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File: 061796_DOC_125_Investigational_New_Drug_Availability_03.txt
Page: 03
Total Pages: 2

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ROUTINE               I     U N C L ~ S S      F I E D      I   TC)D =
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R~~UZYUw RHIP~~~243~ O()71701 -LJUUU--RHIUP~4 RUDCH~~ Rt.JDOH~~ RUE~DWD
RUEKJCS RUEORDE -
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R fl.71322~ J~N 91
FM USCINCCENT/ /CCSG~ /
TO RLIDCH~~~COMUSARrENT M4iN//~C1//
RUDDHS~~COMtJSN~YLO~75UPFOR/ /N9/ f
RH I LjF~~~USCENT~F FWD HO.~ ELEMENT / /56/ /
INFO RUF.KJCS/~JCS W~SHINGTON nr//J4-t.Rr//
RUE~Dwr)/H~ ~ W~SHINGTON ii://ms6-r..~x//
RUEORDE/C:DR US~MRDC FT flETRICK MD//
BT
UNCL~S
OPER/DESERT SHIEL~D//
MS(3ID/SYS. RRM/USCENTCOM CCSO//
4MPN/SUF3JECT   I NYEST I 64T tON~L' NEW DRUG ~Y~ ~ L.~E3 IL rTY//
RMKS/1.   TWO INVESTIG~TION~L NEW DRlJGS    IND) SPONSOREr) By THE US
~RMY MEDIC~L RESE~RCH ~Nfl DEVEL.OPMENT COMM~ND (US~MRri:.) ~RE
~V~IL~BLE FOR SPECIFIC ~ND LIMITED INflIC~TIONS.     THESE TWO
DRUGS ~RE CENTOXIN (~LSO KNOWN ~S H~-1~ OR J9 ~NTIBODY) ~ND
RIB~VIRIN.   THREE PROTOCOLS H~VE BEEN ~PPROVEfl FOR THE
EMERGENCY USE OF THESE DRUGS IN THE DESERT SHIEt~D ~RE~ OF
RESPONSIBILITY  (~OR) BY THE lJS~MRfl(:. THE FOOD ~ND DRUG
~DMINISTR~TION (F~).   4Nfl THE M~NUF~CTtiFING COMP~NIES.
2.   CENTOXIN:  THIS INTR~VENOtJSLY ~I3r\INiSTERED DRUG IS ~ HUM~N
tOM ~NTIBODY R~ISEfl ~G~INST ~ MUT~NT E COLI STR~IN (J~) WHOSE
EXPOSED LIPOPOLYS~CC~RIDE (LPS OR ENDOTOXIN) CONT~INS ~ COMMON


P~GE O2 RHIP~~~\\\\ UNCLAS
OR~M NEO~TIYE ENDOTOXIN ~NTIOEN.   THE PROIJUCT H~S BEEN
PRODUCED IN INDtiSTRI~L ~LJ~NTiTTES FROM ~ MURINE/HUM~N
HYBRIDOM~ LINE ~ND IS VERY EXPENSIVE ($~5C?O PER VI~L).
INDIC~TION FOR USE IS THE GR~M NEG~TIVE SEPTIC SHOCK SVNflPOMF
STRICT ~DHERENCE TO THE PROTOCOL IS RE~lIRED.
a.   RIB~VIRIN.  RIB~YIRIN IS ~ SYNTHETIC NUCLEOSIDE TH~T IN
E~Rt~Y STUDIES H~S SHOWN EFFIC~CY ~G~INS~ BUNY~VIRUS
HEMflRRH~OIC FEVERS (CRIME~N CONGO HEMORFIH~GIC FEVER.   RIFT
Y~LLEY FEVER. ~ND HF.MORRH~GIC FEVER WITh REN~L SYNDROME).
CCHF IS KNOWN TO EXIST IN THE THE~TER OF OPER~TIONS WITH ~N
OUTBRE~K iN THE eC)'S IN BAGHD~~D, ~ C~SE IN It~~T~R IN THE 8()'S.
~ND SEVER~L C~5ES ON THE WEST CO~ST OF S~iDI ~R~BI~ IN t99O.
~ HOSPIT~ BASED SEROSURYEY IN KUW~IT FROM 1~7q. TO 19S2 SHOWED
4% TO BE POSITIVE FOR CCHF. TWO PROTOCOLS H~VE ElEEN ~PPROVED
FOR THIS ENTITY.   THE FIRST IS FOR INTR4VENOtJS THER~PY OF
OVERT, CLINIC~L r~SES OF HEMORRH~Gir FEVER.      THE SECOND IS FOR
OR~L  (~ND IN SOME INST~NCES INTR~VENOUS) PROPHY~~XIS OF HE~LTH
C~RE WORKERS EXPOSED TO ~N OVERT C~SE OF HEMORRH4OIC FEVER
MOST OUT8RE~S INCLUDE NOSOCOMI~L TR~NSMISSION FROM THE INDEX
C~SE TO HE4LTH C~RE PROVIDERS WITH ~ 9OY4 F~r~~ITY R~~E (R~NG~

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ROUTINE                        N C L ~ S .9 1 F I E 0       I


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