Composition
Sodium Hyaluronate ………………..10mg/ml
NaCl ……………………………...…..…..7.8mg/ml
Na2HPO4………………………..…..…..0.9mg/ml
NaH2PO4.H2O………………………..…......0.4mg/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.
[lndications]
Singclean® is indicated for helping to prevent or reduce postoperative adhesions after abdominal and pelvic surgery.
[Usage]
Upon the completion of the operation, apply Singclean® evenly onto the rough wounds where postoperative adhesion often occurs.
[Adverse Reactions]
Fistula, leak, peritonitis, sepsis and abdomino pelvic abscess have been reported.
[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. Do not use if the blister package has been opened or damaged, or if there are cracks or breakage in the pre-filled syringe;
3. Must not inject Singclean® intravascularly;
4. Avoid concomitantly using disinfectants containing quaternary ammonium salts for skin preparation because sodium hyaluronate can precipitate in their presence.
5.The amount of gel in every single use depends on the area of surgical wounds. The maximum dosage regimen is no more than 50mL.
[Contraindications]
Do not administer Singclean® to patients with known hypersensitivity (allergy) 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 2 ℃-20 ℃.
Keep out of reach of children.
The safety and effectiveness of Singclean® have not been established in pediatric patients, pregnant or lactating woman.
[Storage]
Store between 2℃ and 20℃ Do not freeze.
Relative humidity should not be above 80%, well ventilated, avoiding corrosive gas and extrusion.
Protect from light.
[Specifications]
10mg/mL
0.5mL,0.75mL,1.0mL,2.0mL,2.5mL,3.0mL,5.0mL,15mL,17mL,20mL
[Shelf life]
2 years
Latest version 8.01.04.341 B3 lssued Date: 2021-03-03
