RenehaVis

SODIUM HYALURONATE

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

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

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

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

Warnings
Do not use the product if the packaging is damaged.
Do not use after the expiration date.
Sodium hyaluronate is produced through the fermentation of Streptococcus equi and is then rigorously purified. However, the physician should 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. Treat any possible needle stick injury promptly.