SutriSept Liquid for wounds 250 ml
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Description
SutriSept Liquid for wounds 250 ml
The most important features of the product
first aid for wounds, in solution, spray atomizer, prevents wound infection, cleanses painlessly, accelerates wound healing
Description
A medical device intended for cleaning, washing, moisturizing and caring 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 dried and adhering dressing materials without causing secondary trauma. The preparation cleans wounds mechanically. The surfactants included in the product, by reducing the surface tension, ensure comfortable and painless cleaning of wounds and burns. The preparation contributes to wound healing by providing a highly positive cleansing and moisturizing effect on the surfaces on which it is applied. The preparation prevents wound infection and accelerates its healing. It does not inhibit granulation or epithelialization. It has no irritating properties and does not cause pain. It does not cause allergies and can be safely used for a long period of time. At the same time, it protects against multidrug-resistant pathogens (e.g. MRSA, VRE) and fungal infections. It is well tolerated by mucous membranes and is compatible with all modern wound dressings. The preparation has passed all biocompatibility tests and has been dermatologically tested. The results of the tests showed that the product has no irritating properties, is well tolerated and does not cause hypersensitivity.
Application: one and non-infected acute wounds (e.g. traumatic wounds resulting from cuts, tears, abrasions, crushing, bites, stings, etc., surgical wounds). Infected and uninfected chronic wounds (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, etc.). Infected and non-infected wounds caused by thermal or chemical factors (e.g. 1st and 2nd degree burns, chemical burns, etc.). Wounds caused by electric current. Radiation wounds. Places of insertion of urological catheters. Skin care around the stoma, care of fistulas and abscesses. The preparation is also suitable for: cleaning and caring for the wound surface before applying a dressing; antiseptic cleaning, softening and removal of dried, contaminated and adhering dressing materials, i.e. bandages, dressings, gauze and wound fillers.
Appearance and odor: Clear, colorless and almost odorless solution.
Application: one and non-infected acute wounds (e.g. traumatic wounds resulting from cuts, tears, abrasions, crushing, bites, stings, etc., surgical wounds). Infected and uninfected chronic wounds (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, etc.). Infected and non-infected wounds caused by thermal or chemical factors (e.g. 1st and 2nd degree burns, chemical burns, etc.). Wounds caused by electric current. Radiation wounds. Places of insertion of urological catheters. Skin care around the stoma, care of fistulas and abscesses. The preparation is also suitable for: cleaning and caring for the wound surface before applying a dressing; antiseptic cleaning, softening and removal of dried, contaminated and adhering dressing materials, i.e. bandages, dressings, gauze and wound fillers.
Appearance and odor: Clear, colorless and almost odorless solution.
Storage and use
Instructions for use
Liquid for cleansing, rinsing, moisturizing and caring for wounds
1. Product description
SutriSept in Solution Wound Liquid is a medical device intended for cleansing, washing, moisturizing and caring for acute, chronic and infected wounds as well as 1st and 2nd degree burns.
2. General information
SutriSept in Solution Wound Liquid is a liquid for cleansing, washing, moisturizing and caring for acute, chronic and infected wounds as well as 1st and 2nd degree burns, it can be used together with dressing materials such as bandages, dressings, gauze and wound fillers. It is also suitable for antiseptic cleansing, softening and removal of dried and adhering dressing materials without causing secondary trauma.
Chronic skin wounds are generally covered with crusts and dead (necrotic) tissue and/or biofilm. They are difficult to remove from the wound, and if not removed, they delay the wound healing process. Acute wounds resulting from an accident are also contaminated with factors such as dirt, pieces of damaged skin and microorganisms, which leads to a delay in wound healing. Open wounds also provide a convenient surface for microorganisms to settle. Therefore, it is very important to properly clean the wound bed and its surroundings before applying a dressing or bandage. SutriSept in Solution Wound Liquid cleanses wounds mechanically. The surfactants included in the product, by reducing the surface tension, ensure comfortable and painless cleaning of the wound before dressing it. SutriSept in Solution Wound Liquid contributes to wound healing by providing a highly positive cleansing and moisturizing effect on the surfaces on which it is applied.
