Canaural (Canada)

Ear drops, suspension for dogs and cats

For veterinary use only

Antibiotic/Antifungal/Anti-inflammatory

DIN 02427877

Description

Canaural is an oily suspension of the active ingredients diethanolamine fusidate 5 mg/g, framycetin sulphate 5 mg/g (Ph. Eur.), nystatin 100,000 IU/g (Ph. Eur.) and prednisolone 2.5 mg/g (Ph. Eur.) in an excipient, sesame oil (Ph. Eur.).

Therapeutic Classification

Diethanolamine fusidate, framycetin sulphate and nystatin are antimicrobials. Prednisolone is an anti-inflammatory corticosteroid.

Canaural Indications

Canaural is specifically formulated for the treatment of otitis externa and Otodectes cynotis infestation in dogs and cats.

Canaural Dosage And Administration

Shake the bottle before use.

Instill 5-10 drops of Canaural into the ear canal twice daily. The ear flap should then be held and the ear canal gently massaged to ensure maximum penetration of the Canaural suspension.

Wash hands after use.

One 15 mL bottle will treat one ear for approximately two weeks.

The length of treatment will depend upon the individual case, but a maximum treatment period of 7 days is recommended. When ear mite infestation is present, consideration should be given to treating both ears even if infestation is apparent in only one. Treatment should continue for at least 3 weeks to ensure that successive generations of ear mites are killed. All animals in contact with the infected animal should also be treated.

Following recovery the ears should be checked at regular intervals for any sign of re-infection.

Contra-indications

Do not use in case of perforated eardrum.

Do not use in case of hypersensitivity to the active substances or to the excipients.

The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Use is not recommended during pregnancy or lactation.

Canaural Cautions

For external use only.

The dog’s scratching of the ears might need to be prevented.

When treatment is for a period longer than 7 days, regular clinical re-evaluation should be carried out.

Inappropriate use of the product might increase the prevalence of antimicrobial resistance and might lead to cross resistance.

Hypersensitivity to any of the ingredients might develop. In case of hypersensitivity stop the treatment immediately.

Anti-inflammatory corticosteroids such as prednisolone can exert a wide range of side effects. Dosage for medium to long term use should therefore generally be kept to the minimum. During therapy, effective doses suppress the hypothalamic-pituitary adrenal axis. End of treatment symptoms of adrenal insufficiency can arise and this may render the animal unable to deal adequately with stressful situations. Corticosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to, or exacerbate, existing infections.

Warnings

People known hypersensitivity to the active ingredients or to the excipient should avoid contact with this product.

Allergy or hypersensitivity to one of the ingredients may appear.

When handling the product, avoid oral exposure and direct contact with skin and eyes. Wash hands after use.

If accidental eye contact occurs, wash immediately with copious amounts of water.

Keep out of reach of children.

Adverse Reactions

Although all adverse reactions are not reported, the following information is based on voluntary post-approval drug experience reporting. It is generally recognized that this results in significant under-reporting. The adverse events listed here reflect reporting and not necessarily causality. Adverse events are listed by body system, in decreasing order of frequency:

Dogs:

Ear and labyrinth disorders: deafness, impaired hearing, pinnal irritation

Systemic disorders: lethargy, anorexia, lack of efficacy

Digestive tract disorders: emesis, diarrhea

Application site disorders: application site erythema, application site pruritus

Cats:

Ear and labyrinth disorders: pinnal irritation, internal ear disorder, deafness

Systemic disorders: anorexia, lethargy

Neurological disorders: ataxia, anisocoria

Application site disorders: application site pruritus, application site erythema, application site hair change

On very rare occasions and primarily in geriatric animals, use of otic preparations may be associated with hearing impairment which may be either transient or prolonged.

Other Information

Diethanolamine fusidate:

Diethanolamine fusidate (fusidic acid) is an antibiotic which is highly active against staphylococci, the most commonly found bacterial pathogen in otitis externa in dogs and cats. Fusidic acid has skin penetrating properties which enhances its antimicrobial properties.

Framycetin sulphate:

Framycetin sulphate is a broad spectrum antibiotic which has been incorporated for its activity against Gram negative organisms associated with otitis externa, in particular Pseudomonas spp. and Proteus spp.

Nystatin:

Nystatin is highly active against yeast. The yeast, Malassezia canis is associated with otitis externa in dogs and cats either by itself or with other micro organisms.

Prednisolone:

Prednisolone is incorporated for its anti-inflammatory activity.

Trials have demonstrated that Canaural is effective in the treatment of the ear mite Otodectes cynotis in dogs and cats.

All four active ingredients are suspended in oil that softens and dissolves ceruminous material and readily penetrates the ear canal. Additionally the oil used does not matt the hair around the ear, which would prove objectionable to both the animal and owner.

Storage

Do not store above 25°C. Protect from direct sunlight.

HOW SUPPLIED

Plastic squeeze dropper bottles, supplied in boxes of 1 x 15 mL or 1 x 25 mL.

Dechra Veterinary Products A/S, Mekuvej 9, DK-7171, Uldum, Denmark

IMPORTED AND DISTRIBUTED BY Dechra Veterinary Products Inc., 1 Holiday Avenue, East Tower, Suite 345, Pointe-Claire, Quebec, Canada, H9R 5N3

F1628

CPN: 1786007.1