OSTENIL MINI.

INSTRUCTIONS FOR USE

Sodium hyaluronate 1.0 %. Viscoelastic solution for injection into small joints. Sterile by moist heat.

Composition:
1 ml isotonic solution contains 10.0 mg sodium hyaluro nate from fermentation and sodium chloride, sodium monohydrogenphosphate, sodium dihydrogenphosphate, water for injection.

Indications:
Pain and restricted mobility in degenerative and traumatic changes of small synovial joints, for example, the facet joints of the lumbar spine, the saddle joint of the thumb, the interphalangeal joints of the fingers and toes, the proximal joint of the big toe and the temporomandibular joint. In the treatment of bigger joints, for example the knee, hip or shoulder, OSTENIL® prefilled syringes of 20 mg/2.0 ml should be used.

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

Precautions for use:
Caution should be exercised in patients with known hypersensitivity to drugs. The general precautions for intra-articular injections should be observed, including measures to avoid joint infections. OSTENIL® mini should be injected accurately into the joint cavity, if necessary under imaging control. Avoid injec tions 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® mini is not re commended in these cases. Do not use if the pre-filled syringe or sterile pack are damaged. 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.

Side effects:
Local secondary phenomena such as pain, feeling of heat, redness and swelling/joint effusion may occur in the joint treated with OSTENIL® mini. Application of an ice pack for five to ten minutes onto the treated joint will reduce the incidence of these events. In isolated cases the occurrence of side effects may be due to the intra-articular injection itself.

Interactions with other products:
Avoid using OSTENIL® mini with instruments sterilised with quarternary ammonium salts solutions. No information on the incompatibility of OSTENIL® mini 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.

Dosage and administration:
Inject OSTENIL® mini into the affected joint once a week for a total of 1–3 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 may 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 cortico steroid injection. Treatment with OSTENIL® mini can be started two to three days later. The contents and outer surface of the OSTENIL® mini 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 lock cap from the syringe, attach a suitable needle (for example 19 to 25 G) and secure it by turning slightly. If present remove the air bubble from the syringe prior to injection.

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. 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.

Presentation and package size:
One pre-filled syringe of 10 mg/1.0 ml OSTENIL® mini in a sterile pack.
OSTENIL® mini is a medical device. To be used by a physician only.
Last revision date: November 2009