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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  07/27/2006
 
Trade Name:  Sodium Chloride Injection
 
Generic Name or Proper Name (*):  sodium chloride
 
Indications Studied:  Use in flushing compatible contrast agents through IV administration sets into indwelling intravascular access devices
 
Label Changes Summary:  Safety of manual injection in pediatric patients is supported by reported clinical experience with IV infusion and flush safety and effectiveness of Sodium Chloride Injection, USP 0.9% administered by power injection in pediatric patients have not been established Administration to pediatric patients by power injection is not recommended To minimize the risk of fluid overload, the smallest dose necessary for manually flushing contrast agent through the vascular access line should be used Manual injection to pediatric patients should take into account the patient's weight, fluid status, and concomitant medical conditions to determine if use is appropriate New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Tyco Healthcare
 
NNPS:  FALSE'
 
Therapeutic Category:  Hematology/Coagulation
 
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