DUROLANE INTRA JOINT GEL SYRINGE 3ML

Some potential benefits of DUROLANE® for people affected by osteoarthritis:

- Simple and quick to administer
- Long-term relief of osteoarthritis pain
- Treats the affected joint directly
- A non-drug alternative to taking tablets
- Treatment by your doctor can be repeated as needed
- May help avoid or delay prosthetic hip or knee surgery
- DUROLANE has been developed specifically to produce a treatment administered in a single injection, to treat the symptoms of osteoarthritis

Description of Durolane® Intra Joint Gel

Box of 1 x 3ml pre-filled single use glass syringe with luer-lock tip, blister packed.

Contains 20mg/ml of non-animal stabilized hyaluronic acid (NASHA) in a physiological sodium chloride buffer solution of pH 7

Forms, Presentations

Viscoelastic gel for intra-articular injection, sterile:
Pre-filled glass syringe of 3 ml, with luer-lock tip, blister-packed. Single use. Unit box (ACL code 3401077617592).

The outside of the syringe is not sterile. The contents of the syringe are sterile.

Composition of Durolane®

Physiological solution of sodium chloride, pH 7 qsp 3 ml.

How Durolane® is used

Intra-articular injections for the symptomatic treatment of mild to moderate arthritis of the knee and hip joints.

Durolane has also been approved for the symptomatic treatment of mild to moderate osteoarthritis pain of the ankles, shoulders, elbows, wrists, fingers and toes.

Durolane is also indicated for the treatment of pain following joint arthroscopy in the presence of osteoarthritis within three months of the procedure.

No known contraindications.

Properties of Durolane

Durolane contains 20 mg/mL of non-animal hyaluronic acid stabilized in a physiological buffer solution of sodium chloride adjusted to pH 7. Durolane is a sterile, viscoelastic, transparent gel supplied in a 3 mL glass syringe. The product is for single use only.

Hyaluronic acid is identical in all living organisms. It is a natural polysaccharide that is present in all body tissues and is particularly concentrated in synovial fluid and the skin. Durolane is composed of biosynthetic hyaluronic acid that has been purified and stabilized.

How Durolane® works

The body's own hyaluronic acid is a natural part of the synovial fluid and acts in the joints as a lubricant for cartilage and ligaments and as a shock absorber. Injections of hyaluronic acid to restore viscosity and elasticity in the joint can reduce pain and improve joint mobility.

Durolane is broken down in the body by the same metabolic pathway as endogenous hyaluronic acid.

Durolane® performance

- Clinical studies on the use of Durolane in gonarthrosis and coxarthrosis indicate significant average benefits, including an improvement in knee and hip pain and physical function compared to baseline 6 months after treatment.

- Studies analyzing repeat treatment on the knee 6 months after the initial injection did not indicate an increase in the level of adverse events.

- Controlled trials of Durolane in gonarthrosis indicate significant benefits in the responder, compared to non-inferiority results and saline when compared to corticosteroids in a patient population in which its efficacy has been widely proven.

- Clinical studies of other hyaluronic acid preparations similar to Durolane in joints other than the knee and hip for the treatment of osteoarthritis and in post arthroscopy indicate moderate benefits compared to baseline. Several studies have also shown improvements in the group treated with hyaluronic acid compared to the group treated with a control treatment such as saline and corticosteroids. Pain relief and improved physical function were observed at 6 months post-treatment.

- The half-life of Durolane in the human knee is approximately 4 weeks.

Directions for use Durolane® Intra-articular gel syringe 3ml

Dosage:

Durolane is a preparation consisting of a single injection of a single dose; this product should only be injected once per treatment. The recommended dose is 3 mL per hip, knee or shoulder joint. The recommended dose is 1 to 2 mL for intermediate joints (e.g. elbow, ankle) and approximately 1 mL for small synovial joints (thumb).

This product should be injected by a licensed physician or in accordance with local legislation.

General Administration Information :

- Durolane should only be injected by a licensed physician (or in accordance with local legislation) who is familiar with intra-articular injection techniques into the synovial joints to be treated, using facilities suitable for intra-articular injections.

- Durolane should be injected using strict aseptic technique.

- Durolane should be injected only into the joint cavity.

- Intra-articular injection requires imaging guidance in some synovial joints to ensure accurate positioning and to avoid damage to adjacent vital structures.

- The route of the image-guided or non-image-guided intra-articular injection should be chosen to avoid adjacent vital structures.

- The injection site should be disinfected with alcohol or other appropriate antiseptic solution before injection.

- Remove any joint effusion before injecting Durolane.

- The recommended needle size is 18-22 G and the length should be adequate.

- The use of smaller needles increases the pressure required to deliver the product.