Durolane Syringe Intra-articular Hyaluronic Acid Gel 3ml

DUROLANE

CE 0086 class III medical device.
Durolane is a class III medical device. intended for use as intra-articular injections for the symptomatic treatment of mild to moderate osteoarthritis of the knee or hip. In addition, it is It is intended for use as intra-articular injections for the symptomatic treatment of mild to moderate osteoarthritis of the indicated synovial joints and for the relief of pain following arthroscopic procedures. The product must be injected by a competent physician or in accordance with the to local legislation. Durolane contains 20 mg/ml of non-animal hyaluronic acid stabilized in physiological sodium chloride buffer pH 7. a sterile clear viscoelastic gel supplied in a 3ml 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 stabilized hyaluronic acid. Durolane is assimilated by the body according to the same metabolic pathway as endogenous hyaluronic acid.

Contents
Each ml contains:
Stabilised hyaluronic acid 20 mg, sodium chloride saline, pH 7 qs

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 for cartilage and ligaments and as a shock absorber. Injections of hyaluronic acid into the joint to restore viscosity and the elasticity À they can reduce pain and improve range of motion. of the joint.

Dosage
Durolane is recommended for the joint. a single-dose preparation for single injection and should only be injected once per treatment. The recommended dose is 3 ml for 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).
The product must be injected by medical personnel expert.

Indications
Symptomatic treatment of mild to moderate osteoarthritis of the knee or hip. In addition, the product is; It has been approved for the symptomatic treatment of mild to moderate osteoarthritis in the ankle, shoulder, elbow, wrist, fingers and toes. Durolane is also indicated for the treatment of pain following arthroscopic surgery both in the presence of osteoarthritis and following general surgical repair within 3 months of the procedure.

Contraindications
No established contraindications.

Warnings
- It must not be injected if the synovial joint is infected or highly inflamed.
- It must not be injected in the presence of skin disease or active infection at or near the of the injection site.
- It must not be injected intravascularly or extra-articularly or into capsules or synovial tissues.
- Do not resterilize Durolane to avoid damaging the product.
- It is ; a single-use product and must not be re-sterilized. 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. 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 the associated risk of infection. Dispose of the product in accordance with accepted medical practice and applicable national, local or institutional guidelines.

Precautions
- Should be used with caution in patients with venous stasis or lymphatic in the leg.
- It is not; been tested in pregnant or breastfeeding women or in children.
- It is; A single syringe of DUROLANE should be used for each joint being treated.
- As with any invasive joint surgery, the procedure carries a small risk of infection.
- Durolane should not be injected into patients with known sensitivity to products based on hyaluronic acid.
- The use of local anesthetics is not recommended in case of allergy or sensitivity to hyaluronic acid. of the patient to these products.
- It is not recommended to carry out the injection under fluoroscopic control and with the use of a contrast medium in case of allergy or sensitivity to these products. contrast medium.
- In clinical trials, the effects of repeat injections in the knee with an interval between the first and second injection of less than 6 months were not studied.
- An increase injection pressure may indicate incorrect extra-articular needle placement or joint overfilling. been established.
- Durolane 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 knee and hip clinical studies were It has been described as transient pain, swelling and/or stiffness. located at 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 has shown no additional exclusive side effects. None of the other reported side effects were reported. interpreted as acute inflammatory arthritis or allergic reaction, nor was it required medical attention in the form of surgery or the 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 should only be injected by a competent physician (or in accordance with local legislation), experienced in the technique of intra- articular joint for the synovial joints to be treated, and in duly equipped clinics for intra-articular injections.
- It must be injected using an aseptic technique.
- It must only be injected into the cavity of the joint. joint.
- Intra-articular injection into certain synovial joints requires image guidance to ensure accurate placement and to avoid damage to adjacent vital structures.
- The intra-articular injection site with or without image guidance must be chosen so as to avoid damaging adjacent vital structures.
- Before injection, treat the injection site with alcohol or other antiseptic solution.
- Remove any effusion of the joint before injecting Durolane. The same needle should be used for the removal of the effusion and the injection of Durolane.
- Use a needle of appropriate length, preferably between 18 and 22 G.
- The use of larger needles minors leads to an increase in the pressure necessary for the administration of the product.
Additional information on the treatment of synovial joints that require image guidance.
- Intra-articular injection in the The hip joint should be performed under fluoroscopic (preferably with a contrast medium) or ultrasonographic control to ensure correct placement of the needle in the hip cavity. joint.
- In the other synovial joints, the use of image guidance is essential. at the discretion of the doctor performing the treatment.
- The discomfort of the injection can be 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-arthroscopic treatment.
- After the arthroscopic procedure, the intra-articular injection must be performed outside the sterile field as the external part of the syringe is not exposed. 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 intervention on the joint, it is recommended to avoid physical activities. intense physical exertion (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 may occur, such as pain and/or swelling/stiffness of intensity mild to moderate. If symptoms persist for longer than one week, consult a physician.

Benefits
- Clinical trials of Durolane for knee and hip osteoarthritis have shown significant average benefit, such as reducing knee and hip pain and improving functional function. compared to the baseline clinical values recorded 6 months after treatment.
- Studies that analyzed cases of repetition of knee treatment 6 months after the first injection did not report an increase in side effects.< br />- In controlled trials of Durolane for knee osteoarthritis, significant benefits were observed in the “responder rate” compared to saline and non-inferior results compared to using corticosteroids in a widely adopted high efficacy patient population.
- Clinical studies of other hyaluronic acid preparations similar to Durolane on joints other than the knee and hip for the treatment of osteoarthritis and postarthroscopy indicate average benefits compared to baseline values. Specific studies have also demonstrated improvements in favor of the group treated with hyaluronic acid compared to that of control therapy, for example with physiological solution and corticosteroids. At 6 months after treatment, improvements such as reduction of pain and improvement of function were observed. physics.
- 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 expiration date is indicated on the packaging and the product must not be used after this date. Avoid freezing.

Format
Packaging:
Ddurolane is supplied in a 3ml glass syringe with Luer-lok fitting, boxed blister. The contents of the syringe are sterile. The outside of the syringe is not sealed. sterile.