INFORMATION BROCHURE PENTAVALENT ABCDE BOTULINUM TOXOID

File: 120396_sep96_decls5_0002.txt
Page: 0002
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





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     SENT BY'COC COM. CENTER    9- 6-90  5:01   ATLANTA GAOR@-IA US,-     30156323cll;z i





                                           PRECAUTIQHR


               I    Satulin= toxvid is not      a licensed   product and must bg
               distributed as an Investigational New Drug (IND) in accordance with
               requirements of the v. S. rood and Drug Administration (FDA). it
               must be administered by or under the supervision of the physician
               who request*d the tozoid. The physician must be enrolled as a    ce-
               investigator by completing Po= FD-1572, 'Statement of
               Investigatorn. The completed form should be returned to the      CDC
               Drug Service (DO9). Atlanta, Ga. 30333.

               2. . The tozoid should bo administered only to healthy men       and
               women, between the ages of 18 to 63 years, since investigations so
               far have been conducted exclusively in that population.          The
               effects of administration of the texcid during pregnancy have not
               been studied.   The tomoid should be given only, to individuals
               working in high risk research laboratories that are actively
               working or expect to be working with known cultures and purified
               botulinium toxins.  No one should. be administered a second or
               subsequent booat*r immunization =less laboratory tests have shown
               antitoxin type 8 and/or 'M to be below satisfactory level.
               3.   lich recipient must sign a consent form, CDC 38.43. One copy
               is given to the recipient- one copy is maintained by the clinical
               investigator; and the third copy is returned to the CDC Drug
               service.

               4.   Pom CDC 519.7, "Response to Investigational New Drug"# taust
recipient and returned to the CDC Drug
                    service.























                                               2

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