Jonexa

Syringe with hyaluronic acid

Indications
- Temporarily restores 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 disease;
- 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 osteoarthritis of the knee. Viscosupplementation with Jonexa is indicated for pain relief and functional limitations, allowing for more extensive 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 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 synovial fluid and to inject, but use the same 18-gauge to 20-gauge needle.
Remove the syringe from the package by holding the syringe barrel tightly without touching the plunger rod.
Be especially careful when removing the syringe tip using strictly aseptic procedures.
To ensure a tight seal and to avoid spillage during administration, make sure the needle is firmly seated on the syringe while holding the Luer connector firmly.
Do not tighten or exert excessive pressure when applying the needle or removing the needle guard as this could break the tip of the syringe.
Inject only into the synovial space.
A strictly aseptic administration technique must be used.

Characteristics
Viscoelastic liquid sterile, colorless, pyrogenic, with neutral pH and with osmolality compatible with the synovial fluid. Jonexa is a derivative of hylastan, a sodium hyaluronate (HA) gel that is chemically crosslinked with divinylsulfone and a liquid sodium diyaluronate. Jonexa is a mixture composed of a hylastan gel and an HA-based unliquid in the gel-liquid ratio of 80:20. The sodium hyaluronate used in the preparation of Jonexa is obtained from bacterial fermentation. Hyaluronan (sodium hyaluronate) is a natural complex sugar belonging to the family of glycosaminoglycans consisting of a long-chain polymer of repeated disaccharide units of sodium D-glucuronate and N-acetyl-D-glucosamine, united by means of β-1 glycosidic bonds, 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 alloyaluronan. Hyaluronan is one of the components of the synovial fluid and determines the characteristics of viscoelasticity. The mechanical (viscoelastic) properties of Jonexa are similar to those of the synovial fluid and superior to those of unchanged hyaluronan-based solutions of similar concentration. Jonexa has an elasticity (storage modulus G ') at 5 Hz between 20 and i150 Pascal (Pa) and a dynamic viscosity (shear viscosity) (η) between i30 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 technique that can be superimposed on 2.5 Hz, are respectively equal to G '= 117 Pa and G "= 45 Pa. The preloaded syringes with Jonexa they are sterilized at the end of each production process by means of heat.
The contents of the syringe are sterile and for single use only.
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 skin diseases or skin infections in the area of the injection.
It should not be used if significant intra-articular effusion has occurred prior to the injection.
It must not be injected into the joint in the presence of venous or lymphatic stasis in the affected limb.

Warnings
Do not use concomitantly disinfectants containing quaternary ammonium salts for skin preparation as hyaluronan could precipitate in their presence.
Do not inject outside of joints or into tissues or synovial capsule.
Do not inject into a jar.
As with all invasive joint-related procedures, it is recommended that the patient avoid any excessive motor activity following the intra-articular injection and resume full activity within a few days.
Jonexa has not been tested in pregnant women or in children / adolescents under the age of 18.

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 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 residue.
Do not resterilize.

Format
5 ml glass syringe preloaded with about 4 ml of soft-gel