Hyalbiron Injection (Pre-filled) (Sodium Hyaluronate)

Adult dosage

Administer 25 mg of sodium hyaluronate once a week for 5 consecutive weeks intra-articularly in the knee joint or shoulder joint (shoulder joint cavity, subacromial bursa, or tendon sheath of the long head of the biceps). Increase or decrease the number of administrations appropriately based on symptoms. Ensure strict aseptic technique during intra-articular administration.

This drug should not be administered to certain patients. For example, individuals allergic to this drug or its components should not use it. Moreover, it should not be given if there are skin diseases or infections at the injection site. Patients with liver dysfunction or a history of liver disorders should be cautious, as liver function may worsen with the use of this drug. Those allergic to avian proteins should also avoid this drug. While using this drug, watch carefully for possible side effects. For instance, severe allergic reactions may lead to shock, so treatment should be discontinued immediately and appropriate care should be received if adverse symptoms appear. Symptoms such as swelling of the face or around the eyes, rash, and itching could occur; if these symptoms appear, usage should cease. Temporary pain, swelling, redness, and warmth at the injection site may occur, and bruising may occasionally happen. Symptoms such as nausea, vomiting, fever, and headache may rarely manifest. Administering this drug to joints with severe inflammation may exacerbate the inflammation, so it is advisable to use it after the inflammation has subsided. After administration, it is important to stabilize the joint area and avoid excessive movement. Pain may occur if the drug leaks outside the joint, so it must be injected precisely into the joint. For patients with inflammatory joint diseases like rheumatoid arthritis or gout, there may be a temporary worsening of inflammation, and caution is advised. Avoid vigorous exercise or prolonged weight-bearing activities within 48 hours after administration. The safety and efficacy of using this drug concurrently with other intra-articular injectables has not been established, so it is advisable not to use them together. Women who are pregnant or may become pregnant should use this drug with caution only when the therapeutic benefits are determined to outweigh the risks, as its safety during pregnancy has not been fully established. Additionally, this drug may be transmitted through breast milk, so breastfeeding should be avoided during treatment. The safety of this drug has not been adequately confirmed in children, so it should only be used cautiously when necessary. Elderly patients may have diminished physiological function; therefore, caution should be exercised in their use. Sterile conditions must be strictly maintained during injections, and administration may be continued only up to five times if symptoms do not improve. If fluid has accumulated in the joint, it should be removed prior to administration. This drug should not be used for intravenous injection or for ophthalmic purposes. Due to its viscosity, an appropriate needle should be used during injections, and the solution should be slowly withdrawn from the ampule. It is safe to cut the ampule after thoroughly wiping to prevent contamination. Caution is required as precipitates may form if mixed with certain disinfectants. This drug is for single use; any remaining solution after opening should be discarded, and it is advisable to administer it after local anesthesia.

Serious side effects

Urticaria, swelling (possible severe allergic reaction), shock (severe allergic reaction), severe allergic reaction due to hypersensitivity

Mild side effects

• Facial swelling
• facial redness
• rash
• itching
• pain
• swelling
• edema
• redness
• warmth
• local pressure sensation

This drug should be stored in a sealed container to protect it from air exposure, and the storage temperature should be maintained between 1°C and 30°C to ensure the preservation of its efficacy and safety.

Appearance

A colorless, transparent viscous solution contained in a colorless, transparent glass vial sealed with rubber stoppers at both ends (part of the pre-filled syringe system).

Package unit

2.5 milliliters × 10, 50, 100 vials