Hyruan ONE BDDE-Crosslinked Sodium Hyaluronate Injection

1. Indications and Usage
Osteoarthritis (OA) of the Knee:
Treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen, NSAIDs).
2. Dosage and Administration
Route of Administration:
For Intra-articular Injection ONLY (must be injected directly into the joint space).
Note: Strict aseptic technique is required.
Recommended Dosage:
Standard Course: One injection (typically 3 mL containing 60 mg of hyaluronate) once weekly for 3 consecutive weeks.
Alternative Regimen: Depending on the specific brand formulation, a single injection regimen may be approved if clinically indicated.
Administration:
Ensure the needle is within the joint cavity before injecting.
If there is significant joint effusion (fluid accumulation), aspiration of the fluid should be performed prior to injection.
3. Mechanism of Action
Viscosupplementation:
The drug acts as a temporary substitute and supplement for natural synovial fluid.
BDDE Cross-linking Technology:
Unlike non-crosslinked HA which is rapidly degraded by hyaluronidase in the joint, BDDE creates chemical bonds between HA molecules to form a 3D network structure.
Benefit: This significantly increases resistance to enzymatic degradation, prolonging the residence time and half-life of the drug within the joint cavity.
Therapeutic Effects:
Restores the viscoelasticity of the synovial fluid, providing lubrication to reduce friction, cushioning mechanical shock, and suppressing inflammatory mediators to relieve pain.
4. Safety and Warnings
Contraindications:
Patients with a known hypersensitivity to hyaluronan preparations or any excipients.
Patients with intra-articular infections or skin diseases/infections at the injection site.
Warnings:
Aseptic Technique: Failure to use strict sterile technique may result in serious intra-articular infection (septic arthritis).
Injection Site Reactions: Transient pain, swelling, or warmth may occur immediately after injection.
5.Adverse Reactions
Most Common:
Injection site reactions are the primary adverse events, including:
Pain (arthralgia)
Swelling (effusion)
Erythema (redness)
Warmth at the injection site
These symptoms are usually mild to moderate and resolve spontaneously within a few days to two weeks.
6.Drug Interactions
Chemical Precipitation:
This preparation may form a precipitate if mixed with disinfectants containing quaternary ammonium salts (e.g., Benzalkonium chloride) or Chlorhexidine.
Action: The injection site must be thoroughly flushed with sterile saline after disinfection if such agents are used.
Concurrent Therapy:
Not recommended to be mixed with other intra-articular injectable drugs.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: BDDE-Crosslinked Sodium Hyaluronate.
Concentration: Typically 20 mg/mL (Total 60 mg/3 mL).
Appearance: Clear, colorless to slightly yellow, viscous sterile liquid.
Storage: Store below 30°C. Do not freeze. Keep in the original package to protect from light.