Viscoelastic Gel for Intra-Articular Injection

ArtroSupp is a sterile, biodegradable, viscoelastic and non-pyrogenic solution of purified high molecular weight (2.1-2.4 million daltons) sodium hyaluronate in phosphate buffered saline.

Highly purified sodium hyaluronate is obtained by bacterial fermentation. Sodium hyaluronate (hyaluronic acid sodium salt), a natural polymer of the glycosaminoglycan family, is a mucopolysaccharide composed of disaccharide units consisting of repeating units of N-acetylglucosamine and glucuronate linked by β → 1,3 and β → 1,4 glycosidic acids.

Sodium hyaluronate is available in concentrations of 10 mg/ml, 16 mg/ml, 20 mg/ml, and 25 mg/ml in phosphate-buffered saline. Sterile Sodium Hyaluronate Gel has a pH range of 6.8-7.8, similar to synovial fluid, and an osmolality of 270 to 400 mOsm/kg. The gel is available in pre-filled 2 ml and 3 ml syringes. Each pre-filled syringe is packaged in a sterile individual pack.

Purpose of Use

ArtroSupp is used to reduce pain associated with osteoarthritis in joints by supporting synovial fluid and restoring its viscoelastic properties via intra-articular injection. It increases joint mobility by reducing or eliminating pain.

Instructions for Use

Strict aseptic administration technique should be followed when performing intra-articular injection.

Remove the joint effusion before injecting ArtroSupp; the same needle should be used for effusion removal and ArtroSupp injection.

Carefully remove the protective cap from the syringe.

Tightly screw the needle, which is between 18G and 22G in diameter, onto the Luer lock. To ensure a tight seal and prevent leakage during administration, firmly secure the needle while holding the Luer hub firmly. Do not overtighten or use excessive force when attaching the needle or removing the needle guard, as this may cause the syringe tip to break.

Before injection, the area should be disinfected with a suitable disinfectant.

ArtroSupp gel is then injected into the joint.

Dosage and Administration

ArtroSupp should only be administered by a physician for intra-articular injection therapy. Remove the Luer lock cap from the pre-filled syringe and thread a suitable sterile sharp-tipped needle onto the Luer lock. Use a needle of the appropriate diameter and length, depending on the joint to be treated. Disposable needles are recommended. Remove any air bubbles from the syringe before injection.

Application times vary depending on the concentration of the products. Depending on joint size, 2 mL or 3 mL injections may be administered 1, 3, or 5 times. The beneficial effects of 1, 3, or 5 consecutive treatments persist for at least 6 months.

Multiple joints can be treated simultaneously and treatment cycles can be repeated.

In case of effusion accompanied by severe pain:

First, the patient is monitored. In many patients, the condition resolves spontaneously without any intervention. If deemed necessary, a joint puncture is performed to attempt to drain the product. Or, two needles are punctured into the joint space. One needle injects fluid (physiological saline) and the other needle attempts to flush the joint space. Strict aseptic technique must be followed during these procedures, as outlined in the "Instructions for Use" section.

NOTE : It is recommended to place an ice pack on the treated joint for 5-10 minutes to prevent pain and swelling.