Tissue adhesive for external use and for the application in the oral cavity and at the external genital area. For the application to fresh lacerations, abrasions and surgical incisions and also for protection/closure after removal of skin lesions (nevi, warts, moles, senile freckles and many other more). For the closure of wounds after careful adaption of the wound edges, as a suture substitute, for additional suture support and for protection of infections after sutures
·INSTRUCTIONS FOR USE
1. Wait until the wound stops bleeding. Remove possible foreign bodies from the wound..
2.Clean the area around the wound with alcohol. Do not apply any creams or ointments..
3. Adapt the wound edges and apply a thin layer of EPIGLU®
4.The wound edges might also be fixated with EPIGLU® initially. EPIGLU® sets very quickly.
5. The first layer of adhesive on the wound polymerizes in approximately 10 seconds. The solution should be applied in several thin layers. Allow each layer to set.
6. Aplicar una segunda capa más extensa sin excesos e incluyendo los bordes sanos y esperar 2-3 minutos hasta que endurezca. Si es necesaria una tercera capa puede seguir el mismo procedimiento.
· SOME INDICATIONS
– Epiglu is an antiseptic product and it is not recommended to apply Betadine or similar, as mix of those products may reduce efficiency..
– It is recommended to cover the wound with a dressing if it’s a big or chafing area once Epiglu is totally polymerised (5 min.)
-Once the wound is closed, the patient can immediately resume the daily personal hygiene. The treated area must be cleaned carefully and avoid rubbing because it can cause a realease of Epiglu. Patient can moist wound but needs to avoid bath.
– After 5 / 10 days with the formation of new skin lamellae EPIGLU® detaches itself from the skin like scabI. So, there is no need to visit the doctor..
· APPLICATION IN SINGLE DOSE
|Hold the base of the applicator and the top turn on itself to open. Be aware not to break the pipette.||Prepare the area and drop a few drops of the product over the wound||Spread a thin layer of product on the surface with top disposed above|
|Open application set which contains a palette and an applicator.|
|Place the desired quantity of the product in the palette.|
|Moist the applicator pippette. It is an easy, quick and accurated way to apply the product.
Successive layers can be applied in the same way.
·TUBE APPLICATION (ALTERNATIVE)
|Cut the pippette with a cutter||Place the pippette in the tube||Apply direcetly from the tube|
Do not use on infected, inflamed or extensive (e.g. abraded) wounds or on wounds from bites. Do not use to close wounds of inner organs, the brain surface or the central or peripherical nervous system for EPIGLU is not absorbable. An application to these areas might damage the tissue and the subsequent scarring may cause complications. The application to the intima and media of blood vessels should be avoided, because vascular thrombosis and damage of the vascular wall may occur. In case of a hypersensitivity to one of the ingredients EPIGLU is contraindicated.
Adheres skin and eyelids within seconds. Avoid any contact with eyes and eyelids! EPIGLU® must not come in contact with the eyeball or conjunctival sac. Apply to external wounds, the oral mucosa and external genital area only. Ensure the exact adaption of wound edges prior to application. Keep surfaces to be adhered as dry and free of grease as possible. Liquid or pasty agents must not be applied before adhering. Do not drip EPIGLU® into the depth of the wound, but apply in thin layers to skin surface. Apply to fresh and clean wounds only (not older than 6 hours). Do not use on contaminated or inflamed wounds. Do not inhale fumes! Do not apply EPIGLU® to the breasts during lactation period.
Hint: The vapours which arise during the polymerization of the adhesive may irritate the conjunctiva of the eye and the mucous membrane of the nose. Therefore, we recommend to protect the patient’s eyes and nose with moistened cotton wool when wounds in the face are closed.
If EPIGLU is improperly or too thickly applied thermal tissue damage may occur due to the polymerization process. An extensive, too concentrated layer prevents the healing of connective tissue. Allergic reactions were not observed so far. Local tolerance is excellent if the product is used according to the instructions. Should EPIGLU unintentionally come in contact with healthy skin and polymerize it will detach itself after a while without damaging the skin.
Pay attention to the terms of storage on the package and on the tubes. The expiry date is printed on the tube as well as on the outer package. Do not use EPIGLU® after this date! Discontinue use of the opened tube if the solution does not drip from the tube in a clear watery consistency any longer. The material has then started to polymerize and an exact adaption is no longer possible. The adhesive must not be used any longer. Store EPIGLU® protected from light in the deep freezer (-18°C) or refrigerator (+6°C). Store opened tubes vertically. The mentioned maximum shelf life can only be guaranteed if stored in the deep freezer (-18°C). EPIGLU® can be used immediately after removal from the deep freezer because it does not freeze into a solid block. If EPIGLU® is used several times a day, e.g. in emergency rooms, it is not necessary to store the adhesive in the deep freezer between the applications..