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PRODUCT INFORMATION
NOTES
1. Prior to the liquid bandage application on continuously non-healing wounds, thorough cleaning of a wound surface is required with maximum removal of devitalized tissues.
The skin around a wound should be treated with the alcohol solution of chlorhexidine or any other antiseptic and then the skin should be dried.
Hyperkeratotic growth should be removed with the help of a scalpel. Wound surface as well as callous sides should be moistened with normal saline solution prior to the bandage application.
2. LOKUS Liquid Bandage should not be applied on wounds with plethorically pyorrhea and with symptoms of pseudomonas and anaerobic infection before its treatment.
3. In the case of liquid bandage application on septic wounds, daily medical monitoring is required. If the bandage comes off from a wound surface and there is a wound secretion flowing from it, the bandage should be replaced.
The LOKUS Liquid Bandage will peel itself once the bandage has absorbed the maximum liquid holding capacity. In case the bandage needs to be removed, it should be done by slow separation from the edge of the healthy skin from any side.
The bandage will separate from the wound with minimum discomfort. Cleaning of a wound should be carried out periodically by treating it with antiseptic or ointment of a water-soluble base and then reapply LOKUS Liquid Bandage.
If the bandage does not come off from the wound and there is no wound secretion and no dermahemia around, the bandage will stay on a wound surface up to 5 days until self-separation.
4. In the case of trophic ulcers that has developed against chronic venous insufficiency, in order to lessen possible pain reaction, especially at first bandage application, the ulcer surface should be treated with 10% lidocaine solution.
5. LOKUS Liquid Bandage can be recommended for patients with singes of II and IIIA type, continuously non-healing wounds and trophic ulcers of any etiology, bedsores, donor wounds, for prophylaxis of inflammatory complications of soft tissues around wires for skeletal extension, skin protection around fistula of gastrointestinal tract, fixing of drainages and catheters.
(according to dissertation materials for inaugural dissertation of M.D. A.A.Kuranov, 2005)
SAFETY DATA FOR POLYOL COMPONENT PART A IN CASE OF ACCIDENTAL CONTACT (BEFORE MIXING)
1. This product is not hazardous as per the Globally Harmonized System of Classification and Labelling (GHS).
2. Composition: Glycerol, propylene oxide, ethylene oxide polymer.
3. First Aid Measures:
Inhalation: Move person to fresh air; if effects occur, consult a physician.
Skin Contact: Wash off with plenty of water.
Eye Contact: Flush eyes thoroughly with water for several minutes. Remove contact lenses after the initial 1 – 2 minutes and continue flushing for several additional minutes. If effects occur, consult a physician, preferably an ophthalmologist.
Ingestion: If swallowed, seek medical attention. Do not induce vomiting unless directed to do so by medical personnel.
Notes to Physician: if burn is present, treat as any thermal burn, after decontamination. No specific antidote. Treatment of exposure should be directed at the control of symptoms and the clinical condition of the patient.
4. Toxicological Information:
Oral Toxicity: Low toxicity if swallowed. Small amounts swallowed incidentally as a result of normal handling operations are not likely to cause injury; however, swallowing larger amounts may cause injury.
Dermal Toxicity: Prolonged skin contact is unlikely to result in absorption of harmful amounts.
Inhalation Toxicity: at room temperature, exposure to vapor is minimal due to low volatility; single exposure is not likely to be hazardous. Vapor from heated material or mist may cause respiratory irritation. For narcotic effects: No relevant data found.
Skin Corrosion/Irritation: Prolonged exposure not likely to cause significant skin irritation. May cause more severe response if skin is abraded (scratched or cut). Material may be handled at elevated temperatures; contact with heated material may cause thermal burns.
Eye irritation: May cause slight temporary eye irritation. May cause slight temporary corneal injury.
Sensitization: For this family of materials, sensitization studies done in guinea pigs have been negative.
For respiratory Sensitization: No relevant data found.
