CANAURAL EAR DROPS, SUSPENSION FOR DOGS AND CATS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

DIETHANOLAMINE FUSIDATE, FRAMYCETIN SULFATE, NYSTATIN, PREDNISOLONE

Available from:

Dechra Veterinary Products A/S

ATC code:

QS02CA01

INN (International Name):

DIETHANOLAMINE FUSIDATE, FRAMYCETIN SULFATE, NYSTATIN, PREDNISOLONE

Dosage:

5

Pharmaceutical form:

Ear Drops Suspension

Prescription type:

POM

Therapeutic group:

Canine, Feline

Therapeutic area:

Prednisolone and antiinfectives

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2004-10-01

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Canaural ear drops, suspension for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EXCIPIENTS:
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, suspension.
A yellow oily suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of otitis externa including the ear mite_ Otodectes
cynotis_ infestation in the dog and cat.
4.3 CONTRAINDICATIONS
Do not use in animals with a perforated ear drum.
Do not use concomitantly with products known to be ototoxic.
Do not use in animals with known hypersensitivity to the active
substances or the excipient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
For external use only.
To be used under veterinary supervision.
1 g of suspension contains:
ACTIVE SUBSTANCES:
Diethanolamine fusidate
5
mg
Framycetin sulphate
5
mg
Nystatin
100,000
IU
Prednisolone
2.5 mg
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4.5 SPECIAL PRECAUTIONS FOR USE
Official, national and regional antimicrobial policies should be taken
into account when the product is used.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Following recovery the ears should be checked at regular intervals for
any sign of re-infection.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PE
                                
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