PRODUCT DESCRIPTION
Directions
- Temporarily reconstitutes the viscoelasticity of the synovial fluid;
- brings clinical benefits to patients in all states of joint arthrosis;
- it is more effective in patients who actively and regularly use the joint affected by the pathology;
- achieves its therapeutic effect through viscosupplementation, a process through which the physiological state and rheological characteristics of the tissues of the arthritic joint are restored.
It is indicated for intra-articular use only by a physician for the symptomatic treatment of pain associated with knee osteoarthritis. Viscosupplementation with Jonexa is indicated to relieve pain and functional limitations, allowing greater movement of the joint.
Dosage and method of use
Inject at room temperature.
Strictly adhere to aseptic techniques.
The use of topical and subcutaneous anesthetics is not necessary; their use is at the discretion of the doctor.
Use only 18 gauge to 20 gauge needles.
Remove synovial fluid or effusion before each injection. Gently aspirate the joint.
Do not use the same syringe to aspirate the synovial fluid and to inject, but use the same 18-gauge to 20-gauge needle.
Remove the syringe from the package by holding the body of the syringe tightly without touching the plunger rod.
Pay particular attention when removing the syringe tip using strictly aseptic procedures.
To ensure a perfect seal and avoid leakage during administration, make sure the needle is firmly inserted on the syringe while holding the Luer connector firmly.
Do not tighten or apply excessive pressure when attaching the needle or removing the needle guard as you may break the syringe tip.
Inject only into the synovial space.
A strictly aseptic administration technique must be adopted.
Characteristics
Sterile, colorless, non-pyrogenic viscoelastic liquid, with neutral pH and an osmolality compatible with synovial fluid. Jonexa is a hylastan derivative, a sodium hyaluronate (HA) gel chemically crosslinked with divinylsulfone and a sodium hyaluronate liquid. Jonexa is a mixture composed of a hylastan gel and a HA-based liquid in the gel-liquid ratio of 80:20. The sodium hyaluronate used in the preparation of Jonexa is obtained by bacterial fermentation. Hyaluronan (sodium hyaluronate) is a natural complex sugar belonging to the glycosaminoglycan family consisting of a long-chain polymer of repeating disaccharide units of sodium D-glucoronate and N-acetyl-D-glucosamine, joined by β-glycosidic bonds -1.3 and β-1.4. The contents of each Jonexa syringe are sterile and non-pyrogenic.
Jonexa is metabolised in the body in a biologically similar way to hyaluronan. Hyaluronan is one of the components of synovial fluid and determines its viscoelasticity characteristics. The mechanical (viscoelastic) properties of Jonexa are similar to those of synovial fluid and superior to those of solutions based on unchanged hyaluronan of similar concentration. Jonexa has an elasticity (storage modulus G') at 5 Hz between 20 and 150 Pascal (Pa) and a dynamic viscosity (shear viscosity) (η) between 30 and 100 Pascal/second (Pas) measured at 1 s -1. The elasticity and viscosity of knee synovial fluid in subjects aged between 18 and 27 years, measured with a superimposable technique at 2.5 Hz, are respectively equal to G' = 117 Pa and G" = 45 Pa. The syringes pre-loaded with Jonexa are sterilized at the end of each production process by heat.
The contents of the syringe are sterile and disposable.
It is a Medical Device.
Contraindications
Do not administer to patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.
It must not be used in the presence of infections or severe inflammation or dermopathies or skin infections in the area where the injection was made.
It should not be used if a significant intra-articular effusion has occurred before the injection.
It must not be injected into the joint in the presence of venous or lymphatic stasis in the limb affected by the pathology.
Components per 1 ml
Hyaluronan polymers (modified and unchanged) 10.5 ± 1 mg; sodium chloride 8.5 mg; disodium hydrogen phosphate heptahydrate 2.2 mg; sodium dihydrogen phosphate monohydrate 0.26 mg; water for injections to taste
storage
Store Jonexa at a temperature between 2 and 30°C.
Do not use if package is open or damaged.
The contents of the syringe should be used immediately after opening the package. Discard any unused hylastan SGL-80.
Do not resterilize.
Format
5 ml glass syringe pre-loaded with approximately 4 ml of soft-gel
