Synovialin L-Pre-filled Injection (BDDE Cross-Linked Hyaluronic Acid Sodium Gel)

Adult dosage

1 dose, administer 1 syringe into the knee joint cavity. Adjust the dosing interval according to symptoms to be appropriate for at least 6 months.

This medication should not be administered to certain patients. First, patients who have had an allergic reaction to this medication or its components should not use it. Additionally, it should not be used in joint areas with infection or severe inflammation, or in cases of skin infection or skin disease. Patients with a history of allergy to other medications or with liver dysfunction or a history of liver disease should use this medication cautiously. Severe shock symptoms may occur infrequently during administration of this medication; thus, the patient's condition should be closely monitored during the administration, and if abnormalities are observed, administration should be stopped immediately and appropriate treatment should be provided. Symptoms such as pain, redness, swelling, and warmth may commonly occur at the injection site and usually resolve naturally within 2 weeks. However, if symptoms persist for more than 7 days, careful observation is necessary. Various side effects such as nasopharyngitis, fever, upper respiratory tract infections, myalgia, and dyspepsia have been reported among patients who received this medication. Most are mild or moderate, but if symptoms persist or worsen, medical consultation is advised. If this medication is administered to an inflamed joint, the inflammatory symptoms may worsen; therefore, it is recommended that it be used after the inflammation has subsided. For 48 hours after administration, vigorous exercise or excessive activity should be avoided to prevent stressing the joint, and it is necessary to stabilize the joint. This medication must be precisely administered into the joint cavity, as leaking into the surrounding areas may cause pain, so caution is required. Administration should be performed safely under sterile conditions by experienced medical personnel, and reused or non-sterile syringes should not be used. The safety and effectiveness of this medication when used with other intra-articular injectables have not been established, so it is advisable not to combine them. Pregnant or breastfeeding women should not be administered this medication as its safety has not been established. It is also advisable not to use this medication in children, as its safety and effectiveness have not been confirmed. Elderly patients may require caution when administered due to physiological declines, although no significant differences have been found between elderly patients and the general adult population in clinical trials. Careful aseptic technique should be practiced during administration, and if there is fluid accumulation in the joint, it should be removed prior to administration. Administration should not be performed in vascular or extra-articular tissues, and the injection site should be sanitized with alcohol or similar disinfectants before administration. Any remaining medication, syringes, needles, etc., should be disposed of safely, and separate needles should be used for each knee if administered in both knees. If symptoms do not improve, re-administration is not recommended. This medication should be stored out of reach of children and kept in its original container to avoid misuse or deterioration of quality.

Serious side effects

• Shock symptoms
• chest pain
• systemic weakness
• shortness of breath
• pneumonia
• cardiac arrest
• hypotension
• polyneuropathy
• deep vein thrombosis
• ovarian malignancy

Mild side effects

• Pain at the injection site
• erythema
• swelling
• warmth
• nasopharyngitis
• fever
• upper respiratory tract infection
• limb pain
• cystitis
• dyspepsia

This medication should be stored in a sealed container to prevent exposure to air and light. It is also recommended to store it at a temperature between 1 degree Celsius and 30 degrees Celsius.

Appearance

A colorless, transparent, and viscous gel contained within a colorless transparent glass or plastic vessel (pre-filled syringe), sealed at the top and bottom with rubber caps.

Package unit

3.0 milliliters/pre-filled syringe[x 1]