Intragel 1,6%, 1 filled syringe

Intragel 32 mg/2 ml

Hyaluronic acid sodium salt solution for 

intra-articular injection

Pre-filled syringe

Composition:

Hyaluronic acid sodium salt 32 mg/2 ml (1.6%)

Inactive ingredients: 

Sodium chloride, Disodium 

hydrogen phosphate dodecahydrate, Sodium dihydrogen phosphate dihydrate, Water for injection.

Properties:

Intragel is a sterile, non pyrogenic, viscoelastic solution manufactured with hyaluronic acid sodium salt, obtained by bacterial fermentation from a fraction of high molecular weight (>1500 kDa). 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.

Indications:

Intragel is a temporary synovial fluid replacement for patients affected by degenerative or mechanical arthropathy, that causes an alteration of the functional performances of the synovial liquid, without active synovitis.

Dosage and administration:

Inject Intragel, using a suitable sterile needle (for example 18 or 20 G), in the affected joint at weekly intervals for 3 weeks. Subsequent injections may be performed, if necessary.

Product administration should be performed exclusively by qualified physicians.

All the rules regarding the asepsis and the injection technique should be followed.

Remove any joint effusion, if present, before injecting Intragel.

The sterility also on the outer surface of the syringe makes the use of the product suitable for the operating room.

Contraindications:

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.

Warnings and precautions:

Intragel has not been tested in pregnant women. Ask your doctor before administration.

Do not use it in case of package damage.

Do not use the product after the expiry date reported on the package.

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.

Reuse could lead to illness, infection and/or serious injury to the patient or user.

After use, dispose according to applicable national practice.

Keep out of reach of children.

Side effects:

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.

•Interactions:

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 administration of Intragel® with other intra-articular products.

Storage:

Store at a temperature not exceeding 25°C.

Package:

Carton box contains 1 pre-filled syringe and 1 needle sterile-disposable.