Descrizione Clinica
Medical devices - medical devices Joinart sir 1.6% 2ml 3pz
ENDXPHARMA
JOINART
32 mg/2 ml
Hyaluronic acid salt sodium 1.6%
JOINART
32 mg/2 ml
Hyaluronic acid salt sodium 1.6%
Indications
Joinart is a substitute for the synovial fluid in the joints with degenerative or mechanical arthropathy, which causes pain or reduced mobility.
Description
Joinart is a medical device with a CE mark in compliance with Directive MDD93/42/EEC, 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, apirogenous and viscoelastic solution provided in a 2 ml syringe. Hyaluronic acid is a natural polysaccharide present in many human tissues, especially in the synovial liquid, and acts in the joints both as a lubricant of cartilage and ligaments and as a shock absorber. According to many studies the injections of hyaluronic acid in joints with osteoarthritis restore the viscosity and elasticity of the synovial fluid, resulting in pain attenuation and an improvement in the mobility of the joint.
Joinart acts only at the level of the joint in which it is injected, without exercising any systemic action.
Composition
Main component sterile hyaluronic acid salt sodium 1.6%. Other components: sodium chloride, sodium phosphate and water for injectable preparations.
Packaging
Joinart is supplied in a glass syringe containing 32 mg of hyaluronic acid in 2 ml of buffered physiological solution of sodium chloride, packaged in a blister.
The content of the syringe is sterilized with wet heat.
Instructions for use
Remove any joint deposit before injecting Joinart; for removal of the effusion and Joinart injection must be used the same needle. Remove the protective syringe cap paying special attention to avoid contact with opening.
Securely screw the diameter needle between 18 and 22 G to the Luer type closing collar to ensure a stagnant seal.
Before injection treat the site with an appropriate antiseptic solution. Inject Joinart by adopting a septic technique. Inject only in the joint cavity.
Administration
Joinart should be administered weekly for a total of three weeks or in any case according to the prescription.
Warnings
• The content of the pre-filled syringe is sterile.
The syringe is packaged 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 packaging or syringe is open or damaged.
• The injection point must be on healthy skin.
• Do not inject vascularly. Do not inject outside the joint cavity, tissues or synovial capsules.
• Joinart was not tested in pregnant women or breastfeeding.
• Joinart is disposable and should not be resterilized.
• Avoid the simultaneous administration of Joinart with other intrarticular products to prevent any interaction.
• Do not administer Joinart in the presence of abundant intrarticular deposit.
• Once the package is opened, Joinart must be used immediately and eliminated in accordance with current rules.
• Keep away from the reach of children.
• As with every invasive treatment of jointing, it is recommended for the patient to avoid all intense physical activity for the first 2-3 days after injection.
Contraindications
It should not be administered:
• patients with proven sensitivity to hyaluronic acid and its compounds;
• in case of infection or skin disease near the injection site;
• if the joint is infected or strongly inflamed.
Side effects
Transitional side reactions may occur as a result of Joinart's injection, such as pain, stiffness, feeling of warmth, redness or swelling.
These secondary manifestations can be alleviated with the application of ice on the treated joint. They usually disappear after a short time. If symptoms persist, contact a doctor. As in any invasive treatment of jointing, a septic arthritis may occur if we do not observe the appropriate precautions during injection or injection point is not aseptic.
Conservation and expiry
Joinart must be kept in the original packaging at a temperature between 0 and 25°C, sheltered from direct sunlight and frost. The expiry date is indicated on the packaging.
Cod.
0000000000001
0000000000002
Joinart is a substitute for the synovial fluid in the joints with degenerative or mechanical arthropathy, which causes pain or reduced mobility.
Description
Joinart is a medical device with a CE mark in compliance with Directive MDD93/42/EEC, 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, apirogenous and viscoelastic solution provided in a 2 ml syringe. Hyaluronic acid is a natural polysaccharide present in many human tissues, especially in the synovial liquid, and acts in the joints both as a lubricant of cartilage and ligaments and as a shock absorber. According to many studies the injections of hyaluronic acid in joints with osteoarthritis restore the viscosity and elasticity of the synovial fluid, resulting in pain attenuation and an improvement in the mobility of the joint.
Joinart acts only at the level of the joint in which it is injected, without exercising any systemic action.
Composition
Main component sterile hyaluronic acid salt sodium 1.6%. Other components: sodium chloride, sodium phosphate and water for injectable preparations.
Packaging
Joinart is supplied in a glass syringe containing 32 mg of hyaluronic acid in 2 ml of buffered physiological solution of sodium chloride, packaged in a blister.
The content of the syringe is sterilized with wet heat.
Instructions for use
Remove any joint deposit before injecting Joinart; for removal of the effusion and Joinart injection must be used the same needle. Remove the protective syringe cap paying special attention to avoid contact with opening.
Securely screw the diameter needle between 18 and 22 G to the Luer type closing collar to ensure a stagnant seal.
Before injection treat the site with an appropriate antiseptic solution. Inject Joinart by adopting a septic technique. Inject only in the joint cavity.
Administration
Joinart should be administered weekly for a total of three weeks or in any case according to the prescription.
Warnings
• The content of the pre-filled syringe is sterile.
The syringe is packaged 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 packaging or syringe is open or damaged.
• The injection point must be on healthy skin.
• Do not inject vascularly. Do not inject outside the joint cavity, tissues or synovial capsules.
• Joinart was not tested in pregnant women or breastfeeding.
• Joinart is disposable and should not be resterilized.
• Avoid the simultaneous administration of Joinart with other intrarticular products to prevent any interaction.
• Do not administer Joinart in the presence of abundant intrarticular deposit.
• Once the package is opened, Joinart must be used immediately and eliminated in accordance with current rules.
• Keep away from the reach of children.
• As with every invasive treatment of jointing, it is recommended for the patient to avoid all intense physical activity for the first 2-3 days after injection.
Contraindications
It should not be administered:
• patients with proven sensitivity to hyaluronic acid and its compounds;
• in case of infection or skin disease near the injection site;
• if the joint is infected or strongly inflamed.
Side effects
Transitional side reactions may occur as a result of Joinart's injection, such as pain, stiffness, feeling of warmth, redness or swelling.
These secondary manifestations can be alleviated with the application of ice on the treated joint. They usually disappear after a short time. If symptoms persist, contact a doctor. As in any invasive treatment of jointing, a septic arthritis may occur if we do not observe the appropriate precautions during injection or injection point is not aseptic.
Conservation and expiry
Joinart must be kept in the original packaging at a temperature between 0 and 25°C, sheltered from direct sunlight and frost. The expiry date is indicated on the packaging.
Cod.
0000000000001
0000000000002
