1 ml contains:
Stabilized hyaluronic acid 20 mg
Isotonic saline solution, pH 7 q.s.
Description
DUROLANE* is intended for intra-articular injection for the symptomatic treatment of mild to moderate knee and hip osteoarthritis. Additionally, DUROLANE is intended for intra-articular injection for the symptomatic treatment of mild to moderate osteoarthritis of indicated synovial joints as well as pain following arthroscopic procedures. It must be injected by a licensed physician or according to local regulations.
DUROLANE contains 20 mg/ml stabilized non-animal hyaluronic acid in buffered isotonic saline solution with a pH of 7. DUROLANE is a sterile, transparent viscoelastic gel supplied in a 3-ml glass syringe. The product is intended for single use only.
Hyaluronic acid is identical in all living organisms. It is a natural polysaccharide found in all body tissues, with particularly high Concentrations in synovial fluid and skin. DUROLANE consists of biosynthetically produced hyaluronic acid that has been purified and stabilized. DUROLANE is broken down in the body by the same metabolic processes as endogenous hyaluronic acid.
Mode of action
The body's hyaluronic acid is a natural component of synovial fluid and serves in the joints both as a lubricant for cartilage and tendons and as a shock absorber. Hyaluronic acid injections into the joint to restore viscosity and elasticity can simultaneously relieve pain and improve joint mobility.
Dosage
DUROLANE is a Single-dose preparation in a single-use syringe and may only be injected once per treatment series. The recommended dose is 3 ml per knee, hip, or shoulder joint. The recommended dose is 1–2 ml for compound joints (e.g., elbow or ankle) and about 1 ml for small synovial joints (e.g., thumb).
Indications
Symptomatic treatment of mild to moderate knee and hip osteoarthritis. DUROLANE is also approved for the symptomatic treatment of mild to moderate osteoarthritis pain in ankle, shoulder, elbow, hand, finger, and toe joints. DUROLANE is also indicated for the treatment of pain following arthroscopic procedures on the joint in the presence of osteoarthritis within three months after the procedure.
Contraindications
None known.
Warnings
• DUROLANE must not be used in infected or severely inflamed Synovial joint must not be injected.
• DUROLANE must not be injected in case of active skin disease or infection at or near the injection site.
• DUROLANE must not be injected intravascularly or extra-articularly or injected into the synovial tissue or joint capsule will be.
• DUROLANE must not be re-sterilized, as the product may be damaged. The product may be damaged as a result.
Precautions
• DUROLANE should be used with special caution in patients with venous or lymphatic congestion in the leg.
• The use of DUROLANE in pregnant or breastfeeding women or in children has not yet been studied.
• A separate DUROLANE syringe must be used for each joint to be treated.
• As with all invasive joint treatments, there is a small risk of infection.
• DUROLANE must not be used in patients with known hypersensitivity to the product. Patients must not be injected with products based on hyaluronic acid if they have known hypersensitivity.
• Local anesthetics must not be used in patients with known allergy or hypersensitivity to local anesthetics.
• Injections under fluoroscopic guidance and under Use of a contrast agent is not allowed in known Allergy or hypersensitivity of the patient to should not be performed with the contrast agent.
• Repeat injections into the knee at intervals shorter than 6 months after the initial injection have not yet been studied in clinical trials.
• Increasing injection pressure may indicate that the needle is incorrectly positioned outside the joint or that the joint is overfilled.
• The efficacy of DUROLANE after arthroscopic procedures performed solely for diagnostic or investigative purposes or in the absence of joint osteoarthritis has not been established.
• DUROLANE should be used with caution in patients with existing chondrocalcinosis, as the injection may trigger an acute attack.
Adverse events
Most adverse events reported in clinical studies for the treatment of osteoarthritis of the knee and hip joints were described as temporary pain, swelling, and/or stiffness of the joint. These adverse events were of mild or moderate intensity and required treatment with painkillers or nonsteroidal anti-inflammatory drugs (NSAIDs) in only a few cases.
The use of hyaluronic acid preparations for the treatment of other joints did not lead to any additional specific adverse events.
