Instructions for Use
Sodium hyaluronate from fermentation 1.0 %. Viscoelastic solution for injection into the joint cavity. Sterile by moist heat.
One pre-filled syringe of 20 mg / 2.0 ml OSTENIL® in a sterile pack. OSTENIL® is a medical device. To be used by a clinician only.
1 ml isotonic solution contains 10.0 mg sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, water for injections.
Pain and restricted mobility in degenerative and traumatic changes of the knee joint and other synovial joints.
OSTENIL® should not be used in patients with ascertained hypersensitivity to any of its constituents.
No information on the incompatibility of OSTENIL® with other solutions for intraarticular use is available to date. The concomitant use of an oral analgesic or anti-inflammatory drug during the first few days of treatment may be helpful for the patient.
In very rare cases local and general secondary phenomena such as pain, feeling of heat, redness, inflammation, swelling/joint effusion, tachycardia, hypertension, hypotension, shortness of breath, nausea and pruritus may occur during or after the injection of OSTENIL®.
(Please follow this link to read TRB Chemedica UK's official statement regarding hypo- or hypertension following injection with OSTENIL®.)
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 will last at least six months. Repeat treatment cycles may be administered as required. In case of joint effusion it is advisable to reduce the effusion by aspiration, rest, application of an ice pack and /or intra-articular corticosteroid injection. Treatment with OSTENIL® can be started two to three days later.
The content and the outer surface of the OSTENIL® pre-filled syringe are sterile as long as the sterile pack is intact. Take the pre-filled syringe out of the sterile pack, unscrew the Luer lock cap from the syringe, attach a suitable needle (for example 19 to 21 G) and secure it by turning slightly. Remove any air bubble, if present, before injection.
Caution should be exercised in patients with known hypersensitivity to drugs. As with all invasive joint treatments in very rare cases an infection may occur. Hence, the general precautions for intra-articular injections should be observed, including 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! As no clinical evidence is available on the use of hyaluronic acid in children, pregnant and lactating women or in inflammatory joint diseases such as rheumatoid arthritis or Bechterew disease, treatment with OSTENIL® 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 and this may be associated with a risk of infection. Store between 2 °C and 25 °C! Do not use after the expiry date indicated on the box. Keep out of the reach of children.
CHARACTERISTICS AND MODE OF ACTION:
Synovial fluid, which is viscoelastic due to the presence of hyaluronic acid, is found in all synovial joints, particularly the large weight bearing joints, where it ensures normal, painless movement due to its lubricating and shock-absorbing properties. It is also responsible for the nutrition of the cartilage. 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. As a rule this results in a decrease in pain and an improvement in joint mobility which may last for several months after a treatment cycle of five intra-articular injections.
Last revision date: 2017-03.
TRB CHEMEDICA AG
85622 Feldkirchen/Munich, Germany