Precautions
Those precautions normally considered during injection of substances into joints are recommended. Only individuals familiar with accepted injection techniques for delivering agents to joint spaces should inject sodium hyaluronate for this application. An excess quantity of sodium hyaluronate is not to be used and the patient should be monitored closely. If pain increases during the injection procedure, the injection should be stopped and the needle withdrawn. The space should not be overfilled.
Supplied
Each mL of sterile viscoelastic preparation contains: sodium hyaluronate 15 mg adjusted to 20 000-70 000 centistokes, sodium chloride 9 mg and sterile water for injection USP q.s. Osmolality: approximately 340 mOsm. Disposable glass syringes delivering 2 mL, appropriate for the knee, of sodium hyaluronate dissolved in physiological saline. Contents of unopened and undamaged syringe are sterile. Refrigerated OrthoVisc should be allowed to reach room temperature, approximately 20 to 45 minutes, prior to use. For intra-articular use. Store between 2 and 25°C. Protect from freezing.
Contraindications
At the present time there are no known contraindications to the use of OrthoVisc when used in the symptomatic treatment of joint disease.
OrthoVisc may contain trace quantities of gram positive bacterial proteins and is contraindicated for patients with a history of such allergies. There are minimal risks associated with the procedure of injecting substances into joints in general; primarily infection and bleeding. Pre-existing infections of the skin in the region of the intended injection or known systemic bleeding disorders may constitute relative or absolute contraindications.
Adverse Effects
Sodium hyaluronate is a natural component of the tissues in the body. OrthoVisc is thoroughly tested to determine that each batch is non-inflammatory. Adverse events reported in clinical trials have included mild or moderate reactions at the site of the injection. Based upon clinical studies, these reactions have occurred with a similar incidence in patients treated with saline injections. There is no evidence which attributes reactions to be specifically related to the product.
Indications
OrthoVisc is indicated for the symptomatic treatment of osteoarthritis of the knee.
Description
Sodium hyaluronate is a high molecular weight polysaccharide composed of sodium glucuronate and N-acetylglucosamine. Sodium hyaluronate is ubiquitously distributed throughout the tissues of the body and is present in high concentrations in such tissues as vitreous humor, synovial fluid, umbilical cord and dermis. Sodium hyaluronate functions as a tissue lubricant and is thought to play an important role in modulating the interactions between adjacent tissues. It can also act as a viscoelastic support maintaining a separation between tissues. Different sodium hyaluronate preparations may have different molecular weights, but are thought to have the same chemical structure. The sodium hyaluronate in OrthoVisc has an average molecular weight greater than one million. OrthoVisc is non-inflammatory, is non-pyrogenic and is well tolerated. Sodium hyaluronate has been shown to be non-antigenic. OrthoVisc does not interfere with normal wound healing processes.
Dosage
OrthoVisc is injected by intra-articular injection one week apart for a total of three injections. The required amount of OrthoVisc is slowly infused through a sterile hypodermic needle of suitable gauge into the selected joint space. A plastic-hubbed needle is recommended.
The volume will vary depending upon the size of the joint space, not to exceed 2 mL for the knee.
Do not overfill the joint space.
Overdose
For management of a suspected drug overdose, CPhA recommends that you contact your regional Poison Control Centre. See the eCPS Directories section for a list of Poison Control Centres.
