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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:
06/20/2008
Trade Name:
Kaletra
Generic Name or Proper Name (*):
lopinavir/ ritonavir
Indications Studied:
Use in combination with other antiretroviral agents for HIV-1 infection
Label Changes Summary:
Extended indication from 6 months 12 years to 14 days 18 years The safety, efficacy, and pharmacokinetic profiles in pediatric patients < 14 days have not been established Dose should be calculated based on body weight or body surface area not to exceed adult dose Because no data exists for dosage when administered with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir, it is recommended that lopinavir/ ritonavir not be administered in combination with these drugs in patients < 6 months of age Infants <6 months of age generally had lower lopinavir AUC12 than children 6 months 12 years of age Information on dose, PK parameters, clinical studies, and AEs
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Abbott
Pediatric Exclusivity Granted Date:
03/07/2008
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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