Description
Jonexa
SYRINGEDirections
- Temporarily restores the viscoelasticity of the synovial fluid;
- provides clinical benefits to patients in all states of joint osteoarthritis;
- it is more effective in patients who actively and regularly use the affected joint;
- achieves its therapeutic effect through viscosupplementation, a process through which the physiological state and rheological characteristics of the arthritic joint tissues are restored.
It is indicated for intra-articular use only by a physician for the symptomatic treatment of pain associated with osteoarthritis of the knee. Viscosupplementation with Jonexa is indicated to relieve pain and functional limitations, allowing greater range of motion 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 physician.
Use only 18- 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- to 20-gauge needle.
Remove the syringe from the package by holding the body of the syringe without touching the plunger rod.
Particular care should be taken 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 into the syringe while holding the Luer connector tightly.
Do not squeeze or apply excessive pressure when attaching the needle or removing the needle guard as this may break the syringe tip.
Inject only into the synovial space.
A strictly aseptic administration technique must be adopted.
Characteristics
Sterile, colourless, non-pyrogenic viscoelastic liquid with neutral pH and osmolality compatible with synovial fluid. Jonexa is a derivative of hylastan, a sodium hyaluronate (HA) gel chemically cross-linked with divinylsulfone and a sodium hyaluronate liquid. Jonexa is a mixture of a hylastan gel and an HA-based liquid in a 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-glucuronide and N-acetyl-D-glucosamine, linked by β-1,3 and β-1,4 glycosidic bonds. The contents of each Jonexa syringe are sterile and non-pyrogenic.
Jonexa is metabolised in the body in a biologically similar manner to hyaluronan. Hyaluronan is a component of synovial fluid and determines its viscoelastic characteristics. The mechanical (viscoelastic) properties of Jonexa are similar to those of synovial fluid and superior to those of unchanged hyaluronan solutions 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 the synovial fluid of the knee 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 preloaded with Jonexa are sterilized at the end of each manufacturing process by heat.
The contents of the syringe are sterile and single use.
It is a Medical Device.
Contraindications
Do not administer to patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.
It should not be used in the presence of infections or severe inflammation or skin diseases or infections in the area where the injection is to be given.
It should not be used if significant intra-articular effusion has occurred prior to injection.
It should not be injected into the joint in the presence of venous or lymphatic stasis in the affected limb.
Warnings
Do not use concomitantly with disinfectants containing quaternary ammonium salts for skin preparation as in their presence hyaluronan may precipitate.
Do not inject outside of joints or into synovial tissue or capsule.
Do not inject into a vessel.
As with all invasive joint procedures, it is recommended that the patient avoids any excessive motor activity following the intra-articular injection and resumes full activity within a few days.
Jonexa has not been tested in pregnant women or in children/adolescents under 18 years of age.
Components for 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 qs
Conservation
Store Jonexa at a temperature between 2 and 30°C.
Do not use if package is opened 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-filled with approximately 4 ml of soft-gel
