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U.S. Department of Health and Human Services

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  Opens a new window
 
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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