AURIZON ear drops, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin; Clotrimazole; Dexamethasone acetate

Available from:

Vetoquinol Ireland Limited

ATC code:

QS02CA06

INN (International Name):

Marbofloxacin; Clotrimazole; Dexamethasone acetate

Dosage:

3/10/0.9 milligram(s)/millilitre

Pharmaceutical form:

Ear drops, suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

dexamethasone and antiinfectives

Authorization status:

Authorised

Authorization date:

2001-11-02

Summary of Product characteristics

Health Products Regulatory Authority
27 September 2019
CRN009282
Page 1 of 4
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 acetate
1.0
mg
(equivalent todexamethasone
0.9
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.
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Heavy reliance on a single class of antibiotic may result in the
induction of resistance in a bacterial population. It is prudent to
reserve the fluoroquinolones for the treatment of clinical conditions
which have responded poorly, or are expected to respond
poorly, to other classes of antibiotics.
Before treating with the product, the integrity of the tympanic
membrane must be verified.
The external ear canal should be meticulously cleaned and dried before
treatment.
Health Products Regulatory Authority
27 September 2019
CRN009282
Page 2 of 4
II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCTS TO ANIMALS
Wash hands carefully after applying the product.
Avoid contact with eyes. If splashed in the eye, rinse with copious
amounts of water.
Persons with known hypersensit