Description
Pre-filled syringe with hyaluronic acid sodium salt solution for peritendinal use. Hyalotend È 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 supplied sterile. Hyaluronic acid is one of the main components of synovial fluid, È produced in the normal tendon sheath and is a major 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 properties, viscoelastic, allows you to reduce the superficial friction of the tendons, increases the ability sliding, reduces pain and improves tendon function in tendinopathy, thus accelerating the return to normal activities and sports. Hyalotend È indicated for the treatment of pain and the improvement of elasticity tendinopathy 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.

Mode instructions for 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 they hyaluronic acid can fall 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 more tendons can be treated at the same time. Each syringe is intended for single tendon injection. Repeated treatments can be carried out if required.

Warnings
Hyalotend should not be administered to patients with hypersensitivity to known 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 is not been tested on pregnant women or older individuals. under 18 years of age and therefore È 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 packaging is open or damaged: sterility of the solution È guaranteed provided the package is closed and intact. The syringe È disposable, this is This 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, material structure, 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 these 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 hypersensitivity to the individual.

Storage
The product must be stored at a temperature not exceeding 25 °C in the original packaging protected from light. Do not freeze.

Format
Carton containing 1 pre-filled syringe sealed in a blister.
Carton 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 10000122, 10000123