Description
HYALUBRIX is a sterile viscoelastic solution produced with sodium hyaluronate 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 represents the major component of synovial fluid, to which it provides its characteristic viscosity and elasticity. These properties are fundamental for the fluid to perform its functions as a lubricant and shock absorber in normal joints, in order to protect 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, leading to impaired function and painful symptoms. Many studies indicate that intra-articular administration of hyaluronic acid can restore the viscoelastic properties of synovial fluid.
HYALUBRIX is a treatment for the temporary replacement of synovial fluid in patients suffering from degenerative or mechanical arthropathy, which causes an alteration of the functional performance of the synovial fluid. Intra-articular injection of HYALUBRIX at weekly intervals reduces pain symptoms and improves joint function in patients suffering from degenerative or mechanical arthropathy for 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 for the treatment of persistent pain after initial failure of analgesics or in case of failure or intolerance to non-steroidal anti-inflammatory drugs.

Composition
Sodium hyaluronate 1.5%, sodium chloride, dibasic sodium phosphate 12H₂O, monobasic sodium phosphate 2H₂O, water for injections.

How to use
The injection must be strictly intra-articular. The intra-articular injection must be performed according to the standard technique, using a precise anatomical localization. In the hip, shoulder and other less accessible joints, ultrasound or fluoroscopic guidance is recommended.
All rules regarding asepsis and injection techniques must be observed.
Remove any joint effusions, if present, before 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, further cycles of injections can be performed, although no systematic collection of clinical data is available. Clinical data show the efficacy of HYALUBRIX up to 6 months, however if clinically required the administration cycle can be repeated starting from 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 in subjects 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 indicated on the package. The expiry date refers to the product stored in its original packaging. The syringe is single-use, which means it is to be used only once and on a single patient. Inject the contents into one joint only. For the first 24 hours after the injection, the patient is allowed to continue all routine daily activities, but it is recommended not to overload the treated joint. The syringe complete with needle must be disposed of 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 can lead to disease, infection and/or harm to the patient or user. After use, dispose of according to current regulations. Keep out of reach of children.
Localized pain, swelling, warmth 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 subjects with hypersensitivity to the product components. More marked inflammatory reactions, sometimes with the presence of pyrophosphate sodium crystals, have been occasionally reported in conjunction with intra-articular injections of hyaluronate. As with any intra-articular treatment, septic arthritis may rarely occur if general precautions for injections are not observed or the injection site is not aseptic.
Do not use in conjunction with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence. Avoid 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 in intact packaging: 24 months.

Format
Box containing 1 pre-filled syringe.
The syringe is sealed in a blister sterilized with ethylene oxide and contains 30 mg of sodium hyaluronate in 2 ml of steam-sterilized solution.

Code 10000950