Medication info

Ruflaj (Sodium Hyaluronate)

Prescription medicationInjections
Ingredient · strength
Sodium Hyaluronate›10mg / 1mL
Manufacturer / importer
(주)중헌제약
Appearance
A colorless, transparent, viscous liquid contained in a glass vial (part of the pre-filled syringe system) sealed with rubber stoppers at both ends.
Packaging
2.5 milliliters/vial X 1 vial
Approval status
Active

MFDS item code 201605565 · Notified 2016.09.20

Summary

Main use
Relief of pain in osteoarthritis of the knee and periarthritis of the shoulder
Who uses it
Adults
Adult dosage
As sodium hyaluronate, administer 25mg intra-articularly once a week for 5 consecutive weeks into the knee joint or shoulder joint (shoulder joint cavity, subacromial bursa, or biceps brachii tendon sheath). The number of administrations may be adjusted accordingly based on symptoms. Since it is administered into the knee joint, it must be performed under strict aseptic technique.

Ingredients

Manufacturer
(주)중헌제약

Efficacy & effects

Relief of pain in osteoarthritis of the knee and periarthritis of the shoulder

  • Osteoarthritis of the knee
  • periarthritis of the shoulder
View approved original text

Osteoarthritis of the knee and periarthritis of the shoulder are inflammatory conditions affecting the knee and shoulder respectively, causing pain and limited mobility. This drug is used to relieve the symptoms of these joint diseases, reduce inflammation, and improve joint function.

Dosage and Administration

Adult dosage

As sodium hyaluronate, administer 25mg intra-articularly once a week for 5 consecutive weeks into the knee joint or shoulder joint (shoulder joint cavity, subacromial bursa, or biceps brachii tendon sheath). The number of administrations may be adjusted accordingly based on symptoms. Since it is administered into the knee joint, it must be performed under strict aseptic technique.

Precautions

This medication should not be used in patients who have had an allergic reaction to this drug or any of its components. It should not be used in cases where there is a skin condition or infection at the injection site since it is administered intra-articularly. Caution is necessary for patients with liver function issues or a history of liver disease before using this drug. Patients with allergies to avian proteins should also avoid this medication. Serious allergic reactions such as shock may occur during use, so any unusual symptoms should prompt immediate cessation of administration and treatment. Swelling around the face or eyes, as well as rash, hives, and itching can occur, so this should be monitored closely. Temporary pain, swelling, redness, warmth, pressure sensation, and bruising may arise at the injection site. Occasionally, symptoms such as nausea, vomiting, fever, and headache may occur. In cases of severe arthritis or severe inflammation, this drug may exacerbate inflammation, so it is advisable to use it only after inflammation has subsided. After injection, stabilizing the injection site and avoiding strenuous movements can be helpful. If the drug leaks outside the joint, pain may occur, so care should be taken regarding the injection site. For patients with rheumatoid arthritis or gout arthritis, temporary exacerbation of inflammation may occur. Avoid intense exercise or prolonged weight-bearing activities within 48 hours after administration. Co-administration with other intra-articular injections is not recommended due to lack of confirmed safety and effectiveness. Women who are pregnant or may become pregnant should use this drug with caution and only when the benefits of treatment outweigh the risks. This drug may be excreted in breast milk, so breastfeeding should be avoided during administration. Safety has not been established in children, so it should be used cautiously only when necessary. Elderly patients may have reduced physical function, hence special care is required. Injections should be performed in a clean environment under aseptic conditions, and it should not be administered more than five times if symptoms do not improve. If there is excessive joint fluid, it is advisable to remove it before injection. Intra-vascular injection is strictly prohibited, and it is not suitable for use in the eye. When injecting, appropriate needle size should be used, and the ampoule should be shaken to evenly distribute the contents before slowly drawing it into the syringe. When cutting the ampoule, it is safest to wipe it with a clean cloth to prevent contamination. Be cautious as precipitation may occur when mixed with specific disinfectants. This drug is for single use only, and any remaining drug should be discarded promptly after opening.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • swelling (facial, eyelid, etc.)
  • shock

Mild side effects

Facial flushing, itching, pain (mainly transient pain after administration), swelling, redness, warmth, severe local pressure sensation, petechiae, nausea, vomiting, fever, headache

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a sealed container to prevent exposure to air, and it is best kept at room temperature between 1 to 30 degrees Celsius. Storing it this way can help maintain the effectiveness of the drug.

Appearance and packaging

Appearance

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

Package unit

2.5 milliliters/vial X 1 vial

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.