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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:
03/26/2012
Trade Name:
Intelence
Generic Name or Proper Name (*):
etravirine
Indications Studied:
Treatment of HIV-1 infection in treatment-experienced patients in combination with other antiretroviral agents
Label Changes Summary:
Expanded the indication from adults to pediatric patients 6 years and older Safety and efficacy have not been established in children < 6 years or in treatment naive adult or pediatric patients Adverse reactions were similar to those observed in adults except for rash which was observed more frequently in pediatric patients (15%) compared to adults (10%)Intelence tablet(s) should be swallowed whole. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water Information on dosing in pediatric patients 6 - <18 years and weighing at least 16 kg, dispersing tablet in water, adverse reactions, and clinical trial Postmarketing study
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B,P
Sponsor:
J&J
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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