Descrizione Clinica
Hyalone
Description
Sterile viscoelastic solution produced with hyaluronic heaters sodium salt obtained by bacterial fermentation by a high molecular weight fraction. 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 in the articular cavity and represents the greater 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 tissues from mechanical damage.
In traumatic and degenerative pathologies of the joints, the amount of hyaluronic acid decreases and the synovial liquid loses viscosity, causing a compromise of the function and a painful symptomatology. Many literature data indicate that the administration of hyaluronic acid intra-articular is able to restore the viscoelastic properties of the synovial fluid, with a consequent pain mitigation and an improvement in joint mobility.
Hyalone is a treatment for temporary replacement of synovial fluid in patients with degenerative or mechanical arthropathy of the knee and hip, which causes an alteration of functional performance of the synovial fluid. The intra-articular injection of Hyalone reduces pain symptoms and improves the joint function of the knee and hip, up to six months.
Temporary substitute of the synovial liquid to be administered for intra-articular injection.
Indicated for the treatment of pain and improvement of joint function in patients with degenerative or mechanical and hip mechanical arthropathy. The product is indicated in the treatment of persistent pain after the initial failure of analgesics or in case of ineffectiveness or intolerance to non-steroidal anti-inflammatory drugs.
How to use
Intended exclusively to intrasticular injection.
The supply of the product must be carried out exclusively by specialized doctors (eg orthopedic surgeon, rheumatologist, phythatist radiologist, sports doctor, etc.).
The injection must be strictly intra-articular. Intra-articular injection must be performed according to the standard technique, using an accurate anatomical location. In the hip, ultrasound or radioscopic guide is recommended.
If a payment is present, remove it before administering the product.
All rules concerning asepsis and injective techniques must be observed.
Inject Hyalone using a suitable sterile needle (for example 18 or 20 g), in the appropriate joint.
After the first application, further treatments may be needed to maintain the benefits of treatment over time, depending on the needs of the individual patient.
Clinical data show that the effectiveness of Hyalone persists up to 6 months. A further injection, if required clinically, must be administered after this time period.
Components
Main component: Hyaluronic acid Salt sodium 1.5%.
Other components: sodium chloride, disodium hydrogenophosphate dodecyhydrate, sodium dihydrogenophosphate dihydrate, water for injection preparations.
Warnings
Do not administer to patients with ascertained individual sensitivity to product components.
Do not administer in case of infections or skin diseases in the injection area.
Do not administer to patients with active synovitis.
Use in specific populations
The safety and efficacy of Hyalone in pregnant women, lactating women or in subjects under the age of 18 have not been established and therefore its use is contraindicated in these populations of patients.
Warnings and precautions
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 preserved in its original packaging at a temperature not exceeding 25 ° C.
The syringe is disposable, which means that it is used once only and on a single patient. Inject the content in a single joint.
For the first 24 hours after the injection, the patient is allowed to continue all the routine activities of everyday life, but it is recommended not to overload the treated joint.
The syringe complete with needle must be eliminated immediately after use, even if the solution has not been completely administered.
If the product is reworked and / or registered, FIDIA pharmaceuticals cannot guarantee its performance, functionality, material structure, cleaning or sterility. Re-use can lead to illness, infection and / or serious damage to the patient or the user.
After use, eliminate according to local regulations in force.
Keep away from children.
Side effects
Localized pain, swelling, heat and redness can occasionally occur in the injection site. These symptoms are generally mild and transient. After the intra-articular injection, the application of ice on the articulation dealt with five-ten minutes will reduce the incidence of these events.
Local or systemic allergic reactions may occur in subjects with hypersensitivity to product components.
More marked inflammatory reactions, sometimes with presence of calcium pyroophosphate crystals, have occasionally reported in conjunction with intra-articular injured of hyaluronate.
As with any intra-articular treatment one could rarely manifest a septic arthritis if the general precautions for injections or the point of injection is not obset.
Interactions
Do not use in conjunction with disinfectants containing quaternary ammonium salts, since hyaluronic acid can fall into their presence.
Avoid the simultaneous administration of Hyalone with other products for intra-articular use, in order to prevent any possible interaction.
Storage
Store at a temperature not exceeding 25 ° C.
Format
Premed syringe 60 mg / 4 ml.
Available in packs of 1 piece and 5 pieces.
