Target species
Dogs.
Indications for use for each target species
Treatment of otitis externa of both bacterial and fungal origin respectively due to bacteria sensitive to marbofloxacin, and fungi especially Malassezia pachydermatis sensitive to clotrimazole.
The veterinary medicinal product should be used based on susceptibility testing results.
Contraindications
Do not use in dogs suffering from perforation of the tympanic membrane.
Do not use in cases of hypersensitivity to the active substances, other azole antifungals or fluoroquinolones or to any of the excipient.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
Before treating with the veterinary medicinal product, the integrity of the tympanic membrane must be verified.
The external ear canal should be meticulously cleaned and dried before treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash hands carefully after applying the veterinary medicinal product.
Avoid contact with eyes. In case of accidental contact with the eyes, rinse with copious amounts of water.
People with known hypersensitivity to the active substances or excipients should avoid contact with the veterinary medicinal product.
Special precautions for the protection of the environment:
Not applicable
Adverse events
Dogs:
Rare (1 to 10 animals / 10,000 animals treated): | Deafness1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Changes in biochemical and haematological parameters (such as Elevated serum alkaline phosphatase (ALP)2; Elevated alanine aminotransferase (ALT)2; Elevated aspartate aminotransferase (AST)2; Neutrophilia (limited)2), Skin thinning3 |
Undetermined frequency (cannot be estimated from the available data): | Delayed healing3, Hypoadrenocorticism3,4 |
1 Mainly in elderly dogs and mostly of a transient nature.
2 Usual adverse effects of corticosteroids.
3 Known adverse effects of topical corticosteroids in case of prolonged and intensive use.
4 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.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Do not use during pregnancy or during lactation.
Interaction with other medicinal products and other forms of interaction
None known
Administration routes and dosage
Auricular use.
Shake well before use.
Apply ten drops into the ear once daily for 7 to 14 days.
After 7 days of treatment, the veterinary surgeon should evaluate the necessity to extend the treatment another week.
One drop of the veterinary medicinal product contains 71 µg marbofloxacin, 237 µg clotrimazole and 23.7 µg dexamethasone acetate.
After application, the base of the ear may be massaged briefly and gently to allow the veterinary medical product to penetrate to the lower part of the ear canal.
When the veterinary medicinal product is intended for use in several dogs, use one cannula per dog.
Symptoms of overdose (and where applicable, emergency procedures, antidotes)
Changes in biochemical and hæmatological parameters (such as increase of alkaline phosphatase, aminotransferase, some limited neutrophilia, eosinopenia, lymphopenia) are observed with three fold the recommended dosage; such changes are not serious and will reverse once the treatment has stopped.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.