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 is 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, causing 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 temporary synovial fluid replacement treatment for patients suffering from degenerative or mechanical arthropathy, 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 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
1.5% sodium hyaluronate, sodium chloride, disodium phosphate 12H₂O, monosodium phosphate 2H₂O, water for injections.

How to use
The injection must be strictly intra-articular. Intra-articular injection must be performed according to standard technique, using precise anatomical localization. In the hip, shoulder and other less easily 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, even if systematic collection of clinical data is not available. Clinical data show the efficacy of HYALUBRIX for 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 components of the product. 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 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 shown on the package. The expiry date refers to the product stored in its original packaging. The syringe is for single use, which means it is to be used only once and on one patient. Inject the contents into one joint only. For the first 24 hours after injection, the patient is allowed to continue all routine daily life 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 damage to the patient or user. After use, dispose of according to current regulations. 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 subjects with hypersensitivity to the components of the product. More marked inflammatory reactions, sometimes with the presence of pyrophosphate crystals, have been occasionally reported in conjunction with intra-articular hyaluronate injections. As with any intra-articular treatment, septic arthritis could rarely occur if general precautions for injections 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 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.
Shelf life unopened: 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