Description
HYALUBRIX
Description
HYALUBRIX 60 is a sterile viscoelastic solution produced with hyaluronic acid sodium salt 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 represents the major component of the synovial fluid, to which it provides 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 the cartilage and soft tissues from mechanical damage. In traumatic and degenerative joint diseases, the quantity of hyaluronic acid decreases and the synovial fluid loses viscosity, causing a compromise of the function and painful symptoms. Many data in the literature indicate that the intra-articular administration of hyaluronic acid is able to restore the viscoelastic properties of the synovial fluid, with a consequent reduction in pain and improvement in joint mobility. HYALUBRIX 60 is a treatment for the temporary replacement of synovial fluid in patients with degenerative or mechanical arthropathy of the knee and hip, which causes an alteration in the functional performance of the synovial fluid. The intra-articular injection of HYALUBRIX 60 reduces the symptoms of pain and improves the joint function of the knee and hip, 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 in the treatment of persistent pain after initial failure of analgesics or in case of failure or intolerance to nonsteroidal anti-inflammatory drugs.
Composition
Hyaluronic acid sodium salt 1.5%, sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.
How to use
The injection must be strictly intra-articular. Intra-articular injection must be performed according to the standard technique, using precise anatomical localization. In the hip, ultrasound or radioscopic guidance is recommended.
If there is a spill, remove it before administering the product.
All rules regarding asepsis and injection techniques must be observed.
Inject HYALUBRIX 60 using a suitable sterile needle (e.g. 18 or 20 G), into the affected joint.
After the first application, further treatments may be necessary to maintain the benefits of the treatment over time, depending on the needs of the individual patient.
Clinical data show that the efficacy of HYALUBRIX 60 persists for up to 6 months. A further injection, if clinically required, should be administered after this time 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 diseases in the area of the injection. 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 shown on the package. The expiry date refers to the product stored in its original packaging. The syringe is for single use, which means that it is to be used only once and on a single patient. Inject the contents into a single joint. For the first 24 hours after the injection, the patient is allowed to continue all routine activities of daily life, 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 reworked 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. After use, dispose of in accordance with current regulations. Keep out of reach of children.
Localized pain, swelling, warmth and redness may occasionally occur at the injection site. These symptoms are usually mild and transient. After 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 subjects with hypersensitivity to the components of the product. 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 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 concomitant administration of HYALUBRIX with other products for intra-articular use, in order to prevent any possible interaction.
Conservation
Store at a temperature not exceeding 25°C.
Validity with intact packaging: 24 months.
Format
1 pre-filled syringe with 60 mg hyaluronic acid in 4 ml solution.
Cod. 10000948
HYALUBRIX 60 is a sterile viscoelastic solution produced with hyaluronic acid sodium salt 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 represents the major component of the synovial fluid, to which it provides 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 the cartilage and soft tissues from mechanical damage. In traumatic and degenerative joint diseases, the quantity of hyaluronic acid decreases and the synovial fluid loses viscosity, causing a compromise of the function and painful symptoms. Many data in the literature indicate that the intra-articular administration of hyaluronic acid is able to restore the viscoelastic properties of the synovial fluid, with a consequent reduction in pain and improvement in joint mobility. HYALUBRIX 60 is a treatment for the temporary replacement of synovial fluid in patients with degenerative or mechanical arthropathy of the knee and hip, which causes an alteration in the functional performance of the synovial fluid. The intra-articular injection of HYALUBRIX 60 reduces the symptoms of pain and improves the joint function of the knee and hip, 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 in the treatment of persistent pain after initial failure of analgesics or in case of failure or intolerance to nonsteroidal anti-inflammatory drugs.
Composition
Hyaluronic acid sodium salt 1.5%, sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.
How to use
The injection must be strictly intra-articular. Intra-articular injection must be performed according to the standard technique, using precise anatomical localization. In the hip, ultrasound or radioscopic guidance is recommended.
If there is a spill, remove it before administering the product.
All rules regarding asepsis and injection techniques must be observed.
Inject HYALUBRIX 60 using a suitable sterile needle (e.g. 18 or 20 G), into the affected joint.
After the first application, further treatments may be necessary to maintain the benefits of the treatment over time, depending on the needs of the individual patient.
Clinical data show that the efficacy of HYALUBRIX 60 persists for up to 6 months. A further injection, if clinically required, should be administered after this time 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 diseases in the area of the injection. 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 shown on the package. The expiry date refers to the product stored in its original packaging. The syringe is for single use, which means that it is to be used only once and on a single patient. Inject the contents into a single joint. For the first 24 hours after the injection, the patient is allowed to continue all routine activities of daily life, 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 reworked 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. After use, dispose of in accordance with current regulations. Keep out of reach of children.
Localized pain, swelling, warmth and redness may occasionally occur at the injection site. These symptoms are usually mild and transient. After 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 subjects with hypersensitivity to the components of the product. 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 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 concomitant administration of HYALUBRIX with other products for intra-articular use, in order to prevent any possible interaction.
Conservation
Store at a temperature not exceeding 25°C.
Validity with intact packaging: 24 months.
Format
1 pre-filled syringe with 60 mg hyaluronic acid in 4 ml solution.
Cod. 10000948
