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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:  12/11/2008
 
Trade Name:  PegIntron
 
Generic Name or Proper Name (*):  Peginterferon alfa-2b
 
Indications Studied:  Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha
 
Label Changes Summary:  * Safety and efficacy established in pediatric patients 317 years of age * Safety and effectiveness in patients < 3 years have not been established. * Dosing for pediatric patients is determined by body surface area for peginterferon alfa-2b and by body weight for ritonavir * An open-label study in patients 3 - 17 years showed weight and height gain of pediatric patients treated with combination therapy lags behind that predicted by population data while on treatment. * Adverse events similar to those observed in adults. Most common pediatric adverse events were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, vomiting * Information on PK parameters, and clinical study * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Schering
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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