Description
Sterile viscoelastic solution made with hyaluronic acid sodium salt obtained by bacterial fermentation from a high molecular weight fraction. Hyaluronic acid, a polysaccharide from 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, providing it with its characteristic viscosity and elasticity. These properties are essential for the fluid to perform its lubricating and shock-absorbing functions in normal joints, protecting cartilage and soft tissue from mechanical damage.
In traumatic and degenerative joint diseases, the amount of hyaluronic acid decreases and the synovial fluid loses viscosity, causing impaired function and painful symptoms. Numerous data in the literature indicate that intra-articular administration of hyaluronic acid can restore the viscoelastic properties of the synovial fluid, resulting in pain relief and improved joint mobility.
HYALONE is a treatment for the temporary replacement of synovial fluid in patients with degenerative or mechanical knee and hip arthropathy, which causes an alteration in the functional performance of the synovial fluid. Intra-articular injection of HYALONE reduces pain symptoms and improves knee and hip joint function 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 with degenerative or mechanical arthropathy of the hip and knee. The product is indicated for the treatment of persistent pain after initial analgesic failure or in cases of ineffectiveness or intolerance to nonsteroidal anti-inflammatory drugs.

How to use
Intended for intra-articular injection only.
The product must be administered exclusively by specialized doctors (e.g. orthopedic surgeon, rheumatologist, physiatrist radiologist, sports doctor, etc.).
The injection must be strictly intra-articular. Intra-articular injections must be performed according to standard technique, using a precise anatomical location. In the hip, ultrasound or radioscopic guidance is recommended.
If there is a spill, 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 time period.

Components
Main component: hyaluronic acid sodium salt 1.5%.
Other ingredients: 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 if you have 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 individuals 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 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.
The syringe is disposable, meaning it should be used only once and on a single patient. Inject the contents into only one joint.
For the first 24 hours after the injection, the patient is allowed to continue all routine activities of daily living, but it is recommended not to overload the treated joint.
The syringe complete with needle must be discarded 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 may lead to illness, infection, and/or serious harm to the patient or user.
After use, dispose of in accordance with local regulations.
Keep out of reach of children.
Side 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 association 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, 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.

Conservation
Store below 25°C.

Format
Pre-filled syringe 60 mg/4 ml.
Available in packs of 1 piece and 5 pieces.

Cod. 13001235
Cod. 13001234