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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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