Hyalgan 20 mg/2 ml 1 pre-filled syringe for intra‑articular injection

Hyalgan 20 mg/2 ml 1 pre-filled syringe for intra‑articular injection

Composition:

2 ml syringe contains sodium hyaluronate 20 mg. 
Excipients:
sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injection up to 2 ml.

Product Description:

• Hyaluronic acid is a major component of articular cartilage and synovial fluid.
• Endogenous hyaluronic acid provides viscosity and elasticity of synovial fluid and is essential for proteoglycan formation in cartilage. 
• By normalizing synovial fluid quality and stimulating tissue renewal, Hyalgan improves joint function. 
• It has anti‑inflammatory effects on the synovial epithelium and stimulates natural hyaluronic acid production inside the joint.

Indications for Use:

Mild to moderate knee osteoarthritis.

Method of Administration and Dosage:

Adults: 2 ml (20 mg) intra‑articular injection once weekly for 5 weeks, or as directed by the physician.

Contraindications:

Hypersensitivity to components.
History of allergy to avian proteins.
Severe liver dysfunction.
Intra‑articular injections contraindicated in case of infection or skin disease at injection site.

Precautions:

• Do not use disinfectants containing quaternary ammonium salts, as precipitation may occur.
• Injections must be performed by qualified medical professionals under aseptic conditions. 
• Patients should be examined for acute inflammation before injection. 
• Transient worsening of inflammation may occur in rheumatoid or gouty arthritis. 
• Aspiration of effusion is recommended before injection. 
• Avoid overloading the joint for several hours post‑injection.

Adverse Reactions / Side Effects:

• Injection site reactions: discomfort, pain, swelling, redness, rash, nodules, vesicles, hemorrhage, stiffness, synovitis, effusion.
• Usually resolve within days with rest and ice. 
• Rare prolonged reactions. 
• Hypersensitivity: rash, itching, angioedema, eczema, urticaria, very rare anaphylaxis (non‑fatal). 
• Serum sickness, fever, headache, paresthesia. 
• In rare cases, worsening of chronic inflammation.

Pregnancy and Lactation:

Use only if clearly indicated and under medical supervision.

Storage Conditions:

• Store at ≤25 °C in a dry, cool place.
• Do not freeze.
• Transportation Conditions:
  - For safe transportation of Hyalgan, maintain strict temperature control between 5 °C and 25 °C. 
  - The main task is to protect the solution from overheating in summer and freezing in winter. 
  - Use a thermal bag or container with cold packs, especially in hot weather. 
  - Isolate the package from direct contact with cold packs using fabric or bubble wrap to prevent freezing. 
  - Do not leave the product in a car, as temperatures quickly exceed safe limits. 
  - Carry in hand luggage during flights, since cargo hold temperatures may drop below zero. 
  - Keep in the original box to protect the syringe from mechanical damage and light.

Packaging:

Carton box containing one 2 ml colorless glass syringe and a paper leaflet.