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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:  05/18/2005
 
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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  02/11/2005
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic
 
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