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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:  05/27/2014
 
Trade Name:  Aloxi
 
Generic Name or Proper Name (*):  palonosetron hydrochloride
 
Indications Studied:  Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) and postoperative nausea and vomiting (PONV)
 
Label Changes Summary:  Chemotherapy-Induced Nausea and Vomiting Approved for prevention of acute CINV in 1 month - < 17 yearsSafety and effectiveness in neonates less than 1 month of age have not been establishedPediatric patients require a higher palonosetron dose than adults (20 mcg/kg with max of 1.5 mg x 1 vs 0.25 mg x 1 Adverse reactions were similar to those observed in adults Information on dosing, PK parameters, clinical trial, adverse reactions Postoperative Nausea and Vomiting Studies Safety and efficacy have not been established in pediatric patients for PONV Adverse reactions were similar to those observed in adultsInformation on dosing, clinical trials
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Helsinn Healthcare SA
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiemetic
 
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