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 low pH causes separation of collagen molecules by rupturing the hydrogen bonding. The optimum pH to achieve this effect is between pH2 and pH3.
-
The organic acids react with carboxyl and amino groups in the collagen.
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