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COMFEEL ULCER DRESSING (Hydrocolloid Dressing)

SCHEDULING STATUS:
Not Scheduled

PROPRIETARY NAME
(and dosage form):

COMFEEL ULCER DRESSING (Hydrocolloid Dressing)

COMPOSITION:
Each dressing contains 44,9 mg sodium carboxymethylcellulose per 1 cm²

PHARMACOLOGICAL CLASSIFICATION:
A 14.2 Wound Dressing.

PHARMACOLOGICAL ACTION:
Comfeel Ulcer Dressing is an interactive hydrocolloid wound dressing which provides a moist wound environment that supports the natural healing process. On absorbing wound exudate, the dressing forms a gel which fills the wound cavity and protects granulation tissue and nerve endings.

The hydrocolloid layer is bonded to a layer of polyurethane film, so rendering the dressing impermeable to water and bacteria thereby reducing the risk of secondary infection.

INDICATIONS:
Comfeel Ulcer Dressing absorbs wound exudate. It is indicated for topical use only on:
Leg Ulcers, Pressure Sores, Graft Donor Sites, Superficial Burns and Minor Injuries.

CONTRA-INDICATIONS:
DO NOT use on exposed muscle, tendon or bone.
DO NOT use in cases of known allergy or adverse reaction to one or more of the components.
DO NOT use on deep partial thickness and full thickness burns.

DOSAGE AND DIRECTIONS FOR USE:
For external use only.
The Comfeel Ulcer Dressing may be applied to adults, children and the elderly. The frequency of application depends upon the clinical circumstances.
The flexibility of the dressing allows ease of application over awkward body contours and does not restrict patient mobility whilst ensuring patient comfort.

Application:

1.	Irrigate the wound with sterile isotonic saline solution or sterile water. Gently dry the surrounding skin. {illustrated}
2.	Choose a dressing which extends at least 1,5 cm beyond the wound margin.
3.	Remove the dressing from the pouch, place your thumb in the slot, pull the protective paper to the side, but do not remove totally.
4.	The pulled back protective paper on the one side of the dressing and the polyester foil on the other side of the dressing provide two handles to ensure aseptic appliance of the Comfeel Ulcer Dressing. Place the dressing over the wound and finally remove both handles.

Removal:

1.	The dressing should always be changed when full absorbency has been reached i.e. when the dressing becomes transparent and before leakage occurs.
2.	Remove the dressing slowly from the corners towards the centre of the wound.
3.	With the sterile isotonic solution or sterile water wash away any residue of the hydrocolloid dressing. Dry the surrounding skin and re-apply fresh dressing.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
No dressing can guarantee healing. Comfeel Ulcer Dressing provides an optimal local wound healing environment, but other aspects of patient care should not be left out.
Wound exudate remaining in contact with healthy skin for prolonged periods may cause erythema or irritation. A characteristic odour may develop and will be retained under the dressing. This odour is likely to disappear when the wound is cleaned.
The bacterial barrier property of the dressing will be compromised if exudate is allowed to seep under the edge of the dressing, and it should be replaced immediately.
Wounds with signs of clinical infection including fever and local symptoms such as tenderness, erythema or purulent discharge should be treated by a doctor before continuing with Comfeel Ulcer Dressing.
A medical opinion should be sought before using Comfeel Ulcer Dressing on wounds at high risk of infection (e.g. diabetic ulcers), and ulcers caused by syphilis, tuberculosis and leprosy.
Ulcers entirely or predominantly caused by arterial insufficiency (especially the feet) should regularly be inspected by a doctor.
Remove Comfeel Ulcer Dressing before prolonged radiation treatment (x-ray, ultrasonic, diathermic or microwave treatment).

IDENTIFICATION:
A beige coloured square dressing, one side covered with a polyurethane film, the adhesive side of the film being covered by a printed silicon release paper with a polyester film release handle on one side of the dressing.

PRESENTATION:
Comfeel Ulcer Dressing is sterile and individually contained in a peel pack. The peel packs are packed into cartons with a flap closure. The dressings are available in 4 sizes, please see product chart.

Number per box		Size in cm		Comfeel Ulcer Dressing
10		10 x 10		3213
5		15 x 15		3218
5		20 x 20		3223
30		4 x 6		3233

STORAGE INSTRUCTIONS:
Store in dry place below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
29/14.2/0450

NAME AND BUSINESS ADDRESS OF APPLICANT:
H Lundbeck (Pty) Ltd PO Box 2357, Randburg, 2125

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1995

Use of this product in a manner other than in conformity with the applicant’s, H. Lundbeck (Pty) Ltd. and manufacturer's, Coloplast, current recommendations may lead to injury or other loss, for neither of which they will accept liability.

STERILISATION:

STERILE

R

If packaging is brolken do not use or re-sterelise product.

Do not re-use.

33706232. Design: J A Linneballe . Tryk: Richard Larsen A/S 12.95 87908 Version 1
Comfeel is a registered trademark owned by Coloplast A/S , DK-3060 Espergaerde

Updated on this site: June 2000
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