Actolind® w Gel 50 ml

Cleansing, moisturizing and care gel for acute and chronic wounds

1. DESCRIPTION OF PRODUCTS AND AREAS OF USAGE

Actolind® w Gel is a product used for mechanical cleaning, decontamination,irrigation and moisturizing of the chronic and infected wounds and 1st and 2nd degree burns. If there is not any systemic disease, all wounds are healed by themselves when they are kept clean and moist. However, the air contact, contamination and drying of the wounds may result in growth of various microorganisms. Consequently, acute wounds may become chronic wounds. Actolind® w Gel cleanses and moisturizes the wound surface, and it cuts off the connection of wound and outer environment by forming a protective film layer. It fills the space between dressing and wound surface and helps the healing process to get shorter by keeping the wound stabile.

2. GENERAL INFORMATION

Actolind® w Gel is a cleaning, irrigation, humidification and care gel used in acute and chronic wounds and 1st and 2nd degree burns in combination with medical devices such as bandage, dressing, pad and wound fillers. Chronic skin wounds are covered generally with scabs and dead (necrotic) tissues. It is hard to remove these layers from the wounds and they cause a delay in healing process of wounds. Therefore, regular wound cleaning is important. Actolind® w Gel forms a protective film layer at the application site and prevents the adhesions of the microorganisms to the wound area mechanically. Since Actolind® w Gel does not cause a delay in the healing process of the wound, it can be applied onto the wound bed for days. Meanwhile, it provides decontamination by means of a regular cleaning, moisturizing and the protective layer on the wound. Acute wounds that occur as the result of an accident are also contaminated generally by the agents that delay the healing process of the wounds, including foreign substances, eruptions and dead (necrotic) tissues. Also for acute wounds, therefore, it is very important to keep the wound bed and around clean and humid. Again open wounds offer a suitable surface for microorganisms to settle. Actolind® w Gel forms a thin film layer at the site where the unique combination of the components in its ingredients (Polyhexanide and Poloxamer) is applied; prevents the adhesion of microorganism on this site; keeps the site clean and humid; and contributes to the healing process of the wound. In addition, this thin protective film formed by Actolind® w Gel creates a barrier between the wound surface and dressing and minimizes the adhesion of the dressing on the wound surface and the growth of microorganisms that settle in the dressing surface. Thus, efficiency of the bandages increases.

3. AREAS OF USAGE

It is used for:

1.For washing wounds before dressing,

2. For keeping the wound clean and moist under the dressing, for keeping the wound stable by letting the wound fill itself (It is suitable for moistening and decontamination of the substances such as dried, adhesive or contaminated bandage, dressing, compress and wound filling? before they are removed from the wound),

3. For moistening of materials such as bandage, dressing, compress and wound filling before application, for easy replacement of bandage, for preventing the prolongation of healing process by reopening the wound

4. Wound care according to wound types:

Acute wounds (e.g. traumatic wounds that occur as the result of cuts, tears,excoriation, crushing, being bitten, being stung, etc., or surgical wounds), Chronic wounds (e.g. diabetic ulcers, venous ulcers, bedsore (pressure sore etc.), Thermal or chemical wounds (e.g. 1St and 2nd degree burns, chemical burns,etc.),Wounds that occur as the result of electrical current,radiation wounds,entry regions of urological catheters,cleaning and moisturizing of peristomal skin, fistulas and abscesses, and care of stoma.

4. GENERAL USE

Actolind® w Gel can be applied in combination with Actolind® w Solution. The wound should be cleaned with Actolind® w Solution before the application of Actolind® w Gel to remove the contaminants and deposits. Wound bed should be covered with a plenty of gel prior to dressing and bandage application. Actolind® w Gel can stay on the wound surface until the next dressing replacement. This way, Actolind® w Gel keeps the wound surface moist constantly, and thus it minimizes the adhesion of the dressing on the wound surface. Protective film layer covering the wound surface, which is formed by Actolind® w Gel, can be removed easily from the wound surface at the next dressing replacement. For this purpose, Actolind® w Solution is recommended for the dressing replacement. This application should be repeated on a regular basis in order to remove the dead tissues and scabs during the healing process.

