AURIZON EAR DROPS, SUSPENSION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Available from:

Vetoquinol UK Limited

ATC code:

QS02CA06

INN (International Name):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Dosage:

Unknown

Pharmaceutical form:

Ear Drops Suspension

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

Dexamethasone and antiinfectives

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2016-03-24

Summary of Product characteristics

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:
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.
ACTIVE SUBSTANCES:
Marbofloxacin
3.0
mg
Clotrimazole
10.0 mg
Dexamethasone acetate
1.0
mg
(equivalent to dexamethasone 0.9
mg)
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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 fluoroquinolo