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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:
09/27/2016
Trade Name:
Avelox
Generic Name or Proper Name (*):
moxifloxacin hydrochloride
Indications Studied:
Complicated intra-abdominal infections (cIAI)
Label Changes Summary:
*Safety and efficacy in pediatric patients for tbe treatment of clAl has not been demonstrated. *Pediatric patients 3 months to <18 years of age (N=451) were enrolled in a single randomized, double blind, active controlled trial in clAl including appendicitis with perforation, abscesses and peritonitis. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, clinical trial.
BPCA(B) and PREA(P):
B,P
Sponsor:
Bayer
NNPS:
FALSE
Therapeutic Category:
Antibiotic
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