Medine.co.uk

Dermisol Cream

Revised: June 2014

AN: 00245/2014

SUMMARY OF PRODUCT CHARACTERISTICS


NAME OF THE VETERINARY MEDICINAL PRODUCT


Dermisol Cream


QUALITATIVE AND QUANTITATIVE COMPOSITION


Active ingredients:

Malic acid anhydrous 0.375 % w/v
Benzoic acid 0.025 % w/v
Salicylic acid 0.006 % w/v
Propylene glycol 1.750 % v/v


For the full list of all other excipients see section 6.1


PHARMACEUTICAL FORM


Cream

A white cream for topical application.


CLINICAL PARTICULARS


Target species


Horses, cattle, dogs and cats.


Indications for use, specifying the target species


To encourage healing in horses, cattle, dogs and cats when this process is impaired by the presence of necrotic tissue, coagulum, debris or wax. This may occur in traumatic injury, surgical wounds, infected wounds and otitis externa.


Contraindications


Do not use this product in the treatment of otitis externa if the animal has a ruptured ear drum. If in doubt consult a veterinary surgeon.

Do not use in conjunction with other products e.g. teat dips, udder disinfectants, etc. as these will almost certainly neutralise and reduce the effectiveness of the product.


Special warnings for each target species


Contact with the eyes should be avoided as the solution may prove irritant on account of its low pH.

Special precautions for use


Special precautions for use in animals

See section 4.7 (Use during pregnancy, lactation or lay).

For topical application only.

For external use only.

Special precautions to be taken by the person administering the veterinary medicinal product to animals


Care should be taken to avoid contact with the eyes because of the low pH and a possibleirritant effect.

If contact occurs, rinse with clean, freshwater.

May cause skin irritation. It is recommended that gloves be worn when handling the product if you have sensitive skin.

Wash hands after use.


Adverse reactions (frequency and seriousness)


None.


Use during pregnancy, lactation or lay


When used for treating udder lesions, the teats and udder should be washed and dried immediately before milking.


Interaction with other medicinal products and other forms of interaction


None.


Amounts to be administered and administration route


Apply twice daily although more frequent applications may be made if necessary.

Wounds:The cream should be spread liberally on to wound surfaces and before each new application it is advisable to wash the area with a multicleansing solution so that loose slough and cream from the previous application are removed without raising the pH.

Otitis externa:In cases of otitis externa, ears should be cleaned with a multicleansing solution prior to the introduction of the cream into the external auditory canal.

Overdose (symptoms, emergency procedures, antidotes), if necessary


Not applicable.


Withdrawal periods


Cattle:
Meat – zero days.

Milk – zero hours

Horses: Meat – zero days.


PHARMACOLOGICAL PROPERTIES


The product has antibacterial properties because of its low pH - approximately 2.3 (due to the content of malic acid, benzoic acid and salicylic acid) and the presence of propylene glycol, which together with the sloughing action create an environment in which healthy tissues can readily grow. These components also ensure that the product is adequately preserved.


PHARMACEUTICAL PARTICULARS


List of excipients


White Soft Paraffin

Sorbitan Sesquioleate

Cholesterol

Magnesium Sulphate Heptahydrate

Allantoin

Methyl Hydroxybenzoate

Propyl Hydroxybenzoate

Water Purified


Incompatibilities


Prolonged contact with metal surfaces is inadvisable.


Shelf-life


Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.


Special precautions for storage


Do not store above 25°C.
Prolonged contact with metal surfaces is inadvisable.


Nature and composition of immediate packaging


Epoxyphenolic resin lacquered tube with white polyethylene cap (screwfit), containing either 30 g or 100 g. Not all pack sizes may be marketed.


Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate


Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.


MARKETING AUTHORISATION HOLDER


Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE


MARKETING AUTHORISATION NUMBER


Vm:42058/4035


DATE OF THE FIRST AUTHORISATION


Date:11 August 1992


DATE OF REVISION OF THE TEXT


Date:June 2014


26 June 2014