Joinart

Sodium Salt Hyaluronic Acid

JOINART 32 mg / 2 ml

Hyaluronic acid sodium salt 1.6%

Indications
Joinart is a substitute for synovial fluid in joints affected by degenerative or mechanical arthropathy, which causes pain or reduced mobility.

Description
Joinart is a medical device with CE mark in compliance with the MDD93 / 42 / EEC directive, containing 16 mg / ml of hyaluronic acid obtained by fermentation from a high molecular weight fraction (> 1500 kDa) and not chemically modified.
Joinart is a transparent, sterile, non-pyrogenic and viscoelastic solution supplied in a 2 ml syringe. Hyaluronic acid is a natural polysaccharide present in many human tissues, in particular in the synovial fluid, and acts in the joints both as a lubricant of cartilages and ligaments and as a shock absorber. According to many studies, injections of hyaluronic acid in joints affected by osteoarthritis restore the viscosity and elasticity of the synovial fluid, with a consequent reduction of pain and an improvement in the mobility of the joint.
Joinart acts only at the level of the joint where it is injected, without exerting any systemic action.

Composition
Main component sterile hyaluronic acid 1.6% sodium salt. Other components: sodium chloride, sodium phosphate and water for injections.

Packaging
Joinart is supplied in a glass syringe containing 32 mg of hyaluronic acid in 2 ml of sodium chloride buffered saline, packed in a blister.
The contents of the syringe are sterilized with moist heat.

Instructions for Use
Remove any joint effusion before injecting Joinart; the same needle must be used for the removal of the effusion and the injection of Joinart. Remove the protective cap of the syringe taking special care to avoid contact with the opening.
Firmly screw the 18 to 22 G diameter needle into the Luer-type locking collar to ensure a watertight seal.
Before injection, treat the site with an appropriate antiseptic solution. Inject Joinart using an aseptic technique. Inject into the joint cavity only.

Administration
Joinart should be administered weekly for a total of three weeks or in any case according to the medical prescription.

Warnings
• The contents of the pre-filled syringe are sterile.
The syringe is packed in a sterile blister.
The syringe surface is not sterile.
• Do not use Joinart after the expiry date shown on the package.
• Do not use Joinart if the package or the syringe are open or damaged.
• The injection site must be on healthy skin.
• Do not inject by vascular route. Do not inject outside the joint cavity, into tissues or synovial capsules.
• Joinart has not been tested in pregnant or breastfeeding women.
• Joinart is for single use only and must not be re-sterilized.
• Avoid the simultaneous administration of Joinart with other products for intra-articular use in order to prevent any possible interaction.
• Do not administer Joinart in the presence of abundant intra-articular effusion.
• Once the package has been opened, Joinart must be used immediately and disposed of according to the regulations in force.
• Keep out of reach of children.
• As with any invasive joint treatment, the patient is recommended to avoid all strenuous physical activity for the first 2-3 days after the injection.

Contraindications
It should not be given:
• to patients with proven sensitivity to hyaluronic acid and related compounds;
• if you have an infection or skin disease near the injection site;
• if the joint is infected or severely inflamed.

Side effects
Some transient side reactions may occur following the injection of Joinart, such as pain, stiffness, a feeling of heat, redness or swelling.
These secondary manifestations can be alleviated by applying ice to the treated joint. They usually disappear after a short time. If symptoms persist, seek medical attention. As with any invasive joint treatment, septic arthritis could occur if proper precautions are not observed during injection or if the injection site is not aseptic.

Retention and expiration
Joinart must be stored in the original packaging at a temperature between 0 and 25 ° C, away from direct sunlight and frost. The expiry date is indicated on the package.