Descrizione Clinica
Medical devices - medical devices Supartz sir intra-art 2.5ml 5p Mdm
Supartz
Description
Sterile solution, not sodium hyaluronate pyrogen, highly purified, devoid of flogistic action, with high molecular weight being extracted from gall ridges and is a polysaccharide containing repeated dysaccharide units of D-glucuronic acid and N-acetil-D-glucosamine. Sodium hyaluronate is a common component of all extracellular matrixes of connective tissues. It is found in many different species, including man, but is identical, from the chemical point of view, regardless of the species of origin. Sodium hyaluronate used in the manufacture of Supartz is of avian origin and is derived, through 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 degraded into smaller molecules. Subsequently Supartz enters the bloodstream and is metabolized mainly in the liver. Metabolic products are not toxic and are eliminated by the body through the lungs, the intestines and urinary tract. Supartz is marketed in sterile solution in pre-filled disposable syringes to reduce the risk of contamination during solution aspiration.
Mode of use
-Open the blister by detaching the film and extracting the syringe.
- Grab the thick part of the hood, unscrew it carefully and remove it obliquely.
- Aseptically, attach an appropriate measuring needle on the syringe (e.g. gauge 22-23). To ensure an airtight seal and prevent leaks during administration, smooth the needle firmly holding the luer lock.
- Before injection disinfect the injection site.
-Supartz improves the lube function of the synovial fluid in the artificial articular model and the experimental animal model.
-Supartz is used to cover and protect the surfaces of the damaged cartilage in the experimental animal model.
-Supartz allows to prevent tendon adhesions by acting as a seal barrier in the experimental animal model.
-Supartz reduces pain in knee osteoarthritis and shoulder periarthritis.
-Supartz reduces stiffness in knee osteoarthritis and shoulder periarthritis.
The treatment regimen recommended for Supartz in adults consists of five (5) injections in the joint cavity of the knee or in the jointing of the shoulder ( joint cavity, sub-acromial bag and bicep tendon sheath), at intervals of one per week. However, it may be necessary to synchronize the moment of intra-articular injection with the symptoms of the patient. If symptoms do not improve, finish the administration of Supartz after five (5) injections.
Before injecting Supartz, remove the effusion if it is present, by means of arthrocentesis. As Supartz is viscous, use suitable measuring needles for injections (e.g. size 22-23). To perform injections in the joint cavity of the knee, insert the needle into the joint in horizontal direction or slightly inclined downwards, in the space between rotula and femur. While the needle penetrates the joint capsule is not unusual to perceive a certain resistance. The scapula-omeral joint is more easily accessed from the front, but the rear or lateral approaches are also adopted. To carefully administer Supartz into the peritenònium of the biceps, insert the needle into the epidermis at 20-30° and parallel to the socket. If it penetrates the tendon, a certain resistance to injection will be offered. If available, run an ultrasound guided injection in the biceps sheath to more accurately identify the location.
Warnings
-Adopting maximum caution in administering Supartz in patients with infections or primary injury of the skin in the injection site area.
-Do not administer Supartz to pregnant women, nursing mothers and children since 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 be administered exclusively by medical experts in this type of injection procedure.
-Administer Supartz with caution in patients with hypersensitivity to other drugs whose anamnesi indicates liver dysfunction.
-Administer Supartz with caution in patients with systemic clots.
-administer Supartz with caution in patients with lymphatic or venous stasis in the injection seat.
-Administrate Supartz by taking care of theasepsi, taking the normal precautions adopted in injections.
-Supartz is exclusively disposable. Use it immediately after it was opened and do not reuse it.
-Don't inject Supartz into the vein.
-Do not use Supartz in ophthalmic use.
-Do not use Supart if the packaging or syringe are damaged or opened.
-Do not use Supartz after the expiry date indicated on the label and on the external packaging.
-Supartz can precipitate in the presence of disinfectants containing quaternary ammonium salts (such as benzalconium chloride) and/or chlorexedine. So you have to pay attention to this aspect. (It is recommended to use disinfectants such as iodopovidone).
-Don't 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. Precautions should be taken to handle Supartz syringes in a sterile field.
Precautions: unless injected into the peritenònium of the biceps, make sure Supartz is injected into the joint cavity, since a loss outside the cavity could cause pain. Patients should be trained to maintain the joint after injection of Supartz to reduce the possibility of localized algic symptoms. In the osteoarthritis knee with severe inflammation you will have to reduce the same before injecting Supartz, since the inflammation could worsen due to the injection. Sodium hyaluronate in Supartz is a highly purified biological material of aviary origin. Doctors must be aware of the potential risks that may arise with the injection procedures of any biological substance. Patients should be informed of the need to return to the doctor in case there are symptoms that may be associated with these side effects.
Clinically significant side effects: since they can occur, although rarely Other side effects: during clinical studies and during pharmacovigilance of Supartz, after marketing, cases of undesirable effects have been reported below. If any anomaly occurs, suspend administration and treat patients with appropriate therapy.
The following adverse reactions were found in relation to injection procedures.
- septic arthritis
- hemorrhage to the injection site
- skin necrosis.
Conservation
Store at a temperature between 1C and 25°C.
Protect from freezing.
Use Supartz before the expiry date indicated on the label and the external packaging.
