DUROLANE SJ

Medical device CE 0086 of class III. Durolane SJ (small joints) is intended for use in intra-articular injections for the symptomatic treatment of osteoarthritis of the synovial joints indicated by mild to moderate and for the reduction of pain following arthroscopic procedures. The product must be injected by a competent physician or in accordance with local legislation. Contains 20 mg / ml of non-animal hyaluronic acid stabilized in physiological sodium colride buffer pH 7. DUROLANE SJ is a sterile clear viscoelastic gel supplied in a 1 ml glass syringe. The product is for single use only. Hyaluronic acid is identical in all living organisms. It is a natural polysaccharide present in the tissues of the body, with particularly high concentrations in the synovial fluid and in the skin. It is composed of biosynthetically produced, purified and stabilized hyaluronic acid. It is assimilated by the body along the same metabolic path as endogenous hyaluronic acid.

Content
Each ml contains:
Stabilized hyaluronic acid 20 mg; physiological sodium chloride solution, pH 7q.s.

Mode of action
The body's hyaluronic acid is a natural part of the synovial fluid and acts in the joints both as a lubricant of cartilages 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 SJ is a single-dose preparation for single injection and must be injected once per treatment. The recommended dose is approximately 1 ml for small synovial joints (wrist, fingers, toes) and 1-2 ml for intermediate joints (elbow, ankle). For joints that require a 2ml injection, an additional syringe of Durolane SJ should be used. For larger joints Durolane is available in a 3ml syringe.

Indications
Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankles, elbow, wrist, fingers, toes. Durolane SJ is also indicated for the treatment of pain following arthroscopy both in the presence of osteoarthritis and following general surgical repair within 3 months of the procedure.

Contraindications
No contraindications ascertained.

Warnings
- It must not be injected if the synovial joint is infected or severely inflamed.
- It must not be injected in the presence of skin disease or active infection at or near the injection site.
- It must not be injected intravascularly or extra-articularly or into capsules or synovial tissues.
- Do not resterilize DUROLANE SJ to avoid damaging the product.
- DurolaneSJ is a single use product and must not be resterilized. Once the syringe is removed from the package, use immediately. Do not use the product if the blister pack or syringe is open or damaged. Durolane SJ is not supplied with needles.
- The syringe and any unused material must be disposed of immediately after the treatment session and must not be reused to avoid the risk of contamination of the unused material and related risks of infection. Dispose of the product in accordance with accepted medical practice and applicable national, local or institutional directives.

Precautions
- Durolane SJ should be used with caution in patients with olymphatic venous stasis in the leg.
- It has not been tested in pregnant or lactating women or in children.
- A single Durolane SJ syringe should be used for each joint to be treated.
- As with any invasive joint surgery, the procedure carries a small risk of infection.
- It must 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 patient sensitivity to these products.
- It is not recommended to perform the injection with 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 repeating injections at an interval of less than 6 months between the first and second injection have not been studied.
- An increase in injection pressure could indicate improper extra-articular positioning of the needle or overfilling of the joint.
- The efficacy of Durolane SJ following arthroscopic procedures for diagnostic or examination purposes only has not been established.
- It should be used with caution in patients with pre-existing chondrocalcinosis as the injection could lead to an acute attack of this condition.

Side effects
Most of the side effects seen in clinical trials were described as transient pain, swelling and / or localized stiffness of the joint. These side effects were mild or moderate in intensity and only occasionally required treatment with an NSAID pain reliever. The use of other hyaluronic acid preparations in other joints did not show additional exclusive side effects. None of the other reported side effects were interpreted as acute inflammatory arthritis or allergic reaction, nor required medical attention in the form of surgery or administration of systemic or intra-articular steroids or antibiotics.

Interactions
The safety and efficacy of Durolane SJ in conjunction with other intra-articular injectable products have not been established.

Administration
General information on administration.
- Durolane SJ must only be injected by a competent physician (or in accordance with local legislation), experienced in intra-articular injection technique for the synovial joints to be treated, and in clinics properly equipped for intra-articular injections.
- It must be injected using aseptic technique.
- It must only be injected into the joint cavity.
- Intra-articular injection into certain synovial joints requires imaging to ensure accurate positioning and to avoid damage to adjacent vital structures.
- The intra-articular injection site with or without imaging guidance should be chosen so as to avoid damage to adjacent vital structures.
- Before injection, treat the injection site with alcohol or other antiseptic solution.
- Remove any effusion from the joint before injecting DUROLANE SJ. The same needle must be used for effusion removal and injection of DUROLANE SJ.
- Use a needle of appropriate length, preferably between 18 and 25 G.
- The use of smaller needles increases the pressure necessary for the administration of the product.
Additional information on synovial joint treatment requiring imaging guidance.
- In synovial joints, the use of image guidance is at the discretion of the treating physician.
- The discomfort of the injection can be minimized by using topical freezing agents or local anesthetics administered subcutaneously.
- Imaging guided injection should only be performed by physicians experienced in this type of administration.
Additional information for post-arthroscopy treatment. - Following the arthroscopic procedure, intra-articular injection must be performed outside the sterile field as the outside of the syringe is non-sterile.
Joints that generally undergo 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 for the first 2 days after the injection.
- During the first week following the injection, some transient reactions related to the injection of Durolane SJ, such as mild to moderate pain and / or swelling / stiffness, may occur.
If symptoms persist for more than a week, see a doctor.

Performance
- Clinical studies of other hyaluronic acid preparations similar to Durolane SJ for the treatment of osteoarthritis and post-arthroscopy indicate average benefits over 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 improvement in physical function were observed 6 months after treatment.
- The half-life of the product is approximately four (4) weeks.

Retention and expiration
Durolane SJ must be stored in its original packaging at a temperature not exceeding 30 ° C. The expiry date is indicated on the package and the product should not be used beyond that date. Avoid freezing.

Format
Packaging:
Durolane SJ is supplied in a 1ml glass syringe with Luer-lok fitting, blister pack. The contents of the syringe are sterile. The outside of the syringe is not sterile.

Cod. 1082004