DESCRIPTION
• Supartz is a sterile, non-pyrogenic solution of sodium hyaluronate, purified, with no inflammatory action, with a high molecular weight. Each milliliter of Supartz contains 10 mg of sodium hyaluronate dissolved in a physiological buffer (1.0% solution).
• Hyaluronic acid is a polymer, 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 derived, by means of a prolonged purification process, from cockscomb.
• Supartz is a transparent and odorless solution, with pH from 6.8 to 7.8 and a proportion 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 broken down into smaller molecules. Supartz then enters the bloodstream and is metabolized in the liver. The products of metabolism are non-toxic and are eliminated from the body via the lungs, intestines and urinary tract.
• SUPARTZ is marketed in a pre-filled glass syringe to reduce the risk of contamination during aspiration of the solution.

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

CONTRAINDICATIONS
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).

USE
Studies on patients and animals have given the following results:
• Supartz serves to coat and protect deteriorated cartilage surfaces 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 tendon adhesion 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.

DOSAGE AND ADMINISTRATION
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).

WARNINGS
• 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 for ophthalmic use.
• Do not use Supartz if the package or syringe is damaged or open.
• Do not use Supartz after the expiry date indicated on the label and outer packaging.
• 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 above side effects.

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.

Classification	Frequency from not less than 0.1%, but less than 5%	Frequency less than 0.1%	Unavailable*
Hypersensitivity	/	Dermatitis, hives, itching	Edema (face, eyelid, etc.), redness of the face
Site of intra-articular injection	Pain, swelling	Hydrarthrosis, redness, sensation of heat, sensation of local heaviness	/
Other	/	/	Nausea, vomiting, fever

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

SUPPLY
• Supartz is a sterile solution for intraarticular injections, supplied in a glass syringe that dispenses 2.5 ml of sodium hyaluronate in a physiological sodium chloride phosphate buffer.
• The contents of Supartz syringes are made sterile by filtration and are not pyrogenic.
• Supartz is prepared in syringes with an aseptic process and is packaged in “blister” type packages, in aseptic environmental conditions.

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.

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

Distributor
MDMSpa
Viale Papiniano 22 / B Milan

product CE 0123

Format
Pack of 3 pieces.