Hyalone 60mg, 1 syringe 4 ml, Fidia Farmaceutici

Sodium salt of hyaluronic acid, 1.5% solution for intra-articular injection
Prefilled syringe of 60 mg/4 ml

HYALONE is a temporary substitute for synovial fluid, for patients affected by degenerative or mechanical arthropathy of the knee and hip, which causes alteration of the functional performance of the synovial fluid, without active synovitis. The contents of the syringe are sterilized with steam.

HyalOne quickly reduces pain with a single administration

HyalOne is a natural product based on injectable hyaluronic acid. Due to the high concentration of hyaluronic acid (4 ml), it requires a single administration for effective effects that last between 6 and 12 months. HyalOne is very well tolerated by the body because it is produced with the sodium salt of hyaluronic acid, obtained by bacterial fermentation.

Requires a single administration
Reduces pain and difficulty moving
The effect sets in quickly and is long-lasting (6-12 months).
It is very well tolerated by the body.

HyalOne is the only hyaluronic acid approved by the Food and Drug Administration (FDA)

The HyalOne effect:
Improves joint mobility
Restores the qualities of synovial fluid
Reduces joint friction
Alleviates pain on movement
Effectively lubricates areas with severe cartilage destruction

HyalOne is recommended for:
People with severe cartilage destruction
Patients candidates for surgery
People who have contraindications for surgery
People who are too young for joint replacement? young people
People undergoing physical recovery procedures

HYALONE is a sterile, pyrogen-free, viscoelastic solution produced with the sodium salt of hyaluronic acid, 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 in the joint area and is a major component of the synovial fluid, giving it its characteristic viscosity and elasticity. Such properties are fundamental to the lubricating and shock-absorbing functions exercised by the fluid, usually in joints to protect cartilage and soft tissues from mechanical trauma.

In traumatic and degenerative joint diseases, there is an insufficient amount of hyaluronic acid and a loss of viscosity in the synovial fluid, causing impaired joint function and painful symptoms. Data from the literature indicate that intra-articular administration of hyaluronic acid can restore the viscoelastic properties of the synovial fluid, in addition to relieving pain and improving joint mobility.

Composition:
Main component: sodium salt of hyaluronic acid 1.5%.
Other components:
sodium chloride, disodium hydrogen phosphate dodecadihydrate, sodium dihydrogen phosphate dihydrate, water for
injectable preparations.

Indications:
HYALONE is a temporary substitute for synovial fluid for patients suffering from degenerative or
mechanics at the hip and knee level, which causes a change in the functional performance of the synovial fluid, without active synovitis.

Dosage and administration:
The product will be administered exclusively by specialist doctors.
All rules regarding asepsis and injection technique will be respected.
Remove any excess fluid from the joint, if any, before administration.
It is possible that after the first application, additional treatments may be necessary to maintain the effect over time.
therapy, depending on the individual needs of patients.

Inject HYALONE using a suitable sterile syringe needle (e.g. 18 or 20 G).
When using HYALONE in the hip, it is recommended to perform the injection under ultrasound guidance. This is not necessary when using HYALONE in the knee.
Sterilization of the outer surface of the syringe makes it possible to use the product even in the operating room.

Contraindications:
Do not administer to patients with known individual hypersensitivity to the product components and in the presence of infections or skin diseases in the injection site area.
There is no evidence of contraindications for repeated treatment.

Warnings and precautions:
Although preclinical studies conducted on animals used for experimental purposes indicate that the product has no toxicity
potential on reproductive function and does not develop toxicity, HYALONE has not been tested on pregnant women.
Do not use if the packaging is damaged.
Do not use the product after the expiration date printed on the packaging.
The expiration date refers to the product stored in its original packaging, at a temperature not exceeding 25? C.
The product is single-use, meaning it is intended to be used only once on a single patient.
The assembled syringe should be discarded immediately after use, regardless of whether the solution has been fully administered or not.
If this product is reprocessed and/or reused, Fidia Farmaceutici cannot guarantee performance, functionality,
material structure or the degree of cleanliness or sterility of the product. Reuse could cause illness, infection and/or serious injury to the patient or user.

After use, dispose of according to applicable national practice.
Keep out of reach and sight of children.

Side effects:
Local pain, swelling, warmth and redness may occasionally occur at the injection site. Such symptoms are generally mild and transient.

More marked inflammatory reactions, sometimes with sodium pyrophosphate crystals, have occasionally been reported in association with intra-articular hyaluronate injections.

Regarding intra-articular treatment, septic arthritis may rarely occur when general injection precautions are not followed or the injection site is not aseptic.

Interactions:
Do not use with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence.

To prevent any possible interactions, avoid concurrent administration of HYALONE with other intra-articular products.

Storage:
Store at a temperature not exceeding 25? C.

Packaging method:
A pre-filled syringe containing 60 mg/4 ml of hyaluronic acid sodium salt, steam sterilized, packaged in a blister sterilized with ethylene oxide.

Presentation:
1 syringe