OTOXOLAN EAR DROPS, SUSPENSION FOR DOGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE ACETATE PH. EUR. (EQUIVALENT TO DEXAMETHASONE)

Available from:

Krka, d.d., Novo mesto

ATC code:

QS02CA06

INN (International Name):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE ACETATE PH. EUR. (EQUIVALENT TO DEXAMETHASONE)

Dosage:

3mg/10mg/1mg

Pharmaceutical form:

Ear Drops Suspension

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

Dexamethasone and antiinfectives

Authorization status:

Authorised

Authorization date:

2017-01-20

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Otoxolan ear drops, suspension for dogs
Marbofloxacin/Clotrimazole/Dexamethasone acetate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains:
ACTIVE SUBSTANCES:
Marbofloxacin
3.0 mg
Clotrimazole
10.0 mg
Dexamethasone acetate
1.0 mg
(equivalent to Dexamethasone
0.9 mg)
EXCIPIENTS:
Propyl gallate (E310)
1.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, suspension.
Off yellow, opalescent, viscous 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 use in dogs suffering from perforation of the tympanic
membrane.
Do not use in cases of hypersensitivity to the active substances, to
other azole antifungal agents or to any other
fluoroquinolones or to any of the excipients.
Do not administer to pregnant or lactating bitches.
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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