Description
HYALUBRIX
Description
HYALUBRIX is a sterile viscoelastic solution produced with hyaluronic acid sodium salt 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 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 amount of hyaluronic acid decreases and the synovial fluid loses viscosity, causing a functional impairment and painful symptoms. Many studies indicate that the intra-articular administration of hyaluronic acid is able to restore the viscoelastic properties of the 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 the synovial fluid. Intra-articular injection of HYALUBRIX at weekly intervals reduces the symptoms of pain and improves joint function in patients with degenerative or mechanical arthropathy 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, dibasic sodium phosphate 12H 2 O, monobasic sodium phosphate 2H 2 O, 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, shoulder and other less easily accessible joints, ultrasound or radioscopic guidance is recommended.
All rules regarding asepsis and injection techniques must be observed.
Remove any joint effusions, if present, prior to 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, additional cycles of injections can be performed, although a systematic collection of clinical data is not available. Clinical data demonstrate the efficacy of HYALUBRIX for up to 6 months, however if clinically required the administration cycle can be repeated starting 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 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
Case containing 1 pre-filled syringe.
The syringe is sealed in an ethylene oxide sterilized blister and contains 30 mg of hyaluronic acid sodium salt in 2 ml of steam sterilized solution.
Cod. 10000950
HYALUBRIX is a sterile viscoelastic solution produced with hyaluronic acid sodium salt 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 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 amount of hyaluronic acid decreases and the synovial fluid loses viscosity, causing a functional impairment and painful symptoms. Many studies indicate that the intra-articular administration of hyaluronic acid is able to restore the viscoelastic properties of the 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 the synovial fluid. Intra-articular injection of HYALUBRIX at weekly intervals reduces the symptoms of pain and improves joint function in patients with degenerative or mechanical arthropathy 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, dibasic sodium phosphate 12H 2 O, monobasic sodium phosphate 2H 2 O, 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, shoulder and other less easily accessible joints, ultrasound or radioscopic guidance is recommended.
All rules regarding asepsis and injection techniques must be observed.
Remove any joint effusions, if present, prior to 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, additional cycles of injections can be performed, although a systematic collection of clinical data is not available. Clinical data demonstrate the efficacy of HYALUBRIX for up to 6 months, however if clinically required the administration cycle can be repeated starting 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 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
Case containing 1 pre-filled syringe.
The syringe is sealed in an ethylene oxide sterilized blister and contains 30 mg of hyaluronic acid sodium salt in 2 ml of steam sterilized solution.
Cod. 10000950
