AURIZON
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
05-01-2012
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Active ingredient:
clotrimazole 10 mg/ml, dexamethasone acetate 1 mg/ml, marbofloxacin 3 mg/ml
Available from:
Vetoquinol
ATC code:
QS02CA06
Pharmaceutical form:
Ear drops, suspension
Therapeutic group:
dexamethasone and antiinfectives
Therapeutic area:
Dogs
Authorization date:
2010-11-09
Summary of Product characteristics
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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.
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4.5. Special precautions for use
I) SPECIAL PRECAUTIONS FOR
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