Canaural Ear Drops (Canada)

Manufacturer: Aventix

Ear drops suspension for dogs and cats

For Veterinary Use Only

Composition

Canaural^® is an oily suspension. Each gram suspension contains:

Active ingredients:

Properties: Canaural^® Ear Drops are specifically formulated for the treatment of otitis externa in the dog and cat.

Fusidic acid

Fusidic acid is an antibiotic which is highly active against Staphylococci, the most commonly found bacterial pathogen in otitis externa in the dog and cat. Fusidic acid has skin penetrating properties which enhances its antibacterial 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 the dog and cat either by itself or with other organisms.

Prednisolone

Prednisolone is incorporated for its anti-inflammatory activity.

Trials have determined that Canaural^® is effective in the treatment of the ear mite Otodectes cyonitis in the dog and cat. All four active ingredients are suspended in oil. A bland oil is used which 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.

Canaural Ear Drops Indications

Otitis externa in the dog and cat. Otodectes cynotis infestation in the dog and cat.

Contraindications

- 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. The use is not recommended during pregnancy or lactation.

Canaural Ear Drops Cautions

- For external use only.

- The dogs scratching of the ears might need to be prevented.

- Where 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 bacterial 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 in medium to long term use should therefore generally be kept to the minimum. During therapy effective doses suppress the hypothalamic-pituiteal adrenal axis. Following 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

- KEEP OUT OF REACH OF CHILDREN.

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

- Wash hands after use.

- Avoid contact with the eyes. If any splashes enter the eye, wash immediately with copious amounts of water.

Dosage and Administration

Shake the bottle before use.

5-10 drops of Canaural^® should be instilled 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.

Where ear mite infection is present, consideration should be given to treating both ears, even if infection is apparent in only one.

Treatment should continue for at least 3 weeks to ensure that successive generations of ear mites are killed. In contact animals should also be treated.

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

Storage

Do not store above 25°C.

Protect from direct sunlight.

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

DIN 02277468

Date of revision of the text: 03/2009

^®Regd User

AVENTIX ANIMAL HEALTH CORP., Burlington, Ontario L7L 5R7, Canada

024309-01

NAC No.: 13010121