OSTENIL® TENDON
Sodium hyaluronate 2.0%. Viscoelastic solution for peritendinous injection or injection into the tendon sheath to improve mobility and relieve pain in tendon disorders. Transparent solution made from natural, highly purified sodium hyaluronate obtained by fermentation. Free of animal proteins. Sterilized with moist heat. The content and the outer surface of the OSTENIL® TENDON prefilled syringe are sterile as long as the sterile barrier is intact. For single use only.
Composition:
1 ml isotonic solution (pH 7) contains 20.0 mg sodium hyaluronate, sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol, and water for injection purposes.
Indications:
For the treatment of pain and restricted mobility of tendons with or without involvement of the tendon sheath such as Achilles tendon, tendon at the humeral epicondyle, supraspinatus, patella, peroneal, biceps tendon, as well as iliotibial band.
Contraindications:
OSTENIL® TENDON must not be administered to patients with known hypersensitivity to any of the components of the product.
Precautions:
The use of OSTENIL® TENDON in children, pregnant and breastfeeding women, as well as in acute injuries, is not recommended. The general precautions for peritendinous injections and injections into the tendon sheath, including thorough disinfection of the injection site and other measures to prevent infections, must be observed. OSTENIL® TENDON must be correctly injected into the tendon sheath or correctly injected around the affected tendon, if necessary under imaging guidance. Avoid nerve injuries and injections into blood vessels. Do not use if the prefilled syringe or sterile packaging is damaged. Any solution not used immediately after opening must be discarded. Otherwise, sterility can no longer be guaranteed, which may be associated with a risk of infection. Do not resterilize as this may damage the product. There is currently no information on impairment of diagnostic examinations such as magnetic resonance imaging, clinical assessments, or therapeutic treatments by OSTENIL® TENDON.
Interactions:
There is currently no information available on incompatibility of OSTENIL® TENDON with other medical devices and drugs applied to the tendon.
Side effects:
In very rare cases (in fewer than 1 in 10,000 patients), local side effects such as discomfort, pain, warmth, itching, bruising, redness, and swelling may occur after the use of OSTENIL® TENDON. As with all invasive treatments, infection may occur in very rare cases. Patients should be informed about contraindications and side effects before injection of OSTENIL® TENDON.
Reporting of 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 method of administration:
Inject OSTENIL® TENDON twice in total at weekly intervals around the affected tendon or into the affected tendon sheath. Multiple tendons can be treated simultaneously. Clinical studies showed a reduction in pain and improvement in mobility for up to twelve months. Sodium hyaluronate itself is broken down within a few days. Repeat treatment cycles are possible if needed. 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., 25 to 27 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® TENDON prefilled syringe in household waste. Follow local regulations for proper disposal of the safety container.
Properties and mode of action:
A tendon is a robust structure made of fibrous connective tissue designed to transmit forces from muscles to bones and withstand tension during muscle contraction. Tendons can be surrounded by different structures: fibrous ligaments, synovial sheaths, tendon sheaths, bursae. Overuse or incorrect loading can cause inflammation and/or degenerative changes in the tendon, leading to pain and loss of function. Making the tendon more glidable could reduce pain, improve tendon function, and decrease the possibility of adhesions.
Due to its lubricating and viscoelastic properties, hyaluronic acid can support the gliding ability of tendons as well as the physiological regeneration process. Additionally, hyaluronic acid reduces the free passage of inflammation-promoting cells and molecules due to its macromolecular network structure. Clinical studies showed pain relief and improved mobility for up to twelve months.
OSTENIL® TENDON is a clear solution of natural, highly pure sodium hyaluronate obtained by fermentation and free of animal proteins. OSTENIL® TENDON also contains mannitol, a free radical scavenger that helps stabilize the sodium hyaluronate chains.
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:
One prefilled syringe 40 mg/2.0 ml OSTENIL® TENDON in sterile packaging.
As long as the EUDAMED database is not fully operational, the summary report on safety and clinical performance (SSCP) is available to the public on the company website www.trbchemedica.de.
OSTENIL® TENDON is a medical device. It may only be used by a physician experienced and trained in peritendinous injections and injections into the tendon sheath.
Date of last revision: 2022-11
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