Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate
Virbac
QS02CA03
hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate
Dogs
Otologicals – Corticosteroids and anti-infectives in combination
Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole, in particular Malassezia pachydermatis.
Authorised
2008-11-20
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET : EASOTIC EAR DROPS, SUSPENSION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC 1 ère avenue 2065 m L.I.D. 06516 Carros FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Hydrocortisone aceponate 1.11 mg/ml, Miconazole as nitrate 15.1 mg/ml, Gentamicin as sulphate 1,505 IU/ml. 4. INDICATION(S) Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular _Malassezia pachydermatis_ . 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides. If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Do not use if the eardrum is perforated. Do not use concurrently with substances known to cause ototoxicity. 6. ADVERSE REACTIONS Mild to moderate redness of the ear was common (2.4% of treated dogs). Papules were observed uncommonly (less than 1% of treated dogs). In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy. In very rare cases, the use of the veterinary medicinal product has been associated with hearing impairment (partial hearing loss or deafness), usually temporary, and primarily in geriatric dogs. In this case, treatment should be stopped. See also “Special precautions for use in animals”. In very rare cases, Type-I Hypersensitivity reactions (facial swelling, allergic pruritus) have been observed. If this occurs, treatment should be stopped. The frequency of adverse r Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Hydrocortisone aceponate 1.11 mg/ml Miconazole as nitrate 15.1 mg/ml Gentamicin as sulphate 1,505 IU/ml. EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops, suspension. A white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular _Malassezia pachydermatis_ . 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides. Do not use if the eardrum is perforated. Do not use concurrently with substances known to cause ototoxicity. Do not use in dogs with generalised demodecosis. 4.4 SPECIAL WARNINGS Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing and take into account official and local antimicrobial policies. 3 Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance. In case of parasitic otitis, an appropriate acaricidal treatment sh Прочетете целия документ