Sodium hyaluronate 1.0%. Viscous-elastic solution for injection into small joints to improve mobility and relieve pain in osteoarthritis. Transparent solution made from natural, highly purified sodium hyaluronate obtained by fermentation. Free from animal proteins. Sterilized with moist heat. The content and the outer surface of the OSTENIL® MINI prefilled syringe are sterile as long as the sterile barrier is intact. For single use only.
Composition:
1 ml isotonic solution (pH 7) contains 10.0 mg sodium hyaluronate, sodium chloride, disodium phosphate, sodium dihydrogen phosphate, and water for injection purposes.
Indications:
Pain and limited mobility due to degenerative and traumatic changes in small synovial joints, e.g., facet joints of the lumbar spine, thumb saddle joint, proximal joint of the big toe, and temporomandibular joint.
Contraindications:
OSTENIL® MINI must not be administered to patients with known hypersensitivity to any of the components of the product.
Precautions:
Treatment with OSTENIL® MINI is not recommended for children, pregnant or breastfeeding women, or patients with inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis. If a joint effusion is present, it should be reduced first. National guidelines for intra-articular injections must be followed, including thorough disinfection of the injection site and other measures to prevent joint infections. OSTENIL® MINI should, if necessary under imaging guidance, be injected precisely into the joint space. Avoid injections into blood vessels or surrounding tissue. Do not use if the prefilled syringe or sterile packaging is damaged. Any solution not used immediately after opening must be discarded. Otherwise, sterility cannot be guaranteed, which may increase the risk of infection. Do not resterilize, as this may damage the product. There is currently no information on interference with diagnostic procedures such as MRI, clinical assessments, or therapeutic treatments by OSTENIL® MINI.
Interactions: There is currently no information on incompatibility of OSTENIL® MINI with other medical devices and drugs for intra-articular use or with oral analgesics or anti-inflammatory drugs.
Side effects:
In very rare cases (less than 1 in 10,000 patients), local reactions such as pain, warmth, redness, swelling/joint effusion, and tachycardia (rapid heartbeat) may occur during or after injection of OSTENIL® MINI. As with all invasive joint treatments, infection may occur in very rare cases. Patients should be informed about contraindications and side effects before injection of OSTENIL® MINI.
Reporting side effects:
Any serious incident related to the medical device must be reported to the manufacturer TRB CHEMEDICA AG and the responsible local authority of the user.
Dosage and administration:
Inject OSTENIL® MINI 1 to 3 times at weekly intervals into the affected joint. Multiple joints can be treated simultaneously. Depending on the severity of the joint disease, the positive effect of a treatment cycle of three intra-articular injections can last at least six months. Sodium hyaluronate itself is broken down within a few days. If necessary, the treatment cycle can be repeated. Remove the prefilled syringe from the sterile packaging, remove the Luer Lock cap from the syringe, attach a suitable needle with Luer connection (e.g., 18 to 25 G), and lock it by slight rotation. Remove any air bubbles from the syringe before injection.
Disposal:
Dispose of the syringe immediately after use in an appropriate safety container. Do not dispose of the OSTENIL® MINI prefilled syringe in household waste. Follow local regulations for proper disposal of the safety container.
Properties and mode of action:
Synovial fluid, which behaves viscoelastically due to the presence of hyaluronic acid, is found in all synovial joints, where it ensures normal, pain-free movement due to its lubricating and cushioning properties. In degenerative joint diseases such as osteoarthritis, the viscoelasticity of synovial fluid is significantly reduced, impairing its lubricating and cushioning functions. This increases mechanical stress on the joint and cartilage destruction, ultimately leading to pain and restricted mobility of the affected joint. Supplementing this synovial fluid by intra-articular injections with highly purified hyaluronic acid can improve the viscoelastic properties of the synovial fluid. Lubricating and cushioning properties are enhanced, and mechanical overload of the joint is reduced. Clinical studies have shown pain relief and improved joint mobility for up to six months.
Storage:
Store in a dry, light-protected place at 2°C to 25°C! Do not use after the expiration date indicated on the packaging. Keep out of reach of children.
Dosage form:
1 prefilled syringe containing 10 mg/1.0 ml OSTENIL® MINI in sterile packaging.
As long as the EUDAMED database is not fully operational, the Safety and Clinical Performance Report (SSCP) is available to the public on the company website www.trbchemedica.de.
OSTENIL® MINI is a medical device. It may only be used by a physician experienced and trained in intra-articular injections.
Date of last revision: 2022-04
Joint injections
Dermafiller
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