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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:
12/21/2011
Trade Name:
Isentress
Generic Name or Proper Name (*):
raltegravir
Indications Studied:
In combination with other antiretroviral agents for the treatment of HIV-1 infection
Label Changes Summary:
Isentress Chewable tablets: Expanded indication from adults to pediatric patients 2 - < 12 years and weighing at least 10kg Isentress Tablets: Expanded indication from adults to pediatric patients 6-18 years Safety and effectiveness in patients <2 years have not been establishedBecause the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet Safety profile similar to that observed in adults Information on dosing, adverse reactions, clinical trial and PK parameters New dosage form
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Merck
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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