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File: 120396_sep96_decls46_0004.txt
Page: 0004
Total Pages: 8

Subject: INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID             

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003204

Folder Title: INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID                                                   

Document Number:          1

Folder SEQ  #:         19





        09/07/90 15:38   '&301 663 2982         HQ USAURDC     44. OTSG            Z 004/008


     SENT BY:CDC COM. CENTER     t 9- B-90  8:02    ATLANTA GEORGIA USA@       3016632304;; 5





                                                ITEACTIQNSI


               Bince 1910& almost 10,000 Injections of the tozoid have been
               administered to recipients who were subsequently obiorved for
               adverse reactions-. The rate of moderate and severe local reactions
               was S.8% for the initial series of shots and 10.7% for booster
               shots (Table I)..      ZZL, additions. there was a low incidence of
               systemic reactions (3.0%) for both the initial sari" and the
               booster shots.        The systemic reaction were generally mild.-
               consisting of fever, tiredness, hoadachs, and musels p@ (Table
               11).     Systemic reactions were often concurrent with local
               reactions.

               Moderate or severe systemic reactions and severe local reactions
               are not anticipated and should be reported by telephone to the CvC
               Drug Service,

               Steause- of the documented increase in reactions, now lots of tozoid
               wore manufactured in 1971i but distribution of the original lot was
               continued until 1%81. A recent report on a very limited study an
               the reactogouicity of the now lots of- tozoid indicated that they
               are -probably no less reactagenic than the previous lot (1).

               Noting the higher incidence of I coal reactions f ol I owing aubsequ*At
               yearly boostex-s. than following Initial- series shotsi it was deemed
               advisable to evaluate -the need for boosters by..-@-orminiAv--
               antitoxin levels @ to boost only when necessary. This approach
               revealed that boosters       subsequent to the first one are not
at 2 year intervals and that many
               of these boosters can be avoided. Prior to 1974, yearly boosters
               were routinely given.
               Moderate local roactioni     include orythma, edema and induration.
               Al I such reactions reach a peak in 24 -hours, then gradual I y subside
               and should be gone at 48    or at the most 72 hours. when a moderate
               local reaction occurs,, reduction of the done of each aubsoquent
               injections to 0.23 ml has been shown to alleviate the reaction
               without impairing the antitoxin response.

               Rarelyp an individual may have a reactiot, characterized by a deep,
               painlons, noninfl@tory subcutaneous induration that may persist
               f or 3 to 4 weeks.        These rarsly measure more than 2 to 3
               centimeters in diameter and *re absorbed without residue.

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Document 8 f:/Week-36/BX003204/INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID/informational brochure pentavalent botulinum tox:1122961634164
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003204
Unit = OTSG
Parent Organization = HSC
Folder Title = INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID
Folder Seq # = 19
Subject = INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOX
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 = 22-NOV-1996