Hyalotend 1 Syr 20Mg/2Ml

Description
Pre-filled syringe with sodium hyaluronate solution for peritendinous use. Hyalotend consists of a viscous solution of sodium hyaluronate (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 supplied sterile. Hyaluronic acid is one of the main components of synovial fluid, it is produced in the normal tendon sheath and is a major 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, helps reduce the superficial friction of tendons, increases sliding capacity, reduces pain, and improves tendon function in tendinopathy, thereby accelerating the return to normal activities and sports. Hyalotend is indicated for the treatment of pain and the improvement of tendon elasticity in tendinopathy of the upper and lower limbs.

Composition
Sodium hyaluronate, sodium chloride, disodium phosphate dihydrate, monosodium phosphate dihydrate, water for injections.

Mode of use
The product must be administered exclusively by trained medical personnel. Perform administration with an ultrasound probe to guide the injection, if necessary. All rules regarding aseptic technique must be strictly followed. Do not use in conjunction 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. 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, more tendons can be treated simultaneously. Each syringe is intended for injection into a single tendon. Repeated treatments can be performed if required.

Precautions
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 printed on the packaging. Do not use the product if the package is open or damaged: the sterility of the solution is guaranteed as long as the package is sealed and intact. The syringe is single-use, meaning it must be used for one injection only. The assembled syringe should be disposed of immediately after use, regardless of 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 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 can cause serious health and safety risks to the patient. After use, dispose of according to current regulations. As with any invasive joint procedure, care is recommended to avoid overloading the joint immediately after peritendinous injection. Keep out of reach of children. Local reactions such as pain and warmth or redness/swelling/ecchymosis at the injection site may occur. Usually, these symptoms are transient and resolve spontaneously within a few days by resting the affected joint and applying ice locally. After hyaluronic acid injection, occasional local or systemic allergic reactions due to individual hypersensitivity may be recorded.

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

Format
Box containing 1 prefilled syringe sealed in a blister.
Box containing 3 prefilled syringes, each sealed in a blister.
The 20 mg/2 ml sodium hyaluronate solution contained in the prefilled syringe is sterilized with steam.

Code 10000122, 10000123