Synvisc-One

Warnings
Precautions

WARNINGS

  • Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.
  • Do not inject Synvisc-One (hylan g-f 20 single intra-articular injection) extra-articularly or into the synovial tissues and capsule.
  • Intravascular injections of Synvisc-One (hylan g-f 20 single intra-articular injection) may cause systemic adverse events.

PRECAUTIONS

General

  • The safety and efficacy of Synvisc-One (hylan g-f 20 single intra-articular injection) in locations other than the knee and for conditions other than osteoarthritis have not been established.
  • The safety and effectiveness of the use of Synvisc-One (hylan g-f 20 single intra-articular injection) concomitantly with other intra-articular injectables have not been established.
  • Use caution when injecting Synvisc-One (hylan g-f 20 single intra-articular injection) into patients who are allergic to avian proteins, feathers or egg products.
  • The safety and efficacy of Synvisc-One (hylan g-f 20 single intra-articular injection) in severely inflamed knee joints have not been established.
  • Strict aseptic administration technique must be followed.
  • STERILE CONTENTS. The syringe is intended for single use. The contents of the syringe must be used immediately after its packaging is opened. Discard any unused Synvisc-One (hylan g-f 20 single intra-articular injection) .
  • Do not use Synvisc-One (hylan g-f 20 single intra-articular injection) if package is opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.
  • Remove any synovial fluid or effusion before injecting Synvisc-One (hylan g-f 20 single intra-articular injection) .
  • Synvisc-One (hylan g-f 20 single intra-articular injection) should be used with caution when there is evidence of lymphatic or venous stasis in the leg to be injected.

Information for Patients

  • Provide patients with a copy of the Patient Labeling prior to use.
  • Mild to moderate pain, swelling and/or effusion of the injected knee have been reported in clinical trials that were related to intra-articular injection of Synvisc-One (hylan g-f 20 single intra-articular injection) . These events were typically transient and usually resolved on their own or with conservative treatment.
  • As with any invasive joint procedure, it is recommended that the patient avoid strenuous activities (for example, high-impact sports such as soccer, tennis or jogging) or prolonged weightbearing activities for approximately 48 hours following the intraarticular injection. The patient should consult his or her physician regarding the appropriate time to resume such activities.

Use in Specific Populations

  • Pregnancy: The safety and effectiveness of Synvisc-One (hylan g-f 20 single intra-articular injection) have not been established in pregnant women.
  • Nursing mothers: It is not known if Synvisc-One (hylan g-f 20 single intra-articular injection) is excreted in human milk. The safety and effectiveness of Synvisc-One (hylan g-f 20 single intra-articular injection) have not been established in lactating women.
  • Pediatrics: The safety and effectiveness of Synvisc-One (hylan g-f 20 single intra-articular injection) have not been established in pediatric patients. Pediatric patients are defined as patients ≤ 21 years of age.

Last reviewed on RxList: 7/29/2010
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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