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Important Drug Information Notice Regarding Sodium Thiosulfate Injection, USP, 10% (100mg/mL), 10mL Single Dose Vials and 25% (250mg/mL), 50mL Single Dose Vials
Date:3/29/2011

he contents. DO NOT USE IF PARTICULATES ARE PRESENT.  USE A NEW VIAL.
  • Use a 5 micron filter needle to withdraw the required calculated volume of Sodium Thiosulfate Injection, USP.
  • Remove the filter needle and attach a standard needle to the syringe before adding to a larger volume of IV fluid and/or prior to patient administration.
  • Visually inspect the final IV admixture solution.  DO NOT USE IF PARTICULATES ARE VISIBLE.  USE A NEW VIAL.
  • Use a 0.22 micron in-line filter when administering the final IV admixture to patients.

  • If particulates are observed, or if you require additional information, please call American Regent at 1-877-788-3232 then press 2 for the Professional Services Department (Monday - Friday:  9:00am-5:00pm ET) or by e-mail at inquiry@americanregent.com

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm  

  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm . Mail to address on the pre-addressed form.

  • Fax: 1-800-FDA-0178

  • This letter is being distributed with the knowledge of the U.S. Food & Drug Administration.

    We apologize for any inconvenience that you may experience and appreciate your cooperation in this matter.

    Sincerely yours,

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    SOURCE American Regent, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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