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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:
12/20/2013
Trade Name:
Isentress
Generic Name or Proper Name (*):
raltegravir
Indications Studied:
HIV-1 infection
Label Changes Summary:
Packet for oral suspension: Approved for use in infants 4 weeks and older, weighing at least 3 kg to < 20 kg. Chewable tablet previously approved down to 2 yearsSafety and dosing information have not been established in infants less than 4 weeks Adverse reactions similar to those observed in adultsInformation on dosing,clinical trial and PK parametersInformation on preparation of a suspensionNew dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Merck Sharp & Dohme Corp.
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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