• Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronic acid can precipitate in their presence.
• Anaphylactoid and allergic reactions have been reported with this product. See Adverse Events Section for more detail.
• Transient increases in inflammation in the injected knee following Hyalgan® injection in some patients with inflammatory arthritis such as rheumatoid arthritis or gouty arthritis have been reported.

General

• The effectiveness of a single treatment cycle of less than 3 injections has not been established.
• The safety and effectiveness of the use of Hyalgan® in joints other than the knee have not been established.
• The safety and effectiveness of the use of Hyalgan® concomitantly with other intra-articular injectables have not been established.
• Use caution when injecting Hyalgan® into patients who are allergic to avian proteins, feathers, and egg products.
• Strict aseptic administration technique must be followed.
• STERILE CONTENTS. The vial/syringe is intended for single use. The contents of the vial must be used immediately once the container has been opened. Discard any unused Hyalgan®.
• Do not use Hyalgan® if the package is opened or damaged. Store in the original packaging (protected from light) below 77° F (25° C). DO NOT FREEZE.
• Remove joint effusion, if present, before injecting Hyalgan®.

Information for Patients

• Provide patients with a copy of the Patient Information prior to use.
• Transient pain and/or swelling of the injected joint may occur after intra-articular injection of Hyalgan®.
• As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing activities such as jogging or tennis within 48 hours following the intra-articular injection.

Use in Specific Populations

• Pregnancy: Teratogenic Effects Reproductive toxicity studies, including multigeneration studies, have been performed in rats and rabbits at doses up to 11 times the anticipated human dose (1.43 mg/kg per treatment cycle) and have revealed no evidence of impaired fertility or harm to the experimental animal fetus due to intra-articular injections of Hyalgan®. Animal reproduction studies are not always predictive of human response. The safety and effectiveness of Hyalgan® have not been established in pregnant women.
• Nursing Mothers: It is not known if Hyalgan® is excreted in human milk. The safety and effectiveness of Hyalgan® have not been established in lactating women.
• Pediatrics: The safety and effectiveness of Hyalgan® have not been demonstrated in children.

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