Cod. 13001235
Cod. 13001234
Sterile viscoelastic solution produced with hyaluronic heaters sodium salt obtained by bacterial fermentation by a high molecular weight fraction. 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 in the articular cavity and represents the greater 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 tissues from mechanical damage.
In traumatic and degenerative pathologies of the joints, the amount of hyaluronic acid decreases and the synovial liquid loses viscosity, causing a compromise of the function and a painful symptomatology. Many literature data indicate that the administration of hyaluronic acid intra-articular is able to restore the viscoelastic properties of the synovial fluid, with a consequent pain mitigation and an improvement in joint mobility.
Hyalone is a treatment for temporary replacement of synovial fluid in patients with degenerative or mechanical arthropathy of the knee and hip, which causes an alteration of functional performance of the synovial fluid. The intra-articular injection of Hyalone reduces pain symptoms and improves the joint function of the knee and hip, up to six months.
Temporary substitute of the synovial liquid to be administered for intra-articular injection.
Indicated for the treatment of pain and improvement of joint function in patients with degenerative or mechanical and hip mechanical arthropathy. The product is indicated in the treatment of persistent pain after the initial failure of analgesics or in case of ineffectiveness or intolerance to non-steroidal anti-inflammatory drugs.
How to use
Intended exclusively to intrasticular injection.
The supply of the product must be carried out exclusively by specialized doctors (eg orthopedic surgeon, rheumatologist, phythatist radiologist, sports doctor, etc.).
The injection must be strictly intra-articular. Intra-articular injection must be performed according to the standard technique, using an accurate anatomical location. In the hip, ultrasound or radioscopic guide is recommended.
If a payment is present, remove it before administering the product.
All rules concerning asepsis and injective techniques must be observed.
Inject Hyalone using a suitable sterile needle (for example 18 or 20 g), in the appropriate joint.
After the first application, further treatments may be needed to maintain the benefits of treatment over time, depending on the needs of the individual patient.
Clinical data show that the effectiveness of Hyalone persists up to 6 months. A further injection, if required clinically, must be administered after this time period.
Components
Main component: Hyaluronic acid Salt sodium 1.5%.
Other components: sodium chloride, disodium hydrogenophosphate dodecyhydrate, sodium dihydrogenophosphate dihydrate, water for injection preparations.
Warnings
Do not administer to patients with ascertained individual sensitivity to product components.
Do not administer in case of infections or skin diseases in the injection area.
Do not administer to patients with active synovitis.
Use in specific populations
The safety and efficacy of Hyalone in pregnant women, lactating women or in subjects under the age of 18 have not been established and therefore its use is contraindicated in these populations of patients.
Warnings and precautions
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 preserved in its original packaging at a temperature not exceeding 25 ° C.
The syringe is disposable, which means that it is used once only and on a single patient. Inject the content in a single joint.
For the first 24 hours after the injection, the patient is allowed to continue all the routine activities of everyday life, but it is recommended not to overload the treated joint.
The syringe complete with needle must be eliminated immediately after use, even if the solution has not been completely administered.
If the product is reworked and / or registered, FIDIA pharmaceuticals cannot guarantee its performance, functionality, material structure, cleaning or sterility. Re-use can lead to illness, infection and / or serious damage to the patient or the user.
After use, eliminate according to local regulations in force.
Keep away from children.
Side effects
Localized pain, swelling, heat and redness can occasionally occur in the injection site. These symptoms are generally mild and transient. After the intra-articular injection, the application of ice on the articulation dealt with five-ten minutes will reduce the incidence of these events.
Local or systemic allergic reactions may occur in subjects with hypersensitivity to product components.
More marked inflammatory reactions, sometimes with presence of calcium pyroophosphate crystals, have occasionally reported in conjunction with intra-articular injured of hyaluronate.
As with any intra-articular treatment one could rarely manifest a septic arthritis if the general precautions for injections or the point of injection is not obset.
Interactions
Do not use in conjunction with disinfectants containing quaternary ammonium salts, since hyaluronic acid can fall into their presence.
Avoid the simultaneous administration of Hyalone with other products for intra-articular use, in order to prevent any possible interaction.
Storage
Store at a temperature not exceeding 25 ° C.
Format
Premed syringe 60 mg / 4 ml.
Available in packs of 1 piece and 5 pieces.
Cod. 13001235
Cod. 13001234
