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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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