens.

Dose to be administered and administration route

For auricular and cutaneous use.

Shake well before use. Any contamination of the dropper should be strictly avoided.

At the beginning of treatment, hair surrounding or covering the lesions must be clipped; this should be repeated during treatment if necessary.

Infections of the external auditory canal (otitis externa):

Clean the external ear canal and auricle and place 5 drops of the veterinary medicinal product into the external auditory canal twice a day. Massage the ear and the auditory canal thoroughly to ensure proper distribution of the active substances, but gently enough to avoid causing pain to the animal.

Treatment should be continued without interruption until a few days after complete disappearance of the clinical symptoms, at least for 7 - 10 days up to 14 days. The success of the treatment should be verified by a veterinarian before discontinuing treatment.

Skin infections (small localised superficial):

Apply a few drops of the veterinary medicinal product to the skin lesions to be treated twice a day and rub well.

Treatment should be continued without interruption until a few days after complete disappearance of the clinical symptoms, up to 14 days.

In some persistent cases (ear or skin infections), treatment may need to be continued for 2 to 3 weeks. In cases where prolonged treatment is necessary repeated clinical examinations including a re- assessment of the diagnosis are required.

Adverse reactions

Dogs, cats:

Very rare

(<1 animal / 10 000 animals treated, including isolated reports):

Deafness¹

Undetermined frequency (cannot be estimated from the available data):

Other immune system disorders^2,3;

Application site infection², Application site bleeding^2,4;

Skin thinning²;

Delayed healing², Systemic disorder² (e.g. Adrenal gland disorder^2,5); Telangiectasia².

¹ Especially in older dogs. In this case treatment should be discontinued.

² After prolonged and extensive use of topical corticosteroid preparations.

³ Local immunosuppression including increased risk of infections.

⁴ Increased vulnerability of the skin to bleeding.⁵ Suppression of adrenal function.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.