Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  10/05/2010
 
Trade Name:  Aridol Powder for Inhalation
 
Generic Name or Proper Name (*):  mannitol
 
Indications Studied:  Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma
 
Label Changes Summary:  New indication in patients 6 years and olderEfficacy assessed in a total of 246 children and adolescents 6 to 17 years in 2 clinical trialsBronchial challenge testing should not be performed in children < 6 years due to their inability to provide reliable spirometric measurements Adverse events similar to adultsInformation on adverse events and clinical studiesNew indication, dosage form, and route of administration
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Pharmaxis
 
NNPS:  FALSE'
 
Therapeutic Category:  Diagnostic aid
 
-
-