Description
HYALUBRIX
Description
Sterile, apyrogenic, viscoelastic solution produced with hyaluronic acid sodium salt, obtained by bacterial fermentation from a high molecular weight fraction (>1,500 kDa). 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 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 function and painful symptoms.
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
Inject Hyalubrix, using a suitable sterile needle (e.g. 18 or 20 G), into the injured joint at weekly intervals for a total of 3 weeks. Additional injections may be performed if necessary. The administration of the product should be performed only by medical specialists. All rules regarding asepsis and injection techniques must be observed. If an effusion is present, remove it before injecting Hyalubrix. Sterility also on the external surface of the syringe makes the product suitable for use in the operating room.
Warnings
Do not administer to patients with known individual sensitivity to the components of the product in case of infections or skin diseases in the area of injection. Although studies performed on laboratory animals indicate that the product has no potential toxicity on reproduction and development, Hyalubrix has not been tested in pregnant women.
Do not use if the packaging is damaged. Do not use the product after the expiry date shown on the packaging. The expiry date refers to the product stored in its original packaging at a temperature not exceeding 25°C. Hyalubrix is disposable, which means that it is to be used only once and on a single patient. The syringe complete with needle must be disposed of 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 and 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.
-Undesirable effects: Localized pain, swelling, heat and redness may occasionally occur at the injection site. These symptoms are generally mild and transient. 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.
-Interactions: Do not use in conjunction with disinfectants containing quaternary ammonium salts, because 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: 18 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. 105460
Sterile, apyrogenic, viscoelastic solution produced with hyaluronic acid sodium salt, obtained by bacterial fermentation from a high molecular weight fraction (>1,500 kDa). 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 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 function and painful symptoms.
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
Inject Hyalubrix, using a suitable sterile needle (e.g. 18 or 20 G), into the injured joint at weekly intervals for a total of 3 weeks. Additional injections may be performed if necessary. The administration of the product should be performed only by medical specialists. All rules regarding asepsis and injection techniques must be observed. If an effusion is present, remove it before injecting Hyalubrix. Sterility also on the external surface of the syringe makes the product suitable for use in the operating room.
Warnings
Do not administer to patients with known individual sensitivity to the components of the product in case of infections or skin diseases in the area of injection. Although studies performed on laboratory animals indicate that the product has no potential toxicity on reproduction and development, Hyalubrix has not been tested in pregnant women.
Do not use if the packaging is damaged. Do not use the product after the expiry date shown on the packaging. The expiry date refers to the product stored in its original packaging at a temperature not exceeding 25°C. Hyalubrix is disposable, which means that it is to be used only once and on a single patient. The syringe complete with needle must be disposed of 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 and 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.
-Undesirable effects: Localized pain, swelling, heat and redness may occasionally occur at the injection site. These symptoms are generally mild and transient. 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.
-Interactions: Do not use in conjunction with disinfectants containing quaternary ammonium salts, because 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: 18 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. 105460
