SUPARTZ HYALURONIC ACID 25 MG 2.5 ML INTRA-ARTICULAR PRE-FILLED SYRINGE 3 PIECES

Description
SUPARTZ is a sterile, non-pyrogenic, highly purified, non-inflammatory, high molecular weight sodium hyaluronate solution extracted by bacterial fermentation and is a polysaccharide containing repeating 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 its 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 to saline ratio of 1.0 to 1.2.
After injection into the joint, SUPARTZ is poorly metabolized in the synovial fluid, but is incorporated into the synovial tissues where it is partially degraded into smaller molecules. SUPARTZ then enters the bloodstream and is metabolized primarily in the liver. The metabolites are non-toxic and are permanently eliminated from the body through the lungs, intestines, and urinary tract.
SUPARTZ is marketed as a sterile solution in a pre-filled disposable syringe to reduce the risk of contamination during aspiration of the solution.
SUPARTZ is indicated for the treatment of knee OA and shoulder periarthritis, and is intended to improve joint motion by supplementing the viscoelasticity of synovial fluid, and to reduce pain in knee OA and shoulder periarthritis.

How to use
The dosage is 2.5 mL (one syringe) per knee joint injected intra-articularly or into the shoulder joint (shoulder socket, subacromial bursa, or tendon sheath of the long head of the biceps brachii).
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 intervals of one injection per week. However, the timing of injections may be adjusted based on the patient's symptoms.
SUPARTZ must be injected only by authorised medical personnel or in accordance with local legislation.
No additional training is required.
Check the expiry date on the package.
Do not use after the expiration date.
Strictly observe aseptic administration techniques.
Aspirate any joint effusion using a 22-23 gauge needle before injecting SUPARTZ. Maintain the needle position in the joint while removing the syringe used to reduce the joint effusion. Discard the syringe containing the aspirated joint effusion. Do not use the same syringe to aspirate the effusion and inject SUPARTZ.
Subcutaneous injection of lidocaine or similar local anaesthetics may be performed prior to injection of SUPARTZ.
Peel the Tyvek sheet from the blister and remove the syringe.
Carefully remove the syringe cap and aseptically attach the syringe to a 22-23G needle. To ensure a tight seal and prevent leaks during administration (or injection), secure the needle by holding the luer lock firmly.
If the effusion has been previously aspirated, connect the syringe to the needle already placed in the joint.
Unscrew the cap before removing it to minimize product spillage.
Inject SUPARTZ into the knee joint or shoulder joint (shoulder socket, subacromial bursa, or tendon sheath of the long head of the biceps brachii) through the needle using an aseptic injection technique.
Inject the entire contents, 2.5 mL of SUPARTZ, into the knee or shoulder (shoulder socket, subacromial bursa, or biceps tendon sheath). If administering to both knees or shoulders, use a separate syringe of SUPARTZ for each knee or shoulder.
To inject into the knee joint, insert the needle horizontally or at a slight downward angle into the joint space between the kneecap and the femur. It's not unusual to feel some resistance as the needle enters the joint capsule.
In the scapulohumeral joint, the needle is usually inserted most easily from the anterior side, but a posterior or lateral approach is also used.
For accurate administration of SUPARTZ into the biceps sheath, insert the needle into the epidermis at a 20-30 degree angle and parallel to the biceps sheath. If the needle penetrates the tendon, resistance to the injection will occur. If available, perform an ultrasound-guided injection into the biceps sheath to more accurately identify the location.

Components
2.5 ml of 1% sodium hyaluronate solution.

Warnings
- Do not administer SUPARTZ to patients with known hypersensitivity (allergy) to SUPARTZ or sodium hyaluronate preparations.
- Extreme caution should be exercised when administering SUPARTZ to patients with infections or skin lesions at the injection site.
- Administer SUPARTZ with caution in patients with hypersensitivity to any medicinal product.
- Administer SUPARTZ with caution in patients with a history of liver dysfunction.
- Administer SUPARTZ with caution in patients with systemic coagulopathies.
- Administer SUPARTZ with caution to patients with lymphatic or venous stasis in the injected limb.
- Do not use disinfectants containing quaternary ammonium salts (such as benzalkonium chloride) for skin preparation simultaneously, as sodium hyaluronate may precipitate in their presence. The use of disinfectants such as povidone-iodine is recommended.
- 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 diseases other than OA.
- The safety and performance of SUPARTZ in combination with other intra-articular injectable solutions have not been established.
- The safety and efficacy 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 any 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 osteoarthritic knees with severe inflammation, the inflammation should be reduced before injecting SUPARTZ, as the inflammation may be aggravated by the injection.
- Use SUPARTZ by the expiry date indicated on the package.
- As with any invasive joint procedure, the patient is advised to avoid any strenuous activity (such as jogging, tennis or other active sports, heavy work) and prolonged weight-bearing activities (such as standing for more than one hour) for 48 hours following treatment with intra-articular injection of SUPARTZ.

Conservation
The expiry date is indicated on the label and on the outer packaging.
Store in the original packaging at a temperature of 1°C-25°C.
Don't conglate.
Shelf life in intact packaging: 36 months.

Format
3 pre-filled syringes 2.5 ml.

Cod. MD030751