Otoxolan ear drops, suspension for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin; Clotrimazole; Dexamethasone acetate

Available from:

Krka, d.d., Novo mesto

ATC code:

QS02CA06

INN (International Name):

Marbofloxacin; Clotrimazole; Dexamethasone acetate

Dosage:

3, 10, 1 milligram(s)/millilitre

Pharmaceutical form:

Ear drops, suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

dexamethasone and antiinfectives

Therapeutic indications:

Not Currently Available

Authorization status:

Authorised

Authorization date:

2017-01-20

Summary of Product characteristics

Health Products Regulatory Authority
21 January 2022
CRN00C9G8
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Otoxolan ear drops, suspension for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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.
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 use in animals, where resistance of causative agents to
marbofloxacin and/or clotrimazole is known.
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Bacterial and fungal otitis is often secondary in nature. The
underlying cause should be identified and treated.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Before treating with the product, the integrity of the tympanic
membrane must be verified.
Use of the product should be based on susceptibility testing of the
bacteria and/or fungi isolated from the animal. If this is not
possible, therapy should be based on local (regional) epidemiological
information about susceptibility of the target pathogens.
Official and local antimicrobial policies should be taken in to
account when the veterinary medicinal product is used.
Health Products Regulatory Authority
21 January 2022
CRN00C9G8
Page 2 of 4
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