Description
HYALUBRIX 60 is a sterile viscoelastic solution produced with hyaluronic acid sodium salt obtained by bacterial fermentation from a fraction with high molecular weight. Hyaluronic acid, a polysaccharide of the glycosaminoglycan family, is naturally present in many human tissues such as cartilage and synovial fluid; is continuously secreted in the joint cavity and represents the largest component of the synovial fluid, to which it provides its characteristic viscosity and elasticity. These properties are fundamental because the fluid performs the functions of lubricant and shock absorber in normal joints, in order to protect cartilage and soft tissue from mechanical damage. In traumatic and degenerative diseases of the joints, the amount of hyaluronic acid decreases and the synovial fluid loses viscosity, causing a compromise of function and a painful symptomatology. Many literature data indicate that the administration of intrarticular hyaluronic acid is able to restore the viscoelastic properties of the synovial fluid, resulting in pain attenuation and an improvement in the mobility of the articulation. HYALUBRIX 60 is a treatment for temporary replacement of the synovial fluid in patients with degenerative or mechanical arthropathy of the knee and hip, which causes an alteration of the functional performance of the synovial fluid. The intrarticular injection of HYALUBRIX 60 reduces pain symptoms and improves joint function of the knee and hip, up to six months.
It is indicated for the treatment of pain and the improvement of joint function in patients suffering from degenerative or mechanical arthropathy of the knee, hip, shoulder, ankle and trapeziometacarpal joint. The product is indicated in the treatment of persistent pain after initial failure of analgesics or in case of failure or intolerance to non-steroidal anti-inflammatory drugs.

Composition
Hyaluronic acid salt sodium 1.5%, sodium chloride, disodium hydrogenphosphate dodecahydrate, sodium hydrogenphosphate dihydrate, water for injectable preparations.

Mode of use
The injection must be strictly intrarticular. The intrarticular injection must be performed according to the standard technique, using a precise anatomical location. In the hip, the ultrasound or radioscopic guide is recommended.
If there is a deposit, remove it before administering the product.
All the rules on axle and injective techniques must be observed.
Inject HYALUBRIX 60 using a suitable sterile needle (e.g. 18 or 20 G), in the affected joint.
After the first application additional treatments may be required to maintain the benefits of treatment over time, depending on the needs of the individual patient.
Clinical data show that the effectiveness of HYALUBRIX 60 persists up to 6 months. An additional injection, if required clinically, should be administered after this period of time.

Warnings
Do not give patients with proven individual sensitivity to product components. Do not administer in case of infections or skin diseases in the injection area. Do not administer patients with active synovitis. Safety and effectiveness of HYALUBRIX in pregnant women, nursing women or women under 18 years of age have not been established and therefore its use is contraindicated in these populations of patients. Do not use if the packaging is damaged. Do not use the product after the expiration date shown on the packaging. The expiry date refers to the product preserved in its original packaging. The syringe is disposable, which means it is to be used only once and on a single patient. Inject content into one joint. For the first 24 hours after injection, the patient is allowed to continue all routine activities of daily life, but it is recommended not to overload the treated joint. The complete needle syringe must be eliminated immediately after use, although the solution has not been fully administered. If the product is processed and/or used, Fidia Farmaceutici cannot guarantee its performance, functionality, structure of the material, cleaning or sterility. Reuse can lead to disease, infection and/or damage to the patient or user. After use delete according to the current rules. Keep away from the reach of children.
Localized pain, swelling, heat and redness may occasionally occur on the injection site. Such symptoms are generally mild and transient. After intrarticular injection, the application of an ice pack on the treated joint for five to ten minutes will reduce the incidence of these events. Local or systemic allergic reactions may occur in subjects with hypersensitivity to product components. More marked inflammatory reactions, sometimes with presence of pyrophosphate sodium crystals, were occasionally reported in conjunction with intrarticular injections of hyaluronate. As with any intrarticular treatment, septic arthritis may rarely occur if general precautions for injections or injection point are not observed.
Do not use in conjunction with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence. Avoid the contemporary administration of HYALUBRIX with other products for intrarticular use, so as to prevent any possible interaction.

Conservation
Store at a temperature not exceeding 25°C.
Validity of whole packaging: 24 months.

Format
1 pre-filled syringe with 60 mg of hyaluronic acid in 4 ml solution.

Cod. 10000948