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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:
07/14/2000
Trade Name:
Malarone
Generic Name or Proper Name (*):
atovaquone/ proguanil
Indications Studied:
Treatment of malaria
Label Changes Summary:
Safety and efficacy for treatment of malaria established down to5 kg. Attributable AE occurring in e 5% of the pediatric patients (5-< 11 kg) was diarrhea (6%) Malarone tablets may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing. The apparent clearance (CL/F) of both atovaquone and proguanil are related to body weight
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Glaxo Wellcome
Pediatric Exclusivity Granted Date:
08/06/2003
NNPS:
FALSE'
Therapeutic Category:
Antimalarial
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