OSTENIL TENDON SmPC
Instructions for Use
Sodium hyaluronate 2.0 %. Viscoelastic solution for peritendinous or intrasheath injection for improvement of mobility and pain relief in tendon disorders. Transparent solution of natural, highly purified sodium hyaluronate obtained by fermentation.
Devoid of animal proteins. Sterile by moist heat. The content and the outer surface of the OSTENIL® TENDON pre-filled syringe are sterile if the sterile barrier is intact. For single use only.
One pre-filled syringe of 40mg/2.0ml OSTENIL® TENDON in a sterile pack. Needle not included.
1 ml isotonic solution (pH 7) contains 20.0 mg sodium hyaluronate, sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol and water for injections.
For the treatment of pain and restricted mobility in tendons with or without tendon sheath, like Achilles, epicondylus humeri, supraspinatus, patella, peroneal, biceps brachii tendons, as well as the iliotibial band.
OSTENIL® TENDON should not be used in patients with ascertained hypersensitivity to any of the constituents.
The treatment with OSTENIL® TENDON is not recommended in children, pregnant and lactating women or in acute traumas. The general precautions for peritendinous and intrasheath injections must be observed, this includes thorough disinfection of the injection site and other measures to avoid infections. OSTENIL® TENDON should be instilled accurately into the tendon sheath or around the affected tendon, if necessary, under imaging control. Avoid nerve lesions and injections into blood vessels. Do not use if the pre-filled syringe or sterile pack are damaged. Any solution not used immediately after opening must be discarded. Otherwise, the sterility is no longer guaranteed and this may be associated with a risk of infection. Do not resterilise as this may damage the product. No information on the impairment of any diagnostic investigations, such as magnetic resonance imaging, clinical condition assessments, or therapeutic treatments by OSTENIL® TENDON have been notified yet.
No information on the incompatibility of OSTENIL® TENDON with other medical devices and drugs administered to tendons have been notified yet.
In very rare cases (less than 1 in 10,000 patients) local secondary phenomena such as discomfort, pain, feeling of heat, itching, bruising, redness and swelling may occur following treatment with OSTENIL® TENDON. As with all invasive treatments, in very rare cases an infection may occur. Before injecting OSTENIL® TENDON, the patient should be informed about contraindications and undesirable effects.
REPORTING OF SIDE-EFFECTS:
Any serious incident that has occurred in relation to the device should be reported to the manufacturer TRB CHEMEDICA AG and the local competent authority of the user.
DOSAGE AND ADMINISTRATION:
Inject OSTENIL® TENDON around the affected tendon or into the affected tendon sheath once a week for a total of 2 injections. Several tendons may be treated at the same time.
Clinical trials showed a pain decrease and improvement in mobility up to twelve months. The sodium hyaluronate itself is degraded within a few days. Repeat treatment cycles may be administered as required. Take the pre-filled syringe out of the sterile pack, unscrew the Luer lock cap from the syringe, attach a suitable needle with Luer connector (for example 25 to 27 G) and secure it by turning slightly. Remove any air bubble, if present, before injection.
Put the used syringe in a sharps disposal container right away after use. Do not throw away the OSTENIL® TENDON prefilled syringe in the household waste. Follow your community guidelines for the right way to dispose of your sharps disposal container.
CHARACTERISTICS AND MODE OF ACTION:
A tendon is a strong structure of fibrous connective tissue designed to transmit forces from muscle to bone and resist load during muscle contraction. Tendons may be surrounded by different structures: fibrous bands, synovial sheaths, peritendon sheaths, tendon bursae. Overuse or inappropriate biomechanical stress may cause inflammation and/or degenerative changes of the tendon, leading to pain and loss of function.
Lubricating the tendon could reduce pain, improve tendon function and reduce the potential for adhesions.
Because of its lubricating and viscoelastic properties, hyaluronic acid can promote tendon gliding and the physiological repair process. In addition, due to its macromolecular meshwork, hyaluronic acid reduces the free passage of inflammatory cells and molecules. Clinical trials showed a pain decrease and improvement in mobility up to twelve months.
OSTENIL® TENDON is a transparent solution of natural and highly purified sodium hyaluronate obtained by fermentation and is devoid of animal protein.
OSTENIL® TENDON also contains mannitol, a free radical scavenger, which helps to stabilise the chains of sodium hyaluronate.
Store between 2 °C and 25 °C in a dry place, protected from light! Do not use after the expiry date indicated on the box. Keep out of the reach of children.
As long as the EUDAMED database is not fully functional, the SSCP is available to the public on the company’s website www.trbchemedica.de.
OSTENIL® TENDON is a medical device. To be used by a clinician experienced and trained in peritendinous and intrasheath injections only.
Last revision date: 2022-11
TRB CHEMEDICA AG
85622 Feldkirchen/Munich, Germany