Sanofi, Synvisc One 48 mg/6ml, 1

p>Product description
Hylan GF 20 is a sterile, non-pyrogenic, elastic-viscous liquid containing hylan polymers A and B produced on the basis of highly purified extract of avian origin. Hylans are derivatives of sodium salt of hyaluronic acid, which contain repeating disaccharide units of N-acetyl-glucosamine and sodium glucuronide.

Indications and action

• for periodic replacement and replenishment of synovial fluid;
• It is used in patients with various stages of degenerative changes in the knee joint;
• effective in patients who actively and regularly use the affected knee joint;
• the therapeutic effect is achieved by viscosupplementation – a process in which the physiological and rheological state of the tissues of the inflamed knee joint is restored;
• reducing pain and discomfort and increasing joint mobility;
• In vitro studies have shown that hylan GF 20 protects cartilage cells against some physical and chemical damage.

The product is intended for adults for single use.

Dosage

• Remove the syringe from the blister (or tray) by holding the barrel, without touching the plunger.
• Administer under strict aseptic conditions, taking particular care when removing the stopper from the vial.
• Before removing the grey safety cap, twist it. This will minimise leakage of the medical device. Use an 18-20 gauge needle.
• To ensure a tight seal and prevent leakage, securely attach the needle while holding the Luer connector firmly during administration.
• When attaching or removing the needle cover, do not overtighten the needle or apply excessive pressure to it as this may cause the syringe tip to break.
• The product should only be administered into the synovial fluid.

Recommended dosage: 1 injection of the entire contents of the pre-filled syringe (6 ml). Depending on the patient’s symptoms, the injection can be repeated after 6 months from the first administration.
Unused Synvisc ONE medical device and its waste should be disposed of in accordance with local regulations. Do not reuse the syringe and/or needle. Reuse of syringes, needles and/or medical device from a used syringe may result in loss of sterility, contamination of the device and/or incomplete treatment. Hylan GF 20 should not be re-sterilized.

Composition
1 ml of hylan GF 20 contains: hylan 8.0 mg (6 ml – 48 mg), sodium chloride 8.5 mg, disodium hydrogen phosphate 0.16 mg, sodium diphosphate monohydrate 0.04 mg, water for injection qs