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

Description
Athenavis one is a sterile, pyrogen-free, viscoelastic solution produced with sodium hyaluronate, obtained by bacterial fermentation from a high molecular weight fraction (>2,000 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 synovial fluid, to which it provides its characteristic viscosity and elasticity.
These properties are fundamental for the fluid to perform its functions as a lubricant and shock absorber in normal joints, in order to protect cartilage and soft tissues from mechanical damage.
In traumatic and degenerative joint pathologies, the quantity of hyaluronic acid decreases and the synovial fluid loses viscosity, causing impaired function and painful symptoms.
Many studies indicate that intra-articular administration of hyaluronic acid can restore the viscoelastic properties of synovial fluid, resulting in reduced pain and improved joint mobility.

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

How to use
Inject Athenavis one, using a suitable sterile needle (e.g. 18 or 20 G), into the injured joint.
If necessary, after the first application, further injections can be performed to maintain the benefit of the treatment over time.
When Athenavis one is used in the hip, it is recommended to perform the injection 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 doctors.
All rules regarding asepsis and injection techniques must be observed.
If an effusion is present, 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 content of the pre-filled syringe is sterile.
The syringe is packaged in a sealed blister.
The outer surface of the syringe is not sterile but has a reduced bacterial load.
Although preclinical studies performed on laboratory animals indicate that the product has no potential toxicity on reproduction and development, Athenavis one has not been tested in pregnant women.
Do not use if the 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.
Athenavis one is for single use; after use, dispose of according to 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 generally 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 could rarely occur if general precautions for injections 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
Box containing 1 pre-filled syringe.
The syringe is sealed in a blister and contains 60 mg/4 ml of sodium hyaluronate, sterilized by moist heat.

Code. 10