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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:
05/12/2005
Trade Name:
Zyvox
Generic Name or Proper Name (*):
linezolid
Indications Studied:
Central nervous system infections
Label Changes Summary:
PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Pfizer
Pediatric Exclusivity Granted Date:
02/11/2005
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
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