Actolind® w Solution 1 lt

Cleaning, irrigation, moistening and care solution for wounds Actolind® w Solution Package leaflet Product Description Actolind® w Solution is a cleansing, irrigation, moistening and care product for acute, chronic and infected wounds as well as 1st and 2nd degree burns. General Information Actolind® w Solution is a cleansing, irrigation, moistening and care solution used together with materials such as bandages, dressings, pads and wound fillers for acute, chronic and infected wounds as well as 1st and 2nd degree burns. It is also suitable for antiseptic cleansing, softening and removal of dressing materials that are dried and adhered to the wound without causing a secondary trauma. Chronic cutaneous wounds are covered generally with scabs and dead (necrotic) tissues and or biofilms. It is hard to remove these layers from wounds and they cause a delay in wound recovery period. Acute wounds that caused by an accident are also contaminated with agents such as dirt, skin debris and microorganisms, which lead to a delay in wound recovery. Also, open wounds offer a suitable surface for the colonization of microorganisms. Hence, it is very important to clean the wound bed and its surroundings properly before application of any dressing or bandage. Actolind® w Solution cleans wounds mechanically. Surface active agents in its composition provide a convenient and painless cleaning needed before wound care by decreasing the surface tension. Actolind® w Solution contributes to the wound healing process by ensuring a highly positive cleansing and moisturizing effect on applied areas. In general, acute and chronic cutaneous wounds provide an ideal growth opportunity for pathogens and/or antibiotic-resistant microorganisms (e.g. MRSA, VRE). These microorganisms settle onto dressing materials such as bandages, dressings, pads applied onto the wound and find an ideal growth opportunity at this site. These dressing materials get dry in time and adhere to the wound surface. Removal of such dried and adhered materials from the wound may traumatize the wound bed and harmful microorganism settled on those materials may infect the wound. This may cause delay in the wound recovery process. Actolind® w Solution can also be used for antiseptic cleansing and softening of dressing materials. Bandages and dressings dried and adhered to the wound can be wetted by Actolind® w Solution before removal, so the microorganisms settled on them can be eliminated and they can be easily removed without causing any secondary trauma to the wound. The antimicrobial effect of Actolind® w Solution offers an ideal solution to prevent biofilm formation on bandages and dressings. Indications i. Infected or uninfected acute wounds (e.g. traumatic wounds that occur as the result of cuts, tears, excoriation, crushing, being bitten, being stung, etc., or surgical wounds), ii. Infected or uninfected chronic wounds (e.g. diabetic ulcers, venous ulcers, decubitus (pressure sore), etc.), iii. Infected or uninfected thermal or chemical wounds (e.g. 1st and 2nd degree burns, chemical burns, etc.), iv. Wounds that caused by electrical current, v. Radiation wounds, vi. Entry regions of urological catheters, vii. Maintenance of peristomal skin, fistulas and abscesses, viii. Suitable for cleaning and maintenance of wound surface prior to dressing, ix. Suitable for antiseptic cleansing, softening and removal of dressing materials, i.e. bandages, dressings, pads and wound fillers that are dried, contaminated and adhered to the wound. Instructions for Use Actolind® w Solution should be used for wound surface cleaning and irrigation before any treatment. Actolind® w Solution can be applied in combination with Actolind® w Gel. The wound should be cleaned with Actolind® w Solution before the application of Actolind® w Gel to remove any contaminants and deposits. Bandages, dressings, pads etc. soaked in Actolind® w Solution can be used to clean wounds. Actolind® w Solution can also be used for antiseptic cleansing and softening of encrusted dressing materials that are dried and adhered to the wound surface and difficult to remove. Actolind® w Solution softens the encrusted bandage and dressing, while eliminating the pathogenic microorganisms that have settled on them and prevents the wound from being infected. Actolind® w Solution does not inhibit granulation or epithelialization. It has neither irritating nor pain giving properties. It causes no sensitization and can be used safely for a long time. Simultaneously, Actolind® w Solution protects against multidrug-resistant (e. g. MRSA, VRE) and mycotic pathogens and is also well tolerated by allergy sufferers and diabetics. The ingredient polyhexanide is millionfold clinically proven, dermatologically harmless and is considered to be the first choice as wound treatment agent*. Actolind® w Solution can be applied directly onto the wound as well as onto the bandage and gauzes. Materials such as bandage, gauze, wiping clothes, etc. should not be used again. Actolind® w Solution can be heated to body temperature prior to use. For a healthy wound recovery process, wound cleaning and care should be performed in regular intervals. *Consensus recommendation of the German Society for Wound Healing and Wound Management e.V. (DgfW) 2004 & 2009. Instructions for wound cleaning The entire wound and its surroundings should be