4.1. Target species Dogs 4.2. Indications for use, specifying the 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 product should be used based on susceptibility testing. 4.3. Contraindications Do not administer to dogs suffering from perforation of the tympanic membrane. Do not administer to dogs with known hypersensitivity to any of the ingredients. Do not administer to pregnant or lactating bitches. 4.4. Special warnings for each target species None.   4.5. Special precautions for use i) Special precautions for use in animals 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 product, the integrity of the tympanic membrane must be verified. The external ear canal should be meticulously cleaned and dried before treatment. ii) Special precautions to be taken by the person administering the medicinal products to animals Wash hands carefully after applying the product. Avoid contact with eyes. If splashed in the eye, rinse with copious amounts of water. Persons with known hypersensitivity to compounds in the product should avoid any contact with the product. 4.6. Adverses reactions (frequency and seriousness) Usual adverse reactions associated with corticosteroid drugs may be observed (changes in biochemical and hæmatological parameters, such as increase of alkaline phosphatase, and of aminotransferase, some limited neutrophilia). Prolonged and intensive use of topical corticosteroid preparations is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed wound healing. On rare occasions, the use of this product may be associated with deafness, mainly in elderly dogs andmostly of a transient nature. 4.7. Use during pregnancy, lactation or lay See “Contraindications”. 4.8. Interaction with other medicinal products and other forms of interaction None known