HYALEXO Sodium Hyaluronate - 1 Syringe of 2ml

Carton with 3 ml pre-filled syringe containing 2 ml solution, closed with rubber stopper.

The contents of the syringe are sterile and have been sterilized to aseptic standards.

Each pre-filled syringe is packaged in a sealed blister pack.

Each syringe contains a single dose of solution. Inject a syringe of Hyalexo Expanscience into the affected joint using a sterile needle (18

to 22 G) once a week for three weeks, using the standard technique. Injections should only be carried out by a qualified physician under strict aseptic conditions. In the event of joint effusion, it is advisable to aspirate the effusion by arthrocentesis prior to injection.

Do not use in case of hypersensitivity to the main constituent or to any of the constituents of the product.

Do not use in the event of infection or skin disease at the injection site.

Do not use if the knee joint is infected or highly inflamed.

Hyalexo Expanscience is indicated for the relief of pain in patients suffering from osteoarthritis or degenerative joint diseases leading to an

functional properties of synovial fluid.

Main constituent: 1% sodium hyaluronate (PE). Other ingredients: sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate and water for injection.

Undesirable effects

Local reactions at the injection site may include discomfort, transient pain (e.g. joint pain, muscle pain, etc.) immediately and up to 48 hours after injection, joint swelling, joint effusion, redness, warmth, bleeding and ecchymosis. These side effects are generally mild to moderate in intensity and disappear spontaneously within a few days. Injections must be carried out under strict aseptic conditions to avoid any risk of septic arthritis.

Hypersensitivity to any of the components :

- Local allergic reactions such as redness, rash, hives and itching may occur. These adverse reactions are rare, mild to moderate in intensity and usually disappear spontaneously within a few days.

- In very rare cases, generalized allergic reactions may occur, with angioedema (e.g. facial edema, eyelid edema, tongue swelling, etc.), facial flushing, difficulty breathing (shortness of breath), syncope, generalized edema or urticaria. If such reactions occur, Hyalexo Expanscience should be discontinued immediately and appropriate measures taken.

In some cases, the injection itself may cause stress symptoms such as nausea, vomiting and syncope.

Precautions

Hyalexo Expanscience should be administered exclusively by intra-articular injection.

The safety and efficacy of Hyalexo Expanscience in joints other than the knee and shoulder have not been studied.

Concomitant administration of Hyalexo Expanscience with any other intra-articular treatment has not been established and should be avoided to prevent any possible interaction.

Do not use at the same time as disinfectants containing quaternary ammonium salts such as benzalkonium chloride, because of the risk of precipitating hyaluronic acid in their presence. All syringes must be discarded after use.

Do not use after expiration date or if packaging is open or damaged.

Pregnancy and breast-feeding

Pregnancy: animal reproduction studies have revealed no evidence of impaired fertility. However, safety and efficacy during pregnancy have not been established. Use in pregnant women or women planning pregnancy may be considered only if the therapeutic benefit justifies the potential risks.

Breast-feeding: to date, no data are available on the excretion of Hyalexo Expanscience in breast milk. The safety and efficacy of Hyalexo Expanscience in women during lactation have not been established.

Use in children

The safety and efficacy of Hyalexo Expanscience in children have not been studied.

Storage conditions

Store at 1-30°C. Protect from sunlight. Do not freeze.

Shelf life

The expiration date indicated on the packaging corresponds to the product stored in its original packaging under the above conditions.