PANAFIL Spray is an enzymatic healing-debriding spray which contains papain, USP (not less than 405,900 units of activity based on Lot IOC389 per gram of spray); urea, USP 10%; and chlorophyllin copper complex sodium, USP 0.5% in a base composed of anhydrous lactose, cetearyl alcohol & ceteth-20 phosphate & dicetyl phosphate, glycerin, methylparaben, mineral oil, propylparaben, purified water and sodium hydroxide.
Papain, the proteolytic enzyme derived from the fruit of carica papaya, is a potent digestant of nonviable protein matter, but is harmless to viable tissue. It has the unique advantage of being active over a wide pH range, 3 to 12. Despite its recognized value as a digestive agent, papain is relatively ineffective when used alone as a debriding agent, primarily because it requires the presence of activators to exert its digestive function. Urea is combined with papain to provide two supplementary chemical actions: (1) to expose by solvent action the activators of papain (sulfhydryl groups) which are always present, but not necessarily accessible, in the nonviable tissue or debris of lesions, and (2) to denature the nonviable protein matter in lesions and thereby render it more susceptible to enzymatic digestion. In pharmacologic studies involving digestion of beef powder, Miller 1 showed that the combination of papain and urea produced twice as much digestion as papain alone. Chlorophyllin Copper Complex Sodium adds healing action to the cleansing action of the proteolytic papain-urea combination. The basic wound-healing properties of Chlorophyllin Copper Complex Sodium are promotion of healthy granulations, control of local inflammation and reduction of wound odors. 2 Specifically, Chlorophyllin Copper Complex sodium inhibits the hemagglutinating and inflammatory properties of protein degradation products in the wound, including the products of enzymatic digestion, thus providing an additional protective factor. 1,3 The incorporation of Chlorophyllin Copper Complex Sodium in PANAFIL Spray permits its continuous use for as long as desired to help produce and then maintain a clean wound base and to promote healing.
PANAFIL Spray is suggested for treatment of acute and chronic lesions such as varicose, diabetic and decubitus ulcers, burns, postoperative wounds, pilonidal cyst wounds, carbuncles and miscellaneous traumatic or infected wounds.
PANAFIL Spray is applied continuously throughout treatment of these conditions (1) for enzymatic debridement of necrotic tissue and liquefaction of fibrinous, purulent debris, (2) to keep the wound clean, and simultaneously (3) to promote normal healing.
Do not use if you are allergic to or have known or suspected hypersensitivity to any ingredient in this product.
See Dosage and Administration . Not to be used in eyes.
PANAFIL Spray is generally well tolerated and nonirritating. A small percentage of patients may experience a transient "burning" sensation on application of the spray. Occasionally, the profuse exudate resulting from enzymatic digestion may cause irritation. In such cases, more frequent changes of dressings until exudate diminishes will alleviate discomfort.
Cleanse the wound with ALLCLENZ® Wound Cleanser or saline. Avoid cleansing with hydrogen peroxide solution as it may inactivate the papain. Note: Papain may also be inactivated by the salts of heavy metals such as lead, silver and mercury. Contact with medications containing these metals should be avoided. In accordance with good wound care practices, protect the periwound with a skin protectant of choice to prevent and/or reduce maceration and irritation due to drainage from the wound. When practicable, daily or twice daily changes of dressings are preferred. Longer intervals between redressings (two or three days) have proved satisfactory, and PANAFIL Spray may be applied under pressure dressings.
Shake well before use.
Prime Container: Upon initial use only, the user will need to prime the non-aerosol PANAFIL Spray pump. Begin first time use by holding PANAFIL Spray upright directly over the wound, and prime the pump 8-12 times.
Once the pump has been primed, hold the PANAFIL Spray bottle approximately 1[Prime ]-2[Prime ] from the wound and use even, firm, and consistent pressure to dispense product. When sprayed from the appropriate distance of 1[Prime ]-2[Prime ], the spray should appear in a nickel-sized diameter.
Completely cover the wound site with the PANAFIL Spray. The wound should not be visible under the product. Cover wound with appropriate dressing of choice (saline-moistened gauze or semi-occlusive dressing are appropriate), and secure into place.
PANAFIL Spray is designed to be used at an angle; however, as the product is dispensed, it may be necessary to hold the bottle in an upright position to achieve a full pump. Wipe nozzle with clean gauze after each use.
33 mL spray bottle. Store upright at controlled room temperature 20-25°C (68-77°F).
Rx ONLY
Marketed by:
HEALTHPOINT®
Healthpoint, Ltd.
Fort Worth, Texas 76107
1-800-441-8227:
www.healthpoint.com
Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215
REORDER NO. 0064-3510-33 (33 mL spray)
128157-1204
PANAFIL is a registered trademark of Healthpoint, Ltd.
ALLCLENZ is a registered trademark of Healthpoint, Ltd.
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