Product features: Prontosan Wound Gel X Instructions for use for cleaning, moisturizing and decontaminating acute, chronic and infected skin wounds and burns. 1. Introduction: Chronic skin wounds are often covered with scabs, necrotic tissue, and/or a biofilm. These coatings are difficult to remove and lead to delayed wound healing. Proper wound cleansing is therefore extremely important. Using Prontosan Wound Gel X enables long-term cleansing and decontamination of the wound between dressing changes. Since acute wounds are generally contaminated with residues and microorganisms, they also require thorough cleansing. These contaminants can hinder the normal wound healing process and lead to complications such as infection. For acute traumatic wounds that require sutures, Prontosan Wound Gel X is applied after surgical treatment and suture placement. Thanks to its unique combination of ingredients (the antimicrobial substance polihexanide and the surfactant betaine), the Prontosan wound irrigation solution is ideally suited to prevent biofilm formation. 2. Product profile and application areas: For cleaning, humidifying and decontaminating: acute infected and non-infected wounds: traumatic wounds (such as lacerations, abrasions or puncture wounds - if suture closure is indicated, Prontosan Wound Gel X should only be used after the surgical procedure). chronic infected and non-infected wounds (including complex, therapy-resistant wounds, wound pockets, and hard-to-reach wounds). postoperative wounds. Burns (1st to 4th degree) caused by heat, chemical substances and after radiation therapy. Frostbite. 3. General application: For optimal results, Prontosan Wound Irrigation Solution should be used to clean the wound and surrounding skin before applying Prontosan Wound Gel X. Apply a generous amount of Prontosan Wound Gel X to the wound bed. Fill any cavities and pockets with Prontosan Wound Gel. Wound dressings, gauze pads, compresses, or other absorbent materials can be moistened with Prontosan Wound Gel X before applying the dressing. Prontosan Wound Gel X can remain on the wound until the next dressing change. Different amounts of Prontosan Wound Gel X are applied depending on the frequency of dressing changes. The wound surface should be kept continuously moist to ensure adequate cleansing and disinfection. Debris is gently loosened and removed with the next dressing change. Application should be frequent enough to ensure that all debris and necrotic residue are easily removed and the wound bed is optimally prepared. Prontosan Wound Gel X should not remain on the wound for more than 30 consecutive days. 4. Tissue compatibility and biological compatibility: Dermatologically tested and classified as non-irritating and well-tolerated. Painless application. Does not inhibit granulation and epithelialization. 5. Side effects: In very rare cases, a slight burning sensation may occur after applying Prontosan, but this usually disappears after a few minutes. Prontosan can cause allergic reactions such as itching (urticaria) and skin rashes (exanthema). Very rarely (affecting less than 1 in 10,000 patients), anaphylactic shock reactions have been reported after using Prontosan products. 6. Contraindications: Prontosan should not be used: in case of known allergies or suspected allergy to any of the products ingredients. in the central nervous system or in the meninges. in the middle or inner ear. in the eye. on hyaline cartilage and in aseptic joint surgery. Should Prontosan come into contact with aseptic cartilage, immediate irrigation with Ringers solution or isotonic saline solution is necessary. in combination with anionic surfactants. along with cleansing soaps, ointments, oils, enzymes, etc. These substances must be carefully removed from the wound before application. 7. Limitations of use: Pregnancy and breastfeeding: There is no evidence of mutagenicity or embryotoxicity associated with the components of this product. Since polihexanide is not systemically reabsorbed, transfer into breast milk is unlikely. Due to a lack of relevant clinical trials and clinical experience in pregnant and breastfeeding women, Prontosan Wound Gel X should only be used in these individuals after careful medical consultation. Newborns and infants: Due to a lack of clinical data, Prontosan Wound Gel X should only be used in newborns and infants in selected cases and under close medical supervision. 8. General safety instructions: For external use only. Do not use for injection or infusion. Do not ingest. Do not use the contents of damaged tubes. Protect bottles from direct sunlight. Keep out of reach of children. 9. Summary/Technical Specifications: Prontosan Wound Gel X contains preservatives and provides a long-lasting antimicrobial barrier. To prevent contamination, the tube should be closed immediately after use. During application, the tube opening should be protected from contamination. Tubes that have come into direct contact with the wound or have been contaminated in any other way should be discarded. Composition: Purified water, glycerol, hydroxyethylcellulose, betaine surfactant, 0.1% polyaminopropyl biguanide (polihexanide). Tubes are intended for use on a single patient only. Appearance and smell: clear, colourless and almost odorless aqueous gel. Durability: 24 months. Store at room temperature. Shelf life after opening: 8 weeks. Authenticity seal: The product is no longer sterile after the first opening. This leaflet was last revised in November 2013. Source: Information from the package insert As of June 2020