Hyalone Alpha Injection (BDDE Cross-linked Sodium Hyaluronate Gel) (Pre-filled)

Adult dosage

Adults: Administer 1 syringe (1 dose) into the knee joint, but administer appropriately considering the interval between doses (at least 6 months) based on symptoms.

This medication should not be administered to patients who have had allergic reactions to this drug or its components. If there is an infection or significant inflammation in the joint, administering this medication could worsen the symptoms and should be avoided. It is also advisable not to use this drug in patients with infections or skin diseases at the injection site. Patients with a history of allergic reactions to other medications or those with poor liver function or a history of liver disease should use this medication with caution. This medication may commonly cause side effects such as pain, redness, swelling, and warmth at the injection site, most of which will resolve naturally within 2 weeks. Rarely, serious allergic reactions such as shock may occur, so symptoms should be monitored closely after administration. For 48 hours after administering this medication, it is advisable to avoid strenuous activities that put stress on the joint and to stabilize the joint. If the medication leaks outside the joint, pain may occur, so it must be administered accurately within the joint cavity. This medication should only be administered by skilled medical professionals in an aseptic environment, and the syringes and needles used should be disposable and not reused. It is recommended not to use this medication in pregnant or breastfeeding women and children, as its safety and efficacy have not been established in these populations. Elderly patients should use this medication with caution due to decreased physiological functions; however, clinical trials have not shown significant differences between elderly patients and younger adults. The safety and efficacy of this medication have not been established when used with other intra-articular injectables, so co-administration is not recommended. Pre-injection drainage of excess joint fluid is preferred, and it should not be injected into blood vessels or tissues outside the joint. Any remaining medication or needles after injection should be disposed of safely, and different needles should be used for injections into both knees. If symptoms do not improve, re-administration is not recommended. Keep this medication out of the reach of children and store it in its original container to prevent misuse or degradation of quality.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

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

This medication is sensitive to light; therefore, it should be stored in a place protected from light. The storage temperature should be between 1 to 30 degrees Celsius and it should be kept in a sealed container until use.

Appearance

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

Package unit

(3.0 mL/pre-filled syringe) × 1