MARBODEX AURAL EAR DROPS, SUSPENSION FOR DOGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Available from:

Norbrook Laboratories Limited

ATC code:

QS02CA06

INN (International Name):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Dosage:

10.0/3.0

Pharmaceutical form:

Ear Drops Suspension

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

Dexamethasone and antiinfectives

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2015-08-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbodex Aural Ear Drops, Suspension for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCES:
Marbofloxacin...........................................................
3.0 mg
Clotrimazole............................................................
10.0 mg
Dexamethasone.........................................................
0.9 mg
(equivalent to dexamethasone acetate..................... 1.0 mg)
EXCIPIENTS
Propyl gallate (E310)……………………………………… 1.0
mg
For the 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 of isolated
bacteria.
4.3 CONTRAINDICATIONS
Do not use in dogs suffering from perforation of the tympanic
membrane.
Do not use in case of hypersensitivity to the active substances or to
any of the excipients.
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The external ear canal should be meticulously cleaned and dried before
treatment.
Bacterial and fungal otitis is often secondary in nature. The
underlying cause should be identified and treated.
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