Rodiyax^®-T

The injection of cross-linked hyaluronic acid into the joints is thought to lubricate the cartilage, which provides long-term pain relief for patients with osteoarthritis. Rodiyax^®-T also includes an ancillary steroid to provide additional short-term pain relief.

Sterile, white gel containing 44 mg cross-linked hyaluronic acid + 9 mg Triamcinolone Hexacetonide (TH), that is supplied in a 2 mL single-use prefilled syringe. The cross-linked hyaluronic acid and TH in Rodiyax^®-T do not physically or chemically interact, as micronized particles of the TH are suspended in the viscoelastic hyaluronic acid gel and reside in the product as a separate solid phase.

Rodiyax^®-T is indicated as a viscoelastic supplement or a replacement for synovial fluid in human joints to relieve the symptoms of osteoarthritis.

Rodiyax^®-T 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 (18-21 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^®-T.

A 2 mL syringe containing 44 mg of cross-linked hyaluronic acid + 9 mg Triamcinolone Hexacetonide and a leaflet.

The single injection of Rodiyax^®-T provides long-term pain relief for patients with osteoarthritis due to its cross-linked hyaluronic acid part. Rodiyax^®-T also includes an ancillary corticosteroid to provide additional short-term pain relief.

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

• Rodiyax^®-T should be used with caution in patients suffering from conditions like hypertension, osteoporosis, psychosis, and Cushing’s syndrome.
• Rodiyax^®-T 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.
• If the blister package or syringe is opened or damaged, do not use it.
• The syringe and any unused material must be discarded immediately after the treatment session.
• Do not re-sterilize the syringe.
• Transient increases in inflammation in the injected joint have been reported in some patients with inflammatory osteoarthritis.
• Remove joint effusion, if present, before injecting Rodiyax^®-T.
• Menstrual irregularities may occur, and in postmenopausal women, vaginal bleeding has been observed.
• This product contains sorbitol. Patients with very rare hereditary problems of fructose intolerance should not use this product.
• Safety and efficacy of Rodiyax^®-T have not been evaluated in pregnant or lactating women or in 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.

Rodiyax^®-T contains 9 mg of Triamcinolone Hexacetonide. Due to the use of advanced technology in the manufacturing process, the cross-linked hyaluronic acid and Triamcinolone Hexacetonide do not interact physically or chemically. The micronized particles of Triamcinolone Hexacetonide are suspended within the viscoelastic hyaluronic acid gel.
This ensures a uniform and sustained release of Triamcinolone Hexacetonide within the joint.