FIDIA FARMACEUTICI
Hyalubrix 60 1 pre-filled syringes, 60mg/4ml

The use of this product should be performed only by specialists. Must be observed all the rules concerning the aseptic and injection techniques. Carefully read the instruction sheet for use before use.

PRODUCT INFORMATION

HYALUBRIX

Solution of hyaluronic acid sodium salt for Intra-articular injection pre-filled syringe

Product Description
HYALUBRIX is a sterile, non-pyrogenic, viscoelastic produced with hyaluronic acid sodium salt, obtained by bacterial fermentation of a fraction of high molecular weight (> 1500 kDa). The hyaluronic acid, a polysaccharide of the family of glycosaminoglycans, is naturally present in many human tissues such as cartilage and synovial fluid: is continuously secreted into the joint cavity and is the major component of synovial fluid, which provides its characteristic viscosity and elasticity. These properties are critical because the fluid carries the
functions of lubricant and shock absorber in normal joints, in order to protect the cartilage and soft tissue from mechanical damage. In traumatic and degenerative diseases of the joints the quantity of hyaluronic acid decreases and the synovial fluid loses viscosity, causing an impairment of the function and a painful symptomatology. Many studies indicate that administration of hyaluronic acid by intraarticular is able to restore the viscoelastic properties of synovial fluid, with a consequent attenuation of pain and improved mobility of the joint.

Composition
Main component: hyaluronic acid sodium salt 1.5%. Other ingredients: sodium chloride, sodium phosphate bibasico.12H₂O, sodium phosphate monobasico.2H₂O, water for injections.

Information
HYALUBRIX is a temporary replacement for the synovial fluid in patients with degenerative joint disease or mechanical, causing a disturbance in the functioning of the synovial fluid, without active synovitis.

Dosage and directions for use
Inject HYALUBRIX, using a suitable sterile needle, articulation injured at weekly intervals for a total of 3 weeks. If necessary, can be carried out further injections. The administration of the product should be performed only by specialists. Must be observed all the rules concerning the aseptic and injection techniques. If there is a spill, remove it before injecting HYALUBRIX.

Contraindications
Do not administer to patients with known sensitivity to the individual components of the product and in case of infections or skin diseases in the area of the injection.

Notes
The content of the pre-filled syringe is sterile. The syringe is packed in a blister sealed. The surface
outside of the syringe is not sterile but in bacterial load reduced. Although preclinical studies performed on laboratory animals indicate that the product has no potential toxicity to reproduction and development, HYALUBRIX has not been tested in pregnant women. Do not use if package is damaged. Do not use after the expiry date printed on the package. The expiry date refers to the product stored in its original packaging at a temperature not exceeding 25 ° C. HYALUBRIX is disposable after use, dispose of according to applicable regulations. Keep out of reach of children.

Side effects
Localized pain, swelling, warmth and redness may occur occasionally at the injection site.
These symptoms are generally mild and transient. More marked inflammatory reactions, sometimes with the presence of crystals of sodium pyrophosphate, have been occasionally reported in conjunction with intra-articular injections of hyaluronate.
As with any intra-articular treatment could manifest, rarely, septic arthritis, if not precautions are observed for the injection or the injection is not aseptic.

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

Storage
Do not store above 25 ° C .

Manufactured by:
Fidia Pharmaceuticals SpA
Via Ponte della Fabbrica, 3 / A
35031 Abano Terme (PD), Italy

Date of issue or the latest revision of the instructions for use: July 2009.