FIDIA Hyalubrix Intra-articular Syringe 30mg 2ml

Description
HYALUBRIX is a sterile viscoelastic solution made 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 in the joint cavity and represents the major component of synovial fluid, providing its characteristic viscosity and elasticity. These properties are essential for the fluid to perform the functions of 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 impairment of function and painful symptoms. Many studies indicate that the administration of hyaluronic acid intra-articularly can restore the viscoelastic properties of synovial fluid.
HYALUBRIX is a treatment for the temporary replacement of synovial fluid in patients with degenerative or mechanical arthropathy, which causes an alteration of the functional performance of synovial fluid. Intra-articular injection of HYALUBRIX at weekly intervals reduces pain symptoms and improves joint functionality in patients with degenerative or mechanical arthropathy for up to six months.
It is indicated for the treatment of pain and improvement of joint functionality in patients with degenerative or mechanical arthropathy of the knee, hip, shoulder, ankle, and trapeziometacarpal joint. The product is indicated in the treatment of persistent pain following 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, monosodium phosphate 2H₂O, water for injection.

How to use
The injection must be strictly intra-articular. Intra-articular injection should be performed according to the standard technique, using a precise anatomical location. 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 injection cycles may be performed, even if no systematic collection of clinical data is available. Clinical data demonstrate 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 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 packaging is damaged. Do not use the product after the expiration date printed on the packaging. The expiration date refers to the product stored in its original packaging. The syringe is for single use only, meaning it is for use once only and on one patient. Inject the content into a single joint. 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 complete syringe 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 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, 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 individuals with hypersensitivity to the product components. More pronounced inflammatory reactions, sometimes with the presence of sodium pyrophosphate crystals, have occasionally been reported in conjunction with intra-articular hyaluronate injections. As with any intra-articular treatment, septic arthritis may rarely occur if general precautions for injections are not observed or if 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 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 sterilized ethylene oxide blister and contains 30 mg of sodium hyaluronate in 2 ml of steam sterilized solution.

Cod. 10000950