Description
DUROLANE
Medical device CE 0086 class III.Durolane is intended for use as intra-articular injections for the symptomatic treatment of mild to moderate osteoarthritis of the knee or hip. It is also intended for use as intra-articular injections for the symptomatic treatment of mild to moderate osteoarthritis of the indicated synovial joints and for the reduction of pain following arthroscopic procedures. The product should be injected by a competent physician or in accordance with local legislation. Durolane contains 20 mg/ml of stabilised non-animal hyaluronic acid in sodium chloride buffered saline pH 7. It is a sterile, clear viscoelastic 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 found in body tissues, with particularly high concentrations in synovial fluid and skin. Durolane is composed of biosynthetically produced, purified and stabilised hyaluronic acid. Durolane is assimilated by the body according to the same metabolic pathway as endogenous hyaluronic acid.
Content
Each ml contains:
Stabilized hyaluronic acid 20 mg, sodium chloride saline solution, pH 7 qs
Mode of action
The body's own hyaluronic acid is a natural part of synovial fluid and acts in the joints as both a lubricant for cartilage and ligaments and as a shock absorber. Injections of hyaluronic acid into the joint to restore viscosity and elasticity can reduce pain and improve joint mobility.
Dosage
Durolane is a single-dose preparation for single injection and should be injected only once per treatment. The recommended dose is 3 ml per knee, hip or shoulder joint. The recommended dose is 1-2 ml for intermediate joints (e.g. elbow, ankle) and approximately 1 ml for small synovial joints (e.g. thumb).
Directions
Symptomatic treatment of mild to moderate osteoarthritis of the knee or hip. The product has also been approved for the symptomatic treatment of mild to moderate osteoarthritis of the ankle, shoulder, elbow, wrist, fingers and toes. Durolane is also indicated for the treatment of pain following arthroscopic surgery in both the presence of osteoarthritis and following general surgical repair within 3 months of the procedure.
Contraindications
No known contraindications.
Warnings
- It should not be injected if the synovial joint is infected or severely inflamed.
- It should not be injected if there is skin disease or active infection at or near the injection site.
- It should not be injected intravascularly or extra-articularly or into synovial capsules or tissues.
- Do not resterilize Durolane as this may damage the product.
- It is a single-use product and must not be resterilized. Once the syringe is removed from the packaging, use immediately.
- Do not use the product if the blister pack or syringe is opened or damaged. The syringe and any unused material should be disposed of immediately after the treatment session and should not be reused to avoid the risk of contamination of the unused material and the associated risks of infection. Dispose of the product in accordance with accepted medical practice and current national, local or institutional guidelines.
Precautions
- It should be used with caution in patients with venous or lymphatic stasis in the leg.
- It has not been tested in pregnant or breastfeeding women or in children.
- A single syringe of DUROLANE should be used for each joint to be treated.
- As with any invasive joint surgery, the procedure carries a small risk of infection.
- Durolane should not be injected in patients with known sensitivity to hyaluronic acid products.
- The use of local anesthetics is not recommended in case of allergy or sensitivity of the patient to such products.
- It is not recommended to perform the injection under fluoroscopic control and with the use of a contrast medium in case of allergy or sensitivity of the patient to the contrast medium.
- In clinical studies, the effects of repeat injections into the knee at an interval between the first and second injections of less than 6 months have not been studied.
- An increase in injection pressure may indicate incorrect extra-articular positioning of the needle or excessive filling of the joint.
- The efficacy of Durolane following arthroscopic procedures for diagnostic or examination purposes only has not been established.
- Durolane should be used with caution in patients with pre-existing chondrocalcinosis as the injection may trigger an acute attack of this condition.
Side effects
Most of the side effects reported in the knee and hip clinical studies were described as transient pain, swelling and/or stiffness localized to the joint. These side effects were mild or moderate in intensity and only occasionally required treatment with painkillers or NSAIDs. The use of other hyaluronic acid preparations in other joints did not show additional unique side effects. None of the other reported side effects were interpreted as acute inflammatory arthritis or allergic reaction, nor did they require medical attention in the form of surgery or administration of systemic or intra-articular steroids or antibiotics.
Interactions
The safety and efficacy of Durolane in conjunction with other intra-articular injectable products have not been established.
Administration
General information on administration.
- Durolane must only be injected by a competent physician (or in accordance with local legislation), experienced in the intra-articular injection technique for the synovial joints to be treated, and in clinics appropriately equipped for intra-articular injections.
- It must be injected using an aseptic technique.
- It must be injected exclusively into the joint cavity.
- Intra-articular injection into certain synovial joints requires imaging guidance to ensure accurate placement and to avoid damage to adjacent vital structures.
- The intra-articular injection site with or without image guidance should be chosen so as to avoid damage to adjacent vital structures.
- Before injecting, treat the injection site with alcohol or other antiseptic solution.
- Remove any effusion from the joint before injecting Durolane. The same needle should be used for removal of the effusion and injection of Durolane.
- Use a needle of appropriate length, preferably between 18 and 22 G.
- The use of smaller needles results in an increase in the pressure required to administer the product.
Additional information on the treatment of synovial joints requiring imaging guidance.
- Intra-articular injection into the hip joints should be performed under fluoroscopic (preferably with a contrast medium) or ultrasonographic control to ensure correct positioning of the needle in the joint cavity.
- In other synovial joints, the use of image guidance is at the discretion of the treating physician.
- Injection discomfort can be minimized by using topical freezing agents or local anesthetics administered subcutaneously.
- Image-guided injection should only be performed by physicians experienced in this type of administration.
Additional information for post-arthroscopy treatment.
- Following the arthroscopic procedure, the intra-articular injection must be performed outside the sterile field as the external part of the syringe is not sterile.
- Joints that are commonly subjected to arthroscopic procedures are the knee, hip, shoulder, elbow, ankle, and wrist.
Please inform the patient that:
- as with any invasive joint surgery, it is recommended to avoid strenuous physical activity (e.g. tennis, jogging or long walks) for the first 2 days after the injection.
- During the first week following the injection, some transient reactions related to the injection of Durolane, such as pain and/or swelling/stiffness of mild to moderate intensity, may occur. If the symptoms persist for more than a week, consult a doctor.
Performance
- Clinical studies of Durolane for osteoarthritis of the knee and hip have shown significant mean benefit, such as reduction in knee and hip pain and improvement in physical function compared to baseline clinical values recorded at 6 months after treatment.
- Studies analyzing cases of repeat knee treatment 6 months after the first injection did not show an increase in side effects.
- In controlled trials of Durolane for knee osteoarthritis, significant benefits in responder rate compared to saline and non-inferior results compared to corticosteroid use were observed in a widely adopted, high-efficacy patient population.
- Clinical studies of other hyaluronic acid preparations similar to Durolane in joints other than the knee and hip for the treatment of osteoarthritis and post-arthroscopy indicate average benefits compared to baseline values. Specific studies have also shown improvements in favor of the group treated with hyaluronic acid compared to that of control therapy, for example with saline and corticosteroids. Improvements such as pain reduction and improved physical function were observed at 6 months after treatment.
- The half-life of Durolane in human knees is approximately four (4) weeks.
Storage and expiry
Durolane should be stored in its original packaging at a temperature not exceeding 30 °C. The expiry date is indicated on the packaging and the product should not be used beyond this date. Avoid freezing.
Format
Packaging:
Ddurolane is supplied in a 3 ml glass syringe with Luer-lok connector, in blister packaging. The contents of the syringe are sterile. The outside of the syringe is not sterile.
Code 1082010
