Otomax Ear Drops 34ml

4.1 Target species Dogs 4.2 Indications for use, specifying the target species Treatment of acute external otitis. Also for treatment of short term exacerbation of the acute signs of chronic external otitis of bacterial and fungal origin due to bacteria susceptible to gentamicin, such as Staphylococcus intermedius, and fungi susceptible to clotrimazole, in particular Malassezia pachydermatis. 4.3 Contraindications Do not administer to dogs with a perforated eardrum. Do not administer in the case of known hypersensitivity to any of the ingredients. See also section 4.7 See also section 4.8 4.4 Special warnings Contact with eyes should be avoided. In case of accidental contact, flush with plenty of water. Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated. 4.5 Special precautions for use i. Special precautions for use in animals Before the product is applied, the external auditory canal must be examined thoroughly to ensure that the eardrum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus. The outer ear should be cleaned meticulously and dried before treatment. Excess hair around the treatment area should be cut. Use of the product should be based on susceptibility of isolated bacteria and/or other appropriate diagnostic tests. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to gentamicin and may decrease the effectiveness of treatment with other aminoglycosides, due to the potential for cross resistance. Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid contact with the product. Wash hands carefully after applying the product. In case of accidental contact with the eyes, rinse with copious amounts of water. Do not handle the product if you have known hypersensitivity against compounds in the product. 4.6 Adverse reactions (frequency and seriousness) Erythematous papules may appear locally; these lesions regress when treatment is discontinued. Temporary impairment of hearing and extremely rare cases of irreversible loss of hearing have been observed, especially in elderly animals. In the event of auditory or vestibular dysfunction, treatment must be discontinued immediately and the auditory canal cleaned carefully using a non-ototoxic solution. Prolonged and extensive use of topical corticosteroid preparations have been known to induce local and systemic side-effects. These include suppression of adrenal function, epidermal thinning, and delayed wound healing. 4.7 Use during pregnancy, lactation or lay Do not administer to pregnant or lactating bitches. 4.8 Interaction with other medicinal products and other forms of interaction Do not administer the product concurrently with other substances known to cause ototoxicity.