1. What is Singclean® Anti-Adhension Solution? 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…
1. What is Singclean® Anti-Adhension Solution?
2. When should consider Singclean® Anti-Adhesion solution?
3. How to use Singclean® Anti-Adhesion solution:
4. Important Safety Information
5. Why should use Singclean® Anti-Adhesion solution?
6. Warnings and Precautions
7. Company Profile
9. Packaging & Shipping
10. Our Services
A 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.
B 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.
Our sterilization equipment is Getinge which can do the best moist heat sterilization.
Terminal sterilization products is 1000 times in Sterile protection level than aseptic processing products with the biggest active ingredient HA.
High efficiency – destroys microorganisms including resistant spores
Large sterilizing volume/ chamber capacity
C Q: Which certificates you have?
A：We already get CE, ISO13485,CFDA, SGS and ISO9001.
12.To study the safety and efficacy of clinical trials for injectable cross-linked sodium hyaluronate gel for moderate and severe nasal lips:
To study the safety and efficacy of yishumei – an injectable cross-linked sodium hyaluronate gel for the relief of moderate and severe nasolabial folds.
Methods A randomized, single-blind, parallel controlled study of volunteers with moderate or nasolabial folds was performed. Bilateral injection of “ll or yishumei” (<1.5 ml) to correct the nasolabial fold. The bilateral nasolabial fold severity scale (WSRS) and adverse events were independently assessed by surgeons and volunteers at 4 weeks, 12 weeks, and 24 weeks before and after surgery. Statistical analysis was performed using SPSS 13.0 software.
Results The average age of 30 selected volunteers (28 women, 2 men) was 45.8 years. The bilateral nasolabial folds decreased after WSRS, and the difference was statistically significant.
WSRS was not statistically significant immediately after 24 weeks (P > 0.05). Two adverse events (2 / 30, 6.67%) occurred during the trial, and one was considered to be related to the study data.
13.Review of drug and medical device review:
China decided to reform the drug and medical device evaluation system to improve drug safety and quality and encourage innovation.
In order to achieve these goals, the State Council has requested that drug approval criteria be improved by adjusting the drug registration classification. Accelerate the evaluation and approval process for innovative drugs, including drugs for the treatment of AIDS, cancer, serious infectious diseases and rare diseases.