Sinovial 1.6% 32 mg/2 ml - 1 prefilled syringe

Product Description

Medical device for intra-articular infiltrations.

Indications

Sinovial 32 2 ml consists of a buffered physiological solution of hyaluronic acid sodium salt with viscoelastic properties.

Hyaluronic acid sodium salt (hyaluronan*) is formed by repeated chains of disaccharide units of n-acetylglucosamine and sodium glucuronate, it is a fundamental component of the synovial fluid, to which it gives its particular viscoelastic properties.

The hyaluronic acid sodium salt of sinovial® 32 2 ml is obtained by fermentation and has not undergone chemical modification processes.

* Alternative names are often used

Composition

Sinovial® 32 2 ml contains 1.6% highly purified hyaluronic acid sodium salt with a molecular weight between 800 and 1,200 kdalton.

The other ingredients of the product are: sodium chloride, sodium phosphate and water for injections.

Directions for use and Dosage

Do not mix Sinovial 32 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.

Warnings

NB: Sinovial 32 2 ml can only be injected by a doctor.

• The contents of the pre-filled syringe are sterile. The syringe is packaged in a sealed blister. The external surface of the syringe is not sterile.
• Do not use Sinovial 32 2 ml after the expiry date shown on the package;
• Do not use Sinovial 32 2 ml if the packaging is open or damaged;
• The injection site must be on healthy skin;
• Do not inject vascularly. Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule;
• Do not administer Sinovial 32 2 ml in the presence of a large intra-articular effusion.
• Do not re-sterilize. The device is intended for single use only.
• Do not reuse to avoid any risk of contamination.
• Store at room temperature and in any case below 25°C and away from heat sources. Do not freeze.
• Once opened, Sinovial 32 2 ml must be used immediately and discarded after use.
• Keep out of the reach and sight of children.
• After the injection, advise the patient to avoid all intense physical activity and to resume normal activities only after a few days.
• The possible presence of an air bubble does not affect the characteristics of the product.

Interactions

To date, no interactions between Sinovial 32 2 ml and other drugs are known.

Contraindications

Sinovial 32 2 ml must not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the area of ​​the injection site. The product should not be used in case of known hypersensitivity to sodium hyaluronate or other components.

Undesirable effects

Extra-articular infiltration of sinovial® 32 2 ml may cause local adverse effects.

During the use of sinovial 32 2 ml, symptoms such as pain, heat, redness, or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area.

They usually disappear after a short time. The physician must ensure that patients inform him of any adverse effects that occur after treatment.

Format

1 pre-filled 2 ml syringe with needle