CE Singclean® Medical Sodium Hyaluronate Gel for Anti-adhesion
CE 2460
[Composition]
Sodium hyaluronate ....................................................... 10 mg/mL
NaCl................................................................................ 7.8 mg/mL
Na2HPO4........................................................................ 0.9 mg/mL
NaH2PO4H2O................................................................... 0.4 mg/mL
Water for injection................................................................ q.s.
[Primary ingredients and performance]
Singclean® is clear gel solution of sodium hyaluronate or hyaluronic acid (hereinafter as“HA"), in phosphate buffered saline, which is contained in a pre-filled syringe. The product is a unique type of linear macromolecular mucopolysaccharide, composed of repeating disaccharide units of glucuronic acid and N-acetylglucosamine, its chemical formula is (C14H21NO11)n.
Singclean® , being animal-origin free and of high viscoelasticity, lubricity, physical alterability and good biocompatibility. It is medical polymer extracted and refined by high-tech bio-engineering from streptococcal fermentation metabolites. It is sterile, and free from pyrogenicity, allergy, genetic toxicity, or skin irritation. Due to fermentation production,the product is free from the risk of virus carriers and dissemination medium when extracting animal tissues or organs. HA is different with other natural mucopolysaccharide: HA molecule does not contain sulfate groups. It is also not covalently bound protein, and can exist free in the body as freedom chain.
Singclean® is processed with moist heat terminal sterilization.The product is for single use only.
[Mode of action]
The main composition of Singclean® is HA. HA is a macromolecular mucopolysaccharide, N-acetylglucosamine and glucuronic acid alternately form a network structure. Therefore, Singclean® can form a network of macromolecules on the surface of the tissue, build a biomechanical barrier, block inflammation from normal serosal membranes and prevent tissue adhesion. Its lubricating properties can also reduce friction during wound healing and promote wound healing.As a barrier to prevent adhesion,appropriate degradation time is crucial, and generally more than 7 days of HA will endanger the healing process of peritoneal wounds. Exogenous HA,under the action of hyaluronidase, is first degraded in lymph nodes and liver. After partial degradation, it enters the blood circulation, breaks down into monosaccharides, and is transferred to the cytoplasm to participate in matrix metabolism, and finally excreted from the body.
[Indications]
Singclean® is indicated for helping to prevent or reduce postoperative adhesions after abdominal and pelvic surgery.
[Clinical benefits]
Singclean® can inhibit the deposition and condensation of fibrin, form a physical barrier and protect the wound surface from friction. It can stay in the body for about 7 days,achieving the effectiveness of postoperative anti-adhesion, and the incidence of adverse events is low.
[Usage]
Before the end of the operation, unscrew the rubber cap or tip cap of the syringe, squeeze the gel, and evenly apply the Singclean® in the syringe barrel to the rough wound surface prone to postoperative adhesions.
[Target patient population]
Patients (except for pediatric patients, pregnant or lactating women)who undergo pelvic and abdominal surgery.
[Adverse Reactions]
Infection and inflammation may occur at the application site, leading to fever，fistula，leakage,peritonitis, sepsis, abdominal pelvic abscess ,and shock. After usage, there are no necessary follow-ups after discharge. If there are new or persistent adverse reactions,patients should inform the doctor in time, so that appropriate measures can be taken for remedial treatment.
Before using this product, the doctor should inform the patient of the above information.
[Precautions]
1.Strict aseptic administration technique must be followed.Free from Cross infection.
2.The pre-filled syringe is intended for single use.The contents of the syringe must be used immediately after the packaging is opened.Discard any unused Singclean® . Secondary use would lead to some infectious diseases.
3.Do not use if the blister package has been opened or damaged, orif there are cracks or breakage in the pre-filled syringe.
4.Must not inject Singclean® intravascularly.
5. Avoid concomitantly using disinfectants containing quaternary ammonium salts for skin preparation because sodium hyaluronate can precipitate in their presence.
6.The amount of gel in every single use depends on the area of surgical wounds.The maximum dosage regimen is no more than 50 mL.
[Contraindications]
Do not administer Singclean® to patients with known hypersensitivity(allergy) to Singclean® or sodium hyaluronate preparations.
Do not use Singclean® to patients having skin diseases or infections in the area of the used part.
[Notes]
Do not use if package is damaged.
The container for medical sodium hyaluronate is composed by glass. Be careful in using.
Do not use after the expiry date printed on the package.The expiry date refers to the product stored in its original packaging at a temperature between 5 ℃ -25 ℃.
The safety and effectiveness of Singclean® have not been established in pediatric patients, pregnant or lactating woman.
In case of any serious incident related to the device，it shall be reported to the manufacturer,distributor, EU authorized representative and the competent authority.
The user must be healthcare professional who have obtained relevant qualifications.
The package contains a pre-printed implant card and a leaflet for implant card, do not forget to complete it and give it to patient.
[Disposal]
The used and expired products should be disposed in compliance with pertinent government regulations regarding medical devices.
[Storage]
Store between 5 ℃ and 25 ℃,Do not freeze.
Relative humidity should not be above 80%, well ventilated, avoiding corrosive gas and extrusion.
Protect from light.
[Specifications]
10 mg/mL
0.5 mL, 0.75 mL, 1.0 mL, 2.0 mL, 2.5 mL, 3.0 mL, 5.0 mL, 15 mL, 17 mL, 20 mL
[Shelf life]
3 years
Latest version 8.01.04.0341 B5 lssued Date: 2024-06-17
