May 24, 2016
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Hyalgan

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Hyalgan




Warnings
Precautions

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® injection in some patients with inflammatory arthritis such as rheumatoid arthritis or gouty arthritis have been reported.
  • Patients should be carefully examined prior to administration to determine signs of acute inflammation, and the physician should evaluate whether Hyalgan® treatment should be initiated when objective signs of inflammation are present.

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® 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 to avoid infections in the injection site.
  • Remove joint effusion, if present, before injecting Hyalgan®.
  • STERILE CONTENTS. The vial/syringe is intended for single use. The contents of the vial/syringe 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° ). DO NOT FREEZE.

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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/15/2016

Warnings
Precautions

Hyalgan - User Reviews

Hyalgan User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Hyalgan sorted by most helpful. Patient Discussions FAQs

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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