RenehaVis

SODIUM HYALURONATE

Reduction of pain and stiffness of the knee joint in patients suffering from synovial joint degeneration.
The duration of effect in patients with grade 1 - 3 medial compartment osteoarthritis may be up to four months, as clinically demonstrated.
The effectiveness of RenehaVis is due to its biocompatibility and physicochemical properties. The LMW and HMW sodium hyaluronate 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 been shown to be the same as the sodium hyaluronate found in the human body. Sodium hyaluronate is found naturally in the synovial joints, but may have been altered by changes of degenerative or traumatic origin in the synovial joint. RenehaVis integrates synovial sodium hyaluronate that has undergone alterations in molecular weight and concentration.

How to use
The injection of RenehaVis must be performed by qualified and authorized healthcare personnel familiar with the technique of intra-articular administration.
The administration schedule provides for administration into the involved synovial joint space once a week and the treatment can go up to a maximum of three injections, depending on the severity of the joint degeneration.
Disinfect the injection site with an antiseptic and allow it to dry before injecting.
In case of effusion, perform aspiration before injecting RenehaVis.
The contents of the syringe are sterile and should be injected using a sterile needle preferably of the appropriate size (recommended needle type: 25G). The syringe is equipped with a Luer lock (6%).
Throw away the needle and syringe after use.

It comprises two clear sterile sodium hyaluronate components in phosphate buffered saline contained in a prefilled two-chamber syringe which allows for single administration by intra-articular injection into the synovial space of the joint.
RenehaVis is a sterile, ready-to-use, pre-filled, two-chamber glass syringe containing:
- Chamber 1 Low Molecular Weight LMW Sodium Hyaluronate 0.7 ml Sterile 2.2% Molecular Weight Sodium Hyaluronate 1 x 106 Da.
- Chamber 2 High Molecular Weight HMW Sodium Hyaluronate 0.7 ml Sterile 1.0% Molecular Weight Sodium Hyaluronate 2 x 106 Da.
RenehaVis 0.7ml LMW and 0.7ml HMW, sterilized by autoclaving, is contained in a ready-to-use disposable glass syringe. The syringe is in turn contained in a blister, packed in a cardboard box.

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

Warnings
Do not use the product if the packaging is damaged.
Do not use beyond the expiration date.
Sodium hyaluronate is produced thanks to a fermentation process of Streptococcus equi and is then rigorously purified. However, the physician will need to consider the potential immunological risk or other potential factors that may be associated with the injection of biological products in general.
Do not use in children.
Follow national or local guidelines for the safe use and disposal of needles. Promptly treat any possible punctures with used needles.