Product features:

Prontosan - Wound irrigation solution

Instructions for use for cleaning, rinsing and moisturizing acute, chronic and infected skin wounds, first and second degree burns

1. Introduction:
Chronic skin wounds are often covered with scabs, necrotic tissue, and/or a biofilm. These deposits are difficult to remove and lead to delayed wound healing. Prontosan wound irrigation solution, with its cleansing action, can eliminate these obstacles to wound healing. 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. Thanks to its unique combination of ingredients (the antimicrobial substance polihexanide and the surfactant betaine), Prontosan wound irrigation solution is ideally suited to prevent biofilm formation.

2. Product profile and application areas:
For cleaning, rinsing, and moistening:

• acute infected and non-infected wounds: traumatic wounds such as skin lacerations, bite wounds, cuts and contusions, postoperative wounds.
• Chronic infected and non-infected wounds: Pressure ulcers%%% Arterial – venous ulcers%%% Diabetic ulcers.
• Thermal and chemical wounds: First and second degree burns, chemical burns of the integument.
• Radiation ulcers.
• Fistulas and abscesses.
• Entry points for urological catheters, PEG&ndash%%%/PEJ&ndash%%% probes or drainage tubes.
• peristomal skin areas.

For intraoperative cleaning and irrigation of wounds. For instillation in combination with negative pressure wound therapy. For moistening crusted wound dressings and bandages before their removal.

3. General application:
Prontosan Wound Irrigation Solution (see separate product information) is intended for cleaning wounds prior to treatment with Prontosan Wound Gel or Prontosan Wound Gel X. Prontosan Wound Irrigation Solution can be used to soak compresses, gauze strips, or swabs for the cleaning process. Frequent application is recommended to achieve and maintain a visibly clean wound. Prontosan Wound Irrigation Solution can be warmed to body temperature before use. Often, wound dressings and bandages become crusted and adhere to the wound surface. Removing these dressings can damage the wound bed, which in turn delays wound healing. If dressings and bandages are difficult to remove due to crusting, they should be soaked with Prontosan Wound Irrigation Solution until they can be easily removed.

4. Wound cleaning:
The entire wound, including the surrounding area, should be thoroughly cleaned with Prontosan wound irrigation solution. For minor and acute wounds, rinsing is sufficient. For large wounds and wounds that are difficult to access, it is recommended to moisten the affected area with a compress soaked in Prontosan wound irrigation solution for at least 15 minutes. The solution should be used undiluted.

5. Tissue compatibility and biological compatibility:
Dermatologically tested and classified as non-irritating and well-tolerated. Painless application. Does not inhibit granulation or epithelialization.

6. 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).

7. Contraindications:
Prontosan should not be used:

• in case of known allergies or suspected allergy to any of the product's 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 Ringer's 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.
• for peritoneal lavage or irrigation.

8. 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 studies and clinical experience in pregnant and breastfeeding women, Prontosan wound irrigation solution should only be used in these individuals after careful medical consultation.

9. 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.

10. Summary/Technical Specifications:
Prontosan wound irrigation solution contains preservatives and can be used for 8 weeks after opening. To prevent contamination, the bottle should be closed immediately after use. The bottle neck should be protected from contamination during use. Bottles that have come into direct contact with the wound or have been contaminated in any other way must be discarded.

Composition:
Purified water, betaine surfactant, 0.1% polyaminopropyl biguanide (polihexanide).

Appearance and smell:
Clear, colourless and almost odorless aqueous solution.

Durability:
See expiry date (use by). Store at room temperature.

Originality:
Sterile: Sealing ring guarantees authenticity. Ampoules: For single use only.

This leaflet was last revised in April 2018.

Source: Information from the package insert
As of June 2020