PRONTOSAN W Wound Irrigation Solution 350 ml

Prontosan - Wound Irrigation Solution

Instructions for use for cleaning, rinsing, and moisturizing 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. Prontosan Wound Irrigation Solution's cleansing action can eliminate these obstacles to wound healing. Furthermore, since acute wounds are generally contaminated with residues and microorganisms, they require thorough cleaning. These contaminants can hinder the normal wound healing process and lead to complications such as infection. Due to the unique combination of ingredients (i.e., the antimicrobial substance polihexanide and the surfactant betaine), Prontosan Wound Irrigation Solution is ideally suited to prevent biofilm formation.

2. Product Profile and Areas of Application:
For cleaning, rinsing, and moisturizing:

• 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, arteriovenous ulcers, diabetic ulcers.
• Thermal and chemical wounds: first and second degree burns, chemical burns of the integumentum.
• Radiation ulcers.
• Fistulas and abscesses.
• Entry points for urological catheters, PEG/PEJ tubes 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 dressings and bandages before their removal.

3. General use:
Prontosan Wound Irrigation Solution (see separate product information) is intended for cleaning wounds before treatment with Prontosan Wound Gel or Prontosan Wound Gel X. Prontosan Wound Irrigation Solution can be used to saturate 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, 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 cleansing:
The entire wound, including the surrounding area, should be thoroughly cleaned with Prontosan wound irrigation solution. Rinsing is sufficient for minor and acute wounds. 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 applied undiluted.

5. Tissue compatibility and biocompatibility:
Dermatologically tested and classified as non-irritating and well-tolerated. Painless application. Does not inhibit granulation and 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). Very rarely (affecting less than 1 in 10,000 patients), anaphylactic shock reactions have been reported.

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. Restrictions on 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 Information:
For external use only. Do not use for injection or infusion. Do not ingest. Do not use the contents of damaged bottles. Protect bottles from direct sunlight. Keep out of reach of children.

10. Summary/Technical Information:
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. During use, the bottle neck should be protected from contamination. 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 odor:
Clear, colorless, and virtually odorless aqueous solution.

Shelf life:
See expiry date (EXP). Store at room temperature.

Tamper-evident:
Sterile: Sealing ring as a guarantee of tamper-evident packaging. Ampoules: For single use only.

Source: Package insert information.
Version: 01/2026

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.

PRONTOSAN W Wound Irrigation Solution 350 ml