Tuesday, February 26, 2008, 20:15 EST (8:15 PM EST)
CDCHAN-00270-2008-02-26-ADV-N
Important Safety Information -- Revised Directions for Using Rabies Immune Globulin (Human), HyperRAB ™ S/D in Fixed Needle 2 mL Pre-filled Syringe
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.
Three lots of HyperRAB S/D have been manufactured with the 2 mL pre-filled syringe configuration (see Table below):
|
Lot Number |
Expiration Date |
Size/Container |
NDC Number |
|
26N87R1 |
Jan-26-2009 |
2 mL pre-filled syringe |
13533-618-03 |
|
26N88K1 |
Jan-26-2009 |
2 mL pre-filled syringe |
13533-618-03 |
|
26N9HP1 |
Feb-18-2010 |
2 mL pre-filled syringe |
13533-618-03 |
Healthcare providers may continue to administer HyperRAB
Directions_for_Syringe_Use__21-FEB-08.pdf
. Talecris has discontinued
manufacturing the HyperRAB S/D fixed needle, 2 mL pre-filled syringe.
For additional information regarding this product, please contact Talecris on-line at www.talecris.com, or call 919-412-1030, or toll free at 1-800-520-2807.
Human rabies PEP (post-exposure prophylaxis) is recommended when potentially infectious material (e.g. saliva) from a rabid animal is introduced via a bite, or comes into direct contact with broken skin or mucous membranes. More detailed information regarding evaluation for and administration of PEP is available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00056176.htm.
For more information about rabies and its prevention, contact your state or local public health official or CDC at 1-800-CDC-INFO or visit www.cdc.gov/rabies.
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