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Important safety information -- Revised directions for using Rabies Immune Globulin (Human), HyperRAB ™ S/D in fixed needle 2 mL prefilled syringe
  • Published Date:
    2/26/08
  • Source:
    HAN ; 270
  • Language:
    English
Filetype[PDF - 22.47 KB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.)
  • Series:
  • Description:
    Tuesday, February 26, 2008, 20:15 EST (8:15 PM EST)

    CDCHAN-00270-2008-02-26-ADV-N

    The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have been notified by Talecris Biotherapeutics, Inc. that its Rabies Immune Globulin (Human), HyperRAB™ S/D in fixed needle 2 mL pre-filled syringe does not address all dosing situations. Specifically, the fixed needle (22 gauge, 1.25 inch) and the absence of graduations on the 2 mL pre-filled syringe do not permit administration of the recommended dose of Rabies Immune Globulin (Human), HyperRAB™ S/D in one or more of the following situations:

    • A dose < 2 mL is required (e.g. for pediatric use);

    • A dose < 2 mL must be injected over multiple sites; or

    • An alternate needle (different length or gauge) is required based on the patient (adult or child), wound or site of injection.

    Healthcare providers may continue to administer HyperRAB S/D supplied in the 2 mL pre-filled syringe by following the "Revised Directions for Use" that are packaged with these lots. The full "Revised Directions for Use" of these lots is available on-line: http://www.talecris.com/us/documents/FINAL_FDA_Approved_Revised_ Directions_for_Syringe_Use 21-FEB-08.pdf . Talecris has discontinued manufacturing the HyperRAB™S/D fixed needle, 2 mL pre-filled syringe.

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