Hyalon 60mg/4ml syringe 4 ml

Hyalon synovial fluid prosthesis is a medical device intended for temporary replacement of synovial fluid in patients with degenerative or mechanical arthropathy of hip and knee joints causing changes in synovial
function, without acute inflammation of synovial membrane. “Hyalon synovial fluid prosthesis” is used for intra-articular injection in the treatment of osteoarthritis (osteoarthritis) and improving joint mobility.

Indications

Hyalon synovial fluid prosthesis is a medical device intended for temporary replacement of synovial fluid in patients with degenerative or mechanical arthropathy of the hip and knee joints, causing changes in synovial function
fluids, without acute inflammation of the synovium. “Hyalon synovial fluid prosthesis” is used for intra-articular injection in the treatment of osteoarthritis (osteoarthritis) and improvement of joint mobility.

Special instructions

Precautions for use
– Do not use if the integrity of the packaging is damaged.
– Do not use after the expiration date indicated on the packaging.
– Do not use simultaneously with disinfectants containing quaternary ammonium salts, because in their presence, hyaluronic acid precipitates.
– Do not allow simultaneous administration of the Hyalon Synovial Fluid Prosthesis with other products or drugs for intra-articular administration.
– “Hyalon synovial fluid prosthesis” should be injected only into those joints for which clinical studies of the effectiveness and safety of the medical device have been conducted.
– The product is single use, which means it can only be used once and only on one patient. The syringe must be thrown away immediately after use, regardless of how much of the medical device was used.
– When reprocessed and/or reused, Gialon does not guarantee the functionality, structure of the material or the purity or sterility of the product.
Reuse may result in illness, infection and/or serious harm to the patient or person administering the medical device.
– Cannot be used simultaneously with disinfectants containing quaternary ammonium salts, because in their presence, hyaluronic acid precipitates.

Composition

Hyaluronic acid (sodium hyaluronate) 57.0-63.0 mg

Sodium chloride 32.4-35.6 mg

Disodium hydrogen phosphate dodecahydrate 2.4 mg
(Na2HPO4 x 12H2O)

Sodium dihydrogen phosphate dihydrate 0.2 mg
(NaH2PO4 x 2H2O)

Water for injection up to 4 ml

Contraindications

Use is contraindicated in patients with established individual hypersensitivity to the components of the product, as well as in the case of infectious or skin diseases at the site of insertion of the product.

Side Effects

In rare cases, local pain, swelling, fever and redness may be observed at the injection site, which are usually mild and disappear quickly. More pronounced inflammatory reactions with precipitation of sodium pyrophosphate crystals have been reported with intra-articular injection of sodium hyaluronate solutions, although no relationship has been identified. If general precautions are not observed when administering the Hyalon Synovial Fluid Prosthesis and insufficient aseptic treatment of the injection site, in rare cases septic arthritis may occur, as with any intra-articular treatment

Recommendations for use

Before inserting the Hyalon Synovial Fluid Prosthesis, the injection site must be disinfected, and joint effusion, if any, must be removed.
The medical product “Hyalon synovial fluid prosthesis” is injected into the affected joint using a sterile needle (18 or 20 gauge) once. Subsequent injections can be carried out, if necessary, to maintain the positive effect.
When introducing the Hyalon synovial fluid prosthesis into the hip joint, it is recommended to perform the procedure using an ultrasound machine. When inserting a medical device into the knee joint, this procedure is not required. After completing the injection, be sure to discard the syringe, needle and remaining solution.

Terms of use
“Hyalon synovial fluid prosthesis” must be administered by a physician skilled in the technique of intra-articular and periarticular administration of hyaluronic acid. A non-surgical doctor must receive special training in this technique and have the appropriate certificate.
The doctor should tell the patient in detail about the indications, contraindications and potential side effects associated with the use of the Hyalon Synovial Fluid Prosthesis. Also, the doctor must check the patient’s condition before introducing the medical device. All rules regarding asepsis and methods of administering a medical device must be followed.

Storage conditions

The medical device should be stored in its original packaging at a temperature of + 2°C to + 25°C away from sunlight. Do not freeze.

Shelf life

24 months. Estimated residence time in the joint (120 hours).
Do not use the “Hyalon synovial fluid prosthesis” after the expiration date indicated on the package.
The number of repeated cycles of administration of a medical device during the treatment period (one injection every 6 months).

Manufacturer

Fidia Pharmaceutical S.p.A., Italy