Supartz® Intra-articular Syringe MDM 5x2.5ml

Supartz® Intra-articular Syringe MDM Hyaluronic Acid Solution

It serves to coat and protect the surfaces of deteriorated cartilage in the experimental animal model

Supartz® contributes to the improvement of mobile joints through the integration of the viscoelasticity of the synovial fluid and the reduction of pain from osteoarthritis (OA) of the knee and periarthritis of the shoulder.
Supartz® is a sterile, non-pyrogenic solution of sodium hyaluronate, highly purified, free of inflammatory action, with high molecular weight that is extracted from cockscomb 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 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.
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 broken down into smaller molecules. Supartz® then enters the bloodstream and is metabolised mainly 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 sterile solution in pre-filled disposable syringes to reduce the risk of contamination when aspirating the solution.
Use:
Supartz® allows to improve the lubricating function of the synovial fluid in the artificial joint model and in the experimental animal model.
Supartz® serves to coat and protect the surfaces of deteriorated cartilage in the experimental animal model.
Supartz® allows to prevent tendon adhesions by acting as a physical barrier in the experimental animal model.
Supartz® reduces pain in knee osteoarthritis and shoulder periarthritis.
Supartz® reduces stiffness in knee osteoarthritis and shoulder periarthritis.

Indications

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

How to use

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 injections (e.g. size 22-23).
To perform injections in the joint cavity of the knee, insert the needle into the joint in a horizontal direction or slightly inclined downwards, in the space between the patella and the femur. It is not unusual to feel some resistance as the needle enters the joint capsule.
The scapulohumeral joint is accessed more easily from the anterior side, but posterior or lateral approaches are also adopted.
To accurately administer Supartz® in the peritenum of the biceps, insert the needle into the epidermis at 20-30 ° and parallel to the hollow. If it enters the tendon, some resistance will be offered to the injection. If available, perform an ultrasound guided injection into the bicep sheath to more accurately identify the position.

Instructions for Use

Open the blister by peeling off the foil and take out the syringe.
Grasp the thick part of the cap, carefully unscrew it and remove it obliquely.
Aseptically, attach a needle of appropriate size (eg 22-23 gauge) to the syringe. To ensure a tight seal and prevent leakage during administration, secure the needle securely by holding the luer lock firmly.
Disinfect the injection site before the injection

Warnings

Do not administer Supartz® to patients with a history of hypersensitivity to components present in Supartz®. Supartz® should not be used in patients in whom hypersensitivity to substances of avian origin or to protein-containing drugs is known or suspected.
Exercise extreme caution when administering Supartz® to patients with primary skin infections or 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 knee osteoarthritis or shoulder periarthritis and should therefore only be administered 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 to patients with lymphatic or venous stasis in the injection site limb.
Administer Supartz® taking care of asepsis, taking the normal precautions taken in 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 indicated 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. (Use of disinfectants such as povidone iodine is recommended.)
Do not resterilize 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 within a sterile field.
Precautions:
Unless injected into the peritenum of the biceps, make sure 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 painful symptoms.
In osteoarthritis knee with severe inflammation, the inflammation will have to be reduced before injecting Supartz®, as the inflammation could 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 can arise with injection procedures of any biological substance.
Patients should be advised of the need to return to their doctor in case of symptoms that may be associated with the aforementioned 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 studies 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 Not less than 0.1% but less than 5% Less than 0.1% Not available (known) Frequency Hypersensitivity Dermatitis, urticaria, pruritus Edema (face, eyelid, etc.) redness of the face Site of intra-articular infection Pain, swelling Moisture, redness, sensation of heat, sensation of local heaviness Other Nausea, vomiting, fever Note) the frequency of undesirable effects is not available as these are adverse reactions in voluntary reports. The following adverse reactions have been reported in connection with injection procedures.

• Septic arthritis
• Injection site bleeding
• Skin necrosis

The contents of Supartz® syringes are made sterile by filtration and are not pyrogenic. Supartz® is prepared in pre-filled syringes with aseptic process and is packaged in blister-type packages, under 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. Store at a temperature between 1 ° C and 25 ° C. Protect from freezing.

Components and Ingredients

Sodium hyaluronate.

Format

Pack with 5 pre-filled plastic syringes 2.5 ml with viscoelastic solution based on sodium hyaluronate.