INTRA-ARTICULAR SYRINGE HYALUBRIX HYALURONIC ACID 1,5% 30 MG 2 ML
Sterile, apyrogenic, viscoelastic solution produced with hyaluronic acid sodium salt, obtained by bacterial fermentation from a high molecular weight fraction.
It is indicated for the treatment of pain and the 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 non-steroidal anti-inflammatory drugs.
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 affected joint at weekly intervals for 3 weeks.
If necessary, further courses of injections may be performed, although no systematic collection of clinical data is available.
Clinical data demonstrate the efficacy of HYALUBRIX up to 6 months, however, if clinically required, the administration cycle can be repeated starting from 3 months after the first treatment cycle.
Notes: HYALUBRIX is intended for intra-articular injection only.
The administration of the product must be performed only by specialized doctors.
The injection must be strictly intra-articular. The intra-articular injection should be performed according to the standard technique, using a precise anatomical location. In the hip, shoulder, and other less easily accessible joints, ultrasound or x-ray guidance is recommended.
All rules regarding asepsis and injection techniques must be observed. The sterility also on the external surface of the syringe makes the use of the product suitable for the operating room.
Do not administer to patients with known individual sensitivity to the components of the product. Do not administer in case of skin infections or diseases in the injection area. Do not administer to patients with active synovitis.
The safety and efficacy of HYALUBRIX in pregnant women, lactating women or in individuals below 18 years of age have not been established and therefore its use is contraindicated in these patient populations.
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. The syringe is for single use only, which means that it is for single use only and on one patient only. Inject the content 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 should be discarded immediately after use, even if the solution has not been fully administered. Reuse can lead to illness, infection and / or harm to the patient or user. After use, eliminate according to the regulations in force. 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 the intra-articular injection, applying 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 conjunction 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 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: 24 months.
Carton 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.