Acute and chronic skin wounds generally create ideal conditions for the development of pathogens, including antibiotic-resistant microorganisms (e.g. MRSA, VRE). Microorganisms settle on dressing materials, such as bandages, dressings, and gauze pads placed on the wound, where they find perfect conditions for development. Dressing materials dry out over time and stick to the wound surface. Removing dried, adherent dressing materials from a wound can damage the wound bed, and harmful microorganisms on these materials can infect the wound. This may delay the wound healing process. SutriSept in Solution Wound Liquid can also be used for antiseptic cleansing and softening of dressing materials. Bandages and dressings that are dried and sticking to the wound can be soaked with SutriSept in Solution before removal to eliminate any microorganisms found on them, to facilitate removal of the dressings and to avoid secondary injury to the wound. The antimicrobial effect of SutriSept in Solution is an ideal solution in terms of preventing the formation of biofilm on bandages and dressings.
3. Indications
a. infected and uninfected acute wounds (e.g. traumatic wounds resulting from cuts, tears, abrasions, crushing, bites, stings, etc., surgical wounds);
b. infected and uninfected chronic wounds (e.g. diabetic foot ulcers, venous ulcers, pressure sores, etc.);
c. infected and non-infected wounds caused by thermal or chemical factors (e.g. 1st and 2nd degree burns, chemical burns, etc.);
d. wounds caused by electric current;
e. radiation wounds;
f. places of insertion of urological catheters;
g. skin care around the stoma, care of fistulas and abscesses;
h. suitable for cleaning and caring for the wound surface before applying a dressing;
i. suitable for antiseptic cleansing, softening and removal of dried, contaminated and adhering dressing materials to the wound, i.e. bandages, dressings,
gauze and wound fillers.
Instructions for use
4. Instructions for use
SutriSept in Solution Wound Liquid should be used to cleanse the wound surface and irrigate it before further care/treatment. SutriSept in Solution Liquid for wounds can be used in combination with the medical device SutriSept Hydrogel for wounds. Before applying SutriSept Hydrogel, the wound should be washed with SutriSept in Solution to remove impurities and deposits. Bandages, dressings, gauze pads, etc. soaked in SutriSept in Solution can be used to clean wounds.
SutriSept in Solution Wound Liquid can also be used for antiseptic cleaning and softening of dressing materials that are dry, stick to the wound surface and are difficult to remove. SutriSept in Solution Wound Liquid softens dried bandages and dressings and eliminates pathogenic microorganisms that have settled in them, preventing infection of the wound. SutriSept in Solution Wound Liquid does not inhibit granulation or epithelialization. SutriSept in Solution Liquid for wounds does not have irritating properties and does not cause pain. It does not cause allergies and can be safely used for a long period of time. At the same time, SutriSept in Solution Wound Liquid protects against multidrug-resistant pathogens (e.g. MRSA, VRE) and fungal infections. SutriSept in Solution Wound Liquid is well tolerated by people prone to allergies and people with diabetes. The polyhexanide component of SutriSept in Solution, clinically proven many times, is harmless to the skin and is considered the first choice in the treatment of wounds*. SutriSept in Solution can be applied directly to the wound, as well as to bandages and gauze. Dressing materials such as bandages, gauze, cleansing pads, etc. cannot be reused. SutriSept in Solution can be warmed to body temperature before use. To ensure proper wound healing, wound cleaning and care should be performed at regular intervals.
*Consensus of the German Association for Wound Healing and Treatment (DgfW), 2004, 2009.
4.1. Wound cleansing instructions
The entire wound and its surrounding area should be thoroughly cleansed using SutriSept in Solution Wound Liquid to minimize the risk of transfer of contaminants and microorganisms to the wound surface. For optimal wound cleansing, it is recommended to soak a deep wound with extensive tissue necrosis for at least 10-15 minutes with a fully soaked compress (by applying a wet dressing). The application can be repeated depending on the condition of the wound, without any time limits. The liquid should not be diluted! The SutriSept Hydrogel wound medical device can be applied to the cleaned wound and then bandaged appropriately.
