Država: Irska
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
clotrimazole 10 mg/ml, dexamethasone acetate 1 mg/ml, marbofloxacin 3 mg/ml
Vetoquinol
QS02CA06
Ear drops, suspension
dexamethasone and antiinfectives
Dogs
2010-11-09
VETOQUINOL/AURI ZON/EUROPEAN RENEWAL/JUNE 2010 1/10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AURIZON ear drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ML OF AURIZON CONTAINS: ACTIVE SUBSTANCES: Marbofloxacin ............................................................... 3.0 mg Clotrimazole ............................................................... 10.0 mg Dexamethasone acetat e................................................ 1.0 mg ( equivalent to dexamethasone .................................... 0.9 mg) EXCIPIENTS Propyl galate (E310)……………………………………… 1.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops, suspension Homogenous beige to yellow oily 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. 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. VETOQUINOL/AURI ZON/EUROPEAN RENEWAL/JUNE 2010 2/10 4.5. Special precautions for use I) SPECIAL PRECAUTIONS FOR Pročitajte cijeli dokument