Important safety information -- Revised directions for using Rabies Immune Globulin (Human), HyperRAB ™ S/D in fixed needle 2 mL prefilled syringe

Details

• Alternative Title:
  Revised directions for using Rabies Immune Globulin (Human), HyperRAB ™ S/D in fixed needle 2 mL prefilled syringe
• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.)
• 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.
  
  
• Subjects:
  Immunoglobulins, Intravenous Injections, Intramuscular Rabies/prevention & Control Rabies Vaccines/administration & Dosage
• Source:
  HAN ; 270
• Series:
  Health Alert Network
• Document Type:
  HAN Health Advisory
• Pages in Document:
  2 unnumbered pages
• Issue:
  270
• Collection(s):
  Health Alert Network (HAN)
• Main Document Checksum:
  urn:sha-512:13fd4992f9db7d2f8e04605476760c807ac4dcec6b75afe95182756f07e551c9102fa3a385a80dfca9e3728d37dd41fc048f41f7d3fd5c636c4f684380aca7bc
• Download URL:
  https://stacks.cdc.gov/view/cdc/25181/cdc_25181_DS1.pdf
• File Type:
  [PDF - 22.47 KB ]