FIDIA FARMACEUTICI, Hyalotend 3×20 Mg / 2 Ml FIDIA FARMACEUTICI

“Composition
Sodium hyaluronate, sodium chloride, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, water for injection.

Directions
Pre-filled syringes with sodium hyaluronate solution for peritendinous use.
Hyalotend is a viscous solution of sodium hyaluronate (500-730 kDa), obtained by bacterial fermentation, in a buffered saline solution for peritendinous injection.
The solution (20 mg/2 ml) is contained in a pre-filled syringe and is supplied sterile.
Hyaluronic acid is the main component of synovial fluid, is produced in the normal tendon sheath and is the main component of the tendon extracellular matrix.
The introduction of exogenous sodium hyaluronic acid into the peritendinous space, due to its viscoelastic properties, reduces tendon surface friction, increases gliding ability, reduces pain and improves tendon function in tendinopathy, thereby accelerating the return to normal activity and sports.
Hyalotend is indicated for the treatment of pain and improvement of tendon elasticity in tendinopathy of the upper and lower extremities.

The product is a CE medical device.

Method of administration and dosage
The product should only be administered by experienced medical personnel.
If necessary, perform the injection using an ultrasound probe to control the injection.
All rules regarding aseptic technique of administration must be strictly observed.
Do not use together with disinfectants containing quaternary ammonium salts, as in their presence hyaluronic acid may precipitate.
Use a suitable sterile needle (21-25 G) as directed by your physician.
Discard the syringe and needle after single use.
Administer 3 injections of Peritendin at weekly intervals as directed by your physician.
If necessary, several tendons can be treated simultaneously. Each syringe is intended for injection into one tendon.
Repeat treatments can be performed if necessary.

Warnings
Hyalotend should not be administered to patients with known hypersensitivity to any component of the product.
Hyalotend peritendin injections are contraindicated in cases of infection or skin disease 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 categories of patients.
Do not use the product after the expiration date stated on the package.
Do not use the product if the packaging is open or damaged: the sterility of the solution is guaranteed if the packaging is closed and intact.
The syringe is for single use only, i.e. it should be used for one injection only.
The assembled syringe must be discarded immediately after use, whether or not the entire solution has been administered.
If the 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, purity or sterility.
Reprocessing and/or reuse may seriously harm the health and safety of patients.
Dispose of after use in accordance with current regulations.
As with any invasive procedure on joints, care should be taken not to overload the joint immediately after injection in the peritendinous space.
Keep out of the reach of children.
Local reactions such as pain and heat or redness/swelling/bruising at the injection site may occur.
These symptoms are usually temporary and resolve spontaneously within a few days with rest for the affected joint and local application of ice.
Local or systemic allergic reactions due to individual hypersensitivity have been reported sporadically after hyaluronic acid injections.

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