Data sheet

RenehaVis to relieve symptoms of knee osteoarthritis by providing support and lubrication to the knee joint

 

Presentation:

RenehaVis™ comprises two transparent sterile sodium hyaluronate components in a phosphate-buffered saline solution contained in a prefilled two-chamber syringe that allows a single administration by intra-articular injection into the synovial space of the joint. RenehaVis™ is a pre-filled, ready-to-use, sterile two-chamber glass syringe containing: Chamber 1 Low Molecular Weight Sodium Hyaluronate (LMW) 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 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 type. The syringe is itself contained in a blister pack, packaged in a cardboard case.
Dosage and administration: Injection of RenehaVis™ must be performed by qualified and licensed health care personnel who are familiar with intra-articular administration technique. The dosing schedule involves administration into the involved synovial joint space once a week, and treatment can be up to a maximum of three injections, depending on the severity of joint degeneration. Disinfect the injection site with an antiseptic and allow it to dry before giving the injection. In case of effusion, proceed with aspiration before injecting RenehaVis™. The contents of the syringe are sterile and should be injected using a sterile needle preferably of appropriate size (recommended needle type: 25 G). The syringe is equipped with Luer lock (6%). Discard needle and syringe after their use.

 

Directions:

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

 

Contraindications:

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

 

Warnings and precautions:

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

 

Side effects:

Temporary pain and swelling may occur with intra-articular injection. After intra-articular injection of RenehaVis™, a temporary increase in inflammation in the treated synovial joint may occur in patients with inflammatory osteoarthritis. Rarely, an inflammatory reaction may be observed that could be associated with RenehaVis™.

 

Incompatibility:

RenehaVis™ has not been tested for its compatibility with other substances administered by intra-articular injection. Therefore, combination or simultaneous administration with other intra-articular injectables is not recommended.

 

Conservation:

Store between 2°C and 25°C. Do not freeze. Protect from light. Do not use if the package is damaged. Sterile product that can be used only once. Do not use beyond the expiration date.

 

Manufacturer:

Hyaltech Limited, Heriot Watt Research Park, Edinburgh EH14 4AP UK www.hyaltech.com

Licensed by:

MDT Int’l SA