Description
CE Medical Device (Dir. 93/42/EEC) Class III. Sterile.
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.

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 peritendinous 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 the injection of a single tendon. Repeated treatments may be performed if necessary.

Composition
Main component: hyaluronic acid sodium salt.
Other ingredients: 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. Peritendineal injections of HYALOTEND are contraindicated in cases of infections or skin diseases at the injection site. HYALOTEND has not been tested in 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 shown 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 for single use only, 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. 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 the health and safety of the patient. Dispose of the product according to current regulations after use. As with any invasive joint procedure, care should be taken not to overload the joint immediately after the peritendinous injection. Keep out of reach of children.

Conservation
Store below 25°C. Do not freeze.
Shelf life in unopened packaging: 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.

Cod. 10000123