• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
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
Sponsor:  Merck
Pediatric Exclusivity Granted Date:  02/11/2005
Therapeutic Category:  Antibiotic