Intra-articular Hyalone Hyaluronic Acid Syringe 1.5% 60 Mg 4 Ml 1 Piece

Description
Sterile viscoelastic solution produced with hyaluronic acid sodium salt obtained by bacterial fermentation from 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 into the joint cavity and is 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 lubricating and shock-absorbing functions in normal joints, in order to protect cartilage and soft tissues from mechanical damage.
In traumatic and degenerative joint diseases, the amount of hyaluronic acid decreases and the synovial fluid loses viscosity, leading to impaired function and painful symptoms. Many literature data indicate that intra-articular administration of hyaluronic acid can restore the viscoelastic properties of synovial fluid, with a consequent reduction in pain and an improvement in joint mobility.
HYALONE is a treatment for the temporary replacement of synovial fluid in patients suffering from degenerative or mechanical arthropathy of the knee and hip, which causes an alteration in the functional performance of the synovial fluid. Intra-articular injection of HYALONE reduces pain symptoms and improves joint function of the knee and hip for up to six months.
Temporary substitute for synovial fluid to be administered by intra-articular injection.
Indicated for the treatment of pain and improvement of joint function in patients suffering from degenerative or mechanical arthropathy of the hip and knee. The product is indicated in the treatment of persistent pain after initial failure of analgesics or in case of ineffectiveness or intolerance to non-steroidal anti-inflammatory drugs.

Directions for use
Intended for intra-articular injection only.
The administration of the product must be performed exclusively by specialized doctors (e.g., orthopedic surgeon, rheumatologist, physiotherapist radiologist, sports doctor, etc.).
The injection must be strictly intra-articular. Intra-articular injection must be performed according to standard technique, using precise anatomical localization. In the hip, ultrasound or fluoroscopic guidance is recommended.
If an effusion is present, remove it before administering the product.
All rules regarding asepsis and injection techniques must be observed.
Inject HYALONE using a suitable sterile needle (e.g., 18 or 20 G) into the affected joint.
After the first application, further treatments may be necessary to maintain the benefits of the treatment over time, depending on the needs of the individual patient.
Clinical data show that the efficacy of HYALONE persists for up to 6 months. A further injection, if clinically required, should be administered after this period.

Components
Main component: hyaluronic acid sodium salt 1.5%.
Other components: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.

Warnings
Do not administer to patients with known individual sensitivity to the 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, breastfeeding women or subjects under 18 years of age have not been established and therefore its use is contraindicated in these patient populations.
Warnings and Precautions
Do not use if the package is damaged.
Do not use the product after the expiry date indicated on the package.
The expiry date refers to the product stored in its original packaging at a temperature not exceeding 25°C.
The syringe is for single use, meaning it is to be used only once and on only one patient. Inject the contents into only one joint.
For the first 24 hours after injection, the patient is allowed to continue all routine daily activities, but it is recommended not to overload the treated joint.
The syringe with needle must be disposed of immediately after use, even if the solution has not been completely administered.
If the product is reprocessed and/or reused, Fidia Farmaceutici cannot guarantee its performance, functionality, material structure, cleanliness or sterility. Reuse can lead to illness, infection and/or serious harm to the patient or user.
After use, dispose of according to local regulations.
Keep out of reach of children.
Undesirable effects
Localized pain, swelling, heat and redness may occasionally occur at the injection site. These symptoms are generally mild and transient. After intra-articular injection, applying ice to the treated joint for five to ten minutes will reduce the incidence of these events.
Local or systemic allergic reactions may occur in subjects with hypersensitivity to the product components.
More marked inflammatory reactions, sometimes with the presence of calcium pyrophosphate crystals, have occasionally been reported in conjunction with intra-articular hyaluronate injections.
As with any intra-articular treatment, septic arthritis could rarely occur if general precautions for injections are not observed or if the injection site is not aseptic.
Interactions
Do not use concomitantly with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence.
Avoid concomitant 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
Pre-filled syringe 60 mg/4 ml.
Available in packs of 1 piece and 5 pieces.

Code. 13001235
Code. 13001234