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File: 120396_sep96_decls5_0001.txt
Page: 0001
Total Pages: 8

Subject: INFORMATION BROCHURE PENTAVALENT ABCDE BOTULINUM TOXOID         

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003203

Folder Title: INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID                                             

Document Number:          1

Folder SEQ  #:         40



          09/ 07/90                  1 663 2982             H                  --- OTSG                 1@002,'008
                       15:37    IM30
                                                             q U


        SENT 5Y:COC COM, CENTER             S- 5-50     8:01     ATLANTA  GEORGIA USA@              3016632304;.-



                                                  Informational Brochure
                                        P*Atavalent (ABCDE) lotulinum              Tozoid



                                   on of aluminum phosphate-aid@sioirnbuemd                 d derived from
                    Z@aval:2t (ABCDE) B-Qtulinum tox-,.               43           Ph
                    a       in ti                                                    t=ate Jkdsorbod is
                    fD=Zlin-iZ2et      ivated, partially purified types a#S#C* I)i and R
                    botulinum toxins.             Each vial contains 0.022% formaldehyde and
                    1:10,000 tl%iineronal as a preservative. The currently distributexl-
                    toxcid is m=ufacturod by the Michigan Department of Public Health..



                    Administration and Dosage
                    SUM WELL' before withdrawing each does.                               Do not itject
                    intracutenecusly or into superficial structures. A 48 hour post
                    vaccine arm examination in required following each inoculation.
                    The first injection is represented by week 0. Thar* is a 2 week
                    interval between the first and second injection and a 12 week
                    interval between the first and third injection.


                           Initial Viocinatign Seriesl - 0 .5 ml. deep subcutaneo9x44@. ik-_
                                                                    2-12 weeks.
                           Firgt Dogatert 0.5 ml. dM xubeutansously 3.2 months after
he initial series.
                           Subs@jit I$ocgters., .0.5 ml. @ subcutaneously at 2 Yeag
                                                          int*rvals, based on antitoxin titers.
                           Bubasament boosters Are not to-@ administered until after
                    &er= step                * checked for antitoxin levels by M.
                                  imans ar


                    antitoxin levels against the toxin typo 3 and/or E is evaluated at
                    CDC.     A report is -sent to the clinical investigator indicating
                    whether or not a booster is needed.                     if the in=ity.l*vel is
                    adequate (ser= titers of 1:16 or 0.15 - 0.30 iu antitoxin per
                    ml.) p the booster should not be considered for another two years at
                    which time the i==ity level should be reassessed.

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Document 8 f:/Week-36/BX003203/INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID/information brochure pentavalent abcde botulinum:1108961508426
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID
Folder Seq # = 40
Subject = INFORMATION BROCHURE PENTAVALENT ABCDE BOTULINUM
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 08-NOV-1996