4.1. Instructions for cleaning the wound

The entire wound and its around should be cleaned thoroughly with Actolind® w Solution in order to reduce the risk of transferring the contaminants and microorganisms to the wound surface. The cleaned wound should be covered with Actolind® w Gel and the wound should be dressed properly. Thanks to its unique combination, Actolind® w Gel forms a protective film layer between wound surface and dressing and prevents the adhesion of pathogenic microorganisms on the wound surface mechanically.

4.2. Use during pregnancy and lactation

There is no evidence of mutagenicity or embryo toxicity associated with the ingredients of this product. Since polyhexanide has no systemic reabsorption, likelihood of its excretion to breast milk is almost zero. Due to the lack of clinical trials and experiences with the pregnant and lactating women, Actolind® w Gel should only be used carefully after a medical assessment in such cases. For newborns and infants: Due to the insufficiency of clinical information, Actolind® w Gel is not recommended in newborns and infants. It should be used only under a strict and close medical supervision.

5. GENERAL TIPS FOR USE

1. Actolind® w Gel is a ready-to-use product

2. Actolind® w Gel can be applied directly onto the wound as well as onto the bandage and gauzes.

3. Products such as bandage, gauze, wiping clothes, etc. should not be used again.

4. Actolind® w Gel is product that contains preservatives and has a shelf life of 8 weeks after opening.

5. Close the tube immediately after using in order to prevent contamination.

6. Opening of the tube should be protected in order to avoid contamination while using. Tubes that contact directly with the wound or are contaminated in some other ways should be disposed.

7. The opened product should be used in one single patient in order to avoid the risk of any contamination.

6. SIDE EFFECTS

Actolind® w Gel contains polyhexanide. Even though there is no notification about Actolind® w Gel, it was reported that the polyhexanide substance in its ingredients may cause an allergic effect. It is contraindicated for those who are hypersensitive to this substance. In very rare cases, a mild burning sensation may occur after application of Actolind® w Gel, however this sensation disappears in a couple of minutes. Actolind® w Gel may cause allergic reactions such as itching (urticaria) and rash (eczema).

7. CONTRAINDICATIONS

Do not use Actolind® w Gel in the following cases:

1. It is not suitable for use in hyaline cartilage and aseptic joint surgeries, in the middle and internal ear and in the eye. If Actolind® w Gel contacts with aseptic cartilage, wash immediately with Ringer solution or physiological saline solution.

2. If the patient is known or suspected to be hypersensitive to any of the raw materials in the ingredients (polyhexanide)

3. On central nervous system or meninx

4. Along with anionic surface active agents, cleansing soaps, creams, oils, enzymes, etc. These substances should be removed fully from the wound surface before use.

8. WARNINGS-CAUTIONS

Read the instructions for use prior to use. Only for external application to skin. Do not use in patients for infusion or injection purposes. Patients with hypersensitive to any substance in the ingredients should not use. Do not swallow! Keep out of the reach of children. Do not use the tubes whose seal under the cap is torn and which are damaged. Shelf life of the product at the room temperature under 25°C is three (3) years. Use the product with an open package within 8 (eight) weeks. Close the tube immediately after using in order to prevent contamination. Opening of the tube should be protected in order to avoid contamination while using. Tubes that contact directly with the wound or are contaminated in some other ways should be disposed. Only keep it in its original package. Keep the tubes away from direct sunlight. Keep out of the reach of children.

9. SUMMARY OF TECHNICAL INFORMATION

Actolind® w Gel passed all biocompatibility tests and also tested dermatologically. As the result of the biocompatibility tests, it was concluded that the product was not irritating, was tolerated well, was not cytotoxic and did not cause hypersensitivity. It was observed that it had no inhibiting effect on granulation and epithelization. Actolind® w Gel is an irrigation, moisturizing and care gel used for skin and wounds. It is a Class III Medical Device according to Directive on Medical Devices 93/42/EEC and 2007/47/EC amendments. Ingredients: %0.1 Polyhexanide, Poloxamer and auxiliary substances. Appearance and odor: Clear, colorless and almost odorless hydrogel. Shelf life: Please see the expiry date; keep at room temperature. Shelf life at the room temperature conditions is 3 years.