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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:
05/18/2005
Trade Name:
Invanz
Generic Name or Proper Name (*):
ertapenem
Indications Studied:
Complicated Intra-abdominal Infections; Complicated Skin and Skin Structure Infections; Community Acquired Pneumonia; Complicated Urinary Tract Infections; Acute Pelvic Infections
Label Changes Summary:
Approved for use down to 3 months of age. Efficacy extrapolated from studies in adults and supported by PK and safety studies in pediatric patients Not recommended in infants under 3 months of age as no data are available Not recommended in the treatment of meningitis in the pediatric population due to lack of sufficient CSF penetration Information on dose, PK parameters, AE profile and clinical studies
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Merck
Pediatric Exclusivity Granted Date:
02/11/2005
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
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