None of the other reported adverse events were interpreted as acute joint inflammation or allergic reaction. They did not require any medical interventions such as surgical procedures or administration of systemic or intra-articular steroids or antibiotics.
Adverse events must be reported to the regional Bioventus representative.
Interactions
The safety and efficacy of DUROLANE in combination with other intra-articular injection agents have not yet been studied.
Application
General information on use
• DUROLANE may only be injected by a licensed physician (or according to applicable local regulations) familiar with the intra-articular injection technique for the synovial joint being treated, and only in facilities specially equipped for intra-articular injections.
• DUROLANE must be injected under strictly aseptic conditions.
• DUROLANE must only be injected into the joint space. • For intra-articular injection into certain synovial joints, image guidance is required to ensure correct positioning and to avoid damage to adjacent to avoid damage to vital structures.
• With or without image guidance, the injection path for the the intra-articular injection should be chosen to avoid damage to adjacent vital structures.
• Before injection, clean the injection site with alcohol or another suitable antiseptic solution.
• Any existing joint effusion should be removed before injecting DUROLANE. For removing the effusion and injecting DUROLANE, use the same needle.
• The recommended needle gauge is 18 to 22 G; the needle should be chosen sufficiently long.
• Using smaller needles reduces the pressure needed for the pressure required to introduce the product increases.
Additional information on treatment of synovial joints with image guidance
• Intra-articular injection into hip joints should be performed under fluoroscopic control (preferably using may be administered with contrast medium or under ultrasound guidance to ensure correct needle placement in the joint space.
• The decision to treat other synovial joints is made by the treating physician.
• Pain from the injection can be minimized by using topical freezing agents or subcutaneously administered local anesthesia.
• Image-guided injections should only be performed by physicians experienced with such procedures.
Additional information on treatment after arthroscopic procedures
• After the arthroscopic procedure, the intra-articular to perform the injection outside the sterile field because the outside of the syringe is not sterile.
• Joints frequently undergoing arthroscopic procedures
The joints commonly treated are the knee, hip, shoulder, elbow, ankle, and wrist.
Please inform the patient of the following:
• As with all invasive joint treatments, strenuous activities should be avoided for the first two days after the injection (e.g., tennis, jogging, or long walks).
• In the first week after the DUROLANE injection, temporary reactions such as pain and/or swelling/stiffness may occur. They are of mild to moderate intensity. If symptoms persist for more than one week, a doctor should be consulted.
Effect
• Clinical studies on DUROLANE in osteoarthritis of the knee and hip show significant moderate benefits 6 months after treatment significant moderate improvement compared to baseline Benefits such as improvement in pain and mobility of the knee and hip.
• Studies investigating repeated treatments of the knee 6 months after the first injection showed no increase in adverse events.
• Controlled studies of DUROLANE in osteoarthritis of the knee joint showed a significant benefit in responsive patients compared to saline solution and no worse results compared to a corticosteroid in a targeted patient population.
• Clinical studies of other hyaluronic acid products comparable to DUROLANE for the treatment of osteoarthritis as well as after arthroscopic procedures on joints other than the knee and hip showed a moderate benefit compared to baseline. Certain studies also showed improvements in the hyaluronic acid-treated group compared to control therapies such as saline solution and corticosteroids. Improvements in pain and mobility were observed up to 6 months after treatment.
• The half-life of DUROLANE in the human knee is approximately 4 weeks.
Scope of delivery
DUROLANE is supplied in a 3 ml glass syringe with a Luer-Lock connection, packaged in a blister pack. The contents of the syringe are sterile. The outside of the syringe is not sterile.
DUROLANE is intended for single use only and must not be re-sterilized. The product must be used immediately after removing the syringe from its packaging. Opened or damaged blister packs or syringes must not be used.
The syringe and unused material must be disposed of immediately after treatment and must not be reused due to the risk of contamination for unused material and the associated other risks, such as infection risk. When disposing, recognized medical procedures as well as applicable national or local regulations and the guidelines of the respective institution must be observed.
Shelf life and storage
DUROLANE must be stored in its original packaging at temperatures below 30°C. The expiration date is indicated on the packaging. Do not use the product after this date. Protect from frost.
Joint injections
Dermafiller
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