Prontosan solution

Active Ingredients

• Purified Water
• Betaine surfactant 0.1 %
• Polyaminopropyl Biguanide (Polihexanide)

Indications

Chronic skin wounds are often coated with slough, necrotic tissue and/or biofilm. These coatings are difficult to remove and lead to delayed wound healing. Prontosan wound irrigation solution is able to remove these barriers to wound healing through its cleansing activity.

Acute wounds also require proper cleansing as they are generally contaminated with debris and microorganisms. These contaminants can interfere with 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 is ideal for the prevention of biofilm formation.

Product profile and areas for use

For cleansing and irrigation plus moistening of:

a) Acute non-infected and infected wounds: - traumatic wounds (e.g. skin lacerations, bites, cuts or crush injuries); -postoperative wounds.

b) Chronic non-infected and infected wounds including: pressure sores; venous ulcers; diabetic ulcers.

c) Thermal and chemical wounds: 1st and 2nd degree burns; chemical burns.

d) Post-radiation wounds.

e) Fistulas and abscesses.

f) Entry ports of urological catheters, PEG/PEJ tubes or drainage tubes.

g) Peristomal skin.

For intraoperative cleansing and irrigation of wounds.

For instillation in combination with negative pressure wound therapy.

For moistening encrusted dressings and bandages prior to removal.

Instructions

For external use only. Do not swallow.

Prontosan wound irrigation solution may be used to saturate compresses, gauzes or pads for cleansing as needed. Application should be conducted frequently in order to achieve and maintain an visually clean wound.

Prontosan wound irrigation solution may be warmed to body temperature prior to use.

Wound dressings and bandages are frequently encrusted and adhere to the wound surface. Removal of these dressings can traumatize the wound bed, which in turn delays wound healing. In cases where dressings and bandages are difficult to release due to encrustation, soaking the dressing with Prontosan wound irrigation solution is recommended until they can be gently removed.

The entire wound, as well as the surrounding area, should be thoroughly cleansed with Prontosan wound irrigation solution.

For non-severe and acute wounds rinsing is sufficient. For wounds covering a large area and also wounds difficult to access, soaking the affected area with Prontosan wound irrigation solution for at least 15 minutes with a saturated compress is recommended. The solution should be used undiluted.

Prontosan wound irrigation solution is a preserved product and has a shelf life of 8 weeks after opening. The bottle should be closed immediately after use to prevent contamination. The top of the bottle should be protected from contamination during use. Bottles that have come into direct contact with the wound or have become contaminated in another way must be discarded.

Warnings

Prontosan wound irrigation solution should not be used if the patient is known to be allergic or if it is suspected that the patient may be allergic to one of the ingredients of the product.

Prontosan wound irrigation solution should not be used on the CNS or the meninges.

Prontosan wound irrigation solution should not be used in the middle or inner ear.

Prontosan wound irrigation solution should not be used in the eyes.

Prontosan wound irrigation solution should not be used on hyaline cartilage and in aseptic joint surgery. If Prontosan does come into contact with aseptic cartilage, it should be immediately irrigated with Ringer's solution or normal saline.

Prontosan wound irrigation solution should not be used in combination with anionic tensides.

Prontosan wound irrigation solution should not be used in combination with cleansing soaps, ointments, oils, enzymes, etc. These substances should be thoroughly removed from the wound before use.

Prontosan wound irrigation solution should not be used for peritoneal lavage or rinsing.

Pregnancy and lactation period:

There is no evidence of mutagenic or embryo toxicity associated with the ingredients of this product. As there is no systemic reabsorption of polihexanide, transmission to breast milk is unlikely. Due to the lack of relevant clinical trials and clinical experience with pregnant and breast feeding women, Prontosan wound irrigation solution should only be used after careful medical consultation in these cases.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.