4.2. Use of the product with dressings and bandages
Thoroughly soak dressings and bandages adhering to the wound surface using SutriSept in Solution Wound Liquid, wait approximately 5-10 minutes. until they soften, then carefully remove them from the wound. Soaking dressing materials with SutriSept in Solution prevents them from sticking to the wound surface and makes changing the dressing much easier. To maintain a moist wound environment, the dressing can be changed daily, and if necessary, even several times a day.
SutriSept in Solution for wounds is compatible with all modern wound dressings.
4.3. Catheter care
Possible infections can be avoided by regularly cleaning catheter inlets, flexible connectors and their surroundings with SutriSept in Solution. SutriSept in Solution Liquid for wounds should be sprayed on the area from a short distance and wait about 1-5 minutes. The ingredients of SutriSept in Solution are well tolerated by mucous membranes and also cleanse the material from which catheters and PEG systems are made without damaging it. As with wound care, dried medical materials can be easily removed after soaking them in SutriSept in Solution.
5. Restrictions on use
Use during pregnancy and lactation: There is no evidence of mutagenic or toxic effects of the ingredients of SutriSept in Solution Wound Liquid on the embryo. Since polyhexanide is not absorbed into the systemic circulation, the probability of its excretion into breast milk is almost zero. Due to the lack of clinical trials and experience in using the product in pregnant and breastfeeding women, SutriSept in Solution Wound Liquid should be used with caution, after medical evaluation.
Newborns and Infants: Due to insufficient clinical data in newborns and infants, SutriSept in Solution Wound Lotion should only be used under close medical supervision.
6. Side effects
SutriSept in Solution Wound Liquid contains polyhexanide. To date, there are no reports of adverse reactions to SutriSept in Solution Wound Liquid, but rare cases (incidence less than 1 in 10,000) of anaphylactic shock caused by polyhexanide have been reported.
If necessary, it is recommended to perform skin tests before using the product. Although polyhexanide, like all antimicrobial agents, has cytotoxic effects, it was found that the biocompatibility index of the SutriSept medical device in Solution Wound Liquid is >1 and is characterized by high biocompatibility with tissues.
SutriSept in Solution Wound Lotion may cause allergic reactions such as itching (urticaria) and rash (eczema). Do not use the product in people who are hypersensitive to this substance. In very rare cases, a mild burning sensation may occur after using SutriSept in Solution, but it disappears within a few minutes.
7. Contraindications
SutriSept w Solution Liquid should not be used on wounds in the following cases:
1. SutriSept in Solution Liquid for wounds is not suitable for use on hyaline cartilage and in the case of aseptic surgery on joints, middle and inner ear, it cannot be applied to the eyes (If SutriSept in Solution comes into contact with aseptic cartilage, it should be washed immediately with the solution Ringer's or physiological saline solution).
2. If the patient is diagnosed or suspected of hypersensitivity to any of the ingredients of the product.
3. Within the central nervous system and meninges.
4. Together with anionic surfactants, soaps, creams, oils, enzymes, etc., these substances should be thoroughly removed from the wound surface before using the product.
5. For rinsing and washing the peritoneum.
6. Do not use in the first four months of pregnancy. Depending on the benefit/risk assessment, the use of SutriSept in Solution later in pregnancy should be assessed in accordance with your doctor's advice.
8. Warnings and precautions
Please read these instructions for use carefully before use. For external use on the skin only. SutriSept in Solution Liquid for wounds must not be administered by intravenous infusion or injection. Contains polyhexamethylene biguanide (polyhexanide, PHMB). May cause an allergic reaction. The product should not be used in patients with hypersensitivity to any of its ingredients. SutriSept in Solution Liquid for wounds must not be swallowed! Keep out of the reach of children. Do not use if the seal under the cap is broken/damaged. The shelf life of the product stored at room temperature below 25 °C is 3 (three) years. Once opened, the product should be used within 8 (eight) weeks. Close the bottle immediately after use to avoid contamination of the solution. The rims of the bottle should be properly protected from direct contact with the wound to avoid contamination of the contents during use. Bottles that have come into direct contact with a wound or have been otherwise contaminated should be thrown away. Store in the original packaging. Protect from sunlight. Dispose of in accordance with local regulations.
