Medine.co.uk

Dermisol Multicleanse Cutaneous Solution

Revised: June 2014

AN: 00245/2014

SUMMARY OF PRODUCT CHARACTERISTICS


NAME OF THE VETERINARY MEDICINAL PRODUCT


Dermisol Multicleanse Cutaneous Solution


QUALITATIVE AND QUANTITATIVE COMPOSITION


Active ingredients:

Malic acid anhydrous 2.2500 % w/v
Benzoic acid 0.1500 % w/v
Salicylic acid 0.0375 % w/v
Propylene glycol 40.0000 % v/v


For the full list of all other excipients see section 6.1


PHARMACEUTICAL FORM


Cutaneous solution.

A clear colourless aqueous solution for topical administration.

CLINICAL PARTICULARS


Target species


Horses, cattle, dogs and cats.


Indications for use, specifying the target species


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


Contraindications


Do not use this product in the treatment of otitis externa if the animal has a ruptured ear drum.
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.

Avoid contact with the eyes.

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 possible irritant effect. If contact occurs, rinse with clean, fresh water. Seek medical attention if irritation persists.

May cause skin irritation. It is recommended that gloves be worn when handling this 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


For topical application only.

General cleansing:The solution should be used generously to remove dirt, grit, coagulum, etc. The residual solution will promote sloughing of de-vitalised tissues.

Otitis externa:Use liberally to clean the ear canal. Where hardened wax is present the solution may be left in-situ, thereby softening the wax and allowing easy removal next day. The application may be repeated 2-3 times daily as necessary.


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


Not applicable.


Withdrawal periods


Cattle: Meat – Zero days

Milk – Zero hours

Horses: Meat – Zero days


PHARMACOLOGICAL PROPERTIES


Dermisol aids the removal of dead tissue and embedded debris by causing maximum differential swelling between living and dead areas. This is achieved in two ways;

The insertion of the organic acid forces the collagen chains apart.

In both cases, the devitalised tissues absorb water and swell markedly.

Healthy tissues are unaffected because of natural barriers to the organic acids and sufficient buffering capacity to maintain a near neutral pH.


PHARMACEUTICAL PARTICULARS


List of excipients


Rose Oil

Ethanol (96 per cent)

Water purified


Incompatibilities


Prolonged contact with metal surfaces is inadvisable.


Shelf-life


Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.


Special precautions for storage


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


Nature and composition of immediate packaging


Dermisol Multicleanse Solution is available in white low-density polyethylene bottles closed with a black urea-formaldehyde cap. The bottles contain 100 ml or 340 ml of the solution. 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:42058/4036


DATE OF THE FIRST AUTHORISATION


Date:30 April 1992


DATE OF REVISION OF THE TEXT


Date:June 2014


26 June 2014