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Description
A sterile, non-pyrogenic, highly purified, non-inflammatory solution of high molecular weight sodium hyaluronate extracted from cockscombs. It is a polysaccharide containing repeating disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine. Sodium hyaluronate is a common component of all extracellular matrices of connective tissues. It is found in many different species, including humans, but is chemically identical regardless of the species of origin. The sodium hyaluronate used in the manufacture of Supartz is of avian origin and is derived through a lengthy purification process. Supartz is a clear, odorless solution with a pH of 6.8 to 7.8 and an osmotic pressure/saline ratio of 1.0 to 1.2. After injection into the joint, a small amount of Supartz is metabolized in the synovial fluid, while the remainder is distributed to the synovial tissues, where it is partially degraded into smaller molecules. Supartz then enters the bloodstream and is metabolized primarily in the liver. The metabolites are non-toxic and are eliminated from the body through the lungs, intestines, and urinary tract. Supartz is marketed as a sterile solution in single-use pre-filled syringes to reduce the risk of contamination during aspiration of the solution.

How to use
- Open the blister by removing the foil and remove the syringe.
- Grasp the thick part of the lid, carefully unscrew it and remove it at an angle.
- Aseptically attach an appropriately sized needle (e.g., 22-23 gauge) to the syringe. To ensure a tight seal and prevent leakage during administration, secure the needle by holding firmly on the Luer connector.
- Disinfect the injection site before injection.
-Supartz allows for the improvement of the lubricating function of synovial fluid in the artificial joint model and in the experimental animal model.
Supartz has the role of covering and protecting the surfaces of damaged cartilage in the experimental animal model.
Supartz helps prevent tendon adhesions by acting as a physical barrier in the experimental animal model.
Supartz helps reduce pain in knee osteoarthritis and shoulder periarthritis.
Supartz helps reduce stiffness in knee osteoarthritis and shoulder periarthritis.
The recommended treatment regimen for Supartz in adults is five (5) injections into the knee joint cavity or shoulder joint (joint cavity, subacromial bursa, and biceps tendon sheath), at one-week intervals. However, it may be necessary to synchronize the timing of the intra-articular injection with the patient's symptoms. If symptoms do not improve, discontinue Supartz after five (5) injections.
Before injecting Supartz, remove any effusion by arthrocentesis. Because Supartz is viscous, use needles of appropriate size for injection (e.g., size 22-23). ​​To inject into the knee joint cavity, insert the needle horizontally or at a slight downward angle into the space between the patella and the femur. It is not uncommon to feel some resistance as the needle enters the joint capsule. The scapulohumeral joint is most easily accessed from the anterior aspect, but posterior or lateral approaches are also used. To accurately administer Supartz into the biceps sheath, insert the needle into the epidermis at a 20-30° angle and parallel to the biceps sheath. If it enters the tendon, some resistance will be felt during injection. If available, perform an ultrasound-guided injection into the biceps sheath to more accurately identify the location.

warnings
-Extreme caution should be exercised when administering Supartz to patients with underlying skin infections or lesions at the injection site.
Do not administer Supartz to pregnant women, nursing mothers, and children, as the safety of the drug has not been tested in these populations.
Supartz is intended for injection into the joints of patients suffering from osteoarthritis of the knee or periarthritis of the shoulder and should therefore only be administered by doctors experienced in this type of injection procedure.
Supartz should be administered with caution to patients with hypersensitivity to other drugs and a history of liver dysfunction.
Supartz should be administered with caution to patients with systemic coagulopathies.
- Administer Supartz with caution to patients with lymphatic or venous stasis in the injected limb.
- Administer Supartz using aseptic technique, taking the usual precautions used for injections.
Supartz is for single use only. Use immediately after opening and do not reuse.
Do not inject Supartz into a vein.
Do not use Supartz for ophthalmic purposes.
Do not use Supart if the packaging or syringe is damaged or opened.
Do not use Supartz after the expiry date which is stated on the label and outer carton.
Supartz may precipitate in the presence of disinfectants containing quaternary ammonium salts (such as benzalkonium chloride) and/or chlorhexedine. Therefore, caution is advised in this regard. (The use of disinfectants such as povidone iodine is recommended.)
Do not resterilize Supartz.
- Do not reuse syringes and needles.
- Only the solution contained in Supartz syringes is sterile. The outer surface of Supartz syringes is not sterile. Appropriate precautions should be taken when handling Supartz syringes in a sterile field.
Precautions : Unless injected into the peritenonal biceps, ensure that Supartz is injected into the joint cavity, as leakage outside the cavity may cause pain. Patients should be instructed to keep the affected joint at rest after injection of Supartz to reduce the possibility of localized pain. In the case of knees with severely inflamed osteoarthritis, the joint should be reduced before injection of Supartz, as the injection may aggravate the inflammation. The sodium hyaluronate in Supartz is a highly purified biological material of avian origin. Physicians should be aware of the potential risks associated with the injection of any biological substance. Patients should be advised to seek medical advice if they experience symptoms that may be associated with the adverse reactions mentioned above.
Clinically significant adverse reactions : Since symptoms of shock may occur, although rarely (incidence <0.1%), patients receiving Supartz should be carefully monitored. If abnormalities occur, administration should be discontinued and patients should be treated appropriately.
Other adverse reactions : During clinical trials and post-marketing surveillance of Supartz, the following adverse reactions have been reported. If abnormalities occur, discontinue administration and treat patients with appropriate therapy.
The following adverse reactions have been reported in connection with injection procedures.
- septic arthritis
- bleeding at the injection site
- skin necrosis.

Conservation
Store at a temperature between 1°C and 25°C.
Protect from frost.
Use Supartz before the expiry date which is stated on the label and outer packaging.
Shelf life with intact packaging: 3 years.

Format
Available:
-1 pre-filled syringe 2.5 ml;
-3 pre-filled syringes of 2.5 ml each;
-5 pre-filled syringes of 2.5 ml each.

Code MD030701