Healthcare Professionals - Prescribing information

RenehaVis

LMW Sodium hyaluronate 15.4mg/0.7ml HMW Sodium hyaluronate 7.0mg/0.7ml

For the relief of the symptoms of osteoarthritis of the knee by providing support and lubrication to the knee joint.

Presentation

RenehaVis™ comprises two clear solutions of sterile sodium hyaluronate, both in phosphate buffered saline contained separately in a two chamber pre-filled syringe enabling a single intra-articular injection into the synovial space of the knee joint.

RenehaVis™ is a sterile pre-filled two-chamber ready to use disposable glass syringe containing:

Chamber 1 Sodium hyaluronate Low Molecular Weight (LMW) 0.7ml sterile 2.2% sodium hyaluronate 1,000,000 Da molecular weight.

Chamber 2 Sodium hyaluronate High Molecular Weight (HMW): 0.7ml sterile 1.0% sodium hyaluronate 2,000,000 Da molecular weight.

RenehaVis™ 0.7ml LMW and 0.7ml HMW, terminally sterilised by moist heat, is enclosed within a ready to use, disposable glass syringe. The syringe is packed within a blister pack and an outer cardboard carton.

Dosage and Administration

Injection of RenehaVis™ should only be administered by a Healthcare Professional trained in the technique.

The dosage regimen is injection into the affected synovial joint space once a week for up to three injections depending on the severity of the degenerative change to the knee joint.

Clean the skin around the injection site with antiseptic and allow to dry before injection is given

If joint effusion is present it should be aspirated before injection of RenehaVis™.

The contents of the syringe are sterile and should be injected using a sterile needle of an appropriate size (25 gauge needle is recommended). The syringe is fitted with a Luer lock (6%).

Discard the syringe and needle after single use.

Uses

For the relief of pain and stiffness of the knee joint in patients with degenerative changes to the synovial joint.

The duration of effect in patients with grade 1 to 3 medial compartment osteoarthritis has been demonstrated to be up to twelve (12) months.

The performance of RenehaVis™ is due to its biocompatibility and physiochemical properties. The LMW and HMW sodium hyaluronate contained in RenehaVis™ is a biopolymer composed of multiple disaccharide units of N-acetylglucosamine and glucuronic acid. Although biosynthesised by the bacterium Streptococcus equi it has been shown to be physiologically identical to the sodium hyaluronate which is found in the human body. RenehaVis™ supplements the endogenous Sodium Hyaluronate found naturally in the synovial fluid but which has become depleted by degenerative and traumatic changes to the synovial joint.

Contra-indications

Do not inject RenehaVis™ if the area of the injection is infected or where there is any evidence of skin disease.

Patients with known sensitivity to sodium hyaluronate.

Warnings and Precautions

Do not use if packaging has been damaged. Do not use after the expiry date.

Sodium hyaluronate is manufactured by fermentation of Streptococcus equi and rigorously purified. However, the physician should consider the immunological and potential risks that can be associated with the injection of any biological material.

Do not use with children.

Follow national or local guidelines for the safe use and disposal of needles. Obtain prompt medical attention if injury occurs.

Adverse Reactions

Transient pain and swelling may occur with intra-articular injections.

Transient increases in inflammation in the injected synovial joint following injection of RenehaVis™ may occur in patients with inflammatory osteoarthritis.

Very occasionally an inflammatory reaction could occur which may or may not be associated with RenehaVis™.

Incompatibilities

RenehaVis™ has not been tested for compatibility with other substances for intra-articular injection. Therefore the mixing or simultaneous administration with other intra-articular injectables is not recommended.

Storage

Store between 2°C and 25°C. Do not freeze. Protect from light.
Do not use if sterile packaging has been damaged.
Sterile product for single use only.
Do not use after expiry date.