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ATHENAVIS ONE Description Athenavis one is a sterile, apyrogenic, viscoelastic solution produced with hyaluronic acid sodium salt, obtained by bacterial fermentation from a high molecular weight fraction (>2,000 kDa). Hyaluronic acid, a polysaccharide from the glycosaminoglycan family, is naturally present in many human tissues such as cartilage and synovial fluid: it is continuously secreted into the joint cavity and represents the major component of synovial fluid, to which it provides its characteristic viscosity and elasticity. These properties are essential for the fluid to perform the functions of lubricant and shock absorber in normal joints, in order to protect the cartilage and soft tissues from mechanical damage. In traumatic and degenerative joint diseases, the amount of hyaluronic acid decreases and the synovial fluid loses viscosity, causing impaired function and painful symptoms. Many studies indicate that the intra-articular administration of hyaluronic acid is able to restore the viscoelastic properties of the synovial fluid, resulting in pain relief and improved joint mobility. Composition Main component: hyaluronic acid sodium salt 1.5% (equal to 60 mg/4 ml). Other ingredients: sodium chloride, dibasic sodium phosphate 2H 2 O, monobasic sodium phosphate 2H 2 0, water for injections. Indications Athenavis one is a temporary substitute for synovial fluid indicated for the treatment of pain and reduced mobility in patients with degenerative or traumatic arthropathy of the synovial joints of the hip and knee, without active synovitis. The product works by providing lubrication and mechanical support and is particularly suitable for the treatment of OA symptoms. How to use Inject Athenavis one, using a suitable sterile needle (for example 18 or 20 G), into the injured joint. If necessary, after the first application, further injections can be performed to maintain the benefit of the treatment over time. When Athenavis one is used in the hip, it is recommended that the injection be performed under ultrasound guidance. This is not necessary when Athenavis one is used in the knee. The product should be administered exclusively by medical specialists. All rules regarding asepsis and injection techniques must be observed. If an effusion is present, remove it before injecting Athenavis one. Contraindications Do not administer to patients with known individual sensitivity to the components of the product and in case of infections or skin diseases in the injection area. Warnings The contents of the pre-filled syringe are sterile. The syringe is packaged in a sealed blister. The external surface of the syringe is not sterile but has a reduced bacterial load. Although preclinical studies performed on laboratory animals indicate that the product has no potential toxicity on reproduction and development, Athenavis one has not been tested in pregnant women. Do not use if package is damaged. Do not use the product after the expiry date shown on the package. The expiry date refers to the product stored in its original packaging at a temperature not exceeding 25°C. Athenavis one is for single use only; after use, dispose of according to local regulations. Keep out of reach of children. Side effects Localized pain, swelling, warmth, and redness may occasionally occur at the injection site. These symptoms are usually mild and transient. More marked inflammatory reactions, sometimes with the presence of sodium pyrophosphate crystals, have occasionally been reported in association with intra-articular injections of hyaluronate. As with any intra-articular treatment, septic arthritis may rarely occur if general injection precautions are not observed or the injection site is not aseptic. Interactions Do not use in conjunction with disinfectants containing quaternary ammonium salts, because hyaluronic acid may precipitate in their presence. Avoid concomitant administration of Athenavis one with other products for intra-articular use, in order to prevent any possible interaction. Conservation Store below 25°C. Format Case containing 1 pre-filled syringe. The syringe is sealed in a blister and contains 60 mg/4 ml of hyaluronic acid sodium salt, sterilized by moist heat. Code 10
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