INTRA-ARTICULAR PRE-FILLED SYRINGE SUPARTZ HYALURONIC ACID 25 MG 2.5 ML 5 PIECES
Sterile, non-pyrogenic solution of sodium hyaluronate, highly purified, with no 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 remainder 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 through the lungs, intestines and urinary tract. Supartz is marketed in sterile solution in pre-filled disposable syringes to reduce the risk of contamination during aspiration of the solution.
How to use
- Open the blister by peeling off the film and take out the syringe.
- Grasp the thick part of the cap, unscrew it carefully 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 injection.
-Supartz improves the lubricating function of the synovial fluid in the artificial joint model and in the experimental animal model.
-Supartz serves to coat and protect deteriorated cartilage surfaces in the experimental animal model.
-Supartz allows to prevent tendon adhesions by acting as a physical barrier in the experimental animal model.
-Supartz allows to reduce pain in knee osteoarthritis and shoulder periarthritis.
-Supartz allows to reduce stiffness in knee osteoarthritis and shoulder periarthritis.
The recommended treatment regimen for Supartz in adults consists of five (5) injections into the knee joint cavity or shoulder joint (joint cavity, 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, discontinue Supartz 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 into the peritenon 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.
- Exercise extreme caution when administering Supartz to patients with primary skin infections or lesions at the injection site.
-Do not give 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 Supart 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 in a sterile field.
Precautions: Unless injected into the peritenum of the biceps, ensure that Supartz is injected into the joint cavity, as a leak 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 may 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 the doctor in case of symptoms that may be associated with the above side effects.
Clinically significant undesirable effects: since they can occur, although rarely, (incidence Other side effectsCases of the following undesirable effects have been reported during clinical trials and during the pharmacovigilance of Supartz, after marketing. If any abnormality occurs, discontinue administration and treat patients with appropriate therapy.
The following adverse reactions have been reported in relation to injection procedures.
- septic arthritis
- bleeding at the injection site
- skin necrosis.
Store at a temperature between 1 ° C and 25 ° C.
Protect from freezing.
Use Supartz before the expiration date indicated on the label and outer carton.
Validity for intact packaging: 3 years.
-1 pre-filled syringe 2.5 ml;
-3 pre-filled syringes 2.5 ml;
-5 pre-filled syringes 2.5 ml.