Fidia Hyalotend Intra-articular Syringe 20mg/2ml 3 Pieces

Description
CE Medical Device (Dir. 93/42/EEC) Class III. Sterile.
Viscous solution of hyaluronic acid sodium salt (500-730 kDa) obtained by bacterial fermentation, in buffered physiological solution, for peritendinous injection. The solution (20 mg/2 ml) is contained in a pre-filled syringe and is supplied sterile. Hyaluronic acid is one of the main components of synovial fluid, is produced in the normal tendon sheath, and is a major component of the tendon's extracellular matrix. The administration of exogenous hyaluronic acid sodium salt into the peritendinous space, thanks to its viscoelastic properties, reduces the surface friction of tendons, increases sliding capacity, reduces pain, and improves tendon function in tendinopathy, thus accelerating the return to normal activities and sports.

Instructions for use
The product must be administered exclusively by experienced medical personnel. Administer with an ultrasound probe to guide the injection, if necessary. All rules regarding aseptic administration technique must be strictly followed. Do not use concomitantly with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence. Use a suitable sterile needle (21-25 G) as per medical advice. Discard the syringe and needle after single use.
Administer 3 peritendinous injections of the product at weekly intervals, according to medical advice. If necessary, multiple tendons can be treated simultaneously. Each syringe is intended for the injection of a single tendon. Repeated treatments can be carried out if required.

Composition
Main component: hyaluronic acid sodium salt.
Other components: sodium chloride, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, water for injections.

Warnings
HYALOTEND should not be administered to patients with known hypersensitivity to any component of the product. Peritendinous injections of HYALOTEND are contraindicated in case of infections or skin diseases in the area of the injection site. HYALOTEND has not been tested on pregnant women or individuals under 18 years of age and is therefore contraindicated in these patient populations.
Do not use the product after the expiration date indicated on the package. Do not use the product if the package is open or damaged: the sterility of the solution is guaranteed provided the package is closed and intact. The syringe is for single use, meaning it should be used for only one injection. The assembled syringe must be disposed of immediately after use, regardless of whether the solution has been completely administered or not. If a syringe is used for a subsequent injection, there is a risk of contamination that could lead to illness, infection, and/or serious harm to the patient. If the product is reprocessed and/or reused, Fidia farmaceutici cannot guarantee its performance, functionality, material structure, cleanliness, or sterility. Reprocessing and/or reuse can cause serious harm to the patient's health and safety. After use, dispose of according to current regulations. As with any invasive joint procedure, care should be taken not to overload the joint immediately after peritendinous injection. Keep out of reach of children.

Storage
Store below 25°C. Do not freeze.
Shelf life of unopened package: 36 months.

Format
Box containing 3 pre-filled syringes, each sealed in a blister.
The 20 mg/2 ml solution of hyaluronic acid sodium salt contained in the pre-filled syringe is sterilized with steam.

Code. 10000123