Supartz
Description
Sterile, non-pyrogenic, highly purified solution of sodium hyaluronate, free from inflammatory action, with a high molecular weight, extracted from rooster combs; 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 obtained through a prolonged purification process. Supartz is a clear, odourless solution with a pH of 6.8 to 7.8 and an osmotic pressure ratio to saline solution of 1.0-1.2. After injection into the joint, a small amount of Supartz is metabolised in the synovial fluid, while the rest is distributed in the synovial tissues where it is partially broken down into smaller molecules. Supartz then enters the bloodstream and is metabolised mainly in the liver. The metabolic products are non-toxic and are eliminated from the body through the lungs, intestine and urinary tract. Supartz is supplied as a sterile solution in single-use prefilled syringes to reduce the risk of contamination when drawing up the solution.
Directions for use
-Open the blister by peeling off the film and remove the syringe.
- Grip the thick part of the cap, carefully unscrew it and remove it at an angle.
- Aseptically fit a needle of appropriate size to the syringe (e.g. 22-23 gauge). To ensure an airtight seal and prevent leakage during administration, secure the needle firmly while holding the luer lock tightly.
- Disinfect the injection site before injection.
-Supartz improves the lubricating function of synovial fluid in the artificial joint model and in the experimental animal model.
-Supartz coats and protects the surfaces of deteriorated 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 osteoarthritis of the knee and periarthritis of the shoulder.
-Supartz helps reduce stiffness in osteoarthritis of the knee and periarthritis of the shoulder.
The recommended treatment regimen for Supartz in adults consists of five (5) injections into the knee joint cavity or shoulder joint (joint cavity, subacromial bursa and biceps tendon sheath), at intervals of one per week. However, it may be necessary to time the intra-articular injection according to the patient's symptoms. If symptoms do not improve, stop administration of Supartz after five (5) injections.
Before injecting Supartz, remove any effusion by arthrocentesis. As Supartz is viscous, use needles of a suitable size for injection (e.g. 22-23 gauge). For injections into the knee joint cavity, insert the needle into the joint horizontally or slightly angled downwards, in the space between the patella and the femur. It is not unusual to feel some resistance as the needle penetrates the joint capsule. The glenohumeral joint is most easily accessed from the anterior side, but posterior or lateral approaches are also used. To administer Supartz accurately into the biceps peritenon, insert the needle into the skin at 20-30° and parallel to the groove. If it penetrates the tendon, some resistance to injection will be felt. If available, perform an ultrasound-guided injection into the biceps sheath to identify the position more accurately.
Warnings
-Exercise the utmost caution when administering Supartz to patients with infections or skin lesions in the area of the injection site.
-Do not administer Supartz to pregnant women, breastfeeding mothers or children, as its safety 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 must therefore be administered only by doctors experienced in this type of injection procedure.
-Administer Supartz with caution in patients with hypersensitivity to other medicines whose medical history indicates liver dysfunction.
-Administer Supartz with caution in patients with systemic coagulopathies.
-Administer Supartz with caution in patients with lymphatic or venous stasis in the limb where the injection is given.
-Administer Supartz under aseptic conditions, taking the normal precautions used for injections.
-Supartz is for single use only. Use it immediately after opening and do not reuse it.
-Do not inject Supartz into a vein.
-Do not use Supartz for ophthalmic use.
-Do not use Supartz if the pack or syringe is damaged or open.
-Do not use Supartz after the expiry date shown on the label and outer pack.
-Supartz may precipitate in the presence of disinfectants containing quaternary ammonium salts (such as benzalkonium chloride) and/or chlorhexidine, so care must be taken in this respect. (The use of disinfectants such as povidone-iodine is recommended.)
-Do not resterilise Supartz.
-Do not reuse syringes and needles.
-Only the solution contained in the Supartz syringes is sterile. The outer surface of the Supartz syringes is not sterile. Suitable precautions must be taken when handling Supartz syringes within a sterile field.
Precautions: except when injecting into the biceps peritenon, make sure that Supartz is injected into the joint cavity, as leakage outside the cavity could cause pain. Patients should be instructed to rest the affected joint after the injection of Supartz to reduce the possibility of localised pain. In an osteoarthritic knee with severe inflammation, the inflammation should be reduced before injecting Supartz, as it could worsen as a result of the injection. The sodium hyaluronate in Supartz is a highly purified biological material of avian origin. Doctors should be aware of the potential risks that may arise with injection procedures involving any biological substance. Patients should be told to return to their doctor if they develop symptoms that could be associated with the above-mentioned side effects.
Clinically significant side effects: as symptoms of shock may occur, albeit rarely (incidence <0.1%), carefully monitor patients who have been given Supartz. If any abnormality occurs, stop administration and treat patients with appropriate therapy.
Other side effects: during clinical studies and post-marketing pharmacovigilance of Supartz, the side effects listed below have been reported. If any abnormality occurs, stop administration and treat patients with appropriate therapy.
The following adverse reactions have been observed in connection with the injection procedures.
- septic arthritis
- bleeding at the injection site
- skin necrosis.
Storage
Store at a temperature between 1°C and 25°C.
Protect from freezing.
Use Supartz before the expiry date shown on the label and outer pack.
Shelf life in intact packaging: 3 years.
Pack size
Available:
-1 prefilled syringe 2.5 ml;
-3 prefilled syringes 2.5 ml;
-5 prefilled syringes 2.5 ml.
Code MD030701