thoroughly cleaned with Actolind® w Solution to minimize the risk of transmission of contaminants and microorganisms to the wound surface. For optimal wound cleaning, it is recommended to wet the wound consisting of deep and intensively necrotic tissues, for at least 10-15 min. with the help of a fully wetted compress (application of wet dressing). The application can be repeated according to the wound conditions without any time limits. Do not dilute the solution! The cleaned wound can be covered with Actolind® w Gel and bandaged properly. Usage with dressings and bandages Thoroughly wet dressings and bandages adhered to the wound surface with Actolind® w Solution, wait ca. 5-10 min. for softening and remove them carefully from wound. Wetting the dressing materials with Actolind® w Solution prevents adhering to the wound surface and facilitates dressing change significantly. In order to maintain a moist wound climate, the dressing can be changed daily, if necessary, several times a day. Actolind® w Solution is compatible with all modern wound dressings. Catheter care Possible infections can be avoided by regular cleaning catheter inlet ports, flexible connectors and its environment by Actolind® w Solution. Spray Actolind® w Solution on the area from a short distance and wait ca. 1-5 min. The ingredients of Actolind® w Solution are particularly mucous membrane-friendly, cleanse catheter and PEG material without damaging it. As with wound care, encrusted sticking plasters can be removed easily after wetting with Actolind® w Solution. Restrictions of use 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 absorption, likelihood of its excretion to breast milk is almost zero. Due to the lack of clinical trials and experiences with pregnant women and lactating women, Actolind® w Solution should only be used carefully after a medical assessment. For newborns and infants: Due to the insufficiency of clinical information, Actolind® w Solution should be used only under a strict and close medical supervision on newborns and infants. Side Effects Actolind® w Solution contains polyhexanide. Even though there is no notification about Actolind® w Solution, it was reported that polyhexanide may cause an anaphylactic shock in rare cases (less than 1 out of 10,000). When needed allergic skin testing is recommended before use. Although polyhexanide has a cytotoxic effect as an antimicrobial agent, the biocompatibility index of Actolind® w Solution is found to be >1 and has a high tissue compatibility. Actolind® w Solution may cause allergic reactions such as itching (urticaria) and rash (eczema). 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 Solution, however this sensation disappears in a couple of minutes. Contraindications Do not use Actolind® w Solution 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 Solution contacts the 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 ingredients, 3. On central nervous system or meninx, 4. Along with anionic surfactants, cleansing soaps, creams, oils, enzymes, etc. These substances should be removed fully from the wound surface before use, 5. For peritoneal lavage and washing, 6. It should not be used in the first four months of pregnancy. Depending on the risk-benefit evaluation, its use later in pregnancy should be evaluated according to the doctor's recommendation. Warnings and Precautions Read the instructions carefully before use. Only for external application onto skin. Do not use for infusion or injection purposes. Contains polyhexamethylene biguanide. May produce an allergic reaction. Patients hypersensitive to any of the ingredients should not use the product. Do not swallow! Keep out of reach of children. Do not use if the sealing under the cap is torn or broken. Shelf life of the product is 3 (three) years at room temperature under 25°C. Consume the open product within 8 (eight) weeks. Close the bottle immediately after use to avoid any contamination. The rim of the bottle should be protected from direct contact to avoid contamination while using. Bottles, which directly contact the wound or are contaminated in some other ways should be disposed. Keep only in original package. Protect from sunlight. Dispose according to local regulations. Summary Technical Information Actolind® w Solution passed all biocompatibility tests and is also tested dermatologically. The test results showed that the product is not irritating, well tolerated and cause no hypersensitivity. No inhibition on granulation and epithelization was observed. Actolind® w Solution is a ready-to-use product. No expertise is required for the application. Apply according to the instructions of use. Ask your doctor or pharmacist if you are not sure. Actolind® w Solution is a cleansing, irrigation, moistening and care solution for acute, chronic and infected wounds as well as 1st and 2nd degree burns. It contains preservatives and has a shelf life of 8 weeks after opening. This product is a Class III Medical Device according to the rule 13 of Annex IX of the Medical Device Directive 93/42/EEC and the 2007/47/EC amendments. Ingredients: Water, Poloxamer and Polyhexanide (PHMB, 0.1%). Appearance and odour: Clear, colourless and almost odourless solution. Shelf life: Please see the expiry date. Close the cap tightly and store in a cool and dry environment. Shelf life is 3 (three) years at room temperature under 25°C.