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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:  06/15/2017
 
Trade Name:  Calcium Gluconate
 
Generic Name or Proper Name (*):  calcium gluconate
 
Indications Studied:  Treatment of acute symptomatic hypocalcemia
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. *Pediatric approval is not based on adequate and well-controlled clinical studies. Safety and dosing recommendations in pediatric patients are based on published literature and clinical experience. *Concomitant use of ceftriaxone and calcium gluconate Injection is contraindicated in neonates (28 days or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. In patients older than 28 days, ceftriaxone and calcium gluconate Injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. *This product contains up to 400 mcg/L aluminum which may be toxic, particularly for premature neonates due to immature renal function. Parenteral administration of aluminum greater than 4 to 5 mcg/kg/day is associated with central nervous system and bone toxicity. *New drug.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Fresenius Kabi USA, LLC
 
NNPS:  FALSE
 
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