AQUACEL® Ag Advantage

• Kills a broad spectrum of bacteria within the dressing, including antibiotic-resistant microorganisms
• Sustained antimicrobial activity in dressing up to seven days and prevents microbial reformation
• Ethylenediaminetetraacetic acid disodium salt (EDTA) helps break up bacterial aggregates and prevents their formation and reformation
• Benzethonium chloride (BEC) is a surfactant that reduces the viscosity or surface tension of anything to which it comes in contact, including exudate and microorganisms, which allows for increased mobility of EDTA and ionic silver within the dressing, enhancing the ionic silver's ability to contact and kill microorganisms
• Silver in the dressing kills microorganisms held within the dressing; the dressing (including bacteria, yeasts and mold) and provides an antimicrobial barrier to protect the wound bed
• 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)

Under the supervision of a health care professional, AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber may be used as stated in the Instructions for Use for the management of wounds as an effective barrier to bacterial penetration of the dressing, which may help reduce the risk of infection; partial-thickness (second-degree) burns; diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/injuries (partial- and full-thickness); surgical wounds left to heal by secondary intention such as dehisced surgical incisions; surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular); traumatic wounds; wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; oncology wounds with exudate, mycosis fungoides (cutaneous T-cell lymphoma) tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma; painful wounds; infected wounds.

AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components (ionic silver, ethylenediaminetetraacetic acid disodium salt (EDTA) and benzethonium chloride).

• Sterility is guaranteed unless pouch is damaged or opened prior to use.
• This device is for single use only and should not be reused. Reuse may lead to increased risk of infection or cross-contamination. Physical properties of the device may no longer be optimal for intended use.
• When dressing sinus, tracking/tunneling or undermining wounds, use AQUACEL® Ag Advantage ribbon with strengthening fiber.
• During the body's normal healing process, non-viable tissue is removed from the wound (autolytic debridement), which could initially make the wound appear larger. If the wound continues to grow larger after the first few dressing changes, consult a health care professional. The wound should be inspected during dressing changes. Consult a health care professional if you see (a) signs of infection (increased pain, increased redness, wound drainage), (b) bleeding, (c) a change in wound color and/or odor, (d) irritation (increased redness and/or inflammation), (e) maceration (skin whitening), (f) hypergranulation (excessive tissue formation), (g) sensitivity (allergic reaction), (h) no signs of healing.
• If you have difficulty removing the dressing, it should be soaked with water or sterile saline until it removes easily.
For partial-thickness burns, please refer to the FOR PARTIAL-THICKNESS BURNS (SECOND-DEGREE BURNS) section of the package insert.
• Because AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber provides a moist environment that supports the growth of new blood vessels, the delicate, newly formed blood vessels may occasionally produce blood-stained wound fluid.
• AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber is not compatible with oil-based products, such as petrolatum.
• Secondary dressings should be used as stated in the DIRECTIONS FOR USE section of the package insert.
• For leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), diabetic ulcers, pressure ulcers/injuries, partial-thickness (second-degree) burns, donor sites and surgical, oncology or traumatic wounds left to heal by primary or secondary intention:
• Treatment of wounds listed above should be under the supervision of a health care professional.
• Appropriate supportive measures should be taken where indicated (e.g., use of graduated compression bandaging in the management of venous leg ulcers or pressure relief measures in the management of pressure injuries, systemic antibiotics and frequent monitoring in the treatment of wound infection, control of blood glucose for diabetic ulcers, etc.).
• For oncology wounds, a secondary dressing of high absorbency may be required.
• AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber is not intended for use as a surgical sponge.
• The use of AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber has not been studied in wounds due to herpes simplex or impetigo.
• Clinicians/health care professionals should be aware that there are very limited data on prolonged and repeated use of silver-containing products, particularly in children and neonates.
• AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber is determined to be MR-Safe according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-13 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
• Blue skin discoloration (i.e., argyria) may occur after prolonged contact with a silver-containing material. Frequent or prolonged use of this preparation may result in permanent discoloration of skin and mucous membranes.

This product is for single use only and is supplied sterile. Discard any unused portion of the product after dressing the wound. If the immediate product packaging is damaged, do not use.

The following adverse reactions have been identified during use of AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber:
• Skin irritation/rash/mucosal irritation
• Allergic response (localized)
• Mild pain/discomfort
• Superficial tissue damage
• Delayed healing/abnormal scarring of wound
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber exposure. The absolute number of adverse events is unknown, but believed to be very low. Such events are generally transitory in nature and should resolve shortly after discontinuing treatment with the dressing. Should symptoms persist or worsen, please seek medical advice.

Store at room temperature (10⁰C-25⁰C, 50⁰F-77⁰F). Keep dry.