Ostenil

Ostenil

sodium hyaluronate

Manufacturer:

TRB Chemedica

Distributor:

TRB Chemedica
Full Prescribing Info
Contents
Sodium hyaluronate.
Description
1 ml isotonic solution contains 10.0 mg sodium hyaluronate and sodium chloride, sodium monohydrogenphosphate, sodium dihydrogenphosphate, water for injection.
Action
Pharmacology: Pharmacodynamics: 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.
Indications/Uses
Relief of pain and delay progression of knee osteoarthritis. Relief of pain in osteoarthritis of the hip, ankle and shoulder.
Dosage/Direction for Use
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 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 contents and outer surface of the OSTENIL 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 21 G) and secure it by turning slightly. If present remove the bubble from the syringe prior to injection.
Contraindications
OSTENIL should not be used in patients with ascertained hypersensitivity to one of the constituents.
Special 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 Bechterew disease, treatment with OSTENIL is not recommended in these cases. Do not use if the pre-filled syringe or sterile pack are damaged. Store below 25°C.
Use In Pregnancy & Lactation
As no clinical evidence is available on the use of hyaluronic acid in pregnant and lactating women, treatment with OSTENIL is not recommended in these cases.
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 events.
Drug Interactions
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.
Storage
Store below 25°C.
ATC Classification
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Inj (pre-filled syringe) 20 mg/2 mL x 2 mL x 1's, 3's.
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