9. Summary of technical data
SutriSept in Solution Wound Liquid has passed all biocompatibility tests and has been dermatologically tested. The results of the tests showed that the product has no irritating properties, is well tolerated and does not cause hypersensitivity. No inhibition of granulation or epithelialization was observed. SutriSept in Solution Wound Liquid is a ready-to-use product. Experience in using the product is not required. Use in accordance with the instructions for use. If in doubt, ask your doctor or pharmacist. SutriSept in Solution Wound Liquid is a solution for cleansing, washing, moisturizing and caring for acute, chronic and infected wounds and 1st and 2nd degree burns. It contains preservatives and the shelf life after opening is 8 (eight) weeks. SutriSept in Solution Wound Liquid is a class III medical device in accordance with rules 4 and 13 of Annex IX of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
Storage: Store at ambient temperature
Dimensions: Height: 209 mm. Width: 52 mm. Depth: 52 mm.
Packaging: Box
Liquid for cleansing, rinsing, moisturizing and caring for wounds
1. Product description
SutriSept in Solution Wound Liquid is a medical device intended for cleansing, washing, moisturizing and caring for acute, chronic and infected wounds as well as 1st and 2nd degree burns.
2. General information
SutriSept in Solution Wound Liquid is a liquid for cleansing, washing, moisturizing and caring for acute, chronic and infected wounds as well as 1st and 2nd degree burns, it can be used together with dressing materials such as bandages, dressings, gauze and wound fillers. It is also suitable for antiseptic cleansing, softening and removal of dried and adhering dressing materials without causing secondary trauma.
Chronic skin wounds are generally covered with crusts and dead (necrotic) tissue and/or biofilm. They are difficult to remove from the wound, and if not removed, they delay the wound healing process. Acute wounds resulting from an accident are also contaminated with factors such as dirt, pieces of damaged skin and microorganisms, which leads to a delay in wound healing. Open wounds also provide a convenient surface for microorganisms to settle. Therefore, it is very important to properly clean the wound bed and its surroundings before applying a dressing or bandage. SutriSept in Solution Wound Liquid cleanses wounds mechanically. The surfactants included in the product, by reducing the surface tension, ensure comfortable and painless cleaning of the wound before dressing it. SutriSept in Solution Wound Liquid contributes to wound healing by providing a highly positive cleansing and moisturizing effect on the surfaces on which it is applied.
Acute and chronic skin wounds generally create ideal conditions for the development of pathogens, including antibiotic-resistant microorganisms (e.g. MRSA, VRE). Microorganisms settle on dressing materials, such as bandages, dressings, and gauze pads placed on the wound, where they find perfect conditions for development. Dressing materials dry out over time and stick to the wound surface. Removing dried, adherent dressing materials from a wound can damage the wound bed, and harmful microorganisms on these materials can infect the wound. This may delay the wound healing process. SutriSept in Solution Wound Liquid can also be used for antiseptic cleansing and softening of dressing materials. Bandages and dressings that are dried and sticking to the wound can be soaked with SutriSept in Solution before removal to eliminate any microorganisms found on them, to facilitate removal of the dressings and to avoid secondary injury to the wound. The antimicrobial effect of SutriSept in Solution is an ideal solution in terms of preventing the formation of biofilm on bandages and dressings.
3. Indications
a. infected and uninfected acute wounds (e.g. traumatic wounds resulting from cuts, tears, abrasions, crushing, bites, stings, etc., surgical wounds);
b. infected and uninfected chronic wounds (e.g. diabetic foot ulcers, venous ulcers, pressure sores, etc.);
c. infected and non-infected wounds caused by thermal or chemical factors (e.g. 1st and 2nd degree burns, chemical burns, etc.);
d. wounds caused by electric current;
e. radiation wounds;
f. places of insertion of urological catheters;
g. skin care around the stoma, care of fistulas and abscesses;
h. suitable for cleaning and caring for the wound surface before applying a dressing;
i. suitable for antiseptic cleansing, softening and removal of dried, contaminated and adhering dressing materials to the wound, i.e. bandages, dressings,
gauze and wound fillers.
