DURLAND

Medical device CE 0086 class III.
Durolane is intended for use in intraarticular injections for symptomatic treatment of osteoarthritis of the knee or hip from mild to moderate. In addition, it is intended for use in intraarticular injections for the symptomatic treatment of osteoarthritis of synovial joints indicated by mild to moderate and for the reduction of pain following arthritis procedures. The product must be injected by a competent physician or in accordance with local legislation. Durolane contains 20 mg/ml of non-animal hyaluronic acid stabilized in physiological solution pH 7 sodium chloride buffer. It is a sterile transparent viscoelastic gel provided in a 3 ml glass syringe. The product is exclusively disposable. Hyaluronic acid is identical in all living organisms. It is a natural polysaccharide present in the body tissues, with particularly high concentrations in the synovial liquid and in the skin. Durolane is composed of hyaluronic acid produced biosynthetically, purified and stabilized. Durolane is assimilate by the body according to the same metabolic path of endogenous hyaluronic acid.

Content
Each ml contains:
Hyaluronic acid stabilized 20 mg, physiological solution of sodium chloride, pH 7 q.s.

Mode of action
Hyaluronic acid of the body is a natural part of the synovial liquid and acts in the joints both as lubrication of cartilage and ligaments and as a shock absorber. Hyaluronic acid injections in the joint to restore viscosity and elasticity can reduce pain and improve joint mobility.

Dosage
Durolane is a single injection monodose preparation and must be injected once for treatment. The recommended dose is 3 ml for knee joint, hip or shoulder. The recommended dose is 1-2 ml for intermediate joints (e.g., elbow, ankle) and about 1 ml for small synovial joints (e.g. thumb).

Indications
Syntomatic treatment of osteoarthritis of the knee or hip from mild to moderate. In addition, the product has been approved for the symptomatic care of light to moderate osteoarthritis in the ankle, shoulder, elbow, wrist, fingers and foot. Durolane is also indicated for the treatment of pain following an arthroscopy intervention both in the presence of osteoarthritis and following general surgical repair within 3 months of the procedure.

Contraindications
No contraindications.

Warnings
- It should not be injected if the synovial joint is infected or strongly inflamed.
- It should not be injected in the presence of dermopathy or active infection in correspondence or near the injection site.
- It should not be injected intravascularly or extra-articularly or in capsules or synovial tissues.
- Do not resterilize Durolane in order to avoid damaging the product.
- Ès a disposable product and should not be resterilized. Once you remove the syringe from the package, use immediately.
- Do not use the product if the blister packaging or syringe are open or damaged. The syringe and any unused material must be disposed of immediately after the treatment session and should not be reused to avoid the risk of contamination of the unused material and its risks of infection. Dispose of the product according to accepted medical practice and the current national, local or institutional directives.

Precautions
- It must be used with caution in patients with venous or lymphatic stasis in the leg.
- It was not tested in pregnant or nursing women or children.
- You need to use a single DUROLANE syringe for each joint to be treated.
- As with any invasive intervention on jointing, the procedure involves a slight risk of infection.
- Durolane should not be injected into patients with proven sensitivity to products based on hyaluronic acid.
- We do not recommend the use of local anesthetics in case of allergy or sensitivity of the patient to such products.
- We do not recommend injection with fluoroscopic control and using a contrast medium in case of allergy or patient sensitivity to the contrast medium.
- In clinical studies, the effects of repeating injections in the knee were not studied at a interval between the first and the second injection below 6 months.
- An increase in injection pressure may indicate an incorrect extra-articular positioning of the needle or excessive filling of the joint.
- Durolane's effectiveness after arthroscopic procedures for diagnostic or examination purposes was not established.
- Durolane should be used with caution in patients with pre-existing chondrocalcinosis as injection may result in acute attack of such a condition.

Side effects
Most of the side effects found in clinical studies of the knee and hip were described as transient pain, swelling and/or stiffness localized to the joint. Such side effects were mild or moderate intensity and only occasionally required treatment with painkillers or NSAIDs. The use of other preparations of hyaluronic acid in other joints did not show any additional exclusive side effects. None of the other reported side effects has been interpreted as acute arthritis or allergic reaction, nor has it required medical attention in the form of surgery or administration of systemic or intraarticorial steroids or antibiotics.

Interactions
Durolane’s safety and effectiveness have not been established in conjunction with other intra-articular injectable products.

Administration
General information on administration.
- Durolane must be injected exclusively by a competent physician (or in accordance with local legislation), expert in the intra-articular injection technique for the synovial joints to be treated, and in duly equipped clinics for intra-articocular injections.
- It must be injected by adopting an aseptic technique.
- It must be injected exclusively in the joint cavity.
- Intra-articular injection in certain synovial joints requires guidance through images to ensure accurate positioning and to avoid damaging adjacent vital structures.
- The intra-articular injection site with or without guidance through images 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. For the removal of the efffusion and the injection of Durolane must be used the same needle.
- Use an appropriate length needle, preferably between 18 and 22 G.
- The use of smaller needles entails an increase in the pressure required for product administration.
Additional information on the treatment of synovial joints requiring guidance through images.
- The intra-articular injection of the hip joints must be carried out under fluoroscopic control (preferably with a contrast medium) or ultrasound to ensure the correct positioning of the needle in the joint cavity.
- In other synovial joints, the use of guidance through images is at the discretion of the doctor who performs the treatment.
- The discomfort of the injection can be reduced to a minimum by using topical or local anesthetic agents administered subcutaneously.
- Image-driven injection must only be performed by experienced doctors in this type of administration.
Additional information for post-artroscopy treatment.
- After the arthroscopic procedure, intra-articular injection must be performed outside the sterile field as the outer part of the syringe is not sterile.
- The joints that are generally subjected to arthroscopic procedures are knee, hip, shoulder, elbow, ankle and wrist.
Please inform the patient that:
- as for any invasive intervention on the articulation, it is recommended to avoid intense physical activities (e.g. tennis, jogging or long walks) for the first 2 days after injection.
- During the first week after injection, some transient reactions related to Durolane injection may occur, such as pain and/or swelling/rigidity of mild to moderate intensity. If symptoms persist for more than a week, consult a doctor.

Benefits
- Durolane's clinical studies for knee and hip osteoarthritis have made a significant average benefit, such as reducing knee and hip pain and improving physical functionality compared to clinical values at 6 months away from treatment.
- Studies that analyzed cases of repetition of the treatment to the knee 6 months after the first injection did not record an increase of the side effects.
- In the controlled experiments of Durolane for the osteoarthritis of the knee, considerable benefits were observed in the “responder rate” regarding the physiological solution and results not lower than the use of corticosteroids in a population of highly effective patients widely adopted.
- Clinical studies of other preparations of hyaluronic acid similar to Durolane on joints other than knee and hip for osteoarthritis treatment and post-arthritis indicate average benefits compared to basal values. Specific studies have also shown improvements to the group treated with hyaluronic acid compared to that of control therapy, for example with physiological and corticosteroid solution. Improvements such as pain reduction and improvement of physical functionality were observed at 6 months from treatment.
- Durolane halving time in human knees is about four (4) weeks.

Conservation and expiry
Durolane must be preserved 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 that date. Avoid freezing.

Format
Packaging:
the Ddurolane comes in a 3 ml glass syringe with Luer-lok fitting, in blister pack. The content of the syringe is sterile. The outer part of the syringe is not sterile.

Cod. 1082010