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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:
12/19/2014
Trade Name:
Merrem I.V.
Generic Name or Proper Name (*):
meropenem
Indications Studied:
Complicated intra-abdominal infections
Label Changes Summary:
*Indication extended to pediatric patients less than 3 months of age with intra-abdominal infections *Efficacy for cIAI upported by evidence from adequate and well-controlled studies in adults with additional data from a pediatric PK and safety study *A PK study was conducted in pediatric patients less than 3 months of age, including preterm infants. *Dosing for patients with normal renal function in this age group is based on gestational age and postnatal age. *Off-patent Written Request.
Product Labeling:
[INVALID]
BPCA(B) and PREA(P):
B
Sponsor:
AstraZeneca
Therapeutic Category:
Antibiotic
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