Instructions for use
4. Instructions for use
SutriSept in Solution Wound Liquid should be used to cleanse the wound surface and irrigate it before further care/treatment. SutriSept in Solution Liquid for wounds can be used in combination with the medical device SutriSept Hydrogel for wounds. Before applying SutriSept Hydrogel, the wound should be washed with SutriSept in Solution to remove impurities and deposits. Bandages, dressings, gauze pads, etc. soaked in SutriSept in Solution can be used to clean wounds.
SutriSept in Solution Wound Liquid can also be used for antiseptic cleaning and softening of dressing materials that are dry, stick to the wound surface and are difficult to remove. SutriSept in Solution Wound Liquid softens dried bandages and dressings and eliminates pathogenic microorganisms that have settled in them, preventing infection of the wound. SutriSept in Solution Wound Liquid does not inhibit granulation or epithelialization. SutriSept in Solution Liquid for wounds does not have irritating properties and does not cause pain. It does not cause allergies and can be safely used for a long period of time. At the same time, SutriSept in Solution Wound Liquid protects against multidrug-resistant pathogens (e.g. MRSA, VRE) and fungal infections. SutriSept in Solution Wound Liquid is well tolerated by people prone to allergies and people with diabetes. The polyhexanide component of SutriSept in Solution, clinically proven many times, is harmless to the skin and is considered the first choice in the treatment of wounds*. SutriSept in Solution can be applied directly to the wound, as well as to bandages and gauze. Dressing materials such as bandages, gauze, cleansing pads, etc. cannot be reused. SutriSept in Solution can be warmed to body temperature before use. To ensure proper wound healing, wound cleaning and care should be performed at regular intervals.
*Consensus of the German Association for Wound Healing and Treatment (DgfW), 2004, 2009.
4.1. Wound cleansing instructions
The entire wound and its surrounding area should be thoroughly cleansed using SutriSept in Solution Wound Liquid to minimize the risk of transfer of contaminants and microorganisms to the wound surface. For optimal wound cleansing, it is recommended to soak a deep wound with extensive tissue necrosis for at least 10-15 minutes with a fully soaked compress (by applying a wet dressing). The application can be repeated depending on the condition of the wound, without any time limits. The liquid should not be diluted! The SutriSept Hydrogel wound medical device can be applied to the cleaned wound and then bandaged appropriately.
4.2. Use of the product with dressings and bandages
Thoroughly soak dressings and bandages adhering to the wound surface using SutriSept in Solution Wound Liquid, wait approximately 5-10 minutes. until they soften, then carefully remove them from the wound. Soaking dressing materials with SutriSept in Solution prevents them from sticking to the wound surface and makes changing the dressing much easier. To maintain a moist wound environment, the dressing can be changed daily, and if necessary, even several times a day.
SutriSept in Solution for wounds is compatible with all modern wound dressings.
4.3. Catheter care
Possible infections can be avoided by regularly cleaning catheter inlets, flexible connectors and their surroundings with SutriSept in Solution. SutriSept in Solution Liquid for wounds should be sprayed on the area from a short distance and wait about 1-5 minutes. The ingredients of SutriSept in Solution are well tolerated by mucous membranes and also cleanse the material from which catheters and PEG systems are made without damaging it. As with wound care, dried medical materials can be easily removed after soaking them in SutriSept in Solution.
5. Restrictions on use
Use during pregnancy and lactation: There is no evidence of mutagenic or toxic effects of the ingredients of SutriSept in Solution Wound Liquid on the embryo. Since polyhexanide is not absorbed into the systemic circulation, the probability of its excretion into breast milk is almost zero. Due to the lack of clinical trials and experience in using the product in pregnant and breastfeeding women, SutriSept in Solution Wound Liquid should be used with caution, after medical evaluation.
Newborns and Infants: Due to insufficient clinical data in newborns and infants, SutriSept in Solution Wound Lotion should only be used under close medical supervision.
6. Side effects
SutriSept in Solution Wound Liquid contains polyhexanide. To date, there are no reports of adverse reactions to SutriSept in Solution Wound Liquid, but rare cases (incidence less than 1 in 10,000) of anaphylactic shock caused by polyhexanide have been reported.
