Durolane SJ 20 mg Syringe Hyaluronic Acid Small Joints 1 ml

Durolane SJ 20mg is a CE 0086 class III product intended for intra-articular injections of small or medium-sized joints.

Indications

Durolane SJ 20 mg is indicated for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, 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.

How does Durolane SJ 20 mg work?

The Durolane SJ pre-filled syringe contains 20 mg / ml of non-animal hyaluronic acid stabilized in sodium colride buffered saline pH 7. It 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 according to the same metabolic path as endogenous hyaluronic acid. 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.

How to use and Dosage

Durolane SJ is a single-dose preparation for single injection and must be injected once per treatment. For small joints (wrist, fingers, toes) the dose is 1 ml, while for intermediate joints (elbow, ankle) the dose is 1-2 ml.

Warnings and Contraindications

It must not be injected if the synovial joint is infected or severely inflamed.
It must not be injected if there is 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.
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 does not come 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.
Durolane SJ should be used with caution in patients with venous or lymphatic stasis in the leg.
It has not been tested in pregnant or lactating women or 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 sensitivity of the patient 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: 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 pain relievers or NSAIDs.
The safety and efficacy of Durolane SJ in conjunction with other intra-articular injectable products have not been established.
Durolane SJ should 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 guidance 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 the injection, treat the injection site with alcohol or other antiseptic solution.
Remove any effusion from the joint before injecting Durolane SJ.
The same needle should be used for effusion removal and injection of Durolane SJ.
Use a needle of the appropriate length, preferably measuring 18-25G.
The use of smaller needles leads to an increase in the pressure necessary for the administration of the product.
The discomfort of the injection can be minimized by using topical freezing agents or local anesthetics administered subcutaneously.
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.
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 physiological solution 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.
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.

Ingredients and Composition

Each ml contains: Stabilized hyaluronic acid 20 mg; physiological sodium chloride solution, pH 7 qs

Format

1 sterile 1 ml glass syringe with Luer-lok connector, in blister pack