Hyaluroneal Prefilled Injection (BDDE Cross-Linked Sodium Hyaluronate Gel)

Adult dosage

Administer 1 syringe into the intra-articular space of the knee. Depending on symptoms, the dosage interval should be appropriately considered to be at least 6 months apart.

This medication should not be administered to patients who have had allergic reactions to this medication or its ingredients. It is also advisable not to administer this medication if there is an infection or severe inflammation at the joint area, or if there is a skin infection or disease at the injection site. Patients who have experienced allergic reactions to other medications, have liver function problems, or have a history of liver disease should exercise caution when using this medication. Rarely, serious allergic reactions such as shock may occur after administration, so if any abnormal symptoms occur during administration, it should be immediately stopped, and appropriate treatment should be sought. At the injection site, symptoms such as pain, redness, swelling, and warmth are common, and these usually resolve naturally within 2 weeks. When using this medication, it is crucial to inject it accurately into the joint, ensuring that the medication does not leak out of the injection site. One should avoid intense physical activity that puts strain on the joint for at least 48 hours after administration, and stabilizing the joint is recommended. This medication must be administered by experienced healthcare professionals in a sterile environment safely. The safety and efficacy of co-administration with other intra-articular injections have not been confirmed, so it is advisable not to use them together. The medication is not recommended for use in pregnant or breastfeeding women, and its safety and efficacy have not been established in children. For elderly patients, careful observation is required as physiological functions may be diminished. This medication is for intra-articular use only and should not be injected into blood vessels or surrounding soft tissue. Before use, the injection site should be cleaned with alcohol or similar substances, and used syringes or needles should be disposed of without reuse. Do not use if packaging or syringes are damaged, and store in a safe place out of reach of children. If symptoms do not improve, it is advisable not to re-administer this medication. The long-term safety and efficacy of this medication have not been confirmed, so it is best to use it for the specified duration.

Serious side effects

Urticaria, shock symptoms, severe allergic reactions, difficulty breathing, pneumonia, chest pain, cardiac arrest, hypotension, polyneuropathy, deep vein thrombosis, suspected jaundice symptoms (yellowing of skin or eyes), severe skin adverse reactions, severe neurological symptoms, severe edema or urinary abnormalities

Mild side effects

• Pain at the injection site
• redness
• swelling
• warmth
• nasopharyngitis
• fever
• upper respiratory infection
• limb pain
• cystitis
• indigestion

This medication is sensitive to light, so it should be stored in a dark place, ideally at a temperature between 1 and 30 degrees Celsius. It should also be stored in a sealed container to prevent air or moisture from entering.

Appearance

A colorless, transparent, viscous gel contained in a colorless, transparent glass or plastic syringe (pre-filled syringe) sealed at both ends with rubber stoppers.

Package unit

(3.0mL/pre-filled syringe)×1