Ostenil® Mini 10mg/1ml prefilled syringe, 1 ST

OSTENIL® MINI Fermented sodium hyaluronate 1.0%. Viscoelastic solution for injection into small joints. Sterilised by moist heat.

Indications

• Pain and restricted mobility associated with degenerative and traumatic changes in small synovial joints, such as the facet joints of the lumbar spine, the thumb saddle joint, the interphalangeal joints of the fingers and toes, the metatarsophalangeal joint of the big toe and the temporomandibular joint. For the treatment of large joints, such as the knee, hip or shoulder joints, OSTENIL® pre-filled syringes containing 20 mg/2.0 ml should be used.

Properties and mechanism of action

• Synovial fluid, which exhibits viscoelastic behaviour due to its hyaluronic acid content, is present in all synovial joints, where its lubricating and shock-absorbing properties ensure normal, pain-free movement. It is also responsible for supplying the articular cartilage with nutrients. In degenerative joint diseases, such as osteoarthritis, the viscoelasticity of the synovial fluid is significantly impaired, which reduces its lubricating and shock-absorbing effects. As a result, the mechanical stress on the joint and the breakdown of the articular cartilage increase to such an extent that pain and restricted mobility occur in the affected joint.
• Improving the quality of the synovial fluid through the intra-articular administration of high-purity hyaluronic acid can enhance its viscoelastic properties. This enhances its lubricating and shock-absorbing effects and reduces the mechanical strain on the joint. The result is usually a reduction in pain and an improvement in joint mobility, which can last for several months following a course of treatment.

Dosage form

Injection

Usage

Inject OSTENIL® MINI into the affected joint a total of 1–3 times at weekly intervals. Several joints may be treated simultaneously. Depending on the severity of the joint condition, the effect of treatment may last for more than six months. Repeated treatment cycles are possible if required. In the event of joint effusion, it is advisable to drain the effusion, immobilise the joint, apply an ice pack and/or administer corticosteroids intra-articularly. Treatment with OSTENIL® MINI should commence two to three days later.

As long as the sterile packaging remains unopened, the contents and surface of the pre-filled syringe are sterile. Remove the pre-filled syringe from the sterile packaging, unscrew the cap from the Luer-Lock connector, attach a suitable needle (e.g. 19 to 25 G) and lock it in place with a gentle twist. Before injection, any air bubbles present in the syringe must be removed.

Ingredients

1 ml of isotonic solution contains 10.0 mg of sodium hyaluronate, as well as sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and water for injection.