Hyalic^®

Sodium Hyaluronate

20mg/2mL in one pre-filled syringe

COMPOSITION:

Active ingredient: Sodium Hyaluronate 20mg

Excipients: Sodium chloride, Monobasic sodium phosphate dihydrate, Dibasic sodium phosphate dodecahydrate, Water for injection q.s. to 2 mL.

THERAPEUTIC CLASS:

Hyaluronanand derivatives

INDICATIONS:

-Pain associated osteoarthritis of the knee in patients who have failed to respond adequately to conservative non pharmacologic therapy and to simple analgesic. The intra-articular administration of Sodium Hyaluronate into arthritic joints improves joint function, due to the normalization of synovial fluid viscoelasticity.

-Traumatic and degenerative joint disease.

-Adjuvant in orthopaedic surgery.

DOSAGE:

Inject 2mL into affected knee once a week for a total of 3-5 injection or as directed by the physician.

ADMINISTRATION:

Intra-articular route

Use contents of pre-filled syringe immediately after opening, discard any unused solution.

CONTRAINDICATION:

-Intra-articular injection with presence of infections or skin diseases in the area of the injection site.

-Individual hypersensitivity to the product.

WARNINGS/PRECAUTIONS:

It is essential to use a correct technique of intra-articular injection in accurately aseptic conditions.

Keep out of reach of children.

If you have severe hypersensitivity to hyaluronateproducts, consult with your physician.

Do not administer Hyalic^®If you notice acute inflammation of the inflammation before injection, such as inflammation in patients with rheumatoid arthritis, refractory injection.

PREGNANCY AND LACTATION:

SafetyHyalic^®have not been established in pregnant and lactating womwn.

ADVERSE REACTIONS:

Injection-site pain, knee swelling/effusion, local skin reactions pruritus.

PATIENT COUNSELING:

The transient pain/swelling of injected joint may occur after injection. Avoid strenuous activities or prolonged (<1 hr) weight-bearing activities (eg, jigging, tennis) within 48 hrs following therapy.

STORAGE:

Store below25˚C (77˚F). Protect from light. Do not freeze. Discard any unused portions.

Keep out of reach of children.