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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:
09/17/2015
Trade Name:
Epzicom
Generic Name or Proper Name (*):
abacavir sulfate and lamivudine
Indications Studied:
Once-daily dosing for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg
Label Changes Summary:
*Expanded indication from adults to pediatric patients weighing at least 25kg. *Dosing recommendations in this population are based on the safety and efficacy established in a controlled trial conducted using either the combination of Epivir and Ziagen or Epzicom. *In pediatric patients weighing less than 25 kg, use of abacavir and lamivudine as single products is recommended. *The adverse reactions in pediatric patients are similar to those observed in adults. *Information on dosing, PK, clinical studies.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
ViiV Healthcare
Therapeutic Category:
Antiviral
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