Canaural Ear Drops, Suspension for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Diethanolamine Fusidate, Framycetin Sulphate, Nystatin, Prednisolone

Available from:

Dechra Veterinary Products A/S

ATC code:

QS02CA01

INN (International Name):

Diethanolamine Fusidate, Framycetin Sulphate, Nystatin, Prednisolone

Pharmaceutical form:

Ear drops, suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1996-01-09

Summary of Product characteristics

Revised: September 2012
AN: 00364/2012
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Canaural ear drops, suspension for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g suspension contains:
ACTIVE SUBSTANCES:
Diethanolamine fusidate
5.0 mg
Framycetin sulphate
5.0 mg
Nystatin
100,000 IU
Prednisolone
2.5 mg
EXCIPIENT:
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 eardrum.
Do not use concomitantly with products known to be ototoxic.
Do not use in animals with known hypersensitivity to the active
substances or
to the excipient.
4.4
SPECIAL WARNINGS
For external use only.
To be used under veterinary supervision.
Revised: September 2012
AN: 00364/2012
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Official, national and regional antimicrobial policies should be taken
into
account when the product is used.
i.
Special precautions for use in animals
Following recovery the ears should be checked at regular intervals for
any signs of re-infection.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Avoid contact with the product.
Wash hands after use.
If the product comes into contact with the eyes, rinse immediately
with
plenty of water.
People with known hypersensitivity to any of the active substances or
the excipient in the product should avoid contact with the veterinary
medicinal product.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
On very rare occasions and primarily in geriatric animals, use of
auricular
preparations may be associated with hearing impairment which may be
either
transient or prolonged.
Allergy or hypersensitivity reactions to the a