Monovisc

WARNINGS

  • Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation as hyaluronan can precipitate in their presence.
  • Transient increases in inflammation in the injected knee following Monovisc™ injection have been reported in some patients with inflammatory osteoarthritis.

PRECAUTIONS

General

  • Strict aseptic injection technique should be used during the application of Monovisc™.
  • The safety and effectiveness of the use of Monovisc™ in joints other than the knee have not been demonstrated.
  • The effectiveness of Monovisc™ 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 Monovisc™. Do not resterilize.
  • Do not use Monovisc™ if the package has been opened or damaged.
  • Store Monovisc™ in its original package at room temperature (below 77°F/25°C). DO NOT FREEZE.
  • Remove joint effusion, if present, before injecting Monovisc™.
  • Only medical professionals trained in accepted injection techniques for delivering agents into the knee joint should inject Monovisc™ for the indicated use.

Information for Patients

  • 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 or prolonged (i.e., more than one hour) weight-bearing activities such as running or tennis within 48 hours following the intra-articular injection.

Use In Specific Populations

Pregnancy

The safety and effectiveness of the use of Monovisc™ in pregnant women has not been tested.

Nursing Mothers

It is not known if Monovisc™ is excreted in human milk. The safety and effectiveness of the use of the product in lactating women has not been tested.

Pediatrics

The safety and effectiveness of the use of Monovisc™ in pediatric patients ( ≤ 21 years of age) has not been tested.

Last reviewed on RxList: 3/21/2014
This monograph has been modified to include the generic and brand name in many instances.

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