Instructions for Use
Sodium hyaluronate 1.0 %. Viscoelastic solution for injection into the joint cavity for improvement of mobility and pain relief in osteoarthritis. 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® pre-filled syringe are sterile if the sterile barrier is intact. For single use only.
1 pre-filled syringes of 20 mg/2.0 ml, each syringe individually sterile packed.
1 ml isotonic solution (pH 7) contains 10.0 mg sodium hyaluronate, sodium chloride, disodium phosphate, sodium dihydrogen phosphate and water for injections.
Pain and restricted mobility of the knee and other big synovial joints like hip and shoulder.
OSTENIL® should not be used in patients with ascertained hypersensitivity to any of its constituents.
The treatment with OSTENIL® is not recommended in children, pregnant and lactating women or in inflammatory joint diseases such as rheumatoid arthritis or Bechterew disease. In case of joint effusion, the effusion should be reduced first. The national guidelines for intra-articular injections must be observed, this includes thorough disinfection of the injection site and other measures to avoid joint infections. OSTENIL® should be injected accurately into the joint cavity, if necessary, under imaging control. Avoid injections into blood vessels or surrounding tissues.
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 resterilize 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® have been notified yet.
No information on the incompatibility of OSTENIL® with other medical devices and drugs for intra-articular use or oral analgesic or anti-inflammatory drugs have been notified yet.
In very rare cases (less than 1 in 10,000 patients) local secondary phenomena such as pain, feeling of heat, redness, swelling/joint effusion, pruritus and other local incompatibility reactions may occur during or after the injection of OSTENIL®. As with all invasive joint treatments, in very rare cases an infection may occur. It cannot be completely excluded that in very rare cases the intra-articular injection per se causes systemic side effects like tachycardia, hypotension, hypertension, palpitations, nausea and shortness of breath. Those reactions may occur independently from the solution applied. Before injecting OSTENIL®, 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® into the affected joint once a week for a total of 3 – 5 injections. Several joints may be treated at the same time. Depending on the severity of the joint disease the beneficial effects of a treatment cycle of five intra articular injections may last for six months or longer. 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 18 to 25 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® prefilled syringe in the household trash. Follow your community guidelines for the right way to dispose of your sharps disposal container.
CHARACTERISTICS AND MODE OF ACTION:
Synovial fluid, which is viscoelastic due to the presence of hyaluronic acid, is found in all synovial joints, where it ensures normal, painless movement due to its lubricating and shock-absorbing properties. In degenerative joint disorders such as osteoarthritis, the viscoelasticity of the synovial fluid is markedly reduced thereby decreasing its lubricating and shock-absorbing functions. This increases mechanical loading of the joint and cartilage destruction which ultimately results in pain and restricted mobility of the affected joint. Supplementing this synovial fluid with intra-articular injections of highly purified hyaluronic acid can ameliorate the viscoelastic properties of synovial fluid. This improves its lubricating and shock-absorbing functions and reduces mechanical overload of the joint. Clinical trials showed a pain decrease and improvement in joint mobility up to six months.
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.1 pre-filled syringes of 20 mg/2.0 ml, each syringe individually sterile packed.
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® is a medical device. To be used by a clinician experienced and trained in intra-articular injections only.
Last revision date: 2022-01
TRB CHEMEDICA AG
85622 Feldkirchen/Munich, Germany