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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:  06/21/2013
 
Trade Name:  Mycamine
 
Generic Name or Proper Name (*):  micafungin sodium
 
Indications Studied:  Treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses; treatment of patients with esophageal candidiasis; prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients 4 months and older have been demonstrated based on the evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data*Safety and effectiveness in pediatric patients < 4 months have not been established*In all pediatric studies with Mycamine, 439/479 (92%) patients experienced at least one treatment-emergent adverse reaction. Gastrointestinal symptoms including vomiting, diarrhea, nausea, abdominal pain, and abdominal distension occurred in 285 pediatric patients (60%)*Information on population PK, dosing, adverse reactions, and clinical trials *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Astellas
 
Therapeutic Category:  Antiviral
 
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