SUPARTZ SIR INTRA-ART 2.5ML 5P

Description
Sterile, non-pyrogenic solution of sodium hyaluronate, highly purified, devoid of inflammatory action, with high molecular weight that is extracted from rooster combs and is a polysaccharide containing repeated disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine. Sodium hyaluronate is a common component of all extracellular matrices of connective tissue. 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 prolonged purification process. Supartz is a clear, odorless solution, with a pH of 6.8 to 7.8 and an osmotic pressure to saline solution ratio of 1.0-1.2. After injection into the joint, a small amount of Supartz is metabolized in the synovial fluid, while the remainder distributes in the synovial tissues where it is partially degraded into smaller molecules. Subsequently, Supartz enters the bloodstream and is mainly metabolized in the liver. The metabolic products are non-toxic and are eliminated from the body through the lungs, intestines, and urinary tract. Supartz is marketed in a sterile solution in pre-filled single-use syringes to reduce the risk of contamination during the aspiration of the solution.

Method of use
-Open the blister by peeling back the film and pulling out the syringe.
-Grip the thick part of the cap, unscrew it carefully, and remove it at an angle.
-Aseptically, attach an appropriately sized needle to the syringe (e.g. gauge 22-23). To ensure an airtight seal and prevent leaks during administration, securely fasten the needle while holding the luer lock firmly.
-Before injection, disinfect the injection site.
-Supartz helps improve the lubricating function of the synovial fluid in the artificial joint model and in the experimental animal model.
-Supartz is used to coat and protect 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 consists of five (5) injections into the knee joint cavity or shoulder joint (joint cavity, sub-acromial bursa, and biceps tendon sheath), at intervals of one per week. 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 the administration of Supartz after five (5) injections.
Before injecting Supartz, remove any effusion if present, by means of arthrocentesis. Since Supartz is viscous, use appropriately sized needles for injections (e.g. size 22-23). To perform injections into the knee joint cavity, insert the needle into the joint horizontally or slightly angled downwards, into the space between the patella and femur. While the needle penetrates the joint capsule, it is not unusual to feel some resistance. Accessing the scapulo-humeral joint is easier from the anterior side, but posterior or lateral approaches are also used. To accurately administer Supartz into the biceps peritendon, insert the needle into the epidermis at a 20-30° angle and parallel to the hollow. If it penetrates the tendon, some resistance will be felt during the injection. If available, perform an ultrasound-guided injection in the biceps sheath to more accurately identify the location.

Warnings
-Exercise utmost caution when administering Supartz in patients with infections or elementary lesions of the skin at the injection site.
-Do not administer Supartz to pregnant women, nursing mothers, or children as the safety of the drug has not been tested in these populations.
-Supartz is intended to be injected into the joints of patients suffering from knee osteoarthritis or shoulder periarthritis and must therefore be administered exclusively by physicians experienced in this type of injection procedure.
-Administer Supartz with caution in patients with hypersensitivity to other drugs whose history indicates liver dysfunction.
-Administer Supartz with caution in patients suffering from systemic coagulopathies.
-Administer Supartz with caution in patients with lymphatic or venous stasis in the limb at the injection site.
-Administer Supartz with attention to asepsis, taking normal precautions adopted in injections.
-Supartz is for single use only. Use it immediately after it is opened and do not reuse it.
-Do not inject Supartz intravenously.
-Do not use Supartz for ophthalmic use.
-Do not use Supartz if the packaging or syringe is damaged or opened.
-Do not use Supartz after the expiration date indicated on the label and on the outer packaging.
-Supartz may precipitate in the presence of disinfectants containing quaternary ammonium salts (e.g., benzalkonium chloride) and/or chlorhexidine. Therefore, caution should be given to this aspect. (The use of disinfectants such as iodopovidone 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 biceps peritendon, ensure that Supartz is injected into the joint cavity, as a leak 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 localized pain symptoms. In the osteoarthritic knee with severe inflammation, it should be reduced first before injecting Supartz, as inflammation may worsen due to the injection. The sodium hyaluronate in Supartz is a highly purified biological material of avian origin. Physicians should be aware of the potential risks that may arise with the injection procedures of any biological substance. Patients should be informed of the need to return to the physician if symptoms arise that could be associated with the aforementioned side effects.
Significant clinically adverse effects: since symptoms of shock may occur, although rarely (incidence <0.1%), closely monitor patients who have been administered Supartz. If any abnormality occurs, suspend administration and treat patients with appropriate therapy.
Other adverse effects: during clinical studies and during the pharmacovigilance of Supartz, after marketing, cases of adverse effects listed below have been reported. If any abnormality occurs, suspend administration and treat patients with appropriate therapy.
The following adverse reactions have been reported in relation to 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 expiration date indicated on the label and on the outer packaging.
Validity with intact packaging: 3 years.

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

Code MD030701