sino

Sinovial 1.6%

32 mg/2 ml Hyaluronic acid sodium salt

Composition

Viscosuppletive joint device.

Sterile – disposable.

Sinovial® constitutes a buffered physiological solution of hyaluronic acid with viscoelastic properties.

Sinovial® contains 1.6% highly purified hyaluronic acid sodium salt with a molecular weight of 800 – 1200 kDaltons. The other components of the product are: sodium chloride, sodium phosphate and water for injectable preparations.

Hyaluronic acid sodium salt (hyaluronan[1][2]) is formed by repetitive chains of disaccharide units of N-acetylglucosamine and sodium glucuronate. It is a fundamental component of synovial fluid, to which it confers special viscoelastic properties. The hyaluronic acid sodium salt in Sinovial® is obtained by fermentation and has not undergone chemical change processes.

Sinovial® appears in the form of a 2.25 ml glass syringe containing 2 ml of solution.

The content of the syringe is sterile and pyrogen-free.

Indications

Pain or reduced mobility due to degenerative diseases, post-traumatic diseases or joint alterations.

Sinovial® is a substitute for synovial fluid, which allows the re-establishment of the physiological and rheological properties of joints affected by arthrosis.

This therapeutic action is rendered by the special characteristics of the hyaluronic acid used. The hyaluronic acid contained in Sinovial®, obtained by fermentation and not chemically modified, has excellent tolerability. By re-establishing the viscoelastic properties of the synovial fluid, Sinovial® reduces the pain and re-establishes joint mobility.

Sinovial® acts only at the level of the joint into which it is injected, without exercising any systemic action.

Inject Sinovial® at weekly intervals for a total of three weeks. If necessary, further injections may be administered. It is the doctor’s responsibility to evaluate the appropriateness of repeating the cycle of treatment and its frequency for each patient, taking into consideration the risk/benefit ratio of the treatment in each case.

Contraindications

Sinovial® must not be injected in the presence of an infected or seriously inflamed joint or if the patient has a cutaneous disease or an infection in the area of the injection site.

Side Effects

Extra-articular seepage of Sinovial® may cause undesired effects locally. During the use of Sinovial®, symptoms such as pain, the sensation of heat, reddening or swelling may appear at the injection site. These secondary emergences can be relieved by applying ice to the treated joint. They generally disappear in a short space of time. Doctors must ensure that patients notify them of any undesired effects which occur after the treatment.

Warnings and Precautions

  • The content of the pre-filled syringe is sterile. The syringe is packed in a sealed blister pack. The external surface of the syringe is not sterile.
  • Do not use Sinovial® after the expiry date shown on the pack.
  • Do not use Sinovial® if the packaging is open or damaged.
  • The injection site must be on healthy skin.
  • Do not inject intravenously. Do not inject outside the joint cavity, into the synovial tissue or into the articular capsule.
  • Do not administer Sinovial® in the presence of heavy intra-articular effusion.
  • Do not sterilise again. The device was foreseen as a throwaway device only.
  • Do not reuse to avoid any risk of contamination.
  • Store at 0 °- 25°C away from heat sources. Do not freeze.
  • Once opened, Sinovial® must be used immediately and discarded after use.
  • Keep out of reach and sight of children.
  • After the intra-articular injection advise the patient to avoid any intense physical activity and to resume his or her normal activities only after several days.
  • The presence of an air bubble does not alter in any way the quality of the product.

Precautions for use

Do not concomitantly use disinfectants containing quaternary ammonium salts or chlorhexidine for skin preparation as hyaluronic acid can precipitate in their presence.

Drug Interactioons

None known at present.

Packaging

Packs of 1, 3 and 5 syringes.

Pre-filled syringes (32.0 mg hyaluronic acid sodium salt in 2 ml buffered physiological solution of sodium chloride).

Steam sterilized.

Instructions for use

  • Aspirate any joint effusion before proceeding with the injection of Sinovial®.
  • Insert the grip support, included, pushing until it is perfectly in place in the flange of the syringe.
  • Pull out the cap of the syringe, being particularly careful to avoid contact with the opening.
  • Insert the needle, of 18-22 G diameter.
  • Screw the needle tightly to the Luer type closure neck of the syringe to ensure an airtight seal and prevent leakage of liquid during the medication.
  • Inject Sinovial® at ambient temperature and under strict asepsis conditions. Inject Sinovial ®only into the synovial space.

LAST PATIENT INFORMATION LEAFLET REVIEW:

APRIL 2010

TO BE SOLD ON MEDICAL PRESCRIPTION ONLY.

THE INTRA-ARTICULAR INJECTION MAY ONLY BE ADMINISTERED BY A DOCTOR.