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