Q2370_canaural_ear_dro.1_8.tp

Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200
CANAURAL® EAR DROPS, SUSPENSION FOR
Contraindications, warnings, etc
DOGS AND CATS
Do not use concomitantly with products known to Presentation
Do not use in animals with known hypersensitivity to the active substances or to the excipient.
Special precautions for use: Official, national and regional antimicrobial policies should be taken into Special precautions for use in animals: Following Ear drops, suspension. A yellow oily suspension.
recovery the ears should be checked at regularintervals for any signs of re-infection.
For the treatment of otitis externa, including Special precautions to be taken by the person the ear mite, Otodectes cynotis, in the dog and cat.
administering the veterinary medicinal product toanimals: Avoid contact with the product. Wash hands administration Where
prior to administration, the ear canal and the sur- If the product comes into contact with the eyes, rounding area should be cleaned mechanically or by rinse immediately with plenty of water.
irrigation, taking care to avoid further damage to the People with known hypersensitivity to any of the skin. Any excess exudate, hair or debris should be active substances or the excipient should avoid carefully removed prior to the application of the ear contact with the veterinary medicinal product.
drops. Animal owners should only do this on the Adverse reactions: On very rare occasions, and direction of the prescribing veterinary surgeon.
primarily in geriatric animals, use of auricular prep- arations may be associated with hearing impairment Instil 5-10 drops into the ear according to the size of which may be either transient or prolonged.
the animal and ear canal twice daily. Without allowing Allergy or hypersensitivity reactions to the active the animal to shake its head, very gently massage the substances or the excipient might occur.
ear canal after administration holding the pinna in an Anti-inflammatory corticosteroids such as predni- upright position to ensure penetration of the drops solone can exert a wide range of side effects. Dosage in medium to long term use should therefore gener- Where ear mite infection is present, consideration should be given to treating both ears, even if infection During therapy, effective doses suppress the hypo- is apparent in only one. Treatment should continue thalamic-pituitreal adrenal axis. Following cessation for at least 3 weeks to ensure that successive genera- of treatment symptoms of adrenal insufficiency can tions of ear mites are killed. Animals that are in arise and this may render the animal unable to deal adequately with stressful situations.
Where treatment is for a period longer than 7 days, Corticosteroids may delay wound healing and the regular clinical re-evaluation should be carried out.
immunosuppressant actions may weaken resistance Where gram-negative infections are involved, the use to, or exacerbate existing infections.
of the veterinary medicinal product should be based Use during pregnancy and lactation: The safety of on bacterial sensitivity testing. In cases where the the veterinary medicinal product has not been estab- treatment period is prolonged, in vitro sensitivityshould be re-evaluated.
lished during pregnancy and/or lactation. Use is not Further information
recommended during pregnancy and/or lactation.
Keep out of the reach and sight of children. For external use only. To be used under veterinary Incompatibilities: None known.
supervision. To be supplied only on veterinary pre-scription.
Pharmaceutical precautions
Manufacturer responsible for the batch release: 25˚C. Protect from direct sunlight. Keep the bottle in Dales Pharmaceuticals, Snaygill Industrial Estate, the outer carton. Do not use after the expiry date Keighley Road, Skipton, North Yorkshire, BD23 2RW.
stated on the label and carton after EXP.
Shelf life of the veterinary medicinal product as Shelf life after first opening the immediate packag- Marketing authorisation holder (if different from
distributor)
Disposal: Any unused veterinary medicinal product or waste materials derived from such veterinarymedicinal products should be disposed of in accor-dance with local requirements.
Marketing authorisation number Vm 24883/4004
Legal category POM-V
GTIN (Global Trade Item No)
Packaging quantities
Canaural Ear Drops, Suspension for Dogs and Cats squeeze dropper bottles, supplied in boxes of 1x15 ml, 10x15 ml, 1x25 ml or 1x100 ml. Not all pack Canaural Ear Drops, Suspension for Dogs and Cats Requested by: kate.gittins@dechra.com
Approved datasheets found: 1
Creation date: 10/12/2012 16:27:58 (UK)
Approved for book but not on website: 0
Datasheets marked as draft (ignored): 0
Canaural Ear Drops, Suspension for Dogs and Directory of participants
Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200Fax: 01939 211201email: info.uk@dechra.comwww.dechra.com LIST OF PRODUCTS BY THERAPEUTIC INDICATION List of Products by Therapeutic Indication
PHARMACEUTICALS
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Topical preparations
List of Products by Species
Please note that a species in brackets after a product name may not necessarily be a part of that product namebut is intended to make the index easier to use.
Canaural Ear Drops, Suspension for Dogs and Canaural Ear Drops, Suspension for Dogs and List of Products by Active Ingredients
This index of non-proprietary names (active ingredients) is provided to enable users of the Compendium toidentify the brand names of relevant products when only the non-proprietary names are known.
It should be noted that although different products may contain the same active ingredient this does not implythat they are equivalent in regard to bioavailability or therapeutic activity.
Some products contain a number of ingredients and it has not been possible in every instance to identify suchproducts by a reference in this index to each ingredient.
Non-proprietary name in bold type. Proprietary name in ordinary type.
Diethanolamine Fusidate
Nystatin
Canaural Ear Drops, Suspension for Dogs and Canaural Ear Drops, Suspension for Dogs and Framycetin Sulfate
Prednisolone
Canaural Ear Drops, Suspension for Dogs and Canaural Ear Drops, Suspension for Dogs and GRED
IN
E
IV
Alphabetical Index of Products

Source: http://www.dechra.es/files/dechra/Downloads/Pharma/Datasheets/Canaural_Ear_Drops_Suspension-11-12-12.pdf