Hyalotend Intra-Articular Syringe

Pre-filled syringe with hyaluronic acid sodium salt solution for peritendinous use. Hyalotend is consisting of a viscous solution of hyaluronic acid sodium salt (500-730 kDa) obtained by bacterial fermentation, in buffered physiological solution, by peritendinous injection. The solution (20 mg/2 ml) is contained in a pre-filled syringe and is It is supplied sterile. Hyaluronic acid is one of the main components of synovial fluid, is produced in the normal tendon sheath and is a main component of the extracellular matrix of the tendon. The administration of the sodium salt of exogenous hyaluronic acid into the peritendinous space, thanks to its viscoelastic properties, allows the surface friction of the tendons to be reduced, increases the sliding capacity, reduces pain and improves tendon function in tendinopathy, thus accelerating the return to normal activities and sport. Hyalotend is indicated for the treatment of pain and the improvement of tendon elasticity in tendinopathy of the upper and lower limbs.

Composition
Hyaluronic acid sodium salt, sodium chloride , dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, water for injections.

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

Warnings
Hyalotend should not be administered to patients with known hypersensitivity to any component of the product. Hyalotend peritendino injections 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 the age of 18 and is therefore contraindicated in these patient populations. Do not use the product after the expiry date shown on the package. Do not use the product if the package is open or damaged: the sterility of the solution is guaranteed as long as the package is closed and intact. The syringe is disposable, which means it should only be used for one injection. The assembled syringe should be discarded 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 which could lead to illness, infection and/or serious harm to the patient. If the product is reworked and/or reused, Fidia Farmaceutici cannot guarantee its performance, functionality, structure of the material, cleanliness or sterility. Reprocessing and/or reuse can cause serious harm to patient health and safety. After use, dispose of according to current regulations. As with any invasive joint procedure, it is recommended that care is taken not to overload the joint immediately following the peritendinous injection. Keep out of reach of children. Local reactions such as pain and warmth or redness/swelling/bruising at the injection site may occur. Usually such symptoms are transient and disappear spontaneously within a few days by keeping the affected joint at rest and applying ice locally. After the injection of hyaluronic acid, local or systemic allergic reactions have been sporadically recorded due to individual hypersensitivity.

Storage
The product must be stored at temperatures no higher than at 25 °C in the original packaging protected from light. Do not freeze.

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