Supartz Hyaluronic Acid Intra-articular Pre-Filled Syringe

SUPARTZ is indicated for the treatment of knee osteoarthritis and shoulder periarthritis.

Studies on patients and animals have given the following results:
Supartz serves to coat and protect the surfaces of deteriorated cartilage and spreads into the cartilage matrix. With this, it prevents the detachment of the proteoglycan from the matrix and decreases the degenerative changes of the cartilage.
Supartz prevents adhesion of tendons and improves joint movement by acting as a physical barrier between the tendon and its sheath.
Supartz serves to improve the lubricating function of the synovial fluid by increasing the viscosity and molecular weight of the hyaluronic acid of the pathological synovial fluid.
Supartz inhibits the action of algogenic mediators (such as bradykinin) by coating the intra-articular tissues.

Do not administer Supartz to patients with a history of hypersensitivity to components present in Supartz.
Physicians should evaluate the immunological and other potential risks that may be associated with the injection of any biological substance. Supartz should not be used with patients in whom hypersensitivity to a substance of avian origin or to protein-containing drugs is known or suspected (see WARNINGS and PRECAUTIONS).

The recommended treatment regimen for Supartz in adults consists of five (5) injections into the knee joint or shoulder joint (joint socket, subacromial 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, terminate SUPARTZ administration after five (5) injections.
• Before injecting Supartz, remove the effusion if present by means of arthrocentesis.
• Since Supartz is viscous, use needles of a suitable size for the injections (for example: size 22-23).

The sodium hyaluronate in Supartz is of avian origin and is derived by means of a prolonged purification process from cockscomb. Physicians will need to assess the immunological and other potential risks that may arise with the injection of any biological substance.
The safety of Supartz has not been demonstrated in pregnancy, lactation and children; therefore Supartz should not be used in these patients.
Supartz is intended to be injected into the joints of patients suffering from knee osteoarthritis or shoulder periarthritis and should therefore only be used by physicians experienced in this type of procedure.
Administer Supartz with caution in patients with hypersensitivity to other drugs whose history indicates hepatic dysfunction.
Administer Supartz taking care of the asepsis, taking the normal precautions adopted in intra-articular injections.
Supartz is for single use only. Use it immediately after it has been opened and do not reuse it.
Do not inject Supartz into a vein.
Do not use Supartz in ophthalmic use.
Do not use Supartz if the package or syringe is damaged or open.
Do not use Supartz after the expiry date stated on the label and outer carton.
Supartz can precipitate in the presence of disinfectants that contain quaternary ammonium salts (such as benzalkonium chloride) and / or chlorexedine. So attention must be paid to this aspect.
Do not resterilize Supartz.
Do not reuse syringes and needles.
Only the solution contained in the 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

Make sure Supartz is injected into the joint cavity, as a leak outside the joint could cause pain.
Patients should be instructed to keep the affected joint at rest after Supartz injection to reduce the possibility of localized painful symptoms.
In osteoarthritis knee with severe inflammation, the inflammation will have to be reduced before injecting Supartz, as the inflammation may be aggravated by the injection.
Patients should be advised of the need to return to their doctor in the event of symptoms that may be associated with the aforementioned side effects.

Clinically significant undesirable effects: Since symptoms of shock may occur, albeit rarely (incidence <0.1%), closely monitor patients receiving Supartz. If any abnormality occurs, discontinue administration and treat patients with appropriate therapy.
Other undesirable effects: During the clinical trials and during the pharmacovigilance of Supartz, after marketing, cases of undesirable effects have been reported below.
If any abnormality occurs, discontinue administration and treat patients with appropriate therapy.

* frequency of undesirable effects is not available as these are adverse reactions in voluntary reports

Shelf life

Supartz has a shelf life of three (3) years from the date of manufacture.
Use Supartz before the expiration date indicated on the label and outer carton.

Instructions for storage

Store at a temperature below 25 ° C.
Protect from freezing.