SUPARTZ SIR INTRA-ART 2.5ML 5P

Description
Sterile, non-pyrogenic solution of sodium hyaluronate, highly purified, free of inflammatory action, with high molecular weight 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 tissues. It is found in many different species, including humans, but is identical, from a chemical point of view, 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 transparent and odorless solution, with pH from 6.8 to 7.8 and a ratio of 1.0-1.2 between osmotic pressure and saline solution. After injection into the joint, a small amount of Supartz is metabolized in the synovial fluid, while the rest is distributed in the synovial tissues where it is partially degraded into smaller molecules. Subsequently, Supartz enters the bloodstream and is primarily metabolized in the liver. The metabolic products are non-toxic and are eliminated by the body through the lungs, intestines, and urinary tract. Supartz is marketed in sterile solution in pre-filled single-use syringes to reduce the risk of contamination during solution aspiration.

Method of use
-Open the blister by tearing the film and extract the syringe.
- Grasp the thick part of the cap, unscrew it carefully, and remove it obliquely.
- Aseptically, attach an appropriate size needle (e.g., gauge 22-23) to the syringe. To ensure a hermetic seal and prevent leaks during administration, tightly fix the needle, holding the luer lock firmly.
- Before injection, disinfect the injection site.
-Supartz helps to improve the lubricating function of the synovial fluid in the artificial joint model and the experimental animal model.
-Supartz is used to coat and protect 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 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 bicipital tendon sheath), at intervals of one per week. However, it may be necessary to synchronize the time of intra-articular injection with the patient's symptoms. If symptoms do not improve, discontinue Supartz after five (5) injections.
Before injecting Supartz, remove effusion if present, via arthrocentesis. Since Supartz is viscous, use suitably sized needles for injections (e.g., size 22-23). To perform injections into the knee joint cavity, insert the needle in a horizontal or slightly downward inclined direction, into the space between the kneecap and the femur. When the needle penetrates the joint capsule, some resistance may be felt. The glenohumeral joint is more easily accessed from the anterior side, but posterior or lateral approaches are also used. To accurately administer Supartz into the peritenon of the biceps, insert the needle into the epidermis at 20-30° and parallel to the groove. If it pierces the tendon, some resistance during injection will be encountered. If available, perform ultrasound-guided injection into the biceps sheath to more accurately identify the location.

Precautions
-Exercise maximum caution when administering Supartz to patients with infections or superficial skin injuries 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 for injection into the joints of patients suffering from knee osteoarthritis or shoulder periarthritis and should therefore be administered exclusively by experienced physicians in this type of injection procedure.
-Administer Supartz with caution in patients with hypersensitivity to other drugs or with a history of 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 of injection.
-Administer Supartz with aseptic precautions, following the usual injection procedures.
-Supartz is strictly for single use. Use immediately after opening and do not reuse.
-Do not inject Supartz into a vein.
-Do not use Supartz for ophthalmic use.
-Do not use Supartz if the packaging or syringe are damaged or opened.
-Do not use Supartz after the expiration date indicated on the label and outer packaging.
-Supartz may precipitate in the presence of disinfectants containing quaternary ammonium salts (such as benzalconium chloride) and/or chlorhexidine. Attention should be paid to this aspect. (It is recommended to use disinfectants like povidone-iodine).
-Do not re sterilize 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. Appropriate precautions should be taken when handling Supartz syringes in a sterile field.
Precautions: unless 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 the injection of Supartz to reduce the risk of localized pain symptoms. In severe inflammatory osteoarthritis of the knee, inflammation should be reduced before injecting Supartz, as the inflammation might 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 doctor if symptoms that could be associated with the aforementioned adverse effects occur.
Clinically significant adverse effects: since symptoms of shock may rarely (incidence <0.1%) occur, closely monitor patients who have been administered Supartz. If any abnormality occurs, suspend the administration and treat the patients with appropriate therapy.
Other adverse effects: during clinical trials and during pharmacovigilance of Supartz, after marketing, cases of adverse effects have been reported as listed below. If any abnormality occurs, suspend the administration and treat the patients with appropriate therapy.
The following adverse reactions have been reported related 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 outer packaging.
Shelf life 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