Hyalotend 3 Sir 20Mg/2Ml

Description
Medical Device CE (Dir. 93/42/EEC) Class III. Sterile.
Viscous solution of hyaluronic acid sodium salt (500-730 kDa) obtained by bacterial fermentation, in 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 one of the main components of synovial fluid, it is produced in the normal tendon sheath and is a main component of the extracellular matrix of the tendon. The administration of exogenous hyaluronic acid sodium salt into the peritendinous space, thanks to its viscoelastic properties, allows to reduce superficial friction of tendons, increases sliding capacity, reduces pain and improves tendon function in tendinopathy, thus speeding up the return to normal activities and sports.

Directions for Use
The administration of the product must be carried out exclusively by experienced medical personnel. Perform the injection under ultrasound guidance if necessary. All rules regarding sterile technique of administration must be strictly followed. Do not use concurrently with disinfectants containing quaternary ammonium salts, as hyaluronic acid can precipitate in their presence. Use a sterile needle suitable (21-25 G) as per medical advice. Dispose of 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 injection into a single tendon. Repeated treatments can be carried out if required.

Composition
Main component: hyaluronic acid sodium salt.
Other components: sodium chloride, disodium phosphate dibasic dodecahydrate, monosodium phosphate dihydrate, water for injections.

Warnings
HYALOTEND must not be administered to patients with known hypersensitivity to any component of the product. Peritendinous injections of HYALOTEND are contraindicated in case of infections or skin diseases 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 expiry date indicated 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 remains closed and intact. The syringe is for single use only, meaning it must be used for one injection. The assembled syringe must be disposed of immediately after use, whether the solution has been fully administered or not. If a syringe is used for a subsequent injection, there is a risk of contamination that could lead to disease, 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 can cause serious health and safety damages to the patient. After use, dispose of according to current regulations. As with any invasive joint procedure, be careful not to overload the joint immediately after peritendinous injection. Keep out of the reach of children.

Storage
Store below 25°C. Do not freeze.
Shelf life with intact packaging: 36 months.

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

Code 10000123