PRODUCT DESCRIPTION

AQUACEL® Ag with Hydrofiber® (Aquacel Ag), silver impregnated antimicrobial dressing is a soft, sterile, non- woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver which allows for a maximum of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing, reduces the number of bacteria where the dressing conforms to the wound and aids in creating an antimicrobial environment. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). Moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection. 1 , 2

INDICATIONS

For over-the-counter use, Aquacel Ag may be used for:

Under the supervision of a health care professional, Aquacel Ag may be used for the management of:

Aquacel Ag may be used on minimally exuding, non-exuding and dry wounds, as stated in the DIRECTIONS FOR USE .

CONTRAINDICATIONS

Aquacel Ag should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.

PRECAUTIONS AND OBSERVATIONS

In addition, for leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology), diabetic ulcers, pressure ulcers/sores, partial thickness (second degree burns), and surgical, oncology or traumatic wounds left to heal by secondary intention:

DIRECTIONS FOR USE

FOR PARTIAL THICKNESS BURNS (SECOND DEGREE BURNS):

FOR DRY WOUNDS

Place the Aquacel Ag in the wound and then wet with sterile saline over the wound area only. The vertical absorption properties of Aquacel Ag will help to maintain the moist area over the wound only and reduce the risk of maceration. Cover the dressing with a moisture retentive dressing such as DuoDERM® Extra Thin to avoid drying out of the dressing and subsequent dressing adherence to the wound.

7-day sustained activity test
(simulated wound model)
Zone of inhibition test
(Spectrum of activity)
Staphylococcus
  aureus
X X
Pseudomonas
  aeruginosa
X X
Candida albicans X X
MRSA   X
VRE   X
Serratia marscesens
 (abtc resistant)
  X
P. aeruginosa
  (abtc resistant)
  X
Enterobacter cloacae   X
Klebsiella
  pneumoniae
  X
Escherichia coli   X
Enterococcus faecalis   X
Streptococcus
  pyogenes
  X
Bacteroides fragilis   X
Peptostreptococcus
  anaerobius
  X
Clostridium ramosum   X
Clostridium
  clostridioforme
  X
Clostridium cadaveris   X
Clostridium
  perfringens
  X
Prevotella corporis   X

HOW SUPPLIED

Aquacel Ag is available in a range of sizes as follows;

Packages of sheets:

5cm × 5cm

10cm × 12cm

15cm × 15cm

20cm × 30cm

2g × 45cm ribbon

If the immediate product packaging is damaged, do not use.

Store at room temperature (10[ordm ]C - 25[ordm ]C/50[ordm ]F - 77[ordm ]F). Keep dry.

If further information or guidance is needed, please contact ConvaTec Professional Services.

1 The biocompatability of Aquacel Ag has been demonstrated through appropriate in vivo and in vitro tests.
2 Anitmicrobial activity has been demonstrated by relevant in vitro microbiological assays.

Manufactured by:

ConvaTec Limited

Unit 33

First Avenue

Deeside Industrial Park

Deeside CH5 2NU, UK

ConvaTec

Division of E. R. Squibb & Sons, L.L.C.

Princeton, NJ 08543

1-800-422-8811

ConvaTec

Division of/de Bristol-Myers Squibb Canada, Inc.

Montréal, Québec, Canada

1-800-465-6302

ConvaTec

A Division of Bristol-Myers Squibb Australia Pty Ltd.

PO Box 240

NOBLE PARK, VICTORIA 3174

Free Call 1800 335 276

(03) 9554 9400

ConvaTec

A Division of Bristol-Myers Squibb Pharmaceuticals

Pty Ltd.

P.O. Box 62663

Central Park

AUCKLAND NEW ZEALAND

Free Call 800 441 763

www.convatec.com

Made in UK

© 2003 E.R. Squibb & Sons, L.L.C.

®/™ is a registered trademark of E.R. Squibb & Sons, L.L.C.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.

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Copyright© 2006 Thomson PDR