SAFETY DATA FOR MDI PREPOLYMER BASED COMPONENT PART B IN CASE OF ACCIDENTAL CONTACT (BEFORE MIXING)
1. Composition: Diphenylmethanediisocyanate
2. First Aid Measures:
If inhaled: Call a physician or poison control center immediately. If unconscious, place in recovery position and seek medical advice.
In case of skin contact: If on skin, rinse well with water.
In case of eye contact: Flush eyes with water as a precaution. Remove contact lenses. Protect unharmed eye. Keep eye wide open while rinsing. If eye irritation persists, consult a specialist.
If swallowed: Keep the respiratory tract clear. Do not give milk or alcoholic beverages. Never give anything by mouth to an unconscious person. If symptoms persist, call a physician.
Most important symptoms and effects, both acute and delayed: None known.Toxicological information:Information on likely routes of exposure: None known
3. Toxicological information:
Information on likely routes of exposure: None known
COMPOSITION AND BASIC PROPERTIES
If inhaled: Call a physician or poison control center immediately. If unconscious, place in recovery position and seek medical advice.
The sachet contains one section of polyol component (15 ml) and another section of MDI Prepolymer Based component (5 ml).
After vigorous mixing, a foamed mass will be formed with mild heat around 42 degrees Celsius which cools down rapidly upon application on a wound and forms into a polyurethane foam with a total foam volume per sachet of about 150cm³.
The bandage is non-toxic, and self-aseptic (non – medicated) in the process of preparation and adheres to dry healthy skin.
The bandage’s thick, elastic and spongy consistency provides wound protection against secondary traumatization and infection.
LOKUS Liquid Bandage enhances moderate pain-relieving effect (non – medicated) and also provides long-term absorption of any wound secretion up until it’s saturation.
It has a fine air permeability and moisture-proof properties, making gas composition on a wound optimal for healing.
LOKUS Liquid Bandage does not stick to a moist wound surface, allowing painless bandaging without damage to epithelium and granulation upon its removal.
APPLY TO
Continuously non-healing and granulating wounds
Trophic ulcers
Bedsores
Donor and degloving injuries
To protect skin and as a prophylaxis of osteomyelitis on sites of wires introduction for skeletal extension
To protect skin at fistulas of the gastrointestinal tract
To strengthen drainage on body skin and etc.
RELATIVE CONTRAINDICATIONS
(Pre-treat before applying Lokus bandage)
Suppurative Inflammations; remove exudates & treat inflammations.
Arterial & Venous bleeding; apply pressure or use a topical hemostatic agent to stop bleeding.
Pseudomonas Aeruginosa Infections; perform drainage, debridement and treat with topical antibiotics if applicable.
Necrotic Wounds; perform debridement and treat with an antimicrobial agent if applicable.
Sensitivity/intolerance to Lokus bandage; consult the doctor first.
SIDE EFFECTS
Short term painful sensations may occur on burn wounds. Pre-treats with a local anesthetic to ease the pain.
SPECIAL INDICATIONS
LOKUS Liquid Bandage cannot be applied on the face in the area of nose, lips, eyes.
It is recommended to remove hair around a wound prior to applying LOKUS Liquid Bandage.
Do not fix used LOKUS Liquid bandage to a wound with adhesive plaster, bandage, etc.
SAFETY MEASURES
Do not touch LOKUS Liquid Bandage applied on a wound until it cools down (4 – 6 minutes)
In case some LOKUS components fall on skin surface, swab out the fall off surface with ethyl alcohol and wash thoroughly with warm water and soap.
METHOD OF APPLICATIONS
For external use ONLY
PHARMACEUTICAL FORM
Double sachet bag of laminated aluminium film
SHELF LIFE
30 months from the date of manufacture
GENERAL NOTES
The bandage will solidified in around 4 – 6 minutes and it does not need additional fixation on the wound in most cases.
The bandage will stay on the wound up to 5 days depending on the amount of wound exudates absorbed into Lokus bandage.
The bandage will peel off itself once bandage fully absorbed the exudates. Use warm water if necessary to remove easily and painlessly and for any remaining bandage.e use.
