Usual Adult Dose for Thermal Burn

Usual dose:

• Apply a 3 mm thick layer to an area of up to 15% body surface area (BSA) in a single application.
• If the wound area is more than 15% BSA, apply in 2 separate sessions (e.g., 15% BSA in one session and up to 5% BSA in a second session).
• The second application of this product should be applied twenty-four hours after the first application to the same or new burn wound area.
• The total treatment area must not exceed 20% BSA (40 grams of lyophilized powder) across two treatment sessions.

Comments:

• The safety and efficacy of this product have not been established for treatment of:
• Chemical or electrical burns
• Burns on the face, perineum, or genitalia
• Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease
• Circumferential burns
• Burns in patients with significant cardiopulmonary disease, including inhalation injury
• This product should not be used for wounds contaminated with radioactive and other hazardous substances to avoid unexpected reactions and an increased risk of spreading the harmful substance.

Use: Eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any of the other components.
• Known hypersensitivity to papayas or papain.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This product should only be administered by a healthcare professional.
• Healthcare professionals should use precautions (e.g., use of gloves, surgical masks, and other protective coverings) during preparation and administration of this product.
• The drug powder and gel vehicle must be mixed prior to administration.
• This preparation is only meant for topical use.

Storage requirements:

• Store upright and refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light.
• Do not freeze.

Preparation techniques:

• The dressing procedure is carried out in four steps:
• Preparation of wound area
• Preparation of this product
• Application of this product
• Removal of this product

Preparation of wound area:

• Clean the wound thoroughly to get rid of any charred tissue, blisters, and any topical medications.
• For at least two hours, apply a dressing that has been dipped in an antibacterial solution to the treatment area.
• Make sure there are no traces of topical agent in the wound bed (e.g. silver sulfadiazine or povidone iodine).
• To create an ointment barrier, apply an ointment skin protectant (such as petrolatum) 2 to 3 cm outside of the treatment area.
• Skin protectant ointments or ointment gauze should be applied to any open wounds (such as laceration, abraded skin, and escharotomy incision) to avoid potential exposure of this product.
• Do not apply ointment directly to the treatment area, as that would prevent this product from making direct contact with the eschar.

Preparation of this product:

• Throughout the application, continue to manage pain as you would during a thorough dressing change for burn wounds. Make sure adequate pain management is in place to at least 15 minutes before applying this product.
• Within 15 minutes before the intended application, get the product ready at the patient's bedside.
• Aseptically combine the gel vehicle and lyophilized powder of this product as follows:
• Pour the lyophilized powder into the gel vehicle jar.
• Use a sterile tool (such as a tongue depressor or spatula) to thoroughly combine the lyophilized powder and gel vehicle until the mixture is uniform.
• The final concentration of the preparation is 8.8% w/w.
• If this preparation is not used within 15 minutes of preparation, it should be discarded because, after mixing, the product's enzymatic activity gradually declines.

Application of this product:

Apply the product within 15 minutes of preparation as follows:

• Spray sterile 0.9% sodium chloride irrigation onto the burn wound to moisten the treatment area.
• Apply a layer of the prepared product that is 3 mm thick (roughly the thickness of a tongue depressor) and completely covers the burn wound area over the moistened treatment area.
• Dress the treated wound with an occlusive sterile dressing.
• To ensure adhesion between the occlusive film dressing and the sterile ointment barrier and to achieve complete containment of treated area, gently press the occlusive film dressing at the area of contact with the ointment barrier. There should be no air visible beneath the occlusive film dressing, and gel should completely fill the treatment area.
• Use a sterile, loose, thick, fluffy dressing to dress the wound and secure it with a sterile bandage.
• For 4 hours, keep the dressing and product in place.
• Any unused product should be thrown away.

Removal of the product:

• After four hours, remove the product. Prior to removing this product, gather the required materials. All materials must be sterile.
• Use pain management techniques during the following removal procedure for extensive burn wound dressing change:
• Aseptically remove the occlusive film dressing.
• Remove the ointment barrier using a clean, blunt-edged tool.
• With a sterile blunt instrument, scrape away the dissolved eschar from the wound.
• Use a sizable piece of sterile dry gauze to thoroughly clean the wound then wipe it with a piece of sterile gauze that has been moistened with sterile 0.9% Sodium Chloride Irrigation.
• Rub the treated area until a clean dermis or subcutaneous tissues appears with pinpoint bleeding.
• Apply a dressing that has been soaked in an antibacterial solution for at least two hours to remove any traces of dissolved eschar.

A second application of this product may be applied 24 hours following the first application to either the same area previously treated with this product or to a new area.

Monitoring:
Monitor patients for signs of local or systemic allergics. If a hypersensitivity reaction occurs, remove this product from the treatment area and initiate appropriate therapy.

Patient advice:

• Patients should be informed about the risk of hypersensitivity reactions, including anaphylaxis.