SINOVIAL 3 PREFILLED SYRINGES OF 2ML
Sinovial® is indicated in cases of pain or reduced mobility in order to restore the physiological and rheological properties of arthritic joints.
Highly purified 0.8% sodium hyaluronate (8 mg hyaluronic acid/1 ml physiological buffered sodium chloride solution), sodium chloride, sodium phosphate and water for injection (qsp 100%).
Sinovial is a buffered physiological hyaluronic acid solution with viscoelastic properties. Sinovial contains hyaluronic acid with a molecular weight between 800 and 1200 kDalton.
Sodium hyaluronate consists of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. It is an essential component of the synovial fluid and gives it its visco-elastic properties.
Sinovial 2 ml is indicated in case of pain or reduced mobility due to degenerative diseases (osteoarthritis), post-traumatic diseases or alterations of joints and tendons. The improvement is instantaneous: the global WOMAC index decreases after the first injection and, from the third injection onwards, the reduction becomes statistically significant.
Sinovial Mini is suitable for viscosupplementation of small joints: all wrist and hand joints, including interphalangeal, intercarpal, metacarpophalangeal, carpometacarpal, distal radio-ulnar and radiocarpal joints, all foot joints and the temporomandibular joint, and tendon sheaths (e.g. in cases of flexor tendon tenosynovitis or finger impingement)
Sinovial is a suitable joint fluid replacement agent. It restores the physiological and rheological conditions of the arthritic joint. The therapeutic effect is based on the special properties of its hyaluronic acid. The hyaluronic acid in Sinovial is obtained by fermentation and is chemically unmodified.
Sinovial acts only in the joints in which it has been injected; it has no systemic effect.
Directions for use, Dosage
It is recommended that Sinovial 2 ml be administered in a regimen of 3-5 injections given at one-week intervals, leading to a reduction in pain and swelling, as well as improvement in function, which may last up to 24 weeks.
It is recommended that Sinovial Mini be administered in a regimen of 2-3 treatments per year, with intervals of 4-6 months, as determined by the physician.
Aspirate any joint effusion before injecting Sinovial. Do not use Sinovial if the package is open or damaged. Inject Sinovial at room temperature and observe strict aseptic precautions. Be especially careful not to touch the syringe opening when removing the cap. Use the needle provided (Sinovial 2 ml) or an appropriate size needle from 18 to 22G (Sinovial Mini). To ensure a tight connection and prevent leakage during administration, fit the needle securely to the syringe connector.
Do not inject Sinovial into an infected or severely inflamed joint, or in patients with a skin condition or infection at the injection site.
Precautions for use
Intra-articular injection should only be performed by a physician.
Do not use disinfectants containing quaternary ammonium salts or chlorhexidine to prepare the skin, as precipitation of hyaluronic acid is possible in their presence.
The possible presence of an air bubble does not compromise the characteristics of the product.
The injection site must be located on healthy skin. Inject only into the joint space. Do not inject intravascularly or outside the tendon sheath. Do not inject outside the joint space, into the synovial tissue or the joint capsule. Extra-articular infiltration of Sinovial, or outside the tendon sheath, may cause local adverse effects. Do not use Sinovial in the presence of significant intra-articular effusion.
Do not resterilize. Syringe and needles are for single use only. Do not reuse to avoid contamination.
The contents of the pre-filled syringe are sterile. The syringe and needle are supplied in a sealed blister pack. The outer surface of the syringe is not sterile.
As with any invasive joint procedure, it is recommended that the patient refrain from physical exertion after the joint injection and only resume normal activities after a few days.
Associated manifestations such as pain, warmth, redness or swelling may occur at the injection site after the use of Sinovial.
Ice applied to the treated joint may relieve such associated events. These usually subside within a short time.
The patient should inform the physician of any adverse effects that may occur later.
No interactions with other drugs have been reported to date.
Conditions of storage
Do not use after the date shown on the package.
Store at a temperature between 0°C and 25°C, away from sources of heat.
Do not freeze.
Sinovial should be used immediately after opening and discarded after use.
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