Rodiyax^®-C – Cross-linked Hyaluronic Acid

Hyaluronic acid occurs naturally in the synovial fluid of human joints, acting as a lubricant and shock absorber for cartilage and ligaments. Synovial fluid in joints affected by osteoarthritis has a much lower viscosity and elasticity than in healthy joints. Injecting hyaluronic acid into the joint can restore these properties and alleviate pain while improving joint mobility.

Rodiyax^®-C contains 40 mg of high molecular weight cross-linked hyaluronic acid stabilized in a physiological sodium chloride solution supplied in a 2 mL single-use prefilled syringe.

Rodiyax^®-C is indicated for symptomatic treatment of mild to moderate joint osteoarthritis. Rodiyax^®-C is also indicated for pain reduction following joint arthroscopy in the presence of osteoarthritis within 3 months of the procedure.

Rodiyax^®-C is for single dose intra-articular injection and should be injected by a healthcare professional using a healthcare facility-approved aseptic technique. After removal of the protective rubber cap on the tip of the syringe, securely attach a proper gauge needle (18-22 gauge) to the tip by a healthcare professional using a healthcare facility-approved aseptic technique. The healthcare provider should ensure proper penetration into joint synovial space prior to injecting Rodiyax^®-C.

A 2 mL syringe containing 40 mg of high molecular weight cross-linked hyaluronic acid stabilized in a physiological sodium chloride solution and a leaflet.

A single Injection of cross-linked hyaluronic acid into the joint can restore the viscosity and elasticity of the synovial fluid in joints and provides long-term pain relief while improving joint mobility.

• Rodiyax^®-C should be stored in its original package at a temperature of 2-25°C and protected from freezing.
• Refrigerated Rodiyax^®-C should be allowed to reach room temperature (approximately 20 to 45 minutes) prior to use.

• Rodiyax^®-C should be used with caution in patients with venous or lymphatic stasis present in the leg.
• Rodiyax^®-C should not be injected if the synovial joint is infected or severely inflamed or if there is an active skin disease or infection present at or near the injection site.
• The prefilled syringe is intended for single use only.
• The contents of the syringe should be used immediately after opening.
• The syringe and any unused material must be discarded immediately after the treatment session.
• Do not re-sterilize the syringe.
• It is recommended that patients avoid strenuous activity or prolonged (i.e., more than one hour) weight-bearing activities such as running or tennis within 48 hours following the intra-articular injection.
• If the blister package or syringe is opened or damaged, do not use it.
• Transient pain or swelling may occur after the intra-articular injection.
• Remove joint effusion, if present, before injecting Rodiyax^®-C.
• Safety and efficacy of Rodiyax^®-C have not been evaluated in pregnant or lactating women or children.

The cross-linking of several strands of linear hyaluronic acid forms cross-linked hyaluronic acid. This structure makes the hyaluronic acid molecule less prone to degradation by the body’s enzymes. Therefore, cross-linked hyaluronic acid has a higher molecular weight, enhanced stability, and longer persistence than linear hyaluronic acid.
Linear hyaluronic acid is converted into cross-linked hyaluronic acid in a laboratory environment under specific temperature and pH conditions using special materials known as cross-linkers.
Studies have shown that injecting a single dose of cross-linked hyaluronic acid into the joints of patients with osteoarthritis has reduced patient’s pain for an extended period.