Principal component: Hyaluronic acid sodium salt 1.5%.
HYALONE is a sterile, non pyrogenic, viscoelastic solution manufactured with hyaluronic acid sodium salt, obtained by bacterial fermentation from a fraction of high molecular weight. 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 space and represents a major component of the synovial fluid, to which it provides its characteristic viscosity and elasticity. Such properties are fundamental for the lubricating and shock absorbing functions exerted by the fluid in normal joints to protect cartilage and soft tissues against mechanical injuries.
In traumatic and degenerative joint disorders, an insufficient amount of hyaluronic acid and a loss of viscosity occur in synovial fluid, resulting in an impairment of joint function and in a painful symptomatology. Extensive data in the literature indicate that intra-articular administration of hyaluronic acid is capable to restore the visco-elastic properties of the synovial fluid, with alleviation of pain and improvement of joint mobility.
Excipients/Inactive Ingredients: Sodium chloride, Disodium hydrogen phosphate dodecahydrate, Sodium dihydrogen phosphate dihydrate, Water for injection.
HYALONE is a temporary synovial fluid replacement for patients affected by degenerative or mechanical arthropathy of the hip and knee, that causes an alteration of the functional performances of the synovial liquid, without active synovitis.
Product administration shall be performed exclusively by qualified physicians.
All the rules regarding the asepsis and the injection technique shall be followed.
Remove any joint effusion, if present, before the administration.
Further treatments after the first application may be needed to maintain the benefit of the treatment over time, depending from the individual patient needs.
Inject HYALONE using a suitable sterile needle (for example 18 or 20 G).
When HYALONE is used in the hip, it is recommended to perform the injection under ultra-sound guidance. This is not necessary when HYALONE is used in the knee.
The sterility also on the outer surface of the syringe makes the use of the product suitable for the operating room.
Do not administer to patients with ascertained individual hypersensitivity to the product components and in cases of infections or skin diseases in the area of the injection site.
There is no evidence of contraindications to repeat the treatment.
Although pre-clinical studies performed in experimental animals indicate that the product has no potential reproductive and developmental toxicity, HYALONE has not been tested in pregnant women.
Do not use in case of package damage.
The product is for single use, that means it is intended to be used once only for a single patient. The assembled syringe must be discarded immediately after use, regardless of whether or not the solution has been completely administered.
If this product is reprocessed and/or reused, Fidia Farmaceutici cannot guarantee performance, functionality, material structure, or cleanliness or sterility of the product. Reuse could lead to illness, infection and/or serious injury to the patient or user.
After use, dispose according to applicable national practice.
Local pain, swelling, heat and redness may occur sporadically at the injection site. Such symptoms are generally mild and transient.
More marked inflammatory reactions, sometimes with sodium pyrophosphate crystals, have been occasionally reported in association with intra-articular injections of hyaluronate.
As for any intra-articular treatment, septic arthritis may rarely occur when general precautions for injections are not observed or the site of injection is not aseptic.
Do not use concomitantly with disinfectants containing quaternary ammonium salts, because hyaluronic acid can precipitate in their presence.
In order to prevent any possible interactions, avoid the contemporary administration of HYALONE with other intra-articular products.
Store at a temperature not exceeding 25°C.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Inj (pre-filled syringe) 15 mg/mL x 4 mL x 1's.