MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT

File: 970107_sep96_decls14_0001.txt
Page: 0001
Total Pages: 11

Subject: MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT     

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: MEDICAL PRODUCTS UNDER FDA REGULATIONS                                                          

Document Number:     930001

Folder Seq  #:     930000









                                                         3 October 1990

                   MEDICAL PRODUCTS UNDER FDA REGUIATIONS
          WHICH ARE REQUIRED OR ARE UNDER CONSIDERATION FOR DEPLOYMENT
                    IN SUPPORT OF OPERATION DESERT SHIELD



         DRUG PRODUCTS:



         1. Diazepam Autoinjector

             a. IND # 33,358, sponsored by the US Army Office of the
         Surgeon General.

             h. Manufacturer: Duphar BV, Amsterdam.

             C. IND listed Indication: Prevention of Nerve Agent induced
         convulsions. This is the intended indication for use in
         Operation Desert Shield.

             d. Operation Desert Shield status: required immediately.

             e. Consequences of not deploying diazepam autoinjectors to
         operation Desert Shield: Moderate to severe chemical warfare
         nerve agent casualties are predicted to suffer convulsions and
         brain injury not prevented by the current nerve agent
         pretreatment and treatment regimen. Data support the use of
         diazepam autoinjectors, as an adjunct to the current regimen, to
         reduce the incidence and severity of nerve agent induced
         convulsions and brain injury.

             f. Informed consent status: Informed consent will not be
         feasible.

             g. Scheduled Availability: Available to field 26 September
         1990. On schedule.

             h. Point of contact: Lt Col Lehmann, 301-663-2051.

Document 11 f:/Week-36/BX003201/MEDICAL PRODUCTS UNDER FDA REGULATIONS/medical prod under fda reg required consider for:01029715471415
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = MEDICAL PRODUCTS UNDER FDA REGULATIONS
Folder Seq # = 930000
Subject = MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR
Document Seq # = 930001
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 = 02-JAN-1997