Description
SUPARTZ is a sterile, non-pyrogenic solution of highly purified, non-phlogistic, high molecular weight sodium hyaluronate extracted from bacterial fermentation. It is a polysaccharide containing repeated disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine.
Sodium hyaluronate is a common component of the 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 bacterial origin and is derived through fermentation and purification.
SUPARTZ is a clear, odorless solution, with a pH of 6.8 to 7.8 and an osmotic pressure ratio to saline solution of 1.0-1.2.
After injection into the joint, SUPARTZ is minimally metabolized in the synovial fluid but is incorporated into the synovial tissues where it is partially degraded into smaller molecules. Subsequently, SUPARTZ enters the bloodstream and is mainly metabolized in the liver. The metabolic products are non-toxic and are ultimately eliminated from the body through the lungs, intestines, and urinary tract.
SUPARTZ is marketed as a sterile solution in a single-use pre-filled syringe to reduce the risk of contamination during solution aspiration.
SUPARTZ is indicated for the treatment of knee OA and shoulder periarthritis, and aims to improve joint movement by supplementing the viscoelasticity of the synovial fluid, and to reduce pain in knee OA and shoulder periarthritis.

Instructions for use
The dosage is 2.5 mL (one syringe) per knee joint injected intra-articularly or into the shoulder joint (shoulder joint cavity, subacromial bursa, or long head of the biceps brachii tendon sheath).
The recommended treatment regimen for SUPARTZ in adults consists of five injections into the knee joint cavity or shoulder joint (joint cavity, subacromial bursa, or biceps tendon sheath), at weekly intervals. However, the timing of injections may be modified based on the patient's symptoms.
SUPARTZ should only be injected by authorized medical personnel or in accordance with local legislation.
No additional training is required.
Check the expiration date on the package.
Do not use after the expiration date.
Strictly observe aseptic administration techniques.
Aspirate any joint effusion using a 22-23 G needle before injecting SUPARTZ. Maintain the needle's position in the joint while detaching the used syringe to reduce joint effusion. Discard the syringe containing the aspirated joint effusion. Do not use the same syringe to aspirate effusion and inject SUPARTZ.
Subcutaneous lidocaine injection or similar local anesthetics may be administered before SUPARTZ injection.
Peel the Tyvek sheet from the blister and remove the syringe.
Carefully remove the syringe cap and aseptically attach a 22-23 G needle to the syringe. To ensure an airtight seal and prevent leakage during administration (or injection), firmly attach the needle by securely holding the luer lock.
If effusion has been previously aspirated, connect the syringe to the needle already positioned in the joint.
Unscrew the cap before removing it to minimize product spillage.
Inject SUPARTZ into the knee joint or shoulder joint (shoulder joint cavity, subacromial bursa, or long head of the biceps brachii tendon sheath) through the needle using an aseptic injection technique.
Inject the entire content, 2.5 mL of SUPARTZ, into the knee or shoulder (shoulder joint cavity, subacromial bursa, or long head of the biceps brachii tendon sheath). If treatment is administered to both knees or shoulders, use a different SUPARTZ syringe for each knee or shoulder.
To perform injections into the knee joint cavity, insert the needle into the joint horizontally or slightly angled downwards, into the space between the patella and the femur. It is not unusual to feel some resistance as the needle penetrates the joint capsule.
In the glenohumeral joint, the needle is usually easily inserted from the anterior side, but the posterior or lateral approach is also adopted.
For accurate administration of SUPARTZ into the bicipital peritendon, insert the needle into the epidermis at 20-30 degrees and parallel to the groove. If it penetrates the tendon, there will be resistance to injection. If available, perform an ultrasound-guided injection into the biceps sheath to more accurately identify the position.

Components
Sodium hyaluronate 25.0 mg, sodium chloride 21.25 mg, dibasic sodium phosphate dodecahydrate 1.343 mg, sodium dihydrogen phosphate dihydrate 0.04 mg, water for injections q.s. to 2.5 mL.

Warnings
- Do not administer SUPARTZ to patients with known hypersensitivity (allergy) to SUPARTZ or sodium hyaluronate preparations.
- Exercise extreme caution when administering SUPARTZ to patients with skin infections or lesions in the injection site area.
- Administer SUPARTZ with caution to patients with hypersensitivity to any medication.
- Administer SUPARTZ with caution to patients with a medical history of liver dysfunction.
- Administer SUPARTZ with caution to patients with systemic coagulopathies.
- Administer SUPARTZ with caution to patients with lymphatic or venous stasis in the limb receiving the injection.
- Do not simultaneously use disinfectants containing quaternary ammonium salts (such as benzalkonium chloride) for skin preparation, as sodium hyaluronate may precipitate in their presence. It is recommended to use disinfectants such as iodopovidone.
- Do not inject SUPARTZ intravascularly.
- Strictly observe aseptic administration techniques.
- Aspirate any joint effusion before injecting SUPARTZ.
- The safety and performance of SUPARTZ have not been established in joints other than the knee or shoulder and for conditions other than OA.
- The safety and performance of SUPARTZ in conjunction with other injectable intra-articular solutions have not been established.
- The safety and performance of SUPARTZ in severely inflamed knee joints have not been established.
- Do not inject SUPARTZ extra-articularly or into the synovial membrane and capsule.
- STERILE CONTENTS. The pre-filled syringe is for single use only. The contents of the syringe must be used immediately after opening the package. Discard unused SUPARTZ.
- Do not use SUPARTZ if the blister is open or damaged or if there are cracks or breaks in the pre-filled syringe.
- In an osteoarthritic knee with severe inflammation, the inflammation should be reduced before injecting SUPARTZ, as the inflammation may worsen due to the injection.
- Use SUPARTZ within the expiration date indicated on the package.
- As with any invasive joint procedure, the patient is advised to avoid any strenuous activities (such as jogging, tennis or other active sports, heavy work) and prolonged weight-bearing activities (such as standing for more than an hour) for 48 hours after intra-articular SUPARTZ injection treatment.

Storage
The expiration date is indicated on the label and outer packaging.
Store in the original package at a temperature of 1 °C-25 °C.
Do not freeze.
Shelf life with intact packaging: 36 months.

Format
1 pre-filled syringe 2.5 ml.

Code MD030701