Ostenil®

Sodium hyaluronate 1.0%.
Viscoelastic solution for injection into the joint cavity. Sterile by moist heat.

Composition: Active substance: 1 ml of isotonic solution contains 10.0 mg of sodium hyaluronate. Excipients:  Sodium chloride, sodium monohydrogenphosphate, sodium dihydrogenphosphate and water for injection. The hyaluronic acid in Ostenil® produced by bacterial fermentation is highly purified and contains no animal proteins. 

Indications : Pain and restrictive mobility in degenerative and traumatic changes of the knee joint and other synovial joints.

Dosage and administration: Inject Ostenil® into the affected joint once a week for a total of 3 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 three 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 an intra-articular corticosteroid injection. Treatment with Ostenil® can be started two to three days later.
The contents and outer surface of the Ostenil® pre-filled syringe are sterile as long as the pack remains unbroken. Take the pre-filled syringe out of the pack, remove the Luer Lock cap from the syringe, attach a suitable cannula (for example, 19 or 21 G) and secure it by turning slightly. The new Ostenil® pre-filled syringe does not contain any air bubbles.  

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, and 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 improve the viscoelastic properties of the 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 3 intra-articular injections.

Precautions : Caution should be exercised in patients with known hypersensitivity to drugs. The general precautions for intra-articular injections should be observed. Ostenil® should be injected accurately into the joint cavity. 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 Bekhterev’s disease, treatment with Ostenil® is not recommended in these cases. Do not use if the pre-filled syringe or sterile pack are damaged. Store at a temperature below 25°C. Do not use after the expiry date indicated on the box. Keep out of the reach of children.

Contra-indications : Ostenil® should not be used in patients with ascertained hypersensitivity to one of the constituents.

Possible side effects: Local secondary phenomena such as pain, feeling of heat, redness and swelling may occur in the joint treated with Ostenil®. Application of an ice pack for five to ten minutes onto the treated joint will reduce the incidence of these effects. 

Interactions with other products: No information on the incompatibility of Ostenil® with other solutions for intra-articular 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.

Presentation : One pre-filled syringe of 20mg/2.0 ml of sodium hyaluronate in isotonic solution, in a sterile pack.