Aragan (Sodium Hyaluronate) (Pre-filled)

Adult administration

As sodium hyaluronate, administer 25 mg once a week for 5 consecutive weeks into the knee joint or shoulder joint (shoulder joint cavity, subacromial bursa, or the biceps tendon sheath), but adjust the frequency of administration as appropriate according to symptoms.

This medication should not be used in patients who have had an allergic reaction to this medication or its components. Since this is an injection into the joint, it should not be administered if there are any skin diseases or infections at the injection site. Caution is needed for patients with liver dysfunction or a history of liver disease, as liver function test results may become abnormal. Individuals allergic to avian proteins should not use this medication. Sudden shock symptoms may occur during use, so patients should be closely monitored after administration, and if any abnormal symptoms appear, administration should be immediately stopped, and appropriate treatment should be received. Allergic symptoms such as edema, skin rash, urticaria, and itching may occur; if these symptoms arise, administration should be stopped, and the hospital should be informed. Transient pain, swelling, redness, warmth, severe pressure sensation, or bruising may occur at the injection site, so if any of these symptoms occur, they should be reported to medical personnel. Nausea, vomiting, fever, and headache may rarely occur. If inflammation is severe due to arthritis, it is advisable to reduce inflammation before administering this medication. After administration, it is recommended to stabilize the injection site and avoid excessive movement, and care should be taken to prevent the medication from leaking out of the joint. Patients with rheumatoid arthritis or gouty arthritis may need to be cautious, as inflammation may temporarily worsen. For 48 hours after injection, it is advised to avoid intense activities such as jogging or tennis, or weight-bearing activities for extended periods. The co-administration of other intra-articular injection products has not been confirmed for safety and efficacy, so it is advisable not to use them together. Pregnant women or women who may become pregnant should be cautious, as the safety of this medication is not certain; it should only be used if the benefits of treatment outweigh the risks. Women who are breastfeeding should avoid breastfeeding while using this medication, as it may be passed into breast milk. The safety of this medication has not been established for children, and it should only be used cautiously if absolutely necessary. Elderly patients may have decreased physical function, so considerable care is needed when administering this medication. Aseptic conditions must be strictly maintained during administration, and if there is no effect, administration should be stopped after five injections. If there is a lot of joint fluid present, it is advisable to remove it before the injection. This medication is not suitable for intravenous administration or ophthalmic use. Due to its high viscosity, thick needles should be used when drawing the medication into the syringe, and fine needles should be used for the actual administration. The ampoule should be shaken to allow any medication adhered to the inside to flow down before being slowly injected into the syringe. It is safe to cut the ampoule after disinfecting to prevent foreign substances from entering. Caution is needed as precipitates may form if mixed with certain disinfectants. This medication is for single use only; any unused medication should be discarded after opening. It is preferable to inject this medication after administering a local anesthetic.

Serious side effects

• Urticaria
• edema (severe swelling)
• severe allergic reaction (shock)
• urticaria

Mild side effects

• Edema (facial, eyelid, etc.)
• facial flushing
• rash
• itching
• pain (transient after administration)
• swelling
• redness
• warmth
• severe local pressure sensation
• petechiae

This medication is sensitive to light and should be stored in a sealed container that can block light. It is also important to store the medication at room temperature, specifically between 1 degree and 30 degrees Celsius, to maintain its effectiveness.

Appearance

A pre-filled syringe containing a colorless, transparent, viscous solution, sealed with rubber stoppers at both ends, part of the pre-filled syringe system.

Package unit

For domestic use - 5 pre-filled syringes/box [(2.5 milliliters/pre-filled syringe) × 5], for export - 1 pre-filled syringe/box [(2.5 milliliters/pre-filled syringe) × 1], for export - 5 pre-filled syringes/box [(2.5 milliliters/pre-filled syringe) × 5], for export - 10 pre-filled syringes/box [(2.5 milliliters/pre-filled syringe) × 10]