Descrizione Clinica
Medical devices - medical devices Athenavis one sir intra-art4ml
ATHENAVIS
Solution of hyaluronic acid salt sodium by intrarticular injection.
60 mg/4 ml pre-filled syringe
Product description
Athenavis one is a sterile, apirogenous, viscoelastic solution produced with hyaluronic acid sodium salt, obtained by bacterial fermentation from a fraction of high molecular weight (>2000 kDa).
Hyaluronic acid, a polysaccharide of the glycosaminoglycan family, is naturally present in many human tissues such as cartilage and synovial fluid: is continuously secreted in the joint cavity and represents the largest component of the synovial fluid, to which it provides its characteristic viscosity and elasticity.
These properties are fundamental because the fluid performs the functions of lubricant and shock absorber in normal joints, in order to protect cartilage and soft tissue from mechanical damage.
In traumatic and degenerative diseases of the joints the amount of hyaluronic acid decreases and the synovial fluid loses viscosity, causing a compromise of function and a painful symptomatology.
Many studies indicate that the administration of intrarticular hyaluronic acid is able to restore the viscoelastic properties of the synovial liquid, resulting in pain attenuation and an improvement in the mobility of the joint.
Composition
Main component: hyaluronic acid salt sodium 1.5% (equal to 60 mg/4 ml).
Other components: chloride sodium, 2H phosphate sodium2O, sodium phosphate monobasic 2H20, water for injectable preparations.
Directions Athenavis one is a temporary replacement of the synovial fluid indicated in the treatment of pain and reduction of mobility in patients suffering from degenerative or traumatic arthropathy at the level of the synovial joints of hip and knee, without active synovitis.
The product acts by providing lubrication and mechanical support and is particularly suitable for treating OA symptoms.
Doses and modes of 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, additional injections can be made to maintain the benefit of the treatment over time.
When Athenavis one is used in the hip, it is recommended to injection under ultrasound guidance.
This is not necessary when Athenavis one is used in the knee.
The administration of the product should be carried out exclusively by specialist doctors.
All the rules on axle and injective techniques must be observed.
If there is a deposit, remove it before injecting Athenavis one.
Contraindications
Do not give patients with proven individual sensitivity to product components 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 with reduced bacterial charge.
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 packaging is damaged.
Do not use the product after the expiration date shown on the packaging.
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 according to the applicable rules. Keep away from the reach of children.
Undesirable effects
Localized pain, swelling, heat and redness may occasionally occur on the injection site.
Such symptoms are generally mild and transient.
More marked inflammatory reactions, sometimes with presence of pyrophosphate sodium crystals, were occasionally reported in conjunction with intrarticular injections of hyaluronate.
As with any intrarticular treatment, septic arthritis may rarely occur if general precautions for injections or injection point are not observed.
Interactions
Do not use in conjunction with disinfectants containing quaternary ammonium salts, because hyaluronic acid may precipitate in their presence.
Avoid the contemporary administration of Athenavis one with other products for intrarticular use, so as to prevent any possible interaction.
Conservation
Store at a temperature not exceeding 25°C.
Format
Cap containing 1 pre-filled syringe.
The syringe is sealed in blister and contains 60 mg/4 ml of sodium salt hyaluronic acid, sterilized to the humid heat.
60 mg/4 ml pre-filled syringe
Product description
Athenavis one is a sterile, apirogenous, viscoelastic solution produced with hyaluronic acid sodium salt, obtained by bacterial fermentation from a fraction of high molecular weight (>2000 kDa).
Hyaluronic acid, a polysaccharide of the glycosaminoglycan family, is naturally present in many human tissues such as cartilage and synovial fluid: is continuously secreted in the joint cavity and represents the largest component of the synovial fluid, to which it provides its characteristic viscosity and elasticity.
These properties are fundamental because the fluid performs the functions of lubricant and shock absorber in normal joints, in order to protect cartilage and soft tissue from mechanical damage.
In traumatic and degenerative diseases of the joints the amount of hyaluronic acid decreases and the synovial fluid loses viscosity, causing a compromise of function and a painful symptomatology.
Many studies indicate that the administration of intrarticular hyaluronic acid is able to restore the viscoelastic properties of the synovial liquid, resulting in pain attenuation and an improvement in the mobility of the joint.
Composition
Main component: hyaluronic acid salt sodium 1.5% (equal to 60 mg/4 ml).
Other components: chloride sodium, 2H phosphate sodium2O, sodium phosphate monobasic 2H20, water for injectable preparations.
Directions Athenavis one is a temporary replacement of the synovial fluid indicated in the treatment of pain and reduction of mobility in patients suffering from degenerative or traumatic arthropathy at the level of the synovial joints of hip and knee, without active synovitis.
The product acts by providing lubrication and mechanical support and is particularly suitable for treating OA symptoms.
Doses and modes of 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, additional injections can be made to maintain the benefit of the treatment over time.
When Athenavis one is used in the hip, it is recommended to injection under ultrasound guidance.
This is not necessary when Athenavis one is used in the knee.
The administration of the product should be carried out exclusively by specialist doctors.
All the rules on axle and injective techniques must be observed.
If there is a deposit, remove it before injecting Athenavis one.
Contraindications
Do not give patients with proven individual sensitivity to product components 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 with reduced bacterial charge.
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 packaging is damaged.
Do not use the product after the expiration date shown on the packaging.
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 according to the applicable rules. Keep away from the reach of children.
Undesirable effects
Localized pain, swelling, heat and redness may occasionally occur on the injection site.
Such symptoms are generally mild and transient.
More marked inflammatory reactions, sometimes with presence of pyrophosphate sodium crystals, were occasionally reported in conjunction with intrarticular injections of hyaluronate.
As with any intrarticular treatment, septic arthritis may rarely occur if general precautions for injections or injection point are not observed.
Interactions
Do not use in conjunction with disinfectants containing quaternary ammonium salts, because hyaluronic acid may precipitate in their presence.
Avoid the contemporary administration of Athenavis one with other products for intrarticular use, so as to prevent any possible interaction.
Conservation
Store at a temperature not exceeding 25°C.
Format
Cap containing 1 pre-filled syringe.
The syringe is sealed in blister and contains 60 mg/4 ml of sodium salt hyaluronic acid, sterilized to the humid heat.
