Sinovial Hl 64 2ml Ibsa 1 Piece + 1 Kit

Sinovial Hl 64 2ml Ibsa Disposable

3.2% - 32 mg (H-HA) + 32 mg (L-HA) / 2 ml Hyaluronic acid sodium salt

Sterile

The sodium salt of hyaluronic acid is formed by repeated chains of disaccharide units of N-acetylglucosamine and sodium glucuronate and represents a fundamental component of the synovial fluid, to which it confers its particular viscoelastic properties.

SINOVIAL® HL 64 2 ml consists of a buffered physiological solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The high and low molecular weight hyaluronic acid used in the device is obtained by fermentation and has not undergone any chemical modification processes. This results in excellent tolerability. Furthermore, the HA chains of different molecular weight present in SINOVIAL® HL 64 2 ml, thanks to a specific and patented treatment of the solution, interact with each other giving SINOVIAL® HL 64 2 ml unique rheological characteristics that allow to administer, with the same amount of viscosity of the solution, higher concentrations of hyaluronic acid. The different molecular weight HA chains of SINOVIAL® HL 64 2 ml provide greater resistance to hyaluronidase since this enzyme is unable to recognize the conformation of these high and low molecular weight complexes, therefore, SINOVIAL® HL 64 2 ml is best suited for in vivo applications in tissues. In vitro studies were performed to identify any incompatibilities and / or interactions between SINOVIAL® HL 64 2 ml and Platelet Rich Plasma (PRP), used for the intraarticular infiltrative treatment of osteoarthritis. The results obtained show that PRP does not modify the rheological behavior of sodium hyaluronate, which therefore preserves the viscosupplementation function; in addition, the results of studies conducted on cultures of human mesenchymal stem cells (MSCs) differentiated into chondrocytes, demonstrate that there is no cellular suffering, index of toxicity: there is therefore no reason to believe that the biocompatibility of SINOVIAL® HL 64 2 ml is modified by the simultaneous administration of the PRP.

The other components of the product are

Sodium chloride, sodium phosphate and water for injections.

SINOVIAL® HL 64 2 ml is presented in the form of a 2.25 ml glass syringe containing 2 ml of solution. The contents of the syringe are sterile and non-pyrogenic.

INSTRUCTIONS FOR USE

Aspirate any joint effusion before proceeding with the injection.

Carefully unscrew the syringe cap, keeping the "Luer Lock" locking collar firmly between the fingers and paying particular attention to avoid contact with the opening (figure A). Needle sterilized with ethylene oxide

Insert the needle into the Luer Lock collar of the syringe (needle diameter between 18G and 22G) by screwing it firmly, until a slight pressure is felt, in order to ensure a watertight seal and prevent liquid leakage during administration , keeping the "Luer Lock" collar firmly between the fingers (figure B)

Inject SINOVIAL® HL 64 2 ml at room temperature and under strictly aseptic conditions

Inject SINOVIAL® HL 64 2 ml into the synovial space of the joint or into the tendon sheath / peri-tendon area, depending on the identified medical need

WARNINGS

The contents of the pre-filled syringe are sterile. The syringe and needle are packaged in a sealed blister. - The outer surface of the syringe is not sterile. - Do not use SINOVIAL® HL 64 2 ml after the expiry date stated on the package. - Do not use SINOVIAL® HL 64 2 ml if the packaging is open or damaged. - The injection site must be on healthy skin. - Do not inject by vascular route. Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule. - Do not administer SINOVIAL® HL 64 2 ml in the presence of abundant intra-articular effusion. - Do not sterilize again. The device is intended for single use only. - Do not reuse to avoid any risk of contamination. - Store at room temperature and AB 2. 1. 3. in any case below 25 ° C and away from heat sources. Do not freeze. - Once SINOVIAL® HL 64 2 ml has been opened it must be used immediately and discarded after use. - Keep out of the reach and sight of children. - After the injection, advise the patient to avoid all strenuous physical activities and to resume normal activities only after a few days. - The possible presence of an air bubble does not affect the characteristics of the product.

PRECAUTIONS FOR USE

Do not mix SINOVIAL® HL 64 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.

INTERACTIONS

To date, there are no known interactions between SINOVIAL® HL 64 2 ml and other drugs. Based on the in-vitro data available to date, no chemical-physical and biological interactions are known between SINOVIAL® HL 64 2 ml and Platelet Rich Plasma (PRP), used for the intraarticular infiltrative treatment of osteoarthritis.

SIDE EFFECTS

The extra-articular infiltration of SINOVIAL® HL 64 2 ml may locally cause undesirable effects. When using SINOVIAL® HL 64 2 ml, symptoms such as pain, warmth, redness or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. They usually disappear after a short time. The doctor must ensure that patients inform him of any side effects that occur after treatment.

CONTRAINDICATIONS

SINOVIAL® HL 64 2 ml should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the area of the injection site.

SINOVIAL® HL 64 2 ml CAN ONLY BE INJECTED BY A DOCTOR . Validity: 36 months. The expiry date indicates the maximum validity of the medical device.

Format

SINOVIAL® HL 64 2 ml is presented in the form of 1 pre-filled syringe of 2 ml (32 mg (H-HA) + 32 mg (L-HA) of hyaluronic acid sodium salt in 2 ml of buffered saline of chloride sodium) and 1 needle 21G x 1 ½ "(0.8 x 40 mm). Vial - syringe sterilized in moist heat.

Needle sterilized with ethylene oxide.