DUROLANE HYALURONIC ACID GEL 60 MG 3 ML INTRA-ARTICULAR SYRINGE

Description
Class III medical device.
DUROLANE is intended for use by intra-articular injection for the symptomatic treatment of mild to moderate osteoarthritis of the knee or hip and for the reduction of pain following arthroscopic procedures in the presence of osteoarthritis.
DUROLANE is composed of biosynthetically produced, purified and stabilized hyaluronic acid.
DUROLANE is absorbed by the body through the same metabolic pathway as endogenous hyaluronic acid.
Hyaluronic acid is a natural component of synovial fluid and acts as a lubricant for cartilage and ligaments and a shock absorber in joints. Injecting hyaluronic acid into the joint to restore viscosity and elasticity can reduce pain and improve joint mobility.
The product must be injected by a competent physician or in accordance with local legislation.

single-dose preparation for single injection and must be injected only once per treatment.
The recommended dose is 3 ml per knee, hip or shoulder joint.
DUROLANE is indicated for the symptomatic treatment of mild to moderate osteoarthritis of the knee or hip.
DUROLANE 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 the presence of osteoarthritis for three months after the procedure.

Content
20 mg/mL of non-animal hyaluronic acid stabilized in sodium chloride buffered saline pH 7.

Mode of action
Hyaluronic acid is a natural component of synovial fluid and acts as a lubricant for cartilage and ligaments and a shock absorber in joints. Injecting 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).

Warnings
- DUROLANE must not be injected if the synovial joint is infected or severely inflamed.
- DUROLANE should not be injected if you have skin disease or active infection at or near the injection site.
- DUROLANE must not be injected intravascularly or extra-articularly or into synovial capsules or tissues.
- Do not resterilize DUROLANE as this may damage the product.
- DUROLANE should be used with caution in patients with venous or lymphatic stasis in the leg.
- DUROLANE 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-based 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 with an interval between the first and second injections of less than 6 months have not been studied.
- An increase in injection pressure could 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 or in the absence of concomitant osteoarthritis of the joint 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.
DUROLANE 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 open or damaged.

Conservation
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 should not be used after that date. Avoid freezing.
Shelf life in intact packaging: 36 months.

Format
Supplied in a 3 ml glass syringe with a Luer-Lok connector, in a blister pack. The contents of the syringe are sterile. The external part of the syringe is not sterile.

Cod. 1082010