Brand Name: SYNOTEK®
Generic name: Sodium Hyaluronate
The synovial fluid in your knee lubricates and cushions the joint during movement. The major component in synovial fluid is hyaluronic acid. hyaluronic acid and Sodium hyaluronate are a natural polymer from the glycosaminoglycan class, widely distributed in the connective tissues of animal and humans, and plays a significant role in the physiological functions of that fluid. SYNOTEK® is a single use, sterile, non-pyrogenic, 1.6% solution of high molecular weight sodium hyaluronate.
The sodium hyaluronate in SYNOTEK® is highly purified. Intra articular injection of SYNOTEK® improves articular function, thus relieving pain caused by osteoarthritis of the knee and painful shoulder, SYNOTEK® improves articular mobility and normalizes diseased synovial.
2 ml isotonic solution for injection contains 32 mg sodium hyaluronate, sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, and water for injection.
SYNOTEK® is prescribed for pain and restricted mobility due to degenerative and traumatic changes in synovial joints such as the knee and shoulder.
• Do not administer SYNOTEK® to patients with known hypersensitivity (allergy) to sodium hyaluronate, hyaluronan preparations or to one of the other constituents.
• Do not administer SYNOTEK® to patients with cases of infections or skin diseases in the area of the injection site.
• Do not administer SYNOTEK® to patients if the synovial joint is severely inflamed or infected.
• Caution should be exercised in patients with known hypersensitivity to drugs.
• Do not inject SYNOTEK® intra-vascularly as it may cause adverse systemic events.
• Do not use SYNOTEK® if the prefilled syringe or sterile package is opened or damaged.
• If product is stored refrigerated, equilibrate product to room temperature prior to use.
• If the product is re-used, the functionality and sterility of the product cannot be guaranteed.
Re-use could lead to patient injury and/or infection. This product is labeled as “single use” which indicates the device is intended to be used only once for a single patient.
• Do not use after the expiry date indicated on the box and labels.
• Keep out of the reach of children.
Use in Specific Patient Populations:
Patients with autoimmune or connective tissue disorders may be more predisposed to adverse reactions than the general population.
Pediatrics: Since the safety of this product has not been established in children, it must be administered with caution.
Pregnancy: The safety and effectiveness of Viscor® have not been established in pregnant women.
Lactation: Sodium hyaluronate is excreted in milk of treated animals, so it is recommended to discontinue breast feeding during treatment.
Dosage and Administration:
SYNOTEK® should only be administered by a physician for a total of 2-3 injections. Strict aseptic administration technique must be followed.
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 one to two intra-articular injections may last up to 36 Weeks. Treatment cycle may be repeated upon necessity.
Presentation and Package Size:
One pre-filled syringe of 32 mg/2 ml SYNOTEK® in a sterile pack.
To be used only by a physician.
Store below 30°C. DO NOT FREEZE.
Bring to room temperature before injection.