HYALOTEND

Description
Pre-filled syringe with hyaluronic acid sodium salt solution for peritendinous use. Hyalotend is a viscous solution of hyaluronic acid sodium salt (500-730 kDa) obtained by bacterial fermentation, in buffered saline, for peritendinous injection. The solution (20 mg/2 ml) is contained in a pre-filled syringe and is supplied sterile. Hyaluronic acid is a major component 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 surface friction of the tendons, increases sliding capacity, reduces pain, and improves tendon function in tendinopathy, thus accelerating the return to normal activities and sports. Hyalotend is indicated for the treatment of pain and 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 product should be administered only by experienced medical personnel. Use 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) according to medical advice. Discard the syringe and needle after single use.
Administer 3 peritendin injections of the product at weekly intervals, as directed by your doctor. If necessary, multiple tendons can be treated simultaneously. Each syringe is intended for injecting a single tendon. Repeated treatments may be performed if necessary.

Warnings
Hyalotend should not be administered to patients with known hypersensitivity to any component of the product. Hyalotend peritend injections are contraindicated in cases of infection or skin disease at 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 printed on the package. Do not use the product if the package is opened or damaged: the sterility of the solution is guaranteed as long as the package is closed and intact. The syringe is single-use, meaning it should be used for a single injection only. The assembled syringe must 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 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 may cause serious harm to patient health and safety. Dispose of the product after use in accordance with applicable 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. Local reactions such as pain and heat or redness/swelling/bruising at the injection site may occur. These symptoms are usually transient and disappear spontaneously within a few days with rest and local ice application. Local or systemic allergic reactions due to individual hypersensitivity have been reported sporadically after hyaluronic acid injections.

Conservation
The product should be stored at a temperature not exceeding 25°C in its 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.

Cod. 10000122, 10000123