Rodiyax®-N

Rodiyax®-N is a sterile, non-pyrogenic, clear, viscoelastic solution containing 30 mg of high molecular weight, ultra-pure natural Hyaluronic acid dissolved in physiological saline that is supplied in a 2 mL single-use prefilled syringe.

Indications

Treatment of pain in osteoarthritis of the joints in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics.

Instructions for use

  • Rodiyax®-N is injected into the joint in a series of intra-articular injections 1 week apart for a total of 3 or 4 injections.
  • After removal of the protective rubber cap on the tip of the syringe, a proper gauge needle (18-21 gauge) should be attached to the tip.
  • This product is for single use only.
  • If symptoms return, repeat courses of Rodiyax®-N may be administered

Contraindications

  • Patients with known hypersensitivity to hyaluronate preparation or to gram-positive bacterial proteins.
  • Patients with infections or skin diseases in the area of the injection site or joint.

Side effects

  • Injection site reactions such as erythema, pain, swelling and transient inflammation.
  • Arthralgia
  • Backache
  • Headache

Warning & Precautions

  • The effectiveness of a single treatment cycle of less than 3 injections has not been established. Pain relief may not be seen until after the third injection.
  • The pre-filled syringe is intended for single use only.
  • The contents of the syringe should be used immediately after opening.
  • Discard any unused Rodiyax®-N. Do not re-sterilize.
  • Do not use Rodiyax®-N if the package has been opened or damaged.
  • Remove joint effusion, if present, before injecting Rodiyax®-N
  • 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.
  • Safety and efficacy of Rodiyax®-N has not been evaluated in pregnant or lactating women or in children.

Storage

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

FAQ

What is Rodiyax®-N?

Rodiyax®-N has a high molecular weight and is ultra-pure and natural hyaluronic acid for intra-articular injection.

How is the mechanism of action of Rodiyax®-N?

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.

What are the ingredients of Rodiyax®-N?

Rodiyax®-N contains 30 mg of high molecular weight, ultra-pure and natural hyaluronic acid dissolved in a physiological sodium chloride solution that is supplied in a 2 mL single-use prefilled syringe.

What are the indications of Rodiyax®-N?

Rodiyax®-N is indicated for the symptomatic treatment of mild to moderate osteoarthritis of the joints in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

How Rodiyax®-N should be administered?

Rodiyax®-N should be injected by a healthcare professional using a healthcare facility-approved aseptic technique. Rodiyax®-N is injected into the joint in a series of intra-articular injections 1 week apart for a total of 3 or 4 injections. 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 the joint synovial space prior to injecting Rodiyax®-N.

What does the packaging of Rodiyax®-N contain?

A 2 mL syringe containing 30 mg high molecular weight hyaluronic acid and a leaflet.

What are the advantages of Rodiyax®-N?

Injecting hyaluronic acid into the joint can restore the viscosity and elasticity of the synovial fluid in joints and alleviate pain while improving joint mobility.

How is the storage condition of Rodiyax®-N?

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

What is the important safety information about Rodiyax®-N?

  • The prefilled syringe is intended for single use only.
  • The contents of the syringe should be used immediately after opening.
  • 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.
  • The syringe and any unused material must be discarded immediately after the treatment session.
  • Transient pain or swelling may occur after the intra-articular injection.
  • Remove joint effusion, if present, before injecting Rodiyax®-N.
  • Safety and efficacy of Rodiyax®-N have not been evaluated in pregnant or lactating women or in children.

Rodiyax®-C

Sterile, transparent viscoelastic gel supplied in a 2 mL single-use prefilled syringe. 

Rodiyax®-C contains 40 mg of natural cross-linked hyaluronic acid stabilized in a physiological sodium chloride solution. 

Indications

Symptomatic treatment of mild to moderate knee, hip, ankle, shoulder, elbow, wrist, fingers, and toes osteoarthritis. Rodiyax®-C is also indicated for pain following joint arthroscopy in the presence of osteoarthritis within three months of the procedure.

Instructions for use

  • Rodiyax®-C should be injected into the joint cavity only.
  • The recommended dose is 2 mL (one syringe) for large joints (e.g., knee, hip, shoulder), 1-2 mL for intermediate joints (e.g., elbow, ankle) and approximately 1 mL for small synovial joints (e.g., thumb).
  • Remove joint effusion, if present, before injecting Rodiyax®-C.
  • The same needle should be used for both removals of effusion and the injection of Rodiyax®-C.
  • The recommended needle size is 18 to 22 G and with adequate length.

Contraindications

  • Rodiyax®-C should not be injected if the patient is known to be sensitive to hyaluronic acid-based products or gram-positive bacterial proteins.

Side effects

  • Some transient pain, swelling and/or stiffness localized to the joint following intra-articular injection can be anticipated.

Warning & Precautions

  • Rodiyax®-C should be used with caution in patients with venous or lymphatic stasis present in the leg.
  • As with any invasive joint procedure, there is a small risk of infection.
  • It is recommended to avoid strenuous activity (e.g., tennis, jogging or long walks) the first two days after the injection.
  • Rodiyax®-C should not be injected if the synovial joint is infected or severely inflamed or if an active skin disease or infection is present at or near the injection site.
  • Rodiyax®-C is intended for single use only and should not be re-sterilized. It should be used immediately after the syringe has been removed from its packaging.
  • If the blister package or syringe is opened or damaged, do not use it.
  • The safety and efficacy of Rodiyax®-C have not been evaluated in pregnant or lactating women or children.

Storage

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

FAQ

What is Rodiyax®-C?

Rodiyax®-C is a sterile, transparent, viscoelastic gel which contains natural cross-linked hyaluronic acid for intra-articular injection.

How is the mechanism of action of Rodiyax®-C?

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.

What are the ingredients of Rodiyax®-C?

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.

What are the indications of Rodiyax®-C?

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.

How Rodiyax®-C should be administered?

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 the joint synovial space prior to injecting Rodiyax®-C.

What does the packaging of Rodiyax®-C contain?

A 2 mL syringe containing 40 mg of high molecular weight cross-linked hyaluronic acid and a leaflet.

What are the advantages of Rodiyax®-C?

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.

How is the storage condition of Rodiyax®-C?

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.

What is the important safety information about Rodiyax®-C?

  • 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 in children.