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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/27/2007
 
Trade Name:  Voluven
 
Generic or Proper Name (*):  6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection*
 
Indications Studied:  Plasma volume substitute for treatment and prophylaxis of hypovolemia
 
Therapeutic Category:  Coagulant
 
Ages Studied:  newborns to infants < 2 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind
 
No Patients:  41
 
No Centers:  6
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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