Validity of whole packaging: three 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
Sterile solution, not sodium hyaluronate pyrogen, highly purified, devoid of flogistic action, with high molecular weight being extracted from gall ridges and is a polysaccharide containing repeated dysaccharide units of D-glucuronic acid and N-acetil-D-glucosamine. Sodium hyaluronate is a common component of all extracellular matrixes of connective tissues. It is found in many different species, including man, but is identical, from the chemical point of view, regardless of the species of origin. Sodium hyaluronate used in the manufacture of Supartz is of avian origin and is derived, through 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 degraded into smaller molecules. Subsequently Supartz enters the bloodstream and is metabolized mainly in the liver. Metabolic products are not toxic and are eliminated by the body through the lungs, the intestines and urinary tract. Supartz is marketed in sterile solution in pre-filled disposable syringes to reduce the risk of contamination during solution aspiration.
Mode of use
-Open the blister by detaching the film and extracting the syringe.
- Grab the thick part of the hood, unscrew it carefully and remove it obliquely.
- Aseptically, attach an appropriate measuring needle on the syringe (e.g. gauge 22-23). To ensure an airtight seal and prevent leaks during administration, smooth the needle firmly holding the luer lock.
- Before injection disinfect the injection site.
-Supartz improves the lube function of the synovial fluid in the artificial articular model and the experimental animal model.
-Supartz is used to cover and protect the surfaces of the damaged cartilage in the experimental animal model.
-Supartz allows to prevent tendon adhesions by acting as a seal barrier in the experimental animal model.
-Supartz reduces pain in knee osteoarthritis and shoulder periarthritis.
-Supartz reduces stiffness in knee osteoarthritis and shoulder periarthritis.
The treatment regimen recommended for Supartz in adults consists of five (5) injections in the joint cavity of the knee or in the jointing of the shoulder ( joint cavity, sub-acromial bag and bicep tendon sheath), at intervals of one per week. However, it may be necessary to synchronize the moment of intra-articular injection with the symptoms of the patient. If symptoms do not improve, finish the administration of Supartz after five (5) injections.
Before injecting Supartz, remove the effusion if it is present, by means of arthrocentesis. As Supartz is viscous, use suitable measuring needles for injections (e.g. size 22-23). To perform injections in the joint cavity of the knee, insert the needle into the joint in horizontal direction or slightly inclined downwards, in the space between rotula and femur. While the needle penetrates the joint capsule is not unusual to perceive a certain resistance. The scapula-omeral joint is more easily accessed from the front, but the rear or lateral approaches are also adopted. To carefully administer Supartz into the peritenònium of the biceps, insert the needle into the epidermis at 20-30° and parallel to the socket. If it penetrates the tendon, a certain resistance to injection will be offered. If available, run an ultrasound guided injection in the biceps sheath to more accurately identify the location.
Warnings
-Adopting maximum caution in administering Supartz in patients with infections or primary injury of the skin in the injection site area.
-Do not administer Supartz to pregnant women, nursing mothers and children since 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 be administered exclusively by medical experts in this type of injection procedure.
-Administer Supartz with caution in patients with hypersensitivity to other drugs whose anamnesi indicates liver dysfunction.
-Administer Supartz with caution in patients with systemic clots.
-administer Supartz with caution in patients with lymphatic or venous stasis in the injection seat.
-Administrate Supartz by taking care of theasepsi, taking the normal precautions adopted in injections.
-Supartz is exclusively disposable. Use it immediately after it was opened and do not reuse it.
-Don't inject Supartz into the vein.
-Do not use Supartz in ophthalmic use.
-Do not use Supart if the packaging or syringe are damaged or opened.
-Do not use Supartz after the expiry date indicated on the label and on the external packaging.
-Supartz can precipitate in the presence of disinfectants containing quaternary ammonium salts (such as benzalconium chloride) and/or chlorexedine. So you have to pay attention to this aspect. (It is recommended to use disinfectants such as iodopovidone).
-Don't 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. Precautions should be taken to handle Supartz syringes in a sterile field.
Precautions: unless injected into the peritenònium of the biceps, make sure Supartz is injected into the joint cavity, since a loss outside the cavity could cause pain. Patients should be trained to maintain the joint after injection of Supartz to reduce the possibility of localized algic symptoms. In the osteoarthritis knee with severe inflammation you will have to reduce the same before injecting Supartz, since the inflammation could worsen due to the injection. Sodium hyaluronate in Supartz is a highly purified biological material of aviary origin. Doctors must be aware of the potential risks that may arise with the injection procedures of any biological substance. Patients should be informed of the need to return to the doctor in case there are symptoms that may be associated with these side effects.
Clinically significant side effects: since they can occur, although rarely Other side effects: during clinical studies and during pharmacovigilance of Supartz, after marketing, cases of undesirable effects have been reported below. If any anomaly occurs, suspend administration and treat patients with appropriate therapy.
The following adverse reactions were found in relation to injection procedures.
- septic arthritis
- hemorrhage to the injection site
- skin necrosis.
Conservation
Store at a temperature between 1C and 25°C.
Protect from freezing.
Use Supartz before the expiry date indicated on the label and the external packaging.
Validity of whole packaging: three 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
