Medication info

Hyalex Injection (Sodium Hyaluronate)

Prescription medication
Ingredient · strength
Sodium Hyaluronate›10mg / 1mL
Manufacturer / importer
대우제약(주)
Appearance
A colorless and transparent viscous liquid filled in a glass vial sealed with rubber stoppers at both ends (part of a prefilled syringe system)
Packaging
2.5 milliliters/ampoule [2.5 milliliters × 10, 50, 100 ampoules], 2.5 milliliters/cylinder [2.5 milliliters × 10, 50, 100 cylinders]
Approval status
Active

MFDS item code 201904370 · Notified 2019.06.26

Summary

Main use
Relief of symptoms of osteoarthritis of the knee and shoulder periarthritis
Who uses it
Adults
Adult dosage
As sodium hyaluronate, administer 25mg once a week for 5 consecutive weeks into the intra-articular space of the knee or shoulder (shoulder joint space, subacromial bursa, or biceps tendon sheath). The number of administrations may be adjusted according to symptoms. As it is administered into the knee joint, it should be performed under strict aseptic conditions.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Relief of symptoms of osteoarthritis of the knee and shoulder periarthritis

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

Osteoarthritis of the knee and shoulder periarthritis are chronic conditions around the knee and shoulder joints, respectively. Osteoarthritis of the knee results from damage to the cartilage of the knee joint, causing pain and limited motion, while shoulder periarthritis is inflammation in the shoulder area that leads to pain and restricted movement. Treatment aims to relieve pain and improve joint function, and is therefore used for osteoarthritis of the knee and shoulder periarthritis.

Dosage and Administration

Adult dosage

As sodium hyaluronate, administer 25mg once a week for 5 consecutive weeks into the intra-articular space of the knee or shoulder (shoulder joint space, subacromial bursa, or biceps tendon sheath). The number of administrations may be adjusted according to symptoms. As it is administered into the knee joint, it should be performed under strict aseptic conditions.

Precautions

This medication should not be used in patients who have had an allergic reaction to this drug or its components. As it is administered by direct injection into the joint, it should not be given if there are skin diseases or infections at the injection site. Caution is required for patients with liver dysfunction, as abnormal liver function tests may occur. It is also safe to avoid use in individuals with allergies to avian protein. Severe allergic reactions, such as shock, may occur after administration, so patients should be closely monitored, and if any unusual symptoms appear, administration should be stopped immediately, and appropriate treatment should be provided. Swelling, redness, itching, and rashes may occur around the face or eyes, so if these symptoms are observed, use of the medication should be stopped, and medical assistance should be sought. Temporary pain, swelling, redness, warmth, or tenderness may occur at the injection site. Sometimes symptoms such as nausea, vomiting, fever, or headaches may also occur. For patients with severe inflammatory osteoarthritis, it is advisable to use this medication after the inflammation has subsided, and stabilization of the injection site is necessary post-administration. If the drug leaks outside the joint, it may cause pain, so it is important to inject it accurately within the joint. Patients with rheumatoid arthritis or gouty arthritis should take care as inflammation may temporarily worsen. It is recommended to avoid vigorous exercise or prolonged weight-bearing activities within 48 hours following the injection. Use with other intra-articular injectables is not recommended as safety and efficacy have not been confirmed. Women who are pregnant or may become pregnant should use this medication cautiously as its safety is not well established and only if necessary. Additionally, this medication may be transmitted through breast milk, so breastfeeding should be avoided during administration. Safety has not been established in children, so caution should be exercised and should only be used when necessary. Elderly patients should use this medication carefully as their body functions may be weakened. Injections must be administered strictly into the joint under aseptic conditions, and if symptoms do not improve, administration may be repeated up to five times. If fluid accumulates in the joint, it may need to be drained as needed. This drug should not be used for intra-vascular injection or ophthalmic purposes. Due to its high viscosity, care should be taken in selecting syringes and needles, and after shaking the ampoule to ensure even distribution of the medication, it should be slowly drawn into the syringe. When opening the ampoule, it is advisable to clean and cut it carefully to prevent contamination. Care should be taken as some disinfectants may react and form precipitates. This drug is for single use and any remaining medication should be discarded after opening. Administering a local anesthetic before this medication can aid in pain relief.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Facial erythema
  • itching
  • short-term pain at the injection site
  • swelling
  • redness
  • warmth
  • local tenderness
  • petechiae
  • nausea
  • vomiting
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  • fever
  • headache

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

Storage

Prefilled syringes are contained in sealed containers, and should be stored at a temperature between 1°C and 30°C to maintain the medication's effectiveness safely.

Appearance and packaging

Appearance

A colorless and transparent viscous liquid filled in a glass vial sealed with rubber stoppers at both ends (part of a prefilled syringe system)

Package unit

2.5 milliliters/ampoule [2.5 milliliters × 10, 50, 100 ampoules], 2.5 milliliters/cylinder [2.5 milliliters × 10, 50, 100 cylinders]

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

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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.