If necessary, it is recommended to perform skin tests before using the product. Although polyhexanide, like all antimicrobial agents, has cytotoxic effects, it was found that the biocompatibility index of the SutriSept medical device in Solution Wound Liquid is >1 and is characterized by high biocompatibility with tissues.
SutriSept in Solution Wound Lotion may cause allergic reactions such as itching (urticaria) and rash (eczema). Do not use the product in people who are hypersensitive to this substance. In very rare cases, a mild burning sensation may occur after using SutriSept in Solution, but it disappears within a few minutes.
7. Contraindications
SutriSept w Solution Liquid should not be used on wounds in the following cases:
1. SutriSept in Solution Liquid for wounds is not suitable for use on hyaline cartilage and in the case of aseptic surgery on joints, middle and inner ear, it cannot be applied to the eyes (If SutriSept in Solution comes into contact with aseptic cartilage, it should be washed immediately with the solution Ringer's or physiological saline solution).
2. If the patient is diagnosed or suspected of hypersensitivity to any of the ingredients of the product.
3. Within the central nervous system and meninges.
4. Together with anionic surfactants, soaps, creams, oils, enzymes, etc., these substances should be thoroughly removed from the wound surface before using the product.
5. For rinsing and washing the peritoneum.
6. Do not use in the first four months of pregnancy. Depending on the benefit/risk assessment, the use of SutriSept in Solution later in pregnancy should be assessed in accordance with your doctor's advice.
8. Warnings and precautions
Please read these instructions for use carefully before use. For external use on the skin only. SutriSept in Solution Liquid for wounds must not be administered by intravenous infusion or injection. Contains polyhexamethylene biguanide (polyhexanide, PHMB). May cause an allergic reaction. The product should not be used in patients with hypersensitivity to any of its ingredients. SutriSept in Solution Liquid for wounds must not be swallowed! Keep out of the reach of children. Do not use if the seal under the cap is broken/damaged. The shelf life of the product stored at room temperature below 25 °C is 3 (three) years. Once opened, the product should be used within 8 (eight) weeks. Close the bottle immediately after use to avoid contamination of the solution. The rims of the bottle should be properly protected from direct contact with the wound to avoid contamination of the contents during use. Bottles that have come into direct contact with a wound or have been otherwise contaminated should be thrown away. Store in the original packaging. Protect from sunlight. Dispose of in accordance with local regulations.
9. Summary of technical data
SutriSept in Solution Wound Liquid has passed all biocompatibility tests and has been dermatologically tested. The results of the tests showed that the product has no irritating properties, is well tolerated and does not cause hypersensitivity. No inhibition of granulation or epithelialization was observed. SutriSept in Solution Wound Liquid is a ready-to-use product. Experience in using the product is not required. Use in accordance with the instructions for use. If in doubt, ask your doctor or pharmacist. SutriSept in Solution Wound Liquid is a solution for cleansing, washing, moisturizing and caring for acute, chronic and infected wounds and 1st and 2nd degree burns. It contains preservatives and the shelf life after opening is 8 (eight) weeks. SutriSept in Solution Wound Liquid is a class III medical device in accordance with rules 4 and 13 of Annex IX of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
Storage: Store at ambient temperature
Dimensions: Height: 209 mm. Width: 52 mm. Depth: 52 mm.
Packaging: Box
Composition
water, poloxamer 188, polyhexamethylene biguanide (polyhexanide, PHMB) 0.1%
Producer
Verco S.A
Manufacturer's address
Verco S.A
Cardinal Square S. Wyszyńskiego 5,
lock. 6U
01-015 Warsaw
Safety Warning
Cardinal Square S. Wyszyńskiego 5,
lock. 6U
01-015 Warsaw
Warnings: Please read these instructions for use carefully before use. For external use on the skin only. The product should not be used in patients with hypersensitivity to any of its ingredients. Keep out of the reach of children. Do not use if the seal under the cap is broken/damaged. The shelf life of the product stored at room temperature below 25 ℃ is 3 (three) years. Once opened, the product should be used within 8 (eight) weeks.
Distributor's address
Verco S.A
Cardinal Square S. Wyszyńskiego 5,
lock. 6U
01-015 Warsaw
Cardinal Square S. Wyszyńskiego 5,
lock. 6U
01-015 Warsaw
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