Description
A sterile, non-pyrogenic, highly purified, phlogistic-free, high-molecular-weight sodium hyaluronate solution that is extracted from cockscombs 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 tissues. It is found in many different species, including humans, but is chemically identical regardless of species of origin. The sodium hyaluronate used in the manufacture of Supartz is of avian origin and is derived, by means of a prolonged purification process. Supartz is a clear, odorless solution with a pH of 6.8 to 7.8 and a ratio of 1.0 to 1.2 between osmotic pressure and salt solution. After injection into the joint, a small amount of Supartz is metabolized into the synovial fluid, while the rest is distributed into the synovial tissues where it is partially degraded into smaller molecules. Subsequently Supartz enters the bloodstream and is metabolized mainly in the liver. The products of metabolism are nontoxic and are eliminated from the body through the lungs, intestines and urinary tract. Supartz is marketed as a sterile solution in prefilled disposable syringes to reduce the risk of contamination during aspiration of the solution.

Mode of use.
-Open the blister pack by peeling off the foil and pull out the syringe.
- Grasp the thick part of the cap, unscrew it carefully and remove it obliquely.
- Aseptically, graft an appropriately sized needle (e.g., gauge 22-23) onto the syringe. To ensure an airtight seal and prevent leakage during administration, fi x the needle tightly while holding the luer lock.
- Disinfect the injection site before injection.
-Supartz enables improved lubricating function of synovial fluid in the artificial joint model and experimental animal model.
-Supartz serves to coat and protect the surfaces of deteriorated cartilage in the experimental animal model.
-Supartz makes it possible to prevent tendon adhesions by acting as a fi sical 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 socket or shoulder joint (joint socket, sub-acromial bursa, and biceps tendon sheath), at intervals of one per week. However, it may be necessary to synchronize the timing of intra-articular injection with the patient's symptoms. If symptoms do not improve, terminate Supartz administration after five (5) injections.
Before injecting Supartz, remove the effusion if it is present, by arthrocentesis. Because Supartz is viscous, use needles of a suitable size for injections (e.g., size 22-23). To perform injections into the knee joint socket, insert the needle into the joint in a horizontal direction or slightly tilted downward into the space between the patella and femur. As the needle penetrates the joint capsule, it is not unusual to feel some resistance. The scapulohumeral joint is most easily accessed from the anterior side, but posterior or lateral approaches are also adopted. To accurately administer Supartz into the peritenon of the biceps, insert the needle into the epidermis at 20-30° and parallel to the notch. If it penetrates the tendon, some resistance to injection will be offered. If available, perform an ultrasound-guided injection into the biceps sheath to more accurately identify the location.

Warnings
-Adopt caution when administering Supartz in patients with infection or elementary skin lesions in the area of 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 to be injected into the joints of patients suffering from osteoarthritis of the knee or periarthritis of the shoulder and should therefore be administered only by physicians experienced in this type of injection procedure.
-Administer Supartz with caution in patients with hypersensitivity to other drugs whose history indicates hepatic dysfunction.
-Administer Supartz with caution in patients with systemic coagulopathies.
-Administer Supartz with caution in patients with lymphatic or venous stasis in the limb site of injection.
-Administer Supartz taking care of asepsis, taking the normal precautions taken in injections.
-Supartz is for single use only. Use it immediately after it is opened and do not reuse it.
-Do not inject Supartz into the vein.
-Do not use Supartz in ophthalmic use.
-Do not use Supart if the package or syringe is damaged or opened.
-Do not use Supartz after the expiration date indicated on the label and outer package.
-Supartz can precipitate in the presence of disinfectants that contain quaternary ammonium salts (such as benzalkonium chloride) and/or chlorhexidine. Therefore, attention should be paid 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 within a sterile field.
Precautions: except when injected into the peritenon of the biceps, ensure that Supartz is injected into the joint cavity, as leakage outside the cavity could cause pain. Patients should be instructed to keep the affected joint at rest after Supartz injection to reduce the possibility of localized algic symptoms. In the osteoarthritic knee with severe inflammation, it will have to be reduced before Supartz injection, as the inflammation may be aggravated by 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 can occur with injection procedures of any biological substance. Patients should be informed of the need to return to the physician if they experience symptoms that could be associated with the above undesirable effects.
Clinically significant undesirable effects: since they can occur, albeit rarely, (incidence <0,1%) i sintomi di uno shock, monitorare attentamente i pazienti ai quali si sia somministrato Supartz. Se si presenta qualsiasi anomalia, sospendere la somministrazione e trattare i pazienti con una terapia idonea.
Other undesirable effects: During clinical trials and during pharmacovigilance of Supartz, after marketing, cases of side effects were reported below. If any abnormality occurs, discontinue administration and treat patients with appropriate therapy.
The following adverse reactions were encountered 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 freezing.
Use Supartz before the expiration date indicated on the label and outer package.
Validity with intact packaging: 3 years.

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

Code. MD030701