INTRA-ARTICULAR SYRINGE HYALUBRIX 60 HYALURONIC ACID 1,5% 60 MG 4 ML
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 in the joint cavity and represents the major synovial fluid component, 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 pathologies of the joints, the amount of hyaluronic acid decreases and the synovial fluid loses viscosity, causing impaired function and painful symptoms.
Hyaluronic acid sodium salt 1.5%, sodium chloride, dibasic sodium phosphate 12H2O, monobasic sodium phosphate 2H2Or, 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. If necessary, further injections can be performed. Administration of the product should only be performed by medical specialists. All rules regarding asepsis and injection techniques must be observed. If there is a spill, remove it before injecting Hyalubrix. The sterility also on the external surface of the syringe makes the product suitable for use in the operating room.
Do not administer to patients with known individual sensitivity to the components of the product in case of skin infections or diseases in the injection area. Although studies performed on laboratory animals indicate that the product has no potential for reproductive and developmental toxicity, Hyalubrix has not been tested in pregnant women.
Do not use if 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 at a temperature not exceeding 25 ° C. Hyalubrix is for single use only, which means that it is to be used only once and on one patient only. The syringe complete with needle should be discarded immediately after use, even if the solution has not been fully administered. If the product is reprocessed and / or reused, Fidia Farmaceutici cannot guarantee its performance, functionality, material structure, cleanliness and sterility. Reuse can lead to illness, infection and / or harm to the patient or user. After use, eliminate according to current regulations. Keep out of reach of children.
-Undesirable effects: localized pain, swelling, warmth and redness may occasionally occur at the injection site. These symptoms are usually mild and transient. More marked inflammatory reactions, sometimes with the presence of sodium pyrophosphate crystals, have occasionally been reported in conjunction with intra-articular injections of hyaluronate. As with any intra-articular treatment, septic arthritis may rarely occur if general injection precautions are not observed or the injection site is not aseptic.
-Interactions: do not use concomitantly with disinfectants containing quaternary ammonium salts, because hyaluronic acid can precipitate in their presence. Avoid the simultaneous administration of Hyalubrix with other products for intra-articular use, in order to prevent any possible interaction.
Store at a temperature not exceeding 25 ° C.
Validity for intact packaging: 18 months.
Carton containing 1 pre-filled syringe.
The syringe is sealed in an ethylene oxide sterilized blister and contains 60 mg of hyaluronic acid sodium salt in 4 ml of steam sterilized solution.