Description
Superpartz
Description
A sterile, non-pyrogenic, highly purified, non-inflammatory, high molecular weight sodium hyaluronate solution extracted from rooster combs and is a polysaccharide containing repeating 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 species of origin. The sodium hyaluronate used in the manufacture of Supartz is of avian origin and is derived through a lengthy purification process. 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, a small amount of Supartz is metabolised in the synovial fluid, while the remainder is distributed in the synovial tissues where it is partially degraded 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 as a 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 remove the syringe.
- Grasp the thick part of the cap, carefully unscrew it and remove it obliquely.
- Aseptically attach an appropriately sized needle (e.g. 22-23 gauge) to the syringe. To ensure a tight seal and prevent leakage during administration, secure the needle by holding the luer lock firmly.
- Disinfect the injection site before injecting.
-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 helps prevent tendon adhesions by acting as a physical barrier in the experimental animal model.
-Supartz helps reduce pain in knee osteoarthritis and shoulder periarthritis.
-Supartz helps 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 weekly. However, it may be necessary to synchronise the timing of the intra-articular injection with the patient's symptoms. If symptoms do not improve, discontinue administration of Supartz after five (5) injections.
Before injecting Supartz, remove the effusion if present by arthrocentesis. As Supartz is viscous, use needles of the appropriate size for injections (e.g. size 22-23). To inject into the knee joint cavity, insert the needle into the joint horizontally or at a slight downward angle, into 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 best approached from the anterior side, but posterior or lateral approaches are also used. To accurately administer Supartz into the biceps peritenon, insert the needle into the epidermis at 20-30° and parallel to the socket. If it enters the tendon, some resistance will be felt to the injection. If available, perform an ultrasound-guided injection into the biceps sheath to more accurately identify the location.
Warnings
-Use extreme caution when administering Supartz to patients with infections or basic skin lesions at 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 osteoarthritis of the knee or periarthritis of the shoulder and should therefore only be administered by doctors experienced in this type of injection procedure.
-Administer Supartz with caution in patients with hypersensitivity to other drugs whose history indicates 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.
-Administer Supartz taking care of asepsis, taking the normal precautions taken in injections.
-Supartz is for single use only. Use immediately after opening and do not reuse.
-Do not inject Supartz into a vein.
-Do not use Supartz for ophthalmic purposes.
-Do not use Supart if the package or syringe is damaged or opened.
-Do not use Supartz after the expiry date stated on the label and outer packaging.
-Supartz may precipitate in the presence of disinfectants containing quaternary ammonium salts (such as benzalkonium chloride) and/or chlorhexidine. Therefore, care should be taken with this aspect. (The 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 external 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 peritenon of the biceps, ensure that Supartz is injected into the joint cavity, as leakage outside the cavity may cause pain. Patients should be instructed to rest the affected joint following injection of Supartz to reduce the possibility of localised pain. In severely inflamed osteoarthritic knees, the knee should be reduced prior to injecting Supartz, as the inflammation may be aggravated by 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 may arise with the injection procedures of any biological substance. Patients should be advised to return to their physician if they experience symptoms that may be associated with the above adverse effects.
Clinically significant adverse reactions : Since symptoms of shock may occur, although rarely (incidence <0.1%), patients receiving Supartz should be carefully monitored. If any abnormality occurs, discontinue administration and treat patients with appropriate therapy.
Other undesirable effects : During clinical studies and during pharmacovigilance of Supartz, after marketing, cases of undesirable effects listed below have been reported. If any anomaly 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.
Conservation
Store at a temperature between 1°C and 25°C.
Protect from freezing.
Use Supartz before the expiry date shown on the label and outer packaging.
Validity with intact packaging: 3 years.
Format
Available:
-1 pre-filled syringe 2.5 ml;
-3 pre-filled syringes 2.5 ml;
-5 pre-filled syringes 2.5 ml.
Cod. MD030701
A sterile, non-pyrogenic, highly purified, non-inflammatory, high molecular weight sodium hyaluronate solution extracted from rooster combs and is a polysaccharide containing repeating 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 species of origin. The sodium hyaluronate used in the manufacture of Supartz is of avian origin and is derived through a lengthy purification process. 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, a small amount of Supartz is metabolised in the synovial fluid, while the remainder is distributed in the synovial tissues where it is partially degraded 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 as a 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 remove the syringe.
- Grasp the thick part of the cap, carefully unscrew it and remove it obliquely.
- Aseptically attach an appropriately sized needle (e.g. 22-23 gauge) to the syringe. To ensure a tight seal and prevent leakage during administration, secure the needle by holding the luer lock firmly.
- Disinfect the injection site before injecting.
-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 helps prevent tendon adhesions by acting as a physical barrier in the experimental animal model.
-Supartz helps reduce pain in knee osteoarthritis and shoulder periarthritis.
-Supartz helps 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 weekly. However, it may be necessary to synchronise the timing of the intra-articular injection with the patient's symptoms. If symptoms do not improve, discontinue administration of Supartz after five (5) injections.
Before injecting Supartz, remove the effusion if present by arthrocentesis. As Supartz is viscous, use needles of the appropriate size for injections (e.g. size 22-23). To inject into the knee joint cavity, insert the needle into the joint horizontally or at a slight downward angle, into 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 best approached from the anterior side, but posterior or lateral approaches are also used. To accurately administer Supartz into the biceps peritenon, insert the needle into the epidermis at 20-30° and parallel to the socket. If it enters the tendon, some resistance will be felt to the injection. If available, perform an ultrasound-guided injection into the biceps sheath to more accurately identify the location.
Warnings
-Use extreme caution when administering Supartz to patients with infections or basic skin lesions at 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 osteoarthritis of the knee or periarthritis of the shoulder and should therefore only be administered by doctors experienced in this type of injection procedure.
-Administer Supartz with caution in patients with hypersensitivity to other drugs whose history indicates 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.
-Administer Supartz taking care of asepsis, taking the normal precautions taken in injections.
-Supartz is for single use only. Use immediately after opening and do not reuse.
-Do not inject Supartz into a vein.
-Do not use Supartz for ophthalmic purposes.
-Do not use Supart if the package or syringe is damaged or opened.
-Do not use Supartz after the expiry date stated on the label and outer packaging.
-Supartz may precipitate in the presence of disinfectants containing quaternary ammonium salts (such as benzalkonium chloride) and/or chlorhexidine. Therefore, care should be taken with this aspect. (The 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 external 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 peritenon of the biceps, ensure that Supartz is injected into the joint cavity, as leakage outside the cavity may cause pain. Patients should be instructed to rest the affected joint following injection of Supartz to reduce the possibility of localised pain. In severely inflamed osteoarthritic knees, the knee should be reduced prior to injecting Supartz, as the inflammation may be aggravated by 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 may arise with the injection procedures of any biological substance. Patients should be advised to return to their physician if they experience symptoms that may be associated with the above adverse effects.
Clinically significant adverse reactions : Since symptoms of shock may occur, although rarely (incidence <0.1%), patients receiving Supartz should be carefully monitored. If any abnormality occurs, discontinue administration and treat patients with appropriate therapy.
Other undesirable effects : During clinical studies and during pharmacovigilance of Supartz, after marketing, cases of undesirable effects listed below have been reported. If any anomaly 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.
Conservation
Store at a temperature between 1°C and 25°C.
Protect from freezing.
Use Supartz before the expiry date shown on the label and outer packaging.
Validity with intact packaging: 3 years.
Format
Available:
-1 pre-filled syringe 2.5 ml;
-3 pre-filled syringes 2.5 ml;
-5 pre-filled syringes 2.5 ml.
Cod. MD030701
