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SINOVIAL 32 2 ml 1.6% 32mg/2ml Description A synovial fluid substitute that restores the physiological and rheological properties of arthritic joints. This therapeutic effect is achieved due to the specific characteristics of the hyaluronic acid used. The hyaluronic acid in SINOVIAL 32 2 ml, obtained by fermentation and not chemically modified, is excellently tolerable. By restoring the viscoelastic properties of the synovial fluid, SINOVIAL 32 2 ml reduces pain and restores the mobility of joints and tendons. SINOVIAL 32 2 ml acts only on the area where it is injected, without exerting any systemic action. The improvement is immediate: after the first injection, the general WOMAC index decreases, and starting with the third injection the decrease becomes statistically significant. Indicated for acute and chronic tendinopathies and/or those associated with joint disability and in the process of tendon repair, including after surgical interventions. SINOVIAL 32 2 ml is a medical device designed to supplement synovial fluid, restoring the physiological and rheological properties of arthritic joints and tendons. In the joint, SINOVIAL 32 2 ml reduces pain and promotes the recovery of joint and tendon mobility, acting only in the synovial cavity where it is injected, without exerting any systemic action. In addition, SINOVIAL 32 2 ml, due to its lubricating and viscoelastic properties, acts at the level of the tendon sheath, where it improves tendon gliding and physiological healing/repair processes, thus preventing the formation of adhesions in the postoperative period. How to use Aspirate any joint effusion before injection. Carefully unscrew the syringe cap, holding the Luer Lock collar firmly between your fingers and taking special care to avoid contact with the opening. Insert the needle into the Luer Lock collar of the syringe (needle diameter between 18 and 22G) and screw it firmly until you feel a slight pressure to ensure a tight seal and prevent leakage during administration, holding the Luer Lock collar firmly between your fingers. Inject SINOVIAL 32 2 ml at room temperature and under strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peritendinous area, depending on the identified medical need. components Hyaluronic acid 1.6%, highly purified sodium salt (molecular weight between 800 and 1200 kDalton), sodium chloride, sodium phosphate, water for injections. warnings SINOVIAL 32 2 ml can only be injected by a doctor. The contents of the pre-filled syringe are sterile. The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile. Do not use after the expiry date stated on the packaging. Do not use if the packaging is open or damaged. The injection site should be on healthy skin. Do not inject intravascularly. Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule. Do not administer in the presence of extensive intra-articular effusion. Do not sterilize. The device is intended for single use only. Do not reuse to avoid any risk of contamination. Once opened, it should be used immediately and discarded after use. Keep out of the reach and sight of children. After intraarticular or tendon injection with sutacillin, advise the patient to avoid any strenuous physical activity and to resume normal activities only after a few days. The presence of an air bubble does not affect the characteristics of the product. Do not mix SINOVIAL 32 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine, as a precipitate may form. Extra-articular infiltration of SINOVIAL 32 2 ml may cause local adverse reactions. During the use of SINOVIAL 32 2 ml, symptoms such as pain, warmth, redness or swelling may occur at the injection site. These adverse reactions can be relieved by applying ice to the treated area. They usually disappear after a short time. Physicians should ensure that patients are informed of any adverse reactions that occur after treatment. SINOVIAL 32 2 ml should not be injected if the joint is infected or severely inflamed or if the patient has a skin condition or infection in the area of the injection site. The product should not be used in case of known hypersensitivity to sodium hyaluronate or other components. To date, there are no known interactions between SINOVIAL 32 2 ml and other drugs. Do not mix with disinfectants such as quaternary ammonium salts or chlorhexidine, as a precipitate may form. It should not be injected if there is an infected or severely inflamed joint or if the patient has a skin condition or infection at the injection site. The product should not be used in cases of known hypersensitivity to sodium hyaluronate or any of the other ingredients. SINOVIAL 32 2 ml can only be injected by a doctor. Conservation Store at room temperature, below 25°C, away from heat sources. Do not freeze. Shelf life in intact packaging: 36 months. Format Package contains 3 pre-filled syringes (32.0 mg of hyaluronic acid sodium salt in 2 ml of sodium chloride buffered saline) and 3 needles. Code 6000001305
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