Instructions for Use
Name of Product
Sodium hyaluronate from fermentation 2.0%.
Visco-elastic solution for peritendinous or intrasheath injection. Sterile by moist heat.
1ml isotonic solution contains 20.0mg sodium hyaluronate from fermentation, sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol and water for injections.
For the treatment of pain and reduced mobility in tendon disorders.
OSTENIL® TENDON should not be used in patients with ascertained hypersensitivity to any of the constituents.
No information on the incompatibility of OSTENIL® TENDON with other medications administered to tendons is available to date.
Local secondary phenomena such as pain, feeling of heat, bruising, redness or swelling may occur following treatment with OSTENIL® TENDON.
Caution should be exercised in patients with known hypersensitivity to drugs. The general precautions for peritendinous and intrasheath injections should be observed. OSTENIL® TENDON should be injected accurately into the tendon sheath or around the affected tendon, if necessary under imaging control. Avoid nerve lesions or injections into blood vessels! As no clinical evidence is available on the use of sodium hyaluronate in children or in pregnant and lactating women, treatment with OSTENIL® TENDON is not recommended in these cases. 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. Store between 2º C and 25º C! Do not use after the expiry date indicated on the box! Keep out of the reach of children!
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. Repeat treatments may be administered as required.
The content and outer surface of the OSTENIL® TENDON pre-filled syringe are sterile as long as the sterile pack remains unbroken. Take the pre-filled syringe out of the sterile pack, unscrew the Luer-LokTM cap, attach a suitable needle (e.g. 25 to 27 G) and secure it by turning slightly. If present remove any air bubble from the syringe prior to injection.
CHARACTERISTICS AND MODE OF ACTION:
A tendon is a robust structure consisting of fibrous tissue designed to transmit power from muscle to bone and to resist load during muscle contraction. Tendons may be surrounded by different structures: e.g. fibrous ligaments, synovial sheaths, tendon sheaths, or bursae. Overuse or inappropriate straining can 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.
The lubricating and visco-elastic properties of OSTENIL® TENDON promote tendon gliding and the physiological repair process. In addition, due to its macro-molecular structure OSTENIL®TENDON reduces the free passage of inflammatory cells and molecules through the tendon sheath.
OSTENIL® TENDON is a transparent solution of natural, 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. In biocompatibility studies OSTENIL®TENDON was found to be particularly safe.
One pre-filled syringe of 40mg/2.0ml OSTENIL® TENDON in a sterile pack.
OSTENIL® TENDON is a medical device. To be used by a clinician only.
Last revision date: November 2011
Manufacturer: TRB Chemedica AG, Germany