1. What is Singclean® anti-adhension Gel? This product is a biocompatible, absorbable, flowable gel composed of hyaluronic acid sodium salt and physiologically balanced salt. With no sulfate groups in its molecule and no covalent binding with the protein, it can exist as free chain in the body…
This product is a biocompatible, absorbable, flowable gel composed of hyaluronic acid sodium salt and physiologically balanced salt. With no sulfate groups in its molecule and no covalent binding with the protein, it can exist as free chain in the body for lubrication, moisture preservation and mechanical isolation, preventing adhesions.
|Singclean Anti-adhension Gel|
2. When should consider Singclean® Anti-adhension Gel?
Used for the prevention and reduction of postoperative adhesions of the abdominal and pelvic surgery.
3. How to use it
4. Important Safety Information
a.The product is sterilized and free from pyrogenicity, and must be operated in a sterile environment
b.The product is single use only. Do not use if sterile packaging has been damaged
c. This product must not be in contact with drugs containing geramine chloride in order to avoid chaos
d.Must not be used for intravenous injection
5. Why should use Singclean® Anti-adhension Gel?
The Singclean® gel has a longer retention time(7-14days) at the site of injury, which does not cause infiammation, nor inhibitwound healing
The Singclean® gel is the most effective in preventing postoperative adhesions in the abdominal cavity and pelvic cavity. It can mechanically isolate the injured site and prevent the formation of fibrin reticular formation between the surface of the tissue.The Singclean® gel is an effective way to prevent or reduce adhesions.
The 32 case of hysteroscopic surgery were randomly divided into two groups, A grout with hysteroscopy and sodium hyaluronategel treatment,B grout with hysteroscopic treatment,patients were followed for three months. The results showed that the incidenceof intrauterine adhesions in group A was significantly reduced, intrauterine adhesions is reduced also. Therefore, sodium hyaluronate can significantly reduce intrauterine adhesion after uterine surgery.
hyaluronate can significantly reduce intrauterine adhesion after uterine surgery.
Globle research reports indicate that sodium hyaluronate gel can signifcantly reduce the incidence of intrauterine adhesions andseverity of adhesions in 1 month. Injection of sodium hyaluronate gel after intrauterine adhesions separation surgery caused a lowincidence of adhesions, adhesions lesions relatively light.
6. Warnings and Precautions
– Confirm that the surgical site is free of excessive bleeding. Excessive bleeding should be controlledprior to Singclean® Gel instillation.
– Singclean® Gel does not have intrinsic bacteriostatic or bactericidal activity. It is not bacteriostatictoward pre-existing infections, nor does it prevent the occurrence of new infections. In the case of preexisting infections, appropriate treatment should be instituted.
– The concomitant use of Singclean® Gel with other anti-adhesion device has not been evaluated.
– Singclean® Gel has not been evaluated with a dose of over 2 ml/kg of body weight. It is not recommended to use Singclean® Gel over a dose of 2 ml/kg of body weight unless at the discretion of the physician.
– Singclean® Gel has not been evaluated in patients affected by malignant tumors. Preclinical evidencehas shown that the products have no influence on neoplastic diffusion.
– Data on the use of Singclean® Gel on pregnant women are not available. The use of the products is notrecommended in this condition. It is also recommended to avoid pregnancy during the first completemenstrual cycle subsequent to the treatment.
– Do not inject intravascularly.
– Singclean® Gel is provided in single-use, pre-filled syringes. The syringe content only is providedsterile. The external surface of the syringe has a very low controlled bioburden. The syringe is packagedinto a protective blister tray or Tyvek pouch to prevent the contamination of its outer surface and toallow the use of the devices in the surgical theatre. Do not resterilize the syringe content.
– It is recommended to use the product immediately after opening the pouch.
All the assembling operations of the device must be performed in the surgical theatre.
– The syringe is single-use; any non-used product must be discarded accordingly. The reuse of theproduct may cause serious infection.
– The empty containers have to be discarded accordingly.
– Keep out of reach of children.
– If the syringe and /or protective pouch or the blister is damaged, do not use the product and contactlocal distributor.
– Do not use the product after the expiration date.
– Singclean® Gel must be used according to the instruction for use.Read instructions prior to use.
9. Packaging & Shipping
Q: What is hyaluronic acid?
A: Hyaluronic acid (HA) is a unique linear macromolecular mucopolysaccharide. It consists of glucuronic acid and n-acetyl glucosamine disaccharide units alternately connected together, the molecular formula is (C14H21NO11)n. The molecular weight changes between 105~107 based on different tissue of origin. HA is widely distributed in animal and human connective tissue extracellular matrix, with higher concentration in vitreous, umbilical cord, skin, cartilage and synovial fluid. We use bacterial fermentation to product HA material to avoid the risk of carrying virus and media from animal tissues or organs. HA is different from 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. It is high viscosity gel for the anti-adhesion treatment.
Q: Normally, how many methods for sterilizing? What is the application range for each method? Which method we use for our products?
A：The common sterilizing methods are moist heat sterilization, irradiation sterilization, eo sterilization (Ethylene oxide) and aseptic processing (Process control). Moist heat sterilization is used widely, Singclean anti-adhension Gel also use this method.
12.Granulation method of hyaluronic acid sodium acid
The present invention provides a granulation method for cross-linking sodium hyaluronate gel. Under the sealed condition, the cross-linked sodium hyaluronate gel in the container is input into the segment head by aerodynamic force, and continuously enters the gap between the stator and the rotor through the inlet flange and the stator center feed hole, and the stator and the rotor are relatively Rotate and then flow out through the outlet flange to complete the granulation. The entire split is cooled by the cooling water circulation system. At the same time, when the rotor is fixed on the main shaft of the speed regulating motor, the relative rotational speeds of the stator and the rotor can be adjusted. The size of the gap between the stator and the rotor can be achieved by changing different combinations.
13.Anti-sticking intelligent gel material and preparation method thereof
This is a medical anti-blocking intelligent gel material and a preparation method thereof. When the material is lower than 20 ° C, it is a colorless transparent liquid with good fluidity. When the temperature rises to 20-40 ° C, it becomes a solid gel state, and it can change from liquid to gel at body temperature. . The poloxamer 407 is used as the main raw material, a certain proportion of hyaluronic acid, glycerin and propylene glycol are added, and then prepared by low temperature dissolution, vacuum degassing, microfiltration and autoclaving, and the gel material is filled into the bottle. , small bottle, pre-filled syringe quantitative, prevent post-operative adhesion, good effect, easy to use.
14.Singfan is available in Poland!
As part of Singfan’s Singclean global expansion strategy, we are proud to announce the launch of Singfiller in the Polish market in October 2017.