Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: VMD (Veterinary Medicines Directorate)
Clotrimazole, Dexamethasone Acetate, Marbofloxacin
Krka d.d., Novo Mesto
QS02CA06
Clotrimazole, Dexamethasone Acetate, Marbofloxacin
Ear drops, suspension
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Antimicrobial
Authorized
2016-12-23
Revised: March 2022 AN: 00137/2021 & 00139/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Otoxolan Ear Drops, Suspension for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of suspension contains: ACTIVE SUBSTANCES: Marbofloxacin 3.0 mg Clotrimazole 10.0 mg Dexamethasone acetate 1.0 mg (equivalent to Dexamethasone 0.9 mg) EXCIPIENTS: Propyl gallate (E310) 1.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops, suspension. Off yellow, opalescent, viscous suspension. 4. CLINICAL PARTICULARS 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. 4.3 CONTRAINDICATIONS Do not use in dogs suffering from perforation of the tympanic membrane. Do not use in cases of hypersensitivity to the active substances, to other azole antifungal agents or to any other fluoroquinolones or to any of the excipients. Do not use in animals, where resistance of causative agents to marbofloxacin and/or clotrimazole is known. See section 4.7. Revised: March 2022 AN: 00137/2021 & 00139/2021 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Before treating with the product, the integrity of the tympanic membrane must be verified. Use of the product should be based on susceptibility testing of the bacteria and/or fungi isolated from the animal. If this is not possible, therapy should be based on local (regional) epidemiological information about susceptibility of the target pathogens. Official and local antimicrobial policies should be taken in to account when the veterinary medicinal product is used. Heavy reliance on a single class of antibiotic m Aqra d-dokument sħiħ