INTRA-ARTICULAR SYRINGE ATHENAVIS ONE HYALURONIC ACID 1.5% 4 ML

Sodium salt hyaluronic acid solution for intra-articular injection.
60 mg/4 ml pre-filled syringe

Product Description
Athenavis one is a sterile, pyrogenic, viscoelastic solution produced with hyaluronic acid sodium salt, obtained by bacterial fermentation from a high molecular weight fraction (>2000 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 the 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 pathologies of the joints, the quantity of hyaluronic acid decreases and the synovial fluid loses viscosity, causing impairment of function and painful symptoms.
Many studies indicate that intra-articular administration of hyaluronic acid is able to restore the viscoelastic properties of the synovial fluid, with a consequent reduction in pain and an improvement in joint mobility.

Composition
Main component: hyaluronic acid sodium salt 1.5% (equal to 60 mg/4 ml).
Other ingredients: sodium chloride, dibasic sodium phosphate 2H₂O, sodium dihydrogen phosphate 2H₂0, water for injections.
Indications Athenavis one is a temporary substitute for synovial fluid indicated for the treatment of pain and reduced mobility in patients affected by degenerative or traumatic arthropathy of the synovial joints of the hip and knee, without active synovitis.
The product works by providing lubrication and mechanical support and is particularly suitable for the treatment of OA symptoms.

Doses and methods of use
Inject Athenavis one, using a suitable sterile needle (eg 18 or 20 G), into the injured joint.
If necessary, further injections can be performed after the first application to maintain the benefit of the treatment over time.
When Athenavis one is used in the hip, it is recommended to inject under ultrasound guidance.
This is not necessary when Athenavis one is used in the knee.
The administration of the product should only be performed by specialist physicians.
All rules concerning asepsis and injection techniques must be observed.
If there is a spill, remove it before injecting Athenavis one.

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

Warnings
The contents of the pre-filled syringe are sterile.
The syringe is packed in a sealed blister.
The external surface of the syringe is not sterile but with a reduced bacterial load.
Although preclinical studies performed on laboratory animals indicate that the product has no potential for reproductive and developmental toxicity, Athenavis one has not been tested in pregnant women.
Do not use if the packaging is damaged.
Do not use the product after the expiry date stated on the package.
The expiry date refers to the product stored in its original packaging at a temperature not exceeding 25°C.
Athenavis one is disposable; after use, eliminate in accordance with current regulations. Keep out of reach of children.

Side 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 in conjunction with disinfectants containing quaternary ammonium salts, because hyaluronic acid can precipitate in their presence.
Avoid the simultaneous administration of Athenavis one with other products for intra-articular use, in order to prevent any possible interaction.

storage
Store at a temperature not exceeding 25°C.

Format
Carton containing 1 pre-filled syringe.
The syringe is sealed in blister packs and contains 60 mg/4 ml of hyaluronic acid sodium salt, sterilized by moist heat.