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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:
06/21/2013
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 dataSafety and effectiveness in pediatric patients < 4 months have not been establishedIn 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
BPCA(B) and PREA(P):
B,P
Sponsor:
Astellas
Therapeutic Category:
Antiviral
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