Product features: Prontosan wound gel Instructions for use for cleaning, moisturizing and decontaminating acute, chronic and infected skin wounds and first and second degree burns. 1. Introduction: Chronic skin wounds are often covered with scabs, necrotic tissue, and/or biofilm. These deposits are difficult to remove and lead to delayed wound healing. Proper wound cleansing is therefore extremely important. Using Prontosan Wound Gel 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 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: For acute infected and non-infected wounds: traumatic wounds such as lacerations, abrasions or puncture wounds (if suture closure is indicated, Prontosan Wound Gel should be used after the surgical procedure.) Chronic infected and non-infected wounds (especially hard-to-reach wounds with pocket formation), including arterial and venous ulcers, diabetic ulcers, pressure ulcers postoperative wounds. Burns (1st and 2nd degree) caused by heat, chemical substances and after radiation therapy. 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. Apply a generous amount of Prontosan Wound Gel 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 before applying the dressing. Prontosan Wound Gel can remain on the wound until the next dressing change. Different amounts of Prontosan Wound Gel are applied depending on the frequency of dressing changes. The wound surface should be kept continuously moist to ensure adequate cleaning 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. 4. Tissue compatibility and biological compatibility: Dermatologically tested and classified as non-irritating and well-tolerated. Painless application. Does not inhibit granulation or 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). Anaphylactic shock reactions have been reported very rarely (affecting less than 1 in 10,000 patients). 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 there is no systemic reabsorption of polihexanide, transfer into breast milk is unlikely. Due to the lack of relevant clinical trials and clinical experience in pregnant and breastfeeding women, Prontosan Wound Gel should only be used in these individuals after careful medical consultation. Newborns and infants: Due to a lack of clinical data, Prontosan wound gel 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 contents of damaged bottles. Protect bottles from direct sunlight. Keep out of reach of children. 9. Summary/Technical Specifications: Prontosan wound gel contains preservatives and can be used for 8 weeks after opening. To prevent contamination, the bottle should be closed immediately after use. The bottle opening should be protected from contamination during application. Bottles 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, 0.1% betaine surfactant, 0.1% polyaminopropyl biguanide (polihexanide). Appearance and smell: Clear, colourless and almost odorless aqueous gel. Durability: See expiry date (use by). Store at room temperature. Originality: Sterile: Sealing ring as a guarantee of authenticity. Ampoules: For single use only. This patient information leaflet was last revised in November 2013. Source: Information from the package insert As of June 2020