Medication info

Hyaluronic Acid One-Stop Injection (BDDE Cross-linked Sodium Hyaluronate Gel) (Pre-filled)

Prescription medicationInjections
Ingredient · strength
BDDE Cross Linked Sodium Hyaluronate Gel›3g / 1 prefilled syringe
Manufacturer / importer
이연제약(주)
Appearance
A colorless, transparent, and viscous gel contained in a colorless transparent glass or plastic tube (pre-filled syringe) sealed with rubber caps at both ends.
Packaging
(3.0mL/ Pre-filled Syringe) x 1
Approval status
Active

MFDS item code 202501209 · Approved 2025.05.16 · Insurance code 658604901

Summary

Main use
Relief of symptoms of knee osteoarthritis
Who uses it
Adults
Adult dosage
1 dose, 1 syringe injected into the knee joint, but the administration interval should be considered based on symptoms (at least 6 months).

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Relief of symptoms of knee osteoarthritis

  • Symptoms of knee osteoarthritis
View approved original text

Knee osteoarthritis is a condition mainly caused by damage to the cartilage of the knee joint, leading to pain and restriction of movement. This medication is used to relieve the symptoms of knee osteoarthritis and improve joint function.

Dosage and Administration

Adult dosage

1 dose, 1 syringe injected into the knee joint, but the administration interval should be considered based on symptoms (at least 6 months).

Precautions

This medication should not be used in patients with an allergy to this medication or its components. It should not be administered in cases of infection or severe inflammation at the injection site. It is also not to be used if there is skin infection or skin disease at the injection site. Patients with a history of allergic reactions to other medications should use this medication with caution. Patients with liver dysfunction or a history of liver disorders should be careful as well. During the administration of this medication, severe allergic reactions such as shock may occur, so symptoms should be closely monitored. If any abnormal signs occur, administration should be stopped immediately and appropriate treatment should be received. Common reactions at the injection site include pain, redness, swelling, and warmth, but most will resolve naturally over time. For joints with severe inflammation, it is advisable to reduce inflammation before administering this medication. Intense exercise or activities that strain the joint should be avoided for 48 hours after administration, and measures to stabilize the joint are desirable. This medication must be injected accurately into the joint, as it can cause pain if it leaks outside the joint. Administration should be performed by experienced medical personnel under aseptic conditions. The safety and efficacy of using this medication in conjunction with other intra-articular injectable drugs have not been confirmed, so it should not be combined. Pregnant or breastfeeding women are not recommended to use this medication as its safety has not been established. It is also not recommended for children as its safety and efficacy have not been established. Elderly patients may have diminished physiological function, so caution is necessary during administration; however, it is generally known that there is not a large difference in drug response between elderly and younger populations. This medication should be administered into the knee joint under aseptic technique, and if there is a large amount of joint fluid, it should be aspirated before administration. It should not be administered intravascularly, outside the joint, or into lubricating tissues. During administration, the enclosed syringe needle must be used, and care should be taken as it may react with disinfectants and cause precipitation. This medication is for single use and should not be reused or re-sterilized. If the packaging or syringe is damaged, it should not be used. The injection site should be thoroughly disinfected with alcohol or similar agents before administration, and any remaining medication and used syringes should be disposed of safely. When administering to both knees, different needles should be used for each. If symptoms do not improve, it is advisable not to re-administer the medication. Store out of reach of children and keep in the original container to maintain the quality of the medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme drowsiness throughout the body, sudden and severe headache, thunderclap headache, seizures, consciousness disturbances, visual abnormalities, paralysis, urination.

Mild side effects

  • Pain
  • erythema
  • swelling
  • warmth
  • nasopharyngitis
  • fever
  • upper respiratory tract infection
  • limb pain
  • cystitis
  • dyspepsia
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  • sensory disturbance
  • musculoskeletal pain
  • plantar fasciitis
  • cataracts
  • enteritis
  • injection site hematoma
  • bronchitis
  • femoral neck fracture
  • ligament sprain
  • increased levels of CPK in blood
  • diabetes
  • hyperlipidemia
  • joint pain
  • low back pain
  • joint stiffness
  • osteoarthritis
  • bursitis
  • dizziness
  • headache
  • allergic rhinitis
  • allergies.

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

Storage

This medication should be stored in a container that can block light and is best kept at room temperature between 1°C and 30°C. Additionally, care should be taken to ensure that the container is sealed tightly to prevent air and moisture ingress when using the medication.

Appearance and packaging

Appearance

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

Package unit

(3.0mL/ Pre-filled Syringe) x 1

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

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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.