Description
HYALUBRIX is a sterile viscoelastic solution produced with hyaluronic acid sodium salt obtained by bacterial fermentation from a high molecular weight fraction.
Hyaluronic acid is naturally present in many human tissues, such as cartilage and synovial fluid. It is continuously secreted into the joint cavity and is the major component of synovial fluid, providing it with its characteristic viscosity and elasticity. These properties are essential for the fluid to perform its lubricating and shock-absorbing functions in normal joints, protecting cartilage and soft tissue 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 intra-articular administration of hyaluronic acid can restore the viscoelastic properties of the synovial fluid.
HYALUBRIX is a treatment for the temporary replacement of synovial fluid in patients with degenerative or mechanical joint disease, which causes an alteration in the functional performance of the synovial fluid. Intra-articular injection of HYALUBRIX at weekly intervals reduces pain symptoms and improves joint function in patients with degenerative or mechanical joint disease for up to six months.
It is indicated for the treatment of pain and improvement of joint function in patients with degenerative or mechanical arthropathy of the knee, hip, shoulder, ankle, and trapeziometacarpal joint. The product is indicated for the treatment of persistent pain after initial analgesic failure or in cases of failure or intolerance to nonsteroidal anti-inflammatory drugs.

Composition
Hyaluronic acid sodium salt 1.5%, sodium chloride, dibasic sodium phosphate 12H ₂ O, monobasic sodium phosphate 2H ₂ O, water for injections.

How to use
The injection must be strictly intra-articular. Intra-articular injections must be performed according to standard technique, using a precise anatomical location. In the hip, shoulder, and other less easily accessible joints, ultrasound or radioscopic guidance is recommended.
All rules regarding asepsis and injection techniques must be observed.
Remove any joint effusions, if present, prior to administration.
Inject HYALUBRIX using a suitable sterile needle (e.g. 18 or 20 G), into the affected joint at weekly intervals for 3 weeks.
If necessary, additional cycles of injections can be performed, although systematic collection of clinical data is not available. Clinical data demonstrate the efficacy of HYALUBRIX for up to 6 months, however, if clinically necessary, the administration cycle can be repeated starting 3 months after the first treatment cycle.

Warnings
Do not administer to patients with known individual sensitivity to the product components. Do not administer in case of infections or skin diseases in the injection area. Do not administer to patients with active synovitis. The safety and efficacy of HYALUBRIX in pregnant women, breastfeeding women, or individuals under 18 years of age have not been established and therefore its use is contraindicated in these patient populations. Do not use if the 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. The syringe is for single use only, meaning it is for single use only and on a single patient. Inject the contents into one joint only. For the first 24 hours after the injection, the patient is permitted to continue all routine daily activities, but it is recommended not to overload the treated joint. The syringe complete with needle must be discarded immediately after use, even if the solution has not been completely administered. If the product is reprocessed and/or reused, Fidia Farmaceutici cannot guarantee its performance, functionality, material structure, cleanliness, or sterility. Reuse may lead to illness, infection, and/or harm to the patient or user. Dispose of it according to applicable regulations after use. Keep out of reach of children.
Localized pain, swelling, heat, and redness may occasionally occur at the injection site. These symptoms are generally mild and transient. After intra-articular 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 product's components. 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.
Do not use concomitantly with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence. Avoid concomitant administration of HYALUBRIX with other products for intra-articular use to prevent any possible interactions.

Conservation
Store below 25°C.
Shelf life in intact packaging: 24 months.

Format
Case containing 1 pre-filled syringe.
The syringe is sealed in an ethylene oxide sterilized blister and contains 30 mg of hyaluronic acid sodium salt in 2 ml of steam sterilized solution.

Cod. 10000950