PRONTOSAN Wound Gel X, Wound prevent infection, reduce healing time

Dosage form:

tube

PRONTOSAN Wound Gel X benefits:

• Removes and helps prevent the reformation of biofilm.
• Helps prevent infection.
• Helps reduce healing time.
• Facilitates gentle dressing replacements.
• Is compatible with commonly used wound dressings.

Prontosan Wound Gel X

Instructions for use for the cleansing, moisturizing, and decontamination of acute, chronic, and infected skin wounds and 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. The application of 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 suturing, Prontosan Wound Gel X is applied after surgical treatment and suture placement. Due to its unique combination of ingredients (i.e., the antimicrobial substance polihexanide and the surfactant betaine), Prontosan wound irrigation solution is ideal for preventing biofilm formation.

2. Product profile and areas of application:
For cleaning, moisturizing, and decontamination of:

• 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, difficult-to-access wounds).
• postoperative wounds.
• burns (1st to 4th degree) caused by heat, chemical substances and after radiotherapy.
• Frostbite.

3. General use:
For optimal results, Prontosan Wound Irrigation Solution should be used to cleanse the wound and surrounding skin before applying Prontosan Wound Gel X. Prontosan Wound Gel X should be applied liberally to the wound bed. Cavities and pockets should be filled with Prontosan Wound Gel. Wound dressings, gauze strips, compresses or other absorbent materials can be moistened with Prontosan Wound Gel X before applying the dressing. Prontosan Wound Gel X can be left 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 lifted and removed with the next dressing change. The application should be frequent enough so that all deposits and necrotic residues can be easily removed and the wound bed is optimally prepared. Prontosan Wound Gel X should not be left on the wound for more than 30 consecutive days.

4. Tissue compatibility and biological compatibility:
Dermatologically tested and found to be non-irritating and well-tolerated. Painless application. No inhibition of 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:

• if you have known allergies or are suspected of being allergic to any of the ingredients in the product.
• in the CNS or in the meninges.
• in the middle or inner ear.
• in the eye.
• on hyaline cartilage and in aseptic joint surgery. If Prontosan comes into contact with aseptic cartilage, it must be immediately rinsed with Ringer's solution or isotonic saline solution.
• in combination with anionic surfactants.
• together with cleansing soaps, ointments, oils, enzymes, etc. These substances must be carefully removed from the wound before use.

7. 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, excretion into breast milk is unlikely. Due to the lack of relevant clinical trials and clinical experience in pregnant and breastfeeding women, the use of Prontosan Wundgel X in these individuals should only be undertaken after careful medical consultation.

Newborns and infants:
Due to the lack of clinical data, Prontosan Wundgel X may only be used in newborns and infants in selected cases and under close medical supervision.

8. General safety information:
For external use only. Do not use for injection or infusion. Do not ingest. Do not use contents of damaged tubes. Protect bottles from direct sunlight. Keep out of reach of children.

9. Summary/technical information:
Prontosan Wundgel X contains preservatives, and the preparation provides a persistent antimicrobial barrier. To avoid contamination, the tube should be closed immediately after use. The opening of the tube should be protected from contamination during use. 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 single-patient use only.

Appearance and odor:
Clear, colorless, and virtually odorless aqueous gel.

Shelf life:
24 months. Store at room temperature. Shelf

life after opening:
8 weeks.

Tamper-evident seal:
The product is no longer sterile after first opening.

This leaflet was last revised in November 2024.

Source: Information from the package leaflet,
as of June 2025.