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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:
10/06/2016
Trade Name:
Pertzye
Generic Name or Proper Name (*):
pancrelipase
Indications Studied:
Postmarketing study
Label Changes Summary:
* Labeling updated to include new dosage strength of 4,000 USP lipase units. * Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or breastfeeding. Do not mix Pertzye capsule contents directly into formula or breast milk prior to administration. * New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Digestive Care, Inc.
NNPS:
FALSE
Therapeutic Category:
Pancreatic enzyme
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