Synovian Injection (BDDE Cross-Linked Sodium Hyaluronate Gel)

Adult administration

One injection of 1 syringe into the knee joint cavity, but administration should be appropriately adjusted according to symptom severity, considering intervals of at least 6 months. 1 single dose of 3mL (1 prefilled syringe) into the knee joint cavity.

This medication is a sodium hyaluronate gel injected into the joint for the treatment of knee osteoarthritis. It should not be administered to individuals who are allergic to this drug or any of its components, those with infections or severe inflammation in the joint cavity, and those with skin infections or diseases at the injection site. Individuals who are allergic to other medications or have liver function issues or a history of such conditions should use this medication with caution. After administration, symptoms such as pain, redness, swelling, and warmth at the injection site may occur, but these usually resolve naturally within 14 days. Rarely, serious allergic reactions such as shock may occur, so symptoms should be monitored closely after administration, and if abnormal symptoms appear, administration should be stopped immediately and appropriate treatment sought. This medication must be accurately administered into the joint, and strict aseptic procedures must be followed during administration. It is advisable to avoid vigorous exercise or actions that strain the joint for 48 hours after administration, and to stabilize the joint. The safety and efficacy of this medication have not been adequately confirmed for pregnant or breastfeeding women, and children, so its use is not recommended. In elderly patients, decreased physiological function may necessitate special caution during administration. Co-administration of this medication with other intra-articular medications has not been validated for safety and efficacy, so they should not be combined. During administration, the included injection needle must be used, and if packaging or the syringe is damaged, it should not be used. Leftover medication and needles should be disposed of safely, and reuse or re-sterilization is strictly prohibited. This medication should be stored out of reach of children, and storing it in the original container is important for maintaining its quality. If symptoms do not improve, further administration is not advisable.

Serious side effects

• Shock symptoms
• chest pain
• generalized weakness
• dyspnea
• pneumonia
• cardiac arrest
• polyneuropathy
• deep vein thrombosis

Mild side effects

• Pain
• erythema
• swelling
• warmth
• nasopharyngitis
• fever
• upper respiratory infection
• limb pain
• cystitis
• indigestion

This medication should be stored in a sealed container to avoid exposure to air or light. It is also important to store it in a temperature range of 1 to 30 degrees Celsius, away from direct sunlight.

Appearance

A colorless, transparent, and viscous gel contained within a plastic tube (prefilled syringe) sealed with rubber stoppers on both ends.

Package unit

(3.0mL/ prefilled syringe) x 1