RenehaVis

SODIUM HYALURONATE

Reducing pain and stiffness of knee joint in patients with synovial joint degeneration.
The duration of the effect in patients suffering from grade 1 - 3 media compartment osteoarthritis can reach up to four months, as clinically proven.
RenehaVis’ effectiveness is due to its biocompatibility and physiochemical properties. The LMW and HMW hyaluronate sodium contained in RenehaVis is a biopolymer composed of disaccharide units of N-acetylglucosamine and glucuronic acid obtained through the biosynthesis of Streptococcus equi, and has shown to be equal to the hyaluronate sodium found in the human body. Hyaluronate sodium is naturally found in the synovial joints, but may have been altered by changes of degenerative or traumatic origin in the synovial articulation. RenehaVis integrates the synovial hyaluronate sodium that has undergone molecular weight and concentration alterations.

Mode of use
RenehaVis injection must be carried out by qualified and authorized health personnel, aware of the intra- articular administration technique.
The diagram of administration provides for the administration in the space of the synovial articulation involved once a week and the treatment can reach up to three injections, depending on the severity of the joint degeneration.
Disinfect the injection site with an antiseptic and let it dry before injection.
In case of effusion, proceed to the aspiration before injection of RenehaVis.
The contents of the syringe are sterile and must be injected using a sterile needle preferably adequately (recommended needle type: 25 G). The syringe is equipped with Luer lock (6%).
Throw needle and syringe after their use.

It includes two transparent components of sterile hyaluronate sodium in a phosphate buffer saline solution contained in a pre-filled two-room syringe that allows a single intra-articular injection in the synovial space of the articulation.
RenehaVis is a pre-filled two-bedroom sterile glass syringe, ready for use, containing:
- Room 1 Low-weight hyaluronate sodium (Low Molecular Weight LMW) 0.7 ml sterile hyaluronate sodium at 2.2% Molecular Weight 1 x 106 Da.
- Room 2 High Molecular Weight HMW Hyaluronate Sodium 0,7 ml Sterile Hyaluronate Sodium at 1.0% Molecular Weight 2 x 106 Da.
RenehaVis 0.7ml LMW and 0.7ml HMW, sterilized by autoclave, is contained in a ready-to-use glass syringe. The syringe is in turn contained in a blister, packaged in a cardboard case.

Contraindications
Do not inject RenehaVis if the injection site is infected or where a skin disease is detected.
Patients with hypersensitivity known to hyaluronate sodium.

Warnings
Do not use the product if the packaging is damaged.
Do not use it beyond the expiry date.
Hyaluronate sodium is produced thanks to a fermentation process of the equi Streptococcus and is then strictly purified. However, the doctor should consider the potential immunological risk or other potential factors that may be associated with injection of organic products in general.
Do not use in children.
Follow national or local directives for safe use and disposal of needles. Quickly treat every possible puncture with used needles.