HYALUBRIX

Description
HYALUBRIX 60 is a sterile viscoelastic solution produced with the sodium salt of 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 into the joint cavity and is the major component of synovial fluid, giving it its characteristic viscosity and elasticity. These properties are essential for the fluid to perform its lubricating and shock-absorbing functions in normal joints, 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 its viscosity, causing impaired function and painful symptoms. Numerous data from the literature indicate that intra-articular administration of hyaluronic acid can restore the viscoelastic properties of synovial fluid, resulting in pain relief and improved joint mobility. HYALUBRIX 60 is a treatment for temporary replacement of synovial fluid in patients with degenerative or mechanical arthropathy of the knee and hip, which causes a change in the functional performance of the synovial fluid. Intra-articular injection of HYALUBRIX 60 reduces pain symptoms and improves knee and hip joint function 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 trapezometacarpal 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
Sodium salt of hyaluronic acid 1.5%, sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate, water for injections.

How to use
The injection should be strictly intra-articular. Intra-articular injections should be performed according to standard technique, using a precise anatomical location. In the hip, ultrasound or radioscopic guidance is recommended.
If there is a leak, remove it before administering the product.
All rules regarding asepsis and injection techniques must be followed.
Inject HYALUBRIX 60 into the affected joint using a suitable sterile needle (e.g. 18 or 20 G).
After the first application, additional treatments may be necessary to maintain the benefits of the treatment over time, depending on the needs of each patient.
Clinical data show that the efficacy of HYALUBRIX 60 persists for up to 6 months. An additional injection, if clinically necessary, should be administered after this period.

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 conditions in the injection area. Do not administer to patients with active synovitis. The safety and efficacy of HYALUBRIX in pregnant women, lactating women or people 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 expiry date stated on the packaging. The expiry date refers to the product kept in the original packaging. The syringe is for single use, i.e. intended for single use and for a single patient. Inject the contents into a single joint. During the first 24 hours after the injection, the patient is allowed to continue all usual daily activities, but it is recommended not to overload the treated joint. The complete syringe with needle should 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 result in illness, infection and/or injury to the patient or user. Dispose of the product according to applicable regulations after use. Keep out of reach of children.
Occasionally, local pain, swelling, warmth and redness may occur at the injection site. These symptoms are generally mild and transient. Following intra-articular injection, application of 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 pronounced inflammatory reactions, sometimes with the presence of sodium pyrophosphate crystals, have been reported occasionally in association with intra-articular hyaluronate injections. As with any intra-articular treatment, septic arthritis may rarely occur if general injection precautions are not followed or if 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
1 pre-filled syringe with 60 mg hyaluronic acid in 4 ml solution.

Code 10000948