information listed below). Medical Maggots™ (contained within a sealed plastic bag, completely interfere with the necessary close and frequent Medical Maggots™ should be used within 24 hours of receipt to contained within a second sealed plastic bag) to observation, or may delay definitive treatment ensure sterility and optimal viability. Do not use if ensure that the maggots do not escape. Dispose (i.e., surgery). Description and Natural History - the cap seal is broken or missing. This is a “single straight away.  Maggot therapy is not indicated as the primary use only” item. The vial is not designed for  Beware: Medical Maggots™ may try to escape treatment for infected bone or tendons. These Each vial of Medical Maggots contains two 2” x 2” multiple dosing, and the unused maggots should from the dressing, especially when they have structures usually require surgical and/or gauze pads, each seeded with approximately 300 not be applied to the same or another patient, for debrided all necrotic tissue or when they are antibiotic treatment as the primary therapy (with Phaenicia (=Lucilia) sericata (blow fly) eggs, from they may become contaminated with each opening satiated (finished eating). Medical Maggots™ or without adjunctive maggot therapy). which approximately 125 – 250 maggots per pad (250 of the product. Unused larvae are germ-free, and may escape through stretchable weave fabrics, or  Maggot therapy should never be used to treat – 500 per vial) will have hatched before the vial leaves may be discarded (after securing the lid) with pores larger than 200 microns. More likely, wounds which are not directly exposed to the our laboratory. Most of the Medical Maggots will routine non-infectious waste. “Used” maggots satiated larvae will squeeze between the skin and outside (for example, abscesses not incised and be in the gauze pad and difficult to see; think of this become contaminated by the patient’s wound, and the dressing (i.e., hydrocolloid pad) to make their drained). Deep wounds should not be allowed to dressing as “maggot-impregnated gauze.” To prevent must be handled as contaminated medical waste escape. This can usually be prevented by framing close (heal) over the Medical Maggots™. the larvae from crawling along the sides or top of the [see Disposal and Restrictions and Disclaimers]. the dressing with a transparent membrane  Use of Medical Maggots™ is contraindicated vial, each maggot-impregnated gauze pad has been dressing, partially covering the edges of the in patients whose circulatory integrity is placed within a small container. Simply unscrew or Warnings - polyester net and partly extending outwards, over compromised to the extent that the wound peel back the top of the container and remove the  Patients allergic to fly larvae, brewer's yeast, or the peripheral, peri-wound skin. This way, any ultimately has no chance of healing. In such maggot-impregnated gauze. Any maggots that crawled soy/whey proteins may manifest allergic larvae that manage to squeeze between the skin circumstances, maggot therapy is likely to and hydrocolloid will likely be trapped by the off the gauze can be wiped back onto the gauze as the reactions to Medical Maggots™ which are enlarge the wound as it is debrided, removing transparent membrane dressing (see Figure 1). gauze is withdrawn from the container. Use the prepared in such media. Special preparation and necrotic tissue and debris, but leaving the Escapes are most common after 48 hours, by amount of gauze needed to match the required dose media is available upon request. patient with a wound which will again succumb which time some of the larvae are mature and (5-8 larvae per cm sq): i.e., for half the maggots  Medical Maggots™ can cause discomfort or to advancing infection. When in doubt, it is ready to leave the host to pupate. Any dressings contained in the vial, use just half of the gauze. pain, particularly in patients with painful reasonable to provide a trial of maggot therapy, left on for more than 48 hours are at increased risk wounds. Maggot-associated pain or discomfort as long as everyone is prepared to close, protect for escapes, and should be well secured. P. sericata eggs are yellow, rice-shaped, 2 mm long. usually manifests at about 24-36 hours into or resect that wound, as needed, after treatment. After hatching, the egg shells will turn brown, soft, therapy, and increases as the larvae grow. If  Medical Maggots™ should not be used on more  Mild bleeding is common during maggot and ultimately dissolve. The newly hatched larvae are systemic analgesics do not control the pain, than one patient, nor allowed to wander away from debridement, and it is common that the wound 2 mm long, and translucent white. Young P. sericata remove the maggot dressing to achieve their host patient. Once they have been applied to drainage is blood-tinged. Patients with natural larvae feed upon necrotic tissue and wound fluids. The immediate pain relief. Do not apply local a patient, they must be considered as fomites. or pharmacologically induced coagulopathies maggots release their digestive enzymes into the local anesthetics (i.e.: lidocaine) to the wound while Escaping maggots have been known to upset the are at risk of significant bleeding during maggot environment, and ingest the liquefying and semi-solid hospital staff and/or patients. If not properly Medical Maggots™ are in place. therapy. Maggot therapy in such individuals, if tissue. As they grow, they molt twice. In nature, the disposed, escaped maggots could pupate and done at all, should be done under close maggots would leave their food source when satiated,  This product is for single-use only. Every batch mature to adult flies approx. two weeks later. of Medical Maggots™ is cultured during supervision. and burry themselves in a suitably protected area.  During the first application, and whenever production to ensure sterility; but  Maggot debridement of, or around, necrotic There they would pupate in relative safety. Adult flies problems with infection, pain or dressing integrity contamination can occur any time the vial is blood vessels may lead to life-threatening emerge (eclose) approximately 10-20 days later. are likely, the maggot dressings should be opened or the air-permeable filter is damaged. rupture of those blood vessels, and therefore it is Developmental times are temperature-dependent. inspected at least once daily until removed. Medical Maggots™ should not be used if the contraindicated. If maggot therapy is attempted,  See also Contraindications and Dosage and sterile seal is broken, if the filter is damaged, if the patient must receive close, continuous, Administration. Mechanisms of Action - the maggots have a strong offensive odor, or if intensive observation for bleeding, infection, or

Debridement results partly from the Medical they are known or suspected of being thrombosis. Maggots proteolytic digestive enzymes liquefying contaminated. The vial of Medical Maggots™ Contraindications -  Medical Maggots™ should not be given the necrotic tissue and partly from the physical action is not intended for multiple dosing.  Patients allergic to fly larvae, brewer's yeast, soy unlimited access to deep organs and tissues of the mouth hooks on the tissue, which pierce and  Wounds should never be allowed to close over bean or whey protein may manifest allergic when such access could disrupt important tear the necrotic tissue, allowing the digestive the maggots. reactions to Medical Maggots™, which are neurovascular structures or intact sterile enzymes to reach the depths of the necrotic tissue.  Patients with fever or changes in mental status prepared in such media. Patients allergic to the cavities. should be evaluated for spread of infection (i.e., other maggots dressing materials also may  Medical Maggots™ may not survive in Clinical Indications: bacteremia, cellulitis) or elevated serum manifest contact dermatitis or more serious patients (usually animals) receiving insecticides Medical Maggots and maggot debridement therapy ammonia levels. Maggot dressings may need to immunologic reactions. Patients with serious or insect-toxic drugs (MDT) are indicated for: debridement of non-healing be removed immediately to facilitate wound allergic reactions should not be treated with  Medical Maggots™ should not be introduced necrotic skin and soft-tissue wounds such as pressure inspection. Medical Maggots™, or should be treated in such into sterile body cavities; they are ulcers, neuropathic foot ulcers, chronic leg ulcers, or  Medical Maggots™ should not be allowed to a way as to avoid all contact with the offending contraindicated for use in eyes, upper non-healing traumatic or post-operative wounds. remain in the wound when they are dead; for antigens. If treatment is undertaken, then it should gastrointestinal tract, or respiratory tract. they may trigger an allergic response or may be done only with close attention and immediate  Pseudomonas aerugenosa wound infections Storage & Handling - become the nidus for further infection. access to care. may not be controlled by maggot therapy alone. Upon arrival, Medical Maggots™ should be  After use, handle Medical Maggots™ as you  Patients with acute, rapidly advancing, life- or Specific anti-pseudomonal therapy may be inspected for maggot activity; any problems must be would other infectious dressing waste. Used limb-threatening infections should not be treated needed before or during treatment with reported to the manufacturer immediately (contact maggot dressings should be double-bagged with maggot debridement dressings, as it may Medical Maggots™.

L-0801-01-01-MMGW3_Medical Maggots Package Insert_Rev C Dosage & Administration - How supplied - The recommended dose of Medical Maggots is 5- Open the vial and remove the maggot- Dressing removal. To remove the maggot cage Each vial contains two 2" x 2" maggot- 8/cm2 of wound surface; applied topically as maggot- impregnated gauze from its wrapper by dressings with minimal effort, loosen the maggot impregnated gauze pads, each in its own heat impregnated gauze. The maggots are very small and unscrewing or peeling back the lid from the tiny cage dressing from the patient’s skin, and then peel sealed container to keep the maggots from may be difficult to see; look for movement of little jar. Medical Maggots™ are intended to be used back the dressing with one hand while wiping up the wandering off during transport. Approximately black dots, which are their mouthhooks. Warming the with the gauze. Apply the amount of gauze needed maggots with a wet 4" x 4" gauze pad held in the 300 germ-free P. sericata eggs were placed on vial in an incubator (i.e., 37oC) will increase their to match the required dose of maggots (5-8 larvae other hand, sandwiching the maggots between the each pad, along with sterile soy- and/or whey- activity and make them easier to see. If no maggots per cm sq): i.e., for half the maggots contained in two hands. Discard the maggots as you do your other based protein. At least 125 Medical Maggots will are seen, they may have died during transport. Do not the vial, use just half of the gauze. potentially infectious dressing waste (i.e., discard in hatch from these eggs (total of at least 250 larvae use; call supplier immediately for refund or "red bag"), securely sealed to prevent escape. Seal in the vial). The specific (calculated) number of replacement instructions. Placement of the Maggots. Medical Maggots™ the bag within another bag, and seal the second bag. hatched larvae contained in the vial will be labeled are supplied as “maggot-impregnated gauze.” If Discard straight away. on the vial. Date of preparation is recorded on the Dressing application. Gently wash the wound of any you need half of the maggots in the vial (the dose vial as the “batch number” (YYYY-MM-DD). 2 residual medications, secretions or debris. Clean the is 5-8 larvae per cm of wound surface area), then Duration of therapy. The total number of cycles will peri-wound skin with a gentle skin cleaner, and take half the gauze; if you need one quarter of the depend upon the size and character of the wound, Restrictions and Disclaimers - maggots, then take one quarter of the gauze, and clinical response, and goals of therapy. Debridement protect the skin from wound drainage during Medical Maggots™ are provided for the sole place it on the wound surface. If the maggot- is usually completed in 1-6 cycles treatments with a polyurethane or similar skin purpose of patient care, as prescribed by the impregnated gauze does not cover the entire protectant. Do not use povidone iodine or other ordering physician. The recipient is not authorized wound, you may add additional sterile, water- or Disposal - potential skin irritants. nor licensed to rear, breed, re-sell, or redistribute saline-moistened gauze over the wound. A little After use, handle and discard Medical Maggots™ these larvae or their progeny without specific loose gauze will provide the larvae with more and their dressings as you do your other infectious You will want to contain the maggots with a mesh permission. Unused larvae must be destroyed and surface area for the maggots to crawl on, but do dressing waste (ie, discard in "red bags" destined for dressing that permits air to reach the larvae, and not allowed to mature. not tightly pack the wound. autoclaving or incineration). To prevent escape, seal facilitates drainage of maggot secretions and patient exudates out from the wound (that is, a pore size of the bag securely, and seal that bag within a second, sealed waste bag [see also Dosage and Practitioners outside the Continental United States 100-160u). Examples include Creature Comforts™, After the Medical Maggots™ have been require valid import permits by their local applied, cage them on the wound, using a mesh Administration - Dressing removal]. Unused larvae LeFlap™ or LeSoc™ (for non-planar surfaces like must be destroyed in a similar fashion, or they may Departments of Agriculture before ordering or fabric (i.e., Creature ComfortsTM or LeSoc™ heels, toes, and amputation stumps), by Monarch be returned to the original vial and tightly sealed; accepting Medical Maggots. Practitioners in Labs. Alternatively, some people find nylon stockings by Monarch Labs). Then cover the mesh and they should not be allowed to mature. The recipient is Europe should contact one of the European to be a reasonable alternative (although they have a dressing loosely with a breathable absorbent pad not authorized nor licensed to breed, re-sell, or commercial suppliers, listed on our internet site. larger pore size and stretchable weave, allowing the (i.e., two ply of cotton gauze). For added security redistribute Medical Maggots™ without specific smallest maggots to escape before they start growing). (especially in areas likely to perspire, become permission [see Restrictions and Disclaimers]. Medical Maggots™ will be replaced or refunded soiled, or loosen due to skin movement), frame the if contaminated or if not viable upon arrival. No dressing with a transparent semi-permeable Overdosage - warranty is made or implied regarding their long- membrane dressing, with about 1 cm over the Large maggot burdens in blow fly infested sheep term viability, therapeutic efficacy or safety for dressing and the remainder of the membrane over (>60,000 maggots per animal) are associated with any specific patient. the skin. Remember: transparent “semi- serious complications (“blow fly strike” including permeable” dressings are not permeable enough to elevated serum ammonia levels (presumably due to Report problems or adverse events to the provide air to the maggots. Do not cover the the large protein breakdown in the wound), and manufacturer (949-679-3000), supplier, or FDA, central mesh area with transparent membrane encephalopathy. Elevated serum ammonia levels immediately. Report forms can be found at: dressings or any other dressing besides a and/or hepatic encephalopathy may occur in humans, www.MonarchLabs.com/ae-report.pdf breathable loose absorbent gauze-like dressing especially those with a predisposition to such because the maggots may suffocate. (hepatitis or hepatic insufficiency) and should be Inquiries and Orders - sought in patients who develop fevers or altered Medical Maggots™ are produced and distributed Change the top absorbent pad every 4 - 8 hours mental states while receiving maggot therapy. per specifications of Ronald Sherman, by: and whenever it becomes soiled. If it is not wet Furthermore, patients should not be treated with more after 8 hours, the wound and maggots may be too than 3,000 larvae at a time. Figure 1. Multi-layered dressing sample. dry. Moisten the wound through the mesh with a Monarch Labs little sterile irrigation fluid (water or saline). Many It has been suggested that too many maggots within a 17875 Sky Park Circle, Ste K; Irvine, CA 92614 In order to minimize skin trauma with strong tapes or therapists do this routinely with each dressing rigid dressing --- especially in an insensate wound --- Phone: (949) 679-3000 ~ Fax: (949) 679-3001 glues or other tacky materials, the mesh can be affixed change. Leave the maggot containment dressings could cause increased pressure on the wound as the e-mail: [email protected] to a hydrocolloid pad with a central hole cut out to in place for about 48 hours. If left longer than 48 maggots grow. This could lead to further ischemia www.MonarchLabs.com match the wound margins. This multi-layered maggot hours, the risk of maggots escaping increases. and necrosis of the wound, leading to further dressing is shown in Figure 1, and a detailed Beware: Escaping maggots may upset the staff, debridement and growth of the maggots, leading to description of dressing designs can be found in Plast patients, and/or hospital administrators. more pressure still. Although never reported, this Reconstr Surg 1997; 100: 451-6; and Arch Dermatol scenario must be considered when building cage- 1996;132: 254-256. dressings.

L-0801-01-01-MMGW3_Medical Maggots Package Insert_Rev C