Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction 
Company name: Dechra Veterinary Products Limited
Address: (A business unit of Dechra Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Telephone: 01939 211200
Fax: 01939 211201
Email: info@dechra-uk.com
Website: www.dechra.com
Presentation
A yellow oily suspension. 1 g suspension contains:
Diethanolamine fusidate
| 5.0 mg
| Framycetin sulphate
| 5.0 mg
| Nystatin
| 100,000 I.U.
| Prednisolone
| 2.5 mg
|
Excipient: Seseme oil.
Uses
Canaural® is effective against the micro-organisms commonly associated with otitis externa, including the ear mite, Otodectes cynotis, and is specifically formulated for the treatment of otitis externa in the dog and cat.
Dosage and administration
Where appropriate, prior to administration, the ear canal and the surrounding area should be cleaned mechanically or by irrigation, taking care to avoid further damage to the skin. Any excess exudate, hair or debris should be carefully removed prior to the application of the ear drops. Animal owners should only do this on the direction of the prescribing veterinary surgeon.
Shake the bottle well before use.
Instil 5-10 drops into the ear according to the size of the animal and ear canal twice daily. Without allowing the animal to shake its head, very gently massage the ear canal after administration holding the pinna in an upright position to ensure penetration of the drops into the ear.
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. Animals that are in contact should also be treated.
Where treatment is for a period longer than 7 days, regular clinical re-evaluation should be carried out. Where Gram-negative infections are involved, the use of the veterinary medicinal product should be based on bacterial sensitivity testing. In cases where the treatment period is prolonged, in vitro sensitivity should be re-evaluated.
Advice on correct administration: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Contraindications, warnings, etc
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.
Not recommended for use in pregnant animals.
Adverse reactions: Allergy or hypersensitivity reactions to the active substances or the excipient might occur.
Anti-inflammatory corticosteroids such as prednisolone are known to 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 hypothalamo-pituitreal-adrenal axis. Following cessation 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.
If you notice any serious effects or other effects not mentioned in the data sheet, please inform your veterinary surgeon.
Special precautions for use in animals: Following recovery the ears should be checked at regular intervals for any signs of re-infection.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Avoid skin contact with this product. Wash hands thoroughly after applying the product.
In case of accidental eye contact, rinse thoroughly with water and seek medical advice.
People with known hypersensitivity to any of the active substances or the excipient should avoid contact with the veterinary medicinal product.
Special warnings: For animal treatment only.
For external use only.
To be used under veterinary supervision.
Not recommended for use in pregnant and lactating animals.
Keep out of the reach and sight of children.
Pharmaceutical precautions
Do not store above 25°C. Protect from direct sunlight. Keep the bottle in the outer carton.
Do not use after the expiry date stated on the label and carton after EXP.
Shelf life after first opening the container: 3 months. In order to calculate the date on which any product remaining in the bottle should be discarded, add 3 months to the date on which the bottle is opened for the first time. This discard date should be written in the space provided on the carton.
Disposal: Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Legal category
POM-V
Packaging quantities
Plastic squeeze dropper bottles, supplied in boxes of 1 × 15 ml, 10 x 15 ml, 1 × 25 ml or 1 × 100 ml.
Not all pack sizes may be marketed.
Further information Manufacturer responsible for the batch release: Dales Pharmaceuticals, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW.
To be supplied only on veterinary prescription.
Veterinary medicinal product authorised for use in UK and IE.
Marketing authorisation holder (if different from distributor)
Dechra Veterinary Products A/S, Mekuvej 9, DK-7171 Uldum, Denmark.
Marketing authorisation number
Vm 24883/4004.
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