HYALUBRIX
Description
HYALUBRIX 60 is a sterile viscoelastic solution produced with sodium salt hyaluronic acid obtained by bacterial fermentation from a high molecular weight fraction. Hyaluronic acid, a polysaccharide of the glycosaminoglycan family, is naturally present in many human tissues such as cartilage and synovial fluid; it is continuously secreted in the joint cavity and represents the largest component of synovial fluid, to which it provides its characteristic viscosity and elasticity. Such properties are critical for the fluid to perform 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 impaired function and painful symptoms. Many literature data indicate that the administration of hyaluronic acid intrarticular route is able to restore the viscoelastic properties of the synovial fluid, with a consequent attenuation of pain and an improvement in the joint mobility. HYALUBRIX 60 is a treatment for temporary synovial fluid replacement in patients suffering from degenerative or mechanical arthropathy of the knee and hip, which causes an alteration in the functional performance of the synovial fluid. Intrarticular injection of HYALUBRIX 60 reduces pain symptoms and improves knee and hip joint function, up to six months.
It is indicated for the treatment of pain and 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 sodium salt 1.5%, sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injection.
How to use
The injection must be strictly intrarticular. Intrarticular injection should be performed according to the standard technique, using a precise anatomical localization. In the hip, ultrasound or radioscopic guidance is recommended.
If there is an effusion, remove it before administering the product.
All rules regarding asepsis and injection techniques must be observed.
Inject HYALUBRIX 60 using a suitable sterile needle (e. g. 18 or 20G), into the affected joint.
After the first application further treatment may be required to maintain the benefits of treatment over time, depending on the needs of the individual patient.
Clinical data show that the efficacy of HYALUBRIX 60 persists for up to 6 months. A further injection, if clinically required, should be administered after this period of time.
Warnings
Do not administer to patients with established individual sensitivity to the components of the product. Do not administer in case of infections or skin diseases in the area of the injection. Do not administer to patients with active synovitis. The safety and efficacy of HYALUBRIX in pregnant women, lactating women or individuals under the age of 18 have not been established and therefore its use is contraindicated in these patient populations. Do not use if the packaging is damaged. Do not use the product after the expiration date on the package. The expiration date refers to the product stored in its original packaging. The syringe is disposable, which means that it is to be used only once and on one patient. Inject the contents into one joint. For the first 24 hours after the 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 should be eliminated immediately after use, even if the solution has not been fully administered. If the product is reworked and/or reused, Fidia Farmaceutici cannot guarantee its performance, functionality, structure of the material, cleanliness or sterility. Reuse may lead to illness, infection and/or harm to the patient or user. After use eliminate according to current regulations. Keep out of reach of children.
Localized pain, swelling, heat and redness may occur occasionally at the injection site. Such symptoms are usually mild and transient. After intrarticular injection, applying an ice pack to the treated joint for five to ten minutes will reduce the incidence of these events. Local or systemic allergic reactions may occur in individuals with hypersensitivity to the components of the product. More marked inflammatory reactions, sometimes with the presence of sodium pyrophosphate crystals, have occasionally been reported concomitantly with intrarticular injections of hyaluronate. As with any intra-articular treatment, septic arthritis may rarely occur, if general precautions are not observed for injections or the injection point is not aseptic.
Do not use concomitantly with disinfectants containing quaternary ammonium salts, as hyaluronic acid can precipitate in their presence. Avoid the simultaneous administration of HYALUBRIX with other products for intra-articular use, in order to prevent any possible interaction.
storage
Store at a temperature not exceeding 25 °C.
Validity with intact packaging: 24 months.
Format
1 pre-filled syringe with 60 mg of hyaluronic acid in 4 ml of solution.
Cod. 10000948