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DEBRISAN® BEADLETS (Dusting Powder)

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

DEBRISAN^® BEADLETS (Dusting Powder)

COMPOSITION
Dusting Powder consisting of dextranomer 100% m/m.

PHARMACOLOGICAL CLASSIFICATION
A 14.1 Wound disinfectants

PHARMACOLOGICAL ACTION
DEBRISAN^® BEADLETS consist of a three dimensional network of cross-linked dextran, which is available as an insoluble powder, rendered sterile by gamma-irradiation. DEBRISAN^® BEADLETS are hydrophilic and have powerful fluid absorbing (imbibing) properties. One gram of dry powder can imbibe up to 4 mL of fluid. DEBRISAN^® BEADLETS can generate a suction force of up to 200 mm Hg. When the powder is saturated with fluid it has a gel-like appearance.
When DEBRISAN^® BEADLETS are applied to a wound surface they suck up wound secretions. Substances with a molecular weight of less than 5 000 can be absorbed into the matrix of the individual beads. A chromatographic effect is obtained in that the low molecular weight components of the wound secretion are found both within and outside the swollen beads, whilst the larger molecules such as plasma proteins, fibrinogen and its high molecular weight split products are retained between the swollen particles. No wound crust is formed, because coagulation and desiccation of protein in the wound secretions are prevented. Fibrinogen is continuously removed from the wound surface. Furthermore, the wound secretions imbibed into the bed of the DEBRISAN^® BEADLETS have a high fibrinolytic activity, which is demonstrated by the bed's lack of fibrinogen, yet high content of fibrin split products. Bacteria, bacterial toxins and larger particles can also be transported in the same way as large molecules. This appears to reduce infection and prevents toxic effects to the tissues. Inflammation is reduced, oedema subsides, the wound is cleansed and granulation tissue is obtained by which wound healing is speeded.

INDICATIONS
Accelerated healing of all types of weeping and infected wounds, for example, second and third degree burns or chronic leg ulcers.

DOSAGE AND DIRECTIONS FOR USE
To attain the best possible results with DEBRISAN^® BEADLETS, only a few simple instructions should be followed:

1.	Clean the wound by rinsing (Fig. 1) and/or use a compress moistened with water or some kind of wound cleansing solution (Fig. 2). The wound should remain wet, since this increases the cleansing effect of DEBRISAN®BEADLETS.
2.	Sprinkle the DEBRISAN® BEADLETS over the wound and apply a bandage (Fig. 4-6, see text below). Always cover the wound surface with a layer of DEBRISAN® BEADLETS, at least 2 mm to 3 mm thick. To obtain an optimal cleansing effect, DEBRISAN® BEADLETS must be applied generously.
	When treating an ulcer, a compress or a thin perforated plastic foil can be used to keep DEBRISAN® BEADLETS in place. The following procedure is currently recommended:
-	First use an ointment on the skin outside the edges of the ulcer (Fig. 3).
-	Then attach the compress or the perforated plastic foil, along the edge of the ulcer on one side, so that it sticks to the ointment (Fig. 4). Generously sprinkle the beadlets over the ulcer (Fig. 4).
-	Fold the compress (Fig. 5), or the perforated plastic foil, over the ulcer.
-	Apply a bandage (Fig. 6).
-	When treating hand burns, a soft plastic bag should be used. Put your hand half-way into the bag and generously sprinkle DEBRISAN®BEADLETS directly on to the wound (Fig. 7).
-	Let the beadlets that do not stick to the hand remain in the bag. Fasten the bag at the wrist with gauze (Fig. 8). Make air holes in the upper part of the bag using a clean fork or other sharp object. The excess DEBRISAN® BEADLETS in the bag become attached to the wound surface as the hand is turned.
3.	Change of dressing - how often? DEBRISAN® BEADLETS should be rinsed away as shown in Fig. 1 and 2. Fresh DEBRISAN® BEADLETS are sprinkled over the wet ulcer. As a rule, DEBRISAN®BEADLETS should be changed twice a day. If the wound exudation is slight, one change may be sufficient. Profusely exudating wounds and burns may need three or four changes a day. If the beadlets are not changed often enough, they tend to dry in the wound ulcer and form a crust, that is generally difficult to remove.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Although no cases have been reported, the possibility of an anaphylactoid reaction should be borne in mind.

IDENTIFICATION
DEBRISAN^® BEADLETS appear as a white to pale, straw-coloured dusting powder.

PRESENTATION
Securitainers of 60 g.

STORAGE INSTRUCTIONS
Store in well sealed containers below 25°C.
Protect from moisture.
Keep out of reach of children.

REGISTRATION NUMBER
J/14.1/248

NAME AND ADDRESS OF THE APPLICANT
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
MIDRAND

DATE OF PUBLICATION OF THIS PACKAGE INSERT
6 January 1978

New addition to this site: January 2005
Source: Pharmaceutical Industry
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