Hyalubrix Hyaluronic Acid 30mg/2ml Intra-articular Medical Device 1 Pre-filled Syringe

Hyalubrix it's one injectable solution sterile viscoelastic based hyaluronic acid sodium salt, obtained by bacterial fermentation from an ad fraction high molecular weight. It comes in a pre-filled syringe ready for use.intra-articular injection and it is a medical device Fidia Farmaceutici.

Thehyaluronic acid it is naturally present in many human tissues, such as cartilage and synovial fluid. It is secreted continuously in the joint and is the main component of the synovial fluid, to which it gives its characteristic viscosity and elasticity: it is these properties that allow the fluid to carry out the functions of lubricant and shock absorber, protecting 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: joint function is compromised and painful symptoms appear. Le manufacturer's instructions for use report that «many studies indicate that the administration of hyaluronic acid intra-articularly is able to restore the viscoelastic properties of the synovial fluid».

Hyalubrix is a treatment for temporary replacement of synovial fluid in patients affected by degenerative or mechanical arthropathy which leads to an alteration of the functional performance of the synovial fluid. It is used in the knee, in thehip, in shoulder, in ankle and in thetrapeziometacarpal joint, even when pain persists after initial failure of analgesics or in case of intolerance to non-steroidal anti-inflammatory drugs.

Each syringe contains 30 mg of hyaluronic acid sodium salt in 2 ml of solution, i.e. a concentration of1,5%, together with sodium chloride, dibasic and monobasic sodium phosphate and water for injections. It is a disposable product, intended for administration by a specialist doctor.

INDICATIONS

Why is Hyalubrix Hyaluronic Acid 30mg/2ml Intra-articular Medical Device 1 Pre-filled Syringe used? What is it for?

Hyalubrix is a treatment for temporary replacement of synovial fluid in patients affected by degenerative or mechanical arthropathy, which causes an alteration in the functional performance of the synovial fluid.

It is indicated for the treatment of pain and the improvement of joint function in patients suffering from 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 of non-steroidal anti-inflammatory drugs.

INGREDIENTS

What ingredients does Hyalubrix Hyaluronic Acid 30mg/2ml Intra-articular Medical Device 1 Pre-filled Syringe contain?

Hyaluronic acid sodium salt 1.5%, sodium chloride, dibasic sodium phosphate 12H2O, monobasic sodium phosphate 2H2O, water for injections.

HOW TO USE

How do I use Hyalubrix Hyaluronic Acid 30mg/2ml Intra-articular Medical Device 1 Pre-filled Syringe?

The administration of the product must be carried out by a specialist doctor.

The injection must be strictly intra-articular and performed according to the standard technique, using precise anatomical localization. In the hip, shoulder and other less easily accessible joints, it is recommended ultrasound or radioscopic guidance. All rules regarding asepsis and injection techniques must be observed. Remove any joint effusions, if any, before administration.

Inject Hyalubrix using a suitable sterile needle (e.g. 18 or 20 G) in the affected joint, e.g weekly intervals for 3 weeks. If necessary, further courses of injections can be performed, although systematic collection of clinical data is not available. If clinically required, the administration cycle can be repeated starting 3 months after the first treatment cycle.

WARNINGS

What are the warnings of Hyalubrix Hyaluronic Acid 30mg/2ml Intra-articular Medical Device 1 Pre-filled Syringe?

Contraindications
Do not administer to patients with proven individual sensitivity to the components of the product.
Do not administer if you have infections or skin diseases in the injection area.
Do not administer to patients with active synovitis.

Interactions
Do not use in conjunction with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence.
Avoid the simultaneous administration of Hyalubrix with other products for intra-articular use, in order to prevent any possible interaction.

Pregnancy and breastfeeding
The safety and efficacy of Hyalubrix in pregnant women, lactating women, or individuals under the age of 18 years have not been established and therefore its use is contraindicated in these patient populations.

Warnings
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 disposable: it is to be used only once and on a single patient. Inject the contents into one joint only.
For the first 24 hours after the injection the patient is allowed to continue all routine activities of daily living, 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. After use, dispose of according to current regulations.
If the product is reworked and/or reused, Fidia Farmaceutici cannot guarantee its performance, functionality, structure of the material, cleanliness or sterility. Reuse may lead to illness, infection and/or harm to the patient or user.
Keep out of reach of children.
Localized pain, swelling, warmth and redness may occasionally occur at the injection site: these symptoms are generally 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 individuals 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 injection precautions are not observed or the injection site is not aseptic.

CONSERVATION

How is Hyalubrix Hyaluronic Acid 30mg/2ml Intra-articular Medical Device 1 Pre-filled Syringe stored?

Store at temperatures not exceeding 25°C.

FORMAT

What is the format of Hyalubrix Hyaluronic Acid 30mg/2ml Intra-articular Medical Device 1 Pre-filled Syringe?

Case containing 1 pre-filled syringe 2 ml, with 30 mg of hyaluronic acid sodium salt.