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Hyalgan

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Hyalgan

Hyalgan

WARNINGS

  • 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® (hyaluronate) injection in some patients with inflammatory arthritis such as rheumatoid arthritis or gouty arthritis have been reported.

PRECAUTIONS

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® (hyaluronate) in joints other than the knee have not been established.
  • he safety and effectiveness of the use of Hyalgan® (hyaluronate) concomitantly with other intra-articular injectables have not been established.
  • Use caution when injecting Hyalgan® (hyaluronate) 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® (hyaluronate) .
  • Do not use Hyalgan® (hyaluronate) 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® (hyaluronate) .

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® (hyaluronate) .
  • 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® (hyaluronate) . Animal reproduction studies are not always predictive of human response. The safety and effectiveness of Hyalgan® (hyaluronate) have not been established in pregnant women.
  • Nursing Mothers: It is not known if Hyalgan® (hyaluronate) is excreted in human milk. The safety and effectiveness of Hyalgan® (hyaluronate) have not been established in lactating women.
  •  Pediatrics: The safety and effectiveness of Hyalgan (hyaluronate) ® have not been demonstrated in children.

Last reviewed on RxList: 12/15/2008
This monograph has been modified to include the generic and brand name in many instances.

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Hyalgan - User Reviews

Hyalgan User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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