ORTHOVISC®

• Strict aseptic injection technique should be used during the application of ORTHOVISC®.
• The safety and effectiveness of the use of ORTHOVISC® in joints other than the knee have not been demonstrated.
• The effectiveness of a single treatment cycle of less than 3 injections has not been established. Pain relief may not be seen until after the third injection.
• The effectiveness of ORTHOVISC® has not been established for more than one course of treatment.
• STERILE CONTENTS. The pre-filled syringe is intended for single use only. The contents of the syringe should be used immediately after opening. Discard any unused ORTHOVISC®. Do not resterilize.
• Do not use ORTHOVISC® if the package has been opened or damaged.
• Store ORTHOVISC® in its original package at room temperature (below 77°F/25°C). DO NOT FREEZE.
• Remove joint effusion, if present, before injecting ORTHOVISC®.
• Only medical professionals trained in accepted injection techniques for delivering agents into the knee joint should inject ORTHOVISC® for the indicated use.

ORTHOVISC® is indicated in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen.

ORTHOVISC® is supplied as a sterile-filled solution, in a single-use syringe, sealed in a sterile pouch inside a carton. The product is presented as a sterile, non-pyrogenic solution in a 3 mL syringe. Each syringe is labeled “ORTHOVISC®” for ready identification. A rubber cap is provided on the syringe tip to prevent leakage and protect sterility of the product. The ORTHOVISC® syringe components contain no latex.

1. ORTHOVISC® is injected into the knee joint in a series of intra-articular injections one week apart for a total of three or four injections. Standard intra-articular injection site preparation, aseptic technique and precautions should be used. Do not concomitantly use disinfectants containing quarternary ammonium salts for skin preparation as hyaluronic acid can precipitate in their presence.
2. After removal of the protective rubber cap on the tip of the syringe, securely attach a small gauge needle (18-21 gauge) to the tip.
3. Inject ORTHOVISC® into the knee joint using proper injection technique.
4. Inject the full contents of the syringe into one knee only.
5. If treatment is bilateral, a separate syringe should be used for each knee.
6. If symptoms return, repeat courses of ORTHOVISC® may be administered.

Contraindications

• Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations.
• Do not administer to patients with known hypersensitivity (allergy) to gram positive bacterial proteins.
• Do not inject ORTHOVISC® in the knees of patients with infections or skin diseases in the area of the injection site or joint.

After-care

• Transient pain or swelling may occur after the intra-articular (IA) injection.
• As with any invasive joint procedure, it is recommended that patients avoid strenuous activity or prolonged (i.e., more than one hour) weight-bearing activities such as running or tennis within 48 hours following the intra-articular injection.