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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B) and PREA(P):
B,P
Sponsor:
Helsinn Healthcare SA
NNPS:
FALSE'
Therapeutic Category